Testen van de combinatie van pevonedistat met chemotherapie voor galwegkanker van de lever
23 oktober 2026 bijgewerkt door: National Cancer Institute (NCI)
Een fase 2-studie van pevonedistat in combinatie met carboplatine en paclitaxel bij gevorderd intrahepatisch cholangiocarcinoom
This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help the study doctors find out how well pevonedistat shrinks bile duct cancer of the liver when given alone and when in combination with paclitaxel and carboplatin.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
- Stadium III Intrahepatisch Cholangiocarcinoom AJCC v8
- Stadium IIIA intrahepatisch cholangiocarcinoom AJCC v8
- Stadium IIIB Intrahepatisch Cholangiocarcinoom AJCC v8
- Inoperabel hepatocellulair carcinoom
- Gemetastaseerd cholangiocarcinoom
- Stadium III hepatocellulair carcinoom AJCC v8
- Stadium IIIA Hepatocellulair carcinoom AJCC v8
- Stadium IV hepatocellulair carcinoom AJCC v8
- Stadium IVA Hepatocellulair carcinoom AJCC v8
- Stadium IVB Hepatocellulair carcinoom AJCC v8
- Stadium IV Intrahepatisch Cholangiocarcinoom AJCC v8
- Inoperabel cholangiocarcinoom
- Stadium IIIB Hepatocellulair carcinoom AJCC v8
- Gemetastaseerd hepatocellulair carcinoom
- Inoperabel intrahepatisch cholangiocarcinoom
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVE:
I. To determine the objective response rate of pevonedistat as a single agent and in combination with carboplatin and paclitaxel in patients with unresectable intrahepatic cholangiocarcinoma.
SECONDARY OBJECTIVES:
I. To evaluate the safety profile of pevonedistat alone and in combination with carboplatin and paclitaxel in patients with intrahepatic cholangiocarcinoma.
II. To determine the clinical benefit rate of patients with advanced intrahepatic cholangiocarcinoma (ICC) treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.
III. To determine progression-free survival of patients treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.
IV. To determine overall survival of patients treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.
EXPLORATORY OBJECTIVES:
I. To determine whether overexpression of NEDD8, NAE1, and UBC12 predict response to treatment.
II. To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway.
III. To bank specimens for further future investigations.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive pevonedistat intravenously (IV) over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
After completion of study treatment, patients are followed up at 30 days after last dose of study treatment, then every 3 months for the first year and every 6 months for years 2-3.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Alaska
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Anchorage, Alaska, Verenigde Staten, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Verenigde Staten, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Verenigde Staten, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Verenigde Staten, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Verenigde Staten, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Verenigde Staten, 99504
- Anchorage Radiation Therapy Center
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Arizona
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Kingman, Arizona, Verenigde Staten, 86401
- Kingman Regional Medical Center
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Phoenix, Arizona, Verenigde Staten, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Hot Springs, Arkansas, Verenigde Staten, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Verenigde Staten, 93420
- PCR Oncology
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Arroyo Grande, California, Verenigde Staten, 93420
- Mission Hope Medical Oncology - Arroyo Grande
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Auburn, California, Verenigde Staten, 95602
- Sutter Auburn Faith Hospital
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Auburn, California, Verenigde Staten, 95603
- Sutter Cancer Centers Radiation Oncology Services-Auburn
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Berkeley, California, Verenigde Staten, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burbank, California, Verenigde Staten, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Cameron Park, California, Verenigde Staten, 95682
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
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Castro Valley, California, Verenigde Staten, 94546
- Eden Hospital Medical Center
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Davis, California, Verenigde Staten, 95616
- Sutter Davis Hospital
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Duarte, California, Verenigde Staten, 91010
- City of Hope Comprehensive Cancer Center
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Fremont, California, Verenigde Staten, 94538
- Palo Alto Medical Foundation-Fremont
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Modesto, California, Verenigde Staten, 95355
- Memorial Medical Center
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Mountain View, California, Verenigde Staten, 94040
- Palo Alto Medical Foundation-Camino Division
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Mountain View, California, Verenigde Staten, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
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Palo Alto, California, Verenigde Staten, 94301
- Palo Alto Medical Foundation Health Care
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Roseville, California, Verenigde Staten, 95661
- Sutter Cancer Centers Radiation Oncology Services-Roseville
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Roseville, California, Verenigde Staten, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Verenigde Staten, 95816
- Sutter Medical Center Sacramento
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San Francisco, California, Verenigde Staten, 94115
- California Pacific Medical Center-Pacific Campus
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San Mateo, California, Verenigde Staten, 94401
- Mills Health Center
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Santa Cruz, California, Verenigde Staten, 95065
- Palo Alto Medical Foundation-Santa Cruz
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Santa Maria, California, Verenigde Staten, 93444
- Mission Hope Medical Oncology - Santa Maria
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Santa Rosa, California, Verenigde Staten, 95403
- Sutter Pacific Medical Foundation
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Sunnyvale, California, Verenigde Staten, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Vallejo, California, Verenigde Staten, 94589
- Sutter Solano Medical Center/Cancer Center
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Verenigde Staten, 80909
- UCHealth Memorial Hospital Central
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Colorado Springs, Colorado, Verenigde Staten, 80907
- Rocky Mountain Cancer Centers-Penrose
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Colorado Springs, Colorado, Verenigde Staten, 80920
- Memorial Hospital North
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Denver, Colorado, Verenigde Staten, 80210
- AdventHealth Porter
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Durango, Colorado, Verenigde Staten, 81301
- Mercy Medical Center
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Durango, Colorado, Verenigde Staten, 81301
- CommonSpirit Cancer Center Mercy
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Fort Collins, Colorado, Verenigde Staten, 80524
- Poudre Valley Hospital
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Fort Collins, Colorado, Verenigde Staten, 80528
- Cancer Care and Hematology-Fort Collins
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Greeley, Colorado, Verenigde Staten, 80631
- UCHealth Greeley Hospital
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Lakewood, Colorado, Verenigde Staten, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Verenigde Staten, 80122
- AdventHealth Littleton
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Longmont, Colorado, Verenigde Staten, 80501
- Longmont United Hospital
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Longmont, Colorado, Verenigde Staten, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, Verenigde Staten, 80538
- Medical Center of the Rockies
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Parker, Colorado, Verenigde Staten, 80138
- AdventHealth Parker
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Pueblo, Colorado, Verenigde Staten, 81004
- Saint Mary Corwin Medical Center
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Florida
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Coral Gables, Florida, Verenigde Staten, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach, Florida, Verenigde Staten, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Fort Lauderdale, Florida, Verenigde Staten, 33308
- Holy Cross Hospital
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Miami, Florida, Verenigde Staten, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Verenigde Staten, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Verenigde Staten, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Verenigde Staten, 96817
- The Cancer Center of Hawaii-Liliha
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Honolulu, Hawaii, Verenigde Staten, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, Verenigde Staten, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, Verenigde Staten, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Verenigde Staten, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Verenigde Staten, 96817
- Hawaii Cancer Care Inc-Liliha
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Honolulu, Hawaii, Verenigde Staten, 96817
- Kuakini Medical Center
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Honolulu, Hawaii, Verenigde Staten, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, Verenigde Staten, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Verenigde Staten, 96813
- Island Urology
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Lihue, Hawaii, Verenigde Staten, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
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‘Aiea, Hawaii, Verenigde Staten, 96701
- Hawaii Cancer Care - Westridge
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‘Aiea, Hawaii, Verenigde Staten, 96701
- Pali Momi Medical Center
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‘Aiea, Hawaii, Verenigde Staten, 96701
- Queen's Cancer Center - Pearlridge
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‘Aiea, Hawaii, Verenigde Staten, 96701
- The Cancer Center of Hawaii-Pali Momi
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Idaho
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Boise, Idaho, Verenigde Staten, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Verenigde Staten, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Verenigde Staten, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Verenigde Staten, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, Verenigde Staten, 83617
- Walter Knox Memorial Hospital
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Fruitland, Idaho, Verenigde Staten, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Verenigde Staten, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Verenigde Staten, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Verenigde Staten, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Verenigde Staten, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Verenigde Staten, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Verenigde Staten, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Verenigde Staten, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern University
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Lake Forest, Illinois, Verenigde Staten, 60045
- Northwestern Medicine Lake Forest Hospital
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46237
- Franciscan Health Indianapolis
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Indianapolis, Indiana, Verenigde Staten, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Mooresville, Indiana, Verenigde Staten, 46158
- Franciscan Health Mooresville
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Richmond, Indiana, Verenigde Staten, 47374
- Reid Health
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Terre Haute, Indiana, Verenigde Staten, 47804
- Union Hospital
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Iowa
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Ames, Iowa, Verenigde Staten, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Verenigde Staten, 50010
- McFarland Clinic - Ames
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Boone, Iowa, Verenigde Staten, 50036
- McFarland Clinic - Boone
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Clive, Iowa, Verenigde Staten, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Verenigde Staten, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Council Bluffs, Iowa, Verenigde Staten, 51503
- Alegent Health Mercy Hospital
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Creston, Iowa, Verenigde Staten, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Verenigde Staten, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Verenigde Staten, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Verenigde Staten, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Verenigde Staten, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Verenigde Staten, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Verenigde Staten, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Verenigde Staten, 50501
- McFarland Clinic - Trinity Cancer Center
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Fort Dodge, Iowa, Verenigde Staten, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
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Jefferson, Iowa, Verenigde Staten, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Verenigde Staten, 50158
- McFarland Clinic - Marshalltown
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West Des Moines, Iowa, Verenigde Staten, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Verenigde Staten, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Fairway, Kansas, Verenigde Staten, 66205
- University of Kansas Clinical Research Center
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Hays, Kansas, Verenigde Staten, 67601
- HaysMed
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Kansas City, Kansas, Verenigde Staten, 66160
- University of Kansas Cancer Center
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Kansas City, Kansas, Verenigde Staten, 66112
- University of Kansas Cancer Center-West
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Lawrence, Kansas, Verenigde Staten, 66044
- Lawrence Memorial Hospital
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Olathe, Kansas, Verenigde Staten, 66061
- The University of Kansas Cancer Center - Olathe
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Overland Park, Kansas, Verenigde Staten, 66210
- University of Kansas Cancer Center-Overland Park
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Pittsburg, Kansas, Verenigde Staten, 66762
- Mercy Hospital Pittsburg
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Salina, Kansas, Verenigde Staten, 67401
- Salina Regional Health Center
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Topeka, Kansas, Verenigde Staten, 66606
- University of Kansas Health System Saint Francis Campus
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Westwood, Kansas, Verenigde Staten, 66205
- University of Kansas Hospital-Westwood Cancer Center
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Kentucky
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Bardstown, Kentucky, Verenigde Staten, 40004
- CommonSpirit Saint Joseph Hospital - Bardstown
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Corbin, Kentucky, Verenigde Staten, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Verenigde Staten, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Verenigde Staten, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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London, Kentucky, Verenigde Staten, 40741
- CommonSpirit Saint Joseph Hospital London
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Louisville, Kentucky, Verenigde Staten, 40202
- Jewish Hospital
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Louisville, Kentucky, Verenigde Staten, 40245
- UofL Health Medical Center Northeast
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Louisville, Kentucky, Verenigde Staten, 40215
- Saints Mary and Elizabeth Hospital
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Shepherdsville, Kentucky, Verenigde Staten, 40165
- Jewish Hospital Medical Center South
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Maine
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Brewer, Maine, Verenigde Staten, 04412
- Lafayette Family Cancer Center-EMMC
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Massachusetts
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Springfield, Massachusetts, Verenigde Staten, 01104
- Mercy Medical Center
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Worcester, Massachusetts, Verenigde Staten, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Verenigde Staten, 49017
- Bronson Battle Creek
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Bay City, Michigan, Verenigde Staten, 48706
- McLaren Cancer Institute-Bay City
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Brighton, Michigan, Verenigde Staten, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Verenigde Staten, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Verenigde Staten, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Canton, Michigan, Verenigde Staten, 48188
- Trinity Health Medical Center - Canton
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Caro, Michigan, Verenigde Staten, 48723
- Caro Cancer Center
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Chelsea, Michigan, Verenigde Staten, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea, Michigan, Verenigde Staten, 48118
- Chelsea Hospital
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Clarkston, Michigan, Verenigde Staten, 48346
- McLaren Cancer Institute-Clarkston
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Clarkston, Michigan, Verenigde Staten, 48346
- Hematology Oncology Consultants-Clarkston
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Clarkston, Michigan, Verenigde Staten, 48346
- Newland Medical Associates-Clarkston
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Detroit, Michigan, Verenigde Staten, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, Verenigde Staten, 48236
- Henry Ford Health Saint John Hospital
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East China Township, Michigan, Verenigde Staten, 48054
- Henry Ford River District Hospital
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Farmington Hills, Michigan, Verenigde Staten, 48334
- Weisberg Cancer Treatment Center
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Flint, Michigan, Verenigde Staten, 48532
- McLaren Cancer Institute-Flint
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Flint, Michigan, Verenigde Staten, 48532
- Singh and Arora Hematology Oncology PC
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Flint, Michigan, Verenigde Staten, 48503
- Hurley Medical Center
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Flint, Michigan, Verenigde Staten, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Verenigde Staten, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Verenigde Staten, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grosse Pointe Woods, Michigan, Verenigde Staten, 48236
- Henry Ford Saint John Hospital - Academic
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Grosse Pointe Woods, Michigan, Verenigde Staten, 48236
- Henry Ford Saint John Hospital - Breast
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Grosse Pointe Woods, Michigan, Verenigde Staten, 48236
- Henry Ford Saint John Hospital - Van Elslander
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Kalamazoo, Michigan, Verenigde Staten, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Verenigde Staten, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Verenigde Staten, 49048
- Beacon Kalamazoo
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Lansing, Michigan, Verenigde Staten, 48912
- Mid-Michigan Physicians-Lansing
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Lansing, Michigan, Verenigde Staten, 48910
- Karmanos Cancer Institute at McLaren Greater Lansing
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Lansing, Michigan, Verenigde Staten, 48912
- University of Michigan Health - Sparrow Lansing
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Lapeer, Michigan, Verenigde Staten, 48446
- McLaren Cancer Institute-Lapeer Region
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Livonia, Michigan, Verenigde Staten, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Livonia, Michigan, Verenigde Staten, 48154
- Hope Cancer Clinic
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Macomb, Michigan, Verenigde Staten, 48044
- Henry Ford Warren Hospital - Breast Macomb
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Macomb, Michigan, Verenigde Staten, 48044
- Henry Ford Saint John Hospital - Macomb Medical
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Marlette, Michigan, Verenigde Staten, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
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Mount Clemens, Michigan, Verenigde Staten, 48043
- McLaren Cancer Institute-Macomb
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Mount Pleasant, Michigan, Verenigde Staten, 48858
- McLaren Cancer Institute-Central Michigan
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Muskegon, Michigan, Verenigde Staten, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Verenigde Staten, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Verenigde Staten, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Petoskey, Michigan, Verenigde Staten, 49770
- McLaren Cancer Institute-Northern Michigan
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Pontiac, Michigan, Verenigde Staten, 48341
- Hope Cancer Center
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Pontiac, Michigan, Verenigde Staten, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Pontiac, Michigan, Verenigde Staten, 48341
- Michigan Healthcare Professionals Pontiac
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Pontiac, Michigan, Verenigde Staten, 48341
- Trinity Health IHA Medical Group-Alice Gustafson Center
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Port Huron, Michigan, Verenigde Staten, 48060
- McLaren-Port Huron
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Reed City, Michigan, Verenigde Staten, 49677
- Corewell Health Reed City Hospital
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Rochester Hills, Michigan, Verenigde Staten, 48309
- Henry Ford Rochester Hospital
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Saginaw, Michigan, Verenigde Staten, 48604
- Oncology Hematology Associates of Saginaw Valley PC
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Saginaw, Michigan, Verenigde Staten, 48601
- MyMichigan Medical Center Saginaw
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Saint Joseph, Michigan, Verenigde Staten, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint Joseph, Michigan, Verenigde Staten, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
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Sterling Heights, Michigan, Verenigde Staten, 48312
- Bhadresh Nayak MD PC-Sterling Heights
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Tawas City, Michigan, Verenigde Staten, 48764
- MyMichigan Medical Center Tawas
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Traverse City, Michigan, Verenigde Staten, 49684
- Munson Medical Center
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Warren, Michigan, Verenigde Staten, 48088
- Advanced Breast Care Center PLLC
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Warren, Michigan, Verenigde Staten, 48093
- Macomb Hematology Oncology PC
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Warren, Michigan, Verenigde Staten, 48093
- Henry Ford Madison Heights Hospital - Breast
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Warren, Michigan, Verenigde Staten, 48093
- Henry Ford Health Warren Hospital
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Warren, Michigan, Verenigde Staten, 48093
- Henry Ford Warren Hospital - GLCMS
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West Branch, Michigan, Verenigde Staten, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
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Wyoming, Michigan, Verenigde Staten, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Verenigde Staten, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Ypsilanti, Michigan, Verenigde Staten, 48106
- Huron Gastroenterology PC
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Minnesota
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Burnsville, Minnesota, Verenigde Staten, 55337
- Fairview Ridges Hospital
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Burnsville, Minnesota, Verenigde Staten, 55337
- Minnesota Oncology - Burnsville
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Cambridge, Minnesota, Verenigde Staten, 55008
- Cambridge Medical Center
-
Coon Rapids, Minnesota, Verenigde Staten, 55433
- Mercy Hospital
-
Edina, Minnesota, Verenigde Staten, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Verenigde Staten, 55432
- Unity Hospital
-
Maple Grove, Minnesota, Verenigde Staten, 55369
- Fairview Clinics and Surgery Center Maple Grove
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Maplewood, Minnesota, Verenigde Staten, 55109
- Saint John's Hospital - Healtheast
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Maplewood, Minnesota, Verenigde Staten, 55109
- Minnesota Oncology Hematology PA-Maplewood
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Minneapolis, Minnesota, Verenigde Staten, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Verenigde Staten, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Verenigde Staten, 55454
- Health Partners Inc
-
Monticello, Minnesota, Verenigde Staten, 55362
- Monticello Cancer Center
-
New Ulm, Minnesota, Verenigde Staten, 56073
- New Ulm Medical Center
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Princeton, Minnesota, Verenigde Staten, 55371
- Fairview Northland Medical Center
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Robbinsdale, Minnesota, Verenigde Staten, 55422
- North Memorial Medical Health Center
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Saint Louis Park, Minnesota, Verenigde Staten, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Verenigde Staten, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Verenigde Staten, 55102
- United Hospital
-
Shakopee, Minnesota, Verenigde Staten, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Verenigde Staten, 55082
- Lakeview Hospital
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Waconia, Minnesota, Verenigde Staten, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Verenigde Staten, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Verenigde Staten, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Wyoming, Minnesota, Verenigde Staten, 55092
- Fairview Lakes Medical Center
-
-
Missouri
-
Kansas City, Missouri, Verenigde Staten, 64154
- University of Kansas Cancer Center - North
-
Kansas City, Missouri, Verenigde Staten, 64108
- University Health Truman Medical Center
-
Lee's Summit, Missouri, Verenigde Staten, 64064
- University of Kansas Cancer Center - Lee's Summit
-
North Kansas City, Missouri, Verenigde Staten, 64116
- University of Kansas Cancer Center at North Kansas City Hospital
-
-
Montana
-
Anaconda, Montana, Verenigde Staten, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Verenigde Staten, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Verenigde Staten, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Verenigde Staten, 59405
- Great Falls Clinic
-
Great Falls, Montana, Verenigde Staten, 59405
- Benefis Sletten Cancer Institute
-
Kalispell, Montana, Verenigde Staten, 59901
- Logan Health Medical Center
-
Missoula, Montana, Verenigde Staten, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Verenigde Staten, 59804
- Community Medical Center
-
-
Nebraska
-
Grand Island, Nebraska, Verenigde Staten, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Verenigde Staten, 68847
- CHI Health Good Samaritan
-
Lincoln, Nebraska, Verenigde Staten, 68510
- Saint Elizabeth Regional Medical Center
-
Omaha, Nebraska, Verenigde Staten, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Verenigde Staten, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Verenigde Staten, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Verenigde Staten, 68130
- Alegent Health Lakeside Hospital
-
Papillion, Nebraska, Verenigde Staten, 68046
- Midlands Community Hospital
-
-
Nevada
-
Carson City, Nevada, Verenigde Staten, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, Verenigde Staten, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Verenigde Staten, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Verenigde Staten, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Verenigde Staten, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Verenigde Staten, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Verenigde Staten, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, Verenigde Staten, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, Verenigde Staten, 89074
- Urology Specialists of Nevada - Green Valley
-
Henderson, Nevada, Verenigde Staten, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Verenigde Staten, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Verenigde Staten, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Verenigde Staten, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Verenigde Staten, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Verenigde Staten, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Verenigde Staten, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Verenigde Staten, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Verenigde Staten, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Verenigde Staten, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Verenigde Staten, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Verenigde Staten, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Verenigde Staten, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Verenigde Staten, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Verenigde Staten, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Verenigde Staten, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Verenigde Staten, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Verenigde Staten, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Verenigde Staten, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Verenigde Staten, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Verenigde Staten, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, Verenigde Staten, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Verenigde Staten, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Verenigde Staten, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, Verenigde Staten, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, Verenigde Staten, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, Verenigde Staten, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, Verenigde Staten, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, Verenigde Staten, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, Verenigde Staten, 89169
- University Cancer Center
-
Las Vegas, Nevada, Verenigde Staten, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, Verenigde Staten, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Verenigde Staten, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, Verenigde Staten, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Verenigde Staten, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Verenigde Staten, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Verenigde Staten, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Lebanon, New Hampshire, Verenigde Staten, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Teaneck, New Jersey, Verenigde Staten, 07666
- Holy Name Hospital
-
-
New York
-
Buffalo, New York, Verenigde Staten, 14263
- Roswell Park Cancer Institute
-
Rochester, New York, Verenigde Staten, 14642
- University of Rochester
-
-
North Carolina
-
Chapel Hill, North Carolina, Verenigde Staten, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Greenville, North Carolina, Verenigde Staten, 27834
- East Carolina University
-
Hillsborough, North Carolina, Verenigde Staten, 27278
- University of North Carolina-Hillsborough Campus
-
-
Ohio
-
Beavercreek, Ohio, Verenigde Staten, 45431
- Indu and Raj Soin Medical Center
-
Boardman, Ohio, Verenigde Staten, 44512
- Saint Elizabeth Boardman Hospital
-
Centerville, Ohio, Verenigde Staten, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Verenigde Staten, 45459
- Dayton Physicians LLC-Miami Valley South
-
Cincinnati, Ohio, Verenigde Staten, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Verenigde Staten, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, Verenigde Staten, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cincinnati, Ohio, Verenigde Staten, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, Verenigde Staten, 45255
- TriHealth Cancer Institute-Anderson
-
Cleveland, Ohio, Verenigde Staten, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Verenigde Staten, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Dayton, Ohio, Verenigde Staten, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Verenigde Staten, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Verenigde Staten, 45415
- Dayton Physician LLC - Englewood
-
Findlay, Ohio, Verenigde Staten, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Verenigde Staten, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Verenigde Staten, 45840
- Orion Cancer Care
-
Franklin, Ohio, Verenigde Staten, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Verenigde Staten, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Verenigde Staten, 45331
- Wayne Hospital
-
Greenville, Ohio, Verenigde Staten, 45331
- Dayton Physicians LLC-Wayne
-
Kettering, Ohio, Verenigde Staten, 45429
- Kettering Medical Center
-
Kettering, Ohio, Verenigde Staten, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, Verenigde Staten, 45420
- First Dayton Cancer Care
-
Mansfield, Ohio, Verenigde Staten, 44906
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, Verenigde Staten, 44124
- Hillcrest Hospital Cancer Center
-
Sandusky, Ohio, Verenigde Staten, 44870
- North Coast Cancer Care
-
Strongsville, Ohio, Verenigde Staten, 44136
- Cleveland Clinic Cancer Center Strongsville
-
Troy, Ohio, Verenigde Staten, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Verenigde Staten, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, Verenigde Staten, 44484
- Saint Joseph Warren Hospital
-
Warrensville Heights, Ohio, Verenigde Staten, 44122
- South Pointe Hospital
-
Wooster, Ohio, Verenigde Staten, 44691
- Cleveland Clinic Wooster Family Health and Surgery Center
-
Youngstown, Ohio, Verenigde Staten, 44501
- Saint Elizabeth Youngstown Hospital
-
-
Oklahoma
-
Lawton, Oklahoma, Verenigde Staten, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, Verenigde Staten, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Baker City, Oregon, Verenigde Staten, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Bend, Oregon, Verenigde Staten, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Verenigde Staten, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Verenigde Staten, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Verenigde Staten, 97420
- Bay Area Hospital
-
Newberg, Oregon, Verenigde Staten, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, Verenigde Staten, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Portland, Oregon, Verenigde Staten, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Verenigde Staten, 97225
- Providence Saint Vincent Medical Center
-
Redmond, Oregon, Verenigde Staten, 97756
- Saint Charles Health System-Redmond
-
-
Pennsylvania
-
Allentown, Pennsylvania, Verenigde Staten, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Verenigde Staten, 18017
- Lehigh Valley Hospital - Muhlenberg
-
East Stroudsburg, Pennsylvania, Verenigde Staten, 18301
- Pocono Medical Center
-
Hazleton, Pennsylvania, Verenigde Staten, 18201
- Lehigh Valley Hospital-Hazleton
-
Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Philadelphia, Pennsylvania, Verenigde Staten, 19140
- Temple University Hospital
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15232
- UPMC Hillman Cancer Center
-
-
South Carolina
-
Boiling Springs, South Carolina, Verenigde Staten, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Easley, South Carolina, Verenigde Staten, 29640
- Prisma Health Cancer Institute - Easley
-
Greenville, South Carolina, Verenigde Staten, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Verenigde Staten, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Verenigde Staten, 29605
- Prisma Health Cancer Institute - Butternut
-
Greer, South Carolina, Verenigde Staten, 29650
- Prisma Health Cancer Institute - Greer
-
Seneca, South Carolina, Verenigde Staten, 29672
- Prisma Health Cancer Institute - Seneca
-
-
South Dakota
-
Sioux Falls, South Dakota, Verenigde Staten, 57105
- Avera Cancer Institute
-
-
Tennessee
-
Bristol, Tennessee, Verenigde Staten, 37620
- Bristol Regional Medical Center
-
Franklin, Tennessee, Verenigde Staten, 37067
- Vanderbilt-Ingram Cancer Center Cool Springs
-
Franklin, Tennessee, Verenigde Staten, 37067
- Vanderbilt-Ingram Cancer Center at Franklin
-
Kingsport, Tennessee, Verenigde Staten, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, Verenigde Staten, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Nashville, Tennessee, Verenigde Staten, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Verenigde Staten, 37204
- Vanderbilt Breast Center at One Hundred Oaks
-
-
Texas
-
Bryan, Texas, Verenigde Staten, 77802
- Saint Joseph Regional Cancer Center
-
Dallas, Texas, Verenigde Staten, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Verenigde Staten, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Fort Worth, Texas, Verenigde Staten, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Richardson, Texas, Verenigde Staten, 75080
- UT Southwestern Clinical Center at Richardson/Plano
-
-
Virginia
-
Bristol, Virginia, Verenigde Staten, 24201
- Ballad Health Cancer Care - Bristol
-
Martinsville, Virginia, Verenigde Staten, 24112
- Sovah Health Martinsville
-
Norton, Virginia, Verenigde Staten, 24273
- Ballad Health Cancer Care - Norton
-
-
Washington
-
Aberdeen, Washington, Verenigde Staten, 98520
- Providence Regional Cancer System-Aberdeen
-
Bellevue, Washington, Verenigde Staten, 98004
- Overlake Medical Center
-
Bellingham, Washington, Verenigde Staten, 98225
- PeaceHealth Saint Joseph Medical Center
-
Burien, Washington, Verenigde Staten, 98166
- Saint Anne Hospital
-
Centralia, Washington, Verenigde Staten, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Verenigde Staten, 98026
- Swedish Cancer Institute-Edmonds
-
Enumclaw, Washington, Verenigde Staten, 98022
- Saint Elizabeth Hospital
-
Everett, Washington, Verenigde Staten, 98201
- Providence Regional Cancer Partnership
-
Federal Way, Washington, Verenigde Staten, 98003
- Saint Francis Hospital
-
Issaquah, Washington, Verenigde Staten, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, Verenigde Staten, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, Verenigde Staten, 98503
