NCT06682572Active, not recruitingPhase 2
A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients
A Phase 2 Study of Avutometinib (VS-6766, a Dual RAF/MEK Inhibitor) In Combination With Defactinib (FAK Inhibitor) in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in Japanese Patients
Source: ClinicalTrials.gov · Last updated 17 Dec 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 5 Nov 2024
- Start date
- 30 Oct 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Verastem, Inc.
- Diseases
- Ovarian cancer
- NCT number
- NCT06682572
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 16
- From 30 Oct 2024 to the primary completion date, Dec 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery within 4 weeks
- Symptomatic brain metastases requiring steroids or other interventions
- Known SARS-Cov2 infection (clinical symptoms) ≤28 days prior to first dose of study therapy
- For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor
- Concurrent ocular disorders
- Concurrent heart disease or severe obstructive pulmonary disease
- Patients with the inability to swallow oral medications
Other illness
- Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy
- Co-existing high-grade ovarian cancer or another histology
- Active skin disorder that has required systemic therapy within the past year
- History of rhabdomyolysis
Age
- History of prior malignancy, excluding ovarian cancer, with recurrence \<3 years from the time of enrollment
Who the study is looking for
- Histologically proven LGSOC (ovarian, peritoneal)
- Documented mutational status of KRAS by validated diagnostic test of tumor tissue
- Documented disease progression (radiographic or clinical) or recurrence of LGSOC and have received at least one platinum-based chemotherapy agent
- Measurable disease according to RECIST 1.1
- An Eastern Cooperative Group (ECOG) performance status ≤ 1.
- Adequate organ function
- Adequate recovery from toxicities related to prior treatments
- Agreement to use highly effective method of contraceptive, if necessary
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Jikei University Hospital Coordinator of this site? Confirm its status | Minato | Japan | Unknown status |
| Aichi Cancer Center Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Tohoku University Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Mie University Hospital Coordinator of this site? Confirm its status | Tsu | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.