This purpose of this study is to help to evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment and to evaluate the safety and establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of every 7-week treatment cycle in patients with hepatic impairment. Pharmacokinetics (or PK) is the study of how your body absorbs, breaks down, and removes a study drug.
This is an open-label, non-randomized, multi-center study to evaluate the PK and safety of pralatrexate in patients with advanced solid tumor or hematological malignancy with normal hepatic function or mild, moderate, or severe hepatic impairment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Pralatrexate will be administered based on Child-Pugh Classification of liver impairment
TOI Clinical Research
Cerritos, California, United States
WITHDRAWNNorthwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITINGGabrail Cancer Center
Canton, Ohio, United States
RECRUITINGTo evaluate the pharmacokinetic (PK) profile of pralatrexate.
Blood will be collected to evaluate the pharmacokinetic (PK) profile of pralatrexate (plasma concentration levels) when administered to patients with various degrees of hepatic impairment.
Time frame: During week 1 of the first cycle of treatment (each cycle is 7 weeks).
To evaluate the safety of pralatrexate
The number and severity of treatment-related adverse events. This will be as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale, Version 5.0.
Time frame: This will be evaluated during the study through 14(±3) days after the last dose in Cycle 1, or 35(±5) days after the final dose in any cycle or until all treatment-related AEs have resolved or returned to Baseline/Grade
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.