Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
This study has been completed.
Sponsor:
Dendreon
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00849290
First received: February 19, 2009
Last updated: March 12, 2013
Last verified: March 2013
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Results First Received: May 28, 2010
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Metastatic Androgen Independent Prostate Cancer |
| Intervention: |
Biological: APC8015F |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Participants were registered between April 2004 and January 2009 across 52 clinical trial sites. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 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. |
Reporting Groups
| Description | |
|---|---|
| APC8015F | APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart. |
Participant Flow: Overall Study
| APC8015F | |
|---|---|
| STARTED | 113 |
| COMPLETED | 58 |
| NOT COMPLETED | 55 |
| Adverse Event | 3 |
| Death | 14 |
| Withdrawal by Subject | 11 |
| Lost to Follow-up | 2 |
| Protocol Violation | 5 |
| Disease Progression | 20 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| APC8015F | No text entered. |
Baseline Measures
| APC8015F | |
|---|---|
|
Number of Participants
[units: participants] |
113 |
|
Age
[units: years] Mean ( Full Range ) |
70.0
( 40 to 87 ) |
|
Gender
[units: participants] |
|
| Female | 0 |
| Male | 113 |
Outcome Measures
| 1. Primary: | Safety of APC8015F by Review of Reported Adverse Events [ Time Frame: periodically over 24 months ] |
| 2. Secondary: | To Evaluate the Efficacy of APC8015F in Delaying Prostate Specific Antigen Doubling Time and on Overall Clinical Response [ Time Frame: periodically over 24 months ] |
Results not yet posted. Anticipated Posting Date:
No text entered.
Safety Issue:
No