Spots Global Cancer Trial Database for NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
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Trial Identification
Brief Title: NGR015: Study in Second Line for Patient With Advanced Malignant Pleural Mesothelioma Pretreated With Pemetrexed
Official Title: NGR015: Randomized Double-blind Phase III Study of NGR-hTNF Plus Best Investigator's Choice (BIC) Versus Placebo Plus BIC in Previously Treated Patients With Advanced Malignant Pleural Mesothelioma (MPM)
Study ID: NCT01098266
Conditions
Study Description
Brief Summary: The main objective of the trial is to document the efficacy of NGR-hTNF administered at low dose weekly in advanced Malignant Pleural Mesothelioma patients previously treated with a pemetrexed-based chemotherapy regimen.
Detailed Description: Currently, there are no regulatory-approved or widely accepted treatment options for patients failing a standard pemetrexed-based chemotherapy regimen. For this reason, the best supportive care (BSC) alone might be considered as a standard reference for a randomized phase III trial in this setting. However, single-agent chemotherapeutic agents (such as doxorubicin,gemcitabine, or vinorelbine) with a well-documented safety profile and antitumor activity are also used in clinical practice. Therefore, the best investigator's choice (BIC) between either best supportive care alone or combined with a few selected single-agent chemotherapy (including doxorubicin, gemcitabine, or vinorelbine) might be considered as an acceptable reference arm as well in this setting. The current phase III study aims to show a superior efficacy in terms of overall survival duration of NGR-hTNF 0.8 µg/mq weekly plus BIC versus placebo plus BIC in advanced MPM patients progressing after a standard pemetrexed-based chemotherapy.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Wilshire Oncology Medical Group, Corona, California, United States
City of Hope-Comprehensive Cancer Cente, Duarte, California, United States
H. Lee Moffitt ancer Center and Research Institute, Tampa, Florida, United States
Johns Hopkins, Baltimore, Maryland, United States
Columbia University, New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
UTsouthwestern medical center, Dallas, Texas, United States
Antwerp University Hospital, Edegem, Antwerp, Belgium
Centre Hospitalier Universitaire de Liège, Liège, Liege, Belgium
Institut Jules Bordet, Bruxelles, , Belgium
Cliniques Universitarie St. Luc, Bruxelles, , Belgium
Universitair Ziekenhuis, Gent, , Belgium
UAB - Alberta Cancer Board - Cross Cancer Institute, Edmonton, Alberta, Canada
University Health Network, Princess Margaret Hospital, Toronto, Ontario, Canada
National Cancer Institute, Cairo, , Egypt
Hôpitaux de Marseille Hôpital Nord, Marseille, , France
St James's Hospital, Dublin, , Ireland
Ospedale Santo Spirito, Casale Monferrato, Alessandria, Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano, Torino, Italy
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria, , Italy
Centro di Riferimento Oncologico, Aviano, , Italy
Ospedale Valduce, Como, , Italy
Azienda Ospedaliero-Universitaria Careggi di Firenze, Firenze, , Italy
Istituto Nazionale per la Ricerca sul Cancro, Genoa, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Meldola, , Italy
Fondazione San Raffaele del Monte Tabor, Milan, , Italy
Azienda Ospedaliera San Gerardo, Monza, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Azienda Ospedaliero Universitaria di Parma, Parma, , Italy
Azienda Unità Sanitaria locale di Ravenna, Ravenna, , Italy
A.O. Salvini Garbagnate, Ospedale di Rho, Rho, , Italy
Azienda Ospedaliera Senese, Siena, , Italy
St. Jansdal Hospital, Harderwijk, Gelderland, Netherlands
St. Antonius Hospital, Nieuwegein, Utrecht, Netherlands
Medical University of Gdansk, Gdansk, , Poland
Maria Sklodowska Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital Vall d'Hebron, Barcelona, , Spain
The University Hospital, Linkoping, , Sweden
Chest Clinic, Wythenshawe Hospital, Manchester, Greater Manchester, United Kingdom
Kent Oncology Centre Maidstone Hospital, Maidstone, Kent, United Kingdom
University Hospitals of Leicester, Leicester, Leicestershire, United Kingdom
Mount Vernon Cancer Centre, Middlesex, Northwood, United Kingdom
Edinburgh Cancer Centre, Western General Hospital, Edinburgh, Scotland, United Kingdom
The Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom
The Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Castle Hill Hospital, Cottingham, Yorkshire, United Kingdom
Guy's Hospital, London, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Contact Details
Name: Antonio Lambiase, MD
Affiliation: AGC Biologics S.p.A.
Role: STUDY_DIRECTOR
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