drugset / Trial / NCT01297491

Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

NCT01297491

Phase 2 Completed 63 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.

Timeline

Start
2011-05
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Buparlisib Small molecule 100 mg Oral