Trial Condition(s):
Carcinoma, Non Small Cell Lung
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | ||
|---|---|---|---|
Locations Krankenhaus Grosshansdorf Großhansdorf, Germany, 22927 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Asklepios Fachkliniken München Gauting Gauting, Germany, 82131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Asklepios Klinik Harburg Hamburg, Germany, 21075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Helios Klinikum Emil von Behring Berlin, Germany, 14165 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Charité Campus Benjamin Franklin Berlin, Germany, 12200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Zentralklinikum Augsburg Augsburg, Germany, 86156 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Klinikum Bremen-Ost gGmbH Bremen, Germany, 29325 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Kliniken Nord und Süd Nürnberg, Germany, 90419 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Klinikum der Ernst-Moritz-Arndt-Universität Greifswald, Germany, 17475 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Hanse-Klinikum Stralsund Stralsund, Germany, 17475 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Klinik Löwenstein gGmbH Löwenstein, Germany, 74245 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH Halle, Germany, 06120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Städtisches Klinikum Magdeburg Magdeburg, Germany, 39130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Städtische Kliniken Frankfurt am Main / Hoechst Frankfurt, Germany, 65929 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Universitätsklinikum Leipzig AöR Leipzig, Germany, 04103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available | |
Locations Bezirksklinikum Obermain Kutzenbeg Ebensfeld, Germany, 96250 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
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.Timeframe: Tumor evaluation (MRI or scan) every 2 cycles until disease progression.
Secondary Outcome
- Secondary objectives : investigate the safety and tolerability of ZK 219477Timeframe: Continuously
Additional Information
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