CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 174 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
AG-013736 (axitinib) 5 mg orally twice daily continuous dosing, plus docetaxel standard of care dosingAI-extracted
Key inclusion· 1
  • Female patients with histologically or cytologically proven metastatic breast cancer (stage IV, or recurrent with local/regional spread or distant metastatic disease)
Key exclusion· 2
  • Adjuvant chemotherapy within the past 12 months
  • Uncontrolled brain metastases

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00076024
NCT00076024Phase 2Completed

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

Pfizer·interventional·Posted Jan 14, 2004·Updated Jun 26, 2012

In Brief

A Phase 2 clinical trial evaluating Placebo, Docetaxel, and 1 other intervention for Breast Neoplasms. Completed, enrolled 174 participants across 54 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Czechia, Germany, India, Italy, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 14, 2004
Enrollment StartFeb 1, 2004
Primary CompletionJan 1, 2007
Study CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 22.5 years ago

Interventions

Placebodrug

5 mg twice daily \[bid\] continuous dosing

Docetaxeldrug

Standard of care drug administration

AG-013736 (axitinib)drug

5mg twice daily \[bid\] continuous dosing

Docetaxeldrug

Standard of care drug administration