GR008 A phase II study of NGR-hTNF administered as single agent every 3 weeks in patients affected by advanced or metastatic hepatocellular carcinoma HCC previously treated with no more than one systemic therapeutic regimen - NGR008

• Conditions: Patients affected by advanced or metastatic hepatocellular carcinoma HCC previously treated with no more than one systemic therapeutic regimen; MedDRA version: 9.1Level: LLTClassification code 10055110Term: Hepatic cancer metastatic

• Registration Number: EUCTR2006-005696-18-IT
• Lead Sponsor: MOLMED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients 18 years affected by advanced or metastatic HCC previously treated with no more than one systemic therapeutic regimen Histologically confirmed HCC not amenable to curative surgery Child-Pugh scale class A ECOG Performance status 0 1 Patients in progression disease at study entry Adequate baseline bone marrow, hepatic and renal function, defined as follows Neutrophils 1.5 x 109/L and platelets 100 x 109/L; Bilirubin 2 x ULN;Transaminases 3 x ULN;AST and/or ALT 2.5 x ULN in absence of liver metastasis;AST and/or ALT 5 x ULN in presence of liver metastasis Absence of any conditions in which hypervolaemia and its consequences e.g. increased stroke volume, elevated blood pressure or haemodilution could represent a risk for the patient reference appendix Technical data sheet human albumin Normal cardiac function and absence of uncontrolled hypertension written informed consent
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

Decompensated cirrhosis Child-Pugh score 7 Concurrent anticancer therapy Patients may not receive any other investigational agents while on study Clinical signs of CNS involvement Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol Pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified