Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

March 27, 2017

Primary Completion Date

October 31, 2019

Study Completion Date

November 29, 2019

Conditions
Diffuse Large B Cell LymphomaPrimary Mediastinal LymphomaMantle Cell LymphomaAdvanced Solid TumorMarginal Zone Lymphoma
Interventions
DRUG

Tazemetostat

Tazemetostat is a selective oral small molecule inhibitor of EZH2

DRUG

Fluconazole

200mg will be orally administered QD for 4 days in order to determine CYP3A4 inhibition when administered concomitantly with tazemetostat

DRUG

Omeprazole

Using 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

Repaglinide

Using 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.

Trial Locations (3)

10032

Columbia University Medical Center, New York

33612

Moffitt Cancer Center, Tampa

85719

University of Arizona Cancer Center, Tucson

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Epizyme, Inc.

INDUSTRY