drugset / Trial / NCT00788333
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BMS-754807 | Small molecule | 50 mg | Oral |
| Subject | BMS-754807 | Small molecule | 200 mg | Oral |
| Subject | Trastuzumab | Monoclonal antibody | 2 mg/kg | Intravenous |