A Phase II Study of Targeted Therapies for Meningiomas with Specific Genetic Mutations

Full Title

Phase II Trial of SMO/AKT/NF2/CDK Inhibitors in Progressive Meningiomas with SMO/AKT/NF2/CDK Pathway Mutations (A071401)

Purpose

This study is assessing the safety and effectiveness of two drugs against meningiomas that contain certain genetic mutations. One mutation is in the SMO gene and the other is in the NF2 gene. Patients whose tumors contain an SMO mutation will receive the drug vismodegib, which blocks the receptor for the SMO protein. Those whose tumors contain NF2 mutations will receive GSK2256098, which seems to work better against tumors with this mutation. Both drugs are taken orally (by mouth).

Some patients may have mutations in both genes. In this case, they’ll receive one drug first, and if the tumor continues growing, they’ll receive the other drug instead.

GSK2256098 is an investigational drug. Vismodegib is approved for treating basal cell skin cancer, but its use in this study is considered investigational.

Protocol
16-104
Phase
Phase II (phase 2)
Disease Status
Newly Diagnosed & Relapsed/Refractory
Investigator
Co-Investigators
ClinicalTrials.gov ID
NCT02523014