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Tests treatment safety and results for Advanced Solid Tumors
Official title 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
ClinicalTrials.gov ID: NCT07036133
What this study is testing
What is Pralatrexate Injection?
Pralatrexate Injection is an investigational medicine, given as an once-weekly, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Patient has adequate hematologic and renal function as defined by: Absolute neutrophil count (ANC) ≥1000/μL Platelet count ≥100,000/μL Creatinine ≤...
You likely 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...
- Patient has an active, uncontrolled infection, underlying medical condition, or other serious illness that would impair the patient's ability to...
- 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.
See the full eligibility 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cerritos, California, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Canton, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cerritos, California, United States; Chicago, Illinois, United States; Detroit, Michigan, United States; Canton, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.