title: A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor

summary: This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.

status: Terminated

location_country:
Italy
Sweden
Netherlands
Germany
Finland
France
Greece
Puerto Rico
Russian Federation
Spain
Denmark
United States


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS US 196 0140

summary: This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Gilead Sciences

location_country:
Austria
Netherlands
Germany
France
Poland
Belgium
United States
United Kingdom

location_facility: Academisch Medisch Centrum Universiteit Van Amsterdam

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi

location_facility: Hôpital de I´Archet 2, Service Hépatologie

location_facility: Emory University, Infectious Disease Clinic

location_facility: Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny

location_facility: Liver Institute of Virginia, Bon Secours

location_facility: Henry Ford Health System-Columbus center

location_facility: Radaboud University Nijmegen Medical Centre (UMC St Radboud)

location_facility: Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research

location_facility: Erasmus University Medical Center Rotterdam

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: San Francisco Veterans Affairs Medical Center

location_facility: Centre Hospitalier Régional d'Orléans, Hôpital de la Source

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Digestive Health Specialists of the Southeast

location_facility: Virginia Mason Medical Center, Digestive Disease Institute

location_facility: Cornell University Gastroenterology & Hepatology

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: University Hospitals Case Medical Center

location_facility: Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby

location_facility: South Florida Center of Gastroenterology, LLC

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Columbia Medical Group, The Frist Clinic

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Pol-SaNa-Med" Sp. z o.o.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.

ReferenceType: derived

ReferenceCitation: Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11.

family: Esquenazi

full_name: Alberto Esquenazi

given: Alberto

sequence: first

family: Brashear

full_name: Allison Brashear

given: Allison

sequence: additional

name: Service de Médecine Physique et Réadaptation, Centre Hospitalier Universitaire UCL  Yvoir Belgium

family: Deltombe

full_name: Thierry Deltombe

given: Thierry

name: Department of Neurology, Faculty of Medicine and Health Service Andrzej Frycz Modrzewski Krakow University  Krakow Poland

family: Rudzinska‐Bar

full_name: Monika Rudzinska‐Bar

given: Monika

name: Centrum Medyczne Plejady ul  Kraków Poland

family: Krawczyk

full_name: Malgorzata Krawczyk

given: Malgorzata

name: Pavlov First St Petersburg State Medical University  St Petersburg Russia

family: Skoromets

full_name: Alexander Skoromets

given: Alexander

name: Department of Rehabilitation Medicine Weill Cornell Medicine  New York NY USA

family: O'Dell

full_name: Michael W. O'Dell

given: Michael W.

family: Grandoulier

full_name: Anne‐Sophie Grandoulier

given: Anne‐Sophie

family: Vilain

full_name: Claire Vilain

given: Claire

family: Picaut

full_name: Philippe Picaut

given: Philippe

name: EA 7377 BIOTN, Université Paris‐Est Créteil, Service de Rééducation Neurolocomotrice, Hôpitaux Universitaires Henri Mondor  Créteil France

family: Gracies

full_name: Jean‐Michel Gracies

given: Jean‐Michel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: PM&R

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.

name: Department of Physical Medicine and RehabilitationMossRehab Gait and Motion Analysis Laboratory Elkins Park PA USA

name: Physical and Rehabilitation Medicine Department, Cliniques universitaires Saint‐LucCatholic University of Louvain Brussels Belgium

family: Stoquart

full_name: Gaëtan Stoquart

given: Gaëtan

name: Department of Neurology, Division of Movement DisordersVanderbilt University Nashville TN USA

family: Hedera

full_name: Peter Hedera

given: Peter

name: Centro de Medicina de Reabilitação de Alcoitão, Estoril Estoril Portugal

family: Jacinto

full_name: Luis Jorge Jacinto

given: Luis Jorge

name: Division of Physical Medicine and Rehabilitation, Department of Surgical SciencesUniversity of Turin Turin Italy

family: Dimanico

full_name: Ugo Dimanico

given: Ugo

name: Unités de Médecine Physique et de Réadaptation, Hôpital SébastopolUniversité de Reims Champagne‐Ardenne Reims France

family: Constant‐Boyer

full_name: Francois Constant‐Boyer

given: Francois

name: School of MedicineUniversity of California Davis Sacramento CA

name: Department of NeurologyWake Forest School of Medicine Winston‐Salem NC

name: BiostatisticsIpsen Pharma Les Ulis France

name: Service de Rééducation NeurolocomotriceEA 7377 BIOTN, Université Paris‐Est, Hospital Albert Chenevier‐Henri Mondor Créteil France

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

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.

repository_institution: Jagiellonian University - Jagiellonian University Repository

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Italy
France
Czechia
Poland
Slovakia
Hungary
Belgium
Australia
Russian Federation
Portugal
United States

location_facility: Servizio di Neurofisiologia Clinica-Ospedale San Raffaele

location_facility: State Institution "Scientific Centre of Neurology of Russian Academy of Medical Sciences"

location_facility: Wake Forest University Baptist Medical Center

location_facility: University of North Carolina - Chapel Hill

location_facility: Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan

location_facility: Polo IRCCS Eugenio Medea La Nostra Famiglia

location_facility: Neurologicka klinika, Univerzitna nemocnica Bratislava

location_facility: Associated Neurologists of Southern CT, PC

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: Hôpital Sébastopol, Médecine Physique et Réadaptation, CHU Reims

location_facility: National Institute for Medical Rehabilitation

location_facility: Parkinson's Disease & Movement Disorders Center of Boca Raton

location_facility: The University of Texas Southwestern Medical Center at Dallas


title: Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons

summary: This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

study_start_date_type: Actual

lead_sponsor: GlaxoSmithKline

location_country:
Germany
United States
France
Spain


ReferenceCitation: Gökbuget N, Zugmaier G, Dombret H, Stein A, Bonifacio M, Graux C, Faul C, Brüggemann M, Taylor K, Mergen N, Reichle A, Horst HA, Havelange V, Topp MS, Bargou RC. Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2020 Nov;61(11):2665-2673. doi: 10.1080/10428194.2020.1780583. Epub 2020 Jul 3.

family: Gökbuget

full_name: Nicola Gökbuget

given: Nicola

family: Zugmaier

full_name: Gerhard Zugmaier

given: Gerhard

name: University Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Université de Paris, Paris, France

family: Dombret

full_name: Hervé Dombret

given: Hervé

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

family: Stein

full_name: Anthony Stein

given: Anthony

family: Bonifacio

full_name: Massimiliano Bonifacio

given: Massimiliano

name: CHU UCL Namur – Site Godinne, Université Catholique de Louvain, Yvoir, Belgium

family: Graux

full_name: Carlos Graux

given: Carlos

family: Faul

full_name: Christoph Faul

given: Christoph

family: Brüggemann

full_name: Monika Brüggemann

family: Taylor

full_name: Kate Taylor

given: Kate

family: Mergen

full_name: Noemi Mergen

given: Noemi

name: Department of Hematology and Oncology, University Hospital Regensburg, Regensburg, Germany

family: Reichle

full_name: Albrecht Reichle

given: Albrecht

family: Horst

full_name: Heinz-August Horst

given: Heinz-August

name: Department of Hematology, Cliniques Universitaires St. Luc, Brussels, Belgium

family: Havelange

full_name: Violaine Havelange

given: Violaine

name: Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany and

family: Topp

full_name: Max S. Topp

given: Max S.

name: Comprehensive Cancer Center Mainfranken, Uniklinikum Würzburg, Würzburg, Germany

family: Bargou

full_name: Ralf C. Bargou

given: Ralf C.

journal_name: Leukemia & Lymphoma

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Jen EY, Xu Q, Schetter A, Przepiorka D, Shen YL, Roscoe D, Sridhara R, Deisseroth A, Philip R, Farrell AT, Pazdur R. FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease. Clin Cancer Res. 2019 Jan 15;25(2):473-477. doi: 10.1158/1078-0432.CCR-18-2337. Epub 2018 Sep 25.

family: Jen

full_name: Emily Y. Jen

given: Emily Y.

family: Xu

full_name: Qing Xu

given: Qing

family: Schetter

full_name: Aaron Schetter

given: Aaron

family: Przepiorka

full_name: Donna Przepiorka

given: Donna

family: Shen

full_name: Yuan Li Shen

given: Yuan Li

family: Roscoe

full_name: Donna Roscoe

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Gökbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Brüggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22. Erratum in: Blood. 2019 Jun 13;133(24):2625.

name: University Hospital, Frankfurt, Germany;

name: University Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, University Paris Diderot, Paris, France;

name: Department of Medicine, Section of Hematology, Verona University, Verona, Italy;

name: University Hospital Regensburg, Regensburg, Germany;

name: Université Catholique de Louvain, CHU UCL Namur (Godinne), Yvoir, Belgium;

name: University Hospital and Comprehensive Cancer Center Tübingen, Universitätsklinikum Tübingen, Tübingen, Germany;

name: Department of Hematology and Oncology, Medizinische Hochschule, Hannover, Germany;

name: Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany;

name: Klinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Kiel, Germany;

name: Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium;

name: Amgen Research (Munich), GmbH, Munich, Germany;

ReferenceCitation: Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE(®)) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.

title: Blinatumomab, a Bispecific T-cell Engager (BiTE®) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications

location_country:
Italy
Austria
Netherlands
France
Poland
Romania
Belgium
Russian Federation
Spain
Germany
United Kingdom

location_facility: 1213 - Centre Hospitalier Universitaire de Nice

location_facility: 1001 - Julius-Maximilians-Universität Würzburg

location_facility: 1402 - Complexo Hospitalario Universitario A Coruña

location_facility: 1405 - Hospital Universitari Son Espases

location_facility: 2106 - Institutul Oncologic "Prof. Dr. I. Chiricuta"

location_facility: 1905 - Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: 1010 - Klinikum der Universität München - Großhadern

location_facility: 1003 - Universitätsklinikum Schleswig-Holstein

location_facility: 1312 - Azienda Ospedaliera Universitaria San Martino

location_facility: 1401 - ICO Hospital Germans Trias I Pujol

location_facility: 1404 - Hospital Clínic Servei d´Hematologia

location_facility: 1314 - Azienda Ospedaliera Spedali Civili Brescia

location_facility: 1202 - CHU de Bordeaux - Hôpital Haut Lévêque

location_facility: 1310 - Fondazione Policlinico Tor Vergata

location_facility: 1407 - Unidad de Citogenética Oncológica

location_facility: 1315 - Azienda Ospedaliero-Universitaria S. Giovanni Battista (Le Molinette)

location_facility: 2101 - Institutul Clinic Fundeni, Hematologie II

location_facility: 1308 - Ospedali Riuniti "Villa Sofia-Cervello"

location_facility: 2102 - Spitalul Clinic Coltea, Hematologie

location_facility: 1607 - Nottingham City Hospital NHS Trust

location_facility: 1309 - Azienda Ospedaliera Antonio Cardarelli

location_facility: 1502 - Cliniques Universitaires de Saint-Luc

location_facility: 1406 - Hospital Universitari i Politècnic La Fe de Valencia

location_facility: 1303 - Istituto di Ematologia "L.& A.Seràgnoli" Azienda

location_facility: 1501 - Cliniques Universitaires UCL de Mont Godinne

location_facility: 1901 - Klinika Hematologii - Instytut Hematologii i Transfuzjologii

location_facility: 2001 - Russian Hematology Research Center

location_facility: 1022 - Universitätsklinkum Carl Gustav Carus Dresden

title: A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)

summary: The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.


title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

summary: The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

ReferenceCitation: Vieta E, Thase ME, Naber D, D'Souza B, Rancans E, Lepola U, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. Eur Neuropsychopharmacol. 2014 Apr;24(4):564-74. doi: 10.1016/j.euroneuro.2013.12.008. Epub 2013 Dec 21.

family: Vieta

full_name: Eduard Vieta

given: Eduard

family: Thase

full_name: Michael E. Thase

given: Michael E.

family: Naber

full_name: Dieter Naber

given: Dieter

family: D’Souza

full_name: Bernadette D’Souza

given: Bernadette

family: Rancans

full_name: Elmars Rancans

given: Elmars

family: Lepola

full_name: Ulla Lepola

given: Ulla

family: Olausson

full_name: Bengt Olausson

given: Bengt

family: Szamosi

full_name: Johan Szamosi

given: Johan

family: Wilson

full_name: Ellis Wilson

given: Ellis

family: Hosford

full_name: David Hosford

given: David

family: Dunbar

full_name: Geoffrey Dunbar

given: Geoffrey

family: Tummala

full_name: Raj Tummala

given: Raj

family: Eriksson

full_name: Hans Eriksson

given: Hans

journal_name: European Neuropsychopharmacology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: AstraZeneca

location_country:
Sweden
Finland
France
Poland
Lithuania
Hungary
Latvia
Estonia
Germany
Czech Republic


ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Yamaguchi K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Omuro Y, Tamura T, Piao Y, Homma G, Jen MH, Liepa AM, Muro K. Quality of Life Associated with Ramucirumab Treatment in Patients with Advanced Gastric Cancer in Japan: Exploratory Analysis from the Phase III RAINBOW Trial. Clin Drug Investig. 2021 Jan;41(1):53-64. doi: 10.1007/s40261-020-00979-3. Epub 2020 Dec 23.

family: Yamaguchi

full_name: Kensei Yamaguchi

given: Kensei

family: Shimada

full_name: Yasuhiro Shimada

given: Yasuhiro

family: Hironaka

full_name: Shuichi Hironaka

given: Shuichi

family: Sugimoto

full_name: Naotoshi Sugimoto

given: Naotoshi

family: Komatsu

full_name: Yoshito Komatsu

given: Yoshito

family: Nishina

full_name: Tomohiro Nishina

given: Tomohiro

family: Omuro

full_name: Yasushi Omuro

given: Yasushi

family: Tamura

full_name: Takao Tamura

given: Takao

family: Piao

full_name: Yongzhe Piao

given: Yongzhe

family: Homma

full_name: Gosuke Homma

given: Gosuke

family: Jen

full_name: Min-Hua Jen

given: Min-Hua

family: Liepa

full_name: Astra M. Liepa

given: Astra M.

family: Muro

full_name: Kei Muro

given: Kei

journal_name: Clinical Drug Investigation

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Cascinu S, Bodoky G, Muro K, Van Cutsem E, Oh SC, Folprecht G, Ananda S, Girotto G, Wainberg ZA, Miron MLL, Ajani J, Wei R, Liepa AM, Carlesi R, Emig M, Ohtsu A. Tumor Response and Symptom Palliation from RAINBOW, a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer. Oncologist. 2021 Mar;26(3):e414-e424. doi: 10.1002/onco.13623. Epub 2020 Dec 23.

name: Department of Oncology and Hematology, Modena University Hospital, University of Modena and Reggio Emilia  Modena Italy

family: Cascinu

full_name: Stefano Cascinu

given: Stefano

name: Department of Oncology, St. Laszlo Hospital  Budapest Hungary

family: Bodoky

full_name: György Bodoky

given: György

name: Aichi Cancer Center Hospital  Aichi Japan

name: Gastroenterology/Digestive Oncology, University Hospitals Gasthuisberg Leuven and KULeuven  Leuven Belgium

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

name: Korea University Guro Hospital  Seoul Republic Of Korea

family: Oh

full_name: Sang Cheul Oh

given: Sang Cheul

name: Universitätsklinikum Carl Gustav Carus  Dresden Germany

family: Folprecht

full_name: Gunnar Folprecht

given: Gunnar

name: Faculdade de Medicina, Hospital de Base  São Paulo Brazil

name: University of California Los Angeles  California USA

name: Hospital Universitario Virgen del Rocío  Sevilla Spain

name: University of Texas MD Anderson Cancer Center  Houston Texas USA

name: Statistics, Eli Lilly and Company  Indianapolis, Indiana USA

name: Oncology, Eli Lilly and Company  Indianapolis, Indiana USA

name: National Cancer Center Hospital East  Chiba Japan

title: Tumor Response and Symptom Palliation from RAINBOW , a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer

ReferenceCitation: De Vita F, Borg C, Farina G, Geva R, Carton I, Cuku H, Wei R, Muro K. Ramucirumab and paclitaxel in patients with gastric cancer and prior trastuzumab: subgroup analysis from RAINBOW study. Future Oncol. 2019 Aug;15(23):2723-2731. doi: 10.2217/fon-2019-0243. Epub 2019 Jun 25. Erratum in: Future Oncol. 2021 Sep;17(25):3409.

name: Division of Medical Oncology, Department of Precision Medicine, University of Campania ‘Luigi Vanvitelli’, Naples, 80138, Italy

name: Department of Medical Oncology, University Hospital of Besançon, Besançon, 25000, France

name: Department of Medical Oncology, Fatebenefratelli Sacco Hospital, Milan, 20121, Italy

name: Oncology Division, Tel Aviv University, Tel Aviv, 6997801, Israel

name: Eli Lilly & Company, Brussels, 1000, Belgium

name: Eli Lilly & Company, Florence, 50019, Italy

name: Eli Lilly & Company, Indianapolis, IN 46285, USA

name: Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, 464-8681, Japan

ReferenceCitation: Chau I, Fuchs CS, Ohtsu A, Barzi A, Liepa AM, Cui ZL, Hsu Y, Al-Batran SE. Association of quality of life with disease characteristics and treatment outcomes in patients with advanced gastric cancer: Exploratory analysis of RAINBOW and REGARD phase III trials. Eur J Cancer. 2019 Jan;107:115-123. doi: 10.1016/j.ejca.2018.11.013. Epub 2018 Dec 14.

ReferenceCitation: Tabernero J, Ohtsu A, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Ajani JA, Tomasek J, Safran H, Chandrawansa K, Hsu Y, Heathman M, Khan A, Ni L, Melemed AS, Gao L, Ferry D, Fuchs CS. Exposure-Response Analyses of Ramucirumab from Two Randomized, Phase III Trials of Second-line Treatment for Advanced Gastric or Gastroesophageal Junction Cancer. Mol Cancer Ther. 2017 Oct;16(10):2215-2222. doi: 10.1158/1535-7163.MCT-16-0895. Epub 2017 Jul 17.

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Al-Batran SE, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov ON, Kim TY, Cunningham D, Rougier P, Muro K, Liepa AM, Chandrawansa K, Emig M, Ohtsu A, Wilke H. Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma. Ann Oncol. 2016 Apr;27(4):673-9. doi: 10.1093/annonc/mdv625. Epub 2016 Jan 7.

ReferenceCitation: Shitara K, Muro K, Shimada Y, Hironaka S, Sugimoto N, Komatsu Y, Nishina T, Yamaguchi K, Segawa Y, Omuro Y, Tamura T, Doi T, Yukisawa S, Yasui H, Nagashima F, Gotoh M, Esaki T, Emig M, Chandrawansa K, Liepa AM, Wilke H, Ichimiya Y, Ohtsu A. Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer. 2016 Jul;19(3):927-38. doi: 10.1007/s10120-015-0559-z. Epub 2015 Oct 28.

ReferenceCitation: Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, Hironaka S, Sugimoto N, Lipatov O, Kim TY, Cunningham D, Rougier P, Komatsu Y, Ajani J, Emig M, Carlesi R, Ferry D, Chandrawansa K, Schwartz JD, Ohtsu A; RAINBOW Study Group. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1224-35. doi: 10.1016/S1470-2045(14)70420-6. Epub 2014 Sep 17.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Lithuania
Poland
Argentina
Korea, Republic of
Chile
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Estonia

title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine

summary: This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.


ReferenceCitation: Naccarelli GV, Bhatt DL, Camm AJ, Le Heuzey JY, Lombardi F, Tamargo J, Martinez JM, Naditch-Brûlé L; ARTEMIS AF Investigators. Evaluation of the Switch From Amiodarone to Dronedarone in Patients With Atrial Fibrillation: Results of the ARTEMIS AF Studies. J Cardiovasc Pharmacol Ther. 2020 Sep;25(5):425-437. doi: 10.1177/1074248420926874. Epub 2020 Jun 5.

name: Division of Cardiology, Heart and Vascular Institute, Penn State University College of Medicine, Hershey, PA, USA

family: Naccarelli

full_name: Gerald V. Naccarelli

given: Gerald V.

name: Brigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

name: Cardiology Clinical Academic Group Molecular & Clinical Sciences Institute, St George’s University of London, London, UK

family: Camm

full_name: A. John Camm

given: A. John

name: Hôpital Européen Georges Pompidou, Université Paris V René Descartes, Paris, France

family: Le Heuzey

full_name: Jean-Yves Le Heuzey

given: Jean-Yves

name: Cardiologia, Fondazione IRCCS Ospedale Maggiore Policlinico, Milan, Italy

name: Department of Clinical Science and Health Community, University of Milan, Milan, Italy

family: Lombardi

full_name: Federico Lombardi

given: Federico

name: Department of Pharmacology and Toxicology, School of Medicine, CIBERCV, University Complutense, Madrid, Spain

family: Tamargo

full_name: Juan Tamargo

given: Juan

family: Martinez

full_name: Jean-Marie Martinez

given: Jean-Marie

family: Naditch-Brûlé

full_name: Lisa Naditch-Brûlé

given: Lisa

journal_name: Journal of Cardiovascular Pharmacology and Therapeutics

evidence: open (via page says license)

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

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

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

version: acceptedVersion

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Sanofi

location_country:
Italy
Austria
Switzerland
Mexico
Netherlands
Spain
Finland
France
Israel
Australia
Portugal
Estonia
Germany
United Kingdom
Korea, Republic of
Taiwan

acronym: ARTEMIS Load

location_facility:
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Investigational Site Number 004
Investigational Site Number 007
Investigational Site Number 756002
Investigational Site Number 380-004
Investigational Site Number 528001

source: euctr

title: A Randomized, International, Multi-center, Open-label Study to Document Optimal Timing of Initiation of Dronedarone Treatment After Conversion With Loading Dose of Amiodarone in Patients With Persistent Atrial Fibrillation Requiring Conversion of AF.

summary:
Primary Objective:

- Evaluate the rate of Atrial Fibrillation (AF) recurrences one month after randomization according to different timings of initiation of dronedarone.

Secondary Objective:

Evaluate the rate of AF recurrences two months after randomization.
Assess the safety of the change from amiodarone to dronedarone
Assess dronedarone safety
Explore dronedarone and its active metabolite plasma level (in a subset of countries)
Explore potential Pharmacokinetic (PK) interaction between dronedarone and amiodarone (in a subset of countries)


ReferenceCitation: Colao A, Bronstein MD, Brue T, De Marinis L, Fleseriu M, Guitelman M, Raverot G, Shimon I, Fleck J, Gupta P, Pedroncelli AM, Gadelha MR. Pasireotide for acromegaly: long-term outcomes from an extension to the Phase III PAOLA study. Eur J Endocrinol. 2020 Jun;182(6):583. doi: 10.1530/EJE-19-0762.

name: 1Università Federico II di Napoli, Naples, Italy

family: Colao

full_name: Annamaria Colao

given: Annamaria

name: 2University of São Paulo Medical School, São Paulo, Brazil

family: Bronstein

full_name: Marcello D Bronstein

given: Marcello D

name: 3Aix-Marseille Université, Institut National de la Santé et de la Recherche Médicale INSERM U1251, Marseille Medical Genetics and Assistance Publique Hôpitaux de Marseille (APHM), Hôpital de la Conception, Marseille, France

family: Brue

full_name: Thierry Brue

given: Thierry

name: 4Università Cattolica del Sacro Cuore, Rome, Italy

family: De Marinis

full_name: Laura De Marinis

given: Laura

name: 5Northwest Pituitary Center, Oregon Health & Science University, Portland, Oregon, USA

family: Fleseriu

full_name: Maria Fleseriu

given: Maria

name: 6Endocrinology Division, Carlos G Durand Hospital, Buenos Aires, Argentina

family: Guitelman

full_name: Mirtha Guitelman

given: Mirtha

name: 7Groupement Hospitalier Est, Hospices Civils de Lyon and Lyon 1 University, Lyon, France

family: Raverot

full_name: Gerald Raverot

given: Gerald

name: 8Rabin Medical Center and Sackler School of Medicine, Tel-Aviv University, Petah-Tiqva, Israel

family: Shimon

full_name: Ilan Shimon

given: Ilan

family: Fleck

full_name: Jürgen Fleck

given: Jürgen

name: 10Novartis Healthcare Private Limited, Hyderabad, India

family: Gupta

full_name: Pritam Gupta

given: Pritam

family: Pedroncelli

full_name: Alberto M Pedroncelli

given: Alberto M

name: 11Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil

family: Gadelha

full_name: Mônica R Gadelha

given: Mônica R

journal_name: European Journal of Endocrinology

repository_institution: PubMed Central - Europe PMC

publisher: Bioscientifica

publisher_dissemination: Bioscientifica

publisher_group: Bioscientifica

publisher_normalized: Bioscientifica

ReferenceCitation: Gadelha MR, Bronstein MD, Brue T, Coculescu M, Fleseriu M, Guitelman M, Pronin V, Raverot G, Shimon I, Lievre KK, Fleck J, Aout M, Pedroncelli AM, Colao A; Pasireotide C2402 Study Group. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2014 Nov;2(11):875-84. doi: 10.1016/S2213-8587(14)70169-X. Epub 2014 Sep 24.

family: Coculescu

full_name: Mihail Coculescu

given: Mihail

location_country:
Italy
United States
Brazil
Saudi Arabia
Germany
France
Poland
Israel
Norway
Romania
Belgium
Argentina
Russian Federation
Spain
Turkey
Canada
United Kingdom
Colombia

location_facility: University of Texas Southwestern Medical Center Division of Hematology/Oncolog

location_facility: Swedish Neuroscience Institute 550 17th Avenue, Suite 500

title: A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acromegaly

summary: This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.


title: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients With Type 2 Diabetes

acronym: SAVOR- TIMI 53

summary: The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

ReferenceCitation: Cavallari I, Bhatt DL, Steg PG, Leiter LA, McGuire DK, Mosenzon O, Im K, Raz I, Braunwald E, Scirica BM. Causes and Risk Factors for Death in Diabetes: A Competing-Risk Analysis From the SAVOR-TIMI 53 Trial. J Am Coll Cardiol. 2021 Apr 13;77(14):1837-1840. doi: 10.1016/j.jacc.2021.02.030.

family: Cavallari

full_name: Ilaria Cavallari

given: Ilaria

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

family: Steg

full_name: Ph. Gabriel Steg

given: Ph. Gabriel

family: Leiter

full_name: Lawrence A. Leiter

given: Lawrence A.

family: McGuire

full_name: Darren K. McGuire

given: Darren K.

family: Mosenzon

full_name: Ofri Mosenzon

given: Ofri

family: Im

full_name: Kyungah Im

given: Kyungah

family: Raz

full_name: Itamar Raz

given: Itamar

family: Braunwald

full_name: Eugene Braunwald

given: Eugene

family: Scirica

full_name: Benjamin M. Scirica

given: Benjamin M.

journal_name: Journal of the American College of Cardiology

title: Causes and Risk Factors for Death in Diabetes

ReferenceCitation: Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.

name: TIMI Study Group, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA (D.D.B., S.D.W., B.M.S., Y.G., S.A.M., D.L.B., E.B., M.S.S.).

family: Berg

full_name: David D. Berg

given: David D.

family: Wiviott

full_name: Stephen D. Wiviott

given: Stephen D.

family: Gurmu

full_name: Yared Gurmu

given: Yared

name: Hadassah Hebrew University Hospital, Jerusalem, Israel (O.M., I.R.).

family: Murphy

full_name: Sabina A. Murphy

given: Sabina A.

name: Li Ka Shing Knowledge Institute, St Michael’s Hospital, University of Toronto, Canada (L.A.L.).

name: University of Liverpool, United Kingdom (J.P.H.W.).

family: Wilding

full_name: John P.H. Wilding

given: John P.H.

name: AstraZeneca, Gothenburg, Sweden (P.J., P.A.J., A.M.L.).

family: Johanson

full_name: Per Johanson

given: Per

ReferenceCitation: Bergmark BA, Bhatt DL, McGuire DK, Cahn A, Mosenzon O, Steg PG, Im K, Kanevsky E, Gurmu Y, Raz I, Braunwald E, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Metformin Use and Clinical Outcomes Among Patients With Diabetes Mellitus With or Without Heart Failure or Kidney Dysfunction: Observations From the SAVOR-TIMI 53 Trial. Circulation. 2019 Sep 17;140(12):1004-1014. doi: 10.1161/CIRCULATIONAHA.119.040144. Epub 2019 Jul 31.

name: Thrombolysis in Myocardial Infarction (TIMI) Study Group (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women’s Hospital and Harvard Medical School, Boston, MA.

name: Cardiovascular Division, Heart and Vascular Center (B.A.B., D.L.B., K.I., E.K., Y.G., E.B., B.M.S.), Brigham and Women’s Hospital and Harvard Medical School, Boston, MA.

name: Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas (D.K.M.).

name: Diabetes Unit, Division of Internal Medicine, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (A.C., O.M., I.R.).

name: FACT (French Alliance for Cardiovascular Clinical Trials), Département Hospitalo-Universitaire FIRE (Fibrosis, Inflammation, Remodelling), Université de Paris, Sorbonne Paris-Cité, France (P.G.S.).

name: Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, France (P.G.S.).

name: National Heart and Lung Institute, Imperial College, Royal Brompton Hospital, London, UK (P.G.S.).

name: On behalf of the SAVOR-TIMI 53 Steering Committee and Investigators

ReferenceCitation: Scirica BM, Mosenzon O, Bhatt DL, Udell JA, Steg PG, McGuire DK, Im K, Kanevsky E, Stahre C, Sjöstrand M, Raz I, Braunwald E. Cardiovascular Outcomes According to Urinary Albumin and Kidney Disease in Patients With Type 2 Diabetes at High Cardiovascular Risk: Observations From the SAVOR-TIMI 53 Trial. JAMA Cardiol. 2018 Feb 1;3(2):155-163. doi: 10.1001/jamacardio.2017.4228.

name: Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

name: Diabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel

name: Département Hospitalo-Universitaire Fibrosis, Inflammation and REmodeling, INSERM U-1148, Université Paris-Diderot, Hôpital Bichat, Assistance Publique–Hôpitaux de Paris, Paris, France

name: National Heart and Lung Institute, Imperial College, Institute of Cardiovascular Medicine and Sciences, Royal Brompton Hospital, London, United Kingdom

ReferenceCitation: Xia C, Goud A, D'Souza J, Dahagam C, Rao X, Rajagopalan S, Zhong J. DPP4 inhibitors and cardiovascular outcomes: safety on heart failure. Heart Fail Rev. 2017 May;22(3):299-304. doi: 10.1007/s10741-017-9617-4. Review.

ReferenceCitation: Mosenzon O, Leibowitz G, Bhatt DL, Cahn A, Hirshberg B, Wei C, Im K, Rozenberg A, Yanuv I, Stahre C, Ray KK, Iqbal N, Braunwald E, Scirica BM, Raz I. Effect of Saxagliptin on Renal Outcomes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2017 Jan;40(1):69-76. doi: 10.2337/dc16-0621. Epub 2016 Oct 17.

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Raz I, Cavender MA, Im K, Mosenzon O, Udell JA, Hirshberg B, Pollack PS, Steg PG, Jarolim P, Morrow DA. Prognostic Implications of Biomarker Assessments in Patients With Type 2 Diabetes at High Cardiovascular Risk: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2016 Dec 1;1(9):989-998. doi: 10.1001/jamacardio.2016.3030.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

name: Women’s College Research Institute and Cardiovascular Division, Department of Medicine, Women’s College Hospital, Toronto, Ontario, Canada4Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada

name: AstraZeneca Research and Development, Gaithersburg, Maryland

name: National Heart and Lung Institute, Imperial College, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, London, England7INSERM U-1148, Département Hospitalo-Universitaire FIRE (Fibrosis-Inflammation-Remodelling), Université Paris-Diderot, Paris, France8Hôpital Bichat, Assistance Publique–Hôpitaux de Paris, Paris, France

name: Department of Pathology, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts

ReferenceCitation: Cavender MA, Scirica BM, Raz I, Steg PG, McGuire DK, Leiter LA, Hirshberg B, Davidson J, Cahn A, Mosenzon O, Im K, Braunwald E, Bhatt DL. Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c. Am J Med. 2016 Mar;129(3):340.e1-8. doi: 10.1016/j.amjmed.2015.09.022. Epub 2015 Oct 31.

ReferenceCitation: Mosenzon O, Wei C, Davidson J, Scirica BM, Yanuv I, Rozenberg A, Hirshberg B, Cahn A, Stahre C, Strojek K, Bhatt DL, Raz I. Incidence of Fractures in Patients With Type 2 Diabetes in the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Nov;38(11):2142-50. doi: 10.2337/dc15-1068. Epub 2015 Sep 10.

ReferenceCitation: Leiter LA, Teoh H, Braunwald E, Mosenzon O, Cahn A, Kumar KM, Smahelova A, Hirshberg B, Stahre C, Frederich R, Bonnici F, Scirica BM, Bhatt DL, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial. Diabetes Care. 2015 Jun;38(6):1145-53. doi: 10.2337/dc14-2868. Epub 2015 Mar 10.

title: Efficacy and Safety of Saxagliptin in Older Participants in the SAVOR-TIMI 53 Trial

ReferenceCitation: Udell JA, Bhatt DL, Braunwald E, Cavender MA, Mosenzon O, Steg PG, Davidson JA, Nicolau JC, Corbalan R, Hirshberg B, Frederich R, Im K, Umez-Eronini AA, He P, McGuire DK, Leiter LA, Raz I, Scirica BM; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial. Diabetes Care. 2015 Apr;38(4):696-705. doi: 10.2337/dc14-1850. Epub 2014 Dec 31.

name: for the SAVOR-TIMI 53 Steering Committee and Investigators

title: Saxagliptin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Moderate or Severe Renal Impairment: Observations From the SAVOR-TIMI 53 Trial

ReferenceCitation: Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, Udell JA, Mosenzon O, Im K, Umez-Eronini AA, Pollack PS, Hirshberg B, Frederich R, Lewis BS, McGuire DK, Davidson J, Steg PG, Bhatt DL; SAVOR-TIMI 53 Steering Committee and Investigators*. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial. Circulation. 2014 Oct 28;130(18):1579-88. doi: 10.1161/CIRCULATIONAHA.114.010389. Epub 2014 Sep 4. Erratum in: Circulation. 2015 Oct 13;132(15):e198.

name: From the Thrombolysis in Myocardial Infarction (TIMI) Study Group, Cardiovascular Division (B.M.S., E.B., M.A.C., D.A.M., K.I., A.A.U.-E., D.L.B.) and Department of Pathology (P.J.), Brigham and Women’s Hospital and Harvard Medical School, Boston, MA; Diabetes Unit (I.R., O.M.), Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel; Cardiovascular Division (J.A.U.), Women’s College Hospital and Toronto General Hospital, University of Toronto, Toronto, Canada;...

title: Heart Failure, Saxagliptin, and Diabetes Mellitus: Observations from the SAVOR-TIMI 53 Randomized Trial

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Frederich R, Wiviott SD, Hoffman EB, Cavender MA, Udell JA, Desai NR, Mosenzon O, McGuire DK, Ray KK, Leiter LA, Raz I; SAVOR-TIMI 53 Steering Committee and Investigators. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-26. doi: 10.1056/NEJMoa1307684. Epub 2013 Sep 2.

repository_institution: The University of Queensland - Queensland's institutional digital repository

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

title: Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus

ReferenceCitation: Mosenzon O, Raz I, Scirica BM, Hirshberg B, Stahre CI, Steg PG, Davidson J, Ohman P, Price DL, Frederich B, Udell JA, Braunwald E, Bhatt DL. Baseline characteristics of the patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI 53 trial. Diabetes Metab Res Rev. 2013 Jul;29(5):417-26. doi: 10.1002/dmrr.2413. Epub 2013 May 21.

name: Diabetes Unit, Department of Medicine; Hadassah University Hospital; Jerusalem; Israel

name: TIMI Study Group, Cardiovascular Division; Brigham and Women's Hospital and Harvard Medical School; Boston; MA; USA

name: AstraZeneca Research and Development; Wilmington; DE; USA

name: AstraZeneca Research and Development; Mölndal; Sweden

name: Université Paris-Diderot, Sorbonne Paris-Cité, INSERM U-698, CHU Bichat, AP-HP; Paris; France

name: Division of Endocrinology, Department of Internal Medicine; University of Texas Southwestern Medical School; Dallas; TX; USA

name: Bristol-Myers Squibb; Princeton; NJ; USA

journal_name: Diabetes/Metabolism Research and Reviews

ReferenceCitation: Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, Ohman P, Price DL, Chen R, Udell J, Raz I. The design and rationale of the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study. Am Heart J. 2011 Nov;162(5):818-825.e6. doi: 10.1016/j.ahj.2011.08.006.

title: The design and rationale of the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus–Thrombolysis in Myocardial Infarction (SAVOR-TIMI) 53 Study

location_country:
Peru
Australia
Russian Federation
Czech Republic
Taiwan
India
France
Poland
Thailand
Argentina
Canada
South Africa
Chile
Sweden
Hong Kong
Netherlands
Hungary
Puerto Rico
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
Spain


ReferenceType: result

ReferenceCitation: Grothey A, Van Cutsem E, Sobrero A, Siena S, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Tabernero J, Yoshino T, Lenz HJ, Goldberg RM, Sargent DJ, Cihon F, Cupit L, Wagner A, Laurent D; CORRECT Study Group. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2013 Jan 26;381(9863):303-12. doi: 10.1016/S0140-6736(12)61900-X. Epub 2012 Nov 22.

