title: Effect of Passive Immunization on the Progression of Alzheimer's Disease: LY2062430 Versus Placebo

summary:
Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD.

LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.

ReferenceCitation: Reed C, Belger M, Dell'Agnello G, Kahle-Wrobleski K, Sethuraman G, Hake A, Raskin J, Henley D. Representativeness of European clinical trial populations in mild Alzheimer's disease dementia: a comparison of 18-month outcomes with real-world data from the GERAS observational study. Alzheimers Res Ther. 2018 Apr 3;10(1):36. doi: 10.1186/s13195-018-0360-4.

family: Reed

full_name: Catherine Reed

given: Catherine

family: Belger

full_name: Mark Belger

given: Mark

family: Dell’Agnello

full_name: Grazia Dell’Agnello

given: Grazia

family: Kahle-Wrobleski

full_name: Kristin Kahle-Wrobleski

given: Kristin

family: Sethuraman

full_name: Gopalan Sethuraman

given: Gopalan

family: Hake

full_name: Ann Hake

given: Ann

family: Raskin

full_name: Joel Raskin

given: Joel

family: Henley

full_name: David Henley

given: David

journal_name: Alzheimer's Research & Therapy

title: Representativeness of European clinical trial populations in mild Alzheimer’s disease dementia: a comparison of 18-month outcomes with real-world data from the GERAS observational study

ReferenceCitation: Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.

name: Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA

family: Liu-Seifert

full_name: Hong Liu-Seifert

given: Hong

family: Siemers

full_name: Eric Siemers

given: Eric

family: Price

full_name: Karen Price

given: Karen

family: Han

full_name: Baoguang Han

given: Baoguang

family: Selzler

full_name: Katherine J. Selzler

given: Katherine J.

name: Indiana University School of Medicine, Indianapolis, IN, USA

family: Sundell

full_name: Karen Sundell

name: Department of Neurosciences, University of California San Diego, San Diego, CA, USA

family: Aisen

full_name: Paul Aisen

name: Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA

name: the Alzheimer’s Disease Neuroimaging Initiative

repositories_institution:
Indiana University - IUScholarWorks
PubMed Central - Europe PMC

title: Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer’s Disease

ReferenceCitation: Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Alzheimer’s disease progression by geographical region in a clinical trial setting

ReferenceCitation: Liu-Seifert H, Siemers E, Sundell K, Price K, Han B, Selzler K, Aisen P, Cummings J, Raskin J, Mohs R. Cognitive and functional decline and their relationship in patients with mild Alzheimer's dementia. J Alzheimers Dis. 2015;43(3):949-55. doi: 10.3233/JAD-140792.

title: Cognitive and Functional Decline and Their Relationship in Patients with Mild Alzheimer's Dementia

ReferenceCitation: Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, Raman R, Sun X, Aisen PS, Siemers E, Liu-Seifert H, Mohs R; Alzheimer's Disease Cooperative Study Steering Committee; Solanezumab Study Group. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):311-21. doi: 10.1056/NEJMoa1312889.

title: Phase 3 Trials of Solanezumab for Mild-to-Moderate Alzheimer's Disease

location_country:
Italy
United States
Sweden
France
Japan
Poland
Australia
Russian Federation
Spain
Germany
United Kingdom
Korea, Republic of
Taiwan

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients With Cystic Fibrosis.

summary: The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Moss RB, Mistry SJ, Konstan MW, Pilewski JM, Kerem E, Tal-Singer R, Lazaar AL; CF2110399 Investigators. Safety and early treatment effects of the CXCR2 antagonist SB-656933 in patients with cystic fibrosis. J Cyst Fibros. 2013 May;12(3):241-8. doi: 10.1016/j.jcf.2012.08.016. Epub 2012 Sep 17.

family: Moss

full_name: Richard B. Moss

given: Richard B.

sequence: first

family: Mistry

full_name: Sunil J. Mistry

given: Sunil J.

sequence: additional

family: Konstan

full_name: Michael W. Konstan

given: Michael W.

family: Pilewski

full_name: Joseph M. Pilewski

given: Joseph M.

family: Kerem

full_name: Eitan Kerem

given: Eitan

family: Tal-Singer

full_name: Ruth Tal-Singer

given: Ruth

family: Lazaar

full_name: Aili L. Lazaar

given: Aili L.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Cystic Fibrosis

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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.

lead_sponsor: GlaxoSmithKline

location_country:
United States
France
Israel
Germany
Canada

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceCitation: Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607.

name: Global Clinical Research, Bristol-Myers Squibb, Wallingford, Connecticut

family: Coric

full_name: Vladimir Coric

given: Vladimir

name: Department of Neurology, Brown Medical School, Butler Hospital, Providence, Rhode Island

family: Salloway

full_name: Stephen Salloway

given: Stephen

name: Department of Psychiatry, School of Medicine, Yale University, New Haven, Connecticut

family: van Dyck

full_name: Christopher H. van Dyck

given: Christopher H.

name: Dementia Research Center, Department of Neurology, Cognition, Neuro-imagerie et maladies du Cerveau, University Pierre et Marie Curie Paris 6, Hôpital de la Salpétrière, Paris, France

family: Dubois

full_name: Bruno Dubois

given: Bruno

name: Department of Neurobiology, Karolinska Institute, Stockholm, Sweden

family: Andreasen

full_name: Niels Andreasen

given: Niels

name: Brain Matters Research, Delray Beach, Florida

family: Brody

full_name: Mark Brody

given: Mark

family: Curtis

full_name: Craig Curtis

given: Craig

name: Department of Neurology, University of Eastern Finland, Kuopio, Finland

family: Soininen

full_name: Hilkka Soininen

given: Hilkka

name: Pacific Research Network Inc, San Diego, California

family: Thein

full_name: Stephen Thein

name: California Neuroscience Research Medical Group Inc, Sherman Oaks

family: Shiovitz

full_name: Thomas Shiovitz

given: Thomas

family: Pilcher

full_name: Gary Pilcher

given: Gary

name: Department of Psychiatry, New York University Langone Medical Center, New York

family: Ferris

full_name: Steven Ferris

given: Steven

family: Colby

full_name: Susan Colby

given: Susan

family: Kerselaers

full_name: Wendy Kerselaers

given: Wendy

family: Dockens

full_name: Randy Dockens

given: Randy

family: Soares

full_name: Holly Soares

given: Holly

family: Kaplita

full_name: Stephen Kaplita

family: Luo

full_name: Feng Luo

given: Feng

family: Pachai

full_name: Chahin Pachai

given: Chahin

family: Bracoud

full_name: Luc Bracoud

given: Luc

name: Avid Radiopharmaceuticals, Philadelphia, Pennsylvania

family: Mintun

full_name: Mark Mintun

name: Mary S. Easton Center for Alzheimer’s Disease Research, University of California at Los Angeles

family: Grill

full_name: Joshua D. Grill

given: Joshua D.

name: Institute for Neurodegenerative Disorders, New Haven, Connecticut

family: Marek

full_name: Ken Marek

given: Ken

family: Seibyl

full_name: John Seibyl

given: John

family: Cedarbaum

full_name: Jesse M. Cedarbaum

given: Jesse M.

name: University of British Columbia, Vancouver, British Columbia, Canada

location_country:
Sweden
Finland
France
Denmark
United States
Canada

location_facility: California Neuroscience Research Medical Group, Inc.

location_facility: Robert Wood Johnson Medical School, Umdnj

location_facility: Dean Foundation For Health Research & Education

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Memory Enhancement Center Of Amercia, Inc.

location_facility: Wake Forest University School Of Medicine

location_facility: Cleveland Clinic Lou Ruvo Center For Brain Health

location_facility: Washington University School Of Medicine

title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Prodromal Alzheimer's Disease

summary: The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.


title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult Outpatients With Major Depressive Disorder

summary:
The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned.

The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.

ReferenceCitation: Boyer P, Vialet C, Hwang E, Tourian KA. Efficacy of Desvenlafaxine 50 mg/d Versus Placebo in the Long-Term Treatment of Major Depressive Disorder: A Randomized, Double-Blind Trial. Prim Care Companion CNS Disord. 2015 Aug 27;17(4). doi: 10.4088/PCC.14m01711. eCollection 2015.

family: Boyer

full_name: Patrice Boyer

given: Patrice

family: Vialet

full_name: Cécile Vialet

given: Cécile

family: Hwang

full_name: Eunhee Hwang

given: Eunhee

family: Tourian

full_name: Karen A. Tourian

given: Karen A.

journal_name: The Primary Care Companion For CNS Disorders

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Physicians Postgraduate Press, Inc

publisher_dissemination: Physicians Postgraduate Press, Inc

publisher_group: Physicians Postgraduate Press, Inc

publisher_normalized: Physicians Postgraduate Press, Inc

ReferenceCitation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. A Post Hoc Analysis of the Effect of Weight on Efficacy in Depressed Patients Treated With Desvenlafaxine 50 mg/d and 100 mg/d. Prim Care Companion CNS Disord. 2015 Jun 4;17(3). doi: 10.4088/PCC.14m01741. eCollection 2015.

family: McIntyre

full_name: Roger S. McIntyre

given: Roger S.

family: Fayyad

full_name: Rana S. Fayyad

given: Rana S.

family: Guico-Pabia

full_name: Christine J. Guico-Pabia

given: Christine J.

family: Boucher

full_name: Matthieu Boucher

given: Matthieu

ReferenceCitation: McIntyre RS, Fayyad RS, Guico-Pabia CJ, Boucher M. An Analysis of Relapse Rates and Predictors of Relapse in 2 Randomized, Placebo-Controlled Trials of Desvenlafaxine for Major Depressive Disorder. Prim Care Companion CNS Disord. 2015 Feb 26;17(1). doi: 10.4088/PCC.14m01681. eCollection 2015.

ReferenceCitation: Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.

ReferenceCitation: Rosenthal JZ, Boyer P, Vialet C, Hwang E, Tourian KA. Efficacy and safety of desvenlafaxine 50 mg/d for prevention of relapse in major depressive disorder:a randomized controlled trial. J Clin Psychiatry. 2013 Feb;74(2):158-66. doi: 10.4088/JCP.12m07974.

title: Efficacy and Safety of Desvenlafaxine 50 mg/d for Prevention of Relapse in Major Depressive Disorder

location_country:
South Africa
Chile
Finland
Croatia
France
Lithuania
Poland
Slovakia
Romania
Estonia
United States
Latvia
Canada
Colombia


ReferenceType: result

ReferenceCitation: Vermersch P, Czlonkowska A, Grimaldi LM, Confavreux C, Comi G, Kappos L, Olsson TP, Benamor M, Bauer D, Truffinet P, Church M, Miller AE, Wolinsky JS, Freedman MS, O'Connor P; TENERE Trial Group. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial. Mult Scler. 2014 May;20(6):705-16. doi: 10.1177/1352458513507821. Epub 2013 Oct 14.

name: Neurology, University of Lille Nord de France, Lille, France

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

name: Second Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland

family: Czlonkowska

full_name: Anna Czlonkowska

given: Anna

name: Fondazione Istituto San Raffaele “G. Giglio” di Cefalù, Cefalù, Italy

family: Grimaldi

full_name: Luigi ME Grimaldi

given: Luigi ME

name: Neurology, University Claude Bernard, Lyon, France

family: Confavreux

full_name: Christian Confavreux

given: Christian

name: Neurology and Neurophysiology, University Vita-Salute San Raffaele, Milan, Italy

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

name: Neurology and Department of Biomedicine, University Hospital Basel, Basel, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden

family: Olsson

full_name: Tomas P Olsson

given: Tomas P

name: Global Pharmacovigilance and Epidemiology, Sanofi, Chilly Mazarin, France

family: Benamor

full_name: Myriam Benamor

given: Myriam

name: Statistics, Sanofi, Bridgewater, NJ, USA

family: Bauer

full_name: Deborah Bauer

given: Deborah

family: Truffinet

full_name: Philippe Truffinet

given: Philippe

name: Neurology, Fishawack Communications Ltd, North Wales, PA, USA

family: Church

full_name: Meg Church

given: Meg

name: Corinne Goldsmith Dickinson Centre of Multiple Sclerosis, Icahn School of Medicine at Mount Sinai, New York, NY, USA

family: Miller

full_name: Aaron E Miller

given: Aaron E

name: Neurology, University of Texas Health Science Center at Houston, Houston, TX, USA

family: Wolinsky

full_name: Jerry S Wolinsky

given: Jerry S

name: University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, ON, Canada

family: Freedman

full_name: Mark S Freedman

given: Mark S

name: St Michael’s Hospital, University of Toronto, 30 Bond Street, Toronto, ON, Canada

family: O’Connor

full_name: Paul O’Connor

given: Paul

journal_name: Multiple Sclerosis Journal

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Comi G, Freedman MS, Meca-Lallana JE, Vermersch P, Kim BJ, Parajeles A, Edwards KR, Gold R, Korideck H, Chavin J, Poole EM, Coyle PK. Prior treatment status: impact on the efficacy and safety of teriflunomide in multiple sclerosis. BMC Neurol. 2020 Oct 6;20(1):364. doi: 10.1186/s12883-020-01937-4.

full_name: Mark S. Freedman

given: Mark S.

family: Meca-Lallana

full_name: José E. Meca-Lallana

given: José E.

family: Kim

full_name: Byoung Joon Kim

given: Byoung Joon

family: Parajeles

full_name: Alexander Parajeles

location_country:
Italy
Switzerland
United Kingdom
France
Poland
Greece
Tunisia
Hungary
Belgium
Spain
Germany
Czech Republic
Canada

location_facility:
Investigational Site Number 276007
Investigational Site Number 380008
Investigational Site Number 276001
Investigational Site Number 250005
Investigational Site Number 250004
Investigational Site Number 380001
Investigational Site Number 250002
Investigational Site Number 124004
Investigational Site Number 250001
Investigational Site Number 380004
Investigational Site Number 616002
Investigational Site Number 300002
Investigational Site Number 788002
Investigational Site Number 276010
Investigational Site Number 276009
Investigational Site Number 616003
Investigational Site Number 276004
Investigational Site Number 300001
Investigational Site Number 724001
Investigational Site Number 826003
Investigational Site Number 276006
Investigational Site Number 380007
Investigational Site Number 380010
Investigational Site Number 250003
Investigational Site Number 348001
Investigational Site Number 380005
Investigational Site Number 616001
Investigational Site Number 124002
Investigational Site Number 056002
Investigational Site Number 348007
Investigational Site Number 380003
Investigational Site Number 724003
Investigational Site Number 276005
Investigational Site Number 276011
Investigational Site Number 276012
Investigational Site Number 826002
Investigational Site Number 124003
Investigational Site Number 203004
Investigational Site Number 348003
Investigational Site Number 380002
Investigational Site Number 380006
Investigational Site Number 203003
Investigational Site Number 348005
Investigational Site Number 056003
Investigational Site Number 056001
Investigational Site Number 348002
Investigational Site Number 203002
Investigational Site Number 348004
Investigational Site Number 276003
Investigational Site Number 276002
Investigational Site Number 724007
Investigational Site Number 756002
Investigational Site Number 724002
Investigational Site Number 616004

title: A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period

summary:
Primary objective was to assess the effectiveness evaluated by the time to failure of two doses of teriflunomide in comparison to interferon beta-1a in participants with relapsing Multiple Sclerosis [MS].

Secondary objectives were:

To assess the effect of the two doses in comparison to interferon beta-1a on:

Frequency of relapses,
Fatigue,
Participant's satisfaction with treatment.
To evaluate the safety and tolerability of the two doses in comparison to interferon beta-1a.

The study consisted of a core treatment period with a common end date defined as 48 weeks after randomization of the last participant, followed by an optional long-term extension treatment period until teriflunomide is commercially available in accordance with local regulations.


design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Peru
Switzerland
Germany
France
Belgium
Australia
Spain
Turkey
United States
United Kingdom
Korea, Republic of

location_facility: University of Texas Southwestern Medical Center Dept of Simmons Cancer Center

location_facility: University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)

location_facility: Oregon Health Sciences University Dept. of OHSU (2)

location_facility: North Shore University Hospital North Shore Univ

location_facility: Nebraska Methodist Hospital Nebraska Methodist Hospital(2)

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC (2)

location_facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson (14)

type: EudraCT Number

source: euctr

title: A Phase II Study of Oral Single Agent Panobinostat in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML)

summary: This study was to evaluate the efficacy and safety of single agent oral panobinostat in patients who have refractory de novo or refractory secondary AML.


title: A Randomized Double-Blinded Phase II Study of Carboplatin/Paclitaxel/CT-322 Versus Carboplatin/Paclitaxel/Bevacizumab as First-Line Treatment for Recurrent or Advanced Non-Small Cell Lung Cancer With Non-Squamous Histology

summary: The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

status: Terminated

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Brazil
South Africa
France
Poland
Russian Federation
United States
United Kingdom

location_facility: North Mississippi Hematology And Oncology Associates, Ltd

location_facility: Piedmont Hematology Oncology Associates, Pllc

location_facility: Cancer Center At Cookeville Regional Medical Center

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: University Of Tennessee Cancer Institute

location_facility: Acrc/Arizona Clinical Research Center, Inc.

status_simplified: Unknown


title: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

summary: This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

lead_sponsor: Morphotek

location_country:
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Netherlands
Philippines
Switzerland
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Memorial Health University Medical Center

location_facility: Cheil General Hospital & Women's Healthcare Center

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Klinikum der Universität München - Innenstadt

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Palm Beach Institute of Hematology and Oncology

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Saúde ABC Serviços Médicos Hospitalares Ltda

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

location_facility: Signal Point Clinical Research Center, LLC

location_facility: University of California Los Angeles Medical Center

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPOLFG, EPE)

location_facility: Clínica AMO - Assistência Multidiciplinar em Oncologia

location_facility: Azienda Ospedaliero-Universitaria di Udine

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)

location_facility: Peninsula Cancer Institute - Riverside Gynecology Oncology

location_facility: AZ Groeninge - Campus Maria's Voorzienigheid

location_facility: Chattanooga's Program in Women's Oncology

location_facility: John Theurer Cancer Center at Hackensack University MC

location_facility: Arizona Hematology & Oncology Associates

location_facility: Irmandade Santa Casa de Misericórdia de Porto Alegre

location_facility: Republican Clinical Oncology Center of Bashkortostan Republic Ministry of Healthcare

location_facility: Instituto Ribeirãopretano de Combate ao Câncer

location_facility: Triva Investigaciones Medicas Sociedad Anónima de Capital Variable

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Gainsville Hematology Oncology Associates

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Municipal Institution of Cherkasy Regional Counsil "Cherkasy Regional Oncology Dispensary"

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Clínica de Oncologia de Porto Alegre S/S Ltda

location_facility: Medical Radiology Research Center of RAMS

location_facility: Ospedale Santa Maria della Misericordia di Perugia

location_facility: Linn Medical Center, Clalit Health Services

location_facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie oddzial w Gliwicach

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelöintézet

location_facility: Istituto Ospedaliero Fondazione Poliambulanza

location_facility: Oncology-Hematology Associates of W. Broward P.A.

location_facility: Jupiter Medical center Physician's Group

location_facility: Moscow Research Oncology Institute n.a. P.A.Gertsen

location_facility: Severance Hospital, Yonsei University College of Medicine

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

location_facility: Veszprém Megyei Önkormányzat Csolnoky Ferenc Kórház-Rendelöintézet

location_facility: Instituto de Pesquisas Clínicas para Estudos Multicêntricos

location_facility: Olsztynski Osrodek Onkologiczny "Kopernik" Sp. z o.o.

location_facility: Centro di Ricerca e Formazione ad Alta Tecnologia nelle Scienze Biomediche

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: University of California Davis Cancer Center

location_facility: Hospital Zonal Especializado en Oncología de Lanús

location_facility: St. Joseph's Hospital, Barrow Neurology Clinics

location_facility: Russian Oncology Research Center named after N.N. Blokhin

location_facility: Institut Jean Godinot - Centre de lutte contre le cancer

location_facility: Centre Régional de lutte contre le cancer Paul Papin

location_facility: Bhagwan Mahaveer Cancer Hospital and Research Centre

location_facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia

location_facility: M.S Ramaiah Medical College and Teaching Hospital Ethical Review Board

location_facility: University General Hospital of Heraklion

location_facility: Kapi'olani Medical Center for Women and Children

location_facility: National Kidney and Transplant Institute

location_facility: Harrison Bremerton Hematology and Oncology

location_facility: Ospedale Mater Salutis ULSS 21 della regione Veneto

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

location_facility: Kaiser Permanente - Moanalua Medical Center

location_facility: General Oncology Hospital Kifissias "Oi Agioi Anargyroi"

location_facility: Azienda Ospedaliera Santi Antonio, Biagio e Cesare Arrigo

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

location_facility: Chernivtsi Regional Clinical Oncology Dispansery

location_facility: Weinberg Cancer Institute at Franklin Square

location_facility: Amrita Institute of Medical Sciences and Research Centre

location_facility: Istituto Nazionale per lo studio e la cura dei tumori "Fondazione Giovanni Pascale"

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PAM w Szczecinie

location_facility: Instituto do Câncer Arnaldo Vieira de Carvalho

location_facility: The Center for Cancer and Hematologic Disease

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

location_facility: Northern Virginia Pelvic Surgery Associates

location_facility: University of Texas Health Science Center at Houston Medical School

location_facility: Jawaharlal Nehru Cancer Hospital & Research Centre

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: Frauenarztpraxis Dr. med. Gröll de Rivera

location_facility: MNJ Institute of Oncology and Regional Cancer Centre

location_facility: Instituto Português de Oncologia Francisco Gentil, Centro Regional de Oncologia de Coimbra, EPE

location_facility: International Beneficence Clinical Research, L.L.C.


lead_sponsor: Bayer

location_country:
Italy
Austria
Switzerland
Germany
France
Thailand
Australia
Spain
Canada
Korea, Republic of

acronym: GRIP

title: Prospective Non-randomized (Pharmacoepidemiologic) Cohort Study (Open-label, Multicenter) to Assess the Magnitude of Potential Risk With the Administration of Gadovist in Patients With Moderate to Severe Renal Impairment for the Development of Nephrogenic Systemic Fibrosis (NSF) Based on Diagnostically Specific Clinical and Histopathologic Information

summary:
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Gadovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Gadovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Gadovist. Patients who are enrolled in this study will receive a Gadovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.


ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Sweden
Switzerland
France
United States
Canada

location_facility: Klinik und Poliklinik fuer Urologie, Inselspital

location_facility: Los Angeles Infertility and Prostatitis Medical Group

location_facility: Centre Hospitalier Universitaire de NANTES (CHU)

location_facility: Prostate Cancer Centre / Urology Research

location_facility: Temple University of the Commonwealth System of Higher Education

location_facility: Tri-State Urologic Services PSC, Inc. dba The Urology Group

location_facility: Atlantic Urological Medical Group Incorporated

location_facility: Universitaetsspital Basel, Urologische Klinik

location_facility: Skaraborgs Sjukhus, FoU-centrum och urologkliniken

location_facility: Urology Associates / Urologic Medical Research

location_facility: The Male/Female Health and Research Centre

type: Other Identifier

title: A PHASE 2, 16 WEEK, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED, PARALLEL GROUP PROOF-OF-CONCEPT STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF PAIN ASSOCIATED WITH CHRONIC ABACTERIAL PROSTATITIS

summary: The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.


title: A Multicenter, Randomized, Double Blind, Sham Control, Parallel Arm Trial to Assess Effectiveness and Safety of the Ischemic Stroke System ISS, as an Adjunct to Standard of Care in Subjects With Acute Ischemic Stroke

summary: The primary objective of the study is to assess the safety and effectiveness of SPG stimulation with the ISS in patients with an acute ischemic stroke in the anterior circulation initiated within 24 hours from stroke onset.

ReferenceCitation: Bornstein NM, Saver JL, Diener HC, Gorelick PB, Shuaib A, Solberg Y, Thackeray L, Savic M, Janelidze T, Zarqua N, Yarnitsky D, Molina CA; ImpACT-24B investigators. An injectable implant to stimulate the sphenopalatine ganglion for treatment of acute ischaemic stroke up to 24 h from onset (ImpACT-24B): an international, randomised, double-blind, sham-controlled, pivotal trial. Lancet. 2019 Jul 20;394(10194):219-229. doi: 10.1016/S0140-6736(19)31192-4. Epub 2019 May 24.

family: Bornstein

full_name: Natan M Bornstein

given: Natan M

family: Saver

full_name: Jeffrey L Saver

given: Jeffrey L

family: Diener

full_name: Hans Christoph Diener

given: Hans Christoph

family: Gorelick

full_name: Philip B Gorelick

given: Philip B

family: Shuaib

full_name: Ashfaq Shuaib

given: Ashfaq

family: Solberg

full_name: Yoram Solberg

given: Yoram

family: Thackeray

full_name: Lisa Thackeray

given: Lisa

family: Savic

full_name: Milan Savic

given: Milan

family: Janelidze

full_name: Tamar Janelidze

given: Tamar

family: Zarqua

full_name: Natia Zarqua

given: Natia

family: Yarnitsky

full_name: David Yarnitsky

given: David

family: Molina

full_name: Carlos A Molina

given: Carlos A

family: Hill

full_name: Michael Hill

given: Michael

family: Vaclavik

full_name: Daniel Vaclavik

given: Daniel

family: Skoloudik

full_name: David Skoloudik

family: Fiksa

full_name: Jan Fiksa

given: Jan

family: Andersen

full_name: Grethe Andersen

given: Grethe

family: Jakala

full_name: Pekka Jakala

given: Pekka

family: Tatlisumak

full_name: Turgut Tatlisumak

given: Turgut

family: Kuzmanovski

full_name: Igor Kuzmanovski

given: Igor

family: Guillon

full_name: Benoit Guillon

given: Benoit

family: Chabriat

full_name: Hugues Chabriat

given: Hugues

location_country:
Italy
Serbia
Hong Kong
Spain
North Macedonia
Germany
Finland
France
Czechia
Poland
Israel
Georgia
Slovakia
Portugal
Denmark
United States
Canada
Ukraine

location_facility: Special Hospital for Cerebrovascular Disease Sveti Sava

location_facility: Centro Hospitalar de Douro e Vouga, EPE - Hospital de São Sebastião

location_facility: High Technology Medical Center University Clinic LTD.

location_facility: Foothills Medical Centre/University of Calgary, Department of Clinical Neurosciences

location_facility: University Hospital of Ostrava, Ostrava Poruba

location_facility: Neurologické Oddelenie, Nemocnica s Poliklinikou Spišská

location_facility: University of Toledo Medical Center- Campus 2

location_facility: Neurologické Oddelenie FN Trnava, Fakultná Nemocnica

location_facility: Department of Medicine, Stroke Program, University of Alberta Hospital

location_facility: Complejo Hospitalarion Univiersitario de Santiago

location_facility: University of Toledo Medical Center- Campus 1

location_facility: Emergency Neurology Clinic Neurology Ltd.

location_facility: Vitkovicka nemocnice a.s. Ostrava Vitkovice

location_facility: Unidade de AVC Centro Hospitalar São João

location_facility: Center for Stroke Research at Charite University of Berlin


title: Shockless Implant Evaluation

acronym: SIMPLE

summary:
This trial will assess the safety of defibrillator testing and the influence of defibrillation testing on the efficacy of clinical shocks.

The trial will test the hypothesis that implantable cardioverter defibrillator (ICD) implantation without defibrillation testing (DT) is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.

