CTRI/2018/12/016643Not yet recruitingPhase 3
A randomized, open label, parallel-group, phase 3 study to investigate the efficacy and tolerability of palonosetron, dexamethasone, aprepitant plus Olanzapine versus palonosetron, dexamethasone and aprepitant alone in patients receiving high moderately emetogenic chemotherapeutic (MEC) regimens (OMEC study) - OMEC
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Tata Memorial Hospital
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1.Patients has a confirmed diagnosis of one of the cancers mentioned previously and is receiving one of the mentioned chemotherapy protocols mentioned previously.
- •2.The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
- •3.The patient is aged > 18 years.
- •4.Patients should be chemotherapy naïve.
- •5.The patient has a WHO Performance Status of <=1.
- •6.Hematologic and metabolic status must be adequate for receiving planned chemotherapy, and meet the following criteria:
- •Total neutrophils >= 1500/mm3
- •Platelets >= 100,000/mm3
- •Bilirubin <= 1.5 x ULN (Upper Limits of Normal)
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) <= 3 x ULN
- •GFR >= 50 ml/min
- •7. The patient is able to read, understand, and complete questionnaires and daily components of the Patient Diary for each study cycle.
- •8. For patients of childbearing potential, urine human chorionic gonadotropin (hCG) (urine dipstick pregnancy test) or blood hCG results must be negative at screening.
- •9. Has a normal baseline ECG with no QTc prolongation
Exclusion Criteria
- •1.The patient is unable to read, understand, and complete the forms required for the study.
- •2.The patient is pregnant or lactating.
- •3.The patient has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea (defined as nausea graded as moderate or severe) in the 24 hours preceding the first dose of study medication.
- •4.The patient has a history active peptic ulcer disease, significant or symptomatic, acute or subacute gastrointestinal obstruction, increased intracranial pressure,severe cognitive impairment, known central nervous system disease (e.g. brain metastases/ a seizure disorder).
- •5. hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the patient.
- •6. The patient has a known hypersensitivity or contraindication to palonosetron, another 5-HT3 receptor antagonist, dexamethasone, aprepitant or olanzapine
- •7.The patient has received an investigational drug in the previous 6 months or is scheduled to receive any investigational drug other than fosaprepitant dimeglumine during the study period
- •8.The patient has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medications. Opiate drugs for cancer pain will be permitted if the patient has been on a stable dose and has not experienced emesis or clinically significant nausea from the narcotics in the 24 hours preceding the first dose of study medication.
- •9.The patient has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drugs. This is inclusive of, but not limited to 5 HT3 antagonists, metoclopramide, benzodiazepines, phenothiazines, haloperidol, oral or intravenous steroids, antihistamines, domperidone, olanzapine, antipsychotics.
- •10.Patient on antipsychotics or being planned to receive any of the antiphychotics, amifostine in last 3 months.
- •11.Patient has received concurrent abdominal radiotherapy in last 3 months or being planned to receive the same.
- •12.Patient is receieving or will likey to receive concurrent use of quinolone antibiotic therapy.
- •13.Patient with the history of chronic alcoholism.
- •14.Patient with cardiac arrhythmia, uncontrolled/ controlled heart failure, or acute coronary event or uncontrolled diabetes mellitus within the previous 6 months.
- •15.Has taken drugs which may influence medications used in the study, e.g. CYP inducers or inhibitors. This will have to be evaluated for and decision taken by PI
Investigators
Similar Trials
Active, not recruiting
Phase 1
A phase 3, open label, randomised, parallel group study to compare the effect on prevention and resolution of treatment related adverse events of a simplified, once daily regimen of a fixed dose combination tablet of emtricitabine and tenofovir DF versus twice daily co-formulated zidovudine and lamivudine (Combivir®) or zidovudine and lamivudine, in virologically suppressed, HIV infected patients taking efavirenz. - SWEET StudyHuman immunodeficiency virus (HIV-1) infectionMedDRA version: 7.0Level: PTClassification code 10020161EUCTR2004-002254-59-GBGilead Sciences Limited220
Active, not recruiting
Phase 1
A phase 3, open label, randomised, parallel group study to compare the effect on prevention and resolution of treatment related adverse events of a simplified, once daily regimen of a fixed dose combination tablet of emtricitabine and tenofovir DF versus twice daily co-formulated zidovudine and lamivudine (Combivir®) or zidovudine and lamivudine, in virologically suppressed, HIV infected patients taking efavirenz. - SWEET StudyHuman immunodeficiency virus (HIV-1) infectionMedDRA version: 7.0 Level: PT Classification code 10020161EUCTR2004-002254-59-IEGilead Sciences Limited220
Active, not recruiting
Not Applicable
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In InfantsMeningococcal disease causes high rates of morbidity and mortality even among patients who receive early antibiotic treatment.EUCTR2014-004605-33-Outside-EU/EEAovartis Vaccines & Diagnostics, Inc.4,500
Active, not recruiting
Not Applicable
A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitislcerative colitisMedDRA version: 8.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2006-000410-20-DKCentocor BV60
Active, not recruiting
Not Applicable
A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitislcerative colitisMedDRA version: 8.1Level: LLTClassification code 10045365Term: Ulcerative colitisEUCTR2006-000410-20-BECentocor BV40