백금 저항성 난소암 참가자의 연구자 선택 치료와 비교하여 Rina-S의 효능을 평가하기 위한 연구 (RAINFOL-02)
2026년 11월 2일 업데이트: Genmab
백금 저항성 난소암 환자를 대상으로 리나타바트 세수테칸(Rina-S) 대 연구자 선택(IC) 치료의 제3상 무작위배정, 공개 라벨 연구
This phase 3 study will be conducted in different countries all over the world.
The purpose of this study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.
Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.
All participants will receive active drug; no one will be given placebo.
연구 개요
상태
모집하지 않고 적극적으로
정황
상세 설명
The China extension-study of GCT1184-02 is registered under NCT07604766.
연구 유형
중재적
등록 (실제)
584
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Athens, 그리스, 11527
- General Hospital of Athens
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Chaïdári, 그리스, 12462
- Attikon University General Hospital/General Hospital of West Attica
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Léfkos, 그리스, 2024
- Aretaieio Hospital
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Panórama, 그리스
- Saint Luke's Hospital
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Amsterdam, 네덜란드, 1081 HV
- Amsterdam UMC, location VUmc
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Enschede, 네덜란드, 7512 AV
- Medisch Spectrum Twente - Enschede Koningsplein
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Leiden, 네덜란드, 2333
- Leids Universitair Medisch Centrum (LUMC)
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Maastricht, 네덜란드, 6229
- Maastricht (UMC) Universitair Medisch Centrum
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Rotterdam, 네덜란드, 3015 GD
- Erasmus MC/ Erasmus Medisch Centrum
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Oslo, 노르웨이, 0379
- Oslo Universitetssykehus - Radiumhospitalet
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Tromsø, 노르웨이, 9019
- University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø
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Aalborg, 덴마크, 9000
- Aalborg Universitetshospital
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Copenhagen, 덴마크
- The Royal Hospital (Rigshospitalet)
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Odense, 덴마크, 5000
- Odense Universitets Hospital
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Berlin, 독일, 13125
- Helios Klinikum Berlin-Buch
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Bonn, 독일, 53127
- University Hospital Bonn
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Dresden, 독일, 01307
- University Hospital Carl Gustav Carus Dresden
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Düsseldorf, 독일, 40225
- University Hospital of Düsseldorf
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Essen, 독일, 45136
- Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung
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Frankfurt, 독일, 60596
- Klinikum der Johann Wolfgang Goethe-Universität
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Giessen, 독일, 35392
- Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
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Hamburg, 독일, 20357
- Mammazentrum Hamburg am Krankenhaus Jerusalem
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Hanover, 독일, 30449
- MVZ Onko Medical GmbH Hanover
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Heidelberg, 독일, 69120
- University Hospital Heidelberg /Universitätsklinikum Heidelberg
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Homburg, 독일, 66421
- UniversitY Hospital of Saarland
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Munich, 독일, 80634
- Red Cross Hospital Munich
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Münster, 독일, 48149
- Universitätsklinikum Münster/University Clinic Muenster
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Wiesbaden, 독일, 65199
- Helios Dr. Horst Schmidt Kliniken Wiesbaden
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Alaska
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Anchorage, Alaska, 미국, 99508
- Alaska Women's Cancer Care
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Arizona
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Scottsdale, Arizona, 미국, 85251
- Arizona Center for Cancer Care (ACCC) - Biltmore
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Tucson, Arizona, 미국, 85724
- University of Arizona Cancer Center - Research and Administration at Main Campus
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California
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Burbank, California, 미국, 91505
- Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
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La Jolla, California, 미국, 92093
- University of California San Diego Moores Cancer Center
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San Francisco, California, 미국, 94158
- USCF Mission Bay
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Vallejo, California, 미국, 94589
- Kaiser Permanente - Vallejo Medical Center
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Colorado
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Aurora, Colorado, 미국, 80045
- UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
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Connecticut
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Hartford, Connecticut, 미국, 06106
- Hartford Hospital
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New Haven, Connecticut, 미국, 06510
- Yale School of Medicine
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Norwalk, Connecticut, 미국, 06850
- Norwalk Hospital
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Florida
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Fort Myers, Florida, 미국, 33901-8108
- SCRI - Florida Cancer Specialists - South Region Research Office
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Miami Beach, Florida, 미국, 33140
- Mount Sinai Comprehensive Cancer Center
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Orlando, Florida, 미국, 32806
- Orlando Health Cancer Institute - Downtown Orlando
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Sarasota, Florida, 미국, 34239
- Sarasota Memorial Hospital
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West Palm Beach, Florida, 미국, 33401
- SCRI - Florida Cancer Specialists - West Palm Beach
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Georgia
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Atlanta, Georgia, 미국, 30322
- Winship Cancer Institute of Emory University
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Atlanta, Georgia, 미국, 30342
- Northside Hospital Atlanta
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Augusta, Georgia, 미국, 30912
- Augusta University Georgia Cancer Center
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Hawaii
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Honolulu, Hawaii, 미국, 96826
- Kapi'olani Medical Center for Women and Children
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Indiana
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Dyer, Indiana, 미국, 46311
- Northwest Cancer Center - Dyer
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Cancer Center
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Overland Park, Kansas, 미국, 66211
- HCA Midwest Health
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Kentucky
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Edgewood, Kentucky, 미국, 41017
- St. Elizabeth Healthcare - Edgewood
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Lexington, Kentucky, 미국, 40503
- Baptist Health Lexington
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- Louisiana State University Health Sciences Center (LSU Health) - New Orleans
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Shreveport, Louisiana, 미국, 71103
- Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
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Maine
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Scarborough, Maine, 미국, 04074-7172
- Maine Medical Center Cancer Institute- Scarborough
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Maryland
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Silver Spring, Maryland, 미국, 20910
- Holy Cross Health - Holy Cross Hospital
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Massachusetts
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Boston, Massachusetts, 미국, 02215
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, 미국, 02215
- Dana-Farber Cancer Institute
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Michigan
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Detroit, Michigan, 미국, 48201
- Barbara Ann Karmanos Cancer Institute
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Grand Rapids, Michigan, 미국, 49503
- Corewell Health (Spectrum Health)
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Ypsilanti, Michigan, 미국, 48197
- Saint Joseph Mercy Ann Arbor Hospital
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Nebraska
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Omaha, Nebraska, 미국, 68105
- University of Nebraska Medical Center
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Nevada
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Reno, Nevada, 미국, 89511
- Center of Hope
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New Jersey
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Teaneck, New Jersey, 미국, 07666
- Holy Name Medical Center
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New Mexico
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Albuquerque, New Mexico, 미국, 87131
- University of New Mexico Comprehensive Cancer Center
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New York
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Buffalo, New York, 미국, 14203
- Roswell Park Comprehensive Cancer Center
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New York, New York, 미국, 10032
- Herbert Irving Comprehensive Cancer Center
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New York, New York, 미국, 10065
- New York-Presbyterian - Weill Cornell Medical Center
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New York, New York, 미국, 10016
- Perlmutter Cancer Center - 38th Street
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New York, New York, 미국, 10016
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island
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Rochester, New York, 미국, 14642
- James P. Wilmot Cancer Center
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke Cancer Institute
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Pinehurst, North Carolina, 미국, 28374
- FirstHealth Outpatient Cancer Center
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Ohio
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Cincinnati, Ohio, 미국, 45219
- University of Cincinnati Medical Center
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Cleveland, Ohio, 미국, 44109
- MetroHealth Medical Center
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Cleveland, Ohio, 미국, 44106
- University Hospitals Cleveland Medical Center
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Cleveland, Ohio, 미국, 44195
- Cleveland Clinic Main Campus
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Hilliard, Ohio, 미국, 43026
- JamesCare Gynecologic Oncology at Mill Run
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Oregon
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Portland, Oregon, 미국, 97239
- Oregon Health and Science University
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Portland, Oregon, 미국, 97210
- Legacy Good Samaritan Medical Center
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Portland, Oregon, 미국, 97227
- USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
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Pennsylvania
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Bethlehem, Pennsylvania, 미국, 18015
- St. Luke's University Health Network
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Hershey, Pennsylvania, 미국, 17033
- Penn State Health Milton S. Hershey Medical Center
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Philadelphia, Pennsylvania, 미국, 19111
- Fox Chase Cancer Center
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Pittsburgh, Pennsylvania, 미국, 15224
- Allegheny Health Network - West Penn Hospital
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Willow Grove, Pennsylvania, 미국, 19090
- Jefferson Health - Asplundh Cancer Pavilion
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South Dakota
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Sioux Falls, South Dakota, 미국, 57105
- Avera Cancer Institute
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Tennessee
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Nashville, Tennessee, 미국, 37203
- SCRI Oncology Partners
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Texas
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Abilene, Texas, 미국, 79606
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
