title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

summary: This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3). pii: e001395. doi: 10.1136/rmdopen-2020-001395.

family: Cohen

full_name: Stanley B Cohen

given: Stanley B

family: Tanaka

full_name: Yoshiya Tanaka

given: Yoshiya

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Curtis

full_name: Jeffrey R Curtis

given: Jeffrey R

family: Lee

full_name: Eun Bong Lee

given: Eun Bong

family: Nash

full_name: Peter Nash

given: Peter

family: Winthrop

full_name: Kevin L Winthrop

given: Kevin L

family: Charles-Schoeman

full_name: Christina Charles-Schoeman

given: Christina

family: Wang

full_name: Lisy Wang

given: Lisy

family: Chen

full_name: Connie Chen

given: Connie

family: Kwok

full_name: Kenneth Kwok

given: Kenneth

family: Biswas

full_name: Pinaki Biswas

given: Pinaki

family: Shapiro

full_name: Andrea Shapiro

given: Andrea

family: Madsen

full_name: Ann Madsen

given: Ann

family: Wollenhaupt

full_name: Jürgen Wollenhaupt

given: Jürgen

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

ReferenceCitation: Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.

family: Strand

full_name: Vibeke Strand

given: Vibeke

family: Kaine

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

repository_institution: Newcastle Univesity - Newcastle University ePrints

ReferenceCitation: Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.

ReferenceCitation: Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.

ReferenceCitation: Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

name: Université Paris-Sud, Assistance publique-Hôpitaux de Paris; Hôpitaux Universitaires Paris-Sud; INSERM U1184; Le Kremlin Bicêtre France

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

ReferenceCitation: Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum in: Ann Rheum Dis. 2017 Mar;76(3):611.

ReferenceCitation: Strand V, Burmester GR, Zerbini CA, Mebus CA, Zwillich SH, Gruben D, Wallenstein GV. Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial. Arthritis Care Res (Hoboken). 2015 Apr;67(4):475-83. doi: 10.1002/acr.22453.

name: Biopharmaceutical consultant; Portola Valley California

name: Charité-Universitätsmedizin Berlin; Berlin Germany

name: Centro Paulista de Investigação Clinica; Sao Paulo Brazil

title: Tofacitinib With Methotrexate in Third-Line Treatment of Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Trial

ReferenceCitation: Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

name: Metroplex Clinical Research CenterDallasTexas

name: Universidade Federal do ParanáCuritibaBrazil

name: Hospital Clinico Universitario de SantiagoSantiago de CompostelaSpain

repository_institution: IMA Press - Rheumatology Science and Practice (Nauchno-prakticheskaya revmatologiya)

title: Analysis of Infections and All‐Cause Mortality in Phase II, Phase III, and Long‐Term Extension Studies of Tofacitinib in Patients With Rheumatoid Arthritis

ReferenceCitation: Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C; ORAL Step investigators. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. 2013 Feb 9;381(9865):451-60. doi: 10.1016/S0140-6736(12)61424-X. Epub 2013 Jan 5.

location_country:
Italy
Austria
Brazil
Germany
France
Korea, Republic of
Ireland
Australia
Belgium
Puerto Rico
Spain
United States
Canada
Taiwan


title: A Randomised, Open-label, Multi-centre, 2-stage, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC) in Comparison With LDAC Alone in Patients Aged ≥ 60 With Newly Diagnosed Acute Myeloid Leukaemia (AML)

summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Quintás-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15.

name: Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

family: Quintás-Cardama

full_name: Alfonso Quintás-Cardama

given: Alfonso

sequence: first

family: Ravandi

full_name: Farhad Ravandi

given: Farhad

sequence: additional

family: Liu-Dumlao

full_name: Theresa Liu-Dumlao

given: Theresa

family: Brandt

full_name: Mark Brandt

given: Mark

family: Faderl

full_name: Stefan Faderl

given: Stefan

family: Pierce

full_name: Sherry Pierce

given: Sherry

family: Borthakur

full_name: Gautam Borthakur

given: Gautam

family: Garcia-Manero

full_name: Guillermo Garcia-Manero

given: Guillermo

family: Cortes

full_name: Jorge Cortes

given: Jorge

family: Kantarjian

full_name: Hagop Kantarjian

given: Hagop

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Blood

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

version: publishedVersion

evidence: oa repository (via pmcid lookup)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

lead_sponsor: AstraZeneca

location_country:
Italy
United States
France
Japan
Romania
Australia
Spain
Germany
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

ReferenceType: background

ReferenceCitation: van Lunzen J, Maggiolo F, Arribas JR, Rakhmanova A, Yeni P, Young B, Rockstroh JK, Almond S, Song I, Brothers C, Min S. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial. Lancet Infect Dis. 2012 Feb;12(2):111-8. doi: 10.1016/S1473-3099(11)70290-0. Epub 2011 Oct 20.

lead_sponsor: ViiV Healthcare

location_country:
Italy
United States
France
Russian Federation
Spain
Germany


title: Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled

acronym: LANCELOT

summary:
Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

Plasma glucose (fasting, nocturnal) over time,
Changes from baseline in HbA1c over time,
Percentage of patients who reach the target of HbA1c <7 and <6.5,
Use of prandial insulin as rescue medication at month 6,
Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
Daily dose of insulin,
Change in body weight from baseline,
Evolution of 8-point plasma-glucose (PG) profiles,
Overall safety,
Patient reported outcomes (treatment satisfaction).

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

name: Institute of General Practice and Evidence-Based Health Services Research; Medical University of Graz; Graz Austria

family: Semlitsch

full_name: Thomas Semlitsch

given: Thomas

name: Institute for General Practice; Goethe University; Frankfurt am Main Germany

family: Engler

full_name: Jennifer Engler

given: Jennifer

name: Institute of General Practice and Evidence-Based Health Services Research, Medical University of Graz; Graz, Austria / Institute of General Practice, Goethe University; Frankfurt am Main Austria

family: Siebenhofer

full_name: Andrea Siebenhofer

name: Institute of General Practice and Evidence-Based Health Services Research / Institute for Medical Informatics, Statistics and Documentation; Medical University of Graz; Graz Austria

family: Jeitler

full_name: Klaus Jeitler

given: Klaus

family: Berghold

full_name: Andrea Berghold

name: Institute of General Practice and Evidence-Based Health Services Research / Department of Internal Medicine, Division of Endocrinology and Metabolism; Medical University of Graz; Graz Austria

family: Horvath

full_name: Karl Horvath

given: Karl

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Home PD, Bolli GB, Mathieu C, Deerochanawong C, Landgraf W, Candelas C, Pilorget V, Dain MP, Riddle MC. Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):15-22. doi: 10.1111/dom.12329. Epub 2014 Jul 12.

name: Institute for Cellular Medicine – Diabetes Newcastle University  Newcastle upon Tyne UK

family: Home

full_name: P. D. Home

given: P. D.

name: Department of Medicine University of Perugia  Perugia Italy

family: Bolli

full_name: G. B. Bolli

given: G. B.

name: Department of Endocrinology University Hospital Gasthuisberg  Leuven Belgium

family: Mathieu

full_name: C. Mathieu

given: C.

name: Rajavithi Hospital, College of Medicine Rangsit University, Ministry of Public Health  Bangkok Thailand

family: Deerochanawong

full_name: C. Deerochanawong

family: Landgraf

full_name: W. Landgraf

given: W.

family: Candelas

full_name: C. Candelas

family: Pilorget

full_name: V. Pilorget

given: V.

family: Dain

full_name: M.‐P. Dain

name: Oregon Health & Science University  Portland OR USA

family: Riddle

full_name: M. C. Riddle

given: M. C.

journal_name: Diabetes, Obesity and Metabolism

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Modulation of insulin dose titration using a hypoglycaemia‐sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin‐naïve people with type 2 diabetes

location_country:
Italy
Brazil
Sweden
United Arab Emirates
Switzerland
Mexico
Netherlands
France
Poland
Thailand
Slovakia
Kuwait
Romania
Russian Federation
Egypt
Czech Republic
Korea, Republic of

location_facility:
Investigational Site Number 818001
Investigational Site Number 076-005
Investigational Site Number 642004
Investigational Site Number 410006
Investigational Site Number 616002
Investigational Site Number 703001
Investigational Site Number 410004
Investigational Site Number 642012
Investigational Site Number 076-002
Investigational Site Number 752004
Investigational Site Number 528001
Investigational Site Number 250-004
Investigational Site Number 642010
Investigational Site Number 703006
Investigational Site Number 764004
Investigational Site Number 764003
Investigational Site Number 410001
Investigational Site Number 764006
Investigational Site Number 643-001
Investigational Site Number 642002
Investigational Site Number 414001
Investigational Site Number 250-001
Investigational Site Number 528006
Investigational Site Number 703004
Investigational Site Number 250-006
Investigational Site Number 528005
Investigational Site Number 203010
Investigational Site Number 203009
Investigational Site Number 484003
Investigational Site Number 643-007
Investigational Site Number 643-004
Investigational Site Number 076-001
Investigational Site Number 203007
Investigational Site Number 076-003
Investigational Site Number 410003
Investigational Site Number 203001
Investigational Site Number 643-003
Investigational Site Number 703003
Investigational Site Number 764001
Investigational Site Number 410005
Investigational Site Number 484001
Investigational Site Number 703002
Investigational Site Number 756001
Investigational Site Number 380001
Investigational Site Number 076-007
Investigational Site Number 642003
Investigational Site Number 203005
Investigational Site Number 642009
Investigational Site Number 752003
Investigational Site Number 528004
Investigational Site Number 203006
Investigational Site Number 752002
Investigational Site Number 752001
Investigational Site Number 076-006
Investigational Site Number 764005
Investigational Site Number 484008
Investigational Site Number 784-001
Investigational Site Number 703005
Investigational Site Number 703007
Investigational Site Number 203004
Investigational Site Number 484005
Investigational Site Number 203003
Investigational Site Number 203002
Investigational Site Number 076-004
Investigational Site Number 203011
Investigational Site Number 643-002
Investigational Site Number 764002
Investigational Site Number 250-005
Investigational Site Number 642008
Investigational Site Number 250-002
Investigational Site Number 484002
Investigational Site Number 484009
Investigational Site Number 616003
Investigational Site Number 703008
Investigational Site Number 643-006
Investigational Site Number 642005
Investigational Site Number 642007
Investigational Site Number 528003
Investigational Site Number 410002
Investigational Site Number 616001
Investigational Site Number 642011
Investigational Site Number 528002
Investigational Site Number 643-005
Investigational Site Number 203008
Investigational Site Number 250-003
Investigational Site Number 642001
Investigational Site Number 616004


title: A Multi-center, Randomized, Open Label, Controlled Study to Compare the Sustained Virological Response During Treatment With Neoral or Tacrolimus in Maintenance Liver Transplant Recipients Treated With Pegylated Interferon and Ribavirin for Recurrent Hepatitis C

acronym: SUSTAIN

summary: This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Brazil
United States
Switzerland
Germany
France
Belgium
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of
Colombia


ReferenceCitation: Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. doi: 10.1016/S1470-2045(15)70081-1. Epub 2015 Mar 18.

family: Fassnacht

full_name: Martin Fassnacht

given: Martin

family: Berruti

full_name: Alfredo Berruti

given: Alfredo

family: Baudin

full_name: Eric Baudin

given: Eric

family: Demeure

full_name: Michael J Demeure

given: Michael J

family: Gilbert

full_name: Jill Gilbert

given: Jill

family: Haak

full_name: Harm Haak

given: Harm

family: Kroiss

full_name: Matthias Kroiss

given: Matthias

family: Quinn

full_name: David I Quinn

given: David I

family: Hesseltine

full_name: Elizabeth Hesseltine

given: Elizabeth

family: Ronchi

full_name: Cristina L Ronchi

given: Cristina L

family: Terzolo

full_name: Massimo Terzolo

given: Massimo

family: Choueiri

full_name: Toni K Choueiri

given: Toni K

family: Poondru

full_name: Srinivasu Poondru

given: Srinivasu

family: Fleege

full_name: Tanya Fleege

given: Tanya

family: Rorig

full_name: Ramona Rorig

given: Ramona

family: Chen

full_name: Jihong Chen

given: Jihong

family: Stephens

full_name: Andrew W Stephens

given: Andrew W

family: Worden

full_name: Francis Worden

given: Francis

family: Hammer

full_name: Gary D Hammer

given: Gary D

journal_name: The Lancet Oncology

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

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

intervention_type: Other

study_start_date_type: Actual

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
United States
Netherlands
Germany
France
Poland
Australia
Canada
United Kingdom

acronym: GALACCTIC

location_facility: TGen Clinical Research Service at Scottsdale Healthcare

location_facility: University of Colorado Denver Cancer Center

location_facility: Royal North Shore Hospital Department of Endocrinology

location_facility: Centre hospitalier de l'Université de Montréal (CHUM)

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach

location_facility: CHRU Lille, Clinique Endocrinologique Marc Linquette

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

summary: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens


title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

summary: The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

lead_sponsor: MacroGenics

location_country:
Italy
India
United Kingdom
Mexico
Netherlands
Germany
Finland
France
Poland
Israel
Romania
Belgium
Spain
United States
Czech Republic
Ukraine

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism

location_facility: Ivano-Frankivsk State Regional Pediatric Clinical Hospital

location_facility: The Safra Children's Hospital, The Chaim Sheba Medical Center

location_facility: Herz und Diabeteszentrum Nordrhein-Westfallen

location_facility: B. P. Poddar Hospital & Medical Research Limited

location_facility: Diabetes and Glandular Disease Research Associates, PA

location_facility: Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.

location_facility: Regional Clinical Endocrinology Dispensary of MoH Ukraine

location_facility: Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: John H Stoger Jr. Hospital of Cook County, Cook County Hospital

location_facility: Institutul National De Diabet, Nutritie si Boli Metabolice

location_facility: Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,

location_facility: University Diabetes & Endocrine Consultants

location_facility: Hospital y Clinica OCA / Monterrey International Research Center

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu

location_facility: Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd.

location_facility: Children's Hospitals and Clinics of Minnesota

location_facility: Clinical Innovations Inc. Research Facility

location_facility: Wojewódzki Specjalistyczny Szpital Dzieciecy

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia

location_facility: Donetsk Regional Children Clinical Hospital

location_facility: Ukrainian Children Specialized Clinical Hospital

location_facility: Hospital Universitario Principe de Asturias

location_facility: Maryland Diabetes & Endocrine Associates

location_facility: CHU de Brest Hôpital de la Cavale Blanche

location_facility: Maulana Azad Medical College and Associated Hospitals

location_facility: University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,

location_facility: U.O. di Malattie Metaboliche e Diabetologia

location_facility: University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology

location_facility: East Carolina University, Brody School of Medicine

location_facility: Klinika deti a dorostu FN Kralovske Vinohrady

location_facility: Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole

location_facility: Sheffield Children's Hospital NHS Foundation Trust

location_facility: I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice

location_facility: Queens Medical Centre, Diabetes and Endocrinology Unit

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology

location_facility: Centrum diabetologie, Institut klinicke a experimentalni mediciny

location_facility: Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital Civil

location_facility: Kharkiv Regional Clinical Children Hospital, Department of Endocrinology


title: A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.

summary: The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

enrollment_type: Anticipated

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Kirson ED, Schneiderman RS, Dbalý V, Tovarys F, Vymazal J, Itzhaki A, Mordechovich D, Gurvich Z, Shmueli E, Goldsher D, Wasserman Y, Palti Y. Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). BMC Med Phys. 2009 Jan 8;9:1. doi: 10.1186/1756-6649-9-1.

