Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chemotherapy-Induced Nausea and Vomiting
Intervention: aprepitant (Drug); Comparator: ondansetron (Drug); Comparator: dexamethasone (Drug); Comparator: fosaprepitant dimeglumine (Drug); Comparator; Placebo (unspecified) (Drug); Comparator; Placebo (unspecified) (Drug)
Phase: Phase 3
Sponsored by: Merck Sharp & Dohme Corp.
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
The study will test aprepitant for the prevention of CINV in patients receiving their
initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one
cycle of chemotherapy may opt to participate in an optional second cycle during which the
patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation
of aprepitant will be given in place of the oral formulation on study day one. Study drug
administration on subsequent days will be given orally as in cycle 1.
Official title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Number of Patients Who Reported No Vomiting
Secondary outcome: Number of Patients Who Reported Complete Response
Minimum age: 18 Years.
Maximum age: N/A.
- Patients will be naive to emetogenic chemotherapy with histologically or
cytologically confirmed malignant disease scheduled to receive a single dose of
moderately emetogenic chemotherapy on study day 1
- Karnofsky score of 60 or greater
- Patient is scheduled to receive any dose of cisplatin
- Patient will receive abdominal or pelvic radiation a week prior and up to 6 days
after initiation of chemotherapy
- Any allergies to study drug or antiemetics
- Taking CYP3A4 substrates/prohibited medication
- Significant medical or mental conditions
- Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or
Locations and Contacts
(MedWatch - FDA maintained medical product safety Information)
(Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: January 2007
Last updated: June 8, 2015