Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study (TRuST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02875548|
Recruitment Status : Active, not recruiting
First Posted : August 23, 2016
Last Update Posted : May 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma (DLBCL) Follicular Lymphoma (FL) Synovial Sarcoma Epitheliod Sarcoma (ES) Mesothelioma Advanced Solid Tumors Renal Medullary Carcinoma Non-Hodgkin Lymphoma (NHL)||Drug: Tazemetostat||Phase 2|
This open-label, multicenter, global study will provide continuing access to tazemetostat therapy for subjects who have completed their participation in a prior tazemetostat study (either with monotherapy or combination therapy) without unacceptable toxicity, have not had evidence of tumor progression as defined by disease-appropriate standard criteria, and continue to receive clinical benefit from the therapy.
Subjects will receive tazemetostat as dictated in their antecedent study. Visits will be conducted per Standard of Care (SoC) as appropriate in each country and as determined by the Investigator. Subjects will be followed for long-term safety in addition to time to treatment failure (TTF) and overall survival (OS).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tazemetostat Rollover Study (TRuST): An Open-Label, Rollover Study|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||April 2024|
Experimental: Open-label Tazemetostat
Subjects will continue to receive the same tazemetostat dose and schedule as specified in their antecedent tazemetostat protocol. For subjects on combination therapy, the other therapeutic(s) must have been completed in the antecedent study or be provided by a source other than Epizyme if combination treatment is continued in this clinical rollover study.
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.
- The long-term safety profile of tazemetostat measured by number of AEs and duration of exposure to tazemetostat [ Time Frame: From the date of first dose to discontinuation for any reason, including disease progression, withdrawal of consent or death, up to 7 years ]
- The overall survival (OS) of subjects receiving tazemetostat [ Time Frame: From the date of the first dose of tazemetostat to the date of death due to any cause, up to 7 years ]OS, defined as the interval of time between the date of the first dose of tazemetostat and the date of death due to any cause
- The time to treatment failure (TTF) in subjects receiving tazemetostat [ Time Frame: The time from date of first dose of study treatment to treatment discontinuation for any reason including disease progression, treatment toxicity, subject preference or death, up to 7 years ]TTF, defined as the time from date of first dose of study drug to treatment discontinuation for any reason, including disease progression, treatment toxicity, subject preference, or death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875548