CTRI/2025/01/079007进行中（未招募）3 期
A Phase III Randomized Multicentre Double Blind Parallel Group Prospective Non Inferiority Study to Evaluate the Efficacy and Safety of Ondansetron Extended Release Injectable Suspension Intramuscular When Compared to Zofsetron Injection (Ondansetron 8 mg/4 ml) IM for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patients Receiving Moderately and Highly Emetogenic Chemotherapy
FTF Pharma Pvt Ltd9 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年1月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 9
- 主要终点
- A proportion of patients with complete response (CR) during the overall treatment (0 to 120 hours) following the administration of chemotherapy in Chemo cycles
研究概览
简要总结
This is a randomized multicentric parallel group active controlled double-blind non-inferiority study to evaluate the efficacy and safety of Ondansetron Extended Release Injectable Suspension Intramuscular When Compared to Zofsetron Injection (Ondansetron 8 mg/4 ml) IM for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving moderately or highly emetogenic chemotherapy
The study will be conducted at approximately 8 to 10 centres in India having qualified investigators.The study will be initiated only after receipt of regulatory and ethics committee (EC) approval. The study will involve screening Hospitalization (treatment period) and safety follow up. A total of 5 visits will be scheduled to the Investigator site
The total duration of study will be approximately 13 weeks which includes 7 days of screening and 3 cycle of treatment and safety follow-up after completion of study treatment (21 days)
All patients will be hospitalized for at least 5 days in each cycle to observe the events till 120 hrs (5 days from the day of Randomization and in every cycle for 3 chemo cycles). All Patients will be randomized in 1:1 ration for Test and Reference. All the Patients further will be stratified according to the emetogenicity of their scheduled chemotherapy regimen (MEC or HEC) and randomization will be done as per stratified block randomization. All the MEC/HEC patients will be equally enrolled in 1:1 ratio in both the arms. Patients will visit the study center for at least 6 hours (±1 hour) before the chemotherapy treatment on Day 1 of each cycle and the patient will remain at study center till Day 5 (0 to 120 hours) of each cycle
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing to provide the signed written informed consent 2.Male or female patient greater than or equal to 18 years of age 3.Male or female patients of child-bearing potential must agree to use medically acceptable forms of contraception during the study 4.Eastern Cooperative Oncology Group performance status less than or equal to 2 5.Patients life expectancy must be more than 6 months 6.Men or Women with confirmed malignancy who planned to receive moderately or highly emetogenic chemotherapeutic drug on day 1 of chemo cycle and who were naive to chemotherapy or had previous chemotherapy greater than or equal to 3 weeks prior to screening 7.Patients who are scheduled to receive Moderately Emetogenic Chemotherapy like Alemtuzumab Bendamustine Carboplatin Cyclophosphamide less than 1500 mg per m2 Cytarabine greater than 1000 mg per m2 Daunorubicin Doxorubicin Epirubicin Idarubicin Irinotecan liposomal injection Ifosfamide Temozolomide Trabectedin Or 8.Patients who are scheduled to receive Highly Emetogenic Chemotherapy (HEC) regimen like Anthracycline/cyclophosphamide combination Carmustine Cisplatin Cyclophosphamide greater than or equal to 1500 mg per m2 Dacarbazine Dactinomycin Mechlorethamine Streptozotocin 9.Female patients of either: non-childbearing potential or child-bearing potential with a negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product of Day 1 and with a commitment to consistent and correct use of contraceptive method throughout the clinical trial 10.Hematologic and metabolic status adequate for receiving a moderately or highly emetogenic chemotherapy and fulfilment of the following criteria a)Total Neutrophils greater than or equal to 1500 per mm3 b) Platelets greater or equal than 100000 per mm3 (Standard units: greater or equal than 100.0 x 109 per Liter c)Bilirubin less than or equal to 1.5 x Upper Limit of Normal D)Liver enzymes without known liver metastases, Aspartate aminotransferase and or Alanine aminotransferase less than or equal to 2.5 x ULN with known liver metastases AST and or ALT less than or equal to 5.0 x ULN Serum Creatinine less than or equal to 1.5 mg per dL (Standard units: less or equal than 132.6 microMOL per Liter or Creatinine Clearance greater than or equal to 60 mL per minute.
排除标准
- •1 Patients with vomiting or more than mild nausea within 24 hours before study drug administration 2 A QTc interval greater than 500 ms or a greater than 0 ms change from baseline or any other cardiac abnormality predisposing to significant arrhythmia 3 If female is pregnant or lactating. 4 Current use of illicit drugs or current evidence of alcohol abuse. 5 Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to Day 1 or between Days 1 to 5 in chemo cycles 6 Any vomiting, retching, or mild nausea (grade greater or equal than I as defined by National Cancer Institute) within 24 hours prior to Day
- •7 Symptomatic primary or metastatic CNS malignancy. 8 Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled medical condition (other than malignancy) that, in the opinion of the investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks in administering the study drugs to the patient. 9 Known hypersensitivity or contraindication to 5-HT3 receptor antagonists like palonosetron ondansetron granisetron dolasetron tropisetron ramosetron or dexamethasone. 10 Participation in a clinical trial involving ondansetron administered in combination with palonosetron 11 Any investigational drugs taken within 4 weeks prior to Day 1 of chemo cycle and or is scheduled to receive any investigational drug during the study 12 Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of chemo cycle. However topical and inhaled corticosteroids with a steroid dose of less or equal than 10 mg of prednisone daily or its equivalent are permitted 13 Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy 14 Any medication with known or potential antiemetic activity within 24 hours prior to Day 1 of chemo cycle, including 5 HT3 receptor antagonists example ondansetron granisetron dolasetron tropisetron ramosetron palonosetron) benzamides example metoclopramide alizapride phenothiazines example prochlorperazine promethazine fluphenazine perphenazine thiethylperazine chlorpromazine benzodiazepines except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to Day 1 butyrophenones example haloperidol droperidol anticholinergics example scopolamine, with the exception of inhaled anticholinergics for respiratory disorders ipratropium bromide) chlorphenhyramine), except for prophylactic use for taxane therapy;.
- •domperidone;.
- •mirtazapine oolanzapine;.
- •prescribed 29cannabinoids (e.g. tetrahydrocannabinol or nabilone) 15 History or predisposition to cardiac conduction abnormalities, except for incomplete right bundle branch block. 16 History of risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome). 17 Severe cardiovascular diseases, including myocardial infarction within 3 months prior to Day 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) NYHA class III-IV, and severe uncontrolled arterial hypertension. 18 Any illness or condition that, in the opinion of the investigator, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient. 19 Concurrent medical conditions that would preclude administration of dexamethasone such as systemic fungal infection or uncontrolled diabetes. 20 Active infection or uncontrolled disease except for malignancy. 21 Started any of the restricted medications. 22 Subjects with increased bleeding risk or increased risk of injection site reactions due to other factors (e.g., concomitant anticoagulant therapy, bleeding disorders). 23 Subjects with any degree of hepatic impairment, based on Child-Pugh classification.
结局指标
主要结局
A proportion of patients with complete response (CR) during the overall treatment (0 to 120 hours) following the administration of chemotherapy in Chemo cycles
时间窗: 1.0 to 120 hours following the administration of chemotherapy in Chemo cycles
次要结局
- 1 A proportion of patients with complete response during the acute phase(2 A proportion of patients with complete response during the delayed phase)
研究者
Mr Chandu Gangadhar Devanpally
Ardent Clinical Research Services
研究点 (9)
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