Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
128
16 mg/m2, 3-hour infusion, every 3 weeks
22 mg/m2, 30-min infusion, every 3 weeks
22 mg/m2, 3-hour infusion, every 3 weeks
Unnamed facility
Löwenstein, Baden-Wurttemberg, Germany
Unnamed facility
Augsburg, Bavaria, Germany
Unnamed facility
Gauting, Bavaria, Germany
The primary efficacy variable is defined as Proportion of patients with either CR or PR as 'best overall response'. Tumor assessment is performed according to RECIST criteria.
Time frame: Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
Secondary objectives : investigate the safety and tolerability of ZK 219477
Time frame: Continuously
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Unnamed facility
Nuremberg, Bavaria, Germany
Unnamed facility
Hamburg, Free and Hanseatic City of Hamburg, Germany
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Frankfurt am Main, Hesse, Germany
Unnamed facility
Greifswald, Mecklenburg-Vorpommern, Germany
Unnamed facility
Stralsund, Mecklenburg-Vorpommern, Germany
Unnamed facility
Leipzig, Saxony, Germany
...and 7 more locations