title: Randomized, Double-blind, Evaluation in Secondary Stroke Prevention Comparing the EfficaCy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate (110 mg or 150 mg, Oral b.i.d.) Versus Acetylsalicylic Acid (100 mg Oral q.d.) in Patients With Embolic Stroke of Undetermined Source (RESPECT ESUS)

summary: This trial will enroll approximately 6,000 patients with recent embolic stroke of unknown source (ESUS). Patients will be randomized to dabigatran or acetylsalicyclic acid (ASA) (1:1 ratio) and have visits every three months. The study doctor may prescribe blinded concomitant ASA for pts with coronary artery disease but this is not mandatory. All Adverse Events (AEs), Serious Adverse Events (SAEs), outcome events will be recorded. The trial will conclude when the required number of stroke events are positively adjudicated which is estimated to take 3 years (including 2.5 years of enrollment).

ReferenceCitation: Bahit MC, Sacco RL, Easton JD, Meyerhoff J, Cronin L, Kleine E, Grauer C, Brueckmann M, Diener HC, Lopes RD, Brainin M, Lyrer P, Wachter R, Segura T, Granger CB; RE-SPECT ESUS Steering Committee and Investigators. Predictors of Atrial Fibrillation Development in Patients With Embolic Stroke of Undetermined Source: An Analysis of the RE-SPECT ESUS Trial. Circulation. 2021 Nov 30;144(22):1738-1746. doi: 10.1161/CIRCULATIONAHA.121.055176. Epub 2021 Oct 15.

name: INECO Neurociencias, Cardiology Department, Rosario, Argentina

family: Bahit

full_name: Maria Cecilia Bahit

given: Maria Cecilia

name: University of Miami, Miller School of Medicine, Miami, FL

family: Sacco

full_name: Ralph L. Sacco

given: Ralph L.

name: University of California–San Francisco, San Francisco, CA

family: Easton

full_name: J. Donald Easton

given: J. Donald

name: TA CardioMetabolism Respiratory Med, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany

family: Meyerhoff

full_name: Juliane Meyerhoff

given: Juliane

name: Clinical Development Cardiometabolism, Boehringer Ingelheim Ltd/Ltée, Burlington, ON, Canada

family: Cronin

full_name: Lisa Cronin

given: Lisa

name: Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH  & Co. KG, Ingelheim am Rhein, Germany

family: Kleine

full_name: Eva Kleine

given: Eva

name: Clinical Research, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

family: Grauer

full_name: Claudia Grauer

given: Claudia

name: Clinical Development Cardiometabolism, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany

family: Brueckmann

full_name: Martina Brueckmann

given: Martina

name: Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University Duisburg-Essen, Essen, Germany

family: Diener

full_name: Hans-Christoph Diener

given: Hans-Christoph

name: Duke Clinical Research Institute, Durham, NC

family: Lopes

full_name: Renato D. Lopes

given: Renato D.

name: Danube University Krems, Krems an der Donau, Austria

family: Brainin

full_name: Michael Brainin

given: Michael

name: University Hospital Basel, Basel, Switzerland

family: Lyrer

full_name: Philippe Lyrer

given: Philippe

name: Clinic and Policlinic for Cardiology, University Hospital Leipzig, Germany Clinic for Cardiology and Pneumology, University Medicine Göttingen, Germany DZHK (German Center for Cardiovascular Research), partner site Göttingen, Germany

family: Wachter

full_name: Rolf Wachter

given: Rolf

name: Department of Neurology, Hospital General Universitario de Albacete, Universidad de Castilla-La Mancha, Albacete, Spain

family: Segura

full_name: Tomas Segura

given: Tomas

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

journal_name: Circulation

title: Predictors of Development of Atrial Fibrillation in Patients With Embolic Stroke Of Undetermined Source: An Analysis of the RE-SPECT ESUS Trial

ReferenceCitation: Uchiyama S, Toyoda K, Lee BC, Liou CW, Wong LKS, Grauer C, Brueckmann M, Taniguchi A, Urano Y, Easton JD; RE-SPECT ESUS Investigators. Dabigatran or Aspirin in East Asian Patients With Embolic Stroke of Undetermined Source: RE-SPECT ESUS Subgroup Analysis. Stroke. 2021 Mar;52(3):1069-1073. doi: 10.1161/STROKEAHA.120.031891. Epub 2021 Feb 16.

name: Clinical Research Centre for Medicine, International University of Health and Welfare, Tokyo, Japan (S.U.).

family: Uchiyama

full_name: Shinichiro Uchiyama

given: Shinichiro

name: Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan (K.T.).

family: Toyoda

full_name: Kazunori Toyoda

given: Kazunori

name: Department of Neurology, Hallym Neurological Institute, Hallym University College of Medicine, Seoul, South Korea (B.-C.L.).

family: Lee

full_name: Byung-Chul Lee

given: Byung-Chul

name: Department of Neurology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taiwan (C.-W.L.).

family: Liou

full_name: Chia-Wei Liou

given: Chia-Wei

name: Division of Neurology, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin (L.K.S.W.).

family: Wong

name: Clinical Operations Global, Boehringer Ingelheim Pharma GmbH K.G., Biberach, Germany (C.G.).

name: Department of Cardiometabolic Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany (M.B.).

name: Biostatistics and Data Sciences (A.T.), Nippon Boehringer Ingelheim Co, Ltd, Tokyo, Japan.

name: Primary Care Medicine (Y.U.), Nippon Boehringer Ingelheim Co, Ltd, Tokyo, Japan.

name: Department of Neurology, University of California, San Francisco (J.D.E.).

name: on behalf of the RE-SPECT ESUS Investigators

ReferenceCitation: Diener HC, Chutinet A, Easton JD, Granger CB, Kleine E, Marquardt L, Meyerhoff J, Zini A, Sacco RL. Dabigatran or Aspirin After Embolic Stroke of Undetermined Source in Patients With Patent Foramen Ovale: Results From RE-SPECT ESUS. Stroke. 2021 Mar;52(3):1065-1068. doi: 10.1161/STROKEAHA.120.031237. Epub 2021 Jan 28.

name: Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Germany (H-C.D.).

name: Department of Medicine, Faculty of Medicine, Chulalongkorn Stroke Center, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Thai Red Cross Society, Bangkok, Thailand (A.C.).

name: Duke Clinical Research Institute, Duke University, Durham, NC (C.B.G.).

name: Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany (E.K.).

name: University Department of Neurology, Asklepios Hospital Hamburg Wandsbek, Germany (L.M.).

name: Faculty of Medicine, Semmelweis University Campus Hamburg, Germany (L.M.).

name: Cardiology Medicine, Boehringer Ingelheim International GmbH, Germany (J.M.).

name: IRCCS Istituto delle Scienze Neurologiche di Bologna, Department of Neurology and Stroke Center, Maggiore Hospital, Italy (A.Z.).

name: Department of Neurology, Miller School of Medicine, University of Miami, FL (R.L.S.).

