Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Vomiting
Intervention: MK0869, aprepitant / Duration of Treatment: 3 days (Drug); Comparator: ondansetron / Duration of Treatment: 4 days (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck
Summary
A multicenter trial to assess the safety and efficacy of an investigational drug in the
prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed
solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The
study will evaluate the investigational drug for the treatment of CINV during the first cycle
of treatment with cisplatin. (INTERNATIONAL STUDY LOCATIONS ONLY)
Clinical Details
Official title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Patient vomiting
Secondary outcome: Number of rescue therparies
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient is greater than 18 years of age.
- Patient is scheduled to receive his/her first course of cisplatin chemotherapy for a
solid tumor.
- Patient has a prognosis (life expectancy) greater than or equal to 3 months.
Locations and Contacts
Call for International Site Information, Horsham, Pennsylvania 19044, United States
Additional Information
Related publications: Schmoll HJ, Aapro MS, Poli-Bigelli S, Kim HK, Park K, Jordan K, von Pawel J, Giezek H, Ahmed T, Chan CY. Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol. 2006 Jun;17(6):1000-6. Epub 2006 Mar 8.
Starting date: January 2004
Last updated: November 27, 2006
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