A Phase 2a Study of Modified Vaccinia Virus to Treat Sorafenib-naïve Advanced Liver Cancer

Status:	Completed
Conditions:	Liver Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	June 2012
End Date:	June 2013

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)

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.

KEY Inclusion Criteria:

- Histologic or cytologic confirmation of advanced primary hepatocellular carcinoma
(HCC)

- Measurable tumor (at least one tumor with ≥1 cm LD of contrast-enhancement during the
arterial phase on CT scanning)

- ECOG performance status 0, 1 or 2

- Child-Pugh Class A; or Child-Pugh Class B7 without clinically significant ascites

- Platelet count ≥50,000 plts/mm3

- WBC count ≥2,000 cells/mm3 and ≤50,000 cells/mm3

- Hemoglobin ≥10 g/dL

- Adequate liver function

KEY Exclusion Criteria:

- Received sorafenib as previous treatment for HCC for more than 14 days

- History of severe exfoliative skin condition (e.g., eczema or atopic dermatitis
requiring systemic therapy for > 4 weeks)

- Prior treatment with JX-594

- Known significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or
medication

- Severe or unstable cardiac disease

- Viable CNS malignancy associated with clinical symptoms

- Pregnant or nursing an infant

- Significant bleeding event within the last 12 months.

We found this trial at

sites

Pusan National University Hospital

Pusan,

from

Pusan,