A Prospective, Randomised, Double-blind, Placebo-controlled, Parallel-group, International Multicentre Phase III Trial of PI-88 in the Adjuvant Treatment of Post-resection Hepatocellular Carcinoma (PATHWAY) - PATHWAY
- Conditions
- post-resection hepatocellular carcinomaMedDRA version: 6.1Level: PTClassification code 10019701
- Registration Number
- EUCTR2007-005011-25-IT
- Lead Sponsor
- PROGEN PHARMACEUTICALS LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
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
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 < 2.3 x 109 / litre (<2,300 /mm3) (b) Total neutrophil count < 1.5 x 109 / litre (1,500 /mm3) (c) Serum creatinine > 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 See protocol for others
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The following efficacy measures will be employed in this study:- Disease-free survival (DFS) Overall survival (OS) Time to recurrence (TTR) SF-36 quality of life instrument;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
- Secondary Outcome Measures
Name Time Method