Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00299390

Purpose

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

Condition	Intervention	Phase
Small Cell Lung Cancer	Drug: SH Y03757A	Phase II

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy naïve Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)

Further study details as provided by Bayer:

Primary Outcome Measures:

Tumor response rate (complete or partial response according to RECIST)

Secondary Outcome Measures:

Duration of complete or partial tumor response
Time to tumor progression

Study Start Date:

March 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Small-cell lung cancer
No previous chemotherapy
Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

Previous participation in another trial within the last 4 weeks
Breast feeding
Active infections

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299390

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

+49 30 46811800

More Information

Study ID Numbers:	307972, EudraCT No: 2005-000597-53
Study First Received:	March 3, 2006
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00299390
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009