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Advanced Solid TumorsCancerGut healthDrugPhase 1

What this study is

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.

What's being tested

  • Pralatrexate Injection

    Intervention · DRUG

    Pralatrexate will be administered based on Child-Pugh Classification of liver impairment

Study details

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
Sponsor
Acrotech Biopharma Inc.
Conditions
Advanced Solid Tumors · Hematologic Malignancies
Enrolling
24 people
Starts
2022-12-28
Est. completion
2027-09
Design
Open-label, single group, Phase 1
Record
View on ClinicalTrials.gov ↗