title: The AMADEUS Trial, A Multicenter, Randomized, Open-label, Assessor Blind, Non-inferiority Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous Idraparinux (SR34006) With Adjusted-dose Oral Vitamin-K Antagonists in the Prevention of Thromboembolic Events in Patients With Atrial Fibrillation

summary:
This trial will include patients who have a heart condition called atrial fibrillation. Atrial fibrillation is an abnormal rhythm (irregular beat) in the heart. Patients with atrial fibrillation have an increased chance for a blood clot to form in the heart and move to other blood vessels in the body and cause obstruction. This obstruction may damage tissue. For example, a blood clot plugging a vessel in the brain could cause a stroke. Therefore, patients with atrial fibrillation may be given anticoagulant (blood-thinning) tablets such as warfarin or acenocoumarol.

The purpose of this study is to compare the safety and effectiveness of a new injectable anticoagulant drug that is administered once weekly, SR34006 with warfarin or acenocoumarol tablets.

Assignment to either SR34006 Injection or vitamin K antagonist (warfarin or acenocoumarol) tablets will be purely by chance and will be known by both patients and their doctors.

ReferenceCitation: Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.

family: Prins

full_name: MH Prins

given: MH

family: Guillemin

full_name: I Guillemin

given: I

family: Gilet

full_name: H Gilet

given: H

family: Gabriel

full_name: S Gabriel

given: S

family: Essers

full_name: B Essers

given: B

family: Raskob

full_name: G Raskob

given: G

family: Kahn

full_name: SR Kahn

given: SR

journal_name: Health and Quality of Life Outcomes

title: Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q©)

ReferenceCitation: Amadeus Investigators, Bousser MG, Bouthier J, Büller HR, Cohen AT, Crijns H, Davidson BL, Halperin J, Hankey G, Levy S, Pengo V, Prandoni P, Prins MH, Tomkowski W, Torp-Pedersen C, Wyse DG. Comparison of idraparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: a randomised, open-label, non-inferiority trial. Lancet. 2008 Jan 26;371(9609):315-21. doi: 10.1016/S0140-6736(08)60168-3. Erratum in: Lancet. 2008 Dec 13;372(9655):2022.. Thorp-Pedersen, C [corrected to Torp-Pedersen, C].

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

location_country:
Italy
United States
Netherlands
France
Poland
Australia
New Zealand
Denmark
Canada
United Kingdom

location_facility: Practice of James A. Underberg @ Murray Hill Medical Group

location_facility: Southern Arizona Veterans Affairs Health Care System

location_facility: The Clinic (Lake Charles Medical & Surgical Clinic)

location_facility: Denver Health and Hospital Authority Adult Medicine Clinic

location_facility: Jacksonville Center for Clinical Research

location_facility: The Oregon Health and Science University

location_facility: Dr. M.P.J. Senaratne Professional Corporation

location_facility: Denver Health and Hospital Authority Eastside Health Clinic

location_facility: Cardiovascular Research Institute of Dallas, Inc./Cardiology and Internal Medicine Associates

location_facility: Oracle Research, a Division of: The Heart Center, P.C.

location_facility: Health Care Corporation of St. John's Health Sciences Centre

location_facility: Heart & Vascular Clinic/Advanced Medical Research

location_facility: North Broward Hospital District Cardiovascular Research Institute


title: Continuous Fluorouracil Plus Mitomycin C Versus Mitomycin C Plus Cisplatin As Chemotherapy Combination In Combined Radiochemotherapy For Locally Advanced Anal Cancer. A Phase II-III Study

summary:
RATIONALE: Drugs used in chemotherapy, such as mitomycin, fluorouracil, and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether radiation therapy and mitomycin are more effective when combined with fluorouracil or with cisplatin in treating anal cancer .

PURPOSE: This randomized phase II/III trial is studying how well giving radiation therapy and mitomycin together with fluorouracil works compared to radiation therapy, mitomycin, and cisplatin in treating patients with locally advanced anal cancer.

status: Terminated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Matzinger O, Roelofsen F, Mineur L, Koswig S, Van Der Steen-Banasik EM, Van Houtte P, Haustermans K, Radosevic-Jelic L, Mueller RP, Maingon P, Collette L, Bosset JF; EORTC Radiation Oncology and Gastrointestinal Tract Cancer Groups. Mitomycin C with continuous fluorouracil or with cisplatin in combination with radiotherapy for locally advanced anal cancer (European Organisation for Research and Treatment of Cancer phase II study 22011-40014). Eur J Cancer. 2009 Nov;45(16):2782-91. doi: 10.1016/j.ejca.2009.06.020. Epub 2009 Jul 28.

family: Matzinger

full_name: O. Matzinger

given: O.

sequence: first

family: Roelofsen

full_name: F. Roelofsen

given: F.

sequence: additional

family: Mineur

full_name: L. Mineur

given: L.

family: Koswig

full_name: S. Koswig

given: S.

family: Van Der Steen-Banasik

full_name: E.M. Van Der Steen-Banasik

family: Van Houtte

full_name: P. Van Houtte

given: P.

family: Haustermans

full_name: K. Haustermans

given: K.

family: Radosevic-Jelic

full_name: L. Radosevic-Jelic

family: Mueller

full_name: R.P. Mueller

family: Maingon

full_name: P. Maingon

family: Collette

full_name: L. Collette

family: Bosset

full_name: J.F. Bosset

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cancer

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country: Italy Serbia Netherlands France Belgium Egypt Germany

location_facility: Robert Roessle Comprehensive Cancer Center - Charite Campus Buch

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Urologische Klinik - Universitaetsklinikum Aachen

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Ospedale Busonera - Divisione Oncologia Medica

intervention_type: Radiation

lead_sponsor_type: industriel

status_simplified: Unknown


intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

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.

lead_sponsor: AbbVie

enrollment_type: Anticipated

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

location_facility: Istanbul University Istanbul Medical Faculty /ID# 171364

location_facility: Tokyo Medical University Hospital /ID# 167130

location_facility: Professor Pasechnikov Gastroenterology and Pankreatology clinic /ID# 202997

location_facility: Morales Vargas Centro de Investigacion S.C. /ID# 203494

location_facility: Nemocnice Ceske Budejovice a.s. /ID# 224389

location_facility: Assaf Harofeh Medical Center /ID# 204872

location_facility: Chung-Ang University Hostipal /ID# 207018

location_facility: Hamamatsu University Hospital /ID# 224352

location_facility: Duplicate_Tianjin Med Univ General Hosp /ID# 206994

location_facility: Obudai Egeszsegugyi Centrum Kft. /ID# 201892

location_facility: MNPE Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrohov /ID# 222110

location_facility: Texas Digestive Disease Consultants /ID# 209953

location_facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 206154

location_facility: University Clinical Centre of the Republic of Srpska /ID# 208051

location_facility: The Dudley Group NHS Foundation Trust /ID# 169069

location_facility: Gastroenterology Associates of Central Georgia, LLC /ID# 165478

location_facility: United Health Services Hospitals, Inc /ID# 217485

location_facility: Tokyo Medical And Dental University, Medical Hospital /ID# 165965

location_facility: Dayton Gastroenterology, Inc. /ID# 167627

location_facility: Hospital Universitario y Politecnico La Fe /ID# 201992

location_facility: WIP Warsaw IBD Point Profesor Kierkus /ID# 224301

location_facility: Policlinico San Martino/Univer /ID# 168191

location_facility: Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 168182

location_facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 166771

location_facility: West Tallinn Central Hospital /ID# 202785

location_facility: The First Hospital of Jilin University /ID# 206868

location_facility: Faculdade de Medicina do ABC /ID# 208323

location_facility: Richmond University Medical Center /ID# 201857

location_facility: Yonsei University Health System Severance Hospital /ID# 167590

location_facility: Lahey Hospital and Medical Center /ID# 214726

location_facility: Yokohama City University Medical Center /ID# 167128

location_facility: Toyama Prefectural Central Hospital /ID# 217834

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 204073

location_facility: Scott Shulman Medicine Professional Corporation /ID# 169066

location_facility: Digestive Disease Specialists /ID# 201064

location_facility: Medizinische Universitat Wien /ID# 169465

location_facility: Hyogo College of Medicine College Hospital /Id# 165973

location_facility: Clinical Center University of Sarajevo /ID# 203887

location_facility: Universitaetsklinikum Halle (Saale) /ID# 207455

location_facility: Perm Clinical Center of the Federal Medical and Biological Agency /ID# 202990

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 165960

location_facility: Rush University Medical Center /ID# 165497

location_facility: Southern Star Research Institute, LLC /ID# 169755

location_facility: Agaplesion Markus Krankenhaus /ID# 168758

location_facility: Washington Gastroenterology Associates /ID# 164824

location_facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 171401

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 171332

location_facility: Atrium Health Carolinas Medical Center /ID# 164932

location_facility: Crystal Pharmacology Research /ID# 166081

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207579

location_facility: Karolinska University Hospital Solna /ID# 224488

location_facility: Allen Whey Khye Lim Professional Corporation /ID# 168044

location_facility: Hospital Clinic de Barcelona /ID# 201990

location_facility: Nanfang Hospital of Southern Medical University /ID# 204083

location_facility: Indianapolis Gastroenterology /ID# 164938

location_facility: Montefiore Medical Center - Moses Campus /ID# 166193

location_facility: Concord Repatriation General Hospital /ID# 171512

location_facility: Kazan State Medical University /ID# 169638

location_facility: Hospital Garcia de Orta, EPE /ID# 170241

location_facility: Republican hospital named after V.A. Baranov /ID# 206488

location_facility: Duplicate_Sapporo Higashi Tokushukai Hospital /ID# 167124

location_facility: IRCCS Ospedale Sacro Cuore Don Calabria /ID# 168186

location_facility: Universitatsklinikum Mannheim /ID# 168759

location_facility: Tzaneio general hospital of Piraeus /ID# 206433

location_facility: Encore Borland-Groover Clinical Research /Id# 203499

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 170248

location_facility: University Clinical Center Kragujevac /ID# 205859

location_facility: Pauls Stradins Clinical University Hospital /ID# 169519

location_facility: Hometown Urgent Care and Resea /ID# 201291

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 204081

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 202425

location_facility: Texas Digestive Disease Consultants /ID# 209801

location_facility: Duplicate_Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 166014

location_facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP /ID# 166866

location_facility: Advanced Research Institute, Inc /ID# 164921

location_facility: King's College Hospital NHS Foundation Trusts /ID# 169072

location_facility: Tyler Research Institute, LLC /ID# 168687

location_facility: Ishida Clinic of IBD and Gastroenterology /ID# 167121

location_facility: Inje University Haeundae Hospital /ID# 202630

location_facility: TX Clinical Research Institute /ID# 164896

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 209564

location_facility: Universitaetsklinikum Frankfurt /ID# 203566

location_facility: Wakayama Medical University Hospital /ID# 169482

location_facility: Inselspital, Universitätsspital Bern /ID# 170997

location_facility: AGA Clinical Research Associates, LLC /ID# 164769

location_facility: CHI Nebraska d/b/a CHI Health /ID# 168578

location_facility: University General Hospital of Heraklion PA.G.N.I /ID# 167044

location_facility: Omega Research Maitland, LLC /ID# 203481

location_facility: Johns Hopkins University School of Medicine /ID# 211941

location_facility: Digestive Diseases Ctr Gastro /ID# 169508

location_facility: Louisana Research Center, LLC /ID# 164894

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 170849

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 170245

location_facility: Quality Clinical Research, Inc /ID# 170137

location_facility: Great Lakes Medical Research, LLC /ID# 202010

location_facility: Warrington and Halton Hospitals NHS Foundation Trust /ID# 171383

location_facility: Hanyang University Guri Hospital /ID# 167587

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 205552

location_facility: Plains Clinical Research Center, LLC /ID# 170140

location_facility: Hospital Clinico Universitario de Valencia /ID# 209657

location_facility: Sisli Etfal Train & Res Hosp /ID# 171334

location_facility: University Clinical Center Serbia /ID# 168215

location_facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 169075

location_facility: Carl R. Meisner Medical Clinic /ID# 201061

location_facility: National Taiwan University Hospital /ID# 169792

location_facility: Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 170773

location_facility: Private Practice Dr MN Rajabally /ID# 169853

location_facility: QEII - Health Sciences Centre /ID# 169307

location_facility: Atlanta Gastroenterology Spec /ID# 164799

location_facility: Clin Res Inst of Michigan, LLC /ID# 170133

location_facility: Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166852

location_facility: National Hepatology and Tropical Medicine Research Institute /ID# 170989

location_facility: Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144

location_facility: Immanuel Kant Baltic Federal University /ID# 203811

location_facility: Columbia Univ Medical Center /ID# 164782

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 168188

location_facility: Gastro Health & Nutrition - Victoria /ID# 167812

location_facility: Aichi Medical University Hospital /ID# 165971

location_facility: Centex Studies, Inc. - Houston /ID# 201214

location_facility: HonorHealth Research Institute - Shea /ID# 164821

location_facility: Coral Sea Clinical Research institute /ID# 212988

location_facility: MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935

location_facility: Velocity Clinical Research - Salt Lake City /ID# 166076

location_facility: Mustafa Kemal University Medic /ID# 171336

location_facility: Hoag Memorial Hosp Presbyterian /ID# 222540

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi /ID# 168187

location_facility: Hospital Clinico Universitario de Salamanca /ID# 206358

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 216419

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 201897

location_facility: KL Ling Gastroenterology and Liver Clinic /ID# 217962

location_facility: Duplicate_LUHS hospital Kauno Klinikos /ID# 206936

location_facility: University of Iowa Hospitals and Clinics /ID# 165436

location_facility: Mentahaz Maganorvosi Kozpont /ID# 201895

location_facility: University of Chicago Medicine /ID# 165503

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 166974

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 204091

location_facility: Erciyes University Medical Fac /ID# 171331

location_facility: East View Medical Research, LLC /ID# 171176

location_facility: Clinical Associates in Research Therapeutics of America, LLC /ID# 164786

location_facility: Chikuba Hospital for Proctological and Gastrointestinal Diseases /ID# 166010

location_facility: Toho University Sakura Medical Center /ID# 165963

location_facility: University Clinical Center Tuzla /ID# 210325

location_facility: The First Affiliated Hospital of Nanchang University /ID# 204092

location_facility: Healthcare Research Consultant /ID# 166195

location_facility: Rapid City Medical Center - GI Research /ID# 201735

location_facility: St. Helens and Knowsley Teach /ID# 209086

location_facility: Vanderbilt University Medical Center /ID# 164946

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH /ID# 206741

location_facility: Clinical Research of West Florida, Inc /ID# 208118

location_facility: Osaka City University Hospital /ID# 166015

location_facility: GIRI Gastrointestinal Research Institute /ID# 166975

location_facility: Universitaetsmedizin Essen St. Josef Krankenhaus Werden /ID# 203570

location_facility: Nagoya City University Hospital /ID# 165970

location_facility: NYU Langone Long Island Clinical Research Associates /ID# 164927

location_facility: Medical Centre of "Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV" /ID# 203738

location_facility: Kyungpook National Univ Hosp /ID# 207019

location_facility: Montreal General Hospital - McGill University Health Center /ID# 170119

location_facility: Yamanashi Prefectural Central Hospital /ID# 202464

location_facility: Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167908

location_facility: Inonu Universitesi Turgut Ozal /ID# 201268

location_facility: Tel Aviv Sourasky Medical Center /ID# 204877

location_facility: Vinius University Hospital Santaros Klinikos /ID# 203286

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169958

location_facility: Zhongshan Hospital Xiamen University /ID# 204984

location_facility: Universitaetsklinikum Erlangen /ID# 203552

location_facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 165343

location_facility: Allegiance Research Specialists /ID# 165346

location_facility: Hospital Provincial del Centenario /ID# 171252

location_facility: Wake Forest Baptist Medical Center /ID# 164908

location_facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 200607

location_facility: CB Flock Research Corporation /ID# 166185

location_facility: Tokyo Medical University Hospital /ID# 205980

location_facility: Osaka Medical and Pharmaceutical University Hospital /ID# 206326

location_facility: University of Michigan Health Systems /ID# 164943

location_facility: Gastroenterology Associates, P.A. of Greenville /ID# 164771

location_facility: Virginia Mason - Seattle Orthapedics /ID# 164913

location_facility: Hospital de Clinicas de Porto Alegre /ID# 166862

location_facility: Advanced Research - Coral Springs /ID# 218021

location_facility: Policlinico Universitario Campus Bio-Medico /ID# 168183

location_facility: Hospital Privado Univesitario /ID# 169230

location_facility: Southern California Res. Ctr. /ID# 169655

location_facility: Taichung Veterans General Hosp /ID# 169790

location_facility: P.A. Bayandin Murmansk Regiona /ID# 169639

location_facility: Asahikawa Medical University Hospital /ID# 167120

location_facility: Options Health Research, LLC /ID# 164820

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 169070

location_facility: Hospital Universitario A Coruna - CHUAC /ID# 203910

location_facility: Air Force Specialized Hospital /ID# 170996

location_facility: Clinical Research of West Florida, Inc /ID# 205827

location_facility: Lenasia Clinical Trial Centre /ID# 205145

location_facility: Gastroenterologie am Mexikoplatz /ID# 203575

location_facility: Complejo Hospitalario de Navarra /ID# 202355

location_facility: Peak Gastroenterology Associates, PC /ID# 170143

location_facility: Stockport NHS foundation trust /ID# 208719

location_facility: Hospital Universitari Son Espases /ID# 201998

location_facility: Gastroenterology Consultants PC - Roswell /ID# 218220

location_facility: City Clinical Hospital No. 31 /ID# 208868

location_facility: Riga East Clinical University Hospital /ID# 169498

location_facility: Digestive Health Associates (DHA) - Farmington Hills /ID# 205793

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171013

location_facility: MediSphere Medical Research Center /ID# 166175

location_facility: New Cross Hospital, Royal Wolv /ID# 171382

location_facility: London Health Sciences Center /ID# 221038

location_facility: CliniCore International, LLC /ID# 164902

location_facility: Yamagata University Hospital /ID# 200157

location_facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University /ID# 205228

location_facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 205547

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 168757

location_facility: National Hospital Organization Takasaki General Medical Center /ID# 167127

location_facility: East Tennessee Research Institute /ID# 203613

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 204088

location_facility: Duplicate_Tokai University Hachioji Hospital /ID# 165967

location_facility: Centrum Medyczne Reuma Park w Warszawie /ID# 200490

location_facility: Niigata Cancer Center Hospital /ID# 170045

location_facility: Cabinet Particular Policlinic Algomed /ID# 167818

location_facility: Hospital Universitario de Girona Doctor Josep Trueta /ID# 202645

location_facility: ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico /ID# 168181

