Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC)

AGC Biologics

Status and phase

Completed

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: NGR-hTNF

Study type

Interventional

Funder types

Industry

Identifiers

NCT00484211

2006-005696-18 (EudraCT Number)

NGR008

Details and patient eligibility

About

The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic hepatocellular carcinoma patients treated with NGR-hTNF as single agent.

Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria

Full description

This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic Hepatocellular Carcinoma (HCC) previously treated with no more than one systemic therapeutic regimen, that will be conducted using Simon's two-stage design method.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 CT documented
Adequate baseline bone marrow, hepatic and renal function, defined as follows:
- Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
- Bilirubin < 2 x ULN
- Transaminases < 3 x ULN
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
Patients must give written informed consent

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. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration