search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
NGR-hTNF
Sponsored by
AGC Biologics S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring NGR-hTNF, Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istituto Clinico Humanitas
  • Fondazione San Raffaele del Monte Tabor
  • Istituto Europeo Oncologico

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Antitumour activity defined as progression free survival (PFS)

Secondary Outcome Measures

Tumor growth control rate (TGCR) according to WHO criteria
Pharmacokinetics in patients treated with weekly schedule
Safety
Overall survival (OS)
Experimental imaging study (DCE-MRI)

Full Information

First Posted
June 7, 2007
Last Updated
May 29, 2014
Sponsor
AGC Biologics S.p.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT00484211
Brief Title
Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC)
Official Title
NGR008: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC) Previously Treated With no More Than One Systemic Therapeutic Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AGC Biologics S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
NGR-hTNF, Hepatocellular Carcinoma (HCC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NGR-hTNF
Intervention Description
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF
Primary Outcome Measure Information:
Title
Antitumour activity defined as progression free survival (PFS)
Time Frame
during the study
Secondary Outcome Measure Information:
Title
Tumor growth control rate (TGCR) according to WHO criteria
Time Frame
during the study
Title
Pharmacokinetics in patients treated with weekly schedule
Time Frame
during treatment
Title
Safety
Time Frame
during the study
Title
Overall survival (OS)
Time Frame
During the treatment and during the follow-up
Title
Experimental imaging study (DCE-MRI)
Time Frame
During the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Lambiase, MD
Organizational Affiliation
AGC Biologics S.p.A.
Official's Role
Study Director
Facility Information:
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milan
Country
Italy
Facility Name
Fondazione San Raffaele del Monte Tabor
City
Milan
Country
Italy
Facility Name
Istituto Europeo Oncologico
City
Milan
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20717115
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs