XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer (TROPIC)
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ClinicalTrials.gov Identifier: NCT00417079 |
Recruitment Status :
Completed
First Posted : December 29, 2006
Results First Posted : December 23, 2010
Last Update Posted : March 10, 2011
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Neoplasms Prostatic Neoplasms |
Interventions |
Drug: cabazitaxel (XRP6258) (RPR116258) Drug: mitoxantrone Drug: prednisone |
Enrollment | 755 |
Recruitment Details | 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 |
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). |
Arm/Group Title | Mitoxantrone + Prednisone | Cabazitaxel + Prednisone |
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mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily | cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily |
Period Title: Overall Study | ||
Started | 377 [1] | 378 [1] |
Completed | 46 [1] | 105 [1] |
Not Completed | 331 | 273 |
Reason Not Completed | ||
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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Arm/Group Title | Mitoxantrone + Prednisone | Cabazitaxel + Prednisone | Total | |
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mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily | cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily | Total of all reporting groups | |
Overall Number of Baseline Participants | 377 | 378 | 755 | |
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[Not Specified]
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Age Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 377 participants | 378 participants | 755 participants | |
67.0
(47 to 89)
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68.0
(46 to 92)
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67
(46 to 92)
|
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Sex/Gender, Customized
Measure Type: Number Unit of measure: Participants |
||||
Male | Number Analyzed | 377 participants | 378 participants | 755 participants |
377 | 378 | 755 | ||
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 377 participants | 378 participants | 755 participants |
United States | 106 | 97 | 203 | |
Taiwan | 4 | 7 | 11 | |
Slovakia | 1 | 1 | 2 | |
Spain | 10 | 9 | 19 | |
Chile | 9 | 12 | 21 | |
Russian Federation | 6 | 4 | 10 | |
Italy | 17 | 18 | 35 | |
India | 11 | 9 | 20 | |
France | 44 | 46 | 90 | |
Denmark | 19 | 26 | 45 | |
South Africa | 7 | 9 | 16 | |
Netherlands | 8 | 9 | 17 | |
Korea, Republic of | 8 | 7 | 15 | |
Finland | 4 | 1 | 5 | |
Turkey | 17 | 19 | 36 | |
United Kingdom | 17 | 20 | 37 | |
Hungary | 8 | 7 | 15 | |
Czech Republic | 10 | 12 | 22 | |
Mexico | 2 | 3 | 5 | |
Canada | 16 | 16 | 32 | |
Argentina | 7 | 3 | 10 | |
Brazil | 7 | 4 | 11 | |
Belgium | 16 | 15 | 31 | |
Singapore | 6 | 3 | 9 | |
Germany | 6 | 11 | 17 | |
Sweden | 11 | 10 | 21 | |
Eastern Cooperative Oncology Group (ECOG) Performance Status
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 377 participants | 378 participants | 755 participants |
0 - Fully Active | 120 | 141 | 261 | |
1 - Ambulatory, Restricted Activity | 224 | 209 | 433 | |
2 - Ambulatory, No Work Activities | 33 | 28 | 61 | |
Prostatic Specific Antigen PSA
Median (Full Range) Unit of measure: ng/mL |
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Number Analyzed | 377 participants | 378 participants | 755 participants | |
127.5
(2 to 11220)
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143.9
(2 to 7842)
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135.00
(2 to 11220)
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Measurable disease
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 377 participants | 378 participants | 755 participants |
Measurable disease | 204 | 201 | 405 | |
Not Measurable disease | 173 | 177 | 350 | |
[1]
Measure Description:
Measurability of the disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria: Patients with measurable disease have at least one visceral or soft tissue metastatic lesion (including new lesion). Patient with non-measurable disease have documented rising PSA levels or appearance of new lesion. |
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Extent of disease
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 377 participants | 378 participants | 755 participants |
Metastatic | 356 | 364 | 720 | |
Locoregional Recurrence | 20 | 14 | 34 | |
Missing | 1 | 0 | 1 | |
[1]
Measure Description:
Extent of the disease at screening stage:
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Tumor Location: number of sites involved
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 377 participants | 378 participants | 755 participants |
1 | 134 | 146 | 280 | |
2 | 117 | 112 | 229 | |
3 | 78 | 73 | 151 | |
4 or more | 43 | 44 | 87 | |
Missing | 5 | 3 | 8 |
Name/Title: | International Clinical Development Study Director |
Organization: | sanofi-aventis |
EMail: | GV-Contact-us@sanofi-aventis.com |
Responsible Party: | International Clinical Development Study Director, sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00417079 |
Other Study ID Numbers: |
EFC6193 |
First Submitted: | December 28, 2006 |
First Posted: | December 29, 2006 |
Results First Submitted: | September 20, 2010 |
Results First Posted: | December 23, 2010 |
Last Update Posted: | March 10, 2011 |