Testa kombinationen av pevonedistat med kemoterapi för gallgångscancer i levern
23 oktober 2026 uppdaterad av: National Cancer Institute (NCI)
En fas 2-studie av pevonedistat i kombination med karboplatin och paklitaxel vid avancerad intrahepatisk kolangiokarcinom
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.
Studieöversikt
Status
Aktiv, inte rekryterande
Betingelser
- Steg III intrahepatisk kolangiokarcinom AJCC v8
- Steg IIIA intrahepatisk kolangiokarcinom AJCC v8
- Steg IIIB intrahepatisk kolangiokarcinom AJCC v8
- Ooperabelt hepatocellulärt karcinom
- Metastaserande kolangiokarcinom
- Steg III hepatocellulärt karcinom AJCC v8
- Steg IIIA hepatocellulärt karcinom AJCC v8
- Steg IV hepatocellulärt karcinom AJCC v8
- Steg IVA hepatocellulärt karcinom AJCC v8
- Steg IVB hepatocellulärt karcinom AJCC v8
- Steg IV intrahepatisk kolangiokarcinom AJCC v8
- Ooperabelt kolangiokarcinom
- Steg IIIB hepatocellulärt karcinom AJCC v8
- Metastaserande hepatocellulärt karcinom
- Inoperabelt intrahepatiskt kolangiokarcinom
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alaska
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Anchorage, Alaska, Förenta staterna, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Oncology and Hematology LLC
-
Anchorage, Alaska, Förenta staterna, 99508
- Alaska Women's Cancer Care
-
Anchorage, Alaska, Förenta staterna, 99508
- Anchorage Oncology Centre
-
Anchorage, Alaska, Förenta staterna, 99508
- Katmai Oncology Group
-
Anchorage, Alaska, Förenta staterna, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Förenta staterna, 99504
- Anchorage Radiation Therapy Center
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Arizona
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Kingman, Arizona, Förenta staterna, 86401
- Kingman Regional Medical Center
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Phoenix, Arizona, Förenta staterna, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Hot Springs, Arkansas, Förenta staterna, 71913
- CHI Saint Vincent Cancer Center Hot Springs
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California
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Arroyo Grande, California, Förenta staterna, 93420
- PCR Oncology
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Arroyo Grande, California, Förenta staterna, 93420
- Mission Hope Medical Oncology - Arroyo Grande
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Auburn, California, Förenta staterna, 95602
- Sutter Auburn Faith Hospital
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Auburn, California, Förenta staterna, 95603
- Sutter Cancer Centers Radiation Oncology Services-Auburn
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Berkeley, California, Förenta staterna, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Burbank, California, Förenta staterna, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Cameron Park, California, Förenta staterna, 95682
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
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Castro Valley, California, Förenta staterna, 94546
- Eden Hospital Medical Center
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Davis, California, Förenta staterna, 95616
- Sutter Davis Hospital
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Duarte, California, Förenta staterna, 91010
- City of Hope Comprehensive Cancer Center
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Fremont, California, Förenta staterna, 94538
- Palo Alto Medical Foundation-Fremont
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Modesto, California, Förenta staterna, 95355
- Memorial Medical Center
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Mountain View, California, Förenta staterna, 94040
- Palo Alto Medical Foundation-Camino Division
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Mountain View, California, Förenta staterna, 94040
- Palo Alto Medical Foundation-Gynecologic Oncology
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Palo Alto, California, Förenta staterna, 94301
- Palo Alto Medical Foundation Health Care
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Roseville, California, Förenta staterna, 95661
- Sutter Cancer Centers Radiation Oncology Services-Roseville
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Roseville, California, Förenta staterna, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Förenta staterna, 95816
- Sutter Medical Center Sacramento
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San Francisco, California, Förenta staterna, 94115
- California Pacific Medical Center-Pacific Campus
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San Mateo, California, Förenta staterna, 94401
- Mills Health Center
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Santa Cruz, California, Förenta staterna, 95065
- Palo Alto Medical Foundation-Santa Cruz
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Santa Maria, California, Förenta staterna, 93444
- Mission Hope Medical Oncology - Santa Maria
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Santa Rosa, California, Förenta staterna, 95403
- Sutter Pacific Medical Foundation
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Sunnyvale, California, Förenta staterna, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Vallejo, California, Förenta staterna, 94589
- Sutter Solano Medical Center/Cancer Center
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Förenta staterna, 80909
- UCHealth Memorial Hospital Central
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Colorado Springs, Colorado, Förenta staterna, 80907
- Rocky Mountain Cancer Centers-Penrose
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Colorado Springs, Colorado, Förenta staterna, 80920
- Memorial Hospital North
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Denver, Colorado, Förenta staterna, 80210
- AdventHealth Porter
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Durango, Colorado, Förenta staterna, 81301
- Mercy Medical Center
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Durango, Colorado, Förenta staterna, 81301
- CommonSpirit Cancer Center Mercy
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Fort Collins, Colorado, Förenta staterna, 80524
- Poudre Valley Hospital
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Fort Collins, Colorado, Förenta staterna, 80528
- Cancer Care and Hematology-Fort Collins
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Greeley, Colorado, Förenta staterna, 80631
- UCHealth Greeley Hospital
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Lakewood, Colorado, Förenta staterna, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Förenta staterna, 80122
- AdventHealth Littleton
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Longmont, Colorado, Förenta staterna, 80501
- Longmont United Hospital
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Longmont, Colorado, Förenta staterna, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, Förenta staterna, 80538
- Medical Center of the Rockies
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Parker, Colorado, Förenta staterna, 80138
- AdventHealth Parker
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Pueblo, Colorado, Förenta staterna, 81004
- Saint Mary Corwin Medical Center
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Florida
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Coral Gables, Florida, Förenta staterna, 33146
- UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach, Florida, Förenta staterna, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Fort Lauderdale, Florida, Förenta staterna, 33308
- Holy Cross Hospital
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Miami, Florida, Förenta staterna, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Förenta staterna, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Förenta staterna, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Förenta staterna, 96817
- The Cancer Center of Hawaii-Liliha
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Honolulu, Hawaii, Förenta staterna, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, Förenta staterna, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Förenta staterna, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Förenta staterna, 96817
- Hawaii Cancer Care Inc-Liliha
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Honolulu, Hawaii, Förenta staterna, 96817
- Kuakini Medical Center
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Honolulu, Hawaii, Förenta staterna, 96817
- Queen's Cancer Center - Kuakini
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Honolulu, Hawaii, Förenta staterna, 96826
- Kapiolani Medical Center for Women and Children
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Honolulu, Hawaii, Förenta staterna, 96813
- Island Urology
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Lihue, Hawaii, Förenta staterna, 96766
- Wilcox Memorial Hospital and Kauai Medical Clinic
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‘Aiea, Hawaii, Förenta staterna, 96701
- Hawaii Cancer Care - Westridge
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‘Aiea, Hawaii, Förenta staterna, 96701
- Pali Momi Medical Center
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‘Aiea, Hawaii, Förenta staterna, 96701
- Queen's Cancer Center - Pearlridge
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‘Aiea, Hawaii, Förenta staterna, 96701
- The Cancer Center of Hawaii-Pali Momi
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Idaho
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Boise, Idaho, Förenta staterna, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Förenta staterna, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Förenta staterna, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, Förenta staterna, 83617
- Walter Knox Memorial Hospital
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Fruitland, Idaho, Förenta staterna, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Förenta staterna, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Förenta staterna, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Förenta staterna, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Förenta staterna, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Förenta staterna, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Förenta staterna, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Förenta staterna, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Lake Forest, Illinois, Förenta staterna, 60045
- Northwestern Medicine Lake Forest Hospital
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46237
- Franciscan Health Indianapolis
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Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
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Mooresville, Indiana, Förenta staterna, 46158
- Franciscan Health Mooresville
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Richmond, Indiana, Förenta staterna, 47374
- Reid Health
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Terre Haute, Indiana, Förenta staterna, 47804
- Union Hospital
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
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Boone, Iowa, Förenta staterna, 50036
- McFarland Clinic - Boone
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Clive, Iowa, Förenta staterna, 50325
- Mercy Cancer Center-West Lakes
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Clive, Iowa, Förenta staterna, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Council Bluffs, Iowa, Förenta staterna, 51503
- Alegent Health Mercy Hospital
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Creston, Iowa, Förenta staterna, 50801
- Greater Regional Medical Center
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Des Moines, Iowa, Förenta staterna, 50309
- Iowa Methodist Medical Center
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50314
- Broadlawns Medical Center
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Des Moines, Iowa, Förenta staterna, 50316
- Iowa Lutheran Hospital
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Des Moines, Iowa, Förenta staterna, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Förenta staterna, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Förenta staterna, 50501
- McFarland Clinic - Trinity Cancer Center
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Fort Dodge, Iowa, Förenta staterna, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
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Jefferson, Iowa, Förenta staterna, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Förenta staterna, 50158
- McFarland Clinic - Marshalltown
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West Des Moines, Iowa, Förenta staterna, 50266-7700
- Methodist West Hospital
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West Des Moines, Iowa, Förenta staterna, 50266
- Mercy Medical Center-West Lakes
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Kansas
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Fairway, Kansas, Förenta staterna, 66205
- University of Kansas Clinical Research Center
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Hays, Kansas, Förenta staterna, 67601
- HaysMed
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Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas Cancer Center
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Kansas City, Kansas, Förenta staterna, 66112
- University of Kansas Cancer Center-West
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Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
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Olathe, Kansas, Förenta staterna, 66061
- The University of Kansas Cancer Center - Olathe
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Overland Park, Kansas, Förenta staterna, 66210
- University of Kansas Cancer Center-Overland Park
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Pittsburg, Kansas, Förenta staterna, 66762
- Mercy Hospital Pittsburg
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Salina, Kansas, Förenta staterna, 67401
- Salina Regional Health Center
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Topeka, Kansas, Förenta staterna, 66606
- University of Kansas Health System Saint Francis Campus
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Westwood, Kansas, Förenta staterna, 66205
- University of Kansas Hospital-Westwood Cancer Center
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Kentucky
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Bardstown, Kentucky, Förenta staterna, 40004
- CommonSpirit Saint Joseph Hospital - Bardstown
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Corbin, Kentucky, Förenta staterna, 40701
- Commonwealth Cancer Center-Corbin
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Lexington, Kentucky, Förenta staterna, 40504
- Saint Joseph Radiation Oncology Resource Center
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Lexington, Kentucky, Förenta staterna, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
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London, Kentucky, Förenta staterna, 40741
- CommonSpirit Saint Joseph Hospital London
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Louisville, Kentucky, Förenta staterna, 40202
- Jewish Hospital
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Louisville, Kentucky, Förenta staterna, 40245
- UofL Health Medical Center Northeast
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Louisville, Kentucky, Förenta staterna, 40215
- Saints Mary and Elizabeth Hospital
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Shepherdsville, Kentucky, Förenta staterna, 40165
- Jewish Hospital Medical Center South
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Maine
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Brewer, Maine, Förenta staterna, 04412
- Lafayette Family Cancer Center-EMMC
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Massachusetts
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Springfield, Massachusetts, Förenta staterna, 01104
- Mercy Medical Center
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Worcester, Massachusetts, Förenta staterna, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Förenta staterna, 49017
- Bronson Battle Creek
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Bay City, Michigan, Förenta staterna, 48706
- McLaren Cancer Institute-Bay City
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Brighton, Michigan, Förenta staterna, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Förenta staterna, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Förenta staterna, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Canton, Michigan, Förenta staterna, 48188
- Trinity Health Medical Center - Canton
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Caro, Michigan, Förenta staterna, 48723
- Caro Cancer Center
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Chelsea, Michigan, Förenta staterna, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea, Michigan, Förenta staterna, 48118
- Chelsea Hospital
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Clarkston, Michigan, Förenta staterna, 48346
- McLaren Cancer Institute-Clarkston
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Clarkston, Michigan, Förenta staterna, 48346
- Hematology Oncology Consultants-Clarkston
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Clarkston, Michigan, Förenta staterna, 48346
- Newland Medical Associates-Clarkston
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Detroit, Michigan, Förenta staterna, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, Förenta staterna, 48236
- Henry Ford Health Saint John Hospital
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East China Township, Michigan, Förenta staterna, 48054
- Henry Ford River District Hospital
-
Farmington Hills, Michigan, Förenta staterna, 48334
- Weisberg Cancer Treatment Center
-
Flint, Michigan, Förenta staterna, 48532
- McLaren Cancer Institute-Flint
-
Flint, Michigan, Förenta staterna, 48532
- Singh and Arora Hematology Oncology PC
-
Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
-
Flint, Michigan, Förenta staterna, 48503
- Genesee Hematology Oncology PC
-
Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
-
Flint, Michigan, Förenta staterna, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Förenta staterna, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
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Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- Henry Ford Saint John Hospital - Academic
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Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- Henry Ford Saint John Hospital - Breast
-
Grosse Pointe Woods, Michigan, Förenta staterna, 48236
- Henry Ford Saint John Hospital - Van Elslander
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Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Förenta staterna, 49048
- Beacon Kalamazoo
-
Lansing, Michigan, Förenta staterna, 48912
- Mid-Michigan Physicians-Lansing
-
Lansing, Michigan, Förenta staterna, 48910
- Karmanos Cancer Institute at McLaren Greater Lansing
-
Lansing, Michigan, Förenta staterna, 48912
- University of Michigan Health - Sparrow Lansing
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Lapeer, Michigan, Förenta staterna, 48446
- McLaren Cancer Institute-Lapeer Region
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Livonia, Michigan, Förenta staterna, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Livonia, Michigan, Förenta staterna, 48154
- Hope Cancer Clinic
-
Macomb, Michigan, Förenta staterna, 48044
- Henry Ford Warren Hospital - Breast Macomb
-
Macomb, Michigan, Förenta staterna, 48044
- Henry Ford Saint John Hospital - Macomb Medical
