Outcomes
±2, tumor, Tumor, glioma, tumors, IDH, Cancer
ADVERSE EVENT, TUMOR, TUMOR, GLIOMA, TUMORS, CANCER
The primary end-point of 2-HG concentration in resected tumors was evaluated by comparing concentrations in patients with mSecondary end-points included safety, tumor and plasma pharmacokinetics, and preliminary clinical activity. Exploratory end-points included IDH pathway-related molecular and cellular changes that correlated with 2-HG and radiographic response, where feasible.Safety was assessed by monitoring all AEs from the time of consent through 28 (+ ≤5) d after the last dose using the National Cancer Institute Common Terminology Criteria for Adverse Events, v.4.03 (ref. Tumor measurements were collected using a standardized MRI protocol at screening and surgery. A brain MR image was collected postoperatively as the new baseline before resuming treatment. Additional brain MR images were collected every 56 (±2) d thereafter (that is, while receiving study treatment) and at the end of treatment. Antitumor activity was assessed by the investigator using the Response Assessment in Neuro-Oncology criteria for low-grade glioma (RANO-LGG)