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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

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

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


HPO:
Glioma
Genes 50
TSC2 GLI3 BRCA2 TSC1 LRP5 MLH1 PMS2 APC IDH1 MSH6 POT1 TSC2 CDKN2A NF2 MSH3 MSH6 APC NF1 EPCAM TSC1 TGFBR2 SEMA4A IDH1 IDH2 FAN1 APC MSH3 BMPR1A KRAS MLH1 MSH2 C11ORF95 PMS2 MLH3 PIK3CA NBN RELA SETBP1 IFNG RPS20 NF1 PMS1 CHEK2 APC TP53 MSH2 NBN ERBB2 APC NF2