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MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

NCT05286788 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-08

No results posted yet for this study

Summary

MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. The biological activity of binimetinib that has been evaluated bith in vitro and in vivo in a wide variety of tumor types In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

Conditions

  • Adamantinous Craniopharyngioma
  • Recurrent Adamantinomatous Craniopharyngioma

Interventions

DRUG

Binimetinib Oral Tablet [Mektovi]

Binimetinib oral continuous dosing 32 mg/m2 PO BID for 4 weeks

Sponsors & Collaborators

  • Children's Hospital Colorado

    collaborator OTHER

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Holly Lindsay, MD · Children's Hospital Colorado

  • Todd C Hankinson, MD · Children's Hospital Colorado

  • Maryam Fouladi, MD · Nationwide Children's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2027-04-10
Completion
2027-04-10
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05286788 on ClinicalTrials.gov