Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients With Advanced Solid… (NCT07036133) | Clinical Trial Compass
RecruitingPhase 1
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
United States24 participantsStarted 2022-12-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Patien…
What they're measuring
1
To evaluate the pharmacokinetic (PK) profile of pralatrexate.
Timeframe: During week 1 of the first cycle of treatment (each cycle is 7 weeks).