22
Participants
Start Date
February 28, 2013
Primary Completion Date
January 31, 2014
Study Completion Date
January 31, 2014
BEZ235
The investigational study drug used in this trial is BEZ235, supplied as 200 mg, 300 mg and 400 mg sachets. BEZ235 is administered continuously twice-daily; complete cycle is 28 days. Starting dose is 300mg PO bid. At cycle 1 day 15, based on a clinical assessment, dose is adjusted for the rest of the study:• If no adverse event (AE) or only mild AE (G1) : the dose will be increase to 400 mg bid• If AE = G2 : the patient will continue at 300 mg bid • If G3 AE or higher : BEZ235 will be interrupt until resolved to ≤ G1 then reduce dose to 200 mg bid
Cliniques universitaires Saint-Luc, Brussels
Centre Hospitalier de Luxembourg, Luxembourg
Clinique Saint-Pierre à Ottignies, Ottignies
CHU de Liège site du Sart Tilman, Liège
Clinique et Maternité Ste Elisabeth, Namur
CHU de Mont-Godinne, Yvoir
Grand Hôpital de Charleroi, Charleroi
Clinique du Sud Luxembourg, Arlon
Hôpital de Jolimont, Haine-Saint-Paul
Epicura- RHMS Baudour, Baudour
Centre Hospitalier Wallonie Picarde, Tournai
Universitair Ziekenhuis Gent, Ghent
Collaborators (1)
Novartis
INDUSTRY
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER