SAR3419: Phase I data

Data from 21 evaluable patients in an extension cohort of an open-label, French Phase I trial showed that an optimized regimen of 55 mg/m 2 IV SAR3419 consisting of 4 once-weekly doses followed by 4 bi-weekly doses led to an objective response in 6 patients, including 3 unconfirmed complete responses, plus 9 cases of stable disease. Durations of response ranged from 8-35 weeks. The most common adverse events were asthenia, including 1 patient with grade 3, and gastrointestinal disorders. Grade 3/4 hematological toxicities included neutropenia, thrombocytopenia and anemia. Reversible grade 1 blurred vision/corneal event occurred in 1 patient. There were no DLTs. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. ...