Clinical Trial Details

NCT ID: NCT01358084
Date Last Changed: April 1, 2015

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

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Recruitment Details

Phase
2
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
MolMed S.p.A.
Duration
63 Months
Facility Type
N/A
Compensation

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 (15)

Country State City Zip Facility and Contact
Germany Thuringia Bad Berka 99437 Zentralklinik Bad Berka GmbH
Claus-Peter Schneider, MD

Claus-Peter Schneider, MD
Principal Investigator
Germany München-Gauting 82131 Asklepios Fachkliniken München-Gauting
Joachim von Pawel, MD

Joachim von Pawel, MD
Principal Investigator
Italy Alessandria Casale Monferrato 15033 Ospedale Santo Spirito
Alberto Muzio, MD

Alberto Muzio, MD
Principal Investigator
Italy Forlì-Cesena Meldola 47014 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST
Marco Angelo Burgio, MD

Marco Angelo Burgio, 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 Genoa 16132 IRCCS Azienda Ospedaliera Universitaria San Martino IST Istituto Nazionale per la Ricerca sul Cancro
Francesco Grossi, MD

Francesco Grossi, MD
Principal Investigator
Italy Genova 16149 Asl 3 genovese, Ospedale Villa Scassi
Manlio Mencoboni, MD

Manlio Mencoboni, MD
Principal Investigator
Italy Milano 20132 IRCCS Ospedale San Raffaele
Luca Gianni, MD

Luca Gianni, MD
Principal Investigator

Vanesa Gregorc, MD
Sub-Investigator
Italy Padova 35128 Istituto Oncologico Veneto
Adolfo Favaretto, MD

Adolfo Favaretto, MD
Principal Investigator
Italy Parma 43126 Azienda Ospedaliero-Universitaria di Parma
Marcello Tiseo, MD

Marcello Tiseo, MD
Principal Investigator
Italy Pavia 27100 IRCCS Policlinico S. Matteo
Camillo Porta, MD

Camillo Porta, MD
Principal Investigator
Italy Ravenna 48121 Azienda Unità Sanitaria locale di Ravenna
Claudio Dazzi, MD

Claudio Dazzi, MD
Principal Investigator
Italy Treviso 31100 Ospedale Ca' Foncello
Giovanni Rosti, MD

Giovanni Rosti, MD
Principal Investigator
Russian Federation Saint-Petersburg 197089 Saint Petersburg State Medical University n.a. I. P. Pavlov
Sergey Vladimirovich Orlov, MD

Sergey Vladimirovich Orlov, MD
Principal Investigator

Contact

Armando Santoro, MD
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