Trials / Completed
CompletedNCT00715078
To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 122 (actual)
- Sponsor
- Dendreon · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2012-04-01
- Completion
- 2015-05-01
- First posted
- 2008-07-15
- Last updated
- 2017-05-23
- Results posted
- 2014-05-12
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00715078. Inclusion in this directory is not an endorsement.