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MEK Inhibitor

MEKTOVI for Pediatric Craniopharyngioma

Phase 2

Recruiting

Led By Maryam Fouladi

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

Patients must be ≥ 12 months and ≤ 25 years of age at the time of study enrollment

Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial will test the effectiveness of MEKTOVI (binimetinib) in children with a specific type of brain tumor who have undergone surgery and/or radiation therapy.

Who is the study for?

This trial is for kids and young adults aged 1 to 25 with recurrent Adamantinomatous Craniopharyngioma, a type of brain tumor. They must have measurable disease, stable health conditions, and meet specific organ function criteria. Those who've had recent surgery or certain treatments aren't eligible.Check my eligibility

What is being tested?

The trial tests MEKTOVI (binimetinib), an oral drug that blocks specific enzymes in cancer cells. It's given to patients who've had previous surgeries or radiation therapy for their brain tumors. The study aims to see how well it works in these young patients.See study design

What are the potential side effects?

Possible side effects include digestive issues, liver problems, heart complications like changes in heartbeat rhythm, blood disorders such as low counts of white cells or platelets which can increase infection risk and bleeding tendency respectively.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 months and 25 years old.

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I am mostly able to care for myself, regardless of my age.

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I have been diagnosed with adamantinomatous craniopharyngioma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Sustained objective response rate of patients with measurable ACP who have undergone surgery but have not been previously treated with radiation to treatment with oral binimetinib

Sustained objective response rate of patients with recurrent/progressive previously irradiated ACP to treatment with oral binimetinib

Secondary outcome measures

Biological effects of binimetinib on ACP tumor tissue and cyst fluid.

PFS of ACP patients treated with binimetinib after radiation

PFS of ACP patients treated with binimetinib who have not received radiation

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stratum 1 and Stratum 2Experimental Treatment1 Intervention

Stratum 1: Patients with progressive or recurrent adamantinomatous craniopharyngiomas following radiation therapy. Stratum 2: Patients with measurable adamantinomatous craniopharyngioma who have undergone surgery but have not previously received radiation therapy. Progressive disease is allowed but not required

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,468 Total Patients Enrolled

Children's Hospital ColoradoOTHER

116 Previous Clinical Trials

5,132,577 Total Patients Enrolled

Maryam FouladiPrincipal InvestigatorNationwide Children's Hospital

9 Previous Clinical Trials

475 Total Patients Enrolled

Media Library

Binimetinib (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05286788 — Phase 2

Adamantinous Craniopharyngioma Research Study Groups: Stratum 1 and Stratum 2

Adamantinous Craniopharyngioma Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT05286788 — Phase 2

Binimetinib (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05286788 — Phase 2

Frequently Asked Questions

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

Does this experiment only test on individuals who are 50 or younger?

"In order to be eligible for this trial, potential participants must between the ages of 1 and 25. There are 9 other clinical trials that patients under 18 can participate in and 3 additional trials for patients over 65."

Answered by AI

Are participants being accepted into the clinical trial at this time?

"This study, which was last updated on October 18th, is not enrolling patients at the moment. However, there are 11 other trials that are currently looking for enrollees."

Answered by AI

What goals does this research hope to realize?

"The primary goal of this 24 month study is to determine the efficacy of binimetinib in patients with recurrent/progressive anaplastic large cell lymphoma who have undergone radiation therapy. Additionally, researchers will be measuring one-year progression-free survival rates for two different groups of patients: those that have received radiation therapy and those that have not. Lastly, another aim is to document any negative side effects experienced by children taking binimetinib as a treatment for recurrent or refractory anaplastic large cell lymphoma."

Answered by AI

Who would be an appropriate candidate for this research project?

"This clinical trial is looking for 38 people with adamantinous craniopharyngioma between the ages of 1 Year and 25. Most notable, applicants must meet the following criteria: Age: Patients must be ≥ 12 months and ≤ 25 years of age at the time of study enrollment., Diagnosis: Patients with histologically-confirmed adamantinomatous craniopharyngioma (ACP) Histologic confirmation of ACP may be made on solid tumor or, if no solid tumor can be safely obtained, cyst fluid with classic ACP characteristics of thick, cholesterol-rich, greenish-brown liquid in"

Answered by AI

What are the risks associated with taking Binimetinib Oral Tablet [Mektovi]?

"Binimetinib Oral Tablet [Mektovi] is a medication that, according to our team's research, falls on the second tier of safety. This is due to it being in Phase 2 clinical trials; while there is data suggesting it is safe, none of the studies have shown it to be effective."

Answered by AI

Recent research and studies

DevelopmentJournal

MAPK Pathway Activation in the Embryonic Pituitary Results in Stem Cell Compartment Expansion, Differentiation Defects and Provides Insights into the Pathogenesis of Papillary Craniopharyngioma

Haston, S., S. Pozzi, G. Carreno, S. Manshaei, L. Panousopoulos, J. M. Gonzalez-Meljem, J. R. Apps, et al.. 2017. “MAPK Pathway Activation in the Embryonic Pituitary Results in Stem Cell Compartment Expansion, Differentiation Defects and Provides Insights into the Pathogenesis of Papillary Craniopharyngioma”. Development. The Company of Biologists. doi:10.1242/dev.150490.

Neuro-OncologyJournal

Phase II Study of Peginterferon Alpha-2b for Patients with Unresectable or Recurrent Craniopharyngiomas: A Pediatric Brain Tumor Consortium Report

Goldman, Stewart, Ian F Pollack, Regina I Jakacki, Catherine A Billups, Tina Y Poussaint, Adekunle M Adesina, Ashok Panigrahy, et al.. 2020. “Phase II Study of Peginterferon Alpha-2b for Patients with Unresectable or Recurrent Craniopharyngiomas: A Pediatric Brain Tumor Consortium Report”. Neuro-oncology. Oxford University Press (OUP). doi:10.1093/neuonc/noaa119.

Acta NeuropathologicaJournal

Tumour Compartment Transcriptomics Demonstrates the Activation of Inflammatory and Odontogenic Programmes in Human Adamantinomatous Craniopharyngioma and Identifies the MAPK/ERK Pathway as a Novel Therapeutic Target

Apps, John R., Gabriela Carreno, Jose Mario Gonzalez-Meljem, Scott Haston, Romain Guiho, Julie E. Cooper, Saba Manshaei, et al.. 2018. “Tumour Compartment Transcriptomics Demonstrates the Activation of Inflammatory and Odontogenic Programmes in Human Adamantinomatous Craniopharyngioma and Identifies the MAPK/ERK Pathway as a Novel Therapeutic Target”. Acta Neuropathologica. Springer Science and Business Media LLC. doi:10.1007/s00401-018-1830-2.

Journal of Neuro-OncologyJournal