Hepatocellular Carcinoma MedDRA version: 8.1 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable
Conditions
Interventions
Product Name: Nemorubicin hydrochloride
Product Code: PNU-152243A
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Nemorubicin hydrochloride
CAS Number: 108943-08-4
Current S
Sponsors
Nerviano Medical Sciences S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 - Presence of unresectable HCC, not amenable to radiofrequency ablation (or other ablative techniques), microscopically confirmed HCC, either newly diagnosed or relapsing after prior surgery or other prior ablative techniques (e.g., embolization, radiofrequency, percuteneous ethanol injection [PEI], provided that the lesion(s) present at study entry are vascularized through hepatic artery). If biopsy is contraindicated, the following will be accepted as evidence of HCC: a computerized tomography (CT) or magnetic resonance imaging (MRI) and an AFP level of >/= 400 ng/mL or two separate imaging assessments, independently of AFP value. 2 - Tumor staging at study entry CLIP 0 or 1 or 2, no Child-Pugh stage C and no portal vein thrombosis 3 - At least one bidimensionally measurable lesion that is >/= 2 cm in at least 1 diameter with conventional CT scan or MRI or >/= 1 cm in at least 1 diameter with spiral CT scan 4 - Resolution of all acute toxic effects of any prior surgical procedure or other ablative techniques to NCI CTC Grade /= 18 yrs of age and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 - Histologic classification of HCC, fibrolamellar variant 2 - Child-Pugh stage C 3 - Current enrollment in another clinical trial 4 - Administration of any prior systemic treatment or intra-arterial anticancer therapy for HCC (eg, chemoembolization, chemotherapy, antibody therapy, immunotherapy, hormonal therapy, gene therapy, vaccine therapy, cytokine therapy, or experimental agents) 5 - Prior liver transplantation 6 - Administration of any prior radiotherapy to treat the tumor lesion(s) present at study entry 7 - Extrahepatic metastatic disease including known brain or leptomeningeal disease (baseline CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system metastases) 8 - Patients with vascular invasion 9 - Complete obstruction of the portal vein as documented by angiography or CT or MRI scans 10 - Presence of clinically detectable ascites or pleural effusions 11 - Symptomatic ulceration of the gastric or duodenal mucosa /= 2 years 15 - Any prior history of symptomatic congestive heart failure 16 - Any of the following in the past within the last year: myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event 17 - Irreversible cardiac arrhythmias requiring permanent medication or uncontrolled arterial hypertension (arterial pressure >/= 200/110 mmHg) 18 - Active infection other than chronic active hepatitis. Patients with known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness are not eligible 19 - Pregnancy or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the treatment period and in the following 90 days after the end of the treatment. Male patients must be surgically sterile or must agree to use effective contraception during the treatment period and in the following 180 days after the end of the treatment. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate 20 - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the survival rate at 7 months;Primary end point(s): Survival at 7 months: the survival time is defined as the time from the date of enrolment to the date of death. Patients known to be alive at >/= 7 months will be considered as successes in the primary efficacy analysis.;Secondary Objective: Evaluation of the antitumor efficacy in terms of response rate (RR, i.e. the proportion of patients with confirmed objective tumor response [CR or PR], or tumor downstaging, relative to the number of patients evaluable for efficacy assessment) and frequency of stable disease lasting >/= 3 months. Evaluation of tumor response characteristics (including duration of response, duration of stable disease, progression free survival [PFS], and changes in alpha-fetoprotein [AFP] tumor marker levels). Evaluation of overall survival. Evaluation of safety. Evaluation of the CYP3A4 activity by means of quinine test | — |
Countries
Germany, Italy
Outcome results
None listed