drugset / Trial / NCT01289041

BKM120 as Second-line Therapy for Advanced Endometrial Cancer

NCT01289041

Phase 2 Completed 70 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective multi-center, open-label, single arm, Phase II study to investigate the safety and efficacy of BKM120 in patients with advanced endometrial carcinoma whose disease progressed on or after a first-line antineoplastic treatment. Patients will receive BKM120 orally at a dose of 100 mg/day. Availability of tumor specimen (either archival tissue or a fixed fresh biopsy) is mandatory for assessment of the PI3K (Phosphatidylinositol 3 Kinase (PI3K) pathway activation status.

Timeline

Start
2011-02
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Buparlisib Small molecule 100 mg Oral

Indications