-
Marlette, Michigan, Förenta staterna, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
-
Mount Clemens, Michigan, Förenta staterna, 48043
- McLaren Cancer Institute-Macomb
-
Mount Pleasant, Michigan, Förenta staterna, 48858
- McLaren Cancer Institute-Central Michigan
-
Muskegon, Michigan, Förenta staterna, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Förenta staterna, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Förenta staterna, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Petoskey, Michigan, Förenta staterna, 49770
- McLaren Cancer Institute-Northern Michigan
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Pontiac, Michigan, Förenta staterna, 48341
- Hope Cancer Center
-
Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Pontiac, Michigan, Förenta staterna, 48341
- Michigan Healthcare Professionals Pontiac
-
Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health IHA Medical Group-Alice Gustafson Center
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Port Huron, Michigan, Förenta staterna, 48060
- McLaren-Port Huron
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Reed City, Michigan, Förenta staterna, 49677
- Corewell Health Reed City Hospital
-
Rochester Hills, Michigan, Förenta staterna, 48309
- Henry Ford Rochester Hospital
-
Saginaw, Michigan, Förenta staterna, 48604
- Oncology Hematology Associates of Saginaw Valley PC
-
Saginaw, Michigan, Förenta staterna, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Sterling Heights, Michigan, Förenta staterna, 48312
- Bhadresh Nayak MD PC-Sterling Heights
-
Tawas City, Michigan, Förenta staterna, 48764
- MyMichigan Medical Center Tawas
-
Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
-
Warren, Michigan, Förenta staterna, 48088
- Advanced Breast Care Center PLLC
-
Warren, Michigan, Förenta staterna, 48093
- Macomb Hematology Oncology PC
-
Warren, Michigan, Förenta staterna, 48093
- Henry Ford Madison Heights Hospital - Breast
-
Warren, Michigan, Förenta staterna, 48093
- Henry Ford Health Warren Hospital
-
Warren, Michigan, Förenta staterna, 48093
- Henry Ford Warren Hospital - GLCMS
-
West Branch, Michigan, Förenta staterna, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
-
Wyoming, Michigan, Förenta staterna, 49519
- University of Michigan Health - West
-
Ypsilanti, Michigan, Förenta staterna, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Ypsilanti, Michigan, Förenta staterna, 48106
- Huron Gastroenterology PC
-
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Minnesota
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Burnsville, Minnesota, Förenta staterna, 55337
- Fairview Ridges Hospital
-
Burnsville, Minnesota, Förenta staterna, 55337
- Minnesota Oncology - Burnsville
-
Cambridge, Minnesota, Förenta staterna, 55008
- Cambridge Medical Center
-
Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
-
Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
-
Fridley, Minnesota, Förenta staterna, 55432
- Unity Hospital
-
Maple Grove, Minnesota, Förenta staterna, 55369
- Fairview Clinics and Surgery Center Maple Grove
-
Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center
-
Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Förenta staterna, 55454
- Health Partners Inc
-
Monticello, Minnesota, Förenta staterna, 55362
- Monticello Cancer Center
-
New Ulm, Minnesota, Förenta staterna, 56073
- New Ulm Medical Center
-
Princeton, Minnesota, Förenta staterna, 55371
- Fairview Northland Medical Center
-
Robbinsdale, Minnesota, Förenta staterna, 55422
- North Memorial Medical Health Center
-
Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
-
Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
-
Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
-
Shakopee, Minnesota, Förenta staterna, 55379
- Saint Francis Regional Medical Center
-
Stillwater, Minnesota, Förenta staterna, 55082
- Lakeview Hospital
-
Waconia, Minnesota, Förenta staterna, 55387
- Ridgeview Medical Center
-
Willmar, Minnesota, Förenta staterna, 56201
- Rice Memorial Hospital
-
Woodbury, Minnesota, Förenta staterna, 55125
- Minnesota Oncology Hematology PA-Woodbury
-
Wyoming, Minnesota, Förenta staterna, 55092
- Fairview Lakes Medical Center
-
-
Missouri
-
Kansas City, Missouri, Förenta staterna, 64154
- University of Kansas Cancer Center - North
-
Kansas City, Missouri, Förenta staterna, 64108
- University Health Truman Medical Center
-
Lee's Summit, Missouri, Förenta staterna, 64064
- University of Kansas Cancer Center - Lee's Summit
-
North Kansas City, Missouri, Förenta staterna, 64116
- University of Kansas Cancer Center at North Kansas City Hospital
-
-
Montana
-
Anaconda, Montana, Förenta staterna, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
-
Bozeman, Montana, Förenta staterna, 59715
- Bozeman Health Deaconess Hospital
-
Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic
-
Great Falls, Montana, Förenta staterna, 59405
- Benefis Sletten Cancer Institute
-
Kalispell, Montana, Förenta staterna, 59901
- Logan Health Medical Center
-
Missoula, Montana, Förenta staterna, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Förenta staterna, 59804
- Community Medical Center
-
-
Nebraska
-
Grand Island, Nebraska, Förenta staterna, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Förenta staterna, 68847
- CHI Health Good Samaritan
-
Lincoln, Nebraska, Förenta staterna, 68510
- Saint Elizabeth Regional Medical Center
-
Omaha, Nebraska, Förenta staterna, 68114
- Nebraska Methodist Hospital
-
Omaha, Nebraska, Förenta staterna, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Förenta staterna, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Förenta staterna, 68130
- Alegent Health Lakeside Hospital
-
Papillion, Nebraska, Förenta staterna, 68046
- Midlands Community Hospital
-
-
Nevada
-
Carson City, Nevada, Förenta staterna, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Förenta staterna, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Förenta staterna, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, Förenta staterna, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, Förenta staterna, 89074
- Urology Specialists of Nevada - Green Valley
-
Henderson, Nevada, Förenta staterna, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Förenta staterna, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Förenta staterna, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Förenta staterna, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Förenta staterna, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Förenta staterna, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Förenta staterna, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Förenta staterna, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Förenta staterna, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Förenta staterna, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Förenta staterna, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Förenta staterna, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Förenta staterna, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Förenta staterna, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Förenta staterna, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Förenta staterna, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Förenta staterna, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Förenta staterna, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, Förenta staterna, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Förenta staterna, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Förenta staterna, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, Förenta staterna, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, Förenta staterna, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, Förenta staterna, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, Förenta staterna, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, Förenta staterna, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, Förenta staterna, 89169
- University Cancer Center
-
Las Vegas, Nevada, Förenta staterna, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, Förenta staterna, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, Förenta staterna, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Förenta staterna, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Förenta staterna, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Förenta staterna, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Teaneck, New Jersey, Förenta staterna, 07666
- Holy Name Hospital
-
-
New York
-
Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
-
Rochester, New York, Förenta staterna, 14642
- University of Rochester
-
-
North Carolina
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Greenville, North Carolina, Förenta staterna, 27834
- East Carolina University
-
Hillsborough, North Carolina, Förenta staterna, 27278
- University of North Carolina-Hillsborough Campus
-
-
Ohio
-
Beavercreek, Ohio, Förenta staterna, 45431
- Indu and Raj Soin Medical Center
-
Boardman, Ohio, Förenta staterna, 44512
- Saint Elizabeth Boardman Hospital
-
Centerville, Ohio, Förenta staterna, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Förenta staterna, 45459
- Dayton Physicians LLC-Miami Valley South
-
Cincinnati, Ohio, Förenta staterna, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Förenta staterna, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, Förenta staterna, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cincinnati, Ohio, Förenta staterna, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, Förenta staterna, 45255
- TriHealth Cancer Institute-Anderson
-
Cleveland, Ohio, Förenta staterna, 44109
- MetroHealth Medical Center
-
Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Förenta staterna, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Förenta staterna, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Förenta staterna, 45415
