Status:
COMPLETED
Study of AG-120 and AG-881 in Subjects With Low Grade Glioma
Lead Sponsor:
Institut de Recherches Internationales Servier
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
A phase-1, multi-center study in recurrent non-enhancing gliomas with IDH1 R132H mutation for patients who require surgery. The purpose of this study is to evaluate the suppression of 2-HG by comparin...
Eligibility Criteria
Inclusion
- Be ≥18 years of age.
- Have histologically or cytologically confirmed recurrent Grade 2 or 3 LGG (oligodendroglioma or astrocytoma according to World Health Organization 2016 classification).
- Have documented IDH1 R132H gene mutation by local testing and known 1p19q or ATRX mutation status by local testing.
- Have central confirmation of primarily non-enhancing disease by MRI with less than or equal to 5 mm slice thickness and up to 1 mm interslice gap on either 2D T2 weighted image, 3D T2 weighted image, or FLAIR, with at least 1 non-enhancing tumor measuring 1×1×1 cm.
- Be candidates for clinical resection but for whom surgery is not urgently indicated (eg, for whom surgery within the next 2-4 months is appropriate).
- Have KPS of ≥60%
- Have expected survival of ≥12 months.
Exclusion
- Have received prior systemic anti-cancer therapy within 1 month of the first dose of AG-120 or AG-881 or have received an investigational agent \<14 days prior to their first dose of AG-120 or AG-881. In addition, the first dose of AG-120 or AG-881 should not occur before a period of ≥5 half-lives of the investigational agent has elapsed.
- Have had radiation within 6 months of the first dose of AG-120 or AG-881. (Note: Prior biopsy or surgery is allowed.)
- Have received any prior treatment with an IDH inhibitor.
- Have received any prior treatment with bevacizumab (Avastin).
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03343197
Start Date
March 20 2018
End Date
March 28 2025
Last Update
May 15 2025
Active Locations (6)
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1
United States, California
Los Angeles, California, United States, 90024
2
United States, California
San Francisco, California, United States, 94143
3
United States, Massachusetts
Boston, Massachusetts, United States, 02215
4
United States, New York
New York, New York, United States, 10065