Trial Condition(s):
Non Small Cell Lung Cancer
Safety and efficacy study of a new chemotherapy agent to treat non small cell lung cancer.
Bayer Identifier:
91411
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsmedizin der Georg-August-Universität Göttingen Göttingen, Germany, 37075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Gustave Roussy Villejuif, France, 94805 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Tenon Paris, France, 75970 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de la Pitie Salpetriere Service Oncologie Medicale Paris, France, 75651 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
2
Primary Outcome
- Tumor response rate (complete or partial response according to RECIST).Timeframe: At baseline and every 8 weeks afterwards
Secondary Outcome
- Time to disease progression.Timeframe: At baseline and every 8 weeks afterwards
Additional Information
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