family: Grothey

full_name: Axel Grothey

given: Axel

family: Cutsem

full_name: Eric Van Cutsem

given: Eric Van

family: Sobrero

full_name: Alberto Sobrero

given: Alberto

family: Siena

full_name: Salvatore Siena

given: Salvatore

family: Falcone

full_name: Alfredo Falcone

given: Alfredo

family: Ychou

full_name: Marc Ychou

given: Marc

family: Humblet

full_name: Yves Humblet

given: Yves

family: Bouché

full_name: Olivier Bouché

given: Olivier

family: Mineur

full_name: Laurent Mineur

given: Laurent

family: Barone

full_name: Carlo Barone

given: Carlo

family: Adenis

full_name: Antoine Adenis

given: Antoine

family: Tabernero

full_name: Josep Tabernero

given: Josep

family: Yoshino

full_name: Takayuki Yoshino

given: Takayuki

family: Lenz

full_name: Heinz-Josef Lenz

given: Heinz-Josef

family: Goldberg

full_name: Richard M Goldberg

given: Richard M

family: Sargent

full_name: Daniel J Sargent

given: Daniel J

family: Cihon

full_name: Frank Cihon

given: Frank

family: Cupit

full_name: Lisa Cupit

given: Lisa

family: Wagner

full_name: Andrea Wagner

given: Andrea

family: Laurent

full_name: Dirk Laurent

given: Dirk

journal_name: The Lancet

ReferenceCitation: Mross K, Frost A, Steinbild S, Hedbom S, Büchert M, Fasol U, Unger C, Krätzschmar J, Heinig R, Boix O, Christensen O. A phase I dose-escalation study of regorafenib (BAY 73-4506), an inhibitor of oncogenic, angiogenic, and stromal kinases, in patients with advanced solid tumors. Clin Cancer Res. 2012 May 1;18(9):2658-67. doi: 10.1158/1078-0432.CCR-11-1900. Epub 2012 Mar 15.

family: Mross

full_name: Klaus Mross

given: Klaus

family: Frost

full_name: Annette Frost

given: Annette

family: Steinbild

publisher_group: American Association for Cancer Research

title: A Phase I Dose–Escalation Study of Regorafenib (BAY 73–4506), an Inhibitor of Oncogenic, Angiogenic, and Stromal Kinases, in Patients with Advanced Solid Tumors

ReferenceCitation: Tabernero J, Lenz HJ, Siena S, Sobrero A, Falcone A, Ychou M, Humblet Y, Bouché O, Mineur L, Barone C, Adenis A, Yoshino T, Goldberg RM, Sargent DJ, Wagner A, Laurent D, Teufel M, Jeffers M, Grothey A, Van Cutsem E. Analysis of circulating DNA and protein biomarkers to predict the clinical activity of regorafenib and assess prognosis in patients with metastatic colorectal cancer: a retrospective, exploratory analysis of the CORRECT trial. Lancet Oncol. 2015 Aug;16(8):937-48. doi: 10.1016/S1470-2045(15)00138-2. Epub 2015 Jul 13.

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

location_country:
Italy
Brazil
Switzerland
Netherlands
Spain
Germany
France
Japan
Israel
Hungary
Belgium
Argentina
Australia
China
Turkey
United States
Czech Republic
Canada
Portugal

title: A Randomized, Double-blind, Placebo-controlled Phase III Study of Regorafenib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

summary: This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC


title: Long-term Follow-up of Participants From Studies Evaluating the HIV Vaccine 732462

summary:
The purpose of this long-term follow-up study is to assess the long-term health status of HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the investigational HIV vaccine 732462. This study will provide additional data concerning the long-term benefits/risks associated with vaccination.

No vaccine will be administered during the study period. Vaccines were administered during the primary studies.

primary_purpose: Other

ReferenceCitation: Harrer T, Dinges W, Roman F; TH-HIV-011 study group. Long-term follow-up of HIV-1-infected adults who received the F4/AS01(B) HIV-1 vaccine candidate in two randomised controlled trials. Vaccine. 2018 May 3;36(19):2683-2686. doi: 10.1016/j.vaccine.2018.03.043. Epub 2018 Mar 30.

family: Harrer

full_name: Thomas Harrer

given: Thomas

family: Dinges

full_name: Warren Dinges

given: Warren

family: Roman

full_name: François Roman

given: François

journal_name: Vaccine

title: Long-term follow-up of HIV-1-infected adults who received the F4/AS01 B HIV-1 vaccine candidate in two randomised controlled trials

intervention_type: Procedure


type: Other Identifier

title: Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

acronym: ECLIPSE

summary:
To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

location_country:
Italy
United States
Luxembourg
Netherlands
Germany
France
Poland
Israel
Romania
Hungary
Belgium
Spain
Canada
United Kingdom

location_facility:
Investigational Site Number 376003
Investigational Site Number 124007
Investigational Site Number 250005
Investigational Site Number 642004
Investigational Site Number 840106
Investigational Site Number 840216
Investigational Site Number 840327
Investigational Site Number 840103
Investigational Site Number 616002
Investigational Site Number 840329
Investigational Site Number 840319
Investigational Site Number 840316
Investigational Site Number 616008
Investigational Site Number 724001
Investigational Site Number 724010
Investigational Site Number 276006
Investigational Site Number 840208
Investigational Site Number 840348
Investigational Site Number 840352
Investigational Site Number 840350
Investigational Site Number 840346
Investigational Site Number 840339
Investigational Site Number 380003
Investigational Site Number 250010
Investigational Site Number 840351
Investigational Site Number 840309
Investigational Site Number 840330
Investigational Site Number 124003
Investigational Site Number 642002
Investigational Site Number 840302
Investigational Site Number 056001
Investigational Site Number 724007
Investigational Site Number 276003
Investigational Site Number 724002
Investigational Site Number 840343
Investigational Site Number 840213
Investigational Site Number 528006
Investigational Site Number 380008
Investigational Site Number 840315
Investigational Site Number 840205
Investigational Site Number 250002
Investigational Site Number 642006
Investigational Site Number 528005
Investigational Site Number 250009
Investigational Site Number 124004
Investigational Site Number 250001
Investigational Site Number 724009
Investigational Site Number 616004
Investigational Site Number 840317
Investigational Site Number 840313
Investigational Site Number 826005
Investigational Site Number 840204
Investigational Site Number 840335
Investigational Site Number 276010
Investigational Site Number 276009
Investigational Site Number 840303
Investigational Site Number 840219
Investigational Site Number 840201
Investigational Site Number 840203
Investigational Site Number 250003
Investigational Site Number 124001
Investigational Site Number 840328
Investigational Site Number 840336
Investigational Site Number 724003
Investigational Site Number 276012
Investigational Site Number 724005
Investigational Site Number 840215
Investigational Site Number 826002
Investigational Site Number 348003
Investigational Site Number 840217
Investigational Site Number 348005
Investigational Site Number 276002
Investigational Site Number 724008
Investigational Site Number 840353
Investigational Site Number 380001
Investigational Site Number 840347
Investigational Site Number 840218
Investigational Site Number 840207
Investigational Site Number 840307
Investigational Site Number 840321
Investigational Site Number 840331
Investigational Site Number 840320
Investigational Site Number 276004
Investigational Site Number 528004
Investigational Site Number 840344
Investigational Site Number 124005
Investigational Site Number 380007
Investigational Site Number 840337
Investigational Site Number 724006
Investigational Site Number 840105
Investigational Site Number 840314
Investigational Site Number 250008
Investigational Site Number 840311
Investigational Site Number 840212
Investigational Site Number 840318
Investigational Site Number 276008
Investigational Site Number 380006
Investigational Site Number 380002
Investigational Site Number 124006
Investigational Site Number 348004
Investigational Site Number 826006
Investigational Site Number 276007
Investigational Site Number 276001
Investigational Site Number 442001
Investigational Site Number 250004
Investigational Site Number 376001
Investigational Site Number 826001
Investigational Site Number 840308
Investigational Site Number 376005
Investigational Site Number 840210
Investigational Site Number 840211
Investigational Site Number 840323
Investigational Site Number 616005
Investigational Site Number 840306
Investigational Site Number 250006
Investigational Site Number 840301
Investigational Site Number 840345
Investigational Site Number 642005
Investigational Site Number 056004
Investigational Site Number 840310
Investigational Site Number 616006
Investigational Site Number 376002
Investigational Site Number 840338
Investigational Site Number 348001
Investigational Site Number 840104
Investigational Site Number 528003
Investigational Site Number 616001
Investigational Site Number 840101
Investigational Site Number 724004
Investigational Site Number 840220
Investigational Site Number 840341
Investigational Site Number 840322
Investigational Site Number 642001
Investigational Site Number 840326
Investigational Site Number 056003
Investigational Site Number 840202
Investigational Site Number 840312
Investigational Site Number 616007
Investigational Site Number 840305
Investigational Site Number 840102
Investigational Site Number 250007
Investigational Site Number 528001


ReferenceType: background

ReferenceCitation: Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819.

ReferenceCitation: Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taïeb A, Léauté-Labrèze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.

