NCT01371201

First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma

First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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

Conditions

• Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)

Interventions

Type	Name	Description
DRUG	Sunitinib	sunitinib 37.5 mg per day
DRUG	Placebo	Placebo 37.5 mg per day

Timeline

• Start date: 2011-12-22
• Primary completion: 2013-10-01
• Completion: 2021-04-20
• First posted: 2011-06-10
• Last updated: 2022-08-04

Locations

4 sites across 4 countries: France, Germany, Italy, Netherlands