check_circleStudy Completed
Carcinoma, Non Small Cell Lung
Bayer Identifier:
91374
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 YearsTrial summary
Enrollment Goal
128Trial Dates
August 2005 - April 2009Phase
Phase 2Could I Receive a placebo
NoProducts
Sagopilone (BAY86-5302)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Krankenhaus Grosshansdorf | Großhansdorf, 22927, Germany |
Completed | Asklepios Fachkliniken München Gauting | Gauting, 82131, Germany |
Completed | Asklepios Klinik Harburg | Hamburg, 21075, Germany |
Terminated | Helios Klinikum Emil von Behring | Berlin, 14165, Germany |
Completed | Charité Campus Benjamin Franklin | Berlin, 12200, Germany |
Terminated | Zentralklinikum Augsburg | Augsburg, 86156, Germany |
Terminated | Klinikum Bremen-Ost gGmbH | Bremen, 29325, Germany |
Terminated | Kliniken Nord und Süd | Nürnberg, 90419, Germany |
Completed | Klinikum der Johann Wolfgang Goethe Universität Frankfurt | Frankfurt, 60590, Germany |
Completed | Klinikum der Ernst-Moritz-Arndt-Universität | Greifswald, 17475, Germany |
Terminated | Hanse-Klinikum Stralsund | Stralsund, 17475, Germany |
Completed | Klinik Löwenstein gGmbH | Löwenstein, 74245, Germany |
Completed | Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH | Halle, 06120, Germany |
Completed | Städtisches Klinikum Magdeburg | Magdeburg, 39130, Germany |
Completed | Städtische Kliniken Frankfurt am Main / Hoechst | Frankfurt, 65929, Germany |
Completed | Universitätsklinikum Leipzig AöR | Leipzig, 04103, Germany |
Completed | Bezirksklinikum Obermain Kutzenbeg | Ebensfeld, 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.enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Secondary objectives : investigate the safety and tolerability of ZK 219477date_rangeTime Frame:Continuouslyenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
3Additional Information
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