Overview
Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Status:
Completed
Completed
Trial end date:
2013-04-01
2013-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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 criteriaPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
AGC Biologics S.p.A.
MolMed S.p.A.
Criteria
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