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.
Patient must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements
Patient is diagnosed with advanced solid tumor or hematological malignancy.
Patient is at least 18 years of age and has a life expectancy of at least 6 months.
Patient has normal or abnormal hepatic function as defined by normal, mild (Child-Pugh A), moderate (Child-Pugh B ), or severe (Child-Pugh C) liver impairment
Patient has had previous exposure to pralatrexate
Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
Patient has an active, uncontrolled infection, underlying medical condition, or other serious illness that would impair the patient's ability to receive the protocol-defined treatment.
Patient has known or suspected intolerance or hypersensitivity to the investigational product or any related compound.
Single group
Pralatrexate Injection
DrugPralatrexate will be administered based on Child-Pugh Classification of liver impairment
To 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.
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.
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