title: A Phase 2b, Open-Label, Single-Arm Study of Selinexor (KPT-330) Plus Low-Dose Dexamethasone (Sd) in Patients With Multiple Myeloma Previously Treated With Lenalidomide, Pomalidomide, Bortezomib, Carfilzomib, and an Anti-CD38 Monoclonal Antibody (mAb) Daratumumab, and Refractory to Prior Treatment With Glucocorticoids, an Immunomodulatory Agent, a Proteasome Inhibitor, and an the Anti-CD38 mAb Daratumumab

acronym: STORM

summary: This is a Phase 2b, single-arm, open-label, multicenter study of selinexor 80 mg plus dexamethasone 20 mg (Sd) dosed twice weekly in four-week cycles, in patients with penta-refractory MM (Parts 1 and 2) or quad refractory MM (Part 1 only).

ReferenceCitation: Tremblay G, Daniele P, Breeze J, Li L, Shah J, Shacham S, Kauffman M, Engelhardt M, Chari A, Nooka A, Vogl D, Gavriatopoulou M, Dimopoulos MA, Richardson P, Biran N, Siegel D, Vlummens P, Doyen C, Facon T, Mohty M, Meuleman N, Levy M, Costa L, Hoffman JE, Delforge M, Kaminetzky D, Weisel K, Raab M, Dingli D, Tuchman S, Laurent F, Vij R, Schiller G, Moreau P, Richter J, Schreder M, Podar K, Parker T, Cornell RF, Lionel K, Choquet S, Sundar J. Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study. BMC Cancer. 2021 Sep 6;21(1):993. doi: 10.1186/s12885-021-08453-9.

repository_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Nikolaou A, Ambavane A, Shah A, Ma W, Tosh J, Kapetanakis V, Willson J, Wang F, Hogea C, Gorsh B, Gutierrez B, Sapra S, Suvannasankha A, Samyshkin Y. Belantamab mafodotin for the treatment of relapsed/refractory multiple myeloma in heavily pretreated patients: a US cost-effectiveness analysis. Expert Rev Hematol. 2021 Dec;14(12):1137-1145. doi: 10.1080/17474086.2021.1970522. Epub 2021 Sep 20.

repository_institution: University of Illinois at Chicago - INDIGO

ReferenceCitation: Chari A, Florendo E, Mancia IS, Cho H, Madduri D, Parekh S, Richter J, Dhadwal A, Thomas J, Jiang G, Lagana A, Bhalla S, Jagannath S. Optimal Supportive Care With Selinexor Improves Outcomes in Patients With Relapsed/Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2021 Dec;21(12):e975-e984. doi: 10.1016/j.clml.2021.07.014. Epub 2021 Jul 18.

ReferenceCitation: Chari A, Vogl DT, Gavriatopoulou M, Nooka AK, Yee AJ, Huff CA, Moreau P, Dingli D, Cole C, Lonial S, Dimopoulos M, Stewart AK, Richter J, Vij R, Tuchman S, Raab MS, Weisel KC, Delforge M, Cornell RF, Kaminetzky D, Hoffman JE, Costa LJ, Parker TL, Levy M, Schreder M, Meuleman N, Frenzel L, Mohty M, Choquet S, Schiller G, Comenzo RL, Engelhardt M, Illmer T, Vlummens P, Doyen C, Facon T, Karlin L, Perrot A, Podar K, Kauffman MG, Shacham S, Li L, Tang S, Picklesimer C, Saint-Martin JR, Crochiere M, Chang H, Parekh S, Landesman Y, Shah J, Richardson PG, Jagannath S. Oral Selinexor-Dexamethasone for Triple-Class Refractory Multiple Myeloma. N Engl J Med. 2019 Aug 22;381(8):727-738. doi: 10.1056/NEJMoa1903455.

ReferenceCitation: Vogl DT, Dingli D, Cornell RF, Huff CA, Jagannath S, Bhutani D, Zonder J, Baz R, Nooka A, Richter J, Cole C, Vij R, Jakubowiak A, Abonour R, Schiller G, Parker TL, Costa LJ, Kaminetzky D, Hoffman JE, Yee AJ, Chari A, Siegel D, Fonseca R, Van Wier S, Ahmann G, Lopez I, Kauffman M, Shacham S, Saint-Martin JR, Picklesimer CD, Choe-Juliak C, Stewart AK. Selective Inhibition of Nuclear Export With Oral Selinexor for Treatment of Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 20;36(9):859-866. doi: 10.1200/JCO.2017.75.5207. Epub 2018 Jan 30.

repository_institution: University of California - eScholarship University of California

lead_sponsor: Karyopharm Therapeutics Inc

location_country:
Germany
Austria
Belgium
United States
Greece
France

location_facility: Hopital Saint-Antoine, Service d´Hematologie Clinique et Therapie Cellulaire

location_facility: Emory University / Winship Cancer Institute

location_facility: University Hospital Krems, Department of Internal Medicine II

location_facility: Karmanos Cancer Institute / Wayne State University

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: University Hospital Freiburg, Department of Internal Medicine I

location_facility: Hackensack University Medical Center / John Therurer Cancer Center

location_facility: University of Florida Health Cancer Center- Shands Cancer Center Hospital

location_facility: National & Kapodistrain University of Athens School of Medicine, Alexandra Hospital

location_facility: Medical University Vienna, Department of Internal Medicine I

location_facility: H. Lee Moffitt Cancer Center Research Institute

location_facility: Universitätsklinikum Heidelberg Medizinische Klinik V

location_facility: University Hospital Leuven, Campus Gasthuisberg

location_facility: Universitätsklinikum des Saarlandes Klinik für Innere Medizin I

location_facility: Med. Klinik und Poliklinik II Universitätsklinikum

location_facility: La Pitie-Salpetriere University Hospital, Department of Clinical Hematology

location_facility: Vanderbilt University Ingram Cancer Center

location_facility: Claude Huriez Hospital, Department of Blood Diseases

location_facility: South Lyon Hospital Center, Department of Clinical Hematology

location_facility: Jonnsson Comprehensive Cancer Center / University of Los Angeles

location_facility: University hospital of Tuebingen, Internal Medicine II


title: The REDUCE FMR Trial: Safety and Efficacy of the CARILLON Mitral Contour System® in Reducing Functional Mitral Regurgitation (FMR) Associated With Heart Failure

acronym: REDUCE FMR

summary: The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the CARILLON Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart failure, compared to a randomized Control group which is medically managed according to heart failure guidelines.

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: Schofer J, Siminiak T, Haude M, Herrman JP, Vainer J, Wu JC, Levy WC, Mauri L, Feldman T, Kwong RY, Kaye DM, Duffy SJ, Tubler T, Degen H, Brandt MC, Van Bibber R, Goldberg S, Reuter DG, Hoppe UC. Percutaneous mitral annuloplasty for functional mitral regurgitation: results of the CARILLON Mitral Annuloplasty Device European Union Study. Circulation. 2009 Jul 28;120(4):326-33. doi: 10.1161/CIRCULATIONAHA.109.849885. Epub 2009 Jul 13.

ReferenceCitation: Siminiak T, Wu JC, Haude M, Hoppe UC, Sadowski J, Lipiecki J, Fajadet J, Shah AM, Feldman T, Kaye DM, Goldberg SL, Levy WC, Solomon SD, Reuter DG. Treatment of functional mitral regurgitation by percutaneous annuloplasty: results of the TITAN Trial. Eur J Heart Fail. 2012 Aug;14(8):931-8. doi: 10.1093/eurjhf/hfs076. Epub 2012 May 21.