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S.C. /ID# 207238

location_facility: MNI KRC Kyiv Regional Clinical Hospital /ID# 202454

location_facility: Yokkaichi Hazu Medical Center /ID# 167196

location_facility: Cleveland Clinic Main Campus /ID# 209231

location_facility: Shiga University of Medical Science Hospital /ID# 167129

location_facility: University of Alberta - Zeidler Ledcor Centre /ID# 166971

location_facility: Baylor College of Medicine - Baylor Medical Center /ID# 164947

location_facility: Kanazawa University Hospital /ID# 169218

location_facility: Hospital Universitario San Vic /ID# 200029

location_facility: Debreceni Egyetem Kenezy Gyula /ID# 201723

location_facility: CHA Bundang Medical center CHA University /ID# 167592

location_facility: China Medical University Hosp /ID# 169791

location_facility: The Second Hospital Central South University /ID# 204082

location_facility: Medizinisches Versorgungszentrum Portal 10 /ID# 200214

location_facility: Hospital Universitario Virgen Macarena /ID# 201993

location_facility: Hospital Clinico Universidad De Los Andes /ID# 207466

location_facility: Radboud Universitair Medisch Centrum /ID# 166928

location_facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904

location_facility: CHU Grenoble - Hopital Michallon /ID# 219034

location_facility: Polyclinic and Daily Hospital Dr. Al-Tawil /ID# 217842

location_facility: Clinical Hosp Center Zvezdara /ID# 168214

location_facility: Malopolskie Centrum Kliniczne /ID# 202167

location_facility: Delsol Research Management, Ll /Id# 170145

location_facility: General Hospital of Athens Ippokratio /ID# 167045

location_facility: Kobe Home Clinic of Neurology /ID# 166009

location_facility: Japanese Red Cross Kyoto Daiichi Hosital /ID# 165972

location_facility: The Vancouver Clinic, INC. PS /ID# 164918

location_facility: Hospital Guillermo Grant Benavente de Concepción /ID# 212423

location_facility: General Hospital of Chest Diseases of Athens SOTIRIA /ID# 202104

location_facility: Toyohashi Municipal Hospital /ID# 200175

location_facility: Azienda Ospedaliera San Camillo Forlanini /ID# 168184

location_facility: Univ of California San Francis /ID# 164944

location_facility: Hospital Nossa Senhora das Graças /ID# 166863

location_facility: Sahlgrenska University Hospital /ID# 169171

location_facility: Kyiv Municipal Clinical Hospital #18 /ID# 207889

location_facility: Japanese Red Cross Wakayama Medical Center /ID# 200643

location_facility: Kaiser Clinica e Hospital Dia /ID# 166865

location_facility: Hospital Universitario La Paz /ID# 201994

location_facility: Hospital Italiano de Buenos Aires /ID# 215541

location_facility: Clinical Research Center, Faculty of Medicine, Alexandria university. /ID# 171012

location_facility: Nara Medical University Hospital /ID# 169219

location_facility: Duplicate_Care Access Research /ID# 164794

location_facility: Toronto Digestive Disease Asso /ID# 166972

location_facility: Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762

location_facility: Taunton and Somerset NHS Foundation Trust /ID# 209665

location_facility: Ospedali Riuniti Villa Sofia-C /ID# 168189

location_facility: Kharkiv City Clinical Hospital No.2 n.a. Prof. O.O. Shalimov /ID# 167907

location_facility: Pusan National University Hospital /ID# 167589

location_facility: Citrus Valley Gastroenterology /ID# 166173

location_facility: Consultants for Clinical Res /ID# 164791

location_facility: Gazi Universitesi Tip Fakultes /ID# 217444

location_facility: Ctr for Advanced Gastroenterol /ID# 165353

location_facility: Hadassah Medical Center-Hebrew University /ID# 169928

location_facility: Clin Hosp Ctr Bezanijska Kosa /ID# 168750

location_facility: Treasure Valley Medical Research /ID# 215032

location_facility: Duplicate_Sjaellands Universitets Hospital /ID# 209445

location_facility: A.O. Per L'Emergenza Cannizzaro /ID# 168190

location_facility: South Eastern Health and Social Care Trust /ID# 205323

location_facility: Medical Research Center of CT /ID# 164926

location_facility: Clinical Research Trials of Florida, Inc. /ID# 203485

location_facility: The Sixth Affiliated Hosp Sun /ID# 204077

location_facility: United Medical Doctors - Murrieta /ID# 164945

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

summary: The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

status_simplified: Ongoing


title: A Phase 1b Open Label Study Investigating the Safety and Efficacy of Blinatumomab in Combination With Pembrolizumab in Adult Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (KEYNOTE-348)

summary: Phase 1b: To determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adult subjects with relapsed or refractory (r/r) DLBCL

design_allocation: Non-Randomized

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
United States
Netherlands
France
Australia
Spain
Germany


type: Other Identifier

title: A Multicenter Phase I Open-label Dose-escalation Vaccine Trial of dHER2 Protein With AS15 Adjuvant in HER2-overexpressing Patients With High-risk Breast Cancer

summary:
Treatment phase:

The purpose of this study is to evaluate the safety and the immune response elicited by a new anti-cancer therapy in patients with breast cancer in remission but who are at high risk of relapse. The study product is an immunotherapeutic consisting of the recombinant dHER2 protein combined with an immunostimulant called AS15. The study aims to determine the optimal of three different dose levels of dHER2 combined with the same fixed dose of AS15 by assessing the safety and the immune response elicited after a series of injections of the study product.

Five-year follow-up phase:

This part of the study aims to assess any late onset toxicity of the study treatment through yearly follow-up visits and to monitor the patients' survival and disease status up to five years after the last administration of the study treatment. The patients' immune response is also measured to assess the robustness of the immune response elicited by the study treatment.

status: Completed

study_completion_date_type: Actual

ReferenceType: derived

ReferenceCitation: Limentani SA, Campone M, Dorval T, Curigliano G, de Boer R, Vogel C, White S, Bachelot T, Canon JL, Disis M, Awada A, Berlière M, Amant F, Levine E, Burny W, Callegaro A, de Sousa Alves PM, Louahed J, Brichard V, Lehmann FF. A non-randomized dose-escalation Phase I trial of a protein-based immunotherapeutic for the treatment of breast cancer patients with HER2-overexpressing tumors. Breast Cancer Res Treat. 2016 Apr;156(2):319-30. doi: 10.1007/s10549-016-3751-x. Epub 2016 Mar 18.

family: Limentani

full_name: Steven A. Limentani

given: Steven A.

family: Campone

full_name: Mario Campone

given: Mario

family: Dorval

full_name: Thierry Dorval

given: Thierry

family: Curigliano

full_name: Giuseppe Curigliano

given: Giuseppe

family: de Boer

full_name: Richard de Boer

given: Richard

family: Vogel

full_name: Charles Vogel

given: Charles

family: White

full_name: Shane White

given: Shane

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

family: Canon

full_name: Jean-Luc Canon

given: Jean-Luc

family: Disis

full_name: Mary Disis

given: Mary

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Berlière

full_name: Martine Berlière

given: Martine

family: Amant

full_name: Frédéric Amant

given: Frédéric

family: Levine

full_name: Ellis Levine

given: Ellis

family: Burny

full_name: Wivine Burny

given: Wivine

family: Callegaro

full_name: Andrea Callegaro

given: Andrea

family: de Sousa Alves

full_name: Pedro Miguel de Sousa Alves

given: Pedro Miguel

family: Louahed

full_name: Jamila Louahed

given: Jamila

family: Brichard

full_name: Vincent Brichard

given: Vincent

family: Lehmann

full_name: Frédéric F. Lehmann

given: Frédéric F.

journal_name: Breast Cancer Research and Treatment

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: GlaxoSmithKline

location_country:
Italy
France
Belgium
Australia
United States

intervention_type: Biological


title: A Randomized, Double-blind, Placebo-controlled, Phase Lll Study in Patients With Metastatic Adenocarcinoma of the Colon or Rectum Who Are Receiving First-line Chemotherapy With Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo

summary: To compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and are seeking first chemotherapy treatment

ReferenceCitation: Hecht JR, Trarbach T, Hainsworth JD, Major P, Jäger E, Wolff RA, Lloyd-Salvant K, Bodoky G, Pendergrass K, Berg W, Chen BL, Jalava T, Meinhardt G, Laurent D, Lebwohl D, Kerr D. Randomized, placebo-controlled, phase III study of first-line oxaliplatin-based chemotherapy plus PTK787/ZK 222584, an oral vascular endothelial growth factor receptor inhibitor, in patients with metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):1997-2003. doi: 10.1200/JCO.2010.29.4496. Epub 2011 Apr 4.

name: From the David Geffen School of Medicine at University of California, Los Angeles, Santa Monica, CA; Sarah Cannon Cancer Center, Nashville, TN; The University of Texas MD Anderson Cancer Center, Houston, TX; Virginia Cancer Institute, Richmond, VA; Kansas City Cancer Center, Kansas City, MO; Novartis Oncology, East Hanover, NJ; West German Cancer Center, University Hospital Essen, Essen; Medizinische Klinik II – Onkologie, Frankfurt; Bayer Schering Pharma AG, Berlin, Germany; Juravinski Cancer Centre,...

family: Hecht

full_name: J. Randolph Hecht

given: J. Randolph

family: Trarbach

full_name: Tanja Trarbach

given: Tanja

family: Hainsworth

full_name: John D. Hainsworth

given: John D.

family: Major

full_name: Pierre Major

given: Pierre

family: Jäger

full_name: Elke Jäger

given: Elke

family: Wolff

full_name: Robert A. Wolff

given: Robert A.

family: Lloyd-Salvant

full_name: Katherine Lloyd-Salvant

given: Katherine

family: Bodoky

full_name: György Bodoky

given: György

family: Pendergrass

full_name: Kelly Pendergrass

given: Kelly

family: Berg

full_name: William Berg

given: William

family: Chen

full_name: Bee-Lian Chen

given: Bee-Lian

family: Jalava

full_name: Tarja Jalava

given: Tarja

family: Meinhardt

full_name: Gerold Meinhardt

given: Gerold

family: Laurent

full_name: Dirk Laurent

given: Dirk

family: Lebwohl

full_name: David Lebwohl

given: David

family: Kerr

full_name: David Kerr

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Randomized, Placebo-Controlled, Phase III Study of First-Line Oxaliplatin-Based Chemotherapy Plus PTK787/ZK 222584, an Oral Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Metastatic Colorectal Adenocarcinoma

lead_sponsor: Novartis

location_country:
Italy
United States
Brazil
Sweden
Switzerland
Netherlands
Spain
Germany
France
Czechia
Slovakia
Hungary
Belgium
Australia
New Zealand
Portugal
Canada
United Kingdom
Taiwan

location_facility: Associated Physicians & Surgeons Clinic, L.L.C.

location_facility: Sansum Santa Barbara Foundation Medical Clinic

location_facility: Maine Center for Cancer Medicine & Blood Disorders

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Hematology Oncology Associates of Treasure

location_facility: Hematology-Oncology Associates of New Jersey

location_facility: Kansas City Oncology and Hematology Group

location_facility: University of Tennessee Cancer Institute

location_facility: Heartland Hematology/Oncology Associates, Inc.

location_facility: Glendale Adventist Medical Center Cancer Center

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: North Central Montana Professional Building

location_facility: Oncology Hematology Group of South Florida

location_facility: USC/Norris Comprehensive Cancer Care Center

location_facility: Markey Clinical Oncology Research Program

location_facility: UW Health -- University of Wisconsin Comp

location_facility: Oncology Hematology Associates of Central Illinois, PC

location_facility: Hematology and Oncology Assoc. of Southern Mississippi

location_facility: Washington University School of Medicine

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: George Washington University Medical Center

location_facility: The Center for Cancer and Hematologic Disease

location_facility: California Oncology of the Central Valley

location_facility: Southern Oncology and Hematology Associates

location_facility: Center for Oncology Research & Treatment, PA

location_facility: Synergy Hematology-Oncology Medical Associates

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Innovative Medical Research of South Florida

location_facility: Tulane University Health Sciences Center

location_facility: Compassionate Cancer Care Medical Group, Inc

status_simplified: Completed


lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Czechia
Greece
Japan
Poland
Ireland
Australia
New Zealand
Spain
Canada
United Kingdom

location_facility: Dermatovenerologicka klinika 3. LF UK a FNKV

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow

location_facility: Dermatovenerologicka klinika VFN a 1. LF UK

title: A Phase 3, Randomized, Double-blind Study of BMS-986205 Combined With Nivolumab Versus Nivolumab in Participants With Metastatic or Unresectable Melanoma That is Previously Untreated

summary: The purpose of this study is to see if BMS-986205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating Melanoma that has spread or is unable to be removed by surgery, and has not previously been treated


title: A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Adults With Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, or Allogeneic Hematopoietic Cell Transplant Recipients

summary: The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.

ipd_sharing: No

lead_sponsor: Vical

location_country:
United States
Germany
France
Belgium
Canada
Korea, Republic of

location_facility: UCL Mont-Godinne University Hospitals, Department of Hematology

location_facility: Medical College of Georgia at Augusta University

location_facility: University Hospital Antwerp (UZA), Department of Hematology

location_facility: University of Alabama at Birmingham Hospital, Division of Infectious Diseases

location_facility: Hamilton Health Sciences, Infectious Disease Research

location_facility: Christiana Care Health Services, Department of Medicine

location_facility: Hospital Neuperlach - Municipal Hospital Munich GmbH, Clinic of Hematology and Oncology

location_facility: Fred Hutchinson Cancer Research Center (FHCRC)

location_facility: McGill University Health Centre (MUHC), Division of Infectios Diseases

location_facility: General Hospital Saint-Jan, Department of Hematology

location_facility: University of Minnesota, Department of Medicine

location_facility: UC Davis Health, Dept. of Internal Medicine, Div. of Infectious Diseases

location_facility: University Hospitals Leuven, Campus Gasthuisberg, Department of Hematology

location_facility: Jules Bordet Institute, Department of Infectious Disease

location_facility: The University of Texas Health Science Center, Department of Internal Medicine

location_facility: Grenoble University Hospital Center, Department of Hematology

location_facility: Washington University School of Medicine, Division of Infectious Disease


title: GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease

summary: The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).

primary_purpose: Prevention

lead_sponsor: Incyte Corporation

location_country:
Italy
United States
France
Spain

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)

location_facility: Azienda Ospedaliera San Gerardo Di Monza

location_facility: Winship Cancer Institute of Emory University

location_facility: Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Washington University School of Medicine

location_facility: Chu Vandoeuvre-Les-Nancy, Hopital Brabois

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: John Theurer Cancer Center, Hackensack University Medical Center

location_facility: Anschutz Cancer Pavilion - University of Colorado

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Hospital Clinico Universitario de Valencia


title: A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

acronym: HERA

summary: The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

ReferenceType: background

ReferenceCitation: Jahanzeb M. Adjuvant trastuzumab therapy for HER2-positive breast cancer. Clin Breast Cancer. 2008 Aug;8(4):324-33. doi: 10.3816/CBC.2008.n.037. Review.

ReferenceCitation: Shiroiwa T, Fukuda T, Shimozuma K, Ohashi Y, Tsutani K. The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: based on 2-year follow-up HERA trial data. Breast Cancer Res Treat. 2008 Jun;109(3):559-66. Epub 2007 Jul 28.

ReferenceCitation: Gianni L, Dafni U, Gelber RD, Azambuja E, Muehlbauer S, Goldhirsch A, Untch M, Smith I, Baselga J, Jackisch C, Cameron D, Mano M, Pedrini JL, Veronesi A, Mendiola C, Pluzanska A, Semiglazov V, Vrdoljak E, Eckart MJ, Shen Z, Skiadopoulos G, Procter M, Pritchard KI, Piccart-Gebhart MJ, Bell R; Herceptin Adjuvant (HERA) Trial Study Team. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011 Mar;12(3):236-44. doi: 10.1016/S1470-2045(11)70033-X. Epub 2011 Feb 25.

family: Gianni

full_name: Luca Gianni

given: Luca

family: Dafni

full_name: Urania Dafni

given: Urania

family: Gelber

full_name: Richard D Gelber

given: Richard D

family: Azambuja

full_name: Evandro Azambuja

given: Evandro

family: Muehlbauer

full_name: Susanne Muehlbauer

given: Susanne

family: Goldhirsch

full_name: Aron Goldhirsch

given: Aron

family: Untch

full_name: Michael Untch

given: Michael

family: Smith

full_name: Ian Smith

given: Ian

family: Baselga

full_name: José Baselga

given: José

family: Jackisch

full_name: Christian Jackisch

given: Christian

family: Cameron

full_name: David Cameron

family: Mano

full_name: Max Mano

given: Max

family: Pedrini

full_name: José Luiz Pedrini

given: José Luiz

family: Veronesi

full_name: Andrea Veronesi

given: Andrea

family: Mendiola

full_name: Cesar Mendiola

given: Cesar

family: Pluzanska

full_name: Anna Pluzanska

given: Anna

family: Semiglazov

full_name: Vladimir Semiglazov

given: Vladimir

family: Vrdoljak

full_name: Eduard Vrdoljak

given: Eduard

family: Eckart

full_name: Michael J Eckart

given: Michael J

family: Shen

full_name: Zhenzhou Shen

given: Zhenzhou

family: Skiadopoulos

full_name: George Skiadopoulos

given: George

family: Procter

full_name: Marion Procter

given: Marion

family: Pritchard

full_name: Kathleen I Pritchard

ReferenceCitation: Procter M, Suter TM, de Azambuja E, Dafni U, van Dooren V, Muehlbauer S, Climent MA, Rechberger E, Liu WT, Toi M, Coombes RC, Dodwell D, Pagani O, Madrid J, Hall M, Chen SC, Focan C, Muschol M, van Veldhuisen DJ, Piccart-Gebhart MJ. Longer-term assessment of trastuzumab-related cardiac adverse events in the Herceptin Adjuvant (HERA) trial. J Clin Oncol. 2010 Jul 20;28(21):3422-8. doi: 10.1200/JCO.2009.26.0463. Epub 2010 Jun 7.

name: From Frontier Science Scotland, Kincraig, Kingussie; Imperial College London, London; and St James's Institute of Oncology, St James Hospital, Leeds; and Heathwood and Wexham Park NHS Hospitals Foundation Trust and Mount Vernon Cancer Centre, Northwood, UK; Swiss Cardiovascular Center, University Hospital Bern; Institute of Oncology of Southern Switzerland, Bellinzona; and F. Hoffmann-La Roche, Basel, Switzerland; Institut Jules Bordet, Université Libre de Bruxelles; CHC-Clinique Saint-Joseph, Liege; and...

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Longer-Term Assessment of Trastuzumab-Related Cardiac Adverse Events in the Herceptin Adjuvant (HERA) Trial

ReferenceCitation: Dowsett M, Procter M, McCaskill-Stevens W, de Azambuja E, Dafni U, Rueschoff J, Jordan B, Dolci S, Abramovitz M, Stoss O, Viale G, Gelber RD, Piccart-Gebhart M, Leyland-Jones B. Disease-free survival according to degree of HER2 amplification for patients treated with adjuvant chemotherapy with or without 1 year of trastuzumab: the HERA Trial. J Clin Oncol. 2009 Jun 20;27(18):2962-9. doi: 10.1200/JCO.2008.19.7939. Epub 2009 Apr 13.

name: From the Department of Academic Biochemistry, Royal Marsden Hospital, London, United Kingdom; Frontier Science (Scotland) Ltd, Kincraig, Kingussie, Scotland; National Cancer Institute, National Institutes of Health, Bethesda, MD; Departments of Medical Oncology and Medicine, Institut Jules Bordet, Université Libre de Bruxelles; Breast European Adjuvant Studies Team, Brussels, Belgium; Department of Public Health, School of Nursing, University of Athens, Athens, Greece; TARGOS Molecular Pathology GmbH,...

title: Disease-Free Survival According to Degree ofHER2Amplification for Patients Treated With Adjuvant Chemotherapy With or Without 1 Year of Trastuzumab: The HERA Trial

ReferenceCitation: Untch M, Gelber RD, Jackisch C, Procter M, Baselga J, Bell R, Cameron D, Bari M, Smith I, Leyland-Jones B, de Azambuja E, Wermuth P, Khasanov R, Feng-Yi F, Constantin C, Mayordomo JI, Su CH, Yu SY, Lluch A, Senkus-Konefka E, Price C, Haslbauer F, Suarez Sahui T, Srimuninnimit V, Colleoni M, Coates AS, Piccart-Gebhart MJ, Goldhirsch A; HERA Study Team. Estimating the magnitude of trastuzumab effects within patient subgroups in the HERA trial. Ann Oncol. 2008 Jun;19(6):1090-6. doi: 10.1093/annonc/mdn005. Epub 2008 Feb 21.

ReferenceCitation: McCaskill-Stevens W, Procter M, Goodbrand J, et al.: Disease-free survival according to local immunohistochemistry for HER2 and central fluorescence in situ hydridization for patients treated with adjuvant chemotherapy with and without trastuzumab in the HERA (BIG 01-01) trial. [Abstract] Breast Cancer Res Treat 106 (1): A-71, S18, 2007.

ReferenceCitation: Smith I, Procter M, Gelber RD, Guillaume S, Feyereislova A, Dowsett M, Goldhirsch A, Untch M, Mariani G, Baselga J, Kaufmann M, Cameron D, Bell R, Bergh J, Coleman R, Wardley A, Harbeck N, Lopez RI, Mallmann P, Gelmon K, Wilcken N, Wist E, Sánchez Rovira P, Piccart-Gebhart MJ; HERA study team. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet. 2007 Jan 6;369(9555):29-36.

ReferenceCitation: Suter TM, Procter M, van Veldhuisen DJ, Muscholl M, Bergh J, Carlomagno C, Perren T, Passalacqua R, Bighin C, Klijn JG, Ageev FT, Hitre E, Groetz J, Iwata H, Knap M, Gnant M, Muehlbauer S, Spence A, Gelber RD, Piccart-Gebhart MJ. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol. 2007 Sep 1;25(25):3859-65. Epub 2007 Jul 23.

ReferenceCitation: Piccart-Gebhart MJ, Procter M, Leyland-Jones B, Goldhirsch A, Untch M, Smith I, Gianni L, Baselga J, Bell R, Jackisch C, Cameron D, Dowsett M, Barrios CH, Steger G, Huang CS, Andersson M, Inbar M, Lichinitser M, Láng I, Nitz U, Iwata H, Thomssen C, Lohrisch C, Suter TM, Rüschoff J, Suto T, Greatorex V, Ward C, Straehle C, McFadden E, Dolci MS, Gelber RD; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005 Oct 20;353(16):1659-72.

ReferenceCitation: Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, Castro G Jr, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, McFadden E, Leyland-Jones B, Bell R, Dowsett M, Jackisch C; Herceptin Adjuvant (HERA) Trial Study Team. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017 Mar 25;389(10075):1195-1205. doi: 10.1016/S0140-6736(16)32616-2. Epub 2017 Feb 17. Erratum in: Lancet. 2019 Mar 16;393(10176):1100.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Loi S, Dafni U, Karlis D, Polydoropoulou V, Young BM, Willis S, Long B, de Azambuja E, Sotiriou C, Viale G, Rüschoff J, Piccart MJ, Dowsett M, Michiels S, Leyland-Jones B. Effects of Estrogen Receptor and Human Epidermal Growth Factor Receptor-2 Levels on the Efficacy of Trastuzumab: A Secondary Analysis of the HERA Trial. JAMA Oncol. 2016 Aug 1;2(8):1040-7. doi: 10.1001/jamaoncol.2016.0339.

name: Division of Research and Clinical Medicine, Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia

name: Frontier Science Foundation– Hellas, Athens, Greece3University of Athens, Athens, Greece

name: Frontier Science Foundation– Hellas, Athens, Greece4Athens University of Economics and Business, Athens, Greece

name: Frontier Science Foundation– Hellas, Athens, Greece

name: Avera Cancer Institute, Department of Molecular and Experimental Medicine, Sioux Falls, South Dakota

name: Department of Pathology, University of Chicago, Chicago, Illinois

name: BREAST Datacentre, Institute Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium

name: Breast Cancer Translational Research Laboratory, Institute Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium

name: University of Milan, European Institute of Oncology, Milan, Italy

name: Targos Molecular Pathology GmbH, Kassel, Germany

name: Department of Medicine, Institute Jules Bordet, Universite Libre de Bruxelles and Breast International Group (BIG), Brussels, Belgium12Breast International Group (BIG), Brussels, Belgium

name: INSERM U1018 CESP, Service de Biostatistique et d’Epidémiologie, Villejuif, France

ReferenceCitation: O'Sullivan CC, Bradbury I, Campbell C, Spielmann M, Perez EA, Joensuu H, Costantino JP, Delaloge S, Rastogi P, Zardavas D, Ballman KV, Holmes E, de Azambuja E, Piccart-Gebhart M, Zujewski JA, Gelber RD. Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer and Tumors ≤ 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials. J Clin Oncol. 2015 Aug 20;33(24):2600-8. doi: 10.1200/JCO.2015.60.8620. Epub 2015 Jun 22.

name: Ciara C. O'Sullivan and Jo Anne Zujewski, National Cancer Institute, Bethesda, MD; Ian Bradbury, Christine Campbell, and Eileen Holmes, Frontier Science, Inverness-shire, Scotland; Marc Spielmann and Suzette Delaloge, Institut de Cancérologie Gustave Roussy, Villejuif, France; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Heikki Joensuu, Helsinki University Hospital and University of Helsinki, Helsinki, Finland; Joseph P. Costantino and Priya Rastogi, University of Pittsburgh, Pittsburgh, PA; Dimitrios...

title: Efficacy of Adjuvant Trastuzumab for Patients With Human Epidermal Growth Factor Receptor 2–Positive Early Breast Cancer and Tumors ≤ 2 cm: A Meta-Analysis of the Randomized Trastuzumab Trials

ReferenceCitation: de Azambuja E, Procter MJ, van Veldhuisen DJ, Agbor-Tarh D, Metzger-Filho O, Steinseifer J, Untch M, Smith IE, Gianni L, Baselga J, Jackisch C, Cameron DA, Bell R, Leyland-Jones B, Dowsett M, Gelber RD, Piccart-Gebhart MJ, Suter TM. Trastuzumab-associated cardiac events at 8 years of median follow-up in the Herceptin Adjuvant trial (BIG 1-01). J Clin Oncol. 2014 Jul 10;32(20):2159-65. doi: 10.1200/JCO.2013.53.9288. Epub 2014 Jun 9.

name: Evandro de Azambuja and Martine J. Piccart-Genhart, Institut Jules Bordet; Evandro de Azambuja, Breast European Adjuvant Study Team; Martine J. Piccart-Gebhart, Université Libre de Bruxelles, Brussels, Belgium; Marion J. Procter and Dominique Agbor-Tarh, Frontier Science Scotland, Kincraig, Kingussie; David A. Cameron, University of Edinburgh and Western General Hospital, Edinburgh; Ian E. Smith, Royal Marsden Hospital and the Institute of Cancer Research; Mitch Dowsett, the Royal Marsden National Health...

title: Trastuzumab-Associated Cardiac Events at 8 Years of Median Follow-Up in the Herceptin Adjuvant Trial (BIG 1-01)

ReferenceCitation: Zabaglo L, Stoss O, Rüschoff J, Zielinski D, Salter J, Arfi M, Bradbury I, Dafni U, Piccart-Gebhart M, Procter M, Dowsett M; HERA Trial Study Team. HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab. Ann Oncol. 2013 Nov;24(11):2761-6. doi: 10.1093/annonc/mdt275. Epub 2013 Jul 25.

ReferenceCitation: Goldhirsch A, Gelber RD, Piccart-Gebhart MJ, de Azambuja E, Procter M, Suter TM, Jackisch C, Cameron D, Weber HA, Heinzmann D, Dal Lago L, McFadden E, Dowsett M, Untch M, Gianni L, Bell R, Köhne CH, Vindevoghel A, Andersson M, Brunt AM, Otero-Reyes D, Song S, Smith I, Leyland-Jones B, Baselga J; Herceptin Adjuvant (HERA) Trial Study Team. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet. 2013 Sep 21;382(9897):1021-8. doi: 10.1016/S0140-6736(13)61094-6. Epub 2013 Jul 18.

ReferenceCitation: Metzger-Filho O, Procter M, de Azambuja E, Leyland-Jones B, Gelber RD, Dowsett M, Loi S, Saini KS, Cameron D, Untch M, Smith I, Gianni L, Baselga J, Jackisch C, Bell R, Sotiriou C, Viale G, Piccart-Gebhart M. Magnitude of trastuzumab benefit in patients with HER2-positive, invasive lobular breast carcinoma: results from the HERA trial. J Clin Oncol. 2013 Jun 1;31(16):1954-60. doi: 10.1200/JCO.2012.46.2440. Epub 2013 Apr 15.

name: Otto Metzger-Filho and Richard D. Gelber, Dana-Farber Cancer Institute, Harvard School of Public Health, Harvard Medical School, Boston, MA; Otto Metzger-Filho, Evandro de Azambuja, Kamal S. Saini, Christos Sotiriou, and Martine Piccart-Gebhart, Institut Jules Bordet and Université Libre de Bruxelles, Brussels, Belgium; Marion Procter, Frontier Science Scotland, Kincraig; Mitchell Dowsett and Ian Smith, Royal Marsden Hospital; Ian Smith, Institute of Cancer Research, London; David Cameron, University of...

title: Magnitude of Trastuzumab Benefit in Patients With HER2-Positive, Invasive Lobular Breast Carcinoma: Results From the HERA Trial

location_country:
Guatemala
Greece
Australia
Belgium
Russian Federation
Denmark
Croatia
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
China
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Israel
Spain

location_facility: Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

location_facility: Karolinska University Hospital - Huddinge

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Hospital Universitario San Cecilio de Granada

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Hospital Universitario Nuestra Senora de la Candelaria

location_facility: Windsor Regional Cancer Centre at Windsor Regional Hospital

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Sahlgrenska University Hospital - Molndal at Gothenburg University

location_facility: Trillium Health Centre - Mississauga Site

location_facility: Allan Blair Cancer Centre at Pasqua Hospital

location_facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre

location_facility: Cookridge Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: British Columbia Cancer Agency - Vancouver Cancer Centre

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Fraser Valley Cancer Centre at British Columbia Cancer Agency

location_facility: Prince Edward Island Cancer Centre at Queen Elizabeth Hospital

location_facility: Frauenklinik - Universitaetsklinikum Rostock am Klinikum Sudstadt

location_facility: University of Modena Hospital and Reggio Emilia School of Medicine

location_facility: Hospital General Universitario De Guadalajara

location_facility: Centro Oncologico De Galicia Jose Antonio Quirogay Pineyro

location_facility: Centre Hospitalier Universitaire de Tivoli

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Yonsei Cancer Center at Yonsei University Medical Center

location_facility: Instituto Portugues de Oncologia, Centro Regional de Coimbra

location_facility: Algoma Regional Cancer Program at Sault Area Hospital

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Margaret and Charles Juravinski Cancer Centre

location_facility: Saskatoon Cancer Centre at the University of Saskatchewan

location_facility: British Columbia Cancer Agency - Centre for the Southern Interior

location_facility: Hotel Dieu Health Sciences Hospital - Niagara

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Fovarosi Onkormanyzat Szent Margit Korhaz, Okologia

location_facility: Universitaetsklinik fuer Innere Medizin I

location_facility: Kreiskrankenhaus Leonberg - Frauenklinik

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Ospedale Ostetrico Ginecologica Sant Anna

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: P.A. Hertzen Research Oncology Institute


title: Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma.

PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.

ReferenceCitation: Francart J, Legrand C, Sylvester R, Van Glabbeke M, van Meerbeeck JP, Robert A. Progression-free survival rate as primary end point for phase II cancer clinical trials: application to mesothelioma--The EORTC Lung Cancer Group. J Clin Oncol. 2006 Jul 1;24(19):3007-12.

ReferenceCitation: Bottomley A, Coens C, Efficace F, Gaafar R, Manegold C, Burgers S, Vincent M, Legrand C, van Meerbeeck JP; EORTC-NCIC. Symptoms and patient-reported well-being: do they predict survival in malignant pleural mesothelioma? A prognostic factor analysis of EORTC-NCIC 08983: randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. J Clin Oncol. 2007 Dec 20;25(36):5770-6.

ReferenceCitation: Bottomley A, Gaafar R, Manegold C, Burgers S, Coens C, Legrand C, Vincent M, Giaccone G, Van Meerbeeck J; EORTC Lung-Cancer Group; National Cancer Institute, Canada. Short-term treatment-related symptoms and quality of life: results from an international randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study. J Clin Oncol. 2006 Mar 20;24(9):1435-42. Epub 2006 Jan 30. Erratum in: J Clin Oncol. 2006 Jun 1;24(16):2601. Gaafa, Rabab [corrected to Gaafar, Rahab].

ReferenceCitation: van Meerbeeck JP, Gaafar R, Manegold C, Van Klaveren RJ, Van Marck EA, Vincent M, Legrand C, Bottomley A, Debruyne C, Giaccone G; European Organisation for Research and Treatment of Cancer Lung Cancer Group; National Cancer Institute of Canada. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol. 2005 Oct 1;23(28):6881-9.

ReferenceCitation: Van Meerbeeck JP, Manegold C, Gaafar R, et al.: A randomized phase III study of cisplatin with or without raltitrexed in patients (pts) with malignant pleural mesothelioma (MPM): an intergroup study of the EORTC Lung Cancer Group and NCIC. [Abstract] J Clin Oncol 22 (Suppl 14): A-7021, 622s, 2004.

location_country:
Italy
Peru
Switzerland
Netherlands
France
Poland
Belgium
Egypt
Germany
United Kingdom
Canada

location_facility: Cancer Care Ontario-London Regional Cancer Centre

location_facility: Cancer Care Ontario-Hamilton Regional Cancer Centre

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Assistance Publique Hopitaux de Marseille Hopitaux Sud


title: A Strategic Study to Determine the Optimal Moment to Initiate Systemic Antifungal Therapy With Ambisome in Granulocytopenic Cancer Patients With Unexplained Fever Refractory to Empirical Antibacterials

summary:
RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions.

PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.

primary_purpose: Supportive Care

location_country:
Italy
Sweden
United Arab Emirates
Netherlands
Spain
France
Greece
Israel
Slovakia
Hungary
Belgium
Portugal
Turkey
Germany
Czech Republic

location_facility: Virchow Klinikum Humboldt Universitaet Berlin

location_facility: Athens University-Laikon General Hospital

location_facility: Centre Hospitalier Universitaire Henri Mondor


title: Incidence of Squamous Cell Carcinoma and Other Skin Neoplasia in Subjects With Actinic Keratosis Treated With Ingenol Disoxate Gel 0.018% or 0.037%, or Vehicle Gel

summary:
One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial.

In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.

lead_sponsor: LEO Pharma

location_country:
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Center for Dermatology Clinical Research, Inc.

location_facility: Contour Dermatology & Cosmetic Surgery Center

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: Suzanne Bruce and Associates, P.A., The Center for Skin Research

location_facility: Research Institute of the Southeast, LLC

location_facility: AboutSkin Dermatology and DermSurgery, PC

intervention_type: Other


title: RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.

ReferenceCitation: Le Cesne A, Van Glabbeke M, Woll PJ, et al.: The end of adjuvant chemotherapy (adCT) era with doxorubicin-based regimen in resected high-grade soft tissue sarcoma (STS): pooled analysis of the two STBSG-EORTC phase III clinical trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-10525, 2008.

ReferenceCitation: Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group and the NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. doi: 10.1016/S1470-2045(12)70346-7. Epub 2012 Sep 4.

family: Woll

full_name: Penella J Woll

given: Penella J

family: Reichardt

full_name: Peter Reichardt

given: Peter

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Bonvalot

full_name: Sylvie Bonvalot

given: Sylvie

family: Azzarelli

full_name: Alberto Azzarelli

given: Alberto

family: Hoekstra

full_name: Harald J Hoekstra

given: Harald J

family: Leahy

full_name: Michael Leahy

family: Van Coevorden

full_name: Frits Van Coevorden

given: Frits

family: Verweij

full_name: Jaap Verweij

given: Jaap

family: Hogendoorn

full_name: Pancras CW Hogendoorn

given: Pancras CW

family: Ouali

full_name: Monia Ouali

given: Monia

family: Marreaud

full_name: Sandrine Marreaud

given: Sandrine

family: Bramwell

full_name: Vivien HC Bramwell

given: Vivien HC

family: Hohenberger

full_name: Peter Hohenberger

journal_name: The Lancet Oncology

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
Germany
France
Slovakia
Belgium
Portugal
Denmark
Canada
United Kingdom

location_facility: Middlesex Hospital- Meyerstein Institute

location_facility: Daniel Den Hoed Cancer Center at Erasmus University Medical Center

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

location_facility: British Columbia Cancer Agency - Vancouver Island Cancer Centre

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori

location_facility: Centre Hospitalier Universitaire Vaudois


title: A Multicenter, Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

summary: The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata. Patients from European sites who previously completed a qualifying CTP-543 clinical trial may participate in this study.

status: Recruiting

lead_sponsor: Concert Pharmaceuticals

location_country: France Poland

location_facility: Ot.Co Clinic Klinika Osipowicz & Turkowski Sp. Z O.O.

location_facility: Hôpital Saint Louis, Centre de Santé Sabouraud


title: A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Primary Immune Thrombocytopenia

summary: The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia.

ipd_sharing: Undecided

lead_sponsor: argenx

location_country:
Austria
France
Czechia
Poland
Hungary
Belgium
Spain
Germany
United Kingdom
Ukraine

location_facility:
Ivano-Frankivsk
Gyula
Kaposvar
A Coruna
Valencia
Debrecen
Berlin
Nyiregyhaza
Mont-Godinne
Opole
Paris
Praha
Grenoble
Budapest
Barcelona
Wien
Dnipro
Vienna
Bordeaux
London
Wroclaw
Brno
Leuven
Nikolaev
Lublin
Hanover
Uzhgorod
Madrid
Pecs
Tubingen


ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

lead_sponsor: UCB Biopharma SRL

location_country:
Italy
France
Spain
Germany
Korea, Republic of

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

summary: The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, onset of seizure freedom, change in cognitive function, use of rescue medication and to assess safety and tolerability.


ReferenceCitation: Ferrari MD, Reuter U, Goadsby PJ, Paiva da Silva Lima G, Mondal S, Wen S, Tenenbaum N, Pandhi S, Lanteri-Minet M, Stites T. Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021 Nov 29. pii: jnnp-2021-327480. doi: 10.1136/jnnp-2021-327480. [Epub ahead of print]

family: Ferrari

full_name: Michel Dominique Ferrari

given: Michel Dominique

family: Reuter

full_name: Uwe Reuter

given: Uwe

family: Goadsby

full_name: Peter J Goadsby

given: Peter J

family: Paiva da Silva Lima

full_name: Gabriel Paiva da Silva Lima

given: Gabriel

family: Mondal

full_name: Subhayan Mondal

given: Subhayan

family: Wen

full_name: Shihua Wen

given: Shihua

family: Tenenbaum

full_name: Nadia Tenenbaum

given: Nadia

family: Pandhi

full_name: Shaloo Pandhi

given: Shaloo

family: Lanteri-Minet

full_name: Michel Lanteri-Minet

given: Michel

family: Stites

full_name: Tracy Stites

given: Tracy

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Two-year efficacy and safety of erenumab in participants with episodic migraine and 2–4 prior preventive treatment failures: results from the LIBERTY study

ReferenceCitation: Goadsby PJ, Reuter U, Lanteri-Minet M, Paiva da Silva Lima G, Hours-Zesiger P, Fernandes C, Wen S, Tenenbaum N, Kataria A, Ferrari MD, Klatt J. Long-Term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. 2021 Apr 28. pii: 10.1212/WNL.0000000000012029. doi: 10.1212/WNL.0000000000012029. [Epub ahead of print]

full_name: Peter J. Goadsby

given: Peter J.

family: Hours-Zesiger

full_name: Peggy Hours-Zesiger

given: Peggy

family: Fernandes

full_name: Chrystel Fernandes

given: Chrystel

family: Kataria

full_name: Aditi Kataria

given: Aditi

full_name: Michel D. Ferrari

given: Michel D.

family: Klatt

full_name: Jan Klatt

given: Jan

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Long-term Efficacy and Safety of Erenumab

ReferenceCitation: Lanteri-Minet M, Goadsby PJ, Reuter U, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study. J Neurol Neurosurg Psychiatry. 2021 May;92(5):466-472. doi: 10.1136/jnnp-2020-324396. Epub 2021 Jan 5.

title: Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2–4 preventives were not useful: results from the LIBERTY study

ReferenceCitation: Reuter U, Goadsby PJ, Lanteri-Minet M, Wen S, Hours-Zesiger P, Ferrari MD, Klatt J. Efficacy and tolerability of erenumab in patients with episodic migraine in whom two-to-four previous preventive treatments were unsuccessful: a randomised, double-blind, placebo-controlled, phase 3b study. Lancet. 2018 Nov 24;392(10161):2280-2287. doi: 10.1016/S0140-6736(18)32534-0. Epub 2018 Oct 22.

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

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

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Finland
France
Czechia
Greece
Norway
Australia
Belgium
Spain
Denmark
Germany
United Kingdom

title: A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed Prophylactic Migraine Treatments

summary: The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.


title: Tamoxifen in Duchenne Muscular Dystrophy: A Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Safety and Efficacy 48-week Trial

acronym: TAMDMD

summary:
A randomised, double blind, placebo controlled, 48-week clinical trial with a core population (group A) of 79 ambulant 6.5 to 12 years old Duchenne's muscular dystrophy (DMD) patients that are under stable standard treatment of care with glucocorticoids. Furthermore, the investigators plan to include 6-20 non-ambulant patients who do not receive glucocorticoids (as parallel group B), 10 to 16 years old, to obtain efficacy and safety data in a broader DMD population. All patients will receive 20 mg of tamoxifen (TAM) or placebo once daily during 48 weeks.

An open label extension (OLE) trial for participants of the TAMDMD main study will be performed. All TAMDMD patients on TAM or placebo are offered to enter this OLE.

ReferenceCitation: Nagy S, Hafner P, Schmidt S, Rubino-Nacht D, Schädelin S, Bieri O, Fischer D. Tamoxifen in Duchenne muscular dystrophy (TAMDMD): study protocol for a multicenter, randomized, placebo-controlled, double-blind phase 3 trial. Trials. 2019 Nov 21;20(1):637. doi: 10.1186/s13063-019-3740-6.

family: Nagy

full_name: Sara Nagy

given: Sara

family: Hafner

full_name: Patricia Hafner

given: Patricia

family: Schmidt

full_name: Simone Schmidt

given: Simone

family: Rubino-Nacht

full_name: Daniela Rubino-Nacht

given: Daniela

family: Schädelin

full_name: Sabine Schädelin

given: Sabine

family: Bieri

full_name: Oliver Bieri

given: Oliver

family: Fischer

full_name: Dirk Fischer

given: Dirk

currency_apc_doaj: GBP

journal_name: Trials

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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 (via page says license)

repository_normalized: Research Square

version: submittedVersion

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

repository_institution: Research Square - Research Square

repositories:
PubMed Central
Research Square

repositories_institution:
PubMed Central - Europe PMC
Research Square - Research Square

lead_sponsor: University Hospital, Basel, Switzerland

location_country:
Switzerland
Netherlands
France
Spain
Germany
United Kingdom

location_facility:
University Children's Hospital Basel
The Leeds Teaching Hospitals NHS Trust
Universitätsklinikum Essen
Hôpital de Hautepierre
Hospital Sant Joan de Déu. UB
Hôpitaux Raymond Poincaré
Royal Hospital for Children
Alder Hey Children's Hospital
Radboud umc
DRK Klinik Berlin Westend
Hospital Universitario Virgen del Rocío

lead_sponsor_type: academique


title: Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.

acronym: Renoir

summary:
Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment.

Preterm infants have much higher nutrient requirements than term infants. The preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants.

Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. The current Nutricia HMF (control product) has been available in its current composition since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in accordance with the ESPGHAN recommendations.

Recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development.

The Renoir study will investigate the difference between both HMFs with regards to the growth velocity as well as the safety and tolerance of the new HMF.

lead_sponsor: Nutricia Research

location_country:
Germany
United Kingdom
France
Netherlands

location_facility: CHRU Nancy - Maternité regionale Universitaire A. Pinard

location_facility: Saint-Peter's Hospital NHS Foundation Trust

location_facility: Universitätskinderklinik der Otto-v.-Guericke Universität

location_facility: Norfolk and Norwich NHS Foundation Trust


title: A Randomised, Open-label, Phase I Study to Determine the Effect of Food on the Pharmacokinetics of AZD1775 After Oral Dosing of a Capsule Formulation in Patients With Advanced Solid Tumours

summary: The purpose of this study is to assess the effect of food on the pharmacokinetics (PK) of a single dose of AZD1775 (printed capsules) in patients with advanced solid tumours.

lead_sponsor: AstraZeneca

location_country:
United Kingdom
France
Netherlands


title: A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion

acronym: HOME

summary: The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product) in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with regard to liver function.

ReferenceCitation: Klek S, Chambrier C, Cooper SC, Gabe S, Kunecki M, Pironi L, Rahman F, Sobocki J, Szczepanek K, Wanten G, Lincke N, Glotzbach B, Forbes A. Home parenteral nutrition with an omega-3-fatty-acid-enriched MCT/LCT lipid emulsion in patients with chronic intestinal failure (the HOME study): study protocol for a randomized, controlled, multicenter, international clinical trial. Trials. 2019 Dec 30;20(1):808. doi: 10.1186/s13063-019-3994-z.

family: Klek

full_name: Stanislaw Klek

given: Stanislaw

family: Chambrier

full_name: Cécile Chambrier

given: Cécile

family: Cooper

full_name: Sheldon C. Cooper

given: Sheldon C.

family: Gabe

full_name: Simon Gabe

given: Simon

family: Kunecki

full_name: Marek Kunecki

given: Marek

family: Pironi

full_name: Loris Pironi

given: Loris

family: Rahman

full_name: Farooq Rahman

given: Farooq

family: Sobocki

full_name: Jacek Sobocki

given: Jacek

family: Szczepanek

full_name: Kinga Szczepanek

given: Kinga

family: Wanten

full_name: Geert Wanten

given: Geert

family: Lincke

full_name: Nicole Lincke

given: Nicole

family: Glotzbach

full_name: Bernhard Glotzbach

given: Bernhard

family: Forbes

full_name: Alastair Forbes

given: Alastair

endpoint_id: fhisxppmrqpajgzqkvft

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

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

repository_institution: University of East Anglia - UEA Digital Repository

location_country:
Italy
Netherlands
Poland
France
United Kingdom

location_facility: Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: University of East Anglia, Faculty of Medicine and Health Sciences

location_facility: Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej

location_facility: Hospices Civiles de Lyon - Centre hospitalier Lyon Sud

location_facility: Hôpital Archet 2 - Unité de support nutritionnel

location_facility: Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii


type: Registry Identifier

title: A Phase 1, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CC-90010 in Subjects With Advanced Solid Tumors and Relapsed/Refractory Non-Hodgkin's Lymphomas

summary:
Study CC-90010-ST-001 is an open-label, Phase 1a, dose escalation and expansion, First-in-human (FIH) clinical study of CC-90010 in subjects with advanced or unresectable solid tumors and relapsed and/or refractory advanced Non-Hodgkin's lymphoma (NHL). The dose escalation part (Part A) of the study will explore escalating oral doses of CC-90010 to estimate the maximum tolerated dose (MTD) of CC-90010. The expansion part (Part B) will further evaluate the safety and efficacy of CC-90010 administered at or below the MTD in the following cohorts:

Cohort 1: relapsed and/or refractory DLBCL approximately 20-25 evaluable subjects at 45 mg CC-90010 4-days-on/24-days-off in each 28-day cycle Cohort 2: advanced BCC -enrollment stopped due to recruitment challenges Cohort 3: relapsed and/or refractory DLBCL -approximately 15 evaluable subjects at 30mg CC-90010 3-dayson/11-days-offin each 28-day cycle.

The enrollment of subjects with R/R DLBCL in Cohort 1 and Cohort 3 was closed due to Company's strategic decision and not due to any safety concern or lack of preliminary antitumor efficacy.

The food effect assessment (Part C, Spain only) will evaluate the impact of food on CC-90010 when administered at the RP2D of 45 mg 4-days-on/24-days-off (180 mg per 28-day cycle), by comparison of the PK parameters following fasted and fed (high-fat, high-calorie meal) conditions.

lead_sponsor: Celgene

location_country: Italy France Japan Spain

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

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

location_facility: Hospital Universitario Fundacion Jimenez Diaz


ReferenceCitation: Röth A, Nishimura JI, Nagy Z, Gaàl-Weisinger J, Panse J, Yoon SS, Egyed M, Ichikawa S, Ito Y, Kim JS, Ninomiya H, Schrezenmeier H, Sica S, Usuki K, Sicre de Fontbrune F, Soret J, Sostelly A, Higginson J, Dieckmann A, Gentile B, Anzures-Cabrera J, Shinomiya K, Jordan G, Biedzka-Sarek M, Klughammer B, Jahreis A, Bucher C, Peffault de Latour R. The complement C5 inhibitor crovalimab in paroxysmal nocturnal hemoglobinuria. Blood. 2020 Mar 19;135(12):912-920. doi: 10.1182/blood.2019003399.

name: Department of Hematology, West German Cancer Center, University Hospital Essen, Essen, Germany;

family: Röth

full_name: Alexander Röth

given: Alexander

name: Graduate School of Medicine, Osaka University, Osaka, Japan;

family: Nishimura

full_name: Jun-ichi Nishimura

given: Jun-ichi

name: Semmelweis Egyetem I. Sz., Belgyógyászati Klinika, Budapest, Hungary;

family: Nagy

full_name: Zsolt Nagy

given: Zsolt

family: Gaàl-Weisinger

full_name: Julia Gaàl-Weisinger

given: Julia

name: Department of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation, University Hospital Rheinisch Westfälische Hochschule (RWTH) Aachen, Aachen, Germany;

family: Panse

full_name: Jens Panse

given: Jens

name: Clinical Research Institute, Seoul National University Hospital, Seoul, South Korea;

family: Yoon

full_name: Sung-Soo Yoon

given: Sung-Soo

name: Kaposi Mor Oktato Korhaz, Kaposvar, Hungary;

family: Egyed

full_name: Miklos Egyed

given: Miklos

name: Tohoku University Hospital, Miyagi, Japan;

family: Ichikawa

full_name: Satoshi Ichikawa

given: Satoshi

name: First Department of Internal Medicine, Hematology Division, Tokyo Medical University, Tokyo, Japan;

family: Ito

full_name: Yoshikazu Ito

given: Yoshikazu

name: Yonsei University College of Medicine, Severance Hospital, Seoul, South Korea;

family: Kim

full_name: Jin Seok Kim

given: Jin Seok

name: Faculty of Medicine, Department of Medical Sciences, University of Tsukuba, Tsukuba, Japan;

family: Ninomiya

full_name: Haruhiko Ninomiya

given: Haruhiko

name: Institute of Transfusion Medicine, University Hospital Ulm, Ulm, Germany;

name: Institute of Clinical Transfusion Medicine, German Red Cross (GRC) Blood Transfusion Service Baden-Württemberg-Hessen, Ulm, Germany;

family: Schrezenmeier

full_name: Hubert Schrezenmeier

given: Hubert

name: Fondazione Policlinico Universitario A. Gemelli-Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy;

family: Sica

full_name: Simona Sica

given: Simona

family: Usuki

full_name: Kensuke Usuki

given: Kensuke

name: Centre de Référence Aplasie Médullaire-Hemolyse Paroxystique Nocturne (HPN), Service d’Hématologie-Greffe, Hôpital Saint-Louis, Paris, France;

family: Sicre de Fontbrune

full_name: Flore Sicre de Fontbrune

given: Flore

family: Soret

full_name: Juliette Soret

given: Juliette

name: Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland;

family: Sostelly

full_name: Alexandre Sostelly

given: Alexandre

name: Roche Products Ltd, Welwyn, United Kingdom;

family: Higginson

full_name: James Higginson

given: James

family: Dieckmann

full_name: Andreas Dieckmann

given: Andreas

family: Gentile

full_name: Brittany Gentile

given: Brittany

family: Anzures-Cabrera

full_name: Judith Anzures-Cabrera

given: Judith

family: Shinomiya

full_name: Kenji Shinomiya

given: Kenji

name: Roche Diagnostics GmbH, Penzberg, Germany;

family: Jordan

full_name: Gregor Jordan

given: Gregor

family: Biedzka-Sarek

full_name: Marta Biedzka-Sarek

given: Marta

family: Klughammer

full_name: Barbara Klughammer

given: Barbara

name: Université de Paris, Centre de Référence Aplasie Médullaire–HPN, Service d’Hématologie-Greffe, Centre d’Investigation Clinique, Hôpital Saint-Louis, Paris, France; and

name: Severe Aplastic Anemia Working Party of the European Group for Blood and Marrow Transplantation, Leiden, The Netherlands

location_country:
Italy
Netherlands
France
Japan
Hungary
Germany
Korea, Republic of

location_facility: Seoul National University Hosp; Dept Internal Med Hem Onc

location_facility: Semmelweis Egyetem, 1. Szamu Belgyogyaszati Klinika, Diabetologia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Universitätsklinikum Essen; Klinik für Hämatologie

location_facility: University of Tsukuba Hospital; Hematology

location_facility: Ospedale Di Vicenza; Nefrologia, Ematologia

location_facility: Institut hematologie Centre Hayem CHU paris Saint-Louis Lariboisiere F Widal Hopital St Louis

location_facility: A.O. UNIVERSITARIA FEDERICO II DI NAPOLI;Dipartimento di Medicina Clinica e Chirurgia

location_facility: Elblandklinikum Riesa; Klinik fuer Haematologie Onkologie und Gastroenterologie

location_facility: Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.

location_facility: Osaka University Hospital; Hematology and Oncology

location_facility: Universitätsklinikum Ulm; Institut für Klinische Transfusionsmedizin

title: An Adaptive Phase I/II Study to Assess Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Crovalimab in Healthy Volunteers and Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

summary: This is a Phase I/II, first-in-human study consisting of four sequential parts and an open-label extension (OLE). The safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single doses of crovalimab will be evaluated in healthy volunteers (HV) during part 1. The safety, tolerability, PK and PD of multiple doses of crovalimab will be evaluated in participants with paroxysmal nocturnal hemoglobinuria (PNH) in parts 2, 3, 4, and OLE of the study. Efficacy of crovalimab will be evaluated in Parts 2, 3, and 4.


lead_sponsor: PharmaMar

location_country: Italy France Spain

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

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

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Complejo Hospitalario Regional Virgen Del Rocio

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital General Universitario J.M. Morales Meseguer

location_facility: Institut Català d´Oncologia L´Hospitalet

title: Phase II Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide

summary: This is a multi-center, open-label, single arm, non-comparative phase II trial, designed to evaluate the efficacy of plitidepsin in combination with bortezomib and dexamethasone in patients with Multiple Myeloma (MM) double refractory to bortezomib and lenalidomide.


title: Cochlear Implant and Healthy Aging: A Multinational, Multicentre Observational Study

summary: The purpose of this study is to show that cochlear implant treatment improves the overall health related quality of life and general well-being in elderly individuals.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Marx M, Mosnier I, Belmin J, Wyss J, Coudert-Koall C, Ramos A, Manrique Huarte R, Khnifes R, Hilly O, Martini A, Cuda D. Healthy aging in elderly cochlear implant recipients: a multinational observational study. BMC Geriatr. 2020 Jul 23;20(1):252. doi: 10.1186/s12877-020-01628-2.

family: Marx

full_name: M. Marx

given: M.

family: Mosnier

full_name: I. Mosnier

given: I.

family: Belmin

full_name: J. Belmin

given: J.

family: Wyss

full_name: J. Wyss

family: Coudert-Koall

full_name: C. Coudert-Koall

given: C.

family: Ramos

full_name: A. Ramos

given: A.

family: Manrique Huarte

full_name: R. Manrique Huarte

given: R.

family: Khnifes

full_name: R. Khnifes

family: Hilly

full_name: O. Hilly

given: O.

family: Martini

full_name: A. Martini

family: Cuda

full_name: D. Cuda

given: D.

journal_name: BMC Geriatrics

lead_sponsor: Cochlear

location_country: Israel Italy France Spain

location_facility: Groupe Hospitalier de La Pitié Salpétrière

location_facility: ENT Department Ospedale Guglielmo da Saliceto

location_facility: Complejo Hospitalario Universitario Insular Materno Infantil

location_facility: ENT Otosurgery Department-Azienda Ospedaliera di Padova

intervention_type: Device