acronym: GARDENIA

summary: This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.

ReferenceCitation: Danese S, Colombel JF, Lukas M, Gisbert JP, D'Haens G, Hayee B, Panaccione R, Kim HS, Reinisch W, Tyrrell H, Oh YS, Tole S, Chai A, Chamberlain-James K, Tang MT, Schreiber S; GARDENIA Study Group. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):118-127. doi: 10.1016/S2468-1253(21)00294-6. Epub 2021 Nov 17.

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: GZA Ziekenhuizen - Campus Sint-Vincentius

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft

location_facility: Universitair Ziekenhuis Brussel; Neurology

location_facility: Keimyung University Dongsan Medical Center

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

location_facility: IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: Seoul National University Bundang Hospital

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

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

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

title: Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Germany
Czechia
Canada
France
Portugal
Hungary
Switzerland
Romania
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Israel


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Pfizer

summary:
The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study.

Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: NY Presbyterian - Weill Cornell Medical Center

location_facility: TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I

location_facility: Emory University, Winship Cancer Institute

location_facility: General Hospital of Athens "Evangelismos"

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of California, San Francisco Medical Center

status: Completed

title: A Multicenter Phase 2 Study of Single-agent Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma

primary_purpose: Treatment

type: EudraCT Number

type: Other Identifier

source: euctr

enrollment_type: Actual

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

study_completion_date_type: Actual

location_country:
Germany
United Kingdom
Belgium
United States
Spain
Greece
Canada
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


acronym: SAVE-ONCO

lead_sponsor: Sanofi

summary:
The primary objective was to compare the efficacy of once daily subcutaneous injections of Semuloparin sodium (AVE5026) with placebo in the prevention of venous thromboembolism [VTE] in cancer patients at high risk for VTE and who were undergoing chemotherapy.

The secondary objectives were to evaluate the safety of Semuloparin sodium (AVE5026), to document Semuloparin sodium (AVE5026) exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

ReferenceType: result

ReferenceCitation: Agnelli G, George DJ, Kakkar AK, Fisher W, Lassen MR, Mismetti P, Mouret P, Chaudhari U, Lawson F, Turpie AG; SAVE-ONCO Investigators. Semuloparin for thromboprophylaxis in patients receiving chemotherapy for cancer. N Engl J Med. 2012 Feb 16;366(7):601-9. doi: 10.1056/NEJMoa1108898.

ReferenceType: derived

ReferenceCitation: Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of Bern - Bern Open Repository and Information System

version: publishedVersion

license: cc-by

license_normalized: cc-by

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

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

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title: A Multinational, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy

primary_purpose: Prevention

design_allocation: Randomized

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Croatia
Chile
Canada
Serbia
France
Czech Republic
Belarus
Lithuania
Colombia
Portugal
Slovenia
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Latvia
Ukraine
Indonesia
India
Romania
Belgium
China
Malaysia
Peru
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: FIRST

lead_sponsor: Celgene

summary: The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.

ReferenceType: background

ReferenceCitation: Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11.

ReferenceCitation: Hulin C, Belch A, Shustik C, Petrucci MT, Duhrsen U, Lu J, Song K, Rodon P, Pegourie B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295.

ReferenceCitation: Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13.

ReferenceCitation: Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.

ReferenceCitation: Vogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22.

ReferenceCitation: Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathe Y, Facon T. A predictive model for risk of early grade >/= 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.

ReferenceCitation: Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.

ReferenceCitation: Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.

ReferenceCitation: Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.

ReferenceCitation: Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.

ReferenceCitation: Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.

ReferenceCitation: Bahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4.

oa_colors: green hybrid

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repository_institution: PubMed Central - Europe PMC

repository_institution: University of Wolverhampton - Wolverhampton Intellectual Repository and E-Theses

repositories_concat: PubMed Central;wlv.openrepository.com

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publisher_dissemination: Springer-Nature

ReferenceCitation: Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.

evidence: open (via crossref license)

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repositories_concat: PubMed Central

location_facility: Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH

location_facility: Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology

location_facility: Dept of Haematology St Bartholomews Hospital

location_facility: Maine Center for Cancer Medicine Blood Disorders

location_facility: Unità Operativa di Oncoematologia, Ospedale di Matera

location_facility: Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust

location_facility: H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat

location_facility: Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali

location_facility: CHUQ - Hotel-Dieu de QuebecHematology - Oncology

location_facility: Azienda Policlinico Umberto I, Universita La Sapienzadi Roma

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: University of California, San Francisco- California

location_facility: Ruijin Hospital Shanghai Jiaotong University

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Abteilung Onkologie Haematologie des Kantonsspitals Aarau

location_facility: Medizinische Klinik III Klinikum der Universität München-Großhadern

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: U.O. di Ematologia e Trapianto di Midollo Osseo

location_facility: University of Tennessee Cancer Institute

location_facility: Hospital of the Barmherzigen Bruder Vienna

location_facility: Hwasun Chonnam National University Hospital

location_facility: Clinique Pont de chaume Oncologie et Radiotherapie

location_facility: Hospital General Universitario Morales Messeguer

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce

location_facility: Daegu Catholic University Medical Center 3056-6

location_facility: Cedar Sinai Medical Center Dept of Medicine

location_facility: Universitaetsklinikum Dusseldorf Klinik fuer Haematologie

location_facility: Medizinische Fakultat der Universitat Rostock

location_facility: Alexandra Hospital, University of Athens

location_facility: Policlinico San Matteo Universita Di Pavia

location_facility: Centre Hospitalier Universitaire Vaudois CHUV

location_facility: Instituto Catalan de Oncologia-Hospital Duran

location_facility: Casa di Cura La Maddalena, Divisione di Ematologia

location_facility: MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III

location_facility: Centre Antoine Lacassagne Oncologie medicale et Hematologie

location_facility: Seoul National University Bundang Hospital

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia

location_facility: Belfast City Hospital Haematology Department

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Oncologia Medica, Università della Magna Grecia

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: Cliniques Universitaires UCL de Mont-Godine

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: West China Hospital of Sichuan University

location_facility: Staedtische Kliniken Frankfurt am Main Hochst

location_facility: Hospital Universtario Marques de Valdecilla

location_facility: Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp

title: A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.

location_country:
Germany
Ireland
New Zealand
Australia
Canada
France
Portugal
Switzerland
United States
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Sweden


lead_sponsor: MedImmune LLC

summary: The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).

ReferenceCitation: Antonia S, Goldberg SB, Balmanoukian A, Chaft JE, Sanborn RE, Gupta A, Narwal R, Steele K, Gu Y, Karakunnel JJ, Rizvi NA. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol. 2016 Mar;17(3):299-308. doi: 10.1016/S1470-2045(15)00544-6. Epub 2016 Feb 6.

version: acceptedVersion

publisher_dissemination: Elsevier

title: A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

location_country:
Italy
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Spain
Taiwan
France


title: An International, Observational Study to Evaluate the Impact of Educational Material on the Compliance and Persistence Rates to Adjuvant Aromatase Inhibitor (AI) Medication for Postmenopausal Woman

acronym: CARIATIDE

summary: This observational study is restricted to postmenopausal women with hormone-sensitive early breast cancer, who have decided to take prescribed adjuvant use of AIs, anastrozole or letrozole, according to the current product SmPCs. There is no Investigational Medicinal Product (IMP) to be taken in this observational study. The adjuvant AI medication must not have exceeded thirteen weeks. In CARIATIDE (Compliance of ARomatase Inhibitors AssessmenT In Daily practicE through Educational approach), impact of educational material on women's compliance and persistence rates will be evaluated.

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: AstraZeneca

location_country:
Finland
France
Italy
Colombia
United Kingdom
Venezuela
Romania
Australia
Sweden
Switzerland
Austria
Belgium
Greece
Croatia
Chile
Turkey
Peru
Czech Republic


title: A Post-Marketing Observational Surveillance Programme for Ambrisentan (VOLT)

acronym: VOLT

summary: The purpose of the programme is to collect safety data on ambrisentan when used in clinical practice

lead_sponsor: GlaxoSmithKline

location_country:
France
Germany
Italy
Slovakia
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Belgium
Spain
Greece
Canada
Czech Republic


title: A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

acronym: CELESTIAL

summary: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.

ReferenceCitation: Freemantle N, Mollon P, Meyer T, Cheng AL, El-Khoueiry AB, Kelley RK, Baron AD, Benzaghou F, Mangeshkar M, Abou-Alfa GK. Quality of life assessment of cabozantinib in patients with advanced hepatocellular carcinoma in the CELESTIAL trial. Eur J Cancer. 2022 Jun;168:91-98. doi: 10.1016/j.ejca.2022.03.021. Epub 2022 Apr 26.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

ReferenceCitation: El-Khoueiry AB, Meyer T, Cheng AL, Rimassa L, Sen S, Milwee S, Kelley RK, Abou-Alfa GK. Safety and efficacy of cabozantinib for patients with advanced hepatocellular carcinoma who advanced to Child-Pugh B liver function at study week 8: a retrospective analysis of the CELESTIAL randomised controlled trial. BMC Cancer. 2022 Apr 9;22(1):377. doi: 10.1186/s12885-022-09453-z.

oa_colors: green gold

evidence: oa journal (via doaj)

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: gold

ReferenceCitation: Kelley RK, Miksad R, Cicin I, Chen Y, Klumpen HJ, Kim S, Lin ZZ, Youkstetter J, Hazra S, Sen S, Cheng AL, El-Khoueiry AB, Meyer T, Abou-Alfa GK. Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade. Br J Cancer. 2022 Mar;126(4):569-575. doi: 10.1038/s41416-021-01532-5. Epub 2021 Oct 7.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Trojan J, Mollon P, Daniele B, Marteau F, Martin L, Li Y, Xu Q, Piscaglia F, Zaucha R, Sarker D, Lim HY, Venerito M. Comparative Efficacy of Cabozantinib and Ramucirumab After Sorafenib for Patients with Hepatocellular Carcinoma and Alpha-fetoprotein >/= 400 ng/mL: A Matching-Adjusted Indirect Comparison. Adv Ther. 2021 May;38(5):2472-2490. doi: 10.1007/s12325-021-01700-2. Epub 2021 Apr 6.

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Kelley RK, Ryoo BY, Merle P, Park JW, Bolondi L, Chan SL, Lim HY, Baron AD, Parnis F, Knox J, Cattan S, Yau T, Lougheed JC, Milwee S, El-Khoueiry AB, Cheng AL, Meyer T, Abou-Alfa GK. Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial. ESMO Open. 2020 Aug;5(4):e000714. doi: 10.1136/esmoopen-2020-000714.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Hospices Civils de Lyon

repository_institution: University of California - eScholarship University of California

repositories:
HAL
PubMed Central
UCL Discovery
escholarship.org

ReferenceCitation: Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, Cicin I, Merle P, Chen Y, Park JW, Blanc JF, Bolondi L, Klumpen HJ, Chan SL, Zagonel V, Pressiani T, Ryu MH, Venook AP, Hessel C, Borgman-Hagey AE, Schwab G, Kelley RK. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018 Jul 5;379(1):54-63. doi: 10.1056/NEJMoa1717002.

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Turkey
Canada
France
Hong Kong
United States
Romania
Belgium
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Taiwan


title: A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

acronym: BRAVO

summary: The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice

status: Terminated

ipd_sharing: No

lead_sponsor: Tesaro, Inc.

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

location_country:
Italy
Poland
Portugal
Hungary
Israel
United Kingdom
Netherlands
Belgium
United States
Spain
Greece
Iceland
Canada
France

status_simplified: Unknown


title: Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3 - vs. QW GLP-1)

acronym: SUSTAIN™ 3

summary: This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

ReferenceCitation: Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685. Erratum In: J Clin Endocrinol Metab. 2020 Jan 1;105(1):

ReferenceCitation: Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

ReferenceCitation: Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

oa_host_type: publisher

evidence: open (via free pdf)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: American Diabetes Association

ReferenceCitation: Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.

