title: A Multicentre, Open Label, Early Stopping Design, Proof Of Concept Study With Tasquinimod In Treating Patients With Advanced Or Metastatic Hepatocellular, Ovarian, Renal Cell And Gastric Carcinomas

summary: This was an exploratory proof of concept study to determine the clinical activity of tasquinimod in patients with advanced or metastatic hepatocellular carcinoma, ovarian carcinoma, renal cell carcinoma and gastric carcinoma who had progressed after standard therapies.

design_allocation: Non-Randomized

ReferenceCitation: Escudier B, Faivre S, Van Cutsem E, Germann N, Pouget JC, Plummer R, Vergote I, Thistlethwaite F, Bjarnason GA, Jones R, Mackay H, Edeline J, Fartoux L, Hirte H, Oza A. A Phase II Multicentre, Open-Label, Proof-of-Concept Study of Tasquinimod in Hepatocellular, Ovarian, Renal Cell, and Gastric Cancers. Target Oncol. 2017 Oct;12(5):655-661. doi: 10.1007/s11523-017-0525-2.

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Faivre

full_name: Sandrine Faivre

given: Sandrine

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Germann

full_name: Nathalie Germann

given: Nathalie

family: Pouget

full_name: Jean-Christophe Pouget

given: Jean-Christophe

family: Plummer

full_name: Ruth Plummer

given: Ruth

family: Vergote

full_name: Ignace Vergote

given: Ignace

family: Thistlethwaite

full_name: Fiona Thistlethwaite

given: Fiona

family: Bjarnason

full_name: Georg A. Bjarnason

given: Georg A.

family: Jones

full_name: Robert Jones

given: Robert

family: Mackay

full_name: Helen Mackay

given: Helen

family: Edeline

full_name: Julien Edeline

given: Julien

family: Fartoux

full_name: Laetitia Fartoux

given: Laetitia

family: Hirte

full_name: Hal Hirte

given: Hal

family: Oza

full_name: Amit Oza

given: Amit

journal_name: Targeted Oncology

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: The University of Glasgow - Enlighten: Publications

repository_institution: Newcastle Univesity - Newcastle University ePrints

version: submittedVersion

location_country:
France
Belgium
Spain
Canada
United Kingdom

location_facility: MD Anderson Cancer Centre, Ctra. Colmenar Viejo Km. 9 100,

location_facility: Leuven cancer institute (LKI), Herestraat

location_facility: Hospital Gregorio Marañon, Dr. Esquerdo, 44-46

location_facility: Centre René Gauducheau, Boulevard Jacques Monod

location_facility: Centre Oscar Lambret, 3 rue Frédéric Combemale

location_facility: Princess Margaret, 610 University Avenue

location_facility: Freeman Hospital, Freeman Road, High Heaton

location_facility: London Health Sciences Center, 790 Commissoners Road East

location_facility: Hospital Saint-Antoine, 184 rue du Faubourg St Antoine

location_facility: Centre Eugene Marquis, Avenue bataille Flandres Dunkerque

location_facility: Juravinski Cancer Centre, 699 Concession St

location_facility: Sunnybrook, 2075 Bayview Avenue, Suite T2049

location_facility: Hopital Europeen Georges-Pompidou, AP-HP, 20 Rue Leblanc

location_facility: The Royal Marsden Hospital, Downs Rd, Sutton

location_facility: Leicester General Hospital, Gwndolen Road

location_facility: Bureau d'Etudes Cliniques du Centre Léon Bérard, 28, rue Laennec

location_facility: Ghent University Hospital, 1K12 IE, De Pintelaan 185

location_facility: Hospital Beaujon, 100 Blvd du Général Leclerc

location_facility: Southampton General Hospital, Tremona Road, Shirley

location_facility: Institute Gustave-Roussy, 114 rue Edouard Vaillant

location_facility: Antwerp University Hospital, Wilrijkstraat 10

location_facility: Beatson West of Scotland Cancer Centre, 1053 Great Western Road

location_facility: The Christie Hospital, Wilmslow Road, Withington


type: EudraCT Number

title: A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon

summary: The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. eCollection 2016.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
United States
Spain
Germany
France
Greece
Belgium
Australia
New Zealand
Portugal
Canada
United Kingdom

location_facility: 1241.36.00032 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00010 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.64002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00017 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00035 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00018 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.64001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39026 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00019 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00034 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00029 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39021 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39029 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00033 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49013 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44011 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49011 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39022 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39028 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35103 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39023 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35104 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00015 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00013 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49012 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44010 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00031 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44013 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39025 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.35101 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00030 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39020 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49014 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00024 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00020 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00026 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61007 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.44006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00043 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34003 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00022 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61004 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49008 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61005 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00027 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.01006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.33001 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00044 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.39024 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.30002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00039 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.32006 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.34002 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61009 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.00016 Boehringer Ingelheim Investigational Site

location_facility: 1241.36.61010 Boehringer Ingelheim Investigational Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Assessment of Overall Survival of FOLFOX6m Plus SIR-Spheres Microspheres Versus FOLFOX6m Alone as First-line Treatment in Patients With Non-resectable Liver Metastases From Primary Colorectal Carcinoma in a Randomised Clinical Study

acronym: FOXFIREGlobal

summary:
This study is a randomized, multi-center study that will compare the efficacy and safety of selective internal radiation therapy (SIRT) using SIR-Spheres microspheres plus a standard chemotherapy regimen of FOLFOX6m versus FOLFOX6m alone as first-line therapy in patients with non-resectable liver metastases from primary colorectal carcinoma.

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 Investigator.

study_start_date_type: Actual

ReferenceType: result

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.

sequence: first

family: Heinemann

full_name: Volker Heinemann

given: Volker

sequence: additional

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

given: David

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: 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.

location_country:
Italy
Spain
Germany
France
Israel
Singapore
Belgium
Australia
New Zealand
Portugal
United States
Korea, Republic of
Taiwan

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: SLK-Kliniken Heilbronn GmbH, Klinik fur Radiologie

location_facility: CHU de Poitiers, Pole regional de cancerologie

location_facility: Dipartimento di Oncologia, Ospendali Riuniti di Bergamo

location_facility: Ufficio Sperimentale Cliniche, Oncologia Medica di Carle, Ospendale Santa Croce e Carle di Cuneo

location_facility: TA Sourasky Medical Center, Oncology Department 6

location_facility: Klinikum rechts der Isar der TU Munchen Medizinische Klinik II

location_facility: Klinikum Magdeburg GmbH, Klinik fur Allgemein und Viszeralchirurgie

location_facility: Universitatsklinikum Marburg Klinik fur Hamatologie, Onkologie und Immunologie

location_facility: Stadtisches Klinikum Karlsruheg GMBH Klinik fur Nuklearmedizin

location_facility: U.O. Oncologia Medica II, Nuovo Ospendale Santa Chiara, Azienda Ospendaliero Universitaria Pisana, Presidio Ospendaliero di Cisanello

location_facility: Spartanburg Regional Healthcare / Gibbs Cancer Center

location_facility: Vivantes Klinikum Neukolln Klinik fur Innere Medizin - Hamatologie und Onkologie

location_facility: Universiteits Ziekenhuis Gent - Dienst Digestieve Oncologie

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.

location_facility: Sheba Medical Center - Governmental Hospital - Oncology Division

location_facility: Universitaetsklinikum Magdeburg, Klinik fur Radiologie und Nuklearmedizin

location_facility: Schwerpunktpraxix fur Hamatologie und Onkologie

location_facility: Centre Hospitalier General de Longjumeau


title: A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

summary: The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH Jr, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. J Clin Oncol. 2018 Feb 1;36(4):383-390. doi: 10.1200/JCO.2016.71.8023. Epub 2017 Jul 3.

name: James Larkin, Royal Marsden NHS Foundation Trust, London; Paul Lorigan, The Christie National Health Service Foundation Trust, Manchester, United Kingdom; David Minor, California Pacific Medical Center Research Institute; Adil Daud, University of California San Francisco, San Francisco; Bartosz Chmielowski, University of California, Santa Monica, CA; Sandra D'Angelo, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College; Jeffrey Weber, Perlmutter Cancer Center at New York...

family: Larkin

full_name: James Larkin

given: James

family: Minor

full_name: David Minor

family: D'Angelo

full_name: Sandra D'Angelo

given: Sandra

family: Neyns

full_name: Bart Neyns

given: Bart

family: Smylie

full_name: Michael Smylie

given: Michael

family: Miller

full_name: Wilson H. Miller

given: Wilson H.

suffix: Jr

family: Gutzmer

full_name: Ralf Gutzmer

given: Ralf

family: Linette

full_name: Gerald Linette

given: Gerald

family: Chmielowski

full_name: Bartosz Chmielowski

given: Bartosz

family: Lao

full_name: Christopher D. Lao

given: Christopher D.

family: Lorigan

full_name: Paul Lorigan

family: Grossmann

full_name: Kenneth Grossmann

given: Kenneth

family: Hassel

full_name: Jessica C. Hassel

given: Jessica C.

family: Sznol

full_name: Mario Sznol

given: Mario

family: Daud

full_name: Adil Daud

given: Adil

family: Sosman

full_name: Jeffrey Sosman

given: Jeffrey

family: Khushalani

full_name: Nikhil Khushalani

given: Nikhil

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Hoeller

full_name: Christoph Hoeller

given: Christoph

family: Walker

full_name: Dana Walker

given: Dana

family: Kong

full_name: George Kong

given: George

family: Horak

full_name: Christine Horak

given: Christine

family: Weber

full_name: Jeffrey Weber

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator’s Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial

ReferenceCitation: Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, Hoeller C, Khushalani NI, Miller WH Jr, Lao CD, Linette GP, Thomas L, Lorigan P, Grossmann KF, Hassel JC, Maio M, Sznol M, Ascierto PA, Mohr P, Chmielowski B, Bryce A, Svane IM, Grob JJ, Krackhardt AM, Horak C, Lambert A, Yang AS, Larkin J. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375-84. doi: 10.1016/S1470-2045(15)70076-8. Epub 2015 Mar 18.

location_country:
Italy
Austria
United States
Brazil
Switzerland
Netherlands
Germany
France
Israel
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Sir Mortimer B Davis - Jewish General Hospital

location_facility: Network Office of Research and Innovation

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Washington University School Of Medicine


type: Other Identifier

title: A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

summary:
This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

ReferenceCitation: Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016 Mar;18(3):274-80. doi: 10.1111/dom.12609. Epub 2016 Jan 11.

name: Endocrine and Metabolic Consultants  Rockville MD USA

family: Rodbard

full_name: H. W. Rodbard

given: H. W.

name: Department of Endocrinology l'Institut du Thorax, Nantes University Hospital  Nantes France

family: Cariou

full_name: B. Cariou

given: B.

name: Department of Internal Medicine, Division of Endocrinology and Metabolism Medical University of Graz  Graz Austria

family: Pieber

full_name: T. R. Pieber

given: T. R.

family: Endahl

full_name: L. A. Endahl

given: L. A.

family: Zacho

full_name: J. Zacho

given: J.

name: Department of Medicine Stavanger University Hospital  Stavanger Norway

family: Cooper

full_name: J. G. Cooper

given: J. G.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

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

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Treatment intensification with an insulin degludec ( IDeg )/insulin aspart ( IAsp ) co‐formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial

ReferenceCitation: Haluzík M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.

name: Institute for Clinical and Experimental Medicine and Charles University  Prague Czech Republic

family: Haluzík

full_name: Martin Haluzík

given: Martin

name: Royal North Shore Hospital University of Sydney  Sydney Australia

family: Fulcher

full_name: Greg Fulcher

given: Greg

name: Medical University of Graz  Graz Austria

full_name: Thomas R. Pieber

given: Thomas R.

family: Bardtrum

full_name: Lars Bardtrum

given: Lars

family: Tutkunkardas

full_name: Deniz Tutkunkardas

given: Deniz

name: Endocrine and Metabolic Consultants  Rockville Maryland

full_name: Helena W. Rodbard

given: Helena W.

title: The co‐formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta‐analysis of phase III studies in patients with type 2 diabetes

location_country:
Austria
France
Norway
Algeria
United States


ReferenceCitation: Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. Epub 2016 Aug 23.

ReferenceCitation: Younossi ZM, Elsheikh E, Stepanova M, Gerber L, Nader F, Stamm LM, Brainard DM, McHutchinson JG. Ledipasvir/sofosbuvir treatment of hepatitis C virus is associated with reduction in serum apolipoprotein levels. J Viral Hepat. 2015 Dec;22(12):977-82. doi: 10.1111/jvh.12448. Epub 2015 Aug 17.

name: Center for Liver Diseases; Inova Fairfax Hospital; Falls Church VA USA

name: Betty and Guy Beatty Center for Integrated Research; Inova Health System; Falls Church VA USA

family: Younossi

full_name: Z.M. Younossi

family: Elsheikh

full_name: E. Elsheikh

given: E.

family: Stepanova

full_name: M. Stepanova

given: M.

family: Gerber

full_name: L. Gerber

given: L.

family: Nader

full_name: F. Nader

given: F.

family: Stamm

full_name: L.M. Stamm

family: Brainard

full_name: D.M. Brainard

family: McHutchinson

full_name: J.G. McHutchinson

journal_name: Journal of Viral Hepatitis

ReferenceCitation: Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Bräu N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.

family: Afdhal

full_name: Nezam Afdhal

given: Nezam

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Kwo

full_name: Paul Kwo

given: Paul

family: Chojkier

full_name: Mario Chojkier

given: Mario

family: Gitlin

full_name: Norman Gitlin

given: Norman

family: Puoti

full_name: Massimo Puoti

given: Massimo

family: Romero-Gomez

full_name: Manuel Romero-Gomez

given: Manuel

family: Zarski

full_name: Jean-Pierre Zarski

given: Jean-Pierre

family: Agarwal

full_name: Kosh Agarwal

given: Kosh

family: Buggisch

full_name: Peter Buggisch

given: Peter

family: Foster

full_name: Graham R. Foster

given: Graham R.

family: Bräu

full_name: Norbert Bräu

given: Norbert

family: Buti

full_name: Maria Buti

given: Maria

family: Jacobson

full_name: Ira M. Jacobson

given: Ira M.

family: Subramanian

full_name: G. Mani Subramanian

given: G. Mani

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

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

title: Ledipasvir and Sofosbuvir for Untreated HCV Genotype 1 Infection

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

location_country:
Italy
United States
France
Puerto Rico
Spain
Germany
United Kingdom

title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

summary: The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.


title: A Randomized, Double Blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Ulcerative Colitis

summary: The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points, with no individual subscore > 1 point.

ReferenceCitation: Sandborn WJ, Cyrille M, Hansen MB, Feagan BG, Loftus EV Jr, Rogler G, Vermeire S, Cruz ML, Yang J, Boedigheimer MJ, Abuqayyas L, Evangelista CM, Sullivan BA, Reinisch W. Efficacy and Safety of Abrilumab in a Randomized, Placebo-Controlled Trial for Moderate-to-Severe Ulcerative Colitis. Gastroenterology. 2019 Mar;156(4):946-957.e18. doi: 10.1053/j.gastro.2018.11.035. Epub 2018 Nov 23.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Cyrille

full_name: Marcoli Cyrille

given: Marcoli

family: Hansen

full_name: Mark Berner Hansen

given: Mark Berner

family: Feagan

full_name: Brian G. Feagan

given: Brian G.

family: Loftus

full_name: Edward V. Loftus

given: Edward V.

suffix: Jr.

family: Rogler

full_name: Gerhard Rogler

given: Gerhard

family: Vermeire

full_name: Severine Vermeire

given: Severine

family: Cruz

full_name: Martha L. Cruz

given: Martha L.

family: Yang

full_name: Jun Yang

given: Jun

family: Boedigheimer

full_name: Michael J. Boedigheimer

given: Michael J.

family: Abuqayyas

full_name: Lubna Abuqayyas

given: Lubna

family: Evangelista

full_name: Christine M. Evangelista

given: Christine M.

family: Sullivan

full_name: Barbara A. Sullivan

given: Barbara A.

family: Reinisch

full_name: Walter Reinisch

given: Walter

journal_name: Gastroenterology

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Amgen

location_country:
Italy
Austria
United States
Switzerland
Netherlands
United Kingdom
Germany
France
Czechia
Greece
Poland
Norway
Hungary
Australia
Belgium
Russian Federation
Estonia
Denmark
Canada
Latvia


title: The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)

acronym: DUAL™ III

summary:
This trial is conducted in Europe, Oceania and the United States of America (USA).

The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.

ReferenceCitation: Linjawi S, Bode BW, Chaykin LB, Courrèges JP, Handelsman Y, Lehmann LM, Mishra A, Simpson RW. The Efficacy of IDegLira (Insulin Degludec/Liraglutide Combination) in Adults with Type 2 Diabetes Inadequately Controlled with a GLP-1 Receptor Agonist and Oral Therapy: DUAL III Randomized Clinical Trial. Diabetes Ther. 2017 Feb;8(1):101-114. doi: 10.1007/s13300-016-0218-3. Epub 2016 Dec 10.

family: Linjawi

full_name: Sultan Linjawi

given: Sultan

family: Bode

full_name: Bruce W. Bode

given: Bruce W.

family: Chaykin

full_name: Louis B. Chaykin

given: Louis B.

family: Courrèges

full_name: Jean-Pierre Courrèges

given: Jean-Pierre

family: Handelsman

full_name: Yehuda Handelsman

given: Yehuda

family: Lehmann

full_name: Lucine M. Lehmann

given: Lucine M.

family: Mishra

full_name: Abhishek Mishra

given: Abhishek

family: Simpson

full_name: Richard W. Simpson

given: Richard W.

journal_name: Diabetes Therapy

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Lingvay I, Handelsman Y, Linjawi S, Vilsbøll T, Halladin N, Ranc K, Liebl A. EFFICACY AND SAFETY OF IDEGLIRA IN OLDER PATIENTS WITH TYPE 2 DIABETES. Endocr Pract. 2019 Feb;25(2):144-155. doi: 10.4158/EP-2018-0284. Epub 2018 Nov 1.

family: Lingvay

full_name: Ildiko Lingvay

given: Ildiko

family: Vilsbøll

full_name: Tina Vilsbøll

given: Tina

family: Halladin

full_name: Natalie Halladin

given: Natalie

family: Ranc

full_name: Kristina Ranc

given: Kristina

family: Liebl

full_name: Andreas Liebl

given: Andreas

title: Efficacy and Safety of Ideglira in Older Patients with Type 2 Diabetes

location_country:
France
Slovakia
Hungary
Australia
United States


title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to compare the overall survival of BMS-936558 (Nivolumab) as compared with Docetaxel in subjects with non-squamous cell non-small cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy

ReferenceCitation: Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15. Erratum in: J Clin Oncol. 2021 Apr 1;39(10):1190.

name: Fox Chase Cancer Center, Philadelphia, PA

family: Borghaei

full_name: Hossein Borghaei

given: Hossein

name: Yale Comprehensive Cancer Center, New Haven, CT

family: Gettinger

full_name: Scott Gettinger

given: Scott

name: Univeristy of Chicago Medicine and Biologic Sciences Division, Chicago, IL

family: Vokes

full_name: Everett E. Vokes

given: Everett E.

name: University of Washington, Seattle Cancer Care Alliance, Seattle, WA

family: Chow

full_name: Laura Q. M. Chow

given: Laura Q. M.

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy

family: Burgio

full_name: Marco Angelo Burgio

given: Marco Angelo

name: Hospital De Madrid, Norte Sanchinarro, Madrid, Spain

family: de Castro Carpeno

full_name: Javier de Castro Carpeno

given: Javier

name: Maria Sklodowska-Curie Inst of Oncology, Warsaw, Poland

family: Pluzanski

full_name: Adam Pluzanski

given: Adam

name: Instituto Nacional De Cancerología, Mexico City, Mexico

family: Arrieta

full_name: Oscar Arrieta

given: Oscar

name: Centro de Investigación Clínica Bradford Hill and Centro Internacional de Estudios Clinicos, Santiago, Chile

family: Frontera

full_name: Osvaldo Arén Frontera

given: Osvaldo Arén

name: Ospedale S. Maria Della Misericordia, Perugia, Italy

family: Chiari

full_name: Rita Chiari

given: Rita

name: Cross Cancer Institute, Edmonton, AB, Canada

family: Butts

full_name: Charles Butts

given: Charles

name: Provincial Center of Oncology in Gdańsk, Gdańsk, Poland

family: Wójcik-Tomaszewska

full_name: Joanna Wójcik-Tomaszewska

given: Joanna

name: Centre Georges-François Leclerc, Dijon, France

family: Coudert

full_name: Bruno Coudert

given: Bruno

name: Instituto Nazionale per Lo Studio e La Cura, Milano, Italy

family: Garassino

full_name: Marina Chiara Garassino

given: Marina Chiara

family: Ready

full_name: Neal Ready

given: Neal

name: Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain

family: Felip

full_name: Enriqueta Felip

given: Enriqueta

name: Hospital Universitario Virgen Del Rocio, Sevilla, Spain

family: García

full_name: Miriam Alonso García

given: Miriam Alonso

name: Oncology Hematology Care, Inc, Cincinnati, OH

family: Waterhouse

full_name: David Waterhouse

given: David

name: Fundacion Jimenez Diaz, IIS-FJD Madrid, Spain

family: Domine

full_name: Manuel Domine

given: Manuel

name: Aix Marseille University, CNRS, INSERM, CRCM, APHM, Marseille, France

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

family: Antonia

full_name: Scott Antonia

name: Robert Bosch Cancer Center, Gerlingen, Germany

family: Wohlleber

full_name: Markus Wohlleber

given: Markus

name: UT Southwestern Medical Center, Dallas, TX

family: Gerber

full_name: David E. Gerber

given: David E.

name: Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN

name: Universitaetsmedizin Essen und Ruhrlandklinik, Essen, Germany

name: Johns Hopkins Kimmel Cancer Center, Baltimore, MD

publisher_group: American Society of Clinical Oncology (ASCO)

title: Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non–Small-Cell Lung Cancer

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

ReferenceCitation: Reck M, Brahmer J, Bennett B, Taylor F, Penrod JR, DeRosa M, Dastani H, Spigel DR, Gralla RJ. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer. 2018 Oct;102:23-30. doi: 10.1016/j.ejca.2018.05.005. Epub 2018 Aug 10.

ReferenceCitation: Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Arén Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crinò L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.

ReferenceCitation: Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhäeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crinò L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.

name: Leora Horn, Vanderbilt-Ingram Cancer Center; David R. Spigel, Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN; Everett E. Vokes, University of Chicago, Chicago, IL; Esther Holgado, Hospital De Madrid, Norte Sanchinarro, Madrid; Enriqueta Felip, Hospital Universitari Vall d’Hebron, Barcelona; Luis Paz-Ares, Hospital Universitario Virgen Del Rocio, Seville, Spain; Neal Ready, Duke University Medical Center, Durham, NC; Martin Steins, Thoraxklinik-Heidelberg gGmbH, Heidelberg; Martin...

title: Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057)

ReferenceCitation: Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhäufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crinò L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.

title: Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

location_country:
Peru
Romania
Australia
Russian Federation
France
Poland
Norway
Argentina
Canada
Chile
Hong Kong
Switzerland
Singapore
Hungary
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
Spain

location_facility: University Of Texas Southwestern Medical Center

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Winthrop University Hospital Oncology/Hematology


title: EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)

summary: The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

ReferenceCitation: Kereiakes DJ, Windecker S, Jobe RL, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Underwood P, Allocco DJ, Meredith IT. Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27.

name: The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K., I.J.S.).

family: Kereiakes

full_name: Dean J. Kereiakes

given: Dean J.

name: Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.).

family: Windecker

full_name: Stephan Windecker

given: Stephan

name: UNC-Rex Healthcare, Raleigh, NC (R.L.J.).

family: Jobe

full_name: R. Lee Jobe

given: R. Lee

name: McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada (S.R.M.).

family: Mehta

full_name: Shamir R. Mehta

given: Shamir R.

family: Sarembock

full_name: Ian J. Sarembock

given: Ian J.

name: MediQuest Research AdventHealth Ocala, FL (R.L.F.).

family: Feldman

full_name: Robert L. Feldman

given: Robert L.

name: Morton Plant Mease Healthcare System, Clearwater, FL (B.S.).

family: Stein

full_name: Bernardo Stein

given: Bernardo

name: University Hospital Leuven, Belgium (C.D.).

family: Dubois

full_name: Christophe Dubois

given: Christophe

name: Aspirus Research Institute, Wausau, WI (T.G.).

family: Grady

full_name: Timothy Grady

given: Timothy

name: Shonan Kamakura General Hospital, Kanagawa, Japan (S.S.).

family: Saito

full_name: Shigeru Saito

given: Shigeru

name: Kyoto University Hospital, Japan (T.K.).

family: Kimura

full_name: Takeshi Kimura

given: Takeshi

name: Boston Scientific Corporation, Marlborough, MA (P.U., D.J.A., I.T.M.).

family: Underwood

full_name: Paul Underwood

given: Paul

family: Allocco

full_name: Dominic J. Allocco

given: Dominic J.

family: Meredith

full_name: Ian T. Meredith

given: Ian T.

oa_host_type: publisher

evidence: open (via free pdf)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4). pii: e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.

name: From the Heart and Vascular Center/The Lindner Research Center, Christ Hospital, Cincinnati, OH (D.J.K., I.J.S.); Department of Medicine, MonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia (I.T.M.); Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.); Department of Invasive Cardiology, Wake Medical Center, Raleigh, NC (R.L.J.); Department of Medicine, Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada (S.R.M.);...

family: Lee Jobe

given: R.

title: Efficacy and Safety of a Novel Bioabsorbable Polymer-Coated, Everolimus-Eluting Coronary Stent

location_country:
Italy
Austria
United States
Netherlands
Finland
France
Japan
Poland
Singapore
Australia
Belgium
New Zealand
Spain
Denmark
Canada
Latvia

location_facility: Lindner Center for Research and Education at Christ Hosp

location_facility: Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation

location_facility: National Cerebral and Cardiovascular Center

location_facility: Centre Hospitalier de Lagny - Marne La Vallée

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

location_facility: University of Miami McKnight Brain Institute

location_facility: SK Przemienienia Panskiego UM im.K.Marcinkowskiego

location_facility: Department of Cardiology, Tokyo Women's Medical University

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Medisch Spectrum Twente, Haaksbergerstraat

location_facility: Prairie Cardiovascular Consultants, Ltd.

location_facility: Washington University School of Medicine

location_facility: University Hospitals Case Medical Center

location_facility: Clinique Saint-Hilaire - Centre Frédéric Joliot

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: P. Stradins Clinical University Hospital

location_facility: Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego

location_facility: University of California Davis Health System

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Lahey Clinic Medical Center - Burlington

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel


title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis

acronym: ARCH

summary: The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis.

ReferenceType: background

ReferenceCitation: Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 Oct 12;377(15):1417-1427. doi: 10.1056/NEJMoa1708322. Epub 2017 Sep 11.

ReferenceCitation: Brown JP, Engelke K, Keaveny TM, Chines A, Chapurlat R, Foldes AJ, Nogues X, Civitelli R, De Villiers T, Massari F, Zerbini CAF, Wang Z, Oates MK, Recknor C, Libanati C. Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH) trial. J Bone Miner Res. 2021 Nov;36(11):2139-2152. doi: 10.1002/jbmr.4409. Epub 2021 Aug 10.

name: Centre Hospitalier Universitaire (CHU) de Québec Research Centre, Department of Medicine, Rheumatology Division Laval University  Quebec City Québec Canada

family: Brown

full_name: Jacques P. Brown

given: Jacques P.

name: Department of Medicine 3 Friedrich‐Alexander‐Universität Erlangen‐Nürnberg (FAU) and Universitätsklinikum Erlangen  Erlangen Germany

family: Engelke

full_name: Klaus Engelke

given: Klaus

name: Departments of Mechanical Engineering and Bioengineering University of California Berkeley  Berkeley California USA

family: Keaveny

full_name: Tony M. Keaveny

given: Tony M.

name: Amgen Inc.  Thousand Oaks California USA

family: Chines

full_name: Arkadi Chines

given: Arkadi

name: Institut National de la Santé et de la Recherche Médicale (INSERM) Unités Mixtes de Recherche (UMR) 1033 Université de Lyon, Hôpital E Herriot  Lyon France

family: Chapurlat

full_name: Roland Chapurlat

given: Roland

name: Osteoporosis Center Hadassah Hebrew University Medical Center  Jerusalem Israel

family: Foldes

full_name: A. Joseph Foldes

given: A. Joseph

name: Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Centro de Investigación Biomédica en Red Fragilidad y Envejecimiento Saludable (CIBERFES) Autonomous University of Barcelona  Barcelona Spain

family: Nogues

full_name: Xavier Nogues

given: Xavier

name: Musculoskeletal Research Center Washington University School of Medicine  St. Louis Missouri USA

family: Civitelli

full_name: Roberto Civitelli

given: Roberto

name: Department of Obstetrics and Gynaecology Stellenbosch University  Stellenbosch South Africa

family: De Villiers

full_name: Tobias De Villiers

given: Tobias

name: Instituto de Diagnóstico e Investigaciones Metabólicas  Buenos Aires Argentina

family: Massari

full_name: Fabio Massari

given: Fabio

name: Centro Paulista de Investigação Clinica  São Paulo Brazil

family: Zerbini

full_name: Cristiano A.F. Zerbini

given: Cristiano A.F.

family: Wang

full_name: Zhenxun Wang

given: Zhenxun

family: Oates

full_name: Mary K. Oates

given: Mary K.

name: United Osteoporosis Centers  Gainesville Georgia USA

family: Recknor

full_name: Christopher Recknor

given: Christopher

family: Libanati

full_name: Cesar Libanati

given: Cesar

journal_name: Journal of Bone and Mineral Research

title: Romosozumab improves lumbar spine bone mass and bone strength parameters relative to alendronate in postmenopausal women: results from the Active‐Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk ( ARCH) trial

ReferenceCitation: Cosman F, Lewiecki EM, Ebeling PR, Hesse E, Napoli N, Matsumoto T, Crittenden DB, Rojeski M, Yang W, Libanati C, Ferrari S. T-Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial. J Bone Miner Res. 2020 Jul;35(7):1333-1342. doi: 10.1002/jbmr.3996. Epub 2020 May 22.

name: Department of MedicineCollege of Physicians and Surgeons, Columbia University New York NY USA

family: Cosman

full_name: Felicia Cosman

given: Felicia

name: New Mexico Clinical Research & Osteoporosis Center Albuquerque NM USA

family: Lewiecki

full_name: E Michael Lewiecki

given: E Michael

name: Department of MedicineSchool of Clinical Sciences at Monash Health, Monash University Melbourne Australia

family: Ebeling

full_name: Peter R Ebeling

given: Peter R

name: Institute of Molecular Musculoskeletal Research, Faculty of MedicineLudwig‐Maximilians‐University (LMU) Munich Munich Germany

family: Hesse

name: Campus Bio‐Medico University of Rome Rome Italy

name: Fujii Memorial Institute of Medical Sciences, University of Tokushima Tokushima Japan

name: Service and Laboratory of Bone Diseases, Geneva University Hospital Geneva Switzerland

repository_institution: University of Geneva - Archive ouverte UNIGE

title: T ‐Score as an Indicator of Fracture Risk During Treatment With Romosozumab or Alendronate in the ARCH Trial

location_country:
Peru
Guatemala
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Poland
Lithuania
Slovakia
Norway
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Chile
Sweden
Hong Kong
Netherlands
Bulgaria
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Dominican Republic
Czechia
Israel
New Zealand
Spain
Estonia
Latvia


title: A Phase 3 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection

acronym: Hallmark DUAL

summary: The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.

ReferenceCitation: Kao JH, Lee YJ, Heo J, Ahn SH, Lim YS, Peng CY, Chang TT, Torbeyns A, Hughes E, Bhore R, Noviello S. All-oral daclatasvir plus asunaprevir for chronic hepatitis C virus (HCV) genotype 1b infection: a sub-analysis in Asian patients from the HALLMARK DUAL study. Liver Int. 2016 Oct;36(10):1433-41. doi: 10.1111/liv.13128. Epub 2016 Apr 28.

name: Graduate Institute of Clinical Medicine; National Taiwan University College of Medicine; Taipei Taiwan

family: Kao

full_name: Jia-Horng Kao

given: Jia-Horng

name: Department of Internal Medicine; Inje University Busan-Paik Hospital; Busan Republic of Korea

family: Lee

full_name: Youn-Jae Lee

given: Youn-Jae

name: Department of Internal Medicine; Pusan National University; Busan Republic of Korea

family: Heo

full_name: Jeong Heo

given: Jeong

name: Department of Internal Medicine; Institute of Gastroenterology; Yonsei University College of Medicine; Seoul Republic of Korea

family: Ahn

full_name: Sang-Hoon Ahn

given: Sang-Hoon

name: Department of Gastroenterology; Liver Center; Asan Medical Center; University of Ulsan College of Medicine; Seoul Republic of Korea

family: Lim

full_name: Young-Suk Lim

given: Young-Suk

name: China Medical University; School of Medicine; Taichung Taiwan

family: Peng

full_name: Cheng-Yuan Peng

given: Cheng-Yuan

name: Department of Internal Medicine; College of Medicine; National Cheng Kung University; Tainan Taiwan

family: Chang

full_name: Ting-Tsung Chang

given: Ting-Tsung

name: Global Biometric Sciences; Bristol-Myers Squibb; Braine-l'Alleud Belgium

family: Torbeyns

full_name: Anne Torbeyns

given: Anne

name: Research and Development; Bristol-Myers Squibb; Princeton NJ USA

family: Hughes

full_name: Eric Hughes

given: Eric

family: Bhore

full_name: Rafia Bhore

given: Rafia

family: Noviello

full_name: Stephanie Noviello

given: Stephanie

journal_name: Liver International

ReferenceCitation: Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

name: Graduate Institute of Clinical Medicine; National Taiwan University College of Medicine and Hepatitis Research Center; National Taiwan University Hospital; Taipei Taiwan

name: Center for Liver Diseases; University of Chicago Medical Center; Chicago IL USA

family: Jensen

full_name: Donald M. Jensen

given: Donald M.

name: Hannover Medical School; Hannover Germany

name: German Center for Infection Research; Hannover-Braunschweig Germany

family: Manns

full_name: Michael P. Manns

given: Michael P.

name: Department of Medicine at Mount Sinai Beth Israel Medical Center; New York NY USA

family: Jacobson

full_name: Ira Jacobson

given: Ira

family: Kumada

full_name: Hiromitsu Kumada

given: Hiromitsu

name: Sapporo-Kosei General Hospital; Sapporo Japan

family: Toyota

full_name: Joji Toyota

given: Joji

name: College of Medicine; Pusan National University and Medical Research Institute; Pusan National University Hospital; Busan South Korea

name: Veterans Affairs Medical Center; Baylor College of Medicine; Houston TX USA

family: Yoffe

full_name: Boris Yoffe

given: Boris

name: Monash Health and Monash University; Melbourne Victoria Australia

family: Sievert

full_name: William Sievert

given: William

name: Hospital Provincial del Centenario; Servicio de Gastroenterología y Hepatología; Universidad Nacional de Rosario; Rosario Argentina

family: Bessone

name: School of Medicine; China Medical University; Taichung Taiwan

name: Alfred Hospital and Monash University; Melbourne Victoria Australia

name: Inje University Busan Paik Hospital; Busan South Korea

name: Bristol-Myers Squibb Research and Development; Princeton NJ USA

ReferenceCitation: Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, Everson GT, Heo J, Gerken G, Yoffe B, Towner WJ, Bourliere M, Metivier S, Chu CJ, Sievert W, Bronowicki JP, Thabut D, Lee YJ, Kao JH, McPhee F, Kopit J, Mendez P, Linaberry M, Hughes E, Noviello S; HALLMARK-DUAL Study Team. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014 Nov 1;384(9954):1597-605. doi: 10.1016/S0140-6736(14)61059-X. Epub 2014 Jul 28. Erratum in: Lancet. 2014 Nov 1;384(9954):1576.

location_country:
Italy
Austria
United States
Netherlands
Spain
Germany
France
Poland
Israel
Ireland
Argentina
Australia
New Zealand
Russian Federation
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center

location_facility: The Health Care Authority For Baptist Health

location_facility: Gastrointestinal Research Institute (G.I.R.I.)

location_facility: University Of Colorado Denver And Hospital

location_facility: Toronto General Hospital-University Health Network

location_facility: North Shore-Long Island Jewish Health System

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: University Of North Carolina At Chapel Hill School Of Med

location_facility: Washington University School Of Medicine


status: Unknown status

lead_sponsor: Ziopharm

enrollment_type: Anticipated

location_country:
Italy
United States
France
Poland
Israel
Hungary
Australia
Russian Federation
Canada
United Kingdom
Taiwan

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: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

location_facility: Saint-Petersburg State Medical University n. a. I. P. Pavlov

location_facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego

location_facility: Debreceni Egyetem Orvos és Egészségtudományi Centrum

location_facility: Cancer Research Center n.a. N.N. Blokhin

location_facility: Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center

location_facility: Centre Hospitalier Universitaire -Hôpital Morvan

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

location_facility: GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary

location_facility: Centre Hospitalier Universitaire, Hopital Bretonneau

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Medical Oncology Associates Of Wyoming Valley, PC

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa

location_facility: State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"

location_facility: Indiana University Health Ball Memorial Hospital

location_facility: Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Fairfax Northern Virginia Hematology-Oncology, PC

location_facility: Wisconsin Institutes for Medical Research

location_facility: Texas Oncology- Baylor, Charles A. Sammons Cancer Center

location_facility: Southern Medical Day Oncology Care Centre

location_facility: Institut de Cancérologie de l'Ouest - René Gauducheau

location_facility: Hadassah Medical Organization, Ein Kerem

location_facility: University of Texas Medical Branch at Galveston

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Birmingham Hematology and Oncology Associates, LLC

location_facility: Peachtree Hematology Oncology Consultants

location_facility: Dayton Cancer Center, Medical Oncology Hematology Associates

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

source: euctr

title: A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study

summary:
This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy.

The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis.

Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.

The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed.

