Viewing Study NCT02860286



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Last Modification Date: 2024-10-26 @ 12:07 PM
Study NCT ID: NCT02860286
Status: COMPLETED
Last Update Posted: 2021-04-09
First Post: 2016-07-27

Brief Title: Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma
Sponsor: Epizyme Inc
Organization: Epizyme Inc

Study Overview

Official Title: A Multicenter Study of the EZH2 Inhibitor Tazemetostat in Adult Subjects With Relapsed or Refractory Malignant Mesothelioma With BAP1 Loss of Function
Status: COMPLETED
Status Verified Date: 2021-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a Phase 2 multicenter open-label 2-part single-arm 2-stage study of tazemetostat 800 mg two times a day BID administered orally Screening of subjects to determine eligibility for the study will be performed within 21 days of the first planned dose of tazemetostat

In Part 1 planned to enroll 12 subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status will be treated and undergo pharmacokinetics PK blood sample collection after a single tazemetostat 800 mg

Part 2 plans to include 55 subjects with BAP1-deficient relapsed or refractory malignant mesothelioma

Treatment with tazemetostat will continue until disease progression unacceptable toxicity or withdrawal of consent or termination of the study Response assessment will be evaluated after 6 weeks of treatment and then every 12 weeks thereafter while on study
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None