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Phase 2
18 Years
Not Enrolling
Metastatic Androgen Independent Prostate Cancer

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Trial Information

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of APC8015F by Review of Reported Adverse Events

Outcome Description:

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.

Outcome Time Frame:

periodically over 24 months

Safety Issue:


Principal Investigator

Paul Schellhammer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Devine Tidewater Urology


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

April 2009

Related Keywords:

  • Metastatic Androgen Independent Prostate Cancer
  • Prostatic Neoplasms
  • Disease Progression



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USC Keck School of Medicine Los Angeles, California  90089-9178
Walter Reid Army Medical Center Washington, District of Columbia  20307
Miami Cancer Center Miami, Florida  33133
Hematology/Oncology Associates of the Treasure Coast Port St. Lucie, Florida  34952
Midwest Prostate & Urology Health Center Chicago, Illinois  60640
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