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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1119-8381 | Other Identifier | UTN |
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Primary Objective:
Secondary Objectives:
Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel | Active Comparator | 75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks |
|
| Cabazitaxel | Experimental | 25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CABAZITAXEL (XRP6258) | Drug | Pharmaceutical form: solution Route of administration: intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median time to PSA progression | up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA | up to 60 days | |
| Overall Survival: Median time elapsed between the date of starting treatment until death by any cause | up to a maximum of 2 years |
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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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 004 | Barretos | 14780-480 | Brazil | |||
| Investigational Site Number 008 |
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| DOCETAXEL (XRP6976) | Drug | Pharmaceutical form: solution Route of administration: intravenous |
|
| Number of patients with adverse events | up to a maximum of 2 years |
| Brasília |
| 70390-150 |
| Brazil |
| Investigational Site Number 009 | Londrina | 86015-520 | Brazil |
| Investigational Site Number 003 | Mogi das Cruzes | 0830-500 | Brazil |
| Investigational Site Number 005 | Porto Alegre | 90840-440 | Brazil |
| Investigational Site Number 006 | Rio de Janeiro | 20231-050 | Brazil |
| Investigational Site Number 001 | Rio de Janeiro | 22260-020 | Brazil |
| Investigational Site Number 007 | São Paulo | 01246-000 | Brazil |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C552428 | cabazitaxel |
| C532412 | XRP6258 |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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