This is a phase 1 study to investigate the characteristics of PK, PD and safety in subjects with advanced malignancies with FGF/FGFR alterations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Pemigatinib will be self-administered as at 13.5mg a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule.
Cancer Hospital of Tianjin Medical University
Tianjin, China
Maximum observed plasma concentration (Cmax) during the dosing interval and Cmin of Pemigatinib as monotherapy
Time frame: Day 1 to Day 16
Time to maximum plasma concentration (Tmax) of Pemigatinib as monotherapy
Time frame: Day 1 to Day 16
Area under the single-dose plasma concentration-time curve (AUC0-t) of Pemigatinib as monotherapy
Time frame: Day 1 to Day 16
Safety of pemigatinib as monotherapy as assessed by the frequency, duration, and severity of adverse events
Time frame: From screening through 30-35 days after end of treatment, up to 6 months
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