study_start_date_type: Actual

acronym: PREVENT

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

ReferenceType: derived

ReferenceCitation: Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

oa_colors: green gold

oa_host_type: publisher;repository

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

evidence: oa repository (via OAI-PMH doi match)

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repositories_concat: PubMed Central;eprints.gla.ac.uk

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Braun J, Blanco R, Marzo-Ortega H, Gensler LS, van den Bosch F, Hall S, Kameda H, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Shete A, Richards HB, Haemmerle S, Deodhar A. Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT. Arthritis Res Ther. 2021 Sep 4;23(1):231. doi: 10.1186/s13075-021-02613-9.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

ReferenceCitation: Deodhar A, Blanco R, Dokoupilova E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

unpaywall_oa_status: hybrid

status: Completed

title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

primary_purpose: Treatment

source: euctr

enrollment_type: Actual

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Australia
Japan
Turkey
Czechia
France
Portugal
Hungary
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Bulgaria
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

type: EudraCT Number

title: monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

acronym: monarcHER

summary: The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, Ricci F, Im SA, Kim SB, Johnston SR, Chan A, Goel S, Catron K, Chapman SC, Price GL, Yang Z, Gainford MC, Andre F. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):763-775. doi: 10.1016/S1470-2045(20)30112-1. Epub 2020 Apr 27. Erratum In: Lancet Oncol. 2021 Mar;22(3):e92. Lancet Oncol. 2021 Nov;22(11):e472.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
Brazil
Mexico
Belgium
United States
Korea, Republic of
Spain
Greece
Canada
France

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Central Coast Medical Oncology Corporation

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Fundação Antonio Prudente - Hospital do Câncer A.C Camargo

location_facility: Universitair Ziekenhuis Leuven - Gasthuisberg

location_facility: The Center for Cancer and Blood Disorders

location_facility: Instituto COI de Pesquisa Educação e Gestão

location_facility: North Shore Hematology Oncology Associates

status_simplified: Ongoing


title: A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

ReferenceCitation: Lim M, Weller M, Idbaih A, Steinbach J, Finocchiaro G, Raval RR, Ansstas G, Baehring J, Taylor JW, Honnorat J, Petrecca K, De Vos F, Wick A, Sumrall A, Sahebjam S, Mellinghoff IK, Kinoshita M, Roberts M, Slepetis R, Warad D, Leung D, Lee M, Reardon DA, Omuro A. Phase III trial of chemoradiotherapy with temozolomide plus nivolumab or placebo for newly diagnosed glioblastoma with methylated MGMT promoter. Neuro Oncol. 2022 Nov 2;24(11):1935-1949. doi: 10.1093/neuonc/noac116.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: California Digital Library - eScholarship

publisher_dissemination: Oxford University Press

ReferenceCitation: Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170. No abstract available.

oa_colors: green other

evidence: open (via free article)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Germany
Poland
Australia
Japan
Canada
France
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Russian Federation
Israel

location_facility: Preston Robert Tisch Brain Tumor Center at Duke University

location_facility: Erlanger Oncology & Hematology - Univ. of TN


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Niraparib Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

summary: This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

ReferenceType: background

ReferenceCitation: Gonzalez-Martin A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Perez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.

ReferenceCitation: Lorusso D, Guy H, Samyshkin Y, Hawkes C, Estenson K, Coleman RL. Feasibility Study of a Network Meta-Analysis and Unanchored Population-Adjusted Indirect Treatment Comparison of Niraparib, Olaparib, and Bevacizumab as Maintenance Therapies in Patients with Newly Diagnosed Advanced Ovarian Cancer. Cancers (Basel). 2022 Mar 2;14(5):1285. doi: 10.3390/cancers14051285.

ReferenceCitation: Barretina-Ginesta MP, Monk BJ, Han S, Pothuri B, Auranen A, Chase DM, Lorusso D, Anderson C, Abadie-Lacourtoisie S, Cloven N, Braicu EI, Amit A, Redondo A, Shah R, Kebede N, Hawkes C, Gupta D, Woodward T, O'Malley DM, Gonzalez-Martin A. Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial. Ther Adv Med Oncol. 2022 Sep 22;14:17588359221126149. doi: 10.1177/17588359221126149. eCollection 2022.

ReferenceCitation: O'Cearbhaill RE, Perez-Fidalgo JA, Monk BJ, Tusquets I, McCormick C, Fuentes J, Moore RG, Vulsteke C, Shahin MS, Forget F, Bradley WH, Hietanen S, O'Malley DM, Dorum A, Slomovitz BM, Baumann K, Selle F, Calvert PM, Artioli G, Levy T, Kumar A, Malinowska IA, Li Y, Gupta D, Gonzalez-Martin A. Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study. Gynecol Oncol. 2022 Jul;166(1):36-43. doi: 10.1016/j.ygyno.2022.04.012. Epub 2022 May 9.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories:
PubMed Central
irua

repositories_concat: PubMed Central;irua

ipd_sharing: No

lead_sponsor: Tesaro, Inc.

collaborators: European Network of Gynaecological Oncological Trial Groups (ENGOT)

location_country:
Finland
Germany
Ireland
Poland
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Ukraine
Belgium
Italy
Norway
United Kingdom
Sweden
Spain
Russian Federation
Israel


lead_sponsor: GlaxoSmithKline

summary:
Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE) monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic asthma. The aim of this study is to investigate whether subjects not optimally controlled on their current omalizumab treatment, who are eligible for therapy with mepolizumab can be effectively and safely switched to treatment with mepolizumab to improve asthma control. The study will provide data on the efficacy, safety, immunogenicity, and tolerability of mepolizumab when switched directly from omalizumab without any wash-out. The learnings from this study may help guide physicians when substituting one biologic with another for the treatment of patients with severe eosinophilic asthma.

The study will be a multi-centre, open-label single arm trial. Patients with severe eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be eligible to participate. Subjects will remain on their current maintenance therapy including omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit 2 (week 0) subjects will discontinue their omalizumab treatment and be switched to mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32 weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last dose of mepolizumab.

ReferenceCitation: Liu MC, Chipps B, Munoz X, Devouassoux G, Bergna M, Smith SG, Price RG, Galkin DV, Azmi J, Mouneimne D, Albers FC, Chapman KR. Benefit of switching to mepolizumab from omalizumab in severe eosinophilic asthma based on patient characteristics. Respir Res. 2021 May 10;22(1):144. doi: 10.1186/s12931-021-01733-9.

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

title: A Multi-centre, Open Label, Single Arm, 32-week Treatment Study in Subjects With Severe Eosinophilic Asthma Not Optimally Controlled With Current Omalizumab Treatment Who Are Switched From Omalizumab to Mepolizumab 100mg Subcutaneous (Study Number 204471- the OSMO Study)

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Germany
Argentina
Sweden
Netherlands
Belgium
United States
Spain
Canada
France


title: A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)

acronym: CheckMate 498

summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

location_facility: Johns Hopkins University School Of Medicine

location_facility: Washington University School OF Medicine-Siteman Cancer Center

location_facility: Montreal Neurological Institute and Hospital

location_facility: The Regents of the University of California, San Francisco

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

location_facility: Columbia University Medical Center (Cumc)

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: Emory University - Winship Cancer Institute

location_facility: University Of Texas Southwestern Medical Center


lead_sponsor: Boehringer Ingelheim

summary: The objective of the randomised part of the study is to investigate the efficacy and safety of BI 1356 plus metformin compared to BI 1356 or metformin alone given for 24 weeks to drug naive or previously treated (4 weeks wash-out, 2 weeks placebo run-in) type 2 diabetic patients with insufficient glycaemic control. For the open-label part of the study the objective is to estimate the efficacy and safety of BI 1356 and metformin in type 2 diabetic patients with very poor glycaemic control for 24 weeks

ReferenceCitation: Lv Q, Shen J, Miao L, Ye B, Schepers C, Plat A, Shi Y. Early Combination Therapy with Linagliptin and Metformin in People with Type 2 Diabetes Improves Glycemic Control to HbA1c </= 6.5% without Increasing Hypoglycemia: Pooled Analysis of Two Randomized Clinical Trials. Diabetes Ther. 2020 Jun;11(6):1317-1330. doi: 10.1007/s13300-020-00819-9. Epub 2020 Apr 23.

repository_institution: PubMed Central - Europe PMC

location_facility: 1218.46.49008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2162A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31013 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91013 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91019 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38503 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91012 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38501 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91018 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91020 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91011 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3301A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31011 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38502 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31012 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91015 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91017 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31015 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31014 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.46004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31016 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2163B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38505 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37201 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91014 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38504 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.40001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307E Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2161A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37202 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2161B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3304H Boehringer Ingelheim Investigational Site

location_facility: 1218.46.38003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308F Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3302D Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308B Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91006 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3307A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3306C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.2163A Boehringer Ingelheim Investigational Site

location_facility: 1218.46.37203 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91016 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3308C Boehringer Ingelheim Investigational Site

location_facility: 1218.46.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91010 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31009 Boehringer Ingelheim Investigational Site

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location_facility: 1218.46.38506 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52009 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.46.70007 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52001 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.31008 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.49003 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.52002 Boehringer Ingelheim Investigational Site

location_facility: 1218.46.3303A Boehringer Ingelheim Investigational Site

title: A Phase III Randomised, Double-blind, Placebo-controlled Parallel Group Study to Compare the Efficacy and Safety of Twice Daily Administration of the Free Combination of BI 1356 2.5 mg + Metformin 500 mg, or of BI 1356 2.5 mg + Metformin 1000 mg, With the Individual Components of Metformin (500 mg or 1000 mg Twice Daily), and BI 1356 (5.0 mg Once Daily) Over 24 Weeks in Drug Naive or Previously Treated (4 Weeks Wash-out and 2 Weeks Placebo run-in) Type 2 Diabetic Patients With Insufficient Glycaemic Control

location_country:
Germany
Lithuania
India
Romania
Sweden
Netherlands
Mexico
Tunisia
Croatia
Ukraine
Canada
Estonia
Russian Federation
France


acronym: MAGE3-AS15-MEL-005 (ADJ)

summary:
The purpose of this clinical trial is to evaluate the benefit of the immunotherapeutic product GSK 2132231A in preventing disease relapse when given to melanoma patients, after surgical removal of their tumor.

This Protocol Posting has been updated following Amendments 1 of the Protocol, March 2010. The impacted sections are outcome measures and entry criteria.

ReferenceCitation: Dreno B, Thompson JF, Smithers BM, Santinami M, Jouary T, Gutzmer R, Levchenko E, Rutkowski P, Grob JJ, Korovin S, Drucis K, Grange F, Machet L, Hersey P, Krajsova I, Testori A, Conry R, Guillot B, Kruit WHJ, Demidov L, Thompson JA, Bondarenko I, Jaroszek J, Puig S, Cinat G, Hauschild A, Goeman JJ, van Houwelingen HC, Ulloa-Montoya F, Callegaro A, Dizier B, Spiessens B, Debois M, Brichard VG, Louahed J, Therasse P, Debruyne C, Kirkwood JM. MAGE-A3 immunotherapeutic as adjuvant therapy for patients with resected, MAGE-A3-positive, stage III melanoma (DERMA): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jul;19(7):916-929. doi: 10.1016/S1470-2045(18)30254-7. Epub 2018 Jun 13.

ReferenceCitation: Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.

status: Terminated

title: GSK 2132231A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resected Melanoma

ipd_sharing_description: IPD is available via the Clinical Study Data Request site (click on the link provided below)

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Czechia
Canada
Serbia
France
Switzerland
United States
Ukraine
Romania
Belgium
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel

status_simplified: Unknown


title: A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Multi-Center, Multi-National Study for Evaluation of Efficacy and Safety of Edoxaban (DU-176b) Versus Warfarin In Subjects With Atrial Fibrillation - Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation (ENGAGE - AF TIMI - 48)

summary: This study is to demonstrate the safety and efficacy profile, in two different dose regimens of Edoxaban (DU-176b), (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients will be randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin. The expected duration of the study is 24 months.

primary_purpose: Prevention

ReferenceCitation: Bonaca MP, Antman EM, Cunningham JW, Wiviott SD, Murphy SA, Halperin JL, Weitz JI, Grosso MA, Lanz HJ, Braunwald E, Giugliano RP, Ruff CT. Ischaemic and bleeding risk in atrial fibrillation with and without peripheral artery disease and efficacy and safety of full- and half-dose edoxaban vs. warfarin: insights from ENGAGE AF-TIMI 48. Eur Heart J Cardiovasc Pharmacother. 2022 Sep 29;8(7):695-706. doi: 10.1093/ehjcvp/pvab089.

ReferenceCitation: Oyama K, Giugliano RP, Berg DD, Ruff CT, Jarolim P, Tang M, Murphy SA, Lanz HJ, Grosso MA, Antman EM, Braunwald E, Morrow DA. Serial assessment of biomarkers and the risk of stroke or systemic embolism and bleeding in patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial. Eur Heart J. 2021 May 1;42(17):1698-1706. doi: 10.1093/eurheartj/ehab141.

ReferenceCitation: Steffel J, Ruff CT, Yin O, Braunwald E, Park JG, Murphy SA, Connolly S, Antman EM, Giugliano RP. Randomized, Double-Blind Comparison of Half-Dose Versus Full-Dose Edoxaban in 14,014 Patients With Atrial Fibrillation. J Am Coll Cardiol. 2021 Mar 9;77(9):1197-1207. doi: 10.1016/j.jacc.2020.12.053.

oa_host_type: publisher

ReferenceCitation: Wilkinson C, Wu J, Searle SD, Todd O, Hall M, Kunadian V, Clegg A, Rockwood K, Gale CP. Clinical outcomes in patients with atrial fibrillation and frailty: insights from the ENGAGE AF-TIMI 48 trial. BMC Med. 2020 Dec 24;18(1):401. doi: 10.1186/s12916-020-01870-w.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Vilain K, Li H, Kwong WJ, Antman EM, Ruff CT, Braunwald E, Cohen DJ, Giugliano RP, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Cardiovascular- and Bleeding-Related Hospitalization Rates With Edoxaban Versus Warfarin in Patients With Atrial Fibrillation Based on Results of the ENGAGE AF-TIMI 48 Trial. Circ Cardiovasc Qual Outcomes. 2020 Nov;13(11):e006511. doi: 10.1161/CIRCOUTCOMES.120.006511. Epub 2020 Nov 5.

evidence: open (via free pdf)

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Inciardi RM, Giugliano RP, Claggett B, Gupta DK, Chandra A, Ruff CT, Antman EM, Mercuri MF, Grosso MA, Braunwald E, Solomon SD; ENGAGE AF-TIMI 48 Investigators. Left atrial structure and function and the risk of death or heart failure in atrial fibrillation. Eur J Heart Fail. 2019 Dec;21(12):1571-1579. doi: 10.1002/ejhf.1606. Epub 2019 Nov 27.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Bergmark BA, Kamphuisen PW, Wiviott SD, Ruff CT, Antman EM, Nordio F, Kuder JF, Mercuri MF, Lanz HJ, Braunwald E, Giugliano RP. Comparison of Events Across Bleeding Scales in the ENGAGE AF-TIMI 48 Trial. Circulation. 2019 Nov 26;140(22):1792-1801. doi: 10.1161/CIRCULATIONAHA.119.041346. Epub 2019 Oct 10.

ReferenceCitation: Berg DD, Ruff CT, Jarolim P, Giugliano RP, Nordio F, Lanz HJ, Mercuri MF, Antman EM, Braunwald E, Morrow DA. Performance of the ABC Scores for Assessing the Risk of Stroke or Systemic Embolism and Bleeding in Patients With Atrial Fibrillation in ENGAGE AF-TIMI 48. Circulation. 2019 Feb 5;139(6):760-771. doi: 10.1161/CIRCULATIONAHA.118.038312.

ReferenceCitation: Corbalan R, Nicolau JC, Lopez-Sendon J, Garcia-Castillo A, Botero R, Sotomora G, Horna M, Ruff CT, Hamershock RA, Grip LT, Antman EM, Braunwald E, Giugliano RP. Edoxaban Versus Warfarin in Latin American Patients With Atrial Fibrillation: The ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2018 Sep 25;72(13):1466-1475. doi: 10.1016/j.jacc.2018.07.037.

ReferenceCitation: Yin OQP, Antman EM, Braunwald E, Mercuri MF, Miller R, Morrow D, Ruff CT, Truitt K, Weitz JI, Giugliano RP. Linking Endogenous Factor Xa Activity, a Biologically Relevant Pharmacodynamic Marker, to Edoxaban Plasma Concentrations and Clinical Outcomes in the ENGAGE AF-TIMI 48 Trial. Circulation. 2018 Oct 30;138(18):1963-1973. doi: 10.1161/CIRCULATIONAHA.118.033933.

ReferenceCitation: Aisenberg J, Chatterjee-Murphy P, Friedman Flack K, Weitz JI, Ruff CT, Nordio F, Mercuri MF, Choi Y, Antman EM, Braunwald E, Giugliano RP. Gastrointestinal Bleeding With Edoxaban Versus Warfarin: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis In Myocardial Infarction). Circ Cardiovasc Qual Outcomes. 2018 May;11(5):e003998. doi: 10.1161/CIRCOUTCOMES.117.003998.

ReferenceCitation: Wang K, Li H, Kwong WJ, Antman EM, Ruff CT, Giugliano RP, Cohen DJ, Magnuson EA; ENGAGE AF-TIMI 48 Trial Investigators. Impact of Spontaneous Extracranial Bleeding Events on Health State Utility in Patients with Atrial Fibrillation: Results from the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Aug 11;6(8):e006703. doi: 10.1161/JAHA.117.006703.

repository_institution: St George's University of London - St George's Online Research Archive

ReferenceCitation: Eisen A, Ruff CT, Braunwald E, Hamershock RA, Lewis BS, Hassager C, Chao TF, Le Heuzey JY, Mercuri M, Rutman H, Antman EM, Giugliano RP. Digoxin Use and Subsequent Clinical Outcomes in Patients With Atrial Fibrillation With or Without Heart Failure in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2017 Jun 30;6(7):e006035. doi: 10.1161/JAHA.117.006035.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: De Caterina R, Renda G, Carnicelli AP, Nordio F, Trevisan M, Mercuri MF, Ruff CT, Antman EM, Braunwald E, Giugliano RP. Valvular Heart Disease Patients on Edoxaban or Warfarin in the ENGAGE AF-TIMI 48 Trial. J Am Coll Cardiol. 2017 Mar 21;69(11):1372-1382. doi: 10.1016/j.jacc.2016.12.031. Erratum In: J Am Coll Cardiol. 2019 Feb 12;73(5):627.

ReferenceCitation: Link MS, Giugliano RP, Ruff CT, Scirica BM, Huikuri H, Oto A, Crompton AE, Murphy SA, Lanz H, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Stroke and Mortality Risk in Patients With Various Patterns of Atrial Fibrillation: Results From the ENGAGE AF-TIMI 48 Trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Circ Arrhythm Electrophysiol. 2017 Jan;10(1):e004267. doi: 10.1161/CIRCEP.116.004267.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Murphy SA, Brown K, Jarolim P, Mercuri M, Antman EM, Morrow DA. Cardiovascular Biomarker Score and Clinical Outcomes in Patients With Atrial Fibrillation: A Subanalysis of the ENGAGE AF-TIMI 48 Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):999-1006. doi: 10.1001/jamacardio.2016.3311.

ReferenceCitation: Steffel J, Giugliano RP, Braunwald E, Murphy SA, Mercuri M, Choi Y, Aylward P, White H, Zamorano JL, Antman EM, Ruff CT. Edoxaban Versus Warfarin in Atrial Fibrillation Patients at Risk of Falling: ENGAGE AF-TIMI 48 Analysis. J Am Coll Cardiol. 2016 Sep 13;68(11):1169-1178. doi: 10.1016/j.jacc.2016.06.034. Erratum In: J Am Coll Cardiol. 2017 Jul 25;70(4):512-513.

ReferenceCitation: Eisen A, Ruff CT, Braunwald E, Nordio F, Corbalan R, Dalby A, Dorobantu M, Mercuri M, Lanz H, Rutman H, Wiviott SD, Antman EM, Giugliano RP. Sudden Cardiac Death in Patients With Atrial Fibrillation: Insights From the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 Jul 8;5(7):e003735. doi: 10.1161/JAHA.116.003735.

ReferenceCitation: Rost NS, Giugliano RP, Ruff CT, Murphy SA, Crompton AE, Norden AD, Silverman S, Singhal AB, Nicolau JC, SomaRaju B, Mercuri MF, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Outcomes With Edoxaban Versus Warfarin in Patients With Previous Cerebrovascular Events: Findings From ENGAGE AF-TIMI 48 (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48). Stroke. 2016 Aug;47(8):2075-82. doi: 10.1161/STROKEAHA.116.013540. Epub 2016 Jul 7.

ReferenceCitation: Bohula EA, Giugliano RP, Ruff CT, Kuder JF, Murphy SA, Antman EM, Braunwald E. Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial. Circulation. 2016 Jul 5;134(1):24-36. doi: 10.1161/CIRCULATIONAHA.116.022361.

ReferenceCitation: Kato ET, Giugliano RP, Ruff CT, Koretsune Y, Yamashita T, Kiss RG, Nordio F, Murphy SA, Kimura T, Jin J, Lanz H, Mercuri M, Braunwald E, Antman EM. Efficacy and Safety of Edoxaban in Elderly Patients With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial. J Am Heart Assoc. 2016 May 20;5(5):e003432. doi: 10.1161/JAHA.116.003432.

ReferenceCitation: Xu H, Ruff CT, Giugliano RP, Murphy SA, Nordio F, Patel I, Shi M, Mercuri M, Antman EM, Braunwald E. Concomitant Use of Single Antiplatelet Therapy With Edoxaban or Warfarin in Patients With Atrial Fibrillation: Analysis From the ENGAGE AF-TIMI48 Trial. J Am Heart Assoc. 2016 Feb 23;5(2):e002587. doi: 10.1161/JAHA.115.002587.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Morrow DA, Murphy SA, Kuder JF, Deenadayalu N, Jarolim P, Betcher J, Shi M, Brown K, Patel I, Mercuri M, Antman EM. Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2288-95. doi: 10.1016/S0140-6736(14)61943-7. Epub 2015 Mar 11.

ReferenceCitation: Mega JL, Walker JR, Ruff CT, Vandell AG, Nordio F, Deenadayalu N, Murphy SA, Lee J, Mercuri MF, Giugliano RP, Antman EM, Braunwald E, Sabatine MS. Genetics and the clinical response to warfarin and edoxaban: findings from the randomised, double-blind ENGAGE AF-TIMI 48 trial. Lancet. 2015 Jun 6;385(9984):2280-7. doi: 10.1016/S0140-6736(14)61994-2. Epub 2015 Mar 11.

ReferenceCitation: Ruff CT, Giugliano RP, Braunwald E, Mercuri M, Curt V, Betcher J, Grip L, Cange AL, Crompton AE, Murphy SA, Deenadayalu N, Antman EM. Transition of patients from blinded study drug to open-label anticoagulation: the ENGAGE AF-TIMI 48 trial. J Am Coll Cardiol. 2014 Aug 12;64(6):576-84. doi: 10.1016/j.jacc.2014.05.028.

ReferenceCitation: Giugliano RP, Ruff CT, Rost NS, Silverman S, Wiviott SD, Lowe C, Deenadayalu N, Murphy SA, Grip LT, Betcher JM, Duggal A, Dave J, Shi M, Mercuri M, Antman EM, Braunwald E; ENGAGE AF-TIMI 48 Investigators. Cerebrovascular events in 21 105 patients with atrial fibrillation randomized to edoxaban versus warfarin: Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48. Stroke. 2014 Aug;45(8):2372-8. doi: 10.1161/STROKEAHA.114.006025. Epub 2014 Jun 19.

ReferenceCitation: Gupta DK, Shah AM, Giugliano RP, Ruff CT, Antman EM, Grip LT, Deenadayalu N, Hoffman E, Patel I, Shi M, Mercuri M, Mitrovic V, Braunwald E, Solomon SD; Effective aNticoaGulation with factor xA next GEneration in AF-Thrombolysis In Myocardial Infarction 48 Echocardiographic Study Investigators. Left atrial structure and function in atrial fibrillation: ENGAGE AF-TIMI 48. Eur Heart J. 2014 Jun 7;35(22):1457-65. doi: 10.1093/eurheartj/eht500. Epub 2013 Dec 2.

ReferenceCitation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Salazar DE, Mendell J, Kastrissios H, Green M, Carrothers TJ, Song S, Patel I, Bocanegra TS, Antman EM, Giugliano RP, Kunitada S, Dornseif B, Shi M, Tachibana M, Zhou S, Rohatagi S. Modelling and simulation of edoxaban exposure and response relationships in patients with atrial fibrillation. Thromb Haemost. 2012 May;107(5):925-36. doi: 10.1160/TH11-08-0566. Epub 2012 Mar 8.

ReferenceCitation: Ruff CT, Giugliano RP, Antman EM, Crugnale SE, Bocanegra T, Mercuri M, Hanyok J, Patel I, Shi M, Salazar D, McCabe CH, Braunwald E. Evaluation of the novel factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation: design and rationale for the Effective aNticoaGulation with factor xA next GEneration in Atrial Fibrillation-Thrombolysis In Myocardial Infarction study 48 (ENGAGE AF-TIMI 48). Am Heart J. 2010 Oct;160(4):635-41. doi: 10.1016/j.ahj.2010.06.042.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

sponsor_collaborators:
Daiichi Sankyo, Inc.
The TIMI Study Group

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Ukraine
India
Romania
Belgium
China
Peru
Estonia
Philippines
Italy
Guatemala
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: Post Authorization Safety Study (PASS)

lead_sponsor: Hoffmann-La Roche

summary: This 2 arm safety study will compare the outcome with respect to a composite endpoint of all-cause mortality and non-fatal cardiovascular events (myocardial infarction, stroke) in CKD participants either on dialysis or not receiving renal replacement therapy under treatment with methoxy polyethylene glycol-epoetin beta or reference ESAs. Participants will be randomized to receive intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta at the following doses: for participants not already receiving ESA treatment, methoxy polyethylene glycol-epoetin beta will be administered at a starting dose of 0.6 micrograms per kilograms every 2 weeks (mcg/kg/2wks) iv or sc; for participants receiving maintenance ESA treatment, iv or sc methoxy polyethylene glycol-epoetin beta will be administered at an initial monthly dose of 120, 200 or 360 micrograms (mcg) depending on the weekly dose of ESA received prior to first methoxy polyethylene glycol-epoetin beta administration. Participants randomized to reference ESA treatment will receive iv or sc ESAs in accordance with their prescribed dosing information.

ReferenceCitation: Locatelli F, Hannedouche T, Fishbane S, Morgan Z, Oguey D, White WB. Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial. Clin J Am Soc Nephrol. 2019 Dec 6;14(12):1701-1710. doi: 10.2215/CJN.01380219. Epub 2019 Aug 16.

location_facility: ASST SANTI PAOLO E CARLO; U.O.S. Nefrologia e Dialisi

location_facility: Tan Tock Seng Hospital; Department of Renal Medicine

location_facility: A.O.U. Policlinico G.Martino; U.O.C. Nefrologia e Dialisi

location_facility: Hospital Txagorritxu; Servicio de Nefrologia

location_facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico

location_facility: Uni Hospital of Ioannina; Nephrology Dept.

location_facility: Service de Nephrologie & D'Immunologie; Clinique

location_facility: General Hospital Josip Bencevic; Department of Haemodialysis

location_facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

location_facility: Hospital de Galdakano; Servicio de Nefrologia

location_facility: Clinica de Medicina Interna e Nefrologia (CMIN)

location_facility: Royal Free & University College Medical School; Centre for Nephrology

location_facility: Azienda Ospedaliera Sant'Anna Unità Operativa Complessa di Nefrologia Dialisi

location_facility: Hospital Kuala Lumpur; Department of Medicine

location_facility: Universita' Di Tor Vergata; Clinica Nefrologia Dialisi

location_facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika

location_facility: Ospedale Provinciale S. Maria delle Croci; Divisione Nefrologia e Dialsi

location_facility: Baskent University Hospital; Transplantation

location_facility: Gold Coast Hospital Department of Pharmacology & Therapeutics

location_facility: Clinical Center Nis; Clinic for Nephrology and Hemodialysis

location_facility: Universitaetsklinikum des Saarlandes; Klinik f. Innere Medizin IV

location_facility: Hospital de Cruces; Servicio de Nefrologia

location_facility: NZOZ Stacja Dializ Hand-Prod w Gorlicach

location_facility: Vilnius University Hospital Santariskiu Clinic, Nephrology Center

location_facility: Univeristy Hospital of Larissa; Nephrology

location_facility: Specjalistyczny Szpital im A.Sokołowskiego w Wałbrzychu; Oddzial Nefrologiczny

location_facility: General Hospital Karlovac; Dept of Haemodialysis

location_facility: A.O. Santa Maria Nuova Di Reggio Emilia; Unita Operativa Di Nefrologia E Dialisi

location_facility: Uppsala University Hospital; Department of Internal Medicine, Nephrology Section

location_facility: Ospedale Civile; Servizio Di Nefrologia E Dialisi

location_facility: Hospital Univ. Pedro Ernesto - Hupe; Nefrologia

location_facility: Hopital Civil; Nephrologie Clinique Medicale B

location_facility: KFH Nierenzentrum Bad Hersfeld; Nephrologie

location_facility: Wojewodzki Szpital Zespolony, Stacja Dializ, Skierniewice

location_facility: Cukurova University School of Medicine; Nefrology Department

location_facility: Complejo Hospitalario Torrecardenas; Servicio de Nefrologia

location_facility: Ospedale S. Marta S. Venera Nuovo; U.O. Nefrologia Dialisi

location_facility: Nephrologische Schwerpunktpraxis; Hamburg Barmbek

location_facility: Az. Osp. Di Padova; U.O. Nefrologia 2 E Dialisi

location_facility: Azienda Ospedaliera San Salvatore; Divisione Nefrologia E Dialisi

location_facility: NZOZ Stacja Dializ Hand-Prod w Limanowej

location_facility: Dres. Roland Erwin Winkler Ann Michelsen Dietmar Sehland u.w.

location_facility: Buddhachinaraj Hospital Renal Division; Dept of Medicine

location_facility: Azienda Ospedaliera Santa Maria Misericordia; Divisione Nefrologia Dialisi

location_facility: Hospital de Navarra; Servicio de Nefrologia

location_facility: The Ipswich Hospital Nhs Trust; The Renal Unit

location_facility: Ospedale Maggiore; U.O.Complessa di Nefrologia e Dialisi

location_facility: A.O. Universitaria S. Martino Di Genova; Nefrologia

location_facility: Powiatowy Szpital Specjalistyczny w Stalowej Woli; Oddział Nefrologii i Dializoterapii

location_facility: DaVita Clinical Research Deutschland GmbH

location_facility: Hopital Edouard-Herriot; Nephrologie - Hemodialyse

location_facility: National Taiwan Uni Hospital; Nephrology Dept

location_facility: A.O. Cà Foncello; U.O.Nefrologia, Dialisi e Centro Trapianti

location_facility: Hopital Pellegrin; Departement Nephrologie

location_facility: Gemeinschaftspraxis Dr. Stefan Zinn und Steffen Hengst

location_facility: Presidio Ospedaliero Di Lodi; U.O. Nefrologia E Dialisi

location_facility: Centro Especializado San Fernando; Nefrología, Diálisis y Trasplante Renal

location_facility: Singapore General Hospital; Renal Medicine

location_facility: Leicester General Hospital; Dept of Nephrology

location_facility: UNI-Klinikum Campus Kiel Klinik f.Innere Medizin IV

location_facility: Samsung Medical Center; Nephrology Department

location_facility: Centre Hospitalier Du Dr Duchenes; Service De Nephrologie & Hemodialyse

location_facility: ROYAL ADELAIDE HOSPITAL; Renal Clinical Trials, CNARTS

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Fresenius Nephrocare Polska Sp zo.o. Centrum Dializ Fresenius Osrodek Dializ Nr 42 w Jasle

location_facility: Klinikum Hann. Münden, Nephrologisches Zentrum Niedersachsen

location_facility: Universidade Federal de Sao Paulo - UNIFESP

location_facility: Akademia Medyczna; Klinika Nefrologii I Chorob Wewnetrznych

location_facility: Hospital del Mar; Servicio de Nefrologia

location_facility: Ospedale Bernardo Ramazzi; U.O. Di Nefrologia E Dialisi

location_facility: Royal Preston Hospital; Department of Renal Medicine

location_facility: Hospital Ramon y Cajal; Servicio de Nefrologia

location_facility: University Hospital Coventry And Warwickshire Nhs Trust; Department Of Nephrology

location_facility: National University Hospital; Dept of Medicine

location_facility: Fondazione Salvatore Maugeri; Divisione Di Nefrologia E Dialisi

location_facility: Universitätsklinikum Duesseldorf; Klinik fuer Nephrologie

location_facility: Chang Gung Medical Fundation Kaohsiung Branch; Nephrology

location_facility: Launceston General Hospital; Diabetes and Renal Research Unit

location_facility: Centre Hospitalier Les Chanaux; Service de Néphrologie Unité 12

location_facility: Ospedale S. Giacomo; U.O. Di Nefrologia e Dialisi

location_facility: KfH Kuratorium für Dialyse und Nierentransplantation e.V.; KfH-Nierenzentrum

location_facility: Clinical Center Voivodina; Clinic for Immunology and Nephrology

location_facility: Specjalistyczny Szpital Wojewodzki w Ciechanowie; Oddzial Nefrologiczny

location_facility: A.O. Universitaria Policlinico Di Modena; Nefrologia E Dialisi

location_facility: P.O. Di Conegliano; U.O. Di Nefrologia E Dialisi

location_facility: Centre Hospitalier Uni Ire Gaston Doumergue; Service D'Hemodialyse

location_facility: St.Petersburg State Budget Institution of Healthcare "City Mariinskaya Hospital"

location_facility: Hopital Rangueil; Nephrologie Hemodialyse

location_facility: SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Dipartimento di Nefrologia e Dialisi

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: S.P. Szpital Wojewodzki im. Papieza Jana Pawla II

location_facility: Fresenius Nephrocare Polska Sp zo.o.Centrum Dializ Fresenius Osrodek Dializ Nr 45 w Dabrowie Tarn

location_facility: Nemocnice Strahov; Interni Oddeleni-Strahov

location_facility: Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ numer 71 w Poznaniu

location_facility: Hospital Infanta Sofia; Servico de Nefrologia

location_facility: Uni Hospital of Alexandroupoli; Nephrology Dept.

location_facility: Clinique Lambert; Service de Néphrologie dialyse

location_facility: ASST LARIANA; Divisione di Nefrologia e Dialisi

location_facility: Royal Devon & Exeter Hospital; Dept of Nephrology

location_facility: Salford Royal Foundation Trust; Department Of Nephrology

location_facility: Seoul National Uni Hospital; Internal Medicine

location_facility: Fresenius Nephrocare Polska Sp. z o.o., Centrum Dializ Fresenius, Osrodek Dializ nr 53 w Pabianicach

location_facility: Hopital Louis Pasteur; Nephrologie - Hemodialyse

location_facility: Hospital das Clinicas - FMUSP; Nefrologia

location_facility: University Hospital of Wales; Institute of Nephrology

location_facility: Ospedale Civile; Divisione de Nefrologia E Dialisi

location_facility: Hospital de Basurto; Servicio de Nefrologia

location_facility: Clinical Hospital Osijek; Dept of Haemodialysis

location_facility: Maharaj Nakorn Chiang Mai Hospital; Dept. of Medicine, Renal Division

location_facility: Stacja Dializ NZOZ Centrum Medyczne MEDYK

location_facility: Institut Klinicke A Experimentalni Mediciny Klinika Nefrologie

location_facility: Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi

location_facility: Monash Medical Centre; Renal Transplant Unit

location_facility: Universitätsklinikum Erlangen; Medizinische Klinik 4; Nephrologie und Hypertensiologie

location_facility: University Malaya Medical Centre; Division of Nephrology, Department of Medicine

location_facility: Hospital Severo Ochoa; Servicio de Nefrologia

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Klinicki Bolnicki Centar Zagreb; Dialysis

location_facility: Ospedale Caduti Bollatesi; U.O. Nefrologia E Dialisi

location_facility: National Kidney and Transplant Institute

location_facility: King Chulalongkorn Memorial Hospital; Renal Unit, Department of Medicine

location_facility: SBEI of HPE "Northwestern State Medical University n.a. I.I.Mechnikov" of MoH of RF

location_facility: Robert-Bosch-Krankenhaus; Allgemeine Innere Medizin und Nephrologie

location_facility: Clinical Hospital Center Rijeka; Dialysis

location_facility: St.Petersburg State Budget Institution of Healthcare "City Hospital Saint Hosiomartyr Elisabeth".

location_facility: Fresenius Nephrocare Polska Sp.zo.o.Centrum Dializ FreseniusOśrodek Dializ Nr 62 w Sandomierzu

location_facility: Azienda Ospedaliera Cannizzaro Unità Operativa Nefrologia

location_facility: Derriford Hospital; Department Of Renal Medicine

title: A Randomized, Controlled, Open-Label, Multi-Centre, Parallel-Group Study To Assess All-Cause Mortality And Cardiovascular Morbidity In Patients With Chronic Kidney Disease On Dialysis And Those Not On Renal Replacement Therapy Under Treatment With MIRCERA® Or Reference ESAs.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Croatia
Czechia
Serbia
France
Lithuania
Belgium
Malaysia
Philippines
Italy
United Kingdom
Singapore
Sweden
Mexico
Korea, Republic of
Spain
Greece
Panama
Taiwan
Russian Federation
Israel


title: Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects

summary: The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

ReferenceCitation: Ruiz-Palacios GM, Leroux-Roels G, Beran J, Devaster JM, Esen M, Launay O, McElhaney JE, van Essen GA, Benoit A, Claeys C, Dewe W, Durand C, Duval X, Falsey AR, Feldman G, Galtier F, Gervais P, Hwang SJ, McNeil S, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. Immunogenicity of AS03-adjuvanted and non-adjuvanted trivalent inactivated influenza vaccines in elderly adults: A Phase 3, randomized trial and post-hoc correlate of protection analysis. Hum Vaccin Immunother. 2016 Dec;12(12):3043-3055. doi: 10.1080/21645515.2016.1219809.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

repositories:
HAL
PubMed Central
archive.ugent.be

repositories_concat: HAL;PubMed Central;archive.ugent.be

repositories_institution: Ghent University - Ghent University Academic Bibliography

publisher_dissemination: Informa

ReferenceCitation: van Essen GA, Beran J, Devaster JM, Durand C, Duval X, Esen M, Falsey AR, Feldman G, Gervais P, Innis BL, Kovac M, Launay O, Leroux-Roels G, McElhaney JE, McNeil S, Oujaa M, Richardus JH, Ruiz-Palacios G, Osborne RH, Oostvogels L. Influenza symptoms and their impact on elderly adults: randomised trial of AS03-adjuvanted or non-adjuvanted inactivated trivalent seasonal influenza vaccines. Influenza Other Respir Viruses. 2014 Jul;8(4):452-62. doi: 10.1111/irv.12245. Epub 2014 Apr 4.

repository_institution: Deakin University - Deakin Research Online

ReferenceCitation: McElhaney JE, Beran J, Devaster JM, Esen M, Launay O, Leroux-Roels G, Ruiz-Palacios GM, van Essen GA, Caplanusi A, Claeys C, Durand C, Duval X, El Idrissi M, Falsey AR, Feldman G, Frey SE, Galtier F, Hwang SJ, Innis BL, Kovac M, Kremsner P, McNeil S, Nowakowski A, Richardus JH, Trofa A, Oostvogels L; Influence65 study group. AS03-adjuvanted versus non-adjuvanted inactivated trivalent influenza vaccine against seasonal influenza in elderly people: a phase 3 randomised trial. Lancet Infect Dis. 2013 Jun;13(6):485-96. doi: 10.1016/S1473-3099(13)70046-X. Epub 2013 Mar 19.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Germany
Poland
Norway
United Kingdom
Romania
Netherlands
Mexico
Belgium
United States
Taiwan
Czechia
Canada
Estonia
Russian Federation
France


title: International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.

summary: This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

design_allocation: Non-Randomized

location_country:
Finland
Germany
Ireland
Poland
Australia
Luxembourg
Turkey
Canada
France
Czech Republic
Portugal
Hungary
Denmark
Switzerland
India
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Saudi Arabia
Spain
Greece
Sweden


title: A Phase II, Randomized, Parallel Group Safety, Efficacy, and Pharmacokinetics Study of BI 10773 (1 mg, 5 mg, 10 mg, 25 mg, and 50 mg) Administered Orally Once Daily Over 12 Weeks Compared Double Blind to Placebo With an Additional Open-label Sitagliptin Arm in Type 2 Diabetic Patients With Insufficient Glycemic Control Despite Metformin Therapy

summary: The objective of the current study is to investigate the efficacy, safety and pharmacokinetics of five doses of BI 10773 compared to placebo given for 12 weeks as add-on therapy to on going metformin therapy in patients with T2DM with insufficient glycemic control. In addition, there will be an open-label treatment arm with sitagliptin (JanuviaTM) as add-on therapy to metformin.

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

evidence: oa repository (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

version: submittedVersion

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repository_institution: University of Illinois at Chicago - INDIGO

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Diabetes Association

ReferenceCitation: Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.

location_country:
Finland
France
Germany
Slovakia
Hungary
Argentina
Norway
Romania
Austria
United States
Latvia
Spain
Ukraine
Estonia
Russian Federation
Czech Republic

location_facility: 1245.10.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37106 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10026 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54008 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3302B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37105 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40007 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10021 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37104 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37202 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37107 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.62001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34010 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3309A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3308A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37101 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3301B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3308B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3302A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.54006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3307A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70007 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10028 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10012 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10027 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10010 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311D Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10025 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34004 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37102 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37103 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3303C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.40005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3305C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10024 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3301A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3304B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.58003 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.47005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3311C Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10016 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34001 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.42005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310A Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.43002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.70006 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.34008 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.36005 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.38002 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3310B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.37201 Boehringer Ingelheim Investigational Site

location_facility: 1245.10.3306B Boehringer Ingelheim Investigational Site

location_facility: 1245.10.49004 Boehringer Ingelheim Investigational Site


title: A Phase IIb, Double Blind Randomized, Controlled Clinical Trial, to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) - Aramchol 005 Study

summary:
This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic.

Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1.

The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

ReferenceCitation: Ratziu V, de Guevara L, Safadi R, Poordad F, Fuster F, Flores-Figueroa J, Arrese M, Fracanzani AL, Ben Bashat D, Lackner K, Gorfine T, Kadosh S, Oren R, Halperin M, Hayardeny L, Loomba R, Friedman S; ARREST investigator study group; Sanyal AJ. Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2021 Oct;27(10):1825-1835. doi: 10.1038/s41591-021-01495-3. Epub 2021 Oct 7.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories_concat: HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

lead_sponsor: Galmed Research and Development, Ltd.

collaborators: Diamond Pharma Services Regulatory Affairs Consultancy

collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

location_country:
Germany
Italy
Lithuania
Israel
Hong Kong
Romania
Mexico
United States
Chile
Georgia
France

location_facility: The National Institute for Infectious Diseases "Prof. Dr. Matei Bals", Clinical Department for Adults II

location_facility: Unidad de Hígado Hospital Universitario Dr. José Eleuterio González

location_facility: Centre Hospitalier Universitaire (CHU) d'Angers

location_facility: "Ospedale Cristo Re" dell'Istituto Figlie di N.S. al Monte Calvario

location_facility: Policlinico Univestitario Campus Biomedico

location_facility: Profil Institue for Clinical Research Inc.

location_facility: Vilinius University Hospital Santariskiu Klinikos

location_facility: Consultorio Medico del Dr. Mauricio Castillo Barradas

location_facility: Azienda Ospedaliera di Rilievo Nazionale "A.Cardarelli"

location_facility: University of California Department of Medicine Division of Gastroenterology

location_facility: County Hospital Mures-Gastroenterology Department

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Instituto de Ciencias Medicas y de la Nutricion Salvador Zubiran

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne

location_facility: CHU Centre Hospiatalier Universitaire de Rennes

location_facility: Universitat Leipzig Medizinische Fakultat

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Gastroenterology Consultants of San Antonio

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: San Joseph Service Hepato Gastro Entrologie

location_facility: Azienda Ospidaliera Universitaria Seconda Universita di Napoli


title: A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

summary:
This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.

The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer

ReferenceCitation: Lu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, O'Regan R, Gasch C, Solovieff N, Wang C, Wang Y, Chakravartty A, Ji Y, Tripathy D. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial. Clin Cancer Res. 2022 Mar 1;28(5):851-859. doi: 10.1158/1078-0432.CCR-21-3032.

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Bardia A, Su F, Solovieff N, Im SA, Sohn J, Lee KS, Campos-Gomez S, Jung KH, Colleoni M, Vazquez RV, Franke F, Hurvitz S, Harbeck N, Chow L, Taran T, Rodriguez Lorenc K, Babbar N, Tripathy D, Lu YS. Genomic Profiling of Premenopausal HR+ and HER2- Metastatic Breast Cancer by Circulating Tumor DNA and Association of Genetic Alterations With Therapeutic Response to Endocrine Therapy and Ribociclib. JCO Precis Oncol. 2021 Sep 1;5:PO.20.00445. doi: 10.1200/PO.20.00445. eCollection 2021. Erratum In: JCO Precis Oncol. 2023 Mar;7:e2300102.

repository_institution: Yonsei University Medical Library - YUHSpace

repositories_institution: California Digital Library - eScholarship

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Pare L, Martinez D, Chic N, Martinez-Saez O, Braso-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum In: J Clin Oncol. 2021 Nov 1;39(31):3525. J Clin Oncol. 2023 Apr 20;41(12):2299-2301.

evidence: open (via page says license)

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

publisher_dissemination: Future Science Ltd

ReferenceCitation: Im SA, Lu YS, Bardia A, Harbeck N, Colleoni M, Franke F, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva-Vazquez R, Jung KH, Chakravartty A, Hughes G, Gounaris I, Rodriguez-Lorenc K, Taran T, Hurvitz S, Tripathy D. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019 Jul 25;381(4):307-316. doi: 10.1056/NEJMoa1903765. Epub 2019 Jun 4.

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018 Jul;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4. Epub 2018 May 24.

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Canada
France
Colombia
Portugal
Hungary
Hong Kong
Switzerland
United States
India
Lebanon
Belgium
Malaysia
Italy
Singapore
Mexico
United Arab Emirates
Korea, Republic of
Saudi Arabia
Spain
Greece
Taiwan
Bulgaria
Russian Federation

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: Tennessee Oncology Tennessee Oncology (3)

location_facility: Moanalua Medical Center. Attn: Oncology Dept SC

location_facility: University of Michigan Comprehensive Cancer Center Onc Dept

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3

location_facility: Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc

location_facility: Comprehensive Cancer Center at Saint Joseph Hospital SC

location_facility: Northwest Medical Specialties Dept of Onc

location_facility: The Center for Cancer and Blood Disorders SC

location_facility: Methodist Hospital / Methodist Cancer Center Dept of Oncology

location_facility: Duke University Medical Center Duke (SC)

location_facility: NorthWest Georgia Oncology Centers NW Georgia Oncology


title: A Phase 1, Open-Label, Dose-Escalation Study Evaluating the Safety, Pharmacokinetics, and Clinical Effects of Intravenously Administered PT-112 Injection in Subjects With Advanced Solid Tumors and Subsequent Dose Expansion Cohorts

summary:
This is a Phase 1/2, open-label, multi-center, non-randomized, dose-escalation study to be conducted in two parts: the Dose Escalation Phase and the Dose Expansion Phase. The Dose Escalation Phase will determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose(s) (RP2D) of PT-112 Injection and evaluate its safety and tolerability, and PK (pharmacokinetics).

The Dose Escalation Phase is complete and no longer enrolling.

The Dose Expansion Phase has two cohorts: one cohort for the study of PT-112 in patients with thymoma and thymic carcinoma (Cohort A), and one cohort for the study of PT-112 in metastatic castrate-resistant prostate cancer (mCRPC) (Cohort D).

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Karp DD, Camidge DR, Infante JR, Ames TD, Price MR, Jimeno J, Bryce AH. Phase I study of PT-112, a novel pyrophosphate-platinum immunogenic cell death inducer, in advanced solid tumours. EClinicalMedicine. 2022 May 27;49:101430. doi: 10.1016/j.eclinm.2022.101430. eCollection 2022 Jul.

lead_sponsor: Promontory Therapeutics Inc.

location_country:
United States
France

location_facility: University of Texas MD Anderson Cancer Center


title: Patient Perception of Symptom Variability. A Cross-sectional Study of Patients With Severe COPD.

summary: This study is investigating how patients with severe stable state COPD perceive the variability of their symptoms throughout the day, the week and the year; the impact of these variations on their daily activities or sleep quality and how they deal with their treatments. For this purpose patients will be asked to answer a questionnaire over the phone

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Kessler R, Partridge MR, Miravitlles M, Cazzola M, Vogelmeier C, Leynaud D, Ostinelli J. Symptom variability in patients with severe COPD: a pan-European cross-sectional study. Eur Respir J. 2011 Feb;37(2):264-72. doi: 10.1183/09031936.00051110. Epub 2010 Nov 29.

lead_sponsor: AstraZeneca

location_country:
Finland
Germany
Ireland
Italy
Portugal
Norway
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
Turkey
France


title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies

summary: This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 [Roche protocol WA18062], NCT00106574 [Roche protocol WA18063], and NCT00109408 [Roche protocol WA17824]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

ReferenceCitation: Jones G, Wallace T, McIntosh MJ, Brockwell L, Gomez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

publisher_dissemination: The Journal of Rheumatology

location_country:
Finland
Germany
Argentina
Australia
Brazil
Costa Rica
Thailand
Canada
Serbia
France
Czech Republic
Lithuania
Slovenia
Portugal
Hong Kong
Denmark
Switzerland
United States
Iceland
Belgium
China
Peru
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Spain
Panama
South Africa
Russian Federation
Israel


acronym: PEACE III

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

summary: The primary objective of the trial is to assess if upfront combination of enzalutamide and Ra223 improves radiological progression-free survival (rPFS1) compared to enzalutamide single agent in CRPC patients metastatic to bone

sponsor_collaborators: Latin American Cooperative Oncology Group

location_facility: Assistance Publique - Hopitaux de Paris - CHU Henri Mondor

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: Hamilton And District Urology Association

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: United Lincolnshire Hospitals NHS Trust - Lincoln County Hospital

location_facility: Instituto de Medicina Integral Professor Fernando Figueira - IMIP

location_facility: Royal Marsden Hospital - Chelsea, London

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: CHUM - Centre Hospitalier de l'Université de Montreal - Pavillon Saint-Luc

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Centro de Pesquisas Clinicas em Oncologia - Hospital Sao Lucas

location_facility: Centro de Tratamentos de Tumores Botafogo

location_facility: University Health Network - Oci Princess Margaret Hospital

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Paul Papin

location_facility: Oncology Institute of Southern Switzerland - Ospedale San Giovanni

location_facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre

location_facility: Hospital Clinic Universitari de Barcelona

location_facility: Sao Camilo Oncologia - Instituto Brasileiro de Controle do Cancer

location_facility: Hopitaux Universitaires de Strasbourg - Hôpitaux Universitaires de Strasbourg - Hôpital civil

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Centre de sante et de services sociaux de Chicoutimi

location_facility: Centro de Estudos e Pesquisa Hematologia e Oncologia

title: A Randomized Multicenter Phase III Trial Comparing Enzalutamide vs. a Combination of Ra223 and Enzalutamide in Asymptomatic or Mildly Symptomatic Castration Resistant Prostate Cancer Patients Metastatic to Bone.

location_country:
Ireland
Italy
Poland
Norway
United Kingdom
Denmark
Brazil
Switzerland
Belgium
Spain
Canada
France


title: A DB Four-Arm, Parallel Group, Proof of Concept, Dose-Finding Adaptive Phase 2a/2b RCT to Investigate the Safety, Tolerability and Efficacy and Effect on QoL of Human Recombinant Alkaline Phosphatase in Patients With Sepsis-Associated AKI

acronym: STOP-AKI

summary: The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.

