None listed
Conditions
Interventions
TO STUDY THE RESEARCH HYPOTHESES, APPROXIMATELY 990 PATIENTS (APPROXIMATELY 495 PER TREATMENT ARM) WILL BE RANDOMIZED INTO THE STUDY TO YIELD 950 EVALUABLE PATIENTS.
PATIENTS WILL BE STRATIFIED BY
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. PATIENTS IS FEMALE OR MALE, AND IS ≥ 18 YEARS OF AGE. 2. PATIENT HAS A HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED MALIGNANT DISEASE. 3. PATIENT AGRESS TO PARTICIPATE IN THE STUDY BY GIVING WRITTEN INFORMED CONSENT. THE PATIENT MAY ALSO PROVIDE CONSENT FOR FUTURE BIOMEDICAL RESEARCH. HOWEVER, THE PATIENT MAY PARTICIPE IN THE MAIN TRIAL WITHOUT PARTICIPATING IN FUTURE BIOMEDICAL RESEARCH. 4. PATIENT IS NAÏVE TO MODERATELY AND HIGHLY EMETOGENIC CHEMOTHERAPY AS DEFINED IN THE HESKETH CLASSIFICATION OF EMETOGENIC CHEMOTHERAPY AGENTS (APPENDIX 6.2). 5. PATIENT IS SCHEDULED TO RECEIVE A SINGLE INTRAVENOUS DOSE OF ONE OR MORE MODERATELY EMETOGENIC CHEMOTHERAPEUTIC AGENTS ON DAY 1, EXCEPT FOR THE COMBINATION OF ANTHRACYCLINE AND CYCLOPHOSPHAMIDE (AC MEC) SUCH AS: ALEMTUZUMAB DAUNORUBICIN AZACITIDINE DOXORUBICIN BENDAMUSTINE EPIRUBICIN CARBOPLATIN IDARUBICIN CLOFARABINE IFOSFAMIDE CYCLOPHOSPHAMIDE(1 G/M2) OXALIPLATIN NOTE: OTHER CHEMOTHERAPY AGENTS THAT ARE CATEGORIZED AS HAVING LOW OR MINIMAL EMETIC RISK PER THE HESKETH CLASSIFICATION OF EMETOGENIC CHEMOTHERAPY AGENTS MAY BE ADDED TO THE ABOVE CHEMOTHERAPY REGIMENS.
Exclusion criteria
Exclusion criteria: 1. PATIENT HAS VOMITED IN THE 24 HOURS PRIOR TO TREATMENT DAY 1. 2. PATIENT HAS A SYMPTOMATIC PRIMARY OR METASTATIC SYMPTOMATIC CNS MALIGNANCY CAUSING NAUSEA AND/OR VOMITING. PATIENT WHO IS ASYMPTOMATIC IS ALLOWED TO PARTICIPATE. 3. PATIENT IS SCHEDULED TO RECEIVE THE COMBINATION OF ANTHRACYCLINE + CYCLOPHOSPHAMIDE OR ANY DOSE OF CISPLATIN OR CHEMOTHERAPY AGENT CLASSIFIED AS HIGHLY EMETOGENIC IN THE HESKETH CLASSIFICATION OF CMETOGENIC CHEMOTHERAPY AGENTS (APPENDIX 6.2). 4. PATIENT HAS RECEIVED OR WILL RECEIVE RADIATION THERAPY TO THE ABDOMEN OR PELVIS IN THE WEEK PRIOR TO TREATMENT DAY 1 THROUGH DAY 6. 5. PATIENT HAS AN ACTIVE INFECTION (E.G., PNEUMONIA), ANY UNCONTROLLED DISEASE (E.G., DIABETIC KETOACIDOSIS, CONGESTIVE HEART FAILURE, BRADYARRYTHMIA’S, PRE-EXISTING GASTROINTESTINAL CONDITIONS/GASTROINTESTINAL OBSTRUCTION) EXCEPT FOR MALIGNANCY, OR A. HISTORY OF ANY ILLNESS, WHICH, IN THE OPINION OF THE INVESTIGATOR, MIGHT CONFOUND THE RESULTS OF THE STUDY OR POSE UNWARRANTED RISK IN ADMINISTERING STUDY DRUG/COMPARATOR TO THE PATIENT. 6. PATIENT HAS A KNOWN HISTORY OF QT PROLONGATION. 7. PATIENT CURRENTLY USES ANY ILLICIT DRUGS, INCLUDING MARIJUANA, OR HAS CURRENT EVIDENCE OF ALCOHOL ABUSE (DEFINED USING DSM-IV CRITERIA) AS DETERMINED BY THE INVESTIGATOR.
Countries
Argentina, Bulgaria, Colombia, Czech Republic, Finland, Germany, Greece, Hungary, Italy, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Spain, Sweden, Thailand, Turkey, United States
Contacts
Public ContactRodolfo Hernan Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed