title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Comparing the Efficacy of Bevacizumab in Combination With Rituximab and CHOP (R-CHOP + Bevacizumab) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

summary: This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) chemotherapy (R-CHOP) versus rituximab plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles).

status: Terminated

ReferenceCitation: McCord R, Bolen CR, Koeppen H, Kadel EE 3rd, Oestergaard MZ, Nielsen T, Sehn LH, Venstrom JM. PD-L1 and tumor-associated macrophages in de novo DLBCL. Blood Adv. 2019 Feb 26;3(4):531-540. doi: 10.1182/bloodadvances.2018020602.

oa_colors: green gold

unpaywall_oa_status: gold

publisher_dissemination: American Society of Hematology

ReferenceCitation: Seymour JF, Pfreundschuh M, Trneny M, Sehn LH, Catalano J, Csinady E, Moore N, Coiffier B; MAIN Study Investigators. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014 Aug;99(8):1343-9. doi: 10.3324/haematol.2013.100818. Epub 2014 Jun 3.

evidence: oa journal (via doaj)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

sponsor_collaborators:
Hoffmann-La Roche
Genentech, Inc.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
United States
China
Malaysia
Peru
Philippines
Italy
Ecuador
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Panama
Taiwan
Russian Federation
Sweden

location_facility: Zaklad Opieki Zdrowotnej Mswia; Oddzial Chemioterapii

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Princess Alexandra Hospital; Department of Haematology

location_facility: Clinique Claude Bernard; Onco Hematologie

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

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

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Bradford Royal Infirmary; Haematology Department

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Hospital das Clinicas - UFRGS; Hematologia

location_facility: Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Hospital de Sao Joao; Servico de Hematologia Clinica

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Tianjin Institute of Hematology & Blood Diseases Hospital

location_facility: Hospital Nacional Guillermo Almenara Irigoyen; Oncology

location_facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia

location_facility: Greenslopes Private Hospital; Gallipoli Research Centre

location_facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

location_facility: Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Haematology Research Center; Haematology

location_facility: Universitätsspital Zürich; Klinik für Onkologie

location_facility: CH Dptal Les Oudairies; Hematologie Oncologie

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: National Cancer Inst. ; Dept. of Chemotherapy

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Centre Hospitalier Uni Ire; Service de Medecine D

location_facility: Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

location_facility: Research Inst. of Hematology & Blood Transfusion ; Hematology

location_facility: Medical University School; Dept. of Haematology

location_facility: Border Medical Oncology; Murray Valley Private Hospital

location_facility: Klinikzentrum Mitte; Medizinische Klinik Gastroenterologie Haematologie / Onkologie

location_facility: Ospedale Gen.Le Prov.Le 'C.G.Mazzoni'; Ematologia

location_facility: Klinikum der Universitaet Muenchen; Campus Großhadern; Medizinische Klinik III und Poliklinik

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Ospedale Ferrarotto; Divisione Di Ematologia

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Hospital Universitario la Fe; Servicio de Medicina Intena

location_facility: Fakultni nemocnice Brno; Interni hematoonkologicka klinika

location_facility: Uni Hospital Santariskiu Clinic; Haematology

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Szpital Uniwersytecki W Krakowie; Klinika Hematologii

location_facility: Chuq - Hopital Hotel Dieu de Quebec; Oncology

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Severance Hospital - Yonsei University; Medicine Dept.

location_facility: Uni of Auckland; Dept of Molecular Medicine & Haematology

location_facility: Fakultni Nemocnice Plzen, Hematologicko-Onkologicke Oddeleni

location_facility: North Hampshire Hospital; Dept. of Haematology

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

location_facility: Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: Carl-Thiem-Klinik Cottbus; Medizinische Klinik

location_facility: Hospital Carlos Andrade Marin; Servicio de Oncología

location_facility: St. Johannes Hospital; Abt. Innere Medizin

location_facility: Eberhard-Karls-Universität Tübingen; Medizinische Klinik I

location_facility: Centralny Szpital Kliniczny Mswia; Klinika onkologii, hematologii i chorob wewnetrznych

location_facility: Fakultní Nemocnice Královské Vinohrady; Hematologická Klinika

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Georgios Papanikolaou Hospital; Hematology Department

location_facility: Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Veterans General Hospital; Division of Oncology

location_facility: St Antonius Hospital; Haematologie/Onkologie

location_facility: Fn Hr. Kralove; IV. Interni Hematologicka Klinika

location_facility: Alfred Hospital; Bone Marrow Transplant Unit

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Institut Gustave Roussy; Unite D'Hematologie

location_facility: Helios Klinik Wuppertal; Medizinische Klinik I

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: Evang.Krankenhaus Abt. Hämatologie und Onkologie

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Hematología

location_facility: Uni of California - San Diego; Cancer Center & Dept of Medicine

location_facility: Uni Medical Center; Division Of Hemotology/Oncology

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia

location_facility: Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.

location_facility: Hopital de L'Archet; Hematologie Clinique

location_facility: St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

location_facility: Fov. Onk. Egyesitett Szent Istvan es Szent Laszlo Korhaz; Dept Of Bone Marrow Transplant

location_facility: Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

location_facility: Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Institut Bergonie; Hematologie Oncologie

location_facility: Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates

location_facility: Uni of Texas Southwestern Medical Center

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: Univ. Cattolica La Sapienza; Cattedra Di Ematologia

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

location_facility: University of Colorado Cancer Center Department of Hematology

location_facility: Royal Hallamshire Hospital; Haematology Dept

location_facility: HSK Dr.-Horst-Schmidt-Kliniken; Innere Medizin I Kardiologie; Angiologie und Intensivmedizin

location_facility: First Affiliated Hospital of Soochow University

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Instituto Cancerologia Medellin; Clinica Las Americas

location_facility: Asklepios Klinik St. Georg; Allgemeine Innere Medizin

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Birmingham Heartlands Hospital; Department of Haematology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

location_facility: Krankenhaus Nordwest Medizinische Klinik

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Chu Estaing; Cons Hemato Medecine Interne

location_facility: Städtisches Klinikum Karlsruhe gGmbH, II. Medizinische Klinik

location_facility: St. Joseph Mercy Hospital; Department of Oncology

location_facility: Klinikum Oldenburg gGmbH; Klinik für Onkologie und Hämatologie

location_facility: VshEOBECNÁ FAKULTNÍ NEMOCNICE; I. INTERNI KLINIKA

location_facility: Università Cattolica Del Sacro Cuore S.S. Giovanni Paolo Ii; Uoc Di Onco-Ematologia

location_facility: The Royal Wolverhampton Hospitals NHS Trust; Department of Haematology

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Hospital Mutua de Terrassa; Servicio de Hematologia

location_facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

location_facility: Christchurch Hospital; Canterbury Health Laboratories

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: Clinique Pont de Chaume; Oncologie Et Radiotherapie

location_facility: Cancer Centre of Southeastern Ontario; Kingston General Hospital

location_facility: University of Kansas Medical Center; Department of Hematology

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: General Hospital of Chinese PLA; Department of Hematology

location_facility: Hospital de Basurto; Servicio de Hematologia

location_facility: Semashko Central Clinical Hospital Moscow; Hematology

location_facility: National Kidney and Transplant Institute; Chemotherapy Unit

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: St Marien Krankenhaus; Medizinische Klinik Iii

location_facility: Teodoro Maldonado Carbo Hospital; Oncology Service

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie

location_facility: HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

location_facility: Fakultni nemocnice Olomouc; Hemato-onkologicka klinika

location_facility: Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

location_facility: St.-Marien-Hospital Klinik Knappenstraße; Klinik für Hämatologie und Onkologie

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

location_facility: Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie

location_facility: KRH Klinikum Siloah Medizinische Klinik III

location_facility: Kliniken St. Antonius; Zentrum Für Innere Medizin, Haematologie/Onkologie

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: Royal Liverpool Uni Hospital; Haematology

location_facility: Westfälische Wilhelms-Universität Münster, Medizinische Klinik und Poliklinik A

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

location_facility: Kath.Krankenhaus Hagen gem.GmbH St.-Marien-Hospital

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

location_facility: Col Instituto Tecnologico Y Estudios Superiores de Monterrey


type: Registry Identifier

title: ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

status: Completed

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Dhillon S. Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Drugs. 2012 May 7;72(7):917-30. doi: 10.2165/11208940-000000000-00000.

ReferenceType: result

ReferenceCitation: Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stahle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM; ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. doi: 10.1056/NEJMoa1103799. Erratum In: N Engl J Med. 2012 Jan 19;366(3):284.

ReferenceType: derived

ReferenceCitation: Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.

lead_sponsor: Medical Research Council

location_country:
Germany
United Kingdom
Norway
Australia
France

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Praxis Fuer Haemotologie Und Internistischer Onkologie

location_facility: Charite University Hospital - Campus Virchow Klinikum

location_facility: Gloucestershire Oncology Centre at Cheltenham General Hospital

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

location_facility: Murray Valley Private Hospital and Cancer Treatment Centre

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Portsmouth Oncology Centre at Saint Mary's Hospital

location_facility: Mid Kent Oncology Centre at Maidstone Hospital

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: St. Luke's Cancer Centre at Royal Surrey County Hospital

location_facility: Princess Royal Hospital at Hull and East Yorkshire NHS Trust

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Cancer Therapy Centre at Liverpool Hospital

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Marburg

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

location_facility: Centre for Cancer Research and Cell Biology at Queen's University Belfast

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Klinikum Dorothea Christiane Erxleben - Quedlingburg

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Kreiskrankenhaus Leonberg - Frauenklinik

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Randomized, Open-Label, Multicenter Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics, of ABT-450 With Ritonavir (ABT-450/r) in Combination With ABT-267 and/or ABT-333 With and Without Ribavirin (RBV) for 8, 12 or 24 Weeks in Treatment-Naïve and Null Responder Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

summary: This is a study of combination direct-acting antiviral agents (DAA) with or without ribavirin (RBV) in patients with chronic Hepatitis C Virus (HCV).

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Krishnan P, Tripathi R, Schnell G, Reisch T, Beyer J, Irvin M, Xie W, Larsen L, Cohen D, Podsadecki T, Pilot-Matias T, Collins C. Resistance analysis of baseline and treatment-emergent variants in hepatitis C virus genotype 1 in the AVIATOR study with paritaprevir-ritonavir, ombitasvir, and dasabuvir. Antimicrob Agents Chemother. 2015 Sep;59(9):5445-54. doi: 10.1128/AAC.00998-15. Epub 2015 Jun 22.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Kowdley KV, Lawitz E, Poordad F, Cohen DE, Nelson DR, Zeuzem S, Everson GT, Kwo P, Foster GR, Sulkowski MS, Xie W, Pilot-Matias T, Liossis G, Larsen L, Khatri A, Podsadecki T, Bernstein B. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med. 2014 Jan 16;370(3):222-32. doi: 10.1056/NEJMoa1306227.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
Germany
New Zealand
United Kingdom
Australia
United States
Spain
Canada
Puerto Rico
France

location_facility:
Site Reference ID/Investigator# 57545
Site Reference ID/Investigator# 43568
Site Reference ID/Investigator# 57583
Site Reference ID/Investigator# 43666
Site Reference ID/Investigator# 55534
Site Reference ID/Investigator# 43661
Site Reference ID/Investigator# 55536
Site Reference ID/Investigator# 59132
Site Reference ID/Investigator# 55533
Site Reference ID/Investigator# 43672
Site Reference ID/Investigator# 46583
Site Reference ID/Investigator# 55382
Site Reference ID/Investigator# 43655
Site Reference ID/Investigator# 45667
Site Reference ID/Investigator# 43910
Site Reference ID/Investigator# 61042
Site Reference ID/Investigator# 44610
Site Reference ID/Investigator# 55522
Site Reference ID/Investigator# 44760
Site Reference ID/Investigator# 43572
Site Reference ID/Investigator# 59133
Site Reference ID/Investigator# 46103
Site Reference ID/Investigator# 43588
Site Reference ID/Investigator# 55387
Site Reference ID/Investigator# 43585
Site Reference ID/Investigator# 46106
Site Reference ID/Investigator# 44755
Site Reference ID/Investigator# 55538
Site Reference ID/Investigator# 55386
Site Reference ID/Investigator# 58811
Site Reference ID/Investigator# 59303
Site Reference ID/Investigator# 43665
Site Reference ID/Investigator# 56622
Site Reference ID/Investigator# 45363
Site Reference ID/Investigator# 43569
Site Reference ID/Investigator# 55385
Site Reference ID/Investigator# 55723
Site Reference ID/Investigator# 43578
Site Reference ID/Investigator# 55383
Site Reference ID/Investigator# 58887
Site Reference ID/Investigator# 44847
Site Reference ID/Investigator# 55901
Site Reference ID/Investigator# 43917
Site Reference ID/Investigator# 46484
Site Reference ID/Investigator# 43586
Site Reference ID/Investigator# 55532
Site Reference ID/Investigator# 45668
Site Reference ID/Investigator# 43565
Site Reference ID/Investigator# 43905
Site Reference ID/Investigator# 43662
Site Reference ID/Investigator# 55384
Site Reference ID/Investigator# 59124
Site Reference ID/Investigator# 55526
Site Reference ID/Investigator# 55500
Site Reference ID/Investigator# 43592
Site Reference ID/Investigator# 58889
Site Reference ID/Investigator# 59262
Site Reference ID/Investigator# 43656
Site Reference ID/Investigator# 44621
Site Reference ID/Investigator# 43659
Site Reference ID/Investigator# 57543
Site Reference ID/Investigator# 55530
Site Reference ID/Investigator# 44084
Site Reference ID/Investigator# 44608
Site Reference ID/Investigator# 43566
Site Reference ID/Investigator# 59304
Site Reference ID/Investigator# 57547
Site Reference ID/Investigator# 43577
Site Reference ID/Investigator# 55539
Site Reference ID/Investigator# 43651
Site Reference ID/Investigator# 43587
Site Reference ID/Investigator# 46105
Site Reference ID/Investigator# 44852
Site Reference ID/Investigator# 46102
Site Reference ID/Investigator# 55540
Site Reference ID/Investigator# 59130
Site Reference ID/Investigator# 44849
Site Reference ID/Investigator# 57882
Site Reference ID/Investigator# 58886
Site Reference ID/Investigator# 43584
Site Reference ID/Investigator# 58922
Site Reference ID/Investigator# 45405
Site Reference ID/Investigator# 58884
Site Reference ID/Investigator# 43573
Site Reference ID/Investigator# 43576
Site Reference ID/Investigator# 45671
Site Reference ID/Investigator# 55542
Site Reference ID/Investigator# 43675
Site Reference ID/Investigator# 46485
Site Reference ID/Investigator# 44754
Site Reference ID/Investigator# 43652
Site Reference ID/Investigator# 55531
Site Reference ID/Investigator# 55527
Site Reference ID/Investigator# 44758
Site Reference ID/Investigator# 43574
Site Reference ID/Investigator# 43913
Site Reference ID/Investigator# 44850


title: A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBCL

summary: The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.

study_start_date_type: Actual

lead_sponsor: MedImmune LLC

location_country:
Germany
Poland
Hungary
Israel
United States
Spain
Turkey
Czechia
Canada
Russian Federation
France


title: A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

summary: The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.

ReferenceCitation: Tap WD, Papai Z, Van Tine BA, Attia S, Ganjoo KN, Jones RL, Schuetze S, Reed D, Chawla SP, Riedel RF, Krarup-Hansen A, Toulmonde M, Ray-Coquard I, Hohenberger P, Grignani G, Cranmer LD, Okuno S, Agulnik M, Read W, Ryan CW, Alcindor T, Del Muro XFG, Budd GT, Tawbi H, Pearce T, Kroll S, Reinke DK, Schoffski P. Doxorubicin plus evofosfamide versus doxorubicin alone in locally advanced, unresectable or metastatic soft-tissue sarcoma (TH CR-406/SARC021): an international, multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1089-1103. doi: 10.1016/S1470-2045(17)30381-9. Epub 2017 Jun 23. Erratum In: Lancet Oncol. 2018 Feb;19(2):e78.

oa_host_type: repository

version: acceptedVersion

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Chawla SP, Cranmer LD, Van Tine BA, Reed DR, Okuno SH, Butrynski JE, Adkins DR, Hendifar AE, Kroll S, Ganjoo KN. Phase II study of the safety and antitumor activity of the hypoxia-activated prodrug TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. J Clin Oncol. 2014 Oct 10;32(29):3299-306. doi: 10.1200/JCO.2013.54.3660. Epub 2014 Sep 2.

oa_colors: green other

evidence: open (via free pdf)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Threshold Pharmaceuticals

collaborators: Sarcoma Alliance for Research through Collaboration (SARC)

location_country:
Germany
Italy
Poland
Hungary
Israel
Denmark
Austria
Belgium
United States
Spain
Canada
Russian Federation
France

location_facility: Département d'Oncologie Moléculaire, Institut Paoli-Calmettes (IPC) and U119 Inserm

location_facility: Hospital Sant Joan de Deu, Department de Oncologia

location_facility: Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg

location_facility: Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital

location_facility: IRCCS Centro di Riferimento Oncologico-Struttura Operativa

location_facility: Helios Klinikum Bad Saarow, Department of Hematology, Oncology, and Palliative Care, Sarcoma Center Berlin-Brandenburg

location_facility: Winship Cancer Institute of Emory University, Midtown Campus

location_facility: H.U. Canarias, Hospital Universitario de Canarias. Servicio de Oncología Médica

location_facility: Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology

location_facility: University Hospital Herlev at Copenhagen

location_facility: Wilhelm's University, Universitatsklinikum Muenster, Medizinische Klinik und Poliklinik A, Albert-Schweitzer-Campus 1

location_facility: Medizinische Hochschule Hannover (MHH) - Klinik fuer Haemonstaseologie, Onkologie und Stammzelltransplantation

location_facility: BCCA- Vancouver Cancer Centre - Division of Medical Oncology

location_facility: Univ. Klinik fur Innere Medizin I Internistische Onkologie Medizinische Universitat Innsbruck

location_facility: Mayo Clinic-Florida-Cancer Clinical Studies Unit

location_facility: ASL TO/2 di TORINO_Presidio Sanitario Gradenigo, S.C. di Oncologia

location_facility: Virginia Commonwealth Universtiy-Massey Cancer Center

location_facility: University of Iowa Health Care - University of Iowa Hospital

location_facility: Kootenai Health - Kootenai Cancer Center

location_facility: Magyar Honvedseg Honvedkorhaz, Onkologiai Osztaly

location_facility: Universidad Complutense Madrid Facultad de Medicina - Hospital Universitario 12 de Octubre, Servicio de Oncologia Medica Hospital Universitario 12 de Octubre

location_facility: GUZ "Regional Oncology Dispensay", Kazan

location_facility: Washington University School of Medicine

location_facility: Carolinas Hematology-oncology Associates-Blumenthal Cancer Center

location_facility: South Florida Center for Gynecologic Oncology

location_facility: Fondazione del Piemonte per l'Oncologia, Instituto per la Ricerca e la Cura del cancro (I.R.C.C.), Dipartimento Oncologico, Direzione Operativa Oncologia Medica a Direzione Universitaria

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences - Department of Medicine

location_facility: Div. of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center

location_facility: FGU Moscow Research Institute of Oncology named after P.A. Hertzen of Rosmedtechnology

location_facility: Wake Forest University Baptist Medical Center

location_facility: Sharette Institute of Oncology, Hadassah-Hebrew University Medical Center, Hadassah Medical Org-Ein Karem

location_facility: Azienda Ospedaliero Universitaria-Policlinico Paolo Giacco

location_facility: Pennsylvania Oncology Hematology Associates

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

location_facility: H.Lee Moffitt Cancer Center and Research Institute

location_facility: University Hospitals Seidman Cancer Center

location_facility: Centrum Onkologii Instytut im M. Sklodowskiej-Curie

location_facility: The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Megyei Onkologiai Kozpont


title: A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy

acronym: INTORSECT

summary: This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.

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

oa_host_type: closed

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

ReferenceCitation: Hutson TE, Escudier B, Esteban E, Bjarnason GA, Lim HY, Pittman KB, Senico P, Niethammer A, Lu DR, Hariharan S, Motzer RJ. Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014 Mar 10;32(8):760-7. doi: 10.1200/JCO.2013.50.3961. Epub 2013 Dec 2.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Argentina
Australia
Chile
Canada
France
Hungary
Denmark
Switzerland
United States
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Sweden


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension

acronym: ASCEND in SPMS

summary:
This is a Phase 3b, multicenter, international study conducted in 2 parts. Upon completion of the placebo-controlled period (Part 1), participants will have the option of enrolling in a 2-year open-label extension (Part 2).

Part 1: The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (SPMS).

The secondary objectives of Part 1 of this study are to determine the proportion of participants with consistent improvement in Timed 25-Foot Walk (T25FW), the change in participant-reported ambulatory status as measured by the 12-item MS Walking Scale (MSWS-12), the change in manual ability based on the ABILHAND Questionnaire, the impact of natalizumab on participant-reported quality of life using the Multiple Sclerosis Impact Scale-29 Physical (MSIS-29 Physical), the change in whole brain volume between the end of study and Week 24 using magnetic resonance imaging (MRI) and the proportion of participants experiencing progression of disability as measured by individual physical Expanded Disability Status Scale (EDSS) system scores.

Part 2: The primary objective of Part 2 of the study is to evaluate the safety profile of natalizumab in participants with SPMS.

The secondary objectives of Part 2 of the study are to investigate long-term disability (based on clinical or participant-reported assessments) in participants with SPMS receiving natalizumab treatment for approximately 4 years and to assess change in brain volume and T2 lesion volume.

ReferenceCitation: Beynon V, George IC, Elliott C, Arnold DL, Ke J, Chen H, Zhu L, Ke C, Giovannoni G, Scaramozza M, Campbell N, Bradley DP, Franchimont N, Gafson A, Belachew S. Chronic lesion activity and disability progression in secondary progressive multiple sclerosis. BMJ Neurol Open. 2022 Jun 7;4(1):e000240. doi: 10.1136/bmjno-2021-000240. eCollection 2022.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

ReferenceCitation: Koch MW, Mostert J, Zhang Y, Wolinsky JS, Lublin FD, Strijbis E, Cutter G. Association of Age With Contrast-Enhancing Lesions Across the Multiple Sclerosis Disease Spectrum. Neurology. 2021 Sep 28;97(13):e1334-e1342. doi: 10.1212/WNL.0000000000012603. Epub 2021 Aug 10.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kapoor R, Ho PR, Campbell N, Chang I, Deykin A, Forrestal F, Lucas N, Yu B, Arnold DL, Freedman MS, Goldman MD, Hartung HP, Havrdova EK, Jeffery D, Miller A, Sellebjerg F, Cadavid D, Mikol D, Steiner D; ASCEND investigators. Effect of natalizumab on disease progression in secondary progressive multiple sclerosis (ASCEND): a phase 3, randomised, double-blind, placebo-controlled trial with an open-label extension. Lancet Neurol. 2018 May;17(5):405-415. doi: 10.1016/S1474-4422(18)30069-3. Epub 2018 Mar 12.

repository_institution: University of Florence - Florence Research

lead_sponsor: Biogen

location_country:
Finland
Germany
Ireland
Italy
Poland
Israel
United Kingdom
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Czechia
Canada
Russian Federation
France

status_simplified: Unknown


title: Multicenter, Open-label, Randomized, Controlled Parallel-group Study to Assess Discontinuation Rates, Bleeding Patterns, User Satisfaction and Adverse Event Profile of LCS12 in Comparison to Etonorgestrel Subdermal Implant Over 12 Months of Use in Women 18 to 35 Years of Age

summary:
The primary objective is to demonstrate that discontinuation rates in women (ages 18-35 years inclusive) using LCS12 are not higher than those seen in women using ENG subdermal implant over a period of 12 months.

Secondary objectives are to observe the bleeding patterns, adverse event profiles and the occurrence of unintended pregnancies. Additionally, data on user satisfaction, IUS expulsions and implant site complications will be collected.

primary_purpose: Prevention

ReferenceCitation: Apter D, Briggs P, Tuppurainen M, Grunert J, Lukkari-Lax E, Rybowski S, Gemzell-Danielsson K. A 12-month multicenter, randomized study comparing the levonorgestrel intrauterine system with the etonogestrel subdermal implant. Fertil Steril. 2016 Jul;106(1):151-157.e5. doi: 10.1016/j.fertnstert.2016.02.036. Epub 2016 Mar 24.

license: publisher-specific-oa

license_normalized: publisher-specific

lead_sponsor: Bayer

location_country:
Finland
France
Norway
United Kingdom
Australia
Sweden


acronym: PERFlexS

lead_sponsor: Janssen-Cilag International NV

summary: The purpose of this study is to explore tolerability, safety and effectiveness of flexibly dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with an oral antipsychotic medication.

ReferenceCitation: Schreiner A, Lahaye M, Peuskens J, Naber D, Dilbaz N, Millet B, Franco MA, Rancans E, Turczynski J, Smeraldi E, Lara E, Neznanov NG. Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics. Expert Opin Pharmacother. 2014 Apr;15(5):593-603. doi: 10.1517/14656566.2014.884071. Epub 2014 Feb 3.

publisher_dissemination: Informa

title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia

type: Other Identifier

source: euctr

location_country:
Finland
Germany
Poland
Turkey
Croatia
Serbia
France
Lithuania
Portugal
Hungary
Denmark
Switzerland
Latvia
Belgium
United Kingdom
Sweden
Netherlands
Spain
Greece
Bulgaria
Russian Federation
Israel


title: A 3-Month, Randomised, Open-Label, Parallel-Group, Descriptive Study To Explore And Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis

summary: The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).

location_country:
Finland
Italy
Germany
Norway
United Kingdom
Denmark
Sweden
Netherlands
France

intervention_type: Device


title: Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

summary: This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Bearz A, Passalacqua R, Alabiso O, Cinieri S, Gridelli C, Cravesana C, Crino L. First-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer : analysis of the Italian patients enrolled in the SAiL study. Clin Drug Investig. 2012 Nov;32(11):755-60. doi: 10.1007/s40261-012-0001-9.

ReferenceCitation: Crino L, Dansin E, Garrido P, Griesinger F, Laskin J, Pavlakis N, Stroiakovski D, Thatcher N, Tsai CM, Wu YL, Zhou C. Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. Lancet Oncol. 2010 Aug;11(8):733-40. doi: 10.1016/S1470-2045(10)70151-0. Epub 2010 Jul 23.

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Bosnia and Herzegovina
Turkey
Canada
Serbia
France
Czech Republic
Lithuania
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
Latvia
Iceland
Romania
Lebanon
China
Estonia
Egypt
Italy
Ecuador
United Kingdom
Venezuela
Sweden
Netherlands
Austria
Mexico
Spain
Taiwan
Russian Federation
Israel


title: An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

summary: This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Llombart-Cussac A, Pivot X, Biganzoli L, Cortes-Funes H, Pritchard KI, Pierga JY, Smith I, Thomssen C, Srock S, Sampayo M, Cortes J. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast. 2014 Oct;23(5):656-62. doi: 10.1016/j.breast.2014.06.017. Epub 2014 Jul 19.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Xu BH, Jiang ZF, Shen ZZ, Guan ZZ, Chen ZD, Cheng Y, Zheng H, Jiang J, Wang XJ, Tong ZS, Qin SK, Luo Y, Yao M, Wang LW, He J. Safety and efficacy of first-line bevacizumab combined with taxane therapy in Chinese patients with HER2-negative locally recurrent or metastatic breast cancer: findings from the ATHENA study. Chin Med J (Engl). 2012 Mar;125(5):764-9.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Turkey
Canada
France
Czech Republic
Lithuania
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
Latvia
Morocco
Lebanon
China
Estonia
Egypt
Italy
Ecuador
United Kingdom
Sweden
Netherlands
Austria
Mexico
Saudi Arabia
Spain
Bulgaria
Russian Federation
Israel


title: An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications

summary: To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

ReferenceCitation: Leizorovicz A, Becker F, Buchmuller A, Quere I, Prandoni P, Decousus H; CALISTO Study Group. Clinical relevance of symptomatic superficial-vein thrombosis extension: lessons from the CALISTO study. Blood. 2013 Sep 5;122(10):1724-9. doi: 10.1182/blood-2013-04-498014. Epub 2013 Jul 2.

ReferenceCitation: Decousus H, Prandoni P, Mismetti P, Bauersachs RM, Boda Z, Brenner B, Laporte S, Matyas L, Middeldorp S, Sokurenko G, Leizorovicz A; CALISTO Study Group. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. N Engl J Med. 2010 Sep 23;363(13):1222-32. doi: 10.1056/NEJMoa0912072.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Italy
Poland
Slovakia
Hungary
Israel
Netherlands
Switzerland
Latvia
Spain
Greece
Ukraine
Bulgaria
Estonia
Czech Republic
Russian Federation
France


summary: This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).

ReferenceCitation: EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.

ReferenceCitation: Cohen AT, Dobromirski M. The use of rivaroxaban for short- and long-term treatment of venous thromboembolism. Thromb Haemost. 2012 Jun;107(6):1035-43. doi: 10.1160/TH11-12-0859. Epub 2012 Feb 28.

ReferenceCitation: Prins MH, Lensing AW. Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J. 2013 Jul 6;11(1):13. doi: 10.1186/1477-9560-11-13.

license: cc-by

license_normalized: cc-by

publisher_dissemination: Springer

ReferenceCitation: Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: University of Ottawa - uO Research

ReferenceCitation: Wang Y, Wang C, Chen Z, Zhang J, Liu Z, Jin B, Ying K, Liu C, Shao Y, Jing Z, Meng IL, Prins MH, Pap AF, Muller K, Lensing AW; Chinese EINSTEIN Investigators. Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies. Thromb J. 2013 Dec 16;11(1):25. doi: 10.1186/1477-9560-11-25.

ReferenceCitation: Bamber L, Wang MY, Prins MH, Ciniglio C, Bauersachs R, Lensing AW, Cano SJ. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost. 2013 Oct;110(4):732-41. doi: 10.1160/TH13-03-0243. Epub 2013 Jul 11.

publisher_dissemination: Georg Thieme

ReferenceCitation: van Bellen B, Bamber L, Correa de Carvalho F, Prins M, Wang M, Lensing AW. Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism. Curr Med Res Opin. 2014 May;30(5):829-37. doi: 10.1185/03007995.2013.879439. Epub 2014 Jan 22.

ReferenceCitation: Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes. 2012 Sep 26;10:120. doi: 10.1186/1477-7525-10-120.

ReferenceCitation: Yang L, Wu J. Cost-effectiveness of rivaroxaban compared with enoxaparin plus warfarin for the treatment of hospitalised acute deep vein thrombosis in China. BMJ Open. 2020 Jul 30;10(7):e038433. doi: 10.1136/bmjopen-2020-038433.

ReferenceCitation: Ten Cate H, Lensing AWA, Weitz JI, Middeldorp S, Beyer-Westendorf J, Kubitza D, Brighton T, Raskob GE, Mismetti P, Prandoni P, Gebel M, Prins MH. The prothrombin time does not predict the risk of recurrent venous thromboembolism or major bleeding in rivaroxaban-treated patients. Thromb Res. 2018 Oct;170:75-83. doi: 10.1016/j.thromres.2018.08.008. Epub 2018 Aug 15.

ReferenceCitation: Di Nisio M, Vedovati MC, Riera-Mestre A, Prins MH, Mueller K, Cohen AT, Wells PS, Beyer-Westendorf J, Prandoni P, Bounameaux H, Kubitza D, Schneider J, Pisters R, Fedacko J, Fontes-Carvalho R, Lensing AW. Treatment of venous thromboembolism with rivaroxaban in relation to body weight. A sub-analysis of the EINSTEIN DVT/PE studies. Thromb Haemost. 2016 Sep 27;116(4):739-46. doi: 10.1160/TH16-02-0087. Epub 2016 Aug 18.

ReferenceCitation: Wells PS, Gebel M, Prins MH, Davidson BL, Lensing AW. Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy. Thromb J. 2014 Nov 26;12:26. doi: 10.1186/1477-9560-12-26. eCollection 2014.

repositories_institution:
PubMed Central - Europe PMC
University of Ottawa - uO Research

ReferenceCitation: Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap AF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.

ReferenceCitation: Bauersachs RM, Lensing AW, Prins MH, Kubitza D, Pap AF, Decousus H, Beyer-Westendorf J, Prandoni P. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014 Nov 24;12:25. doi: 10.1186/1477-9560-12-25. eCollection 2014.

sponsor_collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

title: Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

location_country:
Finland
Germany
Poland
New Zealand
Australia
Brazil
Thailand
Canada
France
Czech Republic
Hungary
Hong Kong
Denmark
Switzerland
United States
Indonesia
India
Belgium
China
Malaysia
Puerto Rico
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Israel


title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)

summary: This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

ReferenceCitation: Narula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.

publisher_dissemination: Wiley

ReferenceCitation: Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum In: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

publisher_dissemination: Oxford University Press

ReferenceCitation: Li K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:

evidence: open (via page says license)

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

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

repository_institution: University of California - eScholarship University of California

repositories:
PubMed Central
Pure (Denmark)
escholarship.org

publisher_dissemination: Springer-Nature

ReferenceCitation: Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.

ReferenceCitation: Hibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.

publisher_dissemination: Korean Association for the Study of Intestinal Diseases

ReferenceCitation: Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960. doi: 10.1056/NEJMoa1602773.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: St George's University of London - St George's Online Research Archive

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Croatia
Canada
Serbia
France
Hungary
United States
Iceland
Belgium
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel


title: A Phase II Study of the BRAF Inhibitor Dabrafenib as a Single Agent and in Combination With the MEK Inhibitor Trametinib in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer

summary: This was a Phase II, multicenter, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer. Central confirmation testing for the BRAF V600E mutation was performed and a sufficient number of subjects were enrolled with the intent of having at least 125 centrally confirmed subjects among the three cohorts.

design_allocation: Non-Randomized

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Li J, Sasane M, Zhang J, Zhao J, Ricculli ML, Yao Z, Redhu S, Signorovitch J. Is time to progression associated with post-progression survival in previously treated metastatic non-small cell lung cancer with BRAF V600E mutation? A secondary analysis of phase II clinical trial data. BMJ Open. 2018 Aug 17;8(8):e021642. doi: 10.1136/bmjopen-2018-021642.

