Spots Global Cancer Trial Database for Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
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Trial Identification
Brief Title: Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM)
Official Title: A Randomized, Open-label, Active-controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients With Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Platinum/Pemetrexed-based Chemotherapy
Study ID: NCT02610140
Conditions
Study Description
Brief Summary: The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM). 210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine. Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required. Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses. Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, La Jolla, California, United States
, Aurora, Colorado, United States
, Norwich, Connecticut, United States
, Tampa, Florida, United States
, Chicago, Illinois, United States
, Chicago, Illinois, United States
, New Orleans, Louisiana, United States
, Bethesda, Maryland, United States
, Rochester, Minnesota, United States
, Buffalo, New York, United States
, New York, New York, United States
, Durham, North Carolina, United States
, Cleveland, Ohio, United States
, Dallas, Texas, United States
, Houston, Texas, United States
, St Leonards, New South Wales, Australia
, Woolloogabba, Queensland, Australia
, Adelaide, South Australia, Australia
, Richmond, Victoria, Australia
, Nedlands, Western Australia, Australia
, Bruxelles - Brussel, , Belgium
, Edegem, , Belgium
, Gent, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
, Sint-niklaas, , Belgium
, Calgary, Alberta, Canada
, Hamilton, Ontario, Canada
, London, Ontario, Canada
, Toronto, Ontario, Canada
, Helsinki, , Finland
, Turku, , Finland
, Vaasa, , Finland
, Bordeaux Cedex, , France
, Caen Cedex 5, , France
, Lille Cedex, , France
, Marseille, , France
, Paris, , France
, Paris, , France
, Pierre Benite, , France
, Pordenone, Friuli-Venezia Giulia, Italy
, Bergamo, Lombardia, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Monza Brianza, Lombardia, Italy
, Torino, Piemonte, Italy
, Siena, Toscana, Italy
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Amsterdam, , Netherlands
, Rotterdam, , Netherlands
, Gdansk, , Poland
, Krakow, , Poland
, Krakow, , Poland
, Szczecin, , Poland
, Omsk, , Russian Federation
, Yekaterinburg, , Russian Federation
, A Coruña, , Spain
, Alicante, , Spain
, Barcelona, , Spain
, Madrid, , Spain
, Málaga, , Spain
, Adana, , Turkey
, Ankara, , Turkey
, Eskisehir, , Turkey
, Istanbul, , Turkey
, Malatya, , Turkey
, Yenimahalle, , Turkey
, Plymouth, Devon, United Kingdom
, Maidstone, Kent, United Kingdom
, Leicester, Leicestershire, United Kingdom
, Glasgow, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Newcastle Upon Tyne, , United Kingdom
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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