Diffuse Large B Cell Lymphoma / Primary Mediastinal Lymphoma / Mantle Cell Lymphoma
This is a Phase 1, open-label, two-part, safety, PK, and activity study designed to characterize the DDI potential of tazemetostat. Tazemetostat will be taken orally BID continuously in 28-day cycles in both study parts.
- Drug: TazemetostatTazemetostat is a selective oral small molecule inhibitor of EZH2
- EPZ-6438, E7438
- Drug: Fluconazole200mg will be orally administered QD for 4 days in order to determine CYP3A4 inhibition when administered concomitantly with tazemetostat
- Drug: OmeprazoleUsing omeprazole as a probe substrate, 20mg will be orally administered for a total of 5 days in order to determine the potential of tazemetostat to inhibit or induce CYP2C19. Omeprazole is also being used to determine the effect of increased gastric pH on metabolism of tazemetostat.
- Drug: RepaglinideUsing repaglinide as a probe substrate, 25mg will be orally administered for a total of 2 days in order to determine the potential of tazemetostat to inhibit or induce CYP2C8.
|Ages eligible for Study||18 Years and older|
|Genders eligible for Study||All|
|Accepts Healthy Volunteers||No|
United States (2)
- University of Arizona Cancer CenterrecruitingTucson, Arizona, United States, 85719
- Columbia University Medical CenterrecruitingNew York, New York, United States, 10032
26 March, 2017
18 June, 2017