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A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)

Phase 2
18 Years
Not Enrolling
Hepatocellular Carcinoma

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Trial Information

A Phase 2 Study of the Anti-tumour Activity and Safety of Prolarix™ in Hepatocellular Carcinoma (HCC)

The primary objective of this study is to evaluate the anti-tumour effects of treatment with
Prolarix in subjects with advanced HCC (Child-Pugh A and B only).

All subjects will receive an IV infusion of Prolarix once every 21 days until disease
progression is observed.

Subjects will have CT scans for tumour measurements before starting treatment with Prolarix
and every 6 weeks until disease progression.

Subjects will undergo evaluation for safety (adverse events, vital signs, clinical
laboratory measurements, weight, ECG) every 21 days until disease progression.

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

- 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
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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall best tumor response rate (proportion of subjects with complete or partial response) as defined by modified RECIST

Outcome Time Frame:

Every 6 weeks until progression

Safety Issue:


Principal Investigator

Claire Daugherty, MS

Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

September 2008

Completion Date:

August 2009

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatocellular carcinoma
  • liver cancer
  • Prolarix
  • tretazicar
  • caricotamide
  • Phase 2
  • tumor
  • chemotherapy
  • Carcinoma
  • Carcinoma, Hepatocellular