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Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00160069
First received: September 8, 2005
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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 (BAY86-5302, ZK 219477)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

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 'best overall response'. 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
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour infusion, every 3 weeks
Experimental: Arm 2 Drug: Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-min infusion, every 3 weeks
Experimental: Arm 3 Drug: Sagopilone (BAY86-5302, ZK 219477)
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
Löwenstein, Baden-Württemberg, Germany, 74245
Augsburg, Bayern, Germany, 86156
Gauting, Bayern, Germany, 82131
Nürnberg, Bayern, Germany, 90419
Frankfurt, Hessen, Germany, 60590
Frankfurt, Hessen, Germany, 65929
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Stralsund, Mecklenburg-Vorpommern, Germany, 17475
Halle, Sachsen-Anhalt, Germany, 06120
Magdeburg, Sachsen-Anhalt, Germany, 39130
Leipzig, Sachsen, Germany, 04103
Großhansdorf, Schleswig-Holstein, Germany, 22927
Berlin, Germany, 14165
Berlin, Germany, 12200
Bremen, Germany, 29325
Ebensfeld, Germany, 96250
Hamburg, Germany, 21075
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00160069     History of Changes
Other Study ID Numbers: 91374, 2005-000586-19, 307971
Study First Received: September 8, 2005
Last Updated: April 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Stage IIIB or stage IV non-small-cell lung cancer.

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Lung Diseases
Respiratory Tract Diseases
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013