acronym: CANVAS-R

title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus

lead_sponsor: Janssen Research & Development, LLC

ReferenceCitation: Young TK, Li JW, Kang A, Heerspink HJL, Hockham C, Arnott C, Neuen BL, Zoungas S, Mahaffey KW, Perkovic V, de Zeeuw D, Fulcher G, Neal B, Jardine M. Effects of canagliflozin compared with placebo on major adverse cardiovascular and kidney events in patient groups with different baseline levels of HbA(1c), disease duration and treatment intensity: results from the CANVAS Program. Diabetologia. 2021 Nov;64(11):2402-2414. doi: 10.1007/s00125-021-05524-1. Epub 2021 Aug 26.

ReferenceCitation: Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.

ReferenceCitation: Yu J, Arnott C, Neuen BL, Heersprink HL, Mahaffey KW, Cannon CP, Khan SS, Baldridge AS, Shah SJ, Huang Y, Li C, Figtree GA, Perkovic V, Jardine MJ, Neal B, Huffman MD. Cardiovascular and renal outcomes with canagliflozin according to baseline diuretic use: a post hoc analysis from the CANVAS Program. ESC Heart Fail. 2021 Apr;8(2):1482-1493. doi: 10.1002/ehf2.13236. Epub 2021 Feb 17. Erratum in: ESC Heart Fail. 2021 May 3;:.

ReferenceCitation: Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Blais J, Li Q, Jardine MJ, Perkovic V, Wheeler DC. Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program. Am J Kidney Dis. 2021 Jan;77(1):23-34.e1. doi: 10.1053/j.ajkd.2020.06.018. Epub 2020 Sep 21.

ReferenceCitation: Oshima M, Neal B, Toyama T, Ohkuma T, Li Q, de Zeeuw D, Heerspink HJL, Mahaffey KW, Fulcher G, Canovatchel W, Matthews DR, Perkovic V. Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program. J Am Soc Nephrol. 2020 Oct;31(10):2446-2456. doi: 10.1681/ASN.2019121312. Epub 2020 Jul 21.

ReferenceCitation: Matthews DR, Wysham C, Davies M, Slee A, Alba M, Lee M, Perkovic V, Mahaffey KW, Neal B. Effects of canagliflozin on initiation of insulin and other antihyperglycaemic agents in the CANVAS Program. Diabetes Obes Metab. 2020 Nov;22(11):2199-2203. doi: 10.1111/dom.14143. Epub 2020 Aug 24.

ReferenceCitation: Li J, Woodward M, Perkovic V, Figtree GA, Heerspink HJL, Mahaffey KW, de Zeeuw D, Vercruysse F, Shaw W, Matthews DR, Neal B. Mediators of the Effects of Canagliflozin on Heart Failure in Patients With Type 2 Diabetes. JACC Heart Fail. 2020 Jan;8(1):57-66. doi: 10.1016/j.jchf.2019.08.004. Epub 2019 Oct 29.

ReferenceCitation: Zhou Z, Jardine M, Perkovic V, Matthews DR, Mahaffey KW, de Zeeuw D, Fulcher G, Desai M, Oh R, Simpson R, Watts NB, Neal B. Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program. Diabetologia. 2019 Oct;62(10):1854-1867. doi: 10.1007/s00125-019-4955-5. Epub 2019 Aug 10.

ReferenceCitation: Figtree GA, Rådholm K, Barrett TD, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Neal B. Effects of Canagliflozin on Heart Failure Outcomes Associated With Preserved and Reduced Ejection Fraction in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2591-2593. doi: 10.1161/CIRCULATIONAHA.119.040057. Epub 2019 Mar 17.

ReferenceCitation: Zhou Z, Lindley RI, Rådholm K, Jenkins B, Watson J, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Shaw W, Oh R, Desai M, Matthews DR, Neal B. Canagliflozin and Stroke in Type 2 Diabetes Mellitus. Stroke. 2019 Feb;50(2):396-404. doi: 10.1161/STROKEAHA.118.023009.

ReferenceCitation: Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Desai M, Li Q, Deng H, Rosenthal N, Jardine MJ, Bakris G, Perkovic V. Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function. Circulation. 2018 Oct 9;138(15):1537-1550. doi: 10.1161/CIRCULATIONAHA.118.035901.

ReferenceCitation: Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, Barrett TD, Weidner-Wells M, Deng H, Matthews DR, Neal B. Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. doi: 10.1016/S2213-8587(18)30141-4. Epub 2018 Jun 21.

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: Rådholm K, Figtree G, Perkovic V, Solomon SD, Mahaffey KW, de Zeeuw D, Fulcher G, Barrett TD, Shaw W, Desai M, Matthews DR, Neal B. Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program. Circulation. 2018 Jul 31;138(5):458-468. doi: 10.1161/CIRCULATIONAHA.118.034222.

ReferenceCitation: Mahaffey KW, Neal B, Perkovic V, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Fabbrini E, Sun T, Li Q, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018 Jan 23;137(4):323-334. doi: 10.1161/CIRCULATIONAHA.117.032038. Epub 2017 Nov 13.

ReferenceCitation: Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Russian Federation
Australia
Argentina
Puerto Rico
Mexico
Malaysia
Sweden
Brazil
Canada
Hungary
China
Germany
Taiwan
New Zealand
Korea, Republic of
France
Netherlands

summary: The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.


type: EudraCT Number

type: Other Identifier

title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

acronym: SYNERGY

summary: The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Slovenia
Russian Federation
Australia
Argentina
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Latvia
Estonia
New Zealand
Finland
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Site US10079 PMG Research of Charleston, LLC

location_facility: Site CA15013 Sunnybrook Health Sciences Center

location_facility: Site CZ42015 Centrum ambulantni gynekologie a primarni pece

location_facility: Site US10109 Lynn Health Science Institute

location_facility: Site US10248 Preferred Primary Care Physicians, Inc

location_facility: Site UA38015 Regional Municipal Institution, Urology Department

location_facility: Site US10536 Stanford School of Medicine

location_facility: Site SE46005 Center för Läkemedelsstudier

location_facility: Site LT37012 Klaipeda University Hospital

location_facility: Site MX52001 Centro de Investigacin Basica y Clnica

location_facility: Site US10168 Weill Cornell Medical College

location_facility: Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.

location_facility: Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3

location_facility: Site US10155 Seattle Women's Health, Research, Gynecology

location_facility: Site KR82001 Seoul Saint Mary's Hospital

location_facility: Site SG65003 KK Women's and Children's Hospital

location_facility: Site SK42105 Ruzinovska poliklinika a.s.

location_facility: Site MX52002 Accelerium Clinical Research/ Hospital San Jorge

location_facility: Site US10013 Seattle Urology Research Center

location_facility: Site SG65001 National University Hospital

location_facility: Site US10127 Perimeter North Medical Research, Inc.

location_facility: Site PL48012 Military Institute of Medicine

location_facility: Site US10017 Philadelphia Clinical Research, LLC

location_facility: Site TW88605 Taichung Veteran General Hospital

location_facility: Site NL31002 Academic Medical Center (AMC)

location_facility: Site HU36012 Veszprém County Cholnoky Ferenc Hospital

location_facility: Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna

location_facility: Site PL48016 Prywatny Gabinet Urologiczny

location_facility: Site SE46009 Encia AB, Uppsala Hälsomottagning

location_facility: Site US10545 San Diego Institute for Sexual Medicine

location_facility: Site US10050 Rapid Medical Research, Inc.

location_facility: Site PH63009 Chinese General Hospital and Medical Center

location_facility: Site KR82017 Kyung Hee University Medical Center

location_facility: Site PH63003 University of Santo Tomas Hospital (USTH)

location_facility: Site US10560 Chesapeake Urology Research Associates

location_facility: Site US10040 Premier Medical Group Of The Hudson Valley

location_facility: Site US10026 AccuMed Research Associates

location_facility: Site KR82010 Chonbuk National University Hospital

location_facility: Site US10018 Grove Hill Clinical Research

location_facility: Site FR33011 Centre Hospitalier Lyon Sud

location_facility: Site KR82013 Hallym University Kangdong Sacred Heart Hospital

location_facility: Site RO40005 Spiatlul Clinic Th. Burghele

location_facility: Site HU36007 Mediroyal Prevention Center

location_facility: Site CN86028 General Hospital of Chengdu Military Region of PLA

location_facility: Site KR82014 Soon Chun Hyang University Hospital

location_facility: Site US10122 Orange County Research Institute

location_facility: Site CN86009 Peking University 3rd Hospital

location_facility: Site KR82025 Seoul National University Bundang Hospital

location_facility: Site KR82029 Daegu Catholic Univ. Medical Center

location_facility: Site US10092 Physicians' Research Options/Salt Lake Women's Center

location_facility: Site US10023 Hillcrest Clinical Research, LLC

location_facility: Site KR82009 Wonkwang University Hospital

location_facility: Site TR90017 Bilim University Sisli Florence Nightingale Hospital

location_facility: Site CA15032 Stanley Flax Medical Prof Corp

location_facility: Site SI38602 General Hospital Novo Mesto

location_facility: Site US10120 WR-Mount Vernon Clinical Research

location_facility: Site US10015 Urology Group of New Mexico

location_facility: Site UA38004 Vinnitsa Endocrinology Dispens

location_facility: Site US10558 Chesapeake Urology Research Associates

location_facility: Site US10153 Palmetto Professional Research

location_facility: Site LT37010 Public Institution Vilnius City University Hospital

location_facility: Site ES34003 Hospital Universitario Nuestra Señora de Valme

location_facility: Site AU61015 Repatriation General Hospital

location_facility: Site NO47008 Norsk Helseklinikk (Heiaklinikken)

location_facility: Site KR82019 Chungnam National University Hospital

location_facility: Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia

location_facility: Site CN86016 Guangzhou First People's Hospital

location_facility: Site UA38010 Academy of Medical Sciences of Ukraine

location_facility: Site US10124 Winter Park Urology Associates

location_facility: Site PE51005 Hospital Nacional Hipolito Unanue

location_facility: Site US10549 Associated Urologists of North Carolina

location_facility: Site CA15001 The Male/Female Health & Research Centre

location_facility: Site CA15031 Centre for Applied Urology Research (CAUR)

location_facility: Site CN86029 Southwest Hospital (Chongqing)

location_facility: Site US10046 Coastal Carolina Research Center

location_facility: Site US10154 Montana Medical Research Inc

location_facility: Site US10032 National Clinical Research Inc.

location_facility: Site KR82021 Cheil General Hospital & Women's Healthcare Center

location_facility: Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: Site TW88612 Chi Mei Medical Center, Yong Kang

location_facility: Site US10073 Manhattan Medical Research Practice, PLLC

location_facility: Site US10250 Preferred Primary Care Physicians Inc.

location_facility: Site CA15015 Recherches Cliniques Theradev, Inc.

location_facility: Site US10011 Albuquerque Clinical Trials, Inc.

location_facility: Site KR82005 Yeungnam University Hospital

location_facility: Site ES34009 Hospital Universitario La Paz

location_facility: Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital

location_facility: Site US10159 Urological Research Network

location_facility: Site US10162 Phoenix OB-GYN Associates, LLC

location_facility: Site CN86026 The First Affiliated Hospital of Wenzhou Medical C

location_facility: Site US10593 Upstate Clinical Research Associates LLC

location_facility: Site PE51001 Instituto de Ginecologia y Reproduccion

location_facility: Site AR54003 Hospital Italiano de Buenos Aires

location_facility: Site US10104 Clinical Research Advantage, Inc.

location_facility: Site BG35905 MHAT Alexandrovska Hospital

location_facility: Site AU61011 Illawarra Health and Medical Research Institute

location_facility: Site CZ42001 Fakultni Nemocnice Hradec Kralove

location_facility: Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc

location_facility: Site CN86010 1st Affiliated Hosptital of Suchow University

location_facility: Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud

location_facility: Site US10010 Southeastern Research Group, Inc

location_facility: Site AR54004 Instituto de Investigaciones Clnicas Rosario

location_facility: Site IT39007 Azienda Ospedaliera San Giuseppe Moscati

location_facility: Site RO40001 Spiatlul Clinic Th. Burghele

location_facility: Site LT37005 Public Institution Vilnius City University Hospital

location_facility: Site CA15035 Glenrose Rehabilitation Hospital

location_facility: Site MY60005 Universiti Kebangsaan Malaysia Medical Centre

location_facility: Site CN86020 The First Affiliated Hospital of NanChang Univers

location_facility: Site KR82031 Chonnam National University Hospital

location_facility: Site SI38604 General Hospital Murska Sobota

location_facility: Site US10150 Suncoast Clinical Research, Inc.

location_facility: Site US10049 Coastal Clinical Research, Inc.

location_facility: Site CA15021 Urology South Shore Research

location_facility: Site DE49026 Zentrum fuer Onkologie und Urologie Rostock

location_facility: Site EE37205 West Tallinn Central Hospital

location_facility: Site TH66006 Songklanagarind Hospital, Prince of Songkla University

location_facility: Site CN86015 Zhongnan Hospital of Wuhan University

location_facility: Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic

location_facility: Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.

location_facility: Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan

location_facility: Site US10165 East Coast Institute for Research

location_facility: Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko

location_facility: Site US10004 Integrity Medical Research, LLC

location_facility: Site MX52003 Clinstile, Sociedad Anonima de Capital Variable

location_facility: Site US10095 Florida Urology Specialists

location_facility: Site KR82024 Chungbuk National University Hospital

location_facility: Site US10148 Best Quality Research, Inc.

location_facility: Site NZ64004 John A Tuckey Ltd Ascot Central

location_facility: Site US10114 Bay State Clinical Trials, Inc.

location_facility: Site CA15044 McMaster Institute of Urology

location_facility: Site LT37008 Kaunas 2nd Clinical Hospital

location_facility: Site US10117 Carolina Urologic Research Center

location_facility: Site US10123 Chase Medical Research, LLC

location_facility: Site AR54006 Hospital Italiano de Buenos Aires

location_facility: Site CN86012 The Fifth People's Hospital of Shanghai

location_facility: Site US10539 Citrus Valley Medical Research

location_facility: Site CN86011 The Second Affiliated Hospital of Soochow Universi

location_facility: Site US10097 A.G.A. Clinical Trials DBA Neostart Group

location_facility: Site SE46017 S3 Clinical Research Centers

location_facility: Site CA15027 Diex Research Sherbrooke Inc

location_facility: Site SK42106 Private Urological Care Center

location_facility: Site IT39022 Azienda Ospedale Umberto I (Ancona)

location_facility: Site BE32011 Universitaire Ziekenhuizen Leuven

location_facility: Site US10219 Methodist Urology Associates

location_facility: Site TW88611 Chung Shan Medical University Hospital

location_facility: Site GB44005 North West London Hosp Menopause Clinic

location_facility: Site TW88614 Tri-Service General Hospital

location_facility: Site US10167 University of Pittsburgh Medical Center

location_facility: Site ES34001 Hospital Universitario de Getafe

location_facility: Site DK45013 University Hospital of Aarhus, Skejby

location_facility: Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital

location_facility: Site CN86014 The First Hospital Bethune of Jilin University

location_facility: Site US10093 Pioneer Research Solutions, Inc.

location_facility: Site CA15042 G. Kenneth Jansz Medicine Professional Corporation

location_facility: Site US10067 Family Practice Center of Wadsworth

location_facility: Site NZ64001 Canterbury Urology Research Trust

location_facility: Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric

location_facility: Site US10534 South Florida Medical Research

location_facility: Site SE46012 Karolinska University Hospital Huddinge

location_facility: Site US10090 Protenium Clinical Research, LLC

location_facility: Site KR82012 Konkuk University Medical Center

location_facility: Site US10110 Montana Health Research Institute, Inc.

