NCT07036133 · Acrotech Biopharma Inc.
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
(SPI-FOL-102)
What this study is about
This purpose of this study is to help to evaluate the how the drug moves through the body (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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Cerritos, California
- Chicago, Illinois
- Detroit, Michigan
- Canton, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations