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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225
Last updated 2025-01-29
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)
Conditions
- Low Grade Ovarian Serous Adenocarcinoma
- Ovarian Cancer
Interventions
- DRUG
-
avutometinib (VS-6766)
avutometinib (VS-6766) monotherapy
- DRUG
-
avutometinib (VS-6766) and defactinib
avutometinib (VS-6766) and defactinib combination
Sponsors & Collaborators
-
European Network of Gynaecological Oncological Trial Groups (ENGOT)
collaborator OTHER -
GOG Foundation
collaborator NETWORK -
Verastem, Inc.
lead INDUSTRY
Principal Investigators
-
Susana Banerjee, MBBS,MA,PhD · European Network of Gynaecological Oncological Trial Groups (ENGOT)
-
Rachel Grisham, MD · GOG Foundation
-
MD Verastem · Verastem, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-21
- Primary Completion
- 2024-11-15
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
- France
- Italy
- Spain
- United Kingdom
Study Locations
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