ReferenceCitation: Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland A, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAFV600E-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. doi: 10.1016/S1470-2045(17)30679-4. Epub 2017 Sep 11.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

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

ReferenceCitation: Planchard D, Besse B, Groen HJM, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-993. doi: 10.1016/S1470-2045(16)30146-2. Epub 2016 Jun 6.

repository_institution: University of Turin - Institutional Research Information System University of Turin

version: submittedVersion

repositories_concat: PubMed Central;iris.unito.it

ReferenceCitation: Planchard D, Kim TM, Mazieres J, Quoix E, Riely G, Barlesi F, Souquet PJ, Smit EF, Groen HJ, Kelly RJ, Cho BC, Socinski MA, Pandite L, Nase C, Ma B, D'Amelio A Jr, Mookerjee B, Curtis CM Jr, Johnson BE. Dabrafenib in patients with BRAF(V600E)-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 May;17(5):642-50. doi: 10.1016/S1470-2045(16)00077-2. Epub 2016 Apr 11.

ipd_sharing: Yes

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Norway
United Kingdom
Japan
Netherlands
United States
Korea, Republic of
Spain
Taiwan
France


summary: This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (Tarceva) versus erlotinib at the time of disease progression in participants with advanced NSCLC who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (EGFR)-activating mutation. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo. Participants who progress on placebo will receive erlotinib 150 mg PO once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. Treatments will continue until disease progression, death, or unacceptable toxicity. Participants may also be entered into a final Survival Follow-Up (SFU) period upon treatment discontinuation.

title: A Randomized, Double-Blind, Placebo-Controlled Phase III Study of First-Line Maintenance Tarceva Versus Tarceva at the Time of Disease Progression in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-Based Chemotherapy

location_country:
Poland
Brazil
Thailand
Canada
France
Czech Republic
Lithuania
Slovakia
Hungary
United States
Latvia
Ukraine
Romania
China
Italy
Netherlands
Korea, Republic of
South Africa
Taiwan
Bulgaria


acronym: PIX-R

lead_sponsor: CTI BioPharma

summary: The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.

ReferenceCitation: Pettengell R, Dlugosz-Danecka M, Andorsky D, Belada D, Georgiev P, Quick D, Singer JW, Singh SB, Pallis A, Egorov A, Salles G. Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306). Br J Haematol. 2020 Jan;188(2):240-248. doi: 10.1111/bjh.16255. Epub 2019 Dec 27.

ReferenceCitation: Belada D, Georgiev P, Dakhil S, Inhorn LF, Andorsky D, Beck JT, Quick D, Pettengell R, Daly R, Dean JP, Pavlyuk M, Failloux N, Hubel K. Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma. Future Oncol. 2016 Aug;12(15):1759-68. doi: 10.2217/fon-2016-0137. Epub 2016 Apr 20.

evidence: oa repository (semantic scholar lookup)

repositories_institution: St George's University of London - St George's Online Research Archive

publisher_dissemination: Future Science Ltd

location_facility: Integrated Community Oncology Network-St. Vincent's

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

location_facility: Bucharest University Emergency Hospital, Hematology Clinic

location_facility: Silesia Medical University, Department of Hematology and Bone Marrow Transplantation

location_facility: UMHAT "Sveti Georgi", Plovdiv, Clinical Hematology Clinic

location_facility: Oncology Center of Lublin Land, Department of Clinical Oncology

location_facility: Saint Vincent Hospital Green Bay Oncology

location_facility: Cancer & Hematology Center of Western Michigan

location_facility: Cancer Care Centers of South Texas-HOAST

location_facility: Institut Català de Oncologia (ICO), Hospital Dr Trueta

location_facility: Service d'hématologie clinique, Avenue Laennec Salouel

location_facility: Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L.

location_facility: Green Bay Oncology-St. Mary's Hospital MC

location_facility: Hanusch Hospital, Department of Internal Medicine III

location_facility: General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology

location_facility: Hematology-Oncology Associates of Northern New Jersey

location_facility: Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: Hautepierre Hospital, Department of Hematology and Oncology

location_facility: Romagna Local Health Authority (AUSL Romagna) - "Santa Maria delle Croci"

location_facility: Siena University Hospital Authority Santa Maria alle Scotte Polyclinic

location_facility: University Hospital Ostrava, Institute of Clinical Hematology

location_facility: Christie Hospital, Department of Medical Oncology

location_facility: University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Romagna Local Health Authority (AUSL Romagna) - "Infermi" Hospital

location_facility: University Hospital "Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi"

location_facility: State Healthcare Institution: Republican Clinical Oncology Center

location_facility: Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic

location_facility: J. A. Reiman University Hospital with Polyclinic in Presov

location_facility: Harry and Jeanette Weinberg Cancer Institute at Franklin Square

location_facility: Institute of Hematology and Transfusion Medicine, Clinic of Hematology

location_facility: Metro Minnesota Community Clinical Oncology Program

location_facility: Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology

location_facility: UMHAT "Sveti Georgi", Plovdiv, Department of Medical Oncology

location_facility: Independent Public Healthcare Facility Municipal Hospital Group

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

location_facility: State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1

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

location_facility: A.O.U. Città della Salute e della Scienza di Torino

location_facility: MHAT Hristo Botev, Vratsa, First Department of Internal Medicine

location_facility: University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology

location_facility: Marine Hospital of Polish Red Cross, Department of Chemotheraphy

location_facility: Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation

location_facility: Saint Quentin Hospital Center, Department of Oncology-Hematology

location_facility: General Hospital Delta, Hematology Department

location_facility: MHAT "Tokuda Hospital Sofia", Hematology Clinic

location_facility: University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology

location_facility: George Washington University Department of Medicine

location_facility: Aalborg University Hospital, Department of Hematology

location_facility: Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Department of Clinical Hematology

location_facility: Cancer Care Specialists of Central Illinois

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

location_facility: Polyclinique de Bordeaux nord Acquitaine

location_facility: Malopolskie Medical Center S.C. , Department of Hematology

location_facility: North Shore Hematology/Oncology Associates

location_facility: Saint Luc University Hospital, Department of Hematology

location_facility: Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation

location_facility: General Hospital Turnhout, Hematology Department

location_facility: State Medical Institution: Republican Hospital named after V.A. Baranov

location_facility: University Hospital Martin, Department of Hematology and Transfusiology

location_facility: "Ospedali Riuniti Villa Sofia-Cervello" Hospital

location_facility: State Institution: Institute of Blood Pathology and Transfusion Medicine

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: University Hospital Kralovske Vinohrady, Department of Clinical Hematology

location_facility: National Cancer Institute, Department of Hematology and Transfusiology

location_facility: Integrated Community Oncology Network-Southside

location_facility: St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care

location_facility: St. Istvan and St. Laszlo Hospital of Budapest

title: A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant

location_country:
Germany
Italy
Poland
Slovakia
Hungary
United Kingdom
Denmark
Romania
Austria
Belgium
United States
Spain
Czechia
Bulgaria
Ukraine
Russian Federation
France


title: An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease

summary: An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.

location_country:
Germany
Poland
New Zealand
Australia
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
Estonia
Italy
United Kingdom
Sweden
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A 52 Week Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

summary: A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

location_country:
Germany
Poland
New Zealand
Australia
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
Estonia
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


summary: The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.

ReferenceCitation: Osterborg A, Udvardy M, Zaritskey A, Andersson PO, Grosicki S, Mazur G, Kaplan P, Steurer M, Schuh A, Montillo M, Kryachok I, Middeke JM, Kulyaba Y, Rekhtman G, Gorczyca M, Daly S, Chang CN, Lisby S, Gupta I. Phase III, randomized study of ofatumumab versus physicians' choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2016 Sep;57(9):2037-46. doi: 10.3109/10428194.2015.1122783. Epub 2016 Jan 19.

title: An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)

location_country:
Germany
Ireland
Italy
Poland
Slovakia
Hungary
Israel
Singapore
United Kingdom
Sweden
Austria
Belgium
Czechia
Bulgaria
Ukraine
Russian Federation
France

ipd_sharing: Undecided


lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

summary: The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).

ReferenceCitation: Ungar L, Rodriguez F, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Patel MR, Piccini JP, Mahaffey KW. Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF. Cardiol Ther. 2019 Dec;8(2):283-295. doi: 10.1007/s40119-019-00146-6. Epub 2019 Aug 2.

repositories_concat: PubMed Central;escholarship.org

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Quinn GR, Hellkamp AS, Hankey GJ, Becker RC, Berkowitz SD, Breithardt G, Fava M, Fox KAA, Halperin JL, Mahaffey KW, Nessel CC, Patel MR, Piccini JP, Singer DE. Selective Serotonin Reuptake Inhibitors and Bleeding Risk in Anticoagulated Patients With Atrial Fibrillation: An Analysis From the ROCKET AF Trial. J Am Heart Assoc. 2018 Aug 7;7(15):e008755. doi: 10.1161/JAHA.118.008755.

repositories_concat: PubMed Central;pdfs.semanticscholar.org

ReferenceCitation: Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR, Melloni C. Efficacy and safety of rivaroxaban vs. warfarin in patients with non-valvular atrial fibrillation and a history of cancer: observations from ROCKET AF. Eur Heart J Qual Care Clin Outcomes. 2019 Apr 1;5(2):145-152. doi: 10.1093/ehjqcco/qcy040.

repository_institution: UWA - UWA Profiles and Research Repository

repositories_concat: Pure (Denmark)

ReferenceCitation: Chen ST, Hellkamp AS, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Impact of polyvascular disease on patients with atrial fibrillation: Insights from ROCKET AF. Am Heart J. 2018 Jun;200:102-109. doi: 10.1016/j.ahj.2018.02.013. Epub 2018 Feb 27.

ReferenceCitation: Leef GC, Hellkamp AS, Patel MR, Becker RC, Berkowitz SD, Breithardt G, Halperin JL, Hankey GJ, Hacke W, Nessel CC, Singer DE, Fox KAA, Mahaffey KW, Piccini JP. Safety and Efficacy of Rivaroxaban in Patients With Cardiac Implantable Electronic Devices: Observations From the ROCKET AF Trial. J Am Heart Assoc. 2017 Jun 14;6(6):e004663. doi: 10.1161/JAHA.116.004663.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

ReferenceCitation: Balla SR, Cyr DD, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Fox KAA, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Patel MR. Relation of Risk of Stroke in Patients With Atrial Fibrillation to Body Mass Index (from Patients Treated With Rivaroxaban and Warfarin in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation Trial). Am J Cardiol. 2017 Jun 15;119(12):1989-1996. doi: 10.1016/j.amjcard.2017.03.028. Epub 2017 Mar 29.

ReferenceCitation: Sun Y, Hu D, Stevens S, Lokhnygina Y, Becker RC, Berkowitz SD, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Mahaffey KW, Nessel CC, Piccini JP, Singer DE, Fox KAA, Patel MR. Efficacy and safety of rivaroxaban versus warfarin in patients from mainland China with nonvalvular atrial fibrillation: A subgroup analysis from the ROCKET AF trial. Thromb Res. 2017 Aug;156:184-190. doi: 10.1016/j.thromres.2017.04.010. Epub 2017 Apr 13.

ReferenceCitation: Lindner SM, Fordyce CB, Hellkamp AS, Lokhnygina Y, Piccini JP, Breithardt G, Mahaffey KW, Singer DE, Hacke W, Halperin JL, Hankey GJ, Berkowitz SD, Nessel CC, Becker RC, Fox KA, Patel MR; ROCKET AF Steering Committee and Investigators. Treatment Consistency Across Levels of Baseline Renal Function With Rivaroxaban or Warfarin: A ROCKET AF (Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) Analysis. Circulation. 2017 Mar 7;135(10):1001-1003. doi: 10.1161/CIRCULATIONAHA.116.024666. No abstract available.

ReferenceCitation: Fordyce CB, Hellkamp AS, Lokhnygina Y, Lindner SM, Piccini JP, Becker RC, Berkowitz SD, Breithardt G, Fox KA, Mahaffey KW, Nessel CC, Singer DE, Patel MR; ROCKET AF Steering Committee and Investigators. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF. Circulation. 2016 Jul 5;134(1):37-47. doi: 10.1161/CIRCULATIONAHA.116.021890. Erratum In: Circulation. 2016 Aug 23;134(8):e114. Circulation. 2020 Feb 25;141(8):e98.

ReferenceCitation: Pokorney SD, Piccini JP, Stevens SR, Patel MR, Pieper KS, Halperin JL, Breithardt G, Singer DE, Hankey GJ, Hacke W, Becker RC, Berkowitz SD, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Steering Committee & Investigators; ROCKET AF Steering Committee Investigators. Cause of Death and Predictors of All-Cause Mortality in Anticoagulated Patients With Nonvalvular Atrial Fibrillation: Data From ROCKET AF. J Am Heart Assoc. 2016 Mar 8;5(3):e002197. doi: 10.1161/JAHA.115.002197.

repository_institution: Monash University - Monash University Research Portal

repository_institution: Aberdeen University - Aberdeen University Research Archive

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

repository_institution: University of Modena and Reggio Emilia - IRIS UNIMORE

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;aura.abdn.ac.uk;boa.unimib.it;dash.harvard.edu;iris.unimore.it;monash.edu;pure.ed.ac.uk

ReferenceCitation: Breithardt G, Baumgartner H, Berkowitz SD, Hellkamp AS, Piccini JP, Lokhnygina Y, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Califf RM, Fox KA, Patel MR; ROCKET AF Steering Committee & Investigators. Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban. Heart. 2016 Jul 1;102(13):1036-43. doi: 10.1136/heartjnl-2015-308120. Epub 2016 Feb 17.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Piccini JP, Hellkamp AS, Washam JB, Becker RC, Breithardt G, Berkowitz SD, Halperin JL, Hankey GJ, Hacke W, Mahaffey KW, Nessel CC, Singer DE, Fox KA, Patel MR. Polypharmacy and the Efficacy and Safety of Rivaroxaban Versus Warfarin in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation. Circulation. 2016 Jan 26;133(4):352-60. doi: 10.1161/CIRCULATIONAHA.115.018544. Epub 2015 Dec 16.

ReferenceCitation: Bansilal S, Bloomgarden Z, Halperin JL, Hellkamp AS, Lokhnygina Y, Patel MR, Becker RC, Breithardt G, Hacke W, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Piccini JP, Mahaffey KW, Fox KA; ROCKET AF Steering Committee and Investigators. Efficacy and safety of rivaroxaban in patients with diabetes and nonvalvular atrial fibrillation: the Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF Trial). Am Heart J. 2015 Oct;170(4):675-682.e8. doi: 10.1016/j.ahj.2015.07.006. Epub 2015 Jul 17.

ReferenceCitation: Washam JB, Stevens SR, Lokhnygina Y, Halperin JL, Breithardt G, Singer DE, Mahaffey KW, Hankey GJ, Berkowitz SD, Nessel CC, Fox KA, Califf RM, Piccini JP, Patel MR; ROCKET AF Steering Committee and Investigators. Digoxin use in patients with atrial fibrillation and adverse cardiovascular outcomes: a retrospective analysis of the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF). Lancet. 2015 Jun 13;385(9985):2363-70. doi: 10.1016/S0140-6736(14)61836-5. Epub 2015 Mar 6.

