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

Completed · Phase 2

Conditions studied: Breast Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT00319254

Run by

Pfizer

People needed

75

Starts

2006-05-01

Expected to finish

2009-02-01

Last updated by the study team

2013-01-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Duarte, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Cleveland, Ohio, United States
• Pfizer Investigational Site — Darlinghurst, New South Wales, Australia
• Pfizer Investigational Site — Dijon, France
• Pfizer Investigational Site — Saint-Herblain, France
• Pfizer Investigational Site — Pokfulam, Hong Kong
• Pfizer Investigational Site — Floriana, Malta
• Pfizer Investigational Site — Lodz, Poland
• Pfizer Investigational Site — Wroclaw, Poland
• Pfizer Investigational Site — Moscow, Russia
• Pfizer Investigational Site — Sumy, Ukraine, Ukraine
• Pfizer Investigational Site — Dnipropetrovsk, Ukraine
• Pfizer Investigational Site — Uzhhorod, Ukraine

Full record on ClinicalTrials.gov

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