Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme
Status:
Completed
Trial end date:
2018-12-29
Target enrollment:
Participant gender:
Summary
In this phase I/II study,investigators are evaluating the feasibility and efficacy of the
combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of
patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120
dose to be administered with a standard dose of bevacizumab will be determined in patients
with refractory solid tumors. Although it is unlikely that the concurrent administration of
bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will
be performed on all patients treated during the Phase II portion of the study. Assuming this
combination is feasible, the Phase II portion of the study will proceed, using the doses
determined in the Phase I portion. In the phase II portion, eligible patients will be limited
to those with recurrent/progressive GBM following 1st line combined modality therapy.