MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Nationwide Children's Hospital
Study ID
NCT05286788
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adamantinous Craniopharyngioma
  • Recurrent Adamantinomatous Craniopharyngioma

Eligibility Criteria

Sex
ALL
Age
1 Year - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Binimetinib Oral Tablet [Mektovi] — DRUG
    Binimetinib oral continuous dosing 32 mg/m2 PO BID for 4 weeks

Study Details

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.

Key Dates

Start date
Apr 10, 2023
Status verified
Apr 2026
Primary completion
Apr 10, 2027
Completion
Apr 10, 2027

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum 1 and Stratum 2
    Stratum 1: Patients with progressive or recurrent adamantinomatous craniopharyngiomas following radiation therapy. Stratum 2 (NOT CURRENTLY ENROLLING): Patients with measurable adamantinomatous craniopharyngioma who have undergone surgery but have not previously received radiation therapy. Progressive disease is allowed but not required

Primary Outcome Measure

Sustained objective response rate of patients with recurrent/progressive previously irradiated ACP to treatment with oral binimetinib [ Time Frame: From Day 1 of treatment through 30 days following end of protocol treatment ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Holly Lindsay, MD
[email protected]
720-777-6740
Children's National Medical CenterWashington D.C.District of Columbia20010
Eugene Hwang, MD
[email protected]
202-476-2800
Nicklaus Children's HospitalMiamiFlorida33155
Ziad Khatib, MD
[email protected]
3056628360
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Peter de Blank, MD
[email protected]
513-517-2068
Nationwide Children's HospitalColumbusOhio43205
Maryam Fouladi, MD
[email protected]
614-722-5758

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, COChildren's National Medical Center· Washington D.C., DCNicklaus Children's Hospital· Miami, FLCincinnati Children's Hospital Medical Center· Cincinnati, OHNationwide Children's Hospital· Columbus, OH

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