Last updated on February 2018

Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors


Brief description of study

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 cholangiocarcinoma 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 may also be collected for review and biomarkers.

Clinical Study Identifier: NCT03102320

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Banner MD Anderson Cancer Center
Gilbert, AZ United States
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Mayo Clinic Hospital
Phoenix, AZ United States
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University of Southern California
Los Angeles, CA United States
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Stanford Health Care
Stanford, CA United States
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Yale Cancer Center
New Haven, CT United States
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Georgetown University Medical Center
Washington, D.C., United States
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Mayo Clinic - Jacksonville
Jacksonville, FL United States
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IU Health University Hospital
Indianapolis, IN United States
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Ochsner Medical Center - New Orleans
New Orleans, LA United States
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National Cancer Institute
Bethesda, MD United States
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University of Michigan Health System
Ann Arbor, MI United States
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Barbara Ann Karmanos Cancer Institute
Farmington Hills, MI United States
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Mayo Clinic - Rochester
Rochester, MN United States
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Washington University School of Medicine
Saint Louis, MO United States
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Vanderbilt University Medical Center
Nashville, TN United States
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Texas Oncology, PA
Dallas, TX United States
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University of Texas MD Anderson Cancer Center
Houston, TX United States
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University of Wisconsin - Madison
Madison, WI United States
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Blacktown Cancer & Haematology Centre
Blacktown, Australia
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Mid North Coast Cancer Institute
Coffs Harbour, Australia
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Kinghorn Cancer Centre
Darlinghurst, Australia
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Northern Cancer Institute
St Leonards, Australia
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Flinders Medical Centre
Adelaide, Australia
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Epworth HealthCare
Richmond, Australia
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Sir Charles Gairdner Hospital
Nedlands, Australia
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St John of God Healthcare
Subiaco, Australia
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GZA Ziekenhuizen
Wilrijk, Belgium
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H pital Erasme/Erasmus Ziekenhuis
Bruxelles - Brussel, Belgium
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UZ Antwerpen
Edegem, Belgium
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UZ Leuven Gasthuisberg
Leuven, Belgium
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CHU de Li ge
Liege, Belgium
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Cross Cancer Institute
Edmonton, AB Canada
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Sunnybrook Health Sciences Centre
Toronto, ON Canada
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Princess Margaret Cancer Centre
Toronto, ON Canada
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Sir Mortimer B. Davis Jewish General Hospital
Montreal, QC Canada
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Cedars Cancer Centre - MUHC
Montreal, QC Canada
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Hopital J. Minjoz - Besan on
Besancon, France
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H pital Henri Mondor - Cr teil
Creteil, France
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Centre Oscar Lambret - Lille
Lille Cedex, France
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Centre L on B rard
Lyon Cedex, France
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Institut Paoli Calmettes
Marseille Cedex 9, France
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C.H.U. Timone
Marseille, France
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Centre Ren Gauducheau
Nantes, France
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Centre Antoine Lacassagne - Nice
Nice Cedex 2, France
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Centre Hospitalier Lyon Sud - Pierre B nite
Pierre Benite, France
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Centre Hospitalier Universitaire - Poitiers
Poitiers Cedex, France
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H pital Pontchaillou - Rennes CHU
Rennes Cedex, France
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Centre Eug ne Marquis - Rennes Cedex
Rennes Cedex, France
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Institue Curie - Centre Ren Huguenin
Saint Cloud, France
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Institut Gustave Roussy - Villejuif
Villejuif Cedex, France
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Thoraxklinik-Heidelberg gGmbH
Heidelberg, Germany
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Stadt- und Landkreis Kliniken Heilbronn GmbH
Heilbronn, Germany
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Marienhospital
Stuttgart, Germany
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Klinikum der Universit t M nchen Innenstadt
München, Germany
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St dt. Klinikum M nchen
München, Germany
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Kliniken Nord und S d
Nürnberg, Germany
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Universit tsklinikum Essen
Essen, Germany
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Herne, Germany
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Universit tsklinikum K ln
Köln, Germany
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Kliniken der Stadt K ln - St dt. Krankenhaus K ln-Merheim
Köln, Germany
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Medizinische Fakult t Carl Gustav Carus
Dresden, Germany
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Universit tsklinikum Leipzig A R
Leipzig, Germany
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SRH Wald-Klinikum Gera gGmbH
Gera, Germany
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Evangelische Lungenklinik Berlin
Berlin, Germany
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A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Italy
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A.O.U. di Modena - Policlinico
Modena, Italy
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A.O. di Reggio Emilia
Reggio Emilia, Italy
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IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
Milano, Italy
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Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milano, Italy
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ASST Grande Ospedale Metropolitano Niguarda
Milano, Italy
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A.O.U. Integrata Verona
Verona, Italy
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Asan Medical Center
Seoul, Korea, Republic of
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Seoul National University Hospital
Seoul, Korea, Republic of
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Yonsei University College of Medicine
Seoul, Korea, Republic of
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Samsung Medical Center
Seoul, Korea, Republic of
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Nederlands Kanker Instituut
Amsterdam, Netherlands
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Erasmus Medisch Centrum
Rotterdam, Netherlands
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National University Hospital
Singapore, Singapore
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National Cancer Center
Singapore, Singapore
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Institut Catal d'Oncologia Hospitalet
L'Hospitalet de Llobregat, Spain
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Barcelona, Spain
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Pozuelo de Alarcón, Spain
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Hospital Universitario 12 de Octubre
Madrid, Spain
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Hospital General Universitario Gregorio Mara n
Madrid, Spain
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Centro Integral Oncol gico Clara Campal
Madrid, Spain
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Hospital Virgen de la Victoria
Málaga, Spain
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Kantonsspital Graub nden
Chur, Switzerland
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Ospedale Regionale Bellinzona
Bellinzona, Switzerland
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Leicester Royal Infirmary
Leicester, United Kingdom
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Belfast City Hospital
Belfast, United Kingdom
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Royal Marsden NHS Trust (Surrey)
Sutton, United Kingdom
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Uni. Hospitals Birmingham NHS Fountation Trust
Birmingham, United Kingdom
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Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
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Guy's Hospital
London, United Kingdom
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Royal Marsden Hospital (London)
London, United Kingdom
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University College London Hospitals
London, United Kingdom
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Christie Hospital
Manchester, United Kingdom
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Nottingham City Hospital
Nottingham, United Kingdom
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Southampton General Hospital
Southampton, United Kingdom
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Recruitment Status: Open


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