Xalkori crizotinib: Phase I data
An open-label, North American Phase I trial in patients aged 1-21 with relapsed or refractory ALK-driven tumors showed that Xalkori produced 7 complete responses in 8 evaluable patients with ALCL. Additionally, 2 patients with neuroblastoma had complete responses and 2 patients had partial responses - 1 with an inflammatory myofibroblastic tumor and 1 with non-small cell lung cancer (NSCLC). Dose-limiting toxicities (DLTs) included grade 3 dizziness, grade 4 liver enzyme elevation and neutropenia and grade 5 intratumoral hemorrhage. The trial enrolled 70 patients to receive twice-daily 100, 130, 165, 215, 280 or 365 mg/m 2 Xalkori in 28-day cycles. The trial was conducted by the Children's Oncology Group and was funded by Pfizer and NIH's National Cancer Institute. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...