Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function

NCT04241835 · View on ClinicalTrials.gov ↗

Study Summary

This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe hepatic (liver) impairment will be compared with participants with advanced malignancies and normal hepatic function. An advanced malignancy is a cancer that has recurred (come back) after prior treatment or hasn't controlled with treatment. The trial will also study the safety of the study drug in participants (how well it is tolerated).

Interventions

  • DRUG Tazemetostat

Study Locations (18)

Other

  • Cliniques Universitaires Saint-Luc — Brussels
  • Institut Bergonie — Bordeaux
  • Centre Oscar Lambret — Lille
  • Hopital de la Timone — Marseille
  • Institut de Cancérologie Strasbourg Europe — Strasbourg
  • Summit Clinical Research, s.r.o — Bratislava

Texas

  • Mary Crowley Cancer Research — Dallas
  • Oncology Consultants - Texas Medical Center — Houston

Florida

  • Florida Cancer Specialists & Research Institute — Lake Mary

Illinois

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago

Michigan

  • Hematology Oncology Consultants — Royal Oak

Nevada

  • Comprehensive Cancer Center of Nevada — Las Vegas

New Jersey

  • Rutgers Cancer Institute — New Brunswick

Ohio

  • Gabrail Cancer Center — Canton

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-01-15
Est. Completion 2026-04-30
Phase Phase 1

Sponsor

Epizyme

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04241835

The ClinicalTrials.gov registry entry for NCT04241835 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 Epizyme, which has 3 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 Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention — of which Tazemetostat 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: NCT04241835 reports 18 study locations spanning 12 distinct geographic areas — top geographies include Other, Texas, Florida. 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 NCT04241835 about?

NCT04241835 is a clinical study titled "A Study to Compare the Blood Levels and Safety of Tazemetostat in Participants With Advanced Cancer and Moderate/Severe Liver Impairment to Participants With Advanced Cancer and Normal Liver Function". This main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the study drug tazemetostat. The pharmacokinetics of the study drug in participants with advanced solid tumors and moderate or severe hepatic (liver) impairment will be compared with participants with advan...

What is the current status of trial NCT04241835?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-01-15. Estimated completion is 2026-04-30.

What conditions does trial NCT04241835 study?

This clinical trial studies the following conditions: Hepatic Impairment, Advanced Malignant Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04241835?

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

Who is sponsoring clinical trial NCT04241835?

This trial is sponsored by Epizyme, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04241835 being conducted?

This trial has 18 study locations across Florida, Illinois, Michigan, Nevada, New Jersey. 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