ABOUT THIS STUDY
- 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.
- 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.
- 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
- 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.
- 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
- 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
- Clinically significant cardio/cerebrovascular disease in the 6 months prior to
- 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
- 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.
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