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Brief Title: A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation
Official Title: A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Study ID: NCT04625270
Brief Summary: This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy and in combination with defactinib in subjects with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
Detailed Description: This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Arizona Oncology Associates PC HAL, Scottsdale, Arizona, United States
Sansum Clinic, Santa Barbara, California, United States
Yale School of Medicine, New Haven, Connecticut, United States
Advent Health, Orlando, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
Maryland Oncology and Hematology, P.A., Glenn Dale, Maryland, United States
Minnesota Oncology Hematology PA, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cleveland Clinic Women's Health Institute, Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
University of Oklahoma Medical Center, Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, United States
Northwest Cancer Specialists, Portland, Oregon, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology Austin Central, Austin, Texas, United States
Texas Oncology- Dallas Presbyterian Hospital, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Texas Oncology, Longview, Texas, United States
Texas Oncology, McAllen, Texas, United States
Texas Oncology, San Antonio, Texas, United States
Texas Oncology, The Woodlands, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC, Gainesville, Virginia, United States
UZ Gent Medische Oncologie, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
CHU de Liege, Liège, , Belgium
Centre de recherche di Centre Hospitalier de i'Universite de Montreal, Montréal, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
Hopital Jean Minjoz, Besançon, , France
Centre Leon Berard, Lyon, , France
ICM - Val d'Aurelle, Montpellier, , France
Institut Curie, Paris, , France
Insituto Europeo di Oncologia I.R.C.C.S, Milano, , Italy
U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S., Padova, , Italy
Hospital Universitario Vall D'Hebron, Barcelona, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Western General Hospital, Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
UCLH Cancer Clinical Trials Unit, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Name: Susana Banerjee, MBBS,MA,PhD
Affiliation: European Network of Gynaecological Oncological Trial Groups (ENGOT)
Role: PRINCIPAL_INVESTIGATOR
Name: Rachel Grisham, MD
Affiliation: GOG Foundation
Role: PRINCIPAL_INVESTIGATOR
Name: MD Verastem
Affiliation: Verastem, Inc.
Role: STUDY_DIRECTOR