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mTOR Inhibitor

Ribociclib + Everolimus for Brain Tumors

Phase 2

Waitlist Available

Led By Maryam Fouladi, MD

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months

Awards & highlights

Study Summary

This trial will test if a combo of drugs can help extend life for pediatric and young adult patients with HGG, like DIPG.

Who is the study for?

This trial is for young patients aged between 1 and 30 with high-grade gliomas, including DIPG. They must have a specific body surface area, certain genetic tumor changes, and be able to perform daily activities at least half the time. Pregnant individuals or those on certain drugs that affect liver enzymes or prolong QTc interval are excluded.Check my eligibility

What is being tested?

The study tests Ribociclib and Everolimus in children and young adults with brain tumors like HGG/DIPG. It aims to see if these drugs can extend patients' lives by targeting specific genetic pathways involved in their cancer.See study design

What are the potential side effects?

Possible side effects of Ribociclib and Everolimus may include risk of infections, blood count changes, fatigue, mouth sores, rash, nausea, loss of appetite, altered taste sensation, diarrhea or constipation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date on treatment until date of death due to any cause or date of last follow-up, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish MTD and RP2D of ribociclib and everolimus (Part 2, Stratum D)

Number of participants with ribociclib and everolimus-related adverse events as assessed by CTCAE v5.0 (Part 1- initial feasibility study)

Overall Survival (OS) in DIPG (Part 2, Stratum B)

+1 more

Secondary outcome measures

Evaluate Health-Related Quality of Life Outcomes

Number of participants with ribociclib and everolimus-related adverse events as assessed by CTCAE v5.0

Objective Response Rate (ORR) in DIPG

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Stratum D (n=6-12)Experimental Treatment2 Interventions

Patients with metastatic/disseminated HGG, multifocal HGG, and/or gliomatosis cerebri who received craniospinal irradiation.

Group II: Stratum C (n=6-12)Experimental Treatment2 Interventions

Patients with primary thalamic, spinal cord, and/or secondary (radiation-related) HGG.

Group III: Stratum B (n=40)Experimental Treatment2 Interventions

Patients with DIPG, defined as a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (e.g., diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma).

Group IV: Stratum A (n=40)Experimental Treatment2 Interventions

Patients with localized, intracranial, non-pontine, and non-thalamic HGG (who do not meet criteria for strata B, C, or D).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ribociclib

2018

Completed Phase 3

~2330

Everolimus

2010

Completed Phase 4

~1510

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor

1,610 Previous Clinical Trials

2,719,170 Total Patients Enrolled

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,403 Total Patients Enrolled

Maryam Fouladi, MDPrincipal InvestigatorNationwide Children's Hospital

11 Previous Clinical Trials

2,365 Total Patients Enrolled

Media Library

Everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05843253 — Phase 2

Anaplastic Astrocytoma Research Study Groups: Stratum B (n=40), Stratum D (n=6-12), Stratum C (n=6-12), Stratum A (n=40)

Anaplastic Astrocytoma Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT05843253 — Phase 2

Everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05843253 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age cutoff for participation in this investigation?

"This trial has strict eligibility requirements, limiting participants aged between 12 months and 30 years old. Clinicaltrials.gov houses 155 studies for people under 18 while 708 are available to those over 65."

Answered by AI

How many sites are currently engaging in this research?

"This trial is recruiting from 18 different medical centres, including the Children's National Medical Centre in Washington, Ann & Robert H. Lurie Children's Hospital of Chicago in Chicago and Dana-Farber Cancer Institute in Boston, as well as 15 other sites."

Answered by AI

Is recruitment ongoing for this research study?

"According to clinicaltrials.gov, the current state of this trial does not involve patient recruitment. While it was initially posted on August 15th 2023 and last updated on May 2nd 2023, there are 845 other medical studies currently accepting patients for enrolment."

Answered by AI

Does Stratum A (n=40) have valid regulatory clearance?

"As this is a Phase 2 trial with some evidence of safety but none for efficacy, we have evaluated Stratum A (n=40) to be of moderate risk and assigned it a score of 2."

Answered by AI

Could I feasibly partake in this experiment?

"This clinical trial requires participants to have glioblastoma and must be within the age bracket of 12 months until 30 years old. Approximately 100 people will be admitted."

Answered by AI

What positive results are expected from this clinical investigation?

"The primary outcome for this research endeavour, spanning from the date of treatment to either Progressive Disease or death attributed to any cause and assessed up to 60 months later, is Overall Survival (OS) in DIPG. Assessing Objective Response Rates (ORR) in both HGG and DIPG as well as reporting Adverse Events associated with ribociclib and everolimus via CTCAE v5.0 also form Secondary outcomes for this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Ribociclib and Everolimus in HGG and DIPG

2024. "Study of Ribociclib and Everolimus in HGG and DIPG". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05843253.

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