MedTrace Logo

A Phase 2b Study of Modified Vaccinia Virus to Treat Patients Advanced Liver Cancer Who Failed Sorafenib

NCT01387555 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2015-03-11

No results posted yet for this study

Summary

This study is to determine whether JX-594 (Pexa-Vec) plus best supportive care is more effective in improving survival than best supportive care in patients with advanced Hepatocellular Carcinoma (HCC) who have failed sorafenib.

Conditions

Interventions

BIOLOGICAL

JX-594 recombinant vaccina GM-CSF

Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed.

OTHER

Best Supportive Care

Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.

Sponsors & Collaborators

  • Jennerex Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • James Burke, MD · Jennerex Biotherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Canada
  • France
  • Germany
  • Hong Kong
  • South Korea
  • Taiwan

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 NCT01387555 on ClinicalTrials.gov