Title

Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
AN OPEN LABEL, SINGLE ARM TRIAL OF IMMUNOTHERAPY WITH AUTOLOGOUS ANTIGEN PRESENTING CELLS LOADED WITH PA2024 (APC8015F) FOR MEN WITH OBJECTIVE DISEASE PROGRESSION ON PROTOCOL D9902 PART B
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Indication/Condition

    Metastatic Androgen Independent Prostate Cancer
  • Intervention/Treatment

    apc8015f ...
  • Study Participants

    113
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
Study Started
Apr 30
2004
Primary Completion
Jan 31
2009
Study Completion
Apr 30
2009
Results Posted
Oct 11
2010
Estimate
Last Update
Oct 01
2021

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.

APC8015F Experimental

Criteria

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)

Summary

APC8015F

All Events

Event Type Organ System Event Term APC8015F

Safety of APC8015F by Review of Reported Adverse Events

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.

APC8015F

109.0
participants

To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response

To compare the within-subject pre-and-post-APC8015F PSADT. The pre-and-post-APC8015F PSADT for each subject refers to the PSADT while on Protocol D9902B and Protocol PB01, respectively.

Outcome Measure Data Not Reported

Age, Continuous

70.0
years (Mean)
Full Range: 40.0 to 87.0

Sex: Female, Male

Overall Study

APC8015F

Drop/Withdrawal Reasons

APC8015F