CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
JX-594 recombinant vaccina GM-CSFbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01636284
NCT01636284Phase 2Completed
CompareCT.gov

A Single-Arm, Open-Label Phase 2 Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Weekly Intravenous (IV) Infusions in Sorafenib-naïve Patients With Advanced Hepatocellular Carcinoma (HCC)

Jennerex Biotherapeutics·interventional·Posted Jul 10, 2012·Updated Jan 20, 2021

In Brief

A Phase 2 clinical trial evaluating JX-594 recombinant vaccina GM-CSF for Hepatocellular Carinoma. Completed, enrolled 16 participants across 5 sites in 3 countries.

Detailed Summary

This study is to determine how effectively JX-594 (Pexa-Vec) will prolong life in patients with advanced Hepatocellular Carcinoma (HCC) who have not been previously treated with sorafenib, and the safe administration of JX-594 in five weekly IV infusions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carinoma
CountriesSouth Korea, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 10, 2012
Enrollment StartJun 1, 2012
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.0 years ago

Interventions

JX-594 recombinant vaccina GM-CSFbiological

Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal.