title: Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo

acronym: EXPEDITION 3

summary: To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.

ReferenceCitation: Honig LS, Vellas B, Woodward M, Boada M, Bullock R, Borrie M, Hager K, Andreasen N, Scarpini E, Liu-Seifert H, Case M, Dean RA, Hake A, Sundell K, Poole Hoffmann V, Carlson C, Khanna R, Mintun M, DeMattos R, Selzler KJ, Siemers E. Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease. N Engl J Med. 2018 Jan 25;378(4):321-330. doi: 10.1056/NEJMoa1705971.

name: From the Department of Neurology and Taub Institute for Research on Alzheimer’s Disease and the Aging Brain, Columbia University Medical Center, New York (L.S.H.); Gérontopôle, Centre Hospitalier Universitaire Toulouse, Unité Mixte de Recherche INSERM Unité 1027 Université Toulouse III–Paul Sabatier, Toulouse, France (B.V.); Austin Health Continuing Care Clinical Service Unit, Heidelberg, and the University of Melbourne, Melbourne, VIC — both in Australia (M.W.); Fundació ACE, Alzheimer Research Center...

family: Honig

full_name: Lawrence S. Honig

given: Lawrence S.

family: Vellas

full_name: Bruno Vellas

given: Bruno

family: Woodward

full_name: Michael Woodward

given: Michael

family: Boada

full_name: Mercè Boada

given: Mercè

family: Bullock

full_name: Roger Bullock

given: Roger

family: Borrie

full_name: Michael Borrie

family: Hager

full_name: Klaus Hager

given: Klaus

family: Andreasen

full_name: Niels Andreasen

given: Niels

family: Scarpini

full_name: Elio Scarpini

given: Elio

family: Liu-Seifert

full_name: Hong Liu-Seifert

given: Hong

family: Case

full_name: Michael Case

family: Dean

full_name: Robert A. Dean

given: Robert A.

family: Hake

full_name: Ann Hake

given: Ann

family: Sundell

full_name: Karen Sundell

given: Karen

family: Poole Hoffmann

full_name: Vicki Poole Hoffmann

given: Vicki

family: Carlson

full_name: Christopher Carlson

given: Christopher

family: Khanna

full_name: Rashna Khanna

given: Rashna

family: Mintun

full_name: Mark Mintun

given: Mark

family: DeMattos

full_name: Ronald DeMattos

given: Ronald

family: Selzler

full_name: Katherine J. Selzler

given: Katherine J.

family: Siemers

full_name: Eric Siemers

given: Eric

journal_name: New England Journal of Medicine

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

title: Trial of Solanezumab for Mild Dementia Due to Alzheimer’s Disease

location_country:
Italy
United States
Sweden
Germany
France
Japan
Poland
Australia
Spain
Canada
United Kingdom

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: University of California, Davis - Health Systems

location_facility: Associated Neurologists of Southern Connecticut

location_facility: Miami Jewish Home and Hospital for the Aged

location_facility: Institute for Memory Impairment & Neurological Disorders

location_facility: Quillen College of Medicine, East TN State University

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Vanderbilt Univeristy School of Medicine

location_facility: University Psychiatry Associates Avera Health

location_facility: Institute for Neurodegenerative Disorders

location_facility: American Neuropsychiatric Research Institute, Inc

location_facility: ANI Arizona Neurological Institute Research, PC

location_facility: National Clinical Research - Norfolk Inc

location_facility: Univ of Southern California Medical Center

location_facility: Drexel University College of Medicine at EPPI

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: University of California Los Angeles School of Medicine

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: Rhode Island Mood & Memory Research Institute

location_facility: Jacksonville Center for Clinical Research

location_facility: Veterans Affairs Puget Sound Health Care System

location_facility: Collaborative Neuroscience Network - CNS

location_facility: Parkinson's Disease and Movement Disorders


ReferenceType: derived

ReferenceCitation: Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2021 Oct 27. pii: annrheumdis-2021-221276. doi: 10.1136/annrheumdis-2021-221276. [Epub ahead of print]

family: Taylor

full_name: Peter C Taylor

given: Peter C

sequence: first

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

sequence: additional

family: Burmester

full_name: Gerd R Burmester

given: Gerd R

family: Durez

full_name: Patrick Durez

given: Patrick

family: Smolen

full_name: Josef S Smolen

given: Josef S

family: Deberdt

full_name: Walter Deberdt

given: Walter

family: Issa

full_name: Maher Issa

given: Maher

family: Terres

full_name: Jorge Ross Terres

given: Jorge Ross

family: Bello

full_name: Natalia Bello

given: Natalia

family: Winthrop

full_name: Kevin L Winthrop

given: Kevin L

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of the Rheumatic Diseases

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.

family: Wells

full_name: Alvin F. Wells

given: Alvin F.

family: Jia

full_name: Bochao Jia

given: Bochao

family: Xie

full_name: Li Xie

given: Li

family: Valenzuela

full_name: Guillermo J. Valenzuela

given: Guillermo J.

family: Keystone

full_name: Edward C. Keystone

given: Edward C.

family: Li

full_name: Zhanguo Li

given: Zhanguo

family: Quebe

full_name: Amanda K. Quebe

given: Amanda K.

family: Griffing

full_name: Kirstin Griffing

given: Kirstin

family: Otawa

full_name: Susan Otawa

given: Susan

family: Haraoui

full_name: Boulos Haraoui

ReferenceCitation: Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.

name: University of Texas Southwestern Medical Center  Dallas

name: Keio University School of Medicine  Tokyo Japan

name: Eli Lilly and Company  Indianapolis Indiana

name: Centro Paulista de Investigação Clinica  São Paulo Brazil

title: Efficacy and Safety of Long‐Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate

ReferenceCitation: Tanaka Y, Fautrel B, Keystone EC, Ortmann RA, Xie L, Zhu B, Issa M, Patel H, Gaich CL, de Bono S, Rooney TP, Taylor PC. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30.

ReferenceCitation: Winthrop KL, Bingham CO 3rd, Komocsar WJ, Bradley J, Issa M, Klar R, Kartman CE. Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial substudy. Arthritis Res Ther. 2019 Apr 18;21(1):102. doi: 10.1186/s13075-019-1883-1.

ReferenceCitation: Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum in: J Rheumatol. 2019 Dec;46(12):1648-1649.

ReferenceCitation: Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.

name: University of Occupational and Environmental Health Japan Kitakyushu Japan

name: Botnar Research Centre and University of Oxford Oxford UK

name: Eli Lilly and Company Indianapolis Indiana

name: NIHR Leeds Musculoskeletal Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, and University of Leeds Leeds UK

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

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_institution: The University of Glasgow - Enlighten: Publications

title: Characterization and Changes of Lymphocyte Subsets in Baricitinib‐Treated Patients With Rheumatoid Arthritis

ReferenceCitation: Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20. Review.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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.

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
Croatia
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Hungary
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey
Latvia

location_facility: ELIMATES BRNO s.r.o. Revmatologicka ambulance

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: West Broward Rheumatology Associates, Inc

location_facility: Hokkaido Medical Center for Rheumatic Diseases

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Daegu Catholic University Medical Center

location_facility: Hôpital Arnaud de Villeneuve - CHU Montpellier

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: Krishna Institute of Medical Sciences Ltd.

location_facility: Clinical Emergency Hospital N.V.Solovyov

location_facility: Yoshitama Clinic Rheumatology & Internal Medicine

location_facility: Arthritis and Osteoporosis Consultants of the Carolinas

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet

location_facility: St Marianna University School of Medicine Hospital

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Basingstoke and North Hampshire Hospital

location_facility: Consultorios Asociados de Endocrinologia

location_facility: Hospital Universitario La Fe de Valencia

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: City Clinical Hospital 1 named after N.I. Pirogov

location_facility: Reumatologiska Kliniken Skånes universitetssjukhus Malmö

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Arthritis and Osteporosis Treatment and Research Center

location_facility: Manipal Centre for Clinical Research (MCCR)

location_facility: Niagara Peninsula Arthritis Centre, Inc.

