Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Chemotherapy-induced Nausea and Vomiting (CINV)

Treatments

Drug: Comparator: Placebo to aprepitant

Drug: granisetron

Drug: dexamethasone

Drug: aprepitant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00952341

0869-169

2009_626

Details and patient eligibility

About

This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.

Enrollment

421 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cycle 1:

Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m^2 administered a maximum of 3 hours
Patient has a predicted life expectancy of at least 3 months
Patient is not pregnant

Cycle 2 (optional):

Participation in the study during the next cycle of chemotherapy is considered

appropriate by the investigator and will not pose unwarranted risk to the patient.

Satisfactory completion of the preceding cycle of chemotherapy and related

study procedures.

Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The cisplatin dose may be reduced in subsequent cycle, as long as the new

dose is still no less than 70 mg/m^2.

Exclusion criteria

Cycles 1 & 2:

Patient will receive stem cell therapy in conjunction with cisplatin
Patient has an active infection or any uncontrolled disease (e.g. diabetes)
Patient will receive multiple-day chemotherapy with cisplatin
Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
Patient has vomited within 24 hours prior to cisplatin infusion
Patient received or will receive radiation therapy to the abdomen