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

November 24, 2008 updated by: Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Greenbrae, California, United States, 94904
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80010
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612-3824
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Anti-tumor efficacy

Secondary Outcome Measures

Outcome Measure
Tumor control survival safety pharmacokinetics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

February 13, 2004

First Submitted That Met QC Criteria

February 17, 2004

First Posted (Estimate)

February 18, 2004

Study Record Updates

Last Update Posted (Estimate)

November 26, 2008

Last Update Submitted That Met QC Criteria

November 24, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6181002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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