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IDH1 Inhibitor

AG-120 + AG-881 for Brain Tumor

Phase 1

Waitlist Available

Research Sponsored by Institut de Recherches Internationales Servier

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have KPS of ≥60%

Have documented IDH1 R132H gene mutation by local testing and known 1p19q or ATRX mutation status by local testing

Must not have

Have received any prior treatment with an IDH inhibitor

Have had radiation within 6 months of the first dose of AG-120 or AG-881. (Note: Prior biopsy or surgery is allowed.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying two drugs to see if they can shrink tumors in people with a certain type of brain cancer.

Who is the study for?

This trial is for adults with a confirmed diagnosis of low-grade glioma (a type of brain tumor) that has not been enhanced by previous treatments. Participants must have a specific gene mutation (IDH1 R132H), be fit for surgery but not in urgent need, and have an expected survival time of over 12 months. They should not have had radiation within the last 6 months or any prior treatment with IDH inhibitors or certain other cancer drugs.

What is being tested?

The study tests AG-120 and AG-881's effectiveness at reducing levels of a substance called 2-HG in tumors from patients with IDH-1 mutant gliomas. Before surgical removal, participants will receive one of these drugs to see how well it suppresses this substance in their tumor tissue.

What are the potential side effects?

While specific side effects are not listed here, similar cancer drug trials often involve risks like fatigue, nausea, headaches, skin reactions at the injection site, and potential liver toxicity. The exact side effects would be detailed during informed consent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may need occasional assistance.

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My cancer has a specific IDH1 mutation and I know my 1p19q and ATRX mutation status.

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My low-grade glioma (brain tumor) is confirmed to be Grade 2 or 3.

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I am 18 years old or older.

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My MRI shows a non-growing tumor at least 1cm in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with an IDH inhibitor before.

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I have not had radiation in the last 6 months, but I may have had a biopsy or surgery.

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I have previously been treated with Avastin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: AG-881Experimental Treatment1 Intervention

AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-881.

Group II: AG-120Experimental Treatment1 Intervention

AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-120 .

Group III: No Treatment Pre-SurgeryActive Control1 Intervention

Subjects will not receive treatment prior to surgery. Following surgery, subjects will have the option to receive treatment with AG-120 or AG-881.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AG-120

2017

Completed Phase 3

~370

AG881

2015