Recruiting 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

Phase I Interventional Advanced Solid Tumors Hematologic Malignancies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Pralatrexate Injection.
Who it may be relevant to: Registry conditions: Advanced Solid Tumors, Hematologic Malignancies. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 1, Open-Label, Multicenter 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

Overview

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.

Interventions

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

Primary outcome measures

To evaluate the pharmacokinetic (PK) profile of pralatrexate. [Time frame: During week 1 of the first cycle of treatment (each cycle is 7 weeks).]

Secondary outcome measures (1)

To evaluate the safety of pralatrexate [Time frame: This will be evaluated during the study through 14(±3) days after the last dose in Cycle 1, or 35(±5) days after the final dose in any cycle or until all treatment-related AEs have resolved or returned to Baseline/Grade]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

United States · 4 centers

TOI Clinical Research — Cerritos
Northwestern University - Feinberg School of Medicine — Chicago
Karmanos Cancer Institute — Detroit
Gabrail Cancer Center — Canton

Identifiers

NCT: NCT07036133 · FOL-102

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