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

Tracking Information

First Received Date ^ICMJE

January 12, 2004

Last Updated Date

September 24, 2009

Start Date ^ICMJE

February 2004

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Time to progression

Change History

Complete list of historical versions of study NCT00076024 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

safety, population pharmacokinetics, response rate and duration of response for combination therapy, response rate and duration of response of single agent treatment post docetaxel treatment.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Breast Neoplasms

Intervention ^ICMJE

Drug: Placebo
Drug: AG-013736 (axitinib)

Study Arms / Comparison Groups

Other: Docetaxel + Placebo
Experimental: Docetaxel + AG-013736

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

168

Completion Date

November 2008

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Czech Republic, Germany, India, Italy, Spain, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00076024

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study ID Numbers ^ICMJE

A4061010

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP