Actively Recruiting
MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
Led by Nationwide Children's Hospital · Updated on 2026-04-08
38
Participants Needed
10
Research Sites
208 weeks
Total Duration
On this page
Sponsors
N
Nationwide Children's Hospital
Lead Sponsor
C
Children's Hospital Colorado
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 months and 39 years at enrollment
- Histologically confirmed adamantinomatous craniopharyngioma (ACP) diagnosis
- Measurable disease present
- Stratum 1: Progressive or recurrent ACP at least 6 months after radiation therapy completion
- Karnofsky score 60 50% (patients >16 years) or Lansky score 60 50 (patients 60 16 years)
- Neurologic deficits stable for at least 7 days prior to enrollment
- Recovery or stabilization from prior treatments' acute toxic effects
- At least 7 days since last biologic anti-cancer agent dose
- At least 42 days since completion of systemic immunotherapy
- At least 21 days since last monoclonal antibody dose
- Last radiation fraction at least 6 months prior; no prior craniospinal irradiation
- Stable or decreasing corticosteroid dose for at least 1 week
- At least 21 days since last systemic myelosuppressive therapy
- At least 6 weeks since major or intermediate surgery
- Adequate bone marrow, renal, liver, cardiac, and neurologic function as defined
- Informed consent signed by patient or guardian
You will not qualify if you...
- Pregnant or breast-feeding females
- Inability to use effective contraception if of reproductive potential
- History of serious gastrointestinal disease or inability to absorb oral medications
- Unstable corticosteroid dose within 7 days prior to enrollment
- Currently receiving other investigational drugs or anti-cancer agents
- Uncontrolled infections
- Receipt of live or attenuated vaccines within 3 months prior to therapy
- Significant concurrent medical or surgical conditions jeopardizing safety
- History of HIV, Hepatitis B or C, or Tuberculosis infection
- Prior solid organ transplantation
- History of alcohol, drug, or chemical abuse within 6 months
- Surgery within the last 6 weeks or poor postsurgical wound healing
- Allergic reactions to compounds similar to tocilizumab and its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
5
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
6
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
7
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
8
Perth Children's Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
9
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N
Actively Recruiting
10
CHU Sainte-Justine
Montreal, Quebec, Canada
Actively Recruiting
Research Team
K
Kelsey H Troyer, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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