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Test af kombinationen af pevonedistat med kemoterapi for galdevejskræft i leveren

23. oktober 2026 opdateret af: National Cancer Institute (NCI)

Et fase 2-studie af pevonedistat i kombination med carboplatin og paclitaxel i avanceret intrahepatisk cholangiocarcinom

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

Fase

Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Alaska
  - Anchorage, Alaska, Forenede Stater, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, Forenede Stater, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, Forenede Stater, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, Forenede Stater, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, Forenede Stater, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, Forenede Stater, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, Forenede Stater, 99508
    - Providence Alaska Medical Center
  - Anchorage, Alaska, Forenede Stater, 99504
    - Anchorage Radiation Therapy Center
- Arizona
  - Kingman, Arizona, Forenede Stater, 86401
    - Kingman Regional Medical Center
  - Phoenix, Arizona, Forenede Stater, 85004
    - Cancer Center at Saint Joseph's
- Arkansas
  - Hot Springs, Arkansas, Forenede Stater, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
- California
  - Arroyo Grande, California, Forenede Stater, 93420
    - PCR Oncology
  - Arroyo Grande, California, Forenede Stater, 93420
    - Mission Hope Medical Oncology - Arroyo Grande
  - Auburn, California, Forenede Stater, 95602
    - Sutter Auburn Faith Hospital
  - Auburn, California, Forenede Stater, 95603
    - Sutter Cancer Centers Radiation Oncology Services-Auburn
  - Berkeley, California, Forenede Stater, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burbank, California, Forenede Stater, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Cameron Park, California, Forenede Stater, 95682
    - Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  - Castro Valley, California, Forenede Stater, 94546
    - Eden Hospital Medical Center
  - Davis, California, Forenede Stater, 95616
    - Sutter Davis Hospital
  - Duarte, California, Forenede Stater, 91010
    - City of Hope Comprehensive Cancer Center
  - Fremont, California, Forenede Stater, 94538
    - Palo Alto Medical Foundation-Fremont
  - Modesto, California, Forenede Stater, 95355
    - Memorial Medical Center
  - Mountain View, California, Forenede Stater, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Mountain View, California, Forenede Stater, 94040
    - Palo Alto Medical Foundation-Gynecologic Oncology
  - Palo Alto, California, Forenede Stater, 94301
    - Palo Alto Medical Foundation Health Care
  - Roseville, California, Forenede Stater, 95661
    - Sutter Cancer Centers Radiation Oncology Services-Roseville
  - Roseville, California, Forenede Stater, 95661
    - Sutter Roseville Medical Center
  - Sacramento, California, Forenede Stater, 95816
    - Sutter Medical Center Sacramento
  - San Francisco, California, Forenede Stater, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Mateo, California, Forenede Stater, 94401
    - Mills Health Center
  - Santa Cruz, California, Forenede Stater, 95065
    - Palo Alto Medical Foundation-Santa Cruz
  - Santa Maria, California, Forenede Stater, 93444
    - Mission Hope Medical Oncology - Santa Maria
  - Santa Rosa, California, Forenede Stater, 95403
    - Sutter Pacific Medical Foundation
  - Sunnyvale, California, Forenede Stater, 94086
    - Palo Alto Medical Foundation-Sunnyvale
  - Vallejo, California, Forenede Stater, 94589
    - Sutter Solano Medical Center/Cancer Center
- Colorado
  - Colorado Springs, Colorado, Forenede Stater, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, Forenede Stater, 80909
    - UCHealth Memorial Hospital Central
  - Colorado Springs, Colorado, Forenede Stater, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Colorado Springs, Colorado, Forenede Stater, 80920
    - Memorial Hospital North
  - Denver, Colorado, Forenede Stater, 80210
    - AdventHealth Porter
  - Durango, Colorado, Forenede Stater, 81301
    - Mercy Medical Center
  - Durango, Colorado, Forenede Stater, 81301
    - CommonSpirit Cancer Center Mercy
  - Fort Collins, Colorado, Forenede Stater, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, Forenede Stater, 80528
    - Cancer Care and Hematology-Fort Collins
  - Greeley, Colorado, Forenede Stater, 80631
    - UCHealth Greeley Hospital
  - Lakewood, Colorado, Forenede Stater, 80228
    - CommonSpirit Saint Anthony Hospital Cancer Center
  - Littleton, Colorado, Forenede Stater, 80122
    - AdventHealth Littleton
  - Longmont, Colorado, Forenede Stater, 80501
    - Longmont United Hospital
  - Longmont, Colorado, Forenede Stater, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, Forenede Stater, 80538
    - Medical Center of the Rockies
  - Parker, Colorado, Forenede Stater, 80138
    - AdventHealth Parker
  - Pueblo, Colorado, Forenede Stater, 81004
    - Saint Mary Corwin Medical Center
- Florida
  - Coral Gables, Florida, Forenede Stater, 33146
    - UM Sylvester Comprehensive Cancer Center at Coral Gables
  - Deerfield Beach, Florida, Forenede Stater, 33442
    - UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  - Fort Lauderdale, Florida, Forenede Stater, 33308
    - Holy Cross Hospital
  - Miami, Florida, Forenede Stater, 33136
    - University of Miami Miller School of Medicine-Sylvester Cancer Center
  - Miami, Florida, Forenede Stater, 33176
    - UM Sylvester Comprehensive Cancer Center at Kendall
  - Plantation, Florida, Forenede Stater, 33324
    - UM Sylvester Comprehensive Cancer Center at Plantation
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, Forenede Stater, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Queen's Cancer Cenrer - POB I
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, Forenede Stater, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, Forenede Stater, 96817
    - Hawaii Cancer Care Inc-Liliha
  - Honolulu, Hawaii, Forenede Stater, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, Forenede Stater, 96817
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, Forenede Stater, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Island Urology
  - Lihue, Hawaii, Forenede Stater, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
  - ‘Aiea, Hawaii, Forenede Stater, 96701
    - Hawaii Cancer Care - Westridge
  - ‘Aiea, Hawaii, Forenede Stater, 96701
    - Pali Momi Medical Center
  - ‘Aiea, Hawaii, Forenede Stater, 96701
    - Queen's Cancer Center - Pearlridge
  - ‘Aiea, Hawaii, Forenede Stater, 96701
    - The Cancer Center of Hawaii-Pali Momi
- Idaho
  - Boise, Idaho, Forenede Stater, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Boise, Idaho, Forenede Stater, 83712
    - Saint Luke's Cancer Institute - Boise
  - Caldwell, Idaho, Forenede Stater, 83605
    - Saint Alphonsus Cancer Care Center-Caldwell
  - Coeur d'Alene, Idaho, Forenede Stater, 83814
    - Kootenai Health - Coeur d'Alene
  - Emmett, Idaho, Forenede Stater, 83617
    - Walter Knox Memorial Hospital
  - Fruitland, Idaho, Forenede Stater, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, Forenede Stater, 83642
    - Idaho Urologic Institute-Meridian
  - Meridian, Idaho, Forenede Stater, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, Forenede Stater, 83687
    - Saint Alphonsus Cancer Care Center-Nampa
  - Nampa, Idaho, Forenede Stater, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Post Falls, Idaho, Forenede Stater, 83854
    - Kootenai Clinic Cancer Services - Post Falls
  - Sandpoint, Idaho, Forenede Stater, 83864
    - Kootenai Clinic Cancer Services - Sandpoint
  - Twin Falls, Idaho, Forenede Stater, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Chicago, Illinois, Forenede Stater, 60611
    - Northwestern University
  - Lake Forest, Illinois, Forenede Stater, 60045
    - Northwestern Medicine Lake Forest Hospital
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46237
    - Franciscan Health Indianapolis
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Indiana University/Melvin and Bren Simon Cancer Center
  - Mooresville, Indiana, Forenede Stater, 46158
    - Franciscan Health Mooresville
  - Richmond, Indiana, Forenede Stater, 47374
    - Reid Health
  - Terre Haute, Indiana, Forenede Stater, 47804
    - Union Hospital
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, Forenede Stater, 50010
    - McFarland Clinic - Ames
  - Boone, Iowa, Forenede Stater, 50036
    - McFarland Clinic - Boone
  - Clive, Iowa, Forenede Stater, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, Forenede Stater, 50325
    - UI Health Care Mission Cancer and Blood - West Des Moines Clinic
  - Council Bluffs, Iowa, Forenede Stater, 51503
    - Alegent Health Mercy Hospital
  - Creston, Iowa, Forenede Stater, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, Forenede Stater, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, Forenede Stater, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, Forenede Stater, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, Forenede Stater, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, Forenede Stater, 50309
    - UI Health Care Mission Cancer and Blood - Des Moines Clinic
  - Des Moines, Iowa, Forenede Stater, 50314
    - UI Health Care Mission Cancer and Blood - Laurel Clinic
  - Fort Dodge, Iowa, Forenede Stater, 50501
    - McFarland Clinic - Trinity Cancer Center
  - Fort Dodge, Iowa, Forenede Stater, 50501
    - UI Healthcare Mission Cancer and Blood - Fort Dodge
  - Jefferson, Iowa, Forenede Stater, 50129
    - McFarland Clinic - Jefferson
  - Marshalltown, Iowa, Forenede Stater, 50158
    - McFarland Clinic - Marshalltown
  - West Des Moines, Iowa, Forenede Stater, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, Forenede Stater, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Fairway, Kansas, Forenede Stater, 66205
    - University of Kansas Clinical Research Center
  - Hays, Kansas, Forenede Stater, 67601
    - HaysMed
  - Kansas City, Kansas, Forenede Stater, 66160
    - University of Kansas Cancer Center
  - Kansas City, Kansas, Forenede Stater, 66112
    - University of Kansas Cancer Center-West
  - Lawrence, Kansas, Forenede Stater, 66044
    - Lawrence Memorial Hospital
  - Olathe, Kansas, Forenede Stater, 66061
    - The University of Kansas Cancer Center - Olathe
  - Overland Park, Kansas, Forenede Stater, 66210
    - University of Kansas Cancer Center-Overland Park
