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 (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
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the
sponsor of the trial.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor response rate (complete or partial response according to RECIST)
Every 8 weeks
No
Bayer Study Director
Study Director
Bayer
Austria: Federal Ministry for Health and Women
91464
NCT00288249
December 2005
January 2009
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