A multicenter phase II trial of the triplet antiemetic therapy with palonosetron, aprepitant and olanzapine for cisplatin containing regimen - PATROL-1

niversity of Shizuoka, School of Pharmaceutical Sciences0 个研究点目标入组 85 人开始时间: 2019年4月15日最近更新: 2024年9月2日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 85

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The percentage of patients who achieved TC during the overall phase, the primary endpoint of this study was 31.3%. CR was achieved in 61.4%, 84.3%, and 65.1% of patients during the overall, acute, and delayed phases, respectively. The most frequently reported adverse event was anorexia. The primary endpoint was below the threshold and we could not find benefit in the dexamethasone-free regimen, but CR during the overall phase was similar to that of the conventional three-drug regimen.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•1) Patients who has history of hypersensitivity or allergy for study drugs or similar compounds. 2) Patients taking systemic corticosteroid (oral and intravenous) except for inhaled or topical corticosteroid preparation 3) Patients having a clear vomiting symptom such as brain metastasis or gastrointestinal obstruction to the passage of foods 4) Patients with symptomatic ascites or pleural effusions requiring therapeutic puncture 5) Patients with obstruction of gastrointestinal tract, for example gastric outlet or ileus etc. 6) Patients who have convulsive disorders requiring anticonvulsants therapy 7) Patients receieving adrenaline or pimozide 8) Patients who start taking opioids within 48 h prior to registration 9) Patients who received radiation therapy to abdomen or pelvis within 6 days prior to registration or will receive radiation therapy until 6 days after cisplatin administration 10) Patients regularly taking antiemetics other than study drugs 11) Patients who cannot be hospitalized after administration of cisplatin during 6 days 12) Pregnant, breastfeeding or expecting women or who do not wish to use contraception 13) Patients with diabetes mellitus receiving treatment of antidiabetic agents or having HbA1c (NGSP) >= 6.5 or HbA1c (JDS) >= 6.1 within 28 days before registration 14) Patients with smoking habit 15) Patients who are judged to be inappropriate for the study by the investigator

研究者

发起方

niversity of Shizuoka, School of Pharmaceutical Sciences

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