lead_sponsor: Novartis Pharmaceuticals

summary: The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

ReferenceCitation: Kiura K, Imamura F, Kagamu H, Matsumoto S, Hida T, Nakagawa K, Satouchi M, Okamoto I, Takenoyama M, Fujisaka Y, Kurata T, Ito M, Tokushige K, Hatano B, Nishio M. Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5): Japanese subset. Jpn J Clin Oncol. 2018 Apr 1;48(4):367-375. doi: 10.1093/jjco/hyy016.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Oxford University Press

ReferenceCitation: Shaw AT, Kim TM, Crino L, Gridelli C, Kiura K, Liu G, Novello S, Bearz A, Gautschi O, Mok T, Nishio M, Scagliotti G, Spigel DR, Deudon S, Zheng C, Pantano S, Urban P, Massacesi C, Viraswami-Appanna K, Felip E. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):874-886. doi: 10.1016/S1470-2045(17)30339-X. Epub 2017 Jun 9.

title: A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

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

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

location_country:
Germany
Ireland
Japan
Turkey
Canada
France
Portugal
Hong Kong
Switzerland
United States
Lebanon
Belgium
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
Russian Federation
Israel

ipd_sharing: Undecided


type: EudraCT Number

title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

summary: The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

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: result

ReferenceCitation: Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15. Erratum In: Lancet. 2016 Apr 30;387(10030):1816.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: 10.1016/j.jcv.2018.03.012. Epub 2018 Apr 2.

ReferenceCitation: Arribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

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

version: submittedVersion

unpaywall_oa_status: green

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11.

publisher_dissemination: SAGE Publications

ReferenceCitation: Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naive patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731.

publisher_dissemination: Informa

ReferenceCitation: Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

ReferenceCitation: Wohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.

ReferenceCitation: Custodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015.

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

lead_sponsor: Gilead Sciences

location_country:
Italy
Portugal
United Kingdom
Sweden
Netherlands
Mexico
United States
Dominican Republic
Canada
Puerto Rico
France

location_facility: North Texas Infectious Diseases Consultants

location_facility: University Health Network/Toronto General Hospital

location_facility: Kaiser Permanente - Los Angeles Medical Center

location_facility: Tarrant County Infectious Disease Associates

location_facility: Infectious Disease Specialist of Atlanta

location_facility: Rush University Medical Center, Section of Infectious Diseases

location_facility: University of North Carolina AIDS Clinical Trials Unit

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Carolinas Medical Center Myer's Park Clinic

location_facility: Infectious Disease Research Institute Inc.

location_facility: Archet 1 CHU de Nice, Department of Infectiology

location_facility: East Carolina University The Brody School of Medicine

location_facility: Trinity Health & Wellness Center / AIDS Arms, Inc.

location_facility: Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID)

location_facility: Universitaria di Bologna-Policlicnico S' Orsola Malpighi

location_facility: Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"

location_facility: University of California, Davis Medical Center

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Community Research Initiative of New England

location_facility: La Playa Medical Group and Clinical Research

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Research Institute of McGill University Health Care

location_facility: Saint Louis Hospital of Infectious Diseases

location_facility: University of Hawaii - Hawaii Center for AIDS

location_facility: Serviço de Doenças Infecciosas, HUC-CHUC, EPE

location_facility: North Shore University Hospital - Division of Infectious Diseases

location_facility: Brownlee Centre, Gartnavel General Hospital

location_facility: Instituto Dominicano de Estudios Virologicos--IDEV

location_facility: Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center

location_facility: Centro Hospitalar do Porto - Hospital Joaquim Urbano

location_facility: Karolinska University Hospital, Huddinge

location_facility: University of Southern California AIDS Clinical Trials Group

location_facility: University Hospital of Montpellier (CHU-Gui de Chauliac)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: EORTC protocol 1209-EnTF

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

summary:
For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis pathway has several potential targets. The Receptors for Vascular endothelial growth factor (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation as well as the maintenance of tumor vasculature.

In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in tumor angiogenesis express these receptors as well.

Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. However there is no treatment that is generally considered as standard of care for patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a clinically meaningful benefit yet.

Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF. Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase activity rationale exists to investigate the effect in MTC and DTC.

Because it targets these three major angiogenesis signaling pathways it might prevent further tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in patients who have progressed on agents that target only one pathway.

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: Assistance Publique - Hopitaux de Paris - La Pitié Salpétrière

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Radboud University Medical Center Nijmegen

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Ludwig-Maximilians-Universitaet Muenchen - Klinikum der Universitaet Muenchen - Campus Grosshadern

title: A Phase II Study Exploring the Safety and Efficacy of Nintedanib (BIBF1120) as Second Line Therapy for Patients With Either Differentiated or Medullary Thyroid Cancer Progressing After First Line Therapy.

source: euctr

location_country:
Germany
Italy
Poland
United Kingdom
Denmark
Netherlands
Belgium
Spain
France


title: An Open-label Phase IIIb Study of Riociguat in Patients With In-operable CTEPH, or Recurrent or Persisting PH After Surgical Treatment Who Are Not Satisfactorily Treated and Cannot Participate in Any Other CTEPH Trial

acronym: EAS

summary: The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

status: No longer available

study_type: Expanded Access

ReferenceType: derived

ReferenceCitation: McLaughlin VV, Jansa P, Nielsen-Kudsk JE, Halank M, Simonneau G, Grunig E, Ulrich S, Rosenkranz S, Gomez Sanchez MA, Pulido T, Pepke-Zaba J, Barbera JA, Hoeper MM, Vachiery JL, Lang I, Carvalho F, Meier C, Mueller K, Nikkho S, D'Armini AM. Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm Med. 2017 Dec 28;17(1):216. doi: 10.1186/s12890-017-0563-7.

license: cc-by

license_normalized: cc-by

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

publisher_dissemination: Springer-Nature

lead_sponsor: Bayer

location_country:
Germany
Japan
Turkey
Canada
France
Czech Republic
Colombia
Portugal
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Russian Federation
Sweden

status_simplified: Unknown


summary: To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

ReferenceCitation: Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, Andre F. Patient-Reported Outcomes in Patients With PIK3CA-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1. J Clin Oncol. 2021 Jun 20;39(18):2005-2015. doi: 10.1200/JCO.20.01139. Epub 2021 Mar 29.

oa_colors: green hybrid

evidence: open (via page says license)

repository_institution: University of California - eScholarship University of California

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Andre F, Ciruelos EM, Juric D, Loibl S, Campone M, Mayer IA, Rubovszky G, Yamashita T, Kaufman B, Lu YS, Inoue K, Papai Z, Takahashi M, Ghaznawi F, Mills D, Kaper M, Miller M, Conte PF, Iwata H, Rugo HS. Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol. 2021 Feb;32(2):208-217. doi: 10.1016/j.annonc.2020.11.011. Epub 2020 Nov 25.

evidence: open (via crossref license)

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Rugo HS, Andre F, Yamashita T, Cerda H, Toledano I, Stemmer SM, Jurado JC, Juric D, Mayer I, Ciruelos EM, Iwata H, Conte P, Campone M, Wilke C, Mills D, Lteif A, Miller M, Gaudenzi F, Loibl S. Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer. Ann Oncol. 2020 Aug;31(8):1001-1010. doi: 10.1016/j.annonc.2020.05.001. Epub 2020 May 13.

ReferenceCitation: Andre F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Papai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.

oa_colors: green other

evidence: open (via free article)

endpoint_id: ebkqzhfrceygztdsjokh

repository_institution: University of Padua - Padua Research Archive

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

location_facility: St. Francis Health Comprehensive Cancer Center SC

location_facility: Texas Oncology PA Dallas Presbyterian Hospital SC-1

location_facility: University Hospitals of Cleveland Seidman Cancer Center SC

location_facility: Rutgers Cancer Institute of New Jersey SC-2

location_facility: Rush University Medical Center Rush Uni Medical Center

location_facility: Mays Cancer Ctr Uthsa Mdacc InstituteForDrugDevelopment(4)

location_facility: Massachusetts General Hospital Updated Regulatory

location_facility: NorthShore University Health System NorthShore University

location_facility: Fort Wayne Medical Oncology/Hematology, Inc. Dept.of Fort Wayne Med Onc/Hem

location_facility: Florida Cancer Specialists FL Cancer Specialists

location_facility: Good Samaritan Regional Medical Center Good Samaritan Reg Med Ctr

location_facility: Ironwood Cancer and Research Centers Chandler 2

title: A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

location_country:
Germany
Argentina
Australia
Brazil
Japan
Thailand
Chile
Czechia
Canada
France
Hungary
Hong Kong
United States
India
Romania
Lebanon
Belgium
Peru
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


title: Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF

summary: The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Slovakia
United Kingdom
Denmark
Spain
Bulgaria
Czech Republic
France

location_facility: Boehringer Ingelheim Investigational Site 46

location_facility: Boehringer Ingelheim Investigational Site 127

location_facility: Boehringer Ingelheim Investigational Site 113

location_facility: Boehringer Ingelheim Investigational Site 72

location_facility: Boehringer Ingelheim Investigational Site 34

location_facility: Boehringer Ingelheim Investigational Site 56

location_facility: Boehringer Ingelheim Investigational Site 8

location_facility: Boehringer Ingelheim Investigational Site 154

location_facility: Boehringer Ingelheim Investigational Site 105

location_facility: Boehringer Ingelheim Investigational Site 59

location_facility: Boehringer Ingelheim Investigational Site 71

location_facility: Boehringer Ingelheim Investigational Site 51

location_facility: Boehringer Ingelheim Investigational Site 33

location_facility: Boehringer Ingelheim Investigational Site 23

location_facility: Boehringer Ingelheim Investigational Site 39

location_facility: Boehringer Ingelheim Investigational Site 43

location_facility: Boehringer Ingelheim Investigational Site 73

location_facility: Boehringer Ingelheim Investigational Site 97

location_facility: Boehringer Ingelheim Investigational Site 35

location_facility: Boehringer Ingelheim Investigational Site 101

location_facility: Boehringer Ingelheim Investigational Site 158

location_facility: Boehringer Ingelheim Investigational Site 16

location_facility: Boehringer Ingelheim Investigational Site 102

location_facility: Boehringer Ingelheim Investigational Site 151

location_facility: Boehringer Ingelheim Investigational Site 45

location_facility: Boehringer Ingelheim Investigational Site 84

location_facility: Boehringer Ingelheim Investigational Site 146

location_facility: Boehringer Ingelheim Investigational Site 81

location_facility: Boehringer Ingelheim Investigational Site 134

location_facility: Boehringer Ingelheim Investigational Site 24

location_facility: Boehringer Ingelheim Investigational Site 139

location_facility: Boehringer Ingelheim Investigational Site 128

location_facility: Boehringer Ingelheim Investigational Site 30

location_facility: Boehringer Ingelheim Investigational Site 85

location_facility: Boehringer Ingelheim Investigational Site 19

location_facility: Boehringer Ingelheim Investigational Site 68

location_facility: Boehringer Ingelheim Investigational Site 157

location_facility: Boehringer Ingelheim Investigational Site 103

location_facility: Boehringer Ingelheim Investigational Site 77

location_facility: Boehringer Ingelheim Investigational Site 140

location_facility: Boehringer Ingelheim Investigational Site 7

location_facility: Boehringer Ingelheim Investigational Site 49

location_facility: Boehringer Ingelheim Investigational Site 20

location_facility: Boehringer Ingelheim Investigational Site 95

location_facility: Boehringer Ingelheim Investigational Site 44

location_facility: Boehringer Ingelheim Investigational Site 61

location_facility: Boehringer Ingelheim Investigational Site 133

location_facility: Boehringer Ingelheim Investigational Site 79

location_facility: Boehringer Ingelheim Investigational Site 141

location_facility: Boehringer Ingelheim Investigational Site 32

location_facility: Boehringer Ingelheim Investigational Site 74

location_facility: Boehringer Ingelheim Investigational Site 152

location_facility: Boehringer Ingelheim Investigational Site 94

location_facility: Boehringer Ingelheim Investigational Site 86

location_facility: Boehringer Ingelheim Investigational Site 6

location_facility: Boehringer Ingelheim Investigational Site 99

location_facility: Boehringer Ingelheim Investigational Site 31

location_facility: Boehringer Ingelheim Investigational Site 70

location_facility: Boehringer Ingelheim Investigational Site 76

location_facility: Boehringer Ingelheim Investigational Site 38

location_facility: Boehringer Ingelheim Investigational Site 132

location_facility: Boehringer Ingelheim Investigational Site 92

location_facility: Boehringer Ingelheim Investigational Site 88

location_facility: Boehringer Ingelheim Investigational Site 138

location_facility: Boehringer Ingelheim Investigational Site 161

location_facility: Boehringer Ingelheim Investigational Site 110

location_facility: Boehringer Ingelheim Investigational Site 75

location_facility: Boehringer Ingelheim Investigational Site 107

location_facility: Boehringer Ingelheim Investigational Site 3

location_facility: Boehringer Ingelheim Investigational Site 11

location_facility: Boehringer Ingelheim Investigational Site 66

location_facility: Boehringer Ingelheim Investigational Site 67

location_facility: Boehringer Ingelheim Investigational Site 25

location_facility: Boehringer Ingelheim Investigational Site 149

location_facility: Boehringer Ingelheim Investigational Site 148

location_facility: Boehringer Ingelheim Investigational Site 122

location_facility: Boehringer Ingelheim Investigational Site 14

location_facility: Boehringer Ingelheim Investigational Site 9

location_facility: Boehringer Ingelheim Investigational Site 1

location_facility: Boehringer Ingelheim Investigational Site 100

location_facility: Boehringer Ingelheim Investigational Site 129

location_facility: Boehringer Ingelheim Investigational Site 58

location_facility: Boehringer Ingelheim Investigational Site 156

location_facility: Boehringer Ingelheim Investigational Site 125

location_facility: Boehringer Ingelheim Investigational Site 124

location_facility: Boehringer Ingelheim Investigational Site 147

location_facility: Boehringer Ingelheim Investigational Site 26

location_facility: Boehringer Ingelheim Investigational Site 123

location_facility: Boehringer Ingelheim Investigational Site 47

location_facility: Boehringer Ingelheim Investigational Site 91

location_facility: Boehringer Ingelheim Investigational Site 41

location_facility: Boehringer Ingelheim Investigational Site 130

location_facility: Boehringer Ingelheim Investigational Site 53

location_facility: Boehringer Ingelheim Investigational Site 116

location_facility: Boehringer Ingelheim Investigational Site 135

location_facility: Boehringer Ingelheim Investigational Site 37

location_facility: Boehringer Ingelheim Investigational Site 10

location_facility: Boehringer Ingelheim Investigational Site 80

location_facility: Boehringer Ingelheim Investigational Site 78

location_facility: Boehringer Ingelheim Investigational Site 117

location_facility: Boehringer Ingelheim Investigational Site 120

location_facility: Boehringer Ingelheim Investigational Site 55

location_facility: Boehringer Ingelheim Investigational Site 69

location_facility: Boehringer Ingelheim Investigational Site 89

location_facility: Boehringer Ingelheim Investigational Site 12

location_facility: Boehringer Ingelheim Investigational Site 121

location_facility: Boehringer Ingelheim Investigational Site 18

location_facility: Boehringer Ingelheim Investigational Site 2

location_facility: Boehringer Ingelheim Investigational Site 40

location_facility: Boehringer Ingelheim Investigational Site 150

location_facility: Boehringer Ingelheim Investigational Site 17

location_facility: Boehringer Ingelheim Investigational Site 65

location_facility: Boehringer Ingelheim Investigational Site 42

location_facility: Boehringer Ingelheim Investigational Site 106

location_facility: Boehringer Ingelheim Investigational Site 93

location_facility: Boehringer Ingelheim Investigational Site 143

location_facility: Boehringer Ingelheim Investigational Site 160

location_facility: Boehringer Ingelheim Investigational Site 64

location_facility: Boehringer Ingelheim Investigational Site 83

location_facility: Boehringer Ingelheim Investigational Site 62

location_facility: Boehringer Ingelheim Investigational Site 144

location_facility: Boehringer Ingelheim Investigational Site 4

location_facility: Boehringer Ingelheim Investigational Site 98

location_facility: Boehringer Ingelheim Investigational Site 131

location_facility: Boehringer Ingelheim Investigational Site 52

location_facility: Boehringer Ingelheim Investigational Site 29

location_facility: Boehringer Ingelheim Investigational Site 15

location_facility: Boehringer Ingelheim Investigational Site 63

location_facility: Boehringer Ingelheim Investigational Site 119

location_facility: Boehringer Ingelheim Investigational Site 104

location_facility: Boehringer Ingelheim Investigational Site 159

location_facility: Boehringer Ingelheim Investigational Site 115

location_facility: Boehringer Ingelheim Investigational Site 155

location_facility: Boehringer Ingelheim Investigational Site 82

location_facility: Boehringer Ingelheim Investigational Site 13

location_facility: Boehringer Ingelheim Investigational Site 109

location_facility: Boehringer Ingelheim Investigational Site 136

location_facility: Boehringer Ingelheim Investigational Site 57

location_facility: Boehringer Ingelheim Investigational Site 153

location_facility: Boehringer Ingelheim Investigational Site 111

location_facility: Boehringer Ingelheim Investigational Site 60

location_facility: Boehringer Ingelheim Investigational Site 21

location_facility: Boehringer Ingelheim Investigational Site 28

location_facility: Boehringer Ingelheim Investigational Site 50

location_facility: Boehringer Ingelheim Investigational Site 142

location_facility: Boehringer Ingelheim Investigational Site 54

location_facility: Boehringer Ingelheim Investigational Site 118

location_facility: Boehringer Ingelheim Investigational Site 22

location_facility: Boehringer Ingelheim Investigational Site 112

location_facility: Boehringer Ingelheim Investigational Site 36

location_facility: Boehringer Ingelheim Investigational Site 126

location_facility: Boehringer Ingelheim Investigational Site 137

location_facility: Boehringer Ingelheim Investigational Site 87

location_facility: Boehringer Ingelheim Investigational Site 90

location_facility: Boehringer Ingelheim Investigational Site 145

location_facility: Boehringer Ingelheim Investigational Site 27

location_facility: Boehringer Ingelheim Investigational Site 5

location_facility: Boehringer Ingelheim Investigational Site 96

location_facility: Boehringer Ingelheim Investigational Site 48

location_facility: Boehringer Ingelheim Investigational Site 108

location_facility: Boehringer Ingelheim Investigational Site 114


type: Other Identifier

title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF STAPHYLOCOCCUS AUREUS 4 ANTIGEN VACCINE (SA4AG) IN ADULTS UNDERGOING ELECTIVE OPEN POSTERIOR SPINAL FUSION PROCEDURES WITH MULTILEVEL INSTRUMENTATION

acronym: STRIVE

summary: The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.

status: Terminated

primary_purpose: Prevention

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

lead_sponsor: Pfizer

location_country:
Germany
Hungary
United Kingdom
Japan
Sweden
Austria
United States
Spain
Bulgaria
Canada
France

location_facility: St. David's Neuroscience and Spine Institute

location_facility: Baylor College of Medicine - McNair Campus

location_facility: Twin Cities Spine Surgeons dba Twin Cities Spine Center

location_facility: University of California Irvine Medical Center

location_facility: Carilion Clinic Institute for Orthopaedics and Neurosciences

location_facility: The Feinstein Institute for Medical Research

location_facility: University of Maryland Medical Systems, Investigational Drug Services

location_facility: Detroit Receiving Hospital, Heart Hospital, Harper Hospital at

location_facility: Ronald Reagan Med Center - University of California, Los Angeles (UCLA)

location_facility: Carilion Assessment, Registration and Education for Surgery (C.A.R.E.S)

location_facility: Hospital Clínico Universitario Santiago de Compostela

location_facility: VCU Heatlh Neuroscience Orthopedic and Wellness Center

location_facility: CHI St. Luke's Health Baylor College of Medicine Medical Center

location_facility: University Medical Center of Southern Nevada

location_facility: Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy

location_facility: Abington Jefferson Health-Pharmacy Department

location_facility: Thomas Jefferson University Hospital, Cardiovascular Associates

location_facility: The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center

location_facility: Japan Organization of Occupational Health and Safety, Kanto Rosai Hospital

location_facility: Brigham and Women's Hospital Investigational Drug Services (IDS)

location_facility: Anne Arundel Health System Research Institute (AAHSRI)

location_facility: HonorHealth Scottsdale Osborn Medical Center

location_facility: Orthopaedic Associates of Michigan - Research

location_facility: Milton S. Hershey Medical Center Pharmacy

location_facility: Montreal Neurological Hospital Research Pharmacy

location_facility: Barnes Jewish Center for Advanced Medicine

location_facility: University of Maryland, Medical Systems, Oriole Park

location_facility: The Rothman Institute Marlton, NJ Office

location_facility: The Johns Hopkins Hospital Investigational Drug Service

location_facility: Montreal Neurological Institute and Hospital

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital

location_facility: Foothills Medical Centre, University of Calgary

location_facility: Penn State College of Medicine and Penn State Hershey Milton S. Hershey Medical Center

location_facility: VCU Medical Center Investigational Drug Service

location_facility: Anne Arundel Medical Center Infusion Center

location_facility: Doctors Office Center-Rutgers, The State University of New Jersey-New Jersey Medical School

location_facility: Allina Health - Abbott Northwestern Hospital /

location_facility: University of Colorado Clinical & Translational Research Center Clinic

location_facility: Dell Seton Medical Center at The University of Texas

location_facility: Montreal General Hospital Research Institute of the MUHC- MGH Pharmacy Research

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of Colorado Hospital, Lone Tree Health Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: UMass Memorial Medical Center- Clinical Research Center

location_facility: Service de Chirurgie Orthopedique et Traumatologie

location_facility: Yale New Haven Hospital - St. Raphael campus

location_facility: Northwell Health Physician Partners- Department of Neurosurgery Spine @Great Neck

location_facility: Massachusetts General Hospital, Clinical Research Pharmacy

location_facility: Sentara Medical Group DBA Sentara Neurosurgery Specialists

location_facility: Meridian Hospitals Corp c/o Jersey Shore University Medical Center

location_facility: University of Colorado Department of Pharmacy AIP 2, Pharmacy Bulk Storage

location_facility: Brent H. Greenwald, M.D. Neurological Surgery

location_facility: Santa Monica UCLA Medical Center & Orthopaedic Hospital

location_facility: Scott & White Memorial Hospital and Clinic

location_facility: WVU Medicine Physician Office Center Orthopaedic Surgery

location_facility: South Tees Hospitals NHS Foundation Trust

location_facility: Carolina Neurosurgery and Spine Associates, P.A.

