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Report for Clinical Trial NCT03593993

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Biospecimen Collection Study to Evaluate the Pharmacokinetic, Pharmacodynamic, and Resistance Profile to Trametinib and Dabrafenib in BRAF-V600E Mutated Recurrent Gliomas

This is a surgical biospecimen collection study. The purpose of this study is to understand how much of two drugs (dabrafenib and trametinib) are able to penetrate brain tumors and turn off the RAF signaling pathway. This is important because these drugs are currently FDA approved for other tumors and may have efficacy in brain tumors with the BRAF V600E mutation.

NCT03593993 Glioma BRAF V600E Pleomorphic Xantho-Astrocytoma Glioblastoma
MeSH:Glioblastoma Glioma Astrocytoma
HPO:Astrocytoma Glioblastoma multiforme Glioma Subependymal giant-cell astrocytoma

1 Interventions

Name: Surgical Cohort

Description: Blood, cerebrospinal fluid, and surgical tissue collected during procedure
Type: Procedure
Group Labels: 1

Surgical Cohort


Primary Outcomes

Description: Obtain single time-point concentration of dabrafenib in enhancing brain tissue (ng/mL) using liquid chromatography/mass spectrometry with one single, random sample

Measure: Concentration of dabrafenib in brain tumor

Time: Day 1

Description: Obtain single time-point concentration of trametinib in enhancing brain tissue (ng/mL) using liquid chromatography/mass spectrometry with one single, random sample

Measure: Concentration of trametinib in brain tumor

Time: Day 1

Time Perspective: Prospective

Case-Only


There are 4 SNPs

SNPs


1 V600D

Allowable mutations include V600E, V600K, V600R, and V600D. --- V600E --- --- V600K --- --- V600R --- --- V600D ---


2 V600E

A Biospecimen Collection Study to Evaluate the Pharmacokinetic, Pharmacodynamic, and Resistance Profile to Trametinib and Dabrafenib in BRAF-V600E Mutated Recurrent Gliomas. --- V600E ---

A Biospecimen Collection Study in BRAF-V600E Mutated Recurrent Gliomas This is a surgical biospecimen collection study. --- V600E ---

This is important because these drugs are currently FDA approved for other tumors and may have efficacy in brain tumors with the BRAF V600E mutation. --- V600E ---

Allowable mutations include V600E, V600K, V600R, and V600D. --- V600E ---

Glioma BRAF V600E Pleomorphic Xantho-Astrocytoma Glioblastoma Glioblastoma Glioma Astrocytoma The primary goal of this study is to establish concentrations of dabrafenib and trametinib in enhancing brain tissue and cerebrospinal fluid from people with BRAF-V600E mutant recurrent gliomas who undergo tumor resection. --- V600E ---

Glioma BRAF V600E Pleomorphic Xantho-Astrocytoma Glioblastoma Glioblastoma Glioma Astrocytoma The primary goal of this study is to establish concentrations of dabrafenib and trametinib in enhancing brain tissue and cerebrospinal fluid from people with BRAF-V600E mutant recurrent gliomas who undergo tumor resection. --- V600E --- --- V600E ---


3 V600K

Allowable mutations include V600E, V600K, V600R, and V600D. --- V600E --- --- V600K ---


4 V600R

Allowable mutations include V600E, V600K, V600R, and V600D. --- V600E --- --- V600K --- --- V600R ---



HPO Nodes


HPO: