title: Plegridy™ (Peginterferon β-1a) Real World Effectiveness and Safety Observational Program

acronym: POP

summary: The primary objectives of the study are to determine the incidence of serious adverse events (SAEs) in participants with relapsing forms of multiple sclerosis (MS) in routine clinical practice and to assess the overall long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice. The secondary objectives of this study in this study population are to describe Plegridy prescription and utilization adherence patterns in routine clinical practice; to assess the specific long-term clinical effectiveness of Plegridy in participants with relapsing forms of MS in routine clinical practice; to monitor the safety and tolerability of Plegridy in routine clinical practice by assessing the incidence of adverse events (AEs) of flu-like symptoms (FLS), injection site reactions (ISRs), and AEs (including laboratory abnormalities) leading to treatment discontinuation; to assess the effect of FLS on participant-reported effectiveness of, and satisfaction with, prophylactic management using a FLS-Visual Analog Scale (FLS-VAS); to evaluate the change in health-related quality of life (HRQoL), FLS, FLS-VAS, healthcare resource consumption, and treatment adherence over time.

time_perspective: Prospective

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/

lead_sponsor: Biogen

location_country:
Germany
Ireland
Italy
Portugal
United Kingdom
Denmark
Australia
Netherlands
Austria
Switzerland
United States
Spain
Canada
France

location_facility:
Research site
Research Site


title: iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia

summary: The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Dimopoulos MA, Tedeschi A, Trotman J, Garcia-Sanz R, Macdonald D, Leblond V, Mahe B, Herbaux C, Tam C, Orsucci L, Palomba ML, Matous JV, Shustik C, Kastritis E, Treon SP, Li J, Salman Z, Graef T, Buske C; iNNOVATE Study Group and the European Consortium for Waldenstrom's Macroglobulinemia. Phase 3 Trial of Ibrutinib plus Rituximab in Waldenstrom's Macroglobulinemia. N Engl J Med. 2018 Jun 21;378(25):2399-2410. doi: 10.1056/NEJMoa1802917. Epub 2018 Jun 1.

ReferenceCitation: Dimopoulos MA, Trotman J, Tedeschi A, Matous JV, Macdonald D, Tam C, Tournilhac O, Ma S, Oriol A, Heffner LT, Shustik C, Garcia-Sanz R, Cornell RF, de Larrea CF, Castillo JJ, Granell M, Kyrtsonis MC, Leblond V, Symeonidis A, Kastritis E, Singh P, Li J, Graef T, Bilotti E, Treon S, Buske C; iNNOVATE Study Group and the European Consortium for Waldenstrom's Macroglobulinemia. Ibrutinib for patients with rituximab-refractory Waldenstrom's macroglobulinaemia (iNNOVATE): an open-label substudy of an international, multicentre, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):241-250. doi: 10.1016/S1470-2045(16)30632-5. Epub 2016 Dec 10.

ReferenceType: derived

ReferenceCitation: Buske C, Tedeschi A, Trotman J, Garcia-Sanz R, MacDonald D, Leblond V, Mahe B, Herbaux C, Matous JV, Tam CS, Heffner LT, Varettoni M, Palomba ML, Shustik C, Kastritis E, Treon SP, Ping J, Hauns B, Arango-Hisijara I, Dimopoulos MA. Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenstrom's Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study. J Clin Oncol. 2022 Jan 1;40(1):52-62. doi: 10.1200/JCO.21.00838. Epub 2021 Oct 4.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

repository_normalized: DIGITAL.CSIC (Spain)

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

repository_normalized: HAL

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: submittedVersion

repositories:
DIGITAL.CSIC (Spain)
HAL
PubMed Central

repositories_concat: DIGITAL.CSIC (Spain);HAL;PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Trotman J, Buske C, Tedeschi A, Matous JV, MacDonald D, Tam CS, Tournilhac O, Ma S, Treon SP, Oriol A, Ping J, Briso EM, Arango-Hisijara I, Dimopoulos MA. Single-Agent Ibrutinib for Rituximab-Refractory Waldenstrom Macroglobulinemia: Final Analysis of the Substudy of the Phase III InnovateTM Trial. Clin Cancer Res. 2021 Nov 1;27(21):5793-5800. doi: 10.1158/1078-0432.CCR-21-1497. Epub 2021 Aug 11.

evidence: open (via crossref license)

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

publisher_dissemination: American Association for Cancer Research

ipd_sharing: Yes

ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

lead_sponsor: Pharmacyclics LLC.

sponsor_collaborators:
Pharmacyclics LLC.
Janssen Research & Development, LLC

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

location_facility: University General Hospital of Thessaloniki "AHEPA"

location_facility: ASST di Pavia - Fondazione IRCCS Policlinico San Matteo di Pavia

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero Universitaria Santa Maria della Misericordia di Udine

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Centre Hospitalier de Saint Brieuc Hopital Yves le Foll

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: DIAKO Evangelische Diakonie Krankenhaus gGmbH

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

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)

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.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

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.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

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

source: euctr

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


acronym: TERRANOVA

lead_sponsor: AstraZeneca

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.

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.

oa_host_type: repository

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

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark);iris.unife.it

unpaywall_oa_status: green

publisher_dissemination: 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, Ramirez-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.

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

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: University of Leicester - Leicester Research Archive

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

sponsor_collaborators:
AstraZeneca
MedImmune LLC

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.

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


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.

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. 2022 Jan;243:147-157. doi: 10.1016/j.ahj.2021.08.022. Epub 2021 Sep 8.

oa_host_type: closed

repositories_concat: closed

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.

oa_host_type: publisher

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

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.

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
The TIMI Study Group

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


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.

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.

repository_institution: Ghent University - Ghent University Academic Bibliography

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

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


acronym: ADJUNCT TWO™

lead_sponsor: Novo Nordisk A/S

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.

ReferenceType: result

ReferenceCitation: Ahren B, Hirsch IB, Pieber TR, Mathieu C, Gomez-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.

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

publisher_dissemination: 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.

publisher_dissemination: SAGE Publications

ReferenceCitation: Dejgaard TF, von Scholten BJ, Christiansen E, Kreiner FF, Bardtrum L, von Herrath M, Mathieu C, Madsbad S; ADJUNCT ONE and ADJUNCT TWO Investigators. Efficacy and safety of liraglutide in type 1 diabetes by baseline characteristics in the ADJUNCT ONE and ADJUNCT TWO randomized controlled trials. Diabetes Obes Metab. 2021 Dec;23(12):2752-2762. doi: 10.1111/dom.14532. Epub 2021 Sep 28. Erratum In: Diabetes Obes Metab. 2022 Nov;24(11):2280.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

publisher_dissemination: Wiley

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

type: Other Identifier

type: Registry Identifier

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


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

design_allocation: Non-Randomized

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.

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.

version: acceptedVersion

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

repositories_concat: PubMed Central;figshare.com

repositories_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Garassino MC, Cho BC, Kim JH, Mazieres 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.

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

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

ReferenceCitation: Garassino MC, Cho BC, Kim JH, Mazieres 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:
Germany
Italy
Poland
Hungary
Singapore
United Kingdom
Japan
Austria
Belgium
United States
Korea, Republic of
Spain
Thailand
Taiwan
Czechia
Canada
Philippines
France


lead_sponsor: SecuraBio

summary: A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants 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 (NCT02004522).

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

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


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, Kramer 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.

ReferenceCitation: Cortes JE, Khaled S, Martinelli G, Perl AE, Ganguly S, Russell N, Kramer 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.

ReferenceCitation: Cortes J, Perl AE, Dohner H, Kantarjian H, Martinelli G, Kovacsovics T, Rousselot P, Steffen B, Dombret H, Estey E, Strickland S, Altman JK, Baldus CD, Burnett A, Kramer 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.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

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/

lead_sponsor: Daiichi Sankyo, Inc.

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Ospedaliero Universitaria San Luigi Gonzaga

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

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

location_facility: University of Kansas Medical Center Research Institute Inc

location_facility: University of Pennsylvania Health System

location_facility: Stanford University Medical Center Stanford Comprehensive Cancer Center

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Klinikum der Johann Wolfgang-Goethe-Universität

location_facility: University of Southern California, Norris Comprehensive Cancer Center

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Intezet

location_facility: UNC Linebreger Comprehensive Cancer Center

location_facility: Uniklinik Heidelberg Medizinische Klinik und Poliklinik V

location_facility: Duke Cancer Institute at Duke University Health System

location_facility: The University of Hong Kong, Queen Mary Hospital

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

location_facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar I. Belgyogyaszati Klinika

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

location_facility: Medizinische Klinik A Hämatologie Hämostaseologie Internistische Onkologie und Pneumologie

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: LSU Health Sciences Center Feist Weiller Cancer Center

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Oregon Health and Science University Knight Cancer Institute

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: MD Anderson Center, The University of Texas

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

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

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

location_facility: Princess Margaret Cancer Centre Princess Margaret Hospital

location_facility: L'UOC di Ematologia del Policlinico Tor Vergata

location_facility: Unità Operativa di Ematologia e Unità Operativa CTMO

location_facility: Hopital Haut Leveque Centre Francois Magendie

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Centre Hospitalier Universitaire Grenoble Hopital Michalon

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


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

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

lead_sponsor: Novartis Pharmaceuticals

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

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, Illes A, 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.

repository_institution: PubMed Central - Europe PMC

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

publisher_dissemination: American Society of Hematology


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

location_facility: Cleveland Clinic-Taussig Cancer Institute-R35

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Consorcio Hospitalario Provincial de Castellon

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

location_facility: Azienda Ospedaliera Universitaria Pisana

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

location_facility: University of California Davis Medical Center

location_facility: Azienda Ospedaliera Fatebenefratelli e Oftaimico

location_facility: University of Arkansas for Medical Sciences

location_facility: Louisiana State University Health New Orleans

location_facility: Texas Tech University Health Sciences Center

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Charleston Hematology Oncology Associates (CHOA)

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier de Mont de Marson - Hôpital Layné

location_facility: University of South Alabama Cancer Research Insititute

location_facility: University of Miami Miller School of Medicine

location_facility: Joint Ludwig-Austin Dept of Medical Oncology

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

location_facility: USC Norris Comprehensive Cancer Center and Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Jean Bernard Clinique Victor Hugo

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

location_facility: Chattanooga Oncology Hematology Associates

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

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Algoma District Cancer Program Sault Area Hospital

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

location_facility: Sunnybrook Health Sciences Centre Odette Cancer Center

location_facility: Sir Mortimer B Davis Jewish General Hospital

location_facility: Winship Cancer Institute, Emory University

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: University of Texas Health Science Center at Houston

location_facility: Peachtree Hematology Oncology Consultants, PC

location_facility: Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide

location_facility: Nottingham University Hospitals NHS Trust


acronym: CANVAS-R

lead_sponsor: Janssen Research & Development, LLC

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.

ReferenceCitation: Young TK, Li JW, Kang A, Heerspink HJL, Hockham C, Arnott C, Neuen BL, Zoungas S, Mahaffey KW, Perkovic V, de Zeeuw D, Fulcher G, Neal B, Jardine M. Effects of canagliflozin compared with placebo on major adverse cardiovascular and kidney events in patient groups with different baseline levels of HbA1c, disease duration and treatment intensity: results from the CANVAS Program. Diabetologia. 2021 Nov;64(11):2402-2414. doi: 10.1007/s00125-021-05524-1. Epub 2021 Aug 26.

repository_institution: Imperial College London - Spiral

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

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

ReferenceCitation: Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.

license: public-domain

license_normalized: public-domain

publisher_dissemination: Oxford University Press

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;:

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.

repositories_institution: University College London - UCL Discovery

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.

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.

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.

ReferenceCitation: Figtree GA, Radholm 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. No abstract available.

ReferenceCitation: Zhou Z, Lindley RI, Radholm 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.

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

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.

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: Radholm 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.

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.

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

sponsor_collaborators: The George Institute for Global Health, Australia

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

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


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

location_facility: Site CN86014 The First Hospital Bethune of Jilin University

location_facility: Site US10168 Weill Cornell Medical College

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

location_facility: Site US10063 Preferred Primary Care Physician Research

location_facility: Site CZ42015 Centrum ambulantni gynekologie a primarni pece

location_facility: Site TH66007 Thammasat University Hospital

location_facility: Site GB44024 St James's University Hospital

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

location_facility: Site US10110 Montana Health Research Institute, Inc.

location_facility: Site US10124 Winter Park Urology Associates

location_facility: Site KR82010 Chonbuk National University Hospital

location_facility: Site US10065 Advanced Research Associates

location_facility: Site US10011 Albuquerque Clinical Trials, Inc.

location_facility: Site MX52004 Consultorio de Especialidad en Urologia

location_facility: Site AR54003 Hospital Italiano de Buenos Aires

location_facility: Site PL48016 Prywatny Gabinet Urologiczny

location_facility: Site US10032 National Clinical Research Inc.

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

location_facility: Site SE46005 Center för Läkemedelsstudier

location_facility: Site CA15035 Glenrose Rehabilitation Hospital

location_facility: Site LT37005 Public Institution Vilnius City University Hospital

location_facility: Site SK42104 Urology Outpatient Department

location_facility: Site US10067 Family Practice Center of Wadsworth

location_facility: Site US10095 Florida Urology Specialists

location_facility: Site TW88614 Tri-Service General Hospital

location_facility: Site CN86010 1st Affiliated Hosptital of Suchow University

location_facility: Site NZ64004 John A Tuckey Ltd Ascot Central

location_facility: Site NZ64006 Cardinal Point Specialist Centre

location_facility: Site US10542 Adult & Pediatric Urology Group

location_facility: Site US10560 Chesapeake Urology Research Associates

location_facility: Site MX52003 Clinstile, Sociedad Anonima de Capital Variable

location_facility: Site KR82015 Korea University Medical Center

location_facility: Site TR90017 Bilim University Sisli Florence Nightingale Hospital

location_facility: Site US10536 Stanford School of Medicine

location_facility: Site US10120 WR-Mount Vernon Clinical Research

location_facility: Site MX52001 Centro de Investigacin Basica y Clnica

location_facility: Site SI38602 General Hospital Novo Mesto

location_facility: Site PH63009 Chinese General Hospital and Medical Center

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

location_facility: Site US10539 Citrus Valley Medical Research

location_facility: Site SK42101 Andrologicka a Urologicka Ambulancia

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

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

location_facility: Site LT37010 Public Institution Vilnius City University Hospital

location_facility: Site US10154 Montana Medical Research Inc

location_facility: Site US10037 Atlanta Medical Research Institute

location_facility: Site US10023 Hillcrest Clinical Research, LLC

location_facility: Site AU61015 Repatriation General Hospital

location_facility: Site KR82032 Kyungpook National University Hospital

location_facility: Site US10004 Integrity Medical Research, LLC

location_facility: Site SK42105 Ruzinovska poliklinika a.s.

location_facility: Site US10545 San Diego Institute for Sexual Medicine

location_facility: Site AU61011 Illawarra Health and Medical Research Institute

location_facility: Site US10010 Southeastern Research Group, Inc

location_facility: Site ES34003 Hospital Universitario Nuestra Señora de Valme

location_facility: Site KR82023 Gachon University Gil Hospital

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

location_facility: Site US10250 Preferred Primary Care Physicians Inc.

location_facility: Site SE46017 S3 Clinical Research Centers

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

location_facility: Site US10079 PMG Research of Charleston, LLC

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

location_facility: Site HU36012 Veszprém County Cholnoky Ferenc Hospital

location_facility: Site CN86027 Second Hospital of Lanzhou University

location_facility: Site US10150 Suncoast Clinical Research, Inc.

location_facility: Site KR82019 Chungnam National University Hospital

location_facility: Site NL31001 University Medical Centre Utrecht

location_facility: Site US10123 Chase Medical Research, LLC

location_facility: Site DE49031 Urologisches Zentrum Refrath

location_facility: Site UA38007 Central Outpatient Hospital of Deanyanskyy Distric

location_facility: Site CA15044 McMaster Institute of Urology

location_facility: Site TW88611 Chung Shan Medical University Hospital

location_facility: Site US10540 Demaur Clinical Research, INC

location_facility: Site EE37205 West Tallinn Central Hospital

location_facility: Site MY60004 University Malaya Medical Centre

location_facility: Site CN86025 Beijing Friendship Hospital

location_facility: Site KR82014 Soon Chun Hyang University Hospital

location_facility: Site KR82005 Yeungnam University Hospital

location_facility: Site RO40002 Spitalul Clinic Judetean de Urgenta Timisoara

location_facility: Site RO40001 Spiatlul Clinic Th. Burghele

location_facility: Site CN86009 Peking University 3rd Hospital

location_facility: Site US10090 Protenium Clinical Research, LLC

location_facility: Site MY60005 Universiti Kebangsaan Malaysia Medical Centre

location_facility: Site CA15015 Recherches Cliniques Theradev, Inc.

location_facility: Site NL31005 Canisius-Wilhelmina Ziekenhuis

location_facility: Site SE46009 Encia AB, Uppsala Hälsomottagning

location_facility: Site KR82029 Daegu Catholic Univ. Medical Center

location_facility: Site PL48004 NZOZ Szpital Sw.Rodziny Centrum Medyczne

location_facility: Site RU70002 Pavlov St. Petersburg State Medical University

location_facility: Site GB44005 North West London Hosp Menopause Clinic

location_facility: Site RO40004 Spitalul Clinic de Urgenta Sfantul Ioan

location_facility: Site KR82006 Dong-A University Medical Center

location_facility: Site KR82001 Seoul Saint Mary's Hospital

location_facility: Site KR82013 Hallym University Kangdong Sacred Heart Hospital

location_facility: Site AR54004 Instituto de Investigaciones Clnicas Rosario

location_facility: Site CN86030 Lanzhou University First Hospital

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

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

location_facility: Site LT37004 KHospital of Lithuanian University of Health Science

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

location_facility: Site US10040 Premier Medical Group Of The Hudson Valley

location_facility: Site CA15027 Diex Research Sherbrooke Inc

location_facility: Site CN86011 The Second Affiliated Hospital of Soochow Universi

location_facility: Site RO40015 Spitaul Clinic Judetean de Urgenta Brasov

location_facility: Site US10549 Associated Urologists of North Carolina

location_facility: Site RU70022 St. Petersburg State Public Health Institution

location_facility: Site US10558 Chesapeake Urology Research Associates

location_facility: Site IT39007 Azienda Ospedaliera San Giuseppe Moscati

location_facility: Site PL48012 Military Institute of Medicine

location_facility: Site RO40010 Spitalul Clinic Judetan de Urgenta Sibiu

location_facility: Site LT37012 Klaipeda University Hospital

location_facility: Site CN86021 HuaDong Hosipital Affiliated to Fudan University

location_facility: Site UA38004 Vinnitsa Endocrinology Dispens

location_facility: Site KR82025 Seoul National University Bundang Hospital

location_facility: Site US10114 Bay State Clinical Trials, Inc.

location_facility: Site LT37003 Family Medical Centre Seimos gydytojas

location_facility: Site LT37011 Saules Family Medicine Centre

location_facility: Site AU61022 Brisbane South Clinical Research Centre

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

location_facility: Site KR82009 Wonkwang University Hospital

location_facility: Site CA15021 Urology South Shore Research

location_facility: Site US10026 AccuMed Research Associates

location_facility: Site DE49026 Zentrum fuer Onkologie und Urologie Rostock

location_facility: Site US10073 Manhattan Medical Research Practice, PLLC

location_facility: Site US10248 Preferred Primary Care Physicians, Inc

location_facility: Site TR90013 Uludag University Faculty of Medicine

location_facility: Site KR82016 Pusan National University Hospital

location_facility: Site ES34009 Hospital Universitario La Paz

location_facility: Site US10028 Premier Medical Group of the Hudson Valley

location_facility: Site CA15004 Primehealth Clinical Research

location_facility: Site US10159 Urological Research Network

location_facility: Site US10166 Medical University of South Carolina

location_facility: Site TR90001 Pamukkale University Faculty of Medicine

location_facility: Site CN86015 Zhongnan Hospital of Wuhan University

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

location_facility: Site US10109 Lynn Health Science Institute

location_facility: Site US10148 Best Quality Research, Inc.

location_facility: Site KR82024 Chungbuk National University Hospital

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

location_facility: Site NO47008 Norsk Helseklinikk (Heiaklinikken)

location_facility: Site HU36007 Mediroyal Prevention Center

location_facility: Site US10117 Carolina Urologic Research Center

location_facility: Site MX52002 Accelerium Clinical Research/ Hospital San Jorge

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

location_facility: Site CN86029 Southwest Hospital (Chongqing)

location_facility: Site US10128 Clinical Research Center of CT

location_facility: Site PE51005 Hospital Nacional Hipolito Unanue

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

location_facility: Site PE51006 Hospital Nacional Guillermo Almenara Irigoyen EsSalud

location_facility: Site SG65001 National University Hospital

location_facility: Site NZ64001 Canterbury Urology Research Trust

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

location_facility: Site SE46012 Karolinska University Hospital Huddinge

location_facility: Site NL31002 Academic Medical Center (AMC)

location_facility: Site BG35905 MHAT Alexandrovska Hospital

location_facility: Site KR82017 Kyung Hee University Medical Center

location_facility: Site LT37008 Kaunas 2nd Clinical Hospital

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

location_facility: Site US10017 Philadelphia Clinical Research, LLC

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

location_facility: Site TR90019 Ankara University Medical Faculty Ibni Sina Hospital

location_facility: Site US10049 Coastal Clinical Research, Inc.

location_facility: Site US10122 Orange County Research Institute

location_facility: Site US10162 Phoenix OB-GYN Associates, LLC

location_facility: Site NZ64005 Waikato Urology Research Limited

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

location_facility: Site DK45013 University Hospital of Aarhus, Skejby

location_facility: Site US10078 Heartland Research Associates, LLC

location_facility: Site TW88612 Chi Mei Medical Center, Yong Kang

location_facility: Site FR33011 Centre Hospitalier Lyon Sud

location_facility: Site US10050 Rapid Medical Research, Inc.

location_facility: Site AR54006 Hospital Italiano de Buenos Aires

location_facility: Site RO40005 Spiatlul Clinic Th. Burghele

location_facility: Site UA38010 Academy of Medical Sciences of Ukraine

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

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

location_facility: Site PE51001 Instituto de Ginecologia y Reproduccion

location_facility: Site US10106 West Coast Clinical Research

location_facility: Site NZ64003 Tauranga Urology Research Ltd

location_facility: Site US10093 Pioneer Research Solutions, Inc.

location_facility: Site SK42106 Private Urological Care Center

location_facility: Site US10018 Grove Hill Clinical Research

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

location_facility: Site US10219 Methodist Urology Associates

location_facility: Site US10046 Coastal Carolina Research Center

location_facility: Site ES34001 Hospital Universitario de Getafe

location_facility: Site US10053 Western Clinical Research, Inc.

location_facility: Site IT39022 Azienda Ospedale Umberto I (Ancona)

location_facility: Site AR54005 IUBA - Instituto Urologico de Buenos Aires

location_facility: Site US10165 East Coast Institute for Research

location_facility: Site FR33007 Centre Hospitalier Louis Pasteur

location_facility: Site AU61004 Keogh Institute for Medical Research

location_facility: Site CO57004 Instituto de Coloproctologia ICO SAS

location_facility: Site TH66010 Maharaj Nakorm Chiangmai Hosp

location_facility: Site CN86020 The First Affiliated Hospital of NanChang Univers

location_facility: Site TH66006 Songklanagarind Hospital, Prince of Songkla University

location_facility: Site RU70019 City Multidisciplinary Hospital No. 2

location_facility: Site LT37007 Vilnius University Hospital Santariskiu Klinikos

location_facility: Site CZ42001 Fakultni Nemocnice Hradec Kralove

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

location_facility: Site PL48001 Specjalistyczny Gabinet Lekarski

location_facility: Site RU70018 Bashkirsky State Medical University of Roszdrav

location_facility: Site US10008 Urologic Consultants of Southeastern Pennsylvania

location_facility: Site SI38604 General Hospital Murska Sobota

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

location_facility: Site US10534 South Florida Medical Research

location_facility: Site US10015 Urology Group of New Mexico

location_facility: Site UA38013 Dnipropetrovsk State Medical Academy, Mechnikov Dnipropetrov

location_facility: Site CZ42009 Hospital Uherské Hradiště a.s.

location_facility: Site US10152 Female Pelvic Medicine & Urogynecology Institute

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

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

location_facility: Site CN86016 Guangzhou First People's Hospital

location_facility: Site US10593 Upstate Clinical Research Associates LLC

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

location_facility: Site BE32011 Universitaire Ziekenhuizen Leuven

location_facility: Site US10127 Perimeter North Medical Research, Inc.

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

location_facility: Site CA15042 G. Kenneth Jansz Medicine Professional Corporation

location_facility: Site US10535 South Florida Medical Research

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

location_facility: Site CA15013 Sunnybrook Health Sciences Center

location_facility: Site US10167 University of Pittsburgh Medical Center

location_facility: Site TW88605 Taichung Veteran General Hospital

location_facility: Site LV37105 P.Stradins Clinical University Hospital

location_facility: Site KR82031 Chonnam National University Hospital

location_facility: Site US10153 Palmetto Professional Research

location_facility: Site RU70015 LLC Clinical Research Medical Complex

location_facility: Site CA15032 Stanley Flax Medical Prof Corp

location_facility: Site KR82020 Seoul National University Hospital

location_facility: Site KR82012 Konkuk University Medical Center

location_facility: Site GB44022 The Royal Berkshire Hospital

location_facility: Site UA38015 Regional Municipal Institution, Urology Department

location_facility: Site US10013 Seattle Urology Research Center

location_facility: Site US10002 Urology Center Research Institute

location_facility: Site US10104 Clinical Research Advantage, Inc.


acronym: Simplify 1

lead_sponsor: Sierra Oncology LLC - a GSK company

summary:
This study is to determine the efficacy of momelotinib (MMB) versus ruxolitinib (RUX) 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: 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)

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


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: Safadi R, Rahimi RS, Thabut D, Bajaj JS, Ram Bhamidimarri K, Pyrsopoulos N, Potthoff A, Bukofzer S, Wang L, Jamil K, Devarakonda KR. Pharmacokinetics/pharmacodynamics of L-ornithine phenylacetate in overt hepatic encephalopathy and the effect of plasma ammonia concentration reduction on clinical outcomes. Clin Transl Sci. 2022 Jun;15(6):1449-1459. doi: 10.1111/cts.13257. Epub 2022 Mar 3.

ReferenceCitation: Wang X, Vilchez RA. Population Pharmacokinetic Analysis to Assist Dose Selection of the L-Ornithine Salt of Phenylacetic Acid. Clin Pharmacokinet. 2022 Apr;61(4):515-526. doi: 10.1007/s40262-021-01075-1. Epub 2021 Nov 17.

license: cc-by-nc

license_normalized: cc-by-nc

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.

ipd_sharing: No

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


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:
Finland
Germany
United Kingdom
Netherlands
Belgium
Spain
France

location_facility: Tampereen yliopistollinen sairaala Hospital

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: Clinica Ginecologica Ceoga, Clinic/Outpatient Facility

location_facility: Charité - Universitätsmedizin Berlin Hospital

location_facility: Elisabeth Krankenhaus Essen GmbH - 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: Hospital Regional Universitario Carlos Haya - Hospital Materno Infantil

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

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

location_facility: Grand Hôpital de Charleroi Site Notre-Dame

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

location_facility: Regionaal Ziekenhuis Heilig Hart Tienen Hospital

location_facility: Dumfries and Galloway Royal Infirmary Hospital

location_facility: Liverpool - GUM - Liverpool Centre for Sexual Health

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

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

location_facility: CHU de Nîmes - Hopital Universitaire Caremeau

location_facility: Klinikum der Friedrich Schiller Universität Jena 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:
Germany
Italy
United Kingdom
Australia
Netherlands
United States
Greece
Czechia
Canada
France


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

ReferenceCitation: Janne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crino 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.

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Janne 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.

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)

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

status_simplified: Ongoing


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

location_facility: Karolinska University Hospital - Dept of Infectious Diseases

location_facility: AKh Allgemeines Krankenhaus der Stadt Linz GmbH

location_facility: Gemeinschaftspaxis Dres. Jessen & Kollegen

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

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

location_facility: Royal Free Hospital and University College London Hospital

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Klinikum der Universität München-Großhadern

location_facility: UCD School of Medicine and Medical Sciences

location_facility: Klinikum der Johann Wolfgang Goethe Universitaet

location_facility: Istituto Nazionale per le Malattie Infettive

location_facility: HPP Hospital de Cascais Dr. José de Almeida

location_facility: CUB Hopital Erasme- Free University of Brussels

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

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: Infektionsmedizinisches Centrum Hamburg (ICH)

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico


title: A Multi-centre, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects Who Participated in theMEA115588 or MEA115575 Trials

summary: This is a multi-centre, open-label long-term safety study of 100 milligram (mg) mepolizumab administered subcutaneously (SC) every 4 weeks for 12 months in addition to standard of care in subjects who have severe, refractory asthma and a history of eosinophilic inflammation. Subjects who completed either MEA115588 or MEA115575 will be offered the opportunity to consent for this study.

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

ReferenceCitation: Yancey SW, Ortega HG, Keene ON, Bradford ES. Efficacy of add-on mepolizumab in adolescents with severe eosinophilic asthma. Allergy Asthma Clin Immunol. 2019 Sep 3;15:53. doi: 10.1186/s13223-019-0366-x. eCollection 2019.

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.

repositories_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.

ReferenceCitation: Lugogo N, Domingo C, Chanez P, Leigh R, Gilson MJ, Price RG, Yancey SW, Ortega HG. Long-term Efficacy and Safety of Mepolizumab in Patients With Severe Eosinophilic Asthma: A Multi-center, Open-label, Phase IIIb Study. Clin Ther. 2016 Sep;38(9):2058-2070.e1. doi: 10.1016/j.clinthera.2016.07.010. Epub 2016 Aug 21.

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


summary: The primary purpose of the study was to compare the antitumor activity of LDK378 versus reference chemotherapy. Patients in the chemotherapy arm were given the option to switch to LDK378 after confirmed progressive disease (PD), while also had the choice to continue with pemetrexed treatment.

ReferenceCitation: Soria JC, Tan DSW, Chiari R, Wu YL, Paz-Ares L, Wolf J, Geater SL, Orlov S, Cortinovis D, Yu CJ, Hochmair M, Cortot AB, Tsai CM, Moro-Sibilot D, Campelo RG, McCulloch T, Sen P, Dugan M, Pantano S, Branle F, Massacesi C, de Castro G Jr. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017 Mar 4;389(10072):917-929. doi: 10.1016/S0140-6736(17)30123-X. Epub 2017 Jan 24. Erratum In: Lancet. 2017 Mar 4;389(10072):908.

ReferenceCitation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.

title: A Phase III Multicenter, Randomized Study of Oral LDK378 Versus Standard Chemotherapy in Previously Untreated Adult Patients With ALK Rearranged (ALK-positive), Stage IIIB or IV, Non-squamous Non-small Cell Lung Cancer

location_country:
Germany
Ireland
Poland
Australia
Brazil
Japan
Thailand
Turkey
France
Colombia
Denmark
India
Lebanon
China
Italy
Norway
Singapore
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Sweden


lead_sponsor: Hoffmann-La Roche

summary: This randomized, double-blind, regimen-controlled, phase II, multicenter study will assess the efficacy and safety of two different vismodegib regimens in participants with multiple basal cell carcinoma. Participants will receive vismodegib 150 mg orally once daily either in an intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo (Arm A) or as 24 weeks induction followed by an intermittent schedule of 8 weeks placebo followed by 8 weeks vismodegib (Arm B). Anticipated time on study treatment is 72 weeks.

ReferenceCitation: Jacobsen AA, Kydd AR, Strasswimmer J. Practical management of the adverse effects of Hedgehog pathway inhibitor therapy for basal cell carcinoma. J Am Acad Dermatol. 2017 Apr;76(4):767-768. doi: 10.1016/j.jaad.2016.04.063. No abstract available.

ReferenceCitation: Dreno B, Kunstfeld R, Hauschild A, Fosko S, Zloty D, Labeille B, Grob JJ, Puig S, Gilberg F, Bergstrom D, Page DR, Rogers G, Schadendorf D. Two intermittent vismodegib dosing regimens in patients with multiple basal-cell carcinomas (MIKIE): a randomised, regimen-controlled, double-blind, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):404-412. doi: 10.1016/S1470-2045(17)30072-4. Epub 2017 Feb 8.

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: VU MEDISCH CENTRUM;Afdeling Dermatologie

location_facility: Hospital General Universitario de Guadalajara; Servicio de Dermatologia

location_facility: Hospital Costa Del Sol; Servicio de Dermatologia

location_facility: Università di Brescia; Dipartimento di Dermatologia

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

location_facility: Saint Louis University School of Medicine; Department of Dermatology

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Dermatology and Laser Center of Charleston PA

location_facility: UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: LKH Innsbruck; Universitätsklinik für Dermatologie

location_facility: Skin and Cancer Associates and the Center for Cosmetic Enhancement

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: Washington University School of Medicine

location_facility: FSBI "Russian Oncology Research Center n.a. N. N. Blokhin" of Ministry of Health of the Russian Fed

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

location_facility: Blokhin Cancer Research Center; General Oncology Department

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Arcispedale Santa Maria Nuova; Dermatologia

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Beverly Hospital;Oncology Center Pharmacy

location_facility: Long Island Skin Cancer and Dermatologic Surgery

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: UBC Department of Dermatology & Skin Sciences

location_facility: California Pacific Medical Center Research Institute

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Universitätsklinik Essen; Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Maastricht University Medical Centre; Dermatologie

location_facility: Hospital General Dr. Manuel Gea Gonzalez; Dermatology

title: A Randomized, Double-blinded, Regimen-controlled, Phase II, Multicenter Study to Assess the Efficacy and Safety of Two Different Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas

location_country:
Germany
Italy
Netherlands
Austria
Mexico
United States
Spain
Canada
Russian Federation
France


title: A Randomized, Phase 3 Study of Ganetespib in Combination With Docetaxel Versus Docetaxel Alone in Patients With Advanced Non-Small-Cell Lung Adenocarcinoma

acronym: Galaxy 2

summary: The purpose of this study is to determine whether combining ganetespib (STA-9090) with docetaxel is more effective than docetaxel alone in the treatment of patients with advanced non-small cell lung cancer.

status: Terminated

lead_sponsor: Synta Pharmaceuticals Corp.

location_country:
Germany
Poland
Bosnia and Herzegovina
Croatia
Canada
Serbia
France
Slovenia
Czech Republic
Hungary
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Russian Federation

location_facility: Pneumologisches Forschungsinstitut an der Lungenclinic Gross

location_facility: Sint Antoniusziekenhuis, location Utrecht

location_facility: Istituti Fisioterapici Ospitalieri Regina Elena

location_facility: Hospital de Mataró, Consorci Sanitari del Maresme

location_facility: Institute for pulmonary diseases of Vojvodine

location_facility: Fort Wayne Medical Oncology and Hematology Inc

location_facility: Medizinische Fakultät Mannheim Uni Heidelberg

location_facility: Cancer Care Specialists of Central Illinois, S.C.

location_facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

location_facility: Xerencia de Xestión Integrada A Coruña Hospital Teresa Herrera

location_facility: Eastern Connecticut Hematology Associates

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej - Curie

location_facility: Univerzitetna klinika za pljucne bolesti in alergijo Golnik

location_facility: Baptist Health Medical Group Oncology, LLC

location_facility: Lynn Cancer Institute Center for Hematology Oncology

location_facility: AOU S.Martino, IRCCS, IST-Istituto Nazionale Ricerca Sul Can

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

location_facility: North Shore Hematology Oncology Associates

location_facility: Providence Regional Medical Center Everett

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia, Universi

location_facility: Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a

location_facility: St. Louis Cancer Care, LLP - North County

location_facility: Centre Hosptalier De Villefranche-Sur-Saone

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: Clinical Center University of Sarajevo, Clinic of Oncology

location_facility: Institute for Oncology and Radiology of Serbia

location_facility: Novant Health Presbyterian Medical Center

location_facility: Synta Pharmaceuticals Investigational Site

location_facility: Gemeinschaftspraxis fuer Haematologie und Onkologie

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Erlanger Institute for Clinical Research

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: UC Davis Medical Center - UC Davis Comprehensive Cancer

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: The Center for Cancer and Blood Disorders (CCBD) - Bethesda

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: Synta Pharmaceuticals Investigative Site

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Northern Arizona Hematology & Oncology Associates

location_facility: Johann Wolfgang Goethe University Clinic Frankfurt

location_facility: Borgo Roma, Policlinico G.Rossi, AOU Integrata Verona

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital d

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Green Bay Oncology, Ltd. - St. Mary's Site

location_facility: City of Hope Comprehensive Breast Cancer Center

location_facility: Országos Korányi TBC és Pulmonológiai Intézet

location_facility: Szpital Wojewodzki w Lomzy im. Kardynala S. Wyszynskiego

location_facility: University Of North Carolina At Chapel Hill

location_facility: Emory University - Winship Cancer Institute

location_facility: Wojewodzki Szpital Specjalistyczny im. M.Kopernika

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: New Hanover Regional Medical Center - Zimmer Cancer Center

location_facility: INDC Entité Jolimontoise - Polyclinique de Jolimont

location_facility: Medical Oncology Hematology Consultants, PA

location_facility: St. Joseph Hospital, Center for Cancer Prevention and Treatment

location_facility: Houston Methodist Hospital Research Institute

location_facility: Algemeen Stedelijk Ziekenhuis - Campus Aalst

location_facility: Sozialmedizinisches Zentrum Baumgartner Höhe

location_facility: Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkó

location_facility: University of Miami Health System Sylvester at Deerfield Beach

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: University of South Florida - H. Lee Moffitt

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Presidio Ospedaliero Centrale Belcolle, AUSL Viterbo

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Grand Hôpital de Charleroi - Site Notre-Dame

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

location_facility: Szpital Chorob Pluc im. Sw. Jozefa w Pilchowicach

status_simplified: Unknown