Spots Global Cancer Trial Database for Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole
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Trial Identification
Brief Title: Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole
Official Title: An Open Label, Phase I Study to Assess the Effect of Itraconazole (CYP3A4 and P-gp Inhibitor) on the Pharmacokinetics of Anetumab Ravtansine and to Assess the ECG Effects, Safety and Immunogenicity of Anetumab Ravtansine Given as a Single Agent and Together With Itraconazole in Subjects With Mesothelin-expressing Advanced Solid Cancers
Study ID: NCT02824042
Conditions
Study Description
Brief Summary: Characterize the safety, tolerability, ECG effects, pharmacokinetics and immunogenicity of anetumab ravtansine given as single agent and after inhibition of CYP3A4 and P-gp by concomitant administration of itraconazole in subjects with mesothelin-expressing advanced solid cancers
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA-Santa Monica Medical Center, Santa Monica, California, United States
Henry Ford Health System, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Mary Crowley Medical Research Center, Dallas, Texas, United States
Blacktown Cancer & Haematology Centre, Blacktown, New South Wales, Australia
Epworth HealthCare, Richmond, Victoria, Australia
CU Saint-Luc/UZ St-Luc, Bruxelles - Brussel, , Belgium
UZ Gent, Gent, , Belgium
Hôpital Henri Mondor, Creteil, , France
Centre Georges Francois Leclerc Dijon, Dijon, , France
Hôpital de la Timone - Marseille, Marseille, , France
Nederlands Kanker Instituut, Amsterdam, , Netherlands
VUmc, Amsterdam, , Netherlands
Universitair Medisch Centrum St. Radboud, Nijmegen, , Netherlands
Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona, , Spain
Fundacion Jimenez Diaz (Clinica de la Concepcion), Madrid, , Spain
Hospital Virgen de la Victoria, Málaga, , Spain
Contact Details
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR
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