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Testování kombinace pevonedistatu s chemoterapií pro rakovinu žlučovodů jater

23. října 2026 aktualizováno: National Cancer Institute (NCI)

Studie fáze 2 pevonedistatu v kombinaci s karboplatinou a paklitaxelem u pokročilého intrahepatálního cholangiokarcinomu

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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

Fáze

Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: Randomizované
Intervenční model: Paralelní přiřazení
Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm Skupina účastníků / Arm Skupina nebo podskupina účastníků klinické studie, která podle protokolu studie dostává konkrétní intervenci/léčbu nebo žádnou intervenci.	Intervence / Léčba Intervence / Léčba Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
Experimentální: 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.	Lék: Pevonedistat Given IV Ostatní jména: 4924 MLN Nedd8-aktivující enzymový inhibitor MLN4924
Experimentální: 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.	Lék: Carboplatin Given IV Ostatní jména: Blastocarb Carboplat Carboplatin Hexal Carboplatino Karboplatina Karbosin Carbosol Carbotec CBDCA Displata Ercar JM-8 Nealorin Novoplatina Paraplatin Paraplatin AQ Paraplatina Platinwas Ribocarbo JM8 Lék: Paclitaxel Given IV Ostatní jména: Taxol Anzatax Asotax Bristaxol Praxel Taxol Konzentrat Lék: Pevonedistat Given IV Ostatní jména: 4924 MLN Nedd8-aktivující enzymový inhibitor MLN4924

Skupina účastníků / Arm

Intervence / Léčba

Experimentální: 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.

Lék: Pevonedistat

Given IV

Ostatní jména:

4924 MLN
Nedd8-aktivující enzymový inhibitor MLN4924

Experimentální: 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.

Lék: Carboplatin

Given IV

Ostatní jména:

Blastocarb
Carboplat
Carboplatin Hexal
Carboplatino
Karboplatina
Karbosin
Carbosol
Carbotec
CBDCA
Displata
Ercar
JM-8
Nealorin
Novoplatina
Paraplatin
Paraplatin AQ
Paraplatina
Platinwas
Ribocarbo
JM8

Lék: Paclitaxel

Given IV

Ostatní jména:

Taxol
Anzatax
Asotax
Bristaxol
Praxel
Taxol Konzentrat

Lék: Pevonedistat

Given IV

Ostatní jména:

4924 MLN
Nedd8-aktivující enzymový inhibitor MLN4924

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Objective Response Časové okno: 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

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Clinical Benefit Časové okno: 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) Časové okno: 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) Časové okno: 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

Další výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Výskyt nežádoucí příhody Časové okno: Hodnoceno každé 3 týdny během léčby a po dobu 30 dnů po ukončení léčby, až do 3 let		Hodnoceno každé 3 týdny během léčby a po dobu 30 dnů po ukončení léčby, až do 3 let
Associations Between Response and Overexpression of NEDD8, NAE1, and UBC12 Časové okno: 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 Časové okno: Assessed at baseline	To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway	Assessed at baseline
Specimens Banking Časové okno: Baseline	To bank specimens for further future investigations	Baseline

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Cancer Institute (NCI)

Vyšetřovatelé

Vrchní vyšetřovatel: Dustin A Deming, ECOG-ACRIN Cancer Research Group

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

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.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

16. března 2020

Primární dokončení (Aktuální)

27. listopadu 2023

Dokončení studie (Odhadovaný)

3. září 2027

Termíny zápisu do studia

První předloženo

22. listopadu 2019

První předloženo, které splnilo kritéria kontroly kvality

22. listopadu 2019

První zveřejněno (Aktuální)

25. listopadu 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

26. října 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. října 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

NCI-2019-07769
U10CA180820 (Grant/smlouva NIH USA)
NCI-2019-07769 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
EA2187 (Jiný identifikátor: CTEP)
EA2187 (Jiný identifikátor: ECOG-ACRIN Cancer Research Group)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Testování kombinace pevonedistatu s chemoterapií pro rakovinu žlučovodů jater

Studie fáze 2 pevonedistatu v kombinaci s karboplatinou a paklitaxelem u pokročilého intrahepatálního cholangiokarcinomu

Přehled studie

Postavení

Podmínky

Intervence / Léčba

Detailní popis

Typ studie

Zápis (Aktuální)

Fáze

Kontakty a umístění

Studijní místa

Kritéria účasti

Kritéria způsobilosti

Věk způsobilý ke studiu

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Popis

Studijní plán

Jak je studie koncipována?

Detaily designu

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm

Intervence / Léčba

Co je měření studie?

Primární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Sekundární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Další výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Spolupracovníci a vyšetřovatelé

Sponzor

Vyšetřovatelé

Publikace a užitečné odkazy

Obecné publikace

Termíny studijních záznamů

Hlavní termíny studia

Začátek studia (Aktuální)

Primární dokončení (Aktuální)

Dokončení studie (Odhadovaný)

Termíny zápisu do studia

První předloženo

První předloženo, které splnilo kritéria kontroly kvality

První zveřejněno (Aktuální)

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Naposledy ověřeno

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Popis plánu IPD

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA