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

NCT ID: NCT00484211

Last Updated: 2014-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2013-04-30

Brief 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 criteria

Detailed 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Group Type: EXPERIMENTAL

NGR-hTNF

Intervention Type: DRUG

iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Interventions

NGR-hTNF

iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AGC Biologics S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Lambiase, MD

Role: STUDY_DIRECTOR

AGC Biologics S.p.A.

Locations

Fondazione San Raffaele del Monte Tabor

Milan, Milan, Italy

Istituto Europeo Oncologico

Milan, Milan, Italy

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Countries

Italy

References

Santoro A, Pressiani T, Citterio G, Rossoni G, Donadoni G, Pozzi F, Rimassa L, Personeni N, Bozzarelli S, Rossoni G, Colombi S, De Braud FG, Caligaris-Cappio F, Lambiase A, Bordignon C. Activity and safety of NGR-hTNF, a selective vascular-targeting agent, in previously treated patients with advanced hepatocellular carcinoma. Br J Cancer. 2010 Sep 7;103(6):837-44. doi: 10.1038/sj.bjc.6605858. Epub 2010 Aug 17.

Reference Type: RESULT

PMID: 20717115 (View on PubMed)

Other Identifiers

2006-005696-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NGR008

Identifier Type: -

Identifier Source: org_study_id