Phase II Trial of SMO/AKT/NF2/CDK Inhibitors in Progressive Meningiomas with SMO/AKT/NF2/CDK Pathway Mutations
Categories (click each to see list of all clinical trials associated with that category): Brain/Neuro (ONC)
Current Status: Open
Phase: II (Cancer Control)
Principal Investigator: Shonka, Nicole
Contact Information:
Sarah Kirke, RN
402-559-8065
sarah.kirke@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT02523014?term=NCT02523014&rank=1
Summary
PRIMARY OBJECTIVES:
I. To determine the activity of a smoothened, frizzled class receptor (SMO) and PTCH1 inhibitor in patients with meningiomas harboring SMO 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 neurofibromin 2 (NF2) mutations as measured by 6-month PFS and response rate.
SECONDARY OBJECTIVES:
I. To determine overall survival and progression-free survival of SMO and FAK inhibitors in patients with meningioma.
II. To determine adverse event rates of SMO and FAK inhibitors in patients with meningioma.
III. To determine the activity of SMO and FAK inhibitor as measured by response rate by central radiology review.
TERTIARY OBJECTIVES:
I. To evaluate genetic biomarkers in meningioma.
II. To evaluate dynamic contrast enhanced magnetic resonance imaging (MRI) during treatment with SMO and FAK inhibitors for meningioma.
III. To evaluate volumetric response by central radiology review.