jRCT2061220059进行中（未招募）不适用
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
Institut de Recherches Internationales Servier (I.R.I.S.)0 个研究点目标入组 20 人开始时间: 2022年12月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Safety Lead-in Period
- •Be at least 18 years of age.
- •Have a histologically proven Grade 2 or 3 IDH mutant glioma.
- •Subjects must have disease that has recurred or progressed following radiation and/or chemotherapy or that has not responded to this therapy.
- •Have a documented IDH1 or IDH2 gene-mutation based on local assessment.
- •MRI-evaluable disease as assessed by the site radiologist.
- •Have a KPS >=
- •Have expected survival of at least 3 months.
- •Randomization Period
- •Be at least 18 years of age.
- •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 of >=80%.
排除标准
- •Safety Lead-in Period
- •Subjects who received systemic anticancer therapy or radiotherapy <21 days prior to their first day of study drug administration or who received an investigational agent <14 days prior to their first day of study drug administration. In addition, the first dose of AG-881 should not occur before a period >=5 half-lives of the investigational agent has elapsed.
- •Have had prior treatment with bevacizumab (Avastin).
- •Randomization Period
- •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).
结局指标
主要结局
-
Imaging assessment of Progression-Free Survival (PFS) by blinded independent review committee(BIRC)
次要结局
未报告次要终点
研究者
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