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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: NGR-hTNF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: NGR-hTNF<br>* iv q3W or q1W 0.8 mcg/sqm NGR-hTNF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antitumour activity defined as progression free survival (PFS) |  | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NGR-hTNF, Hepatocellular Carcinoma (HCC)