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Sponsored by: |
Dendreon |
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Information provided by: | Dendreon |
ClinicalTrials.gov Identifier: | NCT00849290 |
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B
Condition | Intervention | Phase |
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Metastatic Androgen Independent Prostate Cancer |
Biological: APC8015F |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Estimated Enrollment: | 160 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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APC8015F: Experimental |
Biological: APC8015F
APC8015F is an autologous active cellular immunotherapy product designed to stimulate an immune response against prostate cancer. APC8015F consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), that have been activated in vitro with a recombinant fusion protein.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Paul Schellhammer, MD | Devine Tidewater Urology |
Responsible Party: | Dendreon Corporation ( Elizabeth Smith ) |
Study ID Numbers: | PB01 |
Study First Received: | February 19, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00849290 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Prostatic Diseases Genital Neoplasms, Male Disease Progression |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |