A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
Start Date
3/18/2024
Completion Date
2/9/2031
Summary
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
Detailed Description
This international, randomized, open-label, Phase 3 study will compare the investigational combination of avutometinib plus defactinib versus Investigator's Choice of Treatments (ICT) in patients with recurrent LGSOC who have progressed on a prior platinum-based therapy. Avutometinib and defactinib are both types of drugs called kinase inhibitors. Kinase inhibitors block cancer cell growth. The study will compare the progression-free survival (PFS) of the combination of avutometinib plus defactinib versus ICT. The study will also evaluate the effect of the combination on safety, overall survival, other efficacy endpoints, and health-related quality of life and disease related symptoms. The study is being conducted by gynecological cancer specialists. Patients who are eligible and agree to participate in this study will be treated with either a combination of avutometinib with defactinib, or with one of four standard of care NCCN and ESMO treatment recommendations for recurrent LGSOC, and then with subsequent follow up appointments. Patients who originally received one of the standards of care treatments who are determined to have progressive disease may be eligible to crossover to receive the investigational combination avutometinib plus defactinib.Avutometinib and defactinib are investigational drugs that have not been approved by the U.S. Food and Drug Administration (FDA)
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
avutometinib
Defactinib
Pegylated liposomal doxorubicin
Paclitaxel
Letrozole
Anastrozole
Conditions
Locations
HonorHealth
Phoenix, Arizona 85016
United States
University of Arkansas
Little Rock, Arkansas 72205
United States
UCLA Health
Los Angeles, California 90095
United States
UC Davis
Sacramento, California 95817
United States
University of California, San Francisco
San Francisco, California 94143
United States
Yale University
New Haven, Connecticut 06520
United States
Florida Cancer Specialists - South
Fort Myers, Florida 33901
United States
Mount Sinai
Miami Beach, Florida 33140
United States
AdventHealth
Orlando, Florida 32804
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Florida Cancer Specialists Research East
West Palm Beach, Florida 33401
United States
Winship Cancer Institute at Emory University
Atlanta, Georgia 30322
United States
NorthShore University HealthSystem
Evanston, Illinois 60201
United States
Louisiana State University
New Orleans, Louisiana 70112
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21287
United States
Karmanos Cancer Center
Detroit, Michigan 48201
United States
Minnesota Oncology Hematology
Minneapolis, Minnesota 55404
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Atrium Health
Charlotte, North Carolina 28203
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Ohio State
Hilliard, Ohio 43026
United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma 73104
United States
Willamette Valley Cancer Institute
Eugene, Oregon 97401
United States
Northwest Cancer Specialists
Portland, Oregon 97227
United States
Asplundh Cancer Pavilion | Jefferson Health
Philadelphia, Pennsylvania 19090
United States
Allegheny Health Network
Pittsburgh, Pennsylvania 15224
United States
Texas Oncology Central
Austin, Texas 78731
United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas 76104
United States
Houston Methodist
Houston, Texas 77030
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Texas Oncology
San Antonio, Texas 78229
United States
Texas Oncology
The Woodlands, Texas 77380
United States
Texas Oncology
Tyler, Texas 75702
United States
Intermountain Medical Center
Murray, Utah 84107
United States
University of Virginia Health System
Charlottesville, Virginia 22908
United States
Virginia Cancer Specialists, PC
Gainesville, Virginia 20155
United States
Prince of Wales Hospital
Randwick, New South Wales 2031
Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland 4066
Australia
Cancer Research South Australia
Adelaide, South Australia 5000
Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009
Australia
UZA
Edegem, 2650
Belgium
University Hospital Ghent
Ghent, 9000
Belgium
Princess Margaret Cancer Center
Toronto, Ontario M5G 1X6
Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0C1
Canada
McGill University Health Centre
Montreal, Quebec H4A 3J1
Canada
British of Columbia
Vancouver, V5Z 4E6
Canada
Aalborg U.H
Aalborg, 9000
Denmark
Centre Hospitalier de Besançon
Besançon, 25000
France
Site Georges François Leclerc
Dijon, 21079
France
Centre Oscar Lambret
Lille, 59020
France
Centre Léon Bérard
Lyon, 69373
France
Institut Curie
Paris,
France
Agaplesion Markus Krankenhaus
Frankfurt am Main, Hesse 60431
Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353
Germany
Universitätsklinikum Carl Gustav Carus
Dresden, 01307
Germany
Kliniken Essen-Mitte
Essen, 45136
Germany
UMC Hamburg-Eppendorf
Hamburg, 20246
Germany
Universitätsklinikum Mannheim GmbH
Mannheim, 68167
Germany
Universitätsfrauenkinik Ulm
Ulm, 89075
Germany
St. James's Hospital
Dublin, 08
Ireland
Centro di Riferimento Oncologico (CRO)
Aviano, 33081
Italy
Spedali Civili
Brescia, 25123
Italy
AO Cannizzaro
Catania, 95126
Italy
San Raffaele Hospital
Milan, 20132
Italy
Humanitas San Pio X
Milan, 20159
Italy
European Institute of Oncology (IEO)
Milan,
Italy
Istituto Nazionale dei Tumori
Milan, 20133
Italy
INT Napoli Hospital
Naples,
Italy
Istituto Oncologico Veneto (IOV)
Padova, 35128
Italy
IRCCS Gemelli
Roma, 00168
Italy
Istituti Fisioterapici Ospitalieri
Rome, 00144
Italy
S.C.D.U. Oncologia
Torino, 10128
Italy
The Mie University Hospital
Tsu, Mie-ken 514-8507
Japan
Aichi Cancer Center Hospital
Aichi, Nagoya 464-8681
Japan
Tohoku University Hospital
Miyagi, 980-8574
Japan
Osaka Medical Center
Osaka,
Japan
The Jikei University Hospital
Tokyo, 3-19-18
Japan
Netherlands Cancer Insitute
Amsterdam, 1066
Netherlands
Radboud UMC
Nijmegen, 6525 GA
Netherlands
Auckland City Hospital
Auckland, 1023
New Zealand
Białostockie Centrum Onkologii
Bialystok, 15-027
Poland
Gdański Uniwersytet Medyczny
Gdansk, 80-214
Poland
Siedleckie Centrum Onkologii
Siedlce, 98-110
Poland
Seoul National University Bundang Hospital
Seongnam, 13620
South Korea
Yonsei University Severance Hospital
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Gangnam Severance Hospital
Seoul, 06273
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Clínico Virgen de La Arrixaca
El Palmar, Murcia 30120
Spain
H. de Donostia
Donostia / San Sebastian, San Sebastian 20014
Spain
H. Vall d´ Hebron
Barcelona,
Spain
Hospital Universitario Reina Sofía
Córdoba,
Spain
H.U. Ramón y Cajal
Madrid,
Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, 15706
Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010
Spain
Greater Glasgow and Clyde (GGC)
Glasgow, Scotland G120YN
United Kingdom
Cambridge University Hospital
Cambridge, CB2 0QQ
United Kingdom
University of Edinburgh Cancer Research Centre
Edinburgh,
United Kingdom
Hope Cancer Trials Centre
Leicester, LE2 7LX
United Kingdom
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
United Kingdom
Royal Marsden Hospital
London, SW7 3RP
United Kingdom
The Christie NHS Foundation Trust
Manchester,
United Kingdom
Royal Marsden Hospital
Sutton, SM2 5PT
United Kingdom