A Two-part Study to Characterize Drug-Drug Interaction Effects on Steady-State Pharmacokinetics of Oral Tazemetostat

    Not Recruiting
  • End date
    Dec 30, 2023
  • participants needed
  • sponsor
    Epizyme, Inc.
Updated on 2 June 2022
renal function
hematologic malignancy
systemic therapy
serum pregnancy test
measurable disease
major surgery
kidney function tests
chemotherapy regimen
cancer chemotherapy
b-cell lymphoma
solid tumor
renal function tests
kaposi's sarcoma


This is a phase I, multi-center, open-label, multi-dose, two-part PK and safety study to characterize the DDI potential of oral Tazemetostat.


This two-part study is designed to characterize the steady-state PK of oral Tazemetostat and its metabolite EPZ 6930 when administered as a single and twice daily dose in subjects with advanced malignancies while taken alone or in combination with either itraconazole or rifampin.

Part 1: Tazemetostat and Itraconazole Drug Interaction Part 1 of the study will evaluate the drug-drug interaction between Tazemetostat and itraconazole in an open-label, fixed sequential cross over design.

Part 2: Tazemetostat and Rifampin Drug Interaction Part 2 of the study will evaluate the drug-drug interaction between Tazemetostat and rifampin in an open-label, fixed sequential cross over design.

For both Parts 1 and 2, safety and tolerability will be assessed throughout the subject's participation. Subjects must have an end of study visit after 30 days of the last dose of Tazemetostat for safety assessment.

Condition All Malignancies, Advanced Malignancies, Hematologic Malignancy, Solid Tumor, Follicular Lymphoma (FL), Non-Hodgkin Lymphoma (NHL), Diffuse Large B-Cell Lymphoma (DLBCL), Epithelioid Sarcoma (ES), Synovial Sarcoma, Renal Medullary Carcinoma, Mesothelioma, Rhabdoid Tumor
Treatment Itraconazole, rifampin, Tazemetostat
Clinical Study IdentifierNCT04537715
SponsorEpizyme, Inc.
Last Modified on2 June 2022

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note