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OncoMatch/Clinical Trials/NCT05286788

MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Is NCT05286788 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Binimetinib Oral Tablet [Mektovi] for adamantinous craniopharyngioma.

Phase 2RecruitingNationwide Children's HospitalNCT05286788Data as of Jun 2026Location: United States · Australia · Canada

Treatment: Binimetinib Oral Tablet [Mektovi]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.

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Extracted eligibility criteria

Treatments studied

Other

Binimetinib Oral Tablet [Mektovi]

Demographics

Ages 1–39

Prior therapy

Cannot have received: craniospinal irradiation

No prior craniospinal irradiation is permitted

Lab requirements

Blood counts

ANC ≥1000/mm3; Platelet count ≥100,000/mm3 (transfusion independent, not receiving platelet transfusions for at least 7 days prior to enrollment); Hemoglobin >8 g/dL (may be transfused)

Kidney function

Creatinine clearance or radioisotope GFR > 70ml/min/1.73 m2 or age/gender-based serum creatinine maximums

Liver function

Total bilirubin ≤ 1.5 × institutional upper limit of normal; AST (SGOT) ≤ 2.5 × institutional upper limit of normal; ALT (SGPT) ≤ 2.5 × institutional upper limit of normal

Cardiac function

Left Ventricular Ejection Fraction greater than the institutional lower limit of normal by echocardiogram; QTc ≤ 480 msec (by Bazett formula)

Adequate Bone Marrow Function... Adequate Renal Function... Adequate Liver Function... Adequate Cardiac Function...

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Children's Hospital Colorado · Aurora, Colorado
  • Children's National Medical Center · Washington D.C., District of Columbia
  • Nicklaus Children's Hospital · Miami, Florida
  • Cincinnati Children's Hospital Medical Center · Cincinnati, Ohio
  • Nationwide Children's Hospital · Columbus, Ohio

Showing up to 5 US sites.

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Frequently asked questions

Is NCT05286788 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior craniospinal irradiation disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 39 years or younger and at least 1 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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