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Active, not recruiting Phase 2

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

NCT06682572 · tracked via the Priya Life Science Japan tracker
Phase
Phase 2
Started
2024-10-30
Last updated
2025-12-17

Condition(s) studied

Low Grade Serous Ovarian CancerOvarian Cancer

Investigational drug(s) / intervention(s)

Avutometinib (VS-6766) + Defactinib (VS-6063)All Avutometinib trials (12) →All Defactinib trials (6) →

Avutometinib (VS-6766) + Defactinib (VS-6063): combination therapy

Study summary

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)

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Confirmed overall response rate (ORR; partial response [PR] + complete response [CR] — From start of treatment to confirmation of response; 24 weeks
    Confirmed overall response rate (ORR; partial response \[PR\] + complete response \[CR\] defined according to Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]) as assessed by the blinded independent central radiology review committee (BICR)

Trial sites (5)

FacilityCityRegionStatus
Aichi Cancer Center Hospital Nagoya Aichi-ken
Kurume University Hospital Kurume Fukuoka
Mie University Hospital Tsu Mie-ken
Tohoku University Hospital Sendai Miyagi
Jikei University Hospital Minato Tokyo
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06682572 on ClinicalTrials.gov ↗ ← All trials in Japan