post-resection hepatocellular carcinoma Carcinoma hepatocelular post-resección MedDRA version: 9.1 Level: LLT Classification code 10019830 Term: Hepatocellular carcinoma resectable
Conditions
Interventions
Product Code: PI-88
Pharmaceutical Form: Powder for solution for injection
CAS Number: 185077-23-0
Current Sponsor code: PI-88
Other descriptive name: Sulfonated monophosphorylated mannose oligosaccha
Sponsors
Progen Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically-proven hepatocellular carcinoma with curative resection performed within 4-6 weeks prior to randomisation and confirmed by negative follow-up chest and abdominal CT scans and abdominal MRI scan 2. Age =18 years 3. Written, signed and dated informed consent to participate in study 4. Able and willing to meet all protocol-required treatments, investigations and visits. This must include the ability for the subject to comply with daily self-administration of a subcutaneous injection, or reliable means for injections to be administered by a dependable third party such as a relative or caregiver. 5. ECOG performance status 0 to 2 6. Child Pugh classification A or B 7. ALT & AST within 2.5 times upper limit of normal (ULN) 8. Total bilirubin within 1.5 times upper limit of normal (ULN) 9. Platelet count = 100 x 109 cells / litre 10. PT-INR less than 1.3 times upper limit of normal (ULN) 11. aPTT within normal range 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any evidence of tumour metastasis or co-existing malignant disease 2. Any prior history of malignant disease, except:- (a) Non-invasive, non-melanomatous skin cancer (b) Treated in-situ cancer of the cervix 3. Any prior recurrence of HCC or any liver resection prior to the most recent procedure 4. Clinically significant non-malignant disease. Subjects who have experienced post-operative complications of liver resection may be enrolled providing that such complications are fully resolved at the time of screening. 5. Significant laboratory abnormalities including, but not limited to:- (a) Total white blood cell (WBC) count 1.5 times upper limit of normal (ULN) 6. History of prior HCC therapy including, but not limited to, radiofrequency ablation, chemoembolization, chemotherapy, radiotherapy, molecular targeting agents, vaccines, liver transplantation or surgical resection prior to the most recent hepatectomy, at any time prior to screening 7. History of allergy and / or hypersensitivity and / or other clinically significant adverse drug reaction to heparin or other anti-coagulant agents 8. History of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies, or laboratory evidence of anti-heparin antibodies, or any previous history of having tested positive to anti-heparin antibodies 9. Concomitant use of aspirin (>150mg / day), non-steroidal anti-inflammatory drugs (except COX-2 selective inhibitors), vitamin K antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomisation, or other anti-platelet drugs (e.g. abciximab, clopidogrel, dipyridamole, ticlopidine and tirofiban). Low-dose aspirin (=150mg / day) and low-dose prophylactic vitamin K antagonists (e.g. warfarin =1mg / day) are permitted as concomitant medications. 10. History of allergic, anaphylactic or other significant adverse reaction to radiographic contrast media (iodinated or noniodinated). 11. Known seropositivity to the human immunodeficiency virus (HIV). 12. Women who are pregnant or breast-feeding, or women of child-bearing potential who are unable or unwilling to practice a highly effective means of contraception 13. Active substance abuse, including alcohol, which, in the opinion of the investigator, risks impairing the ability of the subject to comply with the protocol 14. Current participation in any other clinical study or research project which involves administration of a pharmaceutical product or experimental treatment, or which involves protocol-specified laboratory tests, imaging studies or other investigations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the disease-free survival (DFS) for subjects treated with PI-88 versus placebo.;Secondary Objective: • Overall survival for subjects treated with PI-88 versus placebo • Time to recurrence for subjects treated with PI-88 versus placebo • Safety and tolerability of PI-88 • Impact on quality of life of PI-88 when compared to placebo • Compliance of subjects with self-administration of PI-88;Primary end point(s): Efficacy Parameters: • Disease-free survival (DFS) • Overall survival (OS) • Time to recurrence (TTR) • SF-36 quality of life instrument Safety Parameters: • Physical examination, including vital signs • Adverse event monitoring • Blood chemistry, haematology, liver function, clotting function and urinalysis • Anti-heparin antibodies (in subjects who develop significant thrombocytopaenia) • Treatment compliance Other Parameters: In a cohort of 40-50 subjects at 4-8 selected sites, additional pharmacokinetic and pharmacodynamic measurements will be conducted at two scheduled study visits. | — |
Countries
Italy, Spain
Outcome results
None listed