177
Participants
Start Date
May 30, 2022
Primary Completion Date
May 27, 2024
Study Completion Date
April 15, 2025
Irinotecan liposome injection
Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)
Irinotecan liposome injection
Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase)
Irinotecan liposome injection
Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 1 (Crossover Phase)
Irinotecan liposome injection
Onivyde 70 mg/m2 intravenously over 90 minutes on Cycle 1 Day 15 (Crossover Phase) and from cycle 2 onwards on Day 1 and Day 15 of every 28-day cycle (Extension Phase)
Folinic Acid
LV 400 mg/m2 intravenously over 30 minutes, on Day 1 and Day 15 of every 28-day cycle
5-Fluorouracil
5-FU 2,400 mg/m2 intravenously over 46 hours, on Day 1 and Day 15 every 28-day cycle
Asklepios Klinik Altona, Hamburg
Hospital Universitario Ramon Y Cajal, Madrid
Hospital Universitario Quiron Salud, Madrid
Caritasklinikum Saarbruecken St Theresia, Saarbrücken
Centre Hospitalier Lyon Sud, Pierre-Bénite
Flinders Medical Centre, Bedford Park
Peninsula and Southeast Oncology - Frankston Private Hospital, Frankston
Institut BERGONIE Centre de Lutte Contre le Cancer, Bordeaux
Centre GEORGES FRANÇOIS LECLERC, Dijon
Chu La Miletrie, Poitiers
Centre PAUL STRAUSS, Strasbourg
University Hospital Dresden, Dresden
Mav Korhaz Es Kozponti Rendelointezet, Budapest
Semmelweis Egyetem, Budapest
Clinexpert Kft Fázis I. Vizsgálóhely, Gyöngyös
AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna, Bologna
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola
Instituto Europeo di Oncologia, Milan
Azienda Ospedaliero Universitaria Modena, Modena
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I, Torrette
Ospedale Borgo Roma, Verona
Hospital Senhora Da Oliveira - Hso-Epe, Guimarães
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria, Lisbon
Fundacao Champalimaud, Lisbon
Chuac Hospital Teresa Herrera, A Coruña
Hospital Universitario de Badajoz, Badajoz
Hospital Universitario Vall D Hebron, Barcelona
Instituto Oncologico Dr Rosell Lor, Barcelona
Hospital Universitari de Lleida Arnaud de Villanova, Lleida
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario La Paz, Madrid
Md Anserson Cancer Center, Madrid
Clinica Universidad de Navarra, Pamplona
Hospital Universitario Marques de Valdecilla, Santander
Complejo Hospitalario Universitario de Santiago de Compostela -Chus, Santiago de Compostela
Lead Sponsor
Ipsen
INDUSTRY