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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-000586-19 | EudraCT Number | ||
| 307971 | Other Identifier | Company Internal ID |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sagopilone (BAY86-5302, ZK 219477) | Drug | 16 mg/m2, 3-hour infusion, every 3 weeks |
| |
| Measure | Description | 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. | Tumor evaluation (MRI or scan) every 2 cycles until disease progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives : investigate the safety and tolerability of ZK 219477 | Continuously |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Löwenstein | Baden-Wurttemberg | 74245 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23522488 | Result | 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. |
| Label | URL |
|---|---|
| Click here and search for Bayer product information provided by the EMA | View source |
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| Sagopilone (BAY86-5302, ZK 219477) |
| Drug |
22 mg/m2, 30-min infusion, every 3 weeks |
|
| Sagopilone (BAY86-5302, ZK 219477) | Drug | 22 mg/m2, 3-hour infusion, every 3 weeks |
|
| Augsburg |
| Bavaria |
| 86156 |
| Germany |
| Gauting | Bavaria | 82131 | Germany |
| Nuremberg | Bavaria | 90419 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 21075 | Germany |
| Frankfurt am Main | Hesse | 60590 | Germany |
| Frankfurt am Main | Hesse | 65929 | Germany |
| Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| Stralsund | Mecklenburg-Vorpommern | 17475 | Germany |
| Leipzig | Saxony | 04103 | Germany |
| Halle | Saxony-Anhalt | 06120 | Germany |
| Magdeburg | Saxony-Anhalt | 39130 | Germany |
| Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| Berlin | State of Berlin | 12200 | Germany |
| Berlin | State of Berlin | 14165 | Germany |
| Bremen | 29325 | Germany |
| Ebensfeld | 96250 | Germany |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530494 | sagopilone |
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