Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)
Summary
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Conditions
Chemotherapy-Induced Nausea and Vomiting
Intervention
aprepitant, Comparator: ondansetron, Comparator: dexamethasone, Comparator: fosaprepitant dimeglumine, Comparator; Placebo (unspecified), Comparator; Placebo (unspecified)
Status
Completed
Source
Merck
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00337727
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:44:08-0400
Clinical Trials
This study will determine the appropriate dosing regimen of aprepitant and fosaprepitant for the prevention of chemotherapy induced nausea and vomiting in pediatric patients from 6 months ...
Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule
The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.
This study will assess the bioequivalence of single oral doses of aprepitant (MK0869) to a single intravenous infusion of fosaprepitant (MK0517) and also determine the effect of food on t...
Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)
This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of participants treated with aprepitant is similar to that of participants treated with fosaprepit...
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
PubMed Articles
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Evidence supports olanzapine for prophylaxis of chemotherapy-induced nausea/vomiting (CINV) for highly emetogenic chemotherapy (HEC); however, most studies focus on solid malignancies and single day r...
Identification of novel ondansetron metabolites using LC/MS and NMR.
Ondansetron, a potent and highly sensitive 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist, has been used for the treatment of chemotherapy- and radiotherapy-induced nausea and vomiting. The is...
To study pharmacokinetics of R-(-)ondansetron (R-ond) compared with that of S-(-)ondansetron (S-ond) in rats.
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Medical and Biotech [MESH] Definitions
Dexamethasone
An anti-inflammatory 9-fluoro-glucocorticoid.
Ondansetron
A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.
Dexamethasone Isonicotinate
An anti-inflammatory, anti-allergic glucocorticoid that can be administered orally, by inhalation, locally, and parenterally. It may cause water and salt retention.
Glucocorticoid-induced Tnfr-related Protein
A member of the TNF receptor family that was initially identified as a DEXAMETHASONE-induced protein from a T-CELL line. It may play a role in regulating APOPTOSIS and modulating immune response by T-lymphocytes. Signaling by the activated receptor occurs through its association with TNF RECEPTOR-ASSOCIATED FACTORS.
