drugset / Trial / NCT00076024

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

NCT00076024 ↗

Phase 1/2 Completed 174 enrolled Pfizer
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2004-02
Primary completion
2007-01
Completion
2008-11

Outcome

Missed primary endpoint

registry p = 0.156; Hazard Ratio (HR) 1.237 (95% CI 0.819 to 1.867); Log Rank NCT00076024 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Axitinib Small molecule 5 mg —
Background Docetaxel Small molecule — —

Indications