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NCT00078000 Clinical Trial

A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.

Breast Neoplasms Clinical Trial

Official title:
A Phase 2 Study Of The Efficacy And Safety Of SU011248 In Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00078000
Other study ID # A6181002
Secondary ID
Status Completed
Phase Phase 2
First received February 13, 2004
Last updated November 24, 2008
Start date March 2004
Est. completion date November 2005

Study information
Verified date November 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who have failed selected other therapies.

Other known NCT identifiers
  • NCT00095615

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Anthracycline and taxane-refractory or intolerant metastatic breast cancer

- Female

Exclusion Criteria:

- Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines/taxanes.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SU011248

Locations
Country Name City State
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Greenbrae California
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anti-tumor efficacy
Secondary Tumor control survival safety pharmacokinetics
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