Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03213665
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2017-07-10
Brief Title:
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
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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 SWISNF Complex
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 SWISNF complex subunits SMARCB1 or SMARCA4 at a dose of 520 mgm2dose twice daily for patients without any CNS involvement or 1200 mgm2dose 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 SWISNF 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
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 SWISNF complex subunits SMARCB1 or SMARCA4 at a dose of 520 mgm2dose twice daily for patients without any CNS involvement or 1200 mgm2dose 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 SWISNF 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA180886 | NIH | CTEP | httpsreporternihgovquickSearchU10CA180886 |
| NCI-2017-01245 | REGISTRY | None | None |
| APEC1621C | None | None | None |
| APEC1621C | OTHER | None | None |
| APEC1621C | OTHER | None | None |