Clinical Trials List
Protocol NumberCL3-95032-016
NCT Number(ClinicalTrials.gov Identfier)NCT06780930
Active
2025-01-01 - 2031-06-30
Phase III
Recruiting2
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
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Trial Applicant
A2 HEALTHCARE TAIWAN CORPORATION
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Sponsor
A2 HEALTHCARE TAIWAN CORPORATION
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 王緯歆 Division of Orthopedics
- 吳智君 Division of Radiology
- Yi-Wei Chen Division of Radiation Therapy
- 林士傑 Division of Others
- 王瑞鐸 Division of Orthopedics
- Chun-Fu Lin Division of Orthopedics
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Kuo-Chen Wei
Co-Principal Investigator
- 杜振豐 Division of Radiology
- Pin-Yuan Chen Division of Orthopedics
- 盧郁仁 Division of Orthopedics
- 林亞銳 Division of Orthopedics
- 陳科廷 Division of Orthopedics
- 蕭庭毅 Division of Radiology
- Peng-Wei Hsu Division of Orthopedics
- 黃盈誠 Division of Orthopedics
- 李丞騏 Division of Orthopedics
- Chi-Cheng Chuang Division of Orthopedics
- 蔡宏杰 Division of Orthopedics
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Residual or Recurrent Grade 2 IDH Mutant Glioma
Objectives
Primary Outcome Measures
The time from date of randomization to date of first documented radiographic progressive disease (PD), as assessed by the Blinded Independent Review Committee (BIRC), or date of death due to any cause, whichever occurs earlier.
Secondary Outcome Measures
Dose limiting toxicities (DLTs) (for open-label Safety Lead In (SLI) phase)
Number of adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death
Severity of AEs
Time-To-Next-Intervention (TTNI)
Tumor Growth Rate (TGR) as assessed by volume
Objective response
Time to response
Duration of response
Overall survival
Plasma concentrations of vorasidenib
Number of seizures by month
Test Drug
Vorasidenib
Active Ingredient
Vorasidenib
Dosage Form
tablets
Dosage
10, 40 mg/tablet
Endpoints
The time from date of randomization to date of first documented radiographic progressive disease (PD), as assessed by the Blinded Independent Review Committee (BIRC), or date of death due to any cause, whichever occurs earlier.
Inclution Criteria
Inclusion Criteria:
• Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg.
• Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%.
• Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
• Have had at least 1 prior surgery for glioma with the most recent one having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before randomization, and no other prior anticancer therapy, including radiotherapy and not be in need of immediate chemotherapy or radiotherapy.
• Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease
• Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC for double blind part.
• Be at least 12 years of age (for Randomized Double-Blind phase) and weigh at least 40 kg.
• Have a Karnofsky Performance Scale (KPS) score (for participants ≥16 years of age) or Lansky Play Performance Scale (LPPS) score (for participants <16 years of age) of ≥80%.
• Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
• Have had at least 1 prior surgery for glioma with the most recent one having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before randomization, and no other prior anticancer therapy, including radiotherapy and not be in need of immediate chemotherapy or radiotherapy.
• Have confirmed IDH1 (IDH1 R132H/C/G/S/L mutation variants tested) or IDH2 (IDH2 R172K/M/W/S/G mutation variants tested) gene mutation status disease
• Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC for double blind part.
Exclusion Criteria
Exclusion Criteria:
• Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.
• Concurrent active malignancy except for a) curatively resected nonmelanoma skin cancer or b) curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
• Have any other acute or chronic medical or psychiatric condition that may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of study results.
• Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted.
• Have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, IDH inhibitors, investigational agents, laser ablation, etc.
• Concurrent active malignancy except for a) curatively resected nonmelanoma skin cancer or b) curatively treated carcinoma in situ. Participants with previously treated malignancies are eligible provided they have been disease-free for 3 years at Screening.
• Have any other acute or chronic medical or psychiatric condition that may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of study results.
• Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, known positive human immunodeficiency virus antibody results, or AIDS-related illness. Participants with a sustained viral response to HCV treatment or immunity to prior HBV infection will be permitted. Participants with chronic HBV that is adequately suppressed by institutional practice will be permitted.
The Estimated Number of Participants
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Taiwan
7 participants
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Global
約58 participants