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Austin, Texas, 미국, 78731
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
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Dallas, Texas, 미국, 75390
- University of Texas Southwestern Medical Center
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Fort Worth, Texas, 미국, 76104
- USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
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Virginia
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Fairfax, Virginia, 미국, 22031
- Inova Schar Cancer Institute
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Norfolk, Virginia, 미국, 23502
- USOR - Virginia Oncology Associates - Norfolk
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Washington
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Kennewick, Washington, 미국, 99336
- Kadlec Clinic - Hematology and Oncology
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Seattle, Washington, 미국, 98109
- Fred Hutchinson Cancer Research Center
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Spokane, Washington, 미국, 99204
- Providence Sacred Heart Medical Center
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West Virginia
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Morgantown, West Virginia, 미국, 26506-9600
- West Virginia University Cancer Institute
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Wisconsin
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Madison, Wisconsin, 미국, 53706
- University of Wisconsin - Madison
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Aalst, 벨기에, 9300
- AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
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Brussels, 벨기에, 1000
- Centre Hospitalier Universitaire Saint-Pierre
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Charleroi, 벨기에, 6000
- Grand Hôpital de Charleroi - Site Les Viviers
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Leuven, 벨기에, 3000
- Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
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Liège, 벨기에, 4000
- Centre Hospitalier Chretien - Clinique MontLégia
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Roeselare, 벨기에, 051237111
- Algemeen Ziekenhuis Delta - Campus Rumbeke
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Antwerp
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Turnhout, Antwerp, 벨기에, 2300
- Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth
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A Coruña, 스페인, 15006
- Hospital Universitario de A Coruña
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Donostia / San Sebastian, 스페인, 20014
- Hospital Universitario DE Donostia
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El Palmar, 스페인, 30120
- Hospital Clínico Universitario Virgen de la Arrixaca
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Madrid, 스페인, 28033
- MD Anderson Cancer Center Madrid
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Madrid, 스페인, 28029
- Hospital Universitario La Paz
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Seville, 스페인, 41013
- Virgen del Rocío University Hospital
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Valencia, 스페인, 46009
- IVO - Valencian Institute of Oncology Foundation
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Zaragoza, 스페인, 50009
- Miguel Servet Hospital
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Graz, 오스트리아, 8036
- Medizinische Universität Graz
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Vienna, 오스트리아, 1090
- Medizinische Universität Wien
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State of Vienna
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Vienna, State of Vienna, 오스트리아, 1130
- Krankenhaus Hietzing
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Tyrol
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Innsbruck, Tyrol, 오스트리아, 6020
- Medizinische Universität Innsbruck
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Upper Austria (Oberösterreich)
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Linz, Upper Austria (Oberösterreich), 오스트리아, 4010
- Ordensklinikum Linz GmbH Barmherzige Schwestern
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Milan, 이탈리아, 20132
- Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
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Milan, 이탈리아, 20141
- Istituto Europeo di Oncologia/ European Institute of Oncology
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Milan, 이탈리아, 20159
- Humanitas San Pio X
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Ponderano, 이탈리아, 13875
- Local Health Authority of Biella - Nuovo Ospedale degli Infermi
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Roma, 이탈리아, 00168
- Agostino Gemelli University Hospital Foundation IRCCS
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Torino, 이탈리아, 10128
- Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau
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Apulia
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Brindisi, Apulia, 이탈리아, 72100
- Azienda Sanitaria Locale Brindisi
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Tokyo, 일본, 104-0045
- National Cancer Center Hospital
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Tokyo, 일본, 135-8550
- Cancer Institute Hospital of JFCR
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Aichi Pref
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Nagoya, Aichi Pref, 일본, 4648681
- Aichi Cancer Center
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Fukuoka Pref
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Kurume, Fukuoka Pref, 일본, 8300011
- Kurume University Hospital
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Hokkaido
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Sapporo, Hokkaido, 일본, 0300804
- Hokkaido Cancer Center
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Kanagawa Pref
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Kawasaki, Kanagawa Pref, 일본, 2160015
- St. Marianna University Hospital
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Miyagi Pref
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Sendai, Miyagi Pref, 일본, 9808574
- Tohoku University Hospital
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Niigata Pref
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Niigata, Niigata Pref, 일본, 9518520
- Niigata University Medical and Dental Hospital
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Okayama Pref.
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Okayama, Okayama Pref., 일본, 7008558
- Okayama University Hospital
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Saitama Pref.
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Hidaka, Saitama Pref., 일본, 350-1298
- Saitama Medical University - International Medical Center
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Shizuoka Pref.
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Nagaizumi-chō, Shizuoka Pref., 일본, 4118777
- Shizuoka Cancer Center
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Tochigi Pref.
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Saitama, Tochigi Pref., 일본, 329-0498
- Jichi Medical University Hospital
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Tokyo
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Minato, Tokyo, 일본, 105-0003
- The Jikei University Hospital
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Toon City, Ehime Pref
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Shibukawa, Toon City, Ehime Pref, 일본, 791-0295
- Ehime University Hospital
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Changchun, 중국, 130021
- The First Hospital of Jilin University
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Hanzhou, 중국
- Zhejiang Cancer Hospital
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Shanghai, 중국, 200032
- Fudan University Shanghai Cancer Center
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Tianjin, 중국, 300060
- Tianjin Medical University Cancer Institute & Hospital
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Zhengzhou, 중국
- Henan Cancer Hospital - Zhengzhou University
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Guangdong
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Guangzhou, Guangdong, 중국, 510060
- Sun Yat-Sen University Cancer Center
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Shaanxi
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Xi'an, Shaanxi, 중국, 710049
- The First Affiliated Hospital of Xi'an Jiaotong University
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Brno, 체코, 60200
- Masaryk Memorial Cancer Institute
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Hradec Králové, 체코, 50005
- Fakultní Nemocnice Hradec Králové
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Nový Jičín, 체코, 74101
- Nemocnice AGEL Nový Jičín a.s.
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Prague, 체코, 15000
- Fakultni nemocnice v Motole
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Prague, 체코, 18000
- Bulovka University Hospital
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Prague, 체코, 12808
- Vseobecna Fakultni Nemocnice v Praze
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Prague
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Prague, Prague, 체코
- University Hospital Královské Vinohrady
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Toronto, 캐나다, M4Y 3M5
- Sunnybrook Health Sciences Centre - Bayview Campus
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Ontario
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Toronto, Ontario, 캐나다, M5G2M9
- Princess Margaret Cancer Centre
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Quebec
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Montreal, Quebec, 캐나다, H2X0C1
- Centre Hospitalier de l'Université de Montréal (CHUM)
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Bialystok, 폴란드, 15-027
- Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
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Gdansk, 폴란드, 80-211
- Uniwersyteckie Centrum Kliniczne w Gdańsku
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Lodz, 폴란드, 93-338
- Instytut Centrum Zdrowia Matki Polki
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Poznan, 폴란드, 61-867
- Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
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Siedlce, 폴란드, 08-110
- Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
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Szczecin, 폴란드, 70-111
- Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
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Lesser Poland (Małopolskie)
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Krakow, Lesser Poland (Małopolskie), 폴란드, 30-348
- Jagiellońskie Centrum Innowacj
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San Juan
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Monacillo, San Juan, 푸에르토 리코, 00927
- UPR Comprehensive Cancer Center Hospital
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-
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Nice, 프랑스, 6189
- Centre Antoine Lacassagne
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Paris, 프랑스, 75015
- Hôpital Européen Georges-Pompidou
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Pierre-Bénite, 프랑스, 69310
- Hospital Lyon-Sud (HCL)
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Rennes, 프랑스, 35042
- Centre Eugène Marquis
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Saint-Herblain, 프랑스, 44800
- Western Cancer Institute - Saint-Herblain - René Gauducheau Site
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Toulouse, 프랑스, 31059
- Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
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Villejuif, 프랑스, 94805
- Gustave Roussy
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South Brisbane, 호주
- Mater Misericordiae - Mater Hospital Brisbane
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Subiaco, 호주, 6008
- Saint John of God - Subiaco Hospital
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New South Wales
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New Lambton Heights, New South Wales, 호주
- Newcastle Private Hospital
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Queensland (qld)
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South Brisbane, Queensland (qld), 호주, 4101
- Icon Cancer Centre
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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
여성
설명
Key Inclusion Criteria:
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Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
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Participants may be enrolled regardless of FRα expression level.
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Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
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Participants must have received prior treatment with the following therapies:
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Platinum chemotherapy
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Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
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Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor
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Mirvetuximab soravtansine, if:
- Mirvetuximab soravtansine is available in the enrollment region, and
- The participant is eligible, and
- The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
-
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Participants must have platinum-resistant disease:
- Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between > 91 days and ≤ 183 days after the date of the last dose of platinum.
- Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.
Key Exclusion Criteria:
- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
- Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
- History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
- Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
- Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
- Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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 |
개입 / 치료 |
|---|---|
|
활성 비교기: 수사관의 선택
|
IV infusion IV infusion IV infusion IV infusion |
|
실험적: 리나-S
|
Intravenous (IV) infusion
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival (PFS)
기간: Up to approximately 1.5 years
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator. |
Up to approximately 1.5 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
치료 관련 부작용(TEAE)이 발생한 참가자 수
기간: 최대 약 1.5년
|
최대 약 1.5년
|
|
|
Overall Survival (OS)
기간: Up to approximately 1.5 years
|
OS is defined as the time from date of randomization to date of death due to any cause. |
Up to approximately 1.5 years
|
|
Objective Response Rate (ORR)
기간: Up to approximately 1.5 years
|
ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator. |
Up to approximately 1.5 years
|
|
PFS as Determined by BICR
기간: Up to approximately 1.5 years
|
PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on RECIST version 1.1 as determined by BICR. |
Up to approximately 1.5 years
|
|
ORR as Determined by BICR
기간: Up to approximately 1.5 years
|
ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR. |
Up to approximately 1.5 years
|
|
Duration of Response (DOR)
기간: Up to approximately 1.5 years
|
DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR). |
Up to approximately 1.5 years
|
|
Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria
기간: Up to approximately 1.5 years
|
A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline. |
Up to approximately 1.5 years
|
|
Time to Second Disease Progression or Death From any Cause (PFS2)
기간: Up to approximately 1.5 years
|
PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death. |
Up to approximately 1.5 years
|
|
Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)
기간: Baseline, up to approximately 1.5 years
|
Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level. |
Baseline, up to approximately 1.5 years
|
|
Time to Deterioration (TTD) in the GHS/Qol Score
기간: Up to approximately 1.5 years
|
TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome. |
Up to approximately 1.5 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: Study Official, Genmab
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)
2025년 2월 7일
기본 완료 (실제)
2026년 8월 18일
연구 완료 (추정된)
2027년 10월 1일
연구 등록 날짜
최초 제출
2024년 9월 20일
QC 기준을 충족하는 최초 제출
2024년 9월 25일
처음 게시됨 (실제)
2024년 10월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 11월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 2일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 생식기 질환
- 내분비계 질환
- 비뇨생식기 신생물
- 부위별 신생물
- 신생물
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 생식기 질환, 여성
- 내분비샘 신생물
- 난소 질환
- 부속기 질환
- 생식기 신생물, 여성
- 생식선 장애
- 나팔관 질환
- 난소 신생물
- 나팔관 신생물
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 탄화수소
- 사이클로 파라핀
- 탄화수소, alicyclic
- 탄화수소, 순환
- 테르펜
- Camptothecin
- 알칼로이드
- 박습니다
- 사이클로 데카네
- Diterpenes
- 데 옥시 시티 딘
- 시티 딘
- 피리 미딘 뉴 클레오 시드
- 피리 미딘
- 젬시타빈
- 파클리탁셀
- 토포테칸
- 리포좀 독소루비신
기타 연구 ID 번호
- GCT1184-02
- PRO1184-002 (기타 식별자: Other Sponsor Identifier)
- GOG-3107 (기타 식별자: Other Sponsor Identifier)
- ENGOT-OV86 (기타 식별자: Other Sponsor Identifier)
- 2024-514822-21 (기타 식별자: EU Trial (CTIS) Number)
- jRCT2031250064 (레지스트리 식별자: Japan Registry for Clinical Trials (jRCT))
- CTR20253987 (레지스트리 식별자: ChinaDrugTrials.org.cn)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
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. .