- Providence Regional Cancer System-Lacey
-
Lakewood, Washington, Verenigde Staten, 98499
- Saint Clare Hospital
-
Longview, Washington, Verenigde Staten, 98632
- PeaceHealth Saint John Medical Center
-
Poulsbo, Washington, Verenigde Staten, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Renton, Washington, Verenigde Staten, 98055
- Valley Medical Center
-
Seattle, Washington, Verenigde Staten, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Verenigde Staten, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Verenigde Staten, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Verenigde Staten, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, Verenigde Staten, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, Verenigde Staten, 98584
- Providence Regional Cancer System-Shelton
-
Silverdale, Washington, Verenigde Staten, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Tacoma, Washington, Verenigde Staten, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Verenigde Staten, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
Vancouver, Washington, Verenigde Staten, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Verenigde Staten, 99362
- Providence Saint Mary Regional Cancer Center
-
Yelm, Washington, Verenigde Staten, 98597
- Providence Regional Cancer System-Yelm
-
-
Wisconsin
-
Madison, Wisconsin, Verenigde Staten, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Menomonee Falls, Wisconsin, Verenigde Staten, 53051
- Froedtert Menomonee Falls Hospital
-
Milwaukee, Wisconsin, Verenigde Staten, 53226
- Medical College of Wisconsin
-
New Richmond, Wisconsin, Verenigde Staten, 54017
- Cancer Center of Western Wisconsin
-
West Bend, Wisconsin, Verenigde Staten, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
-
Wyoming
-
Cody, Wyoming, Verenigde Staten, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Verenigde Staten, 82801
- Welch Cancer Center
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
-
Patient must be >= 18 years of age
-
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Patient must have a life expectancy >= 12 weeks
-
Patient must have histologically confirmed intrahepatic cholangiocarcinoma or biphasic hepatocellular carcinoma and cholangiocarcinoma that is metastatic or unresectable and who have progressed on or been intolerant of one prior line of systemic gemcitabine containing chemotherapy regimen.
- NOTE: Prior immunotherapy or targeted therapies are allowed and will not be considered a line of therapy unless administered with cytotoxic chemotherapy
-
Patient must have measurable disease. For patients who have received localized therapy (embolization, chemoembolization, radiofrequency ablation or radiation) are eligible if measurable disease is not within the treatment field or the treated disease has clearly progressed since last localized therapy
-
Leukocytes >= 3,000/mcL (obtained within 14 days prior to randomization)
-
Absolute neutrophil count >= 1,500/mcL (obtained within 14 days prior to randomization)
-
Platelets >= 100,000/mcL (obtained within 14 days prior to randomization)
-
Total bilirubin =< institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin (obtained within 14 days prior to randomization)
-
Hemoglobin >= 9 g/dL (obtained within 14 days prior to randomization)
-
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 14 days prior to randomization)
-
Creatinine =< institutional ULN, OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 (obtained within 14 days prior to randomization)
-
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Known HIV positive patients who meet the following criteria will be considered eligible:
- CD4 count >= 350 cells/mm^3
- Undetectable viral load
- Maintained on modern therapeutic regimens utilizing non-CYP interactive agents (i.e. excluding ritonavir)
- No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections
-
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
-
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
-
Patients who received prior platinum or taxane chemotherapy are eligible
-
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
-
Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. In addition, patients with any of the known cardiopulmonary disease, defined as follows, would be ineligible for this trial:
-
Unstable angina
-
Congestive heart failure (New York Heart Association [NYHA] class III or IV;);
-
Myocardial infarction within 6 months prior to randomization (patients who had ischemic heart disease such as acute coronary syndrome [ACS], myocardial infarction, and/or revascularization greater than 6 months before randomization and who are without cardiac symptoms may enroll)
-
Symptomatic cardiomyopathy
-
Clinically symptomatic pulmonary hypertension requiring pharmacologic therapy
-
Clinically significant arrhythmia, defined as:
- History of polymorphic ventricular fibrillation or torsade de pointes,
- Permanent atrial fibrillation, defined as continuous atrial fibrillation for >= 6 months,
- Persistent atrial fibrillation, defined as sustained atrial fibrillation lasting > 7 days and/or requiring cardioversion in the 4 weeks before randomization,
- Grade 3 atrial fibrillation defined as symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker), or ablation
- Patients with paroxysmal atrial fibrillation or grade < 3 atrial fibrillation for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen
-
-
Patients must have the ability to understand and the willingness to sign a written informed consent document
-
Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
Exclusion Criteria:
- Patients must not have had major surgery within 14 days before randomization. Patients with surgery planned during study period are ineligible
- Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least 4 months after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and continue for at least 4 months after the last dose of protocol treatment
- Male patients must not donate sperm during the course of this study or within 4 months after receiving their last dose of protocol treatment
- Female patients must not donate eggs (ova) during the course of this study or within 4 months after receiving their last dose of protocol treatment
- Patient must not have a prolonged rate corrected QT (QTc) interval >= 480 msec calculated according to institutional guideline
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e. have residual toxicities > grade 1) are ineligible with the exception of alopecia
- Patients with persistent >= grade 2 diarrhea lasting more than 3 days within 14 weeks of randomization are ineligible
- Patients with known central nervous system (CNS) involvement are ineligible
