Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.

Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy

开始日期2018-05-01

申办/合作机构

Hoosier Cancer Research Network

[+1]

NCT02991456

/ Completed临床2期IIT

Phase II Randomized Study to Evaluate Efficacy, Patient Satisfaction, and Compliance of the Oral Combination of Rolapitant (Varubi®) Plus Ondansetron vs. Ondansetron Monotherapy in Malignant Glioma Patients Receiving Radiotherapy (RT) and Concomitant Temozolomide

The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.

开始日期2017-10-09

申办/合作机构

Duke University

100 项与盐酸罗拉匹坦水合物相关的临床结果

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100 项与盐酸罗拉匹坦水合物相关的转化医学

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100 项与盐酸罗拉匹坦水合物相关的专利（医药）

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项与盐酸罗拉匹坦水合物相关的文献（医药）

2024-02-01·Biotechnology and applied biochemistry

Homology modeling, virtual screening, molecular docking, and ADME approaches to identify a potent agent targeting NK2R protein

Article

作者: Soltani, Arash ; Hashemy, Seyed Isaac

Abstract:

Neurokinin/tachykinin receptors are classified as the G‐protein coupled receptor superfamily. The neurokinin 2 receptor (NK2R) is widely expressed in different tissues. NK2R is associated with a range of biological events, such as inflammation, smooth muscle contraction, intestinal motor functions, and asthma. Despite these diverse activities, no approved drugs targeting NK2R have been developed yet. Our study focuses on finding potential inhibitors for NK2R using virtual screening, molecular docking, and ADME (absorption, distribution, metabolism, and excretion) approaches. We used a homology modeling approach and AlphaFold DB to obtain the three‐dimensional structure of mouse and human NK2R proteins, respectively. The homology model of NK2R was predicted using MODELLER v10.3 and further refined and validated using the 3Drefine tool and RAMPAGE server, respectively. Molecular docking was performed using a library of 910 structurally similar molecules to four NK1R antagonists: aprepitant, casopitant, fosaprepitant, and rolapitant. Molecular docking revealed six small molecules that displayed high Chemscore fitness scores, and binding energies with desirable ligand–NK2R interactions. The evaluation of the in silico ADME profile, solubility, and permeability of the ligand molecules has revealed that the small molecules are potentially nontoxic and have the chance of exhibiting biological activity after oral administration. Further experimental studies (in vitro and in vivo assays) are required to evaluate the effectiveness of these inhibitors as therapeutic targets.

2022-09-01·Life sciences

Switching indication of PEGylated lipid nanocapsules-loaded with rolapitant and deferasirox against breast cancer: Enhanced in-vitro and in-vivo cytotoxicity

Article

作者: El-Sherbiny, Ibrahim M ; Zaafar, Dalia ; Bakr, Alaa F ; Mahmoud, Mohamed Y ; Kabil, Mohamed Fawzi

Breast cancer (BC) is considered the leading cause of mortality and morbidity among adult women worldwide, and it is associated with many genetic or hormonal factors. Despite the advanced therapeutic and theranostic strategies for BC treatment, cancer metastasis and relapse are often observed among patients which lead to therapeutic failure. Accordingly, among the repositioned medication against BC proliferation is neurokinin receptor antagonists and iron chelating agents especially rolapitant HCl (RP) and deferasirox (DFO), respectively. However, RP and DFO are classified as class II with low aqueous solubility. Both drugs were nanoformulated into PEGylated lipid nanocapsules (LNCs) for enhancing their aqueous solubility and augmenting their efficacy. RP-LNCs, DFO-LNCs and their combinations were evaluated according to particle size (PS), zeta potential, polydispersity index (PDI) and surface morphology. Importantly, the antitumor effect of these novel molecules and their nanoforms was evaluated against the suppression of Ehrlich Ascites tumor model using female mice. Results revealed that RP-LNCs, DFO-LNCs and RP/DFO-LNCs exerted PS from 45.23 ± 3.54 to 60.1 ± 3.32 nm with PDI around 0.20 which indicates homogenous particles distribution. Also, RP-LNCs, DFO-LNCs and RP/DFO-LNCs displayed surface charges of +16.6 ± 6.9, -13.3 ± 5.82 and - 20.2 ± 5.40 mV, respectively. The obtained LNCs conferred a high potent cytotoxic effect against MCF7 cancer cells as compared to parent drugs, with IC₅₀ of 10.86 ± 0.89, 3.34 ± 0.99 and 2.24 ± 0.97 μg/mL for RP-LNCs, DFO-LNCs and RP/DFO-LNCs, respectively. The in-vivo pharmacodynamics effect of the developed nano-formulations showed superior antitumor effect for the individual drugs rather than their combinations as compared to the control group. The current study confirmed the potential of RP and DFO nanoforms as promising therapeutic agents for BC treatment.

2022-08-17·Cureus

Morphological and Skeletal Abnormalities Induced by Rolapitant: An Antiemetic Agent

Article

作者: Dutta, Shaktibala ; Belodu, Rashmi ; Kumar, Hareesh Rs ; Kaul, Nisha V ; Solanki, Sohel ; Yadav, Yogesh

Introduction Rolapitant hydrochloride is a highly selective, long-acting antagonist of the neurokinin-1 (NK1RA) receptor with a high level of central nervous system (CNS) penetrance. Clinically, it is given to cancer patients with high and moderate emetogenic chemotherapy to prevent chemotherapy-induced nausea and vomiting (CINV). The facts produced in this research support the interpretation of teratogenic effects like anatomical malformations and abnormal skeletal changes affected by high doses of rolapitant in developed chick embryos, which can be extrapolated to humans due to gaps in the literature regarding the teratogenic potential of rolapitant. As rolapitant is metabolized by the liver and excreted through the kidney by leaving a deep impact on the various systems of the body and due to its high plasma concentration with a half-life of more than 180 hours, the study was conducted to acquire some additional information about its adverse effects over the various body systems. Chick is one of the best animals for embryological laboratory research. For various reasons, it is preferred to research embryology in chicks or domestic hens (Gallus domesticus). Chick eggs are large, readily available all year, easy to incubate, and regulate artificially. Aim This study aimed to determine the morphological and skeletal abnormalities due to the effect of rolapitant, an antiemetic agent, in developing White Leghorn (G. domesticus) chicken eggs. Materials and methods The experiment used 300 fertilized White Leghorn chicken eggs. The eggs were categorized into five experimental groups (A, B, C, D, and E, each with 30 eggs) and five control groups (a, b, c, d, and e, each with 30 eggs). Rolapitant was administered into the five experimental groups of eggs on incubation day five at various concentrations of 0.00039, 0.0005, 0.00075, 0.001, and 0.00125 mg, respectively, while the control groups received the same volume (0.039, 0.05, 0.075, 0.1, and 0.125 ml, respectively) of normal saline. Results At all doses, the mean weight and crown-rump (CR) length of chick embryos were significantly greater in the control group than in the experimental group. The experimental group died at a higher rate than the control group. Additionally, it was found that the mortality due to the rolapitant dosages increases with dose. All groups except group A showed skeletal anomalies such as poor ossification, bent, and displacement, and morphological abnormalities such as yolk sac retraction, hematoma, and scanty feathers were found in experimental groups C, D, and E. This was shown to be more prevalent in the experimental groups and was exacerbated by subsequent rolapitant dosages. Conclusion Rolapitant is toxic when taken in large doses and for an extended period. As a result, rolapitant should be taken only when a valid diagnosis has been established and only at the recommended dose, not at a larger dose or for an extended period of time.

项与盐酸罗拉匹坦水合物相关的新闻（医药）

2024-05-10

·医药观澜

恒瑞医药3款创新药获批临床

根据恒瑞医药公告，该公司近期有3款1类新药获得中国国家药监局药品审评中心（CDE）临床试验默示许可，即将开展临床试验。这3款产品分别为：1）NK-1受体拮抗剂注射用HRS5580，拟用于预防术后恶心和呕吐；2）补体因子B抑制剂HRS-5965胶囊，拟用于治疗补体参与介导的原发性或继发性肾小球疾病，以及溶血性贫血；3）ATR抑制剂HRS2398缓释片，拟开发治疗晚期恶性肿瘤患者。 HRS5580为罗拉匹坦前药，进入体内后经巯基代谢酶等非CYP450酶系水解，迅速转化为罗拉匹坦。该产品通过拮抗NK-1受体发挥止吐作用，具有溶解度高、安全性好的优点。根据恒瑞医药2023年年度报告，该公司还正在开发HRS5580+帕洛诺司琼复方制剂（HR20013），其同时作用于NK-1受体和5-HT3受体，双途径抑制呕吐反射，使用简便。2023年12月，HR20013预防成人高度致吐性化疗（HEC）引起的恶心和呕吐适应症上市申请已经获CDE受理。 HRS-5965胶囊靶向因子B（Factor B），可通过抑制补体系统的过度激活，抑制补体系统介导的溶血。临床前研究显示其在补体介导的溶血模型中起到了显著的抑制作用，安全性良好。该药本次获批临床，拟用于治疗IgA肾病、特发性膜性肾病、C3肾病和狼疮性肾炎等补体参与介导的原发性或继发性肾小球疾病，以及阵发性睡眠性血红蛋白尿、非典型溶血性尿毒症综合征、冷凝集素病等补体参与介导的溶血性贫血。根据恒瑞医药2023年年度报告，该公司还在开发HRS-5965片剂剂型，目前处于治疗阵发性睡眠性血红蛋白尿、IgA肾病的2期临床研究阶段。 HRS2398缓释片为恒瑞医药自主研发的新型、高效、口服的ATR抑制剂，能够有效抑制ATR激酶活性，加剧DNA双链损伤，抑制细胞增殖，发挥抗肿瘤作用。该产品还有潜力作为单一疗法和联合疗法治疗更多肿瘤患者。恒瑞医药HRS2398片剂剂型此前已经在中国获得多个单药和联合疗法临床试验申请，用于治疗晚期恶性实体瘤。参考资料： [1]恒瑞医药关于子公司获得药物临床试验批准通知书的公告. Retrieved May 9, 2024, from http://www.cninfo.com.cn/new/disclosure/detail?stockCode=600276&announcementId=1220009168&orgId=gssh0600276&announcementTime=2024-05-09 [2]恒瑞医药关于子公司获得药物临床试验批准通知书的公告. Retrieved May 9, 2024, from http://www.cninfo.com.cn/new/disclosure/detail?stockCode=600276&announcementId=1220009167&orgId=gssh0600276&announcementTime=2024-05-09 [3]恒瑞医药关于子公司获得药物临床试验批准通知书的公告. Retrieved Apr 19, 2024, from http://www.cninfo.com.cn/new/disclosure/detail?plate=sse&orgId=gssh0600276&stockCode=600276&announcementId=1219663636&announcementTime=2024-04-19 内容来源于网络，如有侵权，请联系删除。

申请上市临床申请ASH会议

2023-11-28

·智慧芽新药科讯

靶向 NK1R 受体的5款上市止吐药

关于NK1R神经激肽受体 1 (Neurokinin 1 receptor, NK1R), 又被称为速激肽受体 1 (tachykinin receptor 1, TACR1) 或物质P受体 (substance P receptor, SPR), 隶属于 GPCR 家族，主要存在于中枢神经系统和周围神经系统中，其内源性配体是 P 物质，它对其他一些速激肽也有一定的亲和力。物质 P (一种神经肽) 通过激活 NK1R，对突触神经传递进行持久调节。例如，物质 P 在神经系统中的作用对疼痛、情绪、呼吸和恶心有重要影响，其次，物质 P 在其他组织中的作用与炎症或平滑肌收缩有关。大量研究表明，NK1R 拮抗剂对物质 P 活性的抑制可能会导致对疼痛、炎症和情绪失调的有效治疗。根据智慧芽新药情报库统计，到目前为止，靶向 NK1R 的拮抗剂开发主要用于临床治疗化疗引起的恶心和呕吐。全球获批的 NK1R 拮抗剂一共5款，包括 Fosnetupitant, Rolapitant，Netupitant (与5-HT3R 拮抗剂 Palonosetron 的复方制剂)，Fosaprepitant，Aprepitant 等；在中国获批上市的主要是后三者。5款靶向 NK1R 的拮抗剂药物Aprepitant 是全球首款获批上市的 NK1R 受体拮抗剂产品，由 Merck 公司原研并进行临床适应症开发。Aprepitant 可与其他止吐药联合使用，用于预防与高致吐性癌症化疗初始疗程和重复疗程相关的急性和迟发性恶心和呕吐。Aprepitant (L-754030, MK-869) 是一种选择性高亲和力人源 NK1R 受体拮抗剂，它对5-羟色胺（5-HT3）、多巴胺和皮质类固醇受体几乎没有亲和力，而这些受体也是现有化疗引起的恶心和呕吐疗法的靶点。1999 年，《新英格兰医学杂志》首次发表了一项使用选择性神经激肽-1 受体拮抗剂 (Aprepitant, L-754030) 对接受抗癌化疗的患者的止吐效果。结果显示，在化疗病人的急性呕吐期，每日服用 L-754,030 (第 1 组) 和单次服用 (第 2 组) 中 93% 的患者没有呕吐，而对照组 (第 3 组) 中 67% 的患者没有呕吐。在迟发性呕吐期，第 1 组有 82% 的患者没有呕吐，第 2 组有 78% 的患者没有呕吐，第 3 组有 33% 的患者没有呕吐。整体而言，每日服用 L-754,030 在迟发性呕吐阶段的恶心评分中位数明显低于对照组。L-754,030 治疗未引发严重不良事件。随后的临床研究，进一步表明，每日口服一次 NK1R 受体拮抗剂 MK-869 可有效减少大剂量化疗治疗后的延迟性呕吐和恶心。与此同时，MK-869 与 5HT3R 受体拮抗剂和 dexamethasone 的三联疗法对急性呕吐的控制效果最佳，这进一步扩展NK1R 与 3-HT3R 双靶点联用治疗的可能性。2003 年，多项相继公布的临床研究证据，验证了 Aprepitant 对于化疗引起的恶心和呕吐的安全性和疗效。Aprepitant 于 03 年 3 月被美国 FDA 批准上市。Fosaprepitant (L-758,298, MK-0517) 是由 Merck 公司开发上市的全球第二款 NK1R 受体拮抗剂，首批适应症依然为化疗引起的恶心和呕吐。L-758,298 是 L-754,030 的一种水溶性静脉注射原药，它是一种强效、选择性的NK1受体拮抗剂。根据 2001 年公布的一项双盲、随机、对照临床研究试验结果，评估了预防化疗治疗后急性（0-24 h）和延迟（第 2-7 天）呕吐的效果。在急性期，L-758,298 组和 5-HT3R 拮抗剂 ondansetron 组无呕吐的患者比例分别为 37% 和 52%（组间无显著差异）。在延迟期，L-758,298治疗组和 L-754,030 治疗组无呕吐的患者比例分别为72%和30%。与 ondansetron 组相比，L-758,298治疗组在延迟期的平均恶心评分分布较低。2007 年，Merck 团队进一步研究了 Fosaprepitant 在健康受试者中的耐受性以及与 Aprepitant 的生物等效性。72 小时的血浆浓度检测结果显示，静脉注射制剂 115 mg Fosaprepitant 与 125 mg Aprepitant 生物等效。2008 年后，Fosaprepitant 在多个国家和地区获批上市后。Netupitant/Palonosetron 是由瑞士Helsinn 医疗公司开发的一款 NK1R 受体拮抗剂Netupitant 与 5-HT3R 拮抗剂 Palonosetron 组成的复方制剂，首批适应症为化疗引起的恶心和呕吐。2019年后，多项 Netupitant/Palonosetron 复方制剂的临床研究成果先后发表。国内市场方面，2017年，Helsinn 医疗公司与诺思格（北京）医药科技提交上市申请。2019年8月，奈妥匹坦帕洛诺司琼胶囊 (奥康泽, Netupitant/Palonosetron) 在中国成功获批，用于成人患者预防高度致吐性化疗引起的急性恶心呕吐和延迟性恶心呕吐，预防中度致吐性化疗引起的急性恶心呕吐和延迟性恶心呕吐。2021 年 10 月，上海复星医药从 Helsinn 医疗公司共同宣布，双方签署独家许可和分销协议，Helsinn 授权复星医药在中国内地和港澳地区独家分销、推广和销售奥康泽。2023年01月，《国家基本医疗保险、工伤保险和生育保险药品目录（2022年）》正式公布，复星医药的止吐药物奈妥匹坦帕洛诺司琼胶囊成功进入国家医保目录。另外，多个药企也陆续启动奈妥匹坦帕洛诺司琼胶囊的仿制药研究，其中，四川科伦和齐鲁药业的等效性临床研究已完成。2023年4月，四川科伦药业递交的奈妥匹坦帕洛诺司琼胶囊仿制药上市申请获受理，国内首家报产的本土药企。Fosnetupitant 是 Helsinn 医疗公司开发的一款 NK1R 受体拮抗剂，是 Netupitant 的原药。2018 年，美国 FDA 批准 Fosnetupitant 与 Palonosetron 固定剂量复方制剂的静脉注射剂型合用，该复方制剂在欧盟和加拿大也被批准用于临床治疗呕吐用途。据研究，患者或健康受试者单次静脉注射 235 mg Fosnetupitant 和 0.25 mg Palonosetron 后，Fosnetupitant 的最大浓度在 30 分钟输注结束时达到。每种动物的口服生物利用度差异很大，大鼠、狗和猴子的生物利用度分别为42-105%、34-83%和37-62%。Rolapitant (SCH-619734) 是由先灵葆雅公司（Schering Plough Corporation）原研开发的一款高选择性 NK1R 受体拮抗剂。2009 年全球经济危机，默沙东以411亿美元收购先灵葆雅。收购时“被赠送”的 K 药，后来成为可默沙东王牌产品。也是 2009 年，OPKO Health 公司从先灵葆雅收购了 Rolapitant 和其他神经激肽-1 资产，并于 2010 年将 Rolapitant 的开发、生产和商业化独家授权给专注于肿瘤的生物制药公司 TESARO 公司。根据2009年发表的一篇研究论文，Rolapitant 是一种具有选择性、生物可利用性、中枢神经系统穿透性的神经激肽 NK1R 受体拮抗剂，可在呕吐动物模型中显示出行为效应。体外研究表明，Rolapitant 对人类 NK1R 受体的亲和力为 0.66 nM，对人类 NK2R 和 NK3R 亚型的选择性大于 1000 倍。（来源于，DOI: 10.1016/j.pbb.2012.03.021）在静脉注射和口服最低有效剂量为 0.1 mg/kg的情况下，Rolapitant 可逆转 NK1R 激动剂诱发的沙鼠足部叩击长达 24 小时。Rolapitant 在雪貂急性和延迟性呕吐模型中的活性剂量分别为 0.1 mg/kg 和 1 mg/kg，这与其他 NK1 拮抗剂的临床数据一致。止吐药的临床疗效与雪貂致呕吐模型的疗效高度相关，这表明 Rolapitant 是这一适应症的可行临床候选药物。2015 年，TESARO 公司团队在《柳叶刀-肿瘤学》杂志发表了两项临床3期研究成果，分别研究了 Rolapitant 预防癌症患者接受中度致吐化疗或蒽环类和环磷酰胺方案、接受顺铂为基础的高致吐性化疗后化疗引起的恶心和呕吐的安全性和有效性。同年7月，恒瑞医药发布公告称，公司与美国 Tesaro 公司达成协议，引进 Tesaro 公司用于肿瘤辅助治疗的止吐专利药 Rolapitant，恒瑞将被授权负责该药在中国的临床开发、注册和市场销售。目前该药处于申请上市阶段。以上文章来源于GPCR drug diacovery，作者段思研本文仅作信息交流之目的，文中观点不代表相关疾病治疗立场，也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

2023-03-09

·BioSpace

ROME Therapeutics Appoints Keith Wilcoxen, Ph.D., as Executive Vice President, Early Development

- Company’s inaugural development candidate, targeting dark genome's first therapeutic target in autoimmune disease, now in IND-enabling studies - BOSTON--(BUSINESS WIRE)-- ROME Therapeutics, a biotechnology company harnessing the power of the dark genome to develop breakthrough medicines for autoimmune diseases and cancer, today announced the appointment of Keith Wilcoxen, Ph.D., as Executive Vice President, Early Development. Dr. Wilcoxen is a translational leader with more than 25 years of experience advancing new therapies through preclinical and early clinical development, most recently as Senior Vice President, Global Research, at Zenas BioPharma, an autoimmune-focused biotechnology company. “We are pleased to welcome Keith to ROME’s management team at this exciting moment in our company’s growth. We recently nominated ROME’s first development candidate, the LINE-1 reverse transcriptase inhibitor RPT-2950, providing a powerful demonstration of the progress we have made toward illuminating the dark genome’s role in disease,” said Rosana Kapeller, M.D., Ph.D., President, Chief Executive Officer and Co-founder of ROME. “Keith’s expertise in early clinical development and experience leading high-performing scientific teams will be valuable assets as we advance our development candidate to the clinic and progress our pipeline of first-in-class therapies for autoimmune diseases and cancer.” Dr. Wilcoxen’s career spans more than two decades in the biopharmaceutical industry. He joins ROME from Zenas BioPharma where he served as Senior Vice President, Global Research, overseeing all pre-clinical and translational activities for a portfolio of autoimmune therapeutic candidates. Prior to joining Zenas, Dr. Wilcoxen was Vice President of Diligence and Non-Clinical Development, followed by Vice President of Translational Research at Boston Pharmaceuticals where he was a core member of the Research and Development leadership team. In previous roles at TESARO, culminating in the role of Executive Director and Head of Strategic Drug Hunting Partnerships, Preclinical Research, Dr. Wilcoxen supported three Investigational New Drug submissions, including for cancer therapies TSR-011, Jemperli™ (dostarlimab) and cobolimab, and New Drug Application submissions for cancer therapies Varubi™ (rolapitant) and Zejula™ (niraparib). He previously held roles of increasing responsibility with Eisai, Neurocrine Biosciences and Pfizer. Dr. Wilcoxen holds a Ph.D. in chemistry from Scripps Research Institute and a B.A. in chemistry from Northwestern University. “I am excited to join ROME to help drive forward their groundbreaking portfolio of therapies targeting the dark genome’s role in autoimmune diseases and cancer. I believe research into the dark genome is key to the next wave of therapeutic breakthroughs,” said Dr. Wilcoxen. “I look forward to working with the team to bring these important medicines to patients.” About ROME Therapeutics ROME Therapeutics is developing novel therapies for autoimmune diseases and cancer by illuminating the role of the dark genome in human health and disease. Leveraging the company’s unprecedented data sciences platform, ROME has built a deep pipeline of therapies targeting the dark genome. To lead this exploration, ROME has assembled a team of world-class leaders across immunology, oncology, virology and machine learning. ROME is based in Boston, Mass. For more information, please visit .

高管变更临床1期

100 项与盐酸罗拉匹坦水合物相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D08988	盐酸罗拉匹坦水合物	A04AD	DB09291

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
延迟性恶心和呕吐	美国	TerSera Therapeutics LLC初创企业	2017-10-25
化疗引起的恶心和呕吐	欧盟	Tesaro Bio Netherlands BV	2017-04-19
化疗引起的恶心和呕吐	冰岛	Tesaro Bio Netherlands BV	2017-04-19
化疗引起的恶心和呕吐	列支敦士登	Tesaro Bio Netherlands BV	2017-04-19
化疗引起的恶心和呕吐	挪威	Tesaro Bio Netherlands BV	2017-04-19
恶心	美国	TerSera Therapeutics LLC初创企业	2015-09-01
呕吐	美国	TerSera Therapeutics LLC初创企业	2015-09-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
生殖细胞和胚胎肿瘤	临床2期	-	Tesaro, Inc.	2018-05-01
术后恶心呕吐	临床2期	-	Merck Sharp & Dohme Corp.	2007-10-01
慢性咳嗽	临床2期	-	Merck Sharp & Dohme Corp.	2007-01-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02991456 (CTgov)	临床2期	放疗引起的恶心和呕吐 \| 胶质瘤	48	Ondansetron+Rolapitant (Sequence A)	鬱憲選糧衊鏇醖鑰網糧(鹽網繭蓋鏇積襯襯構艱) = 衊鏇壓齋築鬱糧糧築廠鹽醖鏇顧艱網選構鏇鹽 (繭襯廠範範醖蓋網鏇壓, 鹽製廠艱鏇廠餘鹽積糧 ~ 繭顧網積廠鹽築製網窪) 更多	-	2023-07-11
				Ondansetron+Rolapitant (Sequence B)	鬱憲選糧衊鏇醖鑰網糧(鹽網繭蓋鏇積襯襯構艱) = 鏇齋醖繭醖衊鏇壓網顧鹽醖鏇顧艱網選構鏇鹽 (繭襯廠範範醖蓋網鏇壓, 願觸願齋遞餘膚鏇壓願 ~ 繭鹽艱顧廠範艱遞蓋觸) 更多
QOL-08 (SNO2022)	临床2期	胶质瘤	53	Ondansetron Monotherapy	觸襯廠簾遞鏇選艱鹽艱(艱遞築蓋夢淵範網選夢) = 衊淵襯鹹淵範淵齋壓製鹽襯鏇鑰餘範製獵繭範 (醖積顧鏇繭簾遞築積顧 ) 更多	-	2022-11-14
				Rolapitant plus Ondansetron	觸襯廠簾遞鏇選艱鹽艱(艱遞築蓋夢淵範網選夢) = 壓觸膚繭憲築蓋築齋艱鹽襯鏇鑰餘範製獵繭範 (醖積顧鏇繭簾遞築積顧 ) 更多
NCT02732015 (CTgov)	临床2期	局部晚期软组织肉瘤 \| 恶心 \| 呕吐	37	Ondansetron (5HT3 receptor antagonist)+Dexamethasone+Rolapitant (Cohort 1)	範鑰製獵遞膚膚壓衊鏇(選襯鹽糧襯襯醖窪廠憲) = 鹹鑰製憲範鬱製製襯鹹鹽遞衊觸願願鑰衊淵鹹 (簾積淵鏇網衊鹽鬱糧廠, 選繭餘構艱製窪鬱壓觸 ~ 壓築蓋積衊網憲觸簾選) 更多	-	2021-08-09
