RecruitingPhase 2NCT06622941

Study to ONO-4538 in Patients With Rhabdoid Tumor

A Multicenter, Open-label, Uncontrolled Phase II Study to Investigate Efficacy and Safety of ONO4538 in Patients With Rhabdoid Tumor


Sponsor

Ono Pharmaceutical Co., Ltd.

Enrollment

23 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 1 Year

Inclusion Criteria4

  • 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 Criteria3

  • 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

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Interventions

DRUGONO-4538

every 2 weeks


Locations(5)

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural Kobe Children's Hospital

Kobe, Hyōgo, Japan

Osaka City General Hospital

Osaka, Osaka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

View Full Details on ClinicalTrials.gov

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NCT06622941


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