Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy

PHASE2TerminatedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Carcinoma Transitional Cell
Interventions
DRUG

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

Trial Locations (12)

1200

Cliniques universitaires Saint-Luc, Brussels

1210

Centre Hospitalier de Luxembourg, Luxembourg

1340

Clinique Saint-Pierre à Ottignies, Ottignies

4000

CHU de Liège site du Sart Tilman, Liège

5000

Clinique et Maternité Ste Elisabeth, Namur

5530

CHU de Mont-Godinne, Yvoir

6000

Grand Hôpital de Charleroi, Charleroi

6700

Clinique du Sud Luxembourg, Arlon

7100

Hôpital de Jolimont, Haine-Saint-Paul

7331

Epicura- RHMS Baudour, Baudour

7500

Centre Hospitalier Wallonie Picarde, Tournai

9000

Universitair Ziekenhuis Gent, Ghent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

NCT01856101 - Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy | Biotech Hunter | Biotech Hunter