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Recruiting

Heart Attack Research Program: Platelet Sub-Study (HARP)

Myocardial Infarction

This prospective observational cohort study, will investigate the platelet phenotype, platelet genetic composition, and role of platelets as effector cells in women and men with myocardial infarction (MINOCA or MI-CAD) and controls. This study, which will take place at NYU and Bellevue Medical Center, and participating external sites. May have concurrent enrollment with the HARP Main Imaging (NCT02914483). Additionally, a sex, group of age and race matched disease controls 'CATH-NOCA' composed of women and men with stable angina referred for cardiac catheterization, will be enrolled. Blood obtained during the initial catheterization and 2 months post-MI will be utilized for platelet testing.

Начало: 01.07.2020 Край: 30.06.2027 Възраст: 21–99 г.

United States NYU Langone Health NCT03022552

Recruiting Phase 3

Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])

Lung Non-Small Cell Carcinoma Lung Non-Small Cell Squamous Carcinoma Lung Non-Squamous Non-Small Cell Carcinoma Stage II Lung Cancer AJCC v8 +2

This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.

Начало: 16.06.2020 Край: 31.01.2027 Възраст: от 18 г.

Guam, United States National Cancer Institute (NCI) NCT04267848

Recruiting Phase 2/3

HEALEY ALS Platform Trial - Master Protocol

Amyotrophic Lateral Sclerosis

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.

Начало: 14.06.2020 Край: 01.08.2028 Възраст: от 18 г.

United States Merit E. Cudkowicz, MD NCT04297683

Recruiting Phase 3

Statins In Intracerbral Hemorrhage

Intracerebral Hemorrhage

The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype. An MRI ancillary study (SATURN MRI), in a subset of SATURN participants , will evaluate the effects of continuation vs. discontinuation of statin drugs on hemorrhagic and ischemic MRI markers of cerebral small vessel disease, and whether the presence/burden of hemorrhagic markers (i.e. cerebral microbleeds and/or cortical superficial siderosis) on baseline MRI influences the risk of ICH recurrence on/off statin therapy.

Начало: 10.06.2020 Край: 01.12.2029 Възраст: от 50 г.

United States Beth Israel Deaconess Medical Center NCT03936361

Recruiting

International CIPN Assessment and Validation Study

Chemotherapy-induced Peripheral Neuropathy Quality of Life

This is an observational study of chemotherapy-induced peripheral neurotoxicity (CIPN) patients to be investigated prospectively in order to assess responsiveness of a set of outcome measures in an international multi-center study.

Начало: 08.06.2020 Край: 31.12.2025 Възраст: от 18 г.

Australia, Bangladesh, Brazil +11 University of Milano Bicocca NCT04633655

Recruiting Phase 1

A Study of Sigvotatug Vedotin in Advanced Solid Tumors

Carcinoma, Non-Small Cell Lung Squamous Cell Carcinoma of Head and Neck HER2 Negative Breast Neoplasms Esophageal Squamous Cell Carcinoma +8

This trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.

Начало: 08.06.2020 Край: 22.03.2029 Възраст: от 18 г.

France, South Korea, Spain +4 Seagen, a wholly owned subsidiary of Pfizer NCT04389632

Recruiting Phase 2

Natural History and Management of Von Hippel-Lindau (VHL) Associated Pancreatic Neuroendocrine Tumors

VHL Pancreatic Neuroendocrine Tumors Von Hippel-Lindau Disease Neuroendocrine Tumors

Background: People with von Hippel-Lindau (VHL) can have problems with a variety of organs, such as the pancreas. The disease can cause tumors of the pancreas. This can result in life-threatening complications. Researchers want to learn more about these pancreatic tumors and how to better detect them. This may help them design better future treatment and care for people with VHL disease. Objective: To better understand VHL disease that affects the pancreas and to test whether adding a certain type of scan (68-Gallium DOTATATE PET/CT) can further detect tumors. Eligibility: People ages 12 and older with VHL that causes tumors and cysts to grow in the pancreas Design: Participants will be screened with their medical records and imaging studies. Participants will have an initial evaluation: Participants will have their body examined by different doctors. This will depend on what types of symptoms they have. Participants will have blood and urine tests Participants will have images made of their body using one or more machines: They made have a CT or PET/CT scan in which they lie on a table that moves through a big ring. They may have an MRI in which they lie on a table that moves into a big tube. They may have an ultrasound that uses a small stick that produces sound waves to look at the body. After the first visit, participants will be asked to return to the NIH. Some of the tests performed at the first visit will be repeated. Depending on their disease status, visits will be once a year or every 2 years for life.

Начало: 02.06.2020 Край: 01.07.2036 Възраст: от 12 г.

United States National Cancer Institute (NCI) NCT04074135

Recruiting Phase 1

Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors

Head and Neck Squamous Cell Carcinoma Squamous Cell Carcinoma of Anal Canal Colorectal Cancer Squamous Cell Carcinoma of the Lung +7

The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.

Начало: 01.06.2020 Край: 01.06.2027 Възраст: от 18 г. Treatment

Australia, Canada, United States Bicara Therapeutics NCT04429542

Recruiting Phase 1/2

Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Acute Myeloid Leukemia Blasts More Than 10 Percent of Bone Marrow Nucleated Cells High Risk Myelodysplastic Syndrome Recurrent Acute Myeloid Leukemia +3

This phase I/II trial studies the side effects and best dose of CPX-351 in combination with quizartinib for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351, composed of chemotherapy drugs daunorubicin and cytarabine, works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control acute myeloid leukemia and myelodysplastic syndrome.

Начало: 27.05.2020 Край: 31.12.2027 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT04128748

Recruiting Phase 1/2

INFORM2 Study Uses Nivolumab and Entinostat in Children and Adolescents With High-risk Refractory Malignancies

CNS Tumor Solid Tumor

The aim of this trial is to determine preliminary activity of the combination treatment with nivolumab and entinostat in children and adolescents with high risk refractory/relapsed/progressive tumors harboring a high mutational load, focal MYC(N) amplification or ATRT-MYC subgroup as well as tumors with high tumor infiltrating lymphocytes (TILs) or a tertiary lymphoid structure (TLS).

Начало: 26.05.2020 Край: 30.06.2027 Възраст: 2–21 г. Treatment

Australia, France, Germany +2 University Hospital Heidelberg NCT03838042

Recruiting Phase 2

Lutathera for the Treatment of Inoperable, Progressive Meningioma After External Beam Radiation Therapy

Grade 1 Meningioma Grade 2 Meningioma Grade 3 Meningioma Recurrent Meningioma +1

This phase II trial studies how well lutathera works in treating patients with meningioma that cannot be treated with surgery (inoperable) and is growing, spreading, or getting worse (progressive) after external beam radiation therapy. Lutathera is a radioactive drug administered in the vein that is designed to target and kill tumor cells. The goal of this study is to determine whether this drug is safe and effective in treating meningiomas that progress after radiation treatment. WHO Grade I and Cohort WHO II/III cohorts will be evaluated.

Начало: 14.04.2020 Край: 04.03.2032 Възраст: от 18 г.

United States Mayo Clinic NCT04082520

Recruiting

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.

Начало: 03.04.2020 Край: 31.03.2030

Argentina, Australia, Belgium +20 Bayer NCT04142437

Recruiting Phase 1/2

rTMS to Improve Cognition in Parkinson's

Parkinson's Disease Mild Cognitive Impairment

The purpose of this study is to examine safety, feasibility, and the behavioral and brain effects of a non-invasive treatment, repetitive transcranial magnetic stimulation (rTMS), for Veterans with Parkinson's disease or atypical parkinsonism and mild impairments in their thinking. The hypothesis is that rTMS can improve thinking for people with Parkinson's disease or atypical parkinsonism who are experiencing mild problems with their thinking ability.

Начало: 01.04.2020 Край: 30.03.2028 Възраст: от 50 г.

United States VA Office of Research and Development NCT03836950

Recruiting Phase 2

A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg

Sarcoma Myxofibrosarcoma Undifferentiated Pleomorphic Sarcoma Alveolar Soft Part Sarcoma

The purpose of this study is to find out whether giving the study drug pembrolizumab in combination with the chemotherapy drugs melphalan and dactinomycin, delivered directly to the affected arm or leg using a technique called isolated limb infusion (ILI), is a safe treatment that can delay the time before your disease gets worse (progresses).

Начало: 01.04.2020 Край: 01.04.2027 Възраст: от 12 г.

United States Memorial Sloan Kettering Cancer Center NCT04332874

Recruiting Phase 3

Randomised Evaluation of COVID-19 Therapy

Pneumonia

RECOVERY is a randomised trial of treatments to prevent death in patients hospitalised with pneumonia. The treatments being investigated are: COVID-19: Lopinavir-Ritonavir, Hydroxychloroquine, Corticosteroids, Azithromycin, Colchicine, IV Immunoglobulin (children only), Convalescent plasma, Casirivimab+Imdevimab, Tocilizumab, Aspirin, Baricitinib, Empagliflozin, Sotrovimab, Molnupiravir, Paxlovid or Anakinra (children only) Influenza: Baloxavir marboxil, Oseltamivir, Corticosteroids (dexamethasone) Community-acquired pneumonia: Corticosteroids (dexamethasone)

Начало: 19.03.2020 Край: 30.09.2038

Belgium, Estonia, France +13 University of Oxford NCT04381936

Recruiting Phase 1/2

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

Locally Advanced Solid Tumors Metastatic Solid Tumors Lymphoma Primary CNS Tumors

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.

Начало: 12.03.2020 Край: 30.09.2027 Възраст: до 25 г. Treatment

Australia, Canada, Denmark +8 Turning Point Therapeutics, Inc. NCT04094610

Recruiting

The Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis Study

Aortic Stenosis

Aortic stenosis (AS) affects approximately 5% of individuals \>65 years old, with \~3% of people \>75 years having moderate to severe disease. The prevalence of AS is rising rapidly due to an ageing population and is projected to double in the next two decades. Increasingly clinicians face the dilemma of how to best manage this growing population of mainly elderly patients, many of whom are asymptomatic but have been identified as having severe AS, often as an incidental finding. Reduced aortic valve opening progresses over decades without any apparent symptoms because the heart compensates for the AS. Ultimately, compensatory mechanisms fail resulting in angina, syncope or heart failure. If these symptomatic patients with severe AS remain untreated, they have a dire prognosis. In this situation the only effective treatment is AVR, either surgically or using TAVI. Conversely, conventional teaching and clinical practice in cardiology has been that, in the absence of symptoms, the prognosis is usually excellent and, except in a few very specific circumstances, conservative management and regular review (expectant management) is recommended. This advice is reflected in current international guidelines but is based largely on historical precedent. There has never been a randomised controlled trial to address the relative benefits of early AVR versus expectant management in patients with severe asymptomatic AS. The relative benefits of a strategy of early AVR/TAVI versus expectant management in patients with asymptomatic severe AS are unclear. There is clinical equipoise but it remains one of the few areas of cardiovascular medicine where no randomised controlled trials (RCT) have been performed. The EASY-AS study will provide crucial data on the relative merits of these differing approaches to management, in terms of important patient orientated outcomes, conventional cardiovascular end-points and cost effectiveness.

Начало: 10.03.2020 Край: 01.04.2031 Възраст: от 18 г. Prevention

Australia, Belgium, Netherlands +4 University of Leicester NCT04204915

Recruiting Phase 1

Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer

Prostate Cancer

The overall aim of the trial is to evaluate the safety, tolerability, and pharmacokinetics (PK) of AMG 509 (monotherapy and in combination with abiraterone acetate and enzalutamide) and to evaluate preliminary efficacy. As of Protocol Amendment 10 (09 July 2025), only Parts 4A expansion, 6, and 7 are open to accrual.

Начало: 04.03.2020 Край: 21.03.2032 Възраст: от 18 г. Treatment

Australia, China, Germany +7 Amgen NCT04221542

Recruiting Phase 1

Study of APG-2575 as a Single Agent or in Combination With Other Therapeutic Agents for CLL/SLL

CLL/SLL

Assess the safety and tolerability, identify dose-limiting toxicities (DLT) and determine the maximum tolerated dose (MTD) / recommended phase 2 dose (RP2D) of lisaftoclax.

Начало: 02.03.2020 Край: 30.06.2027 Възраст: 18–85 г. Treatment

Australia, United States Ascentage Pharma Group Inc. NCT04215809

Recruiting Phase 2/3

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Pulmonary Disease Due to Mycobacteria (Diagnosis)

Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.

Начало: 02.03.2020 Край: 30.06.2030 Treatment

Australia, Denmark, Israel +4 The University of Queensland NCT04310930

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