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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Trastuzumab

Criteria

For additional information on this trial, please call [phone]

Inclusion Criteria:

• Subjects with locally advanced or metastatic Her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. Prior treatment with other Her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab DM-1 etc.) is allowed

• Histologic or cytologic diagnosis of Her-2-positive breast cancer

• ECOG status 0 - 1

Exclusion Criteria:

• Symptomatic brain metastasis

• Any condition requiring chronic use of steroids

• Any disorder with dysregulation of glucose homeostasis (history of Type 1 or 2 Diabetes Mellitus or prediabetic symptoms

• History of glucose intolerance

• Women of child-bearing potential unwilling or unable to use acceptable contraception methods