Health Condition 1: R112- Nausea with vomiting, unspecified
Conditions
Interventions
Intervention1: Ondansetron Extended Release Injection suspension 100 mg/ml: 1 mL of ondansetron extended release injectable suspension 100 mg/1 mL through IM route Injection in each cycle by slow int
Sponsors
FTF Pharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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
Exclusion criteria
Exclusion criteria: 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 1. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A proportion of patients with complete response (CR) during the overall treatment (0 to 120 hours) following the administration of chemotherapy in Chemo cyclesTimepoint: 1.0 to 120 hours following the administration of chemotherapy in Chemo cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 A proportion of patients with complete response during the acute phase 2 A proportion of patients with complete response during the delayed phase 3 A proportion of patients following the completion of chemo cycle with total response during the acute phase delayed onset phase, & overall treatment in chemo cycles 4 Proportion of patients following the completion of chemo cycle with major control of emesis less than 2 emetic episodes minor 3 to 5 emetic episodes & failure more than 5 emetic episodes during the onset phase & overall treatment in chemo cycle 6 Number of emetic episodes during the acute & delayed onset phase of chemo cycles 7 Time to first emetic episode during chemo cycles 8 Time to use of rescue medication during chemo cycles 9 Time to treatment failure based on time to first emetic episode time to rescue medication whichever occurs first during chemo cycles 10 Severity of nausea measured daily & overall treatmentTimepoint: 1 0 to 24 hours following the administration of Chemo cycles 2 24 to 120 hours following the completion of chemo cycles 3 cycles 0 to 120 hours 4 0 to 120 hours 5 Acute and delayed onset phase of chemo cycles 6 during chemo cycles 7 during chemo cycles 8 during chemo cycles 9 during chemo cycles 0 to120 hours 10 0 to 120 using visual analog scales 11 on Day 5 of chemo cycles | — |
Countries
India
Contacts
Public ContactDr P Veerendra Kumar
Shilpa Medicare Limited
Outcome results
None listed