SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT02525692

Developed by Shray Alag, 2020.
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
Group Labels: 6

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: