Continued Access to Avutometinib in Combination With Defactinib in Patients With Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)
- Sponsor
- Verastem, Inc.
- Study ID
- NCT07747506
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Low Grade Ovarian Serous Adenocarcinoma
- Ovarian Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- avutometinib + defactininb combination — DRUGAvutometinib: administered orally twice a week Defactinib: administered orally twice daily
Study Details
This Open-Label Extension (OLE) study provides participants with recurrent low-grade serous ovarian cancer (LGSOC) who have completed the VS-6766-201(RAMP-201) study continued, uninterrupted access to avutometinib in combination with defactinib. The study is designed to support patients in France with access to avutometinib and defactinib who maintain ongoing clinical benefit while collecting safety and tolerability data during extended treatment. Participation is restricted to patients transferring directly from VS-6766-201(RAMP-201), ensuring continuity of care without enrollment of new patients.
Key Dates
- First listed
- Aug 5, 2026
- Start date
- Aug 3, 2026
- Status verified
- Jul 2026
- Primary completion
- Aug 1, 2027
- Completion
- Aug 1, 2028
Study Design
- Enrollment
- 2 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Continued Treatment of Avutometinib + DefactinibTo provide continued treatment with avutometinib in combination with defactinib for participants with recurrent LGSOC who are deriving continued clinical benefit after completion of the VS-6766-201 (RAMP-201) study
Primary Outcome Measure
Duration of Treatment Exposure to Avutometinib in Combination With Defactinib [ Time Frame: Until treatment discontinuation (approximately 20 months) ]
Central Contacts
- Verastem Call Center781-292-4204
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