Status:
TERMINATED
Study of Anti-tumour Effects and Safety of Prolarix™ in Hepatocellular Carcinoma
Lead Sponsor:
BTG International Inc.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This an open-label study designed to evaluate the anti-tumour activity and safety of Prolarix in subjects with advanced hepatocellular carcinoma. Prolarix is a chemotherapy comprised of tretazicar as...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00746590
Start Date
September 1 2008
End Date
August 1 2009
Last Update
July 21 2022
Active Locations (1)
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1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200