Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer
Phase 2
Completed
- Conditions
- Carcinoma, Non Small Cell Lung
- Interventions
- Registration Number
- NCT00160069
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
Inclusion Criteria
- Non-small-cell lung cancer
- Only one previous chemotherapy with a platinum-containing drug
- Use of highly effective birth control methods in females of child-bearing potential
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Exclusion Criteria
- No more than 1 previous chemotherapy for advanced disease
- Previous participation in another trial within the last 4 weeks
- Breast feeding
- Active infections
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Sagopilone (BAY86-5302, ZK 219477) - Arm 3 Sagopilone (BAY86-5302, ZK 219477) - Arm 2 Sagopilone (BAY86-5302, ZK 219477) -
- Primary Outcome Measures
Name Time Method 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. Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
- Secondary Outcome Measures
Name Time Method Secondary objectives : investigate the safety and tolerability of ZK 219477 Continuously