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

Phase 2

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: NGR-hTNF

• Registration Number: NCT00484211
• Lead Sponsor: AGC Biologics S.p.A.

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-06-07
• Study First Submitted QC: 2007-06-07
• Study First Posted: 2007-06-08
• Primary Completion: 2011-11
• Study Completion: 2013-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	NGR-hTNF	-

Primary Outcome Measures

Name	Time	Method
Antitumour activity defined as progression free survival (PFS)	during the study

Secondary Outcome Measures

Name	Time	Method
Tumor growth control rate (TGCR) according to WHO criteria	during the study
Pharmacokinetics in patients treated with weekly schedule	during treatment
Safety	during the study
Overall survival (OS)	During the treatment and during the follow-up
Experimental imaging study (DCE-MRI)	During the treatment

Trial Locations

Locations (3)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milan, Italy

Fondazione San Raffaele del Monte Tabor; 🇮🇹 Milan, Italy

Istituto Europeo Oncologico; 🇮🇹 Milan, Italy