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Report for Clinical Trial NCT03295396

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II, Open-label Study of ONC201 in Adults With Recurrent High-grade Glioma

The primary objective of this phase II trial is to determine the efficacy and safety of ONC201, an oral small molecule imipridone DRD2 antagonist, in adult subjects with recurrent high-grade glioma. This study will test the research hypothesis that histone H3 K27M mutation sensitizes to oral administration of ONC201 in gliomas.

NCT03295396 Glioma
MeSH:Glioma
HPO:Glioma

1 Interventions

Name: ONC201

Description: ONC201 is an oral, small molecule selective antagonist of DRD2 that induces tumor cell death.
Type: Drug
Group Labels: 2

Arm A Arm B


Primary Outcomes

Description: Best overall response rate by RANO

Measure: Overall response rate

Time: Through study completion, an average of 1 year

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There are 2 SNPs

SNPs


1 K27M

ONC201 in Adults With Recurrent H3 K27M-mutant Glioma The primary objective of this phase II trial is to determine the efficacy and safety of ONC201, an oral small molecule imipridone DRD2 antagonist, in adult subjects with recurrent high-grade glioma. --- K27M ---

This study will test the research hypothesis that histone H3 K27M mutation sensitizes to oral administration of ONC201 in gliomas. --- K27M ---

Inclusion Criteria: 1. Histologically confirmed diagnosis of high-grade glioma (HGG) in any tumor sample and presence of histone H3 K27M mutation detected in a Clinical Laboratory Improvement Amendment (CLIA) certified laboratory by immunohistochemistry or DNA sequencing test on any glioma tumor sample. --- K27M ---


2 R132H

Tumors with known IDH1 (isocitrate dehydrogenase 1) or known IDH2 mutations as determined by immunohistochemistry for the IDH1 R132H variant or by direct sequencing. --- R132H ---



HPO Nodes


HPO: