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

• Status: Completed
• Trial end date: 2010-05-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Granisetron

Criteria

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