CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 400 enrolled
Drug / intervention
Tazemetostat +2 moredrug
Likely dose
Tazemetostat 800 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01897571
NCT01897571Phase 2Completed

An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma

Epizyme, Inc.·interventional·Posted Jul 12, 2013·Updated Mar 26, 2024

In Brief

A Phase 2 clinical trial evaluating Tazemetostat and Prednisolone for B-cell Lymphomas (Phase 1) and 5 related conditions. Completed, enrolled 400 participants across 52 sites in 10 countries.

Detailed Summary

This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, France, Germany, Italy, Poland, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 12, 2013
Enrollment StartJun 13, 2013
Primary CompletionAug 24, 2021
Study CompletionNov 2, 2021
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 13.0 years ago

Interventions

Tazemetostatdrug

Patients who received 800 mg of tazemetostat, BID, administered in continuous 28-day cycles.

Prednisolonedrug

Patients who received 40 mg/m\^2 prednisolone once daily on Days 1-5 and 15-19 of Cycles 1-4.

Tazemetostatdrug

Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.