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

This study is ongoing, but not recruiting participants.

Sponsored by: 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

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  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




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