  - Pittsburg, Kansas, Forenede Stater, 66762
    - Mercy Hospital Pittsburg
  - Salina, Kansas, Forenede Stater, 67401
    - Salina Regional Health Center
  - Topeka, Kansas, Forenede Stater, 66606
    - University of Kansas Health System Saint Francis Campus
  - Westwood, Kansas, Forenede Stater, 66205
    - University of Kansas Hospital-Westwood Cancer Center
- Kentucky
  - Bardstown, Kentucky, Forenede Stater, 40004
    - CommonSpirit Saint Joseph Hospital - Bardstown
  - Corbin, Kentucky, Forenede Stater, 40701
    - Commonwealth Cancer Center-Corbin
  - Lexington, Kentucky, Forenede Stater, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, Forenede Stater, 40509
    - CommonSpirit Saint Joseph Medical Center - East Lexington
  - London, Kentucky, Forenede Stater, 40741
    - CommonSpirit Saint Joseph Hospital London
  - Louisville, Kentucky, Forenede Stater, 40202
    - Jewish Hospital
  - Louisville, Kentucky, Forenede Stater, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, Forenede Stater, 40215
    - Saints Mary and Elizabeth Hospital
  - Shepherdsville, Kentucky, Forenede Stater, 40165
    - Jewish Hospital Medical Center South
- Maine
  - Brewer, Maine, Forenede Stater, 04412
    - Lafayette Family Cancer Center-EMMC
- Massachusetts
  - Springfield, Massachusetts, Forenede Stater, 01104
    - Mercy Medical Center
  - Worcester, Massachusetts, Forenede Stater, 01655
    - UMass Memorial Medical Center - University Campus
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - Trinity Health Saint Joseph Mercy Hospital Ann Arbor
  - Battle Creek, Michigan, Forenede Stater, 49017
    - Bronson Battle Creek
  - Bay City, Michigan, Forenede Stater, 48706
    - McLaren Cancer Institute-Bay City
  - Brighton, Michigan, Forenede Stater, 48114
    - Trinity Health IHA Medical Group Hematology Oncology - Brighton
  - Brighton, Michigan, Forenede Stater, 48114
    - Trinity Health Medical Center - Brighton
  - Canton, Michigan, Forenede Stater, 48188
    - Trinity Health IHA Medical Group Hematology Oncology - Canton
  - Canton, Michigan, Forenede Stater, 48188
    - Trinity Health Medical Center - Canton
  - Caro, Michigan, Forenede Stater, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, Forenede Stater, 48118
    - Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
  - Chelsea, Michigan, Forenede Stater, 48118
    - Chelsea Hospital
  - Clarkston, Michigan, Forenede Stater, 48346
    - McLaren Cancer Institute-Clarkston
  - Clarkston, Michigan, Forenede Stater, 48346
    - Hematology Oncology Consultants-Clarkston
  - Clarkston, Michigan, Forenede Stater, 48346
    - Newland Medical Associates-Clarkston
  - Detroit, Michigan, Forenede Stater, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Detroit, Michigan, Forenede Stater, 48236
    - Henry Ford Health Saint John Hospital
  - East China Township, Michigan, Forenede Stater, 48054
    - Henry Ford River District Hospital
  - Farmington Hills, Michigan, Forenede Stater, 48334
    - Weisberg Cancer Treatment Center
  - Flint, Michigan, Forenede Stater, 48532
    - McLaren Cancer Institute-Flint
  - Flint, Michigan, Forenede Stater, 48532
    - Singh and Arora Hematology Oncology PC
  - Flint, Michigan, Forenede Stater, 48503
    - Hurley Medical Center
  - Flint, Michigan, Forenede Stater, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, Forenede Stater, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, Forenede Stater, 48503
    - Cancer Hematology Centers - Flint
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Trinity Health Grand Rapids Hospital
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Corewell Health Grand Rapids Hospitals - Butterworth Hospital
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
  - Grosse Pointe Woods, Michigan, Forenede Stater, 48236
    - Henry Ford Saint John Hospital - Academic
  - Grosse Pointe Woods, Michigan, Forenede Stater, 48236
    - Henry Ford Saint John Hospital - Breast
  - Grosse Pointe Woods, Michigan, Forenede Stater, 48236
    - Henry Ford Saint John Hospital - Van Elslander
  - Kalamazoo, Michigan, Forenede Stater, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, Forenede Stater, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, Forenede Stater, 49048
    - Beacon Kalamazoo
  - Lansing, Michigan, Forenede Stater, 48912
    - Mid-Michigan Physicians-Lansing
  - Lansing, Michigan, Forenede Stater, 48910
    - Karmanos Cancer Institute at McLaren Greater Lansing
  - Lansing, Michigan, Forenede Stater, 48912
    - University of Michigan Health - Sparrow Lansing
  - Lapeer, Michigan, Forenede Stater, 48446
    - McLaren Cancer Institute-Lapeer Region
  - Livonia, Michigan, Forenede Stater, 48154
    - Trinity Health Saint Mary Mercy Livonia Hospital
  - Livonia, Michigan, Forenede Stater, 48154
    - Hope Cancer Clinic
  - Macomb, Michigan, Forenede Stater, 48044
    - Henry Ford Warren Hospital - Breast Macomb
  - Macomb, Michigan, Forenede Stater, 48044
    - Henry Ford Saint John Hospital - Macomb Medical
  - Marlette, Michigan, Forenede Stater, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - Mount Clemens, Michigan, Forenede Stater, 48043
    - McLaren Cancer Institute-Macomb
  - Mount Pleasant, Michigan, Forenede Stater, 48858
    - McLaren Cancer Institute-Central Michigan
  - Muskegon, Michigan, Forenede Stater, 49444
    - Trinity Health Muskegon Hospital
  - Niles, Michigan, Forenede Stater, 49120
    - Corewell Health Lakeland Hospitals - Niles Hospital
  - Norton Shores, Michigan, Forenede Stater, 49444
    - Cancer and Hematology Centers of Western Michigan - Norton Shores
  - Petoskey, Michigan, Forenede Stater, 49770
    - McLaren Cancer Institute-Northern Michigan
  - Pontiac, Michigan, Forenede Stater, 48341
    - Hope Cancer Center
  - Pontiac, Michigan, Forenede Stater, 48341
    - Trinity Health Saint Joseph Mercy Oakland Hospital
  - Pontiac, Michigan, Forenede Stater, 48341
    - Michigan Healthcare Professionals Pontiac
  - Pontiac, Michigan, Forenede Stater, 48341
    - Trinity Health IHA Medical Group-Alice Gustafson Center
  - Port Huron, Michigan, Forenede Stater, 48060
    - McLaren-Port Huron
  - Reed City, Michigan, Forenede Stater, 49677
    - Corewell Health Reed City Hospital
  - Rochester Hills, Michigan, Forenede Stater, 48309
    - Henry Ford Rochester Hospital
  - Saginaw, Michigan, Forenede Stater, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saginaw, Michigan, Forenede Stater, 48601
    - MyMichigan Medical Center Saginaw
  - Saint Joseph, Michigan, Forenede Stater, 49085
    - Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
  - Saint Joseph, Michigan, Forenede Stater, 49085
    - Corewell Health Lakeland Hospitals - Saint Joseph Hospital
  - Sterling Heights, Michigan, Forenede Stater, 48312
    - Bhadresh Nayak MD PC-Sterling Heights
  - Tawas City, Michigan, Forenede Stater, 48764
    - MyMichigan Medical Center Tawas
  - Traverse City, Michigan, Forenede Stater, 49684
    - Munson Medical Center
  - Warren, Michigan, Forenede Stater, 48088
    - Advanced Breast Care Center PLLC
  - Warren, Michigan, Forenede Stater, 48093
    - Macomb Hematology Oncology PC
  - Warren, Michigan, Forenede Stater, 48093
    - Henry Ford Madison Heights Hospital - Breast
  - Warren, Michigan, Forenede Stater, 48093
    - Henry Ford Health Warren Hospital
  - Warren, Michigan, Forenede Stater, 48093
    - Henry Ford Warren Hospital - GLCMS
  - West Branch, Michigan, Forenede Stater, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Wyoming, Michigan, Forenede Stater, 49519
    - University of Michigan Health - West
  - Ypsilanti, Michigan, Forenede Stater, 48197
    - Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
  - Ypsilanti, Michigan, Forenede Stater, 48106
    - Huron Gastroenterology PC
- Minnesota
  - Burnsville, Minnesota, Forenede Stater, 55337
    - Fairview Ridges Hospital
  - Burnsville, Minnesota, Forenede Stater, 55337
    - Minnesota Oncology - Burnsville
  - Cambridge, Minnesota, Forenede Stater, 55008
    - Cambridge Medical Center
  - Coon Rapids, Minnesota, Forenede Stater, 55433
    - Mercy Hospital
  - Edina, Minnesota, Forenede Stater, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, Forenede Stater, 55432
    - Unity Hospital
  - Maple Grove, Minnesota, Forenede Stater, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, Forenede Stater, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, Forenede Stater, 55454
    - Health Partners Inc
  - Monticello, Minnesota, Forenede Stater, 55362
    - Monticello Cancer Center
  - New Ulm, Minnesota, Forenede Stater, 56073
    - New Ulm Medical Center
  - Princeton, Minnesota, Forenede Stater, 55371
    - Fairview Northland Medical Center
  - Robbinsdale, Minnesota, Forenede Stater, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, Forenede Stater, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, Forenede Stater, 55102
    - United Hospital
  - Shakopee, Minnesota, Forenede Stater, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, Forenede Stater, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, Forenede Stater, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, Forenede Stater, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Wyoming, Minnesota, Forenede Stater, 55092
    - Fairview Lakes Medical Center
- Missouri
  - Kansas City, Missouri, Forenede Stater, 64154
    - University of Kansas Cancer Center - North
  - Kansas City, Missouri, Forenede Stater, 64108
    - University Health Truman Medical Center
  - Lee's Summit, Missouri, Forenede Stater, 64064
    - University of Kansas Cancer Center - Lee's Summit
  - North Kansas City, Missouri, Forenede Stater, 64116
    - University of Kansas Cancer Center at North Kansas City Hospital
- Montana
  - Anaconda, Montana, Forenede Stater, 59711
    - Community Hospital of Anaconda
  - Billings, Montana, Forenede Stater, 59101
    - Billings Clinic Cancer Center
  - Bozeman, Montana, Forenede Stater, 59715
    - Bozeman Health Deaconess Hospital
  - Great Falls, Montana, Forenede Stater, 59405
    - Great Falls Clinic
  - Great Falls, Montana, Forenede Stater, 59405
    - Benefis Sletten Cancer Institute
  - Kalispell, Montana, Forenede Stater, 59901
    - Logan Health Medical Center
  - Missoula, Montana, Forenede Stater, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, Forenede Stater, 59804
    - Community Medical Center
- Nebraska
  - Grand Island, Nebraska, Forenede Stater, 68803
    - Nebraska Cancer Specialists/Oncology Hematology West PC
  - Kearney, Nebraska, Forenede Stater, 68847
