PALO Pediatric clinical study in Japan

A phase III study of PALO in pediatric patients receiving highly and moderately emetogenic chemotherapy.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223250

Enrollment

Registered

2016-06-27

Start date

2016-12-01

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 : PALO INN of investigational material : Palonosetron Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged from 28 days after birth to 18 years 2. Patients weight at least 3.2 kg 3. Patients with malignant disease who are scheduled to receive initial chemotherapy (excluding multi-day administration) including the Cisplatin, Carboplatin or Cyclophosphamide.

Exclusion criteria

Exclusion criteria: 1. Patients scheduled to receive stem cell rescue therapy together with the cancer chemotherapy.

Design outcomes

Primary

Measure	Time frame
efficacy Efficacy:complete response (defined as no vomiting, no retching and no use of antiemetic rescue medication)	—

Secondary

Measure	Time frame
safety pharmacokinetics Safety Pharmacokinetics	—

Countries

Japan

Outcome results

None listed

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