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:

NCT00160043

EudraCT Number:

2004-002290-22

Study Completed

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
112
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
VEGF-Tyrosine Kinase Inhibitor (BAY86-5127)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Germany, 37075

Status
Completed
 
Locations

Institut Gustave Roussy

Villejuif, France, 94805

Status
Completed
 
Locations

Hospital Tenon

Paris, France, 75970

Status
Completed
 
Locations

Hospital de la Pitie Salpetriere Service Oncologie Medicale

Paris, France, 75651

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Completed
 

Trial Design