Study of Oral Zotiraciclib to Treat Recurrent Brain Gliomas With IDH1 or IDH2 Mutations

What this Trial Is About

Researchers are investigating zotiraciclib, an oral multi-kinase inhibitor, in people aged 15 years and older with recurrent diffuse gliomas that have mutations in the IDH1 or IDH2 genes. These gliomas are aggressive brain and spinal cord tumors that return after prior treatments such as radiation or chemotherapy. This phase III study aims to determine the recommended dose and evaluate the effectiveness of zotiraciclib in this patient group. Participants will take zotiraciclib capsules by mouth on specific days 1, 4, 8, 11, 15, and 18 during 28-day cycles for up to 18 cycles about 1.5 years. Dose levels may be adjusted depending on tolerance, with some participants undergoing surgery and receiving a single dose before tumor biopsy or resection. The study includes several groups based on dose escalation and surgical status. During the study, participants will visit the clinic roughly once a month for physical exams, blood and urine tests, heart function evaluations, and brain MRIs every 8 weeks. They will keep a medication diary to track their doses. Researchers will monitor safety, measure progression-free survival, and assess overall survival over multiple years. The total study participation may last up to 18 cycles of treatment.

A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations