Trials / Completed
CompletedNCT00359359
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
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)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sagopilone (BAY86-5302, ZK 219477) | Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID |
| DRUG | Cisplatin | 75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1 |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2009-03-01
- Completion
- 2009-08-01
- First posted
- 2006-08-02
- Last updated
- 2014-11-04
Locations
10 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00359359. Inclusion in this directory is not an endorsement.