Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy, safety and tolerability of 4 regimen with 3 doses of ZK 219477 [sagopilone] (16 and 12 mg/m2 body surface area as 3-hour infusion or 22 mg/m2 body surface area as 30-minute or 3-hour infusion) in patients with metastatic breast cancer.
Phase of Trial: Phase II
Latest Information Update: 03 Dec 2014
At a glance
- Drugs Sagopilone (Primary)
- Indications Advanced breast cancer
- Focus Therapeutic Use
- Sponsors Bayer HealthCare Pharmaceuticals
- 13 Dec 2009 Results presented at the 32nd Annual San Antonio Breast Cancer Symposium.
- 13 Dec 2009 Primary endpoints not met according to an abstract presented at the 32nd Annual San Antonio Breast Cancer Symposium.
- 13 Jan 2009 Additional trial identifier (91464) added as reported by ClinicalTrials.gov.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History