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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224542
Enrollment
790
Registered
2019-02-01
Start date
2019-02-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced nausea and vomiting

Interventions

investigational material(s) Generic name etc : Pro-NETU INN of investigational material : fosnetupitant Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administratio

Sponsors

Taiho Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who have provided written informed consent 2. Patients who are scheduled to be received cancer chemotherapy including the HEC agents (cisplatin) 3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1

Exclusion criteria

Exclusion 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)

Design outcomes

Primary

MeasureTime frame
safety efficacy Single-dose part: The CR rate during overall period Repeated-dose part: The incidence rate of AEs and side effects—

Secondary

MeasureTime frame
safety efficacy Efficacy Safety—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026