This is a phase 1, 2-part, global, multicenter, open-label, PK, safety and tolerability study
of oral tazemetostat in subjects with either advanced solid tumors, or hematological
malignancies and normal hepatic function or moderate, or severe hepatic impairment.
The study will be conducted in 2 parts for subjects with advanced malignancies and either
normal liver function, or advanced malignancies and moderate, or severe hepatic impairment.
Subjects in Part 1 of the study will receive a single oral, 800 mg dose of tazemetostat on
Day 1 and Day 15. In addition, the subjects will receive tazemetostat (oral 800 mg dose)
tablets to be taken twice daily from Day 5 to Day 14. Blood samples for PK analysis will be
obtained on Day 1 through Day 4 and again on Day 15 through Day 18. Part 1 ends on Day 18.
Subjects continuing treatment in Part 2 will receive tazemetostat (oral 800 mg dose) tablets
to be taken twice daily in repeated 28-day cycles beginning on Day 19 until
Investigator-assessed clinical progression per standard practice, or unacceptable toxicity,
or until another discontinuation criterion is met. Subjects must have an end of study visit
after 30 days of the last dose of tazemetostat for safety assessment. Supplementary study
conduct information not mandated to be present in this protocol is provided in the
accompanying procedure manuals (i.e., laboratory, pharmacy, ECG manuals). Such manuals will
provide the site personnel with administrative and detailed technical information that does
not impact subject safety.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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