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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00160069

Purpose

Phase 2 study to investigate the efficacy and tolerability of epothilone ZK 219477 in patients with stage IIIb or stage IV non-small-cell lung cancer.

Condition	Intervention	Phase
Carcinoma, Non Small Cell Lung	Drug: Sagopilone (ZK 219477, BAY86-5302)	Phase II

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, 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 Second Line Therapy in Patients With Stage IIIB or Stage IV Non Small Cell Lung Cancer (NSCLC)

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy variable is defined as Proportion of patients with either CR or PR as 177best overall response178. Tumor assessment is performed according to RECIST criteria. [ Time Frame: Tumor evaluation (MRI or scan) every 2 cycles until disease progression. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary objectives : investigate the safety and tolerability of ZK 219477 [ Time Frame: Continuously ] [ Designated as safety issue: Yes ]

Enrollment:	127
Study Start Date:	August 2005
Estimated Study Completion Date:	November 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Sagopilone (ZK 219477, BAY86-5302) 16 mg/m2, 3-hour infusion, every 3 weeks
Arm 2: Experimental	Drug: Sagopilone (ZK 219477, BAY86-5302) 22 mg/m2, 30-min infusion, every 3 weeks
Arm 3: Experimental	Drug: Sagopilone (ZK 219477, BAY86-5302) 22 mg/m2, 3-hour infusion, every 3 weeks

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:

Non-small-cell lung cancer
Only one previous chemotherapy with a platinum-containing drug
Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

No more than 1 previous chemotherapy for advanced disease
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: NCT00160069

Locations

Germany, Baden-Württemberg / 276

Löwenstein, Baden-Württemberg / 276, Germany, 74245
Germany, Bayern / 280

Gauting, Bayern / 280, Germany, 82131

Ebensfeld, Bayern / 280, Germany, 96250
Germany, Berlin / 285

Berlin, Berlin / 285, Germany, 12200
Germany, Hamburg / 287

Hamburg, Hamburg / 287, Germany, 21075
Germany, Hessen / 307

Frankfurt, Hessen / 307, Germany, 65929

Frankfurt, Hessen / 307, Germany, 60596
Germany, Mecklenburg-Vorpommern / 309

Greifswald, Mecklenburg-Vorpommern / 309, Germany, 17489
Germany, Sachsen / 313

Leipzig, Sachsen / 313, Germany, 04103
Germany, Sachsen-Anhalt / 311

Halle, Sachsen-Anhalt / 311, Germany, 06120

Magdeburg, Sachsen-Anhalt / 311, Germany, 39130
Germany, Schleswig-Holstein / 306

Großhansdorf, Schleswig-Holstein / 306, Germany, 22927

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91374, EudraCT: 2005-000586-19, 307971
Study First Received:	September 8, 2005
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00160069
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:

Stage IIIB or stage IV non-small-cell lung cancer.

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009