ONO-7436 Phase II Study in Japan
Information source: Ono Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malignant Tumor
Intervention: ONO-7436 (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ono Pharma Official(s) and/or principal investigator(s):
Project Leader, Development Planning, Study Director, Affiliation: Ono Pharma
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
Clinical Details
Official title: ONO-7436 Phase II Study - A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Japan
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Patient proportion of complete response (no vomiting and no rescue treatment).
Secondary outcome: 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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 exclusion criteria as specified in the study protocol
Locations and Contacts
Hokkaido Region Facility, Hokkaido, Japan
Kanto Region Facility, Kanto, Japan
Hokuriku Region Facility, Hokuriku, Japan
Chubu Region Facility, Chubu, Japan
Kinki Region Facility, Kinki, Japan
Chugoku Region Facility, Chugoku, Japan
Shikoku Region Facility, Shikoku, Japan
Kyushu Region Facility, Kyushu, Japan
Tohoku Region Facility, Tohoku, Japan
Additional Information
Starting date: August 2005
Last updated: September 14, 2006
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