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간 담관암에 대한 페보네디스타트와 화학요법의 병용 테스트

2026년 10월 23일 업데이트: National Cancer Institute (NCI)

진행성 간내 담관암종에서 카보플라틴 및 파클리탁셀과 페보네디스타트 병용요법의 2상 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

단계

2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: 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.	의약품: Pevonedistat Given IV 다른 이름들: MLN4924 Nedd8-활성화 효소 억제제 MLN4924
실험적: 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.	의약품: Carboplatin Given IV 다른 이름들: 폭발탄 카르보플라트 카보플라틴 헥살 카르보플라티노 카보플라티넘 카르보신 카보솔 카보텍 CBDCA 디스플라타 에르카르 JM-8 닐로린 노보플라티넘 파라플라틴 파라플라틴 AQ 플라틴와스 리보카르보 JM8 의약품: Paclitaxel Given IV 다른 이름들: 탁솔 안자탁스 아소탁스 브리스타솔 프락셀 탁솔 콘첸트라트 의약품: Pevonedistat Given IV 다른 이름들: MLN4924 Nedd8-활성화 효소 억제제 MLN4924

참가자 그룹 / 팔

개입 / 치료

실험적: 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.

의약품: Pevonedistat

Given IV

다른 이름들:

MLN4924
Nedd8-활성화 효소 억제제 MLN4924

실험적: 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.

의약품: Carboplatin

Given IV

다른 이름들:

폭발탄
카르보플라트
카보플라틴 헥살
카르보플라티노
카보플라티넘
카르보신
카보솔
카보텍
CBDCA
디스플라타
에르카르
JM-8
닐로린
노보플라티넘
파라플라틴
파라플라틴 AQ
플라틴와스
리보카르보
JM8

의약품: Paclitaxel

Given IV

다른 이름들:

탁솔
안자탁스
아소탁스
브리스타솔
프락셀
탁솔 콘첸트라트

의약품: Pevonedistat

Given IV

다른 이름들:

MLN4924
Nedd8-활성화 효소 억제제 MLN4924

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Objective Response 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Clinical Benefit 기간: 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) 기간: 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) 기간: 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

기타 결과 측정

결과 측정	측정값 설명	기간
이상반응 발생률 기간: 치료 중 및 치료 종료 후 30일 동안, 최대 3년 동안 3주마다 평가		치료 중 및 치료 종료 후 30일 동안, 최대 3년 동안 3주마다 평가
Associations Between Response and Overexpression of NEDD8, NAE1, and UBC12 기간: 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 기간: Assessed at baseline	To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway	Assessed at baseline
Specimens Banking 기간: Baseline	To bank specimens for further future investigations	Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

수석 연구원: Dustin A Deming, ECOG-ACRIN Cancer Research Group

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 3월 16일

기본 완료 (실제)

2023년 11월 27일

연구 완료 (추정된)

2027년 9월 3일

연구 등록 날짜

최초 제출

2019년 11월 22일

QC 기준을 충족하는 최초 제출

2019년 11월 22일

처음 게시됨 (실제)

2019년 11월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 23일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

NCI-2019-07769
U10CA180820 (미국 NIH 보조금/계약)
NCI-2019-07769 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
EA2187 (기타 식별자: CTEP)
EA2187 (기타 식별자: ECOG-ACRIN Cancer Research Group)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

간 담관암에 대한 페보네디스타트와 화학요법의 병용 테스트

진행성 간내 담관암종에서 카보플라틴 및 파클리탁셀과 페보네디스타트 병용요법의 2상 연구

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (실제)

단계

연락처 및 위치

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

기타 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

수사관

간행물 및 유용한 링크

일반 간행물

연구 기록 날짜

연구 주요 날짜

연구 시작 (실제)

기본 완료 (실제)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

IPD 계획 설명

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구