ReferenceCitation: Ram Z, Kim CY, Hottinger AF, Idbaih A, Nicholas G, Zhu JJ. Efficacy and Safety of Tumor Treating Fields (TTFields) in Elderly Patients with Newly Diagnosed Glioblastoma: Subgroup Analysis of the Phase 3 EF-14 Clinical Trial. Front Oncol. 2021 Sep 27;11:671972. doi: 10.3389/fonc.2021.671972. eCollection 2021.

family: Ram

full_name: Zvi Ram

given: Zvi

family: Kim

full_name: Chae-Yong Kim

given: Chae-Yong

family: Hottinger

full_name: Andreas F. Hottinger

given: Andreas F.

family: Idbaih

full_name: Ahmed Idbaih

given: Ahmed

family: Nicholas

full_name: Garth Nicholas

given: Garth

family: Zhu

full_name: Jay-Jiguang Zhu

given: Jay-Jiguang

currency_apc_doaj: USD

journal_name: Frontiers in Oncology

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_normalized: HAL

repositories:
HAL
PubMed Central

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

ReferenceCitation: Kim CY, Paek SH, Nam DH, Chang JH, Hong YK, Kim JH, Kim OL, Kim SH. Tumor treating fields plus temozolomide for newly diagnosed glioblastoma: a sub-group analysis of Korean patients in the EF-14 phase 3 trial. J Neurooncol. 2020 Feb;146(3):399-406. doi: 10.1007/s11060-019-03361-2. Epub 2020 Feb 4.

family: Paek

full_name: Sun Ha Paek

given: Sun Ha

family: Nam

full_name: Do-hyun Nam

given: Do-hyun

family: Chang

full_name: Jong-Hee Chang

given: Jong-Hee

family: Hong

full_name: Yong-Kil Hong

given: Yong-Kil

full_name: Jeong Hoon Kim

given: Jeong Hoon

full_name: Oh Lyong Kim

given: Oh Lyong

ReferenceCitation: Ballo MT, Urman N, Lavy-Shahaf G, Grewal J, Bomzon Z, Toms S. Correlation of Tumor Treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1106-1113. doi: 10.1016/j.ijrobp.2019.04.008. Epub 2019 Apr 23.

journal_name: International Journal of Radiation Oncology*Biology*Physics

ReferenceCitation: Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019 Jan;141(2):467-473. doi: 10.1007/s11060-018-03057-z. Epub 2018 Dec 1.

ReferenceCitation: Taphoorn MJB, Dirven L, Kanner AA, Lavy-Shahaf G, Weinberg U, Taillibert S, Toms SA, Honnorat J, Chen TC, Sroubek J, David C, Idbaih A, Easaw JC, Kim CY, Bruna J, Hottinger AF, Kew Y, Roth P, Desai R, Villano JL, Kirson ED, Ram Z, Stupp R. Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):495-504. doi: 10.1001/jamaoncol.2017.5082.

name: Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands

name: Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands

name: Department of Neurosurgery, Rabin Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel

name: Research and Development, Novocure, Haifa, Switzerland

name: Department of Neurology 2, Salpêtrière University Hospital, Assistance Public Hôpitaux de Paris, L’Université Pierre et Marie Curie University, Paris VI University, Paris, France

name: Department of Neurosurgery, Geisinger Medical Center, Danville, Pennsylvania

name: Department of Neuro-oncology, Hospices Civils de Lyon, University Claude Bernard Lyon, Lyon, France

name: Department of Neurosurgery, University of Southern California, Los Angeles

name: Department of Neurosurgery, Na Homolce Hospital, Prague, Czech Republic

name: Department of Neurosurgery, Lahey Clinic, Burlington, Massachusetts

name: Department of Medical Oncology, Cross Cancer Institute, Edmonton, California

name: Department of Neurosurgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Bundang, Korea

name: Department of Neurology, Hospital Universitari Bellvitge, Barcelona, Spain

name: Department of Medical Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

name: Clinical Neuro-Oncology Research Program, Department of Internal Medicine, Methodist Hospital, Houston, Texas

name: Department of Neurology, University of Zurich, Zurich, Switzerland

name: Neurosurgery and Spine Association, Maine Medical Center, Scarborough, Maine

name: Clinical Neuro-Oncology Research Program, Department of Internal Medicine, University of Kentucky Medical Center, Lexington

name: Department of Neurosurgery, Tel Aviv Medical Center, Tel Aviv University, Tel Aviv, Israel

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

name: Northwestern Brain Tumor Institute, Northwestern University Feinberg School of Medicine, Chicago, Illinois

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum in: JAMA. 2018 May 1;319(17):1824.

name: Lou and Jean MalnatiBrain Tumor Institute of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University Feinberg School of Medicine, Chicago, Illinois

name: Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland

name: Inserm U 1127, CNRS UMR 7225, Sorbonne Universités, UPMC Univ Paris 06 UMR S 1127, Institut du Cerveau et de la Moelle épinière, ICM, F-75013, Paris, France

name: Tel Aviv Medical Center, Tel Aviv, Israel

name: Geisinger Health System, Danville, Pennsylvania

name: Cleveland Clinic Foundation, Cleveland, Ohio

name: Baylor University Medical Center, Houston, Texas

name: Istituto Nazionale Neurologico Carlo Besta, Milan, Italy

name: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

name: University of Texas Health Sciences Center at Houston

name: Tufts Medical Center, Boston, Massachusetts

name: Washington University Barnes-Jewish Hospital, St Louis, Missouri

name: University of Pennsylvania, Philadelphia

name: Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

name: Hospital Universitario de Bellvitge, Barcelona, Spain

name: Juravinski Cancer Centre, Hamilton, Ontario, Canada

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

ReferenceCitation: Kesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.

name: Translational Neuro-Oncology Laboratories, UC San Diego, San Diego, CA, USA

name: Department of Neurosciences, UC San Diego, San Diego, CA, USA

name: Department of Translational Neurosciences & Neurotherapeutics, Pacific Neuroscience Institute & John Wayne Cancer Institute at Providence Saint John’s Health Center, Santa Monica, CA, USA

name: Neurosurgery Department, The Tel Aviv Sourasky Medical Center & Tel Aviv University Sackler School of Medicine, Tel Aviv, Israel

title: Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: apost hocanalysis of the EF-14 trial

ReferenceCitation: Meletath SK, Pavlick D, Brennan T, Hamilton R, Chmielecki J, Elvin JA, Palma N, Ross JS, Miller VA, Stephens PJ, Snipes G, Rajaram V, Ali SM, Melguizo-Gavilanes I. Personalized Treatment for a Patient With a BRAF V600E Mutation Using Dabrafenib and a Tumor Treatment Fields Device in a High-Grade Glioma Arising From Ganglioglioma. J Natl Compr Canc Netw. 2016 Nov;14(11):1345-1350.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

name: University Hospital Zurich and University of Zurich, Zurich, Switzerland2Lausanne University Hospital (CHUV), Lausanne, Switzerland

name: Assistance Publique des Hôpitaux de Paris, La Pitié-Salpétrière-University Hospital, Pierre and Marie Curie University, Paris, France

name: Tel Aviv Sourasky Medical Center, Tel Aviv University, Tel Aviv, Israel

name: Baylor University Medical Center, Dallas, Texas

name: Baylor University Medical Center, Dallas, Texas13University of Texas Health Science Center, Houston

name: Swedish Neuroscience Institute, Seattle, Washington

name: University of Southern California, Los Angeles

name: Na Homolce Hospital, Prague, Czech Republic

name: Lausanne University Hospital (CHUV), Lausanne, Switzerland

name: New Jersey Neuroscience Institute, Edison

name: Fondazione Ospedale Maggiore Policlinico, Milan, Italy

name: Houston Methodist Hospital, Houston, Texas

name: Hospices Civils de Lyon, University Claude Bernard Lyon 1, Lyon, France

location_country:
Italy
Austria
Sweden
Switzerland
Germany
France
Korea, Republic of
Israel
Spain
United States
Czech Republic
Canada

location_facility: University of California San Diego Moores Cancer Center (UCSD)

location_facility: Seoul National University Bundang Hospital (SNUBH)

location_facility: (CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie

location_facility: Hospital of the University of Pennsylvania

location_facility: Washington University School of Medicine, Division of Oncology

location_facility: The University of Texas Health Science Center at Houston (UTHSC)

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Chungnam National University Hospital (CNUH)

location_facility: Az. Ospedaliero-Universitaria - Ospedali Riuniti

location_facility: Hospital 12 de Octubre, Servicio de Oncología Médica

location_facility: Hospital Universitari de Bellvitge-ICO Duran i Reynals

location_facility: UF Health Cancer Center at Orlando Health

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

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Centre Hospitalo-Universitaire de Toulouse Purpan

location_facility: Yonsei University Severance Hospital (YUHS)

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Hôpital Saint André Centre Hospitalier Universitaire (CHU) des Hôpitaux de Bordeaux

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Mount Sinai Medical Center, Department of Neurosurgery

location_facility: Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: New Jersey Neuroscience Center - JFK Medical Center

location_facility: University Hospital of Schleswig-Holstein

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: University of Kentucky, Markey Cancer Center

location_facility: Emory University, Winship Cancer Institute

location_facility: McGill - Gerald Bronfman Centre for Clinical Research in Oncology -

location_facility: Seoul National University Hospital (SNUH)


ReferenceType: result

ReferenceCitation: Chanan-Khan A, Egyed M, Robak T, Martinelli de Oliveira FA, Echeveste MA, Dolan S, Desjardins P, Blonski JZ, Mei J, Golany N, Zhang J, Gribben JG. Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial). Leukemia. 2017 May;31(5):1240-1243. doi: 10.1038/leu.2017.47. Epub 2017 Jan 31.

family: Chanan-Khan

full_name: A Chanan-Khan

given: A

family: Egyed

full_name: M Egyed

given: M

family: Robak

full_name: T Robak

given: T

family: Martinelli de Oliveira

full_name: F A Martinelli de Oliveira

given: F A

family: Echeveste

full_name: M A Echeveste

given: M A

family: Dolan

full_name: S Dolan

given: S

family: Desjardins

full_name: P Desjardins

given: P

family: Blonski

full_name: J Z Blonski

given: J Z

family: Mei

full_name: J Mei

given: J

family: Golany

full_name: N Golany

given: N

family: Zhang

full_name: J Zhang

family: Gribben

full_name: J G Gribben

given: J G

journal_name: Leukemia

evidence: open (via page says license)

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Celgene

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Croatia
France
Poland
Slovakia
Canada
Colombia
South Africa
Chile
Netherlands
Bulgaria
Hungary
Portugal
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
New Zealand
Spain

acronym: ORIGIN

location_facility: Russian Academy of Medical Sciences Institution

location_facility: Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: GUS Leningrad Regional Clinical Hospital

location_facility: Fundação Antonio Prudente - AC Camargo Câncer center

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Central Texas Veterans Health Care System

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Szegedi TudomanyegyetemII Belgyogyaszati Klinika

location_facility: Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

location_facility: Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

location_facility: Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

location_facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: Regional Health Authority B-Saint John Regional Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: MHAT Georgi Stranski PlevenHematology Clinic

location_facility: Instituto Clinico Oncologico del Sur ICOS

location_facility: National Specialized Hospital for Active Treatment of Hematology Diseases

location_facility: Instituto de Ensino e Pesquisa Sao Lucas

location_facility: Klinika Chorob wewnetrznych i Hematologii

location_facility: GUZ Nizhegorodskaya Regional Clinical Hospital

location_facility: BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Specjalistyczny Szpital miejski im. Kopernika

location_facility: St. Bartholomew's and The Royal London Hospital

location_facility: University hospital Sveti Georgi Hematology Clinic

location_facility: Herlev University Hospital Dep of hematology

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Instituto Portugues Oncologia do Porto Francisco Gentil EPE

location_facility: Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC

location_facility: Pro Onco Centro de Tratamento Oncologico

location_facility: Hospital General Universitario Morales Messeguer

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Medical University of Vienna Internalmedicine 1, Hematology

type: EudraCT Number

source: euctr

title: A Phase 3, Multicenter, Randomized, Openlabel, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) Versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia (The Origin Trial)

summary: The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.


title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

summary: A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

ReferenceCitation: Wolpin BM, O'Reilly EM, Ko YJ, Blaszkowsky LS, Rarick M, Rocha-Lima CM, Ritch P, Chan E, Spratlin J, Macarulla T, McWhirter E, Pezet D, Lichinitser M, Roman L, Hartford A, Morrison K, Jackson L, Vincent M, Reyno L, Hidalgo M. Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. Ann Oncol. 2013 Jul;24(7):1792-1801. doi: 10.1093/annonc/mdt066. Epub 2013 Feb 28.

location_country:
France
Russian Federation
Spain
United States
Canada

location_facility: State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"

location_facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: State Healthcare Institution "Leningrad Regional Oncologic Dispensary"

location_facility: University of California San Diego Medical Center

location_facility: Hospital Virgen de la Salud, Servicio Oncologia

location_facility: Medical Radiology Research Center of Russian Medical Academy

location_facility: Palm Beach Institute of Hematology and Oncology

location_facility: Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway"

location_facility: Hôpital du Haut Lèvêque, Service d'Hepato Gastroentérologie

location_facility: Clinical Oncology Dispensary of Republic of Tatarstan

location_facility: Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia

location_facility: State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"

location_facility: Kaiser Permanente Northwest Region Oncology Hematology

location_facility: Saint Petersburg State Healthcare Institution "Municipal Clinical Oncology Dispensary"

location_facility: Centre Régional de Lutte Contre le Cancer-Centre Oscar Lambret

location_facility: Vanderbilt University Medical Center, Div. of Medical Oncology

location_facility: Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic

intervention_type: Biological


title: Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic NSCLC

summary: The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.

