title: Study to Investigate Which Clinical Risk Factors Are Considered by Physicians When Conducting Overall Febrile Neutropenia Risk Assessments for Patients Receiving Chemotherapy With an Intermediate (10% - 20%) Febrile Neutropenia Risk.

summary:
This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy.

Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest.

Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited.

This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.

ReferenceType: background

ReferenceCitation: Freyer G, Kalinka-Warzocha E, Syrigos K, Marinca M, Tonini G, Ng SL, Wong ZW, Salar A, Steger G, Abdelsalam M, DeCosta L, Szabo Z. Attitudes of physicians toward assessing risk and using granulocyte colony-stimulating factor as primary prophylaxis in patients receiving chemotherapy associated with an intermediate risk of febrile neutropenia. Med Oncol. 2015 Oct;32(10):236. doi: 10.1007/s12032-015-0682-z. Epub 2015 Aug 28.

ReferenceCitation: Lyman GH, Dale DC, Legg JC, Abella E, Morrow PK, Whittaker S, Crawford J. Assessing patients' risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk? Cancer Med. 2015 Aug;4(8):1153-60. doi: 10.1002/cam4.454. Epub 2015 Mar 23.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Wiley

lead_sponsor: Amgen

location_country: Germany Ireland Italy Poland Romania Australia Austria Spain Greece Canada France


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas

summary: This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Savage KJ, Horwitz SM, Advani R, Christensen JH, Domingo-Domenech E, Rossi G, Morschhauser F, Alpdogan O, Suh C, Tobinai K, Shustov A, Trneny M, Yuen S, Zinzani PL, Trumper L, Ilidge T, O'Connor OA, Pro B, Miao H, Bunn V, Fenton K, Fanale M, Puhlmann M, Iyer S. Role of stem cell transplant in CD30+ PTCL following frontline brentuximab vedotin plus CHP or CHOP in ECHELON-2. Blood Adv. 2022 Oct 11;6(19):5550-5555. doi: 10.1182/bloodadvances.2020003971.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: Oxford - Oxford Academix

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

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;jdc.jefferson.edu;sdu.dk

unpaywall_oa_status: gold

publisher_dissemination: American Society of Hematology

ReferenceCitation: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illes A, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Huttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trumper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. doi: 10.1016/S0140-6736(18)32984-2. Epub 2018 Dec 4. Erratum In: Lancet. 2019 Jan 19;393(10168):228.

oa_host_type: repository

version: acceptedVersion

version: submittedVersion

endpoint_id: fhisxppmrqpajgzqkvft

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

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

unpaywall_oa_status: green

publisher_dissemination: Elsevier

ReferenceCitation: Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Seagen Inc.

sponsor_collaborators:
Seagen Inc.
Millennium Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
Hungary
Israel
Denmark
Australia
Romania
United Kingdom
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
France

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Hospital General Universitario Gregorio Marañon

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

location_facility: Klinik für Innere Medizin II, Friedrich-Schiller-Universität

location_facility: Hopital Saint-Louis / Service d'Hematologie

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Charles A. Sammons Cancer Center / Baylor University Medical Center

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Benaroya Research Institute/Virginia Mason Medical Center

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

location_facility: Virginia Commonwealth University Medical Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: Soroka Medical Center, Dept. of Oncology

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: Memorial Sloan Kettering Cancer Center - Basking Ridge

location_facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino

location_facility: St Vincent's Public Hospital Sydney - Fitzroy

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Holden Comprehensive Cancer Center / University of Iowa

location_facility: Istituto Clinico Humanitas-Humanitas Cancer Center

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: James P. Wilmot Cancer Center / University of Rochester Medical Center

location_facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

location_facility: Shands Cancer Center / University of Florida

location_facility: Università degli Studi di Roma "La Sapienza, Policlinico Umberto I

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: McGill University Department of Oncology / McGill University Health Centre

location_facility: Instituto di Ematologia ed Oncologia Medica

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: Klinikum der Ludwig-Maximilians-Universität München

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire de Poitiers

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: SUNLAND

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

summary: Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with neuroendocrine tumors.

location_facility:
CHU Cochin
UZ Leuven
Institut Mutualiste Montsouris
ULB Erasme
Hôpital Edouard Herriot
CHRU Trousseau
Hopital Saint Vincent de Paul
Institut Jules Bordet
Cliniques Universitaires Saint Luc
Hôpital Pitié Salpêtrière
Hôpital Saint André
CHU La Timone
CHU Rouen
CHU Robert Debré
Hôpital St Antoine
UZ Gent
CHU Pontchaillou
UZ Antwerpen
Hôpital Henri Mondor
Hôpital Beaujon

status: Unknown status

title: A RANDOMIZED PHASE II DOUBLE-BLIND TRIAL OF SUNITINIB VERSUS PLACEBO IN COMBINATION WITH LANREOTIDE IN PATIENTS WITH PROGRESSIVE ADVANCED/METASTATIC MIDGUT CARCINOID TUMORS

source: euctr

study_completion_date_type: Anticipated

location_country: Belgium France

collaborators: Pfizer Ipsen

status_simplified: Unknown


title: A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

summary: The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

status: Terminated

ReferenceCitation: Hanley MJ, Diderichsen PM, Narasimhan N, Srivastava S, Gupta N, Venkatakrishnan K. Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model-Informed Dose Selection for Pediatric Development. J Clin Pharmacol. 2022 Apr;62(4):555-567. doi: 10.1002/jcph.1990. Epub 2021 Dec 16.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: hybrid

ReferenceCitation: Lipton JH, Chuah C, Guerci-Bresler A, Rosti G, Simpson D, Assouline S, Etienne G, Nicolini FE, le Coutre P, Clark RE, Stenke L, Andorsky D, Oehler V, Lustgarten S, Rivera VM, Clackson T, Haluska FG, Baccarani M, Cortes JE, Guilhot F, Hochhaus A, Hughes T, Kantarjian HM, Shah NP, Talpaz M, Deininger MW; EPIC investigators. Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2016 May;17(5):612-21. doi: 10.1016/S1470-2045(16)00080-2. Epub 2016 Apr 12.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: Ariad Pharmaceuticals

location_country:
Finland
Germany
Poland
New Zealand
Australia
Canada
France
Czech Republic
Portugal
Slovakia
Hong Kong
Switzerland
United States
Belgium
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Sweden

location_facility: US Oncology - Cancer Center of Kansas, Site #168

location_facility: Fakultni nemocnice Olomouc, Hematoonkologicka klinika, Site #515

location_facility: VCU Massey Cancer Center, Dalton Oncology Clinic, Site #069

location_facility: Ospedale Niguarda Ca' Granda di Milano, Site #531

location_facility: Complejo Hospitalario Universitario A Coruna, Hospital "Teresa Herrera," Site #554

location_facility: Medical University of South Carolina, Site #148

location_facility: Centre Hospitalier de Versailles, Site #958

location_facility: Norfolk & Norwich University Hospital Foundation Trust, Site #557

location_facility: Clinique Universitaire de Saint-Luc, Department of Haematology, Site #508

location_facility: US Oncology - Comprehensive Cancer Center of Nevada, Site #169

location_facility: Hospital Universitario 12 de Octubre, Site #537

location_facility: Southeastern Medical Oncology Center, Site #188

location_facility: Kent and Medway Cancer Research Network, Site #558

location_facility: Royal Liverpool University Hospital, Site #969

location_facility: Universitätsklinikum Aachen, AÖR, Site #513

location_facility: Mount Sinai School of Medicine, Site #189

location_facility: Hospital Universitario La Princesa, Site #555

location_facility: US Oncology - Providence Health System, Site #167

location_facility: Medizinische Universitat Wien / AKH, Universitatsklinik fur Inniere Medizin I, Site #561

location_facility: Franciscan St. Francis Health, Site #138

location_facility: St. James University Hospital, Site #540

location_facility: Nebraska Hematology-Oncology, P.C., Site # 133

location_facility: Cancer Center of Central Connecticut, Site #147

location_facility: Klinika Hematologii Wojewodzkiego Szpitala Specjalistycznego, Site #550

location_facility: Hospital Universitario de Salamanca, Site #965

location_facility: Mercy Clinic - Cancer & Hematology, Site #151

location_facility: Hospital Universitari Germans Trias i Pujol, Site #512

location_facility: Universitat Heidelberg, CML - Studienzentrale III. Medizinische Klinik, Site #947

location_facility: Helsinki University Central Hospital, Site #542

location_facility: Instituto Portugues de Oncologia, Site #545

location_facility: UZ Gasthuisberg - Department of Hematology, Site #700

location_facility: Charite - Universitatsmedizin Berlin, Site #701

location_facility: Universitatsklinikum Hamburg-Eppendorf, Site #524

location_facility: University of Michigan Medical Center, Site #011

location_facility: Signal Point Clinical Research Center, Site #139

location_facility: CHRU de Brest, Hopital Morvan, Site #523

location_facility: Oregon Health & Science University, Site #048

location_facility: Karolinska University Hospital Solna, Site #763

location_facility: China Medical University Hospital, Site #978

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika, Site #514

location_facility: Weill Cornell Medical College, Site #006

location_facility: U.O.C Ematologia con trapianto di midollo osseo, Site #560

location_facility: UZ Brussel - Department Hematology, Site #544

location_facility: Oxford University Hospitals NHS Trust, Site #543

location_facility: Service Hematologie - Hospital Archet I, Site #509

location_facility: Hospital Universitari Son Espases, Site #553

location_facility: US Oncology - Texas Oncology Dallas, Site #171

location_facility: Nottingham University Hospitals NHS Trust, Site #968

location_facility: Ustav hematologie a krevni transfuse, Site #516

location_facility: University of Texas Southwestern Medical Center, Site #178

location_facility: Universitatsklinikum Koln-AOR, Site #525

location_facility: SCDU Medicina Interna II - Indirizzo Ematologico, Site #785

location_facility: Western Pennsylvania Hospital, Site #159

location_facility: US Oncology - Texas Oncology Austin, Site #172

location_facility: Christiana Care Health Services, Site #155

location_facility: Associates in Oncology & Hematology, Site #186

location_facility: Katedra i Klinika Hematologii, Site #547

location_facility: Willis-Knighton Cancer Center, Site #196

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia Universita La Sapienza - Policlinico Umberto I, Site #511

location_facility: Hospital Universitario Central de Asturias, Site #535

location_facility: The Peter MacCallum Cancer Center, Site #950

location_facility: Kaohsiung Chang Gung Memorial Hospital, Site #980

location_facility: University of Maryland, Greenebaum Cancer Center, Site #040

location_facility: Memorial Sloan-Kettering Cancer Center, Site #078

location_facility: UZ Gent - Department Hematology, Site #756

location_facility: US Oncology - Northwest Cancer Specialists, Site #174

location_facility: A.O. Universitaria Policlinico Vittorio Emanuele di Catania, Site #530

location_facility: Institut Catala d' Oncologia de Girona, S. de Hematologia Clinica, Site #734

location_facility: Green Bay Oncology, Ltd. / St. Mary's Hospital Medical Center, Site #193

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden, Site #526

location_facility: VU Medical Centre - Department Haematology, Site #948

location_facility: Bay Area Cancer Research Group, Site #157

location_facility: US Oncology - Cancer Care Center of South Texas, Site #170

location_facility: National Taiwan University Hospital, Site #979

location_facility: Hospital Clinico Universitario de Valencia, Site #964

location_facility: University of New Mexico Cancer Center, Site #166

location_facility: John H. Stroger, Jr. Hospital of Cook County, Site #192

location_facility: Rocky Mountain Cancer Centers, Site #191

location_facility: Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Medyczne, Site #548

location_facility: Greater Baltimore Medical Center, Site #140

location_facility: Istituto di Ematologia "L. & A. Seragnoli", Site #959

location_facility: University of Iowa Hospitals and Clinics, Site #050

location_facility: Sarah Cannon Research Institute, Site #076

location_facility: Massachusetts General Hospital, Site #047

location_facility: US Oncology - Texas Oncology Midland, Site #173

location_facility: Fundacion de Investigacion de Diego, Site #199

location_facility: Karolinska University Hospital Huddinge, Site #534

location_facility: University of Massachusetts Worcester, Site #152

location_facility: Unita Operativa di Ematologia con Trapianto, Site #529

location_facility: Providence Cancer Center Oncology and Hematology Care Eastside, Site #194

location_facility: Oncology Research Park Nicollet Institute, Site #195

location_facility: U.O. di Ematologia - Ospedale S. Eugenio, Site #962

location_facility: The Catholic University of Korea, Site #938

location_facility: University Health Network, Princess Margaret Hospital, Site #083

location_facility: Bay Area Cancer Research Group, Site #156

location_facility: Universitatsklinikum Freiburg, Site #527

location_facility: Siouxland Hematology-Oncology Associates, Site #198


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

summary: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with 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, Wojcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, Garcia 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.

repositories_concat: PubMed Central;www.repositoriosalud.es

ReferenceCitation: Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central;aacr.figshare.com

publisher_dissemination: American Association for Cancer Research

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: Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Aren 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, Crino 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.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

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, Kohlhaeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crino 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.

ReferenceCitation: Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

evidence: open (via free article)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Chile
Czechia
Canada
France
Hungary
United States
Romania
Peru
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Spain
Russian Federation

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: University Of Texas Southwestern Medical Center


title: An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

summary: This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

design_allocation: Non-Randomized

lead_sponsor: Gilead Sciences

location_country:
France
Germany
Italy
Poland
New Zealand
United Kingdom
Australia
Sweden
Netherlands
Austria
United States
Spain
Canada
Estonia
Puerto Rico
Czech Republic

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: The Gastroenterology Group of South Jersey

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

location_facility: University of Miami Center for Liver Diseases

location_facility: Binghamton Gastroenterology Associates, PC

location_facility: Annette C. and Harold C. Simmons Transplant Center

location_facility: Ente Ospedaliero Ospedali Galliera di Genova

location_facility: Southern California Transplantation Institute, Research Foundation Liver Center

location_facility: Academic Hospital Rotterdam Erasmus Medical Center

location_facility: Gastrointestinal Research Institute (GIRI)

location_facility: Gastointestinal Specialists of Georgia, PC

location_facility: Vancouver Infectious Disease Research and Care Centre

location_facility: Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases

location_facility: University of California Davis Medical Center

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Toronto Digestive Diseases Associates, Inc

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Royal Prince Alfred Hospital, Camperdown

location_facility: Hospital General Universitario de Valencia

location_facility: Remedis s.r.o., Nestátní zdravotnické zarízení

location_facility: Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico

location_facility: Fondazione PTV - Policlinico Tor Vergata

location_facility: Kansas City Gastroenterology and Hepatology

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Gordon & Leslie Diamond Health Care Centre

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Azienda Ospedaliero Universitaria S. Giovanni Battista di Torino

location_facility: Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankheiten

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: Infectious Disease and The Research Institute

location_facility: Centre Hospitalier Universitaire de Strasbourg

location_facility: Royal Free Hospital and University College London Hospital

location_facility: Centre Hospitalier Universitare de Rennes, Hôpital Pontchaillou

location_facility: PraxisZentrum für Gastroenterologie und Endokrinologie

location_facility: Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie

location_facility: Hospital of the University of Pennsylvania

location_facility: Lightsource Medical/Peter J. Ruane MD, Inc.

location_facility: South Florida Center of Gastroenterology, PA.

location_facility: Bon Secours Saint Mary's Hospital of Richmond


title: A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer

acronym: VELVET

summary: This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.

ReferenceCitation: Perez EA, Lopez-Vega JM, Petit T, Zamagni C, Easton V, Kamber J, Restuccia E, Andersson M. Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results. Breast Cancer Res. 2016 Dec 13;18(1):126. doi: 10.1186/s13058-016-0773-6.

evidence: oa journal (via doaj)

publisher_dissemination: Springer-Nature

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Denmark
Brazil
United States
Spain
France


title: A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

acronym: EPOCH

summary: The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.