location_facility: University of Michigan Investigational Pharmacy

location_facility: Thomas Jefferson University Hospital - Pre-Admission Testing Center

location_facility: The Clinical Research Unit at Mount Sinai

location_facility: University of Maryland Medical Systems, Department of Neurosurgery

location_facility: National Hospital Organization Murayama Medical Center

location_facility: Mermorial Hermann - Memorial City Medical Center

location_facility: Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center

location_facility: IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital

location_facility: Mayo Clinic Rochester, Methodist Hospital Campus

location_facility: University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Scott & White Memorial Hospital and Clinic (Scott & White Roney Bone & Joint Institute)

location_facility: Bingham Memorial Family Medicine & Specialty Clinic

location_facility: Cancer Center, Rutgers, The State University of New Jersey-New Jersey Medical School

location_facility: St, Michael's Hospital - St. Michael's Pharmacy

location_facility: WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy

location_facility: The Lindner Center for Research and Education at The Christ Hospital

location_facility: Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists

location_facility: Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

location_facility: Cedars-Sinai Medical Center - Investigational Drug

location_facility: Carilion Clinic - Department of Pharmacy

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Universitario Politecnico La Fe

location_facility: The Rothman Institute Washington Township, NJ Office

location_facility: University of Miami Hospital and Clinics and Research Pharmacy

location_facility: Seton Brain and Spine Institute Williamson

location_facility: Klinikum rechts der Isar, Technische Universitat Munchen

location_facility: University of Colorado Denver, School of Medicine

location_facility: Boulder Community Health - Foothills Hospital

location_facility: Cleveland Clinic Foundation - Investigation Pharmacy

location_facility: University of Massachusetts Medical Center Memorial Campus

location_facility: Cleveland Clinic Foundation Center for Spine Health

location_facility: Japan Community Health care Organization Osaka Hospital

location_facility: Pharmacy Service of Hospital Clinico de Valladolid

location_facility: Yale New Haven Hospital - Investigational Drug Services

location_facility: Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC)

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: Rush University Medical Center Professional Office Building Infusion Pharmacy

location_facility: Northwell Health Physician Partners- Department of Neurosurgery Spine @Lynbrook

intervention_type: Other


title: Clinical and Device Functional Assessment of Real World ICD Patients

acronym: CARAT

summary:
The primary requirement of the implantable cardioverter defibrillator (ICD) is to preserve life by terminating life-threatening arrhythmias (VT/VF). The treatment options vary in terms of techniques and medical devices, based on the patient's condition.

It is extremely important in the clinical practice to identify which patients' subgroup benefits the most from the ICD therapy, which comorbidity has a major impact on the patients' prognosis, or which pre-intra-post procedural behaviors provoke less complications, and affect the patient's outcome (including prolonged or unwanted hospitalizations).

time_perspective: Prospective

lead_sponsor: MicroPort CRM

location_country:
Germany
Italy
Portugal
Slovakia
United Kingdom
Netherlands
Austria
Switzerland
Spain
Czechia
Canada
France

location_facility: Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Professor Doutor Fernando Fonseca

location_facility: Hospital Universitario Clínico San Carlos

intervention_type: Device


lead_sponsor: AstraZeneca

summary: The purpose of this study is to determine the efficacy and safety of investigational medical products (MEDI4736 monotherapy, tremelimumab monotherapy, and MEDI4736 + tremelimumab combination therapy) in the treatment of patients with recurrent or metastatic carcinoma of the head and neck who have progressed during or after treatment with a platinum containing regimen for recurrent/metastatic disease.

ReferenceCitation: Siu LL, Even C, Mesia R, Remenar E, Daste A, Delord JP, Krauss J, Saba NF, Nabell L, Ready NE, Brana I, Kotecki N, Zandberg DP, Gilbert J, Mehanna H, Bonomi M, Jarkowski A, Melillo G, Armstrong JM, Wildsmith S, Fayette J. Safety and Efficacy of Durvalumab With or Without Tremelimumab in Patients With PD-L1-Low/Negative Recurrent or Metastatic HNSCC: The Phase 2 CONDOR Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):195-203. doi: 10.1001/jamaoncol.2018.4628.

license: public-domain

license_normalized: public-domain

repositories_concat: PubMed Central;diposit.ub.edu

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

publisher_dissemination: American Medical Association

sponsor_collaborators:
AstraZeneca
PRA Health Sciences

title: A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination With Tremelimumab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

location_country:
Germany
Hungary
Israel
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Spain
Malaysia
Taiwan
Czechia
Canada
Georgia
France


title: A Prospective, Randomized, Open-label, Parallel-group, Active-controlled, Multicenter Study Exploring the Efficacy and Safety of Once-daily Oral Rivaroxaban (BAY59-7939) Compared With That of Dose-adjusted Oral Vitamin K Antagonists (VKA) for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

acronym: X-VERT

summary: A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

ReferenceType: background

ReferenceCitation: Cappato R, Ezekowitz MD, Klein AL, Camm AJ, Ma CS, Le Heuzey JY, Talajic M, Scanavacca M, Vardas PE, Kirchhof P, Hemmrich M, Lanius V, Meng IL, Wildgoose P, van Eickels M, Hohnloser SH; X-VeRT Investigators. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J. 2014 Dec 14;35(47):3346-55. doi: 10.1093/eurheartj/ehu367. Epub 2014 Sep 2.

ReferenceCitation: Hai Z, Guangrui S. Cardiac paraganglioma. Eur Heart J. 2018 Jun 14;39(23):2219. doi: 10.1093/eurheartj/ehu241. No abstract available.

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

location_country:
Finland
Germany
Italy
Portugal
United Kingdom
Singapore
Denmark
Brazil
Netherlands
Belgium
United States
China
Spain
Greece
South Africa
Canada
France


acronym: LIFE

lead_sponsor: Pierre Fabre Medicament

summary: The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.

location_facility: State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"

location_facility: State Budget Healthcare Institution "City clinical hospital #20"

location_facility: Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"

location_facility: State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"

location_facility: Centro Hospitalar do Porto / Hospital Geral de Santo António

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord

location_facility: Azienda Sanitaria Ospedaliera "San Giovanni Battista"

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: State Institution of Healthcare of Moscow City "City Clinical Hospital #61"

location_facility: Hospital Universitari Germans Trias i Pujol

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

location_facility: Scientific Research Neurology Institute of Russian Academy of Medical Services

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

location_facility: Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

location_facility: Municipal Healthcare Institution "Municipal Clinical Hospital # 3"

location_facility: Professor S.V. Ochapovsky Territorial Clinical Hospital #1

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Smolensk State Medical Academy of RosZdrav

location_facility: Universitätsklinik Charité, Campus Mitte

title: Effect of 3-month Treatment With F2695 (75mg OD) on Improving Functional Recovery of Patients With Ischemic Stroke. A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-Controlled Study

location_country:
Germany
Italy
Portugal
Hungary
Sweden
Switzerland
Belgium
Spain
Czech Republic
Russian Federation
France


title: Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg

acronym: NAVIGATE ESUS

summary: This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

ReferenceCitation: Hart RG, Sharma M, Mundl H, Kasner SE, Bangdiwala SI, Berkowitz SD, Swaminathan B, Lavados P, Wang Y, Wang Y, Davalos A, Shamalov N, Mikulik R, Cunha L, Lindgren A, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi RJ, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni D, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, Endres M, Muir KW, Bornstein N, Ozturk S, O'Donnell MJ, De Vries Basson MM, Pare G, Pater C, Kirsch B, Sheridan P, Peters G, Weitz JI, Peacock WF, Shoamanesh A, Benavente OR, Joyner C, Themeles E, Connolly SJ; NAVIGATE ESUS Investigators. Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source. N Engl J Med. 2018 Jun 7;378(23):2191-2201. doi: 10.1056/NEJMoa1802686. Epub 2018 May 16.

repository_institution: Imperial College London - Spiral

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

ReferenceCitation: Kasner SE, Lavados P, Sharma M, Wang Y, Wang Y, Davalos A, Shamalov N, Cunha L, Lindgren A, Mikulik R, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi R, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni DS, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, DeVries Basson MM, Endres M, Muir K, Bornstein N, Ozturk S, O'Donnell M, Mundl H, Pater C, Weitz J, Peacock WF, Swaminathan B, Kirsch B, Berkowitz SD, Peters G, Pare G, Themeles E, Shoamanesh A, Connolly SJ, Hart RG; NAVIGATE ESUS Steering Committee and Investigators. Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial. J Stroke Cerebrovasc Dis. 2018 Jun;27(6):1673-1682. doi: 10.1016/j.jstrokecerebrovasdis.2018.01.027. Epub 2018 Mar 7.

repositories_concat: PubMed Central;eprints.gla.ac.uk

ReferenceCitation: Hart RG, Sharma M, Mundl H, Shoamanesh A, Kasner SE, Berkowitz SD, Pare G, Kirsch B, Pogue J, Pater C, Peters G, Davalos A, Lang W, Wang Y, Wang Y, Cunha L, Eckstein J, Tatlisumak T, Shamalov N, Mikulik R, Lavados P, Hankey GJ, Czlonkowska A, Toni D, Ameriso SF, Gagliardi RJ, Amarenco P, Bereczki D, Uchiyama S, Lindgren A, Endres M, Brouns R, Yoon BW, Ntaios G, Veltkamp R, Muir KW, Ozturk S, Arauz A, Bornstein N, Bryer A, O'Donnell MJ, Weitz J, Peacock F, Themeles E, Connolly SJ. Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial. Eur Stroke J. 2016 Sep;1(3):146-154. doi: 10.1177/2396987316663049. Epub 2016 Aug 3.

evidence: open (via free pdf)

ReferenceCitation: Sharma M, Smith EE, Pearce LA, Perera KS, Kasner SE, Yoon BW, Ameriso SF, Puig J, Damgaard D, Fiebach JB, Muir KW, Veltkamp RC, Toni DS, Shamalov N, Gagliardi RJ, Mikulik R, Engelter ST, Bereczki D, O'Donnell MJ, Saad F, Shoamanesh A, Berkowitz SD, Mundl H, Hart RG; NAVIGATE ESUS MRI Substudy Investigators. Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy. Int J Stroke. 2022 Aug;17(7):799-805. doi: 10.1177/17474930211058012. Epub 2021 Nov 18.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)
eprints.gla.ac.uk

ReferenceCitation: Merkler AE, Pearce LA, Kasner SE, Shoamanesh A, Birnbaum LA, Kamel H, Sheth KN, Sharma R. Left Ventricular Dysfunction Among Patients With Embolic Stroke of Undetermined Source and the Effect of Rivaroxaban vs Aspirin: A Subgroup Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Dec 1;78(12):1454-1460. doi: 10.1001/jamaneurol.2021.3828.

ReferenceCitation: Sharma M, Smith EE, Pearce LA, Shoamanesh A, Perera KS, Coutts SB, Damgaard D, Ameriso SF, Rha JH, Modrau B, Yoon BW, Romano M, Messe SR, Barlinn J, Lambeck J, Saad F, Berkowitz SD, Mundl H, Connolly SJ, Hart RG; NAVIGATE ESUS MIND MRI Substudy Investigators. Frequency and Patterns of Brain Infarction in Patients With Embolic Stroke of Undetermined Source: NAVIGATE ESUS Trial. Stroke. 2022 Jan;53(1):45-52. doi: 10.1161/STROKEAHA.120.032976. Epub 2021 Sep 20.

ReferenceCitation: Shoamanesh A, Hart RG, Connolly SJ, Kasner SE, Smith EE, Marti-Fabregas J, Liu YY, Uchiyama S, Mikulik R, Veltkamp R, O'Donnell MJ, Ntaios G, Muir KW, Field TS, Santo GC, Olavarria V, Mundl H, Lutsep H, Berkowitz SD, Sharma M. Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Jan 1;78(1):11-20. doi: 10.1001/jamaneurol.2020.3836. Erratum In: JAMA Neurol. 2021 Jan 1;78(1):120.

ReferenceCitation: Scheitz JF, Pare G, Pearce LA, Mundl H, Peacock WF, Czlonkowska A, Sharma M, Nolte CH, Shoamanesh A, Berkowitz SD, Krahn T, Endres M; NAVIGATE-ESUS Biomarker Working Group. High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source. Stroke. 2020 Aug;51(8):2386-2394. doi: 10.1161/STROKEAHA.120.029628. Epub 2020 Jul 9.

ReferenceCitation: Veltkamp R, Pearce LA, Korompoki E, Sharma M, Kasner SE, Toni D, Ameriso SF, Mundl H, Tatlisumak T, Hankey GJ, Lindgren A, Berkowitz SD, Arauz A, Ozturk S, Muir KW, Chamorro A, Perera K, Shuaib A, Rudilosso S, Shoamanesh A, Connolly SJ, Hart RG. Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source: Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2020 Oct 1;77(10):1233-1240. doi: 10.1001/jamaneurol.2020.1995. Erratum In: JAMA Neurol. 2020 Oct 1;77(10):1322.

repository_institution: UWA - UWA Profiles and Research Repository

ReferenceCitation: Mikulik R, Eckstein J, Pearce LA, Mundl H, Rudilosso S, Olavarria VV, Shoamanesh A, Chamorro A, Marti-Fabregas J, Veltkamp R, Ozturk S, Tatlisumak T, Peacock WF, Berkowitz SD, Connolly SJ, Hart RG. Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial. Stroke. 2020 Jul;51(7):2139-2147. doi: 10.1161/STROKEAHA.119.027995. Epub 2020 Jun 10.

ReferenceCitation: Ntaios G, Pearce LA, Veltkamp R, Sharma M, Kasner SE, Korompoki E, Milionis H, Mundl H, Berkowitz SD, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial. Stroke. 2020 Jun;51(6):1797-1804. doi: 10.1161/STROKEAHA.119.028669. Epub 2020 Apr 16.

ReferenceCitation: Martinez-Majander N, Ntaios G, Liu YY, Ylikotila P, Joensuu H, Saarinen J, Perera KS, Marti-Fabregas J, Chamorro A, Rudilosso S, Prats-Sanchez L, Berkowitz SD, Mundl H, Themeles E, Tiainen M, Demchuk A, Kasner SE, Hart RG, Tatlisumak T; NAVIGATE ESUS investigators. Rivaroxaban versus aspirin for secondary prevention of ischaemic stroke in patients with cancer: a subgroup analysis of the NAVIGATE ESUS randomized trial. Eur J Neurol. 2020 May;27(5):841-848. doi: 10.1111/ene.14172. Epub 2020 Mar 11.

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Ntaios G, Pearce LA, Meseguer E, Endres M, Amarenco P, Ozturk S, Lang W, Bornstein NM, Molina CA, Pagola J, Mundl H, Berkowitz SD, Liu YY, Sen S, Connolly SJ, Hart RG. Aortic Arch Atherosclerosis in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Trial. Stroke. 2019 Nov;50(11):3184-3190. doi: 10.1161/STROKEAHA.119.025813. Epub 2019 Sep 17.

ReferenceCitation: Ntaios G, Swaminathan B, Berkowitz SD, Gagliardi RJ, Lang W, Siegler JE, Lavados P, Mundl H, Bornstein N, Meseguer E, Amarenco P, Cucchiara B, Camps-Renom P, Makaritsis K, Korompoki E, Papavasileiou V, Marti-Fabregas J, Milionis H, Vemmos K, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Efficacy and Safety of Rivaroxaban Versus Aspirin in Embolic Stroke of Undetermined Source and Carotid Atherosclerosis. Stroke. 2019 Sep;50(9):2477-2485. doi: 10.1161/STROKEAHA.119.025168. Epub 2019 Aug 12.

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC
Population Health Research Institute

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Israel


title: Non-Interventional Study on the Tolerability and Efficacy of IVIG

summary: Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%

lead_sponsor: Octapharma

location_country:
United Kingdom
Austria
Spain
Canada
France

location_facility:
Octapharma Research Site
Octapharma Research Location
St. Michael's Hospital
Health Sciences Centre
Hospital for Sick Children
Hamilton Health Sciences
St. Paul's Hospital
Octapharma Research Center

intervention_type: Biological


title: A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

acronym: RESONATE™

summary: The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

ReferenceCitation: Munir T, Brown JR, O'Brien S, Barrientos JC, Barr PM, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Kipps TJ, Moreno C, Montillo M, Burger JA, Byrd JC, Hillmen P, Dai S, Szoke A, Dean JP, Woyach JA. Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol. 2019 Dec;94(12):1353-1363. doi: 10.1002/ajh.25638. Epub 2019 Oct 13.

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

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;ddd.uab.cat;eprints.whiterose.ac.uk;escholarship.org

repositories_institution: University of California - eScholarship University of California

publisher_dissemination: Wiley

ReferenceCitation: Coutre SE, Byrd JC, Hillmen P, Barrientos JC, Barr PM, Devereux S, Robak T, Kipps TJ, Schuh A, Moreno C, Furman RR, Burger JA, O'Dwyer M, Ghia P, Valentino R, Chang S, Dean JP, James DF, O'Brien SM. Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. Blood Adv. 2019 Jun 25;3(12):1799-1807. doi: 10.1182/bloodadvances.2018028761.

repository_institution: California Digital Library - eScholarship

publisher_dissemination: American Society of Hematology

ReferenceCitation: Byrd JC, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Barr PM, Furman RR, Kipps TJ, Thornton P, Moreno C, Montillo M, Pagel JM, Burger JA, Woyach JA, Dai S, Vezan R, James DF, Brown JR. Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab. Blood. 2019 May 9;133(19):2031-2042. doi: 10.1182/blood-2018-08-870238. Epub 2019 Mar 6.

ReferenceCitation: O'Brien SM, Jaglowski S, Byrd JC, Bannerji R, Blum KA, Fox CP, Furman RR, Hillmen P, Kipps TJ, Montillo M, Sharman J, Suzuki S, James DF, Chu AD, Coutre SE. Prognostic Factors for Complete Response to Ibrutinib in Patients With Chronic Lymphocytic Leukemia: A Pooled Analysis of 2 Clinical Trials. JAMA Oncol. 2018 May 1;4(5):712-716. doi: 10.1001/jamaoncol.2017.5604.

ReferenceCitation: Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Barr PM, Brown JR, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Mulligan SP, Jaeger U, Furman RR, Cymbalista F, Montillo M, Dearden C, Robak T, Moreno C, Pagel JM, Burger JA, Suzuki S, Sukbuntherng J, Cole G, James DF, Byrd JC. Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL. Blood. 2017 May 11;129(19):2612-2615. doi: 10.1182/blood-2016-12-737346. Epub 2017 Apr 3.

ReferenceCitation: Maddocks KJ, Ruppert AS, Lozanski G, Heerema NA, Zhao W, Abruzzo L, Lozanski A, Davis M, Gordon A, Smith LL, Mantel R, Jones JA, Flynn JM, Jaglowski SM, Andritsos LA, Awan F, Blum KA, Grever MR, Johnson AJ, Byrd JC, Woyach JA. Etiology of Ibrutinib Therapy Discontinuation and Outcomes in Patients With Chronic Lymphocytic Leukemia. JAMA Oncol. 2015 Apr;1(1):80-7. doi: 10.1001/jamaoncol.2014.218.

ReferenceCitation: Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.

sponsor_collaborators:
Pharmacyclics LLC.
Janssen Research & Development, LLC

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

location_facility:
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title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia

acronym: Tugela

summary: The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)

ReferenceCitation: Zelenetz AD, Robak T, et al. Idelalisib Plus Bendamustine and Rituximab (BR) Is Superior to BR Alone in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. American Society ofHematology (ASH) 57th Annual Meeting & Exposition; 5-8 December 2015; Orlando, FL.

ReferenceCitation: Barrientos JC, Brown JR, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 3 study Evaluating Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL and Adverse Prognostic Features. American Society of Clinical Oncology (ASCO) 2016 Annual Meeting; 3-7 June 2016; Chicago, IL.

ReferenceCitation: Hillmen, P, Ferra C, et al. Idelalisib in Combination with Bendamustine and Rituximab Improves Overall Survival in Patients with Relapsed/Refractory CLL: Interim Results of a Phase 3 Randomized Double-Blind Placebo-Controlled Study. European Hematology Association (EHA) 21st Annual Meeting; 9-12 June 2016; Copenhagen, Denmark.

ReferenceCitation: Zelenetz AD, Brown JR et al. Updated Analysis of Overall Survival in Randomized Phase III Study of Idelalisib in Combination with Bendamustine and Rituximab in Patients with Relapsed/Refractory CLL. American Society of Hematology (ASH) 58th Annual Meeting & Exposition; 3-6 December 2016; San Diego, CA

ReferenceCitation: Zelenetz AD, Barrientos JC, Brown JR, Coiffier B, Delgado J, Egyed M, Ghia P, Illes A, Jurczak W, Marlton P, Montillo M, Morschhauser F, Pristupa AS, Robak T, Sharman JP, Simpson D, Smolej L, Tausch E, Adewoye AH, Dreiling LK, Kim Y, Stilgenbauer S, Hillmen P. Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2017 Mar;18(3):297-311. doi: 10.1016/S1470-2045(16)30671-4. Epub 2017 Jan 28.

ReferenceCitation: Montillo M, Illes A, Robak T, Pristupa AS, Wach M, Egyed M, Delgado J, Jurczak W, Morschhauser F, Schuh A, Eradat H, Shreay S, Barrientos JC, Zelenetz AD. Idelalisib addition has neutral to beneficial effects on quality of life in bendamustine/rituximab-treated patients: results of a phase 3, randomized, controlled trial. Health Qual Life Outcomes. 2019 Nov 15;17(1):173. doi: 10.1186/s12955-019-1232-8.

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repositories_concat: PubMed Central;dea.lib.unideb.hu

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
Ireland
Italy
Poland
Portugal
Hungary
United Kingdom
Romania
Australia
Belgium
United States
Spain
Greece
Croatia
Turkey
Czechia
Canada
Russian Federation
France

location_facility: Winship Cancer Institute at Emory University

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Centralny Szpital Kliniczny MSW w Warszawie

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

location_facility: State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko

location_facility: Russian Oncology Research Center (N.N. Blokhin)

location_facility: Ondokuz Mayis University Faculty of Medicine

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Emergency County Clinical Hospital Brasov

location_facility: Ospedale Oncologico Regionale A. Businco

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Gazi University Medical Faculty Gazi Hospital

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Centre Jean Bernard - Clinique Victor Hugo

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

location_facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

location_facility: Research Institute of Hematology and Blood Transfusion

location_facility: Nottingham University Hospitals NHS Trust


title: The BEACON Study (Breast Cancer Outcomes With NKTR-102): A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine

acronym: BEACON

summary:
The study is designed as an open-label, randomized, parallel, two arm, multicenter, international Phase 3 study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102 given once every 21 days to patients who receive treatment of Physician's Choice selected from a list of seven single-agent intravenous therapies.

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

oa_host_type: publisher

ReferenceCitation: Cortes J, Rugo HS, Awada A, Twelves C, Perez EA, Im SA, Gomez-Pardo P, Schwartzberg LS, Dieras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, O'Shaughnessy J. Prolonged survival in patients with breast cancer and a history of brain metastases: results of a preplanned subgroup analysis from the randomized phase III BEACON trial. Breast Cancer Res Treat. 2017 Sep;165(2):329-341. doi: 10.1007/s10549-017-4304-7. Epub 2017 Jun 13. Erratum In: Breast Cancer Res Treat. 2017 Nov;166(1):327-328.

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

ReferenceCitation: Twelves C, Cortes J, O'Shaughnessy J, Awada A, Perez EA, Im SA, Gomez-Pardo P, Schwartzberg LS, Dieras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Rugo HS. Health-related quality of life in patients with locally recurrent or metastatic breast cancer treated with etirinotecan pegol versus treatment of physician's choice: Results from the randomised phase III BEACON trial. Eur J Cancer. 2017 May;76:205-215. doi: 10.1016/j.ejca.2017.02.011. Epub 2017 Mar 27.

ReferenceCitation: Perez EA, Awada A, O'Shaughnessy J, Rugo HS, Twelves C, Im SA, Gomez-Pardo P, Schwartzberg LS, Dieras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Cortes J. Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine (BEACON): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1556-1568. doi: 10.1016/S1470-2045(15)00332-0. Epub 2015 Oct 22.

lead_sponsor: Nektar Therapeutics

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Desert Hematology Oncology Medical Group

location_facility: Peachtree Hematology Oncology Consultants

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Centra Regional de Lutte contre le Cancer

location_facility: Clinical Trials Unit, Velindre Cancer Centre

location_facility: Scientific Research Oncology Institute named after N.N. Petrov

location_facility: Istituto Nazionale tumori Regina Elena IRCCS

location_facility: Northwest Georgia Oncology Centers, P.C.

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

location_facility: Carolinas Hematology Oncology Associates

location_facility: Hematology-oncology Department, Ajou University Hospital

location_facility: Cancer Clinical Trials Centre, Weston Park Hospital

location_facility: Centre Hospitalier Universitaire Ambroise Paré

location_facility: Hematology-oncology Department, Ewha Womans University Mokdong Hospital

location_facility: The Christie Hospitals NHS Foundation Trust

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Non-state Health Institution "Dorozhnaya Clinical Hospital of OAO "Russian Railways"

location_facility: Texas Oncology-Beaumont, Mamie McFaddin Ward Cancer Center

location_facility: Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center

location_facility: Louisville Oncology Clinical Research Program

location_facility: Centre Hospitalier Universitaire de Liège- Site du Sart Tilman

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: State Institution "Russian Oncology Research Centre named after N.N. Blokhin RAMS"

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: Frontier Cancer Center and Blood Institute

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Istituto tumori Giovanni Paolo II-ospedale oncologico, Oncologia Medica e Sperimentale

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Institut Bergonie Service Oncologie Médicale

location_facility: Hopital Tenon Service oncologie médicale

location_facility: Sciode Medical Associates, PLLC, d.b.a. Eastchester Center for Cancer Care

location_facility: St. Petersburg State Budget Healthcare Institution "City Clinical Oncology Dispensary"

location_facility: Azienda Ospedaliero Universitaria Pisana, U.O. Oncologia Medica

location_facility: UZ Leuven, Campus Gasthuisberg, trialbureau Algemene Medische Oncologie

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Institut Paoli Calmettes, Service Pharmacie

location_facility: GZA Ziekenhuizen, Campus St Augustinus, CLINICAL TRIALS ONCOLOGY

location_facility: PMK Medical Group, Inc., DBA Ventura County Hematology Oncology Specialists

location_facility: Centre Régional de Lutte Contre le Cancer Nantes Atlantique René Gauducheau

location_facility: Odette Cancer Centre OCC Clinical Research


acronym: ACT IV

lead_sponsor: Celldex Therapeutics

summary:
This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.

ReferenceCitation: Weller M, Butowski N, Tran DD, Recht LD, Lim M, Hirte H, Ashby L, Mechtler L, Goldlust SA, Iwamoto F, Drappatz J, O'Rourke DM, Wong M, Hamilton MG, Finocchiaro G, Perry J, Wick W, Green J, He Y, Turner CD, Yellin MJ, Keler T, Davis TA, Stupp R, Sampson JH; ACT IV trial investigators. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1373-1385. doi: 10.1016/S1470-2045(17)30517-X. Epub 2017 Aug 23.

repositories_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

repositories_institution: University of Zurich - Zurich Open Repository and Archive

location_facility: New Jersey Neuroscience Institute, JFK Medical Center

location_facility: HCG - Bangalore Institute of Oncology, Bangalore

location_facility: Covenant Clinic / Iowa Spine and Brain Institute

location_facility: University of Manitoba-Cancer Care Manitoba

location_facility: Waikato Hospital, Regional Cancer Center

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

location_facility: Winship Cancer Institute, Emory University School of Medicine

location_facility: Kaiser Permanente, Redwood City Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Notre-Dame

location_facility: University of Pittsburgh Cancer Institute

location_facility: University of Wisconsin Paul P Carbone Comprehensive Cancer Center

location_facility: Medical University Innsbruck, Dept of Neurology, Anichstrabe 35

location_facility: Dra. Sonia Del Barco Berron, ICO Girona Avda,

location_facility: University Hospitals, Case Medical Center (Cleveland)

location_facility: Umiversity Hospital (Fakultni Nemocnice)

location_facility: University of Utah Department of Neurosurgery

location_facility: Dr. Senchkenbergisches Institut fur Neuroonkologie

location_facility: ICO Badalona-Hospital Germans Trias i Pujol

location_facility: Columbia University Medical Center - The Neurologic Institute of New York

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: The Long Island Brain Tumor Center at Neurology Surgery, P.C.

location_facility: Dana-Farber Cancer Institute and Mass General Hospital

location_facility: Amrita Institute of Medical Sciences and Research Centre, Kochi

location_facility: Medical University of South Carolina - Department of Neuroscience

location_facility: Pécsi Tudományegyetem Általános Orvostudományi Kar

location_facility: Ensayos Clínicos y Medicina de Alta Especialidad, S.C.

location_facility: University of South Alabama Mitchell Cancer Institute

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Lehigh Valley Physician Group-Hematology-Oncology Associates

location_facility: Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José

location_facility: Montreal Neurological Institute and Hospital

location_facility: The Crown Princess Mary Cancer Centre, Westmead Hospital

location_facility: University of Cincinnati Cancer Institute

location_facility: Medizinische Universität Wien, Innere Medizin I, Onkologie

location_facility: BC Cancer Agency - Vancouver Island Centre

location_facility: Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram

location_facility: Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Servicios Medicos de Investigacion Clinica Sc

location_facility: UO Oncologie Medica Dipartimento Oncologico

location_facility: University of Arkansas for Medical Sciences

location_facility: Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute

location_facility: The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center

location_facility: Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho

location_facility: Kantonsspital Aarau Medizinische Onkologie Tellstrasse

location_facility: Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

location_facility: Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute

location_facility: Edinburgh Cancer Centre Western General Hospital

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: Marathwada Regional Cancer Centre and Research Institute - Government

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP

location_facility: Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672

location_facility: Providence Portland Medical Center, Oncology & Hematology Care

location_facility: Radboud University Nijmegen Medical Center

location_facility: St. Mary's of Michigan Medical Center/Field Neurosciences Institute

location_facility: Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie

location_facility: University of Virginia Healthcare System

location_facility: British Columbia Cancer Agency, Vancouver Clinic

location_facility: Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base

location_facility: Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály

location_facility: University Hospital Hamburg Kopf und Neurozentrum

location_facility: Brain Tumor Center, University Hospital Zurich

location_facility: University of Massachusetts Memorial Medical Center

location_facility: The Bristol Haematology and Oncology Centre

location_facility: Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt

location_facility: Johns Hopkins University School of Medicine

location_facility: Universita e AO Citta delia Scienza, Universita Di Torino

location_facility: Dr. Rai Memorial Medical Centre, Chennai

location_facility: University of Tennessee Medical Center - Knoxville

location_facility: Institut de Cancerologie de I'Quest-Paul Papin

location_facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse

location_facility: Institut de Cancerologie de L'Quest-Center Rane Gauducheau

location_facility: HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: CHUV, Centre Hospitalier Universitaire Vaudois

location_facility: Hospital Central "Ignacio Morones Prieto"

location_facility: Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited

location_facility: Fondazione IRCCS Instituto Neurologico Carlo Besta

location_facility: Stanford Cancer Institute, Stanford University

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: Guy's and St Thomas' NHS, Westminister Bridge Road

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Regensburg

location_facility: Institut de Cancerologie de l'ouest-Center Rene Gauducheau

location_facility: Waikato Hospital, Regional Cancer Centre

location_facility: Mount Sinai Medical Center, Comprehensive Cancer Center

location_facility: Országos Onkológiai Intézet Sugárterápiás Osztály

title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

location_country:
Germany
New Zealand
Australia
Brazil
Thailand
Czechia
Canada
France
Colombia
Hungary
Switzerland
United States
India
Belgium
Peru
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
Taiwan
Israel


lead_sponsor: GlaxoSmithKline

summary: The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.

title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

design_allocation: Non-Randomized

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Czech Republic
Hungary
Denmark
Belgium
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


title: An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.

summary: The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) was to provide early access to ruxolitinib and evaluate safety information in patients with polycythemia vera (PV) who were hydroxyurea (HU) resistant or intolerant and who had no other standard treatment option, nor did they qualify for another clinical study for PV

location_country: Germany Portugal Norway Sweden Austria Belgium Mexico Thailand Chile Bulgaria Canada France


type: Registry Identifier

title: A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

summary: The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.

status: Active, not recruiting

study_completion_date_type: Anticipated

ipd_sharing: No

lead_sponsor: Canadian Cancer Trials Group

collaborators: Intergroupe Francophone de Cancerologie Thoracique

collaborators: Thoracic Oncology Group of Australasia (TOGA)

collaborators: National Health and Medical Research Council, Australia

collaborators: Central and Eastern European Oncology Group

collaborators: Dutch Society of Physicians for Pulmonology and Tuberculosis

location_country:
Poland
New Zealand
Australia
Brazil
Japan
Canada
France
Hungary
United States
Ukraine
Romania
China
Italy
Singapore
Netherlands
Korea, Republic of
Spain
Taiwan
Bulgaria

location_facility: The Second Xiangya Hospital of Central South Univer

location_facility: Samodzielny Publiczny Szpital Specjalistyczny

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Universita Federico II UOC Oncologia Medica

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: IRCCS Ospedale Oncologico Giovanni Paolo II

location_facility: Chang-Gung Memorial Hospital - Kaohsiung

location_facility: Vinnytsia Regional Clinical Oncology Dispensary

location_facility: Hospital Evangelico de Cachoeiro de Itapemirim

location_facility: The Second Affiliated Hosp of Shantou Medical Colleg

location_facility: Stronach Regional Health Centre at Southlake

location_facility: Dott. Fortunato Ciardiello,Cattedra Oncologia Medica

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Ospedale S. Paolo - U.O. di Oncologia Medica

location_facility: CHUM-Centre Hospitalier de l'Universite de Montreal

location_facility: National Hospital Organization Yamaguchi

location_facility: Keimyung University Dongsan Medical Center

location_facility: Frankston Hospital - Peninsula Oncology Centre

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: The Research Institute of the McGill University

location_facility: Istituti Fisioterapici Ospitalieri IFO Istituto

location_facility: Sir run run shaw hospital School of Medicine

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Centre Integre Universitaire De Sante Et De Services

location_facility: PO A Perrino ASL Brindisi - UOC Oncologia Medica

location_facility: Hematology and Oncology Associates of NEPA

location_facility: Royal Melbourne Hospital Research Foundation

location_facility: Hospital General Universitario de Valencia

location_facility: Spitalul de Psihiatrie Dr. Constantin Gorgos

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: The Affiliated Hospital Of Qingdao University

location_facility: National Hospital Organization Kure Medical Center

location_facility: Universitair medisch centrum Nijmegen st Radboud

location_facility: Fondazione Salvatore Maugeri Oncologia Medica

location_facility: Thunder Bay Regional Health Sciences Centre/Thunder

location_facility: Azienda Ospedaliera di Rilievo Nazionale

location_facility: The Affiliated Hospital Of Xuzhou Medical College

location_facility: Azienda Ospedaliera di Perugia Santa Maria

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Hospital of the University of Occupational and

location_facility: Suporte Nutricional e Quimioterapia LTDA PRONUTRIR

location_facility: Centro de Oncologia e Radioterapia (COR) Mae de Deus

location_facility: Semmelweis University Pulmonology Department

location_facility: Dnipropetrovsk City Clinical Hospital No.4

location_facility: National Hospital Organization Kinki-Chuo

location_facility: Kinki University Hospital Faculty of Medicine

location_facility: Azienda USL di Piacenza, Ospedale Gugliemimo Salieto

location_facility: Unita Sperimentazioni Cliniche Istituto per lo

location_facility: Centre hospitalier universitaire de Montpellier

location_facility: OUC Oncologia Medica - Presidio Ospedaliero

location_facility: U.O. di Oncologia Medica Azienda Ospedaliera G Rummo

location_facility: The People Hospital of Guangxi Zhuang Autonomous Reg

location_facility: Oncologia Medica IRCCS Arcispedale Maria

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Klinika Onkologii i Radioterapii Uniwersyteckie

location_facility: Annemasse - Centre Hospitalier Alpes Leman

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Thonon-les-Bains - Hopital Georges Pianta

location_facility: AOU Policlinico Vittorio Emanuele UOC di Oncologia

location_facility: UOC Oncologia Medica II Instituto Oncologio Veneto

location_facility: Centre Hospitalier Regional Hopital de la Source

location_facility: Liverpool Cancer Therapy Centre, Liverpool Hospital

location_facility: The Catholic University of Korea Bucheon

location_facility: Centre Hospitalier Intercommunal - Elbeuf

status_simplified: Ongoing