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Neuroendocrine Tumors clinical trials

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NCT ID: NCT02943733 Terminated - Cancer Clinical Trials

Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs

Start date: August 22, 2017
Phase: Phase 1
Study type: Interventional

The goal of this study is to establish maximum tolerated doses/recommended phase 2 dose (RP2D) of temozolomide (TMZ) and TAS-102 when these agents are used in combination and to evaluate the safety profile of this drug combination.

NCT ID: NCT02859064 Terminated - Clinical trials for Neuroendocrine Tumors

Study of Lanreotide in Patients With Metastatic Gastrointestinal Neuroendocrine Tumors Who Are Undergoing Liver-directed Radioembolization With Yttrium-90 Microspheres

Start date: July 28, 2017
Phase: Phase 2
Study type: Interventional

Neuroendocrine tumors (NETs) and cancers that originate from the gastrointestinal tract can be resistant to standard chemotherapy and often metastasize to the liver. Lanreotide (Somatuline® Depot) Injection and Yttrium-90 microspheres (SIR-Spheres®) each have FDA approval to treat patients with metastatic NETs. The purpose of this study is to determine if treatment for patients with NETs can be optimized by combining these therapies.

NCT ID: NCT02788578 Terminated - Clinical trials for Neuroendocrine Tumours

A Retrospective Data Analysis of Therapy With PRRT Combined With Lanreotide Autogel® for Neuroendocrine Tumours

PRELUDE
Start date: June 2016
Phase:
Study type: Observational

The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG) combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive neuroendocrine tumours located in the lung or in the digestive system as there is currently limited data on these treatments used together for these types of neuroendocrine tumours.

NCT ID: NCT02683941 Terminated - Clinical trials for Neuroendocrine Tumors in Lung

Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours

SPINET
Start date: March 6, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs. This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period. The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours. Recent updates of National Cancer Institute Cancer Network (NCCN) & European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond 'observation' leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5. The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs.

NCT ID: NCT02592707 Terminated - Clinical trials for Neuroendocrine Tumors

Study to Evaluate the Safety and Preliminary Efficacy of 177Lu-OPS201 in NETs

Start date: March 6, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this clinical phase I/II study was to investigate the safety and tolerability of satoreotide tetraxetan (177Lu-IPN01072, formerly known as 177Lu-OPS201) used for the treatment of patients with neuroendocrine tumors (NETs). The secondary objectives of this study were the assessment of biodistribution, dosimetry and preliminary efficacy of satoreotide tetraxetan.

NCT ID: NCT02465112 Terminated - Liver Metastases Clinical Trials

Metabolic Radiotherapy After Complete Resection of Liver Metastases in Patient With Digestive Neuroendocrine Tumor

TERAVECT
Start date: September 2015
Phase: Phase 3
Study type: Interventional

TERAVECT is a phase III randomized study of patients with digestive neuroendocrine tumors after complete surgical resection of liver metastases treated with In111-Pentetreotide-based adjuvant radiotherapy. In this study, targeted radionuclide therapy is used at an earlier stage of the disease.The objective is to target residual tumor cells and/or micrometastases which escaped surgical resection. Given the poor prognosis associated with recurrence, this treatment should prevent relapse.

NCT ID: NCT02359500 Terminated - Clinical trials for Neuroendocrine Tumors

68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs)

Start date: December 2014
Phase: Phase 1
Study type: Interventional

This study plans to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of response to treatment in patients with Somatostatin receptor expressing tumors who undergo imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors. 68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either at staging or during follow up.

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: 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: 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.