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

NCT04625270 · tracked via the Priya Life Science UK tracker

Sponsor

Verastem, Inc.

Phase

Phase 2

Started

2020-12-21

Last updated

2025-01-29

Condition(s) studied

Low Grade Ovarian Serous AdenocarcinomaOvarian Cancer

Investigational drug(s) / intervention(s)

avutometinib (VS-6766)avutometinib (VS-6766) and defactinib

avutometinib (VS-6766): avutometinib (VS-6766) monotherapy

avutometinib (VS-6766) and defactinib: avutometinib (VS-6766) and defactinib combination

Study 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

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy * Co-existing high-grade ovarian cancer or another histology * History of prior malignancy with recurrence \<3 years from the time of enrollment * Major surgery within 4 weeks * Symptomatic brain metastases requiring steroids or other interventions * Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy * For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor * Active skin disorder that has required systemic therapy within the past year * History of rhabdomyolysis * Concurrent ocular disorders * Concurrent heart disease or severe obstructive pulmonary disease * Subjects with the inability to swallow oral medications

Primary outcome measure(s)

Part A: Determine optimal regimen of avutometinib (VS-6766) monotherapy or in combination with defactinib — From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
Part B: To determine the efficacy of the optimal regimen identified from Part A — From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
Part C: To evaluate additional efficacy parameters for the optimal regimen identified in Part A — From start of treatment to confirmation of response; 24 weeks
Confirmed overall response rate per RECIST 1.1
Part D:To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib — From start of treatment to confirmation of response; 24 weeks
Confirmed ORR defined according to RECIST 1.1

Trial sites (47)

Facility	City	Region
Arizona Oncology Associates PC HAL	Scottsdale	Arizona
Sansum Clinic	Santa Barbara	California
Yale School of Medicine	New Haven	Connecticut
Advent Health	Orlando	Florida
H. Lee Moffitt Cancer Center and Research Institute - Center for Women's Oncology	Tampa	Florida
University of Chicago	Chicago	Illinois
Maryland Oncology and Hematology, P.A.	Glenn Dale	Maryland
Minnesota Oncology Hematology PA	Minneapolis	Minnesota
Washington University School of Medicine	St Louis	Missouri
Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
University of New Mexico Comprehensive Cancer Center	Albuquerque	New Mexico
Memorial Sloan Kettering Cancer Center	New York	New York
Cleveland Clinic Women's Health Institute	Cleveland	Ohio
The Ohio State University Wexner Medical Center	Columbus	Ohio
University of Oklahoma Medical Center	Oklahoma City	Oklahoma
Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
Northwest Cancer Specialists	Portland	Oregon
Sarah Cannon Research Institute	Nashville	Tennessee
Texas Oncology Austin Central	Austin	Texas
Texas Oncology- Dallas Presbyterian Hospital	Dallas	Texas
UT Southwestern Medical Center	Dallas	Texas
Texas Oncology	Longview	Texas
Texas Oncology	McAllen	Texas
Texas Oncology	San Antonio	Texas
Texas Oncology	The Woodlands	Texas
University of Virginia Health System	Charlottesville	Virginia
Virginia Cancer Specialists, PC	Gainesville	Virginia
UZ Gent Medische Oncologie	Ghent	Belgium
UZ Leuven	Leuven	Belgium
CHU de Liege	Liège	Belgium
Centre de recherche di Centre Hospitalier de i'Universite de Montreal	Montreal	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	Milan	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

+ 7 more sites — see the full list on the official registry below.

More Verastem, Inc. trials in the UK

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer Recruiting

Phase 1/2 Study of Avutometinib (VS-6766) + Sotorasib With or Without Defactinib in KRAS G12C NSCLC Patients Active, not recruiting

Other trials for the same condition

Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Active, not recruiting

Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer Active, not recruiting

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Active, not recruiting

A Study of Radspherin® in Patients With Primary Advanced Epithelial Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery Recruiting

ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04625270 on ClinicalTrials.gov ↗ ← All trials in the UK