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NCT03387020 · ClinicalTrials.gov registry record · Phase 1
Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors
A Phase 1 study of Malignant Glioma and Recurrent Medulloblastoma, sponsored by Pediatric Brain Tumor Consortium.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 12
- Study locations
NCT03387020: Completed Phase 1 study of Malignant Glioma and Recurrent Medulloblastoma, sponsored by Pediatric Brain Tumor Consortium.
NCT03387020 is a Phase 1 study of Malignant Glioma and Recurrent Medulloblastoma that has completed, run by Pediatric Brain Tumor Consortium. The registered enrollment target is 22 participants, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (76% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03387020, a Phase 1 study of Malignant Glioma and Recurrent Medulloblastoma, has completed, sponsored by Pediatric Brain Tumor Consortium.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 12
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ribociclib and everolimus may work better at treating malignant brain tumors.
Primary Outcome
Defined as the highest dose level at which six patients have been treated with at most one patient experiencing a dose limiting toxicity (DLT) and the next higher dose level has been determined to be too toxic. Will be estimated using a Rolling-6 phase I design. Only patients who are evaluable for DLT will be consider for estimating of Maximum Tolerated Dose. Patient who were enrolled under Surgical cohort but received sufficient study defined treatment would also be evaluable for DLT.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Everolimus
- DRUG Ribociclib
- OTHER Pharmacological Study
Study Locations (12)
California
- Children's Hospital Los Angeles - Los Angeles
- Lucile Packard Children Hospital Stanford University - Palo Alto
Tennessee
- Pediatric Brain Tumor Consortium - Memphis
- St. Jude Children Research Hospital - Memphis
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Children's Healthcare of Atlanta - Atlanta
Maryland
- National Cancer Institute Pediatric Oncology Branch - Bethesda
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cincinnati Children Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-01-13 |
| Est. Completion | 2020-04-01 |
| Phase | Phase 1 |
What the finished NCT03387020 record still lists
NCT03387020 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 91-participant average among 40 other Malignant Glioma trials with a reported enrollment target (76% lower).
The record links to 7 conditions, with Malignant Glioma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03387020 lists 12 locations in 10 states (California, Tennessee, Colorado).
Frequently Asked Questions
What is clinical trial NCT03387020 about?
NCT03387020 is a clinical study titled "Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors". This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes need...
What is the current status of trial NCT03387020?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2018-01-13. Estimated completion is 2020-04-01.
What conditions does trial NCT03387020 study?
This clinical trial studies the following conditions: Malignant Glioma, Recurrent Medulloblastoma, Recurrent Diffuse Intrinsic Pontine Glioma, Recurrent Childhood Ependymoma, Refractory Diffuse Intrinsic Pontine Glioma.
What interventions are being tested in trial NCT03387020?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Everolimus (DRUG), Ribociclib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT03387020?
This trial is sponsored by Pediatric Brain Tumor Consortium, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03387020 being conducted?
This trial has 12 study locations across California, Colorado, District of Columbia, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Glioma
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 NCT03387020's enrollment target sits among peer trials
22 31st of 40 higher than 8 of 40 other Malignant Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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