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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016864-35 | EudraCT Number | ||
| U1111-1116-5677 | Other Identifier | UTN |
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Primary Objective:
Secondary Objectives:
The main period of the study consists of a maximum of 21-day screening phase, then first 2 treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles).
After Cycle 2, patients will have the option to continue to receive cabazitaxel and should be followed for safety reporting until 30 days after the last dose of cabazitaxel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cabazitaxel | Experimental | At every cycle (every 3 weeks), on Day 1, patients will receive cabazitaxel, administered by intravenous (IV) infusion over 1 hour, at 25 mg/m2. An IV premedication regimen composed of up to 4 treatments (antihistamine, corticosteroids, H2 antagonist other than cimetidine at all cycles, plus palonosetron at cycle 1) will be administered before cabazitaxel infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabazitaxel (XRP6258) | Drug | Pharmaceutical form:solution for infusion Route of administration: intravenous |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in QT interval corrected calculation by Fridericia method | Cycle 1, Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Heart rate, QT, QTcB (QT interval corrected calculation by Bazett method) and QTcN (QT interval with a population-specific correction formulae) intervals | Cycle 1, Day 1 | |
| Other ECG parameters : PR, QRS intervals and ECG morphology |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Investigational Site Number 840006 | San Diego | California | 92103 | United States | ||
| Sanofi-Aventis Investigational Site Number 840002 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C552428 | cabazitaxel |
| C532412 | XRP6258 |
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| Cycle 1, Day 1 |
| Clinical safety based on adverse events, serious adverse event, laboratory assessments according to the National Cancer Institute- Common Terminology Criteria for Adverse Events v4.0 grade scaling | up to treatment discontinuation + 30 days over a maximum study period of 20 months |
| Cabazitaxel plasma concentrations, Cmax and partial AUC - | Cycle 1, Day 1 |
| San Francisco |
| California |
| 94115 |
| United States |
| Sanofi-Aventis Investigational Site Number 840005 | Decatur | Illinois | 62526 | United States |
| Sanofi-Aventis Investigational Site Number 840008 | Wichita | Kansas | 67214 | United States |
| Sanofi-Aventis Investigational Site Number 840010 | Paducah | Kentucky | 42002 | United States |
| Sanofi-Aventis Investigational Site Number 840007 | Kansas City | Missouri | 64128 | United States |
| Sanofi-Aventis Investigational Site Number 840009 | Bethlehem | Pennsylvania | 18015 | United States |
| Sanofi-Aventis Investigational Site Number 840003 | Salt Lake City | Utah | 84132 | United States |
| Sanofi-Aventis Investigational Site Number 056002 | Brussels | 1200 | Belgium |
| Sanofi-Aventis Investigational Site Number 056001 | Ghent | 9000 | Belgium |
| Sanofi-Aventis Investigational Site Number 208002 | Herlev | 2730 | Denmark |
| Sanofi-Aventis Investigational Site Number 208001 | København Ø | 2100 | Denmark |
| Sanofi-Aventis Investigational Site Number 528001 | Maastricht | 6229 HX | Netherlands |
| Sanofi-Aventis Investigational Site Number 752002 | Lund | 221 85 | Sweden |
| Sanofi-Aventis Investigational Site Number 752001 | Uppsala | 751 85 | Sweden |