Phase 3 Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 orIDH2 Mutation

Conditions

• Residual or Recurrent Grade 2 IDH Mutant Glioma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vorasidenib — DRUG
  For oral administration once daily
• Placebo — DRUG
  For oral administration once daily

Study Details

The objective of this study is to determine the efficacy, safety, and pharmacokinetics of vorasidenib in Asian participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation. The study will begin with a safety lead-in (SLI) phase and then will transition to a randomized double-blind placebo-controlled phase. During the study participants will have study visits on day 1 and 15 of the first two cycles, and then only on day 1 of treatment cycles in the frequency included in the study schedule of assessments. All participants will have an end of treatment visit within 7 days after their last dose of study treatment. Approximately 28 (+5) days after treatment has ended, a safety follow-up visit will occur. Study visits may include questionnaires, blood tests, ECG, vital signs, and a physical examination. Beginning at the end of treatment visit participants will be contacted by phone every 6 months for overall survival up to 5 years after the last participant is randomized or until death, withdrawal of consent from overall study participation, lost to follow-up, or sponsor ending the study, whichever occurs first.

Key Dates

Start date

Oct 18, 2024

Status verified

Jun 2026

Primary completion

May 7, 2026

Completion

Oct 31, 2030

Study Design

Enrollment

57 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Randomized Double-Blind Phase: Vorasidenib
• Placebo Comparator: Randomized Double-Blind Phase: Placebo

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Approximately 1.5 years ]