A Phase 2 interventional study of Sagopilone (BAY86-5302, ZK 219477) and Sagopilone (BAY86-5302, ZK 219477) in Carcinoma, Non Small Cell Lung, sponsored by Bayer. Completed at 17 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-04.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 128 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Sagopilone (BAY86-5302, ZK 219477)
Drug: Sagopilone (BAY86-5302, ZK 219477)
Drug: Sagopilone (BAY86-5302, ZK 219477)
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
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
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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