Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas With SMO/ AKT/ NF2/CDK Pathway Mutations
Alliance for Clinical Trials in Oncology
Summary
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.
Description
PRIMARY OBJECTIVES: I. To determine the activity of a SMO inhibitor in patients with meningiomas harboring SMO and PTCH1 mutations as measured by 6-month progression free survival (PFS) and response rate. II. To determine the activity of a FAK inhibitor in patients with meningiomas harboring NF2 mutations as measured by 6-month PFS and response rate. III. To determine the activity of an AKT inhibitor in patients with meningiomas harboring AKT1/PIK3CA/PTEN mutations as measured by 6-month PFS and response rate. IV. To determine the activity of a CDK inhibitor in patients with meningiomas ha…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
* 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, or CCNE1 copy number gain in tumor sample as documented specifically by the central laboratory, regardless of whether prior genotype testing outside of the central laboratory was performed * Progressive OR residual disease, as defined by the following: * Residual measurable disease: residual…
Interventions
- DrugVismodegib
Given PO
- DrugFAK Inhibitor GSK2256098
Given PO
- DrugCapivasertib
Given PO
- DrugAbemaciclib
Given PO
Locations (780)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Anchorage Associates in Radiation MedicineAnchorage, Alaska
- Anchorage Radiation Therapy CenterAnchorage, Alaska
- Alaska Breast Care and Surgery LLCAnchorage, Alaska
- Alaska Oncology and Hematology LLCAnchorage, Alaska
- Alaska Women's Cancer CareAnchorage, Alaska