The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,322
single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.
Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).
Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.
A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).
The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.
Time frame: Overall (in the 120 hours following initiation of cisplatin chemotherapy).
A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).
The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.
Time frame: Delayed phase (25 to 120 hours following initiation of cisplatin).
No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)
The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.
Time frame: Overall (the 120 hours following initiation of cisplatin chemotherapy)
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Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.
single IV dose of 32 mg of ondansetron on Day 1.