check_circleStudy Completed

Carcinoma, Non Small Cell Lung

Bayer Identifier:

91374

ClinicalTrials.gov Identifier:

NCT00160069

EudraCT Number:

2005-000586-19

EU CT Number:

Not Available
Safety and efficacy study of a new chemotherapy agent to treat non-small-cell lung cancer

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - No more than 1 previous chemotherapy for advanced disease
    - Previous participation in another trial within the last 4 weeks
    - Breast feeding
    - Active infections

Trial summary

Enrollment Goal
128
Trial Dates
August 2005 - April 2009
Phase
Phase 2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Krankenhaus GrosshansdorfGroßhansdorf, 22927, Germany
Completed
Asklepios Fachkliniken München GautingGauting, 82131, Germany
Completed
Asklepios Klinik HarburgHamburg, 21075, Germany
Terminated
Helios Klinikum Emil von BehringBerlin, 14165, Germany
Completed
Charité Campus Benjamin FranklinBerlin, 12200, Germany
Terminated
Zentralklinikum AugsburgAugsburg, 86156, Germany
Terminated
Klinikum Bremen-Ost gGmbHBremen, 29325, Germany
Terminated
Kliniken Nord und SüdNürnberg, 90419, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60590, Germany
Completed
Klinikum der Ernst-Moritz-Arndt-UniversitätGreifswald, 17475, Germany
Terminated
Hanse-Klinikum StralsundStralsund, 17475, Germany
Completed
Klinik Löwenstein gGmbHLöwenstein, 74245, Germany
Completed
Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbHHalle, 06120, Germany
Completed
Städtisches Klinikum MagdeburgMagdeburg, 39130, Germany
Completed
Städtische Kliniken Frankfurt am Main / HoechstFrankfurt, 65929, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Completed
Bezirksklinikum Obermain KutzenbegEbensfeld, 96250, Germany

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
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    Safety Issue:
    no

Secondary Outcome

  • Secondary objectives : investigate the safety and tolerability of ZK 219477
    date_rangeTime Frame:
    Continuously
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
3

Additional Information

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