Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme
Status:
Completed
Trial end date:
2016-07-07
Target enrollment:
Participant gender:
Summary
This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent
glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated
dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with
every-three-week carboplatin or buparlisib once daily in combination with every-six-week
lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2
arms, the corresponding phase II portion of the study was to start. Phase II was to assess
the treatment effect of buparlisib in combination with carboplatin in terms of Progression
Free Survival (PFS) and was to compare the treatment effect of buparlisib with lomustine
versus lomustine plus placebo in terms of PFS.
A preliminary assessment for both combinations (buparlisib plus carboplatin or lomustine)
demonstrated that there was not enough antitumor activity compared to historical data with
single agent carboplatin or lomustine. Based on the overall safety profile, and preliminary
anti-tumor activity observed in this study, Novartis decided that no additional patients
would be enrolled into this study. As a consequence, the Phase II part of the study was not
conducted.