Clinical Trial: Phase II Study to Evaluate Efficacy of Rechallenge With Sunitinib in Patients With Metastatic Pancreatic Neuroendocrine Tumor (pNETs) Who Previously Failed to Sunitinib

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase II Study to Evaluate Efficacy of Rechallenge With Sunitinib in Patients With Metastatic Pancreatic Neuroendocrine Tumor (pNETs) Well Differentiated G1/2 Advanced or Metastatic Who Previously Fai

Brief Summary:

The therapeutic goals in the management of pancreatic neuroendocrine tumors (pNET) are the control of symptoms and tumor growth control in order to improve patient survival.

In recent years, data from two phase III studies with targeted therapies, sunitinib and everolimus, have broadened the possibilities for treatment of patients with neuroendocrine tumors of the pancreas.

Unfortunately, patients progress and development of new active drugs and evaluating the best treatment approach is decisive.

Given the lack of data comparing the activity of different treatment strategies, final decisions are based on medical experience and consensus of experts. In this context, different questions are still unanswered, as which is the best sequence of treatment and if all patients can benefit from all available drugs.

Neuroendocrine pancreatic tumors are highly vascularized tumors in which cells may be dependent on this pathway for growth throughout the entire history of the tumor and in which inhibition of this pathway is crucial. On the other hand, this aspect has not been endorsed by the population of patients with pNET who have previously failed treatment with sunitinib.

In this scenario we will assess retreatment with sunitinib to evaluate the activity of this drug in the context of therapeutic rescue in patients with metastatic pNET.


Detailed Summary:
Sponsor: Grupo Espanol de Tumores Neuroendocrinos

Current Primary Outcome: 6 months progression free survival [ Time Frame: 6 months ]

Time form start of treatment to progression disease


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: 2 years ]
    Time form start of treatment to death
  • Progression free survival [ Time Frame: 12 months ]
    Time form start of treatment to progression disease
  • Response duration [ Time Frame: 12 months ]
    Time from first response to progression disease
  • Overall response rate [ Time Frame: 12 months ]
    Complete response + partial response
  • Safety [ Time Frame: 12 months ]
    Number of adverse events per patient


Original Secondary Outcome: Same as current

Information By: Grupo Espanol de Tumores Neuroendocrinos

Dates:
Date Received: March 16, 2016
Date Started: April 2016
Date Completion: July 2019
Last Updated: March 18, 2016
Last Verified: March 2016