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Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00849290
First received: February 19, 2009
Last updated: March 12, 2013
Last verified: March 2013
History of Changes

February 19, 2009
March 12, 2013
April 2004
January 2009   (final data collection date for primary outcome measure)
Safety of APC8015F by Review of Reported Adverse Events [ Time Frame: periodically over 24 months ] [ Designated as safety issue: Yes ]
All subjects who received at least one infusion of APC8015F (N = 109) were included in the safety analysis set and were followed for safety. Refer to Serious Adverse Events and Other Adverse Events.
To assess the safety of APC8015F [ Time Frame: periodically over 24 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00849290 on ClinicalTrials.gov Archive Site
To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response [ Time Frame: periodically over 24 months ] [ Designated as safety issue: No ]
To assess the efficacy of APC8015F in delaying prostate specific antigen (PSA) doubling time (PSADT) and on overall clinical response [ Time Frame: periodically over 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
Not Provided

This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Androgen Independent Prostate Cancer
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.
Experimental: APC8015F
Intervention: Biological: APC8015F
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
April 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Objective disease progression
  • Subjects must have been enrolled in the APC-Placebo arm of D9902B (NCT00065442)

Exclusion Criteria:

  • Infection requiring IV antibiotics
  • Treatment with anticancer interventions within 14 days prior to enrollment
  • Any medical condition which could compromise the study's objectives (discretion from sponsor)
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00849290
PB01
No
Dendreon
Dendreon
Not Provided
Study Chair: Paul Schellhammer, MD Devine Tidewater Urology
Dendreon
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP