Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: SU011248; Drug: Paclitaxel

• Registration Number: NCT00174434
• Lead Sponsor: Pfizer

Brief Summary

This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-15
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-10
• Last Update Submitted: 2009-01-26
• Last Update Posted: 2009-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
• Candidate for treatment with paclitaxel.

Exclusion Criteria

• Prior chemotherapy in the advanced disease setting.
• HER2 positive disease unless previously treated with trastuzumab.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	SU011248	-
A	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Safety of the combination of SU011248 and paclitaxel	9/05-7/07

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of each medication	9/05-7/07
Objective disease response	9/05-7/07
Progression-free survival.	9/05-7/07

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New York, New York, United States