ReferenceCitation: Mulcahy MF, Mahvash A, Pracht M, Montazeri AH, Bandula S, Martin RCG 2nd, Herrmann K, Brown E, Zuckerman D, Wilson G, Kim TY, Weaver A, Ross P, Harris WP, Graham J, Mills J, Yubero Esteban A, Johnson MS, Sofocleous CT, Padia SA, Lewandowski RJ, Garin E, Sinclair P, Salem R; EPOCH Investigators. Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial. J Clin Oncol. 2021 Dec 10;39(35):3897-3907. doi: 10.1200/JCO.21.01839. Epub 2021 Sep 20.

ReferenceCitation: Chauhan N, Mulcahy MF, Salem R, Benson Iii AB, Boucher E, Bukovcan J, Cosgrove D, Laframboise C, Lewandowski RJ, Master F, El-Rayes B, Strosberg JR, Sze DY, Sharma RA. TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial. JMIR Res Protoc. 2019 Jan 17;8(1):e11545. doi: 10.2196/11545.

evidence: oa repository (semantic scholar lookup)

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

license: cc-by-sa

license_normalized: cc-by-sa

repositories:
PubMed Central
UCL Discovery
pdfs.semanticscholar.org

publisher_dissemination: JMIR Publications

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
Biocompatibles UK Ltd

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

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital

location_facility: QEII Health Services Center, Halifax Infirmary Site

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: Oxford University Hospitals NHS Foundation Trust Churchill Hospital

location_facility: Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie

location_facility: The Clatterbrdige Cancer Centre NHSF Trust

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital

location_facility: Szpital Kliniczny im. Heliodora Święcickiego

location_facility: Allina Health, Virginia Piper Cancer Institute

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: University of Miami Miller School of Medicine, Florida

location_facility: Oddział Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Św.Jana z Dukli.

location_facility: Avenida de Roma, s/n, Hospital Universitario Central de Asturias

location_facility: Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

location_facility: Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie

location_facility: Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary

location_facility: The Ohio State University, Wexner Medical Center

location_facility: University of Colorado Denver Anschutz Medical Campus

location_facility: Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi

location_facility: Walsall Healthcare NHS Trust - Manor Hospital

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: The Royal Wolverhampton NHS Trust - New Cross Hospital

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Lynn Clinical Research Center, Boca Raton Regional Hospital

location_facility: Nottingham University Hospital NHS Trust

location_facility: UCLH, University College London Hospitals

location_facility: HCU Lozano Blesa, Planta 11-Oncología-Secretaría

location_facility: CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2

location_facility: McGill University Health Center - Glen Site

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: University of California San Fransico, Moffitt Hospital

location_facility: Great Western Hospitals NHS Foundation Trust - The Great Western Hospital

location_facility: Beatson Cancer Centre and University of Glasgow

location_facility: Onze-Lieve-Vrouwziekenuis VZW Campus Aalst

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie

location_facility: Wayne State Harper Hospita Karmanos Cancer Institute

location_facility: University Health Network , Mount Sinai Hospital

location_facility: Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital

intervention_type: Device


summary:
This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms.

Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.

ReferenceCitation: Rodriguez D, Calmon R, Aliaga ES, Warren D, Warmuth-Metz M, Jones C, Mackay A, Varlet P, Le Deley MC, Hargrave D, Canete A, Massimino M, Azizi AA, Saran F, Zahlmann G, Garcia J, Vassal G, Grill J, Peet A, Dineen RA, Morgan PS, Jaspan T. MRI and Molecular Characterization of Pediatric High-Grade Midline Thalamic Gliomas: The HERBY Phase II Trial. Radiology. 2022 Jul;304(1):174-182. doi: 10.1148/radiol.211464. Epub 2022 Apr 12.

repository_institution: University of Nottingham - Repository@Nottingham

repositories_institution: University College London - UCL Discovery

publisher_dissemination: Radiological Society of North America (RSNA)

ReferenceCitation: Varlet P, Le Teuff G, Le Deley MC, Giangaspero F, Haberler C, Jacques TS, Figarella-Branger D, Pietsch T, Andreiuolo F, Deroulers C, Jaspan T, Jones C, Grill J. WHO grade has no prognostic value in the pediatric high-grade glioma included in the HERBY trial. Neuro Oncol. 2020 Jan 11;22(1):116-127. doi: 10.1093/neuonc/noz142.

repositories_concat: PubMed Central;iris.uniroma1.it

publisher_dissemination: Oxford University Press

ReferenceCitation: Rodriguez D, Chambers T, Warmuth-Metz M, Aliaga ES, Warren D, Calmon R, Hargrave D, Garcia J, Vassal G, Grill J, Zahlmann G, Morgan PS, Jaspan T. Evaluation of the Implementation of the Response Assessment in Neuro-Oncology Criteria in the HERBY Trial of Pediatric Patients with Newly Diagnosed High-Grade Gliomas. AJNR Am J Neuroradiol. 2019 Mar;40(3):568-575. doi: 10.3174/ajnr.A5982. Epub 2019 Feb 28.

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: American Society of Neuroradiology (ASNR)

ReferenceCitation: Mackay A, Burford A, Molinari V, Jones DTW, Izquierdo E, Brouwer-Visser J, Giangaspero F, Haberler C, Pietsch T, Jacques TS, Figarella-Branger D, Rodriguez D, Morgan PS, Raman P, Waanders AJ, Resnick AC, Massimino M, Garre ML, Smith H, Capper D, Pfister SM, Wurdinger T, Tam R, Garcia J, Thakur MD, Vassal G, Grill J, Jaspan T, Varlet P, Jones C. Molecular, Pathological, Radiological, and Immune Profiling of Non-brainstem Pediatric High-Grade Glioma from the HERBY Phase II Randomized Trial. Cancer Cell. 2018 May 14;33(5):829-842.e5. doi: 10.1016/j.ccell.2018.04.004.

repository_institution: University of Nottingham - Nottingham ePrints

ReferenceCitation: Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Canete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, Open-Label, Randomized, Multicenter Trial (HERBY) of Bevacizumab in Pediatric Patients With Newly Diagnosed High-Grade Glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. doi: 10.1200/JCO.2017.76.0611. Epub 2018 Feb 7.

location_facility: Great Ormond Street Hospital; Dept. Of Pediatric Oncology

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Lady Cilento Children's Hospital; Oncology Services Group, Level 12b

location_facility: Sahlgrenska Universitetssjukhuset, Östra Sjukhus; Drottning Silvias Barnsjukhus

location_facility: Semmelweis University, 2nd Dept of Pediatrics Neurooncology Unit

location_facility: Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier d'Angers; Service de cancérologie pédiatrique

location_facility: Kepler Universitätskliniken GmbH - Med Campus IV.

location_facility: Centre Oscar Lambret; Service de Pediatrie

location_facility: CHU ESTAING; Centre Regional de Cancérologie et Thérapie Cellulaire Pédiatrique (CRCTCP)

location_facility: University College London NHS Foundation Trust

location_facility: Karolinska Universitetssjukhuset, Solna; Astrid Lindgrens Barnsjukhus, Barcanceravdelningen

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Addenbrookes Hospital; Paediatric Oncology Ward C2

location_facility: Birmingham Childrens Hospital; Oncology Dept

location_facility: Universitetssjukhuset Linköping; Barn och Ungdomskliniken

location_facility: Skejby Sygehus - Aarhus University Hospital; CF Center, Børneafdeling A

location_facility: Bristol Royal Hospital for Children; Paediatric Haematology, Oncology, BMT

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Fakultni nemocnice Brno; 2. detska klinika, pracoviste Detska nemocnice

location_facility: CHRU de Rennes - Hôpital Sud- Service d'Hématologie Pédiatrique

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii

location_facility: Hopital Lenval; Service Hématologie Infantile

location_facility: Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology

location_facility: CHRU de Tours - Centre de Pédiatrie Clocheville; Service d'Oncopédiatrie

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS; U.O.S. Neuroncologia

location_facility: Hopital Des Enfants; Service d Hemato-Oncologie

title: A Phase II Open-Label, Randomized, Multi-Centre Comparative Study Of Bevacizumab-Based Therapy In Paediatric Patients With Newly Diagnosed Supratentorial, Infratentorial Cerebellar, or Peduncular High-Grade Glioma

location_country:
Italy
Poland
Hungary
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
Spain
Czechia
Canada
France


title: A Multicenter, Randomized, Double-Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1

acronym: MODERN

summary: The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

lead_sponsor: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
Pfizer

location_country:
Finland
Germany
Poland
Australia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Spain
Sweden

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

location_facility: Universitaetsklinikum Bonn, Immunologische Ambulanz HIV

location_facility: Hospital Prof. Doutor Fernando Fonseca E.P.E.

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Hopital Tenon, Service des Maladies Infectieuses

location_facility: East Carolina University Division of Infectious Diseases

location_facility: Kaiser Permanente - Clinical Trials Unit

location_facility: Yale - New Haven Hospital Nathan Smith Clinic

location_facility: University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease

location_facility: Inselspital Universitaetsklinik fuer Infektiologie

location_facility: Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

location_facility: Maple Leaf Research / Maple Leaf Medical Clinic

location_facility: Ian Charleson Day Centre, Royal Free Hospital

location_facility: Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: University of Cincinnati - Department of Internal Medicine

location_facility: TICON I Research Clinic (DEXA Scan only)

location_facility: University of Alabama at Birmingham - 1917 Research Clinic

location_facility: The Office of Dr. Gordon E. Crofoot, M.D., PA

location_facility: SU Ostra sjukhuset, Infektionsmottagningen

location_facility: Clinical Research Unit, Infectious Diseases

location_facility: Universitaetsspital Basel Infektiologie und Spitalhygiene

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Biomedical and Health Institutional Review Board

location_facility: Michigan State University College of Osteopathic Medicine - Department of Internal Medicine

location_facility: Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos

location_facility: University Health Network / Toronto General Hospital

location_facility: UMHC/Sylvester Comprehensive Cancer Center

location_facility: Broward Health - Comprehensive Care Center

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: University of Miami AIDS Clinical Research Unit

location_facility: AIDS Community Research Initiative of America (ACRIA)

location_facility: Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs

location_facility: University of South Florida Health-HIV Clinical Research Unit

location_facility: St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: University of Colorado Denver - University of Colorado Hospital

location_facility: Hvidovre Hospital, Infektionsmedicinsk afd.

location_facility: (DEXA Scan Facility) East Carolina University Brody Outpatient Center

location_facility: Hospital General Universitario de Alicante

location_facility: Infectious Disease Research Institute, Inc.

location_facility: Hospital Universitario Reina Sofia - Hospital Provincial

location_facility: North Texas Infectious Diseases Consultants, PA

location_facility: Community AIDS Resource Inc dba Care Resource

location_facility: Infectious Diseases Associates of Northwest Florida, PA

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: University of Puerto Rico Medical Sciences Campus

location_facility: George Washington University Medical Faculty Associates

location_facility: Beth Israel Medical Center - AIDS Clinical Trials Unit

location_facility: Centre for Sexual Health & HIV Research, University College London

location_facility: Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,

location_facility: EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH

location_facility: Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: AKH Wien Universitaetsklinik fuer Dermatologie

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: HIV Research Department, Elton John Centre

location_facility: Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II

location_facility: Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet

location_facility: Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer

acronym: SELECT

summary: This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period).

ReferenceCitation: Taylor MH, Takahashi S, Capdevila J, Tahara M, Leboulleux S, Kiyota N, Dutcus CE, Xie R, Robinson B, Sherman S, Habra MA, Elisei R, Wirth LJ. Correlation of Performance Status and Neutrophil-Lymphocyte Ratio with Efficacy in Radioiodine-Refractory Differentiated Thyroid Cancer Treated with Lenvatinib. Thyroid. 2021 Aug;31(8):1226-1234. doi: 10.1089/thy.2020.0779. Epub 2021 Apr 29.

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Tahara M, Kiyota N, Hoff AO, Badiu C, Owonikoko TK, Dutcus CE, Suzuki T, Ren M, Wirth LJ. Impact of lung metastases on overall survival in the phase 3 SELECT study of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer. Eur J Cancer. 2021 Apr;147:51-57. doi: 10.1016/j.ejca.2020.12.032. Epub 2021 Feb 19.

ReferenceCitation: Tahara M, Brose MS, Wirth LJ, Suzuki T, Miyagishi H, Fujino K, Dutcus CE, Gianoukakis A. Impact of dose interruption on the efficacy of lenvatinib in a phase 3 study in patients with radioiodine-refractory differentiated thyroid cancer. Eur J Cancer. 2019 Jan;106:61-68. doi: 10.1016/j.ejca.2018.10.002. Epub 2018 Nov 22.

ReferenceCitation: Tahara M, Schlumberger M, Elisei R, Habra MA, Kiyota N, Paschke R, Dutcus CE, Hihara T, McGrath S, Matijevic M, Kadowaki T, Funahashi Y, Sherman SI. Exploratory analysis of biomarkers associated with clinical outcomes from the study of lenvatinib in differentiated cancer of the thyroid. Eur J Cancer. 2017 Apr;75:213-221. doi: 10.1016/j.ejca.2017.01.013. Epub 2017 Feb 24.

repository_institution: Kobe University - Kobe University Repository Kernel

ReferenceCitation: Robinson B, Schlumberger M, Wirth LJ, Dutcus CE, Song J, Taylor MH, Kim SB, Krzyzanowska MK, Capdevila J, Sherman SI, Tahara M. Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer. J Clin Endocrinol Metab. 2016 Nov;101(11):4103-4109. doi: 10.1210/jc.2015-3989. Epub 2016 Aug 22.

publisher_dissemination: The Endocrine Society

ReferenceCitation: Kiyota N, Schlumberger M, Muro K, Ando Y, Takahashi S, Kawai Y, Wirth L, Robinson B, Sherman S, Suzuki T, Fujino K, Gupta A, Hayato S, Tahara M. Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer. Cancer Sci. 2015 Dec;106(12):1714-21. doi: 10.1111/cas.12826. Epub 2015 Nov 2.

ReferenceCitation: Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. doi: 10.1056/NEJMoa1406470.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Portugal
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Russian Federation
Sweden

location_facility:
Facility 5
Eisai Trial Site 1
Facility 2
Eisai Trial Site 2
Facility 4
Facility 3
Facility 1


title: A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

acronym: eBMX-PMR

summary: The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Biosensors Europe SA

location_country:
Germany
Ireland
Lithuania
Poland
Portugal
United Kingdom
Denmark
Switzerland
Austria
Latvia
Spain
Morocco
Jordan
Czechia
Russian Federation
France

location_facility: Hôpital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Brighton and Sussex University Hospitals

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hôpital Militaire d'instruction Mohamed-V


type: Other Identifier

title: Phase 2 Study of LY2157299 in Patients With Hepatocellular Carcinoma

summary: The purpose of this study is to estimate the median time to progression in participants with hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination with sorafenib or ramucirumab.

ReferenceCitation: Giannelli G, Santoro A, Kelley RK, Gane E, Paradis V, Cleverly A, Smith C, Estrem ST, Man M, Wang S, Lahn MM, Raymond E, Benhadji KA, Faivre S. Biomarkers and overall survival in patients with advanced hepatocellular carcinoma treated with TGF-betaRI inhibitor galunisertib. PLoS One. 2020 Mar 25;15(3):e0222259. doi: 10.1371/journal.pone.0222259. eCollection 2020. Erratum In: PLoS One. 2020 Jun 25;15(6):e0235580. PLoS One. 2021 Jun 17;16(6):e0253671.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: Public Library of Science

ReferenceCitation: Addepalli A, Kalyani S, Singh M, Bandyopadhyay D, Mohan KN. CalPen (Calculator of Penetrance), a web-based tool to estimate penetrance in complex genetic disorders. PLoS One. 2020 Jan 29;15(1):e0228156. doi: 10.1371/journal.pone.0228156. eCollection 2020. Erratum In: PLoS One. 2020 Jun 25;15(6):e0235547.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_concat: PubMed Central;figshare.com

ReferenceCitation: Faivre S, Santoro A, Kelley RK, Gane E, Costentin CE, Gueorguieva I, Smith C, Cleverly A, Lahn MM, Raymond E, Benhadji KA, Giannelli G. Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma. Liver Int. 2019 Aug;39(8):1468-1477. doi: 10.1111/liv.14113. Epub 2019 Jun 3.

ReferenceCitation: Li S, Yang F, Ren X. Immunotherapy for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):363-71. doi: 10.5582/ddt.2015.01054.

publisher_dissemination: International Research and Cooperation Association for Bio & Socio-Sciences Advancement (IRCA-BSSA)

ipd_sharing: Yes

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

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
New Zealand
Australia
United States
Spain
France

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.

location_facility: Indiana Univ Melvin & Bren Simon Cancer Center


acronym: ELOQUENT - 2

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS).

ReferenceCitation: Dimopoulos MA, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.

ReferenceCitation: Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M. An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab. AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9.

ReferenceCitation: Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Rollig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.

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

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Bristol-Myers Squibb
AbbVie

location_facility: Acrc/Arizona Clinical Research Center, Inc.

location_facility: Hematology-Oncology Associates Of Fredricksburg, Inc

location_facility: University Of Wisconsin Hospital And Clinics

location_facility: Capitol Comprehensive Cancer Care Center

location_facility: Cancer Center Of Acadiana At Lafayette General

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: University Of Oklahoma Health Sciences Center

location_facility: San Diego Pacific Oncology& Hematology Associates, Inc

location_facility: Washington University School Of Medicine

title: Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM)

location_country:
Germany
Ireland
Poland
Australia
Japan
Turkey
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Austria
United Arab Emirates
Spain
Greece
Israel


title: An International, Cross Sectional, Non-interventional, Study to Assess Neuroendocrine Tumour (NET) Patients Currently Treated by Somatuline Autogel for History of Carcinoid Syndrome Associated With Episodes of Diarrhea

acronym: SYMNET

summary: The purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. The study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with Somatuline Autogel in routine practice.

time_perspective: Cross-Sectional

ReferenceCitation: Ruszniewski P, Valle JW, Lombard-Bohas C, Cuthbertson DJ, Perros P, Holubec L, Delle Fave G, Smith D, Niccoli P, Maisonobe P, Atlan P, Caplin ME; SYMNET study group. Patient-reported outcomes with lanreotide Autogel/Depot for carcinoid syndrome: An international observational study. Dig Liver Dis. 2016 May;48(5):552-558. doi: 10.1016/j.dld.2015.12.013. Epub 2016 Jan 15.

repository_institution: Newcastle Univesity - Newcastle University ePrints

lead_sponsor: Ipsen

location_country:
France
Italy
Poland
Hungary
United Kingdom
Spain
Czechia
Israel

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Unità di Endocrinologia Istituti Fisioterapici Ospitalieri

location_facility: U.O.C. Malattie dell'Apparato Digerente e del Fegato

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1


title: A Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy

summary:
This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients.

This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.

ReferenceCitation: Sieper J, Porter-Brown B, Thompson L, Harari O, Dougados M. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis. 2014 Jan;73(1):95-100. doi: 10.1136/annrheumdis-2013-203559. Epub 2013 Jun 13.

publisher_dissemination: British Medical Journal

location_country:
Germany
Poland
Australia
Brazil
Canada
France
Czech Republic
Lithuania
Slovakia
Denmark
United States
India
Belgium
Italy
United Kingdom
Netherlands
Spain
South Africa
Bulgaria


acronym: SYNERGY

lead_sponsor: Achieve Life Sciences

summary: This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.

ReferenceCitation: Chi KN, Higano CS, Blumenstein B, Ferrero JM, Reeves J, Feyerabend S, Gravis G, Merseburger AS, Stenzl A, Bergman AM, Mukherjee SD, Zalewski P, Saad F, Jacobs C, Gleave M, de Bono JS. Custirsen in combination with docetaxel and prednisone for patients with metastatic castration-resistant prostate cancer (SYNERGY trial): a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2017 Apr;18(4):473-485. doi: 10.1016/S1470-2045(17)30168-7. Epub 2017 Mar 8.

ReferenceCitation: de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

publisher_dissemination: Springer

sponsor_collaborators: Teva Branded Pharmaceutical Products R&D, Inc.

location_facility:
Teva Investigational Site 764
Teva Investigational Site 107
Teva Investigational Site 692
Teva Investigational Site 752
Teva Investigational Site 694
Teva Investigational Site 806
Teva Investigational Site 550
Teva Investigational Site 090
Teva Investigational Site 765
Teva Investigational Site 103
Teva Investigational Site 802
Teva Investigational Site 263
Teva Investigational Site 551
Teva Investigational Site 815
Teva Investigational Site 096
Teva Investigational Site 602
Teva Investigational Site 810
Teva Investigational Site 607
Teva Investigational Site 758
Teva Investigational Site 118
Teva Investigational Site 025
Teva Investigational Site 098
Teva Investigational Site 762
Teva Investigational Site 266
Teva Investigational Site 007
Teva Investigational Site 004
Teva Investigational Site 691
Teva Investigational Site 704
Teva Investigational Site 562
Teva Investigational Site 805
Teva Investigational Site 807
Teva Investigational Site 700
Teva Investigational Site 860
Teva Investigational Site 553
Teva Investigational Site 800
Teva Investigational Site 754
Teva Investigational Site 084
Teva Investigational Site 024
Teva Investigational Site 108
Teva Investigational Site 400
Teva Investigational Site 813
Teva Investigational Site 023
Teva Investigational Site 032
Teva Investigational Site 698
Teva Investigational Site 606
Teva Investigational Site 502
Teva Investigational Site 566
Teva Investigational Site 705
Teva Investigational Site 047
Teva Investigational Site 091
Teva Investigational Site 406
Teva Investigational Site 026
Teva Investigational Site 559
Teva Investigational Site 563
Teva Investigational Site 503
Teva Investigational Site 811
Teva Investigational Site 862
Teva Investigational Site 557
Teva Investigational Site 816
Teva Investigational Site 605
Teva Investigational Site 763
Teva Investigational Site 618
Teva Investigational Site 709
Teva Investigational Site 703
Teva Investigational Site 809
Teva Investigational Site 027
Teva Investigational Site 693
Teva Investigational Site 552
Teva Investigational Site 116
Teva Investigational Site 710
Teva Investigational Site 803
Teva Investigational Site 601
Teva Investigational Site 102
Teva Investigational Site 100
Teva Investigational Site 403
Teva Investigational Site 853
Teva Investigational Site 612
Teva Investigational Site 564
Teva Investigational Site 404
Teva Investigational Site 097
Teva Investigational Site 104
Teva Investigational Site 759
Teva Investigational Site 402
Teva Investigational Site 760
Teva Investigational Site 613
Teva Investigational Site 063
Teva Investigational Site 755
Teva Investigational Site 696
Teva Investigational Site 808
Teva Investigational Site 001
Teva Investigational Site 087
Teva Investigational Site 609
Teva Investigational Site 801
Teva Investigational Site 611
Teva Investigational Site 561
Teva Investigational Site 699
Teva Investigational Site 505
Teva Investigational Site 501
Teva Investigational Site 761
Teva Investigational Site 405
Teva Investigational Site 085
Teva Investigational Site 863
Teva Investigational Site 600
Teva Investigational Site 093
Teva Investigational Site 695
Teva Investigational Site 610
Teva Investigational Site 753
Teva Investigational Site 617
Teva Investigational Site 028
Teva Investigational Site 616
Teva Investigational Site 204
Teva Investigational Site 603
Teva Investigational Site 614
Teva Investigational Site 002
Teva Investigational Site 401
Teva Investigational Site 560
Teva Investigational Site 112
Teva Investigational Site 106
Teva Investigational Site 851
Teva Investigational Site 094
Teva Investigational Site 059
Teva Investigational Site 604
Teva Investigational Site 697
Teva Investigational Site 750
Teva Investigational Site 608
Teva Investigational Site 003
Teva Investigational Site 852
Teva Investigational Site 804
Teva Investigational Site 558
Teva Investigational Site 701
Teva Investigational Site 615
Teva Investigational Site 086
Teva Investigational Site 507
Teva Investigational Site 555
Teva Investigational Site 101
Teva Investigational Site 506
Teva Investigational Site 756
Teva Investigational Site 029
Teva Investigational Site 814
Teva Investigational Site 864

title: A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer

location_country:
Germany
Italy
Hungary
Israel
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Spain
Canada
France


lead_sponsor: Boehringer Ingelheim

summary: To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.

