acronym: THOR

intervention_type: Device

title: A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

location_facility: The Center for Cancer and Blood Disorders

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Associação Mário Penna/Núcleo de Ensino e Pesquisas

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

location_facility: Centro Estatal de Cancerología de Chihuahua

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Städtisches Klinikum Braunschweig gGmbH-Klinik für Urologie und Uroonkologie

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: St. Helena Hospital - Martin-O'Neil Cancer Center

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

location_facility: Universitatsklinikum Carl Gustav Carcus Dresden

location_facility: National Medical Radiological Research Center

location_facility: Seoul National University Bundang Hospital

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: Transkarpathian Regional University Oncology Clinic

location_facility: University of Calif Davis Medical Center

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo Alessandria

location_facility: Eastern Connecticut Hematology & Oncology Assoc.

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: Kobe City Medical Center General Hospital

location_facility: University Hospitals Bristol - Bristol Haematology & Oncolog

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Ist. Clinici Scientifici Maugeri - Unità Operativa di Oncolo

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi, Ic Hastaliklari

location_facility: First Affiliated Hospital of Wenzhou Medical College

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Saint-Petersburg Clinical Scientific And Practical Center For Special Types Of Medical Care

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Frederick Health Hospital - James M Stockman Cancer Institute

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Uniwersytecki Szpital Kliniczny we Wrocławiu

location_facility: GBUZ of Stavropol region Pyatigorsk Oncological Dispensary

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Oncologia Medica-Città Della Salute E Della Scienza Di Torino

location_facility: The First Bethune Hospital of Jilin University

location_facility: MI Dnipropetrovsk Region Clinical Hospital n a I.I.Mechnikov

location_facility: Universitätsklinikum Schleswig Holstein Campus Lübeck

location_facility: Istituti Ospitalieri di Cremona, AO di Cremona

location_facility: Centre de radiothérapie et d'Oncologie médicale de l'Essonne

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: GBUZ Oncology Centre #2 of Healthcare Department of Krasno

location_facility: Istituto Oncologico Veneto Iov Irccs Padova

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Izmir Katip Celebi University Ataturk Training and Research Hospital

location_facility: University Hospitals Seidman Cancer Center

location_facility: Saskatchewan Cancer Agency (SCA) - Allan Blair Cancer Centre

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: Thunder Bay Regional Health Sciences Centre

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: University General Hospital of Rio Patras

location_facility: Derriford Hospital-Department of Medical Oncology

location_facility: FGBOU Vo Mordovian National Research State University N. A. N.P. Ogareva

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Privolzhsky District Medical Center under the Federal Medico-Biological Agency

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Tokyo Women's Medical University Hospital

location_facility: Usl 7 Siena - Ospedale Alta Valdelsa ASL TOSCANA SUD-EST

location_facility: Zaporizhzhia medical Academy of postgraduate education, Zaporizhzhia Regoinal Clinical Hospital

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

location_facility: Multiprofile Hospital for Active Treatment 'Tokuda Hospital Sofia'

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: University Of UA Cancer Center(UACC)/DH-SJHMC

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: 'Papageorgiou' General Hospital of Thessaloniki

location_facility: CEPHO - Centro de Estudos e Pesquisa de Hematologia e Oncologia

location_facility: H. Santa Maria - Centro Hospitalar de Lisboa Norte

location_facility: Kliniken Nordoberpfalz AG/Klinikum Weiden

location_facility: Institut Català D'Oncologia-Hospital Universitari Germans Trias I Pujol

location_facility: Policlinico Hospital San Martino- IRCCS for Oncology

location_facility: Azienda Ospedaliero - Universitaria Ospedali Riuniti

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: INOVA Dwiight &Martha Schar Cancer Institute

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: MemorialCare Research Miller Children's and Women's Hospital Long Beach

location_facility: Champalimaud Foundation Champalimaud Centre

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: University of Miami/Sylvester Cancer Center

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: Friedrich-Alexander Universitaet Urologische Universitaetskl

location_facility: Hospital Das Clinicas Da Universidade Federal De Minas Gerais

location_facility: Multiprofile Hospital for Active Treatment 'Sveta Marina' EAD

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria alle Scotte

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

location_facility: Baskent University Adana Practice and Research Center Kisla Health Campus

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

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

location_facility: Private Medical Institution Euromedservice

location_facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas

location_facility: UOC Oncologia Ospedale Provinciale di Macerata

location_facility: Shengjing Hospital of China Medical University

location_facility: Országos Onkológiai Intézet, Urogenitális Tumorok és Klinikai Farmakológiai Osztály

location_facility: The First Affliated Hospital Of Nanchang University

location_facility: University of Mississippi Medical Center

location_facility: Hospital Araújo Jorge da Associação de Combate ao Câncer em Goiás

location_facility: I.M. Sechenov First Moscow State Medical University

location_facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

location_facility: University of Athens Medical School - Regional General Hospi

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: National Hospital Organizaiton Shikoku Cancer Center

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: FSBSI 'N. N. Blokhin Russian Cancer Research Center'

summary: The purpose of this study is to evaluate efficacy of erdafitinib versus chemotherapy or pembrolizumab in participants with advanced urothelial cancer harboring selected fibroblast growth factor receptor (FGFR) aberrations who have progressed after 1 or 2 prior treatments, at least 1 of which includes an anti-programmed death ligand 1(PD-[L]1) agent (cohort 1) or 1 prior treatment not containing an anti-PD-(L) 1 agent (cohort 2).


status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) Subcutaneous (sc) Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease

study_completion_date_type: Actual

lead_sponsor: Novartis Pharmaceuticals

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Lacroix A, Gu F, Schopohl J, Kandra A, Pedroncelli AM, Jin L, Pivonello R. Pasireotide treatment significantly reduces tumor volume in patients with Cushing's disease: results from a Phase 3 study. Pituitary. 2020 Jun;23(3):203-211. doi: 10.1007/s11102-019-01021-2.

ReferenceCitation: Yedinak CG, Hopkins S, Williams J, Ibrahim A, Cetas JS, Fleseriu M. Medical Therapy with Pasireotide in Recurrent Cushing's Disease: Experience of Patients Treated for At Least 1 Year at a Single Center. Front Endocrinol (Lausanne). 2017 Feb 27;8:35. doi: 10.3389/fendo.2017.00035. eCollection 2017.

ReferenceCitation: Schopohl J, Gu F, Rubens R, Van Gaal L, Bertherat J, Ligueros-Saylan M, Trovato A, Hughes G, Salgado LR, Boscaro M, Pivonello R; Pasireotide B2305 Study Group. Pasireotide can induce sustained decreases in urinary cortisol and provide clinical benefit in patients with Cushing's disease: results from an open-ended, open-label extension trial. Pituitary. 2015 Oct;18(5):604-12. doi: 10.1007/s11102-014-0618-1.

ReferenceCitation: MacKenzie Feder J, Bourdeau I, Vallette S, Beauregard H, Ste-Marie LG, Lacroix A. Pasireotide monotherapy in Cushing's disease: a single-centre experience with 5-year extension of phase III Trial. Pituitary. 2014 Dec;17(6):519-29. doi: 10.1007/s11102-013-0539-4.

ReferenceCitation: Petersenn S, Newell-Price J, Findling JW, Gu F, Maldonado M, Sen K, Salgado LR, Colao A, Biller BM; Pasireotide B2305 Study Group. High variability in baseline urinary free cortisol values in patients with Cushing's disease. Clin Endocrinol (Oxf). 2014 Feb;80(2):261-9. doi: 10.1111/cen.12259. Epub 2013 Jul 15.

ReferenceCitation: Colao A, Petersenn S, Newell-Price J, Findling JW, Gu F, Maldonado M, Schoenherr U, Mills D, Salgado LR, Biller BM; Pasireotide B2305 Study Group. A 12-month phase 3 study of pasireotide in Cushing's disease. N Engl J Med. 2012 Mar 8;366(10):914-24. doi: 10.1056/NEJMoa1105743. Erratum in: N Engl J Med. 2012 Aug 23;367(8):780.

enrollment_type: Actual

location_country:
Denmark
Poland
Brazil
Portugal
Spain
Greece
Italy
Mexico
Argentina
Canada
Finland
United States
France
China
Israel
Belgium
Turkey
Germany

location_facility: Swedish Medical Center Dept.ofSeattle Neuroscience(2)

location_facility: Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.

location_facility: University Chicago Hospital Dept. of Univ of Chicago

location_facility: Dana Farber Cancer Institute The Melanoma Program

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)

location_facility: Stanford University Medical Center Stanford Cancer Center (3)

location_facility: Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed

location_facility: Cleveland Clinic Foundation Dept. of Cleveland Clinic (6)

location_facility: University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr.

summary: This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Multi-center, Double-blind, Placebo-controlled, Parallel-arm Trial to Determine Long-term Safety and Efficacy of Oral Tolvaptan Tablets Regimens in Adult Subjects With Autosomal Dominant Polycystic Kidney Disease

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

ReferenceType: background

ReferenceCitation: Gattone VH 2nd, Wang X, Harris PC, Torres VE. Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist. Nat Med. 2003 Oct;9(10):1323-6. Epub 2003 Sep 21.

ReferenceCitation: Torres VE, Wang X, Qian Q, Somlo S, Harris PC, Gattone VH 2nd. Effective treatment of an orthologous model of autosomal dominant polycystic kidney disease. Nat Med. 2004 Apr;10(4):363-4. Epub 2004 Feb 29.

ReferenceCitation: Torres VE, Meijer E, Bae KT, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang JJ, Czerwiec FS. Rationale and design of the TEMPO (Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and its Outcomes) 3-4 Study. Am J Kidney Dis. 2011 May;57(5):692-9. doi: 10.1053/j.ajkd.2010.11.029. Epub 2011 Feb 17.

ReferenceCitation: Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS; TEMPO 3:4 Trial Investigators. Tolvaptan in patients with autosomal dominant polycystic kidney disease. N Engl J Med. 2012 Dec 20;367(25):2407-18. doi: 10.1056/NEJMoa1205511. Epub 2012 Nov 3.

ReferenceCitation: Watkins PB, Lewis JH, Kaplowitz N, Alpers DH, Blais JD, Smotzer DM, Krasa H, Ouyang J, Torres VE, Czerwiec FS, Zimmer CA. Clinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database. Drug Saf. 2015 Nov;38(11):1103-13. doi: 10.1007/s40264-015-0327-3.

ReferenceCitation: Kher A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257-8. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Spital A. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1257. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Torres VE, Gansevoort RT, Czerwiec FS. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1259. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Jouret F, Krzesinski JM. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258-9. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Sexton DJ. Tolvaptan in autosomal dominant polycystic kidney disease. N Engl J Med. 2013 Mar 28;368(13):1258. doi: 10.1056/NEJMc1300762.

ReferenceCitation: Nowak KL, Steele C, Gitomer B, Wang W, Ouyang J, Chonchol MB. Overweight and Obesity and Progression of ADPKD. Clin J Am Soc Nephrol. 2021 Jun;16(6):908-915. doi: 10.2215/CJN.16871020. Epub 2021 Jun 11.

ReferenceCitation: Heida JE, Gansevoort RT, Torres VE, Devuyst O, Perrone RD, Lee J, Li H, Ouyang J, Chapman AB. The Effect of Tolvaptan on BP in Polycystic Kidney Disease: A Post Hoc Analysis of the TEMPO 3:4 Trial. J Am Soc Nephrol. 2021 Apr 22. pii: ASN.2020101512. doi: 10.1681/ASN.2020101512. [Epub ahead of print]

ReferenceCitation: Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.

ReferenceCitation: McEwan P, Bennett Wilton H, Ong ACM, Ørskov B, Sandford R, Scolari F, Cabrera MV, Walz G, O'Reilly K, Robinson P. A model to predict disease progression in patients with autosomal dominant polycystic kidney disease (ADPKD): the ADPKD Outcomes Model. BMC Nephrol. 2018 Feb 13;19(1):37. doi: 10.1186/s12882-017-0804-2.

ReferenceCitation: Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Dandurand A, Ouyang J, Czerwiec FS, Blais JD; TEMPO 4:4 Trial Investigators. Multicenter, open-label, extension trial to evaluate the long-term efficacy and safety of early versus delayed treatment with tolvaptan in autosomal dominant polycystic kidney disease: the TEMPO 4:4 Trial. Nephrol Dial Transplant. 2018 Mar 1;33(3):477-489. doi: 10.1093/ndt/gfx043.

ReferenceCitation: Muto S, Kawano H, Higashihara E, Narita I, Ubara Y, Matsuzaki T, Ouyang J, Torres VE, Horie S. The effect of tolvaptan on autosomal dominant polycystic kidney disease patients: a subgroup analysis of the Japanese patient subset from TEMPO 3:4 trial. Clin Exp Nephrol. 2015 Oct;19(5):867-77. doi: 10.1007/s10157-015-1086-2. Epub 2015 Feb 7.

location_country:
Denmark
Poland
Romania
United Kingdom
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United States
France
Belgium
Japan
Germany

location_facility: Coastal Nephrology Associates Research Center, LLC

location_facility: Akademicki Szpital Kliniczny im J Mikulicza Radeckiego

location_facility: Hamamatsu University School of Medicine, University Hospital

location_facility: Spitalul Clinic de Nefrologie Dr. Carol Davila

location_facility: Saitama Medical Center Jichi Medical University

location_facility: Niigata University Medical & Dental Hospital

location_facility: Hospital Privado-Centro Medico de Cordoba

location_facility: Tokyo Women's Medical University Hospital

location_facility: Szpital Praski, Samodzielny Publiczny ZOZ

location_facility: University of Colorado Health Sciences Center

location_facility: University of Virginia, Nephrology Clinical Research Center

location_facility: Sussex Renal Unit Royal Sussex County Hospital

location_facility: Jacksonville Center for Clinical Research

location_facility: Università Vita e Salute, Ospedale San Raffaele

location_facility: Międzyleski Szpital Specjalistyczny w Warszawie

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: Tokyo Medical & Dental University Hospital, Faculty of Medicine

location_facility: Royal Free and University College Medical School

location_facility: Kemerovo Medical Academy, Regional Clinical Hospital

location_facility: University of Pennsylvania Medical Center

location_facility: Klinik für Nieren- und Hochdruckkrankheiten

location_facility: University of North Carolina, UNC, Kidney Center

location_facility: Queen Elizabeth II Health Science Center, Division of Nephrology

location_facility: National Hospital Organization Kyoto Medical Center

location_facility: Szpital Praski p.w. Przemienienia Panskiego, Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Szpital Uniwersytecki w Krakowie

location_facility: Hospital Municipal de Vicente Lopez, Dr Bernardo Houssay

location_facility: Klinika Chorób Wewnętrznych i Nefrologii

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Akademickie Centrum Kliniczne AMG

summary: This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.


acronym: Depsipeptide in PTCL

title: A Phase II, Multicenter, Open-Label Trial Evaluating The Activity And Tolerability Of Romidepsin (Depsipeptide, FK228) In Progressive Or Relapsed Peripheral T-Cell Lymphoma Following Prior Systemic Therapy (GPI-06-0002)

lead_sponsor: Celgene

study_start_date_type: Actual

ReferenceCitation: Foss F, Pro B, Miles Prince H, Sokol L, Caballero D, Horwitz S, Coiffier B. Responses to romidepsin by line of therapy in patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Med. 2017 Jan;6(1):36-44. doi: 10.1002/cam4.939. Epub 2016 Dec 16.

ReferenceCitation: Shustov A, Coiffier B, Horwitz S, Sokol L, Pro B, Wolfson J, Balser B, Eisch R, Popplewell L, Prince HM, Allen SL, Piekarz R, Bates S. Romidepsin is effective and well tolerated in older patients with peripheral T-cell lymphoma: analysis of two phase II trials. Leuk Lymphoma. 2017 Oct;58(10):2335-2341. doi: 10.1080/10428194.2017.1295143. Epub 2017 Mar 7.

ReferenceType: result

ReferenceCitation: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Borchmann P, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan S, Shustov A, Nichols J, Carroll S, Balser J, Balser B, Horwitz S. Results from a pivotal, open-label, phase II study of romidepsin in relapsed or refractory peripheral T-cell lymphoma after prior systemic therapy. J Clin Oncol. 2012 Feb 20;30(6):631-6. doi: 10.1200/JCO.2011.37.4223. Epub 2012 Jan 23.

ReferenceCitation: Horwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B. Utility of ¹⁸fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma. Ann Oncol. 2015 Apr;26(4):774-779. doi: 10.1093/annonc/mdv010. Epub 2015 Jan 20.

ReferenceCitation: Foss F, Horwitz S, Pro B, Prince HM, Sokol L, Balser B, Wolfson J, Coiffier B. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial. J Hematol Oncol. 2016 Mar 10;9:22. doi: 10.1186/s13045-016-0243-8. Erratum in: J Hematol Oncol. 2017 Sep 18;10 (1):154.

ReferenceCitation: Foss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomark Res. 2014 Sep 8;2:16. doi: 10.1186/2050-7771-2-16. eCollection 2014.

ReferenceCitation: Coiffier B, Pro B, Prince HM, Foss F, Sokol L, Greenwood M, Caballero D, Morschhauser F, Wilhelm M, Pinter-Brown L, Padmanabhan Iyer S, Shustov A, Nielsen T, Nichols J, Wolfson J, Balser B, Horwitz S. Romidepsin for the treatment of relapsed/refractory peripheral T-cell lymphoma: pivotal study update demonstrates durable responses. J Hematol Oncol. 2014 Jan 23;7:11. doi: 10.1186/1756-8722-7-11.

location_country:
Poland
Spain
United Kingdom
Australia
Ukraine
Sweden
United States
France
Germany
Czechia

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Institute of Blood Pathology and Transfusion Medicine of the AMS of Ukraine

location_facility: R.E.Kavetsky Institute of Experimental Pathology, Oncology and Radiobiology

location_facility: Mater Private Medical Centre - Haematology and Oncology Clinics of Australasia Research Centre

location_facility: Cancer Care and Hematology Specialists of Chicagoland

location_facility: Consultants in Blood Disorders and Cancer

location_facility: Winship Cancer Institute of Emory University

location_facility: UT Southwestern Medical Center Simmons Comprehensive Cancer Center

location_facility: Charite Universitatsmedizin Berlin campus Virchow Klinikum Centrum fur Tumormedizin

location_facility: University of Texas Health Science Center at San Antonio

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: University Hospital of Kralovske Vinohrady

location_facility: Catherine Lewis Centre - Hematology Department

location_facility: Hematology Oncology Assoc. of IL Orchard Research LLC

location_facility: Taussig Cancer Center Cleveland Clinic Foundation

location_facility: Klinikum der Universitat Munchen-Grosshadern

location_facility: Accelerated Community Oncology Research Network Inc ACORN

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: National Cancer Institute Department Of Conservative Methods Of Treatment

location_facility: Klinika Hematologii Akademickie Centrum Kliniczne Akademii Medycznej w Gdansku

summary: The purpose of this study is to evaluate the activity of romidepsin in patients with progressive or relapsed peripheral T-cell lymphoma (PTCL) who have already been treated with systemic therapy.


acronym: THALES

title: A Randomised, Double-Blind, Placebo-Controlled, International, Multicentre, Phase III Study to Investigate the Efficacy and Safety of Ticagrelor and ASA Compared With ASA in the Prevention of Stroke and Death in Patients With Acute Ischaemic Stroke or Transient Ischaemic Attack

lead_sponsor: AstraZeneca

ReferenceCitation: Johnston SC, Amarenco P, Aunes M, Denison H, Evans SR, Himmelmann A, Jahreskog M, James S, Knutsson M, Ladenvall P, Molina CA, Nylander S, Röther J, Wang Y; THALES Investigators. Ischemic Benefit and Hemorrhage Risk of Ticagrelor-Aspirin Versus Aspirin in Patients With Acute Ischemic Stroke or Transient Ischemic Attack. Stroke. 2021 Nov;52(11):3482-3489. doi: 10.1161/STROKEAHA.121.035555. Epub 2021 Sep 3.

ReferenceCitation: Wang Y, Pan Y, Li H, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Birve F, Ladenvall P, Molina CA, Johnston SC; THALES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor and Aspirin in Patients With Moderate Ischemic Stroke: An Exploratory Analysis of the THALES Randomized Clinical Trial. JAMA Neurol. 2021 Sep 1;78(9):1091-1098. doi: 10.1001/jamaneurol.2021.2440.

ReferenceCitation: Yaghi S, de Havenon A, Rostanski S, Kvernland A, Mac Grory B, Furie KL, Kim AS, Easton JD, Johnston SC, Henninger N. Carotid Stenosis and Recurrent Ischemic Stroke: A Post-Hoc Analysis of the POINT Trial. Stroke. 2021 Jul;52(7):2414-2417. doi: 10.1161/STROKEAHA.121.034089. Epub 2021 May 4.

ReferenceCitation: Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators*. Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin. Stroke. 2020 Dec;51(12):3504-3513. doi: 10.1161/STROKEAHA.120.032239. Epub 2020 Nov 16.

ReferenceCitation: Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y, Johnston SC; THALES Steering Committee and Investigators. Ticagrelor Added to Aspirin in Acute Ischemic Stroke or Transient Ischemic Attack in Prevention of Disabling Stroke: A Randomized Clinical Trial. JAMA Neurol. 2020 Nov 7. doi: 10.1001/jamaneurol.2020.4396. [Epub ahead of print] Erratum in: JAMA Neurol. 2021 Feb 1;78(2):253.

ReferenceCitation: Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA. N Engl J Med. 2020 Jul 16;383(3):207-217. doi: 10.1056/NEJMoa1916870.

ReferenceCitation: Johnston SC, Amarenco P, Denison H, Evans SR, Himmelmann A, James S, Knutsson M, Ladenvall P, Molina CA, Wang Y; THALES Investigators. The Acute Stroke or Transient Ischemic Attack Treated with Ticagrelor and Aspirin for Prevention of Stroke and Death (THALES) trial: Rationale and design. Int J Stroke. 2019 Oct;14(7):745-751. doi: 10.1177/1747493019830307. Epub 2019 Feb 12.

ReferenceCitation: Wong KSL, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Himmelmann A, Kasner SE, Knutsson M, Ladenvall P, Minematsu K, Molina CA, Wang Y, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial. Stroke. 2018 Jul;49(7):1678-1685. doi: 10.1161/STROKEAHA.118.020553. Epub 2018 Jun 18.

location_country:
Saudi Arabia
Italy
Spain
Ukraine
Peru
Romania
Belgium
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Thailand
Vietnam
Korea, Republic of
France

summary: Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events


title: A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma

summary: To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.

lead_sponsor: Vical

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Netherlands
Canada
Switzerland
France
United States
Israel
Turkey
Belgium
Germany

location_facility:
Location #97
Location #33
Location #117
Location #47
Location #32
Location #89
Location #67
Location #35
Location #66
Location #1
Location #113
Location #36
Location #59
Location #48
Location #122
Location #106
Location #114
Location #109
Location #57
Location #51
Location #60
Location #93
Location #16
Location #38
Location #116
Location #112
Location #111
Location #55
Location #74
Location #91
Location #4
Location #88
Location #123
Location #99
Location #110
Location #23
Location #50
Location #45
Location #8
Location #95
Location #87
Location #103
Location #80
Location #86
Location #104
Location #27
Location #62
Location #68
Location #44
Location #7
Location #81
Location #105
Location #52
Location #9
Location #58
Location #118
Location #84
Location #26
Location # 75
Location #41
Location #82
Location #85
Location #46
Location #72
Location #28
Location #94
Location #65
Location #61
Location #121
Location #101
Location #12
Location #20
Location #100
Location #24
Location #54
Location #115
Location #90
Location #79
Location #124
Location #40
Location #11
Location #63
Location #43
Location #78
Location #19
Location #37
Location #102
Location #34

intervention_type: Biological


title: A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients

summary: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.

lead_sponsor: Pfizer

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Poland
Portugal
Russian Federation
Austria
Australia
Argentina
Turkey
Panama
Sweden
Slovakia
Canada
Hungary
Germany
Ireland
Finland
Czech Republic
Korea, Republic of
France
Colombia
Netherlands


title: A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.

summary: This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

ReferenceCitation: Gianni L, Romieu GH, Lichinitser M, Serrano SV, Mansutti M, Pivot X, Mariani P, Andre F, Chan A, Lipatov O, Chan S, Wardley A, Greil R, Moore N, Prot S, Pallaud C, Semiglazov V. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 2013 May 10;31(14):1719-25. doi: 10.1200/JCO.2012.44.7912. Epub 2013 Apr 8.

lead_sponsor: Hoffmann-La Roche

location_country:
Bosnia and Herzegovina
Brazil
Romania
Spain
Italy
Austria
Australia
Russian Federation
Argentina
Canada
Czech Republic
United Kingdom
Uruguay
France
Turkey
Mexico


ipd_sharing: Yes

acronym: PRECONNECT

title: An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)

lead_sponsor: Institut de Recherches Internationales Servier

ReferenceCitation: Özet A, Dane F, Aykan NF, Yalçın Ş, Evrensel T, Özkan M, Karabulut B, Ormeci MN, Atasev O, Vidot L, Çiçin İ. Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: PRECONNECT Turkey. Future Oncol. 2022 Sep;18(29):3267-3276. doi: 10.2217/fon-2022-0455. Epub 2022 Aug 30.

ReferenceCitation: Zaniboni A, Barone CA, Banzi MC, Bergamo F, Blasi L, Bordonaro R, Bartolomeo MD, Costanzo FD, Frassineti GL, Garufi C, Giuliani F, Latiano TP, Martinelli E, Personeni N, Racca P, Tamburini E, Tonini G, Besse MG, Spione M, Falcone A. Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer. Future Oncol. 2021 Jun;17(18):2315-2324. doi: 10.2217/fon-2020-1278. Epub 2021 Mar 5.

ReferenceCitation: Bachet JB, Wyrwicz L, Price T, Cremolini C, Phelip JM, Portales F, Ozet A, Cicin I, Atlan D, Becquart M, Vidot L, Mounedji N, Van Cutsem E, Taieb J, Falcone A. Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study. ESMO Open. 2020 Jun;5(3):e000698. doi: 10.1136/esmoopen-2020-000698.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

location_country: Croatia Poland Brazil Portugal Romania Ireland Italy Australia Slovenia Ukraine France Panama Turkey Belgium Bulgaria Slovakia

location_facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

location_facility: Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica

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

location_facility: Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP Núcleo de Pesquisa

location_facility: Hôpital Universitaire Erasme Gastro-Entérologie

location_facility: Ist.Tumori "Giovanni Paolo II" IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica

location_facility: Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive

location_facility: Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1

location_facility: Hospital A C Camargo Unidade de Pesquisa Clínica

location_facility: Centre de lutte contre le cancer Francois Baclesse UCP Digestif

location_facility: Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive

location_facility: CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D

location_facility: Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale

location_facility: Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology

location_facility: The Queen Elizabeth Hospital Haematology and Oncology Unit

location_facility: Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie

location_facility: CHU de Poitiers Pole Régional de Cancérologie

location_facility: Treatment-diagnostic Centre PJSC "House of medicine"

location_facility: Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej

location_facility: Centro Hospitalar de São João E.P.E. Serviço de Oncologia

location_facility: ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica

location_facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

location_facility: Hospital Garcia de Orta Serviço de Oncologia Médica

location_facility: The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19

location_facility: CHD - Les Oudairies service d'hepato-gastroenterologie

location_facility: Erciyes University Mehmet Kemal Dedeman Hematology Oncology

location_facility: Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica

location_facility: Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica

location_facility: St Vincent's Hospital (Melbourne) Cancer Centre

location_facility: Institut Sainte Catherine Institut Sainte Catherine

location_facility: Klinicki bolnicki centar Zagreb Klinika za onkologiju

location_facility: AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada

location_facility: Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA

location_facility: Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology

location_facility: Kyiv City Clinical Oncological Centre Day care facility

location_facility: Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica

location_facility: Cliniques Universitaires St. Luc Oncologie médicale

location_facility: Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica

location_facility: CHU de la Timone Hépato-Gastro-Entérologie

location_facility: Hôpital Nord Pôle Digestif Urologie-Andrologie

location_facility: A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit

location_facility: Military Medical Academy - MHAT Oncology clinic

location_facility: Franco-British Institue Department of Medical Oncology

location_facility: Specialized hospital for active treatment in oncology

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej

location_facility: Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD

location_facility: St Vincent's Hospital The Kinghorn Cancer Centre

location_facility: Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica

location_facility: Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

location_facility: CHU Toulouse Rangueil Oncologie médicale digestive

location_facility: Royal Brisbane & Women's Hospital Clinical Research Unit

location_facility: UZ Leuven Campus Gasthuisberg Digestieve Oncologie

location_facility: Instituto Português de Oncologia do Porto Serviço de Oncologia Médica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: Hopital Privé Les Bonnettes Pharmacie centrale

location_facility: Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

location_facility: Cabrini Hospital Cabrini Haematology and Oncology Centre

location_facility: Ege University Faculty of Medicine Medical Oncology Department

location_facility: CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie

location_facility: Gazi University Faculty of Medicine Medical Oncology Department

location_facility: Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju

location_facility: CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive

location_facility: Arcispedale Santa Maria Nuova Unità di Oncologia

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: Centre Eugène Marquis Service d'Oncologie Médicale

location_facility: Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica

location_facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

location_facility: Hacettepe University Faculty of Medicine

location_facility: Hospital Mãe de Deus Centro Intergrado de Pesquisa

location_facility: Centre Antoine Lacassagne Dpt d'Oncologie Médicale

location_facility: Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

location_facility: A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia

location_facility: Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica

location_facility: Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

location_facility: Universitair Ziekenhuis Antwerpen Oncologie

location_facility: Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale

location_facility: Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

summary:
The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).

Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.


acronym:
LUCY

 LUCY

title: A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.

ReferenceCitation: Gelmon KA, Fasching PA, Couch FJ, Balmaña J, Delaloge S, Labidi-Galy I, Bennett J, McCutcheon S, Walker G, O'Shaughnessy J; Collaborating Investigators. Clinical effectiveness of olaparib monotherapy in germline BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: phase IIIb LUCY interim analysis. Eur J Cancer. 2021 Jul;152:68-77. doi: 10.1016/j.ejca.2021.03.029. Epub 2021 Jun 1.

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:
Poland
Taiwan
Spain
Italy
Russian Federation
United Kingdom
Canada
Hungary
Korea, Republic of
United States
France
Turkey
Japan
Germany
Bulgaria

summary: This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.


title: Phase III, Randomised, Double-blind, Stratified Comparative, Placebo Controlled, Parallel Group, Multi-centre Study to Assess the Effect of Deep Subcutaneous Injections of Lanreotide Autogel 120mg Administered Every 28 Days on Tumour Progression Free Survival in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

acronym: CLARINET

summary: The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.

ReferenceCitation: Caplin ME, Pavel M, Ćwikła JB, Phan AT, Raderer M, Sedláčková E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Blumberg J, Ruszniewski P; CLARINET Investigators. Lanreotide in metastatic enteropancreatic neuroendocrine tumors. N Engl J Med. 2014 Jul 17;371(3):224-33. doi: 10.1056/NEJMoa1316158.

ReferenceCitation: Caplin ME, Pavel M, Phan AT, Ćwikła JB, Sedláčková E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.

ReferenceCitation: Lybaert W, Van Hul E, Woestenborghs H. Long-term disease control of a pancreatic neuroendocrine tumor with lanreotide autogel(®): a case report. Case Rep Oncol. 2014 Sep 26;7(3):673-80. doi: 10.1159/000368207. eCollection 2014 Sep.

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Sweden
United States
France
India
Belgium
Germany
Slovakia
Czechia

location_facility: Hospital Nuestra Senora de la Candelaria

location_facility: Vychodoslovensky onkologicky ustav, Rastislavova

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej - Curie, oddzial w Gliwicach, Zaklad Medycyny Nuklearnej i Endokrynologii Onkologicznej ul.

location_facility: University of Wisconsin School of Medicine and Public Health

location_facility: Szpital Bielanski im. Ks. Jerzego Popieluszki, Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Klinika Endokrynologii Centrum Medycznego Ksztalcenia Podyplomowego

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Katedra i Klinika Chorob Wewnetrznych I Endokrynologii ul. Banacha 1 a

location_facility: Basingstoke and North Hampshire Hospital

location_facility: Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny, Ministrerstwa Spraw Wewnetrznych i Administratracji w Warzawie

location_facility: Katedra i Klinika Endokrynologii Przemiany Materii i Chorob Wewnetrznych Uniwersytetu Medycznego w Poznaniu


title: Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

summary: This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

ReferenceCitation: Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

ReferenceCitation: McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998. Review.

ReferenceCitation: Russell-Jones D, Vaag A, Schmitz O, Sethi BK, Lalic N, Antic S, Zdravkovic M, Ravn GM, Simó R; Liraglutide Effect and Action in Diabetes 5 (LEAD-5) met+SU Study Group. Liraglutide vs insulin glargine and placebo in combination with metformin and sulfonylurea therapy in type 2 diabetes mellitus (LEAD-5 met+SU): a randomised controlled trial. Diabetologia. 2009 Oct;52(10):2046-55. doi: 10.1007/s00125-009-1472-y. Epub 2009 Aug 14.

ReferenceCitation: Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x. Review.

ReferenceCitation: Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

ReferenceCitation: Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes ≥65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

ReferenceCitation: Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13.

ReferenceCitation: Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

ReferenceCitation: Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

ReferenceCitation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

ReferenceCitation: King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

ReferenceCitation: Buse JB, Peters A, Russell-Jones D, Furber S, Donsmark M, Han J, MacConell L, Maggs D, Diamant M. Is insulin the most effective injectable antihyperglycaemic therapy? Diabetes Obes Metab. 2015 Feb;17(2):145-51. doi: 10.1111/dom.12402. Epub 2014 Nov 9.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

ReferenceCitation: Fonseca VA, Devries JH, Henry RR, Donsmark M, Thomsen HF, Plutzky J. Reductions in systolic blood pressure with liraglutide in patients with type 2 diabetes: insights from a patient-level pooled analysis of six randomized clinical trials. J Diabetes Complications. 2014 May-Jun;28(3):399-405. doi: 10.1016/j.jdiacomp.2014.01.009. Epub 2014 Jan 21.

lead_sponsor: Novo Nordisk A/S

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Russian Federation
United Kingdom
Finland
Argentina
Former Serbia and Montenegro
Philippines
France
India
South Africa
Norway
Netherlands
Slovakia


title: A Phase III, Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of 50mg Oral Dosing With the Neurokinin-1 Receptor Antagonist GW679769 for the Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

summary: This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

primary_purpose: Prevention

ReferenceCitation: Altorjay A, Melson T, Chinachoit T, Kett A, Aqua K, Levin J, Blackburn LM, Lane S, Pergolizzi JV Jr. Casopitant and ondansetron for postoperative nausea and vomiting prevention in women at high risk for emesis: a phase 3 study. Arch Surg. 2011 Feb;146(2):201-6. doi: 10.1001/archsurg.2010.327.

