Spots Global Cancer Trial Database for Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
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Trial Identification
Brief Title: Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
Official Title: Phase 1b Multi-indication Study of Anetumab Ravtansine (BAY94-9343) in Patients With Mesothelin Expressing Advanced or Recurrent Malignancies
Study ID: NCT03102320
Conditions
Study Description
Brief Summary: The key purpose of the main part of the study is to assess efficacy and safety of anetumab ravtansine as monotherapy or combination therapy for mesothelin expressing advanced solid tumors. The main purpose of the safety lead-in (dose-finding) part of the study is to determine the safety and tolerability of anetumab ravtansine in combination with cisplatin and in combination with gemcitabine, and to determine the MTD of anetumab ravtansine in combination with cisplatin for mesothelin expressing advanced cholangiocarcinoma and in combination with gemcitabine for mesothelin expressing advanced adenocarcinoma of the pancreas. Patients will receive anetumab ravtansine every three weeks in monotherapy for most indications. In cholangiocarinoma and adenocarinoma of the pancreas, 3-weekly anetumab ravtansine is administered in combination with cisplatin or gemcitabine respectively (both administered in a 2 week on / 1 week off schedule). Treatment will continue until disease progression or until another criterion for withdrawal is met. .Efficacy will be measured by evaluating the tumor's objective response rate. 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 will also be collected for mesothelin expression testing and biomarker analyses.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Hospital, Phoenix, Arizona, United States
University of Southern California, Los Angeles, California, United States
Stanford Health Care, Stanford, California, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Indiana University School of Medicine, Indianapolis, Indiana, United States
Ochsner Medical Center - New Orleans, New Orleans, Louisiana, United States
National Cancer Institute - Maryland, Bethesda, Maryland, United States
Barbara Ann Karmanos Cancer Institute, Farmington Hills, Michigan, United States
Mayo Clinic - Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Texas Oncology, PA, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Blacktown Cancer & Haematology Centre, Blacktown, New South Wales, Australia
Mid North Coast Cancer Institute, Coffs Harbour, New South Wales, Australia
Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia
Northern Cancer Institute, St Leonards, New South Wales, Australia
Flinders Medical Centre, Adelaide, South Australia, Australia
Epworth HealthCare, Richmond, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
St John of God Healthcare, Subiaco, Western Australia, Australia
Hôpital Erasme/Erasmus Ziekenhuis, Bruxelles - Brussel, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
CHU de Liège, Liege, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
Princess Margaret Cancer Centre - UHN, Toronto, Ontario, Canada
Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada
McGill University Health Center, Montreal, Quebec, Canada
Hopital Jean Minjoz, Besancon, , France
Hôpital Henri Mondor, Creteil, , France
Centre Oscar Lambret - Lille, Lille Cedex, , France
Centre Léon Bérard, Lyon Cedex, , France
C.H.U. Timone, Marseille, , France
Centre René Gauducheau, Nantes, , France
Centre Antoine Lacassagne, Nice Cedex 2, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Hôpital de la Milétrie, POITIERS cedex, , France
Hôpital Pontchaillou, Rennes Cedex, , France
Centre Eugène Marquis - Rennes Cedex, Rennes Cedex, , France
Institut Gustave Roussy, Villejuif Cedex, , France
A.O.U. di Bologna Policlinico S.Orsola Malpighi, Bologna, Emilia-Romagna, Italy
A.O.U. di Modena - Policlinico, Modena, Emilia-Romagna, Italy
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A., Milano, Lombardia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, Lombardia, Italy
A.O.U.I. Verona, Verona, Veneto, Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Nederlands Kanker Instituut, Amsterdam, , Netherlands
Maastricht UMC, Maastricht, , Netherlands
National University Hospital, Singapore, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Hospital Universitario Quirón de Madrid, Pozuelo de Alarcón, Madrid, Spain
Hospital del Mar, Barcelona, , Spain
Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona, , Spain
Hospital Clínic i Provincial de Barcelona, Barcelona, , Spain
Hospital General Universitario Gregorio Marañón | Oncología, Madrid, , Spain
Hospital Ramón y Cajal | Oncología, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Centro Integral Oncológico Clara Campal, Madrid, , Spain
Hospital Virgen de la Victoria, Málaga, , Spain
Kantonsspital Graubünden, Chur, Graubünden, Switzerland
Ospedale Regionale Bellinzona, Bellinzona, Ticino, Switzerland
Leicester Royal Infirmary, Leicester, Leicestershire, United Kingdom
Belfast City Hospital, Belfast, North Ireland, United Kingdom
Royal Marsden NHS Trust (Surrey), Sutton, Surrey, United Kingdom
Guy's Hospital, London, , United Kingdom
Royal Marsden Hospital (London), London, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Contact Details
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