Study to ONO-4538 in Patients With Rhabdoid Tumor

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06622941
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ono Pharmaceutical Co. Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Project Leader
Principal Investigator Affiliation Ono Pharmaceutical Co. Ltd
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rhabdoid Tumor
Arms & Interventions

Arms

Experimental: ONO-4538

Interventions

Drug: - ONO-4538

every 2 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Nagoya University Hospital, Nagoya, Aichi, Japan

Status

Not yet recruiting

Address

Nagoya University Hospital

Nagoya, Aichi,

Site Contact

[email protected]

National Cancer Center Hospital, Chuo-ku, Tokyo, Japan

Status

Recruiting

Address

National Cancer Center Hospital

Chuo-ku, Tokyo,

Site Contact

[email protected]

Osaka City General Hospital, Osaka, Japan

Status

Recruiting

Address

Osaka City General Hospital

Osaka, ,

Site Contact

[email protected]

Stay Informed & Connected