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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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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