Malignant Tumor
Conditions
Keywords
ONO-7436, Aprepitant, Vomiting, Nausea
Brief summary
The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor
Interventions
DRUGONO-7436
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients age 20 years or older 2. Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours 3. Patients whose performance status is 0 to 2 4. Other inclusion criteria as specified in the study protocol
Exclusion criteria
1. In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin 2. Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study 3. Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception 4. Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient proportion of complete response (no vomiting and no rescue treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with no vomiting, no rescue treatment, and no nausea (in each category or combination), frequency of vomiting, and time to first vomiting, and first rescue treatment. | — |
Countries
Japan
Outcome results
None listed