Phase 2
N=113
Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
Metastatic Androgen Independent Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00849290 ↗Enrolled (actual)
113
Serious AEs
29.4%
Results posted
Oct 2010
Primary outcome: Primary: Safety of APC8015F by Review of Reported Adverse Events — 109 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- APC8015F (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Dendreon
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of APC8015F by Review of Reported Adverse Events |
109 | — |
Summary
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00849290). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.