Pralatrexate dosing and safety in adults with cancer and differing liver function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open‑label, non-randomized Phase 1 study enrolls adults with advanced solid tumors or hematologic malignancies and groups them by liver function (normal, mild, moderate, or severe hepatic impairment by Child‑Pugh). Participants receive pralatrexate once weekly for 6 weeks of a 7‑week treatment cycle while intensive pharmacokinetic blood sampling and safety monitoring are performed. The study compares drug levels and adverse events across liver‑function groups to recommend appropriate dosing adjustments. Results will inform dosing guidance for pralatrexate in patients with varying degrees of hepatic impairment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements
* Patient is diagnosed with advanced solid tumor or hematological malignancy.
* Patient is at least 18 years of age and has a life expectancy of at least 6 months.
* Patient has normal or abnormal hepatic function as defined by normal, mild (Child-Pugh A), moderate (Child-Pugh B ), or severe (Child-Pugh C) liver impairment
* Patient has adequate hematologic and renal function as defined by:

Absolute neutrophil count (ANC) ≥1000/μL Platelet count ≥100,000/μL Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥50 mL/min

* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
* Patient is willing to practice 2 forms of contraception, one of which must be a barrier method, from study entry until at least 30 days after the last dose of pralatrexate
* Females of childbearing potential must have a negative pregnancy test within 30 days prior to enrollment. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or who are surgically sterilized do not require this test.

Exclusion Criteria:

* Patient has had previous exposure to pralatrexate
* Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
* Patient has an active, uncontrolled infection, underlying medical condition, or other serious illness that would impair the patient's ability to receive the protocol-defined treatment.
* Patient has known or suspected intolerance or hypersensitivity to the investigational product or any related compound.
* Patient has congestive heart failure at Class III/IV according to the New York Heart Association (NYHA) Functional Classification
* Patient has had major surgery within 30 days prior to enrollment.
* Patient with central nervous system (CNS) metastases
* Patient is pregnant or breast-feeding.

Where it's running

• Northwestern University - Feinberg School of Medicine
  Chicago, Illinois, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• Gabrail Cancer Center
  Canton, Ohio, United States Recruiting
• TOI Clinical Research
  Cerritos, California, United States Withdrawn

Study contacts

• Study coordinator: Uma Srinivas Atmuri
• Email: uatmuri@acrotechbiopharma.com
• Phone: 732-917-2420

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.