NCT01897571

Study of Tazemetostat as Single Agent in Solid Tumors or B-cell Lymphomas and in Combination With Prednisolone in DLBCL

An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Epizyme, Inc. · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).

Detailed description

This is a multicenter, open-label, Phase 1/2 study conducted in two parts: The Phase 1 part comprised dose escalation and expansion to establish the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) when tazemetostat was given twice daily (BID) orally on a continuous basis. Additionally, in separate cohorts in Phase 1, the effect of food on the bioavailability of tazemetostat as well as the drug-drug interaction (DDI) potential of tazemetostat were evaluated. The Phase 2 part was initiated once the RP2D was established. Phase 2 enrolled subjects with relapsed/ refectory (R/R) DLBCL (Cohorts 1-3 and 6) and subjects with R/R FL (Cohorts 4 and 5) for the determination of efficacy and safety of tazemetostat monotherapy (Cohorts 1-5) and of tazemetostat in combination with prednisolone (Cohort 6) with placement determined by centrally confirmed histology, cell of origin (COO), and enhancer of zeste homologue 2 (EZH2) mutation status.

Conditions

• B-cell Lymphomas (Phase 1)
• Advanced Solid Tumors (Phase 1)
• Diffuse Large B-cell Lymphoma (Phase 2)
• Follicular Lymphoma (Phase 2)
• Transformed Follicular Lymphoma
• Primary Mediastinal Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tazemetostat	Patients who received 800 mg of tazemetostat, BID, administered in continuous 28-day cycles.
DRUG	Prednisolone	Patients who received 40 mg/m\^2 prednisolone once daily on Days 1-5 and 15-19 of Cycles 1-4.
DRUG	Tazemetostat	Patients who received 100 mg to 1600 mg of tazemetostat, BID, administered in continuous 28-day cycles.

Timeline

• Start date: 2013-06-13
• Primary completion: 2021-08-24
• Completion: 2021-11-02
• First posted: 2013-07-12
• Last updated: 2024-03-26
• Results posted: 2023-08-04

Locations

52 sites across 10 countries: United States, Australia, Canada, France, Germany, Italy, Poland, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study