A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Ca… (NCT06072781) | Clinical Trial Compass
RecruitingPhase 3
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
United States270 participantsStarted 2024-03-18
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
✓. Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
✓. Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
✓. Measurable disease according to RECIST v1.1.
✓. An Eastern Cooperative Group (ECOG) performance status ≤ 1.
✓. Adequate organ function.
✓. Adequate recovery from toxicities related to prior treatments.
Exclusion criteria
✕. Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
✕. Co-existing high-grade serous ovarian cancer or mixed histology.
✕. Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
✕. History of prior malignancy with recurrence \<3 years from the time of enrollment.
✕. Major surgery within 4 weeks, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
What they're measuring
1
Progression Free Survival (PFS) per blinded independent central review (BICR)