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
Recruiting · Phase 1 · NCT07036133
Conditions: Advanced Solid Tumors, Hematologic Malignancies
At a glance
- Research payments reported, 2025
- $10,890
- U.S. investigators named
- 0
- Sites paid
- 0
- Planned or actual enrollment
- 24
About the trial
- Sponsor
- Acrotech Biopharma Inc.
- Tested
- Pralatrexate Injection (drug)
- Dates
- Started 2022-12-28; completion 2027-09
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-02-11. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Acrotech Biopharma Inc. reported $10,890 in research payments for this study in 2025 (3 payments).
Products named: Folotyn
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
Sites paid to run it
- $10,890
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.