location_facility: Site KR82016 Pusan National University Hospital

location_facility: Site LT37004 KHospital of Lithuanian University of Health Science

location_facility: Site KR82020 Seoul National University Hospital

location_facility: Site TH66010 Maharaj Nakorm Chiangmai Hosp

location_facility: Site NZ64003 Tauranga Urology Research Ltd

location_facility: Site RU70015 LLC Clinical Research Medical Complex

location_facility: Site GB44024 St James's University Hospital

location_facility: Site US10170 Yale - New Haven Hospital West Haven VAMC

location_facility: Site CN86022 Tongji Hospital, Tongji Medical College of Hust

location_facility: Site RU70018 Bashkirsky State Medical University of Roszdrav

location_facility: Site GB44022 The Royal Berkshire Hospital

location_facility: Site PH63008 Dr. Pablo O. Torre Memorial Hospital

location_facility: Site NL31005 Canisius-Wilhelmina Ziekenhuis

location_facility: Site BG35904 University Hospital (UMHAT) - George Stranski

location_facility: Site NZ64005 Waikato Urology Research Limited

location_facility: Site AR54005 IUBA - Instituto Urologico de Buenos Aires

location_facility: Site CA15004 Primehealth Clinical Research

location_facility: Site KR82015 Korea University Medical Center

location_facility: Site CO57004 Instituto de Coloproctologia ICO SAS

location_facility: Site LT37007 Vilnius University Hospital Santariskiu Klinikos

location_facility: Site US10002 Urology Center Research Institute

location_facility: Site US10166 Medical University of South Carolina

location_facility: Site US10535 South Florida Medical Research

location_facility: Site KR82006 Dong-A University Medical Center

location_facility: Site AU61004 Keogh Institute for Medical Research

location_facility: Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft

location_facility: Site US10078 Heartland Research Associates, LLC

location_facility: Site US10128 Clinical Research Center of CT

location_facility: Site CN86027 Second Hospital of Lanzhou University

location_facility: Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital

location_facility: Site RU70019 City Multidisciplinary Hospital No. 2

location_facility: Site US10008 Urologic Consultants of Southeastern Pennsylvania

location_facility: Site KR82032 Kyungpook National University Hospital

location_facility: Site CN86025 Beijing Friendship Hospital

location_facility: Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne

location_facility: Site LV37105 P.Stradins Clinical University Hospital

location_facility: Site LT37011 Saules Family Medicine Centre

location_facility: Site CN86030 Lanzhou University First Hospital

location_facility: Site US10053 Western Clinical Research, Inc.

location_facility: Site DE49031 Urologisches Zentrum Refrath

location_facility: Site NZ64006 Cardinal Point Specialist Centre

location_facility: Site LT37003 Family Medical Centre Seimos gydytojas

location_facility: Site US10065 Advanced Research Associates

location_facility: Site CN86021 HuaDong Hosipital Affiliated to Fudan University

location_facility: Site AU61022 Brisbane South Clinical Research Centre

location_facility: Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu

location_facility: Site US10152 Female Pelvic Medicine & Urogynecology Institute

location_facility: Site NL31001 University Medical Centre Utrecht

location_facility: Site RU70022 St. Petersburg State Public Health Institution

location_facility: Site US10037 Atlanta Medical Research Institute

location_facility: Site US10063 Preferred Primary Care Physician Research

location_facility: Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.

location_facility: Site FR33007 Centre Hospitalier Louis Pasteur

location_facility: Site CZ42009 Hospital Uherské Hradiště a.s.

location_facility: Site US10106 West Coast Clinical Research

location_facility: Site RU70002 Pavlov St. Petersburg State Medical University

location_facility: Site US10028 Premier Medical Group of the Hudson Valley

location_facility: Site US10540 Demaur Clinical Research, INC

location_facility: Site PL48001 Specjalistyczny Gabinet Lekarski

location_facility: Site TR90013 Uludag University Faculty of Medicine

location_facility: Site MX52004 Consultorio de Especialidad en Urologia

location_facility: Site KR82023 Gachon University Gil Hospital

location_facility: Site SK42104 Urology Outpatient Department

location_facility: Site US10542 Adult & Pediatric Urology Group

location_facility: Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza

location_facility: Site ZA27013 Synexus Clinical Research SA (Pty) Ltd

location_facility: Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology

location_facility: Site US10070 Physicians' Research Options/Red Rocks OB/GYN

location_facility: Site MY60004 University Malaya Medical Centre

location_facility: Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov

location_facility: Site SK42101 Andrologicka a Urologicka Ambulancia

location_facility: Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov

location_facility: Site TH66007 Thammasat University Hospital

location_facility: Site TR90001 Pamukkale University Faculty of Medicine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: Simplify 1

title: A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

lead_sponsor: Sierra Oncology, Inc.

source: euctr

location_country:
Spain
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Israel
Sweden
Singapore
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Korea, Republic of
France
Netherlands

summary:
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).

Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.


title: Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Associated Hyperammonemia With an Episode of Hepatic Encephalopathy (STOP-HE Study)

acronym: STOP-HE

summary: The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

ReferenceType: derived

ReferenceCitation: Safadi R, Rahimi RS, Thabut D, Bajaj JS, Ram Bhamidimarri K, Pyrsopoulos N, Potthoff A, Bukofzer S, Wang L, Jamil K, Devarakonda KR. Pharmacokinetics/pharmacodynamics of L-ornithine phenylacetate in overt hepatic encephalopathy and the effect of plasma ammonia concentration reduction on clinical outcomes. Clin Transl Sci. 2022 Jun;15(6):1449-1459. doi: 10.1111/cts.13257. Epub 2022 Mar 3.

ReferenceCitation: Wang X, Vilchez RA. Population Pharmacokinetic Analysis to Assist Dose Selection of the L-Ornithine Salt of Phenylacetic Acid. Clin Pharmacokinet. 2022 Apr;61(4):515-526. doi: 10.1007/s40262-021-01075-1. Epub 2021 Nov 17.

ReferenceCitation: Rahimi RS, Safadi R, Thabut D, Bhamidimarri KR, Pyrsopoulos N, Potthoff A, Bukofzer S, Bajaj JS. Efficacy and Safety of Ornithine Phenylacetate for Treating Overt Hepatic Encephalopathy in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2626-2635.e7. doi: 10.1016/j.cgh.2020.10.019. Epub 2020 Oct 16.

ipd_sharing: No

ipd_sharing_description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT01966419) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

lead_sponsor: Ocera Therapeutics, Inc.

location_country:
Denmark
Spain
Italy
Austria
Australia
Estonia
Netherlands
New Zealand
Russian Federation
Hungary
United States
France
Israel
Belgium
Germany
Bulgaria
Czechia


title: A Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate ProCervix Efficacy to Clear HPV 16 and HPV 18 Infection in Women With Normal Cytology or ASCUS/LSIL

acronym: RHEIA-VAC

summary:
Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential.

This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).

ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant.

The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.

lead_sponsor: Genticel

location_country:
Spain
United Kingdom
Netherlands
Finland
France
Belgium
Germany

location_facility: Klinikum der Friedrich Schiller Universität Jena Hospital

location_facility: Centre d'Investigation Clinique de Vaccinologie Cochin Pasteur (CIC BT505)

location_facility: Dumfries and Galloway Royal Infirmary Hospital

location_facility: Elisabeth Krankenhaus Essen GmbH - Clinic/Outpatient Facility

location_facility: Institut Catala d'Oncologia L'Hopitalet de Llobregat

location_facility: Hospital Clinic Dept of Obstetrics and Gynecology C/ Villarroel Unidad de Ginecología Oncológica, Instituto Clínico de Ginecología y Obstetricia y Neonatología (ICGON), Hospital Clínic, Instituto de Investigaciones Biomédi

location_facility: Charité - Universitätsmedizin Berlin Hospital

location_facility: Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil

location_facility: Regionaal Ziekenhuis Heilig Hart Tienen Hospital

location_facility: Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute (VAXINFECTIO) Faculty of Medicine University of Antwerp Belgium

location_facility: Academic O&G University of Manchester Research - St Mary's Hospital

location_facility: Tampereen yliopistollinen sairaala Hospital

location_facility: Grand Hôpital de Charleroi Site Notre-Dame

location_facility: CHU de Nîmes - Hopital Universitaire Caremeau

location_facility: Liverpool - GUM - Liverpool Centre for Sexual Health

location_facility: Center Gynaecological Oncology Amsterdam AMC, NKI-AVL, VUmc

location_facility: The Centre for Immunology and Infection Hull York Medical School University of York

location_facility: Clinica Ginecologica Ceoga, Clinic/Outpatient Facility

intervention_type: Biological


title: A Randomized, Double-blind, Multi-center Phase 2 Trial of Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

summary: This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

ReferenceType: background

ReferenceCitation: Peters S, Danson S, Ejedepang D, Dafni U, Hasan B, Radcliffe HS, Bustin F, Crequit J, Coate L, Guillot M, Surmont V, Rauch D, Rudzki J, O'Mahony D, Barneto Aranda I, Scherz A, Tsourti Z, Roschitzki-Voser H, Pochesci A, Demonty G, Stahel RA, O'Brien M. Combined, patient-level, analysis of two randomised trials evaluating the addition of denosumab to standard first-line chemotherapy in advanced NSCLC - The ETOP/EORTC SPLENDOUR and AMGEN-249 trials. Lung Cancer. 2021 Nov;161:76-85. doi: 10.1016/j.lungcan.2021.09.002. Epub 2021 Sep 9.

lead_sponsor: Amgen

location_country:
United Kingdom
Greece
Italy
Australia
Netherlands
Canada
United States
France
Germany
Czechia


status: Active, not recruiting

title: A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)

study_completion_date_type: Anticipated

lead_sponsor: AstraZeneca

ReferenceCitation: Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial. JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.

ReferenceCitation: Jänne PA, Mann H, Ghiorghiu D. Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1). Clin Lung Cancer. 2016 Mar;17(2):e1-4. doi: 10.1016/j.cllc.2015.12.010. Epub 2015 Dec 30.

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

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Romania
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
France
Chile
Netherlands

summary: The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

status_simplified: Ongoing


title: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

summary: A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Gilead Sciences

location_country:
Poland
Portugal
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Switzerland
Sweden
France
Belgium
Germany

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: UCD School of Medicine and Medical Sciences

location_facility: AKh Allgemeines Krankenhaus der Stadt Linz GmbH

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Gemeinschaftspaxis Dres. Jessen & Kollegen

location_facility: Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra

location_facility: Istituto Nazionale per le Malattie Infettive

location_facility: CUB Hopital Erasme- Free University of Brussels

location_facility: Klinikum der Universität München-Großhadern

location_facility: Infektionsmedizinisches Centrum Hamburg (ICH)

location_facility: Karolinska University Hospital - Dept of Infectious Diseases

location_facility: Royal Free Hospital and University College London Hospital

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: HPP Hospital de Cascais Dr. José de Almeida

location_facility: Imperial College Healthcare NHS Trust St. Mary's Campus

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi


title: A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials

summary: This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4. Review.

ReferenceCitation: Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

ReferenceCitation: Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study. Clin Ther. 2016 Sep;38(9):2058-2070.e1. doi: 10.1016/j.clinthera.2016.07.010. Epub 2016 Aug 21.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
Netherlands
Ukraine
United Kingdom
Korea, Republic of
United States
Chile
France
Belgium
Japan
Germany
Czechia


ipd_sharing: Undecided

title: A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Soria JC, Tan DSW, Chiari R, Wu YL, Paz-Ares L, Wolf J, Geater SL, Orlov S, Cortinovis D, Yu CJ, Hochmair M, Cortot AB, Tsai CM, Moro-Sibilot D, Campelo RG, McCulloch T, Sen P, Dugan M, Pantano S, Branle F, Massacesi C, de Castro G Jr. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017 Mar 4;389(10072):917-929. doi: 10.1016/S0140-6736(17)30123-X. Epub 2017 Jan 24. Erratum in: Lancet. 2017 Mar 4;389(10072):908.

ReferenceCitation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30. Review.

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:
Spain
Italy
United Kingdom
Japan
Poland
Austria
Australia
Russian Federation
India
Turkey
Mexico
Norway
Singapore
Sweden
Brazil
Lebanon
China
Germany
Denmark
Taiwan
Greece
Ireland
Thailand
Korea, Republic of
France
Colombia
Netherlands

summary: The primary purpose of the study was to compare the antitumor activity of LDK378 versus reference chemotherapy. Patients in the chemotherapy arm were allowed to cross-over to LDK378 after confirmed progressive disease (PD).


title: A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Jacobsen AA, Kydd AR, Strasswimmer J. Practical management of the adverse effects of Hedgehog pathway inhibitor therapy for basal cell carcinoma. J Am Acad Dermatol. 2017 Apr;76(4):767-768. doi: 10.1016/j.jaad.2016.04.063.

ReferenceCitation: Dréno B, Kunstfeld R, Hauschild A, Fosko S, Zloty D, Labeille B, Grob JJ, Puig S, Gilberg F, Bergström D, Page DR, Rogers G, Schadendorf D. Two intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas (MIKIE): a randomised, regimen-controlled, double-blind, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):404-412. doi: 10.1016/S1470-2045(17)30072-4. Epub 2017 Feb 8.

location_country:
Spain
Italy
Austria
Netherlands
Russian Federation
Canada
United States
France
Mexico
Germany

location_facility: Dermatology and Laser Center of Charleston PA

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Washington University School of Medicine

location_facility: FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed

location_facility: Saint Louis University School of Medicine; Department of Dermatology

location_facility: Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Arcispedale Santa Maria Nuova; Dermatologia

location_facility: UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

location_facility: Hospital General Dr. Manuel Gea Gonzalez; Dermatology

location_facility: Hospital General Universitario de Guadalajara; Servicio de Dermatologia

location_facility: VU MEDISCH CENTRUM;Afdeling Dermatologie

location_facility: Blokhin Cancer Research Center; General Oncology Department

location_facility: Skin and Cancer Associates and the Center for Cosmetic Enhancement

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: LKH Innsbruck; Universitätsklinik für Dermatologie

location_facility: Hospital Costa Del Sol; Servicio de Dermatologia

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: UBC Department of Dermatology & Skin Sciences

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Long Island Skin Cancer and Dermatologic Surgery

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Maastricht University Medical Centre; Dermatologie

location_facility: California Pacific Medical Center Research Institute

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: Università di Brescia; Dipartimento di Dermatologia

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Beverly Hospital;Oncology Center Pharmacy

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

summary: This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.


title: A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

acronym: Galaxy 2

summary: The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

status: Terminated

lead_sponsor: Synta Pharmaceuticals Corp.

location_country:
Croatia
Bosnia and Herzegovina
Poland
Romania
Serbia
Italy
Austria
Netherlands
Russian Federation
Canada
Czech Republic
Slovenia
Spain
Ukraine
Hungary
United States
France
United Kingdom
Belgium
Germany

location_facility: Cancer Care Specialists of Central Illinois, S.C.

location_facility: Johann Wolfgang Goethe University Clinic Frankfurt

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: North Shore Hematology Oncology Associates

location_facility: Algemeen Stedelijk Ziekenhuis - Campus Aalst

location_facility: Emory University - Winship Cancer Institute

location_facility: Institute for pulmonary diseases of Vojvodine

location_facility: Fort Wayne Medical Oncology and Hematology Inc

location_facility: Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Univerzitetna klinika za pljucne bolesti in alergijo Golnik

location_facility: Erlanger Institute for Clinical Research

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: City of Hope Comprehensive Breast Cancer Center

location_facility: Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach

location_facility: Hospital de Mataró, Consorci Sanitari del Maresme

location_facility: Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo

location_facility: Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

location_facility: Novant Health Presbyterian Medical Center

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Synta Pharmaceuticals Investigational Site

location_facility: Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: University of South Florida - H. Lee Moffitt

location_facility: Eastern Connecticut Hematology Associates

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: Providence Regional Medical Center Everett

