Overview

Study Evaluating SKI-606 (Bosutinib) In Subjects With Breast Cancer

Status:
Completed
Trial end date:
2009-02-01
Target enrollment:
0
Participant gender:
Female
Summary
The purpose of this study is to determine if SKI-606 (Bosutinib) is effective in the treatment of advanced or metastatic breast cancer. Patients must have current Stage IIIB, IIIC or IV breast cancer and have progressed after 1 to 3 prior chemotherapy regimens.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

- Stage IIIB, IIIC or IV breast cancer not curable with available therapy.

- Patients must have progressed after 1 but not more than 3 prior chemotherapy regimens.

- Life expectancy of at least 16 weeks.

- Ability to swallow whole capsules.

Exclusion Criteria:

- Use of or requirement for bisphosphonates within 8 weeks prior to screening.

- Any other cancer within 5 years of screening, except for basal cell carcinoma or
cervical carcinoma in situ

- Uncontrolled cardiac disease including congestive heart failure, angina, heart attack,
etc.

- Recent or ongoing significant gastrointestinal disorder