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Female Urogenital Diseases and Pregnancy Complications

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Infigratinib

BGJ398

Novartis Pharmaceuticals

The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.

A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies

A Phase I, Open-label, Multi-center, Dose Escalation Study of Oral BGJ398, a Pan FGF-R Kinase Inhibitor, in Adult Patients With Advanced Solid Malignancies

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

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 vs. concentration profiles, PK parameters of BGJ398 and known active metabolite(s).

Pre- vs. post treatment serial changes in FGF23 plasma levels (not done for patients enrolled to expansion Arm 4)

Overall tumor response rate (ORR) and PFS assessed by investigator per RECIST

Spots Global Cancer Trial Database for advanced solid tumors with fgfr3 mutation