63
Participants
Start Date
September 7, 2016
Primary Completion Date
June 27, 2018
Study Completion Date
August 5, 2019
Anetumab ravtansine (BAY94-9343)
Anetumab ravtansine given IV On Day 1 of each 21-day treatment cycle Part 1: Cycle 1 Day 1: 6.5 mg/kg of body weight (BW) Cycle 2 Day 1: 0.6 mg/kg BW Part 2: Cycle 1 Day 1: 6.5 mg/kg BW Cycle 2 Day 1: 6.5 mg/kg BW (planned dose) Continuous treatment: Cycles ≥3 Day 1: 6.5 mg/kg BW once every 3 weeks (Q3W)
Itraconazole
Itraconazole 100 mg oral capsules given by mouth Cycle 1 (Day 18): 200 mg twice daily (BID) (Days 19 - 21): 200 mg once daily (QD) Cycle 2 (Days 1-8): 200 mg QD 12 days in total (Part 1 or Part 2)
CU Saint-Luc/UZ St-Luc, Bruxelles - Brussel
Blacktown Cancer & Haematology Centre, Blacktown
Epworth HealthCare, Richmond
UZ Gent, Ghent
Hôpital de la Timone - Marseille, Marseille
Centre Georges Francois Leclerc Dijon, Dijon
Fundacion Jimenez Diaz (Clinica de la Concepcion), Madrid
Hospital Virgen de la Victoria, Málaga
Henry Ford Health System, Detroit
Washington University School of Medicine, St Louis
Mary Crowley Medical Research Center, Dallas
UCLA-Santa Monica Medical Center, Santa Monica
Hôpital Henri Mondor, Créteil
University Hospitals Cleveland Medical Center, Cleveland
Nederlands Kanker Instituut, Amsterdam
VUmc, Amsterdam
Universitair Medisch Centrum St. Radboud, Nijmegen
Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona
Lead Sponsor
Bayer
INDUSTRY