location_facility: Rheumatology Associates of Central Florida

location_facility: Spital Clinic Judetean de Urgenta Tg.Mures

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Comite Mexicano para la Prevencion de la Osteoporosis A.C.

location_facility: CENIT Centro de Neurociencias, Investigación y Tratamiento

location_facility: Unidad de Investigacion en Enfermedades Cronico Degenerative

location_facility: KLES Prabhakar Kore Hospital and Medical Research Centre

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: Immunologisches Zentrum Vogelsang-Gommern GmbH

location_facility: Mexico Centre for Clinical Research SA de CV

location_facility: Rheumatology Practice in Jaunliepaja Primary Health Care Cen

location_facility: The First Affiliate Hospital of AnHui Medical University

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Shizuoka Rheumatism orthopedic Rehabilitation Hospital

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: University of Occupational and Enviromental Health

location_facility: Kyunghee University Hospital at Gangdong

location_facility: Xiangya Hospital, Central South University

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: CEPIC - Centro Paulista de Investigação Clínica

location_facility: Associacao de Assistencia a Crianca Deficiente (AACD)

location_facility: Catholic University of Korea Yeouido St. Mary's Hospital

location_facility: Centro de Medicina Familiar Mindout Research

location_facility: University General Hospital of Heraklion

location_facility: Centro de Enfermedades del Higado y Aparato Digestivo

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: CIR Centro de Investigacions Reumatologicas

location_facility: Center for Arthritis and Rheumatic Diseases, PC

location_facility: JA-Shizuoka Shizuoka-Kosei General Hospital

location_facility: Hospital Privado Centro Medico de Cordoba SA

location_facility: Carolina Rheumatology and Neurology Associates

location_facility: Szabolcs-Szatmar-Bereg M-i Korhazak es Egyetemi Oktatokorhaz

location_facility: Organizacion Medica de Investigacion - OMI

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: Afflilated Hospital of Bengbu Medical College

location_facility: Yoshida Orthopaedic and Rheumatic Clinic

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Tokyo Women's Medical University East Medical Center

location_facility: Pauls Stradins Kliniska Universitates Slimnica

location_facility: Asheville Rheumatology & Osteoporosis Research Assoc, PA

location_facility: 1st Hospital affiliated to Medical College of Shantou Univer

location_facility: Centro de Estudios de Investigacion Basica y Clinica, S.C.

location_facility: CHUV Centre Hospitalier Universitaire Vaudois

location_facility: Allergy Asthma Immunology of Rochester, AAIR Research Ctr

location_facility: Tsuzuki Azuma Clinic: Primary care and Rheumatology

location_facility: Komagamine Orthopedic and Rheumatology Clinic

location_facility: Shri Nidan Hospital & Hope Fertility Centre

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Kondo Clinic for Rheumatism and Orthopaedics

location_facility: Allergy and Rheumatology Medical Clinic Inc

location_facility: (AOA) Arthritis & Osteoporosis Associates

location_facility: Instituto Medico de Alta Complejidad San Isidro

title: A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis

summary:
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study.

The study provides for 7 years of additional treatment with baricitinib.


title: A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy

acronym: METEOR

summary: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Powles T, Choueiri TK, Motzer RJ, Jonasch E, Pal S, Tannir NM, Signoretti S, Kaldate R, Scheffold C, Wang E, Aftab DT, Escudier B, George DJ. Outcomes based on plasma biomarkers in METEOR, a randomized phase 3 trial of cabozantinib vs everolimus in advanced renal cell carcinoma. BMC Cancer. 2021 Aug 7;21(1):904. doi: 10.1186/s12885-021-08630-w. Erratum in: BMC Cancer. 2021 Sep 15;21(1):1023.

family: Powles

full_name: Thomas Powles

given: Thomas

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

family: Motzer

full_name: Robert J. Motzer

given: Robert J.

family: Jonasch

full_name: Eric Jonasch

given: Eric

family: Pal

full_name: Sumanta Pal

given: Sumanta

family: Tannir

full_name: Nizar M. Tannir

given: Nizar M.

family: Signoretti

full_name: Sabina Signoretti

given: Sabina

family: Kaldate

full_name: Rajesh Kaldate

given: Rajesh

family: Scheffold

full_name: Christian Scheffold

given: Christian

family: Wang

full_name: Evelyn Wang

given: Evelyn

family: Aftab

full_name: Dana T. Aftab

given: Dana T.

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: George

full_name: Daniel J. George

given: Daniel J.

currency_apc_doaj: GBP

journal_name: BMC Cancer

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Donskov F, Motzer RJ, Voog E, Hovey E, Grüllich C, Nott LM, Cuff K, Gil T, Jensen NV, Chevreau C, Negrier S, Depenbusch R, Bergmann L, Cornelio I, Champsaur A, Escudier B, Pal S, Powles T, Choueiri TK. Outcomes based on age in the phase III METEOR trial of cabozantinib versus everolimus in patients with advanced renal cell carcinoma. Eur J Cancer. 2020 Feb;126:1-10. doi: 10.1016/j.ejca.2019.10.032. Epub 2019 Dec 27.

family: Donskov

full_name: Frede Donskov

given: Frede

family: Voog

full_name: Eric Voog

family: Hovey

full_name: Elizabeth Hovey

given: Elizabeth

family: Grüllich

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

ReferenceCitation: Flaifel A, Xie W, Braun DA, Ficial M, Bakouny Z, Nassar AH, Jennings RB, Escudier B, George DJ, Motzer RJ, Morris MJ, Powles T, Wang E, Huang Y, Freeman GJ, Choueiri TK, Signoretti S. PD-L1 Expression and Clinical Outcomes to Cabozantinib, Everolimus, and Sunitinib in Patients with Metastatic Renal Cell Carcinoma: Analysis of the Randomized Clinical Trials METEOR and CABOSUN. Clin Cancer Res. 2019 Oct 15;25(20):6080-6088. doi: 10.1158/1078-0432.CCR-19-1135. Epub 2019 Aug 1.

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Cella D, Escudier B, Tannir NM, Powles T, Donskov F, Peltola K, Schmidinger M, Heng DYC, Mainwaring PN, Hammers HJ, Lee JL, Roth BJ, Marteau F, Williams P, Baer J, Mangeshkar M, Scheffold C, Hutson TE, Pal S, Motzer RJ, Choueiri TK. Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial. J Clin Oncol. 2018 Mar 10;36(8):757-764. doi: 10.1200/JCO.2017.75.2170. Epub 2018 Jan 29.

name: David Cella, Northwestern University Feinberg School of Medicine, Chicago, IL; Bernard Escudier, Institut Gustave Roussy, Villejuif; Florence Marteau, Ipsen Pharma, Boulogne-Billancourt; Paul Williams, Mapi Group, Lyon, France; Nizar M. Tannir, University of Texas MD Anderson Cancer Center Hospital, Houston; Hans J. Hammers, University of Texas Southwestern Medical Center; Thomas E. Hutson, Texas Oncology-Baylor Sammons Cancer Center, Dallas, TX; Thomas Powles, Queen Mary University of London, London,...

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Escudier B, Powles T, Motzer RJ, Olencki T, Arén Frontera O, Oudard S, Rolland F, Tomczak P, Castellano D, Appleman LJ, Drabkin H, Vaena D, Milwee S, Youkstetter J, Lougheed JC, Bracarda S, Choueiri TK. Cabozantinib, a New Standard of Care for Patients With Advanced Renal Cell Carcinoma and Bone Metastases? Subgroup Analysis of the METEOR Trial. J Clin Oncol. 2018 Mar 10;36(8):765-772. doi: 10.1200/JCO.2017.74.7352. Epub 2018 Jan 8.

name: Bernard Escudier, Institut Gustave Roussy, Villejuif; Stephane Oudard, Hôpital Européen Georges Pompidou, Paris; Frederic Rolland, Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes, Saint-Herblain, France; Thomas Powles, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom; Robert J. Motzer, Memorial Sloan Kettering Cancer Center, New York, NY; Thomas Olencki, Ohio State University, Columbus, OH; Osvaldo Arén Frontera, Centro Internacional de Estudios Clinicos,...

