Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)

Last updated: May 2, 2017
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Lactose Intolerance

Effects Of Chemotherapy

Stomach Discomfort

Treatment

N/A

Clinical Study ID

NCT00337727
0869-130
2006_016
  • Ages > 18
  • All Genders

Study Summary

The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients will be naive to emetogenic chemotherapy with histologically or cytologicallyconfirmed malignant disease scheduled to receive a single dose of moderatelyemetogenic chemotherapy on study day 1

  • Karnofsky score of 60 or greater

Exclusion

Exclusion Criteria:

  • Patient is scheduled to receive any dose of cisplatin

  • Patient will receive abdominal or pelvic radiation a week prior and up to 6 days afterinitiation 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 orcreatinine).

Study Design

Total Participants: 848
Study Start date:
January 01, 2007
Estimated Completion Date:
November 19, 2008