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A Phase III, open-label, randomized, two-arm clinical trial to compare the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly diagnosed MGMT-unmethylated glioblastoma
THIS IS A PHASE III TRIAL. THIS TRIAL CONSISTS OF: PHASE 1, DURING WHICH PARTICIPANTS WILL RECEIVE EITHER THE STUDY DRUG OR THE COMPARATOR DRUG, AND ALL PARTICIPANTS WILL ALSO RECEIVE RADIATION THERAPY; AND PHASE 2, DURING WHICH PARTICIPANTS WILL CONTINUE TO RECEIVE THE SAME DRUG THEY RECEIVED IN PHASE 1, WITHOUT RADIATION THERAPY.
Technical Summary
- A PHASE III, OPEN-LABEL, RANDOMIZED, TWO-ARM STUDY TO COMPARE THE CLINICAL EFFICACY AND SAFETY OF NIRAPARIB WITH TEMOZOLOMIDE IN ADULT PARTICIPANTS WITH NEWLY DIAGNOSED GLIOBLASTOMA WITHOUT MGMT METHYLATION
- Code EudraCT: 2024-513077-48-00
- Protocol number: IVY-P3-24-021
- Promoter: Ivy Brain Tumor Center (IBTC)
- Molecule/Drug: niraparib
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* 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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