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Trial for the treatment of newly diagnosed diffuse glioma after completion of radiotherapy
THE AIM OF THIS STUDY ARE: - TO TEST WHETHER ONC201 IS EFFECTIVE IN TREATING PATIENTS WITH GLIOMA WHEN GIVEN AFTER RADIATION THERAPY. - TO TEST HOW SAFE AND TOLERABLE ONC201 IS IN PATIENTS WITH GLIOMA COMPARED TO USING A PLACEBO (A CAPSULE THAT LOOKS LIKE ONC201, BUT DOES NOT CONTAIN ANY ACTIVE DRUG). - TO TEST THE EXTENT TO WHICH ONC201 CAN IMPROVE QUALITY OF LIFE AND BRAIN FUNCTION IN GLIOMA PATIENTS.
Technical Summary
- THE ACTION: ONC201 STUDY FOR THE TREATMENT OF NEWLY DIAGNOSED H3 K27M MUTATED DIFFUSE GLIOMA AFTER COMPLETION OF RADIOTHERAPY: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY.
- Code EudraCT: 2022-502051-56-00
- Protocol number: ONC201-108
- Promoter: Chimerix, Inc.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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