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A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.
This study has been completed.
First Received: February 13, 2004   Last Updated: November 24, 2008   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00078000
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: SU011248
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 2 Study Of The Efficacy And Safety Of SU011248 In Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Anti-tumor efficacy

Secondary Outcome Measures:
  • Tumor control survival safety pharmacokinetics

Enrollment: 64
Study Start Date: March 2004
Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00078000

Locations
United States, California
Pfizer Investigational Site
Greenbrae, California, United States, 94904
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
San Francisco, California, United States, 94115
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80010
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612-3824
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A6181002
Study First Received: February 13, 2004
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00078000     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Skin Diseases
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Breast Neoplasms
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Sunitinib
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009