It will also test the hypothesis, that defibrillation testing increases the peri-operative (30 days) complication rate of ICD implantation.

primary_purpose: Supportive Care

ReferenceCitation: Vamos M, Healey JS, Wang J, Connolly SJ, Mabo P, Van Erven L, Kautzner J, Glikson M, Neuzner J, O'Hara G, Vinolas X, Gadler F, Hohnloser SH. Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy. Heart Rhythm. 2018 Mar;15(3):386-392. doi: 10.1016/j.hrthm.2017.11.020. Epub 2017 Nov 20.

family: Vamos

full_name: Mate Vamos

given: Mate

family: Healey

full_name: Jeff S. Healey

given: Jeff S.

family: Wang

full_name: Jia Wang

given: Jia

family: Connolly

full_name: Stuart J. Connolly

given: Stuart J.

family: Mabo

full_name: Philippe Mabo

given: Philippe

family: Van Erven

full_name: Lieselot Van Erven

given: Lieselot

family: Kautzner

full_name: Josef Kautzner

given: Josef

family: Glikson

full_name: Michael Glikson

family: Neuzner

full_name: Jorg Neuzner

given: Jorg

family: O'Hara

full_name: Gilles O'Hara

given: Gilles

family: Vinolas

full_name: Xavier Vinolas

given: Xavier

family: Gadler

full_name: Frederik Gadler

given: Frederik

family: Hohnloser

full_name: Stefan H. Hohnloser

given: Stefan H.

journal_name: Heart Rhythm

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_normalized: HAL

version: submittedVersion

title: Implantable cardioverter–defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy

ReferenceCitation: Vamos M, Healey JS, Wang J, Duray GZ, Connolly SJ, van Erven L, Vinolas X, Neuzner J, Glikson M, Hohnloser SH. Troponin levels after ICD implantation with and without defibrillation testing and their predictive value for outcomes: Insights from the SIMPLE trial. Heart Rhythm. 2016 Feb;13(2):504-10. doi: 10.1016/j.hrthm.2015.11.009. Epub 2015 Nov 11.

family: Duray

full_name: Gabor Z. Duray

given: Gabor Z.

family: van Erven

full_name: Lieselot van Erven

ReferenceCitation: Healey JS, Hohnloser SH, Glikson M, Neuzner J, Mabo P, Vinolas X, Kautzner J, O'Hara G, VanErven L, Gadler F, Pogue J, Appl U, Gilkerson J, Pochet T, Stein KM, Merkely B, Chrolavicius S, Meeks B, Foldesi C, Thibault B, Connolly SJ; Shockless IMPLant Evaluation [SIMPLE] investigators. Cardioverter defibrillator implantation without induction of ventricular fibrillation: a single-blind, non-inferiority, randomised controlled trial (SIMPLE). Lancet. 2015 Feb 28;385(9970):785-91. doi: 10.1016/S0140-6736(14)61903-6. Epub 2015 Feb 23.

location_country:
Austria
Sweden
Hong Kong
Netherlands
Germany
Finland
France
Czechia
Malaysia
Israel
Poland
Norway
Hungary
Australia
Thailand
Spain
Canada
United Kingdom

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: IKEM - Institut klinicke a experimentalni mediciny

location_facility: Medisch Centrum Haaglanden (MCH) - locatie Westeinde

location_facility: Sunnybrook & Women's College Health Sciences Centre

location_facility: Hadassh University Hospital, Mount Scopus

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Semmelweis University, Cardiovascular Center

location_facility: University Hospital Bochum Bergmannsheil

location_facility: Allami Egeszsegugyi Kozpont (AEK) Hospital


ReferenceCitation: Blay JY, Leahy MG, Nguyen BB, Patel SR, Hohenberger P, Santoro A, Staddon AP, Penel N, Piperno-Neumann S, Hendifar A, Lardelli P, Nieto A, Alfaro V, Chawla SP. Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. Eur J Cancer. 2014 Apr;50(6):1137-47. doi: 10.1016/j.ejca.2014.01.012. Epub 2014 Feb 7.

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Leahy

full_name: Michael G. Leahy

given: Michael G.

family: Nguyen

full_name: Binh Bui Nguyen

given: Binh Bui

family: Patel

full_name: Shreyaskumar R. Patel

given: Shreyaskumar R.

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

family: Santoro

full_name: Armando Santoro

given: Armando

family: Staddon

full_name: Arthur P. Staddon

given: Arthur P.

family: Penel

full_name: Nicolas Penel

given: Nicolas

family: Piperno-Neumann

full_name: Sophie Piperno-Neumann

given: Sophie

family: Hendifar

full_name: Andrew Hendifar

given: Andrew

family: Lardelli

full_name: Pilar Lardelli

given: Pilar

family: Nieto

full_name: Antonio Nieto

given: Antonio

family: Alfaro

full_name: Vicente Alfaro

given: Vicente

family: Chawla

full_name: Sant P. Chawla

given: Sant P.

journal_name: European Journal of Cancer

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

location_country:
United States
France
Spain
Germany
United Kingdom

title: A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)

summary: The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).


ReferenceCitation: Herzog TJ, Scambia G, Kim BG, Lhommé C, Markowska J, Ray-Coquard I, Sehouli J, Colombo N, Shan M, Petrenciuc O, Oza A. A randomized phase II trial of maintenance therapy with Sorafenib in front-line ovarian carcinoma. Gynecol Oncol. 2013 Jul;130(1):25-30. doi: 10.1016/j.ygyno.2013.04.011. Epub 2013 Apr 13.

family: Herzog

full_name: Thomas J. Herzog

given: Thomas J.

family: Scambia

full_name: Giovanni Scambia

given: Giovanni

family: Kim

full_name: Byoung-Gie Kim

given: Byoung-Gie

family: Lhommé

full_name: Catherine Lhommé

given: Catherine

family: Markowska

full_name: Janina Markowska

given: Janina

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Sehouli

full_name: Jalid Sehouli

given: Jalid

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Shan

full_name: Minghua Shan

given: Minghua

family: Petrenciuc

full_name: Oana Petrenciuc

given: Oana

family: Oza

full_name: Amit Oza

given: Amit

journal_name: Gynecologic Oncology

location_country:
Italy
United States
Hong Kong
Netherlands
Germany
Finland
France
Japan
Poland
Singapore
Belgium
Spain
Canada
Korea, Republic of

title: A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients Who Have Achieved a Complete Clinical Response After Standard Platinum/Taxane Containing Chemotherapy

summary: Comparison of Nexavar with a placebo as maintenance therapy for patients with advanced Ovarian or primary Peritoneal cancers in complete remission following surgery and one regimen of chemotherapy.


ReferenceCitation: Gore L, Kearns PR, de Martino ML, Lee, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. doi: 10.1200/JCO.2017.75.9597. Epub 2018 Mar 2.

name: Lia Gore, University of Colorado School of Medicine/Children’s Hospital Colorado, Aurora, CO; Pamela R. Kearns, University of Birmingham, Birmingham, West Midlands; Donna Lancaster, Royal Marsden Hospital, Sutton, Surrey, United Kingdom; Maria Lucia de Martino Lee, Support Group for Children and Adolescents with Cancer; Carmino Antonio De Souza, University of Campinas, São Paulo, Brazil; Yves Bertrand, L'Institut d'Hématologie et d'Oncologie Pédiatrique, Lyon, France; Nobuko Hijiya, Ann and Robert H....

family: Gore

full_name: Lia Gore

given: Lia

family: Kearns

full_name: Pamela R. Kearns

given: Pamela R.

family: de Martino

full_name: Maria Lucia de Martino

given: Maria Lucia

family: Lee

full_name: Lee

family: De Souza

full_name: Carmino Antonio De Souza

given: Carmino Antonio

family: Bertrand

full_name: Yves Bertrand

given: Yves

family: Hijiya

full_name: Nobuko Hijiya

given: Nobuko

family: Stork

full_name: Linda C. Stork

given: Linda C.

family: Chung

full_name: Nack-Gyun Chung

given: Nack-Gyun

family: Cardos

full_name: Rocio Cardenas Cardos

given: Rocio Cardenas

family: Saikia

full_name: Tapan Saikia

given: Tapan

family: Fagioli

full_name: Franca Fagioli

given: Franca

family: Seo

full_name: Jong Jin Seo

given: Jong Jin

family: Landman-Parker

full_name: Judith Landman-Parker

given: Judith

family: Lancaster

full_name: Donna Lancaster

given: Donna

family: Place

full_name: Andrew E. Place

given: Andrew E.

family: Rabin

full_name: Karen R. Rabin

given: Karen R.

family: Sacchi

full_name: Mariana Sacchi

given: Mariana

family: Swanink

full_name: Rene Swanink

given: Rene

family: Zwaan

full_name: C. Michel Zwaan

given: C. Michel

journal_name: Journal of Clinical Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

repository_institution: University of Birmingham - University of Birmingham Research Portal

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

repositories:
PubMed Central
Pure (Denmark)
iris.unito.it

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Italy
Brazil
United States
South Africa
India
Mexico
Netherlands
Germany
France
Romania
Singapore
Argentina
Australia
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Jonathan Jaques Children'S Cancer Center

location_facility: Children's Healthcare Of Atlanta - Egleston

location_facility: Hospital Nacional Profesor Alejandro Posadas

location_facility: Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca

title: A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

summary: The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated


title: A Randomized, Double-blind, Placebo-controlled, 2-arm Parallel-group, Multicenter Study With a 24-week Main Treatment Period and an Extension Assessing the Efficacy and Safety of AVE0010 on Top of Pioglitazone in Patients With Type 2 Diabetes Not Adequately Controlled With Pioglitazone

acronym: GETGOAL-P

summary:
The purpose of this study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to pioglitazone with or without metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide when added to pioglitazone on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

Secondary objectives are to assess the effects of lixisenatide when added to pioglitazone on the percentage of patients reaching HbA1c less than 7 percent (%) and less than or equal to 6.5%, fasting plasma glucose (FPG), body weight, beta-cell function (assessed by homeostatic model assessment of beta-cell function [HOMA-beta]), and on fasting plasma insulin (FPI), to assess the safety, tolerability, pharmacokinetics (PK) and anti-lixisenatide antibody development.

