The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
208
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD)
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters
Time frame: 23 months
To assess preliminary anti-tumor activity of BGJ398 for patients in expansion Arm 4 (previously treated patients with advanced/metastatic UCC with FGFR3 gene alterations)
overall response rate (ORR), as assessed by investigator per RECIST v 1.0; overall survival (OS), duration of response (DOR) and disease control rate (DCR) will be assessed
Time frame: 23 months
To determine the pharmacokinetic (PK) profiles of oral BGJ398
Time vs. concentration profiles, PK parameters of BGJ398 and known active metabolite(s).
Time frame: 23 months
To evaluate the pharmacodynamic effect of the drug.
Pre- vs. post treatment serial changes in FGF23 plasma levels (not done for patients enrolled to expansion Arm 4)
Time frame: 23 months
Assess preliminary anti-tumor activity for patients not in Arm 4.
Overall tumor response rate (ORR) and PFS assessed by investigator per RECIST
Time frame: 23 months
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Novartis Investigative Site
Duarte, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Los Angeles, California, United States
University of Colorado Dept. of Anschutz Cancer (3)
Aurora, Colorado, United States
Novartis Investigative Site
New Haven, Connecticut, United States
Novartis Investigative Site
Boston, Massachusetts, United States
Novartis Investigative Site
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center Onc. Dept..
New York, New York, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Columbus, Ohio, United States
...and 40 more locations