A Study to Determine the Short-Term Safety of Continuous Dosing of Abiraterone Acetate and Prednisone in Modified Fasting and Fed States to Patients With Metastatic Castration-Resistant Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier:
NCT01424930
First received: August 26, 2011
Last updated: March 28, 2014
Last verified: March 2014
Results First Received: March 28, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Prostate Neoplasms
Prostate Cancer
Interventions: Drug: Abiraterone acetate and prednisone; low-fat diet
Drug: Abiraterone acetate and prednisone; high-fat diet

  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
The study was conducted from 29 September 2011 to 29 May 2013. Participants were recruited at 2 study centers in Canada.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
25 participants were randomly allocated to the 2 treatment arms. 24 participants completed the food safety evaluation period and were included in the evaluable safety population.

Reporting Groups
  Description
Cohort 1

Participants received abiraterone acetate once daily for 7 days after a standardized low-fat meal from Cycle 1 Day 8 to Cycle

1 Day 14.

Cohort 2 Participants received abiraterone acetate once daily for 7 days after a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.

Participant Flow:   Overall Study
    Cohort 1     Cohort 2  
STARTED     7     18  
COMPLETED     3     4  
NOT COMPLETED     4     14  
Adverse Event                 0                 1  
Death                 1                 0  
Progressive Disease                 3                 6  
Screen Failure                 0                 1  
Reason not specified                 0                 6  



  Baseline Characteristics
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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
Cohort 1

Participants received abiraterone acetate once daily for 7 days after a standardized low-fat meal from Cycle 1 Day 8 to Cycle

1 Day 14.

Cohort 2 Participants received abiraterone acetate once daily for 7 days after a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.
Total Total of all reporting groups

Baseline Measures
    Cohort 1     Cohort 2     Total  
Number of Participants  
[units: participants]
  7     18     25  
Age  
[units: years]
Mean ± Standard Deviation
  75.1  ± 11.01     69.1  ± 7.26     70.8  ± 8.67  
Gender  
[units: participants]
     
Female     0     0     0  
Male     7     18     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Grade 3 or Higher Adverse Events (AEs) of Special Interest or Grade 3 or Higher Serious AEs Due to Study Medication   [ Time Frame: Postdose on Cycle 1 Day 8 to predose on Cycle 2 Day 1 ]

2.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Abiraterone   [ Time Frame: Day 7 and Day 14 ]

3.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of Abiraterone   [ Time Frame: Day 7 and Day 14 ]

4.  Secondary:   Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h)   [ Time Frame: Day 7 and Day 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen-Ortho Inc., Canada
ClinicalTrials.gov Identifier: NCT01424930     History of Changes
Other Study ID Numbers: CR018715, 212082PCR2008
Study First Received: August 26, 2011
Results First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: Canada: Health Canada