OncoMatch/Clinical Trials/NCT07036133
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
Is NCT07036133 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Pralatrexate for advanced solid tumors.
Treatment: Pralatrexate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: pralatrexate (pralatrexate)
Patient has had previous exposure to pralatrexate
Cannot have received: investigational drug, biologic, or device
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.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1000/μL; Platelet count ≥100,000/μL
Kidney function
Creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥50 mL/min
Liver function
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 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 congestive heart failure at Class III/IV according to the New York Heart Association (NYHA) Functional Classification [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- TOI Clinical Research · Cerritos, California
- Northwestern University - Feinberg School of Medicine · Chicago, Illinois
- Karmanos Cancer Institute · Detroit, Michigan
- Gabrail Cancer Center · Canton, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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