Search trials – HealthDB

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Active (not recruiting) Phase 3

Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection

Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III

This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.

Начало: 29.07.2019 Край: 01.01.2027 Възраст: от 18 г.

United States Alliance for Clinical Trials in Oncology NCT03927027

Active (not recruiting) Phase 3

A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B

Hemophilia B

This study will evaluate the efficacy and safety of PF-06838435 (a gene therapy drug) in adult male participants with moderately severe to severe hemophilia B (participants that have a Factor IX circulating activity of 2% or less). The gene therapy is designed to introduce genetic material into cells to compensate for missing or non-functioning Factor IX. Eligible study participants will have completed a minimum 6 months of routine Factor IX prophylaxis therapy during the lead in study (C0371004). Participants will be dosed once (intravenously) and will be evaluated over the course of 6 years. The main objective of the study will evaluate the annualized bleeding rate \[ABR\] for participants treated with gene therapy versus standard of care (SOC) therapy (FIX prophylaxis replacement regimen).

Начало: 29.07.2019 Край: 25.02.2031 Възраст: 18–65 г. Treatment

Australia, Brazil, Canada +13 Pfizer NCT03861273

Active (not recruiting) Phase 3

Study of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease Patients

Sickle Cell Disease (SCD)

The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.

Начало: 26.07.2019 Край: 23.11.2026 Възраст: 12–100 г.

Belgium, Brazil, Canada +18 Novartis Pharmaceuticals NCT03814746

Active (not recruiting) Phase 2

Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Non Small Cell Lung Cancer EGFR Gene Mutation Advanced Cancer Metastatic Cancer

The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.

Начало: 25.07.2019 Край: 01.01.2027 Възраст: от 18 г.

United States Xiuning Le NCT03909334

Active (not recruiting)

A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer

Gynecologic Cancer Cervical Cancer

This research is studying the level of oxygen in tumors during the brachytherapy procedure.

Начало: 16.07.2019 Край: 15.12.2026 Възраст: от 18 г.

United States Brigham and Women's Hospital NCT03970083

Active (not recruiting) Phase 2

Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer

Stage III Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer +5

This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer.

Начало: 08.07.2019 Край: 31.01.2027 Възраст: от 18 г.

United States Laura Huppert, MD, BA NCT03971409

Active (not recruiting) Phase 4

The Effect of General Anesthesia on Pharmacokinetics of Oxycodone in Pediatric

Liquid Oxycodone

Oxycodone is an oral opioid analgesic that is most commonly prescribed for the management of pain in post-operative patients at Boston Children's Hospital. Oxycodone has been widely used in adults and children to relieve post-operative pain. However, its pharmacokinetics (what it does in the body) and pharmacodynamics (how it works) have not been well established in children. Some children, because of their specific genetic make-up, may metabolize the drug more quickly and therefore may be at risk for more side effects in the commonly prescribed dose. The investigators would like to find out more about how general anesthesia (GA) effects how this drug is absorbed, metabolized and excreted in children. In order to study these aspects, the investigators would like to give oxycodone to surgical patients (group one will receive oxycodone at the beginning of GA and group two will receive oxycodone at the end of GA) at Boston Children's Hospital then measure its metabolic activity and also perform a specific genetic analysis.

Начало: 08.07.2019 Край: 01.12.2027 Възраст: 2–8 г.

United States Boston Children's Hospital NCT03054831

Active (not recruiting) Phase 3

A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia

B Acute Lymphoblastic Leukemia B Lymphoblastic Lymphoma Down Syndrome

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

Начало: 03.07.2019 Край: 30.09.2027 Възраст: 365–31 г. Treatment

Australia, Canada, New Zealand +2 National Cancer Institute (NCI) NCT03914625

Active (not recruiting)

ctDNA for Early Detection of Recurrence in Melanoma

Melanoma

This study examines circulating tumor DNA (ctDNA) as a biomarker for early detection of recurrence in high-risk patients, following treatment of primary melanoma. The hypothesis is that ctDNA can provide accurate detection of recurrence or metastasis, at the time of or earlier than current methods, leading to improved management and hopefully prognosis, based on earlier detection.

Начало: 01.07.2019 Край: 01.01.2028 Възраст: от 18 г.

Denmark Herlev and Gentofte Hospital NCT06246227

Active (not recruiting) Phase 2

Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients

B-Cell Acute Lymphoblastic Leukemia

This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive. The study will have the following sequential phases: screening, pre-treatment, treatment \& follow-up, and survival. After tisagenlecleucel infusion, patient will have assessments performed more frequently in the first month and then at Day 29, then every 3 months for the first year, every 6 months for the second year, then yearly until the end of the study. Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study. The study is expected to end in approximately 8 years after first patient first treatment (FPFT). A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines.

Начало: 24.06.2019 Край: 19.10.2027 Възраст: 1–25 г.

Belgium, Canada, Denmark +8 Novartis Pharmaceuticals NCT03876769

Active (not recruiting) Phase 3

Study of Tislelizumab in Combination With Chemotherapy Compared to Chemotherapy Alone for Participants With Urothelial Carcinoma

Urothelial Carcinoma

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study designed to compare the efficacy and safety of tislelizumab + either cisplatin or carboplatin + gemcitabine versus placebo+ either cisplatin or carboplatin + gemcitabine in approximately 420 participants with locally advanced or metastatic urothelial carcinoma who have not received prior systemic therapy.

Начало: 29.05.2019 Край: 21.10.2027 Възраст: 18–75 г.