ReferenceCitation: Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.

ReferenceCitation: Ahren B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.

ReferenceCitation: DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.

repository_institution: Aston University - Aston Publications Explorer

ReferenceCitation: Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.

ReferenceCitation: Malkin SJP, Russel-Szymczyk M, Liidemann G, Volke V, Hunt B. Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes: A Long-Term Cost-Effectiveness Analysis in Estonia. Diabetes Ther. 2019 Feb;10(1):159-176. doi: 10.1007/s13300-018-0542-x. Epub 2018 Dec 7.

ReferenceCitation: Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.

repository_institution: University of Leicester - Leicester Research Archive

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

ReferenceCitation: Overgaard RV, Lindberg SO, Thielke D. Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23.

ReferenceCitation: Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, Weimers P, Rosenstock J. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Cardiovasc Diabetol. 2022 Sep 2;21(1):172. doi: 10.1186/s12933-022-01585-7.

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

repositories:
PubMed Central
cronfa.swan.ac.uk
localhost

repositories_institution:
Swansea University - Cronfa
University of Toronto - TSpace

ReferenceCitation: Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.

repository_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

location_country:
Finland
Germany
Italy
United Kingdom
Argentina
Netherlands
Switzerland
United States
Greece
Croatia
Serbia
Puerto Rico
France


title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis

acronym: SPIRIT A1

summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Eli Lilly and Company

location_country:
France
Germany
Poland
Hungary
Argentina
United Kingdom
Netherlands
Mexico
Belgium
United States
Spain
Canada
Ukraine
Russian Federation
Czech Republic

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


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

summary: The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.

ReferenceCitation: Wilson WH, Wright GW, Huang DW, Hodkinson B, Balasubramanian S, Fan Y, Vermeulen J, Shreeve M, Staudt LM. Effect of ibrutinib with R-CHOP chemotherapy in genetic subtypes of DLBCL. Cancer Cell. 2021 Dec 13;39(12):1643-1653.e3. doi: 10.1016/j.ccell.2021.10.006. Epub 2021 Nov 4.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Younes A, Sehn LH, Johnson P, Zinzani PL, Hong X, Zhu J, Patti C, Belada D, Samoilova O, Suh C, Leppa S, Rai S, Turgut M, Jurczak W, Cheung MC, Gurion R, Yeh SP, Lopez-Hernandez A, Duhrsen U, Thieblemont C, Chiattone CS, Balasubramanian S, Carey J, Liu G, Shreeve SM, Sun S, Zhuang SH, Vermeulen J, Staudt LM, Wilson W; PHOENIX investigators. Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2019 May 20;37(15):1285-1295. doi: 10.1200/JCO.18.02403. Epub 2019 Mar 22.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Denmark
United States
Ukraine
Belgium
China
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

summary: The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

ReferenceCitation: Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.

ReferenceCitation: Tichy E, Torres A, Bassetti M, Kongnakorn T, Di Virgilio R, Irani P, Charbonneau C. Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia, Including Ventilator-associated Pneumonia, in Italy. Clin Ther. 2020 May;42(5):802-817. doi: 10.1016/j.clinthera.2020.03.014. Epub 2020 Apr 27.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

ReferenceCitation: Stone GG, Bradford PA, Tawadrous M, Taylor D, Cadatal MJ, Chen Z, Chow JW. In Vitro Activity of Ceftazidime-Avibactam against Isolates from Respiratory and Blood Specimens from Patients with Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia, in a Phase 3 Clinical Trial. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02356-19. doi: 10.1128/AAC.02356-19. Print 2020 Apr 21.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.

ReferenceCitation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

oa_colors: green other

ReferenceCitation: Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.

evidence: open (via free article)

publisher_dissemination: Oxford University Press

ReferenceCitation: Torres A, Zhong N, Pachl J, Timsit JF, Kollef M, Chen Z, Song J, Taylor D, Laud PJ, Stone GG, Chow JW. Ceftazidime-avibactam versus meropenem in nosocomial pneumonia, including ventilator-associated pneumonia (REPROVE): a randomised, double-blind, phase 3 non-inferiority trial. Lancet Infect Dis. 2018 Mar;18(3):285-295. doi: 10.1016/S1473-3099(17)30747-8. Epub 2017 Dec 16.

location_country:
Poland
Argentina
Japan
Brazil
Vietnam
Turkey
Czechia
France
Slovenia
Hungary
Latvia
Ukraine
India
Romania
China
Peru
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


acronym: Igloo

lead_sponsor: Biota Scientific Management Pty Ltd

summary: This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.

sponsor_collaborators:
Biota Scientific Management Pty Ltd
Department of Health and Human Services

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Mexico Centre for Clinical Research S.A. de C.V

location_facility: Jimboomba Junction Family Practice & Skin Cancer Clinic

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft

location_facility: Synexus SA, Stanza Bopape Clinical Research Centre

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: University of Massachusetts Medical Center

location_facility: Clinique Medicale St-Louis (Recherche) Inc

location_facility: Allergy Diagnostic & Clinical Research Unit

location_facility: ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH

location_facility: Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen

location_facility: DCT - FMC, LLC, d/b/a Discovery Clinical Trials

location_facility: Synexus SA - Watermeyer Clinical Research Centre

location_facility: Institut fuer Praeventive Medizin Freiburg

location_facility: Hospital de Especialidades Centro Medico Puerta de Hierro

location_facility: Facultad Mexicana de Medicina, Universidad La Salle A.C.

location_facility: Syzygy Clinical Research Services Wilgers

location_facility: Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff

location_facility: Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo

location_facility: Oaxaca Site Management Organization S.C.

location_facility: DCT-Stone Oak, LLC dba Discovery Clinical Trials

location_facility: CSALADGYOGYYASZ Szolgaltato es Oktato Bt.

location_facility: Diagnostic Consultative Center II - Sofia OOD

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Centro de Investigacion Clinica Acelerada, S.C.

location_facility: The Asthma & Allergy Center, P.C. master

location_facility: BRCR Medical Center, Inc DBA Boca Raton Clinical Research

location_facility: Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)

location_facility: Phylasis Clinicas Research S de RL de CV

location_facility: Bethesda Allergy, Asthma & Research Center, LLC

location_facility: Hometown Urgent Care & Occupational Health

location_facility: Clinexpert Egeszsegugyi Szolg. es Ker. Kft.

location_facility: Southeast Clinical Research, LLC - Parent

location_facility: San Diego Sports Medicine & Family Health Center

location_facility: Centro de Investigacion Clinica GRAMEL S.C

location_facility: University of Pretoria Clinical Research Unit

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Columbia

location_facility: Nucleo Victoria de Investigacion Clinica S.C.

title: A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection

type: Other Grant/Funding Number

location_country:
Germany
Bulgaria
Colombia
New Zealand
Hungary
United Kingdom
Australia
Mexico
Belgium
United States
Latvia
South Africa
Peru
Canada
Estonia
France


title: A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)

summary: Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.

ReferenceCitation: Siwy J, Klein T, Rosler M, von Eynatten M. Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase-4 Inhibition: A Hypothesis-Generating Analysis from the MARLINA-T2D Trial. Proteomics Clin Appl. 2019 Mar;13(2):e1800144. doi: 10.1002/prca.201800144. Epub 2019 Jan 28.

oa_host_type: closed

ReferenceCitation: Groop PH, Cooper ME, Perkovic V, Hocher B, Kanasaki K, Haneda M, Schernthaner G, Sharma K, Stanton RC, Toto R, Cescutti J, Gordat M, Meinicke T, Koitka-Weber A, Thiemann S, von Eynatten M. Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D trial. Diabetes Obes Metab. 2017 Nov;19(11):1610-1619. doi: 10.1111/dom.13041. Epub 2017 Jul 31.

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

repositories_concat: PubMed Central;dash.harvard.edu

ReferenceCitation: Groop PH, Cooper ME, Perkovic V, Sharma K, Schernthaner G, Haneda M, Hocher B, Gordat M, Cescutti J, Woerle HJ, von Eynatten M. Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA-T2D trial. Diab Vasc Dis Res. 2015 Nov;12(6):455-62. doi: 10.1177/1479164115579002. Epub 2015 Jul 28.

publisher_dissemination: SAGE Publications

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_country:
Finland
Germany
Denmark
Japan
United States
Korea, Republic of
Spain
Vietnam
Taiwan
Canada
Philippines
France

location_facility: Boehringer Ingelheim Investigational Site


title: A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Bushinsky DA, Chertow GM, Cheng S, Deng H, Kopyt N, Martin KJ, Rastogi A, Urena-Torres P, Vervloet M, Block GA. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol Dial Transplant. 2020 Oct 1;35(10):1769-1778. doi: 10.1093/ndt/gfz039. Erratum In: Nephrol Dial Transplant. 2019 May 15;:1642.

lead_sponsor: Amgen

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Czechia
Canada
Russian Federation
France


type: Registry Identifier

type: U.S. NIH Grant/Contract

title: A Pilot Trial of AVD and Brentuximab Vedotin (SGN-35) in the Treatment of Stage II-IV HIV-Associated Hodgkin Lymphoma

summary: This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells.

status: Active, not recruiting

ReferenceCitation: Rubinstein PG, Moore PC, Rudek MA, Henry DH, Ramos JC, Ratner L, Reid E, Sharon E, Noy A; AIDS Malignancy Consortium (AMC). Brentuximab vedotin with AVD shows safety, in the absence of strong CYP3A4 inhibitors, in newly diagnosed HIV-associated Hodgkin lymphoma. AIDS. 2018 Mar 13;32(5):605-611. doi: 10.1097/QAD.0000000000001729.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: National Cancer Institute (NCI)

collaborators: The Lymphoma Academic Research Organisation

location_country:
United States
France

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse

location_facility: University of Miami Miller School of Medicine-Sylvester Cancer Center

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: UCLA Center for Clinical AIDS Research and Education

location_facility: Siteman Cancer Center at Washington University

location_facility: Louisiana State University Health Science Center

location_facility: UCLA / Jonsson Comprehensive Cancer Center

location_facility: Montefiore Medical Center-Einstein Campus

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

status_simplified: Ongoing


title: A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX

acronym: RA-COMPARE

summary:
Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Chile
Czechia
France
Lithuania
Colombia
Hungary
United States
Latvia
Ukraine
Romania
Malaysia
Peru
Italy
Ecuador
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

location_facility:
Investigational Site Number 642040
Investigational Site Number 076006
Investigational Site Number 300012
Investigational Site Number 804023
Investigational Site Number 032051
Investigational Site Number 410015
Investigational Site Number 840117
Investigational Site Number 170007
Investigational Site Number 484004
Investigational Site Number 840201
Investigational Site Number 826021
Investigational Site Number 840207
Investigational Site Number 710007
Investigational Site Number 616059
Investigational Site Number 643051
Investigational Site Number 250008
Investigational Site Number 076013
Investigational Site Number 376032
Investigational Site Number 348010
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Investigational Site Number 804011
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Investigational Site Number 410020
Investigational Site Number 410013
Investigational Site Number 076016
Investigational Site Number 458002
Investigational Site Number 032013
Investigational Site Number 604010
Investigational Site Number 804033
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Investigational Site Number 376011
Investigational Site Number 203032
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Investigational Site Number 203002
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Investigational Site Number 276013
Investigational Site Number 458011
Investigational Site Number 158010
Investigational Site Number 804010
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Investigational Site Number 440005
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Investigational Site Number 643031
Investigational Site Number 152011
Investigational Site Number 380041
Investigational Site Number 036014
Investigational Site Number 218001
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Investigational Site Number 170040
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Investigational Site Number 440006
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Investigational Site Number 158004
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Investigational Site Number 840060
Investigational Site Number 710008
Investigational Site Number 642022
Investigational Site Number 170016
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Investigational Site Number 642013
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Investigational Site Number 218002
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Investigational Site Number 643008
Investigational Site Number 203004
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Investigational Site Number 376001
Investigational Site Number 484013
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Investigational Site Number 643030
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Investigational Site Number 604012
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Investigational Site Number 250005
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Investigational Site Number 643013
Investigational Site Number 036004
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Investigational Site Number 643006
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Investigational Site Number 804003
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Investigational Site Number 616005
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Investigational Site Number 458010
Investigational Site Number 724040
Investigational Site Number 840200
Investigational Site Number 076001
Investigational Site Number 604001
Investigational Site Number 076005
Investigational Site Number 158006
Investigational Site Number 428003
Investigational Site Number 643058


title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

summary: The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

ReferenceCitation: Povoa P, Salluh JI, Martinez ML, Guillamat-Prats R, Gallup D, Al-Khalidi HR, Thompson BT, Ranieri VM, Artigas A. Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial. Crit Care. 2015 Apr 28;19(1):193. doi: 10.1186/s13054-015-0921-x.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

ReferenceCitation: Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gardlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD; PROWESS-SHOCK Study Group. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 May 31;366(22):2055-64. doi: 10.1056/NEJMoa1202290. Epub 2012 May 22.

location_country:
Finland
France
Germany
Italy
India
New Zealand
Portugal
United Kingdom
Australia
Brazil
Netherlands
Mexico
Belgium
Switzerland
United States
Spain
Canada
Czech Republic

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


title: A Multicentre, Open Label, Early Stopping Design, Proof Of Concept Study With Tasquinimod In Treating Patients With Advanced Or Metastatic Hepatocellular, Ovarian, Renal Cell And Gastric Carcinomas

summary: This was an exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced or metastatic hepatocellular carcinoma, ovarian carcinoma, renal cell carcinoma and gastric carcinoma who had progressed after standard therapies.

design_allocation: Non-Randomized

ReferenceCitation: Escudier B, Faivre S, Van Cutsem E, Germann N, Pouget JC, Plummer R, Vergote I, Thistlethwaite F, Bjarnason GA, Jones R, Mackay H, Edeline J, Fartoux L, Hirte H, Oza A. A Phase II Multicentre, Open-Label, Proof-of-Concept Study of Tasquinimod in Hepatocellular, Ovarian, Renal Cell, and Gastric Cancers. Target Oncol. 2017 Oct;12(5):655-661. doi: 10.1007/s11523-017-0525-2.

repository_institution: KU Leuven - Lirias

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: Newcastle Univesity - Newcastle University ePrints

version: submittedVersion

lead_sponsor: Ipsen

location_country:
United Kingdom
Belgium
Spain
Canada
France

location_facility: London Health Sciences Center, 790 Commissoners Road East

location_facility: Antwerp University Hospital, Wilrijkstraat 10

location_facility: The Christie Hospital, Wilmslow Road, Withington

location_facility: Hospital Saint-Antoine, 184 rue du Faubourg St Antoine

location_facility: Sunnybrook, 2075 Bayview Avenue, Suite T2049

location_facility: Institute Gustave-Roussy, 114 rue Edouard Vaillant

location_facility: Princess Margaret, 610 University Avenue

location_facility: Ghent University Hospital, 1K12 IE, De Pintelaan 185

location_facility: Beatson West of Scotland Cancer Centre, 1053 Great Western Road

