drugset / Trial / NCT00788333

Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer

NCT00788333

Phase 1/2 Completed 40 enrolled Bristol-Myers Squibb
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with advanced or metastatic Her-2-positive breast cancer. In addition, the study is expected to identify the recommended dose or dose range of BMS-754807 in combination with trastuzumab for Phase II studies and provide preliminary evidence of anti-tumor activity in Her-2-positive breast cancer subjects after trastuzumab failure

Timeline

Start
2009-07
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject BMS-754807 Small molecule 50 mg Oral
Subject BMS-754807 Small molecule 200 mg Oral
Subject Trastuzumab Monoclonal antibody 2 mg/kg Intravenous

Indications