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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Avutometinib: administered orally twice a week Defactinib: administered orally twice daily
Centre Leon Berard
Lyon, France
Institut Curie
Paris, France
Duration of Treatment Exposure to Avutometinib in Combination With Defactinib
Treatment exposure will be summarized descriptively for participants receiving continued treatment with avutometinib in combination with defactinib after completion of Study VS-6766-201 (RAMP-201).
Time frame: Until treatment discontinuation (approximately 20 months)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Treatment-emergent adverse events will be collected and summarized for participants receiving extended treatment with avutometinib alone or in combination with defactinib.
Time frame: From informed consent until 30 days after the last dose of study treatment (approximately 20 months plus 30 days).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.