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Report for Clinical Trial NCT04164901

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation

Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 366 participants are planned to be randomized 1:1 to receive orally administered AG-881 40 mg QD or placebo.

NCT04164901 Grade 2 Glioma Residual Glioma Recurrent Glioma
MeSH:Glioma
HPO:Glioma

2 Interventions

Name: AG-881

Description: AG-881 oral film-coated tablets
Type: Drug
Group Labels: 1

AG-881

Name: Matching Placebo

Description: Matching Placebo oral tablets
Type: Drug
Group Labels: 1

Matching Placebo


Primary Outcomes

Measure: Progression-Free Survival (PFS)

Time: Up to approximately 30 months

Secondary Outcomes

Measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time: Up to approximately 30 months

Measure: Tumor Growth Rate as Assessed by Volume

Time: Up to approximately 30 months

Measure: Time to Next Intervention

Time: Up to approximately 5 years

Measure: Objective Response Rate

Time: Up to approximately 30 months

Measure: Time to Response

Time: Up to approximately 30 months

Measure: Duration of Response

Time: Up to approximately 30 months

Measure: Overall Survival

Time: Up to approximately 5 years

Description: The FACT-Br is a participant-reported measure designed to assess the quality of life for participants with brain tumors. The FACT-Br is a measure comprising the following subscales: Physical Well-Being, Functional Well-Being, Emotional Well-Being, and Social Well-Being subscales from the FACT-G, with the addition of a brain tumor- specific subscale.

Measure: Health-Related Quality of Life as Measured by Functional Assessment of Cancer Therapy-Brain Questionnaire (FACT-Br)

Time: Up to approximately 30 months

Measure: Progression-Free Survival (PFS) as Assessed by the Investigator

Time: Up to approximately 30 months

Measure: Maximum Observed Serum Concentration (Cmax) of AG-881

Time: Days 1 and 15 of Cycle 1(predose and multiple timepoints up to 4 hours postdose), Day 1 of Cycle 2(predose and multiple time points up to 4 hours postdose), Predose on Day 1 of every cycle thereafter(each cycle is 28 days), and within 7 days of last dose

Measure: Area Under Concentration Time Curve from Time 0 to Tau (AUC0-tau) of AG-881

Time: Days 1 and 15 of Cycle 1(predose and multiple timepoints up to 4 hours postdose), Day 1 of Cycle 2(predose and multiple time points up to 4 hours postdose), Predose on Day 1 of every cycle thereafter(each cycle is 28 days), and within 7 days of last dose

Measure: Time to Reach Maximum Serum Concentration (Tmax) of AG-881

Time: Days 1 and 15 of Cycle 1(predose and multiple timepoints up to 4 hours postdose), Day 1 of Cycle 2(predose and multiple time points up to 4 hours postdose), Predose on Day 1 of every cycle thereafter(each cycle is 28 days), and within 7 days of last dose

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 R132H

- Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory. --- R132H ---


2 R172K

- Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory. --- R132H --- --- R172K ---



HPO Nodes


HPO: