Study of SU011248 in Combination With Docetaxel in Patients With Metastatic Breast Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00291577

Purpose

This study is to evaluate the safety of SU011248 in combination with docetaxel 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: Sunitinib Drug: Taxotere	Phase I

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Explorative Study of Tolerability and Pharmacokinetics of SU011248 In Combination With Docetaxel As First-Line Treatment in Patients With Breast Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

To characterize the pharmacokinetics of docetaxel and SU011248 (and its metabolite, SU012662) according to the schedule adopted in the trial. [ Time Frame: From Cycle 1 day 1 to Cycle 2 Day 4 of 12 patients ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess preliminary anti-tumor activity of the combination SU011248/docetaxel [ Time Frame: From screening until progressive disease ] [ Designated as safety issue: No ]
Overall Safety Profile [ Time Frame: From screening until 28 days after last dose of study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Sunitinib Sunitinib 37, 5 mg in schedule 2/1; Sutent 37, 5 mg in continuous dosing (post discontinuation of axotere) and in accordance with Investigator decision Drug: Taxotere Taxotere 75 mg/m2 iv, once every 3 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Breast cancer with evidence of unresectable, locally recurrent or metastatic disease
Candidate for treatment with docetaxel

Exclusion Criteria:

Prior chemotherapy in the advanced disease setting
Inflammatory breast cancer
HER2 positive disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291577

Locations

Belgium
Pfizer Investigational Site
Bruxelles, Belgium, 1000
Italy
Pfizer Investigational Site
Milano, Italy, 20133
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 171 76

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181100
Study First Received:	February 13, 2006
Last Updated:	January 4, 2009
ClinicalTrials.gov Identifier:	NCT00291577
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

advanced, sunitinib, docetaxel, Phase 1B

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Sunitinib
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009