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NCT ID: NCT03192345 Terminated - Clinical trials for Malignant Solid Tumor

A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors

Start date: June 9, 2017
Phase: Phase 1
Study type: Interventional

Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) - To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and cemiplimab combination therapy) - To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors. Dose expansion (Part 2) Part 2A (SAR439459 monotherapy) - To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1. Part 2B (SAR439459 and cemiplimab combination therapy) - To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). Secondary Objectives: - Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459. - Immunogenicity of SAR439459 monotherapy and combined with cemiplimab. Dose escalation (Part 1) - Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab. - Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab. Dose expansion (Part 2) - Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab. - To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.

NCT ID: NCT03187522 Terminated - Clinical trials for Aortic Aneurysm, Abdominal

An European Union (EU) Post-Approval Registry of the TREO® Stent-Graft

Start date: June 22, 2017
Phase: N/A
Study type: Interventional

This is an EU sponsored trial and independent of the US trial registered under Clinicaltrials.gov ID NCT02009644. The purpose of this registry is to gather clinical data on the safety and performance of the TREO Stent-Graft in patients with infrarenal abdominal aortic aneurysms. The registry is part of TREO's EU post-market surveillance plan providing long-term systematic clinical follow-up.

NCT ID: NCT03186560 Terminated - Leg Ulcer Clinical Trials

Speckle Study: In Arterial, Mixed and Diabetic Foot Ulcers

Start date: February 12, 2018
Phase: N/A
Study type: Interventional

This is a single centre open label study measuring microcirculatory flux using Speckle imaging Device. Microcirculation will be measured using laser speckle contrast imaging, at baseline and with the device active for 30 minutes in the wound, peri-wound and other point on the lower leg. The same procedure will be done on all the different patient groups. Temperature variations can be assessed using Infrared Temperature Scanner (Exergen DermaTemp DT1001), a measurement will be taken at baseline, and then at 5 minutes interval during the 30 minutes activity of the device.

NCT ID: NCT03184584 Terminated - Alström Syndrome Clinical Trials

Open-Label Rollover Study of PBI 4050 in Subjects With Alström Syndrome

Start date: October 9, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Phase 2, open-label, single-arm, multi-centre study evaluating the long term safety and tolerability of PBI-4050 in subjects with Alström Syndrome who have completed a preceding ProMetic-sponsored Alström Syndrome study with PBI-4050.

NCT ID: NCT03184558 Terminated - Clinical trials for Triple Negative Breast Cancer

Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With TNBC

Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

This is an open label, single arm, multi-centre phase II study to assess the anti-tumour activity and safety of bemcentinib (BGB324) in combination with pembrolizumab in participants with previously treated, locally advanced and unresectable, or metastatic TNBC or TN-IBC. The primary objective is objective response rate.

NCT ID: NCT03182257 Terminated - Solid Tumor Clinical Trials

Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors

ONTRK
Start date: July 12, 2017
Phase: Phase 1
Study type: Interventional

This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid tumors harboring NTRK gene fusions.

NCT ID: NCT03177187 Terminated - Clinical trials for Metastatic Castration Resistant Prostate Cancer

Combination Study of AZD5069 and Enzalutamide.

ACE
Start date: November 13, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

ACE is a multi-centre proof of concept Phase I/II trial of the CXCR2 antagonist AZD5069, administered in combination with enzalutamide, in patients with metastatic castration resistant prostate cancer(mCRPC). The investigators will be investigating the safety and toxicity of the combination.

NCT ID: NCT03176264 Terminated - Clinical trials for Metastatic Colorectal Cancer

PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

Start date: September 25, 2017
Phase: Phase 1
Study type: Interventional

This was a phase Ib study of PDR001 in combination with bevacizumab and mFOLFOX6 as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The study was to have assessed primarily, the safety and tolerability and then the efficacy of PDR001 in combination with bevacizumab and mFOLFOX6. Particular attention would have been paid to the level of activity of study drug combinations in CMS4 patients (retrospective analysis). The study was terminated early due to company decision.

NCT ID: NCT03174522 Terminated - Clinical trials for Diabetes Mellitus, Type 2

The Efficacy and Safety of REX-001 to Treat Ischemic Ulcers in Subjects With CLI Rutherford Category 5 and DM

Start date: April 25, 2017
Phase: Phase 3
Study type: Interventional

This trial is a pivotal, placebo-controlled, double-blind, parallel-group, adaptive trial conducted in subjects with DM and CLI Rutherford Category 5. Minimisation will be used to assign eligible subjects in a 2:1 ratio to receive a single intra-arterial administration of REX-001 or matching placebo into the index limb.

NCT ID: NCT03168490 Terminated - Celiac Disease Clinical Trials

In Vivo Effects of the Gluten Friendly Bread in Coeliac Disease

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

In the last two decades, a series of epidemiological studies have shown a particular increase in Coeliac Disease (CD), a life-long intolerance to gluten proteins (the seed storage proteins) present in most cereals (wheat, barley and rye) both in the United States and Europe, and in developing countries. In these subjects, the consumption of cereals containing gluten causes a chronic inflammatory process leading to lesions in the small intestine and a dysfunction in nutrient absorption.The only current treatment for CD is a strict lifelong gluten-free diet. In most cases (some people do not respond) this dietary regimen guarantees the full recovery of small intestine architecture and functions, though for many patients the gluten-free diet is highly restrictive, especially for social events and during travelling. In addition, this dietary therapy has often low content of vitamins and ions, such as vitamins B and calcium, iron, zinc and magnesium, as well as fibre. Furthermore, one of the major risks is to develop obesity and diseases related to metabolic syndrome. Recently a new and innovative detoxification method has been developed with the purpose to overcome the disadvantages of the prior methods. The method is based on the application of microwave energy for few seconds to hydrated wheat kernels; the treatment induces modifications to endosperm components which dramatically reduce the immunogenicity of the most common epitopes involved in coeliac disease, without compromising the technological properties necessary to process flour into bread, pasta and other baked goods. The method is based on the analysis of recent studies that have reported, when high temperatures are applied to the caryopsis of wheat, the protein polymers present in the pasta produced with these "baked grain" present a size distribution pattern that is not observed in pasta during the drying cycles. The researchers Lamacchia and others explained this phenomenon on the basis of the fact that in the caryopsis of wheat, gluten is not yet formed and gluten proteins are deposited in different protein bodies.