-

A phase II study of Pro-NETU in patients receiving highly emetogenic chemotherapy (HEC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223300

Enrollment

585

Registered

2016-08-22

Start date

2016-09-05

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: - Patients with infection, diabetes mellitus, or other disease to whom it difficult to administer of DEX, which is defined in the protocol - Patients who are unable or unwilling to cooperate in the implementation of study procedures

Design outcomes

Primary

Measure	Time frame
efficacy CR rate during the first 120 hours after the start of administration of an HEC	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics - Efficacy - Safety - Pharmacokinetics	—

Countries

Japan

Outcome results

None listed

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

-