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Sipuleucel-T Manufacturing Demonstration Study

NCT01477749 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2015-12-09

Study results available
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Summary

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

Conditions

  • Cancer of Prostate
  • Cancer of the Prostate
  • Neoplasms, Prostate
  • Neoplasms, Prostatic
  • Prostate Cancer
  • Prostate Neoplasms
  • Prostatic Cancer

Interventions

BIOLOGICAL

sipuleucel-T

Each 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.

Sponsors & Collaborators

  • Dendreon

    lead INDUSTRY

Principal Investigators

  • Andrew Stubbs, PhD · Dendreon

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Austria
  • France
  • Netherlands
  • United Kingdom

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 NCT01477749 on ClinicalTrials.gov