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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00076024

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: Docetaxel Drug: AG-013736 (axitinib)	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Axitinib

U.S. FDA Resources

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:	174
Study Start Date:	February 2004
Study Completion Date:	November 2008
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 Drug: Docetaxel Standard of care drug administration
Experimental: A Docetaxel + AG-013736	Drug: AG-013736 (axitinib) 5mg bid continuous dosing Drug: Docetaxel Standard of care drug administration

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 54 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00076024 History of Changes
Other Study ID Numbers:	A4061010
Study First Received:	January 12, 2004
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

metastatic breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012