ReferenceCitation: Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Géczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ; METEOR Investigators. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1814-23. doi: 10.1056/NEJMoa1510016. Epub 2015 Sep 25.

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Chile
Sweden
Netherlands
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Spain
Turkey


type: EudraCT Number

title: A Double-Blind, Placebo-Controlled, Randomised, Phase II Study Evaluating the Efficacy and Safety of Addition of Continuous Multiple Line Bevacizumab Treatment to Lomustine in Second (2nd)-Line Followed by Standard of Care (SOC) in Third (3rd)-Line and Beyond Compared to Addition of Placebo, Following First Progression of Disease (PD1) in Patients With Glioblastoma (GBM) After First (1st)-Line Treatment With Radiotherapy, Temozolomide and Bevacizumab

summary: This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line [2L] treatment) and SOC (in 3rd-line [3L] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant).

study_start_date_type: Actual

ReferenceCitation: Brandes AA, Gil-Gil M, Saran F, Carpentier AF, Nowak AK, Mason W, Zagonel V, Dubois F, Finocchiaro G, Fountzilas G, Cernea DM, Chinot O, Anghel R, Ghiringhelli F, Beauchesne P, Lombardi G, Franceschi E, Makrutzki M, Mpofu C, Urban HJ, Pichler J. A Randomized Phase II Trial (TAMIGA) Evaluating the Efficacy and Safety of Continuous Bevacizumab Through Multiple Lines of Treatment for Recurrent Glioblastoma. Oncologist. 2019 Apr;24(4):521-528. doi: 10.1634/theoncologist.2018-0290. Epub 2018 Sep 28.

name: Department of Medical Oncology, AUSLBolognaItaly

family: Brandes

full_name: Alba A. Brandes

given: Alba A.

name: Institut Catala d'Oncologia, L'Hospitalet, Institut d'Investigació Biomédica de Bellvitge (IDIBELL)BarcelonaSpain

family: Gil‐Gil

full_name: Miguel Gil‐Gil

given: Miguel

name: Royal Marsden National Health Service Foundation Trust, SuttonUnited Kingdom

family: Saran

full_name: Frank Saran

given: Frank

name: Paris 7 University, Assistance publique ‐ Hôpitaux de Paris (AP‐HP) Paris France

family: Carpentier

full_name: Antoine F. Carpentier

given: Antoine F.

name: School of Medicine, University of Western Australia Crawley Australia

family: Nowak

full_name: Anna K. Nowak

given: Anna K.

name: Cancer Clinical Research Unit, Princess Margaret Cancer Centre Toronto Canada

family: Mason

full_name: Warren Mason

given: Warren

name: Department of Clinical and Experimental Oncology, Medical Oncology Unit 1, Veneto Institute of Oncology‐IRCCS Padua Italy

family: Zagonel

full_name: Vittorina Zagonel

given: Vittorina

name: Centre Hospitalier Régional et Universitaire de Lille Lille France

family: Dubois

full_name: François Dubois

given: François

name: Istituto Neurologico Carlo Besta Milan Italy

family: Finocchiaro

full_name: Gaetano Finocchiaro

given: Gaetano

name: Aristotle University of Thessaloniki Thessaloniki Greece

family: Fountzilas

full_name: George Fountzilas

given: George

name: The Oncology Institute “Prof. Dr. Ion Chiricuta,” Cluj‐Napoca Romania

family: Cernea

full_name: Dana Michaela Cernea

given: Dana Michaela

name: Aix‐Marseille University, Assistance publique ‐ Hôpitaux de Marseille (AP‐HM), CHU Timone Marseille France

family: Chinot

full_name: Oliver Chinot

given: Oliver

name: Alexandru Trestioreanu Bucharest Institute of Oncology Bucharest Romania

name: Carol Davila University of Medicine and Pharmacy Bucharest Bucharest Romania

family: Anghel

full_name: Rodica Anghel

given: Rodica

name: Centre Georges Francois Leclerc Dijon France

family: Ghiringhelli

full_name: Francois Ghiringhelli

given: Francois

name: Département de Neuro‐Oncologie, Hôpital Central Nancy France

family: Beauchesne

full_name: Patrick Beauchesne

given: Patrick

family: Lombardi

full_name: Giuseppe Lombardi

given: Giuseppe

family: Franceschi

full_name: Enrico Franceschi

given: Enrico

name: F. Hoffmann‐La Roche Ltd. Basel Switzerland

family: Makrutzki

full_name: Martina Makrutzki

given: Martina

family: Mpofu

full_name: Chiedzo Mpofu

given: Chiedzo

family: Urban

full_name: Hans‐Joerg Urban

given: Hans‐Joerg

name: Institut für Innere Medizin mit Neuroonkologie Linz Austria

family: Pichler

full_name: Josef Pichler

given: Josef

journal_name: The Oncologist

oa_host_type: repository

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

ReferenceCitation: Brandes AA, Mason W, Pichler J, Nowak AK, Gil M, Saran F, Revil C, Lutiger B, Carpentier AF. Can bevacizumab prolong survival for glioblastoma patients through multiple lines of therapy? Future Oncol. 2014 May;10(7):1137-45. doi: 10.2217/fon.14.75.

location_country:
Italy
Austria
Sweden
United Kingdom
Spain
Croatia
Bulgaria
France
Greece
Romania
Portugal
Estonia
Canada
Latvia
Turkey

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Agioi Anargyroi Anticancer Hospital; Radiotherapeutic Clinic

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie

location_facility: Norrlands Universitetssjukhus; Cancer Centrum

location_facility: Riga East Clinical University hospital, Clinic Gailezers, Dept of Neurosurgery

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Ospedale Bellaria; U.O. Oncologia Medica

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hôpital Central; Departement de Neuro-Oncologie

location_facility: University College Hospital; Department of Oncology

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Baskent Universitesi Tıp Fakultesi; Ic Hastalıkları Anabilim Dalı Tıbbi Onkoloji Bilim Dalı

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

location_facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

summary:
Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

Safety and tolerability
Dupilumab systemic exposure and anti-drug antibodies

ReferenceType: result

ReferenceCitation: Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016 Jul 2;388(10039):31-44. doi: 10.1016/S0140-6736(16)30307-5. Epub 2016 Apr 27.

family: Wenzel

full_name: Sally Wenzel

given: Sally

family: Castro

full_name: Mario Castro

given: Mario

family: Corren

full_name: Jonathan Corren

given: Jonathan

family: Maspero

full_name: Jorge Maspero

given: Jorge

family: Wang

full_name: Lin Wang

given: Lin

family: Zhang

full_name: Bingzhi Zhang

given: Bingzhi

family: Pirozzi

full_name: Gianluca Pirozzi

given: Gianluca

family: Sutherland

full_name: E Rand Sutherland

given: E Rand

family: Evans

full_name: Robert R Evans

given: Robert R

family: Joish

full_name: Vijay N Joish

given: Vijay N

family: Eckert

full_name: Laurent Eckert

given: Laurent

family: Graham

full_name: Neil M H Graham

given: Neil M H

family: Stahl

full_name: Neil Stahl

given: Neil

family: Yancopoulos

full_name: George D Yancopoulos

given: George D

family: Louis-Tisserand

full_name: Mariana Louis-Tisserand

given: Mariana

family: Teper

full_name: Ariel Teper

given: Ariel

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Bourdin A, Papi AA, Corren J, Virchow JC, Rice MS, Deniz Y, Djandji M, Rowe P, Pavord ID. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021 Jan;76(1):269-280. doi: 10.1111/all.14611. Epub 2020 Oct 21.

name: Department of Respiratory Diseases INSERM U1046 University of Montpellier Montpellier France

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

name: Università degli Studi di Ferrara Ferrara Italy

family: Papi

full_name: Alberto A. Papi

given: Alberto A.

name: David Geffen School of Medicine at UCLA Los Angeles CA USA

name: Universitätsmedizin Rostock Rostock Germany

family: Virchow

full_name: J. Christian Virchow

given: J. Christian

family: Rice

name: Regeneron Pharmaceuticals, Inc. Tarrytown NY USA

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

title: Dupilumab is effective in type 2‐high asthma patients receiving high‐dose inhaled corticosteroids at baseline

ReferenceCitation: Maspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24.

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Corren J, Castro M, Ford LB, Bernstein JA, Jayawardena S, Maroni J, Rowe P, Amin N, Pirozzi G, Graham NMH, Khan A, Eckert L, Teper A. Dupilumab improves asthma outcomes irrespective of frequency of previous asthma exacerbation history. Ann Allergy Asthma Immunol. 2019 Aug;123(2):222-224.e1. doi: 10.1016/j.anai.2019.04.028. Epub 2019 May 8.

ReferenceCitation: Corren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbé A, Taniou C, Mahajan P, Teper A, Pirozzi G, Eckert L. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019 Jan;122(1):41-49.e2. doi: 10.1016/j.anai.2018.08.005. Epub 2018 Aug 21.

ReferenceCitation: Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, Joish VN, Amin N, Maroni J, Rowe P, Graham NMH, Teper A. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018 Jul;142(1):171-177.e1. doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31.

location_country:
Italy
South Africa
Chile
Mexico
Spain
France
Japan
Poland
Argentina
Australia
New Zealand
Russian Federation
Turkey
United States
Korea, Republic of
Ukraine

location_facility:
Investigational Site Number 250005
Investigational Site Number 840053
Investigational Site Number 840016
Investigational Site Number 392021
Investigational Site Number 792005
Investigational Site Number 840031
Investigational Site Number 710002
Investigational Site Number 410004
Investigational Site Number 032006
Investigational Site Number 804003
Investigational Site Number 616008
Investigational Site Number 792008
Investigational Site Number 036008
Investigational Site Number 643010
Investigational Site Number 724001
Investigational Site Number 804002
Investigational Site Number 792011
Investigational Site Number 840011
Investigational Site Number 392007
Investigational Site Number 392041
Investigational Site Number 840008
Investigational Site Number 380005
Investigational Site Number 840033
Investigational Site Number 792002
Investigational Site Number 152008
Investigational Site Number 380003
Investigational Site Number 410001
Investigational Site Number 250010
Investigational Site Number 392045
Investigational Site Number 392012
Investigational Site Number 643006
Investigational Site Number 032002
Investigational Site Number 152011
Investigational Site Number 392004
Investigational Site Number 392013
Investigational Site Number 392034
Investigational Site Number 792003
Investigational Site Number 392025
Investigational Site Number 392032
Investigational Site Number 036002
Investigational Site Number 840028
Investigational Site Number 392003
Investigational Site Number 840043
Investigational Site Number 392044
Investigational Site Number 724007
Investigational Site Number 840007
Investigational Site Number 792007
Investigational Site Number 152006
Investigational Site Number 032004
Investigational Site Number 724002
Investigational Site Number 032012
Investigational Site Number 152002
Investigational Site Number 380008
Investigational Site Number 792006
Investigational Site Number 392019
Investigational Site Number 840045
Investigational Site Number 840042
Investigational Site Number 250002
Investigational Site Number 392040
Investigational Site Number 840005
Investigational Site Number 840014
Investigational Site Number 250009
Investigational Site Number 840009
Investigational Site Number 554001
Investigational Site Number 250001
Investigational Site Number 484003
Investigational Site Number 392036
Investigational Site Number 392015
Investigational Site Number 840020
Investigational Site Number 643007
Investigational Site Number 840023
Investigational Site Number 392042
Investigational Site Number 392037
Investigational Site Number 643012
Investigational Site Number 036009
Investigational Site Number 392001
Investigational Site Number 804015
Investigational Site Number 643002
Investigational Site Number 840040
Investigational Site Number 152001
Investigational Site Number 250003
Investigational Site Number 792013
Investigational Site Number 032009
Investigational Site Number 840001
Investigational Site Number 392008
Investigational Site Number 410003
Investigational Site Number 840036
Investigational Site Number 840018
Investigational Site Number 840052
Investigational Site Number 804004
Investigational Site Number 840010
Investigational Site Number 724003
Investigational Site Number 392018
Investigational Site Number 710001
Investigational Site Number 036004
Investigational Site Number 643011
Investigational Site Number 152007
Investigational Site Number 392026
Investigational Site Number 643009
Investigational Site Number 840034
Investigational Site Number 724005
Investigational Site Number 804008
Investigational Site Number 840013
Investigational Site Number 392006
Investigational Site Number 840019
Investigational Site Number 840048
Investigational Site Number 804019
Investigational Site Number 410005
Investigational Site Number 392022
Investigational Site Number 484001
Investigational Site Number 840035
Investigational Site Number 840041
Investigational Site Number 792001
Investigational Site Number 840046
Investigational Site Number 380001
Investigational Site Number 840037
Investigational Site Number 032001
Investigational Site Number 380004
Investigational Site Number 840021
Investigational Site Number 392005
Investigational Site Number 840050
Investigational Site Number 643001
Investigational Site Number 804018
Investigational Site Number 152014
Investigational Site Number 036006
Investigational Site Number 840015
Investigational Site Number 032007
Investigational Site Number 392014
Investigational Site Number 036003
Investigational Site Number 840054
Investigational Site Number 804001
Investigational Site Number 380007
Investigational Site Number 380010
Investigational Site Number 840051
Investigational Site Number 724006
Investigational Site Number 152012
Investigational Site Number 250011
Investigational Site Number 840032
Investigational Site Number 840039
Investigational Site Number 032005
Investigational Site Number 250008
Investigational Site Number 392028
Investigational Site Number 792004
Investigational Site Number 840002
Investigational Site Number 484006
Investigational Site Number 392023
Investigational Site Number 032003
Investigational Site Number 380006
Investigational Site Number 380002
Investigational Site Number 804006
Investigational Site Number 484005
Investigational Site Number 840024
Investigational Site Number 032010
Investigational Site Number 840022
Investigational Site Number 032008
Investigational Site Number 392038
Investigational Site Number 392043
Investigational Site Number 392011
Investigational Site Number 152013
Investigational Site Number 840027
Investigational Site Number 250004
Investigational Site Number 392029
Investigational Site Number 840004
Investigational Site Number 840030
Investigational Site Number 036001
Investigational Site Number 840026
Investigational Site Number 392035
Investigational Site Number 616005
Investigational Site Number 840003
Investigational Site Number 616003
Investigational Site Number 250006
Investigational Site Number 392020
Investigational Site Number 392009
Investigational Site Number 392017
Investigational Site Number 152005
Investigational Site Number 643008
Investigational Site Number 616006
Investigational Site Number 840017
Investigational Site Number 484004
Investigational Site Number 392030
Investigational Site Number 840029
Investigational Site Number 392002
Investigational Site Number 554002
Investigational Site Number 840006
Investigational Site Number 410002
Investigational Site Number 616001
Investigational Site Number 804020
Investigational Site Number 380009
Investigational Site Number 724004
Investigational Site Number 152003
Investigational Site Number 036005
Investigational Site Number 804016
Investigational Site Number 643003
Investigational Site Number 840025
Investigational Site Number 392024
Investigational Site Number 840044
Investigational Site Number 804012
Investigational Site Number 616007
Investigational Site Number 250007
Investigational Site Number 616004
Investigational Site Number 392010


intervention_type: Drug

lead_sponsor: Bristol-Myers Squibb

location_country:
Austria
Sweden
Switzerland
Netherlands
Germany
France
Norway
Argentina
United States
Colombia

location_facility: Medical College of WI Froedtert Hospital

location_facility: Medical College of Georgia at Augusta University

location_facility: East Carolina Univ Nephrology Clin Res. Lab

location_facility: University of Utah Depart of Nephrology (PI Address)

location_facility: Medical University of South Carolina, SCTR Research Nexus

location_facility: RUSH University Transplant Program (PI Address)

location_facility: Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston

location_facility: University of Virginia Health System (PI Address)

location_facility: California Pacific Medical Center, Depart of Transplantation (PI Address)

location_facility: University of Colorado Denver (PI Address)

location_facility: Baylor All Saints Medical Center at Ft. Worth

location_facility: Transplant Research Institute (PI Address)

location_facility: Virginia Commonwealth University Medical Center

location_facility: Providence Sacred Heart Medical Center and Childrens Hospital

location_facility: Recanati/Miller Transplantation Institue (PI Address)

location_facility: University Hospitals Cleveland Medical Center

location_facility: Methodist University Hospital Transplant Institute (PI Address)

location_facility: University of Iowa Health Care (PI Address)

location_facility: Vanderbilt University Medical Center- GI Research Office

location_facility: Swedish Medical Center-Swedish Organ Transplant and Liver Center

location_facility: Florida Hospital Transplant Institute (PI Address)

location_facility: University of California, San Francisco (UCSF)-Kidney Transplant Service

location_facility: Tulane University Health Sciences Center

location_facility: University of Washington Medical Center (PI Address & Study Supplies Address)

location_facility: University of Wisconsin School of Medicine and Public Health (PI Address)

location_facility: Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute

source: euctr

title: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression

summary: The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

lead_sponsor_type: industriel

status_simplified: Completed


title: Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes

summary: This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

ReferenceCitation: Oyama K, Raz I, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Park KS, Goudev A, Diaz R, Špinar J, Gause-Nilsson IAM, Mosenzon O, Sabatine MS, Wiviott SD. Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE-TIMI 58 trial. Eur Heart J. 2021 Aug 24. pii: ehab530. doi: 10.1093/eurheartj/ehab530. [Epub ahead of print]

name: TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, 60 Fenwood Road, Suite 7022, Boston, MA 02115, USA

name: Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan

family: Oyama

full_name: Kazuma Oyama

given: Kazuma

name: Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, The Faculty of Medicine, Hebrew University of Jerusalem, Kiryat Hadassah 12000, Jerusalem 91200, Israel

family: Raz

full_name: Itamar Raz

given: Itamar

family: Cahn

full_name: Avivit Cahn

given: Avivit

family: Kuder

full_name: Julia Kuder

given: Julia

family: Murphy

full_name: Sabina A Murphy

given: Sabina A

family: Bhatt

full_name: Deepak L Bhatt

given: Deepak L

name: Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto, 36 Queen St. East, Toronto, ON M5B 1W8, Canada

family: Leiter

full_name: Lawrence A Leiter

given: Lawrence A

name: Division of Cardiology, University of Texas Southwestern Medical Center, Parkland Health and Hospital System, 5323 Harry Hines Blvd. Dallas, TX 75390, USA

family: McGuire

full_name: Darren K McGuire

given: Darren K

name: Department of Cardiovascular and Metabolic Medicine, Institute of Life Course and Medical Sciences, University of Liverpool, 6 West Derby Street, Liverpool, L7 8TX, UK

family: Wilding

full_name: John P H Wilding

given: John P H

name: Department of Internal Medicine, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu Seoul 03080, Republic of Korea

family: Park

full_name: Kyong-Soo Park

given: Kyong-Soo

name: Department of Cardiology, Queen Giovanna University Hospital, 8# Bialo More street, Sofia 1527, Bulgaria

family: Goudev

full_name: Assen Goudev

given: Assen

name: Estudios Clínicos Latino America, Paraguay 160, Rosario, Santa Fe 2000, Argentina

family: Diaz

full_name: Rafael Diaz

given: Rafael

name: Internal Cardiology Department, St. Ann University Hospital, Masaryk University, Pekařská 53 Brno 65691, Czech Republic

family: Špinar

full_name: Jindřich Špinar

given: Jindřich

name: BioPharmaceuticals R&D, AstraZeneca Gothenburg, Pepparedsleden 1, S-431 83, Mölndal, Sweden

family: Gause-Nilsson

full_name: Ingrid A M Gause-Nilsson

given: Ingrid A M

family: Mosenzon

full_name: Ofri Mosenzon

given: Ofri

family: Sabatine

full_name: Marc S Sabatine

given: Marc S

family: Wiviott

full_name: Stephen D Wiviott

given: Stephen D

journal_name: European Heart Journal

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE–TIMI 58 trial

ReferenceCitation: Mosenzon O, Wiviott SD, Heerspink HJL, Dwyer JP, Cahn A, Goodrich EL, Rozenberg A, Schechter M, Yanuv I, Murphy SA, Zelniker TA, Gause-Nilsson IAM, Langkilde AM, Fredriksson M, Johansson PA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS, Raz I. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58. Diabetes Care. 2021 Aug;44(8):1805-1815. doi: 10.2337/dc21-0076. Epub 2021 Jul 7.

full_name: Stephen D. Wiviott

given: Stephen D.

family: Heerspink

full_name: Hiddo J.L. Heerspink

given: Hiddo J.L.

family: Dwyer

full_name: Jamie P. Dwyer

title: The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58

ReferenceCitation: Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained ≥40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.

name: Division of Nephrology University of Toronto  Toronto Ontario Canada

name: Division of Endocrinology, Diabetes and Metabolism University of Tennessee Health Science Center  Memphis Tennessee USA

name: Division of Cardiology University of Texas Southwestern Medical Center, and Parkland Health and Hospital System  Dallas Texas USA

name: Unit of Cardiology Karolinska Institute and Karolinska University Hospital  Stockholm Sweden

name: AdventHealth Translational Research Institute  Orlando Florida USA

name: Department of Biostatistics and Epidemiology Rutgers School of Public Health and Rutgers Cancer Institute of New Jersey  New Brunswick New Jersey USA

name: Clinical Development and Operations Research and Development, Pfizer Inc.  Collegeville Pennsylvania USA

name: Diabetes and Endocrinology MSD Limited  London UK

name: Global Product Development Statistics Merck & Co., Inc.  Kenilworth New Jersey USA

name: Cardiovascular Division, Brigham and Women's Hospital Harvard Medical School  Boston Massachusetts USA

title: Kidney outcomes using a sustained ≥40% decline in eGFR : A meta‐analysis of SGLT2 inhibitor trials

ReferenceCitation: Zelniker TA, Raz I, Mosenzon O, Dwyer JP, Heerspink HHJL, Cahn A, Goodrich EL, Im K, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson I, Langkilde AM, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Cardiovascular Outcomes According to Baseline Kidney Function and Albuminuria Status in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):801-810. doi: 10.1001/jamacardio.2021.0660.

name: Department of Cardiology, Medical University of Vienna, Vienna, Austria

name: The Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel

name: Vanderbilt University Medical Center, Nashville, Tennessee

name: University Medical Center Groningen, University of Groningen, Groningen, the Netherlands

name: The George Institute for International Health, Sydney, Australia

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts

name: Li Ka Shing Knowledge Institute, St Michael’s Hospital, University of Toronto, Ontario, Canada

name: Division of Cardiology, The University of Texas Southwestern Medical Center, Dallas

name: Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom

name: BioPharmaceuticals Research & Development, AstraZeneca, Gothenburg, Sweden

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

ReferenceCitation: Cahn A, Raz I, Leiter LA, Mosenzon O, Murphy SA, Goodrich EL, Yanuv I, Rozenberg A, Bhatt DL, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Langkilde AM, Sabatine MS, Wiviott SD. Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58. Diabetes Care. 2021 May;44(5):1159-1167. doi: 10.2337/dc20-2492. Epub 2021 Mar 2.

