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Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (mCRPC)

This study has been terminated.
(Administrative reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01338012
First Posted: April 19, 2011
Last Update Posted: June 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dendreon
Results First Submitted: April 26, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate 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 Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.

Participant Flow:   Overall Study
    Sipuleucel-T
STARTED   8 
COMPLETED   0 
NOT COMPLETED   8 
Death                4 
Study terminated                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.
Men who previously participated in Dendreon's P-11 clinical study, received Sipuleucel-T as part of P-11, and who developed metastatic castrate resistant prostate cancer (mCRPC), Safety population includes all subjects who received at least one infusion in the current study (P10-1).

Reporting Groups
  Description
Sipuleucel-T Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.

Baseline Measures
   Sipuleucel-T 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      8 100.0% 
Age 
[Units: Years]
Mean (Full Range)
 74.4 
 (66 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      8 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      8 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   8 
Eastern Cooperative Oncology Group (ECOG) performance status [1] 
[Units: Participants]
Count of Participants
 
ECOG 0=Fully Active; No restrictions   6 
ECOG 1= Restricted Strenuous Activity   2 
[1] ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about >50% of waking hour; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead


  Outcome Measures

1.  Primary:   Number of Study Participants Enrolled and Treated Prior to Study Termination   [ Time Frame: Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015 ]


  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
This study was terminated early due to administrative reasons. Only 8 subjects were enrolled and treated. Given the small number of patients enrolled, analyses do not provide reliable results.


  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: Shabnam Vaziri
Organization: Dendreon
phone: 206-455-2323
e-mail: svaziri@dendreon.com



Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT01338012     History of Changes
Other Study ID Numbers: P10-1
First Submitted: March 2, 2011
First Posted: April 19, 2011
Results First Submitted: April 26, 2017
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017