NCT00078000

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2004

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

November 26, 2008

Status Verified

November 1, 2008

First QC Date

February 13, 2004

Last Update Submit

November 24, 2008

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Anti-tumor efficacy

Secondary Outcomes (1)

  • Tumor control survival safety pharmacokinetics

Interventions

SU011248DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anthracycline and taxane-refractory or intolerant metastatic breast cancer
  • Female

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Pfizer Investigational Site

Greenbrae, California, 94904, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80010, United States

Location

Pfizer Investigational Site

Chicago, Illinois, 60612-3824, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21231, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Keyvanjah K, DePrimo SE, Harmon CS, Huang X, Kern KA, Carley W. Soluble KIT correlates with clinical outcome in patients with metastatic breast cancer treated with sunitinib. J Transl Med. 2012 Aug 16;10:165. doi: 10.1186/1479-5876-10-165.

    PMID: 22897944DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 13, 2004

First Posted

February 18, 2004

Study Start

March 1, 2004

Study Completion

November 1, 2005

Last Updated

November 26, 2008

Record last verified: 2008-11

Locations

US(10)