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: University of Miami Health System Sylvester at Deerfield Beach

location_facility: St. Louis Cancer Care, LLP - North County

location_facility: Országos Korányi TBC és Pulmonológiai Intézet

location_facility: Istituti Fisioterapici Ospitalieri Regina Elena

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: UC Davis Medical Center - UC Davis Comprehensive Cancer

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

location_facility: Green Bay Oncology, Ltd. - St. Mary's Site

location_facility: Houston Methodist Hospital Research Institute

location_facility: St. Joseph Hospital, Center for Cancer Prevention and Treatment

location_facility: New Hanover Regional Medical Center - Zimmer Cancer Center

location_facility: University Of North Carolina At Chapel Hill

location_facility: Institutul Oncologic "Prof.Dr.I.Chiricuta" Cluj Napoca

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital d

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: The Center for Cancer and Blood Disorders (CCBD) - Bethesda

location_facility: Synta Pharmaceuticals Investigative Site

location_facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika

location_facility: Sint Antoniusziekenhuis, location Utrecht

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia, Universi

location_facility: Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó

location_facility: Centre Hosptalier De Villefranche-Sur-Saone

location_facility: Lynn Cancer Institute Center for Hematology Oncology

location_facility: INDC Entité Jolimontoise - Polyclinique de Jolimont

location_facility: Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a

location_facility: Medizinische Fakultät Mannheim Uni Heidelberg

location_facility: Sozialmedizinisches Zentrum Baumgartner Höhe

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Pneumologisches Forschungsinstitut an der Lungenclinic Gross

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

location_facility: Clinical Center University of Sarajevo, Clinic of Oncology

location_facility: Gemeinschaftspraxis fuer Haematologie und Onkologie

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

status_simplified: Unknown


title: A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).

acronym: COMPASS

summary:
The primary objectives of this study are:

To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

primary_purpose: Prevention

ReferenceType: result

ReferenceCitation: Anand SS, Caron F, Eikelboom JW, Bosch J, Dyal L, Aboyans V, Abola MT, Branch KRH, Keltai K, Bhatt DL, Verhamme P, Fox KAA, Cook-Bruns N, Lanius V, Connolly SJ, Yusuf S. Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial. J Am Coll Cardiol. 2018 May 22;71(20):2306-2315. doi: 10.1016/j.jacc.2018.03.008. Epub 2018 Mar 11.

ReferenceCitation: Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32409-1. doi: 10.1016/S0140-6736(17)32409-1. PMID:29132880

ReferenceCitation: Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Nov 10. pii: S0140-6736(17)32458-3. doi: 10.1016/S0140-6736(17)32458-3. PMID:29132879

ReferenceCitation: Eikelboom JW, Connolly SJ, Bosch J, Dagenais GR, Hart RG, Shestakovska O, Diaz R, Alings M, Lonn EM, Anand SS, Widimsky P, Hori M, Avezum A, Piegas LS, Branch KRH, Probstfield J, Bhatt DL, Zhu J, Liang Y, Maggioni AP, Lopez-Jaramillo P, O'Donnell M, Kakkar AK, Fox KAA, Parkhomenko AN, Ertl G, Störk S, Keltai M, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Verhamme PB, Vinereanu D, Kim JH, Tonkin AM, Lewis BS, Felix C, Yusoff K, Steg PG, Metsarinne KP, Cook Bruns N, Misselwitz F, Chen E, Leong D, Yusuf S; COMPASS Investigators. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease. N Engl J Med. 2017 Oct 5;377(14):1319-1330. doi: 10.1056/NEJMoa1709118. Epub 2017 Aug 27.

ReferenceCitation: Lamy A, Eikelboom J, Tong W, Yuan F, Bangdiwala SI, Bosch J, Connolly S, Lonn E, Dagenais GR, Branch KRH, Wang WJ, Bhatt DL, Probstfield J, Ertl G, Störk S, Steg PG, Aboyans V, Durand-Zaleski I, Ryden L, Yusuf S; COMPASS Investigators. The cost-effectiveness of Rivaroxaban with or without aspirin in the COMPASS trial. Eur Heart J Qual Care Clin Outcomes. 2022 Aug 24. pii: qcac054. doi: 10.1093/ehjqcco/qcac054. [Epub ahead of print]

ReferenceCitation: Eikelboom JW, Bhatt DL, Fox KAA, Bosch J, Connolly SJ, Anand SS, Avezum A, Berkowitz SD, Branch KRH, Dagenais GR, Félix C, Guzik TJ, Hart RG, Maggioni AP, Muehlhofer E, Sharma M, Shestakovska O, Yusuf S. Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. J Am Coll Cardiol. 2021 Jul 6;78(1):14-23. doi: 10.1016/j.jacc.2021.04.083.

ReferenceCitation: Lamy A, Browne A, Sheth T, Zheng Z, Dagenais F, Noiseux N, Chen X, Bakaeen FG, Brtko M, Stevens LM, Alboom M, Lee SF, Copland I, Salim Y, Eikelboom J; COMPASS Investigators. Skeletonized vs Pedicled Internal Mammary Artery Graft Harvesting in Coronary Artery Bypass Surgery: A Post Hoc Analysis From the COMPASS Trial. JAMA Cardiol. 2021 Sep 1;6(9):1042-1049. doi: 10.1001/jamacardio.2021.1686. Erratum in: JAMA Cardiol. 2021 Aug 18;:null.

ReferenceCitation: Dagenais GR, Dyal L, Bosch JJ, Leong DP, Aboyans V, Berkowitz SD, Bhatt DL, Connolly SJ, Fox KAA, Muehlhofer E, Probstfield JL, Widimsky P, Winkelmann BR, Yusuf S, Eikelboom JW. Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease. Heart. 2021 Jul;107(14):1130-1137. doi: 10.1136/heartjnl-2020-318758. Epub 2021 May 21.

ReferenceCitation: Sen J, Tonkin A, Varigos J, Fonguh S, Berkowitz SD, Yusuf S, Verhamme P, Vanassche T, Anand SS, Fox KAA, Eikelboom JW, Amerena J; COMPASS Trial Investigators. Risk stratification of cardiovascular complications using CHA(2)DS(2)-VASc and CHADS(2) scores in chronic atherosclerotic cardiovascular disease. Int J Cardiol. 2021 Aug 15;337:9-15. doi: 10.1016/j.ijcard.2021.04.067. Epub 2021 May 3.

ReferenceCitation: Guzik TJ, Ramasundarahettige C, Pogosova N, Lopez-Jaramillo P, Dyal L, Berkowitz SD, Muehlhofer E, Bhatt DL, Fox KAA, Yusuf S, Eikelboom JW. Rivaroxaban Plus Aspirin in Obese and Overweight Patients With Vascular Disease in the COMPASS Trial. J Am Coll Cardiol. 2021 Feb 9;77(5):511-525. doi: 10.1016/j.jacc.2020.11.061.

ReferenceCitation: Sharma M, Hart RG, Smith EE, Bosch J, Eikelboom JW, Connolly SJ, Dyal L, Reeh KW, Casanova A, Diaz R, Lopez-Jaramillo P, Ertl G, Störk S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KRH, Probstfield JL, Kim JH, O'Donnell M, Vinereanu D, A A Fox K, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Berkowitz SD, Yusuf S. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline: The COMPASS MRI Substudy. Stroke. 2020 Oct;51(10):2901-2909. doi: 10.1161/STROKEAHA.120.029762. Epub 2020 Sep 21. Erratum in: Stroke. 2021 Jan;52(2):e90.

ReferenceCitation: Catanese L, Eikelboom JW, Bosch J, Shestakovska O, Ng K, Nayar S, Perera KS, Shoamanesh A, Sharma M, Hart RG. Oral factor Xa inhibitors and risk of subdural hematoma: COMPASS trial results and meta-analysis. Neurology. 2020 Aug 4;95(5):e480-e487. doi: 10.1212/WNL.0000000000009826. Epub 2020 Jul 10.

ReferenceCitation: Steffel J, Eikelboom JW, Anand SS, Shestakovska O, Yusuf S, Fox KAA. The COMPASS Trial: Net Clinical Benefit of Low-Dose Rivaroxaban Plus Aspirin as Compared With Aspirin in Patients With Chronic Vascular Disease. Circulation. 2020 Jul 7;142(1):40-48. doi: 10.1161/CIRCULATIONAHA.120.046048. Epub 2020 May 21. Erratum in: Circulation. 2020 Jul 7;142(1):e23.

ReferenceCitation: Bhatt DL, Eikelboom JW, Connolly SJ, Steg PG, Anand SS, Verma S, Branch KRH, Probstfield J, Bosch J, Shestakovska O, Szarek M, Maggioni AP, Widimský P, Avezum A, Diaz R, Lewis BS, Berkowitz SD, Fox KAA, Ryden L, Yusuf S; COMPASS Steering Committee and Investigators. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease: Insights From the COMPASS Trial. Circulation. 2020 Jun 9;141(23):1841-1854. doi: 10.1161/CIRCULATIONAHA.120.046448. Epub 2020 Mar 28.

ReferenceCitation: Bainey KR, Welsh RC, Connolly SJ, Marsden T, Bosch J, Fox KAA, Steg PG, Vinereanu D, Connolly DL, Berkowitz SD, Foody JM, Probstfield JL, Branch KR, Lewis BS, Diaz R, Muehlhofer E, Widimsky P, Yusuf S, Eikelboom JW, Bhatt DL; COMPASS Investigators. Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI). Circulation. 2020 Apr 7;141(14):1141-1151. doi: 10.1161/CIRCULATIONAHA.119.044598. Epub 2020 Mar 17. Erratum in: Circulation. 2020 Jun 9;141(23):e905.

ReferenceCitation: Eikelboom JW, Bosch JJ, Connolly SJ, Shestakovska O, Dagenais GR, Hart RG, Leong DP, O'Donnell M, Fox KAA, Bhatt DL, Cairns JA, Tasto C, Berkowitz SD, Cook Bruns N, Muehlhofer E, Diaz R, Maggioni AP, Yusuf S. Major Bleeding in Patients With Coronary or Peripheral Artery Disease Treated With Rivaroxaban Plus Aspirin. J Am Coll Cardiol. 2019 Sep 24;74(12):1519-1528. doi: 10.1016/j.jacc.2019.07.065.

ReferenceCitation: Perera KS, Ng KKH, Nayar S, Catanese L, Dyal L, Sharma M, Connolly SJ, Yusuf S, Bosch J, Eikelboom JW, Hart RG. Association Between Low-Dose Rivaroxaban With or Without Aspirin and Ischemic Stroke Subtypes: A Secondary Analysis of the COMPASS Trial. JAMA Neurol. 2020 Jan 1;77(1):43-48. doi: 10.1001/jamaneurol.2019.2984.

ReferenceCitation: Eikelboom JW, Connolly SJ, Bosch J, Shestakovska O, Aboyans V, Alings M, Anand SS, Avezum A, Berkowitz SD, Bhatt DL, Cook-Bruns N, Felix C, Fox KAA, Hart RG, Maggioni AP, Moayyedi P, O'Donnell M, Rydén L, Verhamme P, Widimsky P, Zhu J, Yusuf S. Bleeding and New Cancer Diagnosis in Patients With Atherosclerosis. Circulation. 2019 Oct 29;140(18):1451-1459. doi: 10.1161/CIRCULATIONAHA.119.041949. Epub 2019 Sep 12.

ReferenceCitation: Branch KR, Probstfield JL, Eikelboom JW, Bosch J, Maggioni AP, Cheng RK, Bhatt DL, Avezum A, Fox KAA, Connolly SJ, Shestakovska O, Yusuf S. Rivaroxaban With or Without Aspirin in Patients With Heart Failure and Chronic Coronary or Peripheral Artery Disease. Circulation. 2019 Aug 13;140(7):529-537. doi: 10.1161/CIRCULATIONAHA.119.039609. Epub 2019 Jun 5.

ReferenceCitation: Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Störk S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Bruns NC, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar AK, Parkhomenko AN, Ryden L, Pogosova N, Dans AL, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik TJ, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne KP, Fox KAA, Yusuf S; COMPASS Investigators. Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin. Gastroenterology. 2019 Sep;157(3):682-691.e2. doi: 10.1053/j.gastro.2019.05.056. Epub 2019 May 29.

ReferenceCitation: Moayyedi P, Eikelboom JW, Bosch J, Connolly SJ, Dyal L, Shestakovska O, Leong D, Anand SS, Störk S, Branch KRH, Bhatt DL, Verhamme PB, O'Donnell M, Maggioni AP, Lonn EM, Piegas LS, Ertl G, Keltai M, Cook Bruns N, Muehlhofer E, Dagenais GR, Kim JH, Hori M, Steg PG, Hart RG, Diaz R, Alings M, Widimsky P, Avezum A, Probstfield J, Zhu J, Liang Y, Lopez-Jaramillo P, Kakkar A, Parkhomenko AN, Ryden L, Pogosova N, Dans A, Lanas F, Commerford PJ, Torp-Pedersen C, Guzik T, Vinereanu D, Tonkin AM, Lewis BS, Felix C, Yusoff K, Metsarinne K, Fox KAA, Yusuf S; COMPASS Investigators. Pantoprazole to Prevent Gastroduodenal Events in Patients Receiving Rivaroxaban and/or Aspirin in a Randomized, Double-Blind, Placebo-Controlled Trial. Gastroenterology. 2019 Aug;157(2):403-412.e5. doi: 10.1053/j.gastro.2019.04.041. Epub 2019 May 2.

ReferenceCitation: Sharma M, Hart RG, Connolly SJ, Bosch J, Shestakovska O, Ng KKH, Catanese L, Keltai K, Aboyans V, Alings M, Ha JW, Varigos J, Tonkin A, O'Donnell M, Bhatt DL, Fox K, Maggioni A, Berkowitz SD, Bruns NC, Yusuf S, Eikelboom JW. Stroke Outcomes in the COMPASS Trial. Circulation. 2019 Feb 26;139(9):1134-1145. doi: 10.1161/CIRCULATIONAHA.118.035864.

ReferenceCitation: Lamy A, Eikelboom J, Sheth T, Connolly S, Bosch J, Fox KAA, Zhu J, Lonn E, Dagenais G, Widimsky P, Branch KRH, Bhatt DL, Zheng Z, Straka Z, Dagenais F, Kong Y, Marsden T, Lee SF, Copland I, Yusuf S. Rivaroxaban, Aspirin, or Both to Prevent Early Coronary Bypass Graft Occlusion: The COMPASS-CABG Study. J Am Coll Cardiol. 2019 Jan 22;73(2):121-130. doi: 10.1016/j.jacc.2018.10.048.

ReferenceCitation: Bhagirath VC, Eikelboom JW, Anand SS. Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. Future Cardiol. 2018 Nov;14(6):443-453. doi: 10.2217/fca-2018-0059. Epub 2018 Nov 12.

