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 ]

Progression will be assessed by RECIST 1.1 performed every 3 months (centralized imaging)


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 criteria
    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
    Cardiovascular 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