ReferenceCitation: Singer DE, Hellkamp AS, Yuan Z, Lokhnygina Y, Patel MR, Piccini JP, Hankey GJ, Breithardt G, Halperin JL, Becker RC, Hacke W, Nessel CC, Mahaffey KW, Fox KA, Califf RM; ROCKET AF Investigators. Alternative calculations of individual patient time in therapeutic range while taking warfarin: results from the ROCKET AF trial. J Am Heart Assoc. 2015 Mar 3;4(3):e001349. doi: 10.1161/JAHA.114.001349.

ReferenceCitation: Girgis IG, Patel MR, Peters GR, Moore KT, Mahaffey KW, Nessel CC, Halperin JL, Califf RM, Fox KA, Becker RC. Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF. J Clin Pharmacol. 2014 Aug;54(8):917-27. doi: 10.1002/jcph.288. Epub 2014 Mar 26.

ReferenceCitation: Sherwood MW, Douketis JD, Patel MR, Piccini JP, Hellkamp AS, Lokhnygina Y, Spyropoulos AC, Hankey GJ, Singer DE, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Becker RC; ROCKET AF Investigators. Outcomes of temporary interruption of rivaroxaban compared with warfarin in patients with nonvalvular atrial fibrillation: results from the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation (ROCKET AF). Circulation. 2014 May 6;129(18):1850-9. doi: 10.1161/CIRCULATIONAHA.113.005754. Epub 2014 Feb 19.

ReferenceCitation: Goodman SG, Wojdyla DM, Piccini JP, White HD, Paolini JF, Nessel CC, Berkowitz SD, Mahaffey KW, Patel MR, Sherwood MW, Becker RC, Halperin JL, Hacke W, Singer DE, Hankey GJ, Breithardt G, Fox KA, Califf RM; ROCKET AF Investigators. Factors associated with major bleeding events: insights from the ROCKET AF trial (rivaroxaban once-daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation). J Am Coll Cardiol. 2014 Mar 11;63(9):891-900. doi: 10.1016/j.jacc.2013.11.013. Epub 2013 Dec 4.

ReferenceCitation: Mahaffey KW, Wojdyla D, Hankey GJ, White HD, Nessel CC, Piccini JP, Patel MR, Berkowitz SD, Becker RC, Halperin JL, Singer DE, Califf RM, Fox KA, Breithardt G, Hacke W. Clinical outcomes with rivaroxaban in patients transitioned from vitamin K antagonist therapy: a subgroup analysis of a randomized trial. Ann Intern Med. 2013 Jun 18;158(12):861-8. doi: 10.7326/0003-4819-158-12-201306180-00003.

ReferenceCitation: van Diepen S, Hellkamp AS, Patel MR, Becker RC, Breithardt G, Hacke W, Halperin JL, Hankey GJ, Nessel CC, Singer DE, Berkowitz SD, Califf RM, Fox KA, Mahaffey KW. Efficacy and safety of rivaroxaban in patients with heart failure and nonvalvular atrial fibrillation: insights from ROCKET AF. Circ Heart Fail. 2013 Jul;6(4):740-7. doi: 10.1161/CIRCHEARTFAILURE.113.000212. Epub 2013 May 30.

ReferenceCitation: Singer DE, Hellkamp AS, Piccini JP, Mahaffey KW, Lokhnygina Y, Pan G, Halperin JL, Becker RC, Breithardt G, Hankey GJ, Hacke W, Nessel CC, Patel MR, Califf RM, Fox KA; ROCKET AF Investigators. Impact of global geographic region on time in therapeutic range on warfarin anticoagulant therapy: data from the ROCKET AF clinical trial. J Am Heart Assoc. 2013 Feb 19;2(1):e000067. doi: 10.1161/JAHA.112.000067.

ReferenceCitation: Piccini JP, Stevens SR, Lokhnygina Y, Patel MR, Halperin JL, Singer DE, Hankey GJ, Hacke W, Becker RC, Nessel CC, Mahaffey KW, Fox KA, Califf RM, Breithardt G; ROCKET AF Steering Committee & Investigators. Outcomes after cardioversion and atrial fibrillation ablation in patients treated with rivaroxaban and warfarin in the ROCKET AF trial. J Am Coll Cardiol. 2013 May 14;61(19):1998-2006. doi: 10.1016/j.jacc.2013.02.025. Epub 2013 Mar 14.

ReferenceCitation: Piccini JP, Stevens SR, Chang Y, Singer DE, Lokhnygina Y, Go AS, Patel MR, Mahaffey KW, Halperin JL, Breithardt G, Hankey GJ, Hacke W, Becker RC, Nessel CC, Fox KA, Califf RM; ROCKET AF Steering Committee and Investigators. Renal dysfunction as a predictor of stroke and systemic embolism in patients with nonvalvular atrial fibrillation: validation of the R(2)CHADS(2) index in the ROCKET AF (Rivaroxaban Once-daily, oral, direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) and ATRIA (AnTicoagulation and Risk factors In Atrial fibrillation) study cohorts. Circulation. 2013 Jan 15;127(2):224-32. doi: 10.1161/CIRCULATIONAHA.112.107128. Epub 2012 Dec 3.

ReferenceCitation: Hankey GJ, Patel MR, Stevens SR, Becker RC, Breithardt G, Carolei A, Diener HC, Donnan GA, Halperin JL, Mahaffey KW, Mas JL, Massaro A, Norrving B, Nessel CC, Paolini JF, Roine RO, Singer DE, Wong L, Califf RM, Fox KA, Hacke W; ROCKET AF Steering Committee Investigators. Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol. 2012 Apr;11(4):315-22. doi: 10.1016/S1474-4422(12)70042-X. Epub 2012 Mar 7.

ReferenceCitation: Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.

ReferenceCitation: ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J. 2010 Mar;159(3):340-347.e1. doi: 10.1016/j.ahj.2009.11.025.

title: A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Turkey
Chile
Canada
France
Czech Republic
Lithuania
Colombia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
India
Romania
Belgium
China
Malaysia
Peru
Philippines
Norway
Singapore
United Kingdom
Venezuela
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Randomized, Controlled, Open Label, Multicenter, Parallel-group Study to Compare the Effect of Mircera With That of Darbepoetin Alfa, Administered Intravenously at Extended Dosing Intervals, for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Hemodialysis

summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease (CKD) who are on hemodialysis. Eligible patients receiving once-weekly intravenous (IV) darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

ReferenceCitation: Carrera F, Lok CE, de Francisco A, Locatelli F, Mann JF, Canaud B, Kerr PG, Macdougall IC, Besarab A, Villa G, Kazes I, Van Vlem B, Jolly S, Beyer U, Dougherty FC; PATRONUS Investigators. Maintenance treatment of renal anaemia in haemodialysis patients with methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa administered monthly: a randomized comparative trial. Nephrol Dial Transplant. 2010 Dec;25(12):4009-17. doi: 10.1093/ndt/gfq305. Epub 2010 Jun 3.

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