Clinical Trial: First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma (PPGL)
Brief 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 Summary:
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
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Current Primary Outcome: Progression-free survival at 12 months [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective Response Rates (ORR) [ Time Frame: 12 months ]
- Duration of response (DR) [ Time Frame: 12 months ]
- Overall Time to Progression (TTP) [ Time Frame: 12 months ]
- Overall survival (OS) [ Time Frame: 12 months ]
- Number of Adverse Events assessed using NCI -CTC V4 criteria [ Time Frame: 12 months ]Number and description of adverse events and number of patients with adverse events according to NCI -CTC V4 criteria
- Number of patients with cardiovascular toxicity tolerance assessed by specific organisation for blood pressure monitoring [ Time Frame: 12 months ]Cardiovascular tolerance will be assessed by specific organisation for blood pressure monitoring
- Bone Pain evaluation on the Visual Analog Scale [ Time Frame: 12 months ]
Original Secondary Outcome:
- Objective Response Rates (ORR) [ Time Frame: 12 months ]
- Duration of response (DR) [ Time Frame: 12 months ]
- Overall Time to Progression (TTP) [ Time Frame: 12 months ]
- Overall survival (OS) [ Time Frame: 12 months ]
- Number of Adverse Events assessed using NCI -CTC V4 criteriaNumber and description of adverse events and number of patients with adverse events according to NCI -CTC V4 criteria
- Number of patients with cardiovascular toxicity tolerance assessed by specific organisation for blood pressure monitoringCardiovascular tolerance will be assessed by specific organisation for blood pressure monitoring
- Bone Pain evaluation on the Visual Analog Scale
Information By: Gustave Roussy, Cancer Campus, Grand Paris
Dates:
Date Received: June 9, 2011
Date Started: December 2011
Date Completion: June 2021
Last Updated: January 25, 2017
Last Verified: January 2017