To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
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ClinicalTrials.gov Identifier: NCT00715078 |
Recruitment Status :
Completed
First Posted : July 15, 2008
Results First Posted : May 12, 2014
Last Update Posted : May 23, 2017
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Sponsor:
Dendreon
Information provided by (Responsible Party):
Dendreon
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Tracking Information | ||||
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First Submitted Date ICMJE | July 11, 2008 | |||
First Posted Date ICMJE | July 15, 2008 | |||
Results First Submitted Date ICMJE | February 19, 2014 | |||
Results First Posted Date ICMJE | May 12, 2014 | |||
Last Update Posted Date | May 23, 2017 | |||
Study Start Date ICMJE | October 2008 | |||
Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Cumulative CD54 Upregulation Ratio Between Each of the Cohorts. [ Time Frame: Baseline, Months 2, 4 and 6. ] An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.
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Original Primary Outcome Measures ICMJE |
Compare the cumulative CD54 upregulation ratio between each of the cohorts. [ Time Frame: 2010 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen | |||
Official Title ICMJE | A Randomized, Multicenter, Single Blind Study in Men With Metastatic Androgen Independent Prostate Cancer to Evaluate Sipuleucel-T Manufactured With Different Concentrations of PA2024 Antigen | |||
Brief Summary | This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen | |||
Detailed Description | This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with 1 of 3 different concentrations of PA2024 antigen The primary purpose of this study is to compare the changes in CD54 upregulation between each of these 3 groups of subjects. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | |||
Intervention ICMJE | Biological: sipuleucel-T
Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
122 | |||
Original Estimated Enrollment ICMJE |
120 | |||
Actual Study Completion Date ICMJE | May 2015 | |||
Actual Primary Completion Date | April 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: For a subject to be eligible for participation in this study, all of the following criteria must be satisfied.
Exclusion Criteria: A subject will not be eligible for participation in this study if any of the following criteria apply.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00715078 | |||
Other Study ID Numbers ICMJE | P07-2 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Dendreon | |||
Original Responsible Party | Elizabeth Smith, Dendreon Corporation | |||
Current Study Sponsor ICMJE | Dendreon | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Dendreon | |||
Verification Date | April 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |