NCT00484211

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2006

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

4.9 years

First QC Date

June 7, 2007

Last Update Submit

May 29, 2014

Conditions

Hepatocellular Carcinoma

Keywords

NGR-hTNF, Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

  • Antitumour activity defined as progression free survival (PFS)

    during the study

Secondary Outcomes (5)

  • 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

Study Arms (1)

A

EXPERIMENTAL
Drug: NGR-hTNF

Interventions

NGR-hTNFDRUG

iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fondazione San Raffaele del Monte Tabor

Milan, Milan, Italy

Location

Istituto Europeo Oncologico

Milan, Milan, Italy

Location

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Location

Related Publications (1)

  • 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.

    PMID: 20717115RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

tumor necrosis factor-alpha, CNGRC fusion protein, human

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Antonio Lambiase, MD

    AGC Biologics S.p.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2007

First Posted

June 8, 2007

Study Start

December 1, 2006

Primary Completion

November 1, 2011

Study Completion

April 1, 2013

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

IT(3)