E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Unresectable Hepatocellular Carcinoma |
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MedDRA Classification |
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 |
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E.2.2 | Secondary objectives of the trial |
- Safety - Radiological response as measured by Choi criteria - Overall survival - Progression free survival - Overall disease control rate - Overall response rate - Quality of Life - Number of hepatic decompensations
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Patients with the clinical stage C according to the Barcelona Clinic Liver Cancer Staging System 2 Patients with the clinical stage B according to the Barcelona Clinic Liver Cancer Staging System who have a contraindication for transarterial chemoembolisation (TACE) or who are non-responders to TACE 3) Age > 18 years. 4) ECOG Performance Status of 0-2 5) Life expectancy of at least 12 weeks. 6) Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions must be measured by CT-scan or MRI 7) Child Pugh A or B (max. 9 points) 8) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior start of therapy: Hemoglobin > 8.5 g/dl Absolute neutrophil count (ANC) >1,500/mm3 Platelet count 60,000/μl Total bilirubin < 5 mg/dl ALT and AST < 5 x upper limit of normal Normotest >40% [Patients who are being therapeutically anticoagulated with an agent such as coumarin-derivative or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] Serum creatinine < 1.5 x upper limit of normal. 9) Signed and dated informed consent at the beginning of the study.
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E.4 | Principal exclusion criteria |
1) Patients with the clinical stage A or D according to the Barcelona Clinic Liver Cancer Staging System 2) Patients with the clinical stage B according to the Barcelona Clinic Liver Cancer Staging System, who have no contraindication for TACE or who do respond to TACE therapy. 3) History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiering anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. 4) Large oesophageal varices (>5 mm diameter) without prophylactic band ligation 5) History of HIV infection 6) Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) 7) Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) 8) History of organ allograft. The organ allograft may be allowed as protocol specific. 9) Patients undergoing renal dialysis 10) Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry. 11) Patients unable to swallow oral medication 12) Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
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E.5 End points |
E.5.1 | Primary end point(s) |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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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last patient reaching the primary endpoint |
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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 | |
E.8.9.1 | In the Member State concerned days | |