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

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ClinicalTrials.gov Identifier: NCT00160069
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non Small Cell Lung Drug: Sagopilone (BAY86-5302, ZK 219477) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : August 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Secondary objectives : investigate the safety and tolerability of ZK 219477 [ Time Frame: Continuously ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 12200
Berlin, Germany, 14165
Bremen, Germany, 29325
Ebensfeld, Germany, 96250
Hamburg, Germany, 21075
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications of Results:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00160069     History of Changes
Other Study ID Numbers: 91374
2005-000586-19 ( EudraCT Number )
307971 ( Other Identifier: Company Internal ID )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents