Trials / Completed

CompletedNCT02875548

A Study to Assess Long-term Safety of Tazemetostat in Adult Participants of All Ages With Any Disease Treated With Tazemetostat in a Previous Clinical Study

Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study

Status: Completed
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 58 (actual)

Sponsor: Epizyme, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy. The aim of the study will be to assess the long-term safety of tezemetostat.

Detailed description

This open-label, multicenter, global study will provide continuing access to tazemetostat therapy for subjects who have completed their participation in a prior tazemetostat study (either with monotherapy or combination therapy) without unacceptable toxicity, have not had evidence of tumor progression as defined by disease-appropriate standard criteria, and continue to receive clinical benefit from the therapy. Subjects will receive tazemetostat as dictated in their antecedent study. Visits will be conducted per Standard of Care (SoC) as appropriate in each country and as determined by the Investigator. Subjects will be followed for long-term safety in addition to time to treatment failure (TTF) and overall survival (OS).

Conditions

Interventions

Type	Name	Description
DRUG	Tazemetostat	Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of enhancer of Zeste homolog 2 (EZH2), a histone-lysine N-methyltransferase enzyme.

Timeline

Start date: 2016-08-30
Primary completion: 2025-09-26
Completion: 2025-09-26
First posted: 2016-08-23
Last updated: 2025-11-04

Locations

34 sites across 7 countries: United States, Australia, Belgium, France, Poland, Ukraine, United Kingdom

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02875548. Inclusion in this directory is not an endorsement.