/ Not yet recruitingPhase 3 一项在携带IDH1突变、未经治疗或既往接受过1种系统性治疗方案的≥18岁局部晚期或转移性经典型软骨肉瘤受试者中评价艾伏尼布的 III 期、多中心、双盲、随机、安慰剂对照研究（CHONQUER研究）
[Translation] A Phase III, multicenter, double-blind, randomized, placebo-controlled study evaluating ivosidenib in subjects ≥18 years of age with locally advanced or metastatic classical chondrosarcoma who have an IDH1 mutation and are naïve or have received 1 prior systemic therapy (the CHONQUER study)
于 BICR 的肿瘤评估，评估艾伏尼布在1级和2级受试者中的疗效。
[Translation] Tumor assessments in BICR evaluated the efficacy of ivosidenib in subjects with grade 1 and 2 disease.
/ Not yet recruitingPhase 1/2 一项 Vorasidenib 联合替莫唑胺 (TMZ) 治疗 IDH1 或 IDH2 突变的胶质瘤受试者的 Ib/II 期、多中心研究
[Translation] A Phase Ib/II, Multicenter Study of Vorasidenib Combined with Temozolomide (TMZ) in Subjects with Glioma and IDH1 or IDH2 Mutations
本研究的主要目的是评价 Vorasidenib与TMZ联合给药时的安全性和耐受性，并确定（Ib 期）RCD；基于入组 II 期和 Ib 期研究并接受 RCD治疗的 IDH突变的4级星形细胞瘤受试者12个月时的 PFS 率（根据 RANO 2.0），评估 Vorasidenib 联合TMZ的初步临床疗效。次要目的是基于入组 II 期和 Ib 期研究并接受RCD治疗的 IDH突变的4级星形细胞瘤受试者的PFS、OS、ORR 和 CBR，评估Vorasidenib 联合TMZ临床疗效的其他参数。表征Vorasidenib与TMZ 联合给药和单独给药时，血浆中 Vorasidenib 及其代谢物 AGI-69460的PK特征。表征TMZ与Vorasidenib联合给药时血浆中TMZ的PK特征（仅 Ib 期）。
[Translation] The primary objectives of this study are to evaluate the safety and tolerability of vorasidenib in combination with TMZ and to determine the RCD (Phase Ib); to assess the preliminary clinical efficacy of vorasidenib in combination with TMZ based on the PFS rate (per RANO 2.0) at 12 months in subjects with IDH-mutated grade 4 astrocytoma enrolled in Phase II and Phase Ib studies and treated with RCD. Secondary objectives are to assess other parameters of the clinical efficacy of vorasidenib in combination with TMZ based on PFS, OS, ORR, and CBR in subjects with IDH-mutated grade 4 astrocytoma enrolled in Phase II and Phase Ib studies and treated with RCD. To characterize the PK profile of vorasidenib and its metabolite AGI-69460 in plasma when vorasidenib is administered in combination with TMZ and when administered alone. To characterize the PK profile of TMZ in plasma when TMZ is administered in combination with vorasidenib (Phase Ib only).
一项在携带IDH1或IDH2突变的残留或复发性2级胶质瘤亚洲受试者中开展的Vorasidenib（S095032/AG881）的III期、多中心、随机、双盲、安慰剂对照研究
[Translation] A Phase III, multicenter, randomized, double-blind, placebo-controlled study of vorasidenib (S095032/AG881) in Asian subjects with residual or recurrent grade 2 gliomas harboring IDH1 or IDH2 mutations
本研究的目的是在携带IDH1或IDH2突变的残留或复发性2级胶质瘤亚洲受试者中评估Vorasidenib的有效性、安全性和药代动力学（PK）特征。
[Translation] The aim of this study was to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of vorasidenib in Asian subjects with residual or recurrent grade 2 glioma harboring IDH1 or IDH2 mutations.
100 Clinical Results associated with Servier (Beijing) Pharmaceutical R&D Co., Ltd.
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