ReferenceCitation: Diener HC, Sacco RL, Easton JD, Granger CB, Bar M, Bernstein RA, Brainin M, Brueckmann M, Cronin L, Donnan G, Gdovinová Z, Grauer C, Kleine E, Kleinig TJ, Lyrer P, Martins S, Meyerhoff J, Milling T, Pfeilschifter W, Poli S, Reif M, Rose DZ, Šaňák D, Schäbitz WR. Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups. Stroke. 2020 Jun;51(6):1758-1765. doi: 10.1161/STROKEAHA.119.028643. Epub 2020 May 14.

name: From the Faculty of Medicine, Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Germany (H.-C.D.)

name: Clinical and Translational Science, Miller School of Medicine, University of Miami, FL (R.L.S.)

name: Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (C.B.G.)

name: Department of Neurology, University Hospital Ostrava, Ostrava-Poruba-Poruba, Czech Republic (M. Bar)

name: Department of Neurology, Northwestern University, Chicago, IL (R.A.B.)

name: Department of Neurosciences and Preventive Medicine, Danube University Krems, Krems an der Donau, Austria (M. Brainin)

name: Metabolism Medicine, Boehringer Ingelheim International GmbH, Germany (M. Brueckmann)

name: Faculty of Medicine Mannheim of the University of Heidelberg, Germany (M. Brueckmann)

name: Cardiometabolic Medicine, Boehringer Ingelheim Ltd, Burlington, ON, Canada (L.C.)

name: Department of Neurology, Melbourne Brain Centre, University of Melbourne, Parkville, VIC, Australia (G.D.)

name: Department of Neurology, Pavol Jozef Šafárik University in Košice, University Hospital L. Pasteur, Košice, Slovak Republic (Z.G.)

name: Clinical Operations Global, Boehringer Ingelheim Pharma GmbH & Co. K.G., Biberach, Germany (C.G.)

name: Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany (E.K.)

name: Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia (T.J.K.)

name: Division of Neurology, Stroke Center, University Hospital Basel, Switzerland (P.L.)

name: Neurology Service, Hospital de Clínicas de Porto Alegre, Brazil (S.M.)

name: Department of Neurology, Department of Surgery and Perioperative Care, Seton Dell Medical School Stroke Institute, Austin, TX (T.M.)

name: Center of Neurology and Neurosurgery, Goethe University Frankfurt, Frankfurt am Main, Germany (W.P.)

name: Department of Neurology with Focus on Neurovascular Diseases and Neurooncology, University of Tübingen, and Hertie Institute for Clinical Brain Research, Germany (S.P.)

name: Department of Neurology, Cerebrovaskulární ambulance s.r.o., Brno, Czech Republic (M.R.)

name: Department of Neurology, Morsani College of Medicine, University of South Florida, Tampa (D.Z.R.)

name: Comprehensive Stroke Center, Department of Neurology, Palacky University, Olomouc, Czech Republic (D.S.)

name: Department of Neurology, Evangelisches Klinikum Bethel, Bielefeld, Germany (W.-R.S.).

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

title: Antithrombotic Treatment of Embolic Stroke of Undetermined Source

ReferenceCitation: Diener HC, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmünzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K; RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906-1917. doi: 10.1056/NEJMoa1813959.

name: From the University Duisburg-Essen and University Hospital Essen, Essen (H.-C.D.), Boehringer Ingelheim Pharma GmbH K.G., Biberach (C.G.), Boehringer Ingelheim International GmbH, Ingelheim, Faculty of Medicine Mannheim of the University of Heidelberg, Mannheim (M.B.), Kreisklinikum Siegen, Siegen, and the University of Marburg, Marburg (M.G.), University Hospital Erlangen, Erlangen (B.K.), and Johannes Wesling Klinikum Minden and Ruhr University Bochum, Minden (P.D.S.) — all in Germany; Miller School of...

location_country:
Peru
Malaysia
Greece
Australia
Belgium
Russian Federation
Taiwan
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Japan
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Thailand
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Israel
New Zealand
Spain
Estonia

location_facility: Vero Beach Neurology and Research Institute

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: Kortrijk - HOSP AZ Groeninge Kennedylaan

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

location_facility: Univ. Hospital Bern, Neurology Dept, Stroke Center

location_facility: Military Institute of Medicine Neurology Clinic, Warsaw

location_facility: The Second Affiliated Hospital to Nanchang University

location_facility: The Duluth Clinic dba Essentia Health Duluth Clinic

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Noroloji A.B.D.

location_facility: Cardial d.o.o., Specialist out-patient unit, Ljubljana

location_facility: Gesundheit Nord gGmbH | Klinikverbund Bremen

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Helios Dr. Horst Schmidt Kliniken Wiesbaden

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Reserch Institute for Brain and Blood Vessels Akita

location_facility: National Instit.of Neurosciences,Neurology Dept,Budapest

location_facility: RKU - Universitäts- und Rehabilitationskliniken Ulm gGmbH

location_facility: 2nd Affiliated Hosp Zhejiang University College of Medical

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

location_facility: Specialist Holy Spirit Hospital, Neurology Dept,Sandomierz

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: CRU Hungary Ltd, Private Practice, Miskolc

location_facility: Affiliated Hospital, Xuzhou Medical college

location_facility: Kobe City Medical Center General Hospital

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Southern Illinois University School of Medicine

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: UHS Wilson Medical Center,Office of Clin Trials

location_facility: Post Graduate Institute of Medical Education and Research

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Clin.Hosp.Centre Zagreb,Cerebrovascul.disease w/ intens.care

location_facility: Ruan Neurology Clinic and Research Center

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: The First Affiliated Hospital of Jinan University

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: General Hospital of Shenyang Military Region

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: The Affiliated Hospital of Guizhou Medical University

location_facility: Cerebrovascular site, private prac., Brno

location_facility: Univ.Clin.Centr Gibinski of Silesian Med,Neurol.dep,Katowice

location_facility: Spec.Hosp.of Dr. Wladyslaw Bieganski in Grudziadz

location_facility: Special Hosp.for Cerebrovascul.Disease,'Sveti Sava,Belgrade

location_facility: Reg.State Instit.of Healthc.Smolensk Reg.Clin.Hosp,Neurology

location_facility: CHUV - Centre hospitalier universitaire vaudois

location_facility: Zhytomyr Reg.ClinHosp na Gerbachevskiy RegCouncil,Neurol.Dep

location_facility: CityClin.Hosp na I.V.Davydovsky of Dept of Healthcare Moscow

location_facility: Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

location_facility: Reg.Clin.Hosp#1 na S.V.Ochapovskiy,Neurology#1 Dep,Krasnodar

location_facility: Ternopil State Med.Univ.na Gorbachevskiy,Neurology Dept N3

location_facility: Quincy Physicians and Surgeons Clinic, S.C.

location_facility: Veterans Affairs Portland Health Care System

location_facility: Clin.Research Center,Leszek Szczepanski,Private Prac.,Lublin

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Hosp.Hietzing with Neuro.Centr Rosenhuegel,II Neuro.dep,Wien

location_facility: First Affiliated Hospital of Xiamen University

location_facility: Sacred Heart Medical Center at RiverBend

location_facility: Bruce W. Carter, Miami VA Healthcare System

location_facility: Bakirkoy Prof. Dr. Mazhar Osman Ruh Sagligi ve Sinir Hastaliklari

location_facility: Research Inst. of Emerg. Med., Vascul. Center,St. Petersburg

location_facility: The Affiliated Hospital of Hangzhou Normal University

location_facility: KH d. Barmherzigen Brüder Linz, Neurologie

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: Nuovo Ospedale Civile S. Agostino-Estense

location_facility: Università degli Studi Campus Bio-Medico

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Universitätsklinikum Tulln, Abteilung für Neurologie

location_facility: The Ohio State University Wexner Medical Center

location_facility: Instit.f.applicative Research in med.rehab.Dobrna

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E. - Hospital de São Sebastião

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Hospital General Universitario de Albacete

location_facility: Clinica Neurologica e Neurocirurgica de Joinvile

location_facility: Instit.of Neurol,Psychiatry&Narcol,Vascul. Malformations Dep

location_facility: Azienda Ospedaliero Universitaria di Ferrara

location_facility: Saitama Medical University International Medical Center

location_facility: Zhejiang University School of Medicine SIR RUN RUN SHAW Hospital

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

location_facility: Bukovinian Med.Univ.Chernivtsi Reg.Psychiatric Hosp,Neurolog

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: National Hospital Organization Toyohashi Medical Center

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: St. Mary's Hospital and Regional Medical Center

location_facility: Beijing Tiantan Hospital affiliated to Cap Med University

location_facility: Seoul National University Bundang Hospital

location_facility: Interreg. Clinical & Diagnostic Center, Neurol. Dept., Kazan

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

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Hospital General de Culiacán "Dr. Bernardo J. Gastellum"

location_facility: Hospital de Braga - Centro Clínico Académico (2CA)

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH

location_facility: Bakırkoy Dr. Sadi Konuk Egitim Ve Arastirma Hastanesi

location_facility: Eskisehir Osmangazi Universitesi Tip Fakultesi

location_facility: New York Presbyterian Hudson Valley Hospital

location_facility: Medical corporation Suiseikai Suiseikai Kajikawa Hospital

location_facility: City Clin.Emergency Hosp of Kursk, Neurology Department No.2

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Military Medical Academy n.a. C. M. Kirov, St. Petersburg

location_facility: Ltd liabilityCom.CityNeurologic Cntr Sibneiromed,Novosibirsk

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Tokyo Women's Medical University Hospital

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: The affiliated hospital of medicalcollege qingdao university

location_facility: Osp. Guglielmo da Saliceto AUSL di Piacenza

location_facility: Abbott Northwestern Hospital, Radiology Department

location_facility: Centennial Heart Cardiovascular Consultants, LLC

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: City Clin.Hosp#1na N.I.Pirogov,Dept of Healthcare of Moscow

location_facility: Instit.of Gerontology na D.F.Chebotarev,Brain Vascular Path.

location_facility: University Hosp. Zürich, Dept. of Neurology, Stroke Center

location_facility: Univ. Debrecen Medical Health Science Center, Neurology Dept

location_facility: Saratov State Med.Univ na V.I.Razumovsky,FacultyTherapy Clin

location_facility: Center of Clinical Neurology, private prac, Krakow

location_facility: Instituto Nacional de Ciencias Neurológicas

location_facility: Shree Krishna Hospital and Research Centre

location_facility: First Affiliated Hospital of Guangzhou University of TCM

location_facility: Kaiser Permanente Los Angeles Medical Center

location_facility: First Affiliated Hospital of Guangzhou Medical University

location_facility: Regional Hospital Lugano,Neurocenter of Southern Switzerland

location_facility: Sociedad de Cirugia de Bogota Hospital de San José

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Saint Alphonsus Medical Center-Neurology

location_facility: Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO

location_facility: Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb

location_facility: Research&Clini Cent Neuropsychiatry Dep. Healthcare,Moscow

location_facility: Ospedale Policlinico G.B. Rossi (Borgo Roma) di Verona

location_facility: Krankenhaus der Barmherzigen Brüder Trier

location_facility: Canton Hospital Aarau, Neurology Dept., Stroke Center

location_facility: West Tallinn Central Hospital, Neurology Dept.

location_facility: Public Central Clinical Hosp,Neurology Clinic,Warsaw

location_facility: East Estonia Central Hospital, Neurology Dept, Ahtme

location_facility: Hacettepe Universitesi Tip Fakultesi Noroloji A.B.D.

location_facility: Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese

location_facility: Westside Medical Associates of Los Angeles

location_facility: North Estonia Medical Centre Foundation, Tallin

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Mangala Hospital and Mangala Kidney Foundation

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Noroloji A.B.D.


type: EudraCT Number

title: A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma

summary: E7080-G000-304 is a multicenter, randomized, open-label, noninferiority Phase 3 study to compare the efficacy and safety of lenvatinib versus sorafenib as a first-line systemic treatment in participants with unresectable Hepatocellular Carcinoma (HCC).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Vogel A, Qin S, Kudo M, Su Y, Hudgens S, Yamashita T, Yoon JH, Fartoux L, Simon K, López C, Sung M, Mody K, Ohtsuka T, Tamai T, Bennett L, Meier G, Breder V. Lenvatinib versus sorafenib for first-line treatment of unresectable hepatocellular carcinoma: patient-reported outcomes from a randomised, open-label, non-inferiority, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Aug;6(8):649-658. doi: 10.1016/S2468-1253(21)00110-2. Epub 2021 Jun 2.

family: Vogel

full_name: Arndt Vogel

given: Arndt

sequence: first

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full_name: Shukui Qin

given: Shukui

sequence: additional

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Su

full_name: Yun Su

given: Yun

family: Hudgens

full_name: Stacie Hudgens

given: Stacie

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full_name: Tatsuya Yamashita

given: Tatsuya

family: Yoon

full_name: Jung-Hwan Yoon

given: Jung-Hwan

family: Fartoux

full_name: Laetitia Fartoux

given: Laetitia

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full_name: Krzysztof Simon

given: Krzysztof

family: López

full_name: Carlos López

given: Carlos

family: Sung

full_name: Max Sung

given: Max

family: Mody

full_name: Kalgi Mody

given: Kalgi

family: Ohtsuka

full_name: Tatsuroh Ohtsuka

given: Tatsuroh

family: Tamai

full_name: Toshiyuki Tamai

given: Toshiyuki

family: Bennett

full_name: Lee Bennett

given: Lee

family: Meier

full_name: Genevieve Meier

given: Genevieve

family: Breder

full_name: Valery Breder

given: Valery

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Gastroenterology & Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Okusaka T, Ikeda K, Kudo M, Finn R, Qin S, Han KH, Cheng AL, Piscaglia F, Kobayashi M, Sung M, Chen M, Wyrwicz L, Yoon JH, Ren Z, Mody K, Dutcus C, Tamai T, Ren M, Hayato S, Kumada H. Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT. J Gastroenterol. 2021 Jun;56(6):570-580. doi: 10.1007/s00535-021-01785-0. Epub 2021 May 4.

family: Okusaka

full_name: Takuji Okusaka

given: Takuji

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full_name: Kenji Ikeda

given: Kenji

family: Finn

full_name: Richard Finn

ReferenceCitation: Briggs A, Daniele B, Dick K, Evans TRJ, Galle PR, Hubner RA, Lopez C, Siebert U, Tremblay G. Covariate-adjusted analysis of the Phase 3 REFLECT study of lenvatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma. Br J Cancer. 2020 Jun;122(12):1754-1759. doi: 10.1038/s41416-020-0817-7. Epub 2020 Apr 8.

repository_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Yamashita T, Kudo M, Ikeda K, Izumi N, Tateishi R, Ikeda M, Aikata H, Kawaguchi Y, Wada Y, Numata K, Inaba Y, Kuromatsu R, Kobayashi M, Okusaka T, Tamai T, Kitamura C, Saito K, Haruna K, Okita K, Kumada H. REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset. J Gastroenterol. 2020 Jan;55(1):113-122. doi: 10.1007/s00535-019-01642-1. Epub 2019 Nov 12.

title: REFLECT—a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset

ReferenceCitation: Evans TRJ, Kudo M, Finn RS, Han KH, Cheng AL, Ikeda M, Kraljevic S, Ren M, Dutcus CE, Piscaglia F, Sung MW. Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma. Br J Cancer. 2019 Jul;121(3):218-221. doi: 10.1038/s41416-019-0506-6. Epub 2019 Jun 28. Erratum in: Br J Cancer. 2019 Jul 30;:.

ReferenceCitation: Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, Baron A, Park JW, Han G, Jassem J, Blanc JF, Vogel A, Komov D, Evans TRJ, Lopez C, Dutcus C, Guo M, Saito K, Kraljevic S, Tamai T, Ren M, Cheng AL. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173. doi: 10.1016/S0140-6736(18)30207-1.

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

location_country:
Malaysia
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Hong Kong
Philippines
Singapore
China
United States
Germany
United Kingdom
Italy
Israel
Spain

location_facility:
Facility # 8
Facility # 6
Facility # 4
Facility # 7
Facility # 5
Facility # 1
Facility # 3
Facility # 2


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission

acronym: QUAZAR AML-001

summary:
This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy.

The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: background

ReferenceCitation: Roboz GJ, Montesinos P, Selleslag D, Wei A, Jang JH, Falantes J, Voso MT, Sayar H, Porkka K, Marlton P, Almeida A, Mohan S, Ravandi F, Garcia-Manero G, Skikne B, Kantarjian H. Design of the randomized, Phase III, QUAZAR AML Maintenance trial of CC-486 (oral azacitidine) maintenance therapy in acute myeloid leukemia. Future Oncol. 2016 Feb;12(3):293-302. doi: 10.2217/fon.15.326. Epub 2016 Jan 19.

ReferenceCitation: Ravandi F, Roboz GJ, Wei AH, Döhner H, Pocock C, Selleslag D, Montesinos P, Sayar H, Musso M, Figuera-Alvarez A, Safah H, Tse W, Sohn SK, Hiwase D, Chevassut T, Pierdomenico F, La Torre I, Skikne B, Bailey R, Zhong J, Beach CL, Dombret H. Management of adverse events in patients with acute myeloid leukemia in remission receiving oral azacitidine: experience from the phase 3 randomized QUAZAR AML-001 trial. J Hematol Oncol. 2021 Aug 28;14(1):133. doi: 10.1186/s13045-021-01142-x.

family: Ravandi

full_name: Farhad Ravandi

given: Farhad

family: Roboz

full_name: Gail J. Roboz

given: Gail J.

family: Wei

full_name: Andrew H. Wei

given: Andrew H.

family: Döhner

full_name: Hartmut Döhner

given: Hartmut

family: Pocock

full_name: Christopher Pocock

given: Christopher

family: Selleslag

full_name: Dominik Selleslag

given: Dominik

family: Montesinos

full_name: Pau Montesinos

given: Pau

family: Sayar

full_name: Hamid Sayar

given: Hamid

family: Musso

full_name: Maurizio Musso

given: Maurizio

family: Figuera-Alvarez

full_name: Angela Figuera-Alvarez

given: Angela

family: Safah

full_name: Hana Safah

given: Hana

family: Tse

full_name: William Tse

given: William

family: Sohn

full_name: Sang Kyun Sohn

given: Sang Kyun

family: Hiwase

full_name: Devendra Hiwase

given: Devendra

family: Chevassut

full_name: Timothy Chevassut

given: Timothy

family: Pierdomenico

full_name: Francesca Pierdomenico

given: Francesca

family: La Torre

full_name: Ignazia La Torre

given: Ignazia

family: Skikne

full_name: Barry Skikne

given: Barry

family: Bailey

full_name: Rochelle Bailey

given: Rochelle

family: Zhong

full_name: Jianhua Zhong

given: Jianhua

family: Beach

full_name: C. L. Beach

given: C. L.

family: Dombret

full_name: Herve Dombret

given: Herve

repository_institution: University of Sussex - Sussex Research Online

ReferenceCitation: Wei AH, Döhner H, Pocock C, Montesinos P, Afanasyev B, Dombret H, Ravandi F, Sayar H, Jang JH, Porkka K, Selleslag D, Sandhu I, Turgut M, Giai V, Ofran Y, Kizil Çakar M, Botelho de Sousa A, Rybka J, Frairia C, Borin L, Beltrami G, Čermák J, Ossenkoppele GJ, La Torre I, Skikne B, Kumar K, Dong Q, Beach CL, Roboz GJ; QUAZAR AML-001 Trial Investigators. Oral Azacitidine Maintenance Therapy for Acute Myeloid Leukemia in First Remission. N Engl J Med. 2020 Dec 24;383(26):2526-2537. doi: 10.1056/NEJMoa2004444.

name: From the Department of Clinical Haematology, Alfred Hospital, and the Australian Centre for Blood Diseases, Monash University, Melbourne, VIC, Australia (A.H.W.); the Department of Internal Medicine III, Ulm University Hospital, Ulm, Germany (H. Döhner); Kent and Canterbury Hospital, Canterbury, United Kingdom (C.P.); Centro de Investigación Biomédica en Red de Cáncer, Instituto Carlos III, Madrid, and Hospital Universitari i Politècnic La Fe, Valencia — both in Spain (P.M.); Raisa Gorbacheva Memorial...

location_country:
Finland
Australia
Belgium
Russian Federation
Taiwan
France
Poland
Lithuania
Canada
Korea, Republic of
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: University of Florida Health Cancer Center at Orlando Health

location_facility: Centro Hospital e Universitario de Coimbra

location_facility: Cancer Care Centers of South Texas - Loop

location_facility: Ondokuz Mayis University Medical Faculty

location_facility: Centre Hospitalier de Versailles Hopital Andre Mignot

location_facility: University of California San Francisco Fresno Campus

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin

location_facility: Center Hospitalier Universitaire Ambroise Pare

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: George Washington University Cancer Center

location_facility: Norton Cancer Institute Louisville Oncology

location_facility: McGill University, Dept. Oncology Clinical Research Program

location_facility: Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I

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

location_facility: Hospital Angeles Lomas - Consultorio 830

location_facility: Severance Hospital, Yonsei University Health System

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: Hospital Albert Einstein Sociedade Beneficente Israelita Brasileira

location_facility: Providence St Joseph Medical Center Cancer Center

location_facility: Casa di Cura La Maddalena, Divisione di Ematologia

location_facility: Regional Health Authority B-Saint John Regional Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Staedtisches Klinikum Muenchen Schwabing

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

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Azienda ospedeliera della 2 Universita di Napoli

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Froedtert Hospital BMT Medical College of Wisconsin

location_facility: SLK Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen

location_facility: Az. Osp. SS.Antonio e Biagio - SC Ematologia

location_facility: VA Commonwealth University Massey Cancer Center

location_facility: Northwestern University Medical Center Division of Hematology Oncology

location_facility: University of Southern California Norris Cancer Center

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord AORMN

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Washington University School of Medicine

location_facility: University Hospitals Case Medical Center

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Wilhelm-Anton-Hospital Goch gGmbH Hämatologie und Internistische Onkologie

location_facility: University HospitaClinik of internal medicin

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: Centre hospitalier de Boulognes - Duchenne

location_facility: Kaiser Permanente Northwest Oncology Hematology

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Kansas City VA Medical Center University of Kansas Medical Center

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

location_facility: Nizhniy Novgorod State Medical Academy of Roszdrav

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

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

location_facility: Cancer Care and Hematology Specialists of Chicagoland, P.C. - Niles, IL

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Staedtische Kliniken Frankfurt am Main Hochst

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji hospital

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: Queen's Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Instituto Portugues de Oncologia de Lisboa

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

location_facility: Flinders Medical Centre, Dept Of Oncology

location_facility: Saint Petersburg Medical State Institution Municipal n.a. I.P. Pavlov

location_facility: Institute of Internal Diseases University of Medicine

location_facility: IRCCS AziendaOspedaliera Universitaria San Martino

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

location_facility: University of Texas Southwestern Medical Center

location_facility: Fondazione Ca Granda IRCCS Ospedale Maggiore


title: Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

summary:
The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.

The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Gómez SM, Varela MA, Ruiz C, Sung L. Comparable Outcomes of Matched Sibling Donor and Matched Unrelated Donor Stem Cell Transplantation in Children With Acute Leukemia in Argentina. J Pediatr Hematol Oncol. 2021 Oct 1;43(7):e1020-e1024. doi: 10.1097/MPH.0000000000002174.

family: Gómez

full_name: Sergio M. Gómez

given: Sergio M.

family: Varela

full_name: Marcela A. Varela

given: Marcela A.

family: Ruiz

full_name: Claudia Ruiz

given: Claudia

family: Sung

full_name: Lillian Sung

given: Lillian

journal_name: Journal of Pediatric Hematology/Oncology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Peters C, Dalle JH, Locatelli F, Poetschger U, Sedlacek P, Buechner J, Shaw PJ, Staciuk R, Ifversen M, Pichler H, Vettenranta K, Svec P, Aleinikova O, Stein J, Güngör T, Toporski J, Truong TH, Diaz-de-Heredia C, Bierings M, Ariffin H, Essa M, Burkhardt B, Schultz K, Meisel R, Lankester A, Ansari M, Schrappe M; IBFM Study Group;, von Stackelberg A; IntReALL Study Group, Balduzzi A; I-BFM SCT Study Group, Corbacioglu S; EBMT Paediatric Diseases Working Party, Bader P. Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study. J Clin Oncol. 2021 Feb 1;39(4):295-307. doi: 10.1200/JCO.20.02529. Epub 2020 Dec 17.

name: St. Anna Children's Hospital, Children's Cancer Research Institute, University Vienna, Vienna, Austria

family: Peters

full_name: Christina Peters

given: Christina

name: Hôpital Robert Debré, GH APHP-Nord Université de Paris, Paris, France

family: Dalle

full_name: Jean-Hugues Dalle

given: Jean-Hugues

name: Department of Pediatric Hematology and Oncology, IRCCS Ospedale Pediatrico Bambino Gesù, Sapienza University of Rome, Rome, Italy

family: Locatelli

full_name: Franco Locatelli

given: Franco

name: Children's Cancer Research Institute, Vienna, Austria

family: Poetschger

full_name: Ulrike Poetschger

given: Ulrike

name: Department of Pediatric Hematology and Oncology, Motol University Hospital, Prague, Czech Republic

family: Sedlacek

full_name: Petr Sedlacek

given: Petr

name: Department of Pediatric Hematology and Oncology, Oslo University Hospital, Oslo, Norway

family: Buechner

full_name: Jochen Buechner

given: Jochen

name: The Children`s Hospital at Westmead, Sydney, Australia

family: Shaw

full_name: Peter J. Shaw

given: Peter J.

name: Hospital de Pediatría, Buenos Aires, Argentina

family: Staciuk

full_name: Raquel Staciuk

given: Raquel

name: Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark

family: Ifversen

full_name: Marianne Ifversen

given: Marianne

family: Pichler

full_name: Herbert Pichler

given: Herbert

name: Children's Hospital, University of Helsinki, Helsinki, Finland

family: Vettenranta

full_name: Kim Vettenranta

given: Kim

name: National Institute of Children's Diseases, Bratislava, Slovakia

family: Svec

full_name: Peter Svec

given: Peter

name: Belarusian Research Center for Pediatric Oncology, Hematology and Immunology, Borovlyani, Belarus

family: Aleinikova

full_name: Olga Aleinikova

given: Olga

name: Schneider Children's Medical Center of Israel, Sackler Faculty of Medicine, Tel Aviv University, Petach-Tikva, Israel

family: Stein

full_name: Jerry Stein

given: Jerry

family: Güngör

full_name: Tayfun Güngör

given: Tayfun

family: Toporski

full_name: Jacek Toporski

given: Jacek

name: Alberta Children's Hospital Calgary, Calgary, Alberta, Canada

family: Truong

full_name: Tony H. Truong

given: Tony H.

name: Hospital Universitari Vall d’Hebron, Barcelona, Spain

family: Diaz-de-Heredia

name: Princess Máxima Center for Pediatric Oncology, Bilthoven, the Netherlands

name: University of Malaya, Kuala Lumpur, Malaysia

name: King Abdullah Specialist Children's Hospital, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia

name: Children's University Hospital Münster, Münster, Germany

name: University of British Columbia, Vancouver, British Columbia, Canada

name: Division of Pediatric Stem Cell Therapy, Department of Pediatric Oncology, Hematology and Clinical Immunology, Medical Faculty, Heinrich-Heine-University, Duesseldorf, Germany

name: Willem-Alexander Children's Hospital, Leiden, the Netherlands

name: Geneva University Hospital, Geneva, Switzerland

name: Universitätsklinikum Schleswig-Holstein, Kiel, Germany

name: Charité University Hospital Berlin, Berlin, Germany

name: Università degli Studi di Milano—Fondazione MBBM, Monza, Italy

name: Universitätsklinikum Regensburg, Regensburg, Germany

name: Goethe University, University Hospital Frankfurt, Department for Children and Adolescents, Division for Stem Cell Transplantation, Immunology and Intensive Care Medicine, Frankfurt am Main, Germany

name: on behalf of the EBMT Paediatric Diseases Working Party

repository_normalized: HELDA - Digital Repository of the University of Helsinki

repository_institution: University of Geneva - Archive ouverte UNIGE

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories: HELDA - Digital Repository of the University of Helsinki

repositories_institution: University of Geneva - Archive ouverte UNIGE

repositories_institution: University of Zurich - Zurich Open Repository and Archive

publisher: American Society of Clinical Oncology (ASCO)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0.

ReferenceCitation: Choong E, Uppugunduri CRS, Marino D, Kuntzinger M, Doffey-Lazeyras F, Lo Piccolo R, Chalandon Y, Peters C, Daali Y, Ansari M. Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-Validation of Methods and Long-Term Performance. Ther Drug Monit. 2018 Feb;40(1):84-92. doi: 10.1097/FTD.0000000000000468. Erratum in: Ther Drug Monit. 2018 Apr;40(2):284.

full_name: Uppugunduri Chakradhara Rao Satyanarayana

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Denmark
Spain
Croatia
France
Poland
Slovakia
Norway
Argentina
Canada
Slovenia
Chile
Sweden
Saudi Arabia
Switzerland
Netherlands
Hungary
Germany
Italy
Austria
Mexico
Czechia
Israel
New Zealand
Belarus
Turkey

location_facility: University Children's Hospital in Krakow, Department of Transplantation

location_facility: UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie

location_facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin

location_facility: CancerCare Manitoba/University of Manitoba

location_facility: King Abdullah specialists children hospital

location_facility: IInsitutul Clinic Fundeni, Sectia de Transplant Medular

location_facility: Alberta Children's Hospital Division of Pediatric Oncology

location_facility: Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)

location_facility: University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics

location_facility: IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique

location_facility: Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Ege University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Istituto Gaslini Genova Oncoematologia Pediatrica-

location_facility: Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München

location_facility: CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique

location_facility: CHU Nantes, Service d'onco hémato pédiatrie

location_facility: Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Schneider Children's Medical Center of Israel

location_facility: Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin

location_facility: Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT

location_facility: Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet

location_facility: Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie

location_facility: Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit

location_facility: Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie

location_facility: Hospital for Sick Children University of Toronto Division of Haematology/Oncology

location_facility: Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit

location_facility: Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman

location_facility: Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO

location_facility: Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.

location_facility: Universitätsklinikum Erlangen, Kinder- und Jugendklinik

location_facility: CHRU Lille, Service d'Hématologie Pédiatrique

location_facility: Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)

location_facility: CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique

location_facility: Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology

location_facility: Universitätsklinik für Kinder- und Jugendmedizin Tübingen

location_facility: Children's Cancer Centre The Royal Children's Hospital

location_facility: CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant

location_facility: Leiden University Medical Center Department of Pediatrics/BMT unit

location_facility: Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin

location_facility: Hospital Universitario Central de Asturias

location_facility: Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA

location_facility: University Hospital Gent Pediatrische hemato-oncologie

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

location_facility: Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

location_facility: Universitätsklinikum Essen, Klinik für Kinderheilkunde III

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde

location_facility: Azienda Ospedaliera di Padova Oncoematologia Pediatrica

location_facility: Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome

location_facility: Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti

location_facility: Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology

location_facility: Uniklinik RWTH Aachen, Kinder- und Jugendmedizin

location_facility: Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit

location_facility: Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin

location_facility: A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia

location_facility: Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Universitätsklinikum Jena, Sektion für Stammzelltransplantation

location_facility: Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki

location_facility: Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University

location_facility: Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie

location_facility: Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique

location_facility: Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie

location_facility: Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

location_facility: The Children's Hospital at Westmead Oncology Unit

location_facility: CHU Sainte-Justine Hematology-Oncology Division

location_facility: St. Anna Children's Hospital, Vienna, Austria

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

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie

location_facility: University of Medicine and Pharmacy V. BABES, Emergency Children's Hospital LOUIS TURCANU, III. Clinic of Pediatrics , Department of Onco-hematology and Bone Marrow Transplantation

location_facility: University Hospitals Leuven Kinderhemato-oncologie

location_facility: Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin

location_facility: Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit

location_facility: Hospital of Southern Pest, National Insitute of Hematology and Infectious DiseaseHospital of Southern Pest, National Insitute of Hematology and Infectious Disease Pediatric Bone Marrow Transplantation Unit at Central

location_facility: Princess Máxima Center for Pediatric Oncology

location_facility: A.O. San Gerardo di Monza Clinica Pediatrica

location_facility: Saint Sophia Children's Hospital BMT Unit

location_facility: Universitäts-Kinderspital beider Basel (UKBB)

location_facility: University of Malaya, Department of Paediatrics

location_facility: Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin

location_facility: Cape of Hope, Wroclaw Medical University

location_facility: University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology

location_facility: Karolinska University Hospital, Department of Pediatrics

location_facility: Klinikum der Universität München, Dr. von Haunersches Kinderspital

location_facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin


title: An Open-Label, Multicenter, Phase 1/2 Study of Tazemetostat (EZH2 Histone Methyl Transferase [HMT] Inhibitor) as a Single Agent in Subjects With Advanced Solid Tumors or With B-cell Lymphomas and Tazemetostat in Combination With Prednisolone in Subjects With Diffuse Large B Cell Lymphoma

summary: This is a multicenter, open-label, Phase 1/2 study that is being conducted in two parts. The Phase 1 part (closed to accrual as of January 25, 2016) comprised dose escalation and expansion parts to establish the MTD and/or the recommended Phase 2 dose (RP2D) when tazemetostat was given BID (twice daily) orally on a continuous basis. Additionally, in separate cohorts in Phase 1, the effect of food on the bioavailability of tazemetostat as well as the drug-drug interaction (DDI) potential of tazemetostat were evaluated. The Phase 2 part was initiated once the MTD and /or RP2D was established. Phase 2 enrolls subjects with DLBCL (Cohorts 1-3 and 6) and FL (Cohorts 4 and 5) for the determination of efficacy and safety of tazemetostat monotherapy (Cohorts 1-5and of tazemetostat in combination with prednisolone (Cohort 6) with placement determined by centrally confirmed histology, cell of origin (COO), and EZH2 mutation status.

