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Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

NCT01338012 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-06-05

Study results available
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Summary

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Dendreon

    lead INDUSTRY

Principal Investigators

  • Robert Israel, MD · Valeant Pharmaceuticals North America LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01338012 on ClinicalTrials.gov