drugset
drugset / Trial / NCT01248494

PhIb BKM120 or BEZ235+Endocrine Treatment in Post-Menopausal Patients With Hormone Receptor + Metastatic Breast Cancer

NCT01248494 ↗

Phase 1 Completed 72 enrolled Vanderbilt-Ingram Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label phase Ib multi-institution trial that evaluates the safety profile/tolerability and preliminary anti-tumor effect of BKM120 (a PI3K inhibitor) and endocrine therapy combination and BEZ235 (a PI3K/ mTOR inhibitor) and endocrine therapy combination in postmenopausal patients with hormone receptor-positive metastatic breast cancer.

Timeline

Start
2010-11
Primary completion
2012-12
Completion
2016-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Buparlisib Small molecule 60 mg Oral
Subject Buparlisib Small molecule 80 mg Oral
Subject Buparlisib Small molecule 100 mg Oral
Subject Dactolisib Small molecule 200 mg Oral
Subject Dactolisib Small molecule 400 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral

Indications

breast cancer