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NCT ID: NCT03321981 Completed - Clinical trials for Breast Cancer Metastatic

MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.

Start date: January 15, 2018
Phase: Phase 2
Study type: Interventional

A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2. MCLA-128 (zenocutuzumab) is given in combinations in two metastatic breast cancer (MBC) populations, Human Epidermal Growth Factor Receptor (HER) 2-positive/amplified (Cohort 1) and Estrogen Receptor-positive/low HER2 expression (Cohort2). Two combinations treatments will be evaluated in Cohort 1, the doublet and triplet. Initially zenocutuzumab is given in combination with trastuzumab in the doublet. After the safety of the doublet has been assessed in 4-6 patients, MCLA-128 is given in combination with trastuzumab and vinorelbine in the triplet, in parallel to the efficacy expansion of the doublet. The doublet and triplet combinations are both evaluated in two steps with an initial safety run-in followed by a cohort efficacy expansion. In total up to 40 patients evaluable for efficacy are included in both the doublet and triplet. In Cohort 2 zenocutuzumab is administered in combination with the same previous endocrine therapy on which progressive disease is radiologically documented. A total of up to 40 patients evaluable for efficacy are included in the Cohort 2.

NCT ID: NCT03321552 Active, not recruiting - Clinical trials for Critical Limb Ischemia

PROMISE International

Start date: December 15, 2017
Phase: N/A
Study type: Interventional

The objective of this post-market study is to evaluate the safety and effectiveness of the LimFlow System in creating a below-the-knee arterio-venous fistula for venous arterialization in subjects with critical limb ischemia.

NCT ID: NCT03321357 Completed - Clinical trials for Degenerative Disc Disease

Retest-reliability and At-home-assessment Feasibility of the 5R-STS

5RSTS-2
Start date: December 8, 2017
Phase:
Study type: Observational

The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine. The goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.

NCT ID: NCT03320616 Completed - Clinical trials for Hepatitis B, Chronic

EYP001a Food Effect Study in Subjects With Chronic Hepatitis B Virus (HBV) Infection

Start date: February 10, 2017
Phase: Phase 1
Study type: Interventional

The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B. This Phase 1 study is designed primarily to assess Pharmacokinetics (PK) under fed and fasted conditions, and to assess the safety, tolerability and Pharmacodynamics (PD) of single oral doses of EYP001a in subjects with chronic HBV infection.

NCT ID: NCT03320408 Completed - Clinical trials for Abdominal Aortic Aneurysm

Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers

PARIS
Start date: October 4, 2017
Phase:
Study type: Observational [Patient Registry]

First aim: PARIS study The main aim of the current study is to determine the association between abdominal aortic aneurysm (AAA) progression and the evolution of proteases and cytokines levels.To achieve this aim, we will prospectively collect blood, aortic tissue, patient data, and imaging data. Aortic tissue will only be obtained when patients undergo conventional open repair. The other biomaterials will be collected during regular patient follow-up visits, with a maximum frequency of once per year. Second aim: Pearl AAA biobank For future research purposes, a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank. This biobank will be embedded within the infrastructure of the 'Parelsnoer Institute' (PSI) and will be called Pearl AAA. The Pearl AAA will be established in the extension of the PARIS study

NCT ID: NCT03320265 Terminated - Clinical trials for Cardiovascular Diseases

Phosphorylcholine PC-mAb Effects in Subjects With Elevated Lipoprotein a

Start date: October 11, 2017
Phase: Phase 2
Study type: Interventional

Inflammation and abnormal amount of lipids in the blood are key factors for the development and progression of atherosclerosis (thickening of the artery wall) and cardiovascular disease. Lipoprotein (a) is a pro-inflammatory plasma lipoprotein that is believed to be a risk factor for cardiovascular diseases. Vascular inflammation generates a range of effects, including endothelial dysfunction and migration of white blood cells into the vessel wall, which results in increased risk of cardiovascular events. This study is designed to assess the effects of multiple monthly intravenous infusions with the fully human antibody called PC-mAb, in subjects with elevated lipoprotein (a).

NCT ID: NCT03320252 Recruiting - Clinical trials for AAA - Abdominal Aortic Aneurysm

Endurant CHevAr New Indication Trial: ENCHANT

ENCHANT
Start date: October 26, 2017
Phase:
Study type: Observational

The purpose of the post-market study is to assess the clinical outcomes, safety, and performance of the Endurant Chimney Graft Technique (Endurant Stent Graft Systems used with a balloon-expandable covered stent graft) for treatment of juxtarenal aortic aneurysms with a short infrarenal neck in a real world setting.

NCT ID: NCT03319940 Recruiting - Clinical trials for Small Cell Lung Carcinoma

Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Tarlatamab in Adults With Small Cell Lung Cancer (SCLC)

Start date: December 26, 2017
Phase: Phase 1
Study type: Interventional

A study to assess the safety, tolerability, and PK of tarlatamab in participants with SCLC

NCT ID: NCT03319641 Completed - Clinical trials for Adenoid Cystic Carcinoma

PSMA-PET Imaging for Advanced ACC/SDC

Start date: October 25, 2017
Phase: N/A
Study type: Interventional

Diagnostic study which evaluates the level of PSMA expression in patients with locally advanced, recurrent and/or metastatic ACC/SDC of ≥18 years old with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy

NCT ID: NCT03318939 Terminated - NSCLC Clinical Trials

Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

Start date: October 13, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).