    - CHI Health Good Samaritan
  - Lincoln, Nebraska, Forenede Stater, 68510
    - Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, Forenede Stater, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, Forenede Stater, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, Forenede Stater, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, Forenede Stater, 68130
    - Alegent Health Lakeside Hospital
  - Papillion, Nebraska, Forenede Stater, 68046
    - Midlands Community Hospital
- Nevada
  - Carson City, Nevada, Forenede Stater, 89703
    - Carson Tahoe Regional Medical Center
  - Henderson, Nevada, Forenede Stater, 89052
    - Comprehensive Cancer Centers of Nevada - Henderson
  - Henderson, Nevada, Forenede Stater, 89052
    - Cancer and Blood Specialists-Henderson
  - Henderson, Nevada, Forenede Stater, 89052
    - Las Vegas Cancer Center-Henderson
  - Henderson, Nevada, Forenede Stater, 89074
    - Comprehensive Cancer Centers of Nevada-Southeast Henderson
  - Henderson, Nevada, Forenede Stater, 89052
    - Comprehensive Cancer Centers of Nevada-Horizon Ridge
  - Henderson, Nevada, Forenede Stater, 89074
    - Las Vegas Urology - Green Valley
  - Henderson, Nevada, Forenede Stater, 89074
    - Las Vegas Urology - Pebble
  - Henderson, Nevada, Forenede Stater, 89074
    - Urology Specialists of Nevada - Green Valley
  - Henderson, Nevada, Forenede Stater, 89074
    - Oncology Las Vegas - Henderson
  - Las Vegas, Nevada, Forenede Stater, 89144
    - Summerlin Hospital Medical Center
  - Las Vegas, Nevada, Forenede Stater, 89109
    - Sunrise Hospital and Medical Center
  - Las Vegas, Nevada, Forenede Stater, 89102
    - OptumCare Cancer Care at Charleston
  - Las Vegas, Nevada, Forenede Stater, 89106
    - Radiation Oncology Centers of Nevada Central
  - Las Vegas, Nevada, Forenede Stater, 89119
    - Radiation Oncology Centers of Nevada Southeast
  - Las Vegas, Nevada, Forenede Stater, 89128
    - Comprehensive Cancer Centers of Nevada - Northwest
  - Las Vegas, Nevada, Forenede Stater, 89128
    - OptumCare Cancer Care at MountainView
  - Las Vegas, Nevada, Forenede Stater, 89135
    - Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  - Las Vegas, Nevada, Forenede Stater, 89144
    - Comprehensive Cancer Centers of Nevada - Town Center
  - Las Vegas, Nevada, Forenede Stater, 89144
    - Comprehensive Cancer Centers of Nevada-Summerlin
  - Las Vegas, Nevada, Forenede Stater, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, Forenede Stater, 89169
    - Comprehensive Cancer Centers of Nevada - Central Valley
  - Las Vegas, Nevada, Forenede Stater, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, Forenede Stater, 89106
    - Cancer and Blood Specialists-Shadow
  - Las Vegas, Nevada, Forenede Stater, 89109
    - HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
  - Las Vegas, Nevada, Forenede Stater, 89113
    - HealthCare Partners Medical Group Oncology/Hematology-San Martin
  - Las Vegas, Nevada, Forenede Stater, 89128
    - Cancer and Blood Specialists-Tenaya
  - Las Vegas, Nevada, Forenede Stater, 89128
    - HealthCare Partners Medical Group Oncology/Hematology-Tenaya
  - Las Vegas, Nevada, Forenede Stater, 89148-2405
    - Las Vegas Cancer Center-Medical Center
  - Las Vegas, Nevada, Forenede Stater, 89149
    - HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
  - Las Vegas, Nevada, Forenede Stater, 89128
    - Ann M Wierman MD LTD
  - Las Vegas, Nevada, Forenede Stater, 89074
    - Las Vegas Urology - Pecos
  - Las Vegas, Nevada, Forenede Stater, 89102
    - Desert West Surgery
  - Las Vegas, Nevada, Forenede Stater, 89103
    - Hope Cancer Care of Nevada
  - Las Vegas, Nevada, Forenede Stater, 89106
    - Urology Specialists of Nevada - Central
  - Las Vegas, Nevada, Forenede Stater, 89113
    - Las Vegas Prostate Cancer Center
  - Las Vegas, Nevada, Forenede Stater, 89113
    - Las Vegas Urology - Sunset
  - Las Vegas, Nevada, Forenede Stater, 89128
    - Las Vegas Urology - Cathedral Rock
  - Las Vegas, Nevada, Forenede Stater, 89128
    - Las Vegas Urology - Smoke Ranch
  - Las Vegas, Nevada, Forenede Stater, 89128
    - Urology Specialists of Nevada - Northwest
  - Las Vegas, Nevada, Forenede Stater, 89169
    - University Cancer Center
  - Las Vegas, Nevada, Forenede Stater, 89113
    - Urology Specialists of Nevada - Southwest
  - Las Vegas, Nevada, Forenede Stater, 89128
    - Oncology Las Vegas - Tenaya
  - Las Vegas, Nevada, Forenede Stater, 89183
    - OptumCare Cancer Care at Fort Apache
  - Pahrump, Nevada, Forenede Stater, 89048
    - Hope Cancer Care of Nevada-Pahrump
  - Reno, Nevada, Forenede Stater, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, Forenede Stater, 89503
    - Saint Mary's Regional Medical Center
  - Reno, Nevada, Forenede Stater, 89509
    - Radiation Oncology Associates
- New Hampshire
  - Lebanon, New Hampshire, Forenede Stater, 03756
    - Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
- New Jersey
  - Teaneck, New Jersey, Forenede Stater, 07666
    - Holy Name Hospital
- New York
  - Buffalo, New York, Forenede Stater, 14263
    - Roswell Park Cancer Institute
  - Rochester, New York, Forenede Stater, 14642
    - University of Rochester
- North Carolina
  - Chapel Hill, North Carolina, Forenede Stater, 27599
    - UNC Lineberger Comprehensive Cancer Center
  - Greenville, North Carolina, Forenede Stater, 27834
    - East Carolina University
  - Hillsborough, North Carolina, Forenede Stater, 27278
    - University of North Carolina-Hillsborough Campus
- Ohio
  - Beavercreek, Ohio, Forenede Stater, 45431
    - Indu and Raj Soin Medical Center
  - Boardman, Ohio, Forenede Stater, 44512
    - Saint Elizabeth Boardman Hospital
  - Centerville, Ohio, Forenede Stater, 45459
    - Miami Valley Hospital South
  - Centerville, Ohio, Forenede Stater, 45459
    - Dayton Physicians LLC-Miami Valley South
  - Cincinnati, Ohio, Forenede Stater, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, Forenede Stater, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, Forenede Stater, 45236
    - Oncology Hematology Care Inc-Kenwood
  - Cincinnati, Ohio, Forenede Stater, 45247
    - TriHealth Cancer Institute-Westside
  - Cincinnati, Ohio, Forenede Stater, 45255
    - TriHealth Cancer Institute-Anderson
  - Cleveland, Ohio, Forenede Stater, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, Forenede Stater, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, Forenede Stater, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Dayton, Ohio, Forenede Stater, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, Forenede Stater, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, Forenede Stater, 45415
    - Dayton Physician LLC - Englewood
  - Findlay, Ohio, Forenede Stater, 45840
    - Blanchard Valley Hospital
  - Findlay, Ohio, Forenede Stater, 45840
    - Armes Family Cancer Center
  - Findlay, Ohio, Forenede Stater, 45840
    - Orion Cancer Care
  - Franklin, Ohio, Forenede Stater, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Franklin, Ohio, Forenede Stater, 45005
    - Dayton Physicians LLC-Atrium
  - Greenville, Ohio, Forenede Stater, 45331
    - Wayne Hospital
  - Greenville, Ohio, Forenede Stater, 45331
    - Dayton Physicians LLC-Wayne
  - Kettering, Ohio, Forenede Stater, 45429
    - Kettering Medical Center
  - Kettering, Ohio, Forenede Stater, 45409
    - Greater Dayton Cancer Center
  - Kettering, Ohio, Forenede Stater, 45420
    - First Dayton Cancer Care
  - Mansfield, Ohio, Forenede Stater, 44906
    - Cleveland Clinic Cancer Center Mansfield
  - Mayfield Heights, Ohio, Forenede Stater, 44124
    - Hillcrest Hospital Cancer Center
  - Sandusky, Ohio, Forenede Stater, 44870
    - North Coast Cancer Care
  - Strongsville, Ohio, Forenede Stater, 44136
    - Cleveland Clinic Cancer Center Strongsville
  - Troy, Ohio, Forenede Stater, 45373
    - Upper Valley Medical Center
  - Troy, Ohio, Forenede Stater, 45373
    - Dayton Physicians LLC - Troy
  - Warren, Ohio, Forenede Stater, 44484
    - Saint Joseph Warren Hospital
  - Warrensville Heights, Ohio, Forenede Stater, 44122
    - South Pointe Hospital
  - Wooster, Ohio, Forenede Stater, 44691
    - Cleveland Clinic Wooster Family Health and Surgery Center
  - Youngstown, Ohio, Forenede Stater, 44501
    - Saint Elizabeth Youngstown Hospital
- Oklahoma
  - Lawton, Oklahoma, Forenede Stater, 73505
    - Cancer Centers of Southwest Oklahoma Research
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - University of Oklahoma Health Sciences Center
- Oregon
  - Baker City, Oregon, Forenede Stater, 97814
    - Saint Alphonsus Cancer Care Center-Baker City
  - Bend, Oregon, Forenede Stater, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, Forenede Stater, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, Forenede Stater, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Coos Bay, Oregon, Forenede Stater, 97420
    - Bay Area Hospital
  - Newberg, Oregon, Forenede Stater, 97132
    - Providence Newberg Medical Center
  - Ontario, Oregon, Forenede Stater, 97914
    - Saint Alphonsus Cancer Care Center-Ontario
  - Portland, Oregon, Forenede Stater, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, Forenede Stater, 97225
    - Providence Saint Vincent Medical Center
  - Redmond, Oregon, Forenede Stater, 97756
    - Saint Charles Health System-Redmond
- Pennsylvania
  - Allentown, Pennsylvania, Forenede Stater, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, Forenede Stater, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - East Stroudsburg, Pennsylvania, Forenede Stater, 18301
    - Pocono Medical Center
  - Hazleton, Pennsylvania, Forenede Stater, 18201
    - Lehigh Valley Hospital-Hazleton
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - University of Pennsylvania/Abramson Cancer Center
  - Philadelphia, Pennsylvania, Forenede Stater, 19140
    - Temple University Hospital
  - Pittsburgh, Pennsylvania, Forenede Stater, 15232
    - UPMC Hillman Cancer Center
- South Carolina
  - Boiling Springs, South Carolina, Forenede Stater, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Easley, South Carolina, Forenede Stater, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, Forenede Stater, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, Forenede Stater, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, Forenede Stater, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greer, South Carolina, Forenede Stater, 29650
    - Prisma Health Cancer Institute - Greer
  - Seneca, South Carolina, Forenede Stater, 29672
    - Prisma Health Cancer Institute - Seneca
- South Dakota
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Avera Cancer Institute
- Tennessee
  - Bristol, Tennessee, Forenede Stater, 37620
    - Bristol Regional Medical Center
  - Franklin, Tennessee, Forenede Stater, 37067
    - Vanderbilt-Ingram Cancer Center Cool Springs
  - Franklin, Tennessee, Forenede Stater, 37067
    - Vanderbilt-Ingram Cancer Center at Franklin
  - Kingsport, Tennessee, Forenede Stater, 37660
    - Ballad Health Cancer Care - Kingsport
  - Kingsport, Tennessee, Forenede Stater, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Nashville, Tennessee, Forenede Stater, 37232
    - Vanderbilt University/Ingram Cancer Center
  - Nashville, Tennessee, Forenede Stater, 37204
    - Vanderbilt Breast Center at One Hundred Oaks
- Texas
  - Bryan, Texas, Forenede Stater, 77802
    - Saint Joseph Regional Cancer Center
  - Dallas, Texas, Forenede Stater, 75235
    - Parkland Memorial Hospital
  - Dallas, Texas, Forenede Stater, 75390
    - UT Southwestern/Simmons Cancer Center-Dallas
  - Fort Worth, Texas, Forenede Stater, 76104
    - UT Southwestern/Simmons Cancer Center-Fort Worth
  - Richardson, Texas, Forenede Stater, 75080
    - UT Southwestern Clinical Center at Richardson/Plano
- Virginia
  - Bristol, Virginia, Forenede Stater, 24201
    - Ballad Health Cancer Care - Bristol
  - Martinsville, Virginia, Forenede Stater, 24112
    - Sovah Health Martinsville
  - Norton, Virginia, Forenede Stater, 24273
    - Ballad Health Cancer Care - Norton
- Washington
  - Aberdeen, Washington, Forenede Stater, 98520
    - Providence Regional Cancer System-Aberdeen
  - Bellevue, Washington, Forenede Stater, 98004
    - Overlake Medical Center
  - Bellingham, Washington, Forenede Stater, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Burien, Washington, Forenede Stater, 98166
    - Saint Anne Hospital
  - Centralia, Washington, Forenede Stater, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, Forenede Stater, 98026
    - Swedish Cancer Institute-Edmonds
  - Enumclaw, Washington, Forenede Stater, 98022
    - Saint Elizabeth Hospital
  - Everett, Washington, Forenede Stater, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, Forenede Stater, 98003
    - Saint Francis Hospital
  - Issaquah, Washington, Forenede Stater, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, Forenede Stater, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lacey, Washington, Forenede Stater, 98503
    - Providence Regional Cancer System-Lacey
  - Lakewood, Washington, Forenede Stater, 98499
    - Saint Clare Hospital
  - Longview, Washington, Forenede Stater, 98632
    - PeaceHealth Saint John Medical Center
  - Poulsbo, Washington, Forenede Stater, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Renton, Washington, Forenede Stater, 98055
    - Valley Medical Center
  - Seattle, Washington, Forenede Stater, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, Forenede Stater, 98122
    - Swedish Medical Center-First Hill
  - Seattle, Washington, Forenede Stater, 98104
    - Pacific Gynecology Specialists
  - Seattle, Washington, Forenede Stater, 98122-5711
    - Swedish Medical Center-Cherry Hill
  - Sedro-Woolley, Washington, Forenede Stater, 98284
    - PeaceHealth United General Medical Center
  - Shelton, Washington, Forenede Stater, 98584
    - Providence Regional Cancer System-Shelton
  - Silverdale, Washington, Forenede Stater, 98383
    - Saint Joseph Medical Center Hematology and Oncology - Silverdale
  - Tacoma, Washington, Forenede Stater, 98405
    - Northwest Medical Specialties PLLC
  - Tacoma, Washington, Forenede Stater, 98405
    - Franciscan Research Center-Northwest Medical Plaza
  - Vancouver, Washington, Forenede Stater, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, Forenede Stater, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yelm, Washington, Forenede Stater, 98597
    - Providence Regional Cancer System-Yelm
- Wisconsin
  - Madison, Wisconsin, Forenede Stater, 53792
    - University of Wisconsin Carbone Cancer Center - University Hospital
  - Menomonee Falls, Wisconsin, Forenede Stater, 53051
    - Froedtert Menomonee Falls Hospital
  - Milwaukee, Wisconsin, Forenede Stater, 53226
    - Medical College of Wisconsin
  - New Richmond, Wisconsin, Forenede Stater, 54017
    - Cancer Center of Western Wisconsin
  - West Bend, Wisconsin, Forenede Stater, 53095
    - Froedtert West Bend Hospital/Kraemer Cancer Center
- Wyoming
  - Cody, Wyoming, Forenede Stater, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, Forenede Stater, 82801
    - Welch Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: 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.	Medicin: Pevonedistat Given IV Andre navne: MLN4924 Nedd8-aktiverende enzymhæmmer MLN4924
Eksperimentel: 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.	Medicin: Carboplatin Given IV Andre navne: Blastocarb Carboplat Carboplatin Hexal Carboplatino Carboplatin Carbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatin Paraplatin Paraplatin AQ Platinwas Ribocarbo JM8 Medicin: Paclitaxel Given IV Andre navne: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Medicin: Pevonedistat Given IV Andre navne: MLN4924 Nedd8-aktiverende enzymhæmmer MLN4924

