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Efficacy of Rechallenge With Sunitinib in Metastatic Pancreatic Neuroendocrine Tumor Previously Failed to Sunitinib

NCT02713763 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-03-04

No results posted yet for this study

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

Conditions

  • Pancreatic Neuroendocrine Tumour Metastatic

Interventions

DRUG

Sunitinib

Sunitinib 37.5 mg/day

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Apices Soluciones S.L.

    collaborator INDUSTRY

  • Grupo Espanol de Tumores Neuroendocrinos

    lead OTHER

Principal Investigators

  • Enrique Grande · MD Anderson Cancer Center MADRID

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2019-10-23
Completion
2019-10-23

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02713763 on ClinicalTrials.gov