title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis (TRANSFORM-1)

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
South Africa
Belgium
Japan
Austria
Australia
Russian Federation
Israel
Turkey
Sweden
Canada
Germany
Bulgaria
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Medizinische Universitaet Wien /ID# 220906

location_facility: Universitatsklinikum Mannheim /ID# 221523

location_facility: Trakya University Medical Facu /ID# 230754

location_facility: Texas Oncology - Northeast Texas /ID# 241813

location_facility: Mid Illinois Hematology & Oncology Associates, Ltd /ID# 224204

location_facility: Inje University Busan Paik Hospital /ID# 231667

location_facility: Inonu University Medical Faculty /ID# 230758

location_facility: CHU Bordeaux - Hopital Haut Leveque /ID# 222518

location_facility: Tula Regional Clinical Hospital /ID# 221027

location_facility: Radboud Universitair Medisch Centrum /ID# 218948

location_facility: Tel Aviv Sourasky Medical Center /ID# 219134

location_facility: Massachusetts General Hospital /ID# 221559

location_facility: Kansai Medical University Hospital /ID# 221482

location_facility: CHU UCL Namur - site Godinne /ID# 221127

location_facility: Linkou Chang Gung Memorial Hospital /ID# 218983

location_facility: Highlands Oncology Group, PA /ID# 221824

location_facility: Juntendo University Hospital /ID# 221405

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 239100

location_facility: Gabrail Cancer Center Research /ID# 230488

location_facility: University of Yamanashi Hospital /ID# 221701

location_facility: Weill Cornell Medical College /ID# 220933

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 219113

location_facility: ASST Spedali civili di Brescia /ID# 241273

location_facility: Gunmaken Saiseikai Maebashi Hospital /ID# 242806

location_facility: Hospital Universitario Vall d'Hebron /ID# 229690

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 220813

location_facility: Hospital Universitario 12 de Octubre /ID# 229691

location_facility: Klinicki bolnicki centar Split /ID# 230796

location_facility: The Chaim Sheba Medical Center /ID# 219137

location_facility: Leningrad Regional Clinical Hospital /ID# 221028

location_facility: Universitair Medisch Centrum Utrecht /ID# 218949

location_facility: University Clinical Center Kragujevac /ID# 230855

location_facility: Medical Corporation Seijinkai Ikeda Hospital /ID# 242172

location_facility: Hadassah Medical Center-Hebrew University /ID# 219110

location_facility: General Hospital of Athens Laiko /ID# 230785

location_facility: Kanazawa University Hospital /ID# 238424

location_facility: Kyungpook National University Hospital /ID# 231666

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 221347

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 230946

location_facility: Fujita Health University Hospital /ID# 221537

location_facility: Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 221029

location_facility: Feofaniya Clinical Hospital of State Management of Affairs /ID# 232370

location_facility: Hospital Clinico Universitario de Valencia /ID# 220875

location_facility: Nippon Medical School Hospital /ID# 221674

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 221333

location_facility: Indiana Blood & Marrow Transpl /ID# 221586

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 230786

location_facility: Centre Hospitalier de CHAMBERY /ID# 224506

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 219085

location_facility: Hokkaido University Hospital /ID# 242667

location_facility: Bagcilar Medipol Mega Universite Hastanesi /ID# 230757

location_facility: VA Puget Sound Health Care System /ID# 231691

location_facility: Skane University Hospital Lund /ID# 220835

location_facility: OncoResearch Lerchenfeld GmbH /ID# 230867

location_facility: China Medical University Hospital /ID# 218978

location_facility: University of Kansas Cancer Center /ID# 218144

location_facility: Albert Alberts Stem Cell Transplant Centre /ID# 232073

location_facility: Orebro Universitetssjukhuset /ID# 220829

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 218984

location_facility: Florida Cancer Specialist - South /ID# 221726

location_facility: Northwell Health - Monter Cancer Center /ID# 222996

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 219086

location_facility: Juntendo University Shizuoka Hospital /ID# 221782

location_facility: CHU NIMES - Hopital Caremeau /ID# 219114

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 220867

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 221520

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 219056

location_facility: Augusta University Georgia Cancer Center /ID# 221551

location_facility: Medizinische Universitaet Graz /ID# 220910

location_facility: Hospital Universitario Virgen de la Victoria /ID# 220878

location_facility: Moores Cancer Center at UC San Diego /ID# 218012

location_facility: SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 230833

location_facility: Hospital Parc de Salut del Mar /ID# 220913

location_facility: University of Miyazaki Hospital /ID# 221483

location_facility: Klinikum Wels-Grieskirchen GmbH /ID# 220901

location_facility: Townsville University Hospital /ID# 229794

location_facility: Gachon University Gil Medical Center /ID# 222089

location_facility: Almazov National Medical Research Centre /ID# 221033

location_facility: Klinicki bolnicki centar Zagreb /ID# 230793

location_facility: Thompson Cancer Survival Ctr /ID# 231689

location_facility: Universitair Ziekenhuis Leuven /ID# 218806

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 219192

location_facility: CH Roubaix - Hopital Victor Provo /ID# 219116

location_facility: Beth Israel Deaconess Medical Center /ID# 224261

location_facility: Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 218874

location_facility: Seoul National University Hospital /ID# 219055

location_facility: Pusan National University Hospital /ID# 222087

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 229936

location_facility: Hospital Universitario Ramon y Cajal /ID# 220877

location_facility: Hacettepe University Medical Faculty /ID# 230759

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 221907

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 219185

location_facility: Providence Medical Foundation /ID# 241646

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 230720

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 230832

location_facility: Ege University Medical Faculty /ID# 230753

location_facility: University Clinical Center Serbia /ID# 230854

location_facility: Assaf Harofeh Medical Center /ID# 222957

location_facility: University General Hospital Attikon /ID# 230784

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 231161

location_facility: Florida Cancer Specialists - East /ID# 221728

location_facility: Republican hospital named after V.A. Baranov /ID# 221412

location_facility: Hospital Universitario Dr. Negrin /ID# 220897

location_facility: National Taiwan University Hospital /ID# 218976

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 222264

location_facility: Oncology Hematology Care, Inc. /ID# 222556

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 230721

location_facility: Columbus Regional Research Institute /ID# 227272

location_facility: Virginia Cancer Specialists - Fairfax /ID# 242682

location_facility: Dokkyo Medical University Saitama Medical Center /ID# 222333

location_facility: Universitaetsklinikum Aachen /ID# 221519

location_facility: CHUQ- Hôpital de l'Enfant-Jesus /ID# 221754

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 219083

location_facility: University of Texas MD Anderson Cancer Center /ID# 217994

location_facility: Fukushima Medical University Hospital /ID# 222752

location_facility: ICANS - Institut de Cancérologie Strasbourg Europe /ID# 229978

location_facility: Seoul National University Bundang Hospital /ID# 219053

location_facility: Universitair Medisch Centrum Groningen /ID# 218947

location_facility: National Cancer Center Hospital East /ID# 226093

location_facility: Moscow State budget healthcare /ID# 221025

location_facility: Taipei Veterans General Hosp /ID# 221146

location_facility: Rush University Medical Center /ID# 221581

location_facility: United Lincolnshire Hospitals NHS Trust /ID# 231471

location_facility: Florida Cancer Specialists - North /ID# 221727

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 231036

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 221658

location_facility: Minnesota Oncology Hematology /ID# 227357

location_facility: Albert Schweitzer Ziekenhuis /ID# 224015

location_facility: Rocky Mountain Cancer Centers, LLP- Littleton /ID# 222562

location_facility: Dana-Farber Cancer Institute /ID# 218010

location_facility: Utah Cancer Specialists Salt Lake Clinic /ID# 221961

location_facility: Kawasaki Medical School Hospital /ID# 221481

location_facility: Border Medical Oncology Research Unit Albury Wodonga Regional Cancer Centre /ID# 231311

location_facility: Sahlgrenska University Hospital /ID# 218776

summary:
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts body's normal production of blood cells. It causes bone marrow scarring, leading to severe anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an enlarged spleen. The purpose of this study is to see if a combination of navitoclax and ruxolitinib is more effective and safe in assessment of change in spleen volume when compared to ruxolitinib in participants with myelofibrosis.

Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in this study are divided into two groups, called treatment arms. Each group receives a different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled. Around 230 participants will be enrolled in approximately 190 sites worldwide.

Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue untill the participant cannot tolerate the study drug, or benefit is not achieved, or other reasons which qualify for discontinuation of the study drug.

There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests, checking for side effects, and completing questionnaires.


ipd_sharing: Yes

status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment

study_completion_date_type: Actual

lead_sponsor: AbbVie

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panés J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

enrollment_type: Actual

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Malaysia
Singapore
Slovakia
Egypt
Bosnia and Herzegovina
Canada
Switzerland
China
Germany
Bulgaria
Denmark
Taiwan
Belarus
Greece
Ireland
Estonia
Latvia
New Zealand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Vitebsk Regional Advanced Clin /ID# 204807

location_facility: Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171121

location_facility: Unidad de Atencion Medica e Investigacion en Salud /ID# 170765

location_facility: Wojewodzki Szpital Specjalistyczny /ID# 212400

location_facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 212798

location_facility: Hospital Clinico Universitario de Valencia /ID# 209699

location_facility: Regional Clinical Hospital #1 /ID# 200708

location_facility: Universitaetsklinikum Regensburg /ID# 163812

location_facility: Vinius University Hospital Santaros Klinikos /ID# 162524

location_facility: Centex Studies, Inc. - Houston /ID# 201218

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 161307

location_facility: Duplicate_Medical University of Vienna /ID# 158135

location_facility: Evangelisches Krankenhaus Kalk /ID# 212724

location_facility: Duplicate_Policlinico Universitario Campus Bio-Medico /ID# 162433

location_facility: University Clinical Centre of the Republic of Srpska /ID# 165018

location_facility: Hanyang University Guri Hospital /ID# 163351

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie /ID# 209980

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital Faro /ID# 160732

location_facility: Complejo Asistencial Dr. Sotero del Rio /ID# 169383

location_facility: Vanderbilt University Medical Center /ID# 157110

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 157417

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159339

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 162584

location_facility: Montreal General Hospital - McGill University Health Center /ID# 157086

location_facility: Hospital Universitario Virgen Macarena /ID# 159966

location_facility: National Cheng Kung University Hospital /ID# 160129

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 167754

location_facility: Peak Gastroenterology Associates, PC /ID# 165832

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 166910

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 157876

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 160742

location_facility: Hospital Garcia de Orta, EPE /ID# 160688

location_facility: Acibadem City Clinic UMHAT Tokuda /ID# 165698

location_facility: Gastroenterology Group Naples /ID# 165192

location_facility: Tyler Research Institute, LLC /ID# 166795

location_facility: Duplicate_Perm state medical university n.a. E.A. Vagner /ID# 207438

location_facility: Toronto Digestive Disease Asso /ID# 157159

location_facility: Riga East Clinical University Hospital /ID# 159615

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 163218

location_facility: Duplicate_Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz /ID# 202434

location_facility: Icahn School of Medicine at Mount Sinai - The Mount Sinai Medical Center /ID# 165610

location_facility: Adult Gastroenterology Associates - Gen 1 Research /ID# 208857

location_facility: Hadassah Medical Center-Hebrew University /ID# 171062

location_facility: West China Hospital, Sichuan University /ID# 210888

location_facility: Hospital Britanico de Buenos Aires /ID# 168081

location_facility: Hospital Universitario Basurto /ID# 205188

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 171130

location_facility: Duplicate_Wellington Hospital (Capital and Coast District Health Board) /ID# 167213

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 162550

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location_facility: Baylor Scott & White Medical Center- Temple /ID# 204129

location_facility: Southern Star Research Institute, LLC /ID# 168772

location_facility: Southern California Res. Ctr. /ID# 211989

location_facility: Texas Digestive Disease Consultants /ID# 209781

location_facility: West Tallinn Central Hospital /ID# 157073

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 161303

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location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 158039

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location_facility: H-T. Centrum Medyczne - Endoterapia /ID# 212458

location_facility: Hospital Universitario La Paz /ID# 159232

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location_facility: Centrum Medyczne LukaMed Joanna Luka-Wendrowska /ID# 212079

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 205736

location_facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 210626

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 161302

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 157419

location_facility: Western Connecticut Medical Group /ID# 165874

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163889

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 162655

location_facility: Barnsley Hospital NHS Foundation Trust /ID# 202772

location_facility: Soroka University Medical Center /ID# 157789

location_facility: Hospital Privado Univesitario /ID# 168080

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 212218

location_facility: Duplicate_Rambam Medical Center /ID# 171056

location_facility: GIRI Gastrointestinal Research Institute /ID# 157097

location_facility: 1 Wojskowy Szpital Kliniczny Z Poliklinika /Id# 209984

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 158023

location_facility: Universitaetsklinikum Erlangen /ID# 159332

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location_facility: Hospital Universitario y Politecnico La Fe /ID# 157537

location_facility: University Children's Hospital 'Tirsova' /ID# 211480

location_facility: Northwest Gastroenterology Clinic /ID# 158255

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 154919

location_facility: Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 170766

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 159058

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 157100

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159338

location_facility: The Sixth Affiliated Hosp Sun /ID# 210783

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213553

location_facility: Plains Clinical Research Center, LLC /ID# 169712

location_facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 162024

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location_facility: Advanced Research Institute, Inc /ID# 161973

location_facility: National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 204806

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location_facility: Internal Medicine Department, Faculty of Medicine, AinShams University /ID# 158630

location_facility: CHUM - Centre hospitalier de l'Universite de Montréal /ID# 167070

location_facility: Scott Shulman Medicine Professional Corporation /ID# 165910

location_facility: South Florida Research Ph I-IV, Inc. /ID# 161825

location_facility: Children's Hospital of Pittsburgh of UPMC /ID# 212543

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location_facility: Inje University Haeundae Hospital /ID# 202516

location_facility: Theageneio Anticancer Hospital /ID# 163922

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location_facility: Hull University Teaching Hospitals NHS Trust /ID# 158759

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159234

location_facility: St Vincent's University Hospital /ID# 157569

location_facility: National University Hospital /ID# 160662

location_facility: The University of Chicago Medical Center /ID# 157113

location_facility: University of Nebraska Medical Center /ID# 210056

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location_facility: Phoenix VA Health Care System /ID# 162261

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location_facility: Great Lakes Medical Research, LLC /ID# 201774

location_facility: Nemocnice Milosrdnych sester sv. Karla Boromejskeho v Praze /ID# 211304

location_facility: Cabinet Particular Policlinic Algomed /ID# 170889

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 215146

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 158037

location_facility: Louisana Research Center, LLC /ID# 162239

location_facility: Kuzbass Regional Clinical Hospital /ID# 200707

location_facility: Hospital Clinic de Barcelona /ID# 157533

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 201362

location_facility: Rocky Mountain Pediatric Gastroenterology /ID# 207171

location_facility: Medical University of South Carolina /ID# 212859

location_facility: CHA Bundang Medical center CHA University /ID# 163377

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 160676

location_facility: Instituto de Coloproctologia /ID# 158740

location_facility: Universal Axon Clinical Research /ID# 165426

location_facility: Tver Regional Clinical Hospital /ID# 206586

location_facility: Duplicate_Atria Clinical Research /ID# 164504

location_facility: City Clinical Hospital No. 31 /ID# 208865

location_facility: Clinical Research of West Florida, Inc /ID# 208127

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 154891

location_facility: Duplicate_AOU Ospendali Riuniti di Ancona /ID# 162431

location_facility: Virginia Mason - Seattle Orthapedics /ID# 155577

location_facility: Clinical Center University of Sarajevo /ID# 165132

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 160691

location_facility: Taipei Veterans General Hosp /ID# 212711

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 211241

location_facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 161267

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 162549

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 154753

location_facility: United Medical Doctors - Murrieta /ID# 158278

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 210527

location_facility: Duplicate_Institutul Clinic Fundeni /ID# 170888

location_facility: PennState Milton S.Hershey Med /ID# 154894

location_facility: National Taiwan University Hospital /ID# 162189

location_facility: Duplicate_Long Island Clinical Research /ID# 154843

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 157720

location_facility: QEII - Health Sciences Centre /ID# 157089

location_facility: Duplicate_Transcarpathian Regional Clin. /ID# 167958

location_facility: Zagazig University Hospitals /ID# 164018

location_facility: Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207938

location_facility: Texas Digestive Disease Consultants /ID# 209945

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 210925

location_facility: CHU Amiens-Picardie Site Sud /ID# 165056

location_facility: East Tennessee Research Institute /ID# 168735

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 155659

location_facility: Saratoga Schenectady Gastroenterology Associates - Burnt Hills /ID# 213446

location_facility: TX Clinical Research Institute /ID# 159396

location_facility: University Clinical Center Kragujevac /ID# 156961

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 163620

location_facility: Columbia Univ Medical Center /ID# 167545

location_facility: Percuro Clinical Research, Ltd /ID# 161635

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 157534

location_facility: Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 213578

location_facility: Odense Universitets Hospital /ID# 155536

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 157577

location_facility: Second Multiprofile Hospital f /ID# 165699

location_facility: Duplicate_Centrul Medical Tuculanu SRL /ID# 170892

location_facility: Health Pharma Professional Research S.A de C.V /ID# 170763

location_facility: Tel Aviv Sourasky Medical Center /ID# 157787

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 163604

location_facility: National Hepatology and Tropical Medicine Research Institute /ID# 157875

location_facility: Duplicate_Universitaetsklinikum Freiburg /ID# 162025

location_facility: Private Practice Dr MN Rajabally /ID# 171159

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 169766

location_facility: Aalborg Universitets Hospital /ID# 160685

location_facility: Agaplesion Markus Krankenhaus /ID# 159334

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 155656

location_facility: HonorHealth Research Institute - Shea /ID# 165825

location_facility: University Clinical Centre of the Republic of Srpska /ID# 157710

