A PROSPECTIVE,PHASE III,COMPARATIVE, RANDOMISED, OBSERVER BLIND STUDY TO EVALUATE EFFICACY, AND SAFETY OF PALONOSETRON FOR THE PREVENTION OF ACUTE-ONSET AND DELAYED-ONSET CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING FOLLOWING THE ADMINISTRATION OF EITHER MODERATELY OR HIGHLY EMETOGENIC CHEMOTHERAPY REGIMENS

Themis Medicare Limited0 个研究点目标入组 200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 已完成
发起方: Themis Medicare Limited
入组人数: 200

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

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Patients of either sex in the age group between 18 to 70 years.
•2. Patients with histologically or cytologically confirmed malignant disease.
•3. Patients with malignancy at sites other than head and neck or upper gastrointestinal regions.
•4. Patients scheduled to receive a single day of moderate to severe emetogenic chemotherapy for the given malignancy with any of the following anti-cancer drugs in the given doses (for ≤ 4 courses): (1) Cisplatin / Carboplatin > 60 mg/m2. (2) Cycloposphamide > 1100 mg/m2. (3) Doxorubicin > 25 mg/m2. (4) Methotrexate > 250 mg/m2. (5) Dacarbazine, Irinotecan, Epirubicin.
•5. The Chemotherapy administration must be for ≤ 4 hours and the duration of each course ≤ 28 days.
•6. The Chemotherapy must cause nausea and vomitting in 30-100 % of patients if untreated according to Hesketh algorithm.
•7. Patients must not be suffering from greater than mild nausea or any vomitting within 24 hours before beginning study treatment.
•8. Patients with Body performance status (PS) between 0 to 2 and normal ECG recording and normal Liver Function Tests.
•9. Patient ready to give informed consent.

排除标准

•1. Patients admitted in intensive care unit to the hospital for indication other than chemotherapy treatment.
•2. Patients with associated multi-organ involvment / septicemia.
•3. Patients having concomitant chronic infections e.g. tuberculosis.
•4. Patients presenting with prolongation of cardiac conduction intervals (QTc interval ≤500 ms) cardiac abnormality predisposing the patient to arrhythmia and electrolyte disturbances.
•5. Patients with severe cardiac, hepatic and renal diseases. (SGOT upper limit of normal (ULN). SGPT and S. Bilirubin ULN, S.creatinine ULN).
•6. Immuno-compromised and malnourished patients.
•7. Pregnant and lactating females.
•8. Patients with psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation.
•9. Patients with recent history (i.e. ≤ 1 year) of alcohol or drug abuse.
•10. Known hypersensitivity to Palonosetron and other 5-HT3 receptor antagonists.
•11. Patients must not be scheduled to receive radiotherapy 7 days prior to, during and 5 days after completion of study treatment.
•12. Prior chemotherapy must be complete atleast 10 days before enrollment.
•13. Patients should not be receiving concurrent prohibited medications (e.g. CYP3A4 inhibitors or other antiemetic medications) or within the last 10 days prior to enrollment.
•14. Patients should not be receiving any anti-nausea medications within the last 7 days prior to enrollment.
•15. Patients should not be treated concomitantly / within the last 30 days prior to enrollment with any investigational products.
•16. Simultaneous participation in another clinical study.

研究者

发起方

Themis Medicare Limited

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