NCT04625270

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

A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) Alone and In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Verastem, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

This is a multicenter, randomized, open-label Phase 2 study designed to evaluate safety and tolerability and preliminary efficacy of avutometinib (VS-6766) versus avutometinib (VS-6766) in combination with defactinib in subjects with molecularly profiled recurrent LGSOC.

Conditions

• Low Grade Ovarian Serous Adenocarcinoma
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	avutometinib (VS-6766)	avutometinib (VS-6766) monotherapy
DRUG	avutometinib (VS-6766) and defactinib	avutometinib (VS-6766) and defactinib combination

Timeline

• Start date: 2020-12-21
• Primary completion: 2024-11-15
• Completion: 2026-12-01
• First posted: 2020-11-12
• Last updated: 2025-01-29

Locations

47 sites across 7 countries: United States, Belgium, Canada, France, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study