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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

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:
Glioma
Genes 50
TSC2 GLI3 BRCA2 TSC1 LRP5 MLH1 PMS2 APC IDH1 MSH6 POT1 TSC2 CDKN2A NF2 MSH3 MSH6 APC NF1 EPCAM TSC1 TGFBR2 SEMA4A IDH1 IDH2 FAN1 APC MSH3 BMPR1A KRAS MLH1 MSH2 C11ORF95 PMS2 MLH3 PIK3CA NBN RELA SETBP1 IFNG RPS20 NF1 PMS1 CHEK2 APC TP53 MSH2 NBN ERBB2 APC NF2