NYU Langone Health
This is an open-label, dose-finding study of XRD-0394 in subjects with newly diagnosed and recurrent high grade gliomas receiving radiation therapy, with and without concurrent temozolomide based on O6-Methylguanine-DNA methyltransferase (MGMT) status for patients with newly diagnosed high grade gliomas.
Inclusion Criteria: * Willing and able to provide written informed consent. * ≥18 years of age. * For Cohorts A and B, radiographic diagnosis of high-grade glioma that is then confirmed with biopsy. Patients with established histologic diagnosis of high-grade glioma is able to enroll on the study without repeating biopsy. * For Cohort C, histologic diagnosis of high-grade glioma is required to enroll on the study. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. * Subjects must have adequate liver and kidney function, defined as: Liver transaminase levels ≤2.5 × the upper…
Administered orally; small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and DNA-PK.
For Cohort A and Cohort B, the neoadjuvant "boost" radiation dose is 1400cGy delivered over 7 fractions, and the adjuvant radiation dose is 5000cGy delivered over 25 fractions for a total dose of 6400cGy over 32 fractions, accounting for the treatment break between boost and adjuvant RT. For Cohort C, the radiation dose is 3500cGy delivered over 10 fractions.
Resection of tumor tissue.
Arctuva estimate
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