Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Breast Neoplasms

Neoplasm Metastasis

Eligibility:

FEMALE

18+ years

Phase:

PHASE2

Brief 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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2009

Estimated Enrollment :

75 Patients enrolled

Trial Details

Trial ID

NCT00319254

Start Date

May 1 2006

End Date

February 1 2009

Last Update

January 31 2013

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Pfizer Investigational Site

Duarte, California, United States, 91010-3000

2

Pfizer Investigational Site

Santa Monica, California, United States, 90404

3

Pfizer Investigational Site

Tampa, Florida, United States, 33612

4

Pfizer Investigational Site

Cleveland, Ohio, United States, 44195