Metastatic Androgen Independent Prostate Cancer
Conditions
Brief summary
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
Interventions
BIOLOGICALAPC8015F
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.
Sponsors
Dendreon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of APC8015F by Review of Reported Adverse Events | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were registered between April 2004 and January 2009 across 52 clinical trial sites.
Pre-assignment details
Participants who had objective disease progression on Dendreon's Phase 3 trial D9902B (NCT00065442)and who were determined to have received placebo were screened for evaluation of subject eligibility and performance of baseline tests/procedures.
Participants by arm
| Arm | Count |
|---|---|
| APC8015F Subjects receiving APC8015F | 113 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 14 |
| Overall Study | Disease Progression | 20 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | APC8015F |
|---|---|
| Age, Continuous | 70.0 years |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 101 / 109 |
| serious Total, serious adverse events | 32 / 109 |
Outcome results
Primary
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.
Time frame: periodically over 24 months
Population: All participants who received at least one infusion of APC8015F
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| APC8015F | Safety of APC8015F by Review of Reported Adverse Events | 109 Participants |