title: A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

lead_sponsor: Celgene

ReferenceCitation: Feagan BG, Schreiber S, Afzali A, Rieder F, Hyams J, Kollengode K, Pearlman J, Son V, Marta C, Wolf DC, D'Haens GG. Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's disease: The YELLOWSTONE clinical trial program. Contemp Clin Trials. 2022 Oct 5;122:106958. doi: 10.1016/j.cct.2022.106958. [Epub ahead of print]

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
Ukraine
United States
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Bosnia and Herzegovina
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Moldova, Republic of
Denmark
Taiwan
Belarus
Greece
Georgia
Ireland
Latvia
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Washington University School of Medicine

location_facility: Integrated University Hospital Santa Maria della Misericordia of Udine

location_facility: Samara Station Railway Clinical Hospital under OAO Russian Railways

location_facility: GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe

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

location_facility: Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia

location_facility: Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery

location_facility: Advance Clinical Research - Dayton Internal Medicine

location_facility: Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: General Hospital of Thessaloniki Hippokration

location_facility: Queen Fabiola Children's University Hospital

location_facility: Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.

location_facility: Euromed Multi-Specialty Center for Contemporary Medicine LLC

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

location_facility: Korea University Medical Center - Korea University Ansan Hospital

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: JSC Evex Medical Corporation - Telavi Referral Hospital

location_facility: Universitaetsklinikum Charite - Ruppiner Kliniken GmbH

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Bucharest University Emergency Hospital, Department of Internal Medicine II

location_facility: Military Medical Academy, Clinic of Gastroenterology and Hepatology

location_facility: P. Stradins Clinical University Hospital

location_facility: University Hospital Marques de Valdecilla (HUMV)

location_facility: John Hunter Hospital and Hunter Medical Research Institute

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

location_facility: Csongrad County Dr. Bugyi Istvan Hospital

location_facility: General Hospital Djordje Jovanovic Zrenjanin

location_facility: West Edmonton Gastroenterology Consultants

location_facility: Diagnostic and Consulting Center Alexandrovska

location_facility: Polish Mother's Memorial Hospital - Research Institute

location_facility: Allergy, Asthma and Immunology Center, PC

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: University of Pennsylvania Cancer Center

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Institute of Gastroenterology and Hepatology at Ha'Emek Medical Center

location_facility: Multidisciplinary Clinic of the St. Nicholas, LLC

location_facility: Non-Public Healthcare Facility Allmedica Clinical Trials

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Henry Ford Medical Center - New Center One

location_facility: Public City Clinical Hospital of Emergency Medical Care

location_facility: Mid America Gastrointestinal Consultants

location_facility: "Sfanta Treime" Clinical Municipal Hospital

location_facility: Vilnius University Hospital Santariskes Clinics

location_facility: Dnipropetrovsk II Mechnykov Regional Clinical Hospital Surgery Department 2

location_facility: BIK-KYIV Ukrainian German Gastroenterology Center

location_facility: Helsicore - Israeli Georgian Medical Research Clinic

location_facility: G.G. Kuvatov Republican Clinical Hospital

location_facility: Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre

location_facility: Clinical Research Center Early-Phase Research Facility

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: V.T. Zaitsev Institute of General and Emergency Surgery

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Beaujon

location_facility: Sart Tilman Hospital Department of Gastroenterology and Hepatology

location_facility: DiGiovanna Institute for Medical Education And Research

location_facility: The Center for Gastrointestinal Disorders

location_facility: Harvard Medical School - Boston Children's Hospital

location_facility: Diagnostic-Consultative Center Sveta Anna

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Jan Mikulicz Radecki University Hospital

location_facility: Hospital Christus Muquerza del Parque S.A. de C.V.

location_facility: Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Odesa Regional Clinical Hospital Regional Gastroenterology Center Surgery Department

location_facility: General Hospital "Prim.dr. Abdulah Nakas"

location_facility: Bezmialem Foundation University Medical Faculty

location_facility: Washington University School Of Medicine

location_facility: University Of Oklahoma Health Sciences Center

location_facility: St. John Paul 2nd Municipal Hospital in Elblag

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Azienda Socio Sanitaria Territoriale (ASST) di Monza

location_facility: SPb SBIH City Hospital of Saint Martyr Elizaveta

location_facility: Practice for Gastroenterology and Internal Medicine

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Krajská nemocnice Pardubice, Kožní oddelení

location_facility: The Seventh Medical Center of PLA General Hospital

location_facility: UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: S.V. Beliaev Kemerovo Regional Clinical Hospital

location_facility: Cotton ONeil Clinical Research Center Digestive Health

location_facility: Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office

location_facility: Clinical Hospital Center - Dr. Dragisa Misovic-Dedinje

location_facility: JSC Infectious Disease, AIDS and Clinical Immunology Research Center

location_facility: University Of California At San Francisco

location_facility: Ternopil City Public Emergency Medical Care Hospital

location_facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital

location_facility: Gastroenterological Special Practice at Wittenbergplatz

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Ok Clinic Medical Center within International Institute of Clinical Trials, LLC

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: Harry Perkins Medical Research Institute, Fiona Stanley Hospital

location_facility: Clinical Hospital Center Zvezdara Clinic of Internal Diseases

location_facility: World of the Health Inc. General Hospital Rimavska Sobota

location_facility: Zhangzhou Municipal Hospital of Fujian Province

location_facility: Medical Center of Far-Eastern Federal University

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Riga East Clinical University Hospital clinic Gailezers

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice

location_facility: Ohio State University Wexner Medical Center

location_facility: Joint Venture Company Diagnostic Center, Bioterm Ltd.

location_facility: Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes

location_facility: Clinical Center of Vojvodina, Clinic of Gastroenterology and Hepatology

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Craiova County Emergency Clinical Hospital

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi

location_facility: Federal Siberian Research and Clinical Center

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: University of Florida Health Endocrinology - Medical Specialties - Medical Plaza

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Multiprofile Hospital for Active Treatment Medline

location_facility: City Clinical Hospital No 31 - St. Petersburg

location_facility: Targu Mures County Emergency Clinical Hospital

location_facility: A.N. Ryzhikh State Research Center for Coloproctology

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Humanitas Research Hospital - Humanitas Mirasole S.p.A

location_facility: Universidad Nacional De Rosario - Hospital Provincial Del Centenario

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: London Health Sciences Centre, University Hospital

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Brigham and Women's Hospital - Crohn's and Colitis Center

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: University Hospital Puerta de Hierro Majadajonda

location_facility: Medical Scientific Manufacturing Association Dvizheniye Clinic

location_facility: Kornel Gibinski Independent Public Central Clinical Hospital in Katowice

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Biopharma Informatic Inc. Research Center

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: University Hospital of the Canary Islands (HUC) La Laguna

location_facility: Republican Clinical Hospital, Department of Colorectal Surgery

location_facility: ACIBADEM City Clinic Medical Center Bregalnitsa

location_facility: Medical Center Medical Clinic Blagomed LLC

location_facility: Maternal Pediatric and Adolescent Healthcare Centre

location_facility: University Hospital Centre Zagreb, Clinic of Internal Diseases

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: University Polyclinic Hospital G. Martino

location_facility: N.N. Burdenko Penza Regional Clinical Hospital

location_facility: University Hospital Germans Trias i Pujol

location_facility: Palo Alto Center-Palo Alto Medical Foundation Research Institute

location_facility: H-T. Medical Center Sp. z o.o. LLC Limited Partnership

location_facility: Centro de Investigacion Clinica Acelerada (CICA) S.C.

location_facility: Centro Regiomontano de Estudios Clinicos Roma SC.

location_facility: Bat Yamon Medical Center, Clalit Medical Services

location_facility: TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC

location_facility: Saint-Etienne University Hospital Center

location_facility: Southern California Research Institute Medical Group, Inc.

location_facility: Sotiria Chest Diseases Hospital of Athens

location_facility: Children's Center for Digestive Healthcare

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council

location_facility: Cancer Care Associates of OK-N PorterAvenue

location_facility: I.I. Mechnikov North-Western State Medical University

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Instituto Tecnológico y de Estudios Superiores de Monterrey

location_facility: Provincial Specialist Hospital in Olsztyn

location_facility: Univerisity Polyclinic Foundation Agostino Gemelli

location_facility: Advanced Research for Health Improvement

location_facility: University of California at San Francisco

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Semmelweis Egyetem - Altalanos Orvostudomanyi Kar

location_facility: JSC Evex Medical Corporation - Oncology Center

location_facility: Indiana University (IU) Health Physicians - IU Health Neuroscience Center

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: City Clinical Hospital n.a. V.M. Buyanov

location_facility: Endoterapia PFG LLC, Endotherapy PFG Outpatient Clinic Branch No 1

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Gastroenterology Associates of Orangeburg

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine

location_facility: Salve Limited Liability Company Limited Partnership, Outpatient Clinic

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: Helsinki University Central Hospital (HUCH)

location_facility: Gastroenterology Associates Of Central Georgia LLC

location_facility: Primorsky Regional Clinical Hospital No.1

location_facility: University of Oklahoma Health Sciences Center

location_facility: Center of Diagnosis and Treatment Provita

location_facility: Research Associates of South Florida LLC

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi

location_facility: Dr. Carol Davila Central Military Emergency Clinical Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Interdisciplinary Crohn Colitis Center Rhein Main

location_facility: VA Northern California Health Care System

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda

location_facility: Atlanta Center For Gastroenterology, P.C.

location_facility: Atlanta Gastroenterology Associates, Llc

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

location_facility: The Second Affiliated Hospital Of Zhengzhou University

location_facility: Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases

location_facility: University Clinical Hospital of Valencia

location_facility: JSC Evex Medical Corporation - Batumi Referral Hospital

location_facility: Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine

location_facility: "Sf. Arhanghel Mihail" Municipal Clinical Hospital

location_facility: LTD Academician N.Kipshidze Central University Clinic

location_facility: Moscow Clinical Scientific and Practical Center

location_facility: Connecticut Clinical Research Foundation

location_facility: Ural State Medical Academy - Medical Association Novaya Bolnitsa

location_facility: Johann Wolfgang Goethe University Hospital

location_facility: Toronto Digestive Disease Associates Inc

location_facility: University of Calgary Health - The Gastrointestinal Research Group (GIRG)

location_facility: CHU Nantes University Hospital - Hotel Dieu Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

location_facility: Scientific Research Institute of Physiology and Basic Medicine

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: University Hospital of Girona Dr. Josep Trueta

location_facility: Soukroma Gastroenterologicka ambulance a endoskopie

location_facility: State Unitary Enterprise Passengeravtotrans

summary: This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.


status: Recruiting

primary_purpose: Treatment

intervention_type: Other

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

study_completion_date_type: Anticipated

type: Registry Identifier

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

enrollment_type: Anticipated

location_country:
Croatia
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
Ukraine
United States
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Bosnia and Herzegovina
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Moldova, Republic of
Denmark
Taiwan
Belarus
Greece
Georgia
Ireland
Latvia
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Washington University School of Medicine

location_facility: Integrated University Hospital Santa Maria della Misericordia of Udine

location_facility: Samara Station Railway Clinical Hospital under OAO Russian Railways

location_facility: GASTROMED Kopon, Zmudzinski and Partners Specialist Centre for Gastroenterology and Endoscopy, Spe

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

location_facility: Multiprofile Hospital for Active Treatment Tokuda Hospital Sofia

location_facility: Clinical Hospital of the Ministry of Health, Department of Endoscopic Surgery

location_facility: Advance Clinical Research - Dayton Internal Medicine

location_facility: Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: General Hospital of Thessaloniki Hippokration

location_facility: Queen Fabiola Children's University Hospital

location_facility: Investigacion Biomedica para el desarrollo de Farmacos, S.A. de C.V.

location_facility: Euromed Multi-Specialty Center for Contemporary Medicine LLC

location_facility: Centro Hospitalar do Alto Minho - Unidade Local de Saúde do Alto Minho, EPE

location_facility: Korea University Medical Center - Korea University Ansan Hospital

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: JSC Evex Medical Corporation - Telavi Referral Hospital

location_facility: Universitaetsklinikum Charite - Ruppiner Kliniken GmbH

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Bucharest University Emergency Hospital, Department of Internal Medicine II

location_facility: Military Medical Academy, Clinic of Gastroenterology and Hepatology

location_facility: P. Stradins Clinical University Hospital

location_facility: University Hospital Marques de Valdecilla (HUMV)

location_facility: John Hunter Hospital and Hunter Medical Research Institute

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

location_facility: Csongrad County Dr. Bugyi Istvan Hospital

location_facility: General Hospital Djordje Jovanovic Zrenjanin

location_facility: West Edmonton Gastroenterology Consultants

location_facility: Diagnostic and Consulting Center Alexandrovska

location_facility: Polish Mother's Memorial Hospital - Research Institute

location_facility: Allergy, Asthma and Immunology Center, PC

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Clinical Hospital Center Sestre milosrdnice Clinic of Internal Diseases

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Vilnius University Hospital Santariskiu Klinikos

location_facility: University of Pennsylvania Cancer Center

location_facility: Kindred Medical Institute for Clinical Trials, LLC

location_facility: Vrije Universiteit Medisch Centrum (VUMC)

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Institute of Gastroenterology and Hepatology at Ha'Emek Medical Center

location_facility: Multidisciplinary Clinic of the St. Nicholas, LLC

location_facility: Non-Public Healthcare Facility Allmedica Clinical Trials

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Henry Ford Medical Center - New Center One

location_facility: Public City Clinical Hospital of Emergency Medical Care

location_facility: Mid America Gastrointestinal Consultants

location_facility: "Sfanta Treime" Clinical Municipal Hospital

location_facility: Vilnius University Hospital Santariskes Clinics

location_facility: Dnipropetrovsk II Mechnykov Regional Clinical Hospital Surgery Department 2

location_facility: BIK-KYIV Ukrainian German Gastroenterology Center

location_facility: Helsicore - Israeli Georgian Medical Research Clinic

location_facility: G.G. Kuvatov Republican Clinical Hospital

location_facility: Vancouver Hospital Gastrointestinal Research Unit The Gordon and Leslie Diamond Centre

location_facility: Clinical Research Center Early-Phase Research Facility

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: V.T. Zaitsev Institute of General and Emergency Surgery

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Beaujon

location_facility: Sart Tilman Hospital Department of Gastroenterology and Hepatology

location_facility: DiGiovanna Institute for Medical Education And Research

location_facility: The Center for Gastrointestinal Disorders

location_facility: Harvard Medical School - Boston Children's Hospital

location_facility: Diagnostic-Consultative Center Sveta Anna

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Jan Mikulicz Radecki University Hospital

location_facility: Hospital Christus Muquerza del Parque S.A. de C.V.

location_facility: Budget Institution of the Khanty-Mansiysk Autonomous Okrug - Ugra Surgut Regional Clinical Hospital

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Odesa Regional Clinical Hospital Regional Gastroenterology Center Surgery Department

location_facility: General Hospital "Prim.dr. Abdulah Nakas"

location_facility: Bezmialem Foundation University Medical Faculty

location_facility: Washington University School Of Medicine

location_facility: University Of Oklahoma Health Sciences Center

location_facility: St. John Paul 2nd Municipal Hospital in Elblag

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Azienda Socio Sanitaria Territoriale (ASST) di Monza

location_facility: SPb SBIH City Hospital of Saint Martyr Elizaveta

location_facility: Practice for Gastroenterology and Internal Medicine

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Krajská nemocnice Pardubice, Kožní oddelení

location_facility: The Seventh Medical Center of PLA General Hospital

location_facility: UC Davis Health - Gastroenterology and Hepatology Clinical Trials Unit

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: S.V. Beliaev Kemerovo Regional Clinical Hospital

location_facility: Cotton ONeil Clinical Research Center Digestive Health

location_facility: Clinical and Diagnostic Center with an outpatient department under the Presidential Executive Office

location_facility: Clinical Hospital Center - Dr. Dragisa Misovic-Dedinje

location_facility: JSC Infectious Disease, AIDS and Clinical Immunology Research Center

location_facility: University Of California At San Francisco

location_facility: Ternopil City Public Emergency Medical Care Hospital

location_facility: Vinnytsia M.I. Pyrohov Regional Clinical Hospital

location_facility: Gastroenterological Special Practice at Wittenbergplatz

location_facility: Hospital Universitario de Gran Canaria Dr. Negrin

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Ok Clinic Medical Center within International Institute of Clinical Trials, LLC

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: Harry Perkins Medical Research Institute, Fiona Stanley Hospital

location_facility: Clinical Hospital Center Zvezdara Clinic of Internal Diseases

location_facility: World of the Health Inc. General Hospital Rimavska Sobota

location_facility: Zhangzhou Municipal Hospital of Fujian Province

location_facility: Medical Center of Far-Eastern Federal University

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Riga East Clinical University Hospital clinic Gailezers

location_facility: Emory University Health Science Research Building

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Health Centre Metabolic Diseases Outpatient Clinic in Wierzchoslawice

location_facility: Ohio State University Wexner Medical Center

location_facility: Joint Venture Company Diagnostic Center, Bioterm Ltd.

location_facility: Centro Hospitalar do Alto Ave, Hospital da Senhora da Oliveira Guimaraes

location_facility: Clinical Center of Vojvodina, Clinic of Gastroenterology and Hepatology

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Vitebsk Regional Clinical Specialized Center

location_facility: Craiova County Emergency Clinical Hospital

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Bulent Ecevit Universitesi Uygulama ve Arastirma Hastanesi

location_facility: Federal Siberian Research and Clinical Center

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: University of Florida Health Endocrinology - Medical Specialties - Medical Plaza

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Multiprofile Hospital for Active Treatment Medline

location_facility: City Clinical Hospital No 31 - St. Petersburg

location_facility: Targu Mures County Emergency Clinical Hospital

location_facility: A.N. Ryzhikh State Research Center for Coloproctology

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Humanitas Research Hospital - Humanitas Mirasole S.p.A

location_facility: Universidad Nacional De Rosario - Hospital Provincial Del Centenario

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: London Health Sciences Centre, University Hospital

location_facility: SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Brigham and Women's Hospital - Crohn's and Colitis Center

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

location_facility: University Hospital Puerta de Hierro Majadajonda

location_facility: Medical Scientific Manufacturing Association Dvizheniye Clinic

location_facility: Kornel Gibinski Independent Public Central Clinical Hospital in Katowice

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Biopharma Informatic Inc. Research Center

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: University Hospital of the Canary Islands (HUC) La Laguna

location_facility: Republican Clinical Hospital, Department of Colorectal Surgery

location_facility: ACIBADEM City Clinic Medical Center Bregalnitsa

location_facility: Medical Center Medical Clinic Blagomed LLC

location_facility: Maternal Pediatric and Adolescent Healthcare Centre

location_facility: University Hospital Centre Zagreb, Clinic of Internal Diseases

location_facility: Instituto Medico de la Fundacion Estudios Clinicos

location_facility: University Polyclinic Hospital G. Martino

location_facility: N.N. Burdenko Penza Regional Clinical Hospital

location_facility: University Hospital Germans Trias i Pujol

location_facility: Palo Alto Center-Palo Alto Medical Foundation Research Institute

location_facility: H-T. Medical Center Sp. z o.o. LLC Limited Partnership

location_facility: Centro de Investigacion Clinica Acelerada (CICA) S.C.

location_facility: Centro Regiomontano de Estudios Clinicos Roma SC.

location_facility: Bat Yamon Medical Center, Clalit Medical Services

location_facility: TWOJA PRZYCHODNIA Medical Centre of Szczecin LLC

location_facility: Saint-Etienne University Hospital Center

location_facility: Southern California Research Institute Medical Group, Inc.

location_facility: Sotiria Chest Diseases Hospital of Athens

location_facility: Children's Center for Digestive Healthcare

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council

location_facility: Cancer Care Associates of OK-N PorterAvenue

location_facility: I.I. Mechnikov North-Western State Medical University

location_facility: University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

location_facility: Instituto Tecnológico y de Estudios Superiores de Monterrey

location_facility: Provincial Specialist Hospital in Olsztyn

location_facility: Univerisity Polyclinic Foundation Agostino Gemelli

location_facility: Advanced Research for Health Improvement

location_facility: University of California at San Francisco

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz

location_facility: Semmelweis Egyetem - Altalanos Orvostudomanyi Kar

location_facility: JSC Evex Medical Corporation - Oncology Center

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

location_facility: Santa Familia Centrum Badan, Profilaktyki i Leczenia

location_facility: City Clinical Hospital n.a. V.M. Buyanov

location_facility: Endoterapia PFG LLC, Endotherapy PFG Outpatient Clinic Branch No 1

location_facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine

location_facility: Salve Limited Liability Company Limited Partnership, Outpatient Clinic

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: Helsinki University Central Hospital (HUCH)

location_facility: Gastroenterology Associates Of Central Georgia LLC

location_facility: Primorsky Regional Clinical Hospital No.1

location_facility: University of Oklahoma Health Sciences Center

location_facility: Center of Diagnosis and Treatment Provita

location_facility: Research Associates of South Florida LLC

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: Sultan Abdulhamid Han Egitim ve Arastirma Hastanesi

location_facility: Dr. Carol Davila Central Military Emergency Clinical Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Interdisciplinary Crohn Colitis Center Rhein Main

location_facility: VA Northern California Health Care System

location_facility: Maggiore Polyclinic Hospital, IRCCS Ca' Granda

location_facility: Atlanta Center For Gastroenterology, P.C.

location_facility: Atlanta Gastroenterology Associates, Llc

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

location_facility: The Second Affiliated Hospital Of Zhengzhou University

location_facility: Si Institute Of Gastroenterology Of Namsu Dept Of Stomach And Duodenum Diseases

location_facility: University Clinical Hospital of Valencia

location_facility: JSC Evex Medical Corporation - Batumi Referral Hospital

location_facility: Clinical Hospital Center Bezanijska Kosa, Clinic of Internal Medicine

location_facility: Velocity Clinical Research/ Gut Whisperer

summary: This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Completed

acronym: EMERGE

intervention_type: Drug

title: A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. doi: 10.1200/JCO.2013.49.2835. Epub 2013 Sep 3.

