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

  • STATUS
    Not Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    24
  • sponsor
    Epizyme, Inc.
Updated on 2 June 2022
antibiotics
renal function
cancer
hematologic malignancy
lymphoma
systemic therapy
serum pregnancy test
measurable disease
major surgery
kidney function tests
chemotherapy regimen
rifampin
aptt
cancer chemotherapy
b-cell lymphoma
solid tumor
copper
renal function tests
kaposi's sarcoma

Summary

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.

Description

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.

Details
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

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