ONO-7436 Phase II Study in Japan

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double

Interventions

  • Drug: ONO-7436

Clinical Trial Outcome Measures

Primary Measures

  • Patient proportion of complete response (no vomiting and no rescue treatment).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ono Pharmaceutical Co. Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Project Leader, Development Planning, Study Director, Ono Pharmaceutical Co. Ltd

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