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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484211
• Other study ID #: NGR008
• Secondary ID: 2006-005696-18
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2007
• Last updated: May 29, 2014
• Start date: December 2006
• Est. completion date: April 2013

Study information

• Verified date: May 2014
• Source: MolMed S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• NGR-hTNF
iv q3W or q1W 0.8 mcg/sqm NGR-hTNF

Locations

Country	Name	City	State
Italy	Fondazione San Raffaele del Monte Tabor	Milan
Italy	Istituto Europeo Oncologico	Milan
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
MolMed S.p.A.

Country where clinical trial is conducted

Italy, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumour activity defined as progression free survival (PFS)		during the study	No
Secondary	Tumor growth control rate (TGCR) according to WHO criteria		during the study	No
Secondary	Pharmacokinetics in patients treated with weekly schedule		during treatment	No
Secondary	Safety		during the study	Yes
Secondary	Overall survival (OS)		During the treatment and during the follow-up	No
Secondary	Experimental imaging study (DCE-MRI)		During the treatment	No