Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00849290
First received: February 19, 2009
Last updated: March 12, 2013
Last verified: March 2013
Results First Received: May 28, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Androgen Independent Prostate Cancer
Intervention: Biological: APC8015F

  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
Participants were registered between April 2004 and January 2009 across 52 clinical trial sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who had objective disease progression on Dendreon’s Phase 3 trial D9902B (NCT00065442)and who were determined to have received placebo were screened for evaluation of subject eligibility and performance of baseline tests/procedures.

Reporting Groups
  Description
APC8015F APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.

Participant Flow:   Overall Study
    APC8015F  
STARTED     113  
COMPLETED     58  
NOT COMPLETED     55  
Adverse Event                 3  
Death                 14  
Withdrawal by Subject                 11  
Lost to Follow-up                 2  
Protocol Violation                 5  
Disease Progression                 20  



  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
APC8015F No text entered.

Baseline Measures
    APC8015F  
Number of Participants  
[units: participants]
  113  
Age  
[units: years]
Mean ( Full Range )
  70.0  
  ( 40 to 87 )  
Gender  
[units: participants]
 
Female     0  
Male     113  



  Outcome Measures

1.  Primary:   Safety of APC8015F by Review of Reported Adverse Events   [ Time Frame: periodically over 24 months ]

2.  Secondary:   To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response   [ Time Frame: periodically over 24 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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: Kathleen Picha
Organization: Dendreon Corporation
phone: 206-274-6762
e-mail: kpicha@dendreon.com


No publications provided


Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00849290     History of Changes
Obsolete Identifiers: NCT00090922, NCT00170066, NCT00513006
Other Study ID Numbers: PB01
Study First Received: February 19, 2009
Results First Received: May 28, 2010
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration