Recruiting NCT06622941
Study to ONO-4538 in Patients With Rhabdoid Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ONO-4538.
- Who it may be relevant to
- Registry conditions: Rhabdoid Tumor. Basic parameters: from 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor
Overview
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
Interventions
- Drug ONO-4538
every 2 weeks
Primary outcome measures
- Objective response rate (ORR) [Time frame: up to 4.5 years]
Secondary outcome measures (9)
- Objective response rate (ORR) (site investigator assesment) [Time frame: up to 4.5 years]
- Overall survival (OS) [Time frame: up to 4.5 years]
- Progression free survival (PFS) [Time frame: up to 4.5 years]
- Disease control rate (DCR) [Time frame: up to 4.5 years]
- Time to response (TTR) [Time frame: up to 4.5 years]
- Best overall response (BOR) [Time frame: up to 4.5 years]
- Percent change from baseline in the sum of diameters of target lesions [Time frame: up to 4.5 years]
- Best reduction percent change from baseline in the sum of diameters of target lesions [Time frame: up to 4.5 years]
- Incidence of Adverse Events [Safety] [Time frame: Up to 30 days after the last dose]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 14 centers
- Nagoya University Hospital — Nagoya
- Hokkaido University Hospital — Sapporo
- Hyogo Prefectural Kobe Children's Hospital — Kobe
- Osaka City General Hospital — Osaka
- National Cancer Center Hospital — Chuo-ku
- Chiba University Hospital — Chiba
- Kyushu University Hospital — Fukuoka
- Fukushima Medical University Hospital — Fukushima
- … and 6 more centers
Identifiers
NCT: NCT06622941 · ONO-4538-126 · jRCT2051240150