ReferenceCitation: O'Donoghue ML, Kato ET, Mosenzon O, Murphy SA, Cahn A, Herrera M, Tankova T, Šmahelová A, Merlini P, Gause-Nilsson I, Langkilde AM, McGuire DK, Wilding JPH, Leiter LA, Bhatt DL, Raz I, Sabatine MS, Wiviott SD. The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus. Diabetologia. 2021 Jun;64(6):1226-1234. doi: 10.1007/s00125-021-05399-2. Epub 2021 Feb 20.

title: The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus

ReferenceCitation: Bonaca MP, Wiviott SD, Zelniker TA, Mosenzon O, Bhatt DL, Leiter LA, McGuire DK, Goodrich EL, De Mendonca Furtado RH, Wilding JPH, Cahn A, Gause-Nilsson IAM, Johanson P, Fredriksson M, Johansson PA, Langkilde AM, Raz I, Sabatine MS. Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58. Circulation. 2020 Aug 25;142(8):734-747. doi: 10.1161/CIRCULATIONAHA.119.044775. Epub 2020 Aug 3.

name: TIMI (Thrombolysis in Myocardial Infarction) Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital Heart and Harvard Medical School, Boston, MA (M.P.B., S.D.W., T.A.Z., D.L.B., E.L.G., M.S.S.).

name: Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Israel (O.M., A.C., I.R.).

name: Li Ka Shing Knowledge Institute, St Michael’s Hospital, University of Toronto, Ontario, Canada (L.A.L.).

name: Division of Cardiology, University of Texas Southwestern Medical Center, Dallas (D.K.M.).

name: Hospital Albert Einstein and Instituto do Coracao da Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil (R.H.D.M.F.).

name: Institute of Ageing and Chronic Disease, University of Liverpool, United Kingdom (J.P.H.W.).

name: AstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., P.J., M.F., P.A.J., A.M.L.).

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Zelniker TA, Bonaca MP, Furtado RHM, Mosenzon O, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Budaj A, Kiss RG, Padilla F, Gause-Nilsson I, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus: Insights From the DECLARE-TIMI 58 Trial. Circulation. 2020 Apr 14;141(15):1227-1234. doi: 10.1161/CIRCULATIONAHA.119.044183. Epub 2020 Jan 27.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA (T.A.Z., M.P.B., R.H.M.F., J.F.K., S.A.M., D.L.B., M.S.S., S.D.V.).

name: Division of Cardiology, Vienna General Hospital and Medical University of Vienna, Austria (T.A.Z.).

name: University of Colorado School of Medicine, Department of Medicine, Division of Cardiology, and CPC Clinical Research, Aurora (M.P.B.).

name: Hospital Albert Einstein and Instituto do Coracao da Faculdade de Medicina da USP, Sao Paulo, Brazil (R.H.M.F.).

name: The Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, The Faculty of Medicine, Hebrew University of Jerusalem, Israel (O.M., I.R.).

name: Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto, Ontario, Canada (L.A.L.).

name: Department of Cardiology, Centre of Postgraduate Medical Education, Grochowski Hospital, Warsaw, Poland (A.B.).

name: Department of Cardiology, Military Hospital, Budapest, Hungary (R.G.K.).

name: Cardiología Clínica e Intervencionista Tarascos, Guadalajara, Mexico (F.P.).

name: AstraZeneca Gothenburg, Mölndal, Sweden (I.G.-N., A.M.L.).

title: Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus

ReferenceCitation: Cahn A, Mosenzon O, Wiviott SD, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study. Diabetes Care. 2020 Feb;43(2):468-475. doi: 10.2337/dc19-1476. Epub 2019 Dec 16.

title: Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE–TIMI 58 Study

ReferenceCitation: Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.

name: TIMI Study Group, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).

name: Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).

name: Li Ka Shing Knowledge Institute, St Michael’s Hospital, University of Toronto, Canada (L.A.L.).

name: University of Texas Southwestern Medical Center, Dallas (D.K.M.).

name: University of Liverpool, United Kingdom (J.P.H.W.).

name: AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).

ReferenceCitation: Mosenzon O, Wiviott SD, Cahn A, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Heerspink HJL, Zelniker TA, Dwyer JP, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Kato ET, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):606-617. doi: 10.1016/S2213-8587(19)30180-9. Epub 2019 Jun 10. Erratum in: Lancet Diabetes Endocrinol. 2019 Aug;7(8):e20.

title: Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE–TIMI 58 randomised trial

ReferenceCitation: Furtado RHM, Bonaca MP, Raz I, Zelniker TA, Mosenzon O, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Nicolau JC, Gause-Nilsson IAM, Fredriksson M, Langkilde AM, Sabatine MS, Wiviott SD. Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction. Circulation. 2019 May 28;139(22):2516-2527. doi: 10.1161/CIRCULATIONAHA.119.039996. Epub 2019 Mar 18.

name: Thrombolysis in Myocardial Infarction (TIMI) Study Group–Brigham and Women’s Hospital, Boston, MA (R.H.M.F., T.A.Z., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).

name: Instituto do Coracao (InCor), Hospital das Clinicas da Faculdade de Medicina, Universidade de Sao Paulo, Brazil (R.H.M.F., J.C.N.).

name: CPC Clinical Research and Vascular Research Unity, University of Colorado, Denver (M.P.B.).

name: Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (I.R., O.M., A.C.).

name: Institute of Ageing and Chronic Disease, University of Liverpool, UK (J.P.H.W.).

name: AstraZeneca Gothenburg, Mölndal, Sweden (I.A.M.G.-N., M.F., A.M.L.).

ReferenceCitation: Kato ET, Silverman MG, Mosenzon O, Zelniker TA, Cahn A, Furtado RHM, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Bonaca MP, Ruff CT, Desai AS, Goto S, Johansson PA, Gause-Nilsson I, Johanson P, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536. doi: 10.1161/CIRCULATIONAHA.119.040130. Epub 2019 Mar 18.

name: Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Japan (E.T.K.).

name: Cardiology Division, Massachusetts General Hospital, Boston (M.G.S.).

name: Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (O.M., A.C., I.R.).

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA (T.A.Z., R.H.M.F., J.K., S.A.M., D.L.B., C.T.R., M.S.S., S.D.W.).

name: CPC Clinical Research, University of Colorado, Denver (M.P.B.).

name: Cardiovascular Division, Brigham and Women’s Hospital, Boston, MA (A.S.D.).

name: Department of Medicine (Cardiology), Tokai University, Isehara, Japan (S.G.).

name: AstraZeneca, Gothenburg, Sweden (P.A.J., I.G.-N., P.J., A.M.L.).

title: Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus

ReferenceCitation: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.

name: From the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Division of Cardiovascular Medicine, Brigham and Women’s Hospital (S.D.W., M.P.B., T.A.Z., J.F.K., S.A.M., D.L.B., C.T.R., M.S.S.), and the Cardiology Division, Massachusetts General Hospital (M.G.S.) — both in Boston; the Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem (I.R., O.M., A.C.); the Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan (E.T.K.); Li Ka Shing Knowledge...

title: Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes

ReferenceCitation: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Bansilal S, Bhatt DL, Leiter LA, McGuire DK, Wilding JP, Gause-Nilsson IA, Langkilde AM, Johansson PA, Sabatine MS. The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial. Am Heart J. 2018 Jun;200:83-89. doi: 10.1016/j.ahj.2018.01.012. Epub 2018 Feb 7.

title: The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)–TIMI 58 Trial

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

ReferenceCitation: Bloch MJ. Blood pressure effects of SGLT2 inhibitors make them an attractive option in diabetic patients with hypertension. J Am Soc Hypertens. 2016 Mar;10(3):186-7.

ReferenceCitation: Leiter LA, Cefalu WT, de Bruin TW, Xu J, Parikh S, Johnsson E, Gause-Nilsson I. Long-term maintenance of efficacy of dapagliflozin in patients with type 2 diabetes mellitus and cardiovascular disease. Diabetes Obes Metab. 2016 Aug;18(8):766-74. doi: 10.1111/dom.12666. Epub 2016 May 12.

name: Division of Endocrinology and Metabolism, Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science; St Michael's Hospital, University of Toronto; Toronto ON Canada

name: Pennington Biomedical Research Center; Louisiana State University; Baton Rouge LA USA

name: Research & Development; AstraZeneca; Gaithersburg MD USA

name: Biometrics and Informatics; AstraZeneca; Gaithersburg MD USA

name: Global Medical Affairs-CV and Metabolism; AstraZeneca; Gaithersburg MD USA

name: Research & Development; AstraZeneca Gothenburg; Mölndal Sweden

location_country:
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Philippines
Vietnam
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey


ReferenceCitation: Ascierto PA, Lewis KD, Di Giacomo AM, Demidov L, Mandalà M, Bondarenko I, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Simmons B, Ye C, Hooper G, Wongchenko MJ, Goodman GR, Yan Y, Schadendorf D. Prognostic impact of baseline tumour immune infiltrate on disease-free survival in patients with completely resected, BRAF(v600) mutation-positive melanoma receiving adjuvant vemurafenib. Ann Oncol. 2020 Jan;31(1):153-159. doi: 10.1016/j.annonc.2019.10.002.

family: Ascierto

full_name: P.A. Ascierto

family: Lewis

full_name: K.D. Lewis

family: Di Giacomo

full_name: A.M. Di Giacomo

family: Demidov

full_name: L. Demidov

given: L.

family: Mandalà

full_name: M. Mandalà

given: M.

family: Bondarenko

full_name: I. Bondarenko

given: I.

family: Herbert

full_name: C. Herbert

given: C.

family: Mackiewicz

full_name: A. Mackiewicz

given: A.

family: Rutkowski

full_name: P. Rutkowski

given: P.

family: Guminski

full_name: A. Guminski

family: Simmons

full_name: B. Simmons

given: B.

family: Ye

full_name: C. Ye

family: Hooper

full_name: G. Hooper

given: G.

family: Wongchenko

full_name: M.J. Wongchenko

family: Goodman

full_name: G.R. Goodman

family: Yan

full_name: Y. Yan

given: Y.

family: Schadendorf

full_name: D. Schadendorf

given: D.

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Prognostic impact of baseline tumour immune infiltrate on disease-free survival in patients with completely resected, BRAFv600 mutation–positive melanoma receiving adjuvant vemurafenib

ReferenceCitation: Maio M, Lewis K, Demidov L, Mandalà M, Bondarenko I, Ascierto PA, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Goodman GR, Simmons B, Ye C, Yan Y, Schadendorf D; BRIM8 Investigators. Adjuvant vemurafenib in resected, BRAF(V600) mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):510-520. doi: 10.1016/S1470-2045(18)30106-2. Epub 2018 Feb 21. Erratum in: Lancet Oncol. 2018 Apr;19(4):e184.

family: Maio

full_name: Michele Maio

given: Michele

full_name: Karl Lewis

given: Karl

full_name: Lev Demidov

given: Lev

full_name: Mario Mandalà

given: Mario

full_name: Igor Bondarenko

given: Igor

title: Adjuvant vemurafenib in resected, BRAF V600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial

location_country:
Australia
Belgium
Russian Federation
Ukraine
Croatia
France
Poland
Norway
Argentina
Canada
South Africa
Sweden
Switzerland
Netherlands
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
New Zealand
Spain
Estonia

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory

location_facility: University of Kansas Medical Center; Cancer Center

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin

location_facility: Cancer Center Of Santa Barbara; Network Clinical Research Specialist

location_facility: Groote Schuur Hospital Radiation Oncology Department; Department of Radiation Oncology

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: University of Pennsylvania Health System

location_facility: Kaiser Foundation Hospital - Oakland (W. MacArthur)

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: East Tallinn Central Hospital; Clinic of Internal Medicine

location_facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS

location_facility: TRIO-US Network Administration; Network Clinical Research Specialist

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Indiana University Department of Medicine; Division of Infectious Diseases

location_facility: U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology

location_facility: Washington University; Dept of Medicine/Div of Medical Oncology

location_facility: Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

location_facility: MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Duke University Medical Center; Oncology

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Hospital do Espirito Santo; Servico de Oncologia Medica

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Centro Regiomontano de Investigación Clínica

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: The Ottawa Hospital Cancer Center; General Campus

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Stanford University School of Medicine; Stanford Hospital Pharmacy

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Costa del Sol; Servicio de Oncologia

location_facility: BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency

location_facility: Saint Boniface General Hospital; Section of Nephrology BG 007

location_facility: UCLA Department of Medicine; Division of Hematology / Oncology

location_facility: The Townsville Hospital; Townsville Cancer Centre

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

location_facility: Saint John Regional Hospital; Department of Oncology

location_facility: Scientific Research Oncology Institute named after N.N. Petrov

location_facility: Indiana University Health; Goshen Center for Cancer Care

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: Peninsula Oncology Centre; Frankston Private

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: St. Mary's Hospital Regional Cancer Center

location_facility: CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: University of Pretoria Oncology Department

location_facility: Nottingham University Hospitals City Campus

location_facility: LHSC - Victoria Hospital; Department of Pediatrics

location_facility: New York University Medical Center PRIME; NYU Clinical Cancer Center

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: IRCCS Istituto Clinico Humanitas; Farmacia

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence

summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.


title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.

summary: Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Schur N, Gudala K, Vudumula U, Vadapalle S, Bhadhuri A, Casanova A, Adlard N, Schwenkglenks M. Cost Effectiveness and Budget Impact of Siponimod Compared to Interferon Beta-1a in the Treatment of Adult Patients with Secondary Progressive Multiple Sclerosis with Active Disease in Switzerland. Pharmacoeconomics. 2021 May;39(5):563-577. doi: 10.1007/s40273-021-01023-8. Epub 2021 Apr 1.

family: Schur

full_name: Nadine Schur

given: Nadine

family: Gudala

full_name: Kapil Gudala

given: Kapil

family: Vudumula

full_name: Umakanth Vudumula

given: Umakanth

family: Vadapalle

full_name: Sreelatha Vadapalle

given: Sreelatha

family: Bhadhuri

full_name: Arjun Bhadhuri

given: Arjun

family: Casanova

full_name: Alain Casanova

given: Alain

family: Adlard

full_name: Nicholas Adlard

given: Nicholas

family: Schwenkglenks

full_name: Matthias Schwenkglenks

given: Matthias

journal_name: PharmacoEconomics

repository_institution: University of Basel - edoc

version: acceptedVersion

ReferenceCitation: Benedict RHB, Tomic D, Cree BA, Fox R, Giovannoni G, Bar-Or A, Gold R, Vermersch P, Pohlmann H, Wright I, Karlsson G, Dahlke F, Wolf C, Kappos L. Siponimod and Cognition in Secondary Progressive Multiple Sclerosis: EXPAND Secondary Analyses. Neurology. 2021 Jan 19;96(3):e376-e386. doi: 10.1212/WNL.0000000000011275. Epub 2020 Dec 16.

family: Benedict

full_name: Ralph H.B. Benedict

given: Ralph H.B.

family: Tomic

full_name: Davorka Tomic

given: Davorka

family: Cree

full_name: Bruce A. Cree

given: Bruce A.

family: Fox

full_name: Robert Fox

given: Robert

family: Giovannoni

full_name: Gavin Giovannoni

given: Gavin

family: Bar-Or

full_name: Amit Bar-Or

given: Amit

family: Gold

full_name: Ralf Gold

given: Ralf

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

family: Pohlmann

ReferenceCitation: Kappos L, Bar-Or A, Cree BAC, Fox RJ, Giovannoni G, Gold R, Vermersch P, Arnold DL, Arnould S, Scherz T, Wolf C, Wallström E, Dahlke F; EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018 Mar 31;391(10127):1263-1273. doi: 10.1016/S0140-6736(18)30475-6. Epub 2018 Mar 23. Erratum in: Lancet. 2018 Nov 17;392(10160):2170.

