A randomized, double-blind, multicenter, phase III study of Pro-NETU for the prevention of chemotherapy induced nausea and vomiting (CINV) in patients receiving AC/EC based highly emetogenic chemotherapy

JAPIC ID: JapicCTI-194691

Registered date:29/03/2019

Basic Information

• Recruitment status: complete
• Health condition(s) or Problem(s) studied: Chemotherapy-induced nausea and vomiting
• Date of first enrollment: 18/4/2019
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: INTERVENTIONAL

Intervention(s)

Intervention name : Pro-NETU
INN of the intervention : fosnetupitant
Dosage And administration of the intervention : Pro-NETU 235 mg should be intravenously administered with drip infusion before the start of administration of highly emetogenic chemotherapy (HEC).
Control intervention name : Fosaprepitant
INN of the control intervention : Fosaprepitant
Dosage And administration of the control intervention : Fosaprepitant 150 mg should be intravenously administered with drip infusion before the start of administration of HEC.

Outcome(s)

Primary Outcome

safety
The incidence of side effect

Secondary Outcome

safety, efficacy
Efficacy, Safety

Key inclusion & exclusion criteria

• Age minimum: 20
• Gender: BOTH

Include criteria

1. Patients who have provided written informed consent
2. Patients who are scheduled to be received cancer chemotherapy including the HEC agents (AC/EC)
3. ECOG performance status score of 0 to 1

Exclude criteria

1. Patients with infection, diabetes mellitus, or other disease with difficultly to administer of dexamethasone, which is defined in the protocol
2. Patients who are unable or unwilling to cooperate in the implementation of study procedures (eg; writing a study report)

Related Information

• Primary Sponsor: Taiho Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: Taiho Pharmaceutical Co., Ltd.