NCT03010982

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Epizyme, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diffuse Large B Cell Lymphoma
• Primary Mediastinal Lymphoma
• Mantle-Cell Lymphoma
• Follicular Lymphoma
• Marginal Zone Lymphoma
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Tazemetostat and [14C] Tazemetostat	Tazemetostat is a selective oral small molecule inhibitor of EZH2.

Timeline

• Start date: 2018-06-20
• Primary completion: 2019-01-08
• Completion: 2019-01-08
• First posted: 2017-01-05
• Last updated: 2024-03-22

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study