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

Locations: central Contact Info Novartis.email@novartis.com

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Turkey
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain
Estonia
Latvia


title: The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

summary: This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

ReferenceCitation: Aroda VR, Bailey TS, Cariou B, Kumar S, Leiter LA, Raskin P, Zacho J, Andersen TH, Philis-Tsimikas A. Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study). Diabetes Obes Metab. 2016 Jul;18(7):663-70. doi: 10.1111/dom.12661. Epub 2016 May 2. Erratum in: Diabetes Obes Metab. 2016 Sep;18(9):952.

name: MedStar Health Research Institute  Hyattsville MD USA

family: Aroda

full_name: V. R. Aroda

given: V. R.

family: Bailey

full_name: T. S. Bailey

given: T. S.

name: Department of Endocrinology CHU Nantes, l'Institut du Thorax  Nantes France

family: Cariou

full_name: B. Cariou

given: B.

name: WISDEM Centre University Hospitals of Coventry and Warwickshire  Coventry UK

family: Kumar

full_name: S. Kumar

given: S.

name: Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science St Michael's Hospital, University of Toronto  Toronto ON Canada

family: Leiter

full_name: L. A. Leiter

given: L. A.

name: University of Texas Southwestern Medical Center  Dallas TX USA

family: Raskin

full_name: P. Raskin

given: P.

family: Zacho

full_name: J. Zacho

given: J.

family: Andersen

full_name: T. H. Andersen

given: T. H.

name: Scripps Whittier Diabetes Institute  San Diego CA USA

family: Philis‐Tsimikas

full_name: A. Philis‐Tsimikas

given: A.

journal_name: Diabetes, Obesity and Metabolism

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double‐blind randomized controlled trial ( BEGIN : ADD TO GLP ‐1 S tudy)

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
United States
South Africa
United Arab Emirates
Serbia
France
Israel
Germany
United Kingdom
Canada
Ukraine


title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With 5-Fluorouracil, Folinic Acid, and Oxaliplatin (mFOLFOX6) in Patients With Metastatic HER2-Negative, MET-Positive Gastroesophageal Cancer

summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until disease progression, unacceptable toxicity, participant or physician decision to discontinue treatment.

ReferenceCitation: Shah MA, Bang YJ, Lordick F, Alsina M, Chen M, Hack SP, Bruey JM, Smith D, McCaffery I, Shames DS, Phan S, Cunningham D. Effect of Fluorouracil, Leucovorin, and Oxaliplatin With or Without Onartuzumab in HER2-Negative, MET-Positive Gastroesophageal Adenocarcinoma: The METGastric Randomized Clinical Trial. JAMA Oncol. 2017 May 1;3(5):620-627. doi: 10.1001/jamaoncol.2016.5580.

name: Department of Medicine, Weill Cornell Medical College, Center for Advanced Digestive Care, New York–Presbyterian Hospital, New York

family: Shah

full_name: Manish A. Shah

given: Manish A.

name: Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea

family: Bang

full_name: Yung-Jue Bang

given: Yung-Jue

name: University Cancer Center Leipzig, Leipzig, Germany

family: Lordick

full_name: Florian Lordick

given: Florian

name: Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona, Spain5Vall d’Hebron Institute of Oncology, Barcelona, Spain

family: Alsina

full_name: Maria Alsina

given: Maria

name: Biostatistics Department, Roche (China) Holdings Ltd, Shanghai, China

family: Chen

full_name: Meng Chen

given: Meng

name: Genentech Inc, South San Francisco, California

family: Hack

full_name: Stephen P. Hack

given: Stephen P.

family: Bruey

full_name: Jean Marie Bruey

given: Jean Marie

family: Smith

full_name: Dustin Smith

given: Dustin

family: McCaffery

full_name: Ian McCaffery

given: Ian

family: Shames

full_name: David S. Shames

given: David S.

family: Phan

full_name: See Phan

given: See

name: Royal Marsden Hospital, London, United Kingdom

family: Cunningham

full_name: David Cunningham

given: David

journal_name: JAMA Oncology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Hoffmann-La Roche

location_country:
Guatemala
Malaysia
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
France
Panama
Poland
Thailand
Canada
Korea, Republic of
Hong Kong
Switzerland
Singapore
United States
Germany
United Kingdom
Italy
Mexico
Israel
Spain
Turkey


title: A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment

summary:
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment.

Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

status: Terminated

ReferenceCitation: Di Leo A, Johnston S, Lee KS, Ciruelos E, Lønning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csőszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7. Erratum in: Lancet Oncol. 2018 Mar;19(3):e137.

family: Di Leo

full_name: Angelo Di Leo

given: Angelo

family: Johnston

full_name: Stephen Johnston

given: Stephen

family: Lee

full_name: Keun Seok Lee

given: Keun Seok

family: Ciruelos

full_name: Eva Ciruelos

given: Eva

family: Lønning

full_name: Per E Lønning

given: Per E

family: Janni

full_name: Wolfgang Janni

given: Wolfgang

family: O'Regan

full_name: Ruth O'Regan

given: Ruth

family: Mouret-Reynier

full_name: Marie-Ange Mouret-Reynier

given: Marie-Ange

family: Kalev

full_name: Dimitar Kalev

given: Dimitar

family: Egle

full_name: Daniel Egle

given: Daniel

family: Csőszi

full_name: Tibor Csőszi

given: Tibor

family: Bordonaro

full_name: Roberto Bordonaro

given: Roberto

family: Decker

full_name: Thomas Decker

given: Thomas

family: Tjan-Heijnen

full_name: Vivianne C G Tjan-Heijnen

given: Vivianne C G

family: Blau

full_name: Sibel Blau

given: Sibel

family: Schirone

full_name: Alessio Schirone

given: Alessio

family: Weber

full_name: Denis Weber

given: Denis

family: El-Hashimy

full_name: Mona El-Hashimy

given: Mona

family: Dharan

full_name: Bharani Dharan

given: Bharani

family: Sellami

full_name: Dalila Sellami

given: Dalila

family: Bachelot

full_name: Thomas Bachelot

journal_name: The Lancet Oncology

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:
Finland
Greece
Belgium
France
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Netherlands
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Lebanon
Spain

location_facility: University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital

location_facility: The West Clinic Dept. of the West Clinic

location_facility: Moanalua Medical Center. Attn: Oncology Dept

location_facility: University of South Alabama / Mitchell Cancer Institute Univ South AL

location_facility: Emory University School of Medicine/Winship Cancer Institute Emory

location_facility: CINJ at Cooper University Hospital Dept of Onc

location_facility: Texas Oncology P A Texas Oncology - Fort Worth (3

location_facility: Crescent City Research Consortium, LLC SC

location_facility: Morristown Memorial Hospital Morristown Mem

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: Lsu Health Sciences Center/ Lsu School of Medicine Lsu

location_facility: Compassionate Cancer Care Medical Group CCCMG

location_facility: LSU Health Sciences Center Feist-Weiller Cancer Center

location_facility: Texas Oncology PA Dallas Presbyterian Hospital SC

location_facility: Oregon Health and Science University SC-5

location_facility: University of California at Los Angeles UCLA SC

location_facility: Los Angeles Hematology/Oncology Medical Group Onc Dept.

location_facility: University of Texas Southwestern Medical Center

location_facility: Texas Tech University Health Science Center Dept of Texas Tech

location_facility: University of Maryland Medical Center Univ Maryland

location_facility: John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2


title: Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC

acronym: ATLAS

summary: The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.

primary_purpose: Prevention

ReferenceCitation: Gross-Goupil M, Kwon TG, Eto M, Ye D, Miyake H, Seo SI, Byun SS, Lee JL, Master V, Jin J, DeBenedetto R, Linke R, Casey M, Rosbrook B, Lechuga M, Valota O, Grande E, Quinn DI. Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial. Ann Oncol. 2018 Dec 1;29(12):2371-2378. doi: 10.1093/annonc/mdy454.

family: Gross-Goupil

full_name: M. Gross-Goupil

given: M.

family: Kwon

full_name: T.G. Kwon

family: Eto

full_name: M. Eto

family: Ye

full_name: D. Ye

given: D.

family: Miyake

full_name: H. Miyake

given: H.

family: Seo

full_name: S.I. Seo

family: Byun

full_name: S.-S. Byun

family: Lee

full_name: J.L. Lee

family: Master

full_name: V. Master

given: V.

family: Jin

full_name: J. Jin

given: J.

family: DeBenedetto

full_name: R. DeBenedetto

given: R.

family: Linke

full_name: R. Linke

family: Casey

full_name: M. Casey

family: Rosbrook

full_name: B. Rosbrook

given: B.

family: Lechuga

full_name: M. Lechuga

family: Valota

full_name: O. Valota

given: O.

family: Grande

full_name: E. Grande

given: E.

family: Quinn

full_name: D.I. Quinn

location_country:
India
Hong Kong
Spain
France
Japan
China
United States
Korea, Republic of
Taiwan