A PHASE 2 STUDY OF THE ANTI-TUMOUR ACTIVITY AND SAFETY OF PROLARIX™ IN HEPATOCELLULAR CARCINOMA (HCC)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Subject must be >=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). [Note: Subjects who have not yet had a tissue diagnosis may enter the Screening phase of the study if 1) their clinical presentation is considered highly suggestive of HCC by the principal investigator and 2) a tissue diagnosis is considered necessary for their management (subjects for whom a tissue diagnosis is not considered essential for their management should not be enrolled on this study). A tissue diagnosis must be obtained prior to the entry of any subject into the treatment phase of the study. Subjects for whom the principal investigator deems core biopsy to be indicated (as opposed to fine needle aspiration) will be requested to provide informed consent for a second pass biopsy (ie, in addition to the first pass biopsy for tissue diagnosis) for quantification of enzyme DT diaphorase (NQO2) activity. The second pass biopsy is optional and subjects refusing a second pass biopsy may be enrolled in the study and will be treated identically to those accepting the second pass biopsy]

Subject must have a measurable lesion by Response Evaluation Criteria in Solid Tumors (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 clearance is normal or calculated creatinine clearance is =60 mL/min).

Subject has adequate hepatic function (ie, bilirubin =2x upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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