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Report for Clinical Trial NCT03343197

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1, Multicenter, Randomized, Controlled, Open-Label, Perioperative Study of AG-120 and AG-881 in Subjects With Recurrent, Non-Enhancing, IDH1 Mutant, Low Grade Glioma

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
MeSH:Glioma
HPO: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
Group Labels: 1

AG-120

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
Group Labels: 1

AG-881


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


1 R132H

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 ---



HPO Nodes


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