ReferenceType: result

ReferenceCitation: Goy A, Kalayoglu Besisik S, Drach J, Ramchandren R, Robertson MJ, Avivi I, Rowe JM, Herbrecht R, Van Hoof A, Zhang L, Cicero S, Fu T, Witzig T. Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial. Br J Haematol. 2015 Aug;170(4):496-503. doi: 10.1111/bjh.13456. Epub 2015 Apr 28.

ReferenceCitation: Witzig TE, Luigi Zinzani P, Habermann TM, Tuscano JM, Drach J, Ramchandren R, Kalayoglu Besisik S, Takeshita K, Casadebaig Bravo ML, Zhang L, Fu T, Goy A. Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. Am J Hematol. 2017 Oct;92(10):E575-E583. doi: 10.1002/ajh.24854. Epub 2017 Aug 28.

ReferenceCitation: San-Miguel JF, Richardson PG, Günther A, Sezer O, Siegel D, Bladé J, LeBlanc R, Sutherland H, Sopala M, Mishra KK, Mu S, Bourquelot PM, Victoria Mateos M, Anderson KC. Phase Ib study of panobinostat and bortezomib in relapsed or relapsed and refractory multiple myeloma. J Clin Oncol. 2013 Oct 10;31(29):3696-703. doi: 10.1200/JCO.2012.46.7068. Epub 2013 Sep 9.

enrollment_type: Actual

location_country:
Belgium
Spain
Italy
Austria
United Kingdom
Hungary
Puerto Rico
France
United States
Israel
Singapore
Colombia
Turkey
Germany

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: Duran i Reynals Institut Catala d'Oncologia

location_facility: Alvin and Lois Lapidus Cancer Institute Sinai Hospital of Baltimore

location_facility: University of Tennessee Cancer Institute

location_facility: University of Massachusetts Medical Center

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Rochester Cancer Center, James P. Wilmot Cancer Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: Universita Federico II di Napoli Nuovo Policlinico

location_facility: University of Debrecen, DEOEC, Institute of Internal Medicine

location_facility: University of Virginia Cancer Center Clinical Trials Office

location_facility: Boca Raton Community Hospital, Inc., Research Dept.

location_facility: Washington University Siteman Cancer Center

location_facility: Loyola University Medical Center - Smith

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: MD Anderson Cancer Center, Orlando Regional Healthcare

location_facility: Centro De Cancer, Hospital Espanol Auxilio De Puerto Rico

location_facility: Winship Cancer Institute of Emory University

summary: To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

status_simplified: Completed


type: Other Identifier

title: A Phase 2/3, Placebo-Controlled, Efficacy and Safety Study of Once-Weekly, Subcutaneous LY2189265 Compared to Sitagliptin in Patients With Type 2 Diabetes Mellitus on Metformin

summary: This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.

ReferenceCitation: Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Völzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437.

ReferenceCitation: Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged ≥65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

ReferenceCitation: Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

ReferenceCitation: Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20.

ReferenceCitation: Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22.

ReferenceCitation: Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Taiwan
Romania
Spain
Russian Federation
Canada
Korea, Republic of
India
United States
France
Puerto Rico
Mexico
Germany

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


title: Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology

acronym: NSCLC

summary: The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

status: Terminated

ReferenceCitation: Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.

lead_sponsor: Pfizer

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
South Africa
Poland
Slovenia
Russian Federation
Indonesia
Puerto Rico
Brazil
Canada
Switzerland
Hungary
Bulgaria
Taiwan
Greece
Ireland
Latvia
Czech Republic
Korea, Republic of
France
Chile

status_simplified: Unknown


ipd_sharing: Yes

intervention_type: Biological

acronym: COMPLETE (see under A.3 Full title of the trial)

title: A Randomized, Open-Label, Phase III Study of Taxane Based Chemotherapy With Lapatinib or Trastuzumab as First-Line Therapy for Women With HER2/Neu Positive Metastatic Breast Cancer

lead_sponsor: Novartis Pharmaceuticals

type: Other Grant/Funding Number

ReferenceCitation: Liu S, Chen B, Burugu S, Leung S, Gao D, Virk S, Kos Z, Parulekar WR, Shepherd L, Gelmon KA, Nielsen TO. Role of Cytotoxic Tumor-Infiltrating Lymphocytes in Predicting Outcomes in Metastatic HER2-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2017 Nov 9;3(11):e172085. doi: 10.1001/jamaoncol.2017.2085. Epub 2017 Nov 9.

ReferenceCitation: Gelmon KA, Boyle FM, Kaufman B, Huntsman DG, Manikhas A, Di Leo A, Martin M, Schwartzberg LS, Lemieux J, Aparicio S, Shepherd LE, Dent S, Ellard SL, Tonkin K, Pritchard KI, Whelan TJ, Nomikos D, Nusch A, Coleman RE, Mukai H, Tjulandin S, Khasanov R, Rizel S, Connor AP, Santillana SL, Chapman JA, Parulekar WR. Lapatinib or Trastuzumab Plus Taxane Therapy for Human Epidermal Growth Factor Receptor 2-Positive Advanced Breast Cancer: Final Results of NCIC CTG MA.31. J Clin Oncol. 2015 May 10;33(14):1574-83. doi: 10.1200/JCO.2014.56.9590. Epub 2015 Mar 16.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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

summary:
RATIONALE: HER2/neu is a receptor (protein) which is found in unusually high amounts in approximately 1 in 5 cancer patients. Scientific evidence suggests that having high amounts of the HER2/neu receptor is important for breast cancer to grow and spread. Women with previously untreated metastatic breast cancer (breast cancer that has spread to other organs) and with high levels of the HER2/neu receptor receive as their usual treatment chemotherapy with one of the approved chemotherapy drugs paclitaxel or docetaxel (called "taxanes") together with another approved drug called "trastuzumab". Chemotherapy drugs, such as paclitaxel and docetaxel, work either by killing tumour cells or by stopping them from dividing. Trastuzumab is an antibody that is given through a vein in the arm and it works by specifically "targeting" the HER2/neu i.e. it attaches to it and "turns it off". Although some of the patients who receive this taxane plus trastuzumab treatment feel better for some months, the cancer usually starts to grow again. Lapatinib is a new drug. Like trastuzumab, it also works by specifically "targeting" the HER2/neu receptor, but it does so in a different way. Lapatinib is not an antibody. It is a pill that is taken daily by mouth. Because lapatinib works in a different way than trastuzumab, it may be worse, as good as or better than trastuzumab in keeping metastatic HER/neu positive cancer from growing. However, this is not known.

Purpose: This randomized Phase III trial is comparing chemotherapy (a taxane) given together with lapatinib with chemotherapy (a taxane) given together with trastuzumab in women with HER2/neu positive breast cancer.


title: An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis

lead_sponsor: Novartis

location_country:
United Kingdom
Romania
South Africa
Belgium
Poland
Russian Federation
Australia
Israel
Turkey
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Greece
Ireland
Estonia
Finland
Czech Republic
France
Netherlands

location_facility:
Novartis Investigative Site
Novartis Investigational Site
Austin Health, Department of Neurology
Novaratis Investigative Site

summary: This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Docetaxel-Based Chemotherapy

summary: This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed one or two chemotherapy regimens. At least one of the previous chemotherapies must have contained docetaxel.

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

ReferenceCitation: Chi KN, Kheoh T, Ryan CJ, Molina A, Bellmunt J, Vogelzang NJ, Rathkopf DE, Fizazi K, Kantoff PW, Li J, Azad AA, Eigl BJ, Heng DY, Joshua AM, de Bono JS, Scher HI. A prognostic index model for predicting overall survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate after docetaxel. Ann Oncol. 2016 Mar;27(3):454-60. doi: 10.1093/annonc/mdv594. Epub 2015 Dec 18.

ReferenceCitation: Fizazi K, Flaig TW, Stöckle M, Scher HI, de Bono JS, Rathkopf DE, Ryan CJ, Kheoh T, Li J, Todd MB, Griffin TW, Molina A, Ohlmann CH. Does Gleason score at initial diagnosis predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant prostate cancer? An analysis of abiraterone acetate phase III trials. Ann Oncol. 2016 Apr;27(4):699-705. doi: 10.1093/annonc/mdv545. Epub 2015 Nov 25.

ReferenceCitation: Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.

ReferenceCitation: Xu XS, Ryan CJ, Stuyckens K, Smith MR, Saad F, Griffin TW, Park YC, Yu MK, Vermeulen A, Poggesi I, Nandy P. Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate-Treated Castration-Resistant Prostate Cancer Patients. Clin Cancer Res. 2015 Jul 15;21(14):3170-7. doi: 10.1158/1078-0432.CCR-14-1549. Epub 2015 Mar 31.

ReferenceCitation: Scher HI, Heller G, Molina A, Attard G, Danila DC, Jia X, Peng W, Sandhu SK, Olmos D, Riisnaes R, McCormack R, Burzykowski T, Kheoh T, Fleisher M, Buyse M, de Bono JS. Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer. J Clin Oncol. 2015 Apr 20;33(12):1348-55. doi: 10.1200/JCO.2014.55.3487. Epub 2015 Mar 23.

ReferenceCitation: Mulders PF, Molina A, Marberger M, Saad F, Higano CS, Chi KN, Li J, Kheoh T, Haqq CM, Fizazi K. Efficacy and safety of abiraterone acetate in an elderly patient subgroup (aged 75 and older) with metastatic castration-resistant prostate cancer after docetaxel-based chemotherapy. Eur Urol. 2014 May;65(5):875-83. doi: 10.1016/j.eururo.2013.09.005. Epub 2013 Sep 20.

ReferenceCitation: Harland S, Staffurth J, Molina A, Hao Y, Gagnon DD, Sternberg CN, Cella D, Fizazi K, Logothetis CJ, Kheoh T, Haqq CM, de Bono JS, Scher HI; COU-AA-301 Investigators. Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy. Eur J Cancer. 2013 Nov;49(17):3648-57. doi: 10.1016/j.ejca.2013.07.144. Epub 2013 Aug 22.

ReferenceCitation: Ryan CJ, Molina A, Li J, Kheoh T, Small EJ, Haqq CM, Grant RP, de Bono JS, Scher HI. Serum androgens as prognostic biomarkers in castration-resistant prostate cancer: results from an analysis of a randomized phase III trial. J Clin Oncol. 2013 Aug 1;31(22):2791-8. doi: 10.1200/JCO.2012.45.4595. Epub 2013 Jul 1.

ReferenceCitation: Logothetis CJ, Basch E, Molina A, Fizazi K, North SA, Chi KN, Jones RJ, Goodman OB, Mainwaring PN, Sternberg CN, Efstathiou E, Gagnon DD, Rothman M, Hao Y, Liu CS, Kheoh TS, Haqq CM, Scher HI, de Bono JS. Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. Lancet Oncol. 2012 Dec;13(12):1210-7. doi: 10.1016/S1470-2045(12)70473-4. Epub 2012 Nov 9.

ReferenceCitation: Fizazi K, Scher HI, Molina A, Logothetis CJ, Chi KN, Jones RJ, Staffurth JN, North S, Vogelzang NJ, Saad F, Mainwaring P, Harland S, Goodman OB Jr, Sternberg CN, Li JH, Kheoh T, Haqq CM, de Bono JS; COU-AA-301 Investigators. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2012 Oct;13(10):983-92. doi: 10.1016/S1470-2045(12)70379-0. Epub 2012 Sep 18. Erratum in: Lancet Oncol. 2012 Nov;13(11):e464. Lancet Oncol. 2014 Aug;15(9):e365.

ReferenceCitation: de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Fléchon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618.

lead_sponsor: Cougar Biotechnology, Inc.

location_country:
Spain
Ireland
Austria
Australia
Netherlands
Canada
United Kingdom
Hungary
United States
France
Belgium
Germany


acronym: INTORACT

title: Phase 3b, Randomized, Open-Label Study Of Bevacizumab + Temsirolimus Vs. Bevacizumab + Interferon-Alfa As First-Line Treatment In Subjects With Advanced Renal Cell Carcinoma

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

ReferenceCitation: Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

ReferenceCitation: Rini BI, Bellmunt J, Clancy J, Wang K, Niethammer AG, Hariharan S, Escudier B. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol. 2014 Mar 10;32(8):752-9. doi: 10.1200/JCO.2013.50.5305. Epub 2013 Dec 2.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Russian Federation
Australia
Argentina
India
Mexico
Malaysia
Singapore
Slovakia
Brazil
Canada
Hungary
Germany
Taiwan
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Klinika tuberkulozy a plucnych chorob UK JLF a Martinskej fakultnej nemocince

location_facility: R.E.Kavetsky Institute of experimental pathology, oncology and radiobiology NAS of Ukraine,Laborator

location_facility: Klinika pneumologie a ftiziologie FNsP LFUK

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Yonsei University Health System-Severance Hospital

location_facility: Wojskowy Instytut Medyczny, Pracownia Badan Cynnosciowych Ukladu Oddechowego, Klinika Chorob Wewnetr

location_facility: Republican Clinical Oncology Dispensary of Minzdrav of Tatarstan Republic

location_facility: Instituto de Oncologia de Piracicaba S/S Ltda

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. Karola Marcinkowskiego w Poznaniu

location_facility: Cliniques Universitaires de Mont-Godinne UCL

location_facility: Klinikum Region Hannover, Krankenhaus Siloah

location_facility: Clinica de Oncologia de Porto Alegre - Sociedade Simples Ltda.

