Status:
COMPLETED
A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer
Lead Sponsor:
Bayer
Conditions:
Carcinoma, Small Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 di...
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.
Eligibility Criteria
Inclusion
- Small-cell lung cancer
- Stage of extensive disease
- Adequate function of major organs and systems
- Use of highly effective birth control methods in females of child-bearing potential
Exclusion
- Prior chemotherapy for small-cell lung cancer
- Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases
- Superior vena cava syndrome or obstruction of any vital structure
- Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation
- Known allergy or hypersensitivity to platinum-containing drugs
- Pregnancy or breast-feeding
- Use of any investigational drug within 4 weeks before start of the study
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00359359
Start Date
July 1 2006
End Date
August 1 2009
Last Update
November 4 2014
Active Locations (10)
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1
Gerlingen, Baden-Wurttemberg, Germany, 70839
2
Löwenstein, Baden-Wurttemberg, Germany, 74245
3
München, Bavaria, Germany, 80336
4
München, Bavaria, Germany, 81675