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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Drug: trastuzumab (Herceptin®)

Drug: BMS-754807

Study type

Interventional

Funder types

Industry

Identifiers

NCT00788333

EUDRACT #: 2009-013766-78

CA191-004

Details and patient eligibility

About

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

Enrollment

40 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For additional information on this trial, please call (910) 558-2913

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