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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00849290
First Posted: February 23, 2009
Last Update Posted: March 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dendreon
February 19, 2009
February 23, 2009
May 28, 2010
October 11, 2010
March 14, 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 ]
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 ]
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 ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00849290
PB01
No
Not Provided
Not Provided
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