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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000067-29 | EudraCT Number | ||
| 310101 | Other Identifier | Company Internal |
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The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their 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 |
|---|---|---|---|
| Sagopilone and cisplatin | Experimental | The study drug sagopilone was administered in combination with a fixed dose of cisplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sagopilone (BAY86-5302, ZK 219477) | Drug | Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with cisplatin | Phase 1: Baseline up to 3 month of treatment | |
| Phase 2: Efficacy measure | Phase 2: every 6 weeks after start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: PK of Sagopilone + Cisplatin | Upto 336 h after the beginning of the sagopilone infusion and upto 20 h 45 min after the beginning of the cisplatin infusion | |
| Phase 2: Duration of CR or PR | Duration of complete response (CR) or partial response (PR) as 'overall response', defined as time between first date that the measurement criteria for CR or PR as 'overall response' are met and first date that recurrence or overall response of (progressive disease) PD is documented. |
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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 |
|---|---|---|---|---|---|---|
| Gerlingen | Baden-Wurttemberg | 70839 | Germany | |||
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| ID | Term |
|---|---|
| D018288 | Carcinoma, Small Cell |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C530494 | sagopilone |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | 75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1 |
|
| every 6 weeks after start of treatment |
| Phase 2: TTP | Time to tumor progression (TTP) is defined as the time from the date of treatment assignment to the first observation of disease progression or to the last date of a definite assessment (not status unknown), if the patient is progression-free until that assessment. | every 6 weeks after start of treatment |
| Phase 2: PFS | Progression free survival (PFS) is defined as the time from date of treatment assignment to the first observation of disease progression or death of any cause or to the last date of a definite assessment (not status unknown), if the patient was progression-free until that assessment | every 6 weeks after start of treatment |
| Phase 2: OS | Overall survival (OS) is defined as the time from date of treatment assignment until death from any cause or until the last date the patient is known to be alive | every 3 months after start of treatment |
| Löwenstein |
| Baden-Wurttemberg |
| 74245 |
| Germany |
| München | Bavaria | 80336 | Germany |
| München | Bavaria | 81675 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 21075 | Germany |
| Frankfurt am Main | Hesse | 65929 | Germany |
| Wiesbaden | Hesse | 65199 | Germany |
| Essen | North Rhine-Westphalia | 45147 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Berlin | State of Berlin | 12200 | Germany |
| D002283 |
| Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |