A Phase II Study of BKM120 for Patients with Recurrent Glioblastoma and Activated PI3K Pathway
The goal of this clinical research study is to learn if BKM120 (buparlisib) can help to control glioblastoma and/or gliosarcoma. Researchers also want to learn more about how much study drug is in different areas of the body at different time points. The safety of this drug will also be studied. BKM120 is designed to block a protein that is important to the growth and division of cancer cells, which may cause the cells to die.
Treatment Location: N/A
1 Cohort 1 1.1 Primary Objectives To evaluate Phosphatidylinositol 3’-kinase(PI3K) pathway modulation due to BKM120 in tumor tissue To evaluate BKM120 concentration in tumor tissue, plasma, and cerebrospinal fluid 1.2 Secondary Objectives To evaluate effects of BKM120 on tumor cell proliferation and tumor cell death To investigate the safety profile of BKM120 in this population To investigate pharmacokinetics of BKM120 in this population 1.3 Exploratory Objectives Correlation of FDG-Positron Emission Tomography (PET) and FLT-PET with pharmacodynamic effects and 6 month progression-free survival(PFS6). To determine the effects of BKM120 on primary Glioblastoma(GBM) cell lines derived from participants and correlate with participant benefit from BKM120 treatment. 2 Cohort 2 2.1 Primary Objective To investigate the treatment efficacy of BKM120 in participants with recurrent GBM as measured by 6-month progressive-free survival (PFS6). 2.2 Secondary Objectives To investigate the radiographic response to BKM120. To investigate median progression free survival and overall survival of participants with recurrent GBM receiving treatment with BKM120. To investigate the safety profile of BKM120 in participants with recurrent GBM. 2.3 Exploratory Objectives To correlate benefit from BKM120 treatment with molecular genotype of tumor (using immunohistochemistry, mutation analysis and RNA expression profiling), and whole blood proteomics. To correlate benefit from BKM120 treatment with circulating angiogenic biomarkers Use of advance MRI (perfusion, permeability, diffusion imaging) to determine the effects of BKM120 on tumor vasculature and to correlate with benefit from BKM120 treatment
IRB Review and Approval Date: 07/26/2011
Recruitment Status: Closed
Projected Accrual: N/A