A Phase II study of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma

DAIICHI SANKYO Co.,Ltd.0 个研究点目标入组 25 人开始时间: 2020年6月24日最近更新: 2023年10月17日

适应症

试验速览

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•1.Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification
•2.Has confirmed IDH1 mutation at the R132 locus by central laboratory testing.
•3.Has no prior anticancer (including chemotherapy and radiotherapy) for glioma except craniotomy or biopsy.
•4.Has at least 1 measurable and non-enhancing lesion.
•5.Has an interval of at least 90 days from the latest surgery.
•6.Has no sign of malignant transformation including the appearance of enhancing lesion and/or rapid growth of non-enhancing lesion.
•7.Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1.

•1.Has had a histopathological diagnosis of WHO grade III or IV glioma.
•2.Has had a contrast enhancing lesion on brain MRI.
•3.Has received a prior treatment with any mutant IDH1 inhibitor.
•4.Has received other investigational products within 28 days before the start of the study drug treatment.
•5.Has multiple primary malignancies.
•6.Has an active infection requiring systemic treatment.
•7.Has a history of clinically significant cardiac disease.
•8.Is a pregnant or lactating woman

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