78
Participants
Start Date
May 31, 2016
Primary Completion Date
August 1, 2019
Study Completion Date
April 9, 2020
Trifluridine/tipiracil hydrochloride (S 95005)
Film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride, given orally at the dose of 25 or 30 or 35 mg/m2/dose, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
Oxaliplatin
Concentrate for solution for infusion containing 5mg/ml of oxaliplatin, administered intravenously at the dose of 65 to 85 mg/m2, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
Bevacizumab
Concentrate for solution for infusion containing 25mg/ml of bevacizumab, administered intravenously at the dose of 5 mg/kg, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
Nivolumab
Concentrate for solution for infusion containing 10mg/ml of nivolumab, administered intravenously at the dose of 3 mg/kg, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly, Budapest
Semmelweis Egyetem I. sz. Belgyogyaszati Klinika - Klin. Farmakologiai Reszleg, Budapest
Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie, Vienna
"Orszagos Onkologiai Intezet B Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O.", Budapest
CHU de la Timone Hépato-Gastro-Entérologie - Oncology Digestive, Marseille
Universitätsklinikum Hamburg-Eppendorf II. Medizin. Klinik und Poliklinik (Onkologie, Hämatologie), Hamburg
Hospital Unviersitario Gregorio Marañon - Servicio de Oncología Médica, Madrid
H. Univ. Ramon y Cajal - Servicio de Oncología Medica, Madrid
H. Uni. Madrid Sanchinarro - CIOCC Servicio de Oncología, Madrid
Centre Eugène Marquis Service d'Oncologie Médicale, Rennes
Policlinico G.B. Rossi A.O.U.I. di Verona U.O.C. di Oncologia, Verona
Klinikum Wolfsburg Medizinische Klinik II, Wolfsburg
St. Josef-Hospital, Klinikum der Ruhr-Universität Bochum Abteilung für Hämatologie und Onkologie, Bochum
H. Clinico de Valencia INCLIVA - Departamento de Hematologia y Oncologia Medica 8ª planta, Valencia
Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology, Meldola
Hôpital Saint-Antoine Service d'Oncologie Médicale, Paris
La Pitié Salpêtrière Centre Investigation clinique Paris Est, Paris
Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III, München
Universitätsklinikum Ulm Zentrum für Innere Medizin, Klinik für Innere Medizin I, Ulm
Institut Gustave Roussy DITEP, Villejuif
ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica, Catania
ICO Badalona. H. Germans Trials y Pujol - Servicio de Oncología médica, Badalona
H. Valle de Hebrón - Servicio de Oncología - (VHIR), Barcelona
Christie Hospital NHS Foundation Trust GI & Endocrine, Manchester
ADIR, a Servier Group company
INDUSTRY
Institut de Recherches Internationales Servier
OTHER