ReferenceCitation: Ratjen F, Koker P, Geller DE, Langellier-Cocteaux B, Le Maulf F, Kattenbeck S, Moroni-Zentgraf P, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Tiotropium Respimat in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials. J Cyst Fibros. 2015 Sep;14(5):608-14. doi: 10.1016/j.jcf.2015.03.004. Epub 2015 Mar 26.

repository_institution: Queen's University Belfast - Research Portal

repositories_institution: Queen's University Belfast - Research Portal

location_facility: 205.438.61003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33010 Boehringer Ingelheim Investigational Site

location_facility: 205.438.07001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.35004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.35001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49012 Boehringer Ingelheim Investigational Site

location_facility: 205.438.35003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01014 Boehringer Ingelheim Investigational Site

location_facility: 205.438.36003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.34005 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01018 Boehringer Ingelheim Investigational Site

location_facility: 205.438.07005 Boehringer Ingelheim Investigational Site

location_facility: 205.438.42102 Boehringer Ingelheim Investigational Site

location_facility: 205.438.34001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49008 Boehringer Ingelheim Investigational Site

location_facility: 205.438.35301 Boehringer Ingelheim Investigational Site

location_facility: 205.438.32002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.41002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33008 Boehringer Ingelheim Investigational Site

location_facility: 205.438.48002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.44002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33006 Boehringer Ingelheim Investigational Site

location_facility: 205.438.02005 Boehringer Ingelheim Investigational Site

location_facility: 205.438.44005 Boehringer Ingelheim Investigational Site

location_facility: 205.438.43002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.02004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01007 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.02003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.61002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.39003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.32003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.32001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.34004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.97003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.36004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.97004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.32004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01005 Boehringer Ingelheim Investigational Site

location_facility: 205.438.48003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.39002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01006 Boehringer Ingelheim Investigational Site

location_facility: 205.438.42001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.41001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33013 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.61001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.42004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.44004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33007 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49005 Boehringer Ingelheim Investigational Site

location_facility: 205.438.07002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.42103 Boehringer Ingelheim Investigational Site

location_facility: 205.438.39001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.44003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01010 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33014 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49007 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01008 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01021 Boehringer Ingelheim Investigational Site

location_facility: 205.438.44009 Boehringer Ingelheim Investigational Site

location_facility: 205.438.42002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.41003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.61004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33011 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33009 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49006 Boehringer Ingelheim Investigational Site

location_facility: 205.438.48001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01012 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33015 Boehringer Ingelheim Investigational Site

location_facility: 205.438.41004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.35002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.42101 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01011 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33005 Boehringer Ingelheim Investigational Site

location_facility: 205.438.49011 Boehringer Ingelheim Investigational Site

location_facility: 205.438.34002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.97001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01019 Boehringer Ingelheim Investigational Site

location_facility: 205.438.42003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.07004 Boehringer Ingelheim Investigational Site

location_facility: 205.438.97002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.02006 Boehringer Ingelheim Investigational Site

location_facility: 205.438.44007 Boehringer Ingelheim Investigational Site

location_facility: 205.438.33003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.27001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.07003 Boehringer Ingelheim Investigational Site

location_facility: 205.438.43001 Boehringer Ingelheim Investigational Site

location_facility: 205.438.01013 Boehringer Ingelheim Investigational Site

location_facility: 205.438.02007 Boehringer Ingelheim Investigational Site

location_facility: 205.438.36002 Boehringer Ingelheim Investigational Site

location_facility: 205.438.02001 Boehringer Ingelheim Investigational Site

title: A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.

location_country:
Germany
Ireland
Poland
Australia
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Switzerland
United States
Belgium
Italy
United Kingdom
Austria
Spain
South Africa
Russian Federation
Israel


intervention_type: Biological

lead_sponsor: GlaxoSmithKline

summary:
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years.

Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.

ReferenceCitation: Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang SJ, Diez-Domingo J, Godeaux O, Levin MJ, McElhaney JE, Puig-Barbera J, Vanden Abeele C, Vesikari T, Watanabe D, Zahaf T, Ahonen A, Athan E, Barba-Gomez JF, Campora L, de Looze F, Downey HJ, Ghesquiere W, Gorfinkel I, Korhonen T, Leung E, McNeil SA, Oostvogels L, Rombo L, Smetana J, Weckx L, Yeo W, Heineman TC; ZOE-70 Study Group. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70 Years of Age or Older. N Engl J Med. 2016 Sep 15;375(11):1019-32. doi: 10.1056/NEJMoa1603800.

ReferenceCitation: Cunningham AL, Heineman TC, Lal H, Godeaux O, Chlibek R, Hwang SJ, McElhaney JE, Vesikari T, Andrews C, Choi WS, Esen M, Ikematsu H, Choma MK, Pauksens K, Ravault S, Salaun B, Schwarz TF, Smetana J, Abeele CV, Van den Steen P, Vastiau I, Weckx LY, Levin MJ; ZOE-50/70 Study Group. Immune Responses to a Recombinant Glycoprotein E Herpes Zoster Vaccine in Adults Aged 50 Years or Older. J Infect Dis. 2018 May 5;217(11):1750-1760. doi: 10.1093/infdis/jiy095.

ReferenceCitation: Ikematsu H et al. (2018) Efficacy, safety and immunogenicity of new adjuvanted herpes zoster subunit vaccine for Japanese over 50 years old and over 70 years old. Kansenshogaku Zasshi. 92(2):103-114.

ReferenceCitation: Kovac M, Lal H, Cunningham AL, Levin MJ, Johnson RW, Campora L, Volpi A, Heineman TC; ZOE-50/70 Study Group. Complications of herpes zoster in immunocompetent older adults: Incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine. 2018 Mar 14;36(12):1537-1541. doi: 10.1016/j.vaccine.2018.02.029. Epub 2018 Feb 17.

ReferenceCitation: Kim JH, Diaz-Decaro J, Jiang N, Hwang SJ, Choo EJ, Co M, Hastie A, Hui DSC, Irimajiri J, Lee J, Leung EM, Tang H, Tsuru T, Watson P, Wu Z, Yu CJ, Yuan Y, Zahaf T, Cunningham AL, Schuind A. The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults >/= 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials. Hum Vaccin Immunother. 2021 Jul 3;17(7):2050-2057. doi: 10.1080/21645515.2020.1859321. Epub 2021 Feb 19.

publisher_dissemination: Informa

ReferenceCitation: Dagnew AF, Rausch D, Herve C, Zahaf T, Levin MJ, Schuind A; ZOE-50/70 study group. Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials. Rheumatology (Oxford). 2021 Mar 2;60(3):1226-1233. doi: 10.1093/rheumatology/keaa424.

ReferenceCitation: Colindres R, Wascotte V, Brecx A, Clarke C, Herve C, Kim JH, Levin MJ, Oostvogels L, Zahaf T, Schuind A, Cunningham AL. Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials. Hum Vaccin Immunother. 2020 Nov 1;16(11):2628-2633. doi: 10.1080/21645515.2020.1741312. Epub 2020 Apr 29.

