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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-000188-26 | EudraCT Number | ||
| 310301 | Other Identifier | Company Internal |
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The purpose of this study is to: a) Determine how the body takes up the test drug and distributes it into various body organs and tissues, how it processes the drug and how it ultimately removes it; and b) Examine how well the test drug works against cancer, and whether it is safe and tolerable to take
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sagopilone | Experimental | Subjects received 28 mg ZK 219477, containing 14 kBq/7.8 µg [14C]-ZK 219477 in the first infusion (Treatment course 1) followed by subsequent infusions (Treatment courses 2 to n [till disease progression]) of 16 mg/m2 ZK 219477 without radioactive label. Interval between the treatments was at least 21 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sagopilone (BAY 86-5302, ZK 219477) | Drug | First infusion only: 28 mg, containing 14 kBq/7.8 mcg [14C]-ZK 219477. Subsequent infusions: 16 mg/m2 ZK 219477 without radioactive label. IV infusion was given over a period of 30 min. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood, urine and fecal samples will be collected over a period of 336 hours (14 days) to measure 14C, ZK 219477 and its major metabolites following the intravenous administration of 14C-ZK 219477. | 14 days | |
| Cmax | Maximum plasma concentration for [14C]-ZK 219477, ZK 219477 | 14 days |
| tmax | Time to Cmax for [14C]-ZK 219477, ZK 219477 | 14 days |
| AUC | Area under the concentration time curve for [14C]-ZK 219477, ZK 219477 | 14 days |
| AUC(0-tlast) | AUC from administration until the last time point with measurable concentration for [14C]-ZK 219477, ZK 219477 | 14 days |
| AUC(0-24) | AUC from time zero to 24 hours for [14C]-ZK 219477, ZK 219477 | 14 days |
| MRT | Mean residence time for [14C]-ZK 219477, ZK 219477 | 14 days |
| t1/2 | Terminal half-life for [14C]-ZK 219477, ZK 219477 | 14 days |
| λz |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Approximately 12 weeks to 30 weeks | |
| Overall response | Determination of complete response (CR), partial response (PR), unknown, stable disease, progressive disease (PD) by the modified Response Evaluation Criteria in Solid Tumors |
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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 |
|---|---|---|---|---|---|---|
| Liège | 4000 | Belgium |
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C530494 | sagopilone |
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Apparent terminal rate constant for [14C]-ZK 219477, ZK 219477 |
| 14 days |
| CL | Total clearance for ZK 219477 | 14 days |
| Vss | Apparent volume of distribution at steady state for ZK 219477 | 14 days |
| Vz | Apparent volume of distribution during terminal phase for ZK 219477 | 14 days |
| Approximately 10 to 32 weeks |
| Best overall response | Overall response as obtained at all time points available for an individual subject combined to the 'best overall response' | Approximately 10 to 32 weeks |
| Responders | 'Response' was considered to be established if 'Best overall response' of PR or CR was confirmed at any time after the start of study treatment. If response was established, a subject was referred to as a 'responder' | Approximately 10 to 32 weeks |