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Phase II randomized study of nemorubicin hydrochloride (PNU-152243A) or doxorubicin administered in adult patients with unresectable hepatocellular carcinoma - ND

Conditions
MedDRA version: 9.1Level: LLTClassification code 10019698Term: Hepatic neoplasm malignant non-resectable
nresectable hepatocellular carcinoma
Registration Number
EUCTR2006-000798-31-IT
Lead Sponsor
ERVIANO MEDICAL SCIENCES
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
95
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 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 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

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 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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Main Objective: Evaluation of the survival rate at 7 months;Primary end point(s): Evaluation of the survival rate at 7 months;Secondary Objective: Evaluation of the antitumor efficacy in terms of response rate and frequency of stable disease lasting 3 or more 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.
Secondary Outcome Measures
NameTimeMethod
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