Phase 2
Completed N=113
Immunotherapy For Men With Objective Disease Progression On Protocol D9902 Part B (NCT00065442)
Metastatic Androgen Independent Prostate Cancer
Source: ClinicalTrials.gov NCT00849290 ↗
Enrolled (actual)
113
Serious AEs
29.4%
Results posted
Oct 2010
Primary outcomePrimary: Safety of APC8015F by Review of Reported Adverse Events — 109 Participants
Summary
This is an open label, Phase 2 trial of APC8015F immunotherapy in men with objective disease progression on protocol D9902 part B (NCT00065442)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of APC8015F by Review of Reported Adverse Events |
109 | — |
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. Informational only — not medical advice.