China, Taiwan BeiGene NCT03967977

Active (not recruiting) Phase 2

M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

Castration-Resistant Prostate Carcinoma Metastatic Prostate Carcinoma Stage IV Prostate Cancer AJCC v8

This phase II trial studies how well berzosertib (M6620) and carboplatin with or without docetaxel works in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). M6620 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and docetaxel, 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 M6620, carboplatin and docetaxel may work better in treating patients with metastatic castration-resistant prostate cancer compared to carboplatin and docetaxel alone.

Начало: 29.05.2019 Край: 03.04.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT03517969

Active (not recruiting) Phase 3

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

Atopic Dermatitis

The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.

Начало: 24.05.2019 Край: 01.05.2026 Възраст: 2–17 г. Treatment

Argentina, Australia, Austria +14 Eli Lilly and Company NCT03952559

Active (not recruiting)

Whole Genomic Landscape of Advanced EGFR-mutant NSCLC

Locally Advanced or Metastatic NSCLC

This is a phase 2 single-arm, non-randomized multicentre and tissue acquisition study to evaluate acquired resistance mechanisms, efficacy, and safety in advanced, EGFR tyrosine kinase inhibitor-naïve NSCLC patients with EGFR-activating mutations who receive a first-line osimertinib orally at a dose of 80mg once daily.

Начало: 23.05.2019 Край: 31.12.2026 Възраст: от 19 г.

South Korea Seoul National University Hospital NCT03969823

Active (not recruiting)

Lung-Resident Memory Th2 Cells in Asthma

Asthma, Allergic

Determining how memory T helper type 2 (Th2) initiate recall responses to aeroallergens has the potential to change the therapeutic approach to allergic asthma, the most common asthma subtype. \~5-10% of effector Th2 cells recruited into the lung give rise to long-lived tissue resident memory cells that are poised to respond upon allergen re-exposure.Consequently, targeting memory Th2 cell activation is an attractive therapeutic strategy. However, it is not well understood how allergen inhalation initiates a memory Th2 cell response in the lung. The focus of this new study on the role of lung-resident memory Th2 cells in orchestrating the recall response to allergen in the lung, including the recruitment and activation of circulating Th2 cells, is a natural, timely and exciting extension of the investigators' ongoing Allergen Challenge Protocol.

Начало: 23.05.2019 Край: 15.12.2027 Възраст: 18–55 г.

United States Andrew D. Luster, M.D.,Ph.D. NCT03455959

Active (not recruiting)

Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty

Total Knee Arthroplasty

The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.

Начало: 22.05.2019 Край: 31.12.2032 Възраст: от 18 г.

United States Smith & Nephew, Inc. NCT03720782

Active (not recruiting)

Comprehensive Computed Tomography Guidance of Coronary Bypass Graft Surgery

CAD Atheroscleroses, Coronary Computed Tomography Coronary Artery Bypass

Apply CT angiography, CT perfusion imaging and advanced image processing techniques to improve revascularization decision-making and surgical strategies in patients undergoing coronary artery bypass graft surgery.

Начало: 01.05.2019 Край: 01.12.2030 Възраст: от 40 г.

United States Stanford University NCT03894423

Active (not recruiting) Phase 2

Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer

Castrate Sensitive Prostate Cancer

Background: Prostate cancer is a common cancer among men. There are several ways to treat it, including hormone blocking drugs, radiation therapy, and surgery. Researchers want to combine abiraterone and enzalutamide to see if there is a better way to treat prostate cancer. They also want to study a new radiotracer called 18F-DCFPyL, with the help of a scan called positron emission tomography/computed tomography (PET/CT) to see if there is a better way to detect prostate cancer. Objective: To develop improved techniques to localize and detect prostate cancer; and to develop new ways to treat prostate cancer Eligibility: Men ages 18 and older with prostate cancer that has not spread to other parts of the body Design: * Participants will have a medical evaluation to determine eligibility for the study. * Participants will take three different medications daily by mouth and receive two injections during the course of the study. * Participants will have a medical evaluation monthly (for 6 months) while taking the medications. * Participants will have prostate MRI and PET/CT scans before treatment, 2 months after starting treatment and again before surgery. The radiotracer will be given by injection about 2 hours before the whole-body scan. The PET/CT scan itself is about an hour. * Participants may be asked to do a biopsy before treatment and 2 months after starting treatment. * Participants will have a full medical evaluation before surgery to remove their prostate. * Participants will have a follow-up visit 3 months after surgery and then as needed. * Participants will be contacted once a year for their PSA and testosterone levels for 5 years

Начало: 30.04.2019 Край: 01.08.2028 Възраст: 18–99 г.

United States National Cancer Institute (NCI) NCT03860987

Active (not recruiting) Phase 1/2

Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

IgA Nephropathy

Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).

Начало: 08.04.2019 Край: 30.04.2026 Възраст: от 18 г.

South Korea, United Kingdom, United States Novartis Pharmaceuticals NCT03945318

Active (not recruiting)

Intra-operative Pancreatoscopy in Patients With IPMN

Intraductal Papillary Mucinous Neoplasm

To demonstrate the added value of intraoperative pancreatoscopy in patients undergoing partial pancreatic resection for the treatment of Intraductal Papillary Mucinous Neoplasm (IPMN) as it pertains to detection of discontinuous (skip) lesions in the remnant pancreas; to generate a hypothesis for a subsequent randomized control trial.

Начало: 20.03.2019 Край: 01.05.2027 Възраст: от 18 г.

China, India, Japan +3 Boston Scientific Corporation NCT03729453

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