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)
Who is this study for? Patients with recurrent low-grade serous ovarian cancer
Status: Active_not_recruiting
Location: See all (47) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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)
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• Histologically proven LGSOC (ovarian, peritoneal)
• Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
• Measurable disease according to RECIST 1.1
• An Eastern Cooperative Group (ECOG) performance status ≤ 1.
• Adequate organ function
• Adequate recovery from toxicities related to prior treatments
• Agreement to use highly effective method of contraceptive, if necessary
Locations
United States
Arizona
Arizona Oncology Associates PC HAL
Scottsdale
California
Sansum Clinic
Santa Barbara
Connecticut
Yale School of Medicine
New Haven
Florida
Advent Health
Orlando
H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology
Tampa
Illinois
University of Chicago
Chicago
Maryland
Maryland Oncology and Hematology, P.A.
Glenn Dale
Minnesota
Minnesota Oncology Hematology PA
Minneapolis
Missouri
Washington University School of Medicine
Saint Louis
New Mexico
University of New Mexico Comprehensive Cancer Center
Albuquerque
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
Memorial Sloan Kettering Cancer Center
New York
Ohio
Cleveland Clinic Women's Health Institute
Cleveland
The Ohio State University Wexner Medical Center
Columbus
Oklahoma
University of Oklahoma Medical Center
Oklahoma City
Oregon
Willamette Valley Cancer Institute and Research Center
Eugene
Northwest Cancer Specialists
Portland
Tennessee
Sarah Cannon Research Institute
Nashville
Texas
Texas Oncology Austin Central
Austin
Texas Oncology- Dallas Presbyterian Hospital
Dallas
UT Southwestern Medical Center
Dallas
Texas Oncology
Longview
Texas Oncology
Mcallen
Texas Oncology
San Antonio
Texas Oncology
The Woodlands
Virginia
University of Virginia Health System
Charlottesville
Virginia Cancer Specialists, PC
Gainesville
Other Locations
Belgium
UZ Gent Medische Oncologie
Gent
UZ Leuven
Leuven
CHU de Liege
Liège
Canada
Centre de recherche di Centre Hospitalier de i'Universite de Montreal
Montréal
Princess Margaret Cancer Centre
Toronto
France
Hopital Jean Minjoz
Besançon
Centre Leon Berard
Lyon
ICM - Val d'Aurelle
Montpellier
Institut Curie
Paris
Italy
Insituto Europeo di Oncologia I.R.C.C.S
Milano
U.O.C. Oncologia 2, Istituto Oncologico Veneto I.R.C.C.S.
Padova
Spain
Hospital Universitario Vall D'Hebron
Barcelona
Hospital Universitario Reina Sofia
Córdoba
Hospital Universitario Ramon y Cajal
Madrid
Hospital Clínico Universitario de Valencia
Valencia
United Kingdom
Western General Hospital
Edinburgh
Beatson West of Scotland Cancer Centre
Glasgow
UCLH Cancer Clinical Trials Unit
London
The Christie NHS Foundation Trust
Manchester
Royal Marsden Hospital
Sutton
Time Frame
Start Date: 2020-12-21
Completion Date: 2026-12
Participants
Target number of participants: 225
Treatments
Experimental: Part A
To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B)
Experimental: Part B
To determine the efficacy of the optimal regimen identified from Part A
Experimental: Part C:
To evaluate additional efficacy parameters for the optimal regimen identified in Part A.
Experimental: Part D
To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib
Authors
Carolyn Muller, Erika Hamilton, Erin Salinas, Alessandro Santin, Kari Ring, Charles Anderson, Hye Sook Chon, David Miller, Mitul Gandhi, John Diaz, Gregg Newman, Robert Holloway, Suresh Ratnam, Anna M Priebe, Emily Prendergast, Alexander Spira, Kristin Bixel, Premal Thaker, Peter Rose, Kristopher LyBarger, Carol Tweed, Elsa Kalbacher, Manuel Rodrigues, Michel Fabbro, Bradley J Monk, Rachel Grisham, Christine Gennigens, Els Van Nieuewenhuysen, Rosalind Glasspool, Maria Jesus Rubio, Andrew Clamp, Amit Oza, Rowan Miller, Charlie Gourley, Isabelle Ray-Coquard, Hannelore Denys, Ana Oaknin, Nicoletta Colombo, Susana Banerjee, Diane Provencher
Related Therapeutic Areas
Sponsors
Collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation
Leads: Verastem, Inc.