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

Not Applicable

• Registration Number: PER-055-12
• Lead Sponsor: TESARO, Inc,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-15
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 46

Inclusion Criteria

1.SUBJECT IS 18 YEARS OF AGE OR OLDER, OF EITHER GENDER, AND OF ANY RACE.
2.SUBJECT HAS NEVER BEEN TREATED WITH CISPLATIN AND IS TO RECEIVE THE FIRST COURSE OF CISPLATIN-BASED CHEMOTHERAPY ( ≥ 60 MG/M2.
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/MM3.
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 ≤ 5 X 1.5 X ULN, EXCEPT FOR SUBJECTS WITH GILBERT´S SYNDROME.
F.CREATININE ≤ 1.5 X ULN.
IF A SINGLE OR MULTIPLE LABORATORY TEST VALUE EXCEEDS, BUT IS CLOSE TO, THE LIMIT(S) OF THE REFERENCE RANGE(S) AS DEFINED IN THE PROTOCOL INCLUSION CRITERIA, SUBJECTS WILL BE ALLOWED TO REPEAT THESE OUT-OF-RANGE TESTS ONCE. IF THE REPEATED TEST RESULTS MEET THE STUDY REQUIREMENT, THESE SUBJECTS CAN BE ENROLLED.

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 URINE OR SERUM PREGNANCY TEST WITHIN 3 DAYS PRIOR TO STUDY DRUG ADMINISTRATION OR IS BREAST-FEEDING.
4. SUBJECT HAS PREVIOUSLY RECEIVED CISPLATIN OR IS PLANNING TO RECEIVE MULTIPLE DAYS OF CISPLATIN IN A SINGLE CYCLE.
5. 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. BENZAMIDES (METOCLOPRAMIDE, ALIZAPRIDE, ETC.).

Study & Design

• Study Type: Interventional
• Study Design: Not specified