A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients

Sponsor
Verastem, Inc.
Study ID
NCT06682572
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will confirm the safety and efficacy of avutometinib in combination with defactinib in Japanese patients with recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Key Dates

Start date
Oct 30, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2025
Completion
Oct 31, 2027

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: avutometinib + defactinib
    Avutometinib 3.2mg, 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.

Primary Outcome Measure

Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] [ Time Frame: From start of treatment to confirmation of response; 24 weeks ]

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