NCT00901342

Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Dendreon · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

Detailed description

Subjects received sipuleucel-T at 2-week intervals, for a total of 3 infusions. The study evaluated the safety and magnitude of the immune responses to treatment with sipuleucel-T. All subjects were followed for 30 days following the last infusion of sipuleucel-T. Following the Study Completion Visit, survival, treatment-related serious adverse event (SAE)s and cerebrovascular event (CVE)s were collected via Long Term Follow-up Telephone Assessment occurring Q6 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	sipuleucel-T	Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF)

Timeline

• Start date: 2009-10-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2009-05-13
• Last updated: 2017-05-23
• Results posted: 2017-04-12

Locations

18 sites across 1 country: United States