ReferenceCitation: Willer DO, Oostvogels L, Cunningham AL, Gervais P, Gorfinkel I, Hyung Kim J, Talarico C, Wascotte V, Zahaf T, Colindres R, Schuind A; ZOE 50/70 study groups. Efficacy of the adjuvanted recombinant zoster vaccine (RZV) by sex, geographic region, and geographic ancestry/ethnicity: A post-hoc analysis of the ZOE-50 and ZOE-70 randomized trials. Vaccine. 2019 Oct 8;37(43):6262-6267. doi: 10.1016/j.vaccine.2019.09.028. Epub 2019 Sep 16.

ReferenceCitation: Lopez-Fauqued M, Campora L, Delannois F, El Idrissi M, Oostvogels L, De Looze FJ, Diez-Domingo J, Heineman TC, Lal H, McElhaney JE, McNeil SA, Yeo W, Tavares-Da-Silva F; ZOE-50/70 Study Group. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials. Vaccine. 2019 Apr 24;37(18):2482-2493. doi: 10.1016/j.vaccine.2019.03.043. Epub 2019 Mar 29.

repository_institution: University of Wollongong - Research Online

repository_institution: Tampere University - Tampere University Institutional Repository

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

ReferenceCitation: Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S, Diez-Domingo J, Lal H, Andrews C, Athan E, Berglund J, Campora L, de Looze F, Korhonen T, Leung E, Levin M, Volpi A, Johnson RW; ZOE-50/70 Study Group. Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older. J Gerontol A Biol Sci Med Sci. 2019 Jul 12;74(8):1231-1238. doi: 10.1093/gerona/gly150.

repositories_institution: La Trobe University - OPAL (Open@LaTrobe)

title: Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Finland
Germany
Italy
United Kingdom
Hong Kong
Australia
Brazil
Japan
Mexico
Sweden
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Estonia
France


summary:
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.

Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.

ReferenceCitation: Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang SJ, Levin MJ, McElhaney JE, Poder A, Puig-Barbera J, Vesikari T, Watanabe D, Weckx L, Zahaf T, Heineman TC; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015 May 28;372(22):2087-96. doi: 10.1056/NEJMoa1501184. Epub 2015 Apr 28.

ReferenceCitation: Carryn S, Cheuvart B, Povey M, Dagnew AF, Harpaz R, van der Most R, Casabona G. No Consistent Evidence of Decreased Exposure to Varicella-Zoster Virus Among Older Adults in Countries with Universal Varicella Vaccination. J Infect Dis. 2022 Feb 1;225(3):413-421. doi: 10.1093/infdis/jiab500.

repositories_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_institution: Tampere University - Tampere University Institutional Repository

repositories_institution: University of Wollongong - Research Online

title: Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older


acronym: REACH

intervention_type: Other

summary:
This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison.

Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study.

Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm.

Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo.

The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision.

ReferenceCitation: Llovet JM, Singal AG, Villanueva A, Finn RS, Kudo M, Galle PR, Ikeda M, Callies S, McGrath LM, Wang C, Abada P, Widau RC, Gonzalez-Gugel E, Zhu AX. Prognostic and Predictive Factors in Patients with Advanced HCC and Elevated Alpha-Fetoprotein Treated with Ramucirumab in Two Randomized Phase III Trials. Clin Cancer Res. 2022 Jun 1;28(11):2297-2305. doi: 10.1158/1078-0432.CCR-21-4000.

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

ReferenceCitation: Zhu AX, Finn RS, Kang YK, Yen CJ, Galle PR, Llovet JM, Assenat E, Brandi G, Motomura K, Ohno I, Daniele B, Vogel A, Yamashita T, Hsu CH, Gerken G, Bilbruck J, Hsu Y, Liang K, Widau RC, Wang C, Abada P, Kudo M. Serum alpha-fetoprotein and clinical outcomes in patients with advanced hepatocellular carcinoma treated with ramucirumab. Br J Cancer. 2021 Apr;124(8):1388-1397. doi: 10.1038/s41416-021-01260-w. Epub 2021 Feb 3.

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

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

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

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

ReferenceCitation: Reig M, Galle PR, Kudo M, Finn R, Llovet JM, Metti AL, Schelman WR, Liang K, Wang C, Widau RC, Abada P, Zhu AX. Pattern of progression in advanced hepatocellular carcinoma treated with ramucirumab. Liver Int. 2021 Mar;41(3):598-607. doi: 10.1111/liv.14731. Epub 2020 Dec 5.

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

ReferenceCitation: Zhu AX, Nipp RD, Finn RS, Galle PR, Llovet JM, Blanc JF, Okusaka T, Chau I, Cella D, Girvan A, Gable J, Bowman L, Wang C, Hsu Y, Abada PB, Kudo M. Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials. ESMO Open. 2020 Aug;5(4):e000797. doi: 10.1136/esmoopen-2020-000797.

ReferenceCitation: Kudo M, Okusaka T, Motomura K, Ohno I, Morimoto M, Seo S, Wada Y, Sato S, Yamashita T, Furukawa M, Aramaki T, Nadano S, Ohkawa K, Fujii H, Kudo T, Furuse J, Takai H, Homma G, Yoshikawa R, Zhu AX. Ramucirumab after prior sorafenib in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein: Japanese subgroup analysis of the REACH-2 trial. J Gastroenterol. 2020 Jun;55(6):627-639. doi: 10.1007/s00535-020-01668-w. Epub 2020 Feb 27.

ReferenceCitation: Arnold D, Fuchs CS, Tabernero J, Ohtsu A, Zhu AX, Garon EB, Mackey JR, Paz-Ares L, Baron AD, Okusaka T, Yoshino T, Yoon HH, Das M, Ferry D, Zhang Y, Lin Y, Binder P, Sashegyi A, Chau I. Meta-analysis of individual patient safety data from six randomized, placebo-controlled trials with the antiangiogenic VEGFR2-binding monoclonal antibody ramucirumab. Ann Oncol. 2017 Dec 1;28(12):2932-2942. doi: 10.1093/annonc/mdx514.

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

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

ReferenceCitation: Chau I, Peck-Radosavljevic M, Borg C, Malfertheiner P, Seitz JF, Park JO, Ryoo BY, Yen CJ, Kudo M, Poon R, Pastorelli D, Blanc JF, Chung HC, Baron AD, Okusaka T, Bowman L, Cui ZL, Girvan AC, Abada PB, Yang L, Zhu AX. Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib: Patient-focused outcome results from the randomised phase III REACH study. Eur J Cancer. 2017 Aug;81:17-25. doi: 10.1016/j.ejca.2017.05.001. Epub 2017 Jun 4. Erratum In: Eur J Cancer. 2018 Sep;100:135-136.

ReferenceCitation: Zhu AX, Baron AD, Malfertheiner P, Kudo M, Kawazoe S, Pezet D, Weissinger F, Brandi G, Barone CA, Okusaka T, Wada Y, Park JO, Ryoo BY, Cho JY, Chung HC, Li CP, Yen CJ, Lee KD, Chang SC, Yang L, Abada PB, Chau I. Ramucirumab as Second-Line Treatment in Patients With Advanced Hepatocellular Carcinoma: Analysis of REACH Trial Results by Child-Pugh Score. JAMA Oncol. 2017 Feb 1;3(2):235-243. doi: 10.1001/jamaoncol.2016.4115.

ReferenceCitation: Kudo M, Hatano E, Ohkawa S, Fujii H, Masumoto A, Furuse J, Wada Y, Ishii H, Obi S, Kaneko S, Kawazoe S, Yokosuka O, Ikeda M, Ukai K, Morita S, Tsuji A, Kudo T, Shimada M, Osaki Y, Tateishi R, Sugiyama G, Abada PB, Yang L, Okusaka T, Zhu AX. Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial. J Gastroenterol. 2017 Apr;52(4):494-503. doi: 10.1007/s00535-016-1247-4. Epub 2016 Aug 22.

