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)”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: aprepitant
  • aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
• Drug: Comparator: ondansetron
  • Ondansetron 8 mg capsule Three day treatment period.
• Drug: Comparator: dexamethasone
  • dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
• Drug: Comparator: fosaprepitant dimeglumine
  • fosaprepitant dimeglumine 115 mg
• Drug: Comparator; Placebo (unspecified)
  • dexamethasone 12mg Pbo tablets.
• Drug: Comparator; Placebo (unspecified)
  • Aprepitant 80 mg & 125 mg Pbo capsules.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1
  • Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours.
• Other: 2
  • Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1.

Primary Measures

• No Vomiting and Complete Response (no vomiting and no rescue medication)
  • Time Frame: 5 days following administration of chemotherapy
    Safety Issue?: No

Secondary Measures

• Complete response (no vomiting and no rescue medication)
  • Time Frame: 5 days following administration of chemotherapy
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00337727

Study ID Number: 2006_016

ClinicalTrials.gov Identifier: NCT00337727

Health Authority: United States: Food and Drug Administration

(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)