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Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels

NCT04537715 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-19

Study results available
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Summary

The participants of this study will have advanced malignancies (also known as advanced cancer). The main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the tazemtostat (the study drug) when administered in combination with another drug.

Part 1 of the study will evaluate the interaction between the drugs tazemetostat and itraconazole.

Part 2 of the study will evaluate the interaction between the drugs tazemetostat and rifampin

For both Parts 1 and 2, safety and the level that effects of the study drug can be tolerated (known as tolerability) will be assessed throughout.

Conditions

  • 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

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.

Sponsors & Collaborators

  • Epizyme, Inc.

    lead INDUSTRY

Principal Investigators

  • Ipse Medical Director · Ipsen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-23
Primary Completion
2023-04-03
Completion
2023-04-03
FDA Drug
Yes

Countries

  • United States
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04537715 on ClinicalTrials.gov