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NCT03213652 · ClinicalTrials.gov registry record · Phase 2
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)
A Phase 2 study of Malignant Solid Neoplasm and Advanced Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 20
- Study locations
NCT03213652: Active Phase 2 study of Malignant Solid Neoplasm and Advanced Malignant Solid Neoplasm, sponsored by National Cancer Institute (NCI).
NCT03213652 is a Phase 2 study of Malignant Solid Neoplasm and Advanced Malignant Solid Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03213652, a Phase 2 study of Malignant Solid Neoplasm and Advanced Malignant Solid Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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. The revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to determine response and progression in this study, with specific criteria outlined for the different subtypes of tumors (e.g., 2-dimensional measurements for central nervous system (CNS) t
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Bone Scan
- PROCEDURE Bone Marrow Aspiration and Biopsy
- DRUG Ensartinib
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Miller Children's and Women's Hospital Long Beach - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Valley Children's Hospital - Madera
- UCSF Benioff Children's Hospital Oakland - Oakland
- Kaiser Permanente-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
- UCSF Medical Center-Mission Bay - San Francisco
Arizona
- Banner Children's at Desert - Mesa
- Banner University Medical Center - Tucson - Tucson
Colorado
- Children's Hospital Colorado - Aurora
- Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center - Denver
Alabama
- Children's Hospital of Alabama - Birmingham
Alaska
- Providence Alaska Medical Center - Anchorage
Arkansas
- Arkansas Children's Hospital - Little Rock
Connecticut
- Yale University - New Haven
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2026-10-03 |
| Phase | Phase 2 |
What the registry record for NCT03213652 still lists
NCT03213652 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 1,141-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (99% lower).
The record links to 10 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03213652 names 20 study sites across 9 states, led by California, Arizona, Colorado.
Frequently Asked Questions
What is clinical trial NCT03213652 about?
NCT03213652 is a clinical study titled "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 sprea...
What is the current status of trial NCT03213652?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2018-04-17. Estimated completion is 2026-10-03.
What conditions does trial NCT03213652 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Advanced Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Malignant Glioma, Recurrent Medulloblastoma.
What interventions are being tested in trial NCT03213652?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Bone Scan (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE), Ensartinib (DRUG).
Who is sponsoring clinical trial NCT03213652?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03213652 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03213652's enrollment target sits among peer trials
13 168th of 176 higher than 9 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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