The purpose of this research is to test the safety and effectiveness of the investigational drug ruxolitinib when it is combined with standard of care treatment (radiation therapy and temozolomide) for the treatment of newly diagnosed glioblastoma. Half the people in the study will be assigned to take the study drug ruxolitinib in addition to the standard of care temozolomide and radiation therapy and the other half will be assigned to the standard of care temozolomide and radiation therapy only. This assignment will be randomized in a 1-to-1 ratio, like the flip of a coin.
Provision of signed informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Individuals of any sex, gender, race, or ethnicity ≥ 18 years of age.
Histologically confirmed glioblastoma as defined by the World Health Organization (WHO) 2021 Criteria (IDH-wildtype) that is either methylated, unmethylated, or indeterminate MGMT.
Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant.
Patients receiving concurrent therapy for their brain tumor (e.g., chemotherapeutics or investigational agents).
Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this study.
Patients who have had repeat craniotomy for tumor therapy after receiving radiation therapy and temozolomide treatment.
Baptist Health South Florida
Lead sponsor
Incyte Corporation
Collaborator