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A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
Sponsor: Verastem, Inc.
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.
Official title: A Phase 3, Randomized, Open-Label Study of Combination Therapy With Avutometinib Plus Defactinib Versus Investigator's Choice of Treatment in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) (RAMP 301)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
270
Start Date
2024-03-18
Completion Date
2031-02-09
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
avutometinib
Avutometinib: administered orally
Defactinib
Defactinib: administered orally
Pegylated liposomal doxorubicin
administered intravenously
Paclitaxel
administered intravenously
Letrozole
administered orally
Anastrozole
administered orally
Locations (106)
HonorHealth
Phoenix, Arizona, United States
University of Arkansas
Little Rock, Arkansas, United States
UCLA Health
Los Angeles, California, United States
UC Davis
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Mount Sinai
Miami Beach, Florida, United States
AdventHealth
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Florida Cancer Specialists Research East
West Palm Beach, Florida, United States
Winship Cancer Institute at Emory University
Atlanta, Georgia, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Louisiana State University
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Karmanos Cancer Center
Detroit, Michigan, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State
Hilliard, Ohio, United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Asplundh Cancer Pavilion | Jefferson Health
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Texas Oncology Central
Austin, Texas, United States
Texas Oncology-Fort Worth Cancer Center
Fort Worth, Texas, United States
Houston Methodist
Houston, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Texas Oncology
San Antonio, Texas, United States
Texas Oncology
The Woodlands, Texas, United States
Texas Oncology
Tyler, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Icon Cancer Centre Wesley
Auchenflower, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
UZA
Edegem, Belgium
University Hospital Ghent
Ghent, Belgium
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
British of Columbia
Vancouver, Canada
Aalborg U.H
Aalborg, Denmark
Centre Hospitalier de Besançon
Besançon, France
Site Georges François Leclerc
Dijon, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Institut Curie
Paris, France
Agaplesion Markus Krankenhaus
Frankfurt am Main, Hesse, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Kliniken Essen-Mitte
Essen, Germany
UMC Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Mannheim GmbH
Mannheim, Germany
Universitätsfrauenkinik Ulm
Ulm, Germany
St. James's Hospital
Dublin, Ireland
Centro di Riferimento Oncologico (CRO)
Aviano, Italy
Spedali Civili
Brescia, Italy
AO Cannizzaro
Catania, Italy
San Raffaele Hospital
Milan, Italy
Humanitas San Pio X
Milan, Italy
European Institute of Oncology (IEO)
Milan, Italy
Istituto Nazionale dei Tumori
Milan, Italy
INT Napoli Hospital
Naples, Italy
Istituto Oncologico Veneto (IOV)
Padova, Italy
IRCCS Gemelli
Roma, Italy
Istituti Fisioterapici Ospitalieri
Rome, Italy
S.C.D.U. Oncologia
Torino, Italy
The Mie University Hospital
Tsu, Mie-ken, Japan
Aichi Cancer Center Hospital
Aichi, Nagoya, Japan
Tohoku University Hospital
Miyagi, Japan
Osaka Medical Center
Osaka, Japan
The Jikei University Hospital
Tokyo, Japan
Netherlands Cancer Insitute
Amsterdam, Netherlands
Radboud UMC
Nijmegen, Netherlands
Auckland City Hospital
Auckland, New Zealand
Białostockie Centrum Onkologii
Bialystok, Poland
Gdański Uniwersytet Medyczny
Gdansk, Poland
Siedleckie Centrum Onkologii
Siedlce, Poland
Seoul National University Bundang Hospital
Seongnam, South Korea
Yonsei University Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Clínico Virgen de La Arrixaca
El Palmar, Murcia, Spain
H. de Donostia
Donostia / San Sebastian, San Sebastian, 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, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Greater Glasgow and Clyde (GGC)
Glasgow, Scotland, United Kingdom
Cambridge University Hospital
Cambridge, United Kingdom
University of Edinburgh Cancer Research Centre
Edinburgh, United Kingdom
Hope Cancer Trials Centre
Leicester, United Kingdom
University College London Hospitals NHS Foundation Trust
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom