Vismodegib and FAK Inhibitor GSK2256098 in Treating Patients With Progressive Meningiomas
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|ClinicalTrials.gov Identifier: NCT02523014|
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Meningioma Recurrent Meningioma NF2 Gene Mutation||Drug: vismodegib Drug: GSK2256098||Phase 2|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of SMO/AKT/NF2 Inhibitors in Progressive Meningiomas With SMO/AKT/NF2 Mutations|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||August 2019|
Experimental: Arm A - vismodegib
Patients receive vismodegib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm B - GSK2256098
Patients receive FAK inhibitor GSK2256098 PO BID. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Progression free survival (PFS) [ Time Frame: At 6 months ]Point estimates and 95% binomial confidence intervals will be generated for the six month PFS rate within each cohort of each treatment arm. Kaplan-Meier curves will be generated for PFS for each cohort within each treatment arm.
- Response rate defined as a confirmed complete response (CR) or partial response (PR) [ Time Frame: Up to 2 years ]Point estimates will be generated for response rates within each treatment arm with corresponding 95% binomial confidence intervals.
- Overall survival (OS) [ Time Frame: Up to 2 years ]OS will be summarized for each cohort within each treatment group with Kaplan-Meier curves and estimates.
- Incidence of adverse events according to National Cancer Institute CTCAE version 4.0 [ Time Frame: Up to 4 weeks after completion of study treatment ]Adverse events (AEs) will be summarized for each treatment group. They will be summarized as the number and frequency of each event. In addition the AEs will be summarized as the number and frequency of patients who experience any AE, AEs of grade 3+, and AEs of grade 4+.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523014
|Contact: Priscilla Brastianos, MD||617-643-1939|
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|Study Chair:||Priscilla Brastianos, MD||Massachusetts General Hospital|