Type of Study:

Interventional

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:

Yes

Principal Investigator

Paul Schellhammer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Devine Tidewater Urology

Authority:

United States: Food and Drug Administration

Study ID:

PB01

NCT ID:

NCT00849290

Start Date:

April 2004

Completion Date:

April 2009

Related Keywords:

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