Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

April 23, 2020

Primary Completion Date

April 3, 2023

Study Completion Date

April 3, 2023

Conditions
All MalignanciesAdvanced MalignanciesHematologic MalignancySolid TumorFollicular Lymphoma (FL)Non-Hodgkin Lymphoma (NHL)Diffuse Large B-Cell Lymphoma (DLBCL)Epithelioid Sarcoma (ES)Synovial SarcomaRenal Medullary CarcinomaMesotheliomaRhabdoid Tumor
Interventions
DRUG

Tazemetostat

A single, oral, 400 mg dose of tazemetostat on Day 1, Day 15, and Day 36; and tazemetostat (oral 400 mg) tablets twice daily on Days 3 - 14 and Days 21 - 35.

DRUG

Itraconazole

Oral 200 mg itraconazole once daily on Days 18 - 38

DRUG

Tazemetostat

A single, oral, 800 mg dose of tazemetostat on Days 1, 15, and Day 24 ; and tazemetostat (oral 800 mg) twice daily on Days 3 - 14 and on Days 17 - 23.

DRUG

Rifampin

Oral 600 mg rifampin once daily on Days 17 - 25.

Trial Locations (10)

20014

Onkologikoa, Donostia / San Sebastian

28040

Hospital Fundacion Jimenez Diaz, Madrid

44718

Gabrail Cancer Center, Canton

45267

University of Cincinnati Medical Center, Cincinnati

49546

South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids

60611

Northwestern University-Robert H. Lurie Comprehensive Cancer Center, Chicago

75230

Mary Crowley Cancer Research, Dallas

90025

The Angeles Clinic and Research Institute, Los Angeles

92024

California Cancer Associates for Research and Excellence, Inc. (cCARE), Encinitas

08035

Hospital Universitario Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Epizyme, Inc.

INDUSTRY