A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF ROLAPITANT FOR THE PREVENTION OF CHEMOTHERAPY- INDUCED NAUSEA AND VOMITING (CINV) IN SUBJECTS RECEIVING MODERATELY EMETOGENIC CHEMOTHERAPY (MEC)

INTERVENTION: ROLAPITANT OR PLACEBO WILL BE ADMINISTERED ORALLY 1‐2 HOURS PRIOR TO THE INITIATION OF CHEMOTHERAPY ON DAY 1. GRNISETRON (2MG PO) AN DEXAMETASONE (2M MG PO) WILL BE ADMINISTERED APPROXIMATELY 30 MINUTES BEFORE INITIATION OF CHEMOTHERAPY ON DAY 1, EXCEPT IN PATIENTS RECEIVING TAXANES AS PART OF MEC (SEE SECTION 7.4.1.3). ALL SUBJECTS WILL CONTINUE TO RECEIVE GRANISETRON (2MG DAILY) ON DAYS 2 Y 3. SUBJECTS WILL RECORD ALL EVENTS OF EMESIS AND USE OF RESCUE MEDICATION FOR ESTABLISHED NAUSEA AND/OR VOMITING AND WILL INDICATE THE SEVERITY OF NAUSEA THEY EXPERIENCED IN EACH OF THE PREVIOUS 24 HOURS IN THE NAUSEA AND VOMITING (NV) SUBJECT DIARY PRIOR TO MEC ADMINISTRATION THROUGH DAY 6 IN CYCLE 1. HEALTH‐RELATED QUALITY OF LIFE WILL BE MEASURED BY THE FLIE QUESTIONNAIRE ON DAY 6 OF CYCLE 1. SAFETY AND TOLERABILITY WILL BE ASSESSED BY CLINICAL REVIEW OF ADVERSE EVENTS (AES), PHYSICAL AND NEUROLOGICAL EXAMINATIONS, VITAL SIGNS, ELECTROCARDIOGRAMS (ECGS), AND SAFETY LABORATORY VALUES INCLUDING BUN AND CREATININE. ALL SUBJECTS ARE EXPECTED TO COMPLETE CYCLE 1 AND WILL HAVE THE OPTION OF PARTICIPATING IN UP TO FIVE ADDITIONAL CYCLES. THE STUDY WILL INVESTIGATE THE EFFICACY OF ROLAPITANT FOR THE TREATMENT OF C1NV DURING AN INITIAL CHEMOTHERAPY CYCLE (CYCLE 1). SAFETY ANALYSES WILL INCLUDE DATA FROM CYCLE 1 AND FROM SUBSEQUENT CYCLES. AT THE SCREENING VISIT, BLOOD SAMPLES MAY BE COLLECTED AND STORED IN THIS STUDY AND MAY BE ANALYZED FOR FUTURE BIOMARKER RESEARCH RELATED TO SAFETY AND CONDITION: PRIMARY OUTCOME: Complete response (no emetic episodes and no rescue medication) rate in the delayed phase of chemotherapy‐induced nausea and vomiting (from > 24 through 120 hours following initiation of moderately emetogenic chemotherapy administration).; NAME OF THE RESULT: Complete response (no emetic episodes and no rescue medication) rate in the delayed phase of chemotherapy‐induced nausea and vomiting (from > 24 through 120 hours following initiation of moderately emetogenic chemotherapy administration).; USED MEASURING METHOD :Mantel‐Haenszel chi‐square test stratified by gender; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: >24 to 120 hours post chemotherapy. SECONDARY OUTCOME: Complete response (no emetic episodes and no rescue medication) in the acute (0 ‐ 24 hours) and overall (0‐120 hours) phases of chemotherapy‐induced nausea and vomiting ; NAME OF THE RESULT: Complete response (no emetic episodes and no rescue medication) in the acute (0 ‐ 24 hours) and overall (0‐120 hours) phases of chemotherapy‐induced nausea and vomiting ; USED MEASURING METHOD :Mantel‐Haenszel chi‐square test stratified by gender ; PERIOD OF TIME WHERE THE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE SECONDARY RESULT: 0 to 24 hours. INCLUSION CRITERIA: 1. SUBJECT IS 18 YEARS OF AGE OR OLDER, OF EITHER GENDER, AND OF ANY RACE. 2. SUBJECT IS NAÏVE TO MODERATELY OR HIGHLY EMETOGENIC CHEMOTHERAPY, AND IS TO RECEIVE THE FIRST COURSE OF MEC INCLUDING ONE OR MORE OF TH FOLLOWING AGENTS : CYCLOPHOSPHAMIDE IV (< 1500 MG/M2), DOXORUBICIN, EPIRUBICIN, CARBOPLATIN, IDARUBICIN, IFOSFAMIDE IRINOTECAN, DAUNORUBICIN, CYTARABINE IV (> 1 G/M2). THE LENG OF EACH CHEMOTHERAPY CYCLE SHOULD BE NO LESS THAN 2 WEEKS. 3. SUBJECT HAS A KARNOFSKY PERFORMANCE SCORE OF ≥ 60. 4. SUBJECT HAS A PREDICTED LIFE EXPECTANCY OF ≥ 4 MONTHS. 5. SUBJECT HAS ADEQUATE BONE MARROW, KIDNEY, AND LIVER FUNCTION AS EVIDENCED BY: A. ABSOLUTE NEUTROPHIL COUNT ≥ 1500/MM3. B. PLATELET COUNT ≥ 100,000/RNM3. C. ASPARTATE AMINOTRANSFERASE (AST) ≤ 2.5 X UPPER LIMIT OF NORMAL RANGE (ULN). FOR SUBJECTS WITH KNOWN LIVER METASTASES ≤ 5 X ULN. D. ALANINE AMINOTRANSFERASE (ALT) ≤ 2.5 X ULN. FOR SU