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RECRUITING
NCT07036133
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

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