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New treatment option for Adamantinous Craniopharyngioma
Official title MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
ClinicalTrials.gov ID: NCT05286788
What this study is testing
What is Binimetinib Oral Tablet [Mektovi]?
Binimetinib Oral Tablet [Mektovi] is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for adamantinous craniopharyngioma.
Also referred to as MEKTOVI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 39
You may be able to join if
- Age: Patients must be ≥ 12 months and ≤ 39 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...
- Disease Status: Patients must have measurable disease.
- Stratum 1: Patients with progressive or recurrent ACP who demonstrate cystic and/or solid recurrence or progression at least 6 months post completion...
- Stratum 2 (NOT CURRENTLY ENROLLING): Patients with measurable ACP who have undergone surgery but have NOT previously undergone irradiation (but may...
You likely can't join if
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse...
- Gastrointestinal Disease:
- Patients with a history of serious gastrointestinal disease, including inflammatory bowel disease or gastrointestinal perforation
- Patients who are unable to absorb enteral medications
- Administration via NG/NJ/G-tube is allowed
- Concomitant Medications
See the full eligibility criteria
Who can join
- Age: Patients must be ≥ 12 months and ≤ 39 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...
- Disease Status: Patients must have measurable disease.
- Stratum 1: Patients with progressive or recurrent ACP who demonstrate cystic and/or solid recurrence or progression at least 6 months post completion of radiation therapy
- Stratum 2 (NOT CURRENTLY ENROLLING): Patients with measurable ACP who have undergone surgery but have NOT previously undergone irradiation (but may have received prior systemic or intracystic therapy). Progressive...
- Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Note: Neurologic deficits in patients with CNS tumors must have been stable for at...
- Prior Therapy: Patients must have recovered or stabilized from the acute toxic effects of prior treatments
- Biologic (anti-neoplastic agent): At least 7 days must have elapsed after the last (systemic or intracystic) dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after...
- Immunotherapy: At least 42 days after the completion of any type of systemic immunotherapy, e.g. tumor vaccines.
- Monoclonal antibodies: At least 21 days after the last dose of a monoclonal antibody.
- Radiation therapy: Patients must have had their last (conventional or hypofractionated) fraction of: a) Focal irradiation \> 6 months prior to enrollment and b) No prior craniospinal irradiation is permitted.
- Corticosteroids: Patients receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment
- Myelosuppressive systemic therapy: At least 21 days must have elapsed after the last systemic myelosuppressive therapy.
- Surgery: At least 6 weeks must have elapsed since major or intermediate surgery. Major surgery includes major craniotomy for tumor resection of cyst fenestration, organ resection, and exploratory laparotomy...
- Organ Function Requirements Adequate Bone Marrow Function Defined as:
- Peripheral absolute neutrophil count (ANC) ≥1000/mm3
- Platelet count ≥100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
- Hemoglobin \>8 g/dL (may be transfused) Adequate Renal Function Defined as:
- Creatinine clearance or radioisotope GFR \> 70ml/min/1.73 m2 or
- A serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age/gender as follows:
- to \< 2 years: maximum serum creatinine 0.6 mg/dL for males and females. 2 to \< 6 years: maximum serum creatinine 0.8 mg/dL for males and females. 6 to \< 10 years: maximum serum creatinine 1.0 mg/dL for males and...
- 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 Adequate Cardiac Function Defined as:
- Left Ventricular Ejection Fraction greater than the institutional lower limit of normal by echocardiogram
- QTc ≤ 480 msec (by Bazett formula) Adequate Neurologic Function Defined as:
- Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.
- Patients with current seizure disorders may be enrolled if seizures are well-controlled on antiepileptic therapies.
- Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
What rules you out
- Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be...
- Gastrointestinal Disease:
- Patients with a history of serious gastrointestinal disease, including inflammatory bowel disease or gastrointestinal perforation
- Patients who are unable to absorb enteral medications
- Administration via NG/NJ/G-tube is allowed
- Concomitant Medications
- Corticosteroids: Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible.
- Investigational Drugs: Patients who are currently receiving another investigational drug are not eligible.
- Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible.
- Study Specific:
- Patients who have an uncontrolled infection are not eligible.
- Patients who have received any live or attenuated vaccinations within three months prior to start of therapy are not eligible.
- Any significant concurrent medical or surgical condition that would jeopardize the patient's safety or ability to complete the study, including, but not limited to, disease of the nervous, renal, hepatic, cardiac (such...
- Patients who have a history of Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus or Tuberculosis infection are not eligible.
- Patients who have received a prior solid organ transplantation are not eligible.
- Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
- Patients who have a history of alcohol, drug, or chemical abuse within 6 months of screening.
- Patients who have had surgery within the last 6 weeks or who have concerns for poor postsurgical wound healing.
- Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to tocilizumab and its excipients are not eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Randwick, New South Wales, Australia
- South Brisbane, Queensland, Australia
- Perth, Western Australia, Australia
- Vancouver, British Columbia, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 39 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States; Randwick, New South Wales, Australia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.