Rhabdoid Tumor
Conditions
Brief summary
Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors
Interventions
DRUGONO-4538
every 2 weeks
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | up to 4.5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Japan
Contacts
CONTACTNorth America Clinical Trial Support Desk
CONTACTInternational Clinical Trial Support Desk
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co. Ltd
Outcome results
None listed