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

NCT ID: NCT07036133

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-28
• Study Completion Date: 2027-09-30

Brief 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.

Detailed Description

This is an open-label, non-randomized, multi-center study to evaluate the PK and safety of pralatrexate in patients with advanced solid tumor or hematological malignancy with normal hepatic function or mild, moderate, or severe hepatic impairment.

Conditions

Advanced Solid Tumors; Hematologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label treatment with Pralatrexate

Pralatrexate will be administered based on Child-Pugh Classification of liver impairment.

Group Type: OTHER

Pralatrexate Injection

Intervention Type: DRUG

Pralatrexate will be administered based on Child-Pugh Classification of liver impairment

Interventions

Pralatrexate Injection

Pralatrexate will be administered based on Child-Pugh Classification of liver impairment

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acrotech Biopharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erard Gilles, MD, MSc

Role: STUDY_DIRECTOR

Locations

TOI Clinical Research

Cerritos, California, United States

Site Status: RECRUITING

Gabrail Cancer Center

Canton, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Uma Srinivas Atmuri

Role: CONTACT

uatmuri@acrotechbiopharma.com

732-917-2420

Motun Clinical Trial Manager

Role: CONTACT

msolomon@acrotechbiopharma.com

617-694-4296

Other Identifiers

FOL-102

Identifier Type: -

Identifier Source: org_study_id