A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Verastem, Inc.
Study ID
NCT04625270
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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)

Key Dates

Start date
Dec 21, 2020
Status verified
Mar 2024
Primary completion
Nov 15, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib [ Time Frame: From start of treatment to confirmation of response; 24 weeks ]

Locations (27)

FacilityCityStateZIPSite coordinators
Arizona Oncology Associates PC HALScottsdaleArizona85258-
Sansum ClinicSanta BarbaraCalifornia93105-
Yale School of MedicineNew HavenConnecticut06510-
Advent HealthOrlandoFlorida32804-
H. Lee Moffitt Cancer Center and Research Institute - Center for Women's OncologyTampaFlorida33612-
University of ChicagoChicagoIllinois60637-
Maryland Oncology and Hematology, P.A.Glenn DaleMaryland20769-
Minnesota Oncology Hematology PAMinneapolisMinnesota55404-
Washington University School of MedicineSt LouisMissouri63110-
Comprehensive Cancer Centers of NevadaLas VegasNevada89128-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87131-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cleveland Clinic Women's Health InstituteClevelandOhio44195-
The Ohio State University Wexner Medical CenterColumbusOhio43212-
University of Oklahoma Medical CenterOklahoma CityOklahoma73104-
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401-
Northwest Cancer SpecialistsPortlandOregon97227-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Texas Oncology Austin CentralAustinTexas78731-
Texas Oncology- Dallas Presbyterian HospitalDallasTexas75231-
UT Southwestern Medical CenterDallasTexas75390-
Texas OncologyLongviewTexas75601-
Texas OncologyMcAllenTexas78503-
Texas OncologySan AntonioTexas78240-
Texas OncologyThe WoodlandsTexas77380-
University of Virginia Health SystemCharlottesvilleVirginia22908-
Virginia Cancer Specialists, PCGainesvilleVirginia20155-

Find similar trials in Scottsdale, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Arizona Oncology Associates PC HAL· Scottsdale, AZSansum Clinic· Santa Barbara, CAYale School of Medicine· New Haven, CTAdvent Health· Orlando, FLH. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology· Tampa, FLUniversity of Chicago· Chicago, IL

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