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:
Hong Kong
United Kingdom
Ireland
Canada
Thailand
Hungary
United States
France
Philippines
Germany
Pakistan


title: Phase Ib - II Study of Entospletinib (ENTO) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) Patients With aaIPI>=1 Treated by Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP)

summary:
The primary objective of the phase Ib of the study is to determine the recommended phase 2 dose (RP2D) for entospletinib (ENTO) in patients treated with R-CHOP.

The primary objective of the phase II is to determine the complete metabolic response (CMR) rate by the Lugano classification 2014 (Deauville scale 1-3) at the end of treatment.

status: Terminated

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: France Belgium

location_facility: Clinique Universite Catholique de Louvain Saint-Luc

status_simplified: Unknown


title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Assess the Safety and Efficacy of AST-120 in Mild to Moderately Active Crohn's Patients With Fistulas

summary: The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).

ReferenceCitation: Hay JW, Hay AR. Inflammatory bowel disease: costs-of-illness. J Clin Gastroenterol. 1992 Jun;14(4):309-17.

ReferenceCitation: Hugot JP, Chamaillard M, Zouali H, Lesage S, Cézard JP, Belaiche J, Almer S, Tysk C, O'Morain CA, Gassull M, Binder V, Finkel Y, Cortot A, Modigliani R, Laurent-Puig P, Gower-Rousseau C, Macry J, Colombel JF, Sahbatou M, Thomas G. Association of NOD2 leucine-rich repeat variants with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):599-603.

ReferenceCitation: Ogura Y, Bonen DK, Inohara N, Nicolae DL, Chen FF, Ramos R, Britton H, Moran T, Karaliuskas R, Duerr RH, Achkar JP, Brant SR, Bayless TM, Kirschner BS, Hanauer SB, Nuñez G, Cho JH. A frameshift mutation in NOD2 associated with susceptibility to Crohn's disease. Nature. 2001 May 31;411(6837):603-6.

ReferenceCitation: Best WR, Becktel JM, Singleton JW. Rederived values of the eight coefficients of the Crohn's Disease Activity Index (CDAI). Gastroenterology. 1979 Oct;77(4 Pt 2):843-6.

ReferenceCitation: Schwartz DA, Loftus EV Jr, Tremaine WJ, Panaccione R, Harmsen WS, Zinsmeister AR, Sandborn WJ. The natural history of fistulizing Crohn's disease in Olmsted County, Minnesota. Gastroenterology. 2002 Apr;122(4):875-80.

ReferenceCitation: Hellers G, Bergstrand O, Ewerth S, Holmström B. Occurrence and outcome after primary treatment of anal fistulae in Crohn's disease. Gut. 1980 Jun;21(6):525-7.

ReferenceCitation: Farmer RG, Hawk WA, Turnbull RB Jr. Clinical patterns in Crohn's disease: a statistical study of 615 cases. Gastroenterology. 1975 Apr;68(4 Pt 1):627-35.

ReferenceCitation: Gray BK, Lockhartmummery HE, Morson BC. Crohn's disease of the anal region. Gut. 1965 Dec;6(6):515-24.

ReferenceCitation: Schwartz DA, Pemberton JH, Sandborn WJ. Diagnosis and treatment of perianal fistulas in Crohn disease. Ann Intern Med. 2001 Nov 20;135(10):906-18. Review.

ReferenceCitation: Schwartz DA, Herdman CR. Review article: The medical treatment of Crohn's perianal fistulas. Aliment Pharmacol Ther. 2004 May 1;19(9):953-67. Review.

ReferenceCitation: Present DH, Rutgeerts P, Targan S, Hanauer SB, Mayer L, van Hogezand RA, Podolsky DK, Sands BE, Braakman T, DeWoody KL, Schaible TF, van Deventer SJ. Infliximab for the treatment of fistulas in patients with Crohn's disease. N Engl J Med. 1999 May 6;340(18):1398-405.

ReferenceCitation: Present DH, Korelitz BI, Wisch N, Glass JL, Sachar DB, Pasternack BS. Treatment of Crohn's disease with 6-mercaptopurine. A long-term, randomized, double-blind study. N Engl J Med. 1980 May 1;302(18):981-7.

ReferenceCitation: Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9.

ReferenceCitation: Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85.

lead_sponsor: Ocera Therapeutics

location_country:
Poland
United Kingdom
Austria
Netherlands
Canada
Czech Republic
Hungary
United States
France
Israel
Belgium
Germany

location_facility: Long Island Clinical Research Associates, LLP

location_facility: Cleveland Clinic - Department of Gastroenterology

location_facility: Erasmus MC, Department of Gastroenterology and Hepatology

location_facility: Institute for Clinical and Experimental Medicine

location_facility: CHU Hopital Nord, Service de Gastro-enterologie et nutrition

location_facility: CHU Hotel Dieu, Institut des Maladies de l'Appareil Digestif

location_facility: Katedra Klinika Gastroenterologi, Akedemil Medycanej we Wroclawiu

location_facility: Universitatsklinik fur Innere Medizin I der PMU

location_facility: Korektalnej Uniwersytetu Medycznego w Lodzi

location_facility: Hopital Claude Huriez, Service des maladies de l'appareil disgestif

location_facility: Regional Hospital Liberec, Department of Gastroenterology

location_facility: University Hospital Olomouc, 2nd Internal Department

location_facility: Universitatsklinik Heidelberg Abteilung Gastroenterologie und Hepatologie

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet

location_facility: Hopital Nord, Service de Gastro-Enterologie

location_facility: Mount Sinai School of Medicine, IBD Research Center

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Slaskiej AM

location_facility: Universitat Rostock - Midizinische Fakultat

location_facility: University of Louisville, Department of Surgery

location_facility: Rabin Medical Center, Bellinson Hospital

location_facility: Indiana University, Outpatient Clinical Research Facility

location_facility: University Hospital Gasthuisberg, University of Leuven

location_facility: University Hospital Brno, Internal and Gastroenterology Department

location_facility: University of Kentucky Chandler Medical Center

location_facility: The Penn State University, Milton S. Hershey Medical Center

location_facility: Zakaznych Szpitala Uniwersyteckiego w Krakowie

location_facility: Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA

location_facility: University College London Hospital, Dept. of Gastroenterology

location_facility: Hopital Saint-Eloi, Service de Gastro-enterologie et transplantation

location_facility: Szegedi Tudomanyegyetem, I.sz. Belgyogyaszati Klinika

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Leicester General Hospital - GI Research Unit

location_facility: Thomayer's University Hospital Prague, 2nd Internal Department

location_facility: Metropolitan Gastroenterology Group/Chevy Chase Clinical Research

location_facility: University Hospital Prague 2, 4th Department of Internal Medicine

location_facility: Klinikum der Johann-Wolfgang-Goethe Universitat Frankfurt am Main

location_facility: Miskolc Megyei Jogu Onkormanyzat Semmelweis Oktato Korhaz-Rendelointezet

location_facility: Bristol Royal Infirmary, Dept. of Gastroenterology

location_facility: John Radcliffe Hospital, Dept. of Gastroenterology

location_facility: Univ Klinik fur Innere Medizin Innsbruck

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2 im. Heliodora


title: Liraglutide Effect and Action in Diabetes (LEAD-1): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride Versus Glimepiride Monotherapy Versus Glimepiride and Rosiglitazone Combination Therapy in Subjects With Type 2 Diabetes.

summary: This trial is conducted globally (the United States of America excepted). This trial is designed to show the effect of treatment with liraglutide when added to existing glimepiride therapy and to compare this to both glimepiride monotherapy and to rosiglitazone as add-on therapy to glimepiride.

ReferenceCitation: Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.

ReferenceCitation: Marre M, Shaw J, Brändle M, Bebakar WM, Kamaruddin NA, Strand J, Zdravkovic M, Le Thi TD, Colagiuri S; LEAD-1 SU study group. Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU). Diabet Med. 2009 Mar;26(3):268-78. doi: 10.1111/j.1464-5491.2009.02666.x.

ReferenceCitation: Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997.

ReferenceCitation: McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998. Review.

ReferenceCitation: Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x. Review.

ReferenceCitation: Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbæk N, Holst J, Nauck M. Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.

ReferenceCitation: Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes ≥65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.

ReferenceCitation: Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13.

ReferenceCitation: Hegedüs L, Moses AC, Zdravkovic M, Le Thi T, Daniels GH. GLP-1 and calcitonin concentration in humans: lack of evidence of calcitonin release from sequential screening in over 5000 subjects with type 2 diabetes or nondiabetic obese subjects treated with the human GLP-1 analog, liraglutide. J Clin Endocrinol Metab. 2011 Mar;96(3):853-60. doi: 10.1210/jc.2010-2318. Epub 2011 Jan 5.

ReferenceCitation: Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

ReferenceCitation: Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

ReferenceCitation: Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

ReferenceCitation: King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

ReferenceCitation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Review. Erratum in: Diabetes Care. 2015 Aug;38(8):1622.

location_country:
Croatia
Spain
Italy
South Africa
Romania
Philippines
Poland
Australia
Argentina
India
Israel
Turkey
Malaysia
Brazil
Switzerland
Bulgaria
Taiwan
Greece
Finland
Czech Republic
Thailand
Korea, Republic of
France


title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Efficacy and Safety of up to 100 Days of Valganciclovir Versus up to 200 Days of Valganciclovir for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Kidney Allograft Recipients

acronym: IMPACT

summary: This study will determine the relative efficacy and safety of up to 100 days Valcyte prophylaxis relative to up to 200 days Valcyte prophylaxis when given for the prevention of CMV disease in high-risk (D+/R-) kidney allograft recipients. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

ReferenceCitation: Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. doi: 10.1111/j.1600-6143.2010.03074.x. Epub 2010 Mar 26.

location_country:
Poland
Brazil
Romania
Spain
Italy
United Kingdom
Australia
New Zealand
Canada
United States
France
Belgium
Germany

location_facility: Rush-Presbyterian St. Luke'S Medical Center; Rush Uni Renal Transplant Program

location_facility: Royal Prince Alfred Hospital; Renal Transplant Unit

location_facility: Robert Wood Johnson Uni Hospital; Anesthesia

location_facility: Institutul de Urologie Si Transplant Renal Cluj Napoca

location_facility: Auckland City Hospital; Renal Unit, Level 15

location_facility: Hospital de Cruces; Servicio de Enfermedades Infecciosas

location_facility: Faculdade de Medicina de Ribeirao Preto Usp; Campus Uni Rio

location_facility: POLICLINICO Universitatio A.Gemelli, Div. Chirurgia Generale e Trapianti d'Organo

location_facility: Akademia Medyczna Im. Piastow Slaskich; Klinika Nefrologii I Medycyny Transplantacyjnej

location_facility: Institutul de Urologie Si Transplant Renal Fundeni

location_facility: Hahnemann Uni Hospital; Division of Transplant/Dept. of Surgery

location_facility: Hopital Hotel Dieu Et HME; Nephrologie Immunologie Clinique

location_facility: Uni of Minnesota Medical Center; Dept of Surgery

location_facility: Wake Forest Uni School of Medicine; Section on Infectious Diseases

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Royal Liverpool Uni Hospital; Renal Dept

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: Collegium Medicum Uniwersytetu Jagielonskiego; Katedra I Klinika Nefrologii Cmuj

location_facility: Manchester Royal Infirmary; Renal Transplant Unit

location_facility: Uni of Washington Medical Center; Division of Allergy & Infectious Diseases

location_facility: Med. Hochschule Hannover Zentrum Chirurgie Klinik f.Allgemein- Viszeral- und Transplantationschirur

location_facility: Ucsd Medical Center; Kidney Transplantation

location_facility: SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre

location_facility: Klinikum der Universitaet Regensburg; Nephrologie

location_facility: Uni of California San Francisco; Transplant Services

location_facility: Hospital Israelita Albert Einstein; Intensive Care Unit

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

location_facility: Azienda Ospedaliera DI PADOVA; Divisione Malattie Infettive

location_facility: Hospital Universitario 12 de Octubre; Servicio de Enfermedades Infecciosas

location_facility: Charite - Campus, Virchow-Klinikum; Abteilung Fuer Nephrologie Und Intensivmedizin

location_facility: Oregon Health Sciences Uni ; Division of Nephrology

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

location_facility: Churchill Hospital; Oxford Transplant Center Renal Transplant Unit

location_facility: Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Hopital Bretonneau; Nephrologie Transplantations

location_facility: Indiana Uni Medical Center; Surgery & Microbiology/Immunology

location_facility: New England Medical Center; Division of Transplant Surgery

location_facility: Hopital Pellegrin; Departement Nephrologie

location_facility: CHU de Toulouse, Hopital Rangueil; Nephrologie-Tranplantation

location_facility: Monash Medical Centre; Renal Transplant Unit

location_facility: Klinik Johann Wolfgang von Goethe Uni; Innere Medizin - Dialyse

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

location_facility: Hospital Universitario Dr. Peset; Servicio de Nefrologia

location_facility: Nottingham City Hospital; Transplant Unit

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: Uni of Texas Health Science Center At San Antonio; Organ Transplant Program

location_facility: Instytut Transplantologii A.M.; Klinika Medycyny Transplantacyjnej I Nefrologii

location_facility: Charité - Klinikum Mitte; Medizinische Klinik Für Nephrologie

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Medizinische Klinik I


title: A Randomized, Double-Blind, Multi-center, Phase II Fixed Dose Study of Multiple Doses of Ipilimumab (MDX-010) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma

summary: The purpose of this clinical research study is to compare the best overall response rate (BORR)(as per modified WHO criteria) in patients with previously treated, therapy-refractory, or -intolerant, Stage III (unresectable) or Stage IV melanoma receiving ipilimumab doses of 0.3, 3, and 10 mg/kg. The safety of this product will also be evaluated.

enrollment_type: Anticipated

ReferenceCitation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

ReferenceCitation: Wolchok JD, Neyns B, Linette G, Negrier S, Lutzky J, Thomas L, Waterfield W, Schadendorf D, Smylie M, Guthrie T Jr, Grob JJ, Chesney J, Chin K, Chen K, Hoos A, O'Day SJ, Lebbé C. Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study. Lancet Oncol. 2010 Feb;11(2):155-64. doi: 10.1016/S1470-2045(09)70334-1. Epub 2009 Dec 8.

lead_sponsor: Bristol-Myers Squibb

location_country:
Brazil
Australia
Canada
Czech Republic
Hungary
United States
France
South Africa
Belgium
Germany

location_facility: Washington University School Of Medicine

location_facility: Harry And Jeanette Weinberg Cancer Inst At Franklin Square

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: The Angeles Clinic And Research Institution

location_facility: The Christ Hospital Cancer Center Research


title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor Fluctuations

summary: Patients will be randomised to receive either placebo or the study drug for a period of 30 weeks, in addition to their standard Parkinsonian medications. During the first 8 weeks, the patient's levodopa doses may be adjusted if necessary by the investigator. For the remainder of the 22 weeks, all medications should be kept stable. Patients will be required to attend the clinic twice during the screening period and then a further 8 times during the treatment period. They will be required to complete home diaries where they will record their motor function. In addition, their doctor will assess their Parkinson's disease during the clinic visits. There will also be blood draws for safety and pharmacokinetic and pharmacogenomics evaluation. Following the treatment and assessment period, they will return to the clinic one month later for follow up.

lead_sponsor: Eisai Limited

location_country:
Poland
Portugal
Serbia
Spain
Italy
Austria
Estonia
United Kingdom
Lithuania
Czech Republic
Sweden
Hungary
France
Israel
South Africa
Belgium
Germany

location_facility: Centre de Pharmacologie Clinique et Evaluation Therapeutique

location_facility: Uni-klinikum Charite, Campus Virchow-klinikum

location_facility: Vilnius University Hospital, Santariskiu Clinic

location_facility: LMU Munchen, Neurologische Universitatsklinik

location_facility: Centre d'Investigation Clinique, Hospital Purpan

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Universitatsklinik Lubeck Klinik fur Neurologie Ratzeburger Allee 160 D-23538 Lubeck

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska, Gabinet Neur


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study of SB-480848, an Oral Lipoprotein-associated Phospholipase A2 (Lp-PLA2) Inhibitor, in Subjects With Stable Coronary Heart Disease (CHD) or CHD-risk Equivalent to Examine Chronic Inhibition of Lp-PLA2 Effects on Circulating Biomarkers Associated With Cardiovascular Risk, Safety and Tolerability Over 12 Weeks

summary: This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs, electrocardiograms, clinical laboratory safety tests and adverse event assessments will be performed to evaluate the safety and tolerability of SB-480848.

ReferenceCitation: Mohler ER 3rd, Ballantyne CM, Davidson MH, Hanefeld M, Ruilope LM, Johnson JL, Zalewski A; Darapladib Investigators. The effect of darapladib on plasma lipoprotein-associated phospholipase A2 activity and cardiovascular biomarkers in patients with stable coronary heart disease or coronary heart disease risk equivalent: the results of a multicenter, randomized, double-blind, placebo-controlled study. J Am Coll Cardiol. 2008 Apr 29;51(17):1632-41. doi: 10.1016/j.jacc.2007.11.079.

location_country:
Denmark
Spain
Australia
Estonia
Argentina
Canada
Netherlands
New Zealand
Hungary
United States
France
India
Romania
Germany
Bulgaria
Pakistan


title: Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

summary: The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.

ReferenceCitation: Marcus R, Khan A, Rollin L, Morris B, Timko K, Carson W, Sanchez R. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord. 2011 Mar;13(2):133-44. doi: 10.1111/j.1399-5618.2011.00898.x.

location_country:
Croatia
Brazil
Russian Federation
Czech Republic
United States
France
India
South Africa
Bulgaria

location_facility: University Of California, Irvine Medical Center

location_facility: Psychopharmacology Research Network Of Torrance

location_facility: University Of Massachusetts Medical School

location_facility: Behavioral Medical Research Of Staten Island


title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma

summary: This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)

ReferenceCitation: Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.

ReferenceCitation: Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Sweden
Slovakia
Canada
Switzerland
Germany
Greece
France
Netherlands


title: FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.

acronym: FACT

summary: The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

location_country:
Portugal
Italy
Finland
Canada
Guatemala
Sweden
Costa Rica
France
Turkey
Iceland
Norway
Germany


title: A Phase 3, Multicenter, Randomized, Evaluation Committee-Blinded Study to Assess the Efficacy of Topical Omiganan 1% Gel in Preventing Local Catheter Site Infections/Colonization in Patients Undergoing Central Venous Catheterization

summary: The purpose of this study is to determine whether treatment with topical omiganan is more effective than treatment with topical povidone-iodine in preventing local catheter site infections and catheter colonization in patients who have central venous catheters.

lead_sponsor: Cadence Pharmaceuticals

location_country:
Germany
United States
Spain
France


status: Active, not recruiting

title: A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer

study_completion_date_type: Anticipated

ReferenceCitation: Miles D, Gligorov J, André F, Cameron D, Schneeweiss A, Barrios C, Xu B, Wardley A, Kaen D, Andrade L, Semiglazov V, Reinisch M, Patel S, Patre M, Morales L, Patel SL, Kaul M, Barata T, O'Shaughnessy J; IMpassion131 investigators. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021 Aug;32(8):994-1004. doi: 10.1016/j.annonc.2021.05.801. Epub 2021 Jul 1.

location_country:
Croatia
Saudi Arabia
Italy
Spain
United Kingdom
United States
Romania
Japan
South Africa
Czechia
Russian Federation
Argentina
India
Israel
Turkey
Slovakia
Brazil
Canada
China
Germany
Greece
Vietnam
France
Morocco

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Manipal Hospital; Department of Oncology

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

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

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: Uludag University Medical Faculty; Internal Medicine

location_facility: King Fahad Medical City; Gastroentrology

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: ARETAIEION UNIVERSITY HOSPITAL; oncology unit

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

location_facility: Harbin Medical University Cancer Hospital

location_facility: West China Hospital, Sichuan University; Department of Breast

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: The Second Affiliated Hospital of Xi'an Jiao Tong University

location_facility: HOPA im Struensee-Haus, Dres. Erik Engel, Wiebke Hollburg

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Dr. B L Kapur Memorial Hospital; BLK Cancer Centre

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Fondazione Università G. D'Annunzio; Clinical Research Center (CRC); Centro Studi (CESI)

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Centro de Pesquisas Clinicas em Oncologia - CPCO

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Clinique Sainte Catherine; Hopital De Semaine

location_facility: IEO Istituto Europeo di Oncologia;Divisione Oncologia Medica

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Azienda Ospedaliero - Universitaria di Modena Policlinico

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Izmir Ataturk Training and Research Hospital

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Florida Cancer Specialists; Department of Oncology

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

location_facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

location_facility: King Fahad Specialist Hospital; Oncology

location_facility: Klinikum Ernst von Bergmann; Frauenklinik

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Presidio Ospedaliero S. Giovanni Di Dio; U.O. Di Oncologia

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Max Super Speciality Hospital; Medical Oncology

location_facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

location_facility: Ch Pitie Salpetriere; Oncologie Medicale

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Dicle Uni Medical Faculty; Internal Medicine

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

location_facility: Fakultni nemocnice Ostrava; Klinika onkologicka FNO a LF OU

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Universita Campus Bio-Medico di Roma (UCBM)

summary: This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 [PD-L1] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.

status_simplified: Ongoing