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

December 2, 2014 updated by: Bayer

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
      • Berlin, Germany, 14165
      • Bremen, Germany, 29325
      • Ebensfeld, Germany, 96250
      • Hamburg, Germany, 21075
    • Baden-Württemberg
      • Löwenstein, Baden-Württemberg, Germany, 74245
    • Bayern
      • Augsburg, Bayern, Germany, 86156
      • Gauting, Bayern, Germany, 82131
      • Nürnberg, Bayern, Germany, 90419
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
      • Frankfurt, Hessen, Germany, 65929
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Stralsund, Mecklenburg-Vorpommern, Germany, 17475
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
      • Magdeburg, Sachsen-Anhalt, Germany, 39130
    • Schleswig-Holstein
      • Großhansdorf, Schleswig-Holstein, Germany, 22927

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour infusion, every 3 weeks
Drug: Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-min infusion, every 3 weeks
Drug: Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour infusion, every 3 weeks
Experimental: Arm 2
Drug: Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour infusion, every 3 weeks
Drug: Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-min infusion, every 3 weeks
Drug: Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour infusion, every 3 weeks
Experimental: Arm 3
Drug: Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour infusion, every 3 weeks
Drug: Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-min infusion, every 3 weeks
Drug: Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour infusion, every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Tumor evaluation (MRI or scan) every 2 cycles until disease progression.

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary objectives : investigate the safety and tolerability of ZK 219477
Time Frame: Continuously
Continuously

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91374
  • 2005-000586-19 (EudraCT Number)
  • 307971 (Other Identifier: Company Internal ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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