AG-013736 In Combination With Docetaxel Versus Docetaxel Alone For Patients With Metastatic Breast Cancer - Full Text View

Purpose

The primary purpose of the study is to determine the time to progression of the combination of study drug (AG-013736) and docetaxel versus docetaxel alone in patients who have not received prior chemotherapy for metastatic breast cancer. The secondary purpose of the study is to determine the dose of study drug that can be given with docetaxel administered on an every 3 week schedule.

Condition	Intervention	Phase
Breast Neoplasms	Drug: Placebo Drug: AG-013736 (axitinib)	Phase I Phase II

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Docetaxel Axitinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Official Title:	Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study Of AG-013736 In Combination With Docetaxel Versus Docetaxel Alone In Patients With Metastatic Breast Cancer Preceded By A Phase 1 Evaluation Of The Combination

Further study details as provided by Pfizer:

Primary Outcome Measures:

Time to progression [ Time Frame: May 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety, population pharmacokinetics, response rate and duration of response for combination therapy [ Time Frame: May 2008 ] [ Designated as safety issue: No ]
Response rate and duration of response of single agent treatment post docetaxel treatment [ Time Frame: May 2008 ] [ Designated as safety issue: No ]

Enrollment:	168
Study Start Date:	February 2004
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B Docetaxel + Placebo	Drug: Placebo 5 mg bid continuous dosing
A: Experimental Docetaxel + AG-013736	Drug: AG-013736 (axitinib) 5mg bid continuous dosing

Eligibility

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

Criteria

Inclusion Criteria:

Female patients with histologically/cytologically proven metastatic breast carcinoma (stage IV, or recurrent with local or regional spread or distant metastatic disease)
Adequate bone marrow, liver, and renal function

Exclusion Criteria:

Adjuvant chemotherapy given in the past 12 months
Uncontrolled brain metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076024

Show 56 Study Locations

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:	A4061010
First Received:	January 12, 2004
Last Updated:	November 22, 2008
ClinicalTrials.gov Identifier:	NCT00076024
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

metastatic breast cancer

Study placed in the following topic categories:

Docetaxel

Skin Diseases

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00076024