This study will provide continuing availability to tazemetostat for people that have previously completed participation in a tazemetostat study, either with monotherapy (single drug treatment) or combination therapy. The aim of the study will be to assess the long-term safety of tezemetostat.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of enhancer of Zeste homolog 2 (EZH2), a histone-lysine N-methyltransferase enzyme.
University of Arizona Cancer Center
Tucson, Arizona, United States
California Cancer Associates For Research And Excellence, cCARE
Santa Fe, California, United States
Hematology Oncology Associates of the Treasure Coast - Port St. Lucie
Port Saint Lucie, Florida, United States
Moffitt
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Percentage of Participants with Adverse Events (AEs) and Treatment Emergent Adverse Event (TEAEs)
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention Severity of adverse events experienced by all participants will be evaluated by the Investigator based on the CTCAE, version 5.0.
Time frame: Until end of study an average of 7 years
Duration of Study Drug Exposure
The average study drug exposure duration will be reported.
Time frame: Until end of study an average of 7 years
The overall survival (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
Time frame: Until end of study an average of 7 years
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University of Michigan
Ann Arbor, Michigan, United States
Central Care Cancer Center
Bolivar, Missouri, United States
Astera Cancer Center
East Brunswick, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
David H. Koch Center for Cancer Care at memorial Sloan Kettering Cancer Center
New York, New York, United States
...and 24 more locations