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Clinical Trial: Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non Small Cell Lung Cancer.
This study is currently recruiting patients.
Verified by Schering AG, Germany September 2005
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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.
| Condition | Intervention | Phase |
|---|---|---|
| Non Small Cell Lung Cancer | Drug: SH T00268C Drug: PTK787/ ZK 222584 | Phase II |
MedlinePlus related topics: Lung Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Open-Label Study to Investigate the Efficacy and Safety of PTK787/ZK 222584 Orally Administered Once Daily at 1250 Mg as Second-Line Monotherapy in Patients with Stage IIIB or Stage IV Non-Small-Cell Lung Cancer (NSCLC)
Further Study Details:
Primary Outcomes: Tumor response rate (complete or partial response according to RECIST).
Secondary Outcomes: Time to disease progression.
Secondary Outcomes: Time to disease progression.
Study start: March 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00160043
Schering AG, Germany, Medical Affairs +49 30 468 11800
France
Villejuif, F- 94805, France; Recruiting
Paris, F-75970, France; Recruiting
Germany, Niedersachsen
Göttingen, Niedersachsen, D- 37075, Germany; Recruiting
Germany, Nordrhein-Westfalen
ESSEN, Nordrhein-Westfalen, D - 45122, Germany; Recruiting
Germany, Rheinland-Pfalz
Mainz, Rheinland-Pfalz, D- 55101, Germany; Recruiting
Study chairs or principal investigators
Schering AG, Germany, Medical Affairs, Study Director, Schering AG, Germany, Medical Affairs
More Information
Study ID Numbers: 308801
Last Updated: September 11, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00160043
Health Authority: France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 11, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00160043
Health Authority: France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
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- Small Businesses (Centers for Disease Control and Prevention)
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