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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
Sponsor: Acrotech Biopharma Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2022-12-28
Completion Date
2027-09
Last Updated
2026-02-11
Healthy Volunteers
No
Interventions
Pralatrexate Injection
Pralatrexate will be administered based on Child-Pugh Classification of liver impairment
Locations (4)
TOI Clinical Research
Cerritos, California, United States
Northwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Gabrail Cancer Center
Canton, Ohio, United States