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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

Page last updated: June 20, 2008

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