Last updated on February 2018

Vismodegib and FAK Inhibitor GSK2256098 in Treating Patients With Progressive Meningiomas


Brief description of study

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

Detailed Study Description

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.

OUTLINE: Patients are assigned to 1 of 2 treatment arms based on their mutation status.

ARM A (SMO/PTCH1 mutation): Patients receive vismodegib orally (PO) once daily (QD). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM B (NF2 mutation): Patients receive FAK inhibitor GSK2256098 PO twice daily (BID). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for a maximum of 5 years from registration.

Clinical Study Identifier: NCT02523014

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Priscilla Brastianos, MD

Dayton Physicians LLC-Wilson
Sidney, OH United States
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