CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Everolimus +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03387020
NCT03387020Phase 1Completed

A Phase I and Surgical Study of Ribociclib and Everolimus (RAD001) in Children With Recurrent or Refractory Malignant Brain Tumors

Pediatric Brain Tumor Consortium·interventional·Posted Dec 29, 2017·Updated Aug 27, 2021

In Brief

A Phase 1 clinical trial evaluating Everolimus, Laboratory Biomarker Analysis, and 2 other interventions for CNS Embryonal Tumor, Not Otherwise Specified and 6 related conditions. Completed, enrolled 22 participants across 12 sites.

Detailed 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.

Study Details

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 29, 2017
Enrollment StartJan 13, 2018
Primary CompletionApr 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 8.5 years ago

Interventions

Everolimusdrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacological Studyother

Correlative studies

Ribociclibdrug

Given PO