Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00174434

Purpose

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	Intervention	Phase
Breast Neoplasms	Drug: SU011248 Drug: Paclitaxel	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Paclitaxel Sunitinib Sunitinib malate Malic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety of the combination of SU011248 and paclitaxel [ Time Frame: 9/05-7/07 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics of each medication [ Time Frame: 9/05-7/07 ] [ Designated as safety issue: No ]
Objective disease response [ Time Frame: 9/05-7/07 ] [ Designated as safety issue: No ]
Progression-free survival. [ Time Frame: 9/05-7/07 ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	September 2005
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	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. 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.

Arms

Assigned Interventions

A: Experimental

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174434

Locations

United States, Illinois
Pfizer Investigational Site
Harvey, Illinois, United States, 60426
Pfizer Investigational Site
Harvey, Illinois, United States, 60426-4265
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46290
Pfizer Investigational Site
Munster, Indiana, United States, 46321
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181073
Study First Received:	September 12, 2005
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00174434
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Sunitinib
Paclitaxel
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009