NCT04164901进行中（未招募）3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 331
- 试验地点
- 84
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 12 years of age and weigh at least 40 kg.
- •Have Grade 2 oligodendroglioma or astrocytoma per WHO 2016 criteria.
- •Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.
- •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 by central laboratory testing during the Prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization [FISH], comparative genomic hybridization [CGH] array, sequencing) using an accredited laboratory.
- •Have MRI-evaluable, measurable, non-enhancing disease, as confirmed by the BIRC.
- •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%.
排除标准
- •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.
- •Have features assessed as high-risk by the Investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the Investigator (deficits resulting from surgery are allowed), or 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).
研究组 & 干预措施
Matching Placebo
Placebo Comparator
Matching placebo 40 mg, continuous daily dosing.
干预措施: Matching Placebo (Drug)
Vorasidenib
Experimental
Vorasidenib 40 mg, continuous daily dosing.
干预措施: Vorasidenib (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: Up to approximately 30 months
PFS is defined as the time from date of randomization to date of first documented radiographic PD (as assessed by the blinded independent review committee (BIRC) per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas or date of death due to any cause, whichever occurs earlier.
次要结局
- Time to Next Intervention (TTNI)(Up to approximately 3 years)
- Tumor Growth Rate (TGR)(every 6 months, up to 2 years and 9 months)
- Objective Response (OR) as Assessed by the Blinded Independent Review Committee (BIRC)(approximatively 30 months)
- Complete Response (CR) and Partial Response (PR) by BIRC(Approximatively 30 months)
- Time to Response (TTR) by BIRC(Approximatively 30 months)
- Time to CR+PR by BIRC(Approximatively 30 months)
- Duration of Response (DoR)(Approximatively 30 months)
- Duration of CR+PR(Approximatively 30 months)
- Overall Survival (OS)(Approximatively 30 months)
- Progression-Free Survival (PFS) by the Investigator(Approximatively 30 months)
- Health-Related Quality of Life (FACT-Br)(Approximatively 30 months)
研究者
研究点 (84)
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