- Dayton Physician LLC - Englewood
-
Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Förenta staterna, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Förenta staterna, 45840
- Orion Cancer Care
-
Franklin, Ohio, Förenta staterna, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Förenta staterna, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Förenta staterna, 45331
- Wayne Hospital
-
Greenville, Ohio, Förenta staterna, 45331
- Dayton Physicians LLC-Wayne
-
Kettering, Ohio, Förenta staterna, 45429
- Kettering Medical Center
-
Kettering, Ohio, Förenta staterna, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, Förenta staterna, 45420
- First Dayton Cancer Care
-
Mansfield, Ohio, Förenta staterna, 44906
- Cleveland Clinic Cancer Center Mansfield
-
Mayfield Heights, Ohio, Förenta staterna, 44124
- Hillcrest Hospital Cancer Center
-
Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care
-
Strongsville, Ohio, Förenta staterna, 44136
- Cleveland Clinic Cancer Center Strongsville
-
Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Förenta staterna, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, Förenta staterna, 44484
- Saint Joseph Warren Hospital
-
Warrensville Heights, Ohio, Förenta staterna, 44122
- South Pointe Hospital
-
Wooster, Ohio, Förenta staterna, 44691
- Cleveland Clinic Wooster Family Health and Surgery Center
-
Youngstown, Ohio, Förenta staterna, 44501
- Saint Elizabeth Youngstown Hospital
-
-
Oklahoma
-
Lawton, Oklahoma, Förenta staterna, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Baker City, Oregon, Förenta staterna, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Bend, Oregon, Förenta staterna, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Förenta staterna, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Förenta staterna, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Förenta staterna, 97420
- Bay Area Hospital
-
Newberg, Oregon, Förenta staterna, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, Förenta staterna, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Portland, Oregon, Förenta staterna, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Förenta staterna, 97225
- Providence Saint Vincent Medical Center
-
Redmond, Oregon, Förenta staterna, 97756
- Saint Charles Health System-Redmond
-
-
Pennsylvania
-
Allentown, Pennsylvania, Förenta staterna, 18103
- Lehigh Valley Hospital-Cedar Crest
-
Bethlehem, Pennsylvania, Förenta staterna, 18017
- Lehigh Valley Hospital - Muhlenberg
-
East Stroudsburg, Pennsylvania, Förenta staterna, 18301
- Pocono Medical Center
-
Hazleton, Pennsylvania, Förenta staterna, 18201
- Lehigh Valley Hospital-Hazleton
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Philadelphia, Pennsylvania, Förenta staterna, 19140
- Temple University Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15232
- UPMC Hillman Cancer Center
-
-
South Carolina
-
Boiling Springs, South Carolina, Förenta staterna, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Easley, South Carolina, Förenta staterna, 29640
- Prisma Health Cancer Institute - Easley
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Förenta staterna, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Butternut
-
Greer, South Carolina, Förenta staterna, 29650
- Prisma Health Cancer Institute - Greer
-
Seneca, South Carolina, Förenta staterna, 29672
- Prisma Health Cancer Institute - Seneca
-
-
South Dakota
-
Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera Cancer Institute
-
-
Tennessee
-
Bristol, Tennessee, Förenta staterna, 37620
- Bristol Regional Medical Center
-
Franklin, Tennessee, Förenta staterna, 37067
- Vanderbilt-Ingram Cancer Center Cool Springs
-
Franklin, Tennessee, Förenta staterna, 37067
- Vanderbilt-Ingram Cancer Center at Franklin
-
Kingsport, Tennessee, Förenta staterna, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, Förenta staterna, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Förenta staterna, 37204
- Vanderbilt Breast Center at One Hundred Oaks
-
-
Texas
-
Bryan, Texas, Förenta staterna, 77802
- Saint Joseph Regional Cancer Center
-
Dallas, Texas, Förenta staterna, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Förenta staterna, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Fort Worth, Texas, Förenta staterna, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Richardson, Texas, Förenta staterna, 75080
- UT Southwestern Clinical Center at Richardson/Plano
-
-
Virginia
-
Bristol, Virginia, Förenta staterna, 24201
- Ballad Health Cancer Care - Bristol
-
Martinsville, Virginia, Förenta staterna, 24112
- Sovah Health Martinsville
-
Norton, Virginia, Förenta staterna, 24273
- Ballad Health Cancer Care - Norton
-
-
Washington
-
Aberdeen, Washington, Förenta staterna, 98520
- Providence Regional Cancer System-Aberdeen
-
Bellevue, Washington, Förenta staterna, 98004
- Overlake Medical Center
-
Bellingham, Washington, Förenta staterna, 98225
- PeaceHealth Saint Joseph Medical Center
-
