Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma

Inclusion Criteria:

• Subject must be at least 18 years of age.
• Subject must have a histologic or cytologic diagnosis of HCC and be considered unsuitable for resection or other potentially curative options (eg, liver transplant, curative radiofrequency ablation).
• Subject must have a measurable lesion by RECIST on CT scan in at least one site which has not received radiation or any other local therapy [eg, transcatheter arterial chemoembolisation (TACE), radiofrequency ablation, local injection]. (Note: Subjects who have received local therapies will be allowed to participate, provided that they have a target lesion which has not been subjected to local therapy. Subjects who have received TACE must have a target lesion outside of the vascular territory subjected to chemoembolisation.)
• Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
• Subject has had no other active malignancy within the past three years [other than non melanomatous skin cancer or carcinoma in situ (CIS) of the breast, bladder, or uterine cervix. Subjects with Ta (non-invasive papillary carcinoma) or Tis (sessile carcinoma in situ) bladder cancer are allowed].
• Subject has a minimum life expectancy of at least three months as determined by the investigator.
• Subject has adequate bone marrow function (ie, haemoglobin ≥9 g/dL, granulocytes ≥1500/mm3, platelets ≥75,000/mm3).
• Prothrombin time (PT)-international normalised ratio (INR) ≤2.3 or PT ≤6 seconds above control. (Note: Subjects who are being therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that their INR is between 2.0 and 3.0.
• Subject has adequate renal function (ie, serum creatinine is normal or calculated creatinine clearance is ≥60 mL/min).
• Subject has adequate hepatic function (ie, bilirubin ≤2x upper limit of normal (ULN); AST ALT, and alkaline phosphatase ≤5xULN). (Also see exclusion for Child-Pugh class C below).
• Male subjects and females of childbearing potential must agree to use an adequate method of contraception from the time of initiation of treatment through study participation and for 3 months after release from the study.
• Subject is able to give informed consent.

Exclusion Criteria:

• Any prior or current systemic pharmacotherapy for HCC (cytotoxic, targeted or biologic). (Note: TACE is not considered to be systemic pharmacotherapy for the purpose of this study).
• Subject has an absolute contraindication to receiving CT contrast media. (Note: Subjects with a history of minor contrast reactions may be pre-medicated prior to contrast administration in accordance with local or institutional practice).
• Subject has Child-Pugh Class C hepatic impairment.
• Subject has received an investigational drug within 30 days of enrolment in the study.
• Females of childbearing potential unless using adequate contraception.
• Pregnant or lactating females.
• Major variceal bleeding in the last 30 days.
• Subjects with a known history of human immunodeficiency virus (HIV) infection.