Clinical Trials Directory

Trials / Completed

CompletedNCT03213665

Tazemetostat in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With EZH2, SMARCB1, or SMARCA4 Gene Mutations (A Pediatric MATCH Treatment Trial)

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Tazemetostat in Patients With Tumors Harboring Alterations in EZH2 or Members of the SWI/SNF Complex

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
12 Months – 21 Years
Healthy volunteers
Not accepted

Summary

This phase II Pediatric MATCH trial studies how well tazemetostat works in treating patients with brain tumors, solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have come back (relapsed) or do not respond to treatment (refractory) and have EZH2, SMARCB1, or SMARCA4 gene mutations. Tazemetostat may stop the growth of tumor cells by blocking EZH2 and its relation to some of the pathways needed for cell proliferation.

Detailed description

PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with tazemetostat with advanced solid tumors (including central nervous system \[CNS\] tumors), non-Hodgkin lymphoma or histiocytic disorders that harbor gain of function mutations in EZH2, or loss of function mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4 at a dose of 520 mg/m\^2/dose twice daily for patients without any CNS involvement or 1200 mg/m\^2/dose orally twice daily for patients with CNS involvement. SECONDARY OBJECTIVES: I. To estimate the progression-free survival in pediatric patients treated with tazemetostat that harbor gain of function mutations in EZH2, or loss of function mutations in the SWI/SNF complex subunits SMARCB1 or SMARCA4. II. To obtain information about the tolerability of tazemetostat in children with relapsed or refractory cancer. EXPLORATORY OBJECTIVES: I. To evaluate other biomarkers as predictors of response to tazemetostat and specifically, whether tumors that harbor different missense mutations or fusions will demonstrate differential response to tazemetostat treatment. II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive tazemetostat orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

TypeNameDescription
DRUGTazemetostatGiven PO

Timeline

Start date
2017-11-13
Primary completion
2022-03-31
Completion
2024-12-31
First posted
2017-07-11
Last updated
2026-04-13
Results posted
2023-04-27

Locations

117 sites across 2 countries: United States, Puerto Rico

Regulatory

Source: ClinicalTrials.gov record NCT03213665. Inclusion in this directory is not an endorsement.