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NCT04241835 · ClinicalTrials.gov registry record · 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
A Phase 1 study of Hepatic Impairment and Advanced Malignant Solid Tumor, sponsored by Epizyme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 18
- Study locations
NCT04241835 is a Phase 1 study of Hepatic Impairment and Advanced Malignant Solid Tumor that is actively recruiting participants, run by Epizyme. The registered enrollment target is 24 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (33% lower). The trial reports 18 study locations across 12 states.
The verdict
NCT04241835, a Phase 1 study of Hepatic Impairment and Advanced Malignant Solid Tumor, is actively recruiting participants, sponsored by Epizyme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 18
- Study locations
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-01-15 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
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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, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (33% lower). The listed sponsor is Epizyme, which has 16 total studies on file at ClinicalTrials.gov.
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.
NCT04241835 reports 18 study locations spanning 12 distinct geographic areas - top geographies include Other, Texas, Florida.
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.
What interventions are being tested in trial NCT04241835?
The interventions under investigation include: Tazemetostat (DRUG).
Who is sponsoring clinical trial NCT04241835?
This trial is sponsored by Epizyme, which has 16 total clinical trials registered on ClinicalTrials.gov.
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.
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