SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02525692

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Oral ONC201 in Recurrent Glioblastoma, H3 K27M-mutant Glioma, and Diffuse Midline Glioma

ONC201 is a new drug candidate that kills cancer cells but not normal cells in laboratory studies and has been previously evaluated in a phase I clinical trial in advanced cancer patients. This clinical trial will enroll patients with recurrent glioblastoma or recurrent WHO Grade IV gliomas with the H3 K27M mutation.

NCT02525692 Glioblastoma Diffuse Midline Glioma H3 K27M Glioma Thalamic Glioma Infratentorial Glioma Basal Ganglia Glioma
MeSH: Glioblastoma Glioma
HPO: Glioblastoma multiforme Glioma

1 Interventions

Name: ONC201

Type: Drug

A: GBM ONC201 Q3W B: GBM ONC201 Q1W C: GBM Surgical Cohort ONC201 Q1W D: H3 K27M Glioma ONC201 Q1W E: Diffuse Midline Glioma Surgical Cohort ONC201 Q1W F: Non-H3 K27M Diffuse Midline Glioma ONC201 Q1W


Primary Outcomes

Measure: Progression-free survival

Time: 6 months

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 K27M

Oral ONC201 in Recurrent Glioblastoma, H3 K27M-mutant Glioma, and Diffuse Midline Glioma. --- K27M ---

Oral ONC201 in Recurrent GBM, H3 K27M Glioma, and Midline Glioma ONC201 is a new drug candidate that kills cancer cells but not normal cells in laboratory studies and has been previously evaluated in a phase I clinical trial in advanced cancer patients. --- K27M ---

This clinical trial will enroll patients with recurrent glioblastoma or recurrent WHO Grade IV gliomas with the H3 K27M mutation. --- K27M ---

For Arm D: Must have a WHO Grade IV glioma as per above and tumor must harbor a histone H3 K27M mutation as evidenced by testing any tumor sample with an immunohistochemistry or DNA sequencing test. --- K27M ---

For Arm F: Must have a diffuse midline glioma, defined as a WHO Grade IV glioma involving the brainstem, thalamus or spinal cord, without the H3 K27M mutation or with unknown H3 mutation status. --- K27M ---

Glioblastoma Diffuse Midline Glioma H3 K27M Glioma Thalamic Glioma Infratentorial Glioma Basal Ganglia Glioma Glioblastoma Glioma null --- K27M ---


2 R132H

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



HPO Nodes


HPO:
Glioblastoma multiforme
Genes 16
PMS1 APC MLH1 KRAS EPCAM TGFBR2 PIK3CA MSH6 ERBB2 RPS20 BMPR1A PMS2 MSH2 MLH3 SEMA4A FAN1
Glioma
Genes 30
CHEK2 PMS1 APC MLH1 CDKN2A KRAS TGFBR2 LRP5 NBN MSH6 C11ORF95 ERBB2 RPS20 TSC1 BMPR1A TSC2 RELA PMS2 MSH2 MSH3 MLH3 IDH1 IDH2 SEMA4A NF1 NF2 EPCAM PIK3CA SETBP1 FAN1