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Neuroendocrine Tumors clinical trials

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NCT ID: NCT02348749 Active, not recruiting - Clinical trials for Neuroendocrine Tumors

18F-MFBG Imaging for Evaluation of Neuroendocrine Malignancies

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to see how a new tracer named 18F-MFBG (Meta Fluorobenzyl Guanidine) behaves in the body after injection, how it spreads to all the organs and how it is removed from the body. We will also study how long 18F-MFBG lasts in the blood after administered. In addition we want to study if 18F-MFBG can show Neuroendocrine tumors on a PET-CT or PET MR scan.

NCT ID: NCT02315625 Terminated - Clinical trials for Neuroendocrine Tumors

Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery

Start date: April 8, 2015
Phase: Phase 2
Study type: Interventional

Background: - Neuroendocrine tumors (NETs) come from cells of the hormonal and nervous systems. Some people have surgery to shrink the tumor. Sometimes the tumors come back. Researchers think that treatment with drugs based on knowing the defective gene might give better results. Objective: - To see if drugs selected based on the defective gene result in better tumor response. The drugs are Sunitinib and Everolimus. Eligibility: - People age 18 and older with an advanced low- or intermediate-grade gastrointestinal or pancreatic neuroendocrine tumor. Design: - Participants will be screened with: - Medical history - Physical exam - Scans - Blood, urine, and lab tests - The study team will see if participants should have surgery. - If yes, participants will: - Sign a separate consent - Have computed tomography (CT) scan before and after surgery - Have as much of the tumor removed as possible. A small piece will be tested for mutation type. - If no, participants will have a small piece of tumor removed for the testing. - If the surgery might cure them, the participant will leave the study. The other participants will be assigned to take either Sunitinib or Everolimus. - Participants will take their drug by mouth once a day. They will keep a medicine diary. Some will keep track of their blood pressure at least weekly. - Screening tests may be repeated at study visits. Participants also may have their heart evaluated. - About 30 days after the last day of their study drug, participants will have a follow-up visit that repeats the screening tests. - Participants will be contacted every 3 months after this visit.

NCT ID: NCT02305810 Completed - Clinical trials for Pancreatic Neuroendocrine Tumour Metastatic

A Biological Prospective Study in Patients With Metastatic Pancreatic NETs Treated With Everolimus

Start date: September 2013
Phase: Phase 2
Study type: Interventional

Everolimus represents an approved therapy for patients with advanced well/moderately differentiated pancreatic NETs. Although some patients could benefit from this drug in terms of long-term tumor growth control, others are resistant upfront or become resistant during treatment. Therefore, it is crucial to detect some biological factors which can help to identify the responsive tumors. Given that Everolimus is a biological agent and its mechanism of action can be partially directed towards angiogenesis its effects can be studied on different levels and with different methods. Upfront and early surrogate predictive markers of activity/efficacy can be studied on tumor tissue, tumor imaging, and peripheral blood. mTOR pathways alterations, circulating endothelial cells, and other circulating angoigenic factors will be correlated with clinical outcome. Tumor perfusion and circulating markers will be studied also as markers of response compared with the morphological imaging.

NCT ID: NCT02299089 Completed - Clinical trials for Neuroendocrine Tumors

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

Start date: January 2015
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label multicentre, randomised study to assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029 in adult patients with acromegaly or a functional, well-differentiated NET, with carcinoid symptoms.

NCT ID: NCT02288377 Terminated - Clinical trials for Metastatic/Locally Advanced, Non-resectable, Duodeno-pancreatic Neuroendocrine Tumours

A Study Evaluating Lanreotide as Maintenance Therapy in Patients With Non-Resectable Duodeno-Pancreatic Neuroendocrine Tumors (REMINET)

REMINET
Start date: January 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This European, prospective, multicentre, double-blind randomised study will evaluate the effect of lanreotide (120 mg every 28 days until disease progression) versus placebo in patients with metastatic/locally advanced, non-resectable, duodeno-pancreatic neuroendocrine tumours.

NCT ID: NCT02282059 Completed - Clinical trials for Pancreatic Neuroendocrine Tumors

The Safety And Efficacy Of Sunitinib In Chinese Patients With Progressive Advanced Or Metastatic Well-Differentiated Unresectable Pancreatic Neuroendocrine Tumors

Start date: December 12, 2014
Phase:
Study type: Observational

This study is a multi-center, prospective, non-interventional (NI) study evaluating the safety and efficacy of sunitinib in Chinese patients with progressive, unresectable, advanced or metastatic well-differentiated, pancreatic neuroendocrine tumors(pNET). 100 adults with progressive advanced or metastatic well-differentiated unresectable pNET will be recruited in China hospitals. Each subject will be followed up overall survival (OS) time or the date of withdrawal and subjects who remain alive after study completion will have their OS time censored on the last date known to be alive. Eligible subjects will be enrolled to receive at least one dose of sunitinib orally at 37.5 mg once a day on a continuous daily dosing regimen (CDD) or dosage modification is based on daily clinic practice. Subjects will be treated until disease progress, unacceptable toxicity, withdrawal from the study at their own request, or until the final analysis for the study is performed. The NI study will capture observations that will be used for evaluating the safety profile of sunitinib, including: subject demographics, medical history and medications. Safety assessments, treatment data and any other laboratory examination results, which were done according to routine clinical practice, will be collected at all visits.

NCT ID: NCT02279758 Recruiting - Clinical trials for Well-differentiated Neuroendocrine Tumors

A Pilot Study of Metformin Treatment in Patients With Well-differentiated Neuroendocrine Tumors

MetNet
Start date: March 2014
Phase: Phase 2
Study type: Interventional

Neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence. The Mammalian Target of Rapamycin (mTOR), one of most important area of research, has demonstrated be a therapeutic target in these tumors. The metformin has demonstrate in preclinical studies having an antineoplastic action by inhibiting the mTOR pathway, and may be an alternative treatment for this disease. Eligible patients for this study should have metastatic gastroenteropancreatic neuroendocrine tumors well differentiated (grade 1 or grade 2) and will be treated with metformin 850 mg every 12 hours, and each cycle will consist of 30 days. After 180 days of treatment the efficacy of metformin under the control of disease progression will be evaluated. As a secondary outcome the investigator will check the patient adherence to the treatment, the control of patient symptoms with functioning neuroendocrine tumor, and disease free survival. Also will be performed an analysis of immunohistochemical expression of mTOR pathway proteins of these patients.

NCT ID: NCT02279602 Completed - Clinical trials for Neuroendocrine Tumors

Rollover Protocol for Subjects Who Have Responded on Study 4218s - A Phase 2 Study

Start date: December 2014
Phase: Phase 2
Study type: Interventional

Subjects achieving a clinical response in study OX4218s with a biomarker reduction or symptom response are eligible to enroll in this rollover study to continue once every three weeks fosbretabulin infusions for up to one year.

NCT ID: NCT02273752 Terminated - Clinical trials for Stage IV Breast Cancer

Pharmacokinetically Guided Everolimus in Patients With Breast Cancer, Pancreatic Neuroendocrine Tumors, or Kidney Cancer

Start date: November 2014
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well real-time pharmacokinetic therapeutic drug monitoring works in preventing stomatitis from developing in patients with hormone receptor positive breast cancer, pancreatic neuroendocrine tumors, or kidney cancer that are receiving a type of cancer drug called everolimus. Stomatitis is a common side effect of everolimus that causes inflammation of the mouth, with or without oral ulcers, and frequently leads to patients discontinuing the medication. Monitoring the blood levels of everolimus and making adjustments in a patient's dose may be able to decrease the incidence of stomatitis, while maintaining the effectiveness of everolimus to treat the cancer.

NCT ID: NCT02270567 Enrolling by invitation - Clinical trials for Neuroendocrine Carcinoma

RegisterNET - A Registry for Neuroendocrine Tumors in the USA

RegisterNET
Start date: February 2015
Phase:
Study type: Observational [Patient Registry]

Neuroendocrine tumors are derived from the neuroendocrine system of the gastroenteropancreatic and bronchopulmonary tract systems. Treatment options include surgery, medical and ablative therapies as well as peptide-receptor radionuclide therapy. Survival is linked to early and accurate diagnoses or to the effective detection of disease recurrence and/or treatment failure. One challenge is to develop accurate non-invasive blood tests that can detect neuroendocrine tumor activity. A second challenge is to evaluate the effectiveness of molecular biomarkers in the natural history of this disease. RegisterNET registry aims at collecting data and blood samples from patients presenting with a NET in the USA. Data will be entered prospectively and anonymized after informed consent. All physicians who treat neuroendocrine tumor patients are invited to participate to the registry. Data will be evaluated within regular time frames, focusing on diagnostic accuracy for biomarkers in the different types and grades of tumors, treatment modalities and patient outcomes (e.g. disease recurrence and survival), thereby contributing to an understanding of the role of biomarkers in tumor management.