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

NCT ID: NCT00076024

Last Updated: 2012-06-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2008-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Docetaxel + Placebo

Docetaxel + Placebo

Group Type OTHER

Placebo

Intervention Type DRUG

5 mg twice daily \[bid\] continuous dosing

Docetaxel

Intervention Type DRUG

Standard of care drug administration

Docetaxel + AG-013736

Docetaxel + AG-013736

Group Type EXPERIMENTAL

AG-013736 (axitinib)

Intervention Type DRUG

5mg twice daily \[bid\] continuous dosing

Docetaxel

Intervention Type DRUG

Standard of care drug administration

Interventions

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Placebo

5 mg twice daily \[bid\] continuous dosing

Intervention Type DRUG

Docetaxel

Standard of care drug administration

Intervention Type DRUG

AG-013736 (axitinib)

5mg twice daily \[bid\] continuous dosing

Intervention Type DRUG

Docetaxel

Standard of care drug administration

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Tucson, Arizona, United States

Site Status

Pfizer Investigational Site

Tucson, Arizona, United States

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Pfizer Investigational Site

Berkeley, California, United States

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Pfizer Investigational Site

Montebello, California, United States

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Pfizer Investigational Site

Monterey Park, California, United States

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San Francisco, California, United States

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San Gabriel, California, United States

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Whittier, California, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville Beach, Florida, United States

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Melbourne, Florida, United States

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Orange Park, Florida, United States

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Palatka, Florida, United States

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Saint Augustine, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Zion, Illinois, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Stony Brook, New York, United States

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Cleveland, Ohio, United States

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Corvallis, Oregon, United States

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Edmonton, Alberta, Canada

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Pfizer Investigational Site

Ottawa, Ontario, Canada

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Pfizer Investigational Site

Montreal, Quebec, Canada

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Pfizer Investigational Site

Nový Jičín, , Czechia

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Pfizer Investigational Site

Prague, , Czechia

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Pfizer Investigational Site

Berlin, , Germany

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Pfizer Investigational Site

Essen, , Germany

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Pfizer Investigational Site

Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Bangalore, Karnataka, India

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Pune, Maharashtra, India

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Napoli, , Italy

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Roma, , Italy

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Roma, , Italy

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Roma, , Italy

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Rozzano (Mi), , Italy

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Pfizer Investigational Site

Taormina, ME, , Italy

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Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, Spain

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Pfizer Investigational Site

Sabadell, Barcelona, Spain

Site Status

Pfizer Investigational Site

Girona, Girona, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

Site Status

Pfizer Investigational Site

Madrid, Madrid, Spain

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Pfizer Investigational Site

Málaga, Malaga, Spain

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Pfizer Investigational Site

Valencia, Valencia, Spain

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Pfizer Investigational Site

Valencia, Valencia, Spain

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Pfizer Investigational Site

Southampton, Hampshire, United Kingdom

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Pfizer Investigational Site

Rickmansworth, Middlesex, United Kingdom

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Pfizer Investigational Site

Nottingham, Nottinghamshire, United Kingdom

Site Status

Pfizer Investigational Site

Sheffield, Yorkshire, United Kingdom

Site Status

Countries

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United States Canada Czechia Germany India Italy Spain United Kingdom

Other Identifiers

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A4061010

Identifier Type: -

Identifier Source: org_study_id

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