c-MET Inhibitor; PI3K Inhibitor, PTEN Mutations, Homozygous Del. of PTEN or PTEN Neg. by IHC, c-Met Ampli. by FISH, INC280, BKM120, Buparlisib; Recurrent GBM Clinical Trial
Official title:
A Phase Ib/II, Multi-center, Open-label Study of INC280 in Combination With Buparlisib in Patients With Recurrent Glioblastoma
The study assessed the safety and the dose of the combination of INC280 and buparlisib (BKM120), as well as the anti-tumor activity of the combination, in patients with recurrent glioblastoma with PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC. In addition, the anti-tumor activity of INC280 single agent should have been assessed in patients with recurrent glioblastoma with c-Met alteration.
This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to
estimate the MTD and/or to identify the recommended phase II dose (RP2D) for the combination
of INC280 and buparlisib, followed by the phase II part to assess the clinical efficacy of
INC280 single agent and in combination with buparlisib (BKM120), and to further assess the
safety of the combination. In addition, a surgical arm should have started concurrently with
the phase II part, to determine the PK/PD profile of the study drug combination in patients
undergoing tumor resection for recurrent glioblastoma after 7 to 10-days treatment.
RP2D was not declared due to a lack of efficacy of the combination in the phase Ib stage, and
phase II was continued with INC280 monotherapy only.
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