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NCT03598244 · ClinicalTrials.gov registry record · Phase 1
Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors
A Phase 1 study of Recurrent Malignant Glioma and Recurrent Medulloblastoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
- 12
- Study locations
NCT03598244: Active Phase 1 study of Recurrent Malignant Glioma and Recurrent Medulloblastoma, sponsored by National Cancer Institute (NCI).
NCT03598244 is a Phase 1 study of Recurrent Malignant Glioma and Recurrent Medulloblastoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 41 participants, above the 24-participant average among 17 other Recurrent Malignant Glioma trials with a reported enrollment target (71% higher). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598244, a Phase 1 study of Recurrent Malignant Glioma and Recurrent Medulloblastoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
- 12
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of volitinib in treating patients with primary central nervous system (CNS) tumors that have come back (recurrent) or does not respond to treatment (refractory). Volitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
The maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of savolitinib were determined using a Rolling-6 Phase I dose-escalation design. Dose escalation was conducted in cohorts of two to six participants, starting at Dose Level 1. The MTD was defined based on the occurrence of dose-limiting toxicities during the dose-finding period (Course 1: 28 days) according to protocol-specified criteria. No intra-patient dose escalation was permitted. Participants were considered evaluable fo
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE X-Ray Imaging
- DRUG Savolitinib
Study Locations (12)
California
- Children's Hospital Los Angeles - Los Angeles
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Illinois
- Lurie Children's Hospital-Chicago - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Tennessee
- Saint Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2026-04-14 |
| Phase | Phase 1 |
What the registry record for NCT03598244 still lists
NCT03598244 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, above the 24-participant average among 17 other Recurrent Malignant Glioma trials with a reported enrollment target (71% higher).
The record links to 8 conditions, with Recurrent Malignant Glioma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT03598244 lists 12 locations in 10 states (California, Ohio, Colorado).
Frequently Asked Questions
What is clinical trial NCT03598244 about?
NCT03598244 is a clinical study titled "Volitinib in Treating Patients With Recurrent or Refractory Primary CNS Tumors". This phase I trial studies the side effects and best dose of volitinib in treating patients with primary central nervous system (CNS) tumors that have come back (recurrent) or does not respond to treatment (refractory). Volitinib may stop the growth of tumor cells by blocking some of the enzymes nee...
What is the current status of trial NCT03598244?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2018-11-27. Estimated completion is 2026-04-14.
What conditions does trial NCT03598244 study?
This clinical trial studies the following conditions: Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Diffuse Intrinsic Pontine Glioma, Refractory Diffuse Intrinsic Pontine Glioma, Recurrent Primary Central Nervous System Neoplasm.
What interventions are being tested in trial NCT03598244?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), X-Ray Imaging (PROCEDURE), Savolitinib (DRUG).
Who is sponsoring clinical trial NCT03598244?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03598244 being conducted?
This trial has 12 study locations across California, Colorado, District of Columbia, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03598244's enrollment target sits among peer trials
41 3rd of 17 higher than 15 of 17 other Recurrent Malignant Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Malignant Glioma 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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