Treatment of rhabdoid tumors with ONO-4538
A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
PHASE2 · Ono Pharmaceutical Co., Ltd. · NCT06622941
This study is testing a new treatment called ONO-4538 for people with advanced or recurring rhabdoid tumors who haven't had success with regular chemotherapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Ono Pharmaceutical Co., Ltd. (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Nagoya, Aichi-ken and 4 other locations) |
| Trial ID | NCT06622941 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of ONO-4538, a novel treatment, in patients suffering from rhabdoid tumors. It focuses on individuals who have advanced or recurrent forms of this rare cancer and have not responded to standard chemotherapy regimens. The trial aims to assess how well this new intervention works in managing the disease and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 1 year or older with advanced or recurrent rhabdoid tumors who are refractory or intolerant to previous chemotherapy.
Not a fit: Patients with active concurrent malignancies or those requiring immediate radiation therapy or surgical intervention for spinal lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with rhabdoid tumors who have limited treatment choices.
How similar studies have performed: While there may be limited data on ONO-4538 specifically, similar approaches targeting rare tumors have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Gender: Not specified 2. Age (at the time of consent): 1 year or older 3. Patients who are refractory or intolerant to one or more regimens of chemotherapy for rhabdoid Tumors 4. Patients with advanced or recurrent rhabdoid Tumors not eligible for curative resection Exclusion Criteria: 1. Patients with a history of active concurrent malignancy or complications 2. Patients with spinal lesions expected to require radiation therapy or surgical intervention during the trial period 3. Patients with concomitant central nervous system disorders other than AT/RT that are inadequately controlled or may lead to discontinuation of the investigational drug
Where this trial is running
Nagoya, Aichi-ken and 4 other locations
- Nagoya University Hospital — Nagoya, Aichi-ken, Japan (RECRUITING)
- Hokkaido University Hospital — Sapporo, Hokkaido, Japan (RECRUITING)
- Hyogo Prefectural Kobe Children's Hospital — Kobe, Hyōgo, Japan (RECRUITING)
- Osaka City General Hospital — Osaka, Osaka, Japan (RECRUITING)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (RECRUITING)
Study contacts
- Study coordinator: North America Clinical Trial Support Desk
- Email: clinical_trial@ono-pharma.com
- Phone: +18665877745(Toll-Free)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rhabdoid Tumor