ReferenceCitation: Morschhauser F, Tilly H, Chaidos A, McKay P, Phillips T, Assouline S, Batlevi CL, Campbell P, Ribrag V, Damaj GL, Dickinson M, Jurczak W, Kazmierczak M, Opat S, Radford J, Schmitt A, Yang J, Whalen J, Agarwal S, Adib D, Salles G. Tazemetostat for patients with relapsed or refractory follicular lymphoma: an open-label, single-arm, multicentre, phase 2 trial. Lancet Oncol. 2020 Nov;21(11):1433-1442. doi: 10.1016/S1470-2045(20)30441-1. Epub 2020 Oct 6.

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Tilly

full_name: Hervé Tilly

given: Hervé

family: Chaidos

full_name: Aristeidis Chaidos

given: Aristeidis

family: McKay

full_name: Pamela McKay

given: Pamela

family: Phillips

full_name: Tycel Phillips

given: Tycel

family: Assouline

full_name: Sarit Assouline

given: Sarit

family: Batlevi

full_name: Connie Lee Batlevi

given: Connie Lee

family: Campbell

full_name: Phillip Campbell

given: Phillip

family: Ribrag

full_name: Vincent Ribrag

given: Vincent

family: Damaj

full_name: Gandhi Laurent Damaj

given: Gandhi Laurent

family: Dickinson

full_name: Michael Dickinson

given: Michael

family: Jurczak

full_name: Wojciech Jurczak

given: Wojciech

family: Kazmierczak

full_name: Maciej Kazmierczak

given: Maciej

family: Opat

full_name: Stephen Opat

given: Stephen

family: Radford

full_name: John Radford

given: John

family: Schmitt

full_name: Anna Schmitt

given: Anna

family: Yang

full_name: Jay Yang

given: Jay

family: Whalen

full_name: Jennifer Whalen

given: Jennifer

family: Agarwal

full_name: Shefali Agarwal

given: Shefali

family: Adib

full_name: Deyaa Adib

given: Deyaa

family: Salles

full_name: Gilles Salles

given: Gilles

journal_name: The Lancet Oncology

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

ReferenceCitation: Italiano A, Soria JC, Toulmonde M, Michot JM, Lucchesi C, Varga A, Coindre JM, Blakemore SJ, Clawson A, Suttle B, McDonald AA, Woodruff M, Ribich S, Hedrick E, Keilhack H, Thomson B, Owa T, Copeland RA, Ho PTC, Ribrag V. Tazemetostat, an EZH2 inhibitor, in relapsed or refractory B-cell non-Hodgkin lymphoma and advanced solid tumours: a first-in-human, open-label, phase 1 study. Lancet Oncol. 2018 May;19(5):649-659. doi: 10.1016/S1470-2045(18)30145-1. Epub 2018 Apr 9.

location_country:
Italy
United States
Germany
France
Poland
Australia
Canada
United Kingdom
Taiwan
Ukraine


type: Other Identifier

title: The Efficacy and Safety of Liraglutide as Adjunct Therapy to Insulin in the Treatment of Type 1 Diabetes. A 52-week Randomised, Treat-to-target, Placebo-controlled, Double Blinded, Parallel Group, Multinational, Multi-centre Trial

acronym: ADJUNCT ONE™

summary: This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

ReferenceType: result

ReferenceCitation: Mathieu C, Zinman B, Hemmingsson JU, Woo V, Colman P, Christiansen E, Linder M, Bode B; ADJUNCT ONE Investigators. Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial. Diabetes Care. 2016 Oct;39(10):1702-10. doi: 10.2337/dc16-0691. Epub 2016 Aug 9.

family: Mathieu

full_name: Chantal Mathieu

given: Chantal

family: Zinman

full_name: Bernard Zinman

given: Bernard

family: Hemmingsson

full_name: Joanna Uddén Hemmingsson

given: Joanna Uddén

family: Woo

full_name: Vincent Woo

family: Colman

full_name: Peter Colman

given: Peter

family: Christiansen

full_name: Erik Christiansen

given: Erik

family: Linder

full_name: Martin Linder

given: Martin

family: Bode

full_name: Bruce Bode

given: Bruce

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

version: publishedVersion

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

lead_sponsor: Novo Nordisk A/S

location_country:
United States
Sweden
Netherlands
Germany
Finland
France
Poland
Israel
Norway
Ireland
Belgium
Argentina
Australia
Russian Federation
Canada
United Kingdom
Ukraine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Ou SI, Gadgeel SM, Barlesi F, Yang JC, De Petris L, Kim DW, Govindan R, Dingemans AM, Crino L, Léna H, Popat S, Ahn JS, Dansin E, Mitry E, Müller B, Bordogna W, Balas B, Morcos PN, Shaw AT. Pooled overall survival and safety data from the pivotal phase II studies (NP28673 and NP28761) of alectinib in ALK-positive non-small-cell lung cancer. Lung Cancer. 2020 Jan;139:22-27. doi: 10.1016/j.lungcan.2019.10.015. Epub 2019 Oct 14.

family: Ou

full_name: Sai-Hong Ignatius Ou

given: Sai-Hong Ignatius

family: Gadgeel

full_name: Shirish M. Gadgeel

given: Shirish M.

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

full_name: James Chih-Hsin Yang

given: James Chih-Hsin

family: De Petris

full_name: Luigi De Petris

given: Luigi

family: Kim

full_name: Dong-Wan Kim

given: Dong-Wan

family: Govindan

full_name: Ramaswamy Govindan

given: Ramaswamy

family: Dingemans

full_name: Anne-Marie Dingemans

given: Anne-Marie

family: Crino

full_name: Lucio Crino

given: Lucio

family: Léna

full_name: Hervé Léna

given: Hervé

family: Popat

full_name: Sanjay Popat

given: Sanjay

family: Ahn

full_name: Jin Seok Ahn

given: Jin Seok

family: Dansin

full_name: Eric Dansin

given: Eric

family: Mitry

full_name: Emmanuel Mitry

given: Emmanuel

family: Müller

full_name: Barbara Müller

given: Barbara

family: Bordogna

full_name: Walter Bordogna

given: Walter

family: Balas

full_name: Bogdana Balas

given: Bogdana

family: Morcos

full_name: Peter N. Morcos

given: Peter N.

family: Shaw

full_name: Alice T. Shaw

given: Alice T.

journal_name: Lung Cancer

ReferenceCitation: Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.

family: Nueesch

full_name: Eveline Nueesch

given: Eveline

family: Jaminion

full_name: Felix Jaminion

given: Felix

family: Guerini

title: Exposure–response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer

ReferenceCitation: Gadgeel SM, Shaw AT, Govindan R, Gandhi L, Socinski MA, Camidge DR, De Petris L, Kim DW, Chiappori A, Moro-Sibilot DL, Duruisseaux M, Crino L, De Pas T, Dansin E, Tessmer A, Yang JC, Han JY, Bordogna W, Golding S, Zeaiter A, Ou SI. Pooled Analysis of CNS Response to Alectinib in Two Studies of Pretreated Patients With ALK-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2016 Dec;34(34):4079-4085. Epub 2016 Oct 31. Erratum in: J Clin Oncol. 2017 May 10;35(14):1631.

location_country:
Italy
Luxembourg
Sweden
Netherlands
Germany
France
Singapore
Belgium
Australia
Russian Federation
Spain
Denmark
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Charité Campus Virchow-Klinikum; Department of Cardiology

location_facility: Midwestern Regional Medical Center; Office of Research

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Hôpital Nord - AP-HM Marseille#; Gastroenterology and Hepatology

location_facility: Severance Hospital, Yonsei University Health System; Pharmacy

location_facility: Maastricht University Medical Centre; Afdeling Klinische Farmacie en Toxicologie

location_facility: CHU de Grenoble - Hôpital Nord; Service d'Oncologie Thoracique

location_facility: National University Hospital; Investigational Medicine Unit

location_facility: Hospital Regional Universitario de Malaga

location_facility: University Hospitals Case Medical Center

location_facility: Columbia University Medical Center; Department of Hematology/Oncology

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: UCLA Cancer Center; Premiere Oncology, A Medical Corporation

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: Royal Marsden Hospital;Dept of Haematology Oncology Research

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

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

location_facility: Seoul National University Bundang Hospital

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque

title: An Open-Label, Non-Randomized, Multicenter Phase I/II Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment

summary: This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.


title: A 24-week Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Twice Daily Oral Administration of Empagliflozin + Metformin Compared With the Individual Components of Empagliflozin or Metformin in Drug Naive Patients With Type 2 Diabetes Mellitus

summary: This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.

ReferenceCitation: Hadjadj S, Rosenstock J, Meinicke T, Woerle HJ, Broedl UC. Initial Combination of Empagliflozin and Metformin in Patients With Type 2 Diabetes. Diabetes Care. 2016 Oct;39(10):1718-28. doi: 10.2337/dc16-0522. Epub 2016 Aug 4.

family: Hadjadj

full_name: Samy Hadjadj

given: Samy

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Meinicke

full_name: Thomas Meinicke

given: Thomas

family: Woerle

full_name: Hans J. Woerle

given: Hans J.

family: Broedl

full_name: Uli C. Broedl

given: Uli C.

lead_sponsor: Boehringer Ingelheim

location_country:
Peru
Guatemala
Malaysia
Russian Federation
Czech Republic
Taiwan
France
Thailand
Canada
Korea, Republic of
Philippines
Germany
United Kingdom
United States
Brazil
Serbia
Lebanon
Mexico
Egypt
Spain
Turkey

location_facility: 1276.1.10018 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10037 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38105 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70016 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10040 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10042 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38104 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34050 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10019 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10043 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38103 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10041 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10046 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38102 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34027 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10025 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.66003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10027 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10030 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10026 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10033 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34045 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.66001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10014 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.60001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38108 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10028 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10032 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34028 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34034 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10023 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49014 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.60002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.95001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10021 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38101 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10045 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.60003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.66002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.50003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.90006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34051 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10017 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10035 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.42010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10034 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38106 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10015 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70015 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82010 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88005 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.88004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34048 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70017 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10001 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.34052 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20012 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.38107 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10024 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.55006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10044 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10016 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82006 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.82004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.63008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51003 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70018 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.49002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.52007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70013 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10022 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44002 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10036 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10008 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.44007 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.51004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.10009 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.33011 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.20004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.96004 Boehringer Ingelheim Investigational Site

location_facility: 1276.1.70012 Boehringer Ingelheim Investigational Site


ReferenceCitation: Dimopoulos MA, Palumbo A, Corradini P, Cavo M, Delforge M, Di Raimondo F, Weisel KC, Oriol A, Hansson M, Vacca A, Blanchard MJ, Goldschmidt H, Doyen C, Kaiser M, Petrini M, Anttila P, Cafro AM, Raymakers R, San-Miguel J, de Arriba F, Knop S, Röllig C, Ocio EM, Morgan G, Miller N, Simcock M, Peluso T, Herring J, Sternas L, Zaki MH, Moreau P. Safety and efficacy of pomalidomide plus low-dose dexamethasone in STRATUS (MM-010): a phase 3b study in refractory multiple myeloma. Blood. 2016 Jul 28;128(4):497-503. doi: 10.1182/blood-2016-02-700872. Epub 2016 May 25.

ReferenceCitation: Moreau P, Dimopoulos MA, Richardson PG, Siegel DS, Cavo M, Corradini P, Weisel K, Delforge M, O'Gorman P, Song K, Chen C, Bahlis N, Oriol A, Hansson M, Kaiser M, Anttila P, Raymakers R, Joao C, Cook G, Sternas L, Biyukov T, Slaughter A, Hong K, Herring J, Yu X, Zaki M, San-Miguel J. Adverse event management in patients with relapsed and refractory multiple myeloma taking pomalidomide plus low-dose dexamethasone: A pooled analysis. Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.

ReferenceCitation: Qian X, Dimopoulos MA, Amatangelo M, Bjorklund C, Towfic F, Flynt E, Weisel KC, Ocio EM, Yu X, Peluso T, Sternas L, Zaki M, Moreau P, Thakurta A. Cereblon gene expression and correlation with clinical outcomes in patients with relapsed/refractory multiple myeloma treated with pomalidomide: an analysis of STRATUS. Leuk Lymphoma. 2019 Feb;60(2):462-470. doi: 10.1080/10428194.2018.1485915. Epub 2018 Aug 2.

ReferenceCitation: Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. Epub 2016 Jun 7.

lead_sponsor: Celgene

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
Finland
France
Poland
Greece
Slovakia
Norway
Ireland
Belgium
Portugal
Estonia
Denmark
Germany
United Kingdom
Turkey

acronym: STRATUS

location_facility: Azienda Ospedaliera San Giovanni Battista - Ospedale Molinette

location_facility: Universitatsklinik MuensterMedizinische Klinik A

location_facility: Charite, Campus Benjamin Franklin Universitatsmedizin Berlin

location_facility: Universitatsklinkikum DusseldorfKlinik fur Hamatologie, Onkologie und klin. Immunoligie

location_facility: Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: Oslo University Hospital, Rikshospitalet HF

location_facility: Universita degli Studi di Roma La Sapienza - Azienda Policlinico Umberto I

location_facility: Service Hemato-Immunologie Hopital St Louis

location_facility: Belfast City Hospital Haematology Department

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: ASST Grande Ospedale Metropolitano Niguarda, Milano

location_facility: Abt Haematologie - Onkologie / Allg. Krankenhaus Altona

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Hospital Geral de Santo António - Serviço de Hematologia Clínica

location_facility: Hospital Universitario de Coimbra- Hospitais de Universidade de Coimbra

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University Hospital Bratislava - Hospital Ss Cyril and Methodius

location_facility: Cork University HospitalHaematology Consultant

location_facility: Hospital Clinico Universitario De Santiago De Compostela

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

location_facility: Akademia Medyczna w Gdansku Katedra i Klinika Hematologii i Transplantologii

source: euctr

title: A Multicenter, Single-arm, Open-label Study With Pomalidomide in Combination With Low Dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

summary:
The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma.

The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years.

In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses.

The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.