location_country:
Malaysia
Greece
Romania
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
Spain
Croatia
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Switzerland
Netherlands
Bulgaria
Singapore
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Egypt
New Zealand
Turkey
Latvia

location_facility: Saiseikai Fukuoka Genaral Hospital /ID# 225639

location_facility: Sjællands Universitetshospital /ID# 200033

location_facility: Percuro Clinical Research, Ltd /ID# 169109

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158041

location_facility: CliniCore International, LLC /ID# 158218

location_facility: Hospital Universitario San Vic /ID# 171490

location_facility: The Second Hospital of Hebei Medical University /ID# 213018

location_facility: Universitaetsklinikum Freiburg /ID# 162034

location_facility: Sisli Etfal Train & Res Hosp /ID# 171409

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 216102

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 170947

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 161376

location_facility: Precision Research Institute, LLC /ID# 201351

location_facility: Hamamatsu University Hospital /ID# 226727

location_facility: Columbia Univ Medical Center /ID# 161934

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 201819

location_facility: Nagasaki University Hospital /ID# 202674

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171293

location_facility: Hospital Clinico Universitario de Salamanca /ID# 159446

location_facility: The University of Chicago Medical Center /ID# 160521

location_facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 155607

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 163767

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165581

location_facility: Duplicate_Universitaetsklinikum St.Poelten /ID# 169048

location_facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215504

location_facility: Medizinische Universitaet Graz /ID# 169053

location_facility: Colo-proctology Center Matsushima Clinic /ID# 225914

location_facility: Klinicki bolnicki centar Split /ID# 157473

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157660

location_facility: LMU Klinikum Campus Grosshadern /ID# 210481

location_facility: Universitaetsklinikum Regensburg /ID# 163686

location_facility: Kitasato University Kitasato Institute Hospital /ID# 164256

location_facility: Hospital Provincial del Centenario /ID# 170898

location_facility: China Medical University Hospital /ID# 160189

location_facility: Centex Studies, Inc. - Houston /ID# 201222

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 210761

location_facility: Chung Shan Medical University Hospital /ID# 163651

location_facility: Universitair Ziekenhuis Leuven /ID# 170812

location_facility: East Tennessee Research Institute /ID# 168747

location_facility: Erciyes University Medical Fac /ID# 171291

location_facility: Liverpool University Hospitals NHS Foundation Trust /ID# 203858

location_facility: CHU Montpellier - Hôpital Saint Eloi /ID# 223779

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164251

location_facility: Hospital Universitario La Paz /ID# 159459

location_facility: Sir Run Run Shaw Hospital,Meical School Zhejiang University /ID# 211064

location_facility: Servicio de Salud Occidente Hospital San Juan de Dios /ID# 171125

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 160472

location_facility: Toronto Digestive Disease Asso /ID# 169106

location_facility: Great Lakes Medical Research, LLC /ID# 201777

location_facility: Immanuel Kant Baltic Federal University /ID# 204888

location_facility: Fukuoka University Chikushi Hospital /ID# 209055

location_facility: Hiroshima University Hospital /ID# 164426

location_facility: South Lake Pain Institute, Inc /ID# 162878

location_facility: Interdisctrict Multidisciplinary Hospital /ID# 203335

location_facility: Penn State Milton S. Hershey Medical Center /ID# 223563

location_facility: Southern California Res. Ctr. /ID# 169660

location_facility: Huai'an First People's Hospital /ID# 239196

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 171129

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159443

location_facility: Digestive Disease Associates, LTD /ID# 232407

location_facility: Hospital Privado Univesitario /ID# 167779

location_facility: Hospital Alvaro Cunqueiro CHUVI /ID# 167360

location_facility: Duplicate_Centrul Medical Tuculanu SRL /ID# 171268

location_facility: Fujita Health University Hospital /ID# 164261

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 158717

location_facility: Shiga University of Medical Science Hospital /ID# 164440

location_facility: First Moscow State Medical University n.a I.M. Sechenov /ID# 204978

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 170601

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Panstwowy Instytut Bada /ID# 170600

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164347

location_facility: Kaiser Clinica e Hospital Dia /ID# 157680

location_facility: Centro Hospitalar e Universitario de Coimbra, EPE /ID# 166054

location_facility: Hadassah Medical Center-Hebrew University /ID# 171099

location_facility: Japanese Red Cross Wakayama Medical Center /ID# 171195

location_facility: Louisana Research Center, LLC /ID# 201204

location_facility: Ospedale Policlinico San Martino /ID# 164031

location_facility: Chu de Nice-Hopital L'Archet Ii /Id# 171577

location_facility: Plains Clinical Research Center, LLC /ID# 169732

location_facility: Manhattan Clinical Research, LLC /ID# 211805

location_facility: Yonsei University Health System Severance Hospital /ID# 158701

location_facility: Hospital Garcia de Orta, EPE /ID# 165583

location_facility: The Second Hospital Central South University /ID# 211198

location_facility: National Hospital Organization Takasaki General Medical Center /ID# 164437

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217480

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208488

location_facility: Kanazawa University Hospital /ID# 169224

location_facility: Hospital de Clinicas de Porto Alegre /ID# 157662

location_facility: King's College Hospital NHS Foundation Trusts /ID# 158766

location_facility: MVZ fuer Gastroenterlogie am Bayerischen Platz /ID# 159361

location_facility: Hyogo College of Medicine College Hospital /Id# 164424

location_facility: Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219145

location_facility: St.Luke's International Hospital /ID# 225822

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169108

location_facility: Second Multiprofile Hospital f /ID# 200799

location_facility: Renmin Hospital of Wuhan University /ID# 212868

location_facility: CHA University Bundang Medical Center /ID# 158710

location_facility: Private Practice Dr MN Rajabally /ID# 171137

location_facility: Wellington Regional Hospital /ID# 205343

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159440

location_facility: Nemocnice Ceske Budejovice a.s. /ID# 225226

location_facility: Ulyanovsk Regional Clinical Hospital /ID# 203368

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 169767

location_facility: Omega Research Maitland, LLC /ID# 203059

location_facility: Osaka Medical and Pharmaceutical University Hospital /ID# 226035

location_facility: Houma Digestive Health Special /ID# 158317

location_facility: Yale Univ Digestive Diseases /ID# 213179

location_facility: Regional Clinical Hospital #1 /ID# 165754

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 166052

location_facility: Hospital Nossa Senhora das Graças /ID# 157671

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157679

location_facility: Clinic of New Technologies of Medicine /ID# 203369

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 160412

location_facility: Hospital Universitario Miguel Servet /ID# 159445

location_facility: Virginia Mason Medical Center /ID# 160466

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 158221

location_facility: The Sixth Affiliated Hosp Sun /ID# 211231

location_facility: Southern Star Research Institute, LLC /ID# 168776

location_facility: Medizinische Universitaet Wien /ID# 169050

location_facility: Unidad de Atencion Medica e Investigacion en Salud /ID# 203595

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 165582

location_facility: Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 200685

location_facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 210510

location_facility: VA Caribbean Healthcare System /ID# 221245

location_facility: Gastroenterologie Opernstrasse /ID# 163683

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165218

location_facility: Fakultna nemocnica s poliklinikou Nove Zamky /ID# 224099

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 206937

location_facility: Royal Devon and Exeter NHS Trust Hospital /ID# 157587

location_facility: The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 242378

location_facility: Taipei Veterans General Hosp /ID# 163650

location_facility: Barnsley Hospital NHS Foundation Trust /ID# 202770

location_facility: CHRU Nancy - Hôpitaux de Brabois /ID# 200095

location_facility: National Taiwan University Hospital /ID# 162187

location_facility: Cabinet Particular Policlinic Algomed /ID# 171266

location_facility: Tyler Research Institute, LLC /ID# 166800

location_facility: ASST Rhodense/Presidio Ospedaliero di Rho /ID# 211449

location_facility: Praxiszentrum fuer Gastroenterologie /ID# 219069

location_facility: South Florida Research Ph I-IV, Inc. /ID# 161848

location_facility: Hospital Universitario Reina Sofia /ID# 167058

location_facility: Lenus Research & Medical Group /ID# 169730

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 200252

location_facility: The Jikei University Hospital /ID# 164434

location_facility: Ctr for Advanced Gastroenterol /ID# 202811

location_facility: Health Pharma Professional Research S.A de C.V /ID# 203597

location_facility: Atrium Health Carolinas Medical Center /ID# 158512

location_facility: Yokkaichi Hazu Medical Center /ID# 164441

location_facility: Kuzbass Regional Clinical Hospital /ID# 165750

location_facility: Clinical Research Trials of Florida, Inc. /ID# 201783

location_facility: Asahikawa Medical University Hospital /ID# 164433

location_facility: Klinicki bolnicki centar Zagreb /ID# 157471

location_facility: Agaplesion Markus Krankenhaus /ID# 159356

location_facility: Toho University Sakura Medical Center /ID# 164254

location_facility: Bashkir State Medical University /ID# 226928

location_facility: University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 158524

location_facility: Uludag University Medical Faculty /ID# 204182

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 170714

location_facility: Municipal Nonprofit Enterprise Kherson city clinical hospital n.a. Y.Y. Karabel /ID# 224350

location_facility: Cleveland Clinic Main Campus /ID# 209232

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 163395

location_facility: Vanderbilt University Medical Center /ID# 160580

location_facility: DM Clinical Research/Southwest /ID# 165012

location_facility: Robley Rex VA Medical Center /ID# 218648

location_facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224926

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 160523

location_facility: Fırat University Medical Facul /ID# 171292

location_facility: Cedars-Sinai Medical Center-West Hollywood /ID# 163851

location_facility: Digestive Disease Specialists /ID# 170779

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 158018

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 158040

location_facility: Wakayama Medical University Hospital /ID# 169487

location_facility: CNPE of Kyiv Regional Council Kyiv Regional Hospital /ID# 224343

location_facility: UCSF Center for Colitis and Crohn's Disease /ID# 201210

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 200848

location_facility: Gastroenterology Associates LLC - Jefferson Hwy /ID# 161935

location_facility: Pusan National University Hospital /ID# 158711

location_facility: West China Hospital, Sichuan University /ID# 211276

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 200250

location_facility: The Chaim Sheba Medical Center /ID# 211278

location_facility: GBUZ Allergology and Immunology Center of Ministry of Health of Kabardino-Bal /ID# 233973

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 163992

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170915

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 155612

location_facility: Universitatsklinikum Mannheim /ID# 162035

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211233

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 211071

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226793

location_facility: International Medical Center SOGAZ /ID# 206727

location_facility: Texas Digestive Disease Consultants /ID# 209950

location_facility: Praxis fuer Gastroenterologie /ID# 166152

location_facility: Scott Shulman Medicine Professional Corporation /ID# 169113

location_facility: National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203512

location_facility: Universitaetsklinikum Erlangen /ID# 159354

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159461

location_facility: Gastro Health & Nutrition - Victoria /ID# 164321

location_facility: Vilnius University Hospital Santaros Klinikos /ID# 170614

location_facility: Medical Research Center of CT /ID# 160311

location_facility: Faculdade de Medicina do ABC /ID# 163995

location_facility: Massachusetts General Hospital - Crohn's and Colitis Center /ID# 164255

location_facility: General Hospital of Ningxia Medical University /ID# 213911

location_facility: Aichi Medical University Hospital /ID# 164332

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 205738

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226794

location_facility: ProMedica Physicians Digestive Healthcare /ID# 215623

location_facility: Hayang University GuriHospital /ID# 158702

location_facility: Peak Gastroenterology Associates, PC /ID# 165841

location_facility: Taichung Veterans General Hospital /ID# 163649

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 165580

location_facility: Shengjing Hospital of China Medical University /ID# 211646

location_facility: Centro Hosp de Tondela-Viseu /ID# 166053

location_facility: The First Affiliated Hospital of Anhui Medical University /ID# 211228

location_facility: Complejo Asistencial Dr. Sotero del Rio /ID# 169385

location_facility: H-T. Centrum Medyczne - Endoterapia /ID# 230979

location_facility: Stadtisches Klinikum Braunschweig /ID# 163687

location_facility: Tzaneio general hospital of Piraeus /ID# 206439

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159360

location_facility: General Hospital of Athens Laiko /ID# 206440

location_facility: CHU Amiens-Picardie Site Sud /ID# 171576

location_facility: London Health Sciences Center /ID# 169103

location_facility: Rocky Mountain Pediatric Gastroenterology /ID# 207174

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200931

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 200635

location_facility: Air Force Specialized Hospital /ID# 170986

location_facility: Gastroenterology Consultants of Southwest Virginia /ID# 218143

location_facility: Nagoya City University Hospital /ID# 164331

location_facility: CHU Bordeaux - Hopital Haut Lévêque /ID# 171579

location_facility: Fakultni nemocnice u sv. Anny v Brne /ID# 239157

location_facility: Advanced Research Institute, Inc /ID# 161938

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 210813

location_facility: The First Affiliated Hospital of Nanchang University /ID# 212183

location_facility: Nara Medical University Hospital /ID# 169225

location_facility: UOC Medicina Interna e Gastroe /ID# 155608

location_facility: Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213151

location_facility: Texas Digestive Disease Consultants /ID# 209798

location_facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 162033

location_facility: Tokai University Hachioji Hospital /ID# 226899

location_facility: Ospedale Sant Orsola Malpighi /ID# 155611

location_facility: Soroka University Medical Center /ID# 171100

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 158706

location_facility: Tokyo Medical And Dental University Hospital /ID# 164258

location_facility: Quality Clinical Research Inc. /ID# 167313

location_facility: CHU UCL Namur - site Godinne /ID# 200254

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 164036

location_facility: University Clinical Center Serbia /ID# 200152

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227457

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167207

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 165216

location_facility: Inselspital, Universitätsspital Bern /ID# 202911

location_facility: Inje University Haeundae Hospital /ID# 203028

location_facility: Yamagata University Hospital /ID# 171474

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 211072

location_facility: Yeungnam University Medical Center /ID# 158703

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 169104

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 171580

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 209977

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 202059

location_facility: CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203367

location_facility: Inonu Universitesi Turgut Ozal /ID# 203981

location_facility: Sahlgrenska University Hospital Molndal /ID# 202843

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 224348

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 164041

location_facility: The First Hospital of Jilin University /ID# 212278

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 204130

location_facility: Showa University Fujigaoka Hospital /ID# 209555

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166551

location_facility: St. Marianna University School of Medicine Hospital /ID# 226728

location_facility: Sapporo Medical University Hospital /ID# 164432

location_facility: Pauls Stradins Clinical University Hospital /ID# 163803

location_facility: Central Clinical Hospital RZHD Medicine /ID# 204917

location_facility: Klinicki bolnicki centar Zagreb /ID# 201917

location_facility: Atlanta Gastroenterology Spec /ID# 161372

location_facility: Hospital Clinic de Barcelona /ID# 159439

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 208964

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 208378

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 215320

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202266

location_facility: General Hospital of Athens Ippokratio /ID# 229189

location_facility: Linkou Chang Gung Memorial Ho /ID# 222877

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210962

location_facility: Gastroenterology Group Naples /ID# 165212

location_facility: Johns Hopkins University School of Medicine /ID# 211793

location_facility: Theageneio Anticancer Hospital /ID# 165217

location_facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 171226

location_facility: Kitasato University Hospital /ID# 169226

location_facility: Ponce Medical School Foundation /ID# 221244

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211025

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 208945

location_facility: Clinical Hosp Center Zvezdara /ID# 200151

location_facility: Hospital Universitario Virgen Macarena /ID# 159968

location_facility: Gokeikai Ofuna Chuo Hospital /ID# 169300

location_facility: Adult Gastroenterology Associates - Gen 1 Research /ID# 208867

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 216182

location_facility: Hoag Memorial Hosp Presbyterian /ID# 218348

title: A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis

summary:
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2.

The objective of Sub-Study 2 is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.


title: A Phase 3 Randomized, Controlled, Open-label Study of Selinexor, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

acronym: BOSTON

summary: This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Richard S, Chari A, Delimpasi S, Simonova M, Spicka I, Pour L, Kriachok I, Dimopoulos MA, Pylypenko H, Auner HW, Leleu X, Usenko G, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros A, Anderson LD Jr, Bahlis NJ, Facon T, Mateos MV, Cavo M, Chang H, Landesman Y, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Grosicki S, Richardson PG. Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk. Am J Hematol. 2021 Sep 1;96(9):1120-1130. doi: 10.1002/ajh.26261. Epub 2021 Jul 5.

name: Icahn School of Medicine at Mount Sinai Tisch Cancer Institute  New York New York USA

family: Richard

full_name: Shambavi Richard

given: Shambavi

sequence: first

family: Chari

full_name: Ajai Chari

given: Ajai

sequence: additional

name: General Hospital Evangelismos  Athens Greece

family: Delimpasi

full_name: Sosana Delimpasi

given: Sosana

name: Institute of Blood Pathology & Transfusion Medicine of National Academy of Medical Sciences of Ukraine  Lviv Ukraine

family: Simonova

full_name: Maryana Simonova

given: Maryana

name: Charles University and General Hospital  Prague Czech Republic

family: Spicka

full_name: Ivan Spicka

given: Ivan

name: Clinic of Internal Medicine —Hematology and Oncology University Hospital Brno  Brno Czech Republic

family: Pour

full_name: Ludek Pour

given: Ludek

name: National Cancer Institute Ukraine  Kiev Ukraine

family: Kriachok

full_name: Iryna Kriachok

given: Iryna

name: School of Medicine National and Kapodistrian University of Athens School of Medicine  Athens Greece

family: Dimopoulos

full_name: Meletios A. Dimopoulos

given: Meletios A.

name: Department of Hematology Cherkassy Regional Oncological Center  Cherkassy Ukraine

family: Pylypenko

full_name: Halyna Pylypenko

given: Halyna

family: Auner

full_name: Holger W. Auner

given: Holger W.

name: Department of Hematology CHU la Miletrie and Inserm CIC 1402  Poitiers France

family: Leleu

full_name: Xavier Leleu

given: Xavier

name: City Clinical Hospital No. 4 of Dnipro City Council  Dnipro Ukraine

family: Usenko

full_name: Ganna Usenko

given: Ganna

name: Department of Hemato‐oncology, University Hospital Ostrava University of Ostrava  Ostrava Czech Republic

family: Hajek

full_name: Roman Hajek

given: Roman

name: Kings College Hospital NHS Foundation Trust  London UK

family: Benjamin

full_name: Reuben Benjamin

given: Reuben

name: Nil Ratan Sircar Medical College and Hospital  Kolkata India

family: Dolai

full_name: Tuphan Kanti Dolai

given: Tuphan Kanti

name: State Cancer Institute Indira Gandhi Institute of Medical Sciences  Patna India

family: Sinha

full_name: Dinesh Kumar Sinha

given: Dinesh Kumar

name: Cross Cancer Institute University of Alberta  Edmonton Alberta Canada

family: Venner

full_name: Christopher P. Venner

given: Christopher P.

name: University Hospitals of Leicester NHS Trust  Leicester UK

family: Garg

full_name: Mamta Garg

given: Mamta

name: Norton Cancer Institute St. Matthews Campus  Louisville Kentucky USA

family: Stevens

full_name: Don Ambrose Stevens

given: Don Ambrose

name: University of Melbourne, St. Vincent's Hospital  Melbourne Victoria Australia

family: Quach

full_name: Hang Quach

given: Hang

family: Jagannath

full_name: Sundar Jagannath

given: Sundar

name: University Hospital, Hotel‐Dieu  Nantes France

family: Moreau

full_name: Phillipe Moreau

given: Phillipe

name: Baylor University Medical Center  Dallas Texas USA

family: Levy

full_name: Moshe Levy

given: Moshe

name: University of Maryland, Greenebaum Comprehensive Cancer Center  Baltimore Maryland USA

name: Simmons Comprehensive Cancer Center UT Southwestern Medical Center  Dallas Texas USA

name: University of Calgary Charbonneau Cancer Research Institute  Calgary Alberta Canada

name: CHU Lille Service des Maladies du Sang F‐59000  Lille France

name: Hospital Universitario de Salamanca  Salamanca Spain

name: Seràgnoli Institute of Hematology Bologna University School of Medicine  Bologna Italy

name: Karyopharm Therapeutics Inc.  Newton Massachusetts USA

name: Medical University of Silesia  Katowice Poland

name: Dana Farber Cancer Institute  Boston Massachusetts USA

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Mateos MV, Gavriatopoulou M, Facon T, Auner HW, Leleu X, Hájek R, Dimopoulos MA, Delimpasi S, Simonova M, Špička I, Pour L, Kriachok I, Pylypenko H, Doronin V, Usenko G, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros AZ, Anderson LD Jr, Bahlis NJ, Cavo M, Chai Y, Jeha J, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Effect of prior treatments on selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma. J Hematol Oncol. 2021 Apr 13;14(1):59. doi: 10.1186/s13045-021-01071-9.

ReferenceCitation: Auner HW, Gavriatopoulou M, Delimpasi S, Simonova M, Spicka I, Pour L, Dimopoulos MA, Kriachok I, Pylypenko H, Leleu X, Doronin V, Usenko G, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Stevens DA, Quach H, Jagannath S, Moreau P, Levy M, Badros A, Anderson LD Jr, Bahlis NJ, Facon T, Mateos MV, Cavo M, Chai Y, Arazy M, Shah J, Shacham S, Kauffman MG, Richardson PG, Grosicki S. Effect of age and frailty on the efficacy and tolerability of once-weekly selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma. Am J Hematol. 2021 Jun 1;96(6):708-718. doi: 10.1002/ajh.26172. Epub 2021 May 3.

name: The Hugh and Josseline Langmuir Centre for Myeloma Research Imperial College London  London UK

name: Alexandra Hospital, School of Medicine, National and Kapodistrian University of Athens  Athens Greece

name: University Hospital Brno  Brno Czech Republic

name: City Clinical Hospital #40  Moscow Russian Federation

name: Department of Hemato‐oncology University Hospital Ostrava, University of Ostrava  Ostrava Czech Republic

name: State Cancer Institute, Indira Gandhi Institute of Medical Sciences  Patna India

name: Cross Cancer Institute, University of Alberta  Edmonton Alberta Canada

name: Norton Cancer Institute  Louisville Kentucky USA

name: Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai  New York New York USA

name: Simmons Comprehensive Cancer Center, UT Southwestern Medical Center  Dallas Texas USA

name: University of Calgary, Charbonneau Cancer Research Institute  Calgary Alberta Canada

name: Seràgnoli Institute of Hematology, Bologna University School of Medicine  Bologna Italy

title: Effect of age and frailty on the efficacy and tolerability of once‐weekly selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma

ReferenceCitation: Grosicki S, Simonova M, Spicka I, Pour L, Kriachok I, Gavriatopoulou M, Pylypenko H, Auner HW, Leleu X, Doronin V, Usenko G, Bahlis NJ, Hajek R, Benjamin R, Dolai TK, Sinha DK, Venner CP, Garg M, Gironella M, Jurczyszyn A, Robak P, Galli M, Wallington-Beddoe C, Radinoff A, Salogub G, Stevens DA, Basu S, Liberati AM, Quach H, Goranova-Marinova VS, Bila J, Katodritou E, Oliynyk H, Korenkova S, Kumar J, Jagannath S, Moreau P, Levy M, White D, Gatt ME, Facon T, Mateos MV, Cavo M, Reece D, Anderson LD Jr, Saint-Martin JR, Jeha J, Joshi AA, Chai Y, Li L, Peddagali V, Arazy M, Shah J, Shacham S, Kauffman MG, Dimopoulos MA, Richardson PG, Delimpasi S. Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial. Lancet. 2020 Nov 14;396(10262):1563-1573. doi: 10.1016/S0140-6736(20)32292-3.

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Ukraine
India
France
Poland
Canada
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
Spain

location_facility: Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)

location_facility: Medical Center of the University of Pecs, Department of Hematology

location_facility: Independent Public Teaching Hospital No.1 in Lublin, Department of Hematology-Oncology and Bone Marrow Transplantation

location_facility: Polyclinic S. Orsola-Malpighi, Department of Hematology, Oncology and Laboratory Medicine, Operative Unit of Hematology - Cavo

location_facility: First I.P. Pavlov State Medical University of St. Petersburg

location_facility: V.A. Almazov North-West Federal Medical Research Center, Chemotherapy of Oncohematology Diseases and Bone Marrow Transplantation Department #1

location_facility: Boca Raton Clinical Research (BRCR) Medical Center

location_facility: University Hospital Kralovske Vinohrady, Clinic of Internal Hematology

location_facility: Miletrie Hospital, University Hospital Center of Poitiers

location_facility: Semmelweis University, 1st Department of Internal Medicine

location_facility: University Hospital in Krakow, Teaching Unit of the Hematology Department

location_facility: University Hospital San Martino, IRCCA, Dept. of Integrative Cancer Therapies, Operative Unit of Clinical Hematology

location_facility: University Multiprofile Hospital for Active Treatment, Sveti Georgi Clinic of Clinical Hematology

location_facility: Integrated Szent Istvan and Szent laszlo Hospital, Department of Hematology and Stem Cell Transplantation

location_facility: University Hospital Infanta Leonor, Department of Hematology

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Postgraduate Institute of Medical Education & Research (PGIMER)

location_facility: Bucharest University Emergency Hospital, Department of Hematology

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Hematology Department with Intensive Therapy Wards

location_facility: University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital

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

location_facility: University Hospitals of Leicester NHS Trust Royal Leicester Infirmary

location_facility: University Hospital Freiburg, Department of Internal Medicine I

location_facility: Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Department of Hematology

location_facility: Institute of Blood Pathology and Transfusion Medicine, Department of Hematology with Laboratory Group

location_facility: Cardiff & Vale University Health Board University Hospital of Wales

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital

location_facility: Necker Children's Hospital, Department of Adult Hematology

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: Belfast Heatlh & Social Care Trust Belfast City Hospital

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Hematology

location_facility: Stormont Vail Health Care (Cotton O'Neil Cancer Center )

location_facility: University Clinical Hospital of Salamanca, Department of Hematology

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: Royal Liverpool & Broadgreen University Hospital NHS Trust Royal Liverpool University Hospital

location_facility: Tom Baker Cancer Center/ Alberta Health Services

location_facility: Brabois Adults Hospital, University Hospital Center of Nancy

location_facility: Hospital Niguerda Ca Granda, Department of Hematology and Oncology, Hematology Unit

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

location_facility: Colentina Clinical Hospital, Department of Hematology

location_facility: Group Practice for Hematology and Oncology

location_facility: University Hospital San Giovanni Battista of Turin

location_facility: University Hospital Ostrava, Dept. of Hematooncology

location_facility: Hospital Center Departmental La Roche-Sur-Yon

location_facility: St. John of Dukla Oncology Center of Lublin, Department of Hematology

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Clinical Center Nis, Clinic of Hematology and Clinical Immunology

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

location_facility: Hyperclnical MedLife PDR Vulturului Brasov, Hematology Department

location_facility: University Hospital of the Canary Islands

location_facility: Catalan Institute of Oncology (ICO) Badalona

location_facility: Mater Misericordiae Limited and Mater Medical Research

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: The Leeds Teaching Hospitals NHS Trust St. James University Hospital

location_facility: Clinical Center of Vojvodina, Clinic of Hematology

location_facility: London North West Healthcare NHS Trust Northwick Park Hospital

location_facility: Saskatchewan Cancer Agency-Allan Blair Cancer Centre

location_facility: Klinikum Leverkusen gGmbH Medizinisxhe Klinik 3

location_facility: N.A. Semashko Central Clinical Hospital #2 under OJSC Russian Railways

location_facility: Wilhelminen Hospital, Department of Internal Medicine I, Center for Oncology & Hematology

location_facility: Royal Victoria Hospital / McGill University

location_facility: University Hospital Careggi, Department of Hematology

location_facility: Cross Cancer Institute / University of Alberta

location_facility: General Hospital of Athens "Evangelismos", Department of Hematology and Lymphoma

location_facility: University Multiprofile Hospital for Active Treatment, Sveti Ivan Rilski Clinic of Hematology

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases, Clinic of Hematology, Dept. of Clinical Hematology

location_facility: Theageneion Cancer Hospital, Hematology Department

location_facility: Clinical Center Kragujevac, Clinic of Hematology

location_facility: University Hospital Krems, Department of Internal Medicine II

location_facility: Netaji Subhash Chandra Bose Cancer Research Institute

location_facility: The Cancer Institute at St. Francis Hospital

location_facility: Institute of Oncology and Radiology of Serbia, Clinic of Medical Oncology

location_facility: Semmelweis University, 3rd Department of Internal Medicine

location_facility: Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology

location_facility: Alexandra General Hospital, Therapeutic Clinic

location_facility: City Clinical Hospital No.4 of Dnipro City Council, City hematology center

location_facility: The Royal Wolverhampton NHS Trust New Cross Hospital

location_facility: Umberto I Polyclinic of Rome, Department of Cellular Biotechnology and Hematology, Hematology Center

location_facility: Military Institute of Medicine, Department of Internal Medicine and Hematology


type: EudraCT Number

title: A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

summary: The primary objective of the study is to assess the progression-free survival (PFS) of oral veliparib in combination with TMZ or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel in subjects with BRCA1 or BRCA2 mutation and locally recurrent or metastatic breast cancer.

status: Completed

study_completion_date_type: Actual

ReferenceType: background

ReferenceCitation: Han HS, Diéras V, Robson M, Palácová M, Marcom PK, Jager A, Bondarenko I, Citrin D, Campone M, Telli ML, Domchek SM, Friedlander M, Kaufman B, Garber JE, Shparyk Y, Chmielowska E, Jakobsen EH, Kaklamani V, Gradishar W, Ratajczak CK, Nickner C, Qin Q, Qian J, Shepherd SP, Isakoff SJ, Puhalla S. Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study. Ann Oncol. 2018 Jan 1;29(1):154-161. doi: 10.1093/annonc/mdx505.

ReferenceCitation: Isakoff SJ, Puhalla S, Domchek SM, Friedlander M, Kaufman B, Robson M, Telli ML, Diéras V, Han HS, Garber JE, Johnson EF, Maag D, Qin Q, Giranda VL, Shepherd SP. A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale. Future Oncol. 2017 Feb;13(4):307-320. doi: 10.2217/fon-2016-0412. Epub 2016 Oct 14.

name: Department of Medicine, Massachusetts General Hospital, Boston, MA 02114, USA

family: Isakoff

full_name: Steven J Isakoff

given: Steven J

name: Department of Medicine, University of Pittsburgh Cancer Institute, Pittsburgh, PA 15232, USA

family: Puhalla

full_name: Shannon Puhalla

given: Shannon

name: Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA 19104, USA

family: Domchek

full_name: Susan M Domchek

given: Susan M

name: Gynaecological Cancer Centre, Royal Hospital for Women, Sydney, NSW 2031, Australia

family: Friedlander

full_name: Michael Friedlander

given: Michael

name: Department of General Oncology, Chaim Sheba Medical Center, Ramat Gan 52 621, Israel

family: Kaufman

full_name: Bella Kaufman

given: Bella

name: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10022, USA

family: Robson

full_name: Mark Robson

given: Mark

name: Department of Medical Oncology, Stanford University School of Medicine, Stanford, CA 94305, USA

family: Telli

full_name: Melinda L Telli

given: Melinda L

name: Department of Medical Oncology, Institut Curie, Paris 75248, France

family: Diéras

full_name: Véronique Diéras

given: Véronique

name: The Center for Women's Oncology, Moffitt Cancer Center, Tampa, FL 33612, USA

family: Han

full_name: Hyo Sook Han

given: Hyo Sook

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA

family: Garber

full_name: Judy E Garber

given: Judy E

family: Johnson

full_name: Eric F Johnson

given: Eric F

family: Maag

full_name: David Maag

given: David

family: Qin

full_name: Qin Qin

given: Qin

family: Giranda

full_name: Vincent L Giranda

given: Vincent L

family: Shepherd

full_name: Stacie P Shepherd

given: Stacie P

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Future Oncology

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

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.

location_country:
Brazil
Sweden
Netherlands
Spain
Finland
France
Czechia
Poland
Israel
Norway
Hungary
Belgium
Argentina
Australia
Romania
Russian Federation
Denmark
United States
Canada
Ukraine

location_facility: Rush University Medical Center /ID# 65489

location_facility: Hospital de Clinicas de Porto Alegre /ID# 65242

location_facility: Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 63941

location_facility: Florida Cancer Specialists - East /ID# 60762

location_facility: Hospital Universitario Vall d'Hebron /ID# 97415

location_facility: Hospital General Universitario Gregorio Maranon /ID# 97417

location_facility: Massachusetts General Hospital /ID# 64582

location_facility: Houston Methodist Hospital - Scurlock Tower /ID# 60742

location_facility: Medical University of South Carolina /ID# 60752

location_facility: Institut de Cancer de l'Ouest /ID# 63927

location_facility: Chelyabinsk Reg Clin Oncology /ID# 63938

location_facility: Southern Medical Day Care Ctr /ID# 63274

location_facility: Gastroenterology Institute, Division of Medicine /ID# 63931

location_facility: The Angeles Clinic and Researc /ID# 60743

location_facility: lnstitutul Oncologic Trestiore /ID# 96742

location_facility: Spitalul Clinic Judetean de Urgenta /ID# 96741

location_facility: N.N. Petrov Research Inst Onc /ID# 78973

location_facility: Soroka University Medical Center /ID# 65180

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928

location_facility: Hospital Santa Creu i Sant Pau /ID# 97418

location_facility: Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222

location_facility: Washington University-School of Medicine /ID# 62724

location_facility: N.N. Petrov Research Inst Onc /ID# 65269

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 63940

location_facility: Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 65280

location_facility: AZ St-Jan Brugge-Oostende AV /ID# 107315

location_facility: University of Illinois - Chicago /ID# 106175

location_facility: Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 97697

location_facility: UT Southwestern Medical Center /ID# 60745

location_facility: Moore UC San Diego Cancer Center /ID# 60754

location_facility: Cliniques Universitaires Saint Luc /ID# 96135

location_facility: Univ of Colorado Cancer Center /ID# 60751

location_facility: Inst Oncology Prof. Chiricuta /ID# 96740

location_facility: University of Arkansas for Medical Sciences /ID# 60750

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975

location_facility: Communal non-profit enterprise Regional Center of Oncology /ID# 97696

location_facility: Pays-Basque Ctr Oncology/Radio /ID# 65176

location_facility: Haukeland University Hospital /ID# 67982

location_facility: Sunnybrook Health Sciences Ctr /ID# 77373

location_facility: Northwestern University Feinberg School of Medicine /ID# 60755

location_facility: Hospital Clinico Universitario de Valencia /ID# 97975

location_facility: Wielkopolskie Centrum Onkologi /ID# 71061

location_facility: University of Alabama at Birmingham - Main /ID# 62994

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 65178

location_facility: Pyatigorsk Oncology Dispensary /ID# 65264

location_facility: Hospital Universitario Virgen de la Victoria /ID# 97976

location_facility: Hospital Universitario HM Sanchinarro /ID# 97416

location_facility: Penn State University and Milton S. Hershey Medical Center /ID# 62723

location_facility: Banner MD Anderson Cancer Ctr /ID# 118695

location_facility: Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247

location_facility: Centrum Onkologii Lukaszczyka /ID# 73393

location_facility: Rigshospitalet, Finsen Centre /ID# 67822

location_facility: Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263

location_facility: Duke University Medical Center /ID# 60747

location_facility: Cedars-Sinai Medical Center - West Hollywood /ID# 60760

location_facility: Stanford University School of Med /ID# 65488

location_facility: State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415


title: A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination With OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma

summary: The primary objective of this study is to ascertain whether there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.

