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

Breast Neoplasms Clinical Trial

Official title:

A Phase 1 Study Of Paclitaxel In Combination With SU011248 For Patients With Breast Cancer As First-Line Treatment In The Advanced Disease Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174434
• Other study ID #: A6181073
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: January 26, 2009
• Start date: September 2005
• Est. completion date: August 2007

Study information

• Verified date: October 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• SU011248
SU011248 provided as capsules. The starting dose is 25 mg orally, daily in a continuous regimen beginning on day 2. Dose rest for 1 week is allowed. Dose escalation to 37.5 mg po OD is allowed within the constraints of acceptable toxicity parameters. Dosing will continue for 1 year or until disease progression or unacceptable toxicity, whichever comes first.
• Paclitaxel
Paclitaxel is provided as an intravenous infusion for 1 hour weekly for 3 weeks followed by a 1-week rest. The starting dose is 90 mg/m2. The weekly dose may be decreased to 65 mg/m2 in subsequent cycles based on tolerability. Dosing will continue for 1 year or until maximum benefit, disease progression or unacceptable toxicity, whichever comes first.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Harvey	Illinois
United States	Pfizer Investigational Site	Harvey	Illinois
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Munster	Indiana
United States	Pfizer Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the combination of SU011248 and paclitaxel		9/05-7/07	No
Secondary	Pharmacokinetics of each medication		9/05-7/07	No
Secondary	Objective disease response		9/05-7/07	No
Secondary	Progression-free survival.		9/05-7/07	No

External Links

•   To obtain contact information for a study center near you, click here.