SNPMiner Trials by Shray Alag


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Report for Mutation K650E

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 A Phase 0 Study of Infigratinib in Recurrent High-Grade Glioma Participants Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK Triggered Expansion Cohort

This trial is an open-label, multicenter, Phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. In the lead-in cohort, a total of 20 participants will be enrolled into the proposed phase 0 clinical trial. Participants will be administered infigratinib prior to surgical resection of their tumor.

NCT04424966 Glioma Glioblastoma GBM Drug: Infigratinib
MeSH:Glioblastoma Glioma
HPO:Glioblastoma multiforme Glioma

Infigratinib in Recurrent Glioblastoma Patients This trial is an open-label, multicenter, Phase 0 trial that will enroll up to 20 participants with recurrent high-grade glioma with FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation which are scheduled for resection. --- K656E --- --- K650E ---

5. Archival tissue must demonstrate: FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation from NGS sequencing or IHC and RT-PCR. --- K656E --- --- K650E ---

Primary Outcomes

Description: Phase 0: Tumor tissue will be collected approximately 8hrs after infigratinib administration on Day 7 to determine the concentration of infigratinib in the tumor tissue.

Measure: Phase 0: Concentration of infigratinib in enhancing and non-enhancing tumor tissue

Time: Day 7 at 8 hours post dose

Description: Samples will be collected at 8 timepoints during 24 hours after infigratinib administration on Day 7.

Measure: Phase 0: Concentration of infigratinib in plasma (0-24H)

Time: Day 7 at 0, 0.5, 1, 2, 4, 6, 8 and 24 hours post dose

Description: CSF will be collected at approximately 8hrs after infigratinib administration on Day 7 to determine the concentration of infigratinib in CSF.

Measure: Phase 0: Concentration of infigratinib in CSF

Time: Day 7 at 8 hours post dose

Description: Expansion Cohort: 6-month Progression-free survival (PFS6) rate from time of surgery to date of recurrence

Measure: Expansion Cohort: 6-month Progression-free survival

Time: 6 months from the time of surgery

Secondary Outcomes

Description: Phase 0: percentage of pERK+, MIB-1+ and Cleaved Caspase 3+ cells from the surgical tissue will be quantified and compared to baseline archival tissue.

Measure: Phase 0: PD Analysis

Time: Intraoperatively

Description: Number of Adverse Events

Measure: Number of Adverse Events

Time: up to 30 days after the last study dose

Description: Drug-related toxicity

Measure: Incidence of drug-related toxicity

Time: up to 30 days after the last study dose

Description: Treatment-emergent adverse events

Measure: Incidence of treatment-emergent adverse events

Time: up to 30 days after the last study dose

Description: Number and Incidence of Deaths

Measure: Number of Deaths

Time: up to 60 months

Description: Clinical laboratory abnormalities per CTCAE

Measure: Number of clinical laboratory abnormalities per CTCAE

Time: up to 30 days after the last study dose


HPO Nodes