lead_sponsor: Achieve Life Sciences

location_country:
Italy
United States
France
Poland
Spain
Germany
Canada

location_facility: Akademicki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu

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

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Instituto Valenciano de Oncología-Fundación (IVO-FINCIVO)

location_facility: R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health

location_facility: Centre Hospitalier Universitaire, Institut Gustave Roussy

location_facility: Montefiore Medical Center, Albert Einstein College of Medicine

location_facility: Siteman Cancer Center, Washington University School of Medicine

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: Institut Català D'Oncologia, Hospital Duran i Reynals

location_facility: Centre Hospitalier Régional et Universitaire - Hôpital

location_facility: Urology Cancer Center and GU Research Network

location_facility: Zaklad Opieki Zdrowotnej MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Fondazione IRCCS Policlinico San Matteo Pavia

location_facility: Klinikum Rechts der Isar der Technischen Universität

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase IIIB, International, Single Group, Open Study to Define an Optimal Monitoring of IGF-1 in Children Treated With NutropinAq, Using a Novel Capillary Blood Collection Method

acronym: OPTIMA

summary: The main purpose of this study is to establish an optimal monitoring regimen in NutropinAq treated children, using newly developed capillary blood spot IGF-1 measurement technology.

lead_sponsor: Ipsen

location_country:
Italy
Finland
France
Czechia
Greece
Slovakia
Romania
Belgium
Russian Federation
Spain
Denmark
Germany
United Kingdom
Ukraine

location_facility: Clinica Pediatrica, Universita Federico II di Napoli

location_facility: Endocrinology Research Centre RAMS, Institute of Pediatric Endocrinology

location_facility: Institutul de Endocrinologie C.I. Parhon

location_facility: Tushino Pediatric Hospital, RMAPE Department of Endocrinology for Childhood and Adolescent Age

location_facility: Centre Pédiatrique Gatien de Clocheville

location_facility: Azienda Policlinico - Università di Catania

location_facility: Scientific-Research Institute of Endocrinology, Academy of Medical Science of Ukraine

location_facility: Ukrainian Scientific practical Centre of Endocrine surgery, Endocrine Organs and Tissues Transplantation


title: An Open-Label, Phase 2 Trial of Nanatinostat in Combination With Valganciclovir in Patients With Epstein-Barr Virus-Positive (EBV+) Relapsed/Refractory Lymphomas

summary: A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas

study_start_date_type: Anticipated

status: Recruiting

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Viracta Therapeutics, Inc.

location_country:
Italy
United States
France
Korea, Republic of
Singapore
Germany
United Kingdom
Canada
Taiwan

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Cardiff and Vale University Health Board

location_facility: UCSF Hematology and Blood and Marrow Transplant

location_facility: Sidney Kimmel Cancer Center - Jefferson Health

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

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Mid Florida Hematology and Oncology Center

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: The University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Centre Hospitalier Universitaire Limoges

status_simplified: Ongoing


title: Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized FcR Non-Binding Anti-CD3 Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

acronym: PROTECT

summary:
The purpose of this study is to determine whether teplizumab slows the loss of β cells and preserves β cell function in children and adolescent 8-17 years old who have been diagnosed with T1D in the previous 6 weeks..

Subjects will receive two courses of either teplizumab or placebo treatment 6 months apart.

lead_sponsor: Provention Bio, Inc.

location_country:
United States
Germany
France
Czechia
Poland
Hungary
Belgium
Canada
United Kingdom

location_facility: Vanderbilt University Medical Center (Site 024)

location_facility: University of South Florida Diabetes and Endocrinology Center (Site 011)

location_facility: Indiana University Hospital and Riley Hospital for Children (Site 014)

location_facility: St. Luke's Children's Endocrinology (Site 052)

location_facility: Hopitaux Pediatriques de Nice CHU-Lenval service de diabetologie et d'endocrinologia (Site 508)

location_facility: University of Miami Health System (Site 028)

location_facility: Diablo Clinical Research, Inc. (Site 002)

location_facility: CHU UCL Namur, site Clinique Sainte-Elisabeth (Site 205)

location_facility: Universitätsklinikum Heidelberg (Site 608)

location_facility: Sanford Diabetes and Thyroiid Clinical (Site 013)

location_facility: Kinderkrankenhaus Auf Der Bult (Site 604)

location_facility: Children's Mercy Hospitals & Clinics (Site 026)

location_facility: Washington University School of Medicine (Site 018)

location_facility: Universitatsklinikum Carl Gustav Carus (Site 601)

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház ( Site 705)

location_facility: Capital Diabetes & Endocrine Associates (Site 029)

location_facility: All Children's Hospital-Johns Hopkins Medicine (Site 048)

location_facility: Benaroya Research Institute at Virginia Mason (Site 016)

location_facility: Centre Hospitalier Regional (CHR) d'Orleans-Service de pediatrie (Site 513)

location_facility: Instytut "Pomnik - Centrum Zdrowia Dziecka" (Site 801)

location_facility: Cardiff and Vale NHS Trust - University Hospital of Wales (Site 902)

location_facility: AM Diabetes & Endocrinology Center (Site 008)

location_facility: Instytut Diabetologii Sp. z o.o. (Site 802)

location_facility: UF Clinical and Translation Research Building (Site 015)

location_facility: Northwick Park Hospital - Paediatrics (site 904)

location_facility: CHU Hopital de la Timone-Hopital d'Enfants (Site 512)

location_facility: Columbus Regional Research Institute (Site 006)

location_facility: Rady Children's Hospital-San Diego (Site 004)

location_facility: U. Minnesota Health Clinical Research Unit (Site 031)

location_facility: Endocrinology Service Northwest, LLC (Site 034)

location_facility: Universitätsklinikum Freiburg (Site 603)

location_facility: Evangelisches Klinikum Bethel Kinderklinik (Site 602)

location_facility: Nemours Children's Specialty Care-Endocrinology (Site 047)

location_facility: Children's Medical Center Dallas (Site 033)

location_facility: University of Chicago Medical Center (Site 017)

location_facility: Childrens Hospital of Philadelphia - Endocrinology (Site 021)

location_facility: Rocky Mountain Diabetes and Osteoporosis Center (Site 007)

location_facility: Alberta Diabetes Institute Clinical Research Unit Li Ka Shing Centre for Health Research Innovation (Site 103)

location_facility: Montreal Children's Hospital-McGill (Site 101)

location_facility: Groupe Hospitalier Necker Enfants Malades (site 502)

location_facility: UNC Hospitals Children's Specialty Clinic (Site 038)

location_facility: Groupe hospitalier Est-Hopital Femme, Mere, Enfant (Site 509)

location_facility: Sheffield Children's NHS Foundation Trust Western Bank (Site 903)

location_facility: Women and Children's Hospital of Buffalo (Site 010)

location_facility: Rainbow Babies & Children's Hospital (Site 049)

location_facility: Uniwersyteckie Centrum Kliniczne (Site 803)

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu (Site 804)

location_facility: Baystate Pediatric Endocrinology & Diabetes (Site 040)

location_facility: University of Colorado-Barbara Davis Center for Childhood Diabetes (Site 005)

location_facility: Universitätsklinikum Augsburg (Site 606)

location_facility: MultiCare Institute for Research & Innovation (Site 003)

intervention_type: Biological


title: Extended Access of Momelotinib for Subjects With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

summary: The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

status: Enrolling by invitation

design_allocation: Non-Randomized

lead_sponsor: Sierra Oncology, Inc.

location_country:
Italy
United States
Netherlands
Germany
France
Bulgaria
Poland
Israel
Romania
Hungary
Belgium
Australia
Singapore
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: University Multiprofile Hospital for Active Treatment St. Ivan Rilski

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Haematologiai Tanszek

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

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

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuţă

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lub

location_facility: Institut Hospital del Mar d'Investigacions Mèdiques

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Winship Cancer Institute, Emory University

location_facility: Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Hematologii

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA w Poznaniu im. Ledwika Bierkowskiego

location_facility: Semmelweis Egyetem I. sz. Belgyogyaszati Klinika, Hematologia

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Centre Hospitalier Universitaire de Liège Site Sart Tilman

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Barzilai Medical Center, Hematology Institute

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Multiprofile Hospital for Active Treatment Ruse

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

location_facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan

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

location_facility: National Specialized Hospital for Active Treatment of Haematologic Diseases

status_simplified: Unknown


lead_sponsor: AbbVie

location_facility: Strada dr. Sergiu Dumitru Nr 5 /ID# 224154

location_facility: Hospital Clinic de Barcelona /ID# 159462

location_facility: Klinicki bolnicki centar Osijek /ID# 157595

location_facility: Robely Rex VA Medical Center /ID# 218647

location_facility: Plains Clinical Research Center, LLC /ID# 169729

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 216043

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 224347

location_facility: Centro Hosp de Lisboa Central /ID# 165578

location_facility: Hospital Universitario San Vic /ID# 171488

location_facility: Penn State Milton S. Hershey Medical Center /ID# 230474

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE /ID# 166050

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 210960

location_facility: Quality Clinical Research Inc. /ID# 167312

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 158047

location_facility: National Medical Research Center of Coloproctology n.a. A. N. Ryzhikh /ID# 203513

location_facility: Renmin Hospital of Wuhan University /ID# 212867

location_facility: CNE Regional Clinical Hospital of Ivano-Frankivsk RC /ID# 203366

location_facility: UCSF Center for Colitis and Crohn's Disease /ID# 201209

location_facility: Hutt Valley Dist Health Board /ID# 212787

location_facility: Baylor Scott & White Center for Diagnostic Medicine /ID# 204132

location_facility: Cotton-O'Neil Clinical Res Ctr /ID# 160367

location_facility: Saiseikai Fukuoka Genaral Hospital /ID# 225640

location_facility: Fırat University Medical Facul /ID# 171285

location_facility: Yokkaichi Hazu Medical Center /ID# 164316

location_facility: H-T. Centrum Medyczne - Endoterapia /ID# 231501

location_facility: The First Hospital of Jilin University /ID# 212277

location_facility: Shengjing Hospital of China Medical University /ID# 211643

location_facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 217479

location_facility: Advanced Research Institute, Inc /ID# 161945

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 202060

location_facility: Inselspital, Universitaetsklinik /ID# 202909

location_facility: Hospital Nossa Senhora das Graças /ID# 157677

location_facility: Clinical Hosp Center Zvezdara /ID# 200150

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227456

location_facility: Peking University Third Hospital /ID# 221022

location_facility: Yamagata University Hospital /ID# 171481

location_facility: Azienda Policlinico Universitario Umberto I /ID# 171223

location_facility: Faculdade de Medicina do ABC /ID# 163993

location_facility: Sapporo Medical University Hospital /ID# 164278

location_facility: Hospital Universitario Reina Sofia /ID# 167062

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 164039

location_facility: Cleveland Clinic Main Campus /ID# 209235

location_facility: Interdisctrict Multidisciplinary Hospital /ID# 204921

location_facility: Universitaetsklinikum Regensburg /ID# 163693

location_facility: Hospital da Senhora da Oliveira Guimarães, EPE /ID# 165576

location_facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 169122

location_facility: Gastro Health & Nutrition - Victoria /ID# 164308

location_facility: Erciyes University Medical Fac /ID# 171283

location_facility: Theageneio Anticancer Hospital /ID# 165329

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 155628

location_facility: London Health Sciences Center /ID# 169117

location_facility: Fakultna nemocnica s poliklini /ID# 224100

location_facility: Manhattan Clinical Research, LLC /ID# 211803

location_facility: Sjaellands Universitets Hospit /ID# 200073

location_facility: Immanuel Kant Baltic Federal University /ID# 204920

location_facility: Southern California Res. Ctr. /ID# 169659

location_facility: East Tennessee Research Institute /ID# 168744

location_facility: The First Affiliated Hospital of Nanchang University /ID# 212182

location_facility: Azienda Ospedaliera Ospedale N /ID# 170959

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 210762

location_facility: Hoag Memorial Hosp Presbyterian /ID# 218347

location_facility: Corporacion Hospitalaria Juan Cuidad Sede Denominada Hospital Universitario Mayo /ID# 158736

location_facility: Marmara University Medical Fac /ID# 171290

location_facility: South Florida Research Ph I-IV /ID# 161844

location_facility: Hospital of Lithuanian Univers /ID# 201142

location_facility: Johns Hopkins University School of Medicine /ID# 211792

location_facility: Percuro Clinical Research, Ltd /ID# 169123

location_facility: Gokeikai Ofuna Chuo Hospital /ID# 169296

location_facility: Gastroenterology Group Naples /ID# 165210

location_facility: Asahikawa Medical University Hospital /ID# 164324

location_facility: National Hospital Organization Takasaki General Medical Center /ID# 164312

location_facility: Fukuoka University Chikushi Hospital /ID# 209056

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 170910

location_facility: Royal Liverpool and Broadgreen /ID# 203860

location_facility: Centro Hospitalar Universitário do Algarve, EPE - Hospital de Portimão /ID# 166563

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Panstwowy Instytut Bada /ID# 170285

location_facility: Universitaetsklinikum St.Poelten /ID# 169049

location_facility: Praxiszentrum fuer Gastroenterologie /ID# 219072

location_facility: General Hospital of Ningxia Medical University /ID# 213912

location_facility: Gastroenterologische Spezialpraxis am Wittenbergplatz /ID# 219146

location_facility: The Jikei University Hospital /ID# 164279

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 205678

location_facility: Adult Gastroenterology Associates - Main /ID# 208873

location_facility: Instituto Medico de Alta Tecnologia Oncomédica S.A /ID# 207041

location_facility: St. Marianna University School of Medicine Hospital /ID# 226730

location_facility: Universitaetsklinikum Freiburg /ID# 162038

location_facility: Clinic of New Technologies of Medicine /ID# 204926

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 159379

location_facility: International Medical Center SOGAZ /ID# 206832

location_facility: St.Luke's International Hospital /ID# 225969

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 155623

location_facility: Inje University Haeundae Hospital /ID# 203027

location_facility: Gastroenterologie Opernstrasse /ID# 163690

location_facility: The First Affiliated Hospital of Anhui Medical University /ID# 211227

location_facility: UOC Medicina Interna e Gastroe /ID# 155624

location_facility: Rocky Mountain Pediatric Gastroenterology /ID# 207173

location_facility: Health Pharma Professional Research S.A de C.V /ID# 206516

location_facility: General Hospital of Athens Laiko /ID# 206438

location_facility: Atrium Health Carolinas Medical Center /ID# 158543

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934

location_facility: Medical University of Vienna /ID# 169051

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226796

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 163389

location_facility: Digestive Disease Specialists /ID# 170777

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 169125

location_facility: Sechenov First Moscow Medical /ID# 204981

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 164215

location_facility: Colo-proctology Center Matsushima Clinic /ID# 225915

location_facility: Hanyang University Guri Hospital /ID# 158661

location_facility: DM Clinical Research/Southwest /ID# 165009

location_facility: Tzaneio general hospital of Piraeus /ID# 206437

location_facility: Columbia Univ Medical Center /ID# 161929

location_facility: Centro Hospitalar de Entre Douro e Vouga /ID# 166048

location_facility: Ospedale Sant Orsola Malpighi /ID# 155627

location_facility: Nagasaki University Hospital /ID# 205326

location_facility: Fujita Health University Hospital /ID# 164313

location_facility: Sapporo Higashi Tokushukai Hospital /ID# 208493

location_facility: Texas Digestive Disease Consultants - Cedar Park /ID# 209951

location_facility: Yeungnam University Medical Center /ID# 158662

location_facility: Inonu Universitesi Turgut Ozal /ID# 203980

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 157668

location_facility: Gastroenterology Consultants of Southwest Virginia /ID# 218142

location_facility: Renji Hospital, Shanghai Jiaotong University School of Medicine /ID# 211230

location_facility: Hospital Universitario Miguel Servet /ID# 159468

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 169770

location_facility: LMU Klinikum Campus Grosshadern /ID# 210484

location_facility: Wellington Hospital (Capital and Coast District Health Board) /ID# 205338

location_facility: Centrul Medical Tuculanu SRL /ID# 171263

location_facility: Universitair Ziekenhuis Leuven /ID# 170829

location_facility: Klinicki bolnicki centar Split /ID# 157596

location_facility: West China Hospital, Sichuan University /ID# 211275

location_facility: Hospital Universitario Virgen Macarena /ID# 159969

location_facility: Shiga University of Medical Science Hospital /ID# 164323

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 157683

location_facility: CHU Amiens Picardie - Site Sud /ID# 207880

location_facility: Peak Gastroenterology Associat /ID# 165838

location_facility: South Lake Pain Institute, Inc /ID# 162859

location_facility: Scott Shulman Medicine Professional Corporation /ID# 169127

location_facility: Kitasato University Hospital /ID# 169223

location_facility: Nara Medical University Hospital /ID# 169222

location_facility: General Hospital of Athens Ippokratio /ID# 229190

location_facility: China Medical University Hosp /ID# 160194

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 211069

location_facility: Riga East Clinical Univ Hosp /ID# 160204

location_facility: Medizinische Universität Graz /ID# 169052

location_facility: The University of Chicago Medical Center /ID# 160511

location_facility: Japanese Red Cross Wakayama Medical Center /ID# 171196

location_facility: Barnsley Hospital NHS Foundation Trust /ID# 202771

location_facility: Toronto Digestive Disease Asso /ID# 169120

location_facility: Hamamatsu University Hospital /ID# 226729

location_facility: Gastroenterologische Gemeinschaftspraxis Minden /ID# 162037

location_facility: Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 201818

location_facility: Omega Research Maitland, LLC /ID# 203105

location_facility: Hospital Universitario La Paz /ID# 159471

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 165327

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 226795

location_facility: Ospedale Classificato Equiparato Sacro Cuore-Don Calabria /ID# 164029

location_facility: Centex Studies, Inc. - Houston /ID# 201221

location_facility: Hospital Privado Univesitario /ID# 167802

location_facility: Hyogo College of Medicine Hospital /ID# 164238

location_facility: Centro Hosp de Tondela-Viseu /ID# 166049

location_facility: Kanazawa University Hospital /ID# 169221

location_facility: The Second Hospital of Hebei Medical University /ID# 213019

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 216103

location_facility: Complejo Hospitalario Universitario de Pontevedra /ID# 216183

location_facility: National Taiwan University Hospital /ID# 162188

location_facility: Texas Digestive Disease Consultants - Cedar Park /ID# 209799

location_facility: Air Force Specialized Hospital /ID# 170984

location_facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 159466

location_facility: Hospital de Clinicas de Porto Alegre /ID# 157670

location_facility: Hadassah Medical Center-Hebrew University /ID# 171092

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 211024

location_facility: VA Caribbean Healthcare System /ID# 222779

location_facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 159463

location_facility: Klinicka bolnica Dubrava Zagreb /ID# 157598

location_facility: Tokyo Medical And Dental University, Medical Hospital /ID# 164225

location_facility: CHA bundang medical center CHA University /ID# 158669

location_facility: General Hospital of Nikaia-Piraeus "Agios Panteleimon"- general hospital dytikis /ID# 165313

location_facility: Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 224349

location_facility: Nemocnice Ceske Budejovice a.s. /ID# 225228

location_facility: Complejo Asistencial Dr. Sotero del Rio /ID# 169386

location_facility: Kuzbass Regional Clinical Hospital /ID# 165759

location_facility: Linkou Chang Gung Memorial Hos /ID# 222878

location_facility: Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 215505

location_facility: Pusan National University Hospital /ID# 158670

location_facility: King's College Hospital NHS Foundation Trust /ID# 158762

location_facility: Kitasato University Kitasato Institute Hospital /ID# 164222

location_facility: Hospital Clinico Universitario de Salamanca /ID# 159469

location_facility: Uludag University Medical Faculty /ID# 204179

location_facility: Agaplesion Markus Krankenhaus /ID# 159375

location_facility: Virginia Mason - Seattle Orthapedics /ID# 160432

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 211070

location_facility: University of Michigan Health Systems /ID# 159430

location_facility: Hiroshima University Hospital /ID# 164240

location_facility: University Clinical Center Serbia /ID# 200153

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 201824

location_facility: Klinicki bolnicki centar Zagreb /ID# 201915

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 160457

location_facility: Elisabeth Tweesteden Ziekenhuis /ID# 163738

location_facility: Stadtisches Klinikum Braunschweig /ID# 163694

location_facility: Showa University Fujigaoka Hospital /ID# 209606

location_facility: Servicio de Salud Araucanía Norte Hospital Victoria /ID# 213152

location_facility: The Catholic University of Korea, ST. Vincent's Hospital /ID# 158664

location_facility: Universitatsklinikum Mannheim /ID# 162039

location_facility: Unidad de Atencion Medica e Investigacion en Salud /ID# 206515

location_facility: Nagoya City University Hospital /ID# 164229

location_facility: Sisli Etfal Train & Res Hosp /ID# 171415

location_facility: Ponce Medical School Foundation /ID# 222825

location_facility: Lenus Research & Medical Group /ID# 169727

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 163994

location_facility: Charite; Campus Benjamin Frank /ID# 210508

location_facility: Universitaetsklinikum Erlangen /ID# 159373

location_facility: Cedars-Sinai Medical Center-West Hollywood /ID# 163848

location_facility: ProMedica Physicians Digestive Healthcare /ID# 215622

location_facility: DiGiovanna Institute for Medical Education & Research /ID# 171128

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 207882

location_facility: Regional Clinical Hospital #1 /ID# 165763

location_facility: Tokai University Hachioji Hospital /ID# 227102

location_facility: The Sixty Affiliated Hospital Sun Yat-Sen University /ID# 211229

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 200634

location_facility: Taipei Veterans General Hosp /ID# 171436

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 160513

location_facility: Clinical Research Trials of Florida, Inc. /ID# 201794

location_facility: Klinicki bolnicki centar Zagreb /ID# 157594

location_facility: Vanderbilt University Medical Center /ID# 160567

location_facility: Ulyanovsk State clinical hospi /ID# 204923

location_facility: Kaiser Permanente - San Francisco /ID# 212087

location_facility: Toho University Medical Center Sakura Hospital /ID# 164219

location_facility: Medical Centre OK Clinic of International Institute of Clinical Research LLC /ID# 205484

location_facility: Praxis fuer Gastroenterologie /ID# 166154

location_facility: Tyler Research Institute, LLC /ID# 166799

location_facility: Hospital Alvaro Cunqueiro CHUVI /ID# 167359

location_facility: Chung Shan Medical University /ID# 171426

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 206563

location_facility: Ctr for Advanced Gastroenterol /ID# 202820

location_facility: Southern Star Research Institute, LLC /ID# 168774

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 164348

location_facility: Barts and the London NHS Trust /ID# 157617

location_facility: Aichi Medical University Hospital /ID# 164227

location_facility: Louisana Research Center, LLC /ID# 201205

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 165577

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 159473

location_facility: Taichung Veterans General Hosp /ID# 171433

location_facility: Great Lakes Gastroenterology Research LLC /ID# 201778

location_facility: UMHAT Tsaritsa Joanna - ISUL /ID# 209978

location_facility: P. Stradins Clinical Univ Hosp /ID# 160205

location_facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 155626

location_facility: CHU UCL Namur - site Godinne /ID# 200259

location_facility: Groupe Sante CHC - Clinique du MontLegia /ID# 200255

location_facility: Kaiser Clinica e Hospital Dia /ID# 157686

location_facility: Clinical Hospital Center Dr Dragisa Misovic - Dedinje /ID# 224927

location_facility: Clinical Associates in Researc /ID# 161364

location_facility: Cabinet Particular Policlinic Algomed /ID# 171260

location_facility: Ospedale Policlinico San Martino - IRCCS /ID# 164030

location_facility: Yale Univ Digestive Diseases /ID# 213265

location_facility: Hospital Garcia de Orta, E.P.E /ID# 165579

location_facility: Tsujinaka Hospital Kashiwanoha /ID# 225968

location_facility: The Second Xiangya Hospital of Central South University /ID# 211196

location_facility: Houma Digestive Health Special /ID# 158377

location_facility: Moore UC San Diego Cancer Center /ID# 160430

location_facility: Volyn regional clinical hospital /ID# 229849

location_facility: Central Clinical Hospital RZHD Medicine /ID# 204922

location_facility: Osaka Medical and Pharmaceutical University Hospital /ID# 226036

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 167202

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 170286

ipd_sharing: Yes

source: euctr

title: A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis

summary:
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for participants who completed Substudy 1 or 2, or participants who responded to induction treatment in Study M16-067 with no final endoscopy due to the Covid-19 pandemic.


ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

lead_sponsor: Pharmacyclics LLC.

location_country:
Italy
Austria
United States
Spain
Germany
Croatia
France
Japan
Singapore
Hungary
Australia
China
Canada
Korea, Republic of
Taiwan

acronym: iNTEGRATE

location_facility: Ospedale San Raffaele IRCCS /ID# 1140-0523

location_facility: A.O. Univ. Ospedali Riuniti /ID# 1140-0932

location_facility: University of British Columbia (UBC) - Vancouver General Hospital (VGH) /ID# 1140-1166

location_facility: Stanford University/Stanford Cancer Center, Pasteur Drive /ID# 1140-0400

location_facility: Singapore General Hospital /ID# 1140-1162

location_facility: Chinese PLA General Hospital /ID# 1140-1198

location_facility: Osaka City University Hospital /ID# 1140-1157

location_facility: Florida Hospital Cancer Institute/Adventist Health System/Sunbelt, Inc /ID# 1140-1121

location_facility: Fred Hutchinson Cancer Research Center /ID# 1140-0404

location_facility: Vanderbilt University Medical Center Vanderbilt Ingram Cancer Center /ID# 1140-0024

location_facility: Centro Trapianti Cellule Staminali, Ospedale Infantile Regina Margherita /ID# 1140-1156

location_facility: University of Louisville Hospital /ID# 1140-1131

location_facility: National University Cancer Institute - National University Health System /ID# 1140-1155

location_facility: Emory University/Winship Cancer Institute /ID# 1140-1179

location_facility: Hyogo College of Medicine College Hospital /Id# 1140-1434

location_facility: Medical University of South Carolina, MUSC /ID# 1140-0738

location_facility: Hospital Universitario Virgen del Rocio /ID# 1140-0863

location_facility: Arizona Oncology - Scottsdale - Cancer Transplant Institute Location /ID# 1140-1120

location_facility: Osaka Women's and Children's Hospital /ID# 1140-1440

location_facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 1140-1150

location_facility: National Center for Child Health and Development /ID# 1140-1443

