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