ReferenceCitation: Pickkers P, Mehta RL, Murray PT, Joannidis M, Molitoris BA, Kellum JA, Bachler M, Hoste EAJ, Hoiting O, Krell K, Ostermann M, Rozendaal W, Valkonen M, Brealey D, Beishuizen A, Meziani F, Murugan R, de Geus H, Payen D, van den Berg E, Arend J; STOP-AKI Investigators. Effect of Human Recombinant Alkaline Phosphatase on 7-Day Creatinine Clearance in Patients With Sepsis-Associated Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1998-2009. doi: 10.1001/jama.2018.14283.

repository_institution: Radboud University - Radboud Repository

repositories_concat: PubMed Central;repository.ubn.ru.nl

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher_dissemination: American Medical Association

ReferenceCitation: Peters E, Mehta RL, Murray PT, Hummel J, Joannidis M, Kellum JA, Arend J, Pickkers P. Study protocol for a multicentre randomised controlled trial: Safety, Tolerability, efficacy and quality of life Of a human recombinant alkaline Phosphatase in patients with sepsis-associated Acute Kidney Injury (STOP-AKI). BMJ Open. 2016 Sep 27;6(9):e012371. doi: 10.1136/bmjopen-2016-012371.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

lead_sponsor: AM-Pharma

sponsor_collaborators: AM-Pharma PPD

location_country:
Finland
Germany
Ireland
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
Czechia
France

location_facility: University Hospital Frankfurt, Anaesthesia, Intensive Care Medicine & Pain Therapy

location_facility: Tampa General Hospital, Division Emergency Medicine

location_facility: Medizinische Hochschule Hannover Hospital - Zentrum Innere Medizin - Klinik fuer Pneumologie

location_facility: Helios Klinikum Erfurt -Klinik fur Anaesthesie, Intensivmedizin und Schmerztherapie

location_facility: Universitätsmedizin Greifswald Klinik für Anästhesiologie, IntensivmedizinNotfallmedizin und Schmerzmedizin

location_facility: Universitätsklinikum Hamburg Eppendorf Department Intensive Care Medicine

location_facility: Hospital Universitario 12 de Octubre, Unidad de Cuidados Intensivos Hospital General

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Centre Hospitalier Victor Dupouy - hopital

location_facility: Universitatsklinikum Jena - Klinik für Anästhesiologie und Intensivmedzin

location_facility: Hospital Universitario Germans Trias i Pujol Medicina Intensiva Hospital General,

location_facility: Universitätsklinikum Schleswig-Holstein - Klinik für Anästhesiologie und Operative Intensivmedizin

location_facility: Royal Surrey County Hospital - Intensive Care Unit

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: University of Texas Houston Medical School

location_facility: Universitätsklinik für Allgemeine und Chirurgische Intensivmedizin

intervention_type: Other


summary: A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

ReferenceCitation: King-Kallimanis BL, Bhatnagar V, Horodniceanu EG, Chen TY, Kluetz PG. Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events. Clin Trials. 2022 Jun;19(3):267-273. doi: 10.1177/17407745221093935. Epub 2022 May 15.

publisher_dissemination: SAGE Publications

ReferenceCitation: Singh J, Bourke S, Dyer M, Devlin N, Longworth L. An Analysis of 5-Level Version of EQ-5D Adjusting for Treatment Switching: The Case of Patients With Epidermal Growth Factor Receptor T790M-Positive Nonsmall Cell Lung Cancer Treated With Osimertinib. Value Health. 2022 Jul;25(7):1205-1211. doi: 10.1016/j.jval.2022.01.022. Epub 2022 Apr 2.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Papadimitrakopoulou VA, Mok TS, Han JY, Ahn MJ, Delmonte A, Ramalingam SS, Kim SW, Shepherd FA, Laskin J, He Y, Akamatsu H, Theelen WSME, Su WC, John T, Sebastian M, Mann H, Miranda M, Laus G, Rukazenkov Y, Wu YL. Osimertinib versus platinum-pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor: AURA3 overall survival analysis. Ann Oncol. 2020 Nov;31(11):1536-1544. doi: 10.1016/j.annonc.2020.08.2100. Epub 2020 Aug 27.

ReferenceCitation: Papadimitrakopoulou VA, Han JY, Ahn MJ, Ramalingam SS, Delmonte A, Hsia TC, Laskin J, Kim SW, He Y, Tsai CM, Hida T, Maemondo M, Kato T, Jenkins S, Patel S, Huang X, Laus G, Markovets A, Thress KS, Wu YL, Mok T. Epidermal growth factor receptor mutation analysis in tissue and plasma from the AURA3 trial: Osimertinib versus platinum-pemetrexed for T790M mutation-positive advanced non-small cell lung cancer. Cancer. 2020 Jan 15;126(2):373-380. doi: 10.1002/cncr.32503. Epub 2019 Nov 26.

ReferenceCitation: Wu YL, Ahn MJ, Garassino MC, Han JY, Katakami N, Kim HR, Hodge R, Kaur P, Brown AP, Ghiorghiu D, Papadimitrakopoulou VA, Mok TSK. CNS Efficacy of Osimertinib in Patients With T790M-Positive Advanced Non-Small-Cell Lung Cancer: Data From a Randomized Phase III Trial (AURA3). J Clin Oncol. 2018 Sep 10;36(26):2702-2709. doi: 10.1200/JCO.2018.77.9363. Epub 2018 Jul 30.

ReferenceCitation: Lee CK, Novello S, Ryden A, Mann H, Mok T. Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial. J Clin Oncol. 2018 Jun 20;36(18):1853-1860. doi: 10.1200/JCO.2017.77.2293. Epub 2018 May 7.

repository_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Akamatsu H, Katakami N, Okamoto I, Kato T, Kim YH, Imamura F, Shinkai M, Hodge RA, Uchida H, Hida T. Osimertinib in Japanese patients with EGFR T790M mutation-positive advanced non-small-cell lung cancer: AURA3 trial. Cancer Sci. 2018 Jun;109(6):1930-1938. doi: 10.1111/cas.13623. Epub 2018 May 31.

repository_institution: PubMed Central - Europe PMC

repository_institution: Kyoto University - Kyoto University Research Information Repository

ReferenceCitation: Mok TS, Wu Y-L, Ahn M-J, Garassino MC, Kim HR, Ramalingam SS, Shepherd FA, He Y, Akamatsu H, Theelen WS, Lee CK, Sebastian M, Templeton A, Mann H, Marotti M, Ghiorghiu S, Papadimitrakopoulou VA; AURA3 Investigators. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017 Feb 16;376(7):629-640. doi: 10.1056/NEJMoa1612674. Epub 2016 Dec 6.

ReferenceCitation: Soria JC, Wu YL, Nakagawa K, Kim SW, Yang JJ, Ahn MJ, Wang J, Yang JC, Lu Y, Atagi S, Ponce S, Lee DH, Liu Y, Yoh K, Zhou JY, Shi X, Webster A, Jiang H, Mok TS. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol. 2015 Aug;16(8):990-8. doi: 10.1016/S1470-2045(15)00121-7. Epub 2015 Jul 6.

title: A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum-Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3).

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Germany
Italy
Hungary
Hong Kong
United Kingdom
Australia
Japan
Netherlands
Mexico
Sweden
United States
China
Korea, Republic of
Spain
Taiwan
Canada
Russian Federation
France