E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
post-resection hepatocellular carcinoma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019701 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to compare the disease-free survival (DFS) for subjects treated with PI-88 versus placebo |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOCINETICA/FARMACODINAMICA: Versione: Data: Titolo:solo centri selezionati (non in Italia) Obiettivi:
QUALITA DELLA VITA: Versione: Data: Titolo:SF-36 Questionnaire Obiettivi:
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E.3 | Principal 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 |
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E.4 | Principal 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 < 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 |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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I soggetti continueranno ad essere seguiti fino alla conclusione dello studio, che avverra` quando da tutta la popolazione in studio sara` stato totalizzato in totale, un minimo di 317 eventi di fallimento del trattamento. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |