The purpose of this study is to evaluate the safety and tolerability of pemigatinib in Japanese subjects with advanced malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Pemigatinib at the protocol-defined dose administered once daily.
Aichi Cancer Center Hospital
Aichi, Japan
Chiba Cancer Center
Chiba, Japan
National Cancer Central Hospital East
Chiba, Japan
Safety and tolerability assessed by monitoring frequency, duration, and severity of adverse events (AEs)
An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurs after a subject provides informed consent.
Time frame: Baseline through 30 days after end of treatment, up to approximately 16 months.
Overall response rate in subjects with measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Defined as proportion of subjects who meet the response criteria (complete response + partial response) as appropriate for the tumor type.
Time frame: Baseline and Day 15 of every third treatment cycle, up to approximately 6 months
Pharmacodynamics of pemigatinib assessed by changes in serum phosphorus level
Analyzed to look for differences that may be associated with response or safety as well as significant changes associated with treatment.
Time frame: Baseline and protocol-defined timepoints throughout the treatment period, up to approximately 6 months
Observed Plasma Concentration of pemigatinib
PK parameters will be calculated from the blood plasma concentrations of pemigatinib using standard noncompartmental (model independent) PK methods.
Time frame: During the first cycle, up to Day 16
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Kyusyu Cancer Center
Fukuoka, Japan
Kanazawa University Hospital
Ishikawa, Japan
Kanagawa Cancer Center
Kanagawa, Japan
Osaka International Cancer Institute
Osaka, Japan
Saitama Cancer Center
Saitama, Japan
Hokkaido Cancer Center
Sapporo, Japan
Shizuoka Cancer Center
Shizuoka, Japan
...and 2 more locations