Efficacy of Rechallenge With Sunitinib in Metastatic Pancreatic Neuroendocrine Tumor Previously Failed to Sunitinib (RESUNET)
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|ClinicalTrials.gov Identifier: NCT02713763|
Recruitment Status : Active, not recruiting
First Posted : March 21, 2016
Last Update Posted : October 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neuroendocrine Tumour Metastatic||Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Failed to Sunitinib.|
|Actual Study Start Date :||February 14, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Sunitinib 37.5 mg/day
Sunitinib 37.5 mg/day
Other Name: Sutent
- 6 months progression free survival [ Time Frame: 6 months ]Time form start of treatment to progression disease
- 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
- Incidence of Adverse Events [ Time Frame: 12 months ]Number of adverse events per patient
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713763
|Hospital Universitario Central de Asturias|
|Oviedo, Asturias, Spain, 33011|
|Hospital Universitario Valle de Hebrón|
|Barcelona, Spain, 08035|
|Hospital Reina Sofía|
|Córdoba, Spain, 14004|
|Hospital Universitario Donostia|
|Donostia/San Sebastián, Spain, 20014|
|Hospital Ramón y Cajal|
|Madrid, Spain, 28034|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital General Universitario J.M. Morales Meseguer|
|Murcia, Spain, 30008|
|Complejo Hospitalario Regional Virgen Del Rocío|
|Sevilla, Spain, 41013|
|Instituto Valenciano de Oncología|
|Valencia, Spain, 46009|
|Principal Investigator:||Enrique Grande||MD Anderson Cancer Center MADRID|