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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: Recruiting Phase 1 study of Hepatic Impairment and Advanced Malignant Solid Tumor, sponsored by Epizyme.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
When administered as a single and multi-dose in subjects with advanced malignancies and moderate or severe hepatic impairment, compared with participants with advanced malignancies and normal hepatic function.
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 |
What NCT04241835 shows while recruiting
NCT04241835 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (33% lower).
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 lists 18 locations in 12 states (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.
Learn More About Clinical Trials
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Where NCT04241835's enrollment target sits among peer trials
24 33rd of 48 higher than 11 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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