Clinical Trials Directory

Trials / Completed

CompletedNCT01477749

Sipuleucel-T Manufacturing Demonstration Study

An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
47 (actual)
Sponsor
Dendreon · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.

Detailed description

This was an open-label, uncontrolled, multi-center study. Study participants will underwent screening procedures to ensure that they met the inclusion and exclusion criteria. Subjects underwent a standard 1.5 to 2.0 blood volume leukapheresis, followed approximately 3 days later by an infusion of sipuleucel-T. This process was be repeated at approximately 2-week intervals for a total of 3 infusions. In Austria, The Netherlands, and France, a study completion visit occurred between 30 and 37 days post-final infusion, or between 30 and 37 days post-final leukapheresis for subjects not receiving at least 1 infusion. In the UK, a follow-up visit occurred 30 days after the subject's final infusion and a study completion visit occurred 6 months after the subject's final infusion.

Conditions

Interventions

TypeNameDescription
BIOLOGICALsipuleucel-TEach dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.

Timeline

Start date
2012-06-01
Primary completion
2014-06-01
Completion
2014-06-01
First posted
2011-11-23
Last updated
2015-12-09
Results posted
2015-12-09

Locations

4 sites across 4 countries: Austria, France, Netherlands, United Kingdom

Source: ClinicalTrials.gov record NCT01477749. Inclusion in this directory is not an endorsement.