An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.

status_simplified: Unknown


title: A Phase III, Randomized, Double Blind, Parallel Group, Placebo Controlled, Multicentre Study to Assess Efficacy and Safety of Expanded Allogeneic Adipose-derived Stem Cells (eASCs) for the Treatment of Perianal Fistulising Crohn's Disease Over a Period of 24 Weeks and an Extended Follow-up Period up to 104 Weeks.

acronym: ADMIRE-CD

summary: The current multicentre phase III study is proposed to confirm in an add-on therapy design compared to a placebo-control group, the efficacy of adipose-derived stem cells (eASCs) from healthy donors for the treatment of complex anal fistulas in patients with Crohn's disease over a 24-week period and an extended follow-up period up to 104 weeks.

ReferenceCitation: Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Diez MC, Tagarro I, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn's Disease. Gastroenterology. 2018 Apr;154(5):1334-1342.e4. doi: 10.1053/j.gastro.2017.12.020. Epub 2017 Dec 24.

family: Panés

full_name: Julián Panés

given: Julián

family: García-Olmo

full_name: Damián García-Olmo

given: Damián

family: Van Assche

full_name: Gert Van Assche

given: Gert

family: Colombel

full_name: Jean Frederic Colombel

given: Jean Frederic

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Baumgart

full_name: Daniel C. Baumgart

given: Daniel C.

family: Dignass

full_name: Axel Dignass

given: Axel

family: Nachury

full_name: Maria Nachury

given: Maria

family: Ferrante

full_name: Marc Ferrante

given: Marc

family: Kazemi-Shirazi

full_name: Lili Kazemi-Shirazi

given: Lili

family: Grimaud

full_name: Jean C. Grimaud

given: Jean C.

family: de la Portilla

full_name: Fernando de la Portilla

given: Fernando

family: Goldin

full_name: Eran Goldin

given: Eran

family: Richard

full_name: Marie Paule Richard

given: Marie Paule

family: Diez

full_name: Mary Carmen Diez

given: Mary Carmen

family: Tagarro

full_name: Ignacio Tagarro

given: Ignacio

family: Leselbaum

full_name: Anne Leselbaum

family: Danese

full_name: Silvio Danese

given: Silvio

full_name: Jean F. Colombel

given: Jean F.

title: Long-term Efficacy and Safety of Stem Cell Therapy (Cx601) for Complex Perianal Fistulas in Patients With Crohn’s Disease

ReferenceCitation: Panés J, García-Olmo D, Van Assche G, Colombel JF, Reinisch W, Baumgart DC, Dignass A, Nachury M, Ferrante M, Kazemi-Shirazi L, Grimaud JC, de la Portilla F, Goldin E, Richard MP, Leselbaum A, Danese S; ADMIRE CD Study Group Collaborators. Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial. Lancet. 2016 Sep 24;388(10051):1281-90. doi: 10.1016/S0140-6736(16)31203-X. Epub 2016 Jul 29.

location_country: Italy Austria Netherlands France Israel Belgium Spain Germany

location_facility: Azienda Ospedaliera San Camillo-Forlanini

location_facility: Seconda Università degli Studi di Napoli

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola Malpighi


title: An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers

summary: This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.

ReferenceCitation: Kaley T, Touat M, Subbiah V, Hollebecque A, Rodon J, Lockhart AC, Keedy V, Bielle F, Hofheinz RD, Joly F, Blay JY, Chau I, Puzanov I, Raje NS, Wolf J, DeAngelis LM, Makrutzki M, Riehl T, Pitcher B, Baselga J, Hyman DM. BRAF Inhibition in BRAF(V600)-Mutant Gliomas: Results From the VE-BASKET Study. J Clin Oncol. 2018 Dec 10;36(35):3477-3484. doi: 10.1200/JCO.2018.78.9990. Epub 2018 Oct 23.

name: Thomas Kaley, Lisa M. DeAngelis, Jose Baselga, and David M. Hyman, Memorial Sloan Kettering Cancer Center; Thomas Kaley, Lisa M. DeAngelis, Jose Baselga, and David M. Hyman, Weill Cornell Medical College, New York; Igor Puzanov, Roswell Park Cancer Institute, Buffalo, NY; Mehdi Touat and Antoine Hollebecque, Institut Gustave Roussy, Villejuif; Franck Bielle, Assistance Publique–Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpêtrière–Charles Foix, Paris; Florence Joly, Centre François Baclesse, Caen;...

family: Kaley

full_name: Thomas Kaley

given: Thomas

family: Touat

full_name: Mehdi Touat

given: Mehdi

family: Subbiah

full_name: Vivek Subbiah

given: Vivek

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Rodon

full_name: Jordi Rodon

given: Jordi

family: Lockhart

full_name: A. Craig Lockhart

given: A. Craig

family: Keedy

full_name: Vicki Keedy

given: Vicki

family: Bielle

full_name: Franck Bielle

given: Franck

family: Hofheinz

full_name: Ralf-Dieter Hofheinz

given: Ralf-Dieter

family: Joly

full_name: Florence Joly

given: Florence

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Chau

full_name: Ian Chau

given: Ian

family: Puzanov

full_name: Igor Puzanov

given: Igor

family: Raje

full_name: Noopur S. Raje

given: Noopur S.

family: Wolf

full_name: Jurgen Wolf

given: Jurgen

family: DeAngelis

full_name: Lisa M. DeAngelis

given: Lisa M.

family: Makrutzki

full_name: Martina Makrutzki

given: Martina

family: Riehl

full_name: Todd Riehl

given: Todd

family: Pitcher

full_name: Bethany Pitcher

given: Bethany

family: Baselga

full_name: Jose Baselga

given: Jose

family: Hyman

full_name: David M. Hyman

given: David M.

journal_name: Journal of Clinical Oncology

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: BRAF Inhibition in BRAFV600-Mutant Gliomas: Results From the VE-BASKET Study

ReferenceCitation: Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309. Erratum in: N Engl J Med. 2018 Oct 18;379(16):1585.

name: From Memorial Sloan Kettering Cancer Center, New York (D.M.H., E.L.D., J.B.); Vanderbilt University Medical Center, Nashville (I.P., E.C.); University of Texas M.D. Anderson Cancer Center, Houston (V.S.); Massachusetts General Hospital, Boston (J.E.F., N.S.R.); Royal Marsden Hospital, Sutton, Surrey, United Kingdom (I.C.); Centre Léon Bérard, Lyon (J.-Y.B.), Institut Gustave Roussy, Villejuif (A.H.), Centre François Baclesse, Centre Hospitalier Universitaire Côte de Nacre, Caen (R.G.), and Institut...

location_country:
United States
France
Spain
China
Germany
United Kingdom

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: The Royal Marsden Hospital; Dept of Medicine

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Klinik der Uni zu Koeln; Klinik I für Innere Medizin; Onkologie

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Institut Paoli-Calmettes; Oncologie Medicale 1

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia


title: A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared With Telaprevir in Combination With Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C

summary: The purpose of this study is to compare the effectiveness of BMS-790052 (Daclatasvir) and Telaprevir when given in combination with Peginterferon alfa-2a and Ribavirin in genotype 1b patients

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Brazil
Switzerland
Germany
France
Poland
Israel
Argentina
Australia
Russian Federation
Spain
Denmark
United States
United Kingdom
Canada

location_facility: Saint Louis University Gastroenterology & Hepatology

location_facility: University Of North Carolina At Chapel Hill School Of Med


title: Phase III in Partial and Null Responders

acronym: ATTAIN

summary: The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.

ReferenceCitation: Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, Villamil FG, Andreone P, George J, Dammers E, Fu M, Kurland D, Lenz O, Ouwerkerk-Mahadevan S, Verbinnen T, Scott J, Jessner W. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis. 2015 Jan;15(1):27-35. doi: 10.1016/S1473-3099(14)71002-3. Epub 2014 Dec 5. Erratum in: Lancet Infect Dis. 2016 Apr;16(4):404.

family: Reddy

full_name: K Rajender Reddy

given: K Rajender

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Zoulim

full_name: Fabien Zoulim

given: Fabien

family: Weiland

full_name: Ola Weiland

given: Ola

family: Horban

full_name: Andrzej Horban

given: Andrzej

family: Stanciu

full_name: Carol Stanciu

given: Carol

family: Villamil

full_name: Federico Guillermo Villamil

given: Federico Guillermo

family: Andreone

full_name: Pietro Andreone

given: Pietro

family: George

full_name: Jacob George

given: Jacob

family: Dammers

full_name: Elisabeth Dammers

given: Elisabeth

family: Fu

full_name: Min Fu

given: Min

family: Kurland

full_name: Darryl Kurland

given: Darryl

family: Lenz

full_name: Oliver Lenz

given: Oliver

family: Ouwerkerk-Mahadevan

full_name: Sivi Ouwerkerk-Mahadevan

given: Sivi

family: Verbinnen

full_name: Thierry Verbinnen

given: Thierry

family: Scott

full_name: Jane Scott

given: Jane

family: Jessner

full_name: Wolfgang Jessner

given: Wolfgang

journal_name: The Lancet Infectious Diseases

lead_sponsor: Janssen R&D Ireland

location_country:
Greece
Romania
Australia
Belgium
Denmark
Czech Republic
France
Poland
Norway
Argentina
Canada
Sweden
Switzerland
Bulgaria
Hungary
Puerto Rico
Portugal
Germany
United States
United Kingdom
Austria
Brazil
Israel
Spain


title: The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study

acronym: IMAGINE 1

summary:
The purpose of this study is:

To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment.
To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment.
To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment.
To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.

ReferenceCitation: Sanyal A, Cusi K, Hartman ML, Zhang S, Bastyr EJ 3rd, Bue-Valleskey JM, Chang AM, Haupt A, Jacober SJ, Konrad RJ, Zhang Q, Hoogwerf BJ. Cytokeratin-18 and enhanced liver fibrosis scores in type 1 and type 2 diabetes and effects of two different insulins. J Investig Med. 2018 Mar;66(3):661-668. doi: 10.1136/jim-2017-000609. Epub 2017 Nov 21.

family: Sanyal

full_name: Arun Sanyal

given: Arun

family: Cusi

full_name: Kenneth Cusi

given: Kenneth

family: Hartman

full_name: Mark L Hartman

given: Mark L

family: Zhang

full_name: Shuyu Zhang

given: Shuyu

family: Bastyr

full_name: Edward J Bastyr

given: Edward J

suffix: III

family: Bue-Valleskey

full_name: Juliana M Bue-Valleskey

given: Juliana M

family: Chang

full_name: Annette M Chang

given: Annette M

family: Haupt

full_name: Axel Haupt

given: Axel

family: Jacober

full_name: Scott J Jacober

given: Scott J

family: Konrad

full_name: Robert J Konrad

given: Robert J

full_name: Qianyi Zhang

given: Qianyi

family: Hoogwerf

full_name: Byron J Hoogwerf

given: Byron J

journal_name: Journal of Investigative Medicine

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

ReferenceCitation: Orchard TJ, Cariou B, Connelly MA, Otvos JD, Zhang S, Antalis CJ, Ivanyi T, Hoogwerf BJ. The effects of basal insulin peglispro vs. insulin glargine on lipoprotein particles by NMR and liver fat content by MRI in patients with diabetes. Cardiovasc Diabetol. 2017 Jun 6;16(1):73. doi: 10.1186/s12933-017-0555-1.

family: Orchard

full_name: Trevor J. Orchard

given: Trevor J.

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

family: Connelly

full_name: Margery A. Connelly

given: Margery A.

family: Otvos

full_name: James D. Otvos

given: James D.

family: Antalis

full_name: Caryl J. Antalis

given: Caryl J.

family: Ivanyi

full_name: Tibor Ivanyi

given: Tibor

full_name: Byron J. Hoogwerf

given: Byron J.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

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

ReferenceCitation: Cusi K, Sanyal AJ, Zhang S, Hartman ML, Bue-Valleskey JM, Hoogwerf BJ, Haupt A. Non-alcoholic fatty liver disease (NAFLD) prevalence and its metabolic associations in patients with type 1 diabetes and type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1630-1634. doi: 10.1111/dom.12973. Epub 2017 Jun 22.

name: Division of Endocrinology, Diabetes and Metabolism; University of Florida; Gainesville Florida

name: Virginia Commonwealth University Medical Center; Richmond Virginia

name: Eli Lilly and Company, Lilly Corporate Center; Indianapolis Indiana

location_country:
Italy
Austria
Mexico
Germany
France
Japan
Poland
Russian Federation
United States

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


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined With FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma That Has Progressed Following a First Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen

summary: The primary objective of this study is to compare the additive efficacy of SIM versus placebo in combination with leucovorin (folinic acid), irinotecan, and fluorouracil (FOLFIRI) as measured by improvement in progression-free survival (PFS) in participants with metastatic KRAS mutant colorectal adenocarcinoma who have progressed following a first-line oxaliplatin- and fluoropyrimidine-containing regimen.

status: Terminated

ReferenceCitation: Hecht JR, Benson AB 3rd, Vyushkov D, Yang Y, Bendell J, Verma U. A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Simtuzumab in Combination with FOLFIRI for the Second-Line Treatment of Metastatic KRAS Mutant Colorectal Adenocarcinoma. Oncologist. 2017 Mar;22(3):243-e23. doi: 10.1634/theoncologist.2016-0479. Epub 2017 Feb 28.

name: David Geffen School of Medicine at the University of CaliforniaLos Angeles California USA

family: Hecht

full_name: J. Randolph Hecht

given: J. Randolph

name: Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicago Illinois USA

family: Benson

full_name: Al B. Benson

given: Al B.

name: Budgetary Healthcare Institution of Omsk Region, Clinical Oncologic DispensaryOmsk Russia

family: Vyushkov

full_name: Dmitry Vyushkov

given: Dmitry

name: Gilead Sciences, Inc.Foster City California USA

family: Yang

full_name: Yingsi Yang

given: Yingsi

name: Sarah Cannon Research Institute/Tennessee OncologyNashville Tennessee USA

family: Bendell

full_name: Johanna Bendell

given: Johanna

name: The University of Texas Southwestern Medical CenterDallas Texas USA

family: Verma

full_name: Udit Verma

given: Udit

journal_name: The Oncologist

oa_host_type: repository

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: A Phase II, Randomized, Double‐Blind, Placebo‐Controlled Study of Simtuzumab in Combination with FOLFIRI for the Second‐Line Treatment of Metastatic KRAS Mutant Colorectal Adenocarcinoma

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
France
Poland
Russian Federation
Spain
Germany

location_facility: State Institution "Blokhin Cancer Research Centre RAMS"

location_facility: Institut Paoli Calmettes Centre Régional de Lutte Contre le Cancer

location_facility: Krankenanstalt Mutterhaus der Borromäerinnen e.V.

location_facility: Klinikum Region Hannover GmbH, Krankenhaus Siloah

location_facility: University of Texas Southwestern Medical Center at Dallas

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

location_facility: Kaiser Permanente Northwest Region Oncology Hematology

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Peachtree Hematology Oncology Consultants, PC

location_facility: Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan

location_facility: University of California San Diego Medical Center

location_facility: Centre Hospitalier Régional Universitaire Hôpital Saint Eloi

location_facility: Comprehensive Hematology Oncology Centers, Inc.

location_facility: Hôpital Trousseau - Service de Gastroenterologie

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Providence Saint Joseph Medical Center-Disney Family Cancer Center

