Metastatic Malignant Solid Neoplasm Clinical Trial
Official title:
A Phase I Study of Single Agent Tazemetostat in Subjects With Advanced Solid Tumors and B-Cell Lymphomas With Hepatic Dysfunction
This phase I trial studies the best dose and side effects of tazemetostat in treating patients with solid tumors or B-cell lymphomas with liver dysfunction that have spread to other places in the body or cannot be removed by surgery. Tazemetostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine safety, tolerability and recommended phase 2 dose (RP2D) of tazemetostat in
patients with varying degrees of hepatic dysfunction.
SECONDARY OBJECTIVES:
I. To assess the pharmacokinetics (PK) profiles of tazemetostat in patients with varying
degrees of hepatic dysfunction.
II. To observe preliminary antitumor activity of tazemetostat in this population, especially
in tumors with aberrations in EZH2 or SWI/SNF complex pathways.
OUTLINE: This is a dose escalation study.
Patients receive tazemetostat orally (PO) twice daily (BID) on days 1-28. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks.
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