Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
Phase 2
Completed
- Conditions
- Non Small Cell Lung Cancer
- Interventions
- Drug: SH T00268CDrug: PTK787/ ZK 222584
- Registration Number
- NCT00160043
- Lead Sponsor
- Bayer
- Brief Summary
The purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.
- 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
- 112
Inclusion Criteria
- Non small cell lung cancer, Stage IIIB or Stage IV
- One and only 1 prior platinum-based chemotherapy
- No other uncontrolled concurrent illness
- Use of highly effective birth control methods in males or females with reproductive potential
Exclusion Criteria
- Previous participation in another trial within the last 4 weeks
- Surgery within 10 days prior to the start of study treatment
- Brain metastases
- Confirmed diagnosis of infection with the human immunodeficiency virus (HIV)
- Current treatment with warfarin sodium (Coumadin) or similar anticoagulation medication
- Breast feeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 SH T00268C - Arm 2 PTK787/ ZK 222584 -
- Primary Outcome Measures
Name Time Method Tumor response rate (complete or partial response according to RECIST). At baseline and every 8 weeks afterwards
- Secondary Outcome Measures
Name Time Method Time to disease progression. At baseline and every 8 weeks afterwards