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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00174434

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: SU011248 Drug: Paclitaxel	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Sep 1, 2005

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	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. Other Names: sunitinib malate, Sutent Drug: 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.

Arm

Intervention/Treatment

Experimental: A

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.

Other Names:

sunitinib malate, Sutent

Drug: 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.

Outcome Measures

Primary Outcome Measures

Safety of the combination of SU011248 and paclitaxel [9/05-7/07]

Secondary Outcome Measures

Pharmacokinetics of each medication [9/05-7/07]
Objective disease response [9/05-7/07]
Progression-free survival. [9/05-7/07]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Harvey	Illinois	United States	60426-4265
2	Pfizer Investigational Site	Harvey	Illinois	United States	60426
3	Pfizer Investigational Site	Indianapolis	Indiana	United States	46202
4	Pfizer Investigational Site	Indianapolis	Indiana	United States	46290
5	Pfizer Investigational Site	Munster	Indiana	United States	46321
6	Pfizer Investigational Site	New York	New York	United States	10021

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00174434

Other Study ID Numbers:

A6181073

First Posted:

Sep 15, 2005

Last Update Posted:

Jan 27, 2009

Last Verified:

Oct 1, 2008

Additional relevant MeSH terms:

Breast Neoplasms

Paclitaxel

Sunitinib

Study Results

No Results Posted as of Jan 27, 2009