A Phase 1, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid Tumor or Hematological Malignancy and Either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
Summary
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.
Detailed description
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.
Arms & interventions
- DrugPralatrexate Injection
Pralatrexate will be administered based on Child-Pugh Classification of liver impairment
Outcome measures
Primary
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.
Time frame: During week 1 of the first cycle of treatment (each cycle is 7 weeks).
Secondary
To evaluate the safety of pralatrexate
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
Eligibility criteria
Study locations (4)
TOI Clinical Research
Cerritos, California, 90703
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, 60611
Karmanos Cancer Institute
Detroit, Michigan, 48201
Gabrail Cancer Center
Canton, Ohio, 44718