Phase 1b Multi-indication Study of Anetumab Ravtansine in Mesothelin Expressing Advanced Solid Tumors
NCT ID: NCT03102320
Last Updated: 2022-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
173 participants
INTERVENTIONAL
2017-05-26
2021-07-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cholangiocarcinoma
Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with cisplatin. Please note the study is no longer recruiting for the cholangiocarcinoma safety lead-in phase.
During the main study phase anetumab ravtansine will be administered at the determined MTD in combination with cisplatin. Please note the main study phase for cholangiocarcinoma will no longer be going ahead.
Cisplatin
Cisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles
Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
Adenocarcinoma of the pancreas
Safety lead-in phase will determine the MTD of anetumab ravtansine administered in combination with gemcitabine During the main study phase, anetumab ravtansine will be administered at the determined MTD in combination with gemcitabine
Gemcitabine
Gemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle
Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
Other solid tumors
(Non-small cell adenocarcinoma of the lung (NSCLC adenocarcinoma), Adenocarcinoma of the breast - triple negative (TNBC), Gastric adenocarcinoma including gastroesophageal junction (GEJ Cancer, Thymic carcinoma) During the main study phase, anetumab ravtansine will be administered at dose of 6.5 mg/kg in solid tumors
Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
Interventions
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Cisplatin
Cisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles
Gemcitabine
Gemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle
Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
Eligibility Criteria
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Inclusion Criteria
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (or for thymic carcinoma, at least one measurable lesion per International Thymic Malignancy Interest Group (ITMIG) modified RECIST 1.1 criteria
* Adequate bone marrow, liver, renal and coagulation function
* Left ventricular ejection fraction (LVEF) ≥ 50% of the lower limit of normal (LLN) according to local institutional ranges
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion Criteria
* Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
* Symptomatic Central nervous system (CNS) metastases and/or carcinomatous meningitis
* Contraindication to both CT and MRI contrast agents
* Active hepatitis B or C infection
* Pregnant or breast-feeding patients
18 Years
ALL
No
Sponsors
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ImmunoGen, Inc.
INDUSTRY
MorphoSys AG
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Locations
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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 D.C., 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
St 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
Liège, , 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
Besançon, , France
Hôpital Henri Mondor
Créteil, , France
Centre Oscar Lambret - Lille
Lille, , France
Centre Léon Bérard
Lyon, , France
C.H.U. Timone
Marseille, , France
Centre René Gauducheau
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hôpital de la Milétrie
Poitiers, , France
Hôpital Pontchaillou
Rennes, , France
Centre Eugène Marquis - Rennes Cedex
Rennes, , France
Institut Gustave Roussy
Villejuif, , 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.
Milan, Lombardy, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
A.O.U.I. Verona
Verona, Veneto, Italy
Nederlands Kanker Instituut
Amsterdam, , Netherlands
Maastricht UMC
Maastricht, , Netherlands
National University Hospital
Singapore, , Singapore
National Cancer Center Singapore
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
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
Ospedale Regionale Bellinzona
Bellinzona, Canton Ticino, Switzerland
Kantonsspital Graubünden
Chur, Kanton Graubünden, 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
Countries
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Related Links
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Click here to find results for studies related to Bayer products
Other Identifiers
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2016-004002-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15834
Identifier Type: -
Identifier Source: org_study_id
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