Spots Global Cancer Trial Database for MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
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Trial Identification
Brief Title: MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
Official Title: Phase 2 Study of the MEK Inhibitor MEKTOVI® (Binimetinib) for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
Study ID: NCT05286788
Interventions
Study Description
Brief 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.
Detailed Description: Adamantinomatous Craniopharyngioma (ACP) is a highly debilitating pediatric brain tumor that lacks medical anti-tumor therapies. Current therapy, which depends largely on surgery and radiation, is associated with poor quality of life and becomes more challenging and risky in the setting of recurrent disease. Recent discoveries regarding the biological characteristics of ACP indicate that available agents, including Mitogen-activated protein kinase/extracellular signal-regulated kinase (MAPK/ERK) pathway inhibitors may have efficacy in the control of ACP. Binimetinib is one such agent. In this study, up to 38 patients will receive oral binimetinib at the recommended phase 2 pediatric dose (RP2D) of 32 mg/m2/dose PO every 12 hours for 4 weeks which represents one cycle. Cycles will last 28 days and treatment may continue for up to two years (26 cycles). It will be a multi-center Phase 2 trial with two strata for patients aged \>1 year and \<25 years with measurable ACP who may have been previously treated with radiation (Stratum 1, 18 patients) or without radiation (Stratum 2, 18 patients).
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Colorado, Aurora, Colorado, United States
Children's National Medical Center, Washington, District of Columbia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Duke University Health System, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Texas Children's Hospital, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
Queensland Children's Hospital, South Brisbane, Queensland, Australia
Perth Children's Hospital, Perth, Western Australia, Australia
The Hospital for Sick Children (SickKids), Toronto, Ontario, Canada
Montreal Children's Hospital, Montréal, Quebec, Canada
Hopp Children's Cancer Center at NCT Heidelberg (KiTZ), Heidelberg, Baden-Württemberg, Germany
Princess Máxima Center, Utrecht, , Netherlands
Great Ormond Street Hospital, London, , United Kingdom
Contact Details
Name: Kathleen H Dorris
Affiliation: Children's Hospital Colorado
Role: STUDY_CHAIR
Name: Todd C Hankinson
Affiliation: Children's Hospital Colorado
Role: STUDY_CHAIR
Name: Maryam Fouladi
Affiliation: Nationwide Children's Hospital
Role: PRINCIPAL_INVESTIGATOR
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