Clinical Trial Results:
AN OPEN-LABEL STUDY OF SIPULEUCEL-T IN EUROPEAN MEN WITH METASTATIC, CASTRATE RESISTANT PROSTATE CANCER
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Summary
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EudraCT number |
2011-001192-39 |
Trial protocol |
AT GB NL |
Global end of trial date |
10 Jun 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Dec 2016
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First version publication date |
27 Jun 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
P11-1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Dendreon Pharmaceuticals, Inc
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Sponsor organisation address |
1301 2nd Avenue, Seattle, United States,
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Public contact |
Jennifer Lill, Dendreon Pharmaceuticals, Inc, +1 206-455-2174, jlill@dendreon.com
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Scientific contact |
Jennifer Lill, Dendreon Pharmaceuticals, Inc, +1 206-455-2174, jlill@dendreon.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Jun 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Jun 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jun 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with mCRPC at a European manufacturing facility.
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Protection of trial subjects |
Utilization of an Independent Data Monitoring Committee that met at 3 month intervals and established procedures regarding chain of identity to ensure autologous product is delivered correctly.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
13 Jun 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Netherlands: 15
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Country: Number of subjects enrolled |
United Kingdom: 7
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Country: Number of subjects enrolled |
Austria: 17
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Country: Number of subjects enrolled |
France: 8
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Worldwide total number of subjects |
47
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EEA total number of subjects |
47
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
12
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From 65 to 84 years |
34
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85 years and over |
1
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Recruitment
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Recruitment details |
- | ||||||||||
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Pre-assignment
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Screening details |
Administration of informed consent, evaluation of inclusion criteria, clinical evaluations and assorted laboratory tests. | ||||||||||
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Period 1
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Period 1 title |
Overall Trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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sipuleucel-T | ||||||||||
Arm description |
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. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Sipuleucel-T
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Dispersion for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
3 250 mL doses infused approximately 2 weeks apart.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
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Subject analysis sets
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Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects registered were included in the analysis.
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End points reporting groups
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Reporting group title |
sipuleucel-T
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Reporting group description |
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. | ||
Subject analysis set title |
Full analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All subjects registered were included in the analysis.
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End point title |
Cumulative CD54 Upregulation [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Over 3 infusions of Sipuleucel-T
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Cumulative CD54 Upregulation parameters will be summarized descriptively (mean, median, standard deviation, minimum, and maximum) by infusion (1, 2, and 3) and cumulative (summed across infusions). Descriptive statistics are sufficient for this single-arm study. |
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| No statistical analyses for this end point | |||||||||
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End point title |
CD54+ cell count [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Cumulative through infusion 3
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: CD54+ cell count parameters will be summarized descriptively (mean, median, standard deviation, minimum, and maximum) by infusion (1, 2, and 3) and cumulative (summed across infusions) Descriptive statistics are sufficient for this single-arm study. |
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End point title |
Total nucleated cell count [3] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Cumulative through infusion 3
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Total nucleated cell count parameters will be summarized descriptively (mean, median, standard deviation, minimum, and maximum) by infusion (1, 2, and 3) and cumulative (summed across infusions) Descriptive statistics are sufficient for this single-arm study. |
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End point title |
Product viability (percentage) [4] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Infusion 3
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Product viability (percentage) parameters will be summarized descriptively (mean, median, standard deviation, minimum, and maximum) by infusion (1, 2, and 3). Descriptive statistics are sufficient for this single-arm study. |
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From informed consent to last visit
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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01 Jun 2012 |
Quality of Life questionnaire assessments added. Clarification of sample size from 10 up to 45 subjects in the statistical analysis (justification for 45 subjects). Statistical clarification for the decision to stop enrollment. |
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09 Jul 2013 |
Added thromboembolic and CVE reporting criteria of all countries to align with IB, edition 18. |
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02 Dec 2013 |
Updated leukapheresis and sipuleucel-T risks sections, and infusion section to align with IB, edition 19. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
