CompletedPhase 1

Study of AG-120 and AG-881 in Subjects With Low Grade Glioma

United States49 participantsStarted 2018-03-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

2-HG concentration in surgically resected tumors

Timeframe: Up to 4 weeks, on average

Trial details

NCT IDNCT03343197

SponsorInstitut de Recherches Internationales Servier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-02

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