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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

Investigation of Pharmacokinetics (the study of how your body absorbs, breaks down, and removes a study drug) and Safety in Patients with Hepatic Impairment

Recruiting
18 years and older
All
Phase 1

This study investigates the pharmacokinetic profile and safety of an investigational medication in patients with advanced solid tumors or blood-related cancers. The purpose is to understand how the body absorbs, breaks down, and eliminates the medication, particularly in patients with varying levels of liver function, including normal, mild, moderate, or severe impairment.

Participants will receive the investigational medication once a week for six weeks in a seven-week cycle. The study is open-label and non-randomized, meaning all participants will know what treatment they are receiving, and they will not be randomly assigned to different study arms.

  • Who can participate: Adults aged 18 and older with advanced solid tumors or hematological malignancies and normal to severely impaired liver function may participate. Key eligibility includes adequate blood and kidney function and an ECOG performance status of 0-2.
  • Study details: Participants will take the investigational medication weekly and adhere to study requirements, including using two forms of contraception if applicable. The study will monitor the medication's effects on the body and gather safety data.
Study details
    Advanced Solid Tumors
    Hematologic Malignancies

NCT07036133

Acrotech Biopharma Inc.

11 August 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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