Safety and Efficacy Study of a New Chemotherapy Agent to Treat Non-small-cell Lung Cancer
NCT ID: NCT00160069
Last Updated: 2014-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
128 participants
INTERVENTIONAL
2005-08-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour infusion, every 3 weeks
Arm 2
Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-min infusion, every 3 weeks
Arm 3
Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour infusion, every 3 weeks
Interventions
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Sagopilone (BAY86-5302, ZK 219477)
16 mg/m2, 3-hour infusion, every 3 weeks
Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 30-min infusion, every 3 weeks
Sagopilone (BAY86-5302, ZK 219477)
22 mg/m2, 3-hour infusion, every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* Only one previous chemotherapy with a platinum-containing drug
* Use of highly effective birth control methods in females of child-bearing potential
Exclusion Criteria
* Previous participation in another trial within the last 4 weeks
* Breast feeding
* Active infections
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Löwenstein, Baden-Wurttemberg, Germany
Augsburg, Bavaria, Germany
Gauting, Bavaria, Germany
Nuremberg, Bavaria, Germany
Hamburg, City state of Hamburg, Germany
Frankfurt am Main, Hesse, Germany
Frankfurt am Main, Hesse, Germany
Greifswald, Mecklenburg-Vorpommern, Germany
Stralsund, Mecklenburg-Vorpommern, Germany
Leipzig, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Magdeburg, Saxony-Anhalt, Germany
Großhansdorf, Schleswig-Holstein, Germany
Berlin, State of Berlin, Germany
Berlin, State of Berlin, Germany
Bremen, , Germany
Ebensfeld, , Germany
Countries
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References
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Heigener DF, von Pawel J, Eschbach C, Brune A, Schmittel A, Schmelter T, Reck M, Fischer JR. Prospective, multicenter, randomized, independent-group, open-label phase II study to investigate the efficacy and safety of three regimens with two doses of sagopilone as second-line therapy in patients with stage IIIB or IV non-small-cell lung cancer. Lung Cancer. 2013 Jun;80(3):319-25. doi: 10.1016/j.lungcan.2013.02.007. Epub 2013 Mar 20.
Related Links
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Click here and search for Bayer product information provided by the EMA
Other Identifiers
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2005-000586-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
307971
Identifier Type: OTHER
Identifier Source: secondary_id
91374
Identifier Type: -
Identifier Source: org_study_id