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 160677

location_facility: Rapid City Medical Center - GI Research /ID# 163835

location_facility: Duplicate_Clin Hosp Ctr Bezanijska Kosa /ID# 156959

location_facility: Duplicate_Klinicka bolnica Dubrava Zagreb /ID# 157719

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 210857

location_facility: Houma Digestive Health Special /ID# 158253

location_facility: London Health Sciences Center /ID# 157162

location_facility: Pauls Stradins Clinical University Hospital /ID# 159616

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclaw /ID# 212534

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 154846

location_facility: University General Hospital of Ioannina /ID# 157415

location_facility: Hospital General Universitario Gregorio Maranon /ID# 161144

location_facility: Intercity Advanced Gastroentertology Center /ID# 215204

location_facility: NorthShore University HealthSystem /ID# 158254

location_facility: Duplicate_LKH-Univ. Klinikum Graz /ID# 158134

location_facility: Duplicate_Ospedale Policlinico San Martino/ Università Degli Studi Di Genova /ID# 162434

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210842

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 158194

location_facility: Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211882

location_facility: Klinicki bolnicki centar Zagreb /ID# 157703

location_facility: Northwestern University Division of GI/Hepatology /ID# 158250

location_facility: University Multiprofile Hospit /ID# 167576

location_facility: Digestive Disease Associates, LTD /ID# 208296

location_facility: South Lake Pain Institute, Inc /ID# 162798

location_facility: East Tallinn Central Hospital /ID# 157072

location_facility: Duplicate_Gastro-Praxis Wiesbaden /ID# 159335

location_facility: University of Kentucky Chandler Medical Center /ID# 157109

location_facility: Yeungnam University Medical Center /ID# 163366

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 164423

location_facility: Universitaetsklinikum St. Poelten /ID# 166423

location_facility: Duplicate_Universita di Catanzaro Magna Graecia /ID# 212017

location_facility: Stadtisches Klinikum Braunschweig /ID# 163673

location_facility: Hospital Universitario Miguel Servet /ID# 157538

location_facility: Vidant Multispecialty Clinic - Kinston /ID# 161109

location_facility: University of Calgary - Heritage Medical Research Clinic /ID# 157156

location_facility: CliniCore International, LLC /ID# 158191

location_facility: Univerzitna nemocnica Martin /ID# 163205

location_facility: Hospital Clinico Universitario de Salamanca /ID# 157539

location_facility: Duplicate_Northern Care Alliance NHS Group /ID# 207765

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 155535

location_facility: Cleveland Clinic Main Campus /ID# 209225

location_facility: Clinical Hosp Center Zvezdara /ID# 156956

location_facility: Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 212018

location_facility: Universitatsklinikum Mannheim /ID# 162026

location_facility: Velocity Clinical Research - Salt Lake City /ID# 161775

location_facility: University Multiprofile Hospit /ID# 165697

location_facility: The First Affiliated Hospital of Nanchang University /ID# 211035

summary: The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) Versus Crizotinib in Patients With ALK-positive Advanced Lung Cancer

lead_sponsor: Ariad Pharmaceuticals

type: Other Identifier

ReferenceCitation: Camidge DR, Kim HR, Ahn MJ, Yang JCH, Han JY, Hochmair MJ, Lee KH, Delmonte A, García Campelo MR, Kim DW, Griesinger F, Felip E, Califano R, Spira A, Gettinger SN, Tiseo M, Lin HM, Gupta N, Hanley MJ, Ni Q, Zhang P, Popat S. Brigatinib Versus Crizotinib in Advanced ALK Inhibitor-Naive ALK-Positive Non-Small Cell Lung Cancer: Second Interim Analysis of the Phase III ALTA-1L Trial. J Clin Oncol. 2020 Nov 1;38(31):3592-3603. doi: 10.1200/JCO.20.00505. Epub 2020 Aug 11.

ReferenceCitation: Camidge DR, Kim HR, Ahn MJ, Yang JC, Han JY, Lee JS, Hochmair MJ, Li JY, Chang GC, Lee KH, Gridelli C, Delmonte A, Garcia Campelo R, Kim DW, Bearz A, Griesinger F, Morabito A, Felip E, Califano R, Ghosh S, Spira A, Gettinger SN, Tiseo M, Gupta N, Haney J, Kerstein D, Popat S. Brigatinib versus Crizotinib in ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2018 Nov 22;379(21):2027-2039. doi: 10.1056/NEJMoa1810171. Epub 2018 Sep 25.

ReferenceCitation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10.

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

location_country:
Denmark
Taiwan
Hong Kong
Luxembourg
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
Sweden
Korea, Republic of
United States
France
Singapore
Norway
Germany

location_facility: Istituto Tumori Napoli Fondazione G. Pascale

location_facility: Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi

location_facility: Centre Hospitalier Universitaire Hopital Nord

location_facility: Hospital Regional Universitario Carlos Haya Malaga Instituto de Neurociencias Clinicas

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Teresa Herrera - Materno Infantil

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Centre de Lutte Contre le Cancer Francois Baclesse

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Istituto Oncologico di Bari Giovanni Paolo II

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: Istituto Scientifico Universitario San Raffaele

location_facility: Kliniken der Stadt Koeln gGmbH - Krankenhaus Merheim

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Virginia Cancer Specialists - Fairfax Office

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita

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

location_facility: Amphia Ziekenhuis - Locatie Langendijk Breda

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Seoul National University Bundang Hospital

location_facility: Kaiser Permanente Bellflower Medical Offices

location_facility: Studiengesellschaft Haemato-Onkologie Hamburg Prof. Laack und Partner

location_facility: Centre Hospitalier de Luxembourg - Hopital Municipal

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: USOR - Arizona Oncology Associates - Sedona

location_facility: Hospital Universitario Central de Asturias

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Centro di Riferimento Oncologico di Aviano

summary: The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by progression-free survival (PFS).


title: TIGER-2: A Phase 2, Open-label, Multicenter, Safety and Efficacy Study of Oral CO-1686 as 2nd Line EGFR-directed TKI in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC)

acronym: NSCLC

summary: The purpose of this study is to evaluate the safety and anti-tumor effect of rociletinib. The trial is open-ended, which means patients will continue to take rociletinib until the study doctor determines it is no longer beneficial for them.

status: Terminated

lead_sponsor: Clovis Oncology, Inc.

location_country:
Taiwan
Hong Kong
Spain
United Kingdom
Australia
Netherlands
Canada
Switzerland
Korea, Republic of
United States
France
Germany

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire Vaudoise

location_facility: University of California San Diego Moores Cancer Center

location_facility: Centre Hospitalier Regional Universitaire (CHRU) de Besancon - L'Hopital Jean Minjoz

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Universitaetsklinikum Bonn - Zentrum fuer Innere Medizin - Medizinische Klinik und Poliklink III

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Universitaire Hôpital Nord

location_facility: Centre Hospitalier Universitaire Côte de Nacre

location_facility: Guy's and Saint Thomas NHS Foundation Trust

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau

location_facility: University of California Davis Medical Center

location_facility: Yakima Valley Memorial Hospital, North Star Lodge

status_simplified: Unknown


title: Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma

summary:
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 132 adult participants with NHL will be enrolled in 100 sites globally.

In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in combination with anti-neoplastic agents in 28-day cycles for arms 1 and 2 and 21- day cycles for arm 3.

Arm 1: SC epcoritamab in combination with oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Arm 2: SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL.

Arm 3: SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Denmark
Taiwan
Spain
United Kingdom
Netherlands
Hungary
Korea, Republic of
United States
France
Israel
Japan
Germany
Czechia

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 245031

location_facility: Universitaetsklinikum Regensburg /ID# 244517

location_facility: Universitaetsklinikum Leipzig /ID# 245513

location_facility: Maastricht Universitair Medisch Centrum /ID# 243317

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 242450

location_facility: Tel Aviv Sourasky Medical Center /ID# 243012

location_facility: Universitair Medisch Centrum Groningen /ID# 243318

location_facility: The Chaim Sheba Medical Center /ID# 243010

location_facility: Icahn School of Medicine at Mount Sinai /ID# 242123

location_facility: China Medical University Hospital /ID# 242893

location_facility: Vrije Universiteit Medisch Centrum /ID# 243319

location_facility: Imperial College Healthcare NHS Trust /ID# 245851

location_facility: Fakultni nemocnice Hradec Kralove /ID# 241722

location_facility: Hospital Universitario Virgen del Rocio /ID# 243267

location_facility: Leids Universitair Medisch Centrum /ID# 243316

location_facility: Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 242685

location_facility: Christiana Care Health Service /ID# 242301

location_facility: University of Maryland School of Medicine /ID# 242218

location_facility: Universitaetsklinikum Giessen und Marburg /ID# 245308

location_facility: Hokkaido University Hospital /ID# 248999

location_facility: Novant Health Presbyterian Medical Center /ID# 242148

location_facility: Northwell Health - Monter Cancer Center /ID# 245435

location_facility: Universitaetsklinikum Wuerzburg /ID# 245453

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 245056

location_facility: Multicare Institute for Research and Innovation /ID# 242127

location_facility: Novant Health Forsyth Medical Center /ID# 242198

location_facility: National Cancer Center Hospital /ID# 248995

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 242403

location_facility: East Carolina University Brody School of Medicine /ID# 242506

location_facility: Hadassah Medical Center-Hebrew University /ID# 243013

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 243264

location_facility: Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144

location_facility: Joe Arrington Cancer Research /ID# 242226

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268

location_facility: Gabrail Cancer Center Research /ID# 242212

location_facility: Universitaetsmedizin Rostock /ID# 244655

location_facility: CHRU Lille - Hopital Claude Huriez /ID# 242335

location_facility: Seoul National University Hospital /ID# 242402

location_facility: CHU de Rennes - PONTCHAILLOU /ID# 242339

location_facility: Augusta University Georgia Cancer Center /ID# 242140

location_facility: Hospital Universitario Vall d'Hebron /ID# 243260

location_facility: National Cheng Kung University Hospital /ID# 242894

location_facility: Hospital Universitario 12 de Octubre /ID# 243262

location_facility: Thompson Cancer Survival Ctr /ID# 242150

location_facility: Hospital Universitario de Salamanca /ID# 243368

location_facility: Taipei Veterans General Hosp /ID# 242892

location_facility: CHRU Nancy - Hopitaux de Brabois /ID# 242342

location_facility: Seoul National University Bundang Hospital /ID# 242404

location_facility: Swedish Cancer Institute - Edmonds /ID# 242269

location_facility: University of Arizona Cancer Center - North Campus /ID# 242219

location_facility: Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336

location_facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 245935

location_facility: Universitatsklinikum Munster /ID# 248304

location_facility: Hospital Clinico Universitario de Valencia /ID# 243269

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 242345

status_simplified: Ongoing


title: Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Puerto Rico
Israel
Turkey
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Ireland
Korea, Republic of
France
Netherlands

location_facility: Krasnoyarsk Regional Clinical Oncology Dispensary n.a. A.I. Kryzhanovsky /ID# 232065

location_facility: Yokohama Municipal Citizen's Hospital /ID# 248374

location_facility: Houston Methodist Hospital - Scurlock Tower /ID# 213268

location_facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 205309

location_facility: Haematologisch-Onkologische Praxis im Zentrum Augsburg /ID# 232052

location_facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 227011

location_facility: LA Hematology-Oncology Med Group /ID# 203338

location_facility: Niigata Cancer Center Hospital /ID# 216462

location_facility: Goshen Center for Cancer Care /ID# 215584

location_facility: Hospital Universitario Vall d'Hebron /ID# 206997

location_facility: Chonnam National University Hwasun Hospital /ID# 206951

location_facility: Fujian Provincial Cancer Hospital /ID# 210808

location_facility: Oxford University Hospitals NHS Foundation Trust /ID# 205890

location_facility: Koo Foundation Sun Yat-Sen Cancer Center /ID# 227336

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 205601

location_facility: Regional Children's Clinical Hospital of Volgograd /ID# 206520

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 204367

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 205528

location_facility: Matsusaka Municipal Hospital /ID# 230219

location_facility: Princess Margaret Cancer Centre /ID# 204423

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 204878

location_facility: Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti /ID# 227216

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 232024

location_facility: Trakya University Medical Facu /ID# 205242

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 216153

location_facility: Hospital Nuestra Señora de Sonsoles /ID# 232367

location_facility: Linkou Chang Gung Memorial Hospital /ID# 205424

location_facility: National Medical Research Radiological Centre /ID# 231263

location_facility: Affiliated Hospital of Hebei University /ID# 227262

location_facility: Krankenhaus Martha-Maria Halle-Doelau /ID# 205442

location_facility: Acibadem City Clinic Tokuda University Hospital EAD /ID# 232010

location_facility: St. Vincent Frontier Cancer Center /ID# 203292

location_facility: Univ of Colorado Cancer Center /ID# 203212

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211119

location_facility: St Vincent's University Hospital /ID# 205102

location_facility: CHU UCL Namur - Sainte Elisabeth /ID# 234048

location_facility: Vanderbilt Ingram Cancer Center /ID# 203281

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 205423

location_facility: Arkhangelsk Clinical Oncology Dispensary /ID# 216418

location_facility: Hospital Universitario y Politecnico La Fe /ID# 203862

location_facility: Hospital Universitario Ramon y Cajal /ID# 203922

location_facility: Virginia Cancer Specialists - Fairfax /ID# 203224

location_facility: Gabrail Cancer Center Research /ID# 216056

location_facility: Taichung Veterans General Hospital /ID# 205308

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 221844

location_facility: Aichi Cancer Center Hospital /ID# 207790

location_facility: Baylor Scott & White Medical Center- Temple /ID# 216578

location_facility: Taipei Medical University Shuang Ho Hospital /ID# 215356

location_facility: Duplicate_Veszprem Megyei Tudogyogyintez /ID# 213950

location_facility: Gazi University Medical Faculty /ID# 239816

location_facility: Fudan University Shanghai Cancer Center /Id# 210084

location_facility: Providence Cancer Center Oncology and Hematology Care - Westside Portland /ID# 203301

location_facility: Ottawa Hospital Research Institute /ID# 205579

location_facility: University College London Hospitals NHS Foundation Trust /ID# 231467

location_facility: St John Of God Subiaco Hospital /ID# 226943

location_facility: Akdeniz Universitesi Tip Fakul /ID# 205238

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 227623

location_facility: Hospital Universitario Fundacion Alcorcon /ID# 232361

location_facility: Asklepios Fachkliniken Muenchen-Gauting /ID# 207789

location_facility: Kobe Minimally Invasive Cancer Center /ID# 248590

location_facility: Centre Hosp Intercommunal de Creteil /ID# 227108

location_facility: Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej /ID# 231476

location_facility: Joliet Oncology-Hematology Associates, LTD /ID# 203238

location_facility: Dana-Farber Cancer Institute /ID# 203248

location_facility: Universitatsklinikum Mannheim /ID# 228798

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 231948

location_facility: Norton Cancer Institute - St Matthews /ID# 203284

location_facility: Univercity Headache Clynic,LTD /ID# 212080

location_facility: The University of Chicago Medical Center /ID# 203216

location_facility: National Cheng Kung University Hospital /ID# 205307

location_facility: Clinical Oncology Dispensary of Omsk /ID# 239313

location_facility: Evangelisches Krankenhaus Hamm /ID# 208043

location_facility: Kinki-Chuo Chest Medical Center /ID# 216461

location_facility: Soroka University Medical Center /ID# 204898

location_facility: St. Petersburg scientific center for specialized medical care (oncological) /ID# 206405

