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

Sponsor:	Pfizer
Information provided by:	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: AG-013736 (axitinib)	Phase I Phase II

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

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:	168
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
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

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Locations

United States, Arizona
Pfizer Investigational Site
Tucson, Arizona, United States, 85724
Pfizer Investigational Site
Tucson, Arizona, United States, 85724-5024
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94115
Pfizer Investigational Site
Whittier, California, United States, 90602
Pfizer Investigational Site
Monterey Park, California, United States, 91754
Pfizer Investigational Site
San Gabriel, California, United States, 91776
Pfizer Investigational Site
Montebello, California, United States, 90640
Pfizer Investigational Site
Berkeley, California, United States, 94704
United States, Florida
Pfizer Investigational Site
Melbourne, Florida, United States, 32901
Pfizer Investigational Site
Jacksonville, Florida, United States, 32204
Pfizer Investigational Site
Jacksonville, Florida, United States, 32207
Pfizer Investigational Site
Orange Park, Florida, United States, 32073
Pfizer Investigational Site
Jacksonville Beach, Florida, United States, 32250
Pfizer Investigational Site
Jacksonville, Florida, United States, 32223
Pfizer Investigational Site
Palatka, Florida, United States, 32177
Pfizer Investigational Site
St. Augustine, Florida, United States, 32086
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Zion, Illinois, United States, 60099
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02118
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48106
United States, New York
Pfizer Investigational Site
East Setauket, New York, United States, 11735
Pfizer Investigational Site
Stony Brook, New York, United States, 11794
Pfizer Investigational Site
Stony Brook, New York, United States, 11794-9446
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oregon
Pfizer Investigational Site
Corvallis, Oregon, United States, 97330
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Pfizer Investigational Site
MONTREAL, Quebec, Canada, H2L 4M1
Czech Republic
Pfizer Investigational Site
Praha 8, Czech Republic, 180 00
Pfizer Investigational Site
Novy Jicin, Czech Republic, 741 01
Germany
Pfizer Investigational Site
Freiburg, Germany, 79106
Pfizer Investigational Site
Hamburg, Germany, 22081
Pfizer Investigational Site
Frankfurt, Germany, 60590
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Essen, Germany, 45122
India, Karnataka
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 034
India, Maharashtra
Pfizer Investigational Site
Pune, Maharashtra, India, 411 004
Italy
Pfizer Investigational Site
ROMA, Italy, 00144
Pfizer Investigational Site
Rozzano (Mi), Italy, 20089
Pfizer Investigational Site
Napoli, Italy, 80131
Pfizer Investigational Site
Roma, Italy, 00135
Pfizer Investigational Site
Roma, Italy, 00128
Italy, ME
Pfizer Investigational Site
Taormina, ME, Italy, 98039
Spain
Pfizer Investigational Site
GIRONA, Spain, 17007
Pfizer Investigational Site
MADRID, Spain, 28041
Pfizer Investigational Site
VALENCIA, Spain, 46009
Pfizer Investigational Site
Malaga, Spain, 29010
Pfizer Investigational Site
Madrid, Spain, 28040
Pfizer Investigational Site
Valencia, Spain, 46010
Spain, Barcelona
Pfizer Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Sabadell, Barcelona, Spain, 08208
United Kingdom, Hampshire
Pfizer Investigational Site
Southampton, Hampshire, United Kingdom, SO16 6YD
United Kingdom, Middlesex
Pfizer Investigational Site
Rickmansworth, Middlesex, United Kingdom, HA5 2RN
United Kingdom, Nottinghamshire
Pfizer Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
United Kingdom, Yorkshire
Pfizer Investigational Site
Sheffield, Yorkshire, United Kingdom, S10 2SJ

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 Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4061010
Study First Received:	January 12, 2004
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00076024 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

metastatic breast cancer

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009