ReferenceCitation: Léauté-Labrèze C, Hoeger P, Mazereeuw-Hautier J, Guibaud L, Baselga E, Posiunas G, Phillips RJ, Caceres H, Lopez Gutierrez JC, Ballona R, Friedlander SF, Powell J, Perek D, Metz B, Barbarot S, Maruani A, Szalai ZZ, Krol A, Boccara O, Foelster-Holst R, Febrer Bosch MI, Su J, Buckova H, Torrelo A, Cambazard F, Grantzow R, Wargon O, Wyrzykowski D, Roessler J, Bernabeu-Wittel J, Valencia AM, Przewratil P, Glick S, Pope E, Birchall N, Benjamin L, Mancini AJ, Vabres P, Souteyrand P, Frieden IJ, Berul CI, Mehta CR, Prey S, Boralevi F, Morgan CC, Heritier S, Delarue A, Voisard JJ. A randomized, controlled trial of oral propranolol in infantile hemangioma. N Engl J Med. 2015 Feb 19;372(8):735-46. doi: 10.1056/NEJMoa1404710.

name: The authors' affiliations are listed in the Appendix.

family: Léauté-Labrèze

full_name: Christine Léauté-Labrèze

given: Christine

family: Hoeger

full_name: Peter Hoeger

given: Peter

family: Mazereeuw-Hautier

full_name: Juliette Mazereeuw-Hautier

given: Juliette

family: Guibaud

full_name: Laurent Guibaud

given: Laurent

family: Baselga

full_name: Eulalia Baselga

given: Eulalia

family: Posiunas

full_name: Gintas Posiunas

given: Gintas

family: Phillips

full_name: Roderic J. Phillips

given: Roderic J.

family: Caceres

full_name: Hector Caceres

given: Hector

family: Lopez Gutierrez

full_name: Juan Carlos Lopez Gutierrez

given: Juan Carlos

family: Ballona

full_name: Rosalia Ballona

given: Rosalia

family: Friedlander

full_name: Sheila Fallon Friedlander

given: Sheila Fallon

family: Powell

full_name: Julie Powell

given: Julie

family: Perek

full_name: Danuta Perek

given: Danuta

family: Metz

full_name: Brandie Metz

given: Brandie

family: Barbarot

full_name: Sebastien Barbarot

given: Sebastien

family: Maruani

full_name: Annabel Maruani

given: Annabel

family: Szalai

full_name: Zsuzsanna Zsofia Szalai

given: Zsuzsanna Zsofia

family: Krol

full_name: Alfons Krol

given: Alfons

family: Boccara

full_name: Olivia Boccara

given: Olivia

family: Foelster-Holst

full_name: Regina Foelster-Holst

given: Regina

family: Bosch

full_name: Maria Isabel Bosch

given: Maria Isabel

family: Su

full_name: John Su

given: John

family: Buckova

full_name: Hana Buckova

given: Hana

family: Torrelo

full_name: Antonio Torrelo

given: Antonio

family: Cambazard

title: A Randomized, Controlled Trial of Oral Propranolol in Infantile Hemangioma

location_country:
Italy
United States
Peru
Mexico
Germany
France
Poland
Lithuania
Romania
Hungary
Australia
Russian Federation
New Zealand
Spain
Canada
Czech Republic

location_facility: Spitalul Clinic Urgenta pentru Copii Grigore Alexandrescu

location_facility: Spitalul de Urgenta Copii, Louis Turcanu

location_facility: Spitalul Clinic de Urgenta pentu Copii Sf. Maria

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Department of Pediatric Surgery and Oncology

location_facility: Hopital Robert Debre - Consultation de Dermatologie

location_facility: Medical University - Filatov Pediatric Hospital

location_facility: Klinika Onkologii, Centrum Zdrowia Dziecka

location_facility: Hospital Universitario Infantil Niño Jesús

location_facility: Eastern Clinical Research Unit - Box Hill Hospital

location_facility: Klinika Chirurgii i Urologii Dzieci i Mlodziezy Akademii Medycznej

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Servicio de Dermatologia del Hospital Infantil

title: A Randomised, Controlled, Multidose, Multicentre, Adaptive Phase II/III Study in Infants With Proliferating Infantile Hemangiomas (IHs) Requiring Systemic Therapy to Compare 4 Regimens of Propranolol (1 or 3 mg/kg/Day for 3 or 6 Months) to Placebo (Double Blind).

summary: There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.


type: Registry Identifier

title: A Phase II, Randomized, Double-blind, Controlled Study to Evaluate the Immune Responses, Safety and Clinical Efficacy of Three Doses of Neovacs' TNF-Kinoid in Adult Patients With Rheumatoid Arthritis Who Have Relapsed Despite Anti-TNFα Biological Therapy

summary: The objective of this trial is to demonstrate that active immunization with anti-TNFα kinoid (TNF-K) is able to induce polyclonal anti-TNFα antibodies in RA patients who were previously treated with anti-TNFα mAb but have lost susceptibility to therapy.

ReferenceCitation: Durez P, Vandepapeliere P, Miranda P, Toncheva A, Berman A, Kehler T, Mociran E, Fautrel B, Mariette X, Dhellin O, Fanget B, Ouary S, Grouard-Vogel G, Boissier MC. Therapeutic vaccination with TNF-Kinoid in TNF antagonist-resistant rheumatoid arthritis: a phase II randomized, controlled clinical trial. PLoS One. 2014 Dec 17;9(12):e113465. doi: 10.1371/journal.pone.0113465. eCollection 2014.

family: Durez

full_name: Patrick Durez

given: Patrick

family: Vandepapeliere

full_name: Pierre Vandepapeliere

given: Pierre

family: Miranda

full_name: Pedro Miranda

given: Pedro

family: Toncheva

full_name: Antoaneta Toncheva

given: Antoaneta

family: Berman

full_name: Alberto Berman

given: Alberto

family: Kehler

full_name: Tatjana Kehler

given: Tatjana

family: Mociran

full_name: Eugenia Mociran

given: Eugenia

family: Fautrel

full_name: Bruno Fautrel

given: Bruno

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Dhellin

full_name: Olivier Dhellin

given: Olivier

family: Fanget

full_name: Bernard Fanget

given: Bernard

family: Ouary

full_name: Stephane Ouary

given: Stephane

family: Grouard-Vogel

full_name: Géraldine Grouard-Vogel

given: Géraldine

family: Boissier

full_name: Marie-Christophe Boissier

given: Marie-Christophe

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: PLoS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Sorbonne Paris Nord

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

title: Therapeutic Vaccination with TNF-Kinoid in TNF Antagonist-Resistant Rheumatoid Arthritis: A Phase II Randomized, Controlled Clinical Trial

location_country: Chile Croatia Bulgaria France Romania Belgium Argentina

location_facility: "Dr. Constantin Opris" Emergency County Hospital Baia Mare

location_facility: "Sociedad Médica del Aparato Locomotor SA"

location_facility: Hôpital Bicêtre, Université Paris-Sud 11, INSERM U802

location_facility: Universitaires Cliniques St. Luc (Mont-Godinne)

location_facility: Centro de Estudios Reumatológicos- Estudios Clínicos Limitada"

location_facility: National Multiprofile Transport Hospital "Tzar Boris III"

location_facility: Centro de Investigaciones Reumatologicas

location_facility: University Hospital for Active Treatment "Sveti Ivan Rilski"

location_facility: Universiteit ZiekenHuis Katholiek Universiteit Leuven

location_facility: Centro especializado en Investigaciones Medicas (CEIM)


title: An Open-label, Multi-center, Single Arm Study to Evaluate the Safety and Tolerability of Intravenous Zanamivir in the Treatment of Hospitalized Adult, Adolescent and Pediatric Subjects With Confirmed Influenza Infection

summary: The purpose of this study is to determine whether zanamivir aqueous solution given by intravenous injection is safe in treating hospitalized patients with confirmed influenza infection. A single arm open-label design has been selected to achieve the primary objective of providing regulatory authorities with safety data on IV zanamivir.

ReferenceCitation: Marty FM, Man CY, van der Horst C, Francois B, Garot D, Mánez R, Thamlikitkul V, Lorente JA, Alvarez-Lerma F, Brealey D, Zhao HH, Weller S, Yates PJ, Peppercorn AF. Safety and pharmacokinetics of intravenous zanamivir treatment in hospitalized adults with influenza: an open-label, multicenter, single-arm, phase II study. J Infect Dis. 2014 Feb 15;209(4):542-50. doi: 10.1093/infdis/jit467. Epub 2013 Aug 27.

family: Marty

full_name: F. M. Marty

given: F. M.

family: Man

full_name: C. Y. Man

given: C. Y.

family: van der Horst

full_name: C. van der Horst

given: C.

family: Francois

full_name: B. Francois

given: B.

family: Garot

full_name: D. Garot

given: D.

family: Manez

full_name: R. Manez

given: R.

family: Thamlikitkul

full_name: V. Thamlikitkul

given: V.

family: Lorente

full_name: J. A. Lorente

given: J. A.

family: Alvarez-Lerma

full_name: F. Alvarez-Lerma

given: F.

family: Brealey

full_name: D. Brealey

family: Zhao

full_name: H. H. Zhao

given: H. H.

family: Weller

full_name: S. Weller

given: S.

family: Yates

full_name: P. J. Yates

given: P. J.

family: Peppercorn

full_name: A. F. Peppercorn

given: A. F.

journal_name: Journal of Infectious Diseases

evidence: open (via free pdf)

license: implied-oa

license_normalized: implied-oa

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repository_institution: Universidad Europea - ABACUS. Repositorio de Producción Científica

version: submittedVersion

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

title: Safety and Pharmacokinetics of Intravenous Zanamivir Treatment in Hospitalized Adults With Influenza: An Open-label, Multicenter, Single-Arm, Phase II Study

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Brazil
United States
South Africa
Hong Kong
France
Japan
Thailand
Norway
Australia
Russian Federation
Spain
Canada
United Kingdom


ReferenceCitation: Ascierto PA, Ribas A, Larkin J, McArthur GA, Lewis KD, Hauschild A, Flaherty KT, McKenna E, Zhu Q, Mun Y, Dréno B. Impact of initial treatment and prognostic factors on postprogression survival in BRAF-mutated metastatic melanoma treated with dacarbazine or vemurafenib ± cobimetinib: a pooled analysis of four clinical trials. J Transl Med. 2020 Aug 3;18(1):294. doi: 10.1186/s12967-020-02458-x.

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

family: Ribas

full_name: Antoni Ribas

given: Antoni

family: Larkin

full_name: James Larkin

given: James

family: McArthur

full_name: Grant A. McArthur

given: Grant A.

family: Lewis

full_name: Karl D. Lewis

given: Karl D.

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Flaherty

full_name: Keith T. Flaherty

given: Keith T.

family: McKenna

full_name: Edward McKenna

given: Edward

family: Zhu

full_name: Qian Zhu

given: Qian

family: Mun

full_name: Yong Mun

given: Yong

family: Dréno

full_name: Brigitte Dréno

given: Brigitte

currency_apc_doaj: GBP

journal_name: Journal of Translational Medicine

repository_institution: University of Melbourne - Minerva Access

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

ReferenceCitation: Chapman PB, Robert C, Larkin J, Haanen JB, Ribas A, Hogg D, Hamid O, Ascierto PA, Testori A, Lorigan PC, Dummer R, Sosman JA, Flaherty KT, Chang I, Coleman S, Caro I, Hauschild A, McArthur GA. Vemurafenib in patients with BRAFV600 mutation-positive metastatic melanoma: final overall survival results of the randomized BRIM-3 study. Ann Oncol. 2017 Oct 1;28(10):2581-2587. doi: 10.1093/annonc/mdx339.

family: Chapman

full_name: P.B. Chapman

family: Robert

full_name: C. Robert

full_name: J. Larkin

given: J.

family: Haanen

full_name: J.B. Haanen

full_name: A. Ribas

given: A.

family: Hogg

full_name: D. Hogg

family: Hamid

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Yamazaki N, Kiyohara Y, Sugaya N, Uhara H. Phase I/II study of vemurafenib in patients with unresectable or recurrent melanoma with BRAF(V) (600) mutations. J Dermatol. 2015 Jul;42(7):661-6. doi: 10.1111/1346-8138.12873. Epub 2015 Apr 17.

name: Department of Dermatologic Oncology National Cancer Center Hospital TokyoJapan

name: Department of Dermatology Shizuoka Cancer Center ShizuokaJapan

name: Department of Dermatology Shinshu University School of Medicine Nagano Japan

title: Phase I/ II study of vemurafenib in patients with unresectable or recurrent melanoma with BRAF V 600 mutations

ReferenceCitation: Frederick DT, Salas Fragomeni RA, Schalck A, Ferreiro-Neira I, Hoff T, Cooper ZA, Haq R, Panka DJ, Kwong LN, Davies MA, Cusack JC, Flaherty KT, Fisher DE, Mier JW, Wargo JA, Sullivan RJ. Clinical profiling of BCL-2 family members in the setting of BRAF inhibition offers a rationale for targeting de novo resistance using BH3 mimetics. PLoS One. 2014 Jul 1;9(7):e101286. doi: 10.1371/journal.pone.0101286. eCollection 2014.

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

title: Clinical Profiling of BCL-2 Family Members in the Setting of BRAF Inhibition Offers a Rationale for Targeting De Novo Resistance Using BH3 Mimetics

ReferenceCitation: McArthur GA, Chapman PB, Robert C, Larkin J, Haanen JB, Dummer R, Ribas A, Hogg D, Hamid O, Ascierto PA, Garbe C, Testori A, Maio M, Lorigan P, Lebbé C, Jouary T, Schadendorf D, O'Day SJ, Kirkwood JM, Eggermont AM, Dréno B, Sosman JA, Flaherty KT, Yin M, Caro I, Cheng S, Trunzer K, Hauschild A. Safety and efficacy of vemurafenib in BRAF(V600E) and BRAF(V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study. Lancet Oncol. 2014 Mar;15(3):323-32. doi: 10.1016/S1470-2045(14)70012-9. Epub 2014 Feb 7.

title: Safety and efficacy of vemurafenib in BRAFV600E and BRAFV600K mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomised, open-label study

ReferenceCitation: Lacouture ME, Duvic M, Hauschild A, Prieto VG, Robert C, Schadendorf D, Kim CC, McCormack CJ, Myskowski PL, Spleiss O, Trunzer K, Su F, Nelson B, Nolop KB, Grippo JF, Lee RJ, Klimek MJ, Troy JL, Joe AK. Analysis of dermatologic events in vemurafenib-treated patients with melanoma. Oncologist. 2013;18(3):314-22. doi: 10.1634/theoncologist.2012-0333. Epub 2013 Mar 1.

name: aDepartment of Medicine, Memorial Sloan‐Kettering Cancer Center, New York, New York, USA;

name: bDepartment of Dermatology, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA;

name: cDepartment of Dermatology, University Hospital Schleswig‐Holstein, Campus Kiel, Kiel, Germany;

name: dDepartment of Pathology, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA;

name: eDepartment of Dermatology, Cancer Institute Gustave Roussy, Villejuif, France;

name: fDepartment of Dermatology, University Hospital Essen, Essen, Germany;

name: gDepartment of Dermatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA;

name: hMelanoma and Skin Service Team, Peter Macallum Cancer Institute, East Melbourne, Australia;

name: iDepartment of Medicine, Memorial Sloan‐Kettering Cancer Center, New York, New York, USA;

name: kHoffmann‐La Roche, Nutley, New Jersey, USA;

name: lGenentech, San Francisco, California, USA;

name: nDepartment of Dermatology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA

title: Analysis of Dermatologic Events in Vemurafenib‐Treated Patients With Melanoma

ReferenceCitation: Su F, Viros A, Milagre C, Trunzer K, Bollag G, Spleiss O, Reis-Filho JS, Kong X, Koya RC, Flaherty KT, Chapman PB, Kim MJ, Hayward R, Martin M, Yang H, Wang Q, Hilton H, Hang JS, Noe J, Lambros M, Geyer F, Dhomen N, Niculescu-Duvaz I, Zambon A, Niculescu-Duvaz D, Preece N, Robert L, Otte NJ, Mok S, Kee D, Ma Y, Zhang C, Habets G, Burton EA, Wong B, Nguyen H, Kockx M, Andries L, Lestini B, Nolop KB, Lee RJ, Joe AK, Troy JL, Gonzalez R, Hutson TE, Puzanov I, Chmielowski B, Springer CJ, McArthur GA, Sosman JA, Lo RS, Ribas A, Marais R. RAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitors. N Engl J Med. 2012 Jan 19;366(3):207-15. doi: 10.1056/NEJMoa1105358.

repository_institution: The University of Manchester - Research Explorer

title: RASMutations in Cutaneous Squamous-Cell Carcinomas in Patients Treated with BRAF Inhibitors

ReferenceCitation: Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, Dummer R, Garbe C, Testori A, Maio M, Hogg D, Lorigan P, Lebbe C, Jouary T, Schadendorf D, Ribas A, O'Day SJ, Sosman JA, Kirkwood JM, Eggermont AM, Dreno B, Nolop K, Li J, Nelson B, Hou J, Lee RJ, Flaherty KT, McArthur GA; BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 30;364(26):2507-16. doi: 10.1056/NEJMoa1103782. Epub 2011 Jun 5.

title: Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Germany
France
Israel
Australia
New Zealand
Canada
United Kingdom

title: BRIM 3: A Randomized, Open-Label, Controlled, Multicenter, Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib (RO5185426) or Dacarbazine

summary: This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


ReferenceCitation: Roger SD, Kolmakova E, Fung M, Malecki R, Vinhas J, Dellanna F, Thomas M, Manamley N, Ferenczi S. Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis. Nephrology (Carlton). 2014 May;19(5):266-74. doi: 10.1111/nep.12214.

family: Roger

full_name: Simon D Roger

given: Simon D

name: SEI of High Professional Skills ‘North-west State Medical University n.a. I.I.Mechnikov Roszdrava’; Saint-Petersburg Russia

family: Kolmakova

full_name: Elena Kolmakova

given: Elena

name: Amgen Inc.; Thousand Oaks California USA

family: Fung

full_name: Maple Fung

given: Maple

name: Miedzyleski Szpital Specjalistyczny; Warszawa Poland

family: Malecki

full_name: Robert Malecki

given: Robert

name: Centro Hospitalar de Setubal E.P.E. - Hospital de Sao Bernardo; Setúbal Portugal

family: Vinhas

full_name: José Vinhas

given: José

name: Gemeinschaftspraxis Karlstrasse; Düsseldorf Germany

family: Dellanna

full_name: Frank Dellanna

given: Frank

name: Birmingham Heartlands Hospital; Birmingham UK

family: Thomas

full_name: Mark Thomas

given: Mark

family: Manamley

full_name: Nick Manamley

given: Nick

name: Petz Aladar Megyei Oktato Korhaz; B. Braun Avitum Hungary, No 11 Dialysis Center Gyor Hungary

family: Ferenczi

full_name: Sándor Ferenczi

given: Sándor

journal_name: Nephrology

lead_sponsor: Amgen

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Czech Republic
France
Poland
Slovakia
Slovenia
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Italy
Serbia
Mexico
Israel
Spain
Estonia
Latvia

title: A Multicenter, Randomised, Double-Blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis

summary: The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.


ReferenceCitation: Lorente D, Llacer C, Lozano R, de Velasco G, Romero-Laorden N, Rodrigo M, Sánchez-Iglesias Á, di Capua C, Castro E, Ferrer C, Sánchez-Hernández A, Olmos D. Prognostic Score and Benefit from Abiraterone in First-line Metastatic, Castration-resistant Prostate Cancer. Eur Urol. 2021 Nov;80(5):641-649. doi: 10.1016/j.eururo.2021.07.014. Epub 2021 Aug 6.

family: Lorente

full_name: David Lorente

given: David

family: Llacer

full_name: Casilda Llacer

given: Casilda

family: Lozano

full_name: Rebeca Lozano

given: Rebeca

family: de Velasco

full_name: Guillermo de Velasco

given: Guillermo

family: Romero-Laorden

full_name: Nuria Romero-Laorden

given: Nuria

family: Rodrigo

full_name: Miguel Rodrigo

given: Miguel

family: Sánchez-Iglesias

full_name: Ángel Sánchez-Iglesias

given: Ángel

family: di Capua

full_name: Carlos di Capua

given: Carlos

family: Castro

full_name: Elena Castro

family: Ferrer

full_name: Carlos Ferrer

family: Sánchez-Hernández

full_name: Alfredo Sánchez-Hernández

given: Alfredo

family: Olmos

full_name: David Olmos

journal_name: European Urology

ReferenceCitation: Miller K, Carles J, Gschwend JE, Van Poppel H, Diels J, Brookman-May SD. The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-specific Antigen, and Gleason Score. Eur Urol. 2018 Jul;74(1):17-23. doi: 10.1016/j.eururo.2017.08.035. Epub 2017 Sep 20.

family: Miller

full_name: Kurt Miller

given: Kurt

family: Carles

full_name: Joan Carles

given: Joan

family: Gschwend

full_name: Jürgen E. Gschwend

given: Jürgen E.

family: Van Poppel

full_name: Hendrik Van Poppel

given: Hendrik

family: Diels

full_name: Joris Diels

given: Joris

family: Brookman-May

full_name: Sabine D. Brookman-May

given: Sabine D.

oa_host_type: repository

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

ReferenceCitation: de Bono JS, Smith MR, Saad F, Rathkopf DE, Mulders PFA, Small EJ, Shore ND, Fizazi K, De Porre P, Kheoh T, Li J, Todd MB, Ryan CJ, Flaig TW. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302. Eur Urol. 2017 Apr;71(4):656-664. doi: 10.1016/j.eururo.2016.06.033. Epub 2016 Jul 9.

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

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

ReferenceCitation: Saad F, Shore N, Van Poppel H, Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Griffin TA, De Porre P, Londhe A, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ. Impact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302. Eur Urol. 2015 Oct;68(4):570-7. doi: 10.1016/j.eururo.2015.04.032. Epub 2015 May 16.

title: Impact of Bone-targeted Therapies in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer Patients Treated with Abiraterone Acetate: Post Hoc Analysis of Study COU-AA-302

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

publisher_normalized: American Association for Cancer Research

title: Correlation between Prostate-Specific Antigen Kinetics and Overall Survival in Abiraterone Acetate–Treated Castration-Resistant Prostate Cancer Patients

ReferenceCitation: Morris MJ, Molina A, Small EJ, de Bono JS, Logothetis CJ, Fizazi K, de Souza P, Kantoff PW, Higano CS, Li J, Kheoh T, Larson SM, Matheny SL, Naini V, Burzykowski T, Griffin TW, Scher HI, Ryan CJ. Radiographic progression-free survival as a response biomarker in metastatic castration-resistant prostate cancer: COU-AA-302 results. J Clin Oncol. 2015 Apr 20;33(12):1356-63. doi: 10.1200/JCO.2014.55.3875. Epub 2015 Jan 26.

name: Michael J. Morris, Steven M. Larson, and Howard I. Scher, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY; Arturo Molina, Thian Kheoh, Shannon L. Matheny, Vahid Naini, and Thomas W. Griffin, Janssen Research & Development, Los Angeles; Eric J. Small and Charles J. Ryan, Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA; Johann S. de Bono, Institute for Cancer Research and Royal Marsden Hospital, Sutton, United...

publisher: American Society of Clinical Oncology (ASCO)

title: Radiographic Progression-Free Survival As a Response Biomarker in Metastatic Castration-Resistant Prostate Cancer: COU-AA-302 Results

ReferenceCitation: Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, Miller K, Logothetis CJ, Shore ND, Small EJ, Carles J, Flaig TW, Taplin ME, Higano CS, de Souza P, de Bono JS, Griffin TW, De Porre P, Yu MK, Park YC, Li J, Kheoh T, Naini V, Molina A, Rathkopf DE; COU-AA-302 Investigators. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015 Feb;16(2):152-60. doi: 10.1016/S1470-2045(14)71205-7. Epub 2015 Jan 16.

ReferenceCitation: Attard G, de Bono JS, Logothetis CJ, Fizazi K, Mukherjee SD, Joshua AM, Schrijvers D, van den Eertwegh AJ, Li W, Molina A, Griffin TW, Kheoh T, Ricci DS, Zelinsky K, Rathkopf DE, Scher HI, Ryan CJ. Improvements in Radiographic Progression-Free Survival Stratified by ERG Gene Status in Metastatic Castration-Resistant Prostate Cancer Patients Treated with Abiraterone Acetate. Clin Cancer Res. 2015 Apr 1;21(7):1621-7. doi: 10.1158/1078-0432.CCR-14-1961. Epub 2015 Jan 15.

ReferenceCitation: Aggarwal R, Harris A, Formaker C, Small EJ, Molina A, Griffin TW, Ryan CJ. Response to subsequent docetaxel in a patient cohort with metastatic castration-resistant prostate cancer after abiraterone acetate treatment. Clin Genitourin Cancer. 2014 Oct;12(5):e167-72. doi: 10.1016/j.clgc.2014.03.010. Epub 2014 Mar 28.

title: Response to Subsequent Docetaxel in a Patient Cohort With Metastatic Castration-Resistant Prostate Cancer After Abiraterone Acetate Treatment

ReferenceCitation: Rathkopf DE, Smith MR, de Bono JS, Logothetis CJ, Shore ND, de Souza P, Fizazi K, Mulders PF, Mainwaring P, Hainsworth JD, Beer TM, North S, Fradet Y, Van Poppel H, Carles J, Flaig TW, Efstathiou E, Yu EY, Higano CS, Taplin ME, Griffin TW, Todd MB, Yu MK, Park YC, Kheoh T, Small EJ, Scher HI, Molina A, Ryan CJ, Saad F. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol. 2014 Nov;66(5):815-25. doi: 10.1016/j.eururo.2014.02.056. Epub 2014 Mar 6.

title: Updated Interim Efficacy Analysis and Long-term Safety of Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer Patients Without Prior Chemotherapy (COU-AA-302)

ReferenceCitation: Basch E, Autio K, Ryan CJ, Mulders P, Shore N, Kheoh T, Fizazi K, Logothetis CJ, Rathkopf D, Smith MR, Mainwaring PN, Hao Y, Griffin T, Li S, Meyers ML, Molina A, Cleeland C. Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. Lancet Oncol. 2013 Nov;14(12):1193-9. doi: 10.1016/S1470-2045(13)70424-8. Epub 2013 Sep 25.

ReferenceCitation: Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. Erratum in: N Engl J Med. 2013 Feb 7;368(6):584.

title: Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy

location_country:
United States
Sweden
Netherlands
Germany
France
Greece
Belgium
Australia
Spain
Canada
United Kingdom

title: A Phase 3, Randomized, Double-blind, Placebo-Controlled Study of Abiraterone Acetate (CB7630) Plus Prednisone in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

summary: This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).


ReferenceCitation: Lencioni R, Llovet JM, Han G, Tak WY, Yang J, Guglielmi A, Paik SW, Reig M, Kim DY, Chau GY, Luca A, Del Arbol LR, Leberre MA, Niu W, Nicholson K, Meinhardt G, Bruix J. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. J Hepatol. 2016 May;64(5):1090-1098. doi: 10.1016/j.jhep.2016.01.012. Epub 2016 Jan 22.

family: Lencioni

full_name: Riccardo Lencioni

given: Riccardo

family: Llovet

full_name: Josep M. Llovet

given: Josep M.

family: Han

full_name: Guohong Han

given: Guohong

family: Tak

full_name: Won Young Tak

given: Won Young

family: Yang

full_name: Jiamei Yang

given: Jiamei

family: Guglielmi

full_name: Alfredo Guglielmi

family: Paik

full_name: Seung Woon Paik

given: Seung Woon

family: Reig

full_name: Maria Reig

given: Maria

family: Kim

full_name: Do Young Kim

given: Do Young

family: Chau

full_name: Gar-Yang Chau

given: Gar-Yang

family: Luca

full_name: Angelo Luca

given: Angelo

family: del Arbol

full_name: Luis Ruiz del Arbol

given: Luis Ruiz

family: Leberre

full_name: Marie-Aude Leberre

given: Marie-Aude

family: Niu

full_name: Woody Niu

given: Woody

family: Nicholson

full_name: Kate Nicholson

given: Kate

family: Meinhardt

full_name: Gerold Meinhardt

given: Gerold

family: Bruix

full_name: Jordi Bruix

given: Jordi

journal_name: Journal of Hepatology

lead_sponsor: Bayer

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

acronym: Sorafenib or Placebo in combination with TACE for intermediate HCC (SPACE)

location_facility: Gangnam Severance Hospital, Yonsei University

title: A Phase II Randomized, Double-blind, Placebo-controlled Study of Sorafenib or Placebo in Combination With Transarterial Chemoembolization (TACE) Performed With DC Bead and Doxorubicin for Intermediate Stage Hepatocellular Carcinoma (HCC).

summary: This study will look at whether our drug (sorafenib) in combination with chemotherapy delivered directly into your tumor using beads (DC Bead) will slow the progression of the disease. The beads used with the chemotherapy will slowly release the chemotherapy reducing the adverse effects that normally occur with chemotherapy.