Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL) Clinical Trial
Official title:
First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)
The FIRSTMAPPP study is a randomized, double-blind, phase II, international, multicenter study which aims to determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing).
PRIMARY OBJECTIVE: To determine the efficacy of Sunitinib on the progression-free survival at 12 months in subjects with progressive malignant pheochromocytoma and paraganglioma treated with sunitinib at a starting dose of 37.5 mg daily (continuous dosing). SECONDARY OBJECTIVES: - To determine overall survival and progression free survival. - To determine time to progression. - To determine objective response rate at one year. - To determine time to and duration of tumor response. - To assess safety profile including a dedicated cardiovascular management (home-blood pressure monitoring, ECG and echocardiography). EXPLORATORY OBJECTIVES: -Identification of predictors of response as well as surrogate markers of overall survival is anticipated ;