A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer

Conditions

• Low Grade Serous Ovarian Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• avutometinib — DRUG
  Avutometinib: administered orally
• Defactinib — DRUG
  Defactinib: administered orally
• Pegylated liposomal doxorubicin — DRUG
  administered intravenously
• Paclitaxel — DRUG
  administered intravenously
• Letrozole — DRUG
  administered orally
• Anastrozole — DRUG
  administered orally

Study Details

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.

Key Dates

Start date

Mar 18, 2024

Status verified

Apr 2026

Primary completion

Oct 15, 2028

Completion

Feb 9, 2031

Study Design

Enrollment

270 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: avutometinib + defactinib
  Avutometinib 3.2 mg, PO, twice weekly for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day(4 week) cycle.
• Active Comparator: Investigator Choice of Treatment (ICT)
  Patients will receive one of the following therapies as determined by the Investigator: * Pegylated liposomal doxorubicin: 40 mg/m2 IV on Day 1 of each 28-day (4 week) cycle. * Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle. * Anastrozole: 1 mg, PO, once daily of each 28-day (4 week) cycle. * Letrozole: 2.5 mg, PO, once daily of each 28-day (4 week) cycle.

Primary Outcome Measure

Progression Free Survival (PFS) per blinded independent central review (BICR) [ Time Frame: Up to 24 months ]

Central Contacts

• Verastem Call Center
  781-292-4204
  [email protected]

Locations (38)

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