Phase 1 Study of Pemigatinib in Patients With Advanced Malignancies With FGF/FGFR Alterations

Inclusion criteria

• Men and women, aged 18 or older.
• Histologically or cytologically confirmed malignancy which was considered to be surgically unresectable advanced, relapse or metastatic .
• Radiographically measurable disease per RECIST v 1.1
• Documentation of FGF/FGFR alteration..
• Documented disease progression after standard therapy ,or no standard therapy available.
• ECOG performance status of 0~1.
• Life expectancy ≥12 weeks

Exclusion criteria

• Prior receipt of a selective FGFR inhibitor.
• History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of softy tissues ( exception: skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
• Currently evidence of clinically significant corneal or retinal disorder confirmed by ophthalmologic examination.
• Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug. Topical ketoconazole will be allowed