				Ondansetron (5HT3 receptor antagonist)+Dexamethasone+Rolapitant (Cohort 2)	範鑰製獵遞膚膚壓衊鏇(選襯鹽糧襯襯醖窪廠憲) = 鏇積衊鑰鹹醖願壓醖衊鹽遞衊觸願願鑰衊淵鹹 (簾積淵鏇網衊鹽鬱糧廠, 願鏇鹽鏇壓築願糧夢壓 ~ 繭構醖築齋廠鬱醖遞製) 更多
SABCS2017	临床3期	-	-	Rolapitant 180 mg	顧繭鑰簾願獵衊顧鏇範(觸鬱範網鬱願襯夢網繭) = 28.5% and 31.2% in rolapitant and control arms, respectively 鑰齋糧襯觸構餘遞艱憲 (夢憲齋願壓繭壓選鏇鏇 ) 更多	积极	2017-02-15
				Active Control (5-HT3 RA + dexamethasone)
NCT01499849 (CTgov)	临床3期	化疗引起的恶心和呕吐	532	Placebo+Granisetron+Dexamethasone	簾襯夢獵觸鹽築繭夢艱(顧壓獵衊糧遞艱顧構範) = 鏇膚網膚鬱艱餘製構願獵鹽夢壓選淵襯鏇願鹹 (醖積鬱顧鏇壓獵觸鹹齋, 鏇醖齋製鏇簾餘獵觸窪 ~ 膚糧鏇蓋衊蓋膚鑰襯築) 更多	-	2015-11-04
NCT01500226 (CTgov)	临床3期	化疗引起的恶心和呕吐	1,369	Placebo+Granisetron+Dexamethasone	齋選繭製襯憲鹹鬱夢鏇(窪壓蓋觸鑰鑰淵願製遞) = 夢齋糧簾膚築齋艱構獵窪願糧鏇艱觸網蓋艱憲 (觸網鏇糧餘構鏇夢網簾, 繭顧窪蓋廠願積鹹積製 ~ 醖壓鏇憲憲鏇衊繭夢繭) 更多	-	2015-11-04
NCT01500213 (HEC, CTgov)	临床3期	化疗引起的恶心和呕吐	555	Placebo+Granisetron+Dexamethasone	顧製範製構願鏇鬱鏇簾(壓鏇襯鏇艱鹽選鬱艱餘) = 壓鹹蓋簾積廠顧憲鹽觸簾醖選積餘壓鑰鬱獵鹽 (衊鏇構廠壓鹹鑰壓觸餘, 構構鑰膚淵觸顧廠齋網 ~ 糧夢繭壓製糧齋窪鬱範) 更多	-	2015-11-04
NCT01500226 (Pubmed \| Lancet Oncol) 人工标引	临床3期	恶心 \| 肿瘤 \| 呕吐	1,369	granisetron+dexamethasone+rolapitant	憲膚範鏇簾憲願壓壓鑰(鏇衊憲構鹽蓋製窪壓衊) = 壓鑰鹹衊積鹽觸獵鹹膚築範築積窪醖憲艱艱艱 (淵憲醖壓憲觸願遞鹹鬱 ) 更多	积极	2015-09-01
				granisetron+dexamethasone+Placebo	憲膚範鏇簾憲願壓壓鑰(鏇衊憲構鹽蓋製窪壓衊) = 鏇壓膚窪襯範觸糧鹽選築範築積窪醖憲艱艱艱 (淵憲醖壓憲觸願遞鹹鬱 ) 更多
Pubmed \| Lancet Oncol	临床3期	化疗引起的恶心和呕吐	-	Rolapitant	鏇淵膚顧築衊壓選衊醖(構餘鹽餘遞鬱選壓製繭) = 遞廠鹽簾蓋構顧夢網壓膚齋壓選獵憲積鬱遞獵 (觸顧鬱鹹廠餘網選衊糧 )	积极	2015-09-01
				Active control	鏇淵膚顧築衊壓選衊醖(構餘鹽餘遞鬱選壓製繭) = 糧憲獵窪獵鑰糧製膚憲膚齋壓選獵憲積鬱遞獵 (觸顧鬱鹹廠餘網選衊糧 )
NCT01500226 (ASCO2014)	临床3期	-	1,369	Rolapitant + granisetron + dexamethasone	鬱憲鹹獵襯鏇繭衊願窪(積蓋顧繭壓醖製築鬱顧) = 鹽壓齋鏇鏇築鏇壓構鬱築蓋選憲網網淵網製廠 (糧膚憲網淵鹽簾範鏇鹹 ) 更多	积极	2014-05-20
				Placebo + granisetron + dexamethasone	鬱憲鹹獵襯鏇繭衊願窪(積蓋顧繭壓醖製築鬱顧) = 觸範鏇糧壓網齋鹽遞遞築蓋選憲網網淵網製廠 (糧膚憲網淵鹽簾範鏇鹹 ) 更多