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: 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.

Medicin: Pevonedistat

Given IV

Andre navne:

MLN4924
Nedd8-aktiverende enzymhæmmer MLN4924

Eksperimentel: 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.

Medicin: Carboplatin

Given IV

Andre navne:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Carboplatin
Carbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatin
Paraplatin
Paraplatin AQ
Platinwas
Ribocarbo
JM8

Medicin: Paclitaxel

Given IV

Andre navne:

Taxol
Anzatax
Asotax
Bristaxol
Praxel
Taxol Konzentrat

Medicin: Pevonedistat

Given IV

Andre navne:

MLN4924
Nedd8-aktiverende enzymhæmmer MLN4924

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Objective Response Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Clinical Benefit Tidsramme: 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) Tidsramme: 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) Tidsramme: 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

Andre resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Forekomst af uønsket hændelse Tidsramme: Vurderet hver 3. uge under behandling og i 30 dage efter endt behandling, op til 3 år		Vurderet hver 3. uge under behandling og i 30 dage efter endt behandling, op til 3 år
Associations Between Response and Overexpression of NEDD8, NAE1, and UBC12 Tidsramme: 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 Tidsramme: Assessed at baseline	To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway	Assessed at baseline
Specimens Banking Tidsramme: Baseline	To bank specimens for further future investigations	Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

Ledende efterforsker: Dustin A Deming, ECOG-ACRIN Cancer Research Group

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Olaizola P, Olaizola I, Fernandez de Ara M, Lapitz A, Val B, Izquierdo-Sanchez L, Fernandez-Barrena MG, Alvarez L, O'Rourke CJ, Lee-Law PY, Davies K, Gradinaru A, Jimenez-Aguero R, La Casta A, Riano I, Macias RIR, Marin JJG, Martinez-Chantar ML, Avila MA, Aspichueta P, Andersen JB, Boulter L, Bujanda L, Rodrigues PM, Perugorria MJ, Banales JM. Targeting protein hyper-SUMOylation halts cholangiocarcinoma progression by impairing cancer cell viability and tumor-stroma cross talk. Hepatology. 2025 Dec 1;82(6):1461-1479. doi: 10.1097/HEP.0000000000001259. Epub 2025 Feb 11.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. marts 2020

Primær færdiggørelse (Faktiske)

27. november 2023

Studieafslutning (Anslået)

3. september 2027

Datoer for studieregistrering

Først indsendt

22. november 2019

Først indsendt, der opfyldte QC-kriterier

22. november 2019

Først opslået (Faktiske)

25. november 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. oktober 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

NCI-2019-07769
U10CA180820 (U.S. NIH-bevilling/kontrakt)
NCI-2019-07769 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
EA2187 (Anden identifikator: CTEP)
EA2187 (Anden identifikator: ECOG-ACRIN Cancer Research Group)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Test af kombinationen af ​​pevonedistat med kemoterapi for galdevejskræft i leveren

Et fase 2-studie af pevonedistat i kombination med carboplatin og paclitaxel i avanceret intrahepatisk cholangiocarcinom

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Andre resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Anslået)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Test af kombinationen af pevonedistat med kemoterapi for galdevejskræft i leveren