Phase 3
N=2,322
Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
Chemotherapy-Induced Nausea and Vomiting (CINV)
Bottom Line
View on ClinicalTrials.gov: NCT00619359 ↗Enrolled (actual)
2,322
Serious AEs
13.2%
Results posted
Feb 2010
Primary outcome: Primary: A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). — 795; 820 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: fosaprepitant dimeglumine (Drug); Comparator: Aprepitant (Drug); Dexamethasone (Drug); Ondansetron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). |
795; 820 | — |
| SECONDARY A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin). |
822; 841 | — |
| SECONDARY No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin) |
806; 844 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater
- Patient is post menopausal or, if premenopausal, must use double-barrier contraception
Exclusion Criteria
- Patient has symptomatic primary or metastatic CNS malignancy
- Patient has received or will receive Radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 though Day 6
- Patient has vomited in the 24 hours prior to treatment Day 1
- Patient has an active infection; Patient uses illicit drugs or has current evidence of alcohol abuse
- Patient is pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT00619359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.