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To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

NCT00715078 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2017-05-23

Study results available
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Summary

This is a randomized, multicenter, single blind, Phase 2 trial of immunotherapy in men with metastatic androgen independent prostate cancer to evaluate sipuleucel-T manufactured with different concentrations of PA2024 antigen

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
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-04-30
Completion
2015-05-31

Countries

  • United States

Study Locations

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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 NCT00715078 on ClinicalTrials.gov