drugset
drugset / Trial / NCT01495247

Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer

NCT01495247 ↗

Phase 1/2 Terminated 18 enrolled Novartis Pharmaceuticals
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2 negative breast cancer. The first part (phase Ib) will investigate the MTD / Recommended Phase 2 Dose (RP2D) of the combination therapy of BEZ235 twice daily (b.i.d.) and weekly paclitaxel using a Bayesian model. When MTD/ RP2D is established the second part (phase II) will start. Phase II will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid.

Timeline

Start
2012-01-30
Primary completion
2014-05-19
Completion
2014-05-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Dactolisib Small molecule 100 mg Oral
Subject Dactolisib Small molecule 200 mg Oral
Subject Dactolisib Small molecule 300 mg Oral
Subject Dactolisib Small molecule 400 mg Oral
Subject Dactolisib Small molecule 500 mg Oral
Subject Dactolisib Small molecule 600 mg Oral
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous

Indications

female breast carcinoma