一项关于 ME2136(马来酸阿塞那平)联合标准止吐疗法的 II 期研究,适用于接受顺铂化疗的患者,包括糖尿病患者。

IF 3 3区 医学 Q2 ONCOLOGY Investigational New Drugs Pub Date : 2024-10-26 DOI:10.1007/s10637-024-01480-w
Satoshi Hamauchi, Hirofumi Yasui, Tomoya Yokota, Takahiro Tsushima, Kunihiro Fushiki, Tateaki Naito, Akira Ono, Nobuhiro Kado, Yusuke Onozawa, Haruyasu Murakami, Toshiaki Takahashi, Yasuyuki Hirashima, Keita Mori, Kentaro Yamazaki
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引用次数: 0

摘要

奥氮平联合神经激肽-1受体拮抗剂帕洛诺司琼和地塞米松是治疗高致吐性化疗(HEC)引起的化疗诱发恶心和呕吐(CINV)的标准疗法。然而,由于奥氮平具有潜在的高血糖风险,因此对糖尿病(DM)患者使用奥氮平会带来挑战。与奥氮平相似的抗精神病药物 ME2136 与较低的高血糖风险相关。本研究调查了 ME2136 治疗 HEC 的止吐疗效和安全性。这项单臂 2 期研究考察了 ME2136 5 毫克、4 天联合三联止吐疗法的安全性和疗效。安全性评估分为两组:DM组和非DM组。符合条件的患者均患有恶性肿瘤,并首次接受顺铂化疗。主要终点是完全应答率(CR),即在延迟期(24-120 h)内无呕吐且无需使用抢救药物的患者比例。2020 年 12 月至 2022 年 1 月期间,共有 40 名患者入组,每组 20 人。所有患者均纳入安全性分析,35 名患者纳入疗效分析。所有患者在延迟阶段的 CR 率为 71.4% [60% CI 63.1-78.6%],DM 队列为 66.7%,非 DM 队列为 76.5%。未报告≥3级的治疗相关不良事件,包括高血糖。ME2136与标准三联止吐疗法联合使用时,预计可发挥与标准治疗HEC所致CINV相似的止吐效果。目前,ME2136-02 试验正在进行中,以检验三联止吐疗法和 ME2136 5 天疗法的安全性和有效性。该研究已于 2020 年 12 月 10 日在日本临床试验注册中心注册(jRCT2041200071)。临床试验注册:本研究已于 2020 年 12 月 10 日在日本临床试验注册中心注册(jRCT2041200071)。
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A phase II study of ME2136 (Asenapine Maleate) plus standard antiemetic therapy for patients, including diabetic patients, receiving cisplatin-based chemotherapy.

Olanzapine combined with the neurokinin-1 receptor antagonist, palonosetron and dexamethasone is the standard treatment for chemotherapy-induced nausea and vomiting (CINV) due to highly emetogenic chemotherapy (HEC). However, the use of olanzapine poses challenges in patients with diabetes mellitus (DM) due to the potential risk of hyperglycemia. ME2136, antipsychotic similar to olanzapine, is associated with a lower risk of hyperglycemia. This study investigated the antiemetic efficacy and safety of ME2136 for HEC. This single-arm phase 2 study examined the safety and efficacy of ME2136 5 mg for 4 days in combination with triplet-combination antiemetic therapy. Two cohorts were established for the safety assessment: DM and non-DM. Eligible patients had malignant tumors and were receiving cisplatin-based chemotherapy for the first time. The primary endpoint was the complete response (CR) rate, defined as the percentage of patients without vomiting and not requiring rescue medications in the delayed phase (24-120 h). Between December 2020 and January 2022, 40 patients were enrolled, with 20 in each cohort. All patients were included in the safety analysis and 35 in the efficacy analysis. The CR rate in the delayed phase was 71.4% [60% CI 63.1-78.6%] for all patients, 66.7% in the DM cohort, and 76.5% in the non-DM cohort. No treatment-related adverse events ≥ grade 3, including hyperglycemia, were reported. ME2136, when combined with standard triplet-combination antiemetic therapy, is expected to exert similar antiemetic effects to the standard treatment for CINV due to HEC. Currently, ME2136-02 trial is underway to examine the safety and efficacy of triplet-combination antiemetic therapy and a 5-day treatment with ME2136. This study was registered with the Japan Registry of Clinical Trials (jRCT2041200071) on 10 December 2020. Clinical trial registration: This study was registered with the Japan Registry of Clinical Trials (jRCT2041200071) on 10 December 2020.

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来源期刊
CiteScore
7.60
自引率
0.00%
发文量
121
审稿时长
1 months
期刊介绍: The development of new anticancer agents is one of the most rapidly changing aspects of cancer research. Investigational New Drugs provides a forum for the rapid dissemination of information on new anticancer agents. The papers published are of interest to the medical chemist, toxicologist, pharmacist, pharmacologist, biostatistician and clinical oncologist. Investigational New Drugs provides the fastest possible publication of new discoveries and results for the whole community of scientists developing anticancer agents.
期刊最新文献
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