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Brief Title: Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM)
Official Title: A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma
Study ID: NCT02357147
Brief Summary: This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in combination with pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma (MPM) who have not received prior systemic therapy. Per a business decision made by the Sponsor, participants who were randomized to amatuximab and were still on active treatment at the time of the protocol amendment may have consented to continue to receive weekly treatment with amatuximab until disease progression or intolerable toxicity at the discretion of the principal investigator. Participants randomized to placebo or who were in follow-up at the time of the amendment have been discontinued from the study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, La Jolla, California, United States
, Newark, Delaware, United States
, Bethesda, Maryland, United States
, Rochester, Minnesota, United States
, Philadelphia, Pennsylvania, United States
, Dallas, Texas, United States
, Spokane, Washington, United States
, Camperdown, New South Wales, Australia
, Auchenflower, Queensland, Australia
, Richmond, Victoria, Australia
, Perth, Western Australia, Australia
, Caen, , France
, Creteil, , France
, La Tronche, , France
, Lille, , France
, Lyon Cedex, , France
, Marseille, , France
, Rennes, , France
, Toulouse, , France
, Berlin, , Germany
, Esslingen, , Germany
, Frankfurt am Main, , Germany
, Gauting, , Germany
, Hamburg, , Germany
, Hanover, , Germany
, Löwenstein, , Germany
, Ulm, , Germany
, Wöhrendamm, , Germany
, Rozzano, Milano, Italy
, Pisa, Paradisa 2, Italy
, Alessandria, , Italy
, Aviano, , Italy
, Bari, , Italy
, Bergamo, , Italy
, Genoa, , Italy
, Genova, , Italy
, Monza, , Italy
, Orbassano, , Italy
, Parma, , Italy
, Maidstone, Kent, United Kingdom
, Dundee, , United Kingdom
, Hereford, , United Kingdom
, Leicester, , United Kingdom
, London, , United Kingdom
, Middlesex, , United Kingdom
, Preston, , United Kingdom
, Southampton, , United Kingdom
, Swindon, , United Kingdom
, Taunton, , United Kingdom