XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer (TROPIC)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00417079
First received: December 28, 2006
Last updated: March 4, 2011
Last verified: March 2011
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Results First Received: September 20, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Conditions: |
Neoplasms Prostatic Neoplasms |
| Interventions: |
Drug: cabazitaxel (XRP6258) (RPR116258) Drug: mitoxantrone Drug: prednisone |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Multicenter study: 146 actives sites from 26 countries in Europe, USA, South America and Asia Pacific region. Study initiation date: January 2nd, 2007; study completion date/study cut off date: September 25th, 2009. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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165 patients signed informed consent but were not randomized and considered as screen failure. Intention to Treat Population (ITT or randomized patients): 755 patients (377 mitoxantrone, 378 cabazitaxel). Safety population (treated patients): 742 patients (371 mitoxantrone, 371 cabazitaxel) (Patients not treated: 6 mitoxantrone, 7 cabazitaxel). |
Reporting Groups
| Description | |
|---|---|
| Mitoxantrone + Prednisone | mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily |
| Cabazitaxel + Prednisone | cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily |
Participant Flow: Overall Study
| Mitoxantrone + Prednisone | Cabazitaxel + Prednisone | |
|---|---|---|
| STARTED | 377 [1] | 378 [1] |
| COMPLETED | 46 [1] | 105 [1] |
| NOT COMPLETED | 331 | 273 |
| Disease progression | 267 | 180 |
| Adverse Event | 32 | 67 |
| Non-compliance to protocol | 0 | 1 |
| Lost to Follow-up | 2 | 0 |
| Withdrawal by Subject | 17 | 8 |
| Not treated | 6 | 7 |
| Screened failure | 2 | 1 |
| Investigator's decision | 1 | 4 |
| Non-confirmed Disease progression | 1 | 1 |
| Clinical deterioration | 1 | 0 |
| Screening error | 2 | 1 |
| Withdrawal by subject's family | 0 | 1 |
| Patient unable to come to the clinic | 0 | 1 |
| abnormal liver function tests | 0 | 1 |
| [1] | Randomized patients |
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Show Baseline Characteristics
Outcome Measures
| 1. Primary: | Overall Survival [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ] |
| 2. Secondary: | Time to Progression Free Survival (PFS) [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ] |
| 3. Secondary: | Overall Tumor Response [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ] |
| 4. Secondary: | Time to Tumor Progression [ Time Frame: From the date of randomization up to 104 weeks (study cut-off) ] |
| 5. Secondary: | Time to Prostatic Specific Antigen (PSA) Progression [ Time Frame: at screening, day 1 of every treatment cycle, up to 104 weeks (study cut-off) ] |
| 6. Secondary: | PSA (Prostate-Specific Antigen) Response [ Time Frame: from baseline up to 104 weeks (study cut-off) ] |
| 7. Secondary: | Time to Pain Progression [ Time Frame: from baseline up to 104 weeks (study cut-off) ] |
| 8. Secondary: | Pain Response [ Time Frame: from baseline up to 104 weeks (study cut-off) ] |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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