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Centre Oscar Lambret, Dept. de Cancerologie Digestive et Urologique

location_facility: Center for Cancer and Blood Disorders, PC

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

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

location_facility: Universitätsklinikum der Friedrich-Schiller-Universität Jena

location_facility: N.N.Petrov Research Institute of Oncology

location_facility: New York University Clinical Cancer Center

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Spólka z o. o.

location_facility: Ludwig-Maximilians-Universität München Klinikum Großhadern

location_facility: Suburban Hematology Oncology Associates, PC

location_facility: Non-State Institution of healthcare "Central Clinical Hospital #1 OAO RZD"

location_facility: The Center for Cancer and Blood Disorders

location_facility: TORI Network (Translational Oncology Research Intl)

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: Centrum Onkologii - Instytut im Marii Sklodowskiej-Curie

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Central Hematology Oncology Medical Group, Inc.

location_facility: Cancer Research Center n.a. Blokhin, Chemotherapy Dept.

location_facility: Nizhny Novgorod City Oncology Dispensary

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Hematology and Oncology Associates at BridgePoint


title: A Phase 3, Open Label Study of Safety and Efficacy With BMS-790052 Plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected With Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)

summary: The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV

ReferenceCitation: Sulkowski MS, Fessel WJ, Lazzarin A, Berenguer J, Zakharova N, Cheinquer H, Côté P, Dieterich D, Gadano A, Matthews G, Molina JM, Moreno C, Pineda JA, Pulido F, Rivero A, Rockstroh J, Hernandez D, McPhee F, Eley T, Liu Z, Mendez P, Hughes E, Noviello S, Ackerman P. Efficacy and safety of daclatasvir plus pegylated-interferon alfa 2a and ribavirin in previously untreated HCV subjects coinfected with HIV and HCV genotype-1: a Phase III, open-label study. Hepatol Int. 2017 Mar;11(2):188-198. doi: 10.1007/s12072-017-9788-z. Epub 2017 Feb 16.

family: Sulkowski

full_name: Mark S. Sulkowski

given: Mark S.

family: Fessel

full_name: Walford J. Fessel

given: Walford J.

family: Lazzarin

full_name: Adriano Lazzarin

given: Adriano

family: Berenguer

full_name: Juan Berenguer

given: Juan

family: Zakharova

full_name: Natalia Zakharova

given: Natalia

family: Cheinquer

full_name: Hugo Cheinquer

given: Hugo

family: Côté

full_name: Pierre Côté

given: Pierre

family: Dieterich

full_name: Douglas Dieterich

given: Douglas

family: Gadano

full_name: Adrian Gadano

given: Adrian

family: Matthews

full_name: Gail Matthews

given: Gail

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Moreno

full_name: Christophe Moreno

given: Christophe

family: Pineda

full_name: Juan Antonio Pineda

given: Juan Antonio

family: Pulido

full_name: Federico Pulido

given: Federico

family: Rivero

full_name: Antonio Rivero

given: Antonio

family: Rockstroh

full_name: Jurgen Rockstroh

given: Jurgen

family: Hernandez

full_name: Dennis Hernandez

given: Dennis

family: McPhee

full_name: Fiona McPhee

given: Fiona

family: Eley

full_name: Timothy Eley

given: Timothy

family: Liu

full_name: Zhaohui Liu

given: Zhaohui

family: Mendez

full_name: Patricia Mendez

given: Patricia

family: Hughes

full_name: Eric Hughes

given: Eric

family: Noviello

full_name: Stephanie Noviello

given: Stephanie

family: Ackerman

location_country:
Italy
Brazil
Spain
Germany
France
Belgium
Argentina
Australia
Puerto Rico
Russian Federation
United States
United Kingdom
Canada

location_facility: Southern California Permanente Medical Group

location_facility: University Of North Carolina At Chapel Hill

location_facility: University Of Puerto Rico School Of Medicine

location_facility: Upper Delaware Valley Infectious Diseases, Pc


title: A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Solid Tumors and Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

summary: The purpose of the study is to assess the safety, tolerability, pharmacokinetics and immunoregulatory activity of urelumab (BMS-663513) in cancer subjects with advanced and/or metastatic tumors and relapsed/refractory B-Cell Non-Hodgkin's Lymphoma

location_country:
Germany
United States
France
Spain

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Division Of Hematology & Oncology Ctr. For Health Sciences

location_facility: Hospital Of The University Of Pennsylvania


title: LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung

summary: This is a randomised, open-label, phase IIb trial of afatinib to compare to gefitinib in first-line treatment setting with patients who are having epidermal growth factor receptor mutation positive advanced adenocarcinoma of the lung.

ReferenceCitation: Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Märten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

family: Sequist

full_name: Lecia V. Sequist

given: Lecia V.

family: Tan

full_name: Eng-Huat Tan

given: Eng-Huat

family: Geater

full_name: Sarayut L. Geater

given: Sarayut L.

family: Orlov

full_name: Sergey Orlov

given: Sergey

family: Zhang

full_name: Li Zhang

given: Li

family: Lee

full_name: Ki Hyeong Lee

given: Ki Hyeong

family: Tsai

full_name: Chun-Ming Tsai

given: Chun-Ming

family: Kato

full_name: Terufumi Kato

given: Terufumi

family: Barrios

full_name: Carlos H. Barrios

given: Carlos H.

family: Schuler

full_name: Martin Schuler

given: Martin

family: Hirsh

full_name: Vera Hirsh

given: Vera

family: Yamamoto

full_name: Nobuyuki Yamamoto

given: Nobuyuki

family: O’Byrne

full_name: Kenneth O’Byrne

given: Kenneth

family: Boyer

full_name: Michael Boyer

given: Michael

family: Mok

full_name: Tony Mok

given: Tony

family: Peil

full_name: Barbara Peil

given: Barbara

family: Märten

full_name: Angela Märten

given: Angela

family: Chih-Hsin Yang

full_name: James Chih-Hsin Yang

given: James

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Park

full_name: Keunchil Park

given: Keunchil

journal_name: Clinical Lung Cancer

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

ReferenceCitation: Paz-Ares L, Tan EH, O'Byrne K, Zhang L, Hirsh V, Boyer M, Yang JC, Mok T, Lee KH, Lu S, Shi Y, Lee DH, Laskin J, Kim DW, Laurie SA, Kölbeck K, Fan J, Dodd N, Märten A, Park K. Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial. Ann Oncol. 2017 Feb 1;28(2):270-277. doi: 10.1093/annonc/mdw611.

repository_institution: Queensland University of Technology - QUT ePrints

ReferenceCitation: Park K, Tan EH, O'Byrne K, Zhang L, Boyer M, Mok T, Hirsh V, Yang JC, Lee KH, Lu S, Shi Y, Kim SW, Laskin J, Kim DW, Arvis CD, Kölbeck K, Laurie SA, Tsai CM, Shahidi M, Kim M, Massey D, Zazulina V, Paz-Ares L. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial. Lancet Oncol. 2016 May;17(5):577-89. doi: 10.1016/S1470-2045(16)30033-X. Epub 2016 Apr 12.

location_country:
Sweden
Hong Kong
Spain
France
Korea, Republic of
Norway
Ireland
Australia
Singapore
China
Germany
United Kingdom
Canada
Taiwan

location_facility: Haematology & Oncology Clinics of Australasia (HOCA)

location_facility: Cross Cancer Institute (University of Alberta)

location_facility: CTR Oncologie du Pays Basque, Onco, Bayonne

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: British Columbia Cancer Agency (BCCA) - Fraser Valley Cancer

location_facility: The First Hospital of Chinese Medical University

location_facility: Cancer Hospital of Chinese Academy of Medical Science

location_facility: Hospital Regional Universitario de Málaga

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Oslo Universitetssykehus HF, Radiumhospitalet

location_facility: The Affiliated Cancer Hospital, Guangxi Medical University