A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)
A Phase 1/2 Trial of Selinexor (KPT-330) and Radiation Therapy in Newly-Diagnosed Pediatric Diffuse Intrinsic Pontine Glioma (DIPG) and High-Grade Glioma (HGG)
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Clinical Trial Information
Trial Contact: Armatti, Julie M; Parker, Melanie; Doyle, Katherine M; Frankos, Marie
Trial Phone: 321-843-5284 ; 321-843-1036 ; 3218412008 ; 321-842-8738
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IRB No: ACNS1821
Protocol Abbrev: ACNS1821
Principal Investigator:
Phase: Drug: Phase I
Age Group: Pediatric
ClinicalTrials.gov ID: NCT05099003
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Objective
To define toxicities and estimate the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of Selinexor administered as an oral formulation in combination with standard of care radiation therapy (RT), to pediatric patients with newly diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG). (Dose-finding phase/phase I) II. To estimate the event-free survival (EFS) distribution for diffuse midline glioma (DMG)/HGG patients and overall survival (OS) distribution for DIPG patients associated with Selinexor plus RT, followed by Selinexor in patients with newly diagnosed HGG (H3 K27M mutant DMG or H3 K27-wild type HGG) or DIPG, and to compare those outcomes to historical controls. (Efficacy phase/phase II)
