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| ID | Type | Description | Link |
|---|---|---|---|
| 2012/1950 | Other Identifier | CSET number |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing and limited peripheral neuro-toxicity, two major potential advantages in patients with advanced NSGCTs.
Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have demonstrated activity in pre-treated GCTs and are now part of standard treatment, but cabazitaxel has not yet been tested in patients with NSGCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cabazitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel | Drug | On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour |
|
| Measure | Description | Time Frame |
|---|---|---|
| Favorable response | To evaluate the favorable response rate of cabazitaxel treatment in patients with highly-pretreated nonseminomatous germ-cell tumors (NSGCT) | Assessed every 6 weeks from start of treatment up to 72 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate on brain metastases | MRI of the brain every 6 weeks only in case of brain metastases detected at baseline and for all patients at the end of the study. Evaluation will be made using RECIST V1.1 | Assessed every 6 weeks after treatment start up to 72 months |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karim FIZAZI, MD-PhD | Gustave Roussy, Cancer Campus, Grand Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustave Roussy Cancer Campus Grand Paris | Villejuif | Val de Marne | 94805 | France |
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| ID | Term |
|---|---|
| C537844 | Nonseminomatous germ cell tumor |
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| ID | Term |
|---|---|
| C552428 | cabazitaxel |
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| Assessed every 6 weeks from treatment start to progression up to 72 months |
| Overall survival | Assessed every 3 weeks after treatment start up to 72 months |