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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484211
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : May 30, 2014
Information provided by (Responsible Party):
MolMed 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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: NGR-hTNF Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2006
Actual Primary Completion Date : November 2011
Actual Study Completion Date : April 2013

Arm Intervention/treatment
Experimental: A Drug: NGR-hTNF
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Primary Outcome Measures :
  1. Antitumour activity defined as progression free survival (PFS) [ Time Frame: during the study ]

Secondary Outcome Measures :
  1. Tumor growth control rate (TGCR) according to WHO criteria [ Time Frame: during the study ]
  2. Pharmacokinetics in patients treated with weekly schedule [ Time Frame: during treatment ]
  3. Safety [ Time Frame: during the study ]
  4. Overall survival (OS) [ Time Frame: During the treatment and during the follow-up ]
  5. Experimental imaging study (DCE-MRI) [ Time Frame: During the treatment ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484211

Istituto Clinico Humanitas
Rozzano, Milan, Italy
Fondazione San Raffaele del Monte Tabor
Milan, Italy
Istituto Europeo Oncologico
Milan, Italy
Sponsors and Collaborators
MolMed S.p.A.
Study Director: Antonio Lambiase, MD MolMed S.p.A.

Publications of Results:
Responsible Party: MolMed S.p.A. Identifier: NCT00484211     History of Changes
Other Study ID Numbers: NGR008
2006-005696-18 ( EudraCT Number )
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: May 30, 2014
Last Verified: May 2014

Keywords provided by MolMed S.p.A.:
NGR-hTNF, Hepatocellular Carcinoma (HCC)

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases