Condition
Mesothelioma|BAP1 Loss of Function
Estimated Enrollment: 67
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Intervention Model: Single Group Assignment|Masking: No masking|Primary Purpose: Treatment
Study ID Numbers: EZH-203
Study First Received: July 27, 2016
Last Updated: March 23, 2017
Estimated Primary Completion Date: September 2018
Primary Outcome Measures:
Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Cmax|Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): Tmax|Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): AUC(0-t)|Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): AUC(0-∞)|Part 1: Pharmacokinetics profile of tazemetostat and its metabolite (plasma): t1/2|Part 1: Incidence of treatment-emergent adverse events as a measure of safety and tolerability|Part 2: To assess disease control rate (DCR) defined as number of subjects with complete response (CR), partial response (PR) and stable disease (SD)|Part 1 and 2: Incidence of treatment-emergent adverse events as a measure of safety and tolerability|Part 1 and 2: Overall response rate (ORR; complete response + partial response [CR + PR])|Part 1 and 2: Progression-free survival (PFS)|Part 1 and 2: Overall survival (OS)|Part 1 and 2: To evaluate the duration of response (DOR) in subjects with confirmed CR or PR|Part 1: Disease Control Rate (DCR)|Part 2: Population PK parameters: Cmax|Part 2: Population PK parameters: Tmax|Part 2: Population PK parameters: AUC(0-t)|Part 2: Population PK parameters: AUC(0-∞)|Part 2: Population PK parameters: t1/2|Part 2: Changes in H3K27me3 levels in tumor tissue as assessed by IHC
Sponsors and Collaborators:
Epizyme, Inc.
Website Link: https://ClinicalTrials.gov/show/NCT02860286