ReferenceCitation: Siminiak T, Hoppe UC, Schofer J, Haude M, Herrman JP, Vainer J, Firek L, Reuter DG, Goldberg SL, Van Bibber R. Effectiveness and safety of percutaneous coronary sinus-based mitral valve repair in patients with dilated cardiomyopathy (from the AMADEUS trial). Am J Cardiol. 2009 Aug 15;104(4):565-70. doi: 10.1016/j.amjcard.2009.04.021. Epub 2009 May 29.

ReferenceType: derived

ReferenceCitation: Witte KK, Lipiecki J, Siminiak T, Meredith IT, Malkin CJ, Goldberg SL, Stark MA, von Bardeleben RS, Cremer PC, Jaber WA, Celermajer DS, Kaye DM, Sievert H. The REDUCE FMR Trial: A Randomized Sham-Controlled Study of Percutaneous Mitral Annuloplasty in Functional Mitral Regurgitation. JACC Heart Fail. 2019 Nov;7(11):945-955. doi: 10.1016/j.jchf.2019.06.011. Epub 2019 Sep 11.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ipd_sharing: No

lead_sponsor: Cardiac Dimensions Pty Ltd

sponsor_collaborators:
Cardiac Dimensions Pty Ltd
Menzies Institute for Medical Research

location_country:
Germany
Poland
New Zealand
United Kingdom
Australia
Netherlands
Czechia
France

location_facility: Institut klinické a experimentální medicíny (IKEM)

location_facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: A Non-interventional Post Authorization Study (PASS) to Evaluate Long-term Safety of Orfadin Treatment in Hypertyrosinemia Type 1 (HT-1) Patients in Standard Care

acronym: OPAL

summary: The purpose of this study is to look at the long term safety profile of Orfadin treatment in patients suffering from hereditary tyrosinemia type 1 (HT-1). Patients included in the study will use Orfadin according to normal clinical practice.

study_type: Observational

time_perspective: Other

ipd_sharing: Undecided

ipd_sharing_description: Discussions ongoing with regards to data sharing/registry.

lead_sponsor: Swedish Orphan Biovitrum

location_country:
Finland
Germany
Ireland
Italy
Poland
Portugal
Hungary
Norway
Denmark
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
Czechia
France

location_facility: Swedish Orphan Biovitrum Investigational Site

location_facility: Swedish Oprhan Biovitrum Investigational Site

intervention_type: Drug


type: Other Identifier

type: EudraCT Number

title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

acronym: RAINFALL

summary: The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.

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

ReferenceCitation: Fuchs CS, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran SE, Van Cutsem E, Ilson DH, Alsina M, Chau I, Lacy J, Ducreux M, Mendez GA, Alavez AM, Takahari D, Mansoor W, Enzinger PC, Gorbounova V, Wainberg ZA, Hegewisch-Becker S, Ferry D, Lin J, Carlesi R, Das M, Shah MA; RAINFALL Study Group. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):420-435. doi: 10.1016/S1470-2045(18)30791-5. Epub 2019 Feb 1. Erratum In: Lancet Oncol. 2019 May;20(5):e242.

oa_host_type: closed

ipd_sharing: Yes

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

lead_sponsor: Eli Lilly and Company

location_country:
Finland
Germany
Poland
Argentina
Japan
Czechia
Canada
France
Hungary
Denmark
United States
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Mexico
Spain
Russian Federation
Israel

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

location_facility: Florida Cancer Specialists and Research Institute

location_facility: Central Coast Medical Oncology Corporation

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: University of Colorado School of Medicine


title: A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging

acronym: REPAIR

summary: The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year. Patients undergo right heart catheterization (RHC) at baseline and Week 26. They also undergo cardiac magnetic resonance imaging (MRI) at baseline, Week 26 and Week 52. Safety is monitored throughout the study. The study has three stub-studies. Each patient can participate in no sub-study or in one sub-study. The sub-studies are: (1) metabolism sub-study (with PET-MR scans); (2) biopsy sub-study (biopsies taken during the RHC); (3) Echo sub-study.

