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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02523014 | Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas | PHASE2 | RECRUITING | 124 | — | — | Sep 28, 2015 | Jan 1, 2028 | May 8, 2026 | 780 | United States |
Point estimates and 95% binomial confidence intervals will be generated for the six month PFS rate within each cohort of each treatment arm. Kaplan-Meier curves will be generated for PFS for each cohort within each treatment arm.
Point estimates will be generated for response rates within each treatment arm with corresponding 95% binomial confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Arm A (vismodegib) | EXPERIMENTAL | Patients receive vismodegib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL FEBRUARY 2018) |
| Arm B (FAK inhibitor GSK2256098) | EXPERIMENTAL | Patients receive FAK inhibitor GSK2256098 PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL JULY 2017) |
| Arm C (capivasertib) | EXPERIMENTAL | Patients receive capivasertib PO BID on days 1-4. Treatment repeats every 7 days for up to 1 cycle (28 days) in the absence of disease progression or unacceptable toxicity. |
| Arm D (abemaciclib) | EXPERIMENTAL | Patients receive abemaciclib PO Q12H. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Vismodegib | DRUG | Given PO |
| FAK Inhibitor GSK2256098 | DRUG | Given PO |
| Capivasertib | DRUG | Given PO |
| Abemaciclib | DRUG | Given PO |
* Documentation of disease: * Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review * Molecular documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3,...