Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-line Therapy in Chemotherapy-naïve Patients With Extensive-disease (ED) Stage Small-cell Lung Cancer (SCLC)
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: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with carboplatin and bevacizumab
Phase 1: Baseline up to 3 month of treatment
Yes
Bayer Study Director
Study Director
Bayer
Germany: Federal Institute for Drugs and Medical Devices
91495
NCT00359359
July 2006
August 2009
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