Irinotecan: Phase I data

An open-label, dose-escalation, U.S. Phase I trial in 34 patients with recurrent malignant high-grade glioma showed that the MTD of IV MM-398 was 120 mg/m 2 in patients homozygous for UDP glucuronosyltransferase 1 family polypeptide A1 (UGT1A1) and 150 mg/m 2 in patients heterozygous for UGT1A1. Dose-limiting toxicities (DLTs) in both cohorts included diarrhea. Median progression-free survival (PFS) for all patients treated with an initial dose of >=120 mg/m 2 MM-398 was 43 days. The 6-month PFS rate was 0%. The trial was sponsored by University of California San Francisco. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...