Study to ONO-4538 in Patients With Rhabdoid Tumor

Ono Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Rhabdoid Tumor

Treatments: Drug: ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT06622941

ONO-4538-126

jRCT2051240150 (Registry Identifier)

Details and patient eligibility

About

Investigate the efficacy and safety of ONO-4538 for the treatment of rhabdoid Tumors

Enrollment: 23 estimated patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

ONO-4538

Experimental group

Treatment:

Drug: ONO-4538