[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-pancreatic-neuroendocrine-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-pancreatic-neuroendocrine-tumor":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100492052","phase-1-testing-the-addition-of-sunitinib-malate-to-lutetium-lu-177-dotatate-lutathera-in-pancreatic-neuroendocrine-tumors-100492052",false,"NCT05687123","Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors","A Phase I Dose Escalation-Expansion Trial of Sunitinib Malate Plus Lutetium Lu 177 Dotatate (Lutathera) in Somatostatin Receptor Positive Pancreatic Neuroendocrine Tumors","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed metastatic or unresectable well- or moderately-differentiated pancreatic neuroendocrine tumors (PNETs) of all grades (Grade 1, grade 2 and grade 3)\n* Patients with measurable disease per RECIST 1.1 appropriate for lutetium Lu 177 dotatate treatment, as determined by positive screening with SSR PET\u002FCT and appropriate theranostics consultation (nuclear medicine or radiation oncology consultation)\n* Patients may be treatment naïve or have disease progression on or intolerance of up to one line of systemic therapy other than somatostatin analog therapy (somatostatin analog therapy is not considered a line of systemic therapy). Systemic therapy is considered therapy for unresectable or metastatic disease. Any prior adjuvant therapy with curative intent will not be considered a line unless relapse occurs within 6 months. Prior and\u002For concurrent use of somatostatin analogs are allowed\n* Patients who have have received a prior line of therapy must have documented disease progression per RECIST 1.1 within 12 months of initiation of the study protocol\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of sunitinib malate in combination with lutetium Lu 177 dotatate in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 75,000\u002FmcL\n* Total bilirubin =\\\u003C 1.5 institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 × institutional ULN\n* Creatinine clearance \\> 50 ml\u002Fmin OR Glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2\n* Hemoglobin \\> 8.0 g\u002FdL\n* White blood cell count \\> 2000\u002FmL\n* Serum calcium =\\\u003C 12.0 mg\u002FdL\n* International normalized ratio (INR) =\\\u003C 1.5\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have left ventricular ejection fraction of 50% or more. (Patients with no known history and no current symptoms of cardiac disease do not require left ventricular ejection fraction \\[LVEF\\] evaluation at screening)\n* Patients must have blood pressure (BP) no greater than 140 mmHg (systolic) and 90 mmHg (diastolic) for eligibility. Initiation or adjustment of BP medication is permitted prior to study entry, provided that the average of three BP readings at a visit prior to enrollment is less than 140\u002F90 mmHg\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, as determined by a repeat imaging study at least 4 weeks following the completion of treatment. Patients with treated brain metastases must also be off steroids for at least 1 month and stable\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial after consultation with the study chair\n* The effects of lutetium Lu 177 dotatate and sunitinib malate on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because radionucleotides and anti-angiogenic agents are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. All women of childbearing potential must have a negative pregnancy test prior to receiving sunitinib malate. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lutetium Lu 177 dotatate and sunitinib malate administration\n\nExclusion Criteria:\n\n* Patients who have not recovered from acute clinically significant adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib malate or lutetium Lu 177 dotatate\n* Patients who require use of therapeutic doses of coumarin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis. Note: Low molecular weight heparin is permitted provided the patient's INR is =\\\u003C 1.5 and is the preferred anticoagulant in this trial. Other non-coumarin-derivative anticoagulants including direct oral anticoagulants may be used with caution\n* Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain sunitinib tablets are excluded\n* Patients with any of the following conditions are excluded:\n\n  * Serious or non-healing wound, ulcer, or bone fracture\n  * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment\n  * Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry\n  * History of myocardial infarction, cardiac arrhythmia, stable\u002Funstable angina, symptomatic congestive heart failure, or coronary\u002Fperipheral artery bypass graft or stenting within 12 months prior to study entry\n  * History of pulmonary embolism within the past 12 months\n  * Class III or IV heart failure as defined by the New York Heart Association Class (NYHA) functional classification system\n* Patients receiving any medications or substances that are strong CYP3A4 inhibitors within 7 days before dosing, or strong CYP3A4 inducers within 12 days before dosing, are ineligible as sunitinib is a major substrate of CYP3A4. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with a pre-existing thyroid abnormality who are unable to maintain thyroid function in the normal range with medication are ineligible\n* Patients with uncontrolled intercurrent illness\n* Pregnant women are excluded from this study because sunitinib malate is an anti-angiogenic agent and lutetium Lu 177 dotatate is a peptide receptor radionuclide therapy with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib malate and lutetium Lu 177 dotatate, breastfeeding should be discontinued if the mother is treated with sunitinib malate and lutetium Lu 177 dotatate. Breastfeeding should be discontinued for 2.5 months following the last lutetium Lu 177 dotatate treatment. These potential risks may also apply to other agents used in this study\n* Patients who have had prior treatment with sunitinib malate or lutetium Lu 177 dotatate therapy or other radiopharmaceuticals (including, but not limited to, metaiodobenzylguanidine \\[MIBG\\], yttrium-90 \\[Y-90\\], radioactive iodide \\[RAI\\]), as MIBG and RAI could potentially increase risk of myelodysplastic syndrome or irreversible hematologic toxicities","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone.",[26,27,28,29,30],"Metastatic Pancreatic Neuroendocrine Tumor","Pancreatic Neoplasm","Stage III Pancreatic Neuroendocrine Tumor AJCC v8","Stage IV Pancreatic Neuroendocrine Tumor AJCC v8","Unresectable Pancreatic Neuroendocrine Tumor","RECRUITING","2026-05-12",{"date":34,"type":35},"2026-05-13","ACTUAL",{"date":37,"type":35},"2024-08-14",{"date":39,"type":20},"2026-12-14",{"name":41,"class":42},"National Cancer Institute (NCI)","NIH",10,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100567045","phase-1-study-to-test-the-combination-of-fulvestrant-with-lu-dotatate-for-advanced-pancreatic-neuroendocrine-tumors-100567045","NCT06663072","Study to Test the Combination of Fulvestrant With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors","A Phase I Study of Fulvestrant in Combination With Lu-DOTATATE for Advanced Pancreatic Neuroendocrine Tumors","Inclusion Criteria:\n\n* Patients must have histologically confirmed pancreatic neuroendocrine tumor, WHO grades 1-2, Ki-67 index of \\<20%.\n* Patients must have locally advanced disease that is ineligible for curative-intent resection, or metastatic disease.\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.\n* Patients must also have tumors expressing somatostatin receptor, defined as radiotracer avid lesions as assessed by a previous DOTATATE PET scan.\n* Patients must have radiographically progressed (as per RECIST v1.1 criteria) on one or more prior-lines of systemic therapy prior to enrollment in the trial. Prior systemic therapies include but are not limited to somatostatin analogs (octreotide LAR, lanreotide), Capecitabine\u002FTemozolomide, tyrosine kinase inhibitors (e.g. everolimus), VEGF pathway inhibitors (e.g. sunitinib, cabozantinib), and\u002For other systemic chemotherapy.\n* Patients should not have received any prior systemic therapy with peptide receptor radionuclide therapy (including 177Lu-DOTATATE) and\u002For Fulvestrant.\n* Prior treatment with hepatic intra-arterial embolic therapies is allowed if there is recovery from all toxicities, measurable lesions do not include embolized liver unless there has been clear subsequent progression, all measurable lesions are somatostatin receptor avid, and treatment completed at least 2 months prior to registration.\n* Prior treatment with cryoablation or thermal\u002Fradiofrequency ablation of metastases is allowed if there is recovery from all toxicities, measurable lesions do not include treated metastases, and treatment completed at least 2 months prior to registration.\n* Concomitant Medication: Concurrent SSA use while on protocol therapy is allowed provided that the patient: 1) has a functional tumor (evidence of peptide hormones and\u002For bioactive substances associated with a clinical hormone syndrome such as carcinoid syndrome or Cushing's syndrome), 2) has been on a stable dose of somatostatin analog therapy for at least three months, and 3) has previously demonstrated radiographic disease progression while on SSA therapy. There should be a minimum of 28 days between long-acting SSA and 177Lu-DOTATATE dosing. Short-acting SSAs should not be administered within 24 hours of 177Lu-DOTATATE dosing. Following lutetium 177Lu-DOTATATE dosing, long-acting SSAs may be administered between 4 and 24 hours after each dose.\n* Age ≥18 years. As neuroendocrine tumors are very rare in children, patients \\\u003C18 years of age will be excluded from this study. Furthermore, no reliable dosing or adverse event data are currently available on the use of Fulvestrant patients \\\u003C18 years of age.\n* ECOG performance status of 0 or 1.\n* Patients must have adequate organ and marrow function as defined below:\n\n  1. Absolute Neutrophil Count ≥1,500\u002FµL\n  2. Platelet Count ≥100,000\u002FµL\n  3. Hemoglobin ≥ 9g\u002FdL\n  4. Creatinine \\\u003C1.5 mg\u002FdL\n* -OR-\n\n  1. Creatinine Clearance ≥ 50 mL\u002Fmin (Cockroft- Gault calculated)\n  2. Total bilirubin ≤ 1.5 × institutional upper limit of normal\n  3. AST AND ALT ≤ 3 × institutional upper limit of normal\n  4. Serum Albumin ≥ 3.0 g\u002FdL\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients should not have any other active malignancies at the time of study enrollment or a history of myelodysplastic syndromes\u002Facute myeloid leukemia accounting for the rare but serious bone-marrow toxicity of 177Lu-DOTATATE. Patients with a remote history of other malignancies may be eligible for enrollment if the malignancy was curable, they have completed all curative-intent treatment (such as surgery, radiation and adjuvant therapy if warranted), and the malignancy has not recurred after 3 years of initial diagnosis.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 3 months.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Not pregnant and not nursing since the effects of 177Lu-DOTATATE on the developing human fetus are not well-established. For women of childbearing potential only, a negative pregnancy test done ≤ 28 days prior to registration is required.\n* Patients must have a life expectancy of \\>12 weeks.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are unable to provide or understand written informed consent and comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.\n* Patients who are receiving any other investigational agents.\n* Patients with a \"currently active\" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for ≥ 3 years.\n* Pregnant or breastfeeding.\n* Clinical or laboratory signs of imminent organ failure, as determined by the treating investigator.\n* Patients with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.",{"count":52,"type":20},25,[23],"This is a phase I, open-label study to assess the safety and preliminary efficacy of Fulvestrant in combination with 177Lu-DOTATATE for advanced pNETs.",[26],"2026-01-07",{"date":58,"type":35},"2026-01-09",{"date":60,"type":35},"2024-12-13",{"date":62,"type":20},"2026-11",{"name":64,"class":65},"University of Chicago","OTHER",1]