Burien, Washington, Förenta staterna, 98166
- Saint Anne Hospital
-
Centralia, Washington, Förenta staterna, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Förenta staterna, 98026
- Swedish Cancer Institute-Edmonds
-
Enumclaw, Washington, Förenta staterna, 98022
- Saint Elizabeth Hospital
-
Everett, Washington, Förenta staterna, 98201
- Providence Regional Cancer Partnership
-
Federal Way, Washington, Förenta staterna, 98003
- Saint Francis Hospital
-
Issaquah, Washington, Förenta staterna, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, Förenta staterna, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, Förenta staterna, 98503
- Providence Regional Cancer System-Lacey
-
Lakewood, Washington, Förenta staterna, 98499
- Saint Clare Hospital
-
Longview, Washington, Förenta staterna, 98632
- PeaceHealth Saint John Medical Center
-
Poulsbo, Washington, Förenta staterna, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Renton, Washington, Förenta staterna, 98055
- Valley Medical Center
-
Seattle, Washington, Förenta staterna, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Förenta staterna, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Förenta staterna, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Förenta staterna, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, Förenta staterna, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, Förenta staterna, 98584
- Providence Regional Cancer System-Shelton
-
Silverdale, Washington, Förenta staterna, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Tacoma, Washington, Förenta staterna, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Förenta staterna, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
Vancouver, Washington, Förenta staterna, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Förenta staterna, 99362
- Providence Saint Mary Regional Cancer Center
-
Yelm, Washington, Förenta staterna, 98597
- Providence Regional Cancer System-Yelm
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Menomonee Falls, Wisconsin, Förenta staterna, 53051
- Froedtert Menomonee Falls Hospital
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
-
New Richmond, Wisconsin, Förenta staterna, 54017
- Cancer Center of Western Wisconsin
-
West Bend, Wisconsin, Förenta staterna, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
-
Wyoming
-
Cody, Wyoming, Förenta staterna, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
|
|
Experimentell: 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
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective Response
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical Benefit
Tidsram: 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
|
|
Progression-free Survival (PFS)
Tidsram: Every 3 months for the first year and every 6 months for years 2-3
|
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
|
|
Overall Survival (OS)
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Förekomst av biverkningar
Tidsram: Bedöms var tredje vecka under behandlingen och i 30 dagar efter avslutad behandling, upp till 3 år
|
Bedöms var tredje vecka under behandlingen och i 30 dagar efter avslutad behandling, upp till 3 år
|
|
|
Associations Between Response and Overexpression of NEDD8, NAE1, and UBC12
Tidsram: Assessed every 3 months for the first year and every 6 months for years 2-3
|
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
|
|
Mutation Profile of Those Cholangiocarcinomas
Tidsram: Assessed at baseline
|
To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway |
Assessed at baseline
|
|
Specimens Banking
Tidsram: Baseline
|
To bank specimens for further future investigations |
Baseline
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Dustin A Deming, ECOG-ACRIN Cancer Research Group
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
16 mars 2020
Primärt slutförande (Faktisk)
27 november 2023
Avslutad studie (Beräknad)
3 september 2027
Studieregistreringsdatum
Först inskickad
22 november 2019
Först inskickad som uppfyllde QC-kriterierna
22 november 2019
Första postat (Faktisk)
25 november 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
26 oktober 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 oktober 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Leversjukdomar
- Neoplasmer, körtel och epitel
- Adenocarcinom
- Neoplasmer i levern
- Carcinom
- Karcinom, hepatocellulärt
- Kolangiokarcinom
- Organiska kemikalier
- Kolväten
- Cykloparaffiner
- Kolväten, alicyklisk
- Kolväten, cykliska
- Terpener
- Koordinationskomplex
- Taxoids
- Cyklodekaner
- Gentare
- Hälsovårdsekonomi och organisationer
- Ekonomi
- Karboplatin
- Paklitaxel
- Skatter
- pevonedistat
Andra studie-ID-nummer
- NCI-2019-07769
- U10CA180820 (U.S.S. NIH-anslag/kontrakt)
- NCI-2019-07769 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- EA2187 (Annan identifierare: CTEP)
- EA2187 (Annan identifierare: ECOG-ACRIN Cancer Research Group)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .