Health TrialsbyHealthPanel

Study to ONO-4538 in Patients With Rhabdoid Tumor

ConditionRhabdoid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorOno Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • ONO-4538

    Drug

    every 2 weeks

Treatment groups

23 Participants
are divided into 1 treatment group
Group A: ONO-4538Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Time frame
up to 4.5 years

Secondary outcomes

1

Objective response rate (ORR) (site investigator assesment)

Time frame
up to 4.5 years
2

Overall survival (OS)

Time frame
up to 4.5 years
3

Progression free survival (PFS)

Time frame
up to 4.5 years
4

Disease control rate (DCR)

Time frame
up to 4.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ono Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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