Phase II Study of Targeted Oral Treatments for Progressive Meningiomas Based on Specific Gene Mutations

What this Trial Is About

Researchers are evaluating the effects of several targeted drugsvismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclibon patients with progressive meningiomas. These tumors are growing, spreading, or worsening, and the study focuses on different genetic mutations in the tumors to match patients with the appropriate drug. The trial is a phase II study aiming to measure progression-free survival and response rates over six months, along with overall survival and adverse events. Participants are assigned to one of four groups based on their tumor mutation status. Those with SMOPTCH1 mutations receive vismodegib daily those with NF2 mutations receive FAK inhibitor GSK2256098 twice daily patients with AKT1, PIK3CA, or PTEN mutations take capivasertib twice daily on days 1-4 weekly and those with CDK pathway alterations receive abemaciclib twice daily. Treatment cycles repeat every 28 days as long as the disease does not progress or unacceptable side effects occur. After treatment, participants are followed every six months for up to five years. During the study, patients undergo regular monitoring including imaging to assess tumor size and progression, lab tests to monitor blood counts and organ function, and evaluations of side effects. Researchers track progression-free survival at six months and tumor response rates, as well as overall survival. Safety is closely observed up to four weeks after treatment ends. The total study duration includes active treatment cycles and long-term follow-up extending up to five years from registration.

Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas