XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer (TROPIC)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00417079
First received: December 28, 2006
Last updated: March 4, 2011
Last verified: March 2011
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

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



  Baseline Characteristics


  Outcome Measures
  Show All 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) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: International Clinical Development Study Director
Organization: sanofi-aventis
e-mail: GV-Contact-us@sanofi-aventis.com


No publications provided by Sanofi

Publications automatically indexed to this study:

Responsible Party: International Clinical Development Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00417079     History of Changes
Other Study ID Numbers: EFC6193
Study First Received: December 28, 2006
Results First Received: September 20, 2010
Last Updated: March 4, 2011
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada