A PHSE III, RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPATOR-CONTROLLED PARALLEL-GROUP STUDY, CONDUCTED UNDER IN-HOUSE BLINDING CONDITIONS TO EXAMINE THE EFFICACY AND SAFETY OF A SINGLE 150 MG DOSE OF INTRAVENOUS FOSAPREPITANT DIMEGLUMINE FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) ASSOCIATED WITH MODERATELY EMETOGENIC CHEMOTHERAPY

INTERVENTION: 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 GENDER. THE STUDY ANTICIPATES ENROLLING APPROXIMATELY EQUAL NUMBERS OF MALE AND FEMALE PATIENTS. AS PREVIOUSLY NOTED, ENROLLMENT OF PATIENTS SCHEDULED TO RECEIVE OXALIPLATIN WILL CAPPED AT 30%. PROVIDED ALL ENTRY CRITERIA ARE FULFILLED, EACH PATIENT WILL BE ASSIGNED TO I OF 2 TREATMENT REGIMENS. RANDOMIZATION TO STUDY TREATMENT WILL BE DETERMINED BY AN INTERACTIVE VOICE RESPONSE SYSTEM (IVRS). THE TREATMENT REGIMENS ARE OUTLINED IN TABLE 2‐2. THE TIME AND SEQUENCE OF STUDY DRUG ADMINISTRATION FOR BOTH TREATMENT GROUPS ARE AS FOLLOWS: DAY 1 AT APPROXIMATELY ONE HOUR PRIOR TO THE START OF CHEMOTHERAPY THE STUDY COORDINATOR WILL INFUSE FOSAPREPITANT 150 MG IV O.R PLACEBO IV OVER A PERIOD OF 20 TO 30 MINUTES. THE INFUSION WILL BE COMPLETE APPROXIMATELY 30 MINUTES PRIOR TO CHEMOTHERAPY INFUSION. AT 30 MINUTES PRIOR TO CHEMOTHERAPY INFUSION (OR ACCORDING TO CLINIC PRACTICE), THE STUDY COORDINATOR WILL ADMINISTER THE FIRST OF TWO CAPSULES OF ONDANSETRON. AT THIS TIME THE STUDY COORDINATOR WILL ADMINISTER 5 CAPSULES FROM THE BOTTLES CONTAINING DEXAMETHASONE/PLACEBO. CONDITION: PRIMARY OUTCOME: Number of participants with Complete Response from 25 to 120 hours after initiation of MEC.; NAME OF THE RESULT: Number of participants with Complete Response from 25 to 120 hours after initiation of MEC.; USED MEASURING METHOD :Treatment comparisons will be made using the Cochran‐Mantel‐Haenzel (CMH) test stratified by gender.; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 25 to 120 hours. SECONDARY OUTCOME: Number of participants with Complete Response from 0 to 120 hours after initiation of MEC. ; NAME OF THE RESULT: Number of participants with Complete Response from 0 to 120 hours after initiation of MEC. ; USED MEASURING METHOD :Treatment comparisons will be made using the Cochran‐Mantel‐Haenzel (CMH) test stratified by gender. ; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE SECONDARY RESULT: 0 to 120 hours. 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(<1500MG/M2) IRI