Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FAK Inhibitor GSK2256098 · 1 trial · 3 indications
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,...
FAK Inhibitor GSK2256098 is an investigational small molecule being studied for the treatment of intracranial meningioma, including recurrent meningioma and tumors with NF2 gene mutations. It is currently in Phase 2 clinical development and has not been approved by the FDA.
FAK Inhibitor GSK2256098 targets focal adhesion kinase (FAK), an enzyme involved in cell signaling and tumor growth. By inhibiting FAK, the drug aims to disrupt pathways that support cancer cell survival and proliferation in meningiomas.
FAK Inhibitor GSK2256098 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK.
FAK Inhibitor GSK2256098 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.
FAK Inhibitor GSK2256098 is being studied in a Phase 2 clinical trial with the identifier NCT02523014. This trial is recruiting participants with progressive meningiomas and is being conducted in the United States, with an estimated enrollment of 124 patients.
No, FAK Inhibitor GSK2256098 is a distinct drug from Vismodegib, Capivasertib, and Abemaciclib. However, it is being studied in combination with these other agents in a clinical trial for progressive meningiomas, as part of a multi-drug treatment approach.