ReferenceCitation: Vonk Noordegraaf A, Channick R, Cottreel E, Kiely DG, Marcus JT, Martin N, Moiseeva O, Peacock A, Swift AJ, Tawakol A, Torbicki A, Rosenkranz S, Galie N. The REPAIR Study: Effects of Macitentan on RV Structure and Function in Pulmonary Arterial Hypertension. JACC Cardiovasc Imaging. 2022 Feb;15(2):240-253. doi: 10.1016/j.jcmg.2021.07.027. Epub 2021 Nov 17.

oa_colors: green hybrid

oa_host_type: publisher;repository

endpoint_id: fhisxppmrqpajgzqkvft

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

host_type: repository

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

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

version: acceptedVersion

lead_sponsor: Actelion

location_country:
Germany
Italy
Israel
Hong Kong
Singapore
Australia
United Kingdom
Netherlands
United States
Malaysia
Russian Federation
France

location_facility: Russian Cardiology Scientific and Production Complex

location_facility: Medizinische Klinik und Poliklinik II Universitätsklinik Bonn

location_facility: Pulmonology institute, Soroka Medical Center

location_facility: Fondazione IRCCS Policlinico San Matteo Ambulatorio Scompenso Cardiaco e Trapianti

location_facility: Washington University School of Medicine

location_facility: Almazov Federal North-West Medical Research Centre of Department of Health

location_facility: Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz Centrum für Thrombose und Hämostase

location_facility: National University Hospital - The Heart Institute - Cardiac Department

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: University of Texas Southwestern Medical

location_facility: "Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital"

location_facility: "CHRU de Lille - Hôpital Albert Calmette "

location_facility: Institut Jantung Negara (National Heart Institute)


title: A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis

acronym: UC

summary: The purpose of the study is to evaluate the clinical efficacy, safety and tolerability of apremilast (30 mg twice daily [BID] and 40 mg BID), compared with placebo, in participants with active Ulcerative Colitis (UC).

ReferenceCitation: Danese S, Neurath MF, Kopon A, Zakko SF, Simmons TC, Fogel R, Siegel CA, Panaccione R, Zhan X, Usiskin K, Chitkara D. Effects of Apremilast, an Oral Inhibitor of Phosphodiesterase 4, in a Randomized Trial of Patients With Active Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2526-2534.e9. doi: 10.1016/j.cgh.2019.12.032. Epub 2020 Jan 8.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Germany
Italy
Poland
New Zealand
Hungary
Australia
Netherlands
United States
Czechia
Ukraine
Bulgaria
Canada
Russian Federation
France

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: Private Enterprise Private Manufacture Company Acinus

location_facility: IRCCS - Istituo Clinico Humanitas - Humanitas Cancer Center

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Vasútegészségügyi Nonprofit Kiemelten Közhasznú Kft. Debreceni Egészségügyi Központja

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Osrodek Badan Klinicznych CLINSANTE S.C.

location_facility: Municipal Institution Odesa Regional Clinical Hospital

location_facility: Medical Center Asklepion - Humane Medicine Research EOOD

location_facility: Russian Medical Military Academy na SMKirov

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna ISUL EAD

location_facility: Connecticut Clinical Research Foundation

location_facility: Digestive Health Specialists of The Southeast

location_facility: Multiprofile Hospital for Active Treatment Kaspela

location_facility: Southern California Research Institute Medical Group, Inc.

location_facility: Regional Clinical Hospital, Gastroenterology department, State Higher Education Institute Ivano-Frankivsk National Medical University

location_facility: SEIHPE Rostov State Medical University of MoH of RF

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre

location_facility: Vinnytsia Regional Clinical Hospital n a M I Pyrohov

location_facility: University Multiprofile Hospital for Active Treatment ACIBADEM City Clinic Sofia

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Spec. Gabinety Lekarskie

location_facility: Multiprofile Hospital for Active Treatment Sveta Marina EAD

location_facility: University of Iowa Hospitals and Clinics

location_facility: Digestive Research Center/ Gastroenterology Consultants of San Antonio

location_facility: Kremenchuk City Hospital # 1 n.a O.T.Bohaievskyi

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

location_facility: Consultants for Clinical Research of South Florida

location_facility: Lviv Emergency Clinical Hospital, Therapeutics Department No. 1


title: Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma

acronym: ROBUST

summary: To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

ReferenceCitation: Nowakowski GS, Chiappella A, Witzig TE, Spina M, Gascoyne RD, Zhang L, Flament J, Repici J, Vitolo U. ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma. Future Oncol. 2016 Jul;12(13):1553-63. doi: 10.2217/fon-2016-0130. Epub 2016 Apr 18.