location_facility: Southampton General Hospital, Tremona Road, Shirley

location_facility: Centre Oscar Lambret, 3 rue Frédéric Combemale

location_facility: MD Anderson Cancer Centre, Ctra. Colmenar Viejo Km. 9 100,

location_facility: Centre Eugene Marquis, Avenue bataille Flandres Dunkerque

location_facility: Hospital Beaujon, 100 Blvd du Général Leclerc

location_facility: Juravinski Cancer Centre, 699 Concession St

location_facility: Hopital Europeen Georges-Pompidou, AP-HP, 20 Rue Leblanc

location_facility: Centre René Gauducheau, Boulevard Jacques Monod

location_facility: Bureau d'Etudes Cliniques du Centre Léon Bérard, 28, rue Laennec

location_facility: The Royal Marsden Hospital, Downs Rd, Sutton

location_facility: Hospital Gregorio Marañon, Dr. Esquerdo, 44-46

location_facility: Leicester General Hospital, Gwndolen Road

location_facility: Freeman Hospital, Freeman Road, High Heaton

location_facility: Leuven cancer institute (LKI), Herestraat


title: A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon

summary: The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

ReferenceCitation: Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.

repository_institution: PubMed Central - Europe PMC

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

evidence: oa repository (semantic scholar lookup)

repositories_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

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

publisher_dissemination: Informa

location_country:
Germany
Italy
Portugal
New Zealand
United Kingdom
Australia
Belgium
United States
Spain
Greece
Canada
France

location_facility: 1241.36.00010 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00022 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35101 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49011 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00030 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61010 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00029 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39028 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00031 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39025 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00019 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00032 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00026 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44013 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00016 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49013 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39021 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00027 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.64001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00020 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39024 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39026 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39029 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00018 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00013 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00024 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00034 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00015 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00033 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39022 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00035 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00017 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49012 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.64002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39023 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00043 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49014 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39020 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00044 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44010 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00039 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35104 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44011 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35103 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49001 Boehringer Ingelheim Investigational Site


title: Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study

acronym: FOXFIREGlobal

summary:
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the Investigator.

ReferenceCitation: van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodriguez J, Kroning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum In: J Clin Oncol. 2016 Nov 20;34(33):4059.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories_concat: irua

ReferenceCitation: Wolstenholme J, Fusco F, Gray AM, Moschandreas J, Virdee PS, Love S, Van Hazel G, Gibbs P, Wasan HS, Sharma RA. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer. Int J Cancer. 2020 Aug 15;147(4):1078-1085. doi: 10.1002/ijc.32828. Epub 2020 Jan 9.

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

repository_institution: University of Cambridge - Apollo

repositories_concat: University of Melbourne - Minerva Access;ora.ox.ac.uk;www.repository.cam.ac.uk

ReferenceCitation: Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators; van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University College London - UCL Discovery

repository_institution: Cardiff University - ORCA Online Research @Cardiff

repositories_concat: PubMed Central;UCL Discovery;University of Melbourne - Minerva Access;archive.ugent.be;irua;ora.ox.ac.uk;orca.cardiff.ac.uk

ReferenceCitation: Virdee PS, Moschandreas J, Gebski V, Love SB, Francis EA, Wasan HS, van Hazel G, Gibbs P, Sharma RA. Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer. JMIR Res Protoc. 2017 Mar 28;6(3):e43. doi: 10.2196/resprot.7201.

location_country:
Germany
Italy
Portugal
New Zealand
Israel
Singapore
Australia
Belgium
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: Klinikum rechts der Isar der TU Munchen Medizinische Klinik II

location_facility: Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie

location_facility: Centre Hospitalier General de Longjumeau

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie

location_facility: TA Sourasky Medical Center, Oncology Department 6

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

location_facility: U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello

location_facility: Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin

location_facility: Sheba Medical Center - Governmental Hospital - Oncology Division

location_facility: Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin

location_facility: Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo

location_facility: Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie

location_facility: Spartanburg Regional Healthcare / Gibbs Cancer Center

location_facility: Schwerpunktpraxix fur Hamatologie und Onkologie

location_facility: SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie

location_facility: Dipartimento di Oncologia, Ospendali Riuniti di Bergamo

location_facility: Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie

location_facility: CHU de Poitiers, Pole regional de cancerologie