None listed
Conditions
Interventions
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 MINUT
Sponsors
TESARO, Inc,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 ( 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 SUBJECTS WITH KNOWN LIVER METASTASES ≤ 5 X ULN. E. BILIRUBIN ≤ 1.5 X ULN, EXCEPT FOR SUBJECTS WITH GILBERT´S SYNDROME. F. CREATININE ≤ 1.5 X ULN.
Exclusion criteria
Exclusion criteria: 1. ANY CURRENT _TREATMENT, MEDICAL HISTORY, OR UNCONTROLLED CONDITION, OTHER THAN MALIGNANCY (E.G., ALCOHOLISM OR SIGNS OF ALCOHOL ABUSE, SEIZURE DISORDER, MEDICAL OR PSYCHIATRIC CONDITION) THAT, IN THE OPINION OF THE INVESTIGATOR, WOULD CONFOUND THE RESULTS OF THE STUDY OR POSE ANY UNWARRANTED RISK IN ADMINISTERING STUDY DRUG TO THE SUBJECT. 2. SUBJECT HAS A CONTRAINDICATION TO THE ADMINISTRATION OF CISPLATIN, GRANISETRON, OR DEXAMETHASONE INCLUDING, BUT NOT LIMITED TO, A HISTORY OF HYPERSENSITIVITY TO THE DRUGS OR THEIR COMPONENTS, SEVERE RENAL IMPAIRMENT, SEVERE BONE MARROW SUPPRESSION, OR SYSTEMIC INFECTION. 3. SUBJECT IS A WOMAN OF CHILDBEARING POTENTIAL WITH A POSITIVE SERUM OR URINE PREGNANCY TEST WITHIN 3 DAYS PRIOR TO STUDY DRUG ADMINISTRATION, OR IS BREAST-FEEDING. 4. SUBJECT HAS TAKEN THE FOLLOWING AGENTS WITHIN THE LAST 48 HOURS PRIOR TO THE START OF TREATMENT WITH STUDY DRUG. A. 5-HT3 ANTAGONISTS .(ONDANSETRON, GRANISETRON, DOLASETRON, TROPISETRON, ETC.). PALONOSETRON IS NOT PERMITTED WITHIN 7 DAYS PRIOR TO ADMINISTRATION OF INVESTIGATIONAL PRODUCT. B. PHENOTHIAZINES (PROCHLORPERAZINE, FLUPHENAZINE, PERPHENAZINE, THIETHYLPERAZINE, CHLORPROMAZINE, ETC.). C. BENZARNIDES (METOCLOPRAMIDE, ALIZAPRIDE, ETC.). D. DOMPERIDONE.
Countries
United States
Contacts
Public ContactMacbeth Contreras
NUVISAN PHARMA SERVICES PERU S.A.C
Outcome results
None listed