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Lymphoma, B-Cell

Neoplasms by Histologic Type

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Pharmaceutical Solutions

All Drugs and Chemicals

* Tazemetostat 800 mg BID orally as tablets continuously starting on Day 1, with the exception of the morning dose on Day 16;
* A single IV dose of approximately 12 µg tazemetostat that contains approximately 500 nCi of \[14C\] tazemetostat on Day 15;
* A single oral dose of 800 mg tazemetostat as a solution containing approximately 400 µCi (14.8 MBq) of \[14C\] tazemetostat on Day 16.

Tazemetostat is a selective oral small molecule inhibitor of EZH2.

Tazemetostat and [14C] Tazemetostat

Ipsen Medical Director

This is a Phase 1, open-label, two-part study designed to characterize the PK of an IV dose of approximately 12 µg tazemetostat that contains approximately 500 nCi of \[14C\] tazemetostat and the ADME of an oral dose of 800 mg tazemetostat that contains approximately 400 µCi of \[14C\]-labeled tazemetostat in three subjects with B-cell lymphomas or advanced solid tumors.

Open-Label, Multi-Center, Two-Part, Ph1 Study to Characterize the PKs of an Intravenous Micro-Dose of [14C]-Tazemetostat (EPZ 6438) and the ADME of an Oral [14C]-Labeled Dose of Tazemetostat in Subjects With B-Cell Lymphomas or Adv Solid Tumors

An Open-Label, Multi-Center, Two-Part, Phase 1 Study to Characterize the Pharmacokinetics of an Intravenous Micro-Dose of [14C]-Tazemetostat (EPZ 6438) and the Absorption, Distribution, Metabolism and Elimination of an Oral [14C]-Labeled Dose of Tazemetostat in Subjects With B-Cell Lymphomas or Advanced Solid Tumors

Epizyme, Inc.

Spots Global Cancer Trial Database for tazemetostat and [14c] tazemetostat