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ONO-7436 Phase 3 Study

ONO-7436 Phase 3 Study, A Multi-Center, Open Clinical Trial to Examine the Safety, Efficacy and Pharmacokinetics of ONO-7436 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Adolescent Patients with Malignant Tumor.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220825
Enrollment
22
Registered
2009-08-20
Start date
2009-08-20
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 : ONO-7436 INN of investigational material : aprepitant Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration f

Sponsors

ONO PHARMACEUTICAL CO.,LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with malignant tumor who are to be treated with an emetogenic chemotherapy regimen that includes either cisplatin, cyclophosphamide, or carboplatin 2.Patients whose performance status is 0 to 2

Exclusion criteria

Exclusion criteria: 1.Patients will receive stem cell rescue therapy in conjunction with course of chemotherapy.

Design outcomes

Primary

MeasureTime frame
1.Safety [Time Frame: 15 days] 2.Proportion of patints with no vomiting and no use of rescue therapy(Complete Response) [Time Frame: 5 days] 3.Pharmacokinetics [Time Frame: 4 days]

Outcome results

None listed

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