Study to ONO-4538 in Patients With Rhabdoid Tumor
- Registration Number
- NCT06622941
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ONO-4538 ONO-4538 -
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) up to 4.5 years
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) (site investigator assesment) up to 4.5 years Overall survival (OS) up to 4.5 years Progression free survival (PFS) up to 4.5 years Disease control rate (DCR) up to 4.5 years Time to response (TTR) up to 4.5 years Best overall response (BOR) up to 4.5 years Percent change from baseline in the sum of diameters of target lesions up to 4.5 years Best reduction percent change from baseline in the sum of diameters of target lesions up to 4.5 years Incidence of Adverse Events [Safety] Up to 30 days after the last dose
Trial Locations
- Locations (3)
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Osaka City General Hospital
🇯🇵Osaka, Japan