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Completed

NCT Number: NCT01636284

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

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.

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Key information

Conditions

Hepatocellular Carinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pusan National University Hospital, Pusan, South Korea

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About this study

This was a Phase 2a, two-staged, single-arm, open-label study in sorafenib-naïve patients with advanced HCC.

Patients received 5 weekly IV infusions of Pexa-Vec and could have continued to receive IV infusions of Pexa-Vec every 3 weeks until progressive disease (PD).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

JX-594 recombinant vaccina GM-CSF

Biological

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.

Primary outcomes

  1. Number of Participants With Radiographic Response

    Time frame: CT scans every 6 week from Week 6 up to 12 months

    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

Secondary outcomes

  1. Time to Progression (TTP)

    Time frame: CT scans every 6 week from Week 6 up to 12 months.

    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.

  2. Overall Survival (OS)

    Time frame: CT scans every 6 week from Week 6 up to 12 months

    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.

Sponsors and collaborators

Lead sponsor

Jennerex Biotherapeutics

Industry

Registry information

Official study 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)

Acronym: FLASH

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2012
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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