location_facility: Hirosaki University Hospital /ID# 245023

location_facility: Advanced Cancer Treatment Center /ID# 239565

location_facility: Mater Misericordiae Univ Hospital /ID# 231466

location_facility: Wojewodzki Szpital im. Sw. Ojca Pio /ID# 231960

location_facility: KSW Kantonsspital Winterthur /ID# 231284

location_facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 211154

location_facility: The Cancer Institute Hospital Of JFCR /ID# 216463

location_facility: Fujieda Municipal General Hospital /ID# 248589

location_facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 216106

location_facility: The Chaim Sheba Medical Center /ID# 204254

location_facility: Pusan National University Yangsan Hospital /ID# 233871

location_facility: West China Hospital, Sichuan University /ID# 210022

location_facility: Center of Palliative Medicine De Vita /ID# 212900

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 229647

location_facility: Republican Clinical Oncology Dispensary /ID# 206463

location_facility: Harbin Medical University Cancer Hospital /ID# 231573

location_facility: Beth Israel Deaconess Medical Center /ID# 208124

location_facility: Henry Ford Hospital - West Bloomfield /ID# 203220

location_facility: Yamaguchi - Ube Medical Center /ID# 227778

location_facility: The First People's Hospital of Changzhou /ID# 210787

location_facility: CHU Strasbourg - Hopital Civil /ID# 208080

location_facility: Anhui Provincial Cancer Hospital /ID# 239058

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 230595

location_facility: Hospital Universitario HM Sanchinarro /ID# 203913

location_facility: Dartmouth-Hitchcock Medical Center /ID# 203350

location_facility: Medical College of Wisconsin /ID# 210062

location_facility: Sutter Medical Center Sacramen /ID# 203299

location_facility: Universitaetsklinikum Giessen /ID# 231856

location_facility: Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 215082

location_facility: Vseobecna fakultni nemocnice v Praze /ID# 229797

location_facility: Hospital Universitario Virgen del Rocio /ID# 216058

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 205243

location_facility: AdventHealth Cancer Institute - Orlando /ID# 239960

location_facility: National Hospital Organization Kyushu Cancer Center /ID# 206061

location_facility: Adana Sehir Egitim ve Arastirma Hastanesi /ID# 206000

location_facility: Hospital Universitario Dexeus - Grupo Quironsalud /ID# 232368

location_facility: CHU Lille - Hôpital Albert Calmette /ID# 205105

location_facility: National Taiwan University Hospital /ID# 205100

location_facility: NorthShore University HealthSystem /ID# 215583

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 215918

location_facility: Highlands Oncology Group, PA /ID# 215600

location_facility: Institutul Oncologic Prof Dr I Chiricuta /ID# 206320

location_facility: Kostroma region oncology center /ID# 231317

location_facility: National Hospital Organization Shikoku Cancer Center /ID# 232252

location_facility: Azienda Ospedaliero-Universitaria di Parma /ID# 204983

location_facility: Mercy Research Mercy Clinic Oklahoma Communities, Inc. / OKC OK /ID# 230154

location_facility: Nottingham University Hospitals NHS Trust /ID# 231224

location_facility: VA Caribbean Healthcare System /ID# 206336

location_facility: Puerto Rico Hematology Oncolog /ID# 206337

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 227244

location_facility: Northwestern University Feinberg School of Medicine /ID# 203239

location_facility: Massachusetts General Hospital /ID# 203215

location_facility: Washington University-School of Medicine /ID# 203217

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 228868

location_facility: CHU Insular-Materno Infantil /ID# 232362

location_facility: Universitair Ziekenhuis Antwerpen /ID# 217430

location_facility: Central Maine Medical Center /ID# 216583

location_facility: Hospital Universitario Virgen Macarena /ID# 230998

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 205831

location_facility: Thompson Cancer Survival Ctr /ID# 228874

location_facility: Capital Health Medical Center /ID# 203403

location_facility: The First Affiliated Hospital of Guangzhou Medical University /ID# 232261

location_facility: University of California, Los Angeles /ID# 203219

location_facility: The First Affiliated Hospital of Nanchang University /ID# 239380

location_facility: National Cancer Center Hospital /ID# 205066

location_facility: L'Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialità San Giuseppe Mos /ID# 204707

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 206209

location_facility: Seoul National University Bundang Hospital /ID# 204237

location_facility: Torokbalinti Tudogyogyintezet /ID# 204883

location_facility: Rocky Mountain Cancer Centers /ID# 215789

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 205163

location_facility: Osaka International Cancer Institute /ID# 210735

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 205530

location_facility: Guangxi Medical University Cancer Center /ID# 231560

summary: This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3).


title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU)

acronym: MERU

summary: This is a Phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.

ReferenceCitation: Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Belarus
Greece
Ireland
Estonia
Latvia
Finland
Korea, Republic of
France
Netherlands

location_facility: Ege University Medical Faculty /ID# 159243

location_facility: Maastricht Universitair Medisch Centrum /ID# 161669

location_facility: IRST IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori /ID# 160898

location_facility: OOO Centre of Palliative Medicine De Vita /ID# 206855

location_facility: Evangelische Lungenklinik Berl /ID# 158935

location_facility: Northwell Health - Monter Cancer Center /ID# 159252

location_facility: Bobruysk Interdistrict Onco. /ID# 169393

location_facility: Tri-Service General Hospital /ID# 158980

location_facility: Akdeniz Universitesi Tip Fakul /ID# 160791

location_facility: N.N. Petrov Research Inst Onc /ID# 159370

location_facility: Taipei Veterans General Hosp /ID# 203699

location_facility: National Hospital Organization Himeji Medical Center /ID# 165899

location_facility: National Medical Research Cntr /ID# 169885

location_facility: MD Anderson Cancer Center at Cooper - Camden /ID# 156681

location_facility: UT Southwestern Medical Center /ID# 157848

location_facility: Akershus universitetssykehus /ID# 201682

location_facility: Krankenhaus Nord - Klinik Floridsdorf /ID# 201768

location_facility: Salzburger Landeskliniken (SALK) /ID# 201779

location_facility: Sarah Cannon Research Institute-Chattanooga /ID# 202933

location_facility: State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159383

location_facility: Taichung Veterans General Hosp /ID# 159047

location_facility: Sparrow Regional Cancer Center, Sparrow Health System /ID# 156590

location_facility: Chungbuk National University /ID# 159300

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 160016

location_facility: Hospital Parc de Salut del Mar /ID# 159690

location_facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159658

location_facility: Hospital Universitario Vall d'Hebron /ID# 159708

location_facility: Christie NHS Foundation Trust /ID# 159037

location_facility: Kansai Medical University Hospital /ID# 165054

location_facility: Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159661

location_facility: Wojewodzki Szpital Specjalisty /ID# 159603

location_facility: Duke University Medical Center /ID# 156706

location_facility: Haukeland University Hospital /ID# 159573

location_facility: CHA Bundang Medical center CHA University /ID# 161281

location_facility: Assaf Harofeh Medical Center /ID# 201883

location_facility: Riga East Clinical University /ID# 158716

location_facility: Hospital Teresa Herrera - CHUAC /ID# 164368

location_facility: Centro de Investigación Clinica Chapultepec /ID# 160965

location_facility: Erciyes University Medical Fac /ID# 202269

location_facility: Institut za onkologiju i radio /ID# 160904

location_facility: Institute For Pulmonary Diseas /ID# 164250

location_facility: Dalin Tzu Chi General Hospital /ID# 158983

location_facility: R.S. McLaughlin Durham Regional /ID# 170870

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 158953

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 158798

location_facility: Centre Hosp Intercommunal de Creteil /ID# 162686

location_facility: Tel Aviv Sourasky Medical Center /ID# 161467

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 159638

location_facility: British Columbia Cancer Agency /ID# 163721

location_facility: The Affiliated Cancer Hospital of Xinjiang Medical university /ID# 203641

location_facility: Thoraxklinik Heidelberg gGmbH /ID# 158871

location_facility: Cancercare Langenhoven Drive Oncology Centre /ID# 159126

location_facility: National Cheng Kung University Hospital /ID# 158799

location_facility: Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 159864

location_facility: VA Pittsburgh HealthcareSystem /ID# 159284

location_facility: 4th Military Medical Universit /ID# 203986

location_facility: Nemocnice Rudolfa a Stefanie /ID# 159655

location_facility: Hospital Evangelico de Cachoei /ID# 159657

location_facility: Kanazawa University Hospital /ID# 165127

location_facility: Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 158783

location_facility: Universitair Medisch Centrum Utrecht /ID# 158083

location_facility: Palo Alto Veterans Institute for Research /ID# 203695

location_facility: AUSL 8 Arezzo Ospedale San Don /ID# 160897

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 160874

location_facility: Centro Hospitalar do Porto EPE /ID# 203582

location_facility: University Hospital of Ioannin /ID# 159158

location_facility: St Jude Hospital dba St Joseph /ID# 156526

location_facility: Mogilev Reg Clin Oncology Dis /ID# 159384

location_facility: Parkland Health and Hosp Syste /ID# 170933

location_facility: Klinika za plucne bolesti Jordanovac /ID# 159505

location_facility: Houston Methodist Hospital - Scurlock Tower /ID# 202323

location_facility: Kaluga Regional Clinical Oncol /ID# 160180

location_facility: Ospedale Santa Maria delle Cro /ID# 158911

location_facility: Odense Universitets Hospital /ID# 158054

location_facility: The Royal Bournemouth Hospital /ID# 159039

location_facility: Univ Medical Ctr Brackenridge /ID# 155798

location_facility: CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159131

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 159604

location_facility: Smolensk Regional Onc Clin Dis /ID# 159372

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 159709

location_facility: Unidade Local Saude Matosinhos /ID# 159950

location_facility: Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159865

location_facility: North Estonian Medical Centre /ID# 159779

location_facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 159090

location_facility: Asklepios Fachkliniken M. Gaut /ID# 158789

location_facility: West Virginia Univ School Med /ID# 156687

location_facility: Christiana Care Health Service /ID# 159212

location_facility: First Affiliated Hospital of Xi'an Jiaotong University /ID# 203733

location_facility: IFO Istituto Nazionale Tumori /ID# 158912

location_facility: Health Pharma professional Ser /ID# 160734

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 159957

location_facility: Istanbul Medeniyet Universites /ID# 200126

location_facility: Tokushima University Hospital /ID# 166105

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz - Pulmonologia /ID# 202466

location_facility: Korea University Guro Hospital /ID# 159302

location_facility: Aichi Cancer Center Hospital /ID# 164976

location_facility: Ashland-Bellefonte Cancer Ctr /ID# 202901

location_facility: Gabrail Cancer Center Research /ID# 156667

location_facility: Klinicki bolnicki centar Rijeka /ID# 159504

location_facility: Kyungpook National University Chilgok Hospital /ID# 159301

location_facility: Hacettepe University Medical Faculty /ID# 159242

location_facility: Thompson Cancer Survival Ctr /ID# 202460

location_facility: University Hospital Linkoping /ID# 159046

location_facility: Harbin Medical University Cancer Hospital /Id# 203638

location_facility: Soroka University Medical Center /ID# 159762

location_facility: St. Luke's Mountain States Tumor Institute - Boise /ID# 156691

location_facility: Japanese Red Cross Okayama Hospital /ID# 165157

location_facility: Yokohama City University Hospital /ID# 165746

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 160903

location_facility: Liga Norte Rio Grandense Cont. /ID# 159011

location_facility: NorthShore University HealthSystem - Evanston Hospital /ID# 156664

location_facility: East Tallinn Central Hospital /ID# 160019

location_facility: Hopitaux Universitaires de Geneve /ID# 160603

location_facility: Calvary North Adelaide Hospita /ID# 161701

location_facility: General Oncological Hospital /ID# 159159

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 158962

location_facility: University Hospital Waterford /ID# 159713

location_facility: University of Florida - Archer /ID# 155799

location_facility: National Cancer Center Hospital East /ID# 165721

location_facility: Hospital Universitario Fundacion Jimenez Diaz /ID# 159693

location_facility: Kanagawa Cardiovascular and Respiratory Center /ID# 165015

location_facility: Icahn School of Med Mt. Sinai /ID# 159210

location_facility: Hospital Clinico Universitario San Carlos /ID# 159706

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159659

location_facility: Arkhangelsk clinical oncology /ID# 159367

location_facility: Goshen Center for Cancer Care /ID# 156682

location_facility: SMZ Baumgartner Höhe, Otto-Wagner-Spital und Pflegezentrum /ID# 201776

location_facility: Dr Albert, Bouwer and Jordaan Incorporated /ID# 158873

location_facility: Fujian Provincial Cancer Hospital /ID# 204864

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 159044

location_facility: Stavanger Universitetssykehus /ID# 159575

location_facility: Tennessee Oncology-Nashville Centennial /ID# 161168

location_facility: Ordensklinikum Linz GmbH, Elisabethinen /ID# 159564

location_facility: Szpitale Pomorskie Sp. z o.o /ID# 159605

location_facility: Cancercare Outeniqua Oncology Unit /ID# 200689

location_facility: Stony Brook University Hospital /ID# 159272

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 202409

location_facility: Csongrad Megyei Mellkasi Beteg /ID# 158952

location_facility: Bezmi alem Vakif Universitesi /ID# 202267

location_facility: Southeastern Regional Medical /ID# 163064

location_facility: Volyn Regional Medical Oncology Centre /ID# 159133

location_facility: Torbay Hospital - So Devon HC /ID# 159041

location_facility: PE PMC Acinus, Medical and Diagnostic Center /ID# 165543

location_facility: Windsor Regional Cancer Centre /ID# 170869

location_facility: Municipal institution Multifie /ID# 159130

location_facility: Cancer Specialists of North Florida - Southpoint /ID# 156595

location_facility: St Vincent's University Hosp /ID# 161678

location_facility: Klaipeda University Hospital /ID# 160018

location_facility: Queen Elizabeth Medical Centre /ID# 162899

location_facility: China Medical University Hosp /ID# 158981

location_facility: National Cancer Center Hospital /ID# 166547

location_facility: Affinity Clinical Research Ser /ID# 158887

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159160

location_facility: Hospital Universitario La Paz /ID# 159692

location_facility: Metropolitan General Hospital /ID# 202422

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159012

location_facility: University Hospital Limerick /ID# 159714

location_facility: Associação Hospital de Caridade Ijuí - Centro de Tratamento de Cancer - CACON /ID# 159013

location_facility: Nebraska Hematology Oncology /ID# 156534


title: Global Multicentre Kidney Transplant Advagraf Conversion Registry. A Non-interventional Post-authorisation Study (PAS)

acronym: CHORUS

summary: A study to evaluate changes over time in renal function from baseline (time of conversion) up until five years post conversion in kidney transplant patients converted from tacrolimus twice daily (BD) formulations to a once daily formulation as Advagraf.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Serbia
Spain
Italy
United Kingdom
Romania
Philippines
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Malaysia
Canada
Hungary
Germany
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France
Netherlands

location_facility:
Site AT4302
Site PL4801
Site AU6110
Site IT3902
Site HU3601
Site FR3324
Site JP8108
Site IT3907
Site TW8861
Site IT3903
Site JP8110
Site KR8214
Site GR3002
Site ES3403
Site KR8204
Site FR3312
Site PT3511
Site KR8203
Site RO4001
Site IT3901
Site JP8101
Site CA1001
Site GR3004
Site AU6108
Site IT3913
Site FR3315
Site JP8105
Site RO4003
Site KR8202
Site AU6107
Site IT3915
Site FR3313
Site IT3916
Site FR3305
Site FR3306
Site TH6601
Site KR8201
Site TH6602
Site KR8219
Site FR3325
Site FR3323
Site KR8207
Site IT3910
Site IT39013
Site NL3103
Site IT3905
Site MY6001
Site FR3314
Site GB4405
Site PL4807
Site KR8206
Site TW8862
Site NL3105
Site AT4301
Site RO4002
Site FR3319
Site VN8402
Site AU6104
Site JP8109
Site NL3104
Site SB3801
Site HK8521
Site CZ4202
Site IT3908
Site DE4902
Site KR8209
Site HU3602
Site JP8107
Site FR3308
Site SB3802
Site TH6603
Site GB4408
Site FR3317
Site KR8210
Site VN8401
Site FR3321
Site KR8213
Site JP8111
Site IT3912
Site IT3911
Site KR8211
Site HK8201
Site AU6106
Site TW8863
Site GB4401
Site FR3318
Site FR3307
Site FR3309
Site GB4406
Site FR3302
Site IT3904
Site BE3201
Site GB4402
Site ES3410
Site GB4407
Site AT4303
Site IT3906
Site FR3310
Site PL4806
Site JP8102
Site DE4901
Site PL4808
Site FR3322
Site IT3909
Site PH6303
Site KR8208
Site AT4304
Site KR8205
Site JP8104
Site KR8215
Site AU6105
Site KR8218
Site SB3804
Site KR8216
Site GB4403
Site SB3803
Site JP8106
Site FR3301
Site FR3303
Site AU6111
Site DE4903
Site NL3101
Site FR3311
Site FR3316
Site AU6103
Site IT3914
Site ES3401
Site KR8212
Site RO4004


type: Registry Identifier

title: PARALLEL 303: A Phase 2, Double-blind, Randomized Study of BGB-290 Versus Placebo as Maintenance Therapy in Patients With Inoperable Locally Advanced or Metastatic Gastric Cancer That Responded to Platinum-based First-line Chemotherapy

summary: This study will enroll participants with previously-treated advanced or inoperable gastric cancer who have responded to first line platinum therapy into two treatment arms. In Arm A participants will receive BGB-290; in Arm B participants will receive placebo. The purpose of this study is to show that BGB-290 (versus placebo) will improve progression-free survival (PFS) in participants with advanced or inoperable gastric cancer.

status: Active, not recruiting

lead_sponsor: BeiGene

location_country:
Poland
Taiwan
Hong Kong
Romania
Spain
United Kingdom
Georgia
Australia
Russian Federation
Hungary
United States
France
China
Belgium
Japan
Singapore
Czechia

location_facility: The Second Affiliated Hospital of Zhejiang University

location_facility: Osaka International Cancer Institute - Medical Oncology

location_facility: The Affiliated Hospital Of Qingdao University

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

location_facility: Beijing Cancer Hospital - Digestive Tumor Medical

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

location_facility: Guy's and St Thomas NHS Foundation Trust

location_facility: NHS - Guy's & St Thomas' Hospital - Medical Oncology

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Peterborough And Stamford Hospitals - Haematology & Oncology

location_facility: Florida Cancer Specialists - Hematology/Oncology

location_facility: Szpital Specjalist. w Brzozowie,Podkarpacki Ośrodek Onkologi

location_facility: GBUZ "Regional clinical oncologic dispensary of Volgograd"

location_facility: Ballarat Oncology and Haematology Services

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Cancer Hospital of Shantou University Medical College - Oncology

location_facility: Harbin Medical University Cancer Hospital - Oncology

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Oregon Health and Science University Knight Cancer Institute - Hematology Medical Oncology - Hematology Medical Oncology

location_facility: Multiprofile Clinic Consilium Medulla LTD

location_facility: Scientific Research Center of Oncology LTD

location_facility: AZ Maria Middelares - Campus Maria Middelares

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Hyogo College of Medicine College Hospital

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Tri-Service General Hospital - Neihu Branch - Hematology

location_facility: Hôpital Privé des Côtes d'Armor - Service oncologie

location_facility: The first affiliated hospital of Zhengzhou University - Oncology - Oncology

location_facility: N.N. Petrov Research Institute of Oncology

location_facility: Liaoning Cancer Hospital & Institute - Medical Oncology

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendeloint

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: St. Marianna University School of Medicine Hospital

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Anhui Medical University - The Second Hospital

location_facility: Japan Community Health Care Organization (JCHO) Kyushu Hospital - Hospital

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Novant Health & Presbyterian Healthcare - Presbyterian Hospi

location_facility: Vanderbilt University Medical Center (VUMC)

location_facility: Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital

location_facility: LTD Acad.F.Todua Medical Center -Research Institute of Clinical Medicine

location_facility: Aichi Cancer Center Hospital - Clinical Oncology

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: 1st Affiliated Hospital of Nanjing Medical U

location_facility: Baptist Health Medical Group Oncology, LLC - Research Center

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Osaka University Hospital - Medical Oncology

location_facility: The Townsville Hospital and Health Service

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

location_facility: Sun Yat-sen University - Cancer Center (SYSUCC)

location_facility: GBOU VPO NorthWestern State Medical University n.a. I.I. Mec

location_facility: Samara Regional Clinical Oncology Dispensary :

location_facility: Clinical Research Center Sp. z o.o., Medic-R Sp. K.

location_facility: National Hospital Organization - Osaka National Hospital

location_facility: Northern Jiangsu people's hospital - Oncology


title: A Randomized, Placebo-Controlled, Double-Blind, Phase 3 Study Evaluating Safety and Efficacy of the Addition of Veliparib Plus Carboplatin Versus the Addition of Carboplatin to Standard Neoadjuvant Chemotherapy Versus Standard Neoadjuvant Chemotherapy in Subjects With Early Stage Triple Negative Breast Cancer (TNBC)

ReferenceCitation: Filho OM, Stover DG, Asad S, Ansell PJ, Watson M, Loibl S, Geyer CE Jr, Bae J, Collier K, Cherian M, O'Shaughnessy J, Untch M, Rugo HS, Huober JB, Golshan M, Sikov WM, von Minckwitz G, Rastogi P, Maag D, Wolmark N, Denkert C, Symmans WF. Association of Immunophenotype With Pathologic Complete Response to Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: A Secondary Analysis of the BrighTNess Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):603-608. doi: 10.1001/jamaoncol.2020.7310.

ReferenceCitation: Golshan M, Loibl S, Wong SM, Houber JB, O'Shaughnessy J, Rugo HS, Wolmark N, McKee MD, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results From the BrighTNess Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):e195410. doi: 10.1001/jamasurg.2019.5410. Epub 2020 Mar 18. Erratum in: JAMA Surg. 2021 May 1;156(5):503.

ReferenceCitation: Golshan M, Wong SM, Loibl S, Huober JB, O'Shaughnessy J, Rugo HS, Wolmark N, Ansell P, Maag D, Sullivan DM, Metzger-Filho O, Von Minckwitz G, Geyer CE Jr, Sikov WM, Untch M. Early assessment with magnetic resonance imaging for prediction of pathologic response to neoadjuvant chemotherapy in triple-negative breast cancer: Results from the phase III BrighTNess trial. Eur J Surg Oncol. 2020 Feb;46(2):223-228. doi: 10.1016/j.ejso.2019.10.002. Epub 2019 Oct 5.

ReferenceCitation: Loibl S, O'Shaughnessy J, Untch M, Sikov WM, Rugo HS, McKee MD, Huober J, Golshan M, von Minckwitz G, Maag D, Sullivan D, Wolmark N, McIntyre K, Ponce Lorenzo JJ, Metzger Filho O, Rastogi P, Symmans WF, Liu X, Geyer CE Jr. Addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer (BrighTNess): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):497-509. doi: 10.1016/S1470-2045(18)30111-6. Epub 2018 Feb 28.

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Hungary
Korea, Republic of
United States
France
Belgium
Germany
Czechia

location_facility: UT Southwestern Medical Center /ID# 133849

location_facility: Johanniter-Krankenhaus Genthin /ID# 133463

location_facility: Misericordia General Hospital /ID# 119536

location_facility: Florida Cancer Specialists - Fort Myers /ID# 126379

location_facility: Solinksy Center for Cancer Care /ID# 131970

location_facility: Wilke/Wagner/Petzoldt, Fuerth /ID# 133481

location_facility: Leningrad Reg Onc Dispensery /ID# 120938

location_facility: Texas Oncology - Memorial City /ID# 126139

location_facility: Hospital General Universitario Alicante /ID# 135115

location_facility: Arizona Oncology Associates, PC-HOPE /ID# 126137

location_facility: Florida Cancer Specialists - Fort Myers /ID# 121835

location_facility: Hospital Santa Creu i Sant Pau /ID# 145400

location_facility: Texas Oncology - Medical City Dallas /ID# 126141

location_facility: Hospital Clinico Universitario de Valencia /ID# 123076

location_facility: Minnesota Oncology Hematology, PA /ID# 126144

location_facility: Kursk Regional Oncology Dispen /ID# 116688

location_facility: Korea University Anam Hospital /ID# 118857

location_facility: Western Health Sunshine Hosp. /ID# 120715

location_facility: Community Rgnal Cancer Care N /ID# 120456

location_facility: Stanford University School of Med /ID# 130316

location_facility: Hospital Universitario Arnau de Vilanova de Lleida /ID# 120979

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 135112

location_facility: Texas Oncology - Medical City Dallas /ID# 126140

location_facility: Oncology Hematology Care, Inc - Blue Ash /ID# 120478

location_facility: Studiengesellschaft Onk Bielef /ID# 133471

location_facility: Hospital Universitario Ramon y Cajal /ID# 135113

location_facility: Indiana Univ School Medicine /ID# 118215

location_facility: Virginia Oncology Associates /ID# 127260

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 120818

location_facility: Miami Cancer Institute - Baptist Health South Florida /ID# 126145

location_facility: Vrije Universiteit Medisch Centrum /ID# 126302

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 137275

location_facility: Sanford Roger Maris Cancer Cen /ID# 132394

location_facility: Hospital Clinico Universitario San Carlos /ID# 119959

location_facility: Univ Maryland School Medicine /ID# 119235

location_facility: Kyungpook National University Chilgok Hospital /ID# 118855

location_facility: Horizon Oncology Research Center /ID# 116815

location_facility: The Ctr for Cancer and Blood D /ID# 120479

location_facility: Medical Radiological Res Ctr /ID# 124017

location_facility: Sunnybrook Health Sciences Ctr /ID# 123312

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 122855

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 133454

location_facility: Hospital Universitario Virgen del Rocio /ID# 135114

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont /ID# 120834

location_facility: Rutgers Cancer Institute of NJ /ID# 120477

location_facility: Comprehensive Cancer Ctrs Neva /ID# 126136

location_facility: Columbia Univ Medical Center /ID# 141588

location_facility: Hospital General Universitario de Valencia /ID# 135111

location_facility: Istituto Europeo di Oncologia /ID# 120845

location_facility: University Hospitals Case Medical Center /ID# 141691

location_facility: Loyola University Medical Ctr /ID# 120455

location_facility: Klinikum recht der Isar der TU /ID# 133449

location_facility: Northwestern University Feinberg School of Medicine /ID# 133848

location_facility: Pyatigorsk Oncology Dispensary /ID# 120945

location_facility: University of Illinois - Chicago /ID# 134329

location_facility: Petz Aladar Megyei Oktato Korh /ID# 120835

location_facility: St. John of God Subiaco Hosp /ID# 120717

location_facility: Hospital Universitario Miguel Servet /ID# 119195

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 116681

location_facility: Univ of Wisconsin Hosp/Clinics /ID# 120457

location_facility: Hospital Parc de Salut del Mar /ID# 135110

location_facility: Novant Health Oncology Special /ID# 139890

location_facility: Hopital Universitaire Purpan /ID# 120731

location_facility: Fundacion Instituto Valenciano Oncologia IVO /ID# 135116

location_facility: Seoul National University Hospital /ID# 116698

location_facility: St. John of God Hosp - Murdoch /ID# 131788

location_facility: Hosp European, Georges Pompid /ID# 120736

location_facility: Lehigh Valley Health Network /ID# 133372

location_facility: Univ Hosp Bristol NHS Foundati /ID# 120989

location_facility: Cliniques Universitaires Saint Luc /ID# 120719

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 120944

location_facility: Nottingham Univ Hospitals NHS /ID# 122218

location_facility: National Institute of Oncology /ID# 120828

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 135108

location_facility: IRCCS Fondazione Salva Maugeri /ID# 120848

location_facility: Cleveland Clinic Main Campus /ID# 126378

location_facility: Christiana Care Health Service /ID# 137823

location_facility: OSF St. Anthony Medical Center /ID# 139424

location_facility: Gemeinschaftspraxis Dr. Heinrich und Prof. Bangerter /ID# 133472

summary: This is a 3 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin versus the addition of carboplatin to standard neoadjuvant chemotherapy versus standard neoadjuvant chemotherapy in subjects with early stage TNBC.


title: A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

acronym: SOPHIA

summary:
The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy.

A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.

ReferenceCitation: Rugo HS, Im SA, Cardoso F, Cortes J, Curigliano G, Musolino A, Pegram MD, Bachelot T, Wright GS, Saura C, Escrivá-de-Romaní S, De Laurentiis M, Schwartz GN, Pluard TJ, Ricci F, Gwin WR 3rd, Levy C, Brown-Glaberman U, Ferrero JM, de Boer M, Kim SB, Petráková K, Yardley DA, Freedman O, Jakobsen EH, Gal-Yam EN, Yerushalmi R, Fasching PA, Kaufman PA, Ashley EJ, Perez-Olle R, Hong S, Rosales MK, Gradishar WJ; SOPHIA Study Group. Margetuximab Versus Trastuzumab in Patients With Previously Treated HER2-Positive Advanced Breast Cancer (SOPHIA): Final Overall Survival Results From a Randomized Phase 3 Trial. J Clin Oncol. 2022 Nov 4:JCO2102937. doi: 10.1200/JCO.21.02937. [Epub ahead of print]

ReferenceCitation: Rugo HS, Im SA, Cardoso F, Cortés J, Curigliano G, Musolino A, Pegram MD, Wright GS, Saura C, Escrivá-de-Romaní S, De Laurentiis M, Levy C, Brown-Glaberman U, Ferrero JM, de Boer M, Kim SB, Petráková K, Yardley DA, Freedman O, Jakobsen EH, Kaufman B, Yerushalmi R, Fasching PA, Nordstrom JL, Bonvini E, Koenig S, Edlich S, Hong S, Rock EP, Gradishar WJ; SOPHIA Study Group. Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):573-584. doi: 10.1001/jamaoncol.2020.7932.

lead_sponsor: MacroGenics

location_country:
Denmark
Poland
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
Finland
Korea, Republic of
United States
France
Israel
Puerto Rico
Belgium
Germany
Czechia

location_facility: The Center for Cancer and Blood Disorders

location_facility: Helsinki University Central Hospital (HUCH) - Meilahden Sair

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Saint Barnabas Medical Center - The Cancer Center

location_facility: Fondazione Pascale, IRCCS Istituto Nazionale dei Tumori

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: Centro Clínico Champalimaud/Fundação Champalimaud

location_facility: CTCA - Eastern Regional Medical Center, Inc.

location_facility: Institut Català d'Oncologia-Hospital Germans Trias i Pujol

location_facility: New York University Clinical Cancer Center

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Regionshospitalet Herning (Herning Centralsygehus)

location_facility: Wake Forest University Baptist Medical Center (WFUBMC)

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: The Chaim Sheba Medical Center - Insititute of Oncology

location_facility: CTCA - Midwestern Regional Medical Center

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancer

location_facility: New Jersey Hematology Oncology Associates

location_facility: PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

location_facility: ASST Papa Giovanni XXIII - Oncologia-Bergamo

location_facility: Istituto Europeo di Oncologia Via Ripamonti

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Azienda Ospedaliero Universitaria Senese Universita degli St

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto Português Oncologia Francisco Gentil do Porto

location_facility: University of Washington/ Seattle Cancer Care Alliance

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

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftalmico

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: CTCA - Southeastern Regional Medical Center

location_facility: AZ Sint-Jan Brugge - Oostende - Campus Sint-Jan

location_facility: Universitaetsklinikum Essen - Klinik fuer Frauenheilkunde

location_facility: AO S.Andrea, Università degli Studi di Roma La Sapienza

location_facility: Kent Oncology Centre, Maidstone Hospital

location_facility: Hadassah Medical Organisation, Hadassah Medical Center, Ein-Karem

location_facility: H. Santa Maria - Centro Hospitalar Lisboa Norte

location_facility: Swedish Cancer Institute/ Swedish Health Services

location_facility: PO di Cremona, ASST di Cremona - Patologia Mammaria e Breast Unit - Cremona

location_facility: Clalit Health Services - Lin Medical Center

location_facility: University of California, San Francisco Helen Diller Family Comprehensive Cancer Center

location_facility: Ospedale Umberto I, AOU Ospedali Riuniti Umberto I - GM.Lanc

location_facility: University of Texas Southwestern Medical Center

intervention_type: Biological


title: SyncAV Post-Market Trial

acronym: SyncAV

summary: The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.

lead_sponsor: Abbott Medical Devices

location_country:
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
United States
Belgium
Japan
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Puerto Rico
India
Singapore
Sweden
Canada
Switzerland
China
Germany
Taiwan
Finland
Thailand
Korea, Republic of
France
Colombia
Netherlands
United Arab Emirates

location_facility: Washington University School of Medicine

location_facility: New York Presbyterian Brooklyn Methodist Hospital

location_facility: Narayana Institute of Cardiac Sciences, Bommasandra

location_facility: Meshalkin National Medical Research Center

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

location_facility: Institut de Cardiologie de Montreal (Montreal Heart Inst.)

location_facility: Clinical Center of Serbia - Pacemaker Center

location_facility: Helsinki University Central Hospital (HYKS)

location_facility: The University of Hong Kong (Queen Mary Hospital)

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Institut de Cardiologie de Quebec (Hôpital Laval)

location_facility: Hospital Puerta de Hierro - Hospital Universitario

location_facility: Severance Hospital, Yonsei University Health System

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Asian Institute of Gastroenterology (AIG) Hospital

location_facility: Klinikum der Ruprecht-Karls-Universität Heidelberg

location_facility: McGill University Health Centre General Hospital

location_facility: Cardiac Arrhythmia Research Group Inc. (CARGI)

location_facility: Seoul National University Bundang Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Azienda Ospedaliera Universitaria MaterDomini

location_facility: CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

location_facility: Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

location_facility: Cardiovascular Associates of the Delaware Valley

intervention_type: Device


title: A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy

summary: The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.

lead_sponsor: ImmunityBio, Inc.

location_country:
Denmark
Poland
Spain
Italy
Russian Federation
Australia
Canada
Hungary
United States
Chile
France
Israel
Netherlands

location_facility: The James Cancer Hospital and Solove Research Institute

location_facility: Wake Forest University Baptist Medical Center

location_facility: Republican Clinical Oncologic Dispensary of Ministry of Health Republic Tatarstan

location_facility: Sharet Institute of Oncology Hadassah Ein Karem Medical Center

location_facility: Consorcio Hospitalario Provincial de Castellon

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

location_facility: Instituto Clinico Oncologica del Sur (ICOS)

location_facility: Centre Hospitalier Regional et Universitaire - Hospital Bretonneau

location_facility: Centro Integral Oncologico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: State Institution "Blokhin Cancer Research Centre RAMS"

location_facility: University Hospitals Case Medical Center