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A Phase I, Open-label Multi-dose Pharmacokinetic and Safety Study of Oral Tazemetostat in Subjects With Moderate and Severe Hepatic Impairment With Advanced Malignancies.

Primary:
The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) of tazemetostat and its metabolite EPZ-6930, when administered as a single and twice daily oral dose in subjects with advanced malignancies and moderate or severe hepatic impairment (based on the National Cancer Institute (NCI) Organ Dysfunction Working Group (ODWG) criteria), compared with subjects with advanced malignancies and normal hepatic function.

Secondary:
The secondary objective of this study is to evaluate the steady-state safety of tazemetostat and its metabolite EPZ-6930 when administered as a single and twice daily oral dose in subjects with advanced malignancies and moderate or severe hepatic impairment (based on the National Cancer Institute (NCI) Organ Dysfunction Working Group (ODWG) criteria), compared with subjects with advanced malignancies and normal hepatic function.

Protocol Number: 052405
Phase: Phase I
Applicable Disease Sites: Any Site
Drugs Involved: Tazemetostat
Principal Investigator: Sanjay Goel
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

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