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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06072781 | A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer | PHASE3 | RECRUITING | 270 | — | — | Mar 18, 2024 | Feb 9, 2031 | Apr 2, 2026 | 106 | United States, Australia +14 |
| NCT06682572 | A Study of Avutometinib + Defactinib in Recurrent Low-Grade Serous Ovarian Cancer in Japanese Patients | PHASE2 | ACTIVE NOT_RECRUITING | 16 | — | — | Oct 30, 2024 | Oct 1, 2027 | Dec 17, 2025 | 5 | Japan |
Progression-free survival (PFS) according to RECIST version 1.1, per blinded independent central review (BICR)
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)
| Arm | Type | Description |
|---|---|---|
| avutometinib + defactinib | EXPERIMENTAL | Avutometinib 3.2 mg, PO, twice weekly for 21 days on, 7 days off in a 28-day (4 weeks) cycle in combination with defactinib 200 mg, PO, twice daily for 21 days on, 7 days off in a 28-day(4 week) cycle. |
| Investigator Choice of Treatment (ICT) | ACTIVE_COMPARATOR | Patients will receive one of the following therapies as determined by the Investigator: * Pegylated liposomal doxorubicin: 40 mg/m2 IV on Day 1 of each 28-day (4 week) cycle. * Paclitaxel: 80 mg/m2 IV on Days 1, 8, and 15 of each 28-day (4 week) cycle. * Anastrozole: 1 mg, PO, once daily of each 28-day (4 week) cycle. * Letrozole: 2.5 mg, PO, once daily of each 28-day (4 week) cycle. |
| Name | Type | Description |
|---|---|---|
| avutometinib | DRUG | Avutometinib: administered orally |
| Defactinib | DRUG | Defactinib: administered orally |
| Pegylated liposomal doxorubicin | DRUG | administered intravenously |
| Paclitaxel | DRUG | administered intravenously |
| Letrozole | DRUG | administered orally |
| Anastrozole | DRUG | administered orally |
| Avutometinib (VS-6766) + Defactinib (VS-6063) | DRUG | combination therapy |
Inclusion Criteria: Patients may be eligible for inclusion in the study if they meet the following criteria: 1. Histologically proven LGSOC (ovarian, fallopian, peritoneal) 2. Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test. 3. Suitable for treatment with at ...