Clinical Trials in Japan / NCT06682572
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Verastem, Inc. trials in Japan
Other trials for the same condition
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Active, not recruiting
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