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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT00484211
First received: June 7, 2007
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Drug: NGR-hTNF
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by MolMed S.p.A.:

Primary Outcome Measures:
  • Antitumour activity defined as progression free survival (PFS) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor growth control rate (TGCR) according to WHO criteria [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Pharmacokinetics in patients treated with weekly schedule [ Time Frame: during treatment ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
  • Overall survival (OS) [ Time Frame: During the treatment and during the follow-up ] [ Designated as safety issue: No ]
  • Experimental imaging study (DCE-MRI) [ Time Frame: During the treatment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: December 2006
Study Completion Date: April 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NGR-hTNF
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484211

Locations
Italy
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.
Investigators
Study Director: Antonio Lambiase, MD MolMed S.p.A.
  More Information

Publications:
Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00484211     History of Changes
Other Study ID Numbers: NGR008, 2006-005696-18
Study First Received: June 7, 2007
Last Updated: May 29, 2014
Health Authority: Italy: Ethics Committee

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

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

ClinicalTrials.gov processed this record on July 23, 2014