ReferenceCitation: Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.

family: Bennett

full_name: Hayley Bennett

given: Hayley

family: McEwan

full_name: Phil McEwan

given: Phil

family: Hamilton

full_name: Karina Hamilton

given: Karina

family: O’Reilly

full_name: Karl O’Reilly

given: Karl

journal_name: BMC Nephrology

oa_colors: green gold

evidence: oa journal (via doaj)

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

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Perrone RD, Koch G, Ouyang J, McQuade RD, Blais JD, Czerwiec FS, Sergeyeva O; REPRISE Trial Investigators. Tolvaptan in Later-Stage Autosomal Dominant Polycystic Kidney Disease. N Engl J Med. 2017 Nov 16;377(20):1930-1942. doi: 10.1056/NEJMoa1710030. Epub 2017 Nov 4.

name: From the Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN (V.E.T.); the Section of Nephrology, University of Chicago, Chicago (A.B.C.); the Institute of Physiology, University of Zurich, Zurich, Switzerland (O.D.); the Division of Nephrology, Université Catholique de Louvain Medical School, Brussels (O.D.); the Division of Nephrology, University Medical Center Groningen, Groningen, the Netherlands (R.T.G.); the Division of Nephrology, Department of Medicine, Tufts Medical Center,...

family: Torres

full_name: Vicente E. Torres

given: Vicente E.

family: Chapman

full_name: Arlene B. Chapman

given: Arlene B.

family: Devuyst

full_name: Olivier Devuyst

given: Olivier

family: Gansevoort

full_name: Ron T. Gansevoort

given: Ron T.

family: Perrone

full_name: Ronald D. Perrone

given: Ronald D.

family: Koch

full_name: Gary Koch

given: Gary

family: Ouyang

full_name: John Ouyang

given: John

family: McQuade

full_name: Robert D. McQuade

given: Robert D.

family: Blais

full_name: Jaime D. Blais

given: Jaime D.

family: Czerwiec

full_name: Frank S. Czerwiec

given: Frank S.

family: Sergeyeva

full_name: Olga Sergeyeva

given: Olga

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

repository_institution: University College London - UCL Discovery

repositories_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Romania
Belgium
Australia
Russian Federation
Denmark
France
Poland
Norway
Argentina
Canada
South Africa
Sweden
Netherlands
Hungary
Puerto Rico
United States
Germany
United Kingdom
Italy
Czechia
Israel
Spain

title: A Phase 3b, Multi-center, Randomized-withdrawal, Placebo-controlled, Double-blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/Day, Split-dose) in Subjects With Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due to Autosomal Dominant Polycystic Kidney Disease

summary: The purpose of the study is to determine whether tolvaptan is effective and safe for the treatment of late-stage chronic kidney disease due to autosomal dominant polycystic kidney disease (ADPKD)


ReferenceType: derived

ReferenceCitation: Criner GJ, Celli BR, Singh D, Agusti A, Papi A, Jison M, Makulova N, Shih VH, Brooks L, Barker P, Martin UJ, Newbold P. Predicting response to benralizumab in chronic obstructive pulmonary disease: analyses of GALATHEA and TERRANOVA studies. Lancet Respir Med. 2020 Feb;8(2):158-170. doi: 10.1016/S2213-2600(19)30338-8. Epub 2019 Sep 28.

family: Criner

full_name: Gerard J Criner

given: Gerard J

sequence: first

family: Celli

full_name: Bartolome R Celli

given: Bartolome R

sequence: additional

family: Singh

full_name: Dave Singh

given: Dave

family: Agusti

full_name: Alvar Agusti

given: Alvar

family: Papi

full_name: Alberto Papi

given: Alberto

family: Jison

full_name: Maria Jison

given: Maria

family: Makulova

full_name: Natalya Makulova

given: Natalya

family: Shih

full_name: Vivian H Shih

given: Vivian H

family: Brooks

full_name: Laura Brooks

given: Laura

family: Barker

full_name: Peter Barker

given: Peter

family: Martin

full_name: Ubaldo J Martin

given: Ubaldo J

family: Newbold

full_name: Paul Newbold

given: Paul

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet Respiratory Medicine

oa_host_type: repository

host_type: repository

license_normalized: no license

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

version: submittedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramírez-Venegas A, Wei YF, Bjermer L, Shih VH, Jison M, O'Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ; GALATHEA Study Investigators; TERRANOVA Study Investigators. Benralizumab for the Prevention of COPD Exacerbations. N Engl J Med. 2019 Sep 12;381(11):1023-1034. doi: 10.1056/NEJMoa1905248. Epub 2019 May 20.

name: From the Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University, Philadelphia (G.J.C.); Pulmonary and Critical Care Division, Brigham and Women’s Hospital, Harvard Medical School, Boston (B.R.C.); the Institute for Lung Health, Leicester National Institute for Health Research Biomedical Research Centre, Department of Respiratory Sciences, University of Leicester, Leicester (C.E.B.), the University of Manchester, Manchester University NHS Hospital Trust, Manchester ...

full_name: Gerard J. Criner

given: Gerard J.

full_name: Bartolome R. Celli

given: Bartolome R.

family: Brightling

full_name: Christopher E. Brightling

given: Christopher E.

family: Sin

full_name: Don D. Sin

given: Don D.

family: Vogelmeier

full_name: Claus F. Vogelmeier

given: Claus F.

family: Sciurba

full_name: Frank C. Sciurba

given: Frank C.

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

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

repository_institution: University of Leicester - Leicester Research Archive

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

location_country:
Peru
Belgium
Australia
Denmark
Taiwan
Ukraine
Croatia
France
Poland
Thailand
Norway
Argentina
Slovenia
Colombia
Chile
Sweden
Vietnam
Philippines
Bulgaria
United States
Brazil
Serbia
Mexico
Israel
New Zealand
Turkey

title: A Randomised, Double-blind, Double Dummy, 56 Week Placebo-controlled, Multicentre, Parallel Group, Phase 3 Study Evaluating Efficacy/Safety of 3 Benralizumab Doses in Patients With Moderate to Very Severe COPD With Previous Exacerbations.

summary: The purpose of the study is to determine if benralizumab reduces COPD exacerbation rate in symptomatic patients with moderate to very severe COPD who are receiving standard of care therapies.


title: A Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (PM1116197) LosmApimod To Inhibit p38 MAP Kinase as a TherapeUtic Target and moDify Outcomes After an Acute Coronary syndromE (LATITUDE)-TIMI 60.

acronym: LATITUDE

summary: Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceCitation: Cavender MA, O'Donoghue ML, Abbate A, Aylward P, Fox KA, Glaser RX, Park JG, Lopez-Sendon J, Steg PG, Sabatine MS, Morrow DA. Inhibition of p38 MAP kinase in patients with ST-elevation myocardial infarction - findings from the LATITUDE-TIMI 60 trial. Am Heart J. 2021 Sep 8;243:147-157. doi: 10.1016/j.ahj.2021.08.022. [Epub ahead of print]

family: Cavender

full_name: Matthew A. Cavender

given: Matthew A.

family: O'Donoghue

full_name: Michelle O'Donoghue

given: Michelle

family: Abbate

full_name: Antonio Abbate

given: Antonio

family: Aylward

full_name: Philip Aylward

given: Philip

family: Fox

full_name: Keith A.A. Fox

given: Keith A.A.

family: Glaser

full_name: Ruchira X. Glaser

given: Ruchira X.

family: Park

full_name: Jeong-Gun Park

given: Jeong-Gun

family: Lopez-Sendon

full_name: Jose Lopez-Sendon

given: Jose

family: Steg

full_name: Ph. Gabriele Steg

given: Ph. Gabriele

family: Sabatine

full_name: Marc S. Sabatine

given: Marc S.

family: Morrow

full_name: David A. Morrow

given: David A.

journal_name: American Heart Journal

title: Inhibition of p38 MAP Kinase in Patients with ST-Elevation Myocardial Infarction – Findings from the LATITUDE TIMI 60 Trial

ReferenceCitation: O'Donoghue ML, Glaser R, Cavender MA, Aylward PE, Bonaca MP, Budaj A, Davies RY, Dellborg M, Fox KA, Gutierrez JA, Hamm C, Kiss RG, Kovar F, Kuder JF, Im KA, Lepore JJ, Lopez-Sendon JL, Ophuis TO, Parkhomenko A, Shannon JB, Spinar J, Tanguay JF, Ruda M, Steg PG, Theroux P, Wiviott SD, Laws I, Sabatine MS, Morrow DA; LATITUDE-TIMI 60 Investigators. Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1591-9. doi: 10.1001/jama.2016.3609.

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts

family: O’Donoghue

full_name: Michelle L. O’Donoghue

given: Michelle L.

name: Metabolic Pathways and Cardiovascular Unit, Research and Development, GlaxoSmithKline, Collegeville, Pennsylvania

full_name: Ruchira Glaser

given: Ruchira

name: South Australian Health and Medical Research Institute, Flinders University Medical Centre, Adelaide, South Australia, Australia

full_name: Philip E. Aylward

given: Philip E.

family: Bonaca

full_name: Marc P. Bonaca

given: Marc P.

name: Postgraduate Medical School, Grochowski Hospital, Warsaw, Poland

family: Budaj

full_name: Andrzej Budaj

given: Andrzej

family: Davies

full_name: Richard Y. Davies

given: Richard Y.

name: Sahlgrenska University Hospital/Ostra and Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden

family: Dellborg

full_name: Mikael Dellborg

given: Mikael

name: Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland

full_name: Keith A. A. Fox

given: Keith A. A.

family: Gutierrez

name: Kerckhoff Heart Center, Bad Nauheim, University of Giessen, Giessen, Germany

name: Department of Cardiology, Military Hospital, Budapest, Hungary

name: Department of Internal Medicine I, Jessenius Faculty of Medicine in Martin, Comenius University in Bratislava, Martin, Slovak Republic

name: Cardiovascular Division, University Hospital La Paz, Madrid, Spain

name: Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands

name: Ukranian Strazhesko Institute of Cardiology, Kiev, Ukraine

name: PAREXEL International, Durham, North Carolina

name: University Hospital, Jihlavska, Brno, Czech Republic

name: Montreal Heart Institute and University of Montreal, Montreal, Quebec, Canada

name: Cardiology Research Center, Moscow, Russia

name: Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, and Université Paris-Diderot, Paris, France

ReferenceCitation: O'Donoghue ML, Glaser R, Aylward PE, Cavender MA, Crisp A, Fox KA, Laws I, Lopez-Sendon JL, Steg PG, Theroux P, Sabatine MS, Morrow DA. Rationale and design of the LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndromE trial. Am Heart J. 2015 May;169(5):622-630.e6. doi: 10.1016/j.ahj.2015.02.012. Epub 2015 Feb 23.

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Poland
Thailand
Slovakia
Norway
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Mexico
Czechia
Israel
New Zealand
Spain
Estonia


type: EudraCT Number

title: A Multi-Centre, Open-Label, Study of Mepolizumab in a Subset of Subjects With a History of Life Threatening/Seriously Debilitating Asthma Who Participated in the MEA115661 Trial

summary: This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.

ReferenceType: background

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

family: Khurana

full_name: Sandhya Khurana

given: Sandhya

family: Brusselle

full_name: Guy G. Brusselle

given: Guy G.

family: Bel

full_name: Elisabeth H. Bel

given: Elisabeth H.

family: FitzGerald

full_name: J. Mark FitzGerald

given: J. Mark

family: Masoli

full_name: Matthew Masoli

given: Matthew

family: Korn

full_name: Stephanie Korn

given: Stephanie

family: Kato

full_name: Motokazu Kato

given: Motokazu

family: Albers

full_name: Frank C. Albers

given: Frank C.

family: Bradford

full_name: Eric S. Bradford

given: Eric S.

family: Gilson

full_name: Martyn J. Gilson

given: Martyn J.

family: Price

full_name: Robert G. Price

given: Robert G.

family: Humbert

full_name: Marc Humbert

given: Marc

journal_name: Clinical Therapeutics

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repository_institution: Ghent University - Ghent University Academic Bibliography

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
Chile
Netherlands
Spain
Germany
France
Czechia
Japan
Poland
Belgium
Argentina
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of
Ukraine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


ReferenceType: result

ReferenceCitation: Ahrén B, Hirsch IB, Pieber TR, Mathieu C, Gómez-Peralta F, Hansen TK, Philotheou A, Birch S, Christiansen E, Jensen TJ, Buse JB; ADJUNCT TWO Investigators. Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial. Diabetes Care. 2016 Oct;39(10):1693-701. doi: 10.2337/dc16-0690. Epub 2016 Aug 4.

family: Ahrén

full_name: Bo Ahrén

given: Bo

family: Hirsch

full_name: Irl B. Hirsch

given: Irl B.

family: Pieber

full_name: Thomas R. Pieber

given: Thomas R.

family: Mathieu

full_name: Chantal Mathieu

given: Chantal

family: Gómez-Peralta

full_name: Fernando Gómez-Peralta

given: Fernando

family: Hansen

full_name: Troels Krarup Hansen

given: Troels Krarup

family: Philotheou

full_name: Areti Philotheou

given: Areti

family: Birch

full_name: Sune Birch

given: Sune

family: Christiansen

full_name: Erik Christiansen

given: Erik

family: Jensen

full_name: Thomas Jon Jensen

given: Thomas Jon

family: Buse

full_name: John B. Buse

given: John B.

journal_name: Diabetes Care

oa_colors: green other

evidence: open (via free pdf)

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

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Hoogenhout M, Malcolm-Smith S. Theory of mind predicts severity level in autism. Autism. 2017 Feb;21(2):242-252. doi: 10.1177/1362361316636758. Epub 2016 Aug 19.

family: Hoogenhout

full_name: Michelle Hoogenhout

given: Michelle

family: Malcolm-Smith

full_name: Susan Malcolm-Smith

given: Susan

bso_classification: Social sciences

journal_name: Autism

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Austria
United States
South Africa
Sweden
Netherlands
Finland
France
Bulgaria
Belgium
Spain
Denmark
Canada

acronym: ADJUNCT TWO™

type: Other Identifier

type: Registry Identifier

source: euctr

title: A 26-weeks Randomised, Insulin Capped, Placebo-controlled, Double-blind, Parallel Group, Multinational, Multi-centre Trial

summary: This trial is conducted in Africa, Europe and North America. The purpose of the trial is to investigate the efficacy and safety of liraglutide adjunct to insulin treatment in type 1 diabetes.


title: A Phase II,Non-comparative,Open Label, Multi-centre, International Study of MEDI4736, in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least 2 Prior Systemic Treatment Regimens Including 1 Platinum-based Chemotherapy Regimen

acronym: ATLANTIC

summary: A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Gavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21.

name: Faculty CMC of Lomonosov MSU Moscow Russia

family: Gavrilov

full_name: Sergey Gavrilov

given: Sergey

family: Zhudenkov

full_name: Kirill Zhudenkov

given: Kirill

name: Clinical Pharmacology and Quantitative Pharmacology Clinical Pharmacology & Safety Sciences BioPharmaceuticals R&D AstraZeneca Boston Massachusetts USA

family: Helmlinger

full_name: Gabriel Helmlinger

given: Gabriel

family: Dunyak

full_name: James Dunyak

given: James

name: Computational Oncology Group I.M. Sechenov First Moscow State Medical University Moscow Russia

family: Peskov

full_name: Kirill Peskov

family: Aksenov

full_name: Sergey Aksenov

currency_apc_doaj: USD

journal_name: CPT: Pharmacometrics & Systems Pharmacology

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Longitudinal Tumor Size and Neutrophil‐to‐Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non‐Small Cell Lung Cancer Treated With Durvalumab

ReferenceCitation: Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

family: Zhang

full_name: Qu Zhang

given: Qu

family: Luo

full_name: Jia Luo

given: Jia

family: Wu

full_name: Song Wu

given: Song

family: Si

full_name: Han Si

given: Han

family: Gao

full_name: Chen Gao

given: Chen

family: Xu

full_name: Wenjing Xu

given: Wenjing

family: Abdullah

full_name: Shaad E. Abdullah

given: Shaad E.

family: Higgs

full_name: Brandon W. Higgs

given: Brandon W.

family: Dennis

full_name: Phillip A. Dennis

given: Phillip A.

family: van der Heijden

full_name: Michiel S. van der Heijden

given: Michiel S.

family: Segal

full_name: Neil H. Segal

given: Neil H.

family: Chaft

full_name: Jamie E. Chaft

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Garassino MC, Cho BC, Kim JH, Mazières J, Vansteenkiste J, Lena H, Jaime JC, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Poole L, Wadsworth C, Dennis PA, Rizvi NA. Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: The phase II ATLANTIC study. Lung Cancer. 2020 Sep;147:137-142. doi: 10.1016/j.lungcan.2020.06.032. Epub 2020 Jun 30.

ReferenceCitation: Ouwens MJNM, Mukhopadhyay P, Zhang Y, Huang M, Latimer N, Briggs A. Estimating Lifetime Benefits Associated with Immuno-Oncology Therapies: Challenges and Approaches for Overall Survival Extrapolations. Pharmacoeconomics. 2019 Sep;37(9):1129-1138. doi: 10.1007/s40273-019-00806-4.

ReferenceCitation: Garassino MC, Cho BC, Kim JH, Mazières J, Vansteenkiste J, Lena H, Corral Jaime J, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Huang Y, Wadsworth C, Dennis PA, Rizvi NA; ATLANTIC Investigators. Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study. Lancet Oncol. 2018 Apr;19(4):521-536. doi: 10.1016/S1470-2045(18)30144-X. Epub 2018 Mar 12.

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:
Italy
Austria
United States
Philippines
Germany
France
Czechia
Japan
Poland
Thailand
Singapore
Hungary
Belgium
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan


title: Phase 1/2 Study of TAS-120 in Patients With Advanced Solid Tumors Harboring FGF/FGFR Aberrations

summary:
This is an open-label, nonrandomized, Phase 1/2 study for the fibroblast growth factor receptor (FGFR) inhibitor futibatinib (TAS-120). The purpose of the study is to evaluate the safety, tolerability, PK, pharmacodynamic, and anti-tumor activity of futibatinib in patients with advanced solid tumors with and without genomic FGF/FGFR abnormalities. The study will be conducted in 3 parts:

Dose escalation portion to determine the MTD and/ or RP2D of futibatinib.
Phase 1 expansion portion to further evaluate the safety and efficacy of futibatinib in patients with tumors harboring FGF/FGFR aberrations, including patients with cholangiocarcinoma (CCA), primary CNS tumors, urothelial carcinoma, breast cancer, gastric cancer and
Phase 2 study portion to confirm ORR of futibatinib in intrahepatic CCA patients with tumors harboring FGFR2 gene rearrangements (incl fusions).

design_allocation: Non-Randomized

ReferenceCitation: Bahleda R, Meric-Bernstam F, Goyal L, Tran B, He Y, Yamamiya I, Benhadji KA, Matos I, Arkenau HT. Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1-4 inhibitor in patients with advanced solid tumors. Ann Oncol. 2020 Oct;31(10):1405-1412. doi: 10.1016/j.annonc.2020.06.018. Epub 2020 Jul 2.

family: Bahleda

full_name: R. Bahleda

given: R.

family: Meric-Bernstam

full_name: F. Meric-Bernstam

given: F.

family: Goyal

full_name: L. Goyal

given: L.

family: Tran

full_name: B. Tran

given: B.

family: He

full_name: Y. He

given: Y.

family: Yamamiya

full_name: I. Yamamiya

given: I.

family: Benhadji

full_name: K.A. Benhadji

family: Matos

full_name: I. Matos

family: Arkenau

full_name: H.-T. Arkenau

journal_name: Annals of Oncology

repository_normalized: University of Melbourne - Minerva Access

repository_normalized: UCL Discovery

repositories_institution: University College London - UCL Discovery

title: Phase I, first-in-human study of futibatinib, a highly selective, irreversible FGFR1–4 inhibitor in patients with advanced solid tumors

ipd_sharing: No

lead_sponsor: Taiho Oncology, Inc.

location_country:
Italy
United States
Hong Kong
Netherlands
Spain
Germany
France
Japan
Australia
Portugal
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Mary Crowley Cancer Research - Medical City

location_facility: Cancer Treatment Centers of America Zion, IL

location_facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

location_facility: Yonsei University, Severance Hospital (Seoul)

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Sidney Kimmel Cancer Center at Jefferson

location_facility: Cancer Treatment Centers of America Philadelphia, PA

location_facility: Hospital of the University of Pennsylvania

location_facility: Wayne State Universtity (Karmanos Cancer Institute)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Rua Dr. Antonio Bernardino de Almeida

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Kyorin University Hospital,Department of Clinical Pharmacology and Therapeutics

location_facility: Hospital Clinic i Provincial de Barcelona,

location_facility: University of Utah, Huntsman Cancer Hospital

location_facility: University of Wisconsin Clinical Science Center

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

location_facility: The University of Arizona Cancer Center - North Campus

location_facility: Hospital Universitario Madrid Sanchinarro. Medical Oncology

location_facility: Centre Eugene Marquis-Service d'Oncologie Medicale

location_facility: Hopital Neurologique Pierre Wertheimer, Service neuro-oncologie

location_facility: Cento de Investigacao da Fundacao Champalimaud, Avenida Brasilia

location_facility: Academic Medical Center, Department of Oncology

location_facility: Centro Integral Oncológico Clara Campal - Hospital Universitario Madrid Sanchinarro

location_facility: University of Pittsburgh Medical Center Hillman Cancer Center

location_facility: Scientia Clinical Research University of New South Wales

location_facility: UOC Oncologia Medica 1 I"V - Istituto Oncologico Veneto - IRCCS

location_facility: Greenville Health System ITOR,Clinical Research Unit

location_facility: University Hospital Essen, West German Cancer Center, Department of Medical Oncology

location_facility: Hopital BEAUJON Service d'Oncologie Digestive

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center. Mission Bay


title: A Study of IPI-145 and Ofatumumab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07

summary: A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 monotherapy or ofatumumab monotherapy in subjects with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or Ofatumumab in Study IPI-145-07.

lead_sponsor: SecuraBio

location_country:
Italy
Austria
Germany
France
Hungary
Australia
Belgium
New Zealand
Spain
United States
United Kingdom


title: A Phase 3 Open-label Randomized Study of Quizartinib (AC220) Monotherapy Versus Salvage Chemotherapy in Subjects With Tyrosine Kinase 3 - Internal Tandem Duplication (FLT3-ITD) Positive Acute Myeloid Leukemia (AML) Refractory to or Relapsed After First-line Treatment With or Without Hematopoietic Stem Cell Transplantation (HSCT) Consolidation

summary: The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication (FLT3-ITD) positive AML who are refractory to or have relapsed within 6 months, after first-line AML therapy.

ReferenceCitation: Kang D, Ludwig E, Jaworowicz D, Huang H, Fiedler-Kelly J, Cortes J, Ganguly S, Khaled S, Krämer A, Levis M, Martinelli G, Perl A, Russell N, Abutarif M, Choi Y, Yin O. Concentration-QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia. Cancer Chemother Pharmacol. 2021 Apr;87(4):513-523. doi: 10.1007/s00280-020-04204-y. Epub 2021 Jan 8.

family: Kang

full_name: Dongwoo Kang

given: Dongwoo

family: Ludwig

full_name: Elizabeth Ludwig

given: Elizabeth

family: Jaworowicz

full_name: David Jaworowicz

given: David

family: Huang

full_name: Hannah Huang

given: Hannah

family: Fiedler-Kelly

full_name: Jill Fiedler-Kelly

given: Jill

family: Cortes

full_name: Jorge Cortes

given: Jorge

family: Ganguly

full_name: Siddhartha Ganguly

given: Siddhartha

family: Khaled

full_name: Samer Khaled

given: Samer

family: Krämer

full_name: Alwin Krämer

given: Alwin

family: Levis

full_name: Mark Levis

given: Mark

family: Martinelli

full_name: Giovanni Martinelli

given: Giovanni

family: Perl

full_name: Alexander Perl

given: Alexander

family: Russell

full_name: Nigel Russell

given: Nigel

family: Abutarif

full_name: Malaz Abutarif

given: Malaz

family: Choi

full_name: Youngsook Choi

given: Youngsook

family: Yin

full_name: Ophelia Yin

given: Ophelia

journal_name: Cancer Chemotherapy and Pharmacology

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Concentration–QTc analysis of quizartinib in patients with relapsed/refractory acute myeloid leukemia

ReferenceCitation: Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, Krämer A, Dombret H, Hogge D, Jonas BA, Leung AY, Mehta P, Montesinos P, Radsak M, Sica S, Arunachalam M, Holmes M, Kobayashi K, Namuyinga R, Ge N, Yver A, Zhang Y, Levis MJ. Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):984-997. doi: 10.1016/S1470-2045(19)30150-0. Epub 2019 Jun 4. Erratum in: Lancet Oncol. 2019 Jul;20(7):e346.

full_name: Jorge E Cortes

given: Jorge E

ReferenceCitation: Cortes J, Perl AE, Döhner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Krämer A, Russell N, Shah NP, Smith CC, Wang ES, Ifrah N, Gammon G, Trone D, Lazzaretto D, Levis M. Quizartinib, an FLT3 inhibitor, as monotherapy in patients with relapsed or refractory acute myeloid leukaemia: an open-label, multicentre, single-arm, phase 2 trial. Lancet Oncol. 2018 Jul;19(7):889-903. doi: 10.1016/S1470-2045(18)30240-7. Epub 2018 May 31.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Italy
United States
Serbia
Hong Kong
Netherlands
Germany
Croatia
Czechia
France
Poland
Singapore
Hungary
Belgium
Australia
Spain
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: UNC Linebreger Comprehensive Cancer Center

location_facility: Klinikum der Johann Wolfgang-Goethe-Universität

location_facility: The University of Hong Kong, Queen Mary Hospital

location_facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika

location_facility: Duke Cancer Institute at Duke University Health System

location_facility: University of Pennsylvania Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of Southern California, Norris Comprehensive Cancer Center

location_facility: Unità Operativa di Ematologia e Unità Operativa CTMO

location_facility: LSU Health Sciences Center Feist Weiller Cancer Center

location_facility: Centre Hospitalier Universitaire Grenoble Hopital Michalon

location_facility: Oregon Health and Science University Knight Cancer Institute

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Uniwersytecki Szpital Kliniczny w Biatymstoku, Klinika Hematologii z Pododzialem Chorob Naczyn

location_facility: University of Kansas Medical Center Research Institute Inc

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Washington University School of Medicine

location_facility: Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie

location_facility: Seoul National University Bundang Hospital

location_facility: The Chinese University of Hong Kong, Prince of Wales Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet

location_facility: L'UOC di Ematologia del Policlinico Tor Vergata

location_facility: The Catholic University of Korea Seoul St. Mary's Hospital

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach Oddzial Hematologii i Transplantacji Szpiku

location_facility: Stanford University Medical Center Stanford Comprehensive Cancer Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Azienda Ospedaliero Universitaria Senese, Policlinico S. Maria alle Scotte

location_facility: Uniklinik Heidelberg Medizinische Klinik und Poliklinik V

location_facility: Hopital Haut Leveque Centre Francois Magendie

location_facility: MD Anderson Center, The University of Texas

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Princess Margaret Cancer Centre Princess Margaret Hospital

location_facility: Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent Gyorgyi Albert Klinikai Kozpont

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1, Klinika Hematoonkologii i Transplantacji Szpiku


title: A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib

summary: This is a Phase II, open-label, non-randomized, multi-center study of oral Dabrafenib in combination with oral Trametinib in subjects with rare cancers including anaplastic thyroid cancer, biliary tract cancer, gastrointestinal stromal tumor, non-seminomatous germ cell tumor/non-geminomatous germ cell tumor, hairy cell leukemia, World Health Organization (WHO) Grade 1 or 2 glioma, WHO Grade 3 or 4 (high-grade) glioma, multiple myeloma, and adenocarcinoma of the small intestine, with BRAF V600E positive-mutations. This study is designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with oral Trametinib in subjects with rare BRAF V600E mutated cancers. Subjects will need to have a fresh or frozen tumor tissue sample provided to confirm the BRAF V600E mutation status. Only subjects with histologically confirmed advanced disease and no available standard treatment options will be eligible for enrollment. Subjects will undergo screening assessments within 14 days (up to 35 days for ophthalmology exam, echocardiogram or disease assessments) prior to the start of treatment to determine their eligibility for enrollment in the study.

ReferenceCitation: Wen PY, Stein A, van den Bent M, De Greve J, Wick A, de Vos FYFL, von Bubnoff N, van Linde ME, Lai A, Prager GW, Campone M, Fasolo A, Lopez-Martin JA, Kim TM, Mason WP, Hofheinz RD, Blay JY, Cho DC, Gazzah A, Pouessel D, Yachnin J, Boran A, Burgess P, Ilankumaran P, Gasal E, Subbiah V. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial. Lancet Oncol. 2021 Nov 24. pii: S1470-2045(21)00578-7. doi: 10.1016/S1470-2045(21)00578-7. [Epub ahead of print]

family: Wen

full_name: Patrick Y Wen

given: Patrick Y

family: Stein

full_name: Alexander Stein

family: van den Bent

full_name: Martin van den Bent

given: Martin

family: De Greve

full_name: Jacques De Greve

given: Jacques

family: Wick

full_name: Antje Wick

given: Antje

family: de Vos

full_name: Filip Y F L de Vos

given: Filip Y F L

family: von Bubnoff

full_name: Nikolas von Bubnoff

given: Nikolas

family: van Linde

full_name: Myra E van Linde

given: Myra E

family: Lai

full_name: Albert Lai

given: Albert

family: Prager

full_name: Gerald W Prager

given: Gerald W

family: Campone

full_name: Mario Campone

given: Mario

family: Fasolo

full_name: Angelica Fasolo

given: Angelica

family: Lopez-Martin

full_name: Jose A Lopez-Martin

given: Jose A

family: Kim

full_name: Tae Min Kim

given: Tae Min

family: Mason

full_name: Warren P Mason

given: Warren P

family: Hofheinz

full_name: Ralf-Dieter Hofheinz

given: Ralf-Dieter

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Cho

full_name: Daniel C Cho

given: Daniel C

family: Gazzah

full_name: Anas Gazzah

given: Anas

family: Pouessel

full_name: Damien Pouessel

given: Damien

family: Yachnin

full_name: Jeffrey Yachnin

given: Jeffrey

family: Boran

full_name: Aislyn Boran

given: Aislyn

family: Burgess

full_name: Paul Burgess

given: Paul

title: Dabrafenib plus trametinib in patients with BRAFV600E-mutant low-grade and high-grade glioma (ROAR): a multicentre, open-label, single-arm, phase 2, basket trial

ReferenceCitation: Subbiah V, Lassen U, Élez E, Italiano A, Curigliano G, Javle M, de Braud F, Prager GW, Greil R, Stein A, Fasolo A, Schellens JHM, Wen PY, Viele K, Boran AD, Gasal E, Burgess P, Ilankumaran P, Wainberg ZA. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020 Sep;21(9):1234-1243. doi: 10.1016/S1470-2045(20)30321-1. Epub 2020 Aug 17.

title: Dabrafenib plus trametinib in patients with BRAFV600E-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial

ReferenceCitation: Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski C, Cabanillas ME, Urbanowitz G, Mookerjee B, Wang D, Rangwala F, Keam B. Dabrafenib and Trametinib Treatment in Patients With Locally Advanced or Metastatic BRAF V600-Mutant Anaplastic Thyroid Cancer. J Clin Oncol. 2018 Jan 1;36(1):7-13. doi: 10.1200/JCO.2017.73.6785. Epub 2017 Oct 26.

name: Vivek Subbiah and Maria E. Cabanillas, The University of Texas MD Anderson Cancer Center, Houston, TX; Robert J. Kreitman, National Institutes of Health, Bethesda, MD; Zev A. Wainberg, University of California Los Angeles, Los Angeles, CA; Jae Yong Cho, Yonsei University College of Medicine Gangnam Severance Hospital; Bhumsuk Keam, Seoul National University Hospital, Seoul, Republic of Korea; Jan H.M. Schellens, Netherlands Cancer Institute, Amsterdam; Jan H.M. Schellens, Utrecht Institute for...

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

publisher: American Society of Clinical Oncology (ASCO)

title: Dabrafenib and Trametinib Treatment in Patients With Locally Advanced or Metastatic BRAF V600–Mutant Anaplastic Thyroid Cancer

ReferenceCitation: Lee EQ, Ruland S, LeBoeuf NR, Wen PY, Santagata S. Successful Treatment of a Progressive BRAF V600E-Mutated Anaplastic Pleomorphic Xanthoastrocytoma With Vemurafenib Monotherapy. J Clin Oncol. 2016 Apr 1;34(10):e87-9. doi: 10.1200/JCO.2013.51.1766. Epub 2014 Aug 4.

name: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center; and Harvard Medical School, Boston, MA

name: Center for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, Boston, MA

name: Dana-Farber Cancer Institute; and Brigham and Women's Hospital, Boston, MA

name: Harvard Medical School; and Brigham and Women's Hospital, Boston, MA

title: Successful Treatment of a Progressive BRAF V600E–Mutated Anaplastic Pleomorphic Xanthoastrocytoma With Vemurafenib Monotherapy

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:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Japan
Norway
Belgium
Spain
Denmark
Canada
Korea, Republic of


title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab to Demonstrate Efficacy as Assessed by Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) at 16 Weeks of Treatment, Compared to Placebo, and to Assess Long-term Safety, Tolerability, and Efficacy in Subjects With Moderate to Severe Chronic Palmoplantar Pustular Psoriasis - Amended With an Optional Extension Treatment Period of up to a Total of 148 Weeks

summary: A one year study assessing the efficacy and safety of secukinumab compared with placebo in adult patients with moderate to severe palmoplantar pustular psoriasis - amended with an optional extension treatment period of up to a total of 148 weeks

ipd_sharing: Undecided

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Austria
Sweden
France
Poland
Belgium
Russian Federation
Spain
Germany
United Kingdom

intervention_type: Biological


title: A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO)

summary: A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

ReferenceCitation: Flinn IW, Hillmen P, Montillo M, Nagy Z, Illés Á, Etienne G, Delgado J, Kuss BJ, Tam CS, Gasztonyi Z, Offner F, Lunin S, Bosch F, Davids MS, Lamanna N, Jaeger U, Ghia P, Cymbalista F, Portell CA, Skarbnik AP, Cashen AF, Weaver DT, Kelly VM, Turnbull B, Stilgenbauer S. The phase 3 DUO trial: duvelisib vs ofatumumab in relapsed and refractory CLL/SLL. Blood. 2018 Dec 6;132(23):2446-2455. doi: 10.1182/blood-2018-05-850461. Epub 2018 Oct 4.

name: Sarah Cannon Research Institute, Nashville, TN;

family: Flinn

full_name: Ian W. Flinn

given: Ian W.

name: St. James's Institute of Oncology, The Leeds Teaching Hospitals, Leeds, United Kingdom;

family: Hillmen

full_name: Peter Hillmen

given: Peter

name: Department of Haematology and Oncology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy;

family: Montillo

full_name: Marco Montillo

given: Marco

name: First Department of Internal Medicine, Semmelweis University, Budapest, Hungary;

family: Nagy

full_name: Zsolt Nagy

given: Zsolt

name: Department of Hematology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary;

family: Illés

full_name: Árpád Illés

given: Árpád

name: Hematology Department, Institut Bergonie, Bordeaux, France;

family: Etienne

full_name: Gabriel Etienne

given: Gabriel

family: Delgado

full_name: Julio Delgado

given: Julio

name: Flinders Medical Centre-Flinders University, Bedford Park, SA, Australia;

family: Kuss

full_name: Bryone J. Kuss

given: Bryone J.

name: Peter MacCallum Cancer Centre, St. Vincent’s Hospital and University of Melbourne, Melbourne, VIC, Australia;

family: Tam

full_name: Constantine S. Tam

given: Constantine S.

name: Department of Internal Medicine and Hematology, Petz Aladár County Hospital, Győr, Hungary;

family: Gasztonyi

full_name: Zoltán Gasztonyi

given: Zoltán

name: Hematology, University Hospital Ghent, Gent, Belgium;

family: Offner

full_name: Fritz Offner

given: Fritz

family: Lunin

full_name: Scott Lunin

given: Scott

name: Department of Hematology, University Hospital Vall d’Hebron, Barcelona, Spain;

family: Bosch

full_name: Francesco Bosch

given: Francesco

name: Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA;

family: Davids

full_name: Matthew S. Davids

given: Matthew S.

name: New York Presbyterian, Columbia University Medical Center, New York, NY;

family: Lamanna

full_name: Nicole Lamanna

given: Nicole

name: Division of Hematology and Hemostaseology, Department of Medicine I, Medical University of Vienna, Vienna, Austria;

family: Jaeger

full_name: Ulrich Jaeger

given: Ulrich

name: Universita’ Vita-Salute San Raffaele and San Raffaele Scientific Institute, Milan, Italy;

family: Ghia

full_name: Paolo Ghia

given: Paolo

name: Laboratoire d'hématologie, Hôpital Avicenne, Paris, France;

family: Cymbalista

full_name: Florence Cymbalista

given: Florence

name: Division of Hematology and Oncology, University of Virginia, Charlottesville, VA;

family: Portell

full_name: Craig A. Portell

given: Craig A.

name: John Theurer Cancer Center, Hackensack Meridian Health, Hackensack, NJ;

family: Skarbnik

full_name: Alan P. Skarbnik

given: Alan P.

name: Siteman Comprehensive Cancer Center, Washington University, St. Louis, MO;

family: Cashen

full_name: Amanda F. Cashen

given: Amanda F.

family: Weaver

full_name: David T. Weaver

given: David T.

family: Kelly

full_name: Virginia M. Kelly

given: Virginia M.

family: Turnbull

name: Department III of Internal Medicine, University Hospital Ulm, Ulm, Germany; and

name: Klinik für Innere Medizin I, Universitätsklinikum des Saarlandes, Homburg, Germany


title: A Randomized Multicenter Pivotal Study of CDX-011 (CR011-vcMMAE)in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer (The METRIC Study)

acronym: METRIC

summary: The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.

lead_sponsor: Celldex Therapeutics

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

location_facility: Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide

location_facility: University of Arkansas for Medical Sciences

location_facility: Joint Ludwig-Austin Dept of Medical Oncology

location_facility: Centre Hospitalier de Mont de Marson - Hôpital Layné

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: USC Norris Comprehensive Cancer Center and Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Peachtree Hematology Oncology Consultants, PC

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: University of South Alabama Cancer Research Insititute

location_facility: Algoma District Cancer Program Sault Area Hospital

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftaimico

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Louisiana State University Health New Orleans

location_facility: University of California Davis Medical Center

location_facility: Istituto Scientifico romagnolo Per Lo Studio E La Cura Del Tumori IRST

location_facility: Winship Cancer Institute, Emory University

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza de Torino

location_facility: Charleston Hematology Oncology Associates (CHOA)

location_facility: Universite de Montreal-Hopital Du Sacre-Coeur De Montreal

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Texas Tech University Health Sciences Center

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: University of Texas Health Science Center at Houston

location_facility: Sunnybrook Health Sciences Centre Odette Cancer Center

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: University of Miami Miller School of Medicine

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

location_facility: Chattanooga Oncology Hematology Associates

location_facility: Cleveland Clinic-Taussig Cancer Institute-R35


ReferenceCitation: Yu J, Arnott C, Neuen BL, Heersprink HL, Mahaffey KW, Cannon CP, Khan SS, Baldridge AS, Shah SJ, Huang Y, Li C, Figtree GA, Perkovic V, Jardine MJ, Neal B, Huffman MD. Cardiovascular and renal outcomes with canagliflozin according to baseline diuretic use: a post hoc analysis from the CANVAS Program. ESC Heart Fail. 2021 Apr;8(2):1482-1493. doi: 10.1002/ehf2.13236. Epub 2021 Feb 17. Erratum in: ESC Heart Fail. 2021 May 3;:.

name: The George Institute for Global Health UNSW Sydney  Sydney Australia

name: Department of Cardiology Peking University Third Hospital  Beijing China

name: Faculty of Medicine University of New South Wales, Sydney  Sydney Australia

family: Yu

full_name: Jie Yu

given: Jie

name: Department of Cardiology Royal Prince Alfred Hospital  Sydney Australia

name: Sydney Medical School University of Sydney  Sydney Australia

family: Arnott

full_name: Clare Arnott

given: Clare

family: Neuen

full_name: Brendon L. Neuen

given: Brendon L.

name: Department of Clinical Pharmacy and Pharmacology University of Groningen, University Medical Center Groningen  Groningen The Netherlands

family: Heersprink

full_name: Hiddo L. Heersprink

given: Hiddo L.

name: Stanford Center for Clinical Research, Department of Medicine Stanford University School of Medicine  Stanford CA USA

family: Mahaffey

full_name: Kenneth W. Mahaffey

given: Kenneth W.

name: Cardiovascular Division Brigham and Women's Hospital  Boston MA USA

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

name: Center for Global Cardiovascular Health Northwestern University Feinberg School of Medicine  710 N. Lake Shore Drive, Suite 800 Chicago IL 60611 USA

family: Khan

full_name: Sadiya S. Khan

given: Sadiya S.

family: Baldridge

full_name: Abigail S. Baldridge

given: Abigail S.

family: Shah

full_name: Sanjiv J. Shah

given: Sanjiv J.

family: Huang

full_name: Yuli Huang

given: Yuli

family: Li

full_name: Chao Li

given: Chao

name: Kolling Institute Royal North Shore Hospital and University of Sydney  Sydney Australia

family: Figtree

full_name: Gemma A. Figtree

given: Gemma A.

family: Perkovic

full_name: Vlado Perkovic

given: Vlado

family: Jardine

full_name: Meg J. Jardine

given: Meg J.

name: The Charles Perkins Centre University of Sydney  Sydney Australia

name: Faculty of Clinical Epidemiology Imperial College London  London UK

family: Neal

full_name: Bruce Neal

given: Bruce

family: Huffman

full_name: Mark D. Huffman

given: Mark D.

journal_name: ESC Heart Failure

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

ReferenceCitation: Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Blais J, Li Q, Jardine MJ, Perkovic V, Wheeler DC. Relative and Absolute Risk Reductions in Cardiovascular and Kidney Outcomes With Canagliflozin Across KDIGO Risk Categories: Findings From the CANVAS Program. Am J Kidney Dis. 2021 Jan;77(1):23-34.e1. doi: 10.1053/j.ajkd.2020.06.018. Epub 2020 Sep 21.

family: Ohkuma

full_name: Toshiaki Ohkuma

given: Toshiaki

ReferenceCitation: Oshima M, Neal B, Toyama T, Ohkuma T, Li Q, de Zeeuw D, Heerspink HJL, Mahaffey KW, Fulcher G, Canovatchel W, Matthews DR, Perkovic V. Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program. J Am Soc Nephrol. 2020 Oct;31(10):2446-2456. doi: 10.1681/ASN.2019121312. Epub 2020 Jul 21.

journal_name: Journal of the American Society of Nephrology

ReferenceCitation: Matthews DR, Wysham C, Davies M, Slee A, Alba M, Lee M, Perkovic V, Mahaffey KW, Neal B. Effects of canagliflozin on initiation of insulin and other antihyperglycaemic agents in the CANVAS Program. Diabetes Obes Metab. 2020 Nov;22(11):2199-2203. doi: 10.1111/dom.14143. Epub 2020 Aug 24.

name: Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College University of Oxford  Oxford UK

name: University of Washington  Spokane Washington USA

name: Diabetes Research Centre University of Leicester  Leicester UK

name: Janssen Research & Development, LLC  Raritan New Jersey USA

name: The George Institute for Global Health, UNSW Sydney  Sydney New South Wales Australia

name: Stanford Center for Clinical Research, Department of Medicine Stanford University School of Medicine  Stanford California USA

name: The Charles Perkins Centre University of Sydney  Sydney New South Wales Australia

ReferenceCitation: Li J, Woodward M, Perkovic V, Figtree GA, Heerspink HJL, Mahaffey KW, de Zeeuw D, Vercruysse F, Shaw W, Matthews DR, Neal B. Mediators of the Effects of Canagliflozin on Heart Failure in Patients With Type 2 Diabetes. JACC Heart Fail. 2020 Jan;8(1):57-66. doi: 10.1016/j.jchf.2019.08.004. Epub 2019 Oct 29.

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

ReferenceCitation: Zhou Z, Jardine M, Perkovic V, Matthews DR, Mahaffey KW, de Zeeuw D, Fulcher G, Desai M, Oh R, Simpson R, Watts NB, Neal B. Canagliflozin and fracture risk in individuals with type 2 diabetes: results from the CANVAS Program. Diabetologia. 2019 Oct;62(10):1854-1867. doi: 10.1007/s00125-019-4955-5. Epub 2019 Aug 10.

repositories_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Figtree GA, Rådholm K, Barrett TD, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Neal B. Effects of Canagliflozin on Heart Failure Outcomes Associated With Preserved and Reduced Ejection Fraction in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2591-2593. doi: 10.1161/CIRCULATIONAHA.119.040057. Epub 2019 Mar 17.

name: Kolling Institute, Royal North Shore Hospital and University of Sydney, Australia (G.A.F., G.F.).

name: The George Institute for Global Health, University of New South Wales, Sydney, Australia (G.A.F., K.R., V.P., B.N.).

name: Division of Community Medicine, Primary Care, Department of Medicine and Health Sciences, Faculty of Health Sciences, Linköping University, Department of Local Care West, County Council of Östergötland, Sweden (K.R.).

name: Janssen Research & Development, LLC, Raritan, NJ (T.D.B., W.S.).

name: Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, CA (K.W.M.).

name: Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, The Netherlands (D.d.Z.).

name: Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, United Kingdom (D.R.M.).

name: Faculty of Medicine, University of New South Wales, Sydney, Australia (B.N.).

repositories_institution:
Imperial College London - Spiral
Linkoping University - DiVA

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Zhou Z, Lindley RI, Rådholm K, Jenkins B, Watson J, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Shaw W, Oh R, Desai M, Matthews DR, Neal B. Canagliflozin and Stroke in Type 2 Diabetes Mellitus. Stroke. 2019 Feb;50(2):396-404. doi: 10.1161/STROKEAHA.118.023009.

name: From The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (Z.Z., V.P., B.N.)

name: Department of Radiology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, China (Z.Z.)

name: The George Institute for Global Health and University of Sydney, Australia (R.I.L., K.R.)

name: Division of Community Medicine, Primary Care, Department of Medicine and Health Sciences, Faculty of Health Sciences, Linköping University, Department of Local Care West, County Council of Östergötland, Linköping, Sweden (K.R.)

name: Royal North Shore Hospital, St Leonards, Sydney, Australia (B.J.)

name: Faculty of Medicine, University of New South Wales, Sydney, Australia (J.W., B.N.)

name: The Royal North Shore Hospital and University of Sydney, Australia (V.P., G.F.)

name: University of Groningen, University Medical Center Groningen, the Netherlands (D.d.Z.)

name: Janssen Research & Development, LLC, Raritan, NJ (W.S., R.O., M.D.)

name: The Charles Perkins Centre, University of Sydney, Australia (B.N.)

name: Imperial College London, United Kingdom (B.N.).

title: Canagliflozin and Stroke in Type 2 Diabetes Mellitus

ReferenceCitation: Neuen BL, Ohkuma T, Neal B, Matthews DR, de Zeeuw D, Mahaffey KW, Fulcher G, Desai M, Li Q, Deng H, Rosenthal N, Jardine MJ, Bakris G, Perkovic V. Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function. Circulation. 2018 Oct 9;138(15):1537-1550. doi: 10.1161/CIRCULATIONAHA.118.035901.

name: The George Institute for Global Health, University of New South Wales Sydney, Australia (B.L.N., T.O., B.N., Q.L., M.J.J., V.P.).

name: Oxford Centre for Diabetes, Endo-crinology and Metabolism and Harris Manchester College, University of Oxford, United Kingdom (D.R.M.).

name: Royal North Shore Hospital, Sydney, Australia (G.F., V.P.).

name: Janssen Research & Development, LLC, Raritan, NJ (M.D., H.D., N.R.).

name: Concord Repatriation General Hospital, Sydney, Australia (M.J.J.).

name: University of Chicago Medicine, IL (G.B.).

ReferenceCitation: Perkovic V, de Zeeuw D, Mahaffey KW, Fulcher G, Erondu N, Shaw W, Barrett TD, Weidner-Wells M, Deng H, Matthews DR, Neal B. Canagliflozin and renal outcomes in type 2 diabetes: results from the CANVAS Program randomised clinical trials. Lancet Diabetes Endocrinol. 2018 Sep;6(9):691-704. doi: 10.1016/S2213-8587(18)30141-4. Epub 2018 Jun 21.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

ReferenceCitation: Rådholm K, Figtree G, Perkovic V, Solomon SD, Mahaffey KW, de Zeeuw D, Fulcher G, Barrett TD, Shaw W, Desai M, Matthews DR, Neal B. Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program. Circulation. 2018 Jul 31;138(5):458-468. doi: 10.1161/CIRCULATIONAHA.118.034222.

name: Department of Medicine and Health Sciences, Division of Community Medicine, Primary Care, Faculty of Health Sciences, Department of Local Care West, County Council of Ötergötland, Linköping University, Sweden (K.R.).

name: The George Institute for Global Health (K.R., V.P., B.N.)

name: University of New South Wales, Sydney, Australia. Royal North Shore Hospital (G.F., V.P., G.F.)

name: University of Sydney, Australia. Harvard Medical School and Brigham and Women’s Hospital, Boston, MA (S.D.S.).

name: Department of Medicine, Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).

name: Janssen Research & Development, LLC, Raritan, NJ (T.D.B., W.S., M.D.).

name: Oxford Centre for Diabetes, Endocrinology, and Metabolism, University of Oxford, United Kingdom (D.R.M).

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

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

title: Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus

ReferenceCitation: Mahaffey KW, Neal B, Perkovic V, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Fabbrini E, Sun T, Li Q, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events: Results From the CANVAS Program (Canagliflozin Cardiovascular Assessment Study). Circulation. 2018 Jan 23;137(4):323-334. doi: 10.1161/CIRCULATIONAHA.117.032038. Epub 2017 Nov 13.

name: George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia (B.N., V.P., Q.L.)

name: Charles Perkins Centre, University of Sydney, Australia (B.N.)

name: Faculty of Medicine, University of New South Wales, Sydney, Australia (B.N.)

name: Royal North Shore Hospital and University of Sydney, Australia (V.P., G.F.)

name: Janssen Research & Development, LLC, Raritan, NJ (N.E., W.S., E.F., T.S., M.D.)

name: Oxford Centre for Diabetes, Endocrinology and Metabolism and Harris Manchester College, University of Oxford, UK (D.R.M.).

title: Canagliflozin for Primary and Secondary Prevention of Cardiovascular Events

ReferenceCitation: Neal B, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Erondu N, Shaw W, Law G, Desai M, Matthews DR; CANVAS Program Collaborative Group. Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes. N Engl J Med. 2017 Aug 17;377(7):644-657. doi: 10.1056/NEJMoa1611925. Epub 2017 Jun 12.

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

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

title: Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes

location_country:
Malaysia
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Poland
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
New Zealand
Spain

title: A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus

summary: The purpose of this study is to assess the effect of canagliflozin compared to placebo on progression of albuminuria in participants with Type 2 Diabetes Mellitus receiving standard care but with inadequate glycemic control and at elevated risk of cardiovascular events.


title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

acronym: SYNERGY

summary: The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

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

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Peru
Finland
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Poland
Lithuania
Slovakia
Thailand
Norway
Argentina
Canada
Slovenia
Korea, Republic of
Turkey
Colombia
South Africa
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Mexico
Czechia
New Zealand
Spain
Estonia
Latvia

location_facility: Site US10219 Methodist Urology Associates

location_facility: Site CA15004 Primehealth Clinical Research

location_facility: Site CN86017 Affiliated Union Hospital of Fujian Medical Uni.

location_facility: Site NZ64004 John A Tuckey Ltd Ascot Central

location_facility: Site CN86014 The First Hospital Bethune of Jilin University

location_facility: Site US10067 Family Practice Center of Wadsworth

location_facility: Site MX52003 Clinstile, Sociedad Anonima de Capital Variable

location_facility: Site TR90001 Pamukkale University Faculty of Medicine

location_facility: Site LT37008 Kaunas 2nd Clinical Hospital

location_facility: Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud

location_facility: Site CA15027 Diex Research Sherbrooke Inc

location_facility: Site KR82020 Seoul National University Hospital

location_facility: Site KR82012 Konkuk University Medical Center

location_facility: Site CN86012 The Fifth People's Hospital of Shanghai

location_facility: Site US10124 Winter Park Urology Associates

location_facility: Site US10127 Perimeter North Medical Research, Inc.

location_facility: Site US10063 Preferred Primary Care Physician Research

location_facility: Site US10017 Philadelphia Clinical Research, LLC

location_facility: Site US10040 Premier Medical Group Of The Hudson Valley

location_facility: Site MY60004 University Malaya Medical Centre

location_facility: Site US10084 Dynamed Clinical Research of Austin,LLC dba DM Clinical Resc

location_facility: Site US10010 Southeastern Research Group, Inc

location_facility: Site GB44022 The Royal Berkshire Hospital

location_facility: Site US10073 Manhattan Medical Research Practice, PLLC

location_facility: Site US10148 Best Quality Research, Inc.

location_facility: Site US10109 Lynn Health Science Institute

location_facility: Site US10535 South Florida Medical Research

location_facility: Site PL48011 Nzoz Centrum Urologiczne sp. z o.o.

location_facility: Site PE51005 Hospital Nacional Hipolito Unanue

location_facility: Site TW88611 Chung Shan Medical University Hospital

location_facility: Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov

location_facility: Site US10558 Chesapeake Urology Research Associates

location_facility: Site US10092 Physicians' Research Options/Salt Lake Women's Center

location_facility: Site HU36012 Veszprém County Cholnoky Ferenc Hospital

location_facility: Site TH66010 Maharaj Nakorm Chiangmai Hosp

location_facility: Site CN86021 HuaDong Hosipital Affiliated to Fudan University

location_facility: Site CN86030 Lanzhou University First Hospital

location_facility: Site GB44005 North West London Hosp Menopause Clinic

location_facility: Site HU36007 Mediroyal Prevention Center

location_facility: Site US10250 Preferred Primary Care Physicians Inc.

location_facility: Site US10079 PMG Research of Charleston, LLC

location_facility: Site US10536 Stanford School of Medicine

location_facility: Site RU70023 Penza Regional Clinical Hospatal n. a. N.N. Burdenko

location_facility: Site US10065 Advanced Research Associates

location_facility: Site KR82029 Daegu Catholic Univ. Medical Center

location_facility: Site RU70002 Pavlov St. Petersburg State Medical University

location_facility: Site LT37003 Family Medical Centre Seimos gydytojas

location_facility: Site US10159 Urological Research Network

location_facility: Site TH66006 Songklanagarind Hospital, Prince of Songkla University

location_facility: Site HK85204 The Chinese Uni of HK, Prince of Wales Hospital

location_facility: Site SK42106 Private Urological Care Center

location_facility: Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: Site MX52002 Accelerium Clinical Research/ Hospital San Jorge

location_facility: Site US10070 Physicians' Research Options/Red Rocks OB/GYN

location_facility: Site BE32012 Sint-Trudo Ziekenhuis, Campus Sint Jozef/Sint-Anna

location_facility: Site CN86025 Beijing Friendship Hospital

location_facility: Site CN86020 The First Affiliated Hospital of NanChang Univers

location_facility: Site BE32011 Universitaire Ziekenhuizen Leuven

location_facility: Site US10162 Phoenix OB-GYN Associates, LLC

location_facility: Site KR82019 Chungnam National University Hospital

location_facility: Site SK42101 Andrologicka a Urologicka Ambulancia

location_facility: Site KR82013 Hallym University Kangdong Sacred Heart Hospital

location_facility: Site UA38008 Medical Academy of Postgraduate Education, Urology Clinic

location_facility: Site CA15015 Recherches Cliniques Theradev, Inc.

location_facility: Site US10050 Rapid Medical Research, Inc.

location_facility: Site US10248 Preferred Primary Care Physicians, Inc

location_facility: Site US10011 Albuquerque Clinical Trials, Inc.

location_facility: Site DE49031 Urologisches Zentrum Refrath

location_facility: Site US10155 Seattle Women's Health, Research, Gynecology

location_facility: Site GB44024 St James's University Hospital

location_facility: Site DK45013 University Hospital of Aarhus, Skejby

location_facility: Site CA15001 The Male/Female Health & Research Centre

location_facility: Site PL48012 Military Institute of Medicine

location_facility: Site IT39007 Azienda Ospedaliera San Giuseppe Moscati

location_facility: Site US10028 Premier Medical Group of the Hudson Valley

location_facility: Site KR82021 Cheil General Hospital & Women's Healthcare Center

location_facility: Site KR82031 Chonnam National University Hospital

location_facility: Site ZA27013 Synexus Clinical Research SA (Pty) Ltd

location_facility: Site US10097 A.G.A. Clinical Trials DBA Neostart Group

location_facility: Site US10090 Protenium Clinical Research, LLC

location_facility: Site SK42104 Urology Outpatient Department

location_facility: Site PE51001 Instituto de Ginecologia y Reproduccion

location_facility: Site US10008 Urologic Consultants of Southeastern Pennsylvania

location_facility: Site CA15031 Centre for Applied Urology Research (CAUR)

location_facility: Site US10545 San Diego Institute for Sexual Medicine

location_facility: Site KR82005 Yeungnam University Hospital

location_facility: Site CA15032 Stanley Flax Medical Prof Corp

location_facility: Site CA15044 McMaster Institute of Urology

location_facility: Site AR54005 IUBA - Instituto Urologico de Buenos Aires

location_facility: Site AR54003 Hospital Italiano de Buenos Aires

location_facility: Site US10128 Clinical Research Center of CT

location_facility: Site US10004 Integrity Medical Research, LLC

location_facility: Site UA38015 Regional Municipal Institution, Urology Department

location_facility: Site US10170 Yale - New Haven Hospital West Haven VAMC

location_facility: Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital

location_facility: Site CN86011 The Second Affiliated Hospital of Soochow Universi

location_facility: Site FR33011 Centre Hospitalier Lyon Sud

location_facility: Site TR90017 Bilim University Sisli Florence Nightingale Hospital

location_facility: Site PL48016 Prywatny Gabinet Urologiczny

location_facility: Site UA38003 Urology Dpt of Kyiv City Clinical Hospital #3

location_facility: Site HU36003 Dr.Szarka Ödön Kistérségi Egészségügyi Szolgáltató Kft

location_facility: Site AU61011 Illawarra Health and Medical Research Institute

location_facility: Site HK85203 The Chinese Uni of HK, Prince of Wales Hospital

location_facility: Site US10015 Urology Group of New Mexico

location_facility: Site CN86015 Zhongnan Hospital of Wuhan University

location_facility: Site IT39020 Ospedale San Raffaele IRCCS, U.O. di Ginecologia e Ostetricia, Unità Funzionale di Uroginecologia

location_facility: Site US10534 South Florida Medical Research

location_facility: Site ES34001 Hospital Universitario de Getafe

location_facility: Site CZ42015 Centrum ambulantni gynekologie a primarni pece

location_facility: Site AU61015 Repatriation General Hospital

location_facility: Site RO40005 Spiatlul Clinic Th. Burghele

location_facility: Site SI38602 General Hospital Novo Mesto

location_facility: Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu

location_facility: Site SI38604 General Hospital Murska Sobota

location_facility: Site UA38004 Vinnitsa Endocrinology Dispens

location_facility: Site US10026 AccuMed Research Associates

location_facility: Site CN86028 General Hospital of Chengdu Military Region of PLA

location_facility: Site CA15035 Glenrose Rehabilitation Hospital

location_facility: Site RU70015 LLC Clinical Research Medical Complex

location_facility: Site NZ64006 Cardinal Point Specialist Centre

location_facility: Site RO40001 Spiatlul Clinic Th. Burghele

location_facility: Site US10078 Heartland Research Associates, LLC

location_facility: Site CO57004 Instituto de Coloproctologia ICO SAS

location_facility: Site BG35905 MHAT Alexandrovska Hospital

location_facility: Site US10539 Citrus Valley Medical Research

location_facility: Site RU70022 St. Petersburg State Public Health Institution

location_facility: Site CZ42009 Hospital Uherské Hradiště a.s.

location_facility: Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric

location_facility: Site LT37007 Vilnius University Hospital Santariskiu Klinikos

location_facility: Site SK42107 Zeleznicne zdravotnictvo Kosice, s.r.o.

location_facility: Site SE46009 Encia AB, Uppsala Hälsomottagning

location_facility: Site CZ42001 Fakultni Nemocnice Hradec Kralove

location_facility: Site NL31005 Canisius-Wilhelmina Ziekenhuis

location_facility: Site SE46017 S3 Clinical Research Centers

location_facility: Site SG65001 National University Hospital

location_facility: Site TW88614 Tri-Service General Hospital

location_facility: Site NL31001 University Medical Centre Utrecht

location_facility: Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne

location_facility: Site US10032 National Clinical Research Inc.

location_facility: Site NL31002 Academic Medical Center (AMC)

location_facility: Site SE46012 Karolinska University Hospital Huddinge

location_facility: Site CN86010 1st Affiliated Hosptital of Suchow University

location_facility: Site NO47008 Norsk Helseklinikk (Heiaklinikken)

location_facility: Site US10560 Chesapeake Urology Research Associates

location_facility: Site US10053 Western Clinical Research, Inc.

location_facility: Site IT39022 Azienda Ospedale Umberto I (Ancona)

location_facility: Site RU70019 City Multidisciplinary Hospital No. 2

location_facility: Site AR54004 Instituto de Investigaciones Clnicas Rosario

location_facility: Site US10037 Atlanta Medical Research Institute

location_facility: Site US10153 Palmetto Professional Research

location_facility: Site US10049 Coastal Clinical Research, Inc.

location_facility: Site US10117 Carolina Urologic Research Center

location_facility: Site MX52001 Centro de Investigacin Basica y Clnica

location_facility: Site US10593 Upstate Clinical Research Associates LLC

location_facility: Site MX52004 Consultorio de Especialidad en Urologia

location_facility: Site KR82023 Gachon University Gil Hospital

location_facility: Site US10154 Montana Medical Research Inc

location_facility: Site KR82015 Korea University Medical Center

location_facility: Site FR33007 Centre Hospitalier Louis Pasteur

location_facility: Site KR82009 Wonkwang University Hospital

location_facility: Site CN86016 Guangzhou First People's Hospital

location_facility: Site ES34009 Hospital Universitario La Paz

location_facility: Site KR82024 Chungbuk National University Hospital

location_facility: Site US10023 Hillcrest Clinical Research, LLC

location_facility: Site US10093 Pioneer Research Solutions, Inc.

location_facility: Site KR82014 Soon Chun Hyang University Hospital

location_facility: Site PH63003 University of Santo Tomas Hospital (USTH)

location_facility: Site SG65003 KK Women's and Children's Hospital

location_facility: Site US10122 Orange County Research Institute

location_facility: Site SK42105 Ruzinovska poliklinika a.s.

location_facility: Site TR90013 Uludag University Faculty of Medicine

location_facility: Site US10002 Urology Center Research Institute

location_facility: Site US10120 WR-Mount Vernon Clinical Research

location_facility: Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan

location_facility: Site LT37004 KHospital of Lithuanian University of Health Science

location_facility: Site CN86029 Southwest Hospital (Chongqing)

location_facility: Site CN86026 The First Affiliated Hospital of Wenzhou Medical C

location_facility: Site TW88612 Chi Mei Medical Center, Yong Kang

location_facility: Site US10167 University of Pittsburgh Medical Center

location_facility: Site LT37011 Saules Family Medicine Centre

location_facility: Site PH63009 Chinese General Hospital and Medical Center

location_facility: Site RU70018 Bashkirsky State Medical University of Roszdrav

location_facility: Site KR82032 Kyungpook National University Hospital

location_facility: Site CN86022 Tongji Hospital, Tongji Medical College of Hust

location_facility: Site TW88605 Taichung Veteran General Hospital

location_facility: Site US10095 Florida Urology Specialists

location_facility: Site KR82025 Seoul National University Bundang Hospital

location_facility: Site US10549 Associated Urologists of North Carolina

location_facility: Site CA15021 Urology South Shore Research

location_facility: Site AU61004 Keogh Institute for Medical Research

location_facility: Site US10013 Seattle Urology Research Center

location_facility: Site NZ64003 Tauranga Urology Research Ltd

location_facility: Site PH63008 Dr. Pablo O. Torre Memorial Hospital

location_facility: Site BG35904 University Hospital (UMHAT) - George Stranski

location_facility: Site CN86027 Second Hospital of Lanzhou University

location_facility: Site MY60005 Universiti Kebangsaan Malaysia Medical Centre

location_facility: Site NZ64005 Waikato Urology Research Limited

location_facility: Site IT39001 U.O. Dip. di Neuro-Urologia; Univ. di Roma La Sapienza

location_facility: Site US10168 Weill Cornell Medical College

location_facility: Site KR82006 Dong-A University Medical Center

location_facility: Site US10018 Grove Hill Clinical Research

location_facility: Site CA15013 Sunnybrook Health Sciences Center

location_facility: Site US10152 Female Pelvic Medicine & Urogynecology Institute

location_facility: Site US10165 East Coast Institute for Research

location_facility: Site EE37205 West Tallinn Central Hospital

location_facility: Site US10114 Bay State Clinical Trials, Inc.

location_facility: Site LT37005 Public Institution Vilnius City University Hospital

location_facility: Site KR82017 Kyung Hee University Medical Center

location_facility: Site ES34003 Hospital Universitario Nuestra Señora de Valme

location_facility: Site KR82016 Pusan National University Hospital

location_facility: Site US10104 Clinical Research Advantage, Inc.

location_facility: Site SE46005 Center för Läkemedelsstudier

location_facility: Site DE49026 Zentrum fuer Onkologie und Urologie Rostock

location_facility: Site US10542 Adult & Pediatric Urology Group

location_facility: Site US10123 Chase Medical Research, LLC

location_facility: Site NZ64001 Canterbury Urology Research Trust

location_facility: Site TH66007 Thammasat University Hospital

location_facility: Site UA38006 Shapoval Regional Clinical Centre of Urology and Nephrology

location_facility: Site AU61022 Brisbane South Clinical Research Centre

location_facility: Site UA38010 Academy of Medical Sciences of Ukraine

location_facility: Site CA15042 G. Kenneth Jansz Medicine Professional Corporation

location_facility: Site CN86009 Peking University 3rd Hospital

location_facility: Site LT37010 Public Institution Vilnius City University Hospital

location_facility: Site US10046 Coastal Carolina Research Center

location_facility: Site LT37012 Klaipeda University Hospital

location_facility: Site US10106 West Coast Clinical Research

location_facility: Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov

location_facility: Site US10110 Montana Health Research Institute, Inc.

location_facility: Site KR82001 Seoul Saint Mary's Hospital

location_facility: Site US10166 Medical University of South Carolina

location_facility: Site PL48001 Specjalistyczny Gabinet Lekarski

location_facility: Site US10150 Suncoast Clinical Research, Inc.

location_facility: Site AR54006 Hospital Italiano de Buenos Aires

location_facility: Site LV37105 P.Stradins Clinical University Hospital

location_facility: Site US10540 Demaur Clinical Research, INC

location_facility: Site KR82010 Chonbuk National University Hospital


lead_sponsor: Sierra Oncology, Inc.

location_country:
Romania
Australia
Belgium
Denmark
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Singapore
Hungary
Germany
United States
United Kingdom
Austria
Czechia
Israel
Spain

acronym: Simplify 1

title: A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

summary:
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (post-PV/ET MF) who have not yet received treatment with a Janus kinase inhibitor (JAK inhibitor).

Participants will be randomized to receive either MMB or ruxolitinib for 24 weeks during a double-blind treatment phase, after which they will be eligible to receive open-label MMB for up to an additional 216 weeks. After discontinuation of study medication, assessments will continue for 12 additional weeks, after which participants will be contacted for survival follow-up approximately every 6 months for up to 5 years from the date of enrollment or until study termination. For those participants planning to continue treatment with MMB following the end of the study, the Early Study Drug Discontinuation (ESDD), 30-day, 12-Week, and survival follow-up visits are not required.


title: Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Associated Hyperammonemia With an Episode of Hepatic Encephalopathy (STOP-HE Study)

acronym: STOP-HE

summary: The purpose of this study is to determine whether ornithine phenylacetate can speed recovery from an acute hepatic encephalopathy episode requiring hospitalization in cirrhotic patients.

