ONO-7436 Phase II Study in Japan

Phase 2

Completed

• Conditions: Malignant Tumor

• Registration Number: NCT00212602
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-21
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient proportion of complete response (no vomiting and no rescue treatment).

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (9)

Chubu Region Facility; 🇯🇵 Chubu, Japan

Hokkaido Region Facility; 🇯🇵 Hokkaido, Japan

Shikoku Region Facility; 🇯🇵 Shikoku, Japan

Chugoku Region Facility; 🇯🇵 Chugoku, Japan

Kinki Region Facility; 🇯🇵 Kinki, Japan

Kyushu Region Facility; 🇯🇵 Kyushu, Japan

Hokuriku Region Facility; 🇯🇵 Hokuriku, Japan

Tohoku Region Facility; 🇯🇵 Tohoku, Japan

Kanto Region Facility; 🇯🇵 Kanto, Japan