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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    24
  • sponsor
    Epizyme, Inc.
Updated on 4 June 2021
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. Subjects in Cycle 1 of Part 1 will be treated for 39 days. On Days 1, 15 and 36, a single oral dose of 400 mg Tazemetostat will be administered in the morning. From Days 3 - 14 and 21 - 35, subjects will receive an oral 400 mg dose of Tazemetostat twice daily (12 hours apart). From Days 18 - 38, a single dose of oral 200 mg itraconazole will be administered daily in the morning after a meal, co-administered with Tazemetostat when necessary. PK blood samples will be collected on Days 1 - 3, 15 - 18, 21 - 22, and 36 - 39. Sparse PK samples will be collected on Days 25, 28, 31, and 34.

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. Subjects in Cycle 1 of Part 2 will be treated for 26 days. On Days 1, 15 and 24, a single oral dose of 800 mg Tazemetostat will be administered in the morning. From Days 3 - 14 and 17 - 23, subjects will receive an oral 800 mg dose of Tazemetostat twice daily (12 hours apart). From Days 17 - 25, a single dose of oral 600 mg rifampin will be administered daily in the morning one hour before a meal, co-administered with Tazemetostat when necessary. PK blood samples will be collected on Days 1 - 3, 15 - 17 and 24 - 26. Sparse PK samples will be collected on Days 19 and 21.

Subjects may discontinue from the study after completion of Cycle 1 or can continue treatment (Cycle2+ onwards) with Tazemetostat at the recommended therapeutic dose of 800 mg twice daily until Investigator-assessed clinical disease progression per standard practice, unacceptable toxicity, withdrawal of consent, or termination of the study by the sponsor. All subjects who receive the recommended therapeutic dose of 800 mg Tazemetostat twice daily for 9 Cycles or longer, and are eligible to continue receiving Tazemetostat, will transfer to a Rollover Study (EZH-501) for monitoring and continued study drug at the Investigator and Medical Monitor's discretion.

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 Follicular Lymphoma, Hematologic Malignancy, Connective and Soft Tissue Neoplasm, Diffuse Large B-Cell Lymphoma, Rhabdoid Tumor, Blood disorder, Lymphoma, Renal Cell Carcinoma, synovial sarcoma, Lymphoma, Mesothelioma, Sarcoma, Mesothelioma, Non-Hodgkin's Lymphoma, All Solid Tumors, Solid Tumors, Solid Tumor, Malignant Mesothelioma, Solid Neoplasm, All Malignancies, Advanced Malignancies, Solid Tumour, Sarcoma (Pediatric), Blood Cancer, Hematologic Cancer, Renal Cell Cancer, Hematological Disorders, Hematologic Neoplasms, Soft Tissue Sarcoma, non-hodgkin's lymphoma (nhl), diffuse large cell lymphoma, diffuse large b cell lymphoma, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies, epithelioid sarcoma
Treatment Itraconazole, rifampin, Tazemetostat
Clinical Study IdentifierNCT04537715
SponsorEpizyme, Inc.
Last Modified on4 June 2021

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