ReferenceCitation: Rahimi RS, Safadi R, Thabut D, Bhamidimarri KR, Pyrsopoulos N, Potthoff A, Bukofzer S, Bajaj JS. Efficacy and Safety of Ornithine Phenylacetate for Treating Overt Hepatic Encephalopathy in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2626-2635.e7. doi: 10.1016/j.cgh.2020.10.019. Epub 2020 Oct 16.

family: Rahimi

full_name: Robert S. Rahimi

given: Robert S.

family: Safadi

full_name: Rifaat Safadi

given: Rifaat

family: Thabut

full_name: Dominique Thabut

given: Dominique

family: Bhamidimarri

full_name: Kalyan Ram Bhamidimarri

given: Kalyan Ram

family: Pyrsopoulos

full_name: Nikolaos Pyrsopoulos

given: Nikolaos

family: Potthoff

full_name: Amy Potthoff

given: Amy

family: Bukofzer

full_name: Stan Bukofzer

given: Stan

family: Bajaj

full_name: Jasmohan S. Bajaj

given: Jasmohan S.

journal_name: Clinical Gastroenterology and Hepatology

oa_host_type: publisher

ipd_sharing_description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT01966419) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

lead_sponsor: Ocera Therapeutics, Inc.

location_country:
Italy
Austria
Netherlands
Spain
Germany
France
Bulgaria
Czechia
Israel
Hungary
Australia
Belgium
New Zealand
Russian Federation
Estonia
Denmark
United States


title: A Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate ProCervix Efficacy to Clear HPV 16 and HPV 18 Infection in Women With Normal Cytology or ASCUS/LSIL

acronym: RHEIA-VAC

summary:
Human Papillomavirus (HPV) 16 and HPV 18 (the two virus genotypes targeted by the ProCervix vaccine) are the most common HPV genotypes associated with at least 70% of squamous cell carcinomas and 82% of adenocarcinomas of the cervix The strategy of therapeutic vaccination with ProCervix is to activate and enhance the patient's cellular immune response to HPV . The therapeutic vaccine will be used for women infected by HPV 16, HPV 18, or both. The vaccine targets these HPV infected women with normal or mild cervical cellular dyskaryosis as detectable infections with oncogenic potential.

This will be a double-blind, randomised, placebo-controlled, parallel group study assessing the efficacy of ProCervix or placebo (concomitantly administered with imiquimod cream).

ProCervix will be delivered with a topical agent, imiquimod, applied to the injection sites as a vaccine adjuvant.

The population proposed for this study represents an otherwise healthy female population who are infected with HPV 16 and/or HPV 18. The safety and tolerability of this therapeutic vaccine has been shown in the ongoing Phase I study, and the proposed population may in theory derive benefit from this vaccine.

lead_sponsor: Genticel

location_country:
Netherlands
Finland
France
Belgium
Spain
Germany
United Kingdom

location_facility: Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil

location_facility: Elisabeth Krankenhaus Essen GmbH - Clinic/Outpatient Facility

location_facility: Institut Catala d'Oncologia L'Hopitalet de Llobregat

location_facility: Hospital Clinic Dept of Obstetrics and Gynecology C/ Villarroel Unidad de Ginecología Oncológica, Instituto Clínico de Ginecología y Obstetricia y Neonatología (ICGON), Hospital Clínic, Instituto de Investigaciones Biomédi

location_facility: Liverpool - GUM - Liverpool Centre for Sexual Health

location_facility: Grand Hôpital de Charleroi Site Notre-Dame

location_facility: Centre d'Investigation Clinique de Vaccinologie Cochin Pasteur (CIC BT505)

location_facility: Center Gynaecological Oncology Amsterdam AMC, NKI-AVL, VUmc

location_facility: Charité - Universitätsmedizin Berlin Hospital

location_facility: Academic O&G University of Manchester Research - St Mary's Hospital

location_facility: Regionaal Ziekenhuis Heilig Hart Tienen Hospital

location_facility: Klinikum der Friedrich Schiller Universität Jena Hospital

location_facility: Tampereen yliopistollinen sairaala Hospital

location_facility: Clinica Ginecologica Ceoga, Clinic/Outpatient Facility

location_facility: Centre for the Evaluation of Vaccination Vaccine & Infectious Disease Institute (VAXINFECTIO) Faculty of Medicine University of Antwerp Belgium

location_facility: CHU de Nîmes - Hopital Universitaire Caremeau

location_facility: The Centre for Immunology and Infection Hull York Medical School University of York

location_facility: Dumfries and Galloway Royal Infirmary Hospital


title: A Randomized, Double-blind, Multi-center Phase 2 Trial of Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer

summary: This randomized phase 2 trial is studying the effect of adding denosumab to standard chemotherapy in the treatment of advanced lung cancer.

ReferenceCitation: Peters S, Danson S, Ejedepang D, Dafni U, Hasan B, Radcliffe HS, Bustin F, Crequit J, Coate L, Guillot M, Surmont V, Rauch D, Rudzki J, O'Mahony D, Barneto Aranda I, Scherz A, Tsourti Z, Roschitzki-Voser H, Pochesci A, Demonty G, Stahel RA, O'Brien M. Combined, patient-level, analysis of two randomised trials evaluating the addition of denosumab to standard first-line chemotherapy in advanced NSCLC - The ETOP/EORTC SPLENDOUR and AMGEN-249 trials. Lung Cancer. 2021 Nov;161:76-85. doi: 10.1016/j.lungcan.2021.09.002. Epub 2021 Sep 9.

lead_sponsor: Amgen

location_country:
Italy
United States
Netherlands
Germany
France
Czechia
Greece
Australia
Canada
United Kingdom


ReferenceCitation: Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer: The SELECT-1 Randomized Clinical Trial. JAMA. 2017 May 9;317(18):1844-1853. doi: 10.1001/jama.2017.3438.

name: Lowe Center for Thoracic Oncology and the Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute, Boston, Massachusetts

family: Jänne

full_name: Pasi A. Jänne

given: Pasi A.

name: Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands

family: van den Heuvel

full_name: Michel M. van den Heuvel

given: Michel M.

name: Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France

family: Barlesi

full_name: Fabrice Barlesi

given: Fabrice

name: Department of Medical Oncology, Hospital Universitario Málaga General, Instituto de Investigación Biomédica de Málaga, Malaga, Spain

family: Cobo

full_name: Manuel Cobo

given: Manuel

name: Pulmonology Department, Toulouse University Hospital, Toulouse, France

family: Mazieres

full_name: Julien Mazieres

given: Julien

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Istituto di Ricovero e Cura a Carattere Scientifico Meldola, Italy

family: Crinò

full_name: Lucio Crinò

given: Lucio

name: Department of Medicine, Pavlov Medical University, St Petersburg, Russia

family: Orlov

full_name: Sergey Orlov

given: Sergey

name: Manchester University and Christie Hospital NHS Foundation Trust, Manchester, United Kingdom

family: Blackhall

full_name: Fiona Blackhall

given: Fiona

name: Department of Internal Medicine, Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany

family: Wolf

full_name: Juergen Wolf

given: Juergen

name: Medical Oncology Department, University Hospital Ramon y Cajal, Madrid, Spain

family: Garrido

full_name: Pilar Garrido

given: Pilar

name: Department for Clinical and Preclinical Trials, Petrov Research Institute of Oncology, St Petersburg, Russia

family: Poltoratskiy

full_name: Artem Poltoratskiy

given: Artem

family: Mariani

full_name: Gabriella Mariani

given: Gabriella

family: Ghiorghiu

full_name: Dana Ghiorghiu

given: Dana

name: AstraZeneca, Macclesfield, United Kingdom

family: Kilgour

full_name: Elaine Kilgour

given: Elaine

family: Smith

full_name: Paul Smith

given: Paul

family: Kohlmann

full_name: Alexander Kohlmann

given: Alexander

family: Carlile

full_name: David J. Carlile

given: David J.

family: Lawrence

full_name: David Lawrence

given: David

family: Bowen

full_name: Karin Bowen

given: Karin

name: Respiratory Oncology Unit, Department of Respiratory Diseases, University Hospital Katholieke Universiteit Leuven, Leuven, Belgium

family: Vansteenkiste

full_name: Johan Vansteenkiste

given: Johan

journal_name: JAMA

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

title: Selumetinib Plus Docetaxel Compared With Docetaxel Alone and Progression-Free Survival in Patients With KRAS-Mutant Advanced Non–Small Cell Lung Cancer

ReferenceCitation: Jänne PA, Mann H, Ghiorghiu D. Study Design and Rationale for a Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Selumetinib in Combination With Docetaxel as Second-Line Treatment in Patients With KRAS-Mutant Advanced Non-Small Cell Lung Cancer (SELECT-1). Clin Lung Cancer. 2016 Mar;17(2):e1-4. doi: 10.1016/j.cllc.2015.12.010. Epub 2015 Dec 30.

location_country:
Peru
Romania
Australia
Belgium
Russian Federation
Ukraine
France
Poland
Argentina
Canada
Chile
Sweden
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey

title: A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)

summary: The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel.


title: A Phase 4 Cross-Sectional Study of Bone Mineral Density in HIV-1 Infected Subjects

summary: A Phase 4 study is to characterize the profile of low bone mineral density (BMD) in ≥ 50 year old male subjects and post-menopausal female subjects on any tenofovir disoproxil fumarate (TDF)-based regimen

study_type: Observational

time_perspective: Cross-Sectional

lead_sponsor: Gilead Sciences

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
France
Poland
Ireland
Belgium
Portugal
Germany
United Kingdom

location_facility: Karolinska University Hospital - Dept of Infectious Diseases

location_facility: Royal Free Hospital and University College London Hospital

location_facility: Klinikum der Universität München-Großhadern

location_facility: Gemeinschaftspaxis Dres. Jessen & Kollegen

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: Infektionsmedizinisches Centrum Hamburg (ICH)

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Istituto Nazionale per le Malattie Infettive

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: Imperial College Healthcare NHS Trust St. Mary's Campus

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

location_facility: HPP Hospital de Cascais Dr. José de Almeida

location_facility: Sahlgrenska University Hospital - Dpt of Infectious Diseases, SU/Östra

location_facility: CUB Hopital Erasme- Free University of Brussels

location_facility: AKh Allgemeines Krankenhaus der Stadt Linz GmbH

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: UCD School of Medicine and Medical Sciences