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

NCT00076024 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2012-06-26

Study results available
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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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Placebo

5 mg twice daily \[bid\] continuous dosing

DRUG

Docetaxel

Standard of care drug administration

DRUG

AG-013736 (axitinib)

5mg twice daily \[bid\] continuous dosing

DRUG

Docetaxel

Standard of care drug administration

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2007-01-31
Completion
2008-11-30

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • India
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00076024 on ClinicalTrials.gov