Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03213652
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2017-07-10
Brief Title:
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors Non-Hodgkin Lymphoma or Histiocytic Disorders With ALK or ROS1 Genomic Alterations 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 Ensartinib in Patients With Tumors Harboring ALK or ROS1 Genomic Alterations
Status:
RECRUITING
Status Verified Date:
2024-07
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 treatment trial studies how well ensartinib works in treating patients with solid tumors non-Hodgkin lymphoma or histiocytic disorders with ALK or ROS1 genomic alterations that have come back recurrent or does not respond to treatment refractory and may have spread from where it first started to nearby tissue lymph nodes or distant parts of the body advanced Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVE
I To determine the objective response rate ORR complete response partial response in pediatric patients treated with ensartinib with advanced solid tumors including central nervous system CNS tumors non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations
SECONDARY OBJECTIVES
I To estimate the progression free survival in pediatric patients treated with ensartinib with advanced solid tumors including CNS tumors non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations
II To obtain information about the tolerability of ensartinib in children with relapsed or refractory cancer
III To provide preliminary estimates of the pharmacokinetics of ensartinib in children with relapsed or refractory cancer
EXPLORATORY OBJECTIVES
I To evaluate other biomarkers as predictors of response to ensartinib and specifically whether tumors that harbor different missense mutations or fusions including the crizotinib resistant F1174L ALK variant will demonstrate differential response to ensartinib treatment
II To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid DNA
OUTLINE
Patients receive ensartinib orally PO once daily QD on days 1-28 Cycles repeat every 28 days for 2 years up to 26 cycles in the absence of disease progression or unacceptable toxicity Patients undergo an x-ray computed tomography CT scan magnetic resonance imaging MRI positron emission tomography PET scan radionuclide imaging andor bone scan as well as a bone marrow aspiration andor biopsy during screening and on study Patients also undergo blood sample collection on study
After completion of study treatment patients are followed up for 30 days
I To determine the objective response rate ORR complete response partial response in pediatric patients treated with ensartinib with advanced solid tumors including central nervous system CNS tumors non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations
SECONDARY OBJECTIVES
I To estimate the progression free survival in pediatric patients treated with ensartinib with advanced solid tumors including CNS tumors non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations
II To obtain information about the tolerability of ensartinib in children with relapsed or refractory cancer
III To provide preliminary estimates of the pharmacokinetics of ensartinib in children with relapsed or refractory cancer
EXPLORATORY OBJECTIVES
I To evaluate other biomarkers as predictors of response to ensartinib and specifically whether tumors that harbor different missense mutations or fusions including the crizotinib resistant F1174L ALK variant will demonstrate differential response to ensartinib treatment
II To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid DNA
OUTLINE
Patients receive ensartinib orally PO once daily QD on days 1-28 Cycles repeat every 28 days for 2 years up to 26 cycles in the absence of disease progression or unacceptable toxicity Patients undergo an x-ray computed tomography CT scan magnetic resonance imaging MRI positron emission tomography PET scan radionuclide imaging andor bone scan as well as a bone marrow aspiration andor biopsy during screening and on study Patients also undergo blood sample collection on study
After completion of study treatment patients are followed up for 30 days
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-2017-01243 | REGISTRY | None | None |
| APEC1621F | OTHER | None | None |
| APEC1621F | OTHER | None | None |