Pancreatic Neuroendocrine Tumour MetastaticPhase 2RESUNETNCT02713763
Efficacy of Rechallenge With Sunitinib in Metastatic Pancreatic Neuroendocrine Tumor Previously Failed to Sunitinib
A Phase 2 study testing Sunitinib in people with Pancreatic Neuroendocrine Tumour Metastatic, run by Grupo Espanol de Tumores Neuroendocrinos at 9 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neuroendocrine Tumour Metastatic
- What is being tested?
- Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 9 sitesSpain
- Study dates
- 14 Feb 2017to 23 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects > 18 years old and able to give their informed consent.
- Patients diagnosed with Neuroendocrine Tumor of pancreatic origin and histologically confirmed, G1/2 according to the World Health Organization (WHO) classification (Ki67 <20% and/or mitotic count >20 mitoses x 10 HPF).
- Metastatic disease progression in the 12 months prior to baseline visit documented by CT, MRI or Octreoscan.
- Progression to prior treatment with sunitinib administered for metastatic disease and have received at least 1 line and no more than 2 lines of subsequent systemic treatment.
- Measurable disease according to the following criteria RECIST version 1.1
- No disease that can be treated with surgery, radiotherapy or combined treatment with curative intent.
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- Eastern Cooperative Oncology Group (ECOG) 0-2.
- Pretreatment with somatostatin analogues, chemotherapy, anti-VEGF (vascular endothelial growth factor) and mTOR (mammalian target of rapamycin) inhibitors prior to participation in the study is allowed.
- Adequately controlled blood pressure (BP) <150/90 mmHg.
- Hematologic Function: - Absolute neutrophil count >1500 / microliter (uL) - Platelets >100,000 / uL - Hemoglobin >5.6 mmol / L (9 g / dL)
- Liver function: total bilirubin < 1.5 x upper limit of normal (ULN), unless unconjugated hyperbilirubinemia or Gilbert syndrome. - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) < 2.5 x ULN (< 5 times in case of liver metastases).
- Renal function: calculated creatinine clearance according to Cockcroft-Gault > 30 ml / min.
- Blood coagulation: prothrombin time (PT) or International Normalized Ratio (INR) < 1.2 x ULN.
- Proteinuria <2+ urine dipstick. If > 2+ proteinuria, urinary protein <1 g / 24 h.
- Life expectancy> 3 months.
- Patient able to swallow the study drug and comply with the monitoring requirements of the study. - Women of childbearing potential must present a negative pregnancy test. Women of childbearing potential must agree to use contraception.
- Men whose partners are women of childbearing potential must use effective contraception.
Who cannot join
- Neuroendocrine tumors of pancreatic origin G3 according to WHO classification.
- Patients who received 3 or more lines of systemic treatment.
- Major surgery or trauma within 4 weeks prior to the first dose of sunitinib.
- Radiation therapy or tumor embolization within 2 weeks prior to the first dose of sunitinib.
- Chemotherapy, immunotherapy, biologic therapy or investigational therapy within the previous 2 weeks or 5 half-lives of the drug last received before the start of the first dose of sunitinib treatment.
- Prior treatment with high-dose chemotherapy that required hematopoietic rescue.
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- Immunosuppressive therapy or prolonged treatment with corticosteroids concomitantly administered in the previous 3 months.
- Resolution to grade <2 (CTCAE according V4.03) of all previous related toxicities except alopecia treatments.
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 (according CTCAE V4.03) and/or that is progressing in severity, except alopecia.
- Treatment with potent inhibitors or inducers of CYP3A4 or known to prolong the QT interval in the previous 7 days.
- Prior radiotherapy to more than 25% of the bone marrow - Presence of uncontrolled metastatic brain disease, spinal cord compression, meningeal carcinomatosis or leptomeningeal disease.
- Any gastrointestinal malabsorption disorder or any other condition that, at investigator's criteria, may affect the absorption of sunitinib or increase the risk of bleeding or perforation.
- Presence of any non-healing wound or ulcer.
- Grade III/IV diarrhea in the screening period.
- Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri.
- Clinically significant cardio/cerebrovascular disease in the 6 months prior to treatment.
- Cardiac arrhythmias (NCI CTCAE version 4.0 grade >2), atrial fibrillation of any grade that requires medical treatment.
- Corrected QT interval (QTcF) > 180 msec.
- Active hemoptysis in the past 6 weeks.
- Evidence of active bleeding or bleeding diathesis.
- Presence of endobronchial lesions and/or lesions that infiltrate large vessels.
- Current treatment with acenocoumarol at therapeutic doses.
- Known HIV infection.
- Presence of uncontrolled active infection.
- Pregnant or breastfeeding women.
- Previous allergic reaction to components structurally similar to sunitinib or any of the excipients.
- Inability to discontinue any prohibited concomitant medication.
- Any illness (medical or psychiatric) or reason, in the investigator's opinion, that interferes with the patient's ability to participate.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Universitario Valle de Hebrón
Barcelona, 08035
Hospital Reina Sofía
Córdoba, 14004
Hospital Universitario Donostia
Donostia / San Sebastian, 20014
Hospital Ramón y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital General Universitario J.M. Morales Meseguer
Murcia, 30008
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Complejo Hospitalario Regional Virgen Del Rocío
Seville, 41013
Instituto Valenciano de Oncología
Valencia, 46009
About this study
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.
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.
Read more
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.
- Being tested
- Sunitinib
- Keywords
- Sunitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sutent
Sunitinib 37.5 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib | Experimental | Sunitinib 37.5 mg/day Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months progression free survival
Time form start of treatment to progression disease
Measured: 6 months
Secondary outcomes (5)
Overall survival
Time form start of treatment to death
Measured: 2 years
Progression free survival
Time form start of treatment to progression disease
Measured: 12 months
Response duration
Time from first response to progression disease
Measured: 12 months
Overall response rate
Complete response + partial response
Measured: 12 months
Incidence of Adverse Events
Number of adverse events per patient
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start14 Feb 2017
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Neuroendocrine Tumour MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Enrique Grande, Principal investigator, MD Anderson Cancer Center MADRID
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713763
- Sponsor's protocol ID
- GETNE-2016-01
- Other IDs
- 2015-005774-37, 2015
- Acronym
- RESUNET
- Status last verified
- Mar 2020
- First submitted
- 16 Mar 2016
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02713763
- Acronym / sponsor ID
- RESUNET / GETNE-2016-01
- Keywords
- Sunitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Grupo Espanol de Tumores NeuroendocrinosUniversity, hospital or other
- Collaborators
- Pfizer, Apices Soluciones S.L.
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib | Experimental | Drug: SunitinibSunitinib 37.5 mg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects > 18 years old and able to give their informed consent.
- Patients diagnosed with Neuroendocrine Tumor of pancreatic origin and histologically confirmed, G1/2 according to the World Health Organization (WHO) classification (Ki67 <20% and/or mitotic count >20 mitoses x 10 HPF).
- Metastatic disease progression in the 12 months prior to baseline visit documented by CT, MRI or Octreoscan.
- Progression to prior treatment with sunitinib administered for metastatic disease and have received at least 1 line and no more than 2 lines of subsequent systemic treatment.
- Measurable disease according to the following criteria RECIST version 1.1
Key exclusion criteria (28 listed)
- Neuroendocrine tumors of pancreatic origin G3 according to WHO classification.
- Patients who received 3 or more lines of systemic treatment.
- Major surgery or trauma within 4 weeks prior to the first dose of sunitinib.
- Radiation therapy or tumor embolization within 2 weeks prior to the first dose of sunitinib.
- Chemotherapy, immunotherapy, biologic therapy or investigational therapy within the previous 2 weeks or 5 half-lives of the drug last received before the start of the first dose of sunitinib treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SunitinibAlso: SutentSunitinib 37.5 mg/day | Drug | Sunitinib |
Primary outcome
6 months progression free survival
Time frame: 6 months
Time form start of treatment to progression disease
5 secondary outcomes
Overall survival
Time frame: 2 years
Progression free survival
Time frame: 12 months
Response duration
Time frame: 12 months
Overall response rate
Time frame: 12 months
Incidence of Adverse Events
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Grande principal investigator
MD Anderson Cancer Center MADRID
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib in people with Pancreatic Neuroendocrine Tumour Metastatic, run by Grupo Espanol de Tumores Neuroendocrinos at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months progression free survival (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.