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Report for Clinical Trial NCT03343197
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Study to evaluate the suppression of 2-HG (2-hydroxyglutarate) in IDH-1 mutant gliomas in
resected tumor tissue following pre-surgical treatment with AG-120 or AG-881.
NCT03343197 Glioma
2 Interventions
Name: AG-120
Description: Prior to surgery subjects will receive AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects without residual disease following surgery will have the option to receive treatment for up to a year, until disease progression or unacceptable toxicity, whichever occurs first. Subjects with residual disease following surgery will have the option to receive treatment, until disease progression or unacceptable toxicity.
Type: Drug
Name: AG881
Description: Prior to surgery subjects will receive AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects without residual disease following surgery will have the option to receive treatment for up to a year, until disease progression or unacceptable toxicity, whichever occurs first. Subjects with residual disease following surgery will have the option to receive treatment, until disease progression or unacceptable toxicity.
Type: Drug
Primary Outcomes
Measure: 2-HG concentration in surgically resected tumors Time: Up to 4 weeks, on average
Secondary Outcomes
Measure: Safety and tolerability: incidence of adverse events and serious adverse events Time: Up to 48 weeks, on average
Measure: Pharmacodynamics of AG-120 or AG-881 measured by 2-HG concentration in plasma. Time: Up to 4 weeks, on average
Measure: Peak Plasma Concentration (Cmax) of AG-120 or AG-881 Time: Up to 4 weeks, on average
Measure: Time to maximum concentration (Tmax) of AG-120 or AG-881 Time: Up to 4 weeks, on average
Measure: Area Under the Curve (AUC) of AG-120 or AG-881 Time: Up to 4 weeks, on average
Measure: Elimination half-life of AG-120 or AG-881 Time: Up to 4 weeks, on average
Measure: Clinical activity associated with AG-120 or AG-881 according to modified RANO_LGG criteria. Time: Up to 48 weeks, on average
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
3. Have documented IDH1 R132H gene mutation by local testing and known 1p19q or ATRX
mutation status by local testing. --- R132H ---
Glioma
Glioma
A phase-1, multi-center study in recurrent non-enhancing gliomas with IDH1 R132H mutation for
patients who require surgery. --- R132H ---
The safety, tolerability, PK/PD, and anti tumor activity data from the study
in subjects with recurrent non-enhancing Grade 2/3 LGG with an IDH1 R132H mutation for whom
surgical resection is indicated will identify the recommended dose of AG-120 and AG-881 for
future studies in glioma. --- R132H ---