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Набира участници Фаза 1

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

Начало: 09.03.2021 Край: 30.06.2027 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +16 AstraZeneca NCT04686305

Набира участници

Cancer Predisposition Testing by Family-based Whole-genome Sequencing (WGS) in Every Child With Newly Diagnosed Cancer

Neoplastic Syndromes, Hereditary Cancer Genetic Predisposition to Disease

Assessment of the utility of family-based (trio) whole-genome sequencing for cancer predisposition testing in sequential newly diagnosed paediatric and adolescent cancer patients

Начало: 08.03.2021 Край: 15.06.2028 Възраст: до 21 г.

Australia Sydney Children's Hospitals Network NCT04903782

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TAS Test: Online Motor-cognitive Tests for Early Detection of Alzheimer's Disease

Alzheimer Disease Dementia Age-related Cognitive Decline

Global dementia prevalence is rising. Alzheimer's disease (AD), the most common cause, has devastating effects on people's quality of life. AD has a preclinical (pre-AD) period of 10-20 years when brain pathology silently progresses before any cognitive symptoms appear. Current tests for pre-AD are invasive, costly and unsuitable for screening at population level. Similar to screening for pre-diabetes and carcinoma in situ, it is important to detect AD at the preclinical stage in order to offer early interventions before the pathology progresses to the irrerversible degenerative stage. In the study, research will develop a new scalable test (TAS Test) by combining two innovative ideas: hand-movement tests to detect pre-AD \>10 years before cognitive symptoms begin; and computer vision so people can "self-test" online using home computers. This unique approach builds on recent discoveries that hand-movement patterns change in pre-AD. The research team will use exquisitely precise computer vision methods to automatically analyse movement data from thousands of participants, and combine this with machine learning of overall motor-cognitive performance. The project team has access to 3 well-phenotyped cohorts, \>10,000 existing participants and a cutting-edge assay for a blood AD biomarker, ptau181. The research team will develop a TAS Test algorithm to classify hand-movement and cognitive test data for pre-AD risk (p-taua181 levels) and determine TAS Test's precision to prospectively predict 5-year risks of cognitive decline and AD.

Начало: 05.03.2021 Край: 01.12.2030 Възраст: от 50 г.

Australia University of Tasmania NCT05194787

Набира участници Фаза 1

A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma

B-cell Non Hodgkin Lymphoma Diffuse Large B Cell Lymphoma High-grade B-cell Lymphoma Follicular Lymphoma

This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma (B-NHL).

Начало: 02.03.2021 Край: 19.04.2028 Възраст: 18–130 г. Лечение

Australia, Japan, South Korea +2 AstraZeneca NCT04594642

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International CDKL5 Clinical Research Network

CDKL5 CDKL5 Deficiency Disorder CDD

Pathogenic variants in the Cyclin-dependent kinase like 5 (CDKL5) gene cause CDKL5 deficiency disorder (CDD, MIM 300672, 105830), a severe developmental and epileptic encephalopathy associated with cognitive and motor impairments and cortical visual impairment. While capability for disease modifying therapies is accelerating, there is a critical barrier for clinical trial readiness that may result in failure of these therapies, not due to lack of efficacy but due to lack of validated outcome measures and biomarkers. The measures and biomarkers validated here will be adaptable to other developmental and epileptic encephalopathies.

Начало: 15.02.2021 Край: 15.02.2027 Възраст: 1–100 г.

Australia, United States University of Colorado, Denver NCT05558371

Набира участници Фаза 2

Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease

Parkinson Disease Mild Cognitive Impairment Memory Impairment

The present study is a proof-of-concept clinical trial to test the efficacy of low doses of a repurposed anti-epileptic drug (levetiracetam) in treating memory problems in Parkinson's disease (PD). Neuroimaging techniques will be used to determine the effect of the drug on specific brain regions (hippocampal subfields). Finally, baseline brain activity of PD patients with memory problems will be compared to PD patients without memory problems and healthy older adults to determine if activity in specific brain regions (hippocampal subfields) can be used to predict memory problems in PD. This information will be useful for future clinical trials to target drugs to these brain regions.

Начало: 09.02.2021 Край: 01.12.2025 Лечение

Australia The University of Queensland NCT04643327

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ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND)

Acute Respiratory Distress Syndrome Extracorporeal Membrane Oxygenation

ASCEND researchers are partnering with families of children who receive extracorporeal membrane oxygenation (ECMO) after a sudden failure of breathing named pediatric acute respiratory distress syndrome (PARDS). ECMO is a life support technology that uses an artificial lung outside of the body to do the lung's work. ASCEND has two objectives. The first objective is to learn more about children's abilities and quality of life among ECMO-supported children in the year after they leave the pediatric intensive care unit. The second objective is to compare short and long-term patient outcomes in two groups of children: one group managed with a mechanical ventilation protocol that reserves the use of extracorporeal membrane oxygenation (ECMO) until protocol failure to another group supported on ECMO per usual care.

Начало: 04.02.2021 Край: 30.09.2027 Възраст: 14–20 г.

Australia, Canada, Chile +8 University of Michigan NCT05388708

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Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression

Age Related Macular Degeneration Geographic Atrophy AMD Age-related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss worldwide, and nearly two million Australians have some signs of AMD. This proposed project is a prospective, observational study that seeks to to understand the underlying aetiology of AMD, factors associated with differences between age-related macular degeneration (AMD) phenotypes or severities, or between AMD and healthy individuals. It also seeks to understand the natural history of AMD progression and the factors associated with the rate of progression. In this project, the disease phenotype, genotype and severity and rate of progression will be determined based on non-invasive clinical imaging or functional assessment of the retina, from obtaining biological samples from the participants, or from patient-reported outcomes.

Начало: 02.02.2021 Край: 01.11.2040 Възраст: от 18 г.

Australia Center for Eye Research Australia NCT04739319

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SCAD : a Registry of Spontaneous Coronary Artery Dissection

Spontaneous Coronary Artery Dissection

Spontaneous coronary artery dissection (SCAD) is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes (ACS), predominantly afflicting young women without conventional atherosclerotic risk factors. Knowledge of SCAD has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6. Like all rarer diseases however, a better understanding of SCAD will require international collaboration. At present, there is no European or International SCAD registry despite increasing recognition that there are key differences in the diagnosis, interventional and medical management of SCAD compared with conventional atherosclerotic ACS. The ESC-ACCA Study Group on Spontaneous Coronary Artery Dissection supported by the European Observational Research Programme will now build the first pan-European SCAD registry to advance our understanding of current management of this condition, inform guidelines, educate clinical colleagues and advance research.

Начало: 30.01.2021 Край: 01.10.2027 Възраст: от 18 г.

Argentina, Austria, Belgium +19 European Society of Cardiology NCT06601270

Набира участници Фаза 1/2

Isatuximab in Combination With Novel Agents in RRMM - Master Protocol

Plasma Cell Myeloma Refractory

The purpose of this umbrella study is to evaluate isatuximab when combined with novel agents with or without dexamethasone in participants with relapsed or refractory myeloma. Substudy 01 is the control Substudy. Substudies 02, 03, and 06 are controlled experimental substudies. Substudies 04 and 05 are independent experimental substudies.

Начало: 25.01.2021 Край: 20.04.2028 Възраст: от 18 г. Лечение

Australia, France, Germany +8 Sanofi NCT04643002

Набира участници Фаза 3

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

Retroperitoneal Sarcoma Liposarcoma Leiomyosarcoma

This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

Начало: 20.01.2021 Край: 21.04.2028 Възраст: от 18 г. Лечение

Australia, Canada, Cyprus +11 European Organisation for Research and Treatment of Can NCT04031677

Набира участници Фаза 3

Sentinel Node Biopsy in Endometrial Cancer

Endometrial Cancer Stage I Sentinel Lymph Node Surgery

Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \& similar to a lymph node dissection, the value to patients, cost effectiveness \& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients. Primary Outcome Stage 1: Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities. Primary Outcome Stage 2: Treatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and/or histological results.

Начало: 18.01.2021 Край: 01.02.2031 Възраст: от 18 г. Лечение

Argentina, Australia, Brazil +4 Queensland Centre for Gynaecological Cancer NCT04073706

Набира участници Фаза 2/3

A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

Unresectable Head and Neck Squamous Cell Carcinoma Metastatic Head and Neck Cancer Recurrent Head and Neck Cancer

An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand-1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, is an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, is a randomized part to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Patients included in the Safety Run-In Phase of the trial (Part A) will not be randomized to Part B and will continue on-trial treatment (BNT113 plus pembrolizumab) within Part A. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial. Patients will be treated with BNT113 in combination with pembrolizumab or with pembrolizumab monotherapy for approximately up to 24 months.

Начало: 07.01.2021 Край: 01.04.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +18 BioNTech SE NCT04534205

Набира участници Фаза 2

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Down Syndrome Recurrent B Acute Lymphoblastic Leukemia

This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.

Начало: 17.12.2020 Край: 30.06.2028 Възраст: 1–30 г. Лечение

Australia, Canada, Puerto Rico +1 National Cancer Institute (NCI) NCT04546399

Набира участници

Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain

Chronic Pain

The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.

Начало: 15.12.2020 Край: 01.01.2027 Възраст: от 18 г. Лечение

Australia Saluda Medical Pty Ltd NCT04662905

Набира участници Фаза 1

FS222 First in Human Study in Patients With Advanced Malignancies

Advanced Cancer Metastatic Cancer

This study will be conducted in adult participants diagnosed with advanced tumours to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS222. This is a Phase 1, multi-center, open label, multiple-dose, first in human study, designed to systematically assess safety and tolerability, and to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS222 in participants with advanced tumours. Pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Начало: 14.12.2020 Край: 30.10.2027 Възраст: от 18 г. Лечение

Australia, Georgia, Germany +4 invoX Pharma Limited NCT04740424

Набира участници Фаза 2/3

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Advanced Non-Small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer

The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.

Начало: 02.12.2020 Край: 31.10.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +40 Mirati Therapeutics Inc. NCT04613596

Набира участници

Resorbable Magnesium Scaffolds Registry

Coronary Artery Disease

The registry follows the ESC/EACTS guideline and further investigates the clinical performance and short-term safety of RMS (Resorbable Magnesium Scaffolds) in a real world setting within the scope of its intended use without further (medical related) exclusion criteria according to their respective instructions for use (IFU).

Начало: 18.11.2020 Край: 01.05.2030 Възраст: от 18 г.

Australia, Germany, Italy +4 Biotronik AG NCT04679740

Набира участници Фаза 2

Study of PF-07248144 in Advanced or Metastatic Solid Tumors

Locally Advanced or Metastatic ER+ HER2- Breast Cancer Locally Advanced or Metastatic Castration-resistant Prostate Cancer Locally Advanced or Metastatic Non-small Cell Lung Cancer

This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with other agents

Начало: 16.11.2020 Край: 10.08.2029 Възраст: от 18 г. Лечение

Australia, China, Japan +2 Pfizer NCT04606446

Набира участници

Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment

Intra Cerebral Hemorrhage Stroke

A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus standard care within 8 hours of intracerebral hemorrhage. Patients presenting to the emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage \>20mL volume will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomized 50:50 using central computerized allocation to minimally invasive hematoma evacuation using the Aurora surgiscope and evacuator (Integra Lifesciences) versus standard medical therapy. The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design with seamless phase 2b-3 transition if the intermediate endpoint (successful hematoma evacuation) is met in analysis of the first 52 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 160 patients have completed 6 month follow-up (minimum sample size 240, maximum sample size 434).

Начало: 15.11.2020 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia University of Melbourne NCT04434807

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