NCT00160043CompletedPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 112
- Primary Endpoint
- Tumor response rate (complete or partial response according to RECIST).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Arm 1
Experimental
Intervention: SH T00268C (Drug)
Arm 2
Experimental
Intervention: PTK787/ ZK 222584 (Drug)
Outcomes
Primary Outcomes
Tumor response rate (complete or partial response according to RECIST).
Time Frame: At baseline and every 8 weeks afterwards
Secondary Outcomes
- Time to disease progression.(At baseline and every 8 weeks afterwards)
Investigators
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