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A Phase 3, Multicenter, Randomized, Double-blind, Placebo- Controlled Study of Vorasidenib (S095032/AG-881) in Asian Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation
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.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Tiantan Hospital
Beijing, China
Sanbo Brain Hospital, Capital Medical University
Beijing, China
Huashan Hospital Fudan University
Shanghai, China
The Second Affiliated Hospital of Air Force Military Medical University
Xi'an, China
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital,
Taoyuan District, Taiwan
Start Date
October 18, 2024
Primary Completion Date
October 2, 2025
Completion Date
October 31, 2030
Last Updated
January 9, 2026
57
ACTUAL participants
Vorasidenib
DRUG
Placebo
DRUG
Lead Sponsor
Servier
Data Source & Attribution
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