Clinical Trial: NCT03213652
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)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | National Cancer Institute (NCI) |
| Information Provided By: | National Cancer Institute (NCI) |
| Last Update Posted: | 2026-10-06 |
Study Overview
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.
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
Conditions
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Primary Central Nervous System Neoplasm, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Refractory Ependymoma, Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Primary Central Nervous System Neoplasm, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Wilms Tumor
Intervention / Treatment
- Procedure: Biospecimen Collection
- Procedure: Bone Marrow Aspiration and Biopsy
- Procedure: Bone Scan
- Procedure: Computed Tomography
- Drug: Ensartinib
- Other: Laboratory Biomarker Analysis
- Procedure: Magnetic Resonance Imaging
- Other: Pharmacological Study
- Procedure: Positron Emission Tomography
- Procedure: Radionuclide Imaging
- Procedure: X-Ray Imaging
Other Study ID Numbers
- NCI-2017-01243
- NCI-2017-01243
- APEC1621F
- APEC1621F
- U10CA180886
Start Date (Actual)
2018-04-17
Primary Completion Date (Actual)
2025-09-30
Study Completion Date (Estimated)
2027-10-05
Enrollment (Actual)
13
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | National Cancer Institute (NCI) |
| Information Provided By: | National Cancer Institute (NCI) |
| Last Update Posted: | 2026-10-06 |
Study Overview
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.
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
Conditions
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Primary Central Nervous System Neoplasm, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Refractory Ependymoma, Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Primary Central Nervous System Neoplasm, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Wilms Tumor
Intervention / Treatment
- Procedure: Biospecimen Collection
- Procedure: Bone Marrow Aspiration and Biopsy
- Procedure: Bone Scan
- Procedure: Computed Tomography
- Drug: Ensartinib
- Other: Laboratory Biomarker Analysis
- Procedure: Magnetic Resonance Imaging
- Other: Pharmacological Study
- Procedure: Positron Emission Tomography
- Procedure: Radionuclide Imaging
- Procedure: X-Ray Imaging
Other Study ID Numbers
- NCI-2017-01243
- NCI-2017-01243
- APEC1621F
- APEC1621F
- U10CA180886
Start Date (Actual)
2018-04-17
Primary Completion Date (Actual)
2025-09-30
Study Completion Date (Estimated)
2027-10-05
Enrollment (Actual)
13
Study Type
Interventional
Phase
Phase 2