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Clinical Trial Details

Overview

Research Study Summary

A Phase 2 clinical study for patients with Advanced Malignant Pleural Mesothelioma

Research Study Title

NGR019: Randomized Double-blind Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma (MPM)

Purpose

The main objective of the trial is to document the efficacy of NGR-hTNF administered as maintenance treatment at 0.8 µg/m2 weekly in advanced malignant pleural mesothelioma

To Learn more
Phase

2

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

MolMed S.p.A.

Duration

27 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • Age ≥ 18 years

  • Histologically or cytological confirmed malignant pleural mesothelioma of any of the following subtype: epithelial, sarcomatoid, mixed, or unknown

  • Patients with non-progressive disease after six cycles of first-line, pemetrexed-based regimen administered for advanced or metastatic disease

  • Good clinical conditions

  • Adequate baseline bone marrow, hepatic and renal function

  • Measurable or non-measurable disease according to malignant pleural mesothelioma-modified RECIST criteria

  • Patients may have had prior therapy providing the following conditions are met:

  • Surgery: wash-out period of 14 days

  • Radiation therapy: wash-out period of 28 days

  • Chemotherapy: wash-out period of 21 days

Exclusion Criteria:

  • Patients must not receive any other investigational agents while on study

  • Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication

  • Uncontrolled hypertension

  • QTc interval (congenital or acquired) > 450 ms

  • History or evidence upon physical examination of Central Nervous System disease unless adequately treated

  • 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.

Site Locations (6)

Country State City Zip Facility and Contact
Italy Alessandria Casale Monferrato 15033 Ospedale Santo Spirito
Mario Botta, MD

Mario Botta, MD
Principal Investigator
Italy Milan Rozzano 20089 Istituto Clinico Humanitas

Armando Santoro, MD
Principal Investigator

Paolo Zucali, MD
Sub-Investigator
Italy Alessandria 15121 Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Federica Grosso, MD

Federica Grosso, MD
Principal Investigator
Italy Genova 16149 Asl 3 genovese, Ospedale Villa Scassi
Manlio Mencoboni, MD

Manlio Mencoboni, MD
Principal Investigator
Italy Pavia 27100 IRCCS Policlinico S. Matteo
Camillo Porta, MD

Camillo Porta, MD
Principal Investigator
Italy Treviso 31100 Ospedale Ca' Foncello
Giovanni Rosti, MD

Giovanni Rosti, MD
Principal Investigator

Contact

Armando Santoro, MD
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NCT ID: NCT01358084

Date Last Changed: January 28, 2013

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