ReferenceCitation: Zhu AX, Park JO, Ryoo BY, Yen CJ, Poon R, Pastorelli D, Blanc JF, Chung HC, Baron AD, Pfiffer TE, Okusaka T, Kubackova K, Trojan J, Sastre J, Chau I, Chang SC, Abada PB, Yang L, Schwartz JD, Kudo M; REACH Trial Investigators. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015 Jul;16(7):859-70. doi: 10.1016/S1470-2045(15)00050-9. Epub 2015 Jun 18.

title: A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib (REACH)

location_country:
Finland
Germany
Australia
Brazil
Japan
Thailand
Canada
France
Czech Republic
Portugal
Hungary
Hong Kong
Switzerland
United States
Romania
Belgium
Philippines
Italy
Norway
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Israel


acronym: EAGLE

lead_sponsor: Sanofi

summary:
Primary objective:

To demonstrate the superiority of insulin glargine over liraglutide in terms of percentage of patients reaching a Glycosylated Haemoglobin (HbA1c) < 7% at the end of the comparative period (24 weeks) in Type 2 diabetic patients failing lifestyle management and oral agents

Secondary objectives of the comparative period (24 weeks):

>To assess the effect of insulin glargine in comparison with liraglutide on:

HbA1c level
Percentage of patients whose HbA1c has decreased but remains >= 7% at the end of the comparative period
Percentage of patients whose HbA1c has increased at the end of the comparative period
Fasting Plasma Glucose (FPG)
7-point Plasma Glucose (PG) profiles
Hypoglycemia occurrence
Body weight
Adverse events

Objectives of the extension period (24 weeks):

>To assess the effect of insulin glargine in patients not adequately controlled with liraglutide on:

HbA1c level
FPG
7-point PG profiles
Hypoglycemia occurrence
Body weight
Adverse events

location_facility:
Investigational Site Number 250-011
Investigational Site Number 840028
Investigational Site Number 840012
Investigational Site Number 484004
Investigational Site Number 703002
Investigational Site Number 300004
Investigational Site Number 643007
Investigational Site Number 724004
Investigational Site Number 840029
Investigational Site Number 250-003
Investigational Site Number 250-012
Investigational Site Number 528005
Investigational Site Number 643-009
Investigational Site Number 724008
Investigational Site Number 250-006
Investigational Site Number 724001
Investigational Site Number 840038
Investigational Site Number 250-021
Investigational Site Number 203002
Investigational Site Number 250-007
Investigational Site Number 040-007
Investigational Site Number 203003
Investigational Site Number 840036
Investigational Site Number 840020
Investigational Site Number 752-005
Investigational Site Number 124-004
Investigational Site Number 724005
Investigational Site Number 300003
Investigational Site Number 792-001
Investigational Site Number 528006
Investigational Site Number 040-002
Investigational Site Number 840049
Investigational Site Number 124-001
Investigational Site Number 840013
Investigational Site Number 040-003
Investigational Site Number 124-006
Investigational Site Number 840051
Investigational Site Number 840002
Investigational Site Number 040-001
Investigational Site Number 840001
Investigational Site Number 124-007
Investigational Site Number 840037
Investigational Site Number 840023
Investigational Site Number 752-007
Investigational Site Number 840014
Investigational Site Number 203005
Investigational Site Number 724007
Investigational Site Number 484001
Investigational Site Number 840039
Investigational Site Number 124-008
Investigational Site Number 250-008
Investigational Site Number 250-004
Investigational Site Number 752-002
Investigational Site Number 076-007
Investigational Site Number 752-03
Investigational Site Number 840043
Investigational Site Number 703005
Investigational Site Number 840047
Investigational Site Number 250022
Investigational Site Number 703001
Investigational Site Number 840017
Investigational Site Number 250-017
Investigational Site Number 724003
Investigational Site Number 840024
Investigational Site Number 250-016
Investigational Site Number 724010
Investigational Site Number 840044
Investigational Site Number 840026
Investigational Site Number 840009
Investigational Site Number 643008
Investigational Site Number 040-005
Investigational Site Number 840030
Investigational Site Number 724006
Investigational Site Number 203006
Investigational Site Number 721002
Investigational Site Number 040-004
Investigational Site Number 840022
Investigational Site Number 076-005
Investigational Site Number 246003
Investigational Site Number 752-006
Investigational Site Number 840048
Investigational Site Number 484003
Investigational Site Number 376002
Investigational Site Number 250-020
Investigational Site Number 840006
Investigational Site Number 528004
Investigational Site Number 643006
Investigational Site Number 376003
Investigational Site Number 840046
Investigational Site Number 528001
Investigational Site Number 840050
Investigational Site Number 840033
Investigational Site Number 040-006
Investigational Site Number 124-003
Investigational Site Number 703004
Investigational Site Number 703003
Investigational Site Number 840045
Investigational Site Number 246004
Investigational Site Number 840008
Investigational Site Number 246002
Investigational Site Number 484002
Investigational Site Number 840004
Investigational Site Number 840042
Investigational Site Number 840016
Investigational Site Number 643005
Investigational Site Number 076-006
Investigational Site Number 300001
Investigational Site Number 792-002
Investigational Site Number 203001
Investigational Site Number 528007
Investigational Site Number 076-004
Investigational Site Number 840034
Investigational Site Number 840007
Investigational Site Number 250-009
Investigational Site Number 840019
Investigational Site Number 250-002
Investigational Site Number 840035
Investigational Site Number 246001
Investigational Site Number 372001
Investigational Site Number 528002
Investigational Site Number 840031
Investigational Site Number 528003
Investigational Site Number 724009
Investigational Site Number 840027
Investigational Site Number 076-001
Investigational Site Number 752-001
Investigational Site Number 643001
Investigational Site Number 376004
Investigational Site Number 643004
Investigational Site Number 840052
Investigational Site Number 076-002
Investigational Site Number 840010
Investigational Site Number 643003
Investigational Site Number 840011
Investigational Site Number 840005
Investigational Site Number 840015

title: A 24-week, Multicenter, International, Randomized (1:1), Parallel-group, Open-label, Comparative Study of Insulin Glargine Versus Liraglutide in Insulin-naïve Patients With Type 2 Diabetes Treated With Oral Agents and Not Adequately Controlled, Followed by a 24-week Extension Period With Insulin Glargine for Patients Not Adequately Controlled With Liraglutide

location_country:
Finland
France
Ireland
Slovakia
Israel
Brazil
Netherlands
Austria
Mexico
Sweden
United States
Spain
Greece
Turkey
Canada
Russian Federation
Czech Republic


summary: This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.

ReferenceCitation: Coleman R, Finkelstein DM, Barrios C, Martin M, Iwata H, Hegg R, Glaspy J, Perianez AM, Tonkin K, Deleu I, Sohn J, Crown J, Delaloge S, Dai T, Zhou Y, Jandial D, Chan A. Adjuvant denosumab in early breast cancer (D-CARE): an international, multicentre, randomised, controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):60-72. doi: 10.1016/S1470-2045(19)30687-4. Epub 2019 Dec 2.

ReferenceCitation: Coleman R, Zhou Y, Jandial D, Cadieux B, Chan A. Bone Health Outcomes from the International, Multicenter, Randomized, Phase 3, Placebo-Controlled D-CARE Study Assessing Adjuvant Denosumab in Early Breast Cancer. Adv Ther. 2021 Aug;38(8):4569-4580. doi: 10.1007/s12325-021-01812-9. Epub 2021 Jun 29.

sponsor_collaborators:
Amgen
Daiichi Sankyo, Inc.

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
Serbia
France
Slovenia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
India
Romania
Belgium
Malaysia
Peru
Philippines
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: DIAMOND

lead_sponsor: Astellas Pharma Inc

summary: Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.

title: A Multicenter, Three Arm, Randomized, Open Label Clinical Study to Compare Renal Function in Liver Transplant Recipients Receiving an Immunosuppressive Regimen of Advagraf (Immediately or Delayed Post-transplant) and MMF With or Without a Monoclonal Anti-IL2R Antibody (Basiliximab)

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Finland
Germany
Ireland
Poland
Argentina
Brazil
Czechia
Canada
France
Belarus
Colombia
Hungary
Switzerland
Romania
Belgium
Italy
United Kingdom
Austria
Mexico
Spain
South Africa
Russian Federation
Sweden