Tests ONO-4538 in patients with rhabdoid tumor
Tests the drug ONO-4538 in people aged 1 year and older with rhabdoid tumor.
Plain-language title generated from the registry record
Registry title: Study to ONO-4538 in Patients With Rhabdoid Tumor
Key facts
- Where
- Chiba, Chuo Ku, Fukuoka, Fukushima, Hiroshima, Kanazawa, Kobe, Kyoto, Miyagi, Nagoya, Niigata, Osaka, Sapporo, and Tokyo, JapanSee the 14 sites
- Phase
- Phase 2
Where in Japan
- Chiba University HospitalChiba, JapanTaking people
- National Cancer Center HospitalChuo Ku, JapanTaking people
- Kyushu University HospitalFukuoka, JapanNot yet recruiting
- Fukushima Medical University HospitalFukushima, JapanTaking people
- Hiroshima University HospitalHiroshima, JapanTaking people
- Kanazawa University HospitalKanazawa, JapanTaking people
- Hyogo Prefectural Kobe Children's HospitalKobe, JapanTaking people
- University Hospital Kyoto Prefectural University of MedicineKyoto, JapanTaking people
- Tohoku University HospitalMiyagi, JapanTaking people
- Nagoya University HospitalNagoya, JapanTaking people
- Niigata University Medical & Dental HospitalNiigata, JapanTaking people
- Osaka City General HospitalOsaka, JapanTaking people
- Hokkaido University HospitalSapporo, JapanTaking people
- National Center for Child Health and DevelopmentTokyo, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ono Pharmaceutical Co., Ltd.
- Trial code
- NCT06622941
- Record updated
- 4 August 2026
- Original description
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid TumorsRead full original descriptionShow less
A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
Inclusion: Gender: Not specified; Age (at the time of consent): 1 year or older; Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors; Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection.
Exclusion: Patients with a history of active concurrent malignancy or complications; Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period; Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug.