This is a multicenter, randomized, double-blind, active-controlled dose-finding study. About 180 subjects who receive a high emetic chemotherapy are planned to be enrolled and randomized into three groups by a ratio of 1:1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
180
1. HSK21542 injection was administered day 1; 2. Placebo to match Dorasetron was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;
1. HSK21542 injection was administered day 1; 2. Placebo to match Dorasetron was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;
1. Placebo to match HSK21542 injection was administered day 1; 2. Dorasetron injection was administered on day 1; 3. Aprepitant injection was administered on day 1; 4. Dexamethasone tablets was administered on day 1 to day 4;
Acute Complete response
Acute Complete response was defined as no vomiting/retching and no rescue therapy over the first 24 hours after the initiation of high emetic chemotherapy regimen
Time frame: 0 to 24 hours
Overall Complete response
Overall Complete response was defined as no vomiting/retching and no rescue therapy over the first 120 hours after the initiation of high emetic chemotherapy regimen
Time frame: 0 to 120 hours
Delayed Complete response
Delayed Complete response was defined as no vomiting/retching and no rescue therapy over the 24 to 120 hours after the initiation of high emetic chemotherapy regimen
Time frame: 24 to 120 hours
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