SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation K28M

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 ONC201 in Newly Diagnosed Diffuse Intrinsic Pontine Glioma and Recurrent/Refractory Pediatric H3 K27M Gliomas

This is a multicenter, open-label, seven arm, dose escalation, phase I study of oral ONC201 in pediatric patients with newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) and recurrent/refractory H3 K27M gliomas. Arm A will define the RP2D for single agent ONC201 in pediatric patients with glioma who are positive for the H3 K27M mutation (positive testing in CLIA laboratory) and have completed at least one line of prior therapy. This will allow for recurrent patients and also patients who have not yet recurred, but have completed radiation and will inevitably recur based on prior clinical experience and the literature. Arm B will define the RP2D for ONC201 in combination with radiation in pediatric patients with newly diagnosed DIPG. Arm C will determine intratumoral drug concentrations and biomarker expression in pediatric patients with midline gliomas. Arm D will determine H3 K27M DNA levels and drug concentrations in the CSF of pediatric H3 K27M-mutant glioma patients. Arm E will determine the RP2D for single agent ONC201 administered as a liquid formulation in Ora-Sweet to patients with DIPG and/or H3 K27M glioma. Arm F is a dose expansion cohort to confirm the safety and estimate the efficacy in recurrent H3 K27M-mutant glioma population at the RP2D. Arm G will define the RP2D for single agent ONC201 given on two consecutive days of each week in pediatric patients with glioma who are positive for the H3 K27M mutation and have completed at least one line of prior therapy.

NCT03416530
Conditions
  1. Diffuse Intrinsic Pontine Glioma
  2. Glioma, Malignant
Interventions
  1. Drug: ONC201
MeSH:Glioma
HPO:Glioma

Note that the H3 K27M mutation is often reported as H3 K28M in gene sequencing assays. --- K27M --- --- K28M ---

Primary Outcomes

Description: Determination of recommended Phase 2 dose (RP2D) as a single agent or in combination with radiation

Measure: RP2D

Time: 28 days


HPO Nodes