Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04625270 | A Study of Avutometinib (VS-6766) v. Avutometinib (VS-6766) + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer With and Without a KRAS Mutation | PHASE2 | ACTIVE NOT_RECRUITING | 225 | — | — | Dec 21, 2020 | Dec 1, 2026 | Jan 29, 2025 | 47 | United States, Belgium +5 |
Confirmed overall response rate per RECIST 1.1
Confirmed overall response rate per RECIST 1.1
Confirmed overall response rate per RECIST 1.1
Confirmed ORR defined according to RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Part A | EXPERIMENTAL | To determine the optimal regimen, either avutometinib(VS-6766) monotherapy or avutometinib (VS-6766) in combination with defactinib, for subsequent evaluation for efficacy in the Expansion Phase (Part B) |
| Part B | EXPERIMENTAL | To determine the efficacy of the optimal regimen identified from Part A |
| Part C: | EXPERIMENTAL | To evaluate additional efficacy parameters for the optimal regimen identified in Part A. |
| Part D | EXPERIMENTAL | To evaluate additional efficacy parameters for a lower dose of avutometinib in combination with defactinib |
| Name | Type | Description |
|---|---|---|
| avutometinib (VS-6766) | DRUG | avutometinib (VS-6766) monotherapy |
| avutometinib (VS-6766) and defactinib | DRUG | avutometinib (VS-6766) and defactinib combination |
Inclusion Criteria: * Histologically proven LGSOC (ovarian, peritoneal) * Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease. * Measurable disease according to RECIST 1.1 * An Eastern Cooperative Group (ECOG) performance status ≤ 1. * Adequate organ ...