First International Randomized Study in MAlignant Progressive Pheochromocytoma and Paraganglioma

• Conditions: Diagnosis of malignant PPGL, based on imaging or biopsy evidence of metastases in liver, bones, lungs and or lymph nodes, combined with at least one of two further confirmatory diagnoses: 1. diagnosis of PPGL from histopathological review of resected or biopsied tissue performed by a skilled pathologist or 2. in patients where tumor tissue is unavailable for formal pathological review, from combined biochemical and functional imaging evidence of PPGL; MedDRA version: 16.0Level: LLTClassification code 10033792Term: Paraganglion neoplasm NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-024621-20-IT
• Lead Sponsor: Institut Gustave Roussy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-24
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

-Diagnosis of malignant PPGL,
-Metastatic disease not amenable to surgical resection
-Pre-treated or not
-Whatever the genetic status (sporadic or inherited)
-Evaluable disease according to RECIST 1.1 criteria
-ECOG performance status 0-2
-Life expectancy = 6 months as prognosticated by the physician
-Age = 18 years, no superior limit
-Adequate bone marrow reserve (Hb > 8, neutrophils = 1500/mm³ and platelets =80.000/mm³)
-Ability to comply with the protocol procedures
-Ability to take oral medication

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Large or small cell-poorly differentiated neuroendocrine carcinoma according to WHO 2000 classification
-History of prior malignancy,
-Severe renal or hepatic insufficiency
-Patients with cardiac events
-Hypertension
-Brain metastases
-Previous treatment with the drug under study. Prior systemic treatment with any tyrosine kinase inhibitors or anti VEGF angiogenic inhibitors.
-Major surgery for any cause or local radiotherapy within one month prior to visit 1
-Liver embolisation therapy within the last 3 months prior visit 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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 Objective: -To determine overall survival and progression free survival.<br>-To determine time to progression.<br>-To determine objective response rate at one year.<br>-To determine time to and duration of tumor response. <br>-To assess safety profile including a dedicated cardiovascular management.<br>;Primary end point(s): Progression-free survival at 12 months.<br>Progression will be assessed by RECIST 1.1 performed every 3 months (centralized imaging) <br>;Timepoint(s) of evaluation of this end point: Progression-free survival at 12 months.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Objective Response Rates (ORR)<br>-Duration of response (DR) <br>-Overall Progression-free survival (PFS)<br>-Overall Time to Progression (TTP)<br>-Overall survival (OS)<br>-Toxicity (NCI –CTC V4 criteria)<br>-Cardiovascular tolerance assessed by specific organisation for blood pressure monitoring <br>;Timepoint(s) of evaluation of this end point: various timepoints