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 MODERATELYEMETOGENIC CHEMOTHERAPY (MEC)

Not Applicable

• Registration Number: PER-056-12
• 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: 48

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 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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified