A Dose-finding Phase Ib Study Followed by an Open-label, Randomized Phase II Study of BEZ235 Plus Paclitaxel in Patients With HER2 Negative, Inoperable Locally Advanced or Metastatic Breast Cancer
Interventional
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase lb: Dose Limiting Toxicities (DLTs) the first cycle of treatment
DLT is defined as treatment-related toxicity (classified according Common Toxicity Criteria for Adverse Events (CTCAE) Version 4) occurring during the first 28 treatment days and meeting specific protocol-predefined criteria. The information will be integrated in a Bayesian logistic regression model with overdose control to estimate the maximum tolerated dose (MTD).
At first treatment intake (Cycle 1 Day 1 = C1D1), C1D8, C1D15, C1D22 and C2D1 [a cycle = 4 weeks = 28 days]
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CBEZ235B2101
NCT01495247
January 2012
April 2015
Name | Location |
---|---|
Highlands Oncology Group | Springdale, Arkansas 72764 |
US Oncology Central Monitoring | Dallas, Texas 75246 |
Ironwood Cancer and Research Centers Ironwood | Chandler, Arizona 85224 |
Texas Oncology, P.A. Dept.ofTexas Oncology, PA | Dallas, Texas 75246 |