ReferenceCitation: Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R. Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone (GetGoal-P). Diabetes Obes Metab. 2013 Nov;15(11):1000-7. doi: 10.1111/dom.12121. Epub 2013 May 26.

name: Department of Endocrinology and Diabetes HUS  Strasbourg France

family: Pinget

full_name: M. Pinget

given: M.

name: LMC Diabetes and Endocrinology  Thornhill ON Canada

family: Goldenberg

full_name: R. Goldenberg

given: R.

family: Niemoeller

full_name: E. Niemoeller

given: E.

family: Muehlen‐Bartmer

full_name: I. Muehlen‐Bartmer

given: I.

family: Guo

full_name: H. Guo

given: H.

name: LMC Diabetes and Endocrinology  Toronto ON Canada

family: Aronson

full_name: R. Aronson

journal_name: Diabetes, Obesity and Metabolism

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Efficacy and safety of lixisenatide once daily versus placebo in type 2 diabetes insufficiently controlled on pioglitazone ( GetGoal ‐P)

lead_sponsor: Sanofi

location_country:
Austria
Peru
Guatemala
India
Mexico
Germany
France
Greece
Romania
Puerto Rico
Turkey
United States
Canada

location_facility: Sanofi-Aventis Investigational Site Number 840743

location_facility: Sanofi-Aventis Investigational Site Number 840712

location_facility: Sanofi-Aventis Investigational Site Number 840799

location_facility: Sanofi-Aventis Investigational Site Number 840791

location_facility: Sanofi-Aventis Investigational Site Number 840792

location_facility: Sanofi-Aventis Investigational Site Number 840717

location_facility: Sanofi-Aventis Investigational Site Number 484701

location_facility: Sanofi-Aventis Investigational Site Number 840701

location_facility: Sanofi-Aventis Investigational Site Number 840776

location_facility: Sanofi-Aventis Investigational Site Number 840854

location_facility: Sanofi-Aventis Investigational Site Number 840857

location_facility: Sanofi-Aventis Investigational Site Number 840763

location_facility: Sanofi-Aventis Investigational Site Number 840875

location_facility: Sanofi-Aventis Investigational Site Number 840757

location_facility: Sanofi-Aventis Investigational Site Number 840785

location_facility: Sanofi-Aventis Investigational Site Number 642701

location_facility: Sanofi-Aventis Investigational Site Number 250705

location_facility: Sanofi-Aventis Investigational Site Number 840773

location_facility: Sanofi-Aventis Investigational Site Number 276701

location_facility: Sanofi-Aventis Investigational Site Number 840723

location_facility: Sanofi-Aventis Investigational Site Number 124701

location_facility: Sanofi-Aventis Investigational Site Number 124710

location_facility: Sanofi-Aventis Investigational Site Number 840850

location_facility: Sanofi-Aventis Investigational Site Number 124716

location_facility: Sanofi-Aventis Investigational Site Number 840782

location_facility: Sanofi-Aventis Investigational Site Number 840762

location_facility: Sanofi-Aventis Investigational Site Number 840753

location_facility: Sanofi-Aventis Investigational Site Number 320704

location_facility: Sanofi-Aventis Investigational Site Number 840735

location_facility: Sanofi-Aventis Investigational Site Number 840868

location_facility: Sanofi-Aventis Investigational Site Number 642708

location_facility: Sanofi-Aventis Investigational Site Number 840767

location_facility: Sanofi-Aventis Investigational Site Number 840726

location_facility: Sanofi-Aventis Investigational Site Number 840879

location_facility: Sanofi-Aventis Investigational Site Number 840707

location_facility: Sanofi-Aventis Investigational Site Number 300704

location_facility: Sanofi-Aventis Investigational Site Number 840774

location_facility: Sanofi-Aventis Investigational Site Number 484703

location_facility: Sanofi-Aventis Investigational Site Number 642707

location_facility: Sanofi-Aventis Investigational Site Number 840721

location_facility: Sanofi-Aventis Investigational Site Number 642713

location_facility: Sanofi-Aventis Investigational Site Number 840851

location_facility: Sanofi-Aventis Investigational Site Number 124704

location_facility: Sanofi-Aventis Investigational Site Number 840716

location_facility: Sanofi-Aventis Investigational Site Number 840765

location_facility: Sanofi-Aventis Investigational Site Number 840758

location_facility: Sanofi-Aventis Investigational Site Number 250704

location_facility: Sanofi-Aventis Investigational Site Number 630715

location_facility: Sanofi-Aventis Investigational Site Number 840744

location_facility: Sanofi-Aventis Investigational Site Number 840741

location_facility: Sanofi-Aventis Investigational Site Number 840720

location_facility: Sanofi-Aventis Investigational Site Number 276704

location_facility: Sanofi-Aventis Investigational Site Number 840752

location_facility: Sanofi-Aventis Investigational Site Number 040702

location_facility: Sanofi-Aventis Investigational Site Number 356703

location_facility: Sanofi-Aventis Investigational Site Number 356704

location_facility: Sanofi-Aventis Investigational Site Number 642714

location_facility: Sanofi-Aventis Investigational Site Number 124711

location_facility: Sanofi-Aventis Investigational Site Number 840729

location_facility: Sanofi-Aventis Investigational Site Number 840789

location_facility: Sanofi-Aventis Investigational Site Number 840866

location_facility: Sanofi-Aventis Investigational Site Number 840784

location_facility: Sanofi-Aventis Investigational Site Number 840740

location_facility: Sanofi-Aventis Investigational Site Number 642711

location_facility: Sanofi-Aventis Investigational Site Number 300701

location_facility: Sanofi-Aventis Investigational Site Number 840760

location_facility: Sanofi-Aventis Investigational Site Number 300705

location_facility: Sanofi-Aventis Investigational Site Number 642706

location_facility: Sanofi-Aventis Investigational Site Number 840770

location_facility: Sanofi-Aventis Investigational Site Number 840775

location_facility: Sanofi-Aventis Investigational Site Number 040705

location_facility: Sanofi-Aventis Investigational Site Number 630714

location_facility: Sanofi-Aventis Investigational Site Number 840853

location_facility: Sanofi-Aventis Investigational Site Number 840764

location_facility: Sanofi-Aventis Investigational Site Number 840745

location_facility: Sanofi-Aventis Investigational Site Number 840751

location_facility: Sanofi-Aventis Investigational Site Number 276703

location_facility: Sanofi-Aventis Investigational Site Number 792705

location_facility: Sanofi-Aventis Investigational Site Number 276702

location_facility: Sanofi-Aventis Investigational Site Number 840730

location_facility: Sanofi-Aventis Investigational Site Number 840727

location_facility: Sanofi-Aventis Investigational Site Number 320703

location_facility: Sanofi-Aventis Investigational Site Number 604701

location_facility: Sanofi-Aventis Investigational Site Number 840867

location_facility: Sanofi-Aventis Investigational Site Number 040704

location_facility: Sanofi-Aventis Investigational Site Number 840709

location_facility: Sanofi-Aventis Investigational Site Number 642710

location_facility: Sanofi-Aventis Investigational Site Number 250707

location_facility: Sanofi-Aventis Investigational Site Number 840711

location_facility: Sanofi-Aventis Investigational Site Number 840874

location_facility: Sanofi-Aventis Investigational Site Number 276708

location_facility: Sanofi-Aventis Investigational Site Number 124705

location_facility: Sanofi-Aventis Investigational Site Number 840877

location_facility: Sanofi-Aventis Investigational Site Number 320702

location_facility: Sanofi-Aventis Investigational Site Number 840755

location_facility: Sanofi-Aventis Investigational Site Number 642702

location_facility: Sanofi-Aventis Investigational Site Number 040706

location_facility: Sanofi-Aventis Investigational Site Number 840779

location_facility: Sanofi-Aventis Investigational Site Number 840864

location_facility: Sanofi-Aventis Investigational Site Number 840780

location_facility: Sanofi-Aventis Investigational Site Number 840871

location_facility: Sanofi-Aventis Investigational Site Number 840795

location_facility: Sanofi-Aventis Investigational Site Number 840756

location_facility: Sanofi-Aventis Investigational Site Number 840769

location_facility: Sanofi-Aventis Investigational Site Number 320701

location_facility: Sanofi-Aventis Investigational Site Number 250701

location_facility: Sanofi-Aventis Investigational Site Number 840761

location_facility: Sanofi-Aventis Investigational Site Number 040707

location_facility: Sanofi-Aventis Investigational Site Number 124713

location_facility: Sanofi-Aventis Investigational Site Number 840855

location_facility: Sanofi-Aventis Investigational Site Number 840863

location_facility: Sanofi-Aventis Investigational Site Number 840872

location_facility: Sanofi-Aventis Investigational Site Number 840708

location_facility: Sanofi-Aventis Investigational Site Number 642703

location_facility: Sanofi-Aventis Investigational Site Number 484704

location_facility: Sanofi-Aventis Investigational Site Number 840738

location_facility: Sanofi-Aventis Investigational Site Number 840704

location_facility: Sanofi-Aventis Investigational Site Number 840722

location_facility: Sanofi-Aventis Investigational Site Number 124708

location_facility: Sanofi-Aventis Investigational Site Number 840796

location_facility: Sanofi-Aventis Investigational Site Number 840772

location_facility: Sanofi-Aventis Investigational Site Number 356701

location_facility: Sanofi-Aventis Investigational Site Number 642709

location_facility: Sanofi-Aventis Investigational Site Number 642712

location_facility: Sanofi-Aventis Investigational Site Number 250702

location_facility: Sanofi-Aventis Investigational Site Number 356702

location_facility: Sanofi-Aventis Investigational Site Number 840733

location_facility: Sanofi-Aventis Investigational Site Number 604702

location_facility: Sanofi-Aventis Investigational Site Number 040701

location_facility: Sanofi-Aventis Investigational Site Number 840865

location_facility: Sanofi-Aventis Investigational Site Number 840747

location_facility: Sanofi-Aventis Investigational Site Number 840739

location_facility: Sanofi-Aventis Investigational Site Number 642715

location_facility: Sanofi-Aventis Investigational Site Number 840798

location_facility: Sanofi-Aventis Investigational Site Number 840766

location_facility: Sanofi-Aventis Investigational Site Number 124703

location_facility: Sanofi-Aventis Investigational Site Number 604703

location_facility: Sanofi-Aventis Investigational Site Number 604705

location_facility: Sanofi-Aventis Investigational Site Number 840724

location_facility: Sanofi-Aventis Investigational Site Number 792702

location_facility: Sanofi-Aventis Investigational Site Number 300703

location_facility: Sanofi-Aventis Investigational Site Number 840862

location_facility: Sanofi-Aventis Investigational Site Number 124712

location_facility: Sanofi-Aventis Investigational Site Number 276706

location_facility: Sanofi-Aventis Investigational Site Number 840728

location_facility: Sanofi-Aventis Investigational Site Number 276707

location_facility: Sanofi-Aventis Investigational Site Number 840777

location_facility: Sanofi-Aventis Investigational Site Number 840794

location_facility: Sanofi-Aventis Investigational Site Number 642705

location_facility: Sanofi-Aventis Investigational Site Number 840858

intervention_type: Device


ReferenceCitation: Ramalingam SS, Spigel DR, Chen D, Steins MB, Engelman JA, Schneider CP, Novello S, Eberhardt WE, Crino L, Habben K, Liu L, Jänne PA, Brownstein CM, Reck M. Randomized phase II study of erlotinib in combination with placebo or R1507, a monoclonal antibody to insulin-like growth factor-1 receptor, for advanced-stage non-small-cell lung cancer. J Clin Oncol. 2011 Dec 1;29(34):4574-80. doi: 10.1200/JCO.2011.36.6799. Epub 2011 Oct 24.

name: Suresh S. Ramalingam, Winship Cancer Institute of Emory University, Atlanta, GA; David R. Spigel, Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN; David Chen, Kai Habben, Lian Liu, and Carrie M. Brownstein, Roche Pharmaceuticals, Nutley, NJ; Martin B. Steins, University of Heidelberg, Heidelberg; Claus-Peter Schneider, Central Clinic Bad Berka, Bad Berka; Wilfried E.E. Eberhardt, University Hospital Essen of University Duisburg-Essen, Essen; Martin Reck, Hospital Grosshansdorf,...

family: Ramalingam

full_name: Suresh S. Ramalingam

given: Suresh S.

family: Spigel

full_name: David R. Spigel

given: David R.

family: Chen

full_name: David Chen

given: David

family: Steins

full_name: Martin B. Steins

given: Martin B.

family: Engelman

full_name: Jeffrey A. Engelman

given: Jeffrey A.

family: Schneider

full_name: Claus-Peter Schneider

given: Claus-Peter

family: Novello

full_name: Silvia Novello

given: Silvia

family: Eberhardt

full_name: Wilfried E.E. Eberhardt

given: Wilfried E.E.

family: Crino

full_name: Lucio Crino

given: Lucio

family: Habben

full_name: Kai Habben

given: Kai

family: Liu

full_name: Lian Liu

given: Lian

family: Jänne

full_name: Pasi A. Jänne

given: Pasi A.

family: Brownstein

full_name: Carrie M. Brownstein

given: Carrie M.

family: Reck

full_name: Martin Reck

given: Martin

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

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Randomized Phase II Study of Erlotinib in Combination With Placebo or R1507, a Monoclonal Antibody to Insulin-Like Growth Factor-1 Receptor, for Advanced-Stage Non–Small-Cell Lung Cancer

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Germany
France
Poland
Ireland
Belgium
Australia
Spain
Canada
United Kingdom

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

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hopital Albert Michallon; Medecine Aigue Specialisee Pneumologie

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

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

location_facility: SK Przemienienia Panskiego UM im.K.Marcinkowskiego

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Royal Surrey County Hospital; St. Lukes Cancer Centre

location_facility: Wythenshawe Hospital; North West Lung Centre

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin I

location_facility: Hopital de La Croix Rousse; Service de Pneumologie

location_facility: Specjalistyczny Szpital Im. Prof. A. Sokolowskiego; Oddziall Chemioterapii

location_facility: University of Chicago Medical Center; Dept. of Medicine/Section of Nephrology

location_facility: Joliet Oncology Hematology Associates, Ltd.

location_facility: Fondation Hopital Saint Joseph; Pole Cancerologie, Imagerie Medicale Service d'Oncologie

location_facility: Klinikum Leverkusen; Med. Klinik III / Onkologie

location_facility: Flinders Medical Center; Medical Oncology

location_facility: Ludwig-Maximilians Uni Klinik Innenstadt; Medizinische Klinik

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

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

location_facility: Chattanooga Oncology and Hematology Associates, PC

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hopital Larrey; Clinique Des Voies Respiratoires

location_facility: Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte Frauenklinik

title: A Randomized, Placebo Controlled Study to Determine the Effect of Two Dose Schedules of R1507 or Placebo, Both in Combination With Erlotinib (Tarceva®), on Progression-free Survival in Patients With Advanced Non-small Cell Lung Cancer With Disease Progression After First or Second Line Chemotherapy

summary: This 4 arm study in patients with advanced Stage IIIb/IV non-small cell cancer (NSCLC) who failed at least one standard chemotherapy regimen will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva or placebo and Tarceva. Patients will be randomized to one of four treatment arms to receive R1507 (9mg/kg iv) or placebo weekly or R1507 (16mg/kg iv) or placebo every 3 weeks. Tarceva (150mg oral daily) will be administered in all treatment arms. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is <500 individuals.


ReferenceCitation: Hughes TP, Lipton JH, Spector N, Cervantes F, Pasquini R, Clementino NC, Dorlhiac Llacer PE, Schwarer AP, Mahon FX, Rea D, Branford S, Purkayastha D, Collins L, Szczudlo T, Leber B. Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib. Blood. 2014 Jul 31;124(5):729-36. doi: 10.1182/blood-2013-12-544015. Epub 2014 Jun 19.

name: South Australian Health and Medical Research Institute, Division of Haematology and Centre for Cancer Biology, South Australia Pathology, University of Adelaide, Adelaide, Australia;

family: Hughes

full_name: Timothy P. Hughes

given: Timothy P.

name: Princess Margaret Hospital, Leukemia Clinic, Blood and Marrow Transplant Centre, Apheresis Unit, Toronto, ON, Canada;

family: Lipton

full_name: Jeffrey H. Lipton

given: Jeffrey H.

name: Universidade Federal do Rio de Janeiro, Department of Clinical Medicine, Rio de Janeiro, Brazil;

family: Spector

full_name: Nelson Spector

given: Nelson

name: Hospital Clínic L'Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain;

family: Cervantes

full_name: Francisco Cervantes

given: Francisco

name: Universidade Federal do Paraná, Hospital de Clinicas, Curitiba, Paraná, Brazil;

family: Pasquini

full_name: Ricardo Pasquini

given: Ricardo

name: Hospital Das Clinicas da Universidade Federal de Minas Gerais, Belo Horizonte, Brazil;

family: Clementino

full_name: Nelma Cristina D. Clementino

given: Nelma Cristina D.

name: Hospital das Clinicas, Faculdade de Medicina da Universidade de São Paulo, Hematology Department, São Paulo, Brazil;

family: Dorlhiac Llacer

full_name: Pedro Enrique Dorlhiac Llacer

given: Pedro Enrique

name: Hematology Department, Alfred Hospital, Melbourne, Australia;

family: Schwarer

full_name: Anthony P. Schwarer

given: Anthony P.

name: Laboratoire d'Hématologie, Centre Hospitalier Universitaire de Bordeaux and Laboratoire Hématopoïèse Leucémique et Cible Thérapeutique, Biothérapies des Maladies Génétiques et Cancers, Inserm U1035, Université Bordeaux Ségalen, Bordeaux, France;

family: Mahon

full_name: Francois-Xavier Mahon

given: Francois-Xavier

name: Service des Maladies du Sang et EA3518, Hôpital Saint-Louis, Paris, France;

family: Rea

full_name: Delphine Rea

given: Delphine

family: Branford

full_name: Susan Branford

given: Susan

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ; and

family: Purkayastha

full_name: Das Purkayastha

given: Das

family: Collins

full_name: LaTonya Collins

given: LaTonya

family: Szczudlo

full_name: Tomasz Szczudlo

given: Tomasz

name: McMaster University and Juravinski Hospital and Cancer Centre, Hamilton, ON, Canada

family: Leber

full_name: Brian Leber

given: Brian

journal_name: Blood

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

location_country: Brazil France Argentina Australia Spain Canada

title: An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients With Evidence of Persistent Leukemia by RQ-PCR.

summary: The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.


title: A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.

summary: This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

location_country:
Peru
Greece
Romania
Australia
Taiwan
France
Poland
Thailand
Slovakia
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Puerto Rico
United States
Germany
United Kingdom
Mexico
Spain
Turkey


title: A Multi-center, Open-label, Follow-up Study to Assess the Long-term Safety of 125 mg Per Day of Oral Azimilide Dihydrochloride in Patients With an Implantable Cardioverter Defibrillator

summary: This is an open-label, multi-center, long-term, (open-ended) safety study with 125 mg per day of azimilide in patients who completed protocol 2000098.

lead_sponsor: Forest Laboratories

location_country:
United States
Germany
France
Poland
Belgium
Spain
Canada

location_facility:
Research Facility
Research Site


title: A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients

summary: The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

location_country:
United States
France
Poland
Argentina
Spain
Canada
Korea, Republic of
Taiwan

location_facility: Piedmont Hematology Oncology Associates, Pllc


ReferenceCitation: Krauss GL, Perucca E, Kwan P, Ben-Menachem E, Wang XF, Shih JJ, Patten A, Yang H, Williams B, Laurenza A. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase III randomized trials: Study 307. Epilepsia. 2018 Apr;59(4):866-876. doi: 10.1111/epi.14044. Epub 2018 Mar 25.

name: Department of Neurology; Johns Hopkins University; Baltimore MD USA

family: Krauss

full_name: Gregory L. Krauss

given: Gregory L.

name: Department of Internal Medicine and Therapeutics; University of Pavia; Pavia Italy

family: Perucca

full_name: Emilio Perucca

given: Emilio

name: Royal Melbourne Hospital; University of Melbourne; Parkville Vic.  Australia

name: Prince of Wales Hospital; The Chinese University of Hong Kong; Hong Kong  China

family: Kwan

full_name: Patrick Kwan

given: Patrick

family: Ben-Menachem

full_name: Elinor Ben-Menachem

given: Elinor

name: Chongqing Key Laboratory of Neurology; First Affiliated Hospital of Chongqing Medical University; Chongqing China

family: Wang

full_name: Xue-Feng Wang

given: Xue-Feng

name: Department of Neurosciences; UCSD School of Medicine; La Jolla CA USA

family: Shih

full_name: Jerry J. Shih

given: Jerry J.

name: Department of Biostatistics; Eisai Ltd.; Hatfield  UK

family: Patten

full_name: Anna Patten

given: Anna

name: Former Employee of Eisai Inc.; Woodcliff Lake NJ  USA

family: Yang

full_name: Haichen Yang

given: Haichen

name: Eisai Neurology Business Group; Eisai Inc.; Woodcliff Lake NJ USA

family: Williams

full_name: Betsy Williams

given: Betsy

family: Laurenza

full_name: Antonio Laurenza

given: Antonio

journal_name: Epilepsia

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

ReferenceCitation: Rosenfeld W, Conry J, Lagae L, Rozentals G, Yang H, Fain R, Williams B, Kumar D, Zhu J, Laurenza A. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase III randomized clinical studies and a combined extension study. Eur J Paediatr Neurol. 2015 Jul;19(4):435-45. doi: 10.1016/j.ejpn.2015.02.008. Epub 2015 Mar 5.

family: Rosenfeld

full_name: William Rosenfeld

given: William

family: Conry

full_name: Joan Conry

given: Joan

family: Lagae

full_name: Lieven Lagae

given: Lieven

family: Rozentals

full_name: Guntis Rozentals

given: Guntis

family: Fain

full_name: Randi Fain

given: Randi

family: Kumar

full_name: Dinesh Kumar

given: Dinesh

family: Zhu

full_name: Jin Zhu

given: Jin

journal_name: European Journal of Paediatric Neurology

ReferenceCitation: Krauss GL, Perucca E, Ben-Menachem E, Kwan P, Shih JJ, Clément JF, Wang X, Bagul M, Gee M, Zhu J, Squillacote D. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalized seizures: results from phase III extension study 307. Epilepsia. 2014 Jul;55(7):1058-68. doi: 10.1111/epi.12643. Epub 2014 May 27.

name: Johns Hopkins University Baltimore Maryland U.S.A

name: National Neurological Institute IRCSS C Mondino Foundation Pavia Italy

name: Department of Internal Medicine and Therapeutics University of Pavia Pavia Italy

name: The Chinese University of Hong Kong Prince of Wales Hospital Hong Kong China

name: Royal Melbourne Hospital University of Melbourne Parkville Victoria Australia

name: Charles LeMoyne Hospital Greenfield Park Quebec Canada

name: Chongqing Medical University Chongqing China

name: Eisai Ltd. Hatfield Hertfordshire United Kingdom

name: Eisai Inc. Woodcliff Lake New Jersey U.S.A

repository_normalized: University of Melbourne - Minerva Access

title: Long‐term safety of perampanel and seizure outcomes in refractory partial‐onset seizures and secondarily generalized seizures: Results from phase III extension study 307

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
Ukraine
India
France
Poland
Lithuania
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Israel
Spain
Estonia
Latvia

title: An Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures

summary: The purpose of this study was to evaluate the safety and tolerability of perampanel (up to 12 mg/day) given as adjunctive treatment in subjects with refractory partial seizures and to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.


intervention_type: Dietary Supplement

lead_sponsor: Acrotech Biopharma LLC

location_country:
Croatia
France
Belgium
Argentina
Spain
United States

location_facility: The University of Arizona Health Sciences Center

location_facility: Clinic of Oncology and Nuclear Medicine, CH "Sestre Milosrdnice"

location_facility: CHU Zagreb University Hospital Center Rebro in Zagreb

location_facility: CH Split Clinic of Oncology and Radiotherapy

location_facility: University of Utah, Huntsman Cancer Institute

location_facility: Centro de Terapia Radiante Cumbres (CAICI)

title: A Phase 2, Single-Arm Study of Pralatrexate in Patients With Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder

summary: The purpose of this study is to determine whether pralatrexate, given with vitamin B12 and folic acid, is effective in the treatment of advanced or metastatic bladder cancer. The study will also investigate the safety of pralatrexate with vitamin B12 and folic acid in this patient population. Additionally, this study includes the collection of blood samples to investigate the pharmacokinetics (PK) of pralatrexate in this patient population (PK is the activity of a drug in the body over a period of time, including how the drug is absorbed, distributed in the body, localized in the tissues, and excreted from the body).


title: A Multicenter Open Label Phase II Study of the Efficacy and Safety of AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) as Second Line Therapy in Patients With Recurrent Platinum Sensitive Ovarian Cancer

summary: The purpose of this study is to obtain an estimate of the objective response rate (ORR) of AMG 479 in patients with recurrent platinum-sensitive ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma failing frontline chemotherapy.

lead_sponsor: Translational Research in Oncology

location_country:
United States
France
Israel
Ireland
Spain
Germany
Canada

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Hospital Universitario Virgen Macarena de Sevilla

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Ventura County Hematology Oncology Specialists

location_facility: University of Southern California/ Norris Comprehensive Cancer Center

location_facility: North Valley Hematology/ Oncology Medical Group

intervention_type: Biological


title: A 12-week, Open Label, Multicenter, Titration Study, With a 9-month Maintenance Treatment Extension, to Demonstrate Efficacy of SBR759 Compared to Sevelamer HCl in Lowering Serum Phosphate Levels in Chronic Kidney Disease Patients on Hemodialysis

summary: This study will evaluate the efficacy of SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Chronic Kidney Disease patients on hemodialysis

ReferenceCitation: Chen JB, Chiang SS, Chen HC, Obayashi S, Nagasawa M, Hexham JM, Balfour A, Junge G, Akiba T, Fukagawa M. Efficacy and safety of SBR759, a novel calcium-free, iron(III)-based phosphate binder, in Asian patients undergoing hemodialysis: A 12-week, randomized, open-label, dose-titration study versus sevelamer hydrochloride. Nephrology (Carlton). 2011 Nov;16(8):743-50. doi: 10.1111/j.1440-1797.2011.01509.x.

family: CHEN

full_name: JIN-BOR CHEN

given: JIN-BOR

family: CHIANG

full_name: SHOU-SHAN CHIANG

given: SHOU-SHAN

full_name: HUNG-CHUN CHEN

given: HUNG-CHUN

family: OBAYASHI

full_name: SEIICHI OBAYASHI

given: SEIICHI

family: NAGASAWA

full_name: MASAKI NAGASAWA

given: MASAKI

family: HEXHAM

full_name: J MARK HEXHAM

given: J MARK

family: BALFOUR

full_name: ALISON BALFOUR

given: ALISON

family: JUNGE

full_name: GUIDO JUNGE

given: GUIDO

family: AKIBA

full_name: TAKASHI AKIBA

given: TAKASHI

family: FUKAGAWA

full_name: MASAFUMI FUKAGAWA

given: MASAFUMI

journal_name: Nephrology

location_country:
Italy
United States
Sweden
Switzerland
Germany
Finland
France
Norway
Belgium
Australia
Puerto Rico
Canada
United Kingdom

location_facility:
Novarits
Novartis Investigative Site
Novartis


ReferenceCitation: Nauck MA, Petrie JR, Sesti G, Mannucci E, Courrèges JP, Lindegaard ML, Jensen CB, Atkin SL; Study 1821 Investigators. A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):231-41. doi: 10.2337/dc15-0165. Epub 2015 Sep 10.

family: Nauck

full_name: Michael A. Nauck

given: Michael A.

family: Petrie

full_name: John R. Petrie

given: John R.

family: Sesti

full_name: Giorgio Sesti

given: Giorgio

family: Mannucci

full_name: Edoardo Mannucci

given: Edoardo

family: Courrèges

full_name: Jean-Pierre Courrèges

given: Jean-Pierre

family: Lindegaard

full_name: Marie L. Lindegaard

given: Marie L.

family: Jensen

full_name: Christine B. Jensen

given: Christine B.

family: Atkin

full_name: Stephen L. Atkin

given: Stephen L.

journal_name: Diabetes Care

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Austria
South Africa
Former Serbia and Montenegro
India
Switzerland
Finland
France
Bulgaria
Hungary
Spain
Turkey
Germany
United Kingdom

title: Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial

summary: This trial was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.


title: An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712

summary: An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.

ReferenceType: background

ReferenceCitation: Roberts JL, Ortonne JP, Tan JK, Jaracz E, Frankel E; Alefacept Clinical Study Group. The safety profile and sustained remission associated with response to multiple courses of intramuscular alefacept for treatment of chronic plaque psoriasis. J Am Acad Dermatol. 2010 Jun;62(6):968-78. doi: 10.1016/j.jaad.2009.07.032. Epub 2010 Apr 14.

lead_sponsor: Astellas Pharma Inc

location_country:
United States
Netherlands
Germany
France
Belgium
Spain
Denmark
Canada
United Kingdom


title: Cetrorelix Pamoate (AEZS-102) in Patients With Symptomatic BPH: a Double-blind Placebo-controlled Efficacy Study

summary:
Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is characterized by an enlargement of the prostate occurring in human male over the age of 50 which increases in prevalence with age, and among those aged 50 to 80, about 40% report moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve patients' quality of life which primarily depends on the severity of the symptoms of BPH. Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to 52) are eligible to receive the active drug during the open-label part of the study (Week 52 to 90).

lead_sponsor: AEterna Zentaris

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: 19th Central Regional Policlinic, Urology department

location_facility: Aleksandrovska Hospital, Kidney Transplantation Department

location_facility: Urologische Praxisgemeinschaft Frankfurt Höchst

location_facility: Klinikum Offenbach GmbH, Klinik für Urologie

location_facility: Irccs Ospedale San Raffaele Milano, Università Vita Salute-San Raffaele

location_facility: Multiprofil Hospital "Sveta Anna", Urology Department

location_facility: Leighton Hospital, Clinical Trials Dept., Michael Heal Unit

location_facility: National Central Hospital for Active Treatment of Oncology JSC

location_facility: University of Bari, Department of Urology

location_facility: Spitalul Clinic de Urgenta "Sf. Ioan", Clinica Urologie

location_facility: University multiprofil Hospital of Active Treatment "Sveti Georgi", Urology Department

location_facility: Spitalul Clinic de Urologie "Prof. Dr. Th. Burghele"

location_facility: Minsk Regional Clinical Hospital, Clinic of Urology

location_facility: Urocentrum Prague, Out-Patient Clinic of Urology

location_facility: Clinica Chirurgie Urologica si Transplant Renal

location_facility: Leicester General Hospital, Urology Section

location_facility: Policlinic Pod Marjánkou 12, Urological Department

location_facility: Bristol Royal Infirmary, Urology Research Unit

location_facility: Aleksandrovska Hospital, Oncourology Department

location_facility: Urologische Klinik, Ev. Krankenhaus Oberhausen

location_facility: University of Padova, Department of Urology

location_facility: 1st Medical Faculty of Charles University, Deputy Department and Clinic of Urology

intervention_type: Other


title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Randomized, Phase 2/3 Trial to Evaluate the Glycemic Efficacy, Renal Safety, Pharmacokinetics, and Pharmacodynamics of Dapagliflozin in Subjects With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control

summary: The purpose of this study is to determine whether dapagliflozin is effective in the treatment of type 2 diabetes in subjects with poor blood sugar control and moderate renal impairment

ReferenceCitation: Fioretto P, Stefansson BV, Johnsson E, Cain VA, Sjöström CD. Dapagliflozin reduces albuminuria over 2 years in patients with type 2 diabetes mellitus and renal impairment. Diabetologia. 2016 Sep;59(9):2036-9. doi: 10.1007/s00125-016-4017-1. Epub 2016 Jun 15.

family: Fioretto

full_name: Paola Fioretto

given: Paola

family: Stefansson

full_name: Bergur V. Stefansson

given: Bergur V.

family: Johnsson

full_name: Eva Johnsson

given: Eva

family: Cain

full_name: Valerie A. Cain

given: Valerie A.

family: Sjöström

full_name: C. David Sjöström

given: C. David

journal_name: Diabetologia

endpoint_id: ebkqzhfrceygztdsjokh

repository_institution: University of Padua - Padua Research Archive

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Kohan DE, Fioretto P, Tang W, List JF. Long-term study of patients with type 2 diabetes and moderate renal impairment shows that dapagliflozin reduces weight and blood pressure but does not improve glycemic control. Kidney Int. 2014 Apr;85(4):962-71. doi: 10.1038/ki.2013.356. Epub 2013 Sep 25.

family: Kohan

full_name: Donald E. Kohan

given: Donald E.

family: Tang

full_name: Weihua Tang

given: Weihua

family: List

full_name: James F. List

given: James F.

journal_name: Kidney International

location_country:
Italy
United States
Peru
India
Mexico
France
Singapore
Argentina
Australia
Puerto Rico
Spain
Denmark
Canada

location_facility: University Of Medicine And Dentistry Of New Jersey

location_facility: Va Nebraska-Western Iowa Health Care System (Nwihcs)

location_facility: Center For Thyroid Diseases And Endocrinology

location_facility: Zablocki Veterans Affairs Medical Center


ReferenceCitation: Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30.

family: Laine

full_name: L. Laine

given: L.

family: Katz

full_name: P. O. Katz

given: P. O.

family: Johnson

full_name: D. A. Johnson

given: D. A.

family: Ibegbu

full_name: I. Ibegbu

given: I.

family: Goldstein

full_name: M. J. Goldstein

given: M. J.

family: Chou

full_name: C. Chou

given: C.

family: Rossiter

full_name: G. Rossiter

given: G.

family: Lu

full_name: Y. Lu

given: Y.

journal_name: Alimentary Pharmacology & Therapeutics

lead_sponsor: Eisai Inc.

location_country:
United States
Chile
India
Germany
Croatia
Bulgaria
France
Hungary
Argentina
Australia
Estonia
Canada
Latvia

acronym: Not applicable

title: A Randomized Double-Blind Parallel Study of Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)

summary: The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).


title: A Randomized, Open-label, Dose-escalation to Rash Study to Assess the Effect of Tarceva in Combination With Gemcitabine on Overall Survival in Patients With Metastatic Pancreatic Cancer.

summary: This study will compare the efficacy and safety of escalating versus standard doses to rash of Tarceva, in combination with gemcitabine, in patients with metastatic pancreatic cancer. During a 4 week run-in period, all patients will receive Tarceva 100mg/day po plus gemcitabine 1000mg/m2 iv on days 1, 8,15 and 22. After 4 weeks, patients who have not developed rash, or only develop grade 1 rash, will be randomized to one of 2 groups. Group 1 will receive a starting dose of Tarceva 150mg po daily, increased in steps of 50mg every 2 weeks up to a maximum of 250mg/day po, until development of grade 2 rash or other dose-limiting toxicity. Group 2 will continue to receive Tarceva 100mg/day po. All patients will continue to receive gemcitabine 1000mg/m2 iv on days 1, 8 and 15 of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

location_country:
Greece
Romania
Australia
Belgium
Denmark
Taiwan
Croatia
France
Lithuania
Poland
Argentina
Canada
Hong Kong
Singapore
Germany
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
Spain


title: A Prospective Randomized Open-label 6-Month Head-To-Head Trial to Compare Metabolic Effects of Paliperidone ER and Olanzapine in Subjects With Schizophrenia

summary: The purpose of this 6 month study is to compare the metabolic effects of paliperidone ER and olanzapine in patients with schizophrenia, using the ratio of the concentration of lipids (triglycerides (TG)) in the blood to the concentration of good cholesterol (high density lipoproteins (HDL)) in the blood as the primary parameter. Approximately 456 adult patients will participate in this study.

lead_sponsor: Janssen-Cilag International NV

location_country:
South Africa
Jordan
Lebanon
France
Greece
Lithuania
Slovakia
Romania
Argentina
Egypt
Spain
Estonia
Latvia
Turkey