What this study is
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.
What's being tested
- Pralatrexate Injection
Intervention · DRUG
Pralatrexate will be administered based on Child-Pugh Classification of liver impairment
Study details
- 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
- Sponsor
- Acrotech Biopharma Inc.
- Conditions
- Advanced Solid Tumors · Hematologic Malignancies
- Enrolling
- 24 people
- Starts
- 2022-12-28
- Est. completion
- 2027-09
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
3 openNorthwestern University - Feinberg School of Medicine
Chicago, Illinois, United States
- Devalingam Mahalingam, MD · Principal investigator
RecruitingKarmanos Cancer Institute
Detroit, Michigan, United States
- Wasif Saif, MD · Principal investigator
RecruitingGabrail Cancer Center
Canton, Ohio, United States
- Nashat Gabrail, MD · Principal investigator
RecruitingTOI Clinical Research
Cerritos, California, United States
Withdrawn
Study team
Sponsor
Acrotech Biopharma Inc.
Study ID FOL-102
Study director
Erard Gilles, MD, MSc
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.