Spots Global Cancer Trial Database for Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
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Trial Identification
Brief Title: Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial
Official Title: A Phase I/II Randomized Study to Determine the Maximum Tolerated Dose, Safety, Pharmacokinetics and Antitumor Activity of Debio 1143 Combined With Concurrent Chemo-Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
Study ID: NCT02022098
Study Description
Brief Summary: The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose. Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT. Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centre Hospitalier de Bretagne Sud - HÔPITAL DU SCORFF, Lorient, Bp 2233, France
C.H.U. Sud Amiens, Amiens, , France
Institut Sainte-Catherine, Avignon Cedex 9, , France
Centre Jean Perrin, Clermont-Ferrand Cedex 01, , France
CHU Grenoble, Grenoble, , France
CHD Vendée, La Roche Sur Yon cedex 9, , France
Centre Guillaume le Conquérant, Le Havre, , France
Centre Jean Bernard, Le Mans, , France
Hôpital Nord Franche-Comté, Montbéliard, , France
ICM - Val D'Aurelle, Montpellier, , France
Institut Curie, Paris, , France
Centre Henri Becquerel, Rouen, , France
Institut de Cancérologie de l'Ouest (ICO) René Gauducheau, Saint-Herblain, , France
Institut de Cancérologie Lucien Neuwirth (ICLN), Saint-Priest en Jarez, , France
Institut Claudius Regaud, Toulouse, , France
L'Institut de Cancérologie de Lorraine (ICL) Alexis Vautrin, Vandoeuvre-lès-Nancy, , France
Institut Gustave Roussy, Villejuif, , France
Inselspital Bern, Universitätsklinik für Radio-Onkologie, Freiburgstrasse 4, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, , Switzerland
Contact Details
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