At a glance
ClinicalIndex Comparison Record- ✓Age ≥12 years and weight ≥40 kg
- ✓Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria
- ✓At least 1 prior surgery for glioma (biopsy, sub-total or gross-total resection) with most recent surgery 1-5 years before randomization, no other prior anticancer therapy, and not in need of immediate chemotherapy or radiotherapy
- ✓Confirmed IDH1 or IDH2 mutation by central laboratory testing
- ✕Prior anticancer therapy other than surgery (chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation)
- ✕Brainstem involvement as primary location or by tumor extension
- ✕Clinically relevant functional or neurocognitive deficits due to tumor (deficits from surgery are allowed)
- ✕Uncontrolled seizures defined as persistent seizures interfering with activities of daily life AND failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Vorasidenib and Matching Placebo for Grade 2 Glioma and 2 related conditions. Active but no longer recruiting, targeting 331 participants across 84 sites in 11 countries.
Detailed Summary
Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib 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 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.
Study Details
Timeline
Interventions
Vorasidenib oral film-coated tablets
Matching Placebo oral tablets