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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 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-16

No results posted yet for this 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

  • Hepatic Impairment
  • Advanced Malignant Solid Tumor

Interventions

DRUG

Tazemetostat

Tazemetostat (EPZ-6438) in tablet form at a dose of 800 mg once daily on days 1 and 15 and twice daily on days 5 to 14 of the first 28-day cycle. Participants may continue tazemetostat treatment at 800 mg twice daily in additional 28-day cycles until progression or unacceptable toxicity.

Sponsors & Collaborators

  • Sponsor GmbH

    collaborator OTHER

  • Epizyme, Inc.

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2025-03-12
Completion
2025-03-12
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Poland
  • Slovakia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04241835 on ClinicalTrials.gov