Ph II Trial of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas w/ SMO/ AKT/ NF2 Mutations

Cancer
Daniela Bota
Phase II Trial of SMO/AKT/NF2/CDK Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 /CDK Pathway Mutations
Brain and Nervous System

Study Description

This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility

  • Histologically proven intracranial meningioma as documented by

central pathology review

  • Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN

mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1

copy number gain in tumor sample as documented specifically by the central laboratory

  • Male or female who are not pregnant and not nursing
  • Patients who have active bacterial infection
  • Patients who have history of heart diseases as described by the study protocol
  • Patients who have uncontrolled hypertension
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