OXi4503 combretastatin A1 di-phosphate: Final Phase Ib data
Final data from an open-label, dose-escalation Phase Ib trial in 45 patients with advanced solid tumors showed that OXi4503 produced 9 cases of stable disease, plus 2 patients with epithelial ovarian cancer had partial responses. OXi4503 was well tolerated at doses up to 14 mg/m 2 when amlodopine was given as prophylaxis to prevent hypertension. Dose-limiting toxicities of grade 3 hypertension and visual disturbances were observed in 2 patients at 15.4 mg/m 2 OXi4503 before the introduction of amlodopine as prophylaxis. The recommended Phase II dose was determined to be between 11 and 14 mg/m 2 OXi4503. Patients received 0.06-15.4 mg/m 2 IV OXi4503 on days 1, 8 and 15 of a 28-day cycle. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...