Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)

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

Status: Recruiting

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Overall contact:
Toll Fre Number, Phone: 1-888-577-8839

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of 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: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: No Vomiting and Complete Response (no vomiting and no rescue medication)

Secondary outcome: Complete response (no vomiting and no rescue medication)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Patient is scheduled to receive any dose of cisplatin

- Patient will receive abdominal or pelvic radiation a week prior and upto 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

creatinine).

Toll Fre Number, Phone: 1-888-577-8839

Merck Sharp & Dohme (I.A.) Corp., Santiago 6761641, Chile; Recruiting
Jorge Vinces, Phone: 51-1-411-5933

Laboratoires Merck Sharp & Dohme - Chibret, Paris Cedex 8 75114, France; Recruiting
Jean-Marie Goehrs, Phone: 33-1-4754-89-90

Msd Sharp & Dohme Gmbh, Haar 85540, Germany; Recruiting
Thomas Lang, Phone: 49-89-4561-1536

Merck Sharp & Dohme Co. Ltd., Petah Tikva 49192, Israel; Recruiting
Raanan Cohen, Phone: 972-3-9274005

Merck Sharp & Dohme (I.A.) Corp., Panama Site Information, Panama; Recruiting
Patricia Salazar, Phone: 506-2210-0116

Frosst Laboratories Inc., Bogota, Cundinamarca, Colombia; Recruiting
Felipe Arbelaez, Phone: 57-1-592-4400

MSD (Pty) LTD South Africa, Midrand, Gauteng 1685, South Africa; Recruiting
Beverley Cowper, Phone: 27 11 655-3036

Call for Information, Anderson, Indiana 46011, United States; Recruiting

Call for Information, Bronx, New York 10469, United States; Recruiting

Merck Frosst Canada Ltd., Kirkland, Quebec H9H 3L1, Canada; Recruiting
Michel Cimon, Phone: 514-428-2605

Merck Sharp & Dohme Farmaceutica Ltda., Sao Paulo, SP 04717-004, Brazil; Recruiting
Jose Octavio P. Costa Filo, Phone: 55-11-5189-7942

(MedWatch - FDA maintained medical product safety Information)

(PhRMA Clinical Study Results Database - web-based repository for clinical study results)

(Merck: Patient & Caregiver U.S. Product Web Site)

Starting date: December 2006
Last updated: October 29, 2008