ReferenceCitation: Jänne PA, Smith I, McWalter G, Mann H, Dougherty B, Walker J, Orr MC, Hodgson DR, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios CH, Franke FA, Crinò L, Smith P. Impact of KRAS codon subtypes from a randomised phase II trial of selumetinib plus docetaxel in KRAS mutant advanced non-small-cell lung cancer. Br J Cancer. 2015 Jul 14;113(2):199-203. doi: 10.1038/bjc.2015.215. Epub 2015 Jun 30.

family: Jänne

full_name: P A Jänne

given: P A

family: Smith

full_name: I Smith

given: I

family: McWalter

full_name: G McWalter

given: G

family: Mann

full_name: H Mann

given: H

family: Dougherty

full_name: B Dougherty

given: B

family: Walker

full_name: J Walker

family: Orr

full_name: M C M Orr

given: M C M

family: Hodgson

full_name: D R Hodgson

given: D R

family: Shaw

full_name: A T Shaw

given: A T

family: Pereira

full_name: J R Pereira

given: J R

family: Jeannin

full_name: G Jeannin

family: Vansteenkiste

full_name: J Vansteenkiste

family: Barrios

full_name: C H Barrios

given: C H

family: Franke

full_name: F A Franke

family: Crinò

full_name: L Crinò

given: L

full_name: P Smith

journal_name: British Journal of Cancer

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

ReferenceCitation: Jänne PA, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios C, Franke FA, Grinsted L, Zazulina V, Smith P, Smith I, Crinò L. Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: a randomised, multicentre, placebo-controlled, phase 2 study. Lancet Oncol. 2013 Jan;14(1):38-47. doi: 10.1016/S1470-2045(12)70489-8. Epub 2012 Nov 28.

location_country:
Italy
Brazil
United States
Peru
Mexico
France
Bulgaria
Czechia
Hungary
Belgium
Spain
Canada


ReferenceCitation: Färkkilä M, Diener HC, Géraud G, Láinez M, Schoenen J, Harner N, Pilgrim A, Reuter U; COL MIG-202 study group. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012 May;11(5):405-13. doi: 10.1016/S1474-4422(12)70047-9. Epub 2012 Mar 28.

family: Färkkilä

full_name: Markus Färkkilä

given: Markus

family: Diener

full_name: Hans-Christoph Diener

given: Hans-Christoph

family: Géraud

full_name: Gilles Géraud

given: Gilles

family: Láinez

full_name: Miguel Láinez

given: Miguel

family: Schoenen

full_name: Jean Schoenen

given: Jean

family: Harner

full_name: Nadja Harner

given: Nadja

family: Pilgrim

full_name: Alison Pilgrim

given: Alison

family: Reuter

full_name: Uwe Reuter

given: Uwe

journal_name: The Lancet Neurology

title: Efficacy and tolerability of lasmiditan, an oral 5-HT1F receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study

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

lead_sponsor: Eli Lilly and Company

location_country: Finland France Belgium Spain Germany

ipd_sharing: Yes

type: Other Identifier

title: A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine

summary: The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.


ReferenceCitation: Trump D. Commentary on: "Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): A multicentre, randomised, double-blind, phase 3 trial." Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR, CA184-043 Investigators. Departments of Urology and Immunology and Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, MN, USA, Electronic address: kwon.eugene@mayo.edu; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Brady Urological Institute, Baltimore, MD, USA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA; Institut Gustave Roussy, University of Paris-Sud, Villejuif, France; Institut Gustave Roussy, Villejuif, France; VU University Medical Centre, Amsterdam, Netherlands; Vienna General Hospital, Medical University Vienna, Vienna, Austria; Institut Bergonié, Bordeaux, France; CHU Caremeau, Nimes, France; Centro Médico Austral, Buenos Aires, Argentina; Centre Jean Perrin, Clermont-Ferrand, France; St John of God Hospital, Subiaco, WA, Australia; University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy; Hospital de Caridade de Ijuí, Ijuí, Brazil; Nottingham University Hospital, Nottingham, UK; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA; Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania; Hospital Británico de Buenos Aires, Buenos Aires, Argentina; Herlev Hospital, Herlev, Denmark; Odense University Hospital, Odense, Denmark; University of Texas MD Anderson Cancer Center, Houston,. Urol Oncol. 2016 May;34(5):249-50. doi: 10.1016/j.urolonc.2015.03.013. Epub 2015 Apr 20.

family: Trump

full_name: Donald Trump

given: Donald

journal_name: Urologic Oncology: Seminars and Original Investigations

title: Commentary on: “Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): A multicentre, randomised, double-blind, phase 3 trial.” Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR, CA184-043 Investigators. Departments of Urology and Immunology and Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, MN, USA, Electronic address: kwon.eugene@mayo.edu; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Brady Urological Institute, Baltimore, MD, USA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA; Institut Gustave Roussy, University of Paris-Sud, Villejuif, France; Institut Gustave Roussy, Villejuif, France; VU University Medical Centre, Amsterdam, Netherlands; Vienna General Hospital, Medical University Vienna, Vienna, Austria; Institut Bergonié, Bordeaux, France; CHU Caremeau, Nimes, France; Centro Médico Austral, Buenos Aires, Argentina; Centre Jean Perrin, Clermont-Ferrand, France; St John of God Hospital, Subiaco, WA, Australia; University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy; Hospital de Caridade de Ijuí, Ijuí, Brazil; Nottingham University Hospital, Nottingham, UK; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA; Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania; Hospital Británico de Buenos Aires, Buenos Aires, Argentina; Herlev Hospital, Herlev, Denmark; Odense University Hospital, Odense, Denmark; University of Texas MD Anderson Cancer Center, Houston, TX, USA; Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA; Bristol-Myers Squibb, Wallingford, CT, USA; Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands.

ReferenceCitation: Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. doi: 10.1016/S1470-2045(14)70189-5. Epub 2014 May 13.

family: Kwon

full_name: Eugene D Kwon

given: Eugene D

family: Drake

full_name: Charles G Drake

given: Charles G

family: Scher

full_name: Howard I Scher

given: Howard I

family: Fizazi

full_name: Karim Fizazi

given: Karim

family: Bossi

full_name: Alberto Bossi

given: Alberto

family: van den Eertwegh

full_name: Alfons J M van den Eertwegh

given: Alfons J M

family: Krainer

full_name: Michael Krainer

given: Michael

family: Houede

full_name: Nadine Houede

given: Nadine

family: Santos

full_name: Ricardo Santos

given: Ricardo

family: Mahammedi

full_name: Hakim Mahammedi

given: Hakim

family: Ng

full_name: Siobhan Ng

given: Siobhan

family: Maio

full_name: Michele Maio

given: Michele

full_name: Fabio A Franke

given: Fabio A

family: Sundar

full_name: Santhanam Sundar

given: Santhanam

family: Agarwal

full_name: Neeraj Agarwal

given: Neeraj

family: Bergman

full_name: Andries M Bergman

given: Andries M

family: Ciuleanu

full_name: Tudor E Ciuleanu

given: Tudor E

family: Korbenfeld

full_name: Ernesto Korbenfeld

given: Ernesto

family: Sengeløv

full_name: Lisa Sengeløv

given: Lisa

family: Hansen

full_name: Steinbjorn Hansen

given: Steinbjorn

family: Logothetis

full_name: Christopher Logothetis

given: Christopher

family: Beer

full_name: Tomasz M Beer

ReferenceCitation: Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13. Review.

journal_name: JNCI Journal of the National Cancer Institute

title: Novel Therapies for Metastatic Castrate-Resistant Prostate Cancer

location_country:
Peru
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
France
Poland
Argentina
Canada
Colombia
Chile
Netherlands
Hungary
Ireland
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Siouxland Hematology-Oncology Assoc., Llp

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: St. Luke'S Hospital & Health Network Laboratory

location_facility: Mid-Illinois Hematology & Oncology Associates, Ltd

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: Suburban Hematology-Oncology Associates, Pc

location_facility: The Bunting-Blaustein Cancer Research Building

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: Associates In Hematology & Oncology, P.C.

location_facility: The University Of Texas Md Anderson Cancer Center

location_facility: The Center For Cancer And Blood Disorders

location_facility: St Johns Medical Research Institute, Inc.

location_facility: University Of Iowa Hospitals And Clinics

location_facility: Kansas City Veterans Affairs Medical Center

title: A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

summary: The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia

acronym: COMORBID©

summary: Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

ReferenceCitation: Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Büttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.

name: 1st Department of Cardiology; Athens Medical School; Athens Greece

family: Vlachopoulos

full_name: C. Vlachopoulos

given: C.

name: Department of Urology; Hannover Medical School; Hannover Germany

family: Oelke

full_name: M. Oelke

given: M.

family: Maggi

full_name: M. Maggi

name: Memorial Sloan-Kettering Cancer Center; New York NY USA

family: Mulhall

full_name: J. P. Mulhall

given: J. P.

family: Rosenberg

full_name: M. T. Rosenberg

given: M. T.

name: University of Western Ontario; London ON Canada

family: Brock

full_name: G. B. Brock

given: G. B.

name: Inventiv Health Clinical; Indianapolis IN USA

family: Esler

full_name: A. Esler

given: A.

name: Eli Lilly Biomedicines BU - Men's Health Therapeutic Area Europe, c/o Lilly Deutschland; GmbH; Bad Homburg Germany

family: Büttner

full_name: H. Büttner

given: H.

journal_name: International Journal of Clinical Practice

ReferenceCitation: Porst H, Gacci M, Büttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.

family: Porst

full_name: Hartmut Porst

given: Hartmut

family: Gacci

full_name: Mauro Gacci

given: Mauro

full_name: Hartwig Büttner

given: Hartwig

family: Henneges

full_name: Carsten Henneges

given: Carsten

family: Boess

full_name: Frank Boess

given: Frank

journal_name: European Urology

title: Tadalafil Once Daily in Men with Erectile Dysfunction: An Integrated Analysis of Data Obtained from 1913 Patients from Six Randomized, Double-blind, Placebo-controlled, Clinical Studies

location_country:
Italy
United States
Mexico
France
Greece
Russian Federation
Portugal
Germany
Canada

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: CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil

acronym: CONCERT

summary: The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

lead_sponsor: Medivation, Inc.

location_country:
Italy
Sweden
Germany
Finland
France
Belgium
Australia
New Zealand
United States
United Kingdom


title: A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multi-centre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 in Patients With Gastroesophageal Reflux Disease (GERD) Who Are Partial Responders to Proton Pump Inhibitor (PPI) Treatment

summary: The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors

lead_sponsor: Addex Pharma S.A.

location_country:
United States
Switzerland
Netherlands
France
Germany


title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial

acronym: SUNRISE

summary: Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.

ReferenceCitation: Cardozo L, Hessdörfer E, Milani R, Arañó P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.

location_country:
Italy
United Kingdom
Spain
France
Poland
Greece
Slovakia
Hungary
Belgium
Russian Federation
Egypt
Portugal
Germany
Czech Republic


title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

summary: Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete response with first-line rituximab-chemotherapy

primary_purpose: Prevention

ReferenceCitation: Witzig TE, Tobinai K, Rigacci L, Ikeda T, Vanazzi A, Hino M, Shi Y, Mayer J, Costa LJ, Bermudez Silva CD, Zhu J, Belada D, Bouabdallah K, Kattan JG, Kuruvilla J, Kim WS, Larouche JF, Ogura M, Ozcan M, Fayad L, Wu C, Fan J, Louveau AL, Voi M, Cavalli F. Adjuvant everolimus in high-risk diffuse large B-cell lymphoma: final results from the PILLAR-2 randomized phase III trial. Ann Oncol. 2018 Mar 1;29(3):707-714. doi: 10.1093/annonc/mdx764.

family: Witzig

full_name: T.E. Witzig

family: Tobinai

full_name: K. Tobinai

given: K.

family: Rigacci

full_name: L. Rigacci

given: L.

family: Ikeda

full_name: T. Ikeda

given: T.

family: Vanazzi

full_name: A. Vanazzi

family: Hino

full_name: M. Hino

family: Shi

full_name: Y. Shi

given: Y.

family: Mayer

full_name: J. Mayer

given: J.

family: Costa

full_name: L.J. Costa

family: Bermudez Silva

full_name: C.D. Bermudez Silva

family: Zhu

full_name: J. Zhu

family: Belada

full_name: D. Belada

given: D.

family: Bouabdallah

full_name: K. Bouabdallah

family: Kattan

full_name: J.G. Kattan

family: Kuruvilla

full_name: J. Kuruvilla

family: Kim

full_name: W.S. Kim

family: Larouche

full_name: J.-F. Larouche

family: Ogura

full_name: M. Ogura

family: Ozcan

full_name: M. Ozcan

family: Fayad

full_name: L. Fayad

family: Wu

full_name: C. Wu

family: Fan

full_name: J. Fan

family: Louveau

full_name: A.-L. Louveau

family: Voi

full_name: M. Voi

family: Cavalli

full_name: F. Cavalli

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

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

location_country:
Peru
Greece
Australia
Russian Federation
Spain
France
Japan
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
Saudi Arabia
Hong Kong
Switzerland
Singapore
Hungary
China
Germany
United States
Italy
Austria
Brazil
Lebanon
Mexico
Czechia
Venezuela
Israel
Egypt
New Zealand
Turkey

location_facility: Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp.

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (3)

location_facility: South Texas Oncology and Hematology, PA South Texas Oncology (2)

location_facility: Blue Ridge Research Center at Roanoke Neurological Center SC

location_facility: Indiana University Hospital IU Cancer Center

location_facility: Washington University School of Medicine Div. of Medical Oncology

location_facility: University of Tennessee Cancer Institute SC-2

location_facility: Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care

location_facility: University of Pittsburgh Medical Center SC-3

location_facility: University of Virginia Health Systems SC-2

location_facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18)

location_facility: Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)

location_facility: Wake Forest University Baptist Medical Center Dept. of WFUHS

location_facility: Tulane University Health Sciences Center Office of Clinical Research

location_facility: Baylor College of Medicine Dept.of Baylor College of Med.

location_facility: Cancer Centers of the Carolinas Cancer Centers of Carolinas (3

location_facility: University of Vermont Office of Clinical Trials Res.

location_facility: Dartmouth Hitchcock Medical Center Dartmouth

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Denver Health & Hospital Authority CACZ885M2301

location_facility: Rush University Medical Center Div. of Hematology & Oncology

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4)

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD

location_facility: Mayo Clinic - Rochester Dept. of MayoClinic-Rochester


title: A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone

acronym: REGAL

summary: The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.

ReferenceCitation: Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jürgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.

name: Tracy T. Batchelor, Rakesh K. Jain, and Gregory Sorensen, Massachusetts General Hospital, Boston, MA; Paul Mulholland, University College London, London; Rao Gattamaneni, the Christie Foundation Trust Hospital, Manchester, United Kingdom; Bart Neyns, Universitair Ziekenhuis Brussel, Brussels, Belgium; L. Burt Nabors, University of Alabama at Birmingham, Birmingham, AL; Mario Campone, Centre Rene Gauducheau, Saint-Herblain, France; Antje Wick, University of Heidelberg, Heidelberg, Germany; Warren Mason,...

family: Batchelor

full_name: Tracy T. Batchelor

given: Tracy T.

family: Mulholland

full_name: Paul Mulholland

given: Paul

family: Neyns

full_name: Bart Neyns

given: Bart

family: Nabors

full_name: L. Burt Nabors

given: L. Burt

family: Campone

full_name: Mario Campone

given: Mario

family: Wick

full_name: Antje Wick

given: Antje

family: Mason

full_name: Warren Mason

given: Warren

family: Mikkelsen

full_name: Tom Mikkelsen

given: Tom

family: Phuphanich

full_name: Surasak Phuphanich

given: Surasak

family: Ashby

full_name: Lynn S. Ashby

given: Lynn S.

family: DeGroot

full_name: John DeGroot

given: John

family: Gattamaneni

full_name: Rao Gattamaneni

given: Rao

family: Cher

full_name: Lawrence Cher

given: Lawrence

family: Rosenthal

full_name: Mark Rosenthal

given: Mark

family: Payer

full_name: Franz Payer

given: Franz

family: Jürgensmeier

full_name: Juliane M. Jürgensmeier

given: Juliane M.

family: Jain

full_name: Rakesh K. Jain

given: Rakesh K.

family: Sorensen

full_name: A. Gregory Sorensen

given: A. Gregory

family: Xu

full_name: John Xu

family: Liu

full_name: Qi Liu

given: Qi

family: van den Bent

full_name: Martin van den Bent

given: Martin

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase III Randomized Trial Comparing the Efficacy of Cediranib As Monotherapy, and in Combination With Lomustine, Versus Lomustine Alone in Patients With Recurrent Glioblastoma

location_country:
Austria
United States
United Kingdom
Netherlands
Germany
France
Australia
Belgium
Canada
Czech Republic


ReferenceCitation: Pang PS, Mehra M, Maggioni AP, Filippatos G, Middlebrooks J, Turlapaty P, Kazei D, Gheorghiade M; RENO-DEFEND Investigators. Rationale, design, and results from RENO-DEFEND 1: a randomized, dose-finding study of the selective A1 adenosine antagonist SLV320 in patients hospitalized with acute heart failure. Am Heart J. 2011 Jun;161(6):1012-23.e3. doi: 10.1016/j.ahj.2011.03.004.

family: Pang

full_name: Peter S. Pang

given: Peter S.

family: Mehra

full_name: Mandeep Mehra

given: Mandeep

family: Maggioni

full_name: Aldo P. Maggioni

given: Aldo P.

family: Filippatos

full_name: Gerasimos Filippatos

given: Gerasimos

family: Middlebrooks

full_name: Jayne Middlebrooks

given: Jayne

family: Turlapaty

full_name: Prasad Turlapaty

given: Prasad

family: Kazei

full_name: Dmitri Kazei

given: Dmitri

family: Gheorghiade

full_name: Mihai Gheorghiade

given: Mihai

journal_name: American Heart Journal

title: Rationale, design, and results from RENO-DEFEND 1: A randomized, dose-finding study of the selective A1 adenosine antagonist SLV320 in patients hospitalized with acute heart failure

status: Terminated

lead_sponsor: Solvay Pharmaceuticals

location_country:
Italy
Chile
Germany
France
Poland
Romania
Russian Federation
Denmark
United States
Canada
Ukraine

type: Other Grant/Funding Number

title: A Double-Blind, Placebo-Controlled, Randomized, Multi-Center, Dose-Finding Study of SLV320, a Selective A1 Adenosine Receptor Antagonist, to Evaluate the Effect on Renal Function and Safety in Subjects Hospitalized With Acute Decompensated Heart Failure and Renal Dysfunction (Reno-Defend 1)

summary: The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

status_simplified: Unknown


ReferenceCitation: Chari A, Cho HJ, Dhadwal A, Morgan G, La L, Zarychta K, Catamero D, Florendo E, Stevens N, Verina D, Chan E, Leshchenko V, Laganà A, Perumal D, Mei AH, Tung K, Fukui J, Jagannath S, Parekh S. A phase 2 study of panobinostat with lenalidomide and weekly dexamethasone in myeloma. Blood Adv. 2017 Aug 21;1(19):1575-1583. doi: 10.1182/bloodadvances.2017007427. eCollection 2017 Aug 22.

name: Division of Hematology and Oncology, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY

family: Chari

full_name: Ajai Chari

given: Ajai

family: Cho

full_name: Hearn J. Cho

given: Hearn J.

family: Dhadwal

full_name: Amishi Dhadwal

given: Amishi

family: Morgan

full_name: Gillian Morgan

given: Gillian

family: La

full_name: Lisa La

given: Lisa

family: Zarychta

full_name: Katarzyna Zarychta

given: Katarzyna

family: Catamero

full_name: Donna Catamero

given: Donna

family: Florendo

full_name: Erika Florendo

given: Erika

family: Stevens

full_name: Nadege Stevens

given: Nadege

family: Verina

full_name: Daniel Verina

given: Daniel

family: Chan

full_name: Elaine Chan

given: Elaine

family: Leshchenko

full_name: Violetta Leshchenko

given: Violetta

family: Laganà

full_name: Alessandro Laganà

given: Alessandro

family: Perumal

full_name: Deepak Perumal

given: Deepak

family: Mei

full_name: Anna Huo-Chang Mei

given: Anna Huo-Chang

family: Tung

full_name: Kaity Tung

given: Kaity

family: Fukui

full_name: Jami Fukui

given: Jami

family: Jagannath

full_name: Sundar Jagannath

given: Sundar

family: Parekh

full_name: Samir Parekh

given: Samir

journal_name: Blood Advances

ReferenceCitation: Harrison SJ, Hsu AK, Neeson P, Younes A, Sureda A, Engert A, Prince HM, Li M, Savage P, Bugarini R, Williams D, Squier M, Ritchie DS. Early thymus and activation-regulated chemokine (TARC) reduction and response following panobinostat treatment in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant. Leuk Lymphoma. 2014 May;55(5):1053-60. doi: 10.3109/10428194.2013.820287. Epub 2013 Aug 5.

family: Harrison

location_country:
Italy
Brazil
Germany
France
Malaysia
Israel
Singapore
Belgium
Australia
New Zealand
Spain
United States
United Kingdom

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)

location_facility: Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)

location_facility: The Methodist Hospital Cell & Gene Therapy Clinic

location_facility: Karmanos Cancer Institute Div.of Hematology/Oncology

location_facility: University of Pennsylvania Medical Center Dept of UPenn Med Ctr (3)

location_facility: West Virginia University/ Mary Babb Randolph Cancer Center

location_facility: Dana Farber Cancer Institute Hematology / Oncology

location_facility: Georgia Regents University Cancer Clinical Research Unit

location_facility: Rush University Medical Center Divisionof Hem/Onc Research(2)

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(2)

location_facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(5)

title: A Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkins Lymphoma After High-dose Chemotherapy With Autologous Stem Cell Transplant

summary: This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored.


title: A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.

summary: The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.

ReferenceCitation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7:CD013325. doi: 10.1002/14651858.CD013325.pub2.

family: Imamura

full_name: Mari Imamura

given: Mari

name: Medical Statistics Team; University of Aberdeen; Aberdeen UK

family: Scott

full_name: Neil W Scott

given: Neil W

name: Evidence Synthesis Group, Population Health Sciences Institute, Faculty of Medical Sciences; Newcastle University; Newcastle upon Tyne UK

family: Wallace

full_name: Sheila A Wallace

given: Sheila A

name: Obstetrics and Gynaecology; University Hospitals of Morecambe Bay NHS Foundation Trust; Barrow in Furness UK

family: Ogah

full_name: Joseph A Ogah

given: Joseph A

name: Department of Urogynaecology; Imperial Healthcare Trust, St Mary's Hospital; London UK

family: Ford

full_name: Abigail A Ford

given: Abigail A

name: c/o Health Services Research Unit; University of Aberdeen; Aberdeen UK

family: Dubos

full_name: Yann A Dubos

given: Yann A

family: Brazzelli

full_name: Miriam Brazzelli

given: Miriam

repository_institution: Aberdeen University - Aberdeen University Research Archive

ReferenceCitation: Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel α2δ ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.

name: Department of Urology, Queen's University, Kingston, Ontario, Canada

family: Nickel

full_name: J. Curtis Nickel

given: J. Curtis

name: Pfizer Inc, Sandwich, Kent, United Kingdom

family: Crossland

full_name: Anna Crossland

given: Anna

name: Citrus Valley Medical Research, Inc., Glendora, California

family: Davis

full_name: Edward Davis

given: Edward

name: Service d'Urologie, Hospital Tenon, Paris, France

family: Haab

full_name: François Haab

given: François

family: Mills

full_name: Ian W. Mills

given: Ian W.

name: Department of Urology, Medical University of South Carolina, Charleston, South Carolina

family: Rovner

full_name: Eric Rovner

given: Eric

family: Scholfield

full_name: David Scholfield

given: David

family: Crook

full_name: Tim Crook

given: Tim

journal_name: Journal of Urology

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Investigation of a Ca 2+ Channel α2δ Ligand for the Treatment of Interstitial Cystitis: Results of a Randomized, Double-Blind, Placebo Controlled Phase II Trial

lead_sponsor: Pfizer

location_country:
Germany
Finland
France
Denmark
United States
Canada


title: Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

acronym: SIRFLOX

summary:
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.

ReferenceCitation: van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodríguez J, Kröning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum in: J Clin Oncol. 2016 Nov 20;34(33):4059.

name: Guy A. van Hazel, University of Western Australia; Tom Ferguson, Royal Perth Hospital; David Price and Geoff Bower, Mount Medical Center, Perth; Alex Powell, Hollywood Private Hospital, Nedlands, Western Australia; Andrew H. Strickland, Monash Medical Centre, Bentleigh, East Victoria; Vinod Ganju, Frankston Private Hospital Peninsula Oncology Centre, Frankston; Peter Gibbs, Western Hospital, Footscray, Victoria; Euan Walpole, Princess Alexandra Hospital, Woolloongabba; Paul Eliadis, Wesley Medical Centre...

family: van Hazel

full_name: Guy A. van Hazel

given: Guy A.

family: Heinemann

full_name: Volker Heinemann

given: Volker

family: Sharma

full_name: Navesh K. Sharma

given: Navesh K.

family: Findlay

full_name: Michael P.N. Findlay

given: Michael P.N.

family: Ricke

full_name: Jens Ricke

given: Jens

family: Peeters

full_name: Marc Peeters

given: Marc

family: Perez

full_name: David Perez

family: Robinson

full_name: Bridget A. Robinson

given: Bridget A.

family: Strickland

full_name: Andrew H. Strickland

given: Andrew H.

family: Ferguson

full_name: Tom Ferguson

given: Tom

family: Rodríguez

full_name: Javier Rodríguez

given: Javier

family: Kröning

full_name: Hendrik Kröning

given: Hendrik

family: Wolf

full_name: Ido Wolf

given: Ido

family: Ganju

full_name: Vinod Ganju

given: Vinod

family: Walpole

full_name: Euan Walpole

given: Euan

family: Boucher

full_name: Eveline Boucher

given: Eveline

family: Tichler

full_name: Thomas Tichler

given: Thomas

family: Shacham-Shmueli

full_name: Einat Shacham-Shmueli

given: Einat

family: Powell

full_name: Alex Powell

given: Alex

family: Eliadis

full_name: Paul Eliadis

given: Paul

family: Isaacs

full_name: Richard Isaacs

given: Richard

family: Price

full_name: David Price

family: Moeslein

full_name: Fred Moeslein

given: Fred

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Wolstenholme J, Fusco F, Gray AM, Moschandreas J, Virdee PS, Love S, Van Hazel G, Gibbs P, Wasan HS, Sharma RA. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer. Int J Cancer. 2020 Aug 15;147(4):1078-1085. doi: 10.1002/ijc.32828. Epub 2020 Jan 9.

name: Health Economics Research Centre, Nuffield Department of Population HealthUniversity of Oxford Oxford United Kingdom

name: Centre for Health EconomicsUniversity of York York United Kingdom

name: Centre for Statistics in MedicineUniversity of Oxford Oxford United Kingdom

name: Centre for the Prevention of Stroke and Dementia, Nuffield Department of Clinical NeurosciencesUniversity of Oxford Oxford United Kingdom

name: University of Western Australia Perth WA Australia

name: Western Hospital Footscray VIC Australia

name: Department of Oncology and Cancer MedicineImperial College Healthcare NHS Trust & Imperial College London United Kingdom

name: University College London Hospitals Biomedical Research CentreNIHR, UCL Cancer Institute, University College London London United Kingdom

repository_institution: University of Melbourne - Minerva Access

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

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

title: Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE‐global randomised trials of selective internal radiotherapy for metastatic colorectal cancer

ReferenceCitation: Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators, van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_institution: University College London - UCL Discovery

repository_institution: Cardiff University - ORCA Online Research @Cardiff

ReferenceCitation: Virdee PS, Moschandreas J, Gebski V, Love SB, Francis EA, Wasan HS, van Hazel G, Gibbs P, Sharma RA. Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer. JMIR Res Protoc. 2017 Mar 28;6(3):e43. doi: 10.2196/resprot.7201.

ReferenceCitation: Gibbs P, Gebski V, Van Buskirk M, Thurston K, Cade DN, Van Hazel GA; SIRFLOX Study Group. Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study. BMC Cancer. 2014 Dec 1;14:897. doi: 10.1186/1471-2407-14-897.

location_country:
Italy
Switzerland
Germany
France
Poland
Israel
Belgium
Australia
New Zealand
Spain
United States

location_facility: Braxiskooperation Bonn, Fachartze fur Innere Medizin

location_facility: Praxis fur Hamatologie und Internnistische Onkologie

location_facility: Schwerpunktpraxis fur Hamatologie und Onkologie

location_facility: Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie

location_facility: Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik

location_facility: Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Schwerpunktspraxis fur Hamatologie und Internistische Onkologie

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: OL Vrouw Ziekenhuis Aalst Gastro-Enterologie

location_facility: Institut Jules Bordet - Centre de Tumeurs d'ULB

location_facility: Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin

location_facility: Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl

location_facility: Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr

location_facility: Hospital de Navarra, Servicio de Ongoligia, Planta Baja

location_facility: Hospitalier Universitaire de Grenoble C.H.U.

location_facility: Gemeinschaftspraxis Hamatologie und internistische Onkologie

location_facility: Florida International University College of Medicine Practice

location_facility: Imelda Ziekenhuis GI Clinical Research Centre

location_facility: VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel

location_facility: Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

location_facility: Centre Hospitalier General de Longjumeau


title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822

summary: This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
Brazil
Hong Kong
Mexico
Switzerland
Germany
France
Bulgaria
Thailand
Israel
Slovakia
Singapore
Hungary
Argentina
Australia
Canada


title: Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

summary: This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

ReferenceCitation: Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.

family: Rosenstock

full_name: J. Rosenstock

given: J.

family: Balas

full_name: B. Balas

given: B.

family: Charbonnel

full_name: B. Charbonnel

family: Bolli

full_name: G. B. Bolli

given: G. B.

family: Boldrin

full_name: M. Boldrin

given: M.

family: Ratner

full_name: R. Ratner

given: R.

family: Balena

full_name: R. Balena

journal_name: Diabetes Care

oa_colors: green other

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

title: The Fate of Taspoglutide, a Weekly GLP-1 Receptor Agonist, Versus Twice-Daily Exenatide for Type 2 Diabetes: The T-emerge 2 trial

location_country:
Peru
Guatemala
Finland
Greece
Australia
Russian Federation
Denmark
Ukraine
France
Thailand
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Switzerland
Puerto Rico
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
New Zealand
Spain