Hepatocellular Carinoma Clinical Trial
— FLASHOfficial title:
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)
| NCT number | NCT01636284 |
| Other study ID # | JX594-IV-HEP021 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | June 2012 |
| Est. completion date | June 2013 |
| Verified date | December 2020 |
| Source | SillaJen, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Pusan National University Hospital | Pusan | |
| Korea, Republic of | Pusan National University Yangsan Hospital | Yangsan | |
| Spain | University Clinic of Navarra | Pamplona | Navarra |
| United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
| United States | Mayo Clinic | Scottsdale | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| Jennerex Biotherapeutics |
United States, Korea, Republic of, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Radiographic Response | Number of Participants with Complete response [CR] or partial response [PR] per modified Response Evaluation Criteria in Solid Tumors (mRECIST) for target and non-target lesions assessed by enhanced CT scan: CR, disappearance of intratumoral enhancing area; PR, >=30% decrease in sum of diameters of enhancing area; Radiographic Response = CR + PR | CT scans every 6 week from Week 6 up to 12 months | |
| Secondary | Time to Progression (TTP) | TTP (in months) was defined as the number of months from the date of first Pexa-Vec infusion to the date of disease progression. If the patient had no progression then TTP was censored at the date of last evaluable tumor assessment. TTP was summarized and a Kaplan Meier (KM) curve was constructed. | CT scans every 6 week from Week 6 up to 12 months. | |
| Secondary | Overall Survival (OS) | OS was defined as the time from first dose of Pexa-Vec until death from any cause. For patients not known to have died at the time of the analysis, OS was censored on the date they were last known to be alive. OS was summarized and a KM curve was constructed. | CT scans every 6 week from Week 6 up to 12 months |