- Patients must not be receiving any other investigational agents
- Patients must not have received chemotherapy or radiotherapy within 2 weeks prior to randomization. Prior treatment with radiation therapy involving >= 25% of hematopoietically active bone marrow will be ineligible
- Patients must not have received immunotherapy within 8 weeks prior to randomization
- Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pevonedistat, carboplatin, or paclitaxel
- Patient must not be receiving any treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug as below. Clinically significant metabolic enzyme inducers are not permitted during the study. Patients must not be receiving any medications or substances that are strong inducers of CYP3A4/5 (i.e. phenytoin, rifampin, St. Johns wort) or inhibitors of breast cancer resistance protein (BCRP) (i.e. cyclosporine). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if a new medication need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Inhibitors of CYP3A4/5 are allowed
- Patients must not have uncontrolled intercurrent illness
- Patients must not have uncontrolled coagulopathy or bleeding disorder
- Patients must not have active, uncontrolled infection or severe infectious disease such as severe pneumonia, meningitis, or septicemia
- Patients with known moderate chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis are ineligible
- Patients must not have psychiatric illness/social situations that would limit compliance with study requirements
- Participants must not have had prior pevonedistat treatment
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Arm A (pevonedistat)
Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Given IV
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Experimenteel: Arm B (pevonedistat, paclitaxel, carboplatin)
Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician. |
Given IV
Andere namen:
Given IV
Andere namen:
Given IV
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Objective Response
Tijdsspanne: Every 3 months for the first year and every 6 months for years 2-3
|
Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Objective response includes complete response (CR) and partial response (PR). CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
Every 3 months for the first year and every 6 months for years 2-3
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Clinical Benefit
Tijdsspanne: Every 3 months for the first year and every 6 months for years 2-3
|
Clinical benefit was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), including complete response (CR), partial response (PR) and stable disease (SD) that lasted greater than or equal to 24 weeks. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. |
Every 3 months for the first year and every 6 months for years 2-3
|
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Progression-free Survival (PFS)
Tijdsspanne: Every 3 months for the first year and every 6 months for years 2-3
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PFS was defined as the time from randomization to progression or death, whichever came first; patients alive without evidence of disease progression were censored at the date of last disease assessment. Patients who died without documented progression and the death occurred > 6 weeks of last disease assessment will be censored at the date of last disease assessment that showed progression-free. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered as progression. |
Every 3 months for the first year and every 6 months for years 2-3
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Overall Survival (OS)
Tijdsspanne: Every 3 months for the first year and every 6 months for years 2-3
|
OS was defined as the time from randomization to death from any cause, and patients still living were censored at the date last known alive. |
Every 3 months for the first year and every 6 months for years 2-3
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidentie van bijwerkingen
Tijdsspanne: Elke 3 weken beoordeeld tijdens de behandeling en gedurende 30 dagen na het einde van de behandeling, tot 3 jaar
|
Elke 3 weken beoordeeld tijdens de behandeling en gedurende 30 dagen na het einde van de behandeling, tot 3 jaar
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Associations Between Response and Overexpression of NEDD8, NAE1, and UBC12
Tijdsspanne: Assessed every 3 months for the first year and every 6 months for years 2-3
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Associations between response and overexpression of NEDD8, NAE1, and UBC12 will be evaluated. |
Assessed every 3 months for the first year and every 6 months for years 2-3
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Mutation Profile of Those Cholangiocarcinomas
Tijdsspanne: Assessed at baseline
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To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway |
Assessed at baseline
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Specimens Banking
Tijdsspanne: Baseline
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To bank specimens for further future investigations |
Baseline
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dustin A Deming, ECOG-ACRIN Cancer Research Group
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
16 maart 2020
Primaire voltooiing (Werkelijk)
27 november 2023
Studie voltooiing (Geschat)
3 september 2027
Studieregistratiedata
Eerst ingediend
22 november 2019
Eerst ingediend dat voldeed aan de QC-criteria
22 november 2019
Eerst geplaatst (Werkelijk)
25 november 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 oktober 2026
Laatste update ingediend die voldeed aan QC-criteria
23 oktober 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata per site
- Neoplasmata
- Neoplasmata per histologisch type
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Lever Ziekten
- Neoplasmata, glandulair en epitheel
- Adenocarcinoom
- Lever neoplasmata
- Carcinoom
- Carcinoom, hepatocellulair
- Cholangiocarcinoom
- Organische chemicaliën
- Koolwaterstoffen
- Cycloparaffins
- Koolwaterstoffen, alicyclisch
- Koolwaterstoffen, cyclisch
- Terpenen
- Coördinatiecomplexen
- Taxoids
- Cyclodecanes
- Diterpenen
- Gezondheidszorg economie en organisaties
- Economie
- Carboplatine
- Paclitaxel
- Belastingen
- pevonedistat
Andere studie-ID-nummers
- NCI-2019-07769
- U10CA180820 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2019-07769 (Register-ID: CTRP (Clinical Trial Reporting Program))
- EA2187 (Andere identificatie: CTEP)
- EA2187 (Andere identificatie: ECOG-ACRIN Cancer Research Group)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .