A Two-part Study to Characterize Drug-Drug Interaction Effects on Steady-State Pharmacokinetics of Oral Tazemetostat
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Follicular Lymphoma ( FL)
- Advanced Malignancies
- All Malignancies
- Synovial Sarcoma
- Diffuse Large B Cell Lymphoma (DLBCL)
- Epithelioid Sarcoma (ES)
- Hematologic Malignancy
- Mesothelioma
- Non Hodgkin Lymphoma (NHL)
- Renal Medullary Carcinoma
- Rhabdoid Tumor
- Solid Tumor
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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: Tazemetosta...
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.
Tracking Information
- NCT #
- NCT04537715
- Collaborators
- Not Provided
- Investigators
- Not Provided