title: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Phase 3 Efficacy and Safety Study of CGT-2168 Compared With Clopidogrel to Reduce Upper Gastrointestinal Events Including Bleeding and Symptomatic Ulcer Disease

summary:
The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy.

Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens.

The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease.

Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.

enrollment_type: Anticipated

ReferenceCitation: Vaduganathan M, Bhatt DL, Cryer BL, Liu Y, Hsieh WH, Doros G, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Cannon CP; COGENT Investigators. Proton-Pump Inhibitors Reduce Gastrointestinal Events Regardless of Aspirin Dose in Patients Requiring Dual Antiplatelet Therapy. J Am Coll Cardiol. 2016 Apr 12;67(14):1661-71. doi: 10.1016/j.jacc.2015.12.068. Epub 2016 Mar 21.

ReferenceCitation: Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP; COGENT Investigators. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med. 2010 Nov 11;363(20):1909-17. doi: 10.1056/NEJMoa1007964. Epub 2010 Oct 6.

lead_sponsor: Cogentus Pharmaceuticals

location_country:
France
Germany
Italy
Poland
Slovakia
Hungary
Romania
Australia
Mexico
United States
Chile
Ukraine
Bulgaria
Canada
Puerto Rico
Czech Republic

location_facility: Midwest Cardiovascular Research Foundation

location_facility: II.interni klinika kardiologie a angiologie 1. LF UK a VFN v Praze

location_facility: Hospital Regional de Punta Arenas Dr. Lautaro Navarro

location_facility: Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska" AMN Ukrainy, m. Kyiv, viddilenia symptomatychnykh arterial'nykh gipertenziy

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina", Clinic of Internal Diseases - 2nd Internal Department

location_facility: New England Center for Clinical Research, Inc

location_facility: ZOZ w Oławie, Oddział Chorób Wewnętrznych

location_facility: Niepubliczny Zakład Opieki Zdrowotnej POLIMEDICA

location_facility: "Oddział Kardiologii, Wojewódzki Szpital Zespolony w Skierniewicach, "

location_facility: Tokuda Hospital Department of Cardiology

location_facility: Klinikum Mannheim GmbH, Universaitatskinikum

location_facility: Institutul de Boli Cardiovasculare si Transplan Tg. Mures

location_facility: Oddział Wewnetrzny I, Szpital Kolejowy im. dr med. Włodzimierza Roeslera

location_facility: Samodzileny Publiczny Zakład Opieki Zdrowotnej w Puławach, Szpital Specjalistyczny

location_facility: Heart Clinic of Louisiana Clinical Research, LLC.

location_facility: Cardiovascular Research Center of South Florida

location_facility: Azienda Ospedaliera Maggiore Della Carita' Di Novara

location_facility: Duluth Clinic / Saint Marys Medical Center

location_facility: Winchester Medical Center/ Clinical Research Department

location_facility: Southeast Texas Clinical Research Center

location_facility: Zakład Hemodynamiki, Wojewódzki Szpital Specjalistyczny

location_facility: Oddział Kardiologiczny Wojewódzki Szpital Specjalistyczy w Siedlcach

location_facility: Nemocnica s poliklinikou Považská Bystrica

location_facility: Fraser Clinical Trials Inc and Royal Columbian Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Bacau

location_facility: Inland Heart and Vascular Medical Associates

location_facility: Szpital Specjalistyczny w Kościerzynie, Oddział Kardiologii

location_facility: Szpital Specjalistyczny Św.Jana, Oddział Kardiologii,

location_facility: II Oddział Wewnętrzny Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: Fovarosi Onkormanyzat Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet

location_facility: Alabama Clinical Research Institute, Inc. (ACRI)

location_facility: Sewickley Valley Medical Group Cardiology

location_facility: Research Center Phase I-IV of Florida Corp.

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Akademii Medycznej w Warszawie

location_facility: Alegent Health Clinic Heart and Vascular Specialist

location_facility: Specjalistyczny Zakład Opieki Zdrowotnej Poradnia lekarzy specjalistów "Jantar"

location_facility: Medyczne Centrum Hetmańska, Indywiualna Specjalistyczna Praktyka Lekarska, Dr n. med. Piotr Leszczyński

location_facility: "Oddział Kardiologii z Pododdziałem Ostrych Zespołów Wieńcowych i z Ośrodkiem Implantacji Rozruszników Serca,

location_facility: "Oddzial Chorob Wewnetrznych i Kardiologii, Szpital Powiatowy im.Edmunda Biernackiego

location_facility: "Samodzielny Szpital Wojewódzki im. Mikołaja Kopernika, Oddział Kardiologiczny

location_facility: The University of Texas Medical Branch at Galveston

location_facility: Gemeinschaftspraxis Innere Medizin und Kardiologie

location_facility: Centrum Leczenia Chorób Cywilizacyjnych Oddz. Gdynia filla Fikakowo

location_facility: Kilniken Maria Hilf GmbH Krankenhaus St. Franziskus

location_facility: Cardiac Care and Vascular Medicine, Albert Einstein College of Medicine

location_facility: Research Associates of Jackson and Apex Cardiology

location_facility: Hospitalier de l'Universite de Montreal Hotel Dieu

location_facility: National Heart Hospital Department of Cardiology

location_facility: Centre Hospitalier Universitaire de Quebec (CHOQ) Hotel Dieu de Quebec

location_facility: Military Medical Academy, Clinic of Cardiology and Intensive Care

location_facility: "Oddział Kardiologiczny Wałbrzyski Ośrodek Kardiologii Interwencyjnej Specjalityczny Szpital im. Dr Alfreda Sokołowskiego

location_facility: St. Josef-Hospital Medizinische Klinik II, Kardiologie

location_facility: Praxis für Innere Medizin, Gastroenterologie

location_facility: Osrodek Chorob Serca, Klinika Kardiologii 4 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Specjalistyczna Przychodnia Lekarska "Medikard"

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház

location_facility: Cardiology Assocaites of Orlando d/b/a Orlando Heart Center

location_facility: Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny-Cardiology

location_facility: Therapeutic Research Institute of Orange County

location_facility: Kardioarytmologichnyi tsentr Zhytomyrs'koi oblasnoi klinichnoi likarni im. O.F. Gorbachevs'kogo, m. Zhytomyr

location_facility: Northeast Iowa Medical Education Foundation

location_facility: Comprehensive Cardiology Consultants, Inc.

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz", Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną

location_facility: Multiprofile Hospital for Active Treatment ''Sveti Panteleymon'', 2nd Department. of Internal Diseases - Intensive Cardiology Unit

location_facility: Oddział Kardiologii, Szpital Specjalistyczny im. J. Dietla

location_facility: Oddział Chorób Wewnętrznych i Farmakologii Klinicznej Samodzielny Publiczny Centralny Szpital Kliniczny im. Prof. Kornela Gibińskiego Śląskiego Uniwersytetu Medycznego w Katowicach

location_facility: Good Samaritan Hospital (Medstar Health)

location_facility: "Oddział Kardiologiczny Publiczny Samodzielny ZOZ Wojewódzkie Centrum Medyczne

location_facility: University Multiprofile Hospital for Active Treatment ''Tsaritsa Ioanna'' - ISUL, Cardiology Clinic

location_facility: Azienda Ospedaliera Universitaria San Martino-Dipartimento di Medicina Interna e Specialità Mediche

location_facility: Multiprofile Hospital for Active Treatment - Ruse, 4th Department of Internal Diseases

location_facility: 4th Multiprofile Hospital for Active Treatment

location_facility: La Pitié Salpétrière Institut de Cardiologie

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház

location_facility: Executive Health and Research Associates, Inc.

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: Oddział Kardiologiczny Szpital Wojewódzki im. Kardynała Stefana Wyszyńskiego

location_facility: NZOZ Przychodnia Zadebie, Przychodnia Kardiologiczna

location_facility: Mazowieckie Centrum Badań Klinicznych Iwona Czajkowska, Monika Śmietańska s.c.

location_facility: Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbR

location_facility: Instituto de Corazón de Querétaro, S.A. de C.V.

location_facility: Wojewódzki Szpital Zespolony, Oddział Kardiologiczny

location_facility: Cardiovascular Care of Northern Carolina

location_facility: South Suburban Health Professional Group, PC

location_facility: Oddział Kardiologii Samodzielny Publiczny Zakład Opieki Zdrowotnej w Sieradzu im. Kardynała Stefana Wyszyńskiego

location_facility: Fővárosi Önkormányzat Károlyi Sándor Kórház és Rendelőintézet

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Specjalista Sp. z o.o.

location_facility: Oblasnyi klinichnyi kardiologichnyi dyspanser, m. Ivano-Frankivsk, Ivano-Frankivskyi derzhavnyi medychnyi universytet, kafedra terapii # 3

location_facility: "Śląskie Centrum Chorób Serca, III Katedra i Oddział Kliniczny Kardiologii Śląskiego Uniwersytetu Medycznego

location_facility: Texas Regional Heart Center d/b/a Legacy Heart Center

location_facility: Poradnia Kardiologiczna, Oddział Chorob Wewnetrznych Szpital Powiatowy w Limanowej

location_facility: Hospital of the University of Pennsylvania Cardiology Department

location_facility: National Multiprofile Transport Hospital "Tsar Boris III, Cardiology Clinic

location_facility: Natsionalnyi naukovyi tsentr "Instytut kardiologii im. akad. M.D. Strazheska", viddil reanimatsii ta intensyvnoi terapii, m. Kyiv

location_facility: Międzyleski Szpital Specjalistyczny w Warszawie

location_facility: Oddział Chorób Wewnętrzych i Kardiologii , ZOZ w Debicy

location_facility: Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej Oddzial Kardiologiczny

location_facility: Wojewódzki Szpital Meijski im. Biziela, Oddział Kardiologii - SPZOZ

location_facility: Klinika kardiologie Institut klinické a experimentální medicíny

location_facility: Multiprofile Hospital for Active Treatment ''Sveti Georgi'', Cardiology Clinic

location_facility: Chest and Critical Care Consultants, A Medical Group

location_facility: Oddział Kardiologii Wojewódzki Szpital Zespolony

location_facility: Buffalo Cardiology and Pulmonary Associates

location_facility: Hospital Central "Dr. Ignacio Morones Prieto"

location_facility: Jacksonville Center for Clinical Research

location_facility: Centre de Sante et de services sociaux du nord de lanaudiere/CHRDL

location_facility: Azienda Ospedaliera della Provincia di Lodi Presidio Ospedaliero di Codogno

location_facility: Oddział Kardiologii z Zakładem Diagnostyki Kardiologicznej, Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital im. dr J. Biziela,

location_facility: Universitatsklinikum Berlin Campus Charite Mitte Med Klinik Kardiologie und Angiologie

location_facility: Universitäres Herz-und Gefäßzentrum Hamburg"

location_facility: 5. Interna klinika LF UK, FNsP Bratislava, Nemocnica Ruzinov

location_facility: The Heart and Vascular Institute of Florida

location_facility: Oddział Kardiologiczny Szpital Wolski im. dr Anny Gostyńskiej Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: Niepubliczny Zakład Opieki Zdrowotnej, Centrum Badań Klinicznych

location_facility: II Klinika Choroby Wieńcowej Instytutu Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego

location_facility: Saint Patrick Hospital- International Heart Institute of Montana

location_facility: Cardiovascular Associates of the Delaware Valley, P.A.

location_facility: Klinikum Region Hannover Krankenhaus Nordstadt

location_facility: Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski, Clinic of Cardiology

location_facility: "Klinichne obyednannia shvydkoi medychnoi dopomogy, m. Dnipropetrovs'k,Dnipropetrovs'ka derzhavna medychna akademiya, kafedra gospital'noi terapii #2

location_facility: Franciscan Health System dba FHS Research Center

location_facility: Oddzial Chorób Wewnętrznych III Szpital Specjalistyczny im.Stefana Zeromskiego, SPZOZ w Krakowie

location_facility: Clinique de Cardiologie de Trois-Rivieres

location_facility: Cardiovascular Consultants of South Florida

location_facility: "Oddział Kardiologii Inwazyjnej i Angiologii z Pr. Hemodynamiki

location_facility: Verzosa & Ungab Internal Medicine Associates

location_facility: Zakład Opieki Zdrowotnej Trójmiejskie Centrum Medyczne Sp. z o.o

location_facility: Ventura Cardiology Consultants Medical Group, Inc.

location_facility: Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: McMinn Medical Group (DBA: Athens Medical Group)

location_facility: Multiprofile Hospital for Active Treatment and Emergency Medicine "Pirogov". Cardiology Clinic

location_facility: Trinity Hypertension and Diagnostic Res.

location_facility: "Klinika Choroby Wieńcowej Instytut Kardiologii, Collegium Medicum Uniwerytet Jagielloński

location_facility: TOV "Kardiologichna klinika "Sertse i sudyny" m. Kyiv

location_facility: Komunal'na ustanova "Oblasnyi kardiologichnyi dyspanser", viddilenia intensyvnoi terapii, m. Zaporizhzhia

location_facility: Pennsylvania Heart and Vascular Group, P.C.

location_facility: Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwór

location_facility: Multiprofile Hospital for Active Treatment "Sveta Ekaterina", 1st Department of Internal Diseases


title: Effect of Inhalation of a Free Combination of Tiotropium Once Daily 18 Mcg and Salmeterol Twice Daily 50 Mcg Versus a Fixed Combination of Fluticasone and Salmeterol Twice Daily (500/50 Mcg) on Static Lung Volumes and Exercise Tolerance in COPD Patients (a Randomised, Double-blind, Double Dummy, 16 (2 x 8) Weeks, Crossover Study).

summary:
The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD.

The secondary objective includes assessment of safety.

status: Completed

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Magnussen H, Paggiaro P, Schmidt H, Kesten S, Metzdorf N, Maltais F. Effect of combination treatment on lung volumes and exercise endurance time in COPD. Respir Med. 2012 Oct;106(10):1413-20. doi: 10.1016/j.rmed.2012.05.011. Epub 2012 Jun 28.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Italy
Sweden
Austria
Canada
Russian Federation
France

location_facility: 205.334.4907 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1010 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39004 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3306A Boehringer Ingelheim Investigational Site

location_facility: 205.334.3306B Boehringer Ingelheim Investigational Site

location_facility: 205.334.7002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4309 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3302A Boehringer Ingelheim Investigational Site

location_facility: 205.334.1007 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4301 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1009 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1008 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3302B Boehringer Ingelheim Investigational Site

location_facility: 205.334.46002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4901 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1006 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4305 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4908 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39005 Boehringer Ingelheim Investigational Site

location_facility: 205.334.7003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3304A Boehringer Ingelheim Investigational Site

location_facility: 205.334.46001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4308 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4909 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3301A Boehringer Ingelheim Investigational Site

location_facility: 205.334.46003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3303B Boehringer Ingelheim Investigational Site

location_facility: 205.334.4902 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39006 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4306 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3303A Boehringer Ingelheim Investigational Site

location_facility: 205.334.7001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3305A Boehringer Ingelheim Investigational Site

location_facility: 205.334.4302 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4904 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1004 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1005 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39007 Boehringer Ingelheim Investigational Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)

summary: This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

status: Terminated

study_completion_date_type: Actual

design_allocation: Randomized

ReferenceType: result

ReferenceCitation: Fayad L, Ansell SM, Advani R, Coiffier B, Stuart R, Bartlett NL, Forero-Torres A, Kuliczkowski K, Belada D, Ng E, Drachman JG. Dacetuzumab plus rituximab, ifosfamide, carboplatin and etoposide as salvage therapy for patients with diffuse large B-cell lymphoma relapsing after rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone: a randomized, double-blind, placebo-controlled phase 2b trial. Leuk Lymphoma. 2015;56(9):2569-78. doi: 10.3109/10428194.2015.1007504. Epub 2015 Feb 26.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Informa

lead_sponsor: Seagen Inc.

sponsor_collaborators:
Seagen Inc.
Genentech, Inc.

location_country:
Germany
Italy
Poland
Hungary
Australia
Belgium
United States
Spain
Czech Republic
France

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: H. Duran y Reynals Institue Catala D'Oncologia

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Cliniques Universitaires UCL de Mont-Goddine

location_facility: Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine

location_facility: Washington University School of Medicine

location_facility: Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Winship Cancer Institute, Emory University

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: University of Louisville - James Graham Brown Cancer Center

status_simplified: Unknown


title: Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin

summary: The purpose of this study is to assess the ability of eltrombopag to maintain a platelet count sufficient to facilitate initiation of antiviral therapy, to minimise antiviral therapy dose reductions and to avoid permanent discontinuation of antiviral therapy. The clinical benefit of eltrombopag will be measured by the proportion of subjects who are able to achieve a Sustained Virological Response (SVR).

ReferenceCitation: Saleh MI, Obeidat AR, Anter HA, Khanfar AA. Eltrombopag dose predictors in thrombocytopenic subjects with hepatitis C virus infection. Clin Exp Pharmacol Physiol. 2015 Oct;42(10):1030-5. doi: 10.1111/1440-1681.12451.

publisher_dissemination: Wiley

ReferenceCitation: Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gomez M, Dusheiko GM, Iyengar M, Vasey SY, Campbell FM, Theodore D. Non-cirrhotic thrombocytopenic patients with hepatitis C virus: Characteristics and outcome of antiviral therapy. J Gastroenterol Hepatol. 2015 Aug;30(8):1301-8. doi: 10.1111/jgh.12942.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

unpaywall_oa_status: hybrid

ReferenceCitation: Afdhal NH, Dusheiko GM, Giannini EG, Chen PJ, Han KH, Mohsin A, Rodriguez-Torres M, Rugina S, Bakulin I, Lawitz E, Shiffman ML, Tayyab GU, Poordad F, Kamel YM, Brainsky A, Geib J, Vasey SY, Patwardhan R, Campbell FM, Theodore D. Eltrombopag increases platelet numbers in thrombocytopenic patients with HCV infection and cirrhosis, allowing for effective antiviral therapy. Gastroenterology. 2014 Feb;146(2):442-52.e1. doi: 10.1053/j.gastro.2013.10.012. Epub 2013 Oct 12.

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Australia
Brazil
Thailand
Pakistan
Canada
France
Czech Republic
Slovakia
Hong Kong
United States
Ukraine
India
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


summary: The primary objective of this study is to explore the efficacy of BIBW 2992 compared with cetuximab (Erbitux) in patients with metastatic or recurrent head and neck cancer after failure of platinum-containing therapy. In addition, the trial aims to clarify the influence of EGFR genotype on tumor response to the treatment regimens.

ReferenceCitation: Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

license: publisher-specific-oa

license_normalized: publisher-specific

location_facility: 1200.28.0061A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0032 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0062B Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0045 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0002 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0007 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0009 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0058A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0044 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0022 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0005 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0001 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0016 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0052A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0051A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0008 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0062A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0031 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0010 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0012 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0050A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0040 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0024 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0041 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0043 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0004 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0042 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0021 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0059A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0030 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0013 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0055G Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0006 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0020 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0017 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0011 Boehringer Ingelheim Investigational Site

title: A Randomized, Open-label Phase II Study of BIBW 2992 Versus Cetuximab (Erbitux) in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of Platinum-containing Therapy With a Cross-over Period for Progressing Patients

type: EudraCT Number

source: euctr

location_country:
United States
Spain
Belgium
France


title: A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out.

summary:
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.

The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).

As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: University of Oxford - Oxford Academic Notes & Queries

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

publisher_dissemination: British Medical Journal

ReferenceCitation: Paterniti MO, Bi Y, Rekic D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Richeldi L, Costabel U, Selman M, Kim DS, Hansell DM, Nicholson AG, Brown KK, Flaherty KR, Noble PW, Raghu G, Brun M, Gupta A, Juhel N, Kluglich M, du Bois RM. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011 Sep 22;365(12):1079-87. doi: 10.1056/NEJMoa1103690.

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Turkey
Chile
Canada
France
Czech Republic
Portugal
Hungary
Belgium
China
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation

location_facility: 1199.30.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.30004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.06004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3305A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.55002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3306A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.27001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3307A Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35106 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.35301 Mater Misericordiae Hospital

location_facility: 1199.30.82004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39007 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.54002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.90002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.90001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44003 Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.3302A Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.49001 Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.86001 Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.30001 Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.3304C Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88603 Tri-service General Hospital

location_facility: 1199.30.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.56001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39011 Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.3301A Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.36001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3303A Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.32002 Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.88606 Boehringer Ingelheim Investigational Site

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location_facility: 1199.30.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.55001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.32004 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.31002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39008 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.34001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.07002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82003 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.82002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.86005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.61005 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.3305B Boehringer Ingelheim Investigational Site

location_facility: 1199.30.30002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.36002 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.88601 National Taiwan University

location_facility: 1199.30.35105 Boehringer Ingelheim Investigational Site

location_facility: 1199.30.34002 Boehringer Ingelheim Investigational Site


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients

summary: The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.

study_start_date_type: Actual

ReferenceCitation: Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Matsue Y, Sama IE, Postmus D, Metra M, Greenberg BH, Cotter G, Davison BA, Felker GM, Filippatos G, Pang P, Ponikowski P, Severin T, Gimpelewicz C, Voors AA, Teerlink JR. Association of Early Blood Pressure Decrease and Renal Function With Prognosis in Acute Heart Failure. JACC Heart Fail. 2021 Dec;9(12):890-903. doi: 10.1016/j.jchf.2021.07.001. Epub 2021 Oct 6.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

ReferenceCitation: Grand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.

ReferenceCitation: Loungani RS, Teerlink JR, Metra M, Allen LA, Butler J, Carson PE, Chen CW, Cotter G, Davison BA, Eapen ZJ, Filippatos GS, Gimpelewicz C, Greenberg B, Holbro T, Januzzi JL Jr, Lanfear DE, Pang PS, Pina IL, Ponikowski P, Miller AB, Voors AA, Felker GM. Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2. JACC Heart Fail. 2020 Dec;8(12):999-1008. doi: 10.1016/j.jchf.2020.09.010. Epub 2020 Nov 11.

ReferenceCitation: Metra M, Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Voors AA, Adams KF, Anker SD, Arias-Mendoza A, Avendano P, Bacal F, Bohm M, Bortman G, Cleland JGF, Cohen-Solal A, Crespo-Leiro MG, Dorobantu M, Echeverria LE, Ferrari R, Goland S, Goncalvesova E, Goudev A, Kober L, Lema-Osores J, Levy PD, McDonald K, Manga P, Merkely B, Mueller C, Pieske B, Silva-Cardoso J, Spinar J, Squire I, Stepinska J, Van Mieghem W, von Lewinski D, Wikstrom G, Yilmaz MB, Hagner N, Holbro T, Hua TA, Sabarwal SV, Severin T, Szecsody P, Gimpelewicz C; RELAX-AHF-2 Committees Investigators. Effects of Serelaxin in Patients with Acute Heart Failure. N Engl J Med. 2019 Aug 22;381(8):716-726. doi: 10.1056/NEJMoa1801291.

oa_colors: green other

evidence: open (via free article)

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repository_institution: University of Leicester - Leicester Research Archive

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

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

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

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Teerlink JR, Voors AA, Ponikowski P, Pang PS, Greenberg BH, Filippatos G, Felker GM, Davison BA, Cotter G, Gimpelewicz C, Boer-Martins L, Wernsing M, Hua TA, Severin T, Metra M. Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX-AHF-2 study. Eur J Heart Fail. 2017 Jun;19(6):800-809. doi: 10.1002/ejhf.830. Epub 2017 Apr 28.

repository_institution: California Digital Library - eScholarship

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Peru
Puerto Rico
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel


lead_sponsor: Novartis Pharmaceuticals

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.

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.

publisher_dissemination: Frontiers

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.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

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

repository_normalized: HAL

version: submittedVersion

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

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

repositories:
HAL
PubMed Central
irua

repositories_concat: HAL;PubMed Central;irua

repositories_pmh: HAL europepmc.org irua

publisher_dissemination: Springer

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.

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

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

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.

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

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

location_facility: Dana Farber Cancer Institute The Melanoma Program

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

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

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

location_facility: University Chicago Hospital Dept. of Univ of Chicago

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

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

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

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


lead_sponsor: Millennium Pharmaceuticals, Inc.

summary: The purpose of this study is to provide continued access to ixazomib and/or lenalidomide to participants who are continuing to have clinical benefit and to continue collecting relevant safety data to monitor safety in participants with Newly Diagnosed Multiple Myeloma (NDMM) who are not eligible for stem cell transplant.

ReferenceCitation: Facon T, Venner CP, Bahlis NJ, Offner F, White DJ, Karlin L, Benboubker L, Rigaudeau S, Rodon P, Voog E, Yoon SS, Suzuki K, Shibayama H, Zhang X, Twumasi-Ankrah P, Yung G, Rifkin RM, Moreau P, Lonial S, Kumar SK, Richardson PG, Rajkumar SV. Oral ixazomib, lenalidomide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2021 Jul 1;137(26):3616-3628. doi: 10.1182/blood.2020008787.

publisher_dissemination: American Society of Hematology

title: A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral MLN9708 Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Newly Diagnosed Multiple Myeloma

type: Registry Identifier

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
New Zealand
Belgium
United States
Korea, Republic of
Canada
Russian Federation
France

ipd_sharing: Yes


type: Other Identifier

title: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum

summary: The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.

ReferenceCitation: Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. doi: 10.1200/JCO.20.01164. Epub 2020 Aug 21.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: American Society of Clinical Oncology (ASCO)

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.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Ireland
Poland
Australia
Czechia
Canada
France
Hungary
Denmark
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Sweden

location_facility: Centre d'Ophtalmologie du LEZ Centre Medical Les Roques

location_facility: Ospedale Santa Maria delle Croci - Oculistica

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Fairview Hospital Moll Pavilion Cancer Center

location_facility: Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica

location_facility: UCLA Hematology - Oncology Clinic - Westlake Village

location_facility: Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia

location_facility: Policlinico Umberto I - Università Sapienza

location_facility: Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly

location_facility: Ospedale Civile degli Infermi - Servizio di Oculistica

location_facility: University of California, Irvine/UC Irvine Health

location_facility: University Medical Center Groningen, Medical Oncology

location_facility: Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -

location_facility: Instituto de Oftalmologia y Hospital La Arruzafa

location_facility: Avd. for gynekologisk kreft, Radiumhospitalet

location_facility: Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze

location_facility: Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

location_facility: Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica

location_facility: Istituto Nazionale Tumori Regina Elena - Oncologia Medica A

location_facility: University of Cincinnati Physicians Company

location_facility: University of California Los Angeles, Hematology-Oncology Clinic

location_facility: Ospedale Umberto I - Unita Operativa di Oncologia

location_facility: Fundacion IVO-Instituto Valenciano de Oncologia

location_facility: UT Southwestern Medical Center-Clements University Hospital

location_facility: Hospital de Sant Joan Despi Moises Broggi

location_facility: Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Radiology at Centro Medico Sanitas Ressalta

location_facility: University of Colorado Denver, University of Colorado Cancer Center

location_facility: Montefiore Medical Center - Einstein Center for Cancer Care

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

location_facility: Hospital Universitario Reina Sofía/ Provincial

location_facility: Ophthalmology at Instituto Oftalmologico Integral

location_facility: Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame

location_facility: Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi

location_facility: Institut de Cancerologie de I'Ouest - Rene Gauducheau

location_facility: Radiology at Hospital Univeristari de Bellvitge

location_facility: Georgia Regents University Cancer Center

location_facility: UCLA Hematology/Oncology Clinic - Santa Monica

location_facility: SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi

location_facility: Montefiore Medical Center, Green Medical Arts Pavilion

location_facility: Universita degli Studi Federico II di Napoli Oncologia Medica

location_facility: Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C

location_facility: Associated Vitreoretinal and Uveitis Consultants

location_facility: Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology

location_facility: Institut Paoli Calmettes - Departement d'Oncologie Medicale

location_facility: Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico

location_facility: Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica

location_facility: Semmelweis Egyetem AOK Szemeszeti Klinika

location_facility: Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica

location_facility: UT Southwestern Medical Center-Zale Lipshy University Hospital

location_facility: St. Vincent Hospital and Health Care Center, Inc.

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Montefiore Medical Center - Centennial Women's Health

location_facility: Clinique et Maternite Sainte-Elisabeth Namur

location_facility: Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology

location_facility: Stephenson Cancer Center(clinic location)

location_facility: Mater Misericordiae Health Services Brisbane Limited

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: NCT Nationales Centrum für Tumorerkrankungen Heidelberg

location_facility: Stefanie Spielman Comprehensive Breast Cancer

location_facility: James Cancer Hospital & Solove Research Institute

location_facility: UCLA Hematology Oncology Clinic Santa Clarita

location_facility: University of Iowa Hospitals and Clinics

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica

location_facility: Ospedale San Raffaele - Unita Operativa di Oculistica

location_facility: Klinik fur Frauenheilkunde und Geburtshilfe

location_facility: Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica

location_facility: Juravinski Cancer Center, Department of Oncology

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Nottingham University Hospitals NHS Trust


title: A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer

summary: Evaluation of the best therapeutic index for patients with platinum-sensitive ovarian cancer when treatment with bevacizumab and gemcitabine/carboplatin or with bevacizumab and PLD/carboplatin.

ReferenceCitation: Pfisterer J, Shannon CM, Baumann K, Rau J, Harter P, Joly F, Sehouli J, Canzler U, Schmalfeldt B, Dean AP, Hein A, Zeimet AG, Hanker LC, Petit T, Marme F, El-Balat A, Glasspool R, de Gregorio N, Mahner S, Meniawy TM, Park-Simon TW, Mouret-Reynier MA, Costan C, Meier W, Reinthaller A, Goh JC, L'Haridon T, Baron Hay S, Kommoss S, du Bois A, Kurtz JE; AGO-OVAR 2.21/ENGOT-ov 18 Investigators. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2020 May;21(5):699-709. doi: 10.1016/S1470-2045(20)30142-X. Epub 2020 Apr 16. Erratum In: Lancet Oncol. 2022 Jun;23(6):e248.

oa_host_type: repository

version: acceptedVersion

repositories_institution: The University of Glasgow - Enlighten: Publications

unpaywall_oa_status: green

lead_sponsor: AGO Research GmbH

collaborators: Arbeitsgemeinschaft Gynaekologische Onkologie Austria

collaborators: Australia New Zealand Gynaecological Oncology Group

collaborators: Scottish Gynaecological Cancer Study Group

location_country:
Germany
United Kingdom
Australia
Austria
Belgium
France

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck

location_facility: SALK-LKH Salzburg, Universitätsklinik für Frauenheilkunde und Geburtshilfe

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: MUG-Universitätsklinik für Frauenheilkunde Graz

location_facility: Hôpital Michallon, Centre Hospitalier Universitaire de Grenoble

location_facility: The Beatson West of Scotland Cancer Center

location_facility: Clinique Mutualiste de l'Estuaire, Cité Sanitaire

location_facility: Hôpital Privé Villeneuve d'Ascq, Institut de Canérologie

location_facility: Schwerpunktpraxis für Onkologie / Hämatologie

location_facility: Groupe Hospitalier Mutualiste de Grenoble

location_facility: Klinikum Schaumburg, Krankenhaus Stadthagen


title: An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

acronym: PIONEER AF-PCI

summary: The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).

ReferenceCitation: Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Novel Oral Anticoagulant Based Versus Vitamin K Antagonist Based Double Therapy Among Stented Patients With Atrial Fibrillation: Insights From the PIONEER AF-PCI Trial. Circ Cardiovasc Interv. 2019 Nov;12(11):e008160. doi: 10.1161/CIRCINTERVENTIONS.119.008160. Epub 2019 Nov 11.

ReferenceCitation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.

ReferenceCitation: Kerneis M, Yee MK, Mehran R, Nafee T, Bode C, Halperin JL, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Fox KAA, Gibson CM. Association of International Normalized Ratio Stability and Bleeding Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019 Feb;12(2):e007124. doi: 10.1161/CIRCINTERVENTIONS.118.007124.

ReferenceCitation: Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: Aalborg Universitet - VBN Forskningsportal

repositories_concat: Pure (Denmark)

ReferenceCitation: Chi G, Yee MK, Kalayci A, Kerneis M, AlKhalfan F, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Total bleeding with rivaroxaban versus warfarin in patients with atrial fibrillation receiving antiplatelet therapy after percutaneous coronary intervention. J Thromb Thrombolysis. 2018 Oct;46(3):346-350. doi: 10.1007/s11239-018-1703-5.

ReferenceCitation: Kerneis M, Gibson CM, Chi G, Mehran R, AlKhalfan F, Talib U, Pahlavani S, Mir M, Bode C, Halperin JL, Nafee T, Peterson ED, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Fox KAA, Cohen M. Effect of Procedure and Coronary Lesion Characteristics on Clinical Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention: Insights From the PIONEER AF-PCI Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):626-634. doi: 10.1016/j.jcin.2017.11.009. Epub 2018 Mar 14.

ReferenceCitation: Gibson CM, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Birmingham M, Ianus J, Burton P, van Eickels M, Korjian S, Daaboul Y, Lip GY, Cohen M, Husted S, Peterson ED, Fox KA. Prevention of Bleeding in Patients with Atrial Fibrillation Undergoing PCI. N Engl J Med. 2016 Dec 22;375(25):2423-2434. doi: 10.1056/NEJMoa1611594. Epub 2016 Nov 14.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Gibson CM, Pinto DS, Chi G, Arbetter D, Yee M, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Burton P, van Eickels M, Korjian S, Daaboul Y, Jain P, Lip GY, Cohen M, Peterson ED, Fox KA. Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy. Circulation. 2017 Jan 24;135(4):323-333. doi: 10.1161/CIRCULATIONAHA.116.025783. Epub 2016 Nov 14. Erratum In: Circulation. 2017 Mar 21;135(12 ):e789.

repository_institution: PubMed Central - Europe PMC

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

ReferenceCitation: Gibson CM, Mehran R, Bode C, Halperin J, Verheugt F, Wildgoose P, van Eickels M, Lip GY, Cohen M, Husted S, Peterson E, Fox K. An open-label, randomized, controlled, multicenter study exploring two treatment strategies of rivaroxaban and a dose-adjusted oral vitamin K antagonist treatment strategy in subjects with atrial fibrillation who undergo percutaneous coronary intervention (PIONEER AF-PCI). Am Heart J. 2015 Apr;169(4):472-8.e5. doi: 10.1016/j.ahj.2014.12.006. Epub 2014 Dec 20.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
France
Denmark
United States
Ukraine
Romania
Belgium
Malaysia
United Kingdom
Netherlands
Mexico
Korea, Republic of
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden


acronym: CLARION

lead_sponsor: Amgen

summary: The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).

ReferenceType: background

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.

ReferenceCitation: Facon T, Lee JH, Moreau P, Niesvizky R, Dimopoulos M, Hajek R, Pour L, Jurczyszyn A, Qiu L, Klippel Z, Zahlten-Kumeli A, Osman M, Paiva B, San-Miguel J. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2019 May 2;133(18):1953-1963. doi: 10.1182/blood-2018-09-874396. Epub 2019 Feb 28.

ReferenceCitation: Rosenthal A, Luthi J, Belohlavek M, Kortum KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6(1):e384. doi: 10.1038/bcj.2015.112.

location_facility: The First Affiliated Hospital of the Fourth Military Medical University of PLA

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation

location_facility: Medical Center of the University of Pecs, 1st Clinic for Internal Medicine

location_facility: Kharkiv Regional Clinical Oncology Center, Department of Hematology

location_facility: Centre Hospitalier Lyon Sud, Service d'hématologie Clinique

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center

location_facility: Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin

location_facility: CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)

location_facility: Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre

location_facility: Isala Clinics in Zwolle, Department of Oncology

location_facility: Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2

location_facility: Fundacion Centro Oncologieo de Integracion Regional - COIR

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis

location_facility: Institute of Blood Pathology and Transfusion Medicine

location_facility: Oxford University Hospitals NHS Trust, Churchill Hospital

location_facility: University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Beijing Chao Yang Hospital, Capital Medical University

location_facility: National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic

location_facility: University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology

location_facility: Iasi Regional Institute for Oncology, Medical Hematology Department

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical-Hospital

location_facility: Royal North Shore Hospital, Haematology Department

location_facility: Fujian Medical University Union Hospital

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: State Higher Educational Institution St. Petersburg Pavlov State Medical University

location_facility: Maggiore della Carita Hospital of Novara

location_facility: Fundeni Clinical Institute, Hematology Department

location_facility: Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice

location_facility: Saint Joseph Clinic Arlon, Department of Hematology

location_facility: Coltea Clinical Hospital, Hematology Department

location_facility: Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department

location_facility: California Cancer Associates for Research & Excellence, Inc. (cCARE)

location_facility: General University Hospital Prague, 1st Department of Medicine - Department of Hematology

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

location_facility: University of Athens, Alexandra Hospital

location_facility: Rambam Medical Center, Department of Hematology

location_facility: Ein Kerem Hospital, Department of Hematology

location_facility: Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina", Varna

location_facility: Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología

location_facility: Brasov County Emergency Clinical Hospital, Hematology Department

location_facility: Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology

location_facility: A. Novak Zakarpattia Regional Clinical Hospital

location_facility: St. Antonius Ziekenhuis, Department of Hematology

location_facility: The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital

location_facility: Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department

location_facility: Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn

location_facility: Singapore Oncology Consultants, Gleneagles Hospital

location_facility: The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian

location_facility: City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders

location_facility: Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care

location_facility: Khmelnytskyi Regional Hospital, Hematology Department

location_facility: Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau

location_facility: Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology

location_facility: Paoli Calmettes Institute, Department ofHematology 2

location_facility: Hopital Saini Louis, Service d'immuno-Hematologie

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant

location_facility: Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine

location_facility: Bucharest Emergency University Hospital, Hematology Department

location_facility: Kyiv Center for Bone Marrow Transplantation

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology

location_facility: Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: University Hospital Brno, Department of Internal Hematology and Oncology

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: CHRU Hopital Huriez, Departement of Hematology

location_facility: Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic

location_facility: University Hospital Kralovske Vinohrady - Internal Hematology Clinic

location_facility: Independent Public Healthcare Facility University Hospital

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology

location_facility: Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic

location_facility: UO Clinica Ematologica, IRCCS A.O.U. San Martino

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital

location_facility: City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders

location_facility: Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology

location_facility: National Hospitalization Organization Kyushu Cancer Center

location_facility: "Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department

location_facility: State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology

location_facility: University College London, Cancer Centre

location_facility: National Center for Global Health and Medicine

location_facility: Group Practice for Hematology and Oncology

location_facility: AO Città della Salute e della Scienza di Torino, Division of Hematology

location_facility: Ludwig Maximilians University Hospital - Medical Clinic III

location_facility: Medical University of Innsbruck, University Clinic for Internal Medicine V

location_facility: Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences

location_facility: Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine

location_facility: Guy's and St. Thomas' NHS Foundation Trust

location_facility: University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology

location_facility: Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology

location_facility: State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia

location_facility: Maria Sklodowska-Curie Institute of Oncology

title: A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

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


title: A Randomized Prospective Trial of Adjuvant Chemotherapy in Patients With Completely Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer Identified as Intermediate or High Risk by a 14-Gene Prognostic Assay

summary: The optimal treatment for Stage I or Stage IIA non-small cell lung cancer (NSCLC) remains controversial. Radiographic surveillance alone has been recommended for stage I and stage IIA patients after the tumor is removed surgically from the lung, and this standard has been based on the fact that no previous clinical trial has demonstrated a benefit for Stage I or Stage IIA NSCLC patients who receive post-operative chemotherapy. These patients, however, have a substantial risk of death within five years after operation, ranging from approximately 30% to 45%, largely due to metastatic disease that is present immediately after surgery but that is undetectable by conventional methods. Some leading organizations therefore currently recommend post-operative chemotherapy as an alternative standard of care in Stage I or Stage IIA NSCLC patients who are considered to be at particularly high-risk. Up until now, however, there has not been a well-validated means to identify stage I and stage IIA NSCLC patients at high risk of death within five years after operation. A new prognostic tool, a 14-Gene Prognostic Assay, which has been validated and definitively demonstrated in large scale studies to identify intermediate and high-risk stage I or Stage IIA patients with non-squamous NSCLC, is now available to all clinicians through a CLIA-certified laboratory. It is therefore now possible to compare the outcomes of patients randomly assigned to one or the other of these competing standards of care.

status: Recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Kratz JR, He J, Van Den Eeden SK, Zhu ZH, Gao W, Pham PT, Mulvihill MS, Ziaei F, Zhang H, Su B, Zhi X, Quesenberry CP, Habel LA, Deng Q, Wang Z, Zhou J, Li H, Huang MC, Yeh CC, Segal MR, Ray MR, Jones KD, Raz DJ, Xu Z, Jahan TM, Berryman D, He B, Mann MJ, Jablons DM. A practical molecular assay to predict survival in resected non-squamous, non-small-cell lung cancer: development and international validation studies. Lancet. 2012 Mar 3;379(9818):823-32. doi: 10.1016/S0140-6736(11)61941-7. Epub 2012 Jan 27.

ReferenceCitation: Woodard GA, Wang SX, Kratz JR, Zoon-Besselink CT, Chiang CY, Gubens MA, Jahan TM, Blakely CM, Jones KD, Mann MJ, Jablons DM. Adjuvant Chemotherapy Guided by Molecular Profiling and Improved Outcomes in Early Stage, Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2018 Jan;19(1):58-64. doi: 10.1016/j.cllc.2017.05.015. Epub 2017 May 31.

ReferenceCitation: Kratz JR, Van den Eeden SK, He J, Jablons DM, Mann MJ. A prognostic assay to identify patients at high risk of mortality despite small, node-negative lung tumors. JAMA. 2012 Oct 24;308(16):1629-31. doi: 10.1001/jama.2012.13551. No abstract available.

lead_sponsor: Razor Genomics

sponsor_collaborators:
Razor Genomics
Encore Clinical

location_country:
United States
Germany
France

location_facility: Lung Clinic Grosshansdorf-Department of Thoracic Oncology

location_facility: Pius-Hospital Oldenburg Medizinischer Campus Universität Oldenburg

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Providence Medical Foundation Santa Rosa

location_facility: Allegheny Health Network Research Institute

location_facility: Groupe Hospitalier Région de Mulhouse Sud -Alsace

location_facility: Centre Hospitalier Universitaire de Nîmes

location_facility: Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH - Universitätsklinik -

status_simplified: Ongoing


title: Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe

summary: This non-interventional retrospective medical record review study will assess the prevalence of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation testing, this study will also assess data from the laboratory that performed the KRAS test. The study will also monitor changes in the pattern of Vectibix treatment between the different rounds of the study.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Han van Krieken J, Kafatos G, Bennett J, Mineur L, Tomasek J, Rouleau E, Fabian P, De Maglio G, Garcia-Alfonso P, Aprile G, Parkar P, Downey G, Demonty G, Trojan J. Panitumumab use in metastatic colorectal cancer and patterns of RAS testing: results from a Europe-wide physician survey and medical records review. BMC Cancer. 2017 Nov 28;17(1):798. doi: 10.1186/s12885-017-3740-4.

location_country: Germany Italy Denmark Sweden Netherlands Belgium Spain Czechia France

intervention_type: Other


acronym: RESORCE

lead_sponsor: Bayer

summary: The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

ReferenceCitation: Finn RS, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Gerolami R, Caparello C, Cabrera R, Chang C, Sun W, LeBerre MA, Baumhauer A, Meinhardt G, Bruix J. Outcomes of sequential treatment with sorafenib followed by regorafenib for HCC: Additional analyses from the phase III RESORCE trial. J Hepatol. 2018 Aug;69(2):353-358. doi: 10.1016/j.jhep.2018.04.010. Epub 2018 Apr 26.

ReferenceCitation: Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Breder V, Gerolami R, Masi G, Ross PJ, Song T, Bronowicki JP, Ollivier-Hourmand I, Kudo M, Cheng AL, Llovet JM, Finn RS, LeBerre MA, Baumhauer A, Meinhardt G, Han G; RESORCE Investigators. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Jan 7;389(10064):56-66. doi: 10.1016/S0140-6736(16)32453-9. Epub 2016 Dec 6. Erratum In: Lancet. 2017 Jan 7;389(10064):36.

repository_institution: King's College London - Research Portal

ReferenceCitation: Teufel M, Seidel H, Kochert K, Meinhardt G, Finn RS, Llovet JM, Bruix J. Biomarkers Associated With Response to Regorafenib in Patients With Hepatocellular Carcinoma. Gastroenterology. 2019 May;156(6):1731-1741. doi: 10.1053/j.gastro.2019.01.261. Epub 2019 Feb 6.

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

title: A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients With Hepatocellular Carcinoma (HCC) After Sorafenib

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Germany
Argentina
Australia
Brazil
Japan
Czechia
France
Hungary
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation

ipd_sharing: Undecided


lead_sponsor: Hoffmann-La Roche

summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.

ReferenceCitation: von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wulfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.

sponsor_collaborators:
Hoffmann-La Roche
NSABP Foundation Inc
German Breast Group

location_facility: Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Aultman Hospital; Aultman Hospital Cancer Center

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Centre Val Aurelle Paul Lamarque; Recherche Clinique

location_facility: Hospital Nacional Guillermo Almenara Irigoyen; Oncology

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Todd Cancer Institute at Long Beach Memorial Medical Center

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: US oncology research at Minnesota Oncology

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Medical University of South Carolina; Hollings Cancer Center

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Centre Hospitalier de l?Université de Montréal (CHUM)

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

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

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

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

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

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

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Mercy Medical Center; Medical Oncology & Hematology

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: Joe Arrington Cancer Research & Treatment Center

location_facility: Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Ohio State University, Arthur James Cancer Hospital

location_facility: Chang Gung Medical Foundation - Linkou; Dept of Surgery

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

location_facility: UPCO - Unidade de Pesquisas Clínicas em Oncologia

location_facility: University of Florida; Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

location_facility: St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

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

location_facility: PeaceHealth St. John Medical Center - Lower Columbia Cancer Center

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

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

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

location_facility: Rocky Mountain Cancer Centers - Colorado Springs (Circle)

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: The Ottawa Hospital; Division of Infectious Diseases

location_facility: Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Hospital Universitario Dr. Peset; Servicio de Oncologia

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: Houston Methodist Hospital Outpatient Center

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Kantonsspital Aarau AG Medizin Onkologie; ZENTRUM FÜR ONKOLOGIE, HÄMATOLOGIE & TRANSFUSIONSMEDIZIN

location_facility: St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Centre de Cancerologie de la Sarthe, Clinique Victor Hugo SoReCOH

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

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

location_facility: Hospital Angeles Metropolitano; Room 220

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Uni of Pittsburgh; Magee-Women'S Hospital

location_facility: Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Taichung Veterans General Hospital; Dept of Surgery

location_facility: Hämatologie Onkologie im Zentrum MVZ GmbH

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: McGill University Health Centre - Glen Site

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

location_facility: Institute for Oncology and Radiology of Serbia; Clinic for Medical Oncology

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie, PD Dr. Bauer, Dr. Thiel

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

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

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

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

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Batte Cancer Center - Carolinas Medical Center

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Med Star Franklin Square Medical Center/Weinburg Cancer Institute

location_facility: Lake Health/University Hospitals - Mentor Campus

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Luisenkrankenhaus GmbH & Co. KG., Brustzentrum

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

status: Active, not recruiting

title: A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

location_country:
Germany
Ireland
Argentina
Brazil
Turkey
Czechia
Canada
Serbia
France
Colombia
Hong Kong
Switzerland
United States
Belgium
China
Peru
Italy
Guatemala
United Kingdom
Sweden
Austria
Mexico
Spain
Greece
Panama
South Africa
Taiwan
Israel

collaborators:
NSABP Foundation Inc
German Breast Group