Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
Status and phase
Completed
Phase 2
Conditions
Non Small Cell Lung Cancer
Treatments
Drug: PTK787/ ZK 222584
Drug: SH T00268C
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Full 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.
Enrollment
112 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
112 participants in 2 patient groups
Arm 1
Experimental group
Treatment:
Drug: SH T00268C
Arm 2
Experimental group
Treatment:
Drug: PTK787/ ZK 222584
Trial contacts and locations
6
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Data sourced from clinicaltrials.gov
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