drugset / Trial / NCT01870726

Safety and Efficacy of INC280 and Buparlisib (BKM120) in Patients With Recurrent Glioblastoma

NCT01870726 ↗

Phase 1/2 Terminated 43 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2014-01-09
Primary completion
2016-12-23
Completion
2016-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Buparlisib Small molecule 50 mg —
Subject Buparlisib Small molecule 80 mg —
Subject Capmatinib Small molecule 200 mg —
Subject Capmatinib Small molecule 300 mg —
Subject Capmatinib Small molecule 400 mg —