ReferenceCitation: Anand SS, Bosch J, Eikelboom JW, Connolly SJ, Diaz R, Widimsky P, Aboyans V, Alings M, Kakkar AK, Keltai K, Maggioni AP, Lewis BS, Störk S, Zhu J, Lopez-Jaramillo P, O'Donnell M, Commerford PJ, Vinereanu D, Pogosova N, Ryden L, Fox KAA, Bhatt DL, Misselwitz F, Varigos JD, Vanassche T, Avezum AA, Chen E, Branch K, Leong DP, Bangdiwala SI, Hart RG, Yusuf S; COMPASS Investigators. Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):219-229. doi: 10.1016/S0140-6736(17)32409-1. Epub 2017 Nov 10.

ReferenceCitation: Connolly SJ, Eikelboom JW, Bosch J, Dagenais G, Dyal L, Lanas F, Metsarinne K, O'Donnell M, Dans AL, Ha JW, Parkhomenko AN, Avezum AA, Lonn E, Lisheng L, Torp-Pedersen C, Widimsky P, Maggioni AP, Felix C, Keltai K, Hori M, Yusoff K, Guzik TJ, Bhatt DL, Branch KRH, Cook Bruns N, Berkowitz SD, Anand SS, Varigos JD, Fox KAA, Yusuf S; COMPASS investigators. Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial. Lancet. 2018 Jan 20;391(10117):205-218. doi: 10.1016/S0140-6736(17)32458-3. Epub 2017 Nov 10. Erratum in: Lancet. 2017 Dec 21;:.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
United Kingdom
Italy
Ukraine
United States
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Malaysia
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Ireland
Ecuador
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

summary: The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

ReferenceCitation: Robinson JG, Nedergaard BS, Rogers WJ, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R; LAPLACE-2 Investigators. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA. 2014 May 14;311(18):1870-82. doi: 10.1001/jama.2014.4030.

ReferenceCitation: Robinson JG, Rogers WJ, Nedergaard BS, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R. Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2014 Apr;37(4):195-203. doi: 10.1002/clc.22252. Epub 2014 Jan 30.

ReferenceCitation: Daviglus ML, Ferdinand KC, López JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.

ReferenceCitation: Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.

ReferenceCitation: Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

ReferenceCitation: Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.

ReferenceCitation: Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.

ReferenceCitation: Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.

ReferenceCitation: Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, López JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.

ReferenceCitation: Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.

ReferenceCitation: May HT, Muhlestein JB, Ma Y, López JAG, Coll B, Nelson J. Effects of Evolocumab on the ApoA1 Remnant Ratio: A Pooled Analysis of Phase 3 Studies. Cardiol Ther. 2019 Jun;8(1):91-102. doi: 10.1007/s40119-019-0133-6. Epub 2019 Mar 9.

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Czechia
Hong Kong
Russian Federation
Australia
Mexico
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Korea, Republic of
France
Netherlands


title: Efficacy and Safety of Lidocaine 5% Medicated Plaster in Localized Chronic Post-operative Neuropathic Pain

lead_sponsor: Grünenthal GmbH

ReferenceCitation: Palladini M, Boesl I, Koenig S, Buchheister B, Attal N. Lidocaine medicated plaster, an additional potential treatment option for localized post-surgical neuropathic pain: efficacy and safety results of a randomized, placebo-controlled trial. Curr Med Res Opin. 2019 May;35(5):757-766. doi: 10.1080/03007995.2019.1565709. Epub 2019 Jan 21.

location_country:
Denmark
Brazil
Spain
Italy
Austria
United Kingdom
France
Belgium

summary: The purpose of this trial is to investigate the efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain in comparison to placebo plaster.


title: A Study of HSP90 Inhibitor AT13387 Alone and in Combination With Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to evaluate safety and efficacy of AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer.

lead_sponsor: Astex Pharmaceuticals, Inc.

location_country:
Spain
Canada
Korea, Republic of
United States
France

location_facility: Yale University School of Medicine-Yale Cancer Center

location_facility: Northwestern University The Feinberg School of Medicine

location_facility: Indiana University Melvin and and Bren Simon Cancer Center

location_facility: Hospital Regional Universitario de Malaga

location_facility: Washington University School of Medicine

location_facility: The Catholic University of Korea, St. Vincent's Hospital

location_facility: Institut Universitaire de Cardiologie et de Pneumologie De Quebec

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Chonnam National University Hwasun Hospital

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of California, San Diego Medical Center

location_facility: University of Wisconsin-Carbone Cancer Center

location_facility: University of Cincinnati Cancer Institute

location_facility: Centre Hospitalier Regional Universitaire Besancon

location_facility: Sharp Clinical Oncology Research-Sharp Memorial Hospital

location_facility: University of Nebraska Medical Center Eppley Cancer Center

location_facility: The Pennsylvania State University-Penn State

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitari Quiron Dexeus Barcelona

location_facility: Seoul National University Bundang Hospital


title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

acronym: RA-BEAM

summary: The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

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. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.

ReferenceCitation: van der Heijde D, Kartman CE, Xie L, Beattie S, Schlichting D, Mo D, Durez P, Tanaka Y, Fleischmann R. Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND. J Rheumatol. 2022 Feb;49(2):133-141. doi: 10.3899/jrheum.210346. Epub 2021 Sep 15.

ReferenceCitation: Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8. Erratum in: Arthritis Res Ther. 2020 Jul 2;22(1):166.

ReferenceCitation: Schlueter M, Finn E, Díaz S, Dilla T, Inciarte-Mundo J, Fakhouri W. Cost-effectiveness analysis of baricitinib versus adalimumab for the treatment of moderate-to-severe rheumatoid arthritis in Spain. Clinicoecon Outcomes Res. 2019 Jun 6;11:395-403. doi: 10.2147/CEOR.S201621. eCollection 2019.

ReferenceCitation: Michaud K, Pope JE, Emery P, Zhu B, Gaich CL, DeLozier AM, Zhang X, Dickson CL, Smolen JS. Relative Impact of Pain and Fatigue on Work Productivity in Patients with Rheumatoid Arthritis from the RA-BEAM Baricitinib Trial. Rheumatol Ther. 2019 Sep;6(3):409-419. doi: 10.1007/s40744-019-0164-4. Epub 2019 Jun 21.

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: Bingham CO 3rd, Gaich CL, DeLozier AM, Engstrom KD, Naegeli AN, de Bono S, Banerjee P, Taylor PC. Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation. Trials. 2019 Mar 22;20(1):182. doi: 10.1186/s13063-019-3272-0. Erratum in: Trials. 2019 Jun 4;20(1):322.

ReferenceCitation: Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6.

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.

ReferenceCitation: Wells AF, Greenwald M, Bradley JD, Alam J, Arora V, Kartman CE. Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis. Rheumatol Ther. 2018 Jun;5(1):43-55. doi: 10.1007/s40744-018-0110-x. Epub 2018 Apr 21.

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.

ReferenceCitation: Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, Zamora JV, Cobos JAC, Rooney T, Bono S, Arora V, Linetzky B, Weinblatt ME. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study. Ann Rheum Dis. 2017 Nov;76(11):1853-1861. doi: 10.1136/annrheumdis-2017-211259. Epub 2017 Aug 10.

ReferenceCitation: Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345.

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

lead_sponsor: Eli Lilly and Company

location_country:
Croatia
Spain
United Kingdom
Lithuania
United States
Romania
Belgium
Japan
South Africa
Czechia
Poland
Portugal
Slovenia
Russian Federation
Argentina
Puerto Rico
Mexico
Slovakia
Canada
Switzerland
Hungary
China
Germany
Taiwan
Greece
Latvia
Korea, Republic of
France

location_facility: Rheumatology Associates of Central Florida

location_facility: Asheville Rheumatology & Osteoporosis Research Assoc, PA

location_facility: Clinical Research Center of Reading, LLP

location_facility: Carolina Rheumatology and Neurology Associates

location_facility: Center for Arthritis and Rheumatic Diseases, PC

location_facility: (AOA) Arthritis & Osteoporosis Associates

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: Arizona Arthritis & Rheumatology Research

location_facility: Integral Rheumatology & Immunology Specialists


title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

summary: The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses

ReferenceCitation: Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

ReferenceCitation: McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.

ReferenceCitation: Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.

ReferenceCitation: Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Poland
Portugal
Spain
Austria
Australia
Canada
Hungary
United States
France
Netherlands
Czechia


title: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

summary:
The objective of the study (part A) is to evaluate the efficacy and safety of BAY80-6946 in patients with indolent or aggressive Non-Hodgkin's Lymphoma, who have progressed after standard therapy. 30 patients will be enrolled to both indolent and aggressive disease group. The objective of the study part B (CHRONOS-1) is to evaluate the efficacy and safety of BAY80-6946 in patients with relapsed/refractory follicular lymphoma. 120 patients will be enrolled in the part B of the study. Further objectives are to evaluate the pharmacokinetics and biomarkers. Quality of life will be a further objective of part B of the study.

In a cohort of 20 patients (enrolled both in part A and B) an ECG substudy will be performed to assess the potential for cardiac toxicity and QT/QTc interval prolongation of BAY80-6946.

After an up to 28-day screening period, eligible patients will start treatment with BAY80-6946 at a dose of 0.8 mg/kg (Part A) and at a dose of 60 mg (Part B).

Treatment will be continued until disease has progressed or until another criterion is met for withdrawal from study. An end-of-treatment visit will be performed within 7 days after discontinuation of study treatment. Thirty to 35 days after last study drug administration, a safety followup visit will be performed for the collection of adverse events (AEs) and concomitant medication data. Patients will be contacted quarterly to determine overall survival status up to 4 years after last patient completed treatment. Patients who discontinue study drug for reasons other than disease progression will enter the Active Assessment Follow-up period. The end of study notification to Health Authorities will be based on the completion of the collection of survival data.

The efficacy is measured by the decrease in tumor size. Tumor assessments will be done at Screening, every 8 weeks during Year 1, every 12 weeks during Year 2, and every 6 months during Year 3. Blood samples will be collected for pharmacokinetic analysis. Archival tumor tissue and blood samples will be collected for biomarker analysis (mandatory) and for central pathology review (part B), fresh biopsy tissue will also be collected if available.

design_allocation: Non-Randomized

ReferenceCitation: Dreyling M, Morschhauser F, Bouabdallah K, Bron D, Cunningham D, Assouline SE, Verhoef G, Linton K, Thieblemont C, Vitolo U, Hiemeyer F, Giurescu M, Garcia-Vargas J, Gorbatchevsky I, Liu L, Koechert K, Peña C, Neves M, Childs BH, Zinzani PL. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017 Sep 1;28(9):2169-2178. doi: 10.1093/annonc/mdx289.

ReferenceCitation: Panayiotidis P, Follows GA, Mollica L, Nagler A, Ozcan M, Santoro A, Stevens D, Trevarthen D, Hiemeyer F, Garcia-Vargas J, Childs BH, Zinzani PL, Dreyling M. Efficacy and safety of copanlisib in patients with relapsed or refractory marginal zone lymphoma. Blood Adv. 2021 Feb 9;5(3):823-828. doi: 10.1182/bloodadvances.2020002910.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Singapore
Sweden
Canada
Hungary
Germany
Bulgaria
Greece
Ireland
New Zealand
Finland
Korea, Republic of
France


title: A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

ReferenceCitation: Lugtenburg P, Avivi I, Berenschot H, Ilhan O, Marolleau JP, Nagler A, Rueda A, Tani M, Turgut M, Osborne S, Smith R, Pfreundschuh M. Efficacy and safety of subcutaneous and intravenous rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone in first-line diffuse large B-cell lymphoma: the randomized MabEase study. Haematologica. 2017 Nov;102(11):1913-1922. doi: 10.3324/haematol.2017.173583. Epub 2017 Sep 21.

location_country:
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Ukraine
Venezuela
Peru
South Africa
Belgium
Poland
Portugal
Russian Federation
Argentina
Israel
Turkey
Brazil
Canada
Bulgaria
Greece
Ireland
Finland
Thailand
Algeria
France
Colombia
Netherlands

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology

location_facility: Deventer Ziekenhuis; Interne Geneeskunde

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

location_facility: Hospital Punta Europa; Servicio de Hematologia

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: Katedra i Klinika Hematologii i Transplantacji Szpiku SUM

location_facility: Az. Osp. Sant'Andrea; U.O. C. Ematologia

location_facility: Kyiv City Clinical Oncological Center; Chemotherapy Department

location_facility: Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer

location_facility: Southlake Regional Health Center; Community Care Clinic / Oncology

location_facility: Rus Med Academy for Postgraduate Education; Oncology Department

location_facility: Ramathibodi Hospital; Division of Hematology, Department of Medicine

location_facility: Hospital de Donostia; Servicio de Hematologia

location_facility: Hospital Universitario Dr. Peset; Servicio de Hematologia

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Shaare Zedek Medical Center; Hematology Dept.

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Haemek Medical Center; Hematology Department

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: City Clinical Hospital #15; Hematology department

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Hematología

location_facility: Diskapi Research And Training Hospital; hematology

location_facility: Laiko General Hospital; Hematology Clinic

location_facility: Georgios Papanikolaou Hospital; Hematology Department

location_facility: Hospital de Cruces; Servicio de Hematologia

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Hia Sainte Anne; Medecine Interne Oncologie

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Military Medical Academy; Hematology And Oncology

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Gaziantep Uni Medical School; Hematology

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: Hospital Lucus Augusti; Servicio de Hematologia

location_facility: Ospedale Di Circolo E Fondazione Macchi; Ematologia

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

location_facility: A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia

location_facility: Swietokrzyskie Centrum Onkologii; Onkologia Ogolna

location_facility: Maxima Medisch Centrum; Inwendige Geneeskunde

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

location_facility: St James' Hospital; Cancer Clinical Trials Office

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Periph. University General Hospital of Heraklion; Hematology

location_facility: Ondokuzmayis University Medical Faculty Heamatology Department

location_facility: University Hospital of Ioannina; Hematology

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Centre ONCOGARD - Institut de Cancerologie du Gard

location_facility: Hospital de Sao Joao; Servico de Hematologia Clinica

location_facility: Instituto de Oncologia y Hematologia UCV

location_facility: Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo

location_facility: Erasmus Mc - Locatie Centrum; Dept of Hematology

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Hematologia

location_facility: Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny

location_facility: Karadeniz Technical Uni School of Medicine; Hematology

location_facility: Regional health authority A vitalite health network

location_facility: Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

location_facility: Chaim Sheba Medical Center; Hematology BMT & CBB

location_facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

location_facility: Theagenio Anticancer Hospital; Dept. of Haematology

location_facility: University Hospital Sv.Georgi Clnic of Hematology; Hematology

location_facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

location_facility: Hospital Costa del Sol; Servicio de Hematologia

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde

location_facility: Azienda Ospedaliero Uni Ria Policlinico G. Martino; U.O. Di Oncologia Medica

location_facility: IPO do Porto; Servico de Onco-Hematologia

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Meander Medisch Centrum; Locatie Lichtenberg

location_facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Hematologia

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia

location_facility: Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: Hopital Yves Le Foll; Hematologie Oncologie

location_facility: Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: University General Hospital of Alexandroupolis; Haemotology

location_facility: General Hospital of Athens Evangelismos; Hematology

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward

location_facility: Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie

location_facility: Toronto East General Hospital; Haematology/Oncology

location_facility: SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

location_facility: Hospital de Cabueñes; Servicio de Hematología y Hemoterapia

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Hacettepe Uni Medical Faculty; Hematology

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

location_facility: University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division

location_facility: Tygerberg Hospital; Haematology Department

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde

location_facility: Clinical Center Kragujevac;Center for Hematology

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Saint-Petersburg SHI City Clinical Hospital #31

location_facility: Rambam Medical Center; Heamatology & Bone Marrow Transplantation

summary: This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.