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RECRUITING Phase 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

NCT07036133 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Pralatrexate Injection

Study Locations (4)

California

  • TOI Clinical Research — Cerritos

Illinois

  • Northwestern University - Feinberg School of Medicine — Chicago

Michigan

  • Karmanos Cancer Institute — Detroit

Ohio

  • Gabrail Cancer Center — Canton

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2022-12-28
Est. Completion 2027-09
Phase Phase 1

Sponsor

Acrotech Biopharma

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07036133

The ClinicalTrials.gov registry entry for NCT07036133 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acrotech Biopharma, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which Pralatrexate Injection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07036133 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Illinois, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07036133 about?

NCT07036133 is a clinical study titled "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". 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 eve...

What is the current status of trial NCT07036133?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-12-28. Estimated completion is 2027-09.

What conditions does trial NCT07036133 study?

This clinical trial studies the following conditions: Advanced Solid Tumors, Hematologic Malignancies. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07036133?

The interventions under investigation include: Pralatrexate Injection (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07036133?

This trial is sponsored by Acrotech Biopharma, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07036133 being conducted?

This trial has 4 study locations across California, Illinois, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial