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

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

This study has been completed.

Sponsored by:	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

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase II Study Of The Efficacy And Safety Of SU011248 In Patients With Anthracycline- And Taxane-Refractory Or Intolerant Metastatic Breast Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

Anti-tumor efficacy

Secondary Outcome Measures:

Tumor control survival safety pharmacokinetics

Estimated Enrollment:	64
Study Start Date:	March 2004
Estimated 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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to clinicalstudyresults.org results posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	A6181002
First Received:	February 13, 2004
Last Updated:	January 9, 2007
ClinicalTrials.gov Identifier:	NCT00078000
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases

Sunitinib

Breast Neoplasms

Taxane

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Growth Substances

Therapeutic Uses

Physiological Effects of Drugs

Growth Inhibitors

Angiogenesis Modulating Agents

Angiogenesis Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008