NCT03217253

Tazemetostat in Treating Patients With Metastatic or Unresectable Solid Tumors or B-Cell Lymphomas With Liver Dysfunction

A Phase I Study of Single Agent Tazemetostat in Subjects With Advanced Solid Tumors and B-Cell Lymphomas With Hepatic Dysfunction

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ann Arbor Stage III B-Cell Non-Hodgkin Lymphoma
• Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma
• Metastatic Malignant Solid Neoplasm
• Stage III Hepatocellular Carcinoma AJCC v7
• Stage IIIA Hepatocellular Carcinoma AJCC v7
• Stage IIIB Hepatocellular Carcinoma AJCC v7
• Stage IIIC Hepatocellular Carcinoma AJCC v7
• Stage IV Hepatocellular Carcinoma AJCC v7
• Stage IVA Hepatocellular Carcinoma AJCC v7
• Stage IVB Hepatocellular Carcinoma AJCC v7
• Unresectable Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
DRUG	Tazemetostat	Given PO

Timeline

• Start date: 2018-03-16
• Primary completion: 2019-09-19
• Completion: 2019-09-19
• First posted: 2017-07-14
• Last updated: 2020-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study