drugset / Trial / NCT04241835

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

Phase 1 Terminated 18 enrolled Epizyme, Inc. Sponsor GmbH · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2020-01-15
Primary completion
2025-03-12
Completion
2025-03-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tazemetostat Small molecule 800 mg Oral

Indications