location_facility: Jawaharlal Nehru Cancer Hospital, Department of Medical Oncology

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Odette Cancer Centre, Sunnybrook Health Sciences Centre

location_facility: Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira - ICESP

location_facility: Klinika nuklearnej mediciny JLF UK a Martinskej fakultnej nemocnice

location_facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie

location_facility: N.N. Blokhin Russian Cancer Research Center, Department of Urology

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: Josa Andras Oktato Korhaz Nonprofit Kft.

location_facility: Centrum Medyczne Ostrobramska NZOZ "Magodent"

location_facility: Wojskowy Intsytut Medyczny, Zaklad Medycyny Nuklearnej CSK MON

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: "State Institution ""Institute for Occupational Health of the

location_facility: Sezione di Oncologia Medica Centro di Ricerca Clinica

location_facility: ProCura - Centro Goiano de Pesquisa Clínica Ltda

location_facility: Vivantes Klinikum am Urban, Neztwerk fuer Gesundheit GmbH

location_facility: Unità Operativa di Oncologia, Azienda Ospedaliera Policlinico di Modena

location_facility: Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

location_facility: Szegedi Tudomanyegyetem, Urologiai Klinika

location_facility: Oblasnyy onkologychnyy dispanser, onkourologichne viddilennya, Ivano-Frankivskiy Derzhavniy Medichni

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Donetskyy Oblasyy protypukhlynnyy Tsenter

location_facility: Moscow Scientific Research Oncology Institute P.A. Herzen

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Clínica de Oncologia de Porto Alegre Sociedade Simples Ltda

location_facility: N.N. Blokhin Russian Cancer Research Center, Department of Clinical Pharmacology and Chemotherapy

location_facility: Hematology Oncology Services of Arkansas

location_facility: Struttura Complessa di Oncologia Medica Ospedale Santa Maria della Misericordia

location_facility: Szpital Specjalistyczny im. L. Rydygiera Sp. z o.o.

location_facility: Scientific research Institute of Oncology N.N. Petrov

location_facility: Centre de Sante et de Services Sociaux de Rimouski - Neigette

location_facility: University of the Witwatersrand Oncology

location_facility: Privolzhskiy District Medical Center of Federal Biomedical Agency

location_facility: Fakultna Nemocnica s poliklinikou F D Roosevelta

location_facility: Donetske Obl. clinico-teritorial'ne medichne ob'yednannya

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw Jana z Dukli

location_facility: Lakeshore Hospital & Research Center Limited

location_facility: Divisione di Urologia, Azienda Ospedaliera Policlinico Consorziale di Bari

location_facility: Farmacia del Comitato Etico Provinciale di Modena

location_facility: Uchbobo-naukovyi likuvalnyi kompleks DDMU im. M.Gor'kogo

location_facility: Wojskowy Intsytut Medyczny, Zaklad Diagnostyki Laboratoryjnej CSK MON

location_facility: Fakultna Nemocnica s poliklinikou akad L Derera

summary: Primary objective: Comparison of independently assessed progression free survival (PFS) in subjects administered Bevacizumab + Temsirolimus vs. those administered Bevacizumab + Interferon-Alfa. Secondary objectives: safety, Investigator assessed PFS, objective response rate (independently assessed), and overall survival.


title: Randomized, Active-controlled, Double-blind, Parallel Design Study to Evaluate the Efficacy and Safety of a Once-a-week Prophylaxis Treatment With BAY79-4980 Compared to Three Times-per-week Prophylaxis With rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

lead_sponsor: Bayer

ReferenceCitation: Di Minno G, Cerbone AM, Coppola A, Cimino E, Di Capua M, Pamparana F, Tufano A, Di Minno MN. Longer-acting factor VIII to overcome limitations in haemophilia management: the PEGylated liposomes formulation issue. Haemophilia. 2010 Jan;16 Suppl 1:2-6. doi: 10.1111/j.1365-2516.2009.02155.x. Review.

ReferenceCitation: Powell J, Martinowitz U, Windyga J, Di Minno G, Hellmann A, Pabinger I, Maas Enriquez M, Schwartz L, Ingerslev J; LipLong Study Investigators. Efficacy and safety of prophylaxis with once-weekly BAY 79-4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients. A randomised, active-controlled, double-blind study. Thromb Haemost. 2012 Nov;108(5):913-22. doi: 10.1160/TH12-03-0188. Epub 2012 Sep 26.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Romania
Belgium
South Africa
Poland
Austria
Australia
Argentina
Israel
Turkey
Norway
Canada
Switzerland
Germany
Denmark
Taiwan
Estonia
New Zealand
France
Chile
Netherlands

summary: A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.


title: A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)

summary: The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD.

location_country:
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
United Kingdom
United States
France
Turkey
Belgium
Germany

location_facility: Evanstan Northwestern Healthcare Medical Group

location_facility: Veterans Affairs Puget Sound Health Care System

location_facility: Neurology & Neuroscience Associates, Inc.


acronym: TOPIC

title: An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period

lead_sponsor: Sanofi

ReferenceCitation: Miller AE, Wolinsky JS, Kappos L, Comi G, Freedman MS, Olsson TP, Bauer D, Benamor M, Truffinet P, O'Connor PW; TOPIC Study Group. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014 Oct;13(10):977-86. doi: 10.1016/S1474-4422(14)70191-7. Epub 2014 Sep 2.

location_country:
United Kingdom
Lithuania
Ukraine
United States
Romania
Poland
Austria
Australia
Russian Federation
Turkey
Mexico
Canada
Hungary
Germany
Bulgaria
Denmark
Estonia
Finland
Czech Republic
France
Chile

location_facility:
Investigational Site Number 8954
Investigational Site Number 5401
Investigational Site Number 6002
Investigational Site Number 7808
Investigational Site Number 6810
Investigational Site Number 8709
Investigational Site Number 8924
Investigational Site Number 8512
Investigational Site Number 8914
Investigational Site Number 7703
Investigational Site Number 8511
Investigational Site Number 8506
Investigational Site Number 5408
Investigational Site Number 7402
Investigational Site Number 8940
Investigational Site Number 7912
Investigational Site Number 8963
Investigational Site Number 4004
Investigational Site Number 7502
Investigational Site Number 7709
Investigational Site Number 5309
Investigational Site Number 6403
Investigational Site Number 5303
Investigational Site Number 5307
Investigational Site Number 6612
Investigational Site Number 8965
Investigational Site Number 8922
Investigational Site Number 5306
Investigational Site Number 8507
Investigational Site Number 6401
Investigational Site Number 4001
Investigational Site Number 8962
Investigational Site Number 8706
Investigational Site Number 6607
Investigational Site Number 8304
Investigational Site Number 7701
Investigational Site Number 5312
Investigational Site Number 6614
Investigational Site Number 5804
Investigational Site Number 8504
Investigational Site Number 5404
Investigational Site Number 8314
Investigational Site Number 6203
Investigational Site Number 1405
Investigational Site Number 8505
Investigational Site Number 8315
Investigational Site Number 7108
Investigational Site Number 8303
Investigational Site Number 5304
Investigational Site Number 8953
Investigational Site Number 5602
Investigational Site Number 7907
Investigational Site Number 7501
Investigational Site Number 6609
Investigational Site Number 6804
Investigational Site Number 6605
Investigational Site Number 6201
Investigational Site Number 5403
Investigational Site Number 8508
Investigational Site Number 8310
Investigational Site Number 5606
Investigational Site Number 5409
Investigational Site Number 5801
Investigational Site Number 7911
Investigational Site Number 8946
Investigational Site Number 7906
Investigational Site Number 6801
Investigational Site Number 8702
Investigational Site Number 6805
Investigational Site Number 4005
Investigational Site Number 7803
Investigational Site Number 8501
Investigational Site Number 8705
Investigational Site Number 8510
Investigational Site Number 5605
Investigational Site Number 8707
Investigational Site Number 8941
Investigational Site Number 6815
Investigational Site Number 7805
Investigational Site Number 1404
Investigational Site Number 7806
Investigational Site Number 7401
Investigational Site Number 6602
Investigational Site Number 8312
Investigational Site Number 8708
Investigational Site Number 8302
Investigational Site Number 8937
Investigational Site Number 8309
Investigational Site Number 1401
Investigational Site Number 7909
Investigational Site Number 8930
Investigational Site Number 7910
Investigational Site Number 7105
Investigational Site Number 8905
Investigational Site Number 8951
Investigational Site Number 7707
Investigational Site Number 7103
Investigational Site Number 6004
Investigational Site Number 6601
Investigational Site Number 7905
Investigational Site Number 5601
Investigational Site Number 1407
Investigational Site Number 5805
Investigational Site Number 6803
Investigational Site Number 8925
Investigational Site Number 8502
Investigational Site Number 8503
Investigational Site Number 8701
Investigational Site Number 8301
Investigational Site Number 8920
Investigational Site Number 5803
Investigational Site Number 7101
Investigational Site Number 6611
Investigational Site Number 8308
Investigational Site Number 8305
Investigational Site Number 5410
Investigational Site Number 6405
Investigational Site Number 6807
Investigational Site Number 8949
Investigational Site Number 6802
Investigational Site Number 6604
Investigational Site Number 8704
Investigational Site Number 6806
Investigational Site Number 7904
Investigational Site Number 6809
Investigational Site Number 5406
Investigational Site Number 7807
Investigational Site Number 7403
Investigational Site Number 7710
Investigational Site Number 8955
Investigational Site Number 5402

summary:
The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day [mg/day] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives were:

To demonstrate the effect of teriflunomide, in comparison to placebo, on:

Reducing conversion to definite multiple sclerosis (DMS)
Reducing annualized relapse rate (ARR)
Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)
Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)
Proportion of disability-free participants as assessed by the EDSS
Reducing participant-reported fatigue
To evaluate the safety and tolerability of teriflunomide
To evaluate the pharmacokinetics (PK) of teriflunomide
Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes


title: Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)

acronym: SATURN

summary: A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.

ReferenceCitation: Puri R, Nissen SE, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Libby P, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. Sex-related differences of coronary atherosclerosis regression following maximally intensive statin therapy: insights from SATURN. JACC Cardiovasc Imaging. 2014 Oct;7(10):1013-22. doi: 10.1016/j.jcmg.2014.04.019. Epub 2014 Sep 17.

ReferenceCitation: Puri R, Libby P, Nissen SE, Wolski K, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Raichlen JS, Uno K, Kataoka Y, Tuzcu EM, Nicholls SJ. Long-term effects of maximally intensive statin therapy on changes in coronary atheroma composition: insights from SATURN. Eur Heart J Cardiovasc Imaging. 2014 Apr;15(4):380-8. doi: 10.1093/ehjci/jet251. Epub 2014 Jan 20.

ReferenceCitation: Puri R, Nissen SE, Libby P, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. C-reactive protein, but not low-density lipoprotein cholesterol levels, associate with coronary atheroma regression and cardiovascular events after maximally intensive statin therapy. Circulation. 2013 Nov 26;128(22):2395-403. doi: 10.1161/CIRCULATIONAHA.113.004243. Epub 2013 Sep 16.

ReferenceCitation: Nicholls SJ, Ballantyne CM, Barter PJ, Chapman MJ, Erbel RM, Libby P, Raichlen JS, Uno K, Borgman M, Wolski K, Nissen SE. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011 Dec 1;365(22):2078-87. doi: 10.1056/NEJMoa1110874. Epub 2011 Nov 15.

lead_sponsor: AstraZeneca

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Canada
Hungary
United States
France
Belgium
Netherlands


title: Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer

summary: Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.

ReferenceCitation: Langer CJ, Novello S, Park K, Krzakowski M, Karp DD, Mok T, Benner RJ, Scranton JR, Olszanski AJ, Jassem J. Randomized, phase III trial of first-line figitumumab in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone in patients with advanced non-small-cell lung cancer. J Clin Oncol. 2014 Jul 1;32(19):2059-66. doi: 10.1200/JCO.2013.54.4932. Epub 2014 Jun 2.

location_country:
Spain
Italy
Ukraine
United States
Japan
Poland
Hong Kong
Austria
Australia
Russian Federation
Puerto Rico
India
Turkey
Slovakia
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Finland
Czech Republic
Korea, Republic of
France


acronym: DoseFlex

title: A Phase IIIb Open-label run-in Double-blind, Placebo Controlled, Randomized Study to Evaluate the Safety/Efficacy of Certolizumab Pegol Administered Concomitantly With Stable-dose Methotrexate in Patients With Active Rheumatoid Arthritis.

lead_sponsor: UCB Pharma

ReferenceCitation: Furst DE, Shaikh SA, Greenwald M, Bennett B, Davies O, Luijtens K, Staelens F, Koetse W, Bertin P. Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis. Arthritis Care Res (Hoboken). 2015 Feb;67(2):151-60. doi: 10.1002/acr.22496.

location_country:
United States
Canada
France

summary: During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.


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.

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

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

location_facility: Niepubliczny Zakład Opieki Zdrowotnej POLIMEDICA

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

location_facility: Institutul de Boli Cardiovasculare si Transplan Tg. Mures

location_facility: Azienda Ospedaliera Maggiore Della Carita' Di Novara

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

location_facility: Oddział Kardiologiczny Wojewódzki Szpital Specjalistyczy w Siedlcach

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

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

location_facility: Ventura Cardiology Consultants Medical Group, Inc.

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

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

location_facility: Duluth Clinic / Saint Marys Medical Center

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

location_facility: Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwór

location_facility: Heart Clinic of Louisiana Clinical Research, LLC.

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

location_facility: National Heart Hospital Department of Cardiology

location_facility: Szpital Specjalistyczny Św.Jana, Oddział Kardiologii,

location_facility: Niepubliczny Zakład Opieki Zdrowotnej, Centrum Badań Klinicznych

location_facility: Nemocnica s poliklinikou Považská Bystrica

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

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

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

location_facility: Therapeutic Research Institute of Orange County

location_facility: Spitalul Clinic Judetean de Urgenta Bacau

location_facility: Comprehensive Cardiology Consultants, Inc.

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

location_facility: Sewickley Valley Medical Group Cardiology

location_facility: Zakład Hemodynamiki, Wojewódzki Szpital Specjalistyczny

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

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

location_facility: Winchester Medical Center/ Clinical Research Department

location_facility: The Heart and Vascular Institute of Florida

location_facility: II Oddział Wewnętrzny Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: Wojewódzki Szpital Zespolony, Oddział Kardiologiczny

location_facility: Research Associates of Jackson and Apex Cardiology

location_facility: Northeast Iowa Medical Education Foundation

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

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

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

location_facility: Oddział Chorób Wewnętrzych i Kardiologii , ZOZ w Debicy

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

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

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

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

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

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

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

location_facility: Inland Heart and Vascular Medical Associates

location_facility: Tokuda Hospital Department of Cardiology

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

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

location_facility: Jacksonville Center for Clinical Research

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

location_facility: Hospital of the University of Pennsylvania Cardiology Department

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

location_facility: Clinique de Cardiologie de Trois-Rivieres

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

location_facility: Międzyleski Szpital Specjalistyczny w Warszawie

location_facility: Klinikum Mannheim GmbH, Universaitatskinikum

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

location_facility: Centrum Leczenia Chorób Cywilizacyjnych Oddz. Gdynia filla Fikakowo

location_facility: Szpital Specjalistyczny w Kościerzynie, Oddział Kardiologii

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

location_facility: Chest and Critical Care Consultants, A Medical Group

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Akademii Medycznej w Warszawie

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

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

location_facility: Cardiovascular Consultants of South Florida

location_facility: Franciscan Health System dba FHS Research Center

location_facility: Klinikum Region Hannover Krankenhaus Nordstadt

location_facility: Alegent Health Clinic Heart and Vascular Specialist

location_facility: Southeast Texas Clinical Research Center

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

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

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

location_facility: Saint Patrick Hospital- International Heart Institute of Montana

location_facility: Specjalistyczny Gabinet Lekarski Internistyczno-Kardiologiczny-Cardiology

location_facility: Fraser Clinical Trials Inc and Royal Columbian Hospital

location_facility: Verzosa & Ungab Internal Medicine Associates

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

location_facility: The University of Texas Medical Branch at Galveston

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

location_facility: Klinika kardiologie Institut klinické a experimentální medicíny

location_facility: 4th Multiprofile Hospital for Active Treatment

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

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

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

location_facility: Executive Health and Research Associates, Inc.

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

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

location_facility: Gemeinschaftspraxis Innere Medizin und Kardiologie

location_facility: Publiczny Specjalistyczny Zaklad Opieki Zdrowotnej Oddzial Kardiologiczny

location_facility: Cardiovascular Care of Northern Carolina

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

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

location_facility: Good Samaritan Hospital (Medstar Health)

location_facility: Hospital Central "Dr. Ignacio Morones Prieto"

location_facility: NZOZ Przychodnia Zadebie, Przychodnia Kardiologiczna

location_facility: Oddział Internistyczno-Kardiologiczny Samodzielny Publiczny Zakład Opieki Zdrowotnej

location_facility: Fővárosi Önkormányzat Károlyi Sándor Kórház és Rendelőintézet

location_facility: Buffalo Cardiology and Pulmonary Associates

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

location_facility: Hospital Regional de Punta Arenas Dr. Lautaro Navarro

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

location_facility: Oddział Kardiologiczny Szpital Wojewódzki im. Kardynała Stefana Wyszyńskiego

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

location_facility: Centre Hospitalier Intercommunal du Val d'Ariège

location_facility: Specjalistyczna Przychodnia Lekarska "Medikard"

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

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

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

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

location_facility: Cardiovascular Research Center of South Florida

location_facility: La Pitié Salpétrière Institut de Cardiologie

location_facility: New England Center for Clinical Research, Inc

location_facility: South Suburban Health Professional Group, PC

location_facility: "Oddział Kardiologiczny Publiczny Samodzielny ZOZ Wojewódzkie Centrum Medyczne

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

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Universitäres Herz-und Gefäßzentrum Hamburg"

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

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

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

location_facility: Kilniken Maria Hilf GmbH Krankenhaus St. Franziskus

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

location_facility: Midwest Cardiovascular Research Foundation

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház

location_facility: Oddział Kardiologii Wojewódzki Szpital Zespolony

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

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

location_facility: Praxis für Innere Medizin, Gastroenterologie

location_facility: Hospitalier de l'Universite de Montreal Hotel Dieu

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

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

location_facility: Trinity Hypertension and Diagnostic Res.

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

location_facility: ZOZ w Oławie, Oddział Chorób Wewnętrznych


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.

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:
Italy
Austria
Russian Federation
Canada
Sweden
France
Germany

location_facility: 205.334.7001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4301 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1004 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4909 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4305 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4904 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3306B Boehringer Ingelheim Investigational Site

location_facility: 205.334.4908 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4302 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3304A Boehringer Ingelheim Investigational Site

location_facility: 205.334.4308 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3303B Boehringer Ingelheim Investigational Site

location_facility: 205.334.46002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.46003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39005 Boehringer Ingelheim Investigational Site

location_facility: 205.334.46001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.7003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39004 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1006 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3302A Boehringer Ingelheim Investigational Site

location_facility: 205.334.39006 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3305A Boehringer Ingelheim Investigational Site

location_facility: 205.334.1001 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1003 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4309 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3302B Boehringer Ingelheim Investigational Site

location_facility: 205.334.1008 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4907 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1005 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3303A Boehringer Ingelheim Investigational Site

location_facility: 205.334.1007 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3301A Boehringer Ingelheim Investigational Site

location_facility: 205.334.39002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.7002 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4901 Boehringer Ingelheim Investigational Site

location_facility: 205.334.39007 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4306 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1009 Boehringer Ingelheim Investigational Site

location_facility: 205.334.4902 Boehringer Ingelheim Investigational Site

location_facility: 205.334.1010 Boehringer Ingelheim Investigational Site

location_facility: 205.334.3306A Boehringer Ingelheim Investigational Site


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.

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.

lead_sponsor: Seagen Inc.

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

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

location_facility: Washington University School of Medicine

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

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

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

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

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Cliniques Universitaires UCL de Mont-Goddine

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: University of Louisville - James Graham Brown Cancer Center


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.

ReferenceCitation: Giannini EG, Afdhal NH, Sigal SH, Muir AJ, Reddy KR, Vijayaraghavan S, Elkashab M, Romero-Gómez 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.

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.

lead_sponsor: GlaxoSmithKline

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


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

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. Review.

location_country:
United States
France
Spain
Belgium

location_facility: 1200.28.0005 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0010 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0017 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0024 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0043 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0050A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0008 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0055G Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0012 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0016 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0032 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0061A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0001 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0062B Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0013 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0022 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0059A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0040 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0051A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0009 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0002 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0045 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0020 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0021 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0031 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0058A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0052A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0006 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0030 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0042 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0041 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0007 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0062A Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0011 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0044 Boehringer Ingelheim Investigational Site

location_facility: 1200.28.0004 Boehringer Ingelheim Investigational Site

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.