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 26 March 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 on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female ≥ 18 years age at the time of consent
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Has the ability to understand informed consent, and provide signed written informed consent
Life expectancy of > 3 months
Histologically and/or cytologically confirmed advanced metastatic or unresectable solid tumors has progressed after treatment for which there are no standard therapies available OR histologically and/or cytologically confirmed hematologic malignancies that have relapsed, or refractory disease, following at least 2 standard lines of systemic therapy for which there are no standard therapies available
Note: Subjects with prior radiotherapy will be included; however, radiotherapy
alone will not be considered a separate systemic treatment regimen
Must have evaluable or measurable disease
Has all prior treatment (ie, chemotherapy, immunotherapy, radiotherapy) related clinically significant toxicities resolve to ≤ Grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0 or are clinically stable and not clinically significant, at time of consent
All subjects must have completed any prior chemotherapy, targeted therapy and major surgery ≥ 28 days before study entry. For daily or weekly chemotherapy without the potential for delayed toxicity, a washout period of 14 days or 5 half-lives, whichever is shorter may be acceptable
Has normal hepatic function (per NCI-ODWG criteria) as well as adequate hematologic (bone marrow [BM] and coagulation factors) and renal function
Able to swallow and retain orally-administered medication and without clinically significant gastrointestinal abnormalities that could alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
Females of childbearing potential (FCBP) must have a negative serum pregnancy test and must either practice complete abstinence or agree to use a highly effective method of contraception
Male subjects must have had a successful vasectomy OR must either practice complete abstinence or agree to use a latex or synthetic condom during sexual contact with a female of childbearing potential (FCBP) during study treatment (including during dose interruptions), and for 3 months after study drug discontinuation
NOTE: Male subjects must not donate sperm during study treatment (including
during dose interruptions), and for 3 months after study drug discontinuation
Has a QT interval corrected by Fridericia's formula (QTcF) ≤450 msec

Exclusion Criteria

Symptomatic or untreated leptomeningeal or brain metastases or spinal cord compression or primary glioblastoma multiforme
Clinically significant bleeding diathesis or coagulopathy
Known hypersensitivity to any of the components of Tazemetostat, itraconazole, or rifampin
Use of concurrent investigational agent or anticancer therapy
Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements
Have a known active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), AND/OR human T-cell lymphotropic virus 1
Subjects taking medications that are known CYP3A4 inducers or inhibitors (including St. John's Wort)
Is unwilling to exclude grapefruit juice, Seville oranges and grapefruit from the diet and all foods that contain those fruits from 24 hours prior to the first dose of study drug until the last dose of study drug
Any condition or medical problem in addition to the underlying malignancy and organ dysfunction that the Investigator feels would pose unacceptable risk
Has a prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or myeloproliferative neoplasm (MPN) or T-cell lymphoblastic lymphoma (T-LBL)/ T-cell acute lymphoblastic leukemia (T-ALL)
Ingestion of alcohol within 72 hours prior to day 1 of Cycle 1 until the end of Cycle 1 (Day 39 for Part 1 and Day 26 for Part 2). Regular alcohol consumption must not exceed 16 units for males and 7 units for females per week (2 units equals 40mL [a can] of beer, 175mL [a standard glass] of wine, or 50 mL [2 small shots] of spirits
Any form of marijuana use
History of drug abuse (including alcohol) within the last 6 months prior to screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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