Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)
18 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
Phase II Open-label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily or Twice Daily at 1250 mg as Second-line Monotherapy in Patients With Stage IIIB or Stage IV Non-small-cell Lung Cancer (NSCLC)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response rate (complete or partial response according to RECIST).
Outcome Time Frame:
At baseline and every 8 weeks afterwards
Safety Issue:
Yes
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
91411
NCT ID:
NCT00160043
Start Date:
March 2005
Completion Date:
November 2008
Related Keywords:
- Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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