A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)
- 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
- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or
- 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
- 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
- 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.
- 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
- 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.