This placebo-controlled, randomized discontinuation trial is assessing the safety and efficacy of once-daily, oral AV-951 in metastatic renal cell carcinoma patients naive to VEGF targeted therapy at more than 30 sites in Europe and India under a US investigational new drug filing.
In this Phase II trial, all patients receive 16 weeks of AV-951, after which time patients are evaluated for response, stable disease or progressive disease. Those patients who experience a partial or complete response remain on therapy; those patients who experience stable disease are randomized to receive 12 weeks of AV-951 or placebo in a double-blind fashion.
The primary endpoints of this trial are objective response rate after 16 weeks of treatment, percentage of patients who are progression free at 12 weeks following randomization (28 weeks after study entry), and safety.
Tuan Ha-Ngoc, president and CEO of Aveo, said: “Based on our promising, early data, we believe the unique triple VEGF receptor inhibition and tolerability positions AV-951 as a potential best-in-class anti-angiogenic agent.”