Status:
COMPLETED
ONO-7436 Phase II Study in Japan
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Malignant Tumor
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- Patients age 20 years or older
- 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
- Patients whose performance status is 0 to 2
- Other inclusion criteria as specified in the study protocol
Exclusion
- In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin
- 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
- Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception
- Other exclusion criteria as specified in the study protocol
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00212602
Start Date
August 1 2005
Last Update
June 14 2012
Active Locations (9)
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1
Chugoku Region Facility
Chugoku, Japan
2
Chubu Region Facility
Chūbu, Japan
3
Hokkaido Region Facility
Hokkaido, Japan
4
Hokuriku Region Facility
Hokuriku, Japan