ONO-7436 Phase II Study in Japan

Ono Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Malignant Tumor

Treatments: Drug: ONO-7436

Study type: Interventional

Funder types: Industry

Identifiers

NCT00212602

ONO-7436-01

Details and patient eligibility

About

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

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind