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Sipuleucel-T Manufacturing Demonstration Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT01477749
First received: November 19, 2011
Last updated: November 4, 2015
Last verified: November 2015
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Cancer of Prostate
Cancer of the Prostate
Neoplasms, Prostate
Neoplasms, Prostatic
Prostate Cancer
Prostate Neoplasms
Prostatic Cancer
Intervention: Biological: sipuleucel-T

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sipuleucel-T

Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.


Participant Flow:   Overall Study
    Sipuleucel-T  
STARTED     47  
COMPLETED     43  
NOT COMPLETED     4  
Physician Decision                 4  



  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
Sipuleucel-T

Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.


Baseline Measures
    Sipuleucel-T  
Number of Participants  
[units: participants]
  47  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     35  
Gender  
[units: participants]
 
Female     0  
Male     47  
Region of Enrollment  
[units: participants]
 
France     8  
Austria     17  
Netherlands     15  
United Kingdom     7  



  Outcome Measures
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1.  Primary:   Cumulative CD54+ Cell Count   [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ]

2.  Primary:   Cumulative CD54 Upregulation   [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ]

3.  Primary:   Cumulative Total Nucleated Cell (TNC) Count   [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ]

4.  Primary:   Product Viability (Percentage)   [ Time Frame: Before and after culture with PAP-GM-CSF, on Day 3 (first infusion) and on approximately Days 17 and 31 (second and third infusion, respectively) ]


  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 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: Lynn Ngo
Organization: Dendreon Pharmaceuticals, Inc.
phone: 206-274-6763
e-mail: lngo@dendreon.com



Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01477749     History of Changes
Other Study ID Numbers: P11-1
2011-001192-39 ( EudraCT Number )
Study First Received: November 19, 2011
Results First Received: June 10, 2015
Last Updated: November 4, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service