SNPMiner Trials (Home Page)
Report for Mutation K656E
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 ---
5. Archival tissue must demonstrate: FGFR1 K656E or FGFR3 K650E mutation or FGFR3-TACC3 translocation from NGS sequencing or IHC and RT-PCR. --- K656E ---
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 doseDescription: 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 doseDescription: 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 doseDescription: 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 surgerySecondary 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: IntraoperativelyDescription: Number of Adverse Events
Measure: Number of Adverse Events Time: up to 30 days after the last study doseDescription: Drug-related toxicity
Measure: Incidence of drug-related toxicity Time: up to 30 days after the last study doseDescription: Treatment-emergent adverse events
Measure: Incidence of treatment-emergent adverse events Time: up to 30 days after the last study doseDescription: Number and Incidence of Deaths
Measure: Number of Deaths Time: up to 60 monthsDescription: Clinical laboratory abnormalities per CTCAE
Measure: Number of clinical laboratory abnormalities per CTCAE Time: up to 30 days after the last study dose