Combining avutometinib and defactinib for 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
This study is testing a new combination treatment of avutometinib and defactinib to see if it can help Japanese patients with recurrent low-grade serous ovarian cancer who have already tried other chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Verastem, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, avutometinib, defactinib |
| Locations | 5 sites (Nagoya, Aichi and 4 other locations) |
| Trial ID | NCT06682572 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study aims to evaluate the safety and efficacy of a combination treatment of avutometinib and defactinib in Japanese patients diagnosed with recurrent low-grade serous ovarian cancer (LGSOC). The study is multi-center and open-label, focusing on patients who have previously undergone platinum-based chemotherapy and have documented disease progression. The efficacy will be confirmed through independent radiological review, while safety and tolerability will also be assessed throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include Japanese patients with histologically confirmed recurrent low-grade serous ovarian cancer who have received prior platinum-based chemotherapy.
Not a fit: Patients with high-grade ovarian cancer or other histologies, as well as those with recent systemic anti-cancer therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent low-grade serous ovarian cancer.
How similar studies have performed: While this approach is novel in the context of LGSOC, similar combinations have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy * Co-existing high-grade ovarian cancer or another histology * History of prior malignancy, excluding ovarian cancer, with recurrence \<3 years from the time of enrollment * 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 * Active skin disorder that has required systemic therapy within the past year * History of rhabdomyolysis * Concurrent ocular disorders * Concurrent heart disease or severe obstructive pulmonary disease * Patients with the inability to swallow oral medications
Where this trial is running
Nagoya, Aichi and 4 other locations
- Aichi Cancer Center Hospital — Nagoya, Aichi, Japan (Recruiting)
- Kurume University Hospital — Kurume, Fukuoka, Japan (Recruiting)
- Mie University Hospital — Tsu, Mie, Japan (Recruiting)
- Tohoku University Hospital — Sendai, Miyagi, Japan (Recruiting)
- Jikei University Hospital — Minato City, Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Verastem Call Center
- Email: clinicaltrials@verastem.com
- Phone: 781-292-4204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.