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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)
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.
Study details:
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, and/or bone scan, as well as a bone marrow aspiration and/or 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 12 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2018-04-17
Primary completion: 2027-09-30
Study completion finish: 2027-09-30
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT03213652
Intervention or 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
Conditions
- • Advanced Malignant Solid Neoplasm
- • Malignant Solid Neoplasm
- • Recurrent Ependymoma
- • 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 Soft Tissue Sarcoma
- • Refractory Hepatoblastoma
- • Refractory Langerhans Cell Histiocytosis
- • Refractory Malignant Germ Cell Tumor
- • 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
- • Wilms Tumor
- • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- • Recurrent Rhabdomyosarcoma
- • Refractory Ependymoma
- • Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- • Refractory Malignant Glioma
- • Refractory Soft Tissue Sarcoma
Find a site
Closest Location:
Perth Children's Hospital
Research sites nearby
Select from list below to view details:
Perth Children's Hospital
Perth, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Treatment (ensartinib)
| PROCEDURE: Biospecimen Collection
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Objective response rate | A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method. | From enrollment to the end of treatment, up to 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Percentage of patients experiencing grade 3 or higher adverse events | Percentage of patients experiencing grade 3 or higher adverse events will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All patients who receive at least one dose of protocol therapy will be considered in the evaluation of toxicity. | From enrollment to the end of treatment, up to 2 years |
Progression free survival (PFS) | Progression free survival will be defined as time from the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause. PFS along with the confidence intervals will be estimated using the Kaplan-Meier method. | From the initiation of protocol treatment to the occurrence of disease progression or disease recurrence or death from any cause, assessed up to 5 years |
Pharmacokinetic (PK) parameters | A descriptive analysis of PK parameters will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). | Pre-dose, 1, 2, 4, 6-8, and 20-24 hours post day 1 dose and pre-dose, 1, 2, 4, and 6-8 hours post day 28 dose of cycle 1 |
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