A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
NCT06072781 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 270
Last updated 2026-04-02
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.
Conditions
- Low Grade Serous Ovarian Cancer
Interventions
- DRUG
-
avutometinib
Avutometinib: administered orally
- DRUG
-
Defactinib
Defactinib: administered orally
- DRUG
-
Pegylated liposomal doxorubicin
administered intravenously
- DRUG
-
administered intravenously
- DRUG
-
administered orally
- DRUG
-
Anastrozole
administered orally
Sponsors & Collaborators
-
GOG Foundation
collaborator NETWORK -
European Network of Gynaecological Oncological Trial Groups (ENGOT)
collaborator OTHER -
Australia New Zealand Gynaecological Oncology Group
collaborator OTHER -
Korean Gynecologic Oncology Group
collaborator OTHER -
Verastem, Inc.
lead INDUSTRY
Principal Investigators
-
Rachel Grisham, MD · GOG Foundation
-
Susana Banerjee, MBBS, MA, PhD · European Network of Gynecological Oncological Trial Groups (ENGOT)
-
Craig Berman Verastem Medical Monitor · [email protected]
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-18
- Primary Completion
- 2028-10-15
- Completion
- 2031-02-09
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Canada
- Denmark
- France
- Germany
- Ireland
- Italy
- Japan
- Netherlands
- New Zealand
- Poland
- South Korea
- Spain
- United Kingdom
Study Locations
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