An open label, two arm, randomized study to evaluate Dex-sparing benefits of the NEPA, an oral fixed combination of Netupitant and palonosetron, in Highly Emetogenic Chemotherapy (HEC) regimen

Prince Aly Khan Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1. Chemotherapy-naive patients.
•2. Adult male and female subjects aged >=18 years
•3. Scheduled to receive HEC regimen.
•4. Eastern Cooperative Oncology Group (ECOG) performance status 0â??1
•5. Adequate general condition (white blood cell count 3Ã?109 cells/ L), hepatic function (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]
•6. Willing to provide written informed consent.

•1. Seizure disorder needing anticonvulsants, unless clinically stable;
•2. Any Prior vomiting, retching, or grade 2 or higher nausea according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE);
•3. Asymptomatic metastases to the brain
•4. Known hypersensitivity to palonosetron, Netupitant or dexamethasone excipients
•5.Pregnant/breast-feeding women
•6. Those receiving any drug with antiemetic effects
•7. Those who were unable to cooperate or judged by an investigator to be unfit for participation in the study.

发起方

Prince Aly Khan Hospital