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

Running, not enrolling · Phase 2

Conditions studied: Low Grade Ovarian Serous Adenocarcinoma, Ovarian Cancer

In brief

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 facts

Study ID

NCT04625270

Run by

Verastem, Inc.

People needed

225

Starts

2020-12-21

Expected to finish

2026-12-01

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 — St 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

Full record on ClinicalTrials.gov

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