EPZ-6438: IV microtracer and ADME Study
Research type
Research Study
Full title
An Open-Label, Single Center, Two-Part, Phase 1 Study to Characterize the Pharmacokinetics of an Intravenous Micro-Dose of Tazemetostat (EPZ-6438) and the Absorption, Distribution, Metabolism and Elimination of an Oral [14C]-Labeled Dose of Tazemetostat in Subjects with B cell Lymphomas.
IRAS ID
202612
Contact name
Andrew Pettitt
Contact email
Sponsor organisation
Epizyme, Inc.
Eudract number
2016-002166-32
Duration of Study in the UK
0 years, 10 months, 16 days
Research summary
The Study Drug works by targeting and killing certain cancer cells by stopping an enzyme called EZH2 from working. In laboratory studies, the Study Drug has been shown to slow down the growth of or kill cancer cells. There are currently no treatments available for many B-cell lymphomas, or the cancers do not respond to the available treatments. It is hoped that the Study Drug will be effective as a treatment for these types of cancers.
Two doses of the Study Drug will contain carbon-14 (a naturally occurring radioactive form of carbon). This will allow the measurement of the Study Drug and its breakdown products in the blood, urine and faeces. The reason for this is to allow different parts of the Study Drug to be traced after it has been broken down by the body.
All subjects will receive the same doses of the Study Drug.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0498
Date of REC Opinion
20 Sep 2016
REC opinion
Further Information Favourable Opinion