location_facility: Hospital Clinico Universitario de Valencia /ID# 1140-1145

location_facility: National Taiwan Univ Hosp /ID# 1140-1184

location_facility: Barbara Ann Karmanos Cancer In /ID# 1140-0130

location_facility: Royal Melbourne Hospital (RMH) /ID# 1140-0633

location_facility: Jackson Memorial Hospital, University of Miami /ID# 1140-0647

location_facility: China Medical University Hosp /ID# 1140-1199

location_facility: Dana-Farber Cancer Institute /ID# 1140-0349

location_facility: Indiana University Melvin and Bren Simon Cancer Center /ID# 1140-0010

location_facility: Okayama University Hospital /ID# 1140-1430

location_facility: Boston Childrens Hospital /ID# 1140-1615

location_facility: Mayo Clinic, Rochester, MN /ID# 1140-0240

location_facility: Rutgers Cancer Institute of NJ /ID# 1140-0803

location_facility: Montefiore Medical Center - Moses Campus /ID# 1140-0120

location_facility: Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital /ID# 1140-1437

location_facility: University of Pittsburgh - UPMC (Hillman Cancer Center) /ID# 1140-0050

location_facility: Universitaetsklinikum Dresden /ID# 1140-1367

location_facility: The Ottawa Hospital Regional Cancer Center /ID# 1140-0159

location_facility: CHU Amiens Groupe hospitalier Sud /ID# 1140-1205

location_facility: Cath Univ Seoul St Mary's Hosp /ID# 1140-0928

location_facility: Massachusetts General Hospital Cancer Center /ID# 1140-0020

location_facility: Groupe Hospitalier Pitie-Salpetriere /ID# 1140-0918

location_facility: Kyungpook National Univ Hosp /ID# 1140-1153

location_facility: Universitatsklinikum Munster /ID# 1140-1195

location_facility: Columbia University Medical Center, MS-CHONY /ID# 1140-1124

location_facility: Yonsei University Health System, Severance Hospital /ID# 1140-0927

location_facility: New York Presbyterian Hospital/Weill Cornell Med College /ID# 1140-0200

location_facility: Emory University, Winship Cancer Institute /ID# 1140-0033

location_facility: Dr. Haunerschen Kinderspital /ID# 1140-1142

location_facility: Hokkaido University Hospital /ID# 1140-1436

location_facility: UCHSC Anschultz Cancer Pavilion /ID# 1140-0068

location_facility: Stony Brook University Medical Center /ID# 1140-0719

location_facility: Duplicate_University of Tsukuba Hospital /ID# 1140-1445

location_facility: Children's National Medical Center /ID# 1140-1122

location_facility: Hospital Santa Creu i Sant Pau /ID# 1140-0535

location_facility: Princess Margaret Cancer Centre /ID# 1140-0043

location_facility: Dup_Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 1140-1439

location_facility: Royal Brisbane and Women's Hospital /ID# 1140-0190

location_facility: Univ. Klinik for Innere Medizin, Klinische Abteilung for Hematologie, Graz /ID# 1140-0373

location_facility: Tokai University Hospital /ID# 1140-1444

location_facility: Duplicate_Kurashiki Central Hospital /ID# 1140-1442

location_facility: Krankenhaus der Elisabethinen Linz /ID# 1140-0849

location_facility: Hackensack University Medical Center/ John Theurer Cancer Center /ID# 1140-0343

location_facility: University of Rochester Cancer Center /ID# 1140-0127

location_facility: The Kinghorn Cancer Centre /ID# 1140-1165

location_facility: University Hospital of Regensburg /ID# 1140-1446

location_facility: Weill Cornell Physicians - Hematologic Malignancies & Bone Marrow Transplant /ID# 1140-0019

location_facility: Hopital Saint-Louis - Institut Hematologie Centre Hayem CHU /ID# 1140-0735

location_facility: SoonChunHyang University Seoul /ID# 1140-1163

location_facility: The First Affiliated Hospital of Soochow University /ID# 1140-1208

location_facility: Centre Hospitalier Regional Universitaire de Lille /ID# 1140-0750

location_facility: University of North Carolina - Lineberger Comprehensive Cancer Center /ID# 1140-1133

location_facility: Kobe City Medical Center General Hospital /ID# 1140-1438

title: A Randomized, Double-Blind Phase 3 Study of Ibrutinib in Combination With Corticosteroids Versus Placebo in Combination With Corticosteroids in Subjects With New Onset Chronic Graft Versus Host Disease (cGVHD)

summary: To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.


title: A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma

summary: Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).

ReferenceCitation: Noy A, de Vos S, Coleman M, Martin P, Flowers CR, Thieblemont C, Morschhauser F, Collins GP, Ma S, Peles S, Smith SD, Barrientos JC, Chong E, Wu S, Cheung LW, Kwei K, Hauns B, Arango-Hisijara I, Chen R. Durable ibrutinib responses in relapsed/refractory marginal zone lymphoma: long-term follow-up and biomarker analysis. Blood Adv. 2020 Nov 24;4(22):5773-5784. doi: 10.1182/bloodadvances.2020003121.

family: Noy

full_name: Ariela Noy

given: Ariela

name: David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA;

family: de Vos

full_name: Sven de Vos

given: Sven

family: Coleman

full_name: Morton Coleman

given: Morton

family: Martin

full_name: Peter Martin

given: Peter

name: Winship Cancer Institute, Emory University, Atlanta, GA;

family: Flowers

full_name: Christopher R. Flowers

given: Christopher R.

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

name: Hôpital Claude Huriez, Centre Hospitalier Régional Universitaire de Lille, Lille, France;

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

name: Oxford Cancer and Haematology Centre, Churchill Hospital, Oxford, United Kingdom;

family: Collins

full_name: Graham P. Collins

given: Graham P.

name: Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL;

family: Ma

full_name: Shuo Ma

given: Shuo

name: Florida Cancer Specialists, Atlantis, FL;

family: Peles

full_name: Shachar Peles

given: Shachar

name: University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA;

family: Smith

full_name: Stephen D. Smith

given: Stephen D.

name: Division of Medical Oncology and Hematology, Northwell Health Cancer Institute, New Hyde Park, NY;

family: Barrientos

full_name: Jacqueline C. Barrientos

given: Jacqueline C.

name: Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and

family: Chong

full_name: Elizabeth Chong

given: Elizabeth

family: Wu

full_name: Shiquan Wu

given: Shiquan

family: Cheung

full_name: Leo W.-K. Cheung

given: Leo W.-K.

family: Kwei

full_name: Kevin Kwei

given: Kevin

family: Hauns

full_name: Bernhard Hauns

given: Bernhard

family: Arango-Hisijara

full_name: Israel Arango-Hisijara

given: Israel

name: City of Hope National Medical Center, Duarte, CA

family: Chen

full_name: Robert Chen

given: Robert

journal_name: Blood Advances

oa_colors: green gold

evidence: oa journal (via observed oa rate)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

ReferenceCitation: Noy A, de Vos S, Thieblemont C, Martin P, Flowers CR, Morschhauser F, Collins GP, Ma S, Coleman M, Peles S, Smith S, Barrientos JC, Smith A, Munneke B, Dimery I, Beaupre DM, Chen R. Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma. Blood. 2017 Apr 20;129(16):2224-2232. doi: 10.1182/blood-2016-10-747345. Epub 2017 Feb 6.

name: Lymphoma Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY;

name: Weill Department of Medicine, Weill Cornell Medical College, New York, NY;

name: David Geffen School of Medicine at UCLA, Los Angeles, CA;

name: Hemato-oncology Department, Assistance Publique–Hôpitaux de Paris, Hôpital Saint-Louis, Paris Diderot University, Sorbonne Paris-Cité, Paris, France;

name: Winship Cancer Institute of Emory University, Atlanta, GA;

name: Hematologie, Centre Hospitalier Universitaire, Université de Lille, Lille, France;

name: Department of Haematology, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom;

name: Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago, IL;

name: Clinical Research Alliance, Center for Lymphoma and Myeloma, Weill Cornell Medical College, New York, NY;

name: Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, WA;

name: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA;

name: Division of Hematology and Medical Oncology, Department of Medicine, Hofstra Northwell School of Medicine, Hempstead, NY;

location_country:
United States
France
Belgium
Germany
United Kingdom

location_facility:
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Site Reference ID/Investigator# 368
Site Reference ID/Investigator# 348


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.

lead_sponsor: Millennium Pharmaceuticals, Inc.

primary_purpose: Prevention

location_country:
Austria
Germany
France
United States
United Kingdom

location_facility: Centre Hospitalier Universitaire de Nice Hopital l'Archet

location_facility: Saint Helens and Knowsley Teaching Hospitals NHS Trust

location_facility: Les Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

location_facility: University of Miami Leonard M. Miller School of Medicine

location_facility: The University of Chicago Medical Center

location_facility: University of Arkansas for Medical Sciences

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: NYU Langone Inflammatory Bowel Disease Center

location_facility: University of Kentucky Chandler Medical Center

location_facility: University of Colorado Hospital Anschutz Cancer Pavilion

location_facility: Vanderbilt Inflammatory Bowel Disease Clinic

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: University of North Carolina School of Medicine

location_facility: Columbia University Irving Medical Center

type: Registry Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence

summary: The purpose of this study is to evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after a planned laparoscopic ileocecal resection with primary anastomosis.