Try our beta test site

Cabazitaxel Versus Docetaxel Both With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer (FIRSTANA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01308567
First received: March 3, 2011
Last updated: January 12, 2017
Last verified: December 2016
Results First Received: September 8, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Cabazitaxel (XRP6258)
Drug: Docetaxel (XRP6976)
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
The study was conducted at 159 centers in 25 countries. A total of 1510 participants were screened between 17 May 2011 and 09 September 2015 of whom 1168 participants were randomized and 342 were considered as screen failures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1168 participants were randomized in this study. Of these, 21 participants were randomized but were not treated. These participants were included in intent-to-treat (ITT) population and not in safety population.

Reporting Groups
  Description
Docetaxel 75 mg/m^2 Docetaxel (TXT) 75 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant’s refusal.
Cabazitaxel 20 mg/m^2 Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21–day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
Cabazitaxel 25 mg/m^2 Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.

Participant Flow:   Overall Study
    Docetaxel 75 mg/m^2   Cabazitaxel 20 mg/m^2   Cabazitaxel 25 mg/m^2
STARTED   391 [1]   389 [1]   388 [1] 
Treated   388 [2]   382 [3]   377 [4] 
Ongoing Treatment at Data Cut-off   4   6   3 
COMPLETED   389 [5]   385 [5]   384 [5] 
NOT COMPLETED   2   4   4 
Lost to Follow-up                2                4                4 
[1] Randomized
[2] For 1 participant, actual treatment received was Cabazitaxel 25 mg/m^2.
[3] For 15 participants, actual treatment received was Cabazitaxel 25 mg/m^2.
[4] For 2 participants, actual treatment received was Cabazitaxel 20 mg/m^2.
[5] Completed participants included those who withdrew treatment consent but were followed for survival.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Docetaxel 75 mg/m^2 Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
Cabazitaxel 20 mg/m^2 Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21–day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
Cabazitaxel 25 mg/m^2 Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
Total Total of all reporting groups

Baseline Measures
   Docetaxel 75 mg/m^2   Cabazitaxel 20 mg/m^2   Cabazitaxel 25 mg/m^2   Total 
Overall Participants Analyzed 
[Units: Participants]
 391   389   388   1168 
Age, Customized 
[Units: Participants]
       
<65 years   123   128   125   376 
65-74 years   181   187   182   550 
≥75 years   87   74   81   242 
Gender 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      391 100.0%      389 100.0%      388 100.0%      1168 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline up to death or study cut-off date, whichever was earlier (maximum duration: 51 months) ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline up to tumor progression, PSA progression, pain progression or death (maximum duration: 51 months) ]

3.  Secondary:   Time to Tumor Progression Free Survival   [ Time Frame: Baseline up to tumor progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months) ]

4.  Secondary:   Percentage of Participants With Overall Objective Tumor Response   [ Time Frame: Baseline up to DP or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months) ]

5.  Secondary:   Time to Prostate Serum Antigen Progression Free Survival (PSA-PFS)   [ Time Frame: Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier ((maximum duration: 51 months) ]

6.  Secondary:   Percentage of Participants With PSA Response   [ Time Frame: Baseline up to PSA progression or death due to any cause or study cut-off date, whichever was earlier (maximum duration: 51 months) ]

7.  Secondary:   Time to Pain Progression Free Survival (Pain PFS)   [ Time Frame: Baseline until disease progression, death or study cut-off date (maximum duration: 51 months) ]

8.  Secondary:   Percentage of Participants With Pain Response   [ Time Frame: Baseline until pain progression, death or study cut-off date (maximum duration: 51 months) ]

9.  Secondary:   Skeletal Related Events (SRE) Free Survival   [ Time Frame: Baseline until occurrence of first SRE or death (maximum duration: 51 months) ]

10.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score as a Measure of Health Related Quality of Life (HRQoL)   [ Time Frame: Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks) ]

11.  Secondary:   Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P):Trial Outcome Index (TOI) as a Measure of HRQoL   [ Time Frame: Baseline, Day 1 of each cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16 (each cycle 21-day); post-treatment follow up 1, 2, 3, 4, 5, 6 (each up to 12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: Sanofi
e-mail: Contact-US@sanofi.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01308567     History of Changes
Other Study ID Numbers: EFC11784
2010-022064-12 ( EudraCT Number )
U1111-1117-8356 ( Other Identifier: UTN )
Study First Received: March 3, 2011
Results First Received: September 8, 2016
Last Updated: January 12, 2017