RECRUITING

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

Conditions

Advanced Solid Tumors Hematologic Malignancies Pralatrexate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-12-28

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07036133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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.	* 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.

Inclusion Criteria

Exclusion 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:
* 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.

* 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.

Contacts and Locations

Study Contact

Uma Srinivas Atmuri

CONTACT

732-917-2420

uatmuri@acrotechbiopharma.com

Motun Clinical Trial Manager

CONTACT

617-694-4296

msolomon@acrotechbiopharma.com

Principal Investigator

Erard Gilles, MD, MSc

STUDY_DIRECTOR

Study Locations (Sites)

TOI Clinical Research

Cerritos, California, 90703

United States

Gabrail Cancer Center

Canton, Ohio, 44718

United States

Collaborators and Investigators

Sponsor: Acrotech Biopharma Inc.

Erard Gilles, MD, MSc, STUDY_DIRECTOR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-28

Study Completion Date2027-09

Study Record Updates

Study Start Date2022-12-28

Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

Pralatrexate

Additional Relevant MeSH Terms

Advanced Solid Tumors
Hematologic Malignancies