A perioperative study of Safusidenib in patients with IDH1-mutated glioma.

IF 3 4区 医学 Q2 ONCOLOGY Future oncology Pub Date : 2024-01-01 Epub Date: 2024-08-14 DOI:10.1080/14796694.2024.2383064
Sarah A Cain, Monique Topp, Mark Rosenthal, Robert Tobler, Saskia Freytag, Sarah A Best, James R Whittle, Katharine J Drummond
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Abstract

This is a single arm, open label perioperative trial to assess the feasibility, pharmacokinetics and pharmacodynamics of treatment with safusidenib following biopsy, and prior to surgical resection in patients with IDH1 mutated glioma who have not received radiation therapy or chemotherapy. Fifteen participants will receive treatment in two parts. First, biopsy followed by one cycle (28 days) of safusidenib, an orally available, small molecular inhibitor of mutated IDH1, then maximal safe resection of the tumor (Part A). Second, after recovery from surgery, safusidenib until disease progression or unacceptable toxicity (Part B). This research will enable objective measurement of biological activity of safusidenib in patients with IDH1 mutated glioma. Anti-tumor activity will be assessed by progression free survival and time to next intervention.Clinical Trial Registration: NCT05577416 (ClinicalTrials.gov).

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针对IDH1突变胶质瘤患者的Safusidenib围手术期研究。
这是一项单臂、开放标签围手术期试验,目的是评估活检后、手术切除前使用safusidenib治疗未接受放疗或化疗的IDH1突变胶质瘤患者的可行性、药代动力学和药效学。15名参与者将分两部分接受治疗。首先进行活组织检查,然后接受一个周期(28 天)的沙夫西地尼治疗,沙夫西地尼是一种口服的突变 IDH1 小分子抑制剂,然后进行最大限度的肿瘤安全切除(A 部分)。其次,在手术恢复后,服用沙夫西地尼直到疾病进展或出现不可接受的毒性(B 部分)。这项研究将能客观地测量萨福地尼对IDH1突变胶质瘤患者的生物活性。抗肿瘤活性将通过无进展生存期和下一次干预时间进行评估:临床试验注册:NCT05577416(ClinicalTrials.gov)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Future oncology
Future oncology ONCOLOGY-
CiteScore
5.40
自引率
3.00%
发文量
335
审稿时长
4-8 weeks
期刊介绍: Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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