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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Antitumour activity defined as progression free survival (PFS)

Outcome Time Frame:

during the study

Safety Issue:

No

Principal Investigator

Antonio Lambiase, MD

Investigator Role:

Study Director

Investigator Affiliation:

MolMed S.p.A.

Authority:

Italy: Ethics Committee

Study ID:

NGR008

NCT ID:

NCT00484211

Start Date:

December 2006

Completion Date:

June 2013

Related Keywords:

  • Hepatocellular Carcinoma
  • NGR-hTNF, Hepatocellular Carcinoma (HCC)
  • Carcinoma
  • Carcinoma, Hepatocellular

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