ReferenceCitation: Nowakowski GS, Chiappella A, Gascoyne RD, Scott DW, Zhang Q, Jurczak W, Ozcan M, Hong X, Zhu J, Jin J, Belada D, Bergua JM, Piazza F, Mocikova H, Molinari AL, Yoon DH, Cavallo F, Tani M, Yamamoto K, Izutsu K, Kato K, Czuczman M, Hersey S, Kilcoyne A, Russo J, Hudak K, Zhang J, Wade S, Witzig TE, Vitolo U. ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2021 Apr 20;39(12):1317-1328. doi: 10.1200/JCO.20.01366. Epub 2021 Feb 23.

evidence: open (via page says license)

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;iris.unito.it

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Celgene

location_country:
Ireland
New Zealand
Australia
Japan
Turkey
Czechia
Canada
France
Portugal
Switzerland
United States
Belgium
China
Puerto Rico
Italy
Netherlands
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Siouxland Hematology-Oncology Associates, LLP


title: A Phase II Randomized, Double-Blind Study of Neoadjuvant Letrozole Plus GDC-0032 Versus Letrozole Plus Placebo in Postmenopausal Women With ER-positive/HER2-negative, Early Stage Breast Cancer

summary: This is a two-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining letrozole and GDC-0032 (also known as taselisib) versus letrozole and placebo in postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2 (HER2) untreated, Stage I-III operable breast cancer. Participants will be randomized into one of the two treatment arms with a 1:1 randomization ratio. Letrozole at 2.5 milligrams (mg) will be dosed once daily plus either Taselisib at 4 mg (two 2-mg tablets) or placebo on a 5 days-on/ 2 days-off schedule for a total of 16 weeks.

ReferenceCitation: Eiger D, Brandao M, de Azambuja E. Lessons learned at SABCS 2019 and to-dos from immunotherapy in breast cancer. ESMO Open. 2020 Mar;5(2):e000688. doi: 10.1136/esmoopen-2020-000688. No abstract available.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repositories_concat: PubMed Central;dipot.ulb.ac.be

unpaywall_oa_status: gold

ReferenceCitation: Eiger D, Franzoi MA, Ponde N, Brandao M, de Angelis C, Schmitt Nogueira M, de Hemptinne Q, de Azambuja E. Cardiotoxicity of trastuzumab given for 12 months compared to shorter treatment periods: a systematic review and meta-analysis of six clinical trials. ESMO Open. 2020 Feb;5(1):e000659. doi: 10.1136/esmoopen-2019-000659.

ReferenceCitation: Saura C, Hlauschek D, Oliveira M, Zardavas D, Jallitsch-Halper A, de la Pena L, Nuciforo P, Ballestrero A, Dubsky P, Lombard JM, Vuylsteke P, Castaneda CA, Colleoni M, Santos Borges G, Ciruelos E, Fornier M, Boer K, Bardia A, Wilson TR, Stout TJ, Hsu JY, Shi Y, Piccart M, Gnant M, Baselga J, de Azambuja E. Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol. 2019 Sep;20(9):1226-1238. doi: 10.1016/S1470-2045(19)30334-1. Epub 2019 Aug 8.

lead_sponsor: Genentech, Inc.

collaborators: Austrian Breast and Colorectal Cancer Group

sponsor_collaborators: Austrian Breast and Colorectal Cancer Group

location_country:
Germany
Poland
Australia
Brazil
Chile
Czechia
France
Portugal
Hungary
Switzerland
United States
Belgium
El Salvador
Peru
Italy
Guatemala
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Panama

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Klinikum Kreuzschwestern Wels; Iii. Interne Abt.

location_facility: Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Newcastle Mater Misericordiae Hospital; Oncology

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hopital Saint Louis; Service Onco Thoracique

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

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

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Gynäkologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Chirurgie - Abt. für Allgemeinchirurgie

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Centre Jean Perrin; Division De Recherche Clinique

location_facility: Frimley Park Hospital; Breast Resaerch Team

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Hospital Nacional Cayetano Heredia; Hematology - Oncology

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont

location_facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: Instituto Universitario Dexeus; Servicio de Oncología

location_facility: Royal Bournemouth General Hospital; Oncology

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

location_facility: Krankenhaus Der Stadt Wien-Hietzing; Abt. Für Gynäkologie U. Geburtshilfe

location_facility: Hospital Clinico Universitario; Oncologia

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica

location_facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Ordensklinikum Linz Barmherzige Schwestern ; Abt. f. Allgemein- und Viszeralchirurgie

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Hospital Universitario de Fuenlabrada; Servicio de Oncologia

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

location_facility: National Cancer Center; Medical Oncology

location_facility: Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Ospedale Per Acuti Mater Salutis Di Legnago

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

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika

location_facility: Memorial Sloan-Kettering Cancer Center; Hematology/Oncology

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe


intervention_type: Biological

lead_sponsor: Bioverativ, a Sanofi company

summary: The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.

ReferenceCitation: Konigs C, Ozelo MC, Dunn A, Kulkarni R, Nolan B, Brown SA, Schiavulli M, Gunawardena S, Mukhopadhyay S, Jayawardene D, Winding B, Carcao M. First study of extended half-life rFVIIIFc in previously untreated patients with hemophilia A: PUPs A-LONG final results. Blood. 2022 Jun 30;139(26):3699-3707. doi: 10.1182/blood.2021013563. Erratum In: Blood. 2023 Mar 23;141(12):1495.

repositories_concat: PubMed Central

publisher_dissemination: American Society of Hematology

sponsor_collaborators:
Bioverativ, a Sanofi company
Swedish Orphan Biovitrum

title: An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

source: euctr

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Germany
Ireland
Italy
Poland
New Zealand
United Kingdom
Australia
Brazil
Netherlands
Sweden
United States
Spain
Canada
France


title: A Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Evolocumab on Cognitive Function in Patients With Clinically Evident Cardiovascular Disease and Receiving Statin Background Lipid Lowering Therapy: A Study for Subjects Enrolled in the FOURIER (Study 20110118) Trial

acronym: EBBINGHAUS

summary: This study evaluated change over time in neurocognitive testing in patients receiving statin therapy in combination with evolocumab (AMG 145), compared with patients receiving statin therapy in combination with placebo.

primary_purpose: Other

ReferenceCitation: Giugliano RP, Mach F, Zavitz K, Kurtz C, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Design and rationale of the EBBINGHAUS trial: A phase 3, double-blind, placebo-controlled, multicenter study to assess the effect of evolocumab on cognitive function in patients with clinically evident cardiovascular disease and receiving statin background lipid-lowering therapy-A cognitive study of patients enrolled in the FOURIER trial. Clin Cardiol. 2017 Feb;40(2):59-65. doi: 10.1002/clc.22678. Epub 2017 Feb 16.

ReferenceCitation: Giugliano RP, Mach F, Zavitz K, Kurtz C, Im K, Kanevsky E, Schneider J, Wang H, Keech A, Pedersen TR, Sabatine MS, Sever PS, Robinson JG, Honarpour N, Wasserman SM, Ott BR; EBBINGHAUS Investigators. Cognitive Function in a Randomized Trial of Evolocumab. N Engl J Med. 2017 Aug 17;377(7):633-643. doi: 10.1056/NEJMoa1701131.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.

oa_host_type: repository

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

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

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

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_country:
Finland
Germany
Poland
New Zealand
Australia
Japan
Turkey
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
Belgium
Malaysia
Estonia
Italy
Norway
United Kingdom
Netherlands
Spain
Greece
South Africa
Russian Federation
Sweden


title: Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children

summary: The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process [IP]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process [LP]).

primary_purpose: Prevention

ReferenceCitation: Claeys C, Drame M, Garcia-Sicilia J, Zaman K, Carmona A, Tran PM, Miranda M, Martinon-Torres F, Thollot F, Horn M, Schwarz TF, Behre U, Merino JM, Sadowska-Krawczenko I, Szymanski H, Schu P, Neumeier E, Li P, Jain VK, Innis BL. Assessment of an optimized manufacturing process for inactivated quadrivalent influenza vaccine: a phase III, randomized, double-blind, safety and immunogenicity study in children and adults. BMC Infect Dis. 2018 Apr 18;18(1):186. doi: 10.1186/s12879-018-3079-8.

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central;www.repositoriosalud.es

publisher_dissemination: Springer-Nature

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
United States
Spain
Bangladesh
Czechia
France


lead_sponsor: Hoffmann-La Roche

summary: This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.

ReferenceCitation: Zinzani PL, Flinn IW, Yuen SLS, Topp MS, Rusconi C, Fleury I, Le Du K, Arthur C, Pro B, Gritti G, Crump M, Petrich A, Samineni D, Sinha A, Punnoose EA, Szafer-Glusman E, Spielewoy N, Mobasher M, Humphrey K, Kornacker M, Hiddemann W. Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma. Blood. 2020 Dec 3;136(23):2628-2637. doi: 10.1182/blood.2020005588.

sponsor_collaborators:
Hoffmann-La Roche
AbbVie

location_facility: CHU Clermont Ferrand - Hôpital d'Estaing

location_facility: West Virginia Uni Med. Center - Robert Byrd Health Science

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Universitätsklinikum Köln; Klinik I für Innere Medizin

location_facility: University College London, Department of Haematology

location_facility: University of Pennsylvania; School of Medicine

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Primary Healthcare Associates SC - Harvey

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin II

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Chum Hopital Notre Dame; Centre D'Oncologie

location_facility: UCLA School of Medicine; Hematology/Oncology

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: University of Kansas; Medical Center & Medical pavilion

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie

location_facility: Royal Marsden Nhs Trust; Consultant Cancer Physician

location_facility: University of Illinois at Chicago College of Medicine

location_facility: Royal Prince Alfred Hospital; Medical Oncology

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Klinikum Chemnitz gGmbH; Klinik f. Innere Medizin III

location_facility: Az. Osp. Di Careggi; Divisione Di Ematologia

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

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

title: A Phase II, Open-Label Study Evaluating the Safety and Efficacy of GDC-0199 (ABT-199) Plus Bendamustine Plus Rituximab (BR) in Comparison With BR Alone or GDC-0199 Plus Rituximab (R) in Patients With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma

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


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Pyridorin (Pyridoxamine Dihydrochloride) in Subjects With Nephropathy Due to Type 2 Diabetes (PIONEER)

acronym: PIONEER

summary: The purpose of this study is to evaluate the safety and efficacy of oral Pyridorin 300 mg BID in reducing the rate of progression of nephropathy due to type 2 diabetes mellitus.

status: Terminated

study_completion_date_type: Anticipated

lead_sponsor: NephroGenex, Inc.

sponsor_collaborators:
NephroGenex, Inc.
Collaborative Study Group (CSG)
Medpace, Inc.

location_country:
Germany
Poland
Hungary
Hong Kong
Israel
Australia
United States
Spain
Mauritius
Bulgaria
Puerto Rico
France

location_facility:
CSG Investigational Site (#805)
CSG Investigational Site (#135)
CSG Investigational Site (#142)
CSG Investigational Site (#305)
CSG Investigational Site (#604)
CSG Investigational Site (#401)
CSG Investigational Site (#143)
CSG Investigational Site (#307)
CSG Investigational Site (#151)
CSG Investigational Site (# 750)
CSG Investigational Site (#148)
CSG Investigational Site (#104)
CSG Investigational Site (#652)
CSG Investigational Site (#513)
CSG Investigative Site (#204)
CSG Investigational Site (#162)
CSG Investigational Site (#603)
CSG Investigational Site (#123)
CSG Investigational Site (#118)
CSG Investigational Site (#111)
CSG Investigational Site (#129)
CSG Investigational Site (#302)
CSG Investigational Site (#656)
CSG Investigational Site (#804)
CSG Investigational Site (#507)
CSG Investigational Site (#154)
CSG Investigational Site (#605)
CSG Investigative Site (#702)
CSG Investigational Site (#152)
CSG Investigational Site (# 756)
CSG Investigational Site (#312)
CSG Investigational Site (#708)
CSG Investigational Site (#153)
CSG Investigational Site (#131)
CSG Investigational Site (#806)
CSG Investigational Site (#514)
CSG Investigational Site (#155)
CSG Investigational Site (#709)
CSG Investigational Site (#606)
CSG Investigational Site (#506)
CSG Investigational Site (#106)
CSG Investigational Site (#206)
CSG Investigational Site (#201)
CSG Investigational Site (#105)
CSG Investigational Site (#500)
CSG Investigational Site (#655)
CSG Investigational Site (#703)
CSG Investigational Site (#657)
CSG Investigational Site (#300)
CSG Investigational Site (#141)
CSG Investigational Site (#103)
CSG Investigational Site (#651)
CSG Investigational Site (# 607)
CSG Investigational Site (#107)
CSG Investigational Site (#308)
CSG Investigational Site (#314)
CSG Investigational Site (#600)
CSG Investigational Site (#205)
CSG Investigational Site (# 755)
CSG Investigational Site (#108)
CSG Investigational Site (#160)
CSG Investigational Site (#301)
CSG Investigational Site (#701)
CSG Investigational Site (#209)
CSG Investigational Site (#504)
CSG Investigational Site (#159)
CSG Investigational Site (#313)
CSG Investigational Site (#309)
CSG Investigational Site (# 850)
CSG Investigational Site (#150)
CSG Investigational Site (#146)
CSG Investigational Site (#121)
CSG Investigational Site (#124)
CSG Investigational Site (#800)
CSG Investigational Site (#706)
CSG Investigational Site (#304)
CSG Investigational Site (#122)
CSG Investigational Site (#752)
CSG Investigational Site (#501)
CSG Investigational Site (#505)
CSG Investigational Site (#208)
CSG Investigational Site (#502)
CSG Investigational Site (#114)
CSG Investigational Site (#136)
CSG Investigational Site (#144)
CSG Investigational Site (#509)
CSG Investigational Site (#310)
CSG Investigational Site (#757)
CSG Investigational Site (#145)
CSG Investigational Site (#753)
CSG Investigational Site (#306)
CSG Investigational Site (#510)
CSG Investigational Site (#801)
CSG Investigational Site (#115)
CSG Investigational Site (#400)
CSG Investigational Site (#503)
CSG Investigational Site (#802)
CSG Investigational Site (#402)
CSG Investigational Site (#602)
CSG Investigational Site (#137)
CSG Investigational Site (#120)
CSG Investigational Site (#128)
CSG Investigational Site (#109)
CSG Investigational Site (#315)
CSG Investigational Site (#101)
CSG Investigational Site (#147)
CSG Investigational Site (#754)
CSG Investigational Site (#130)
CSG Investigational Site (#117)
CSG Investigational Site (#132)
CSG Investigational Site (#156)
CSG Investigational Site (#700)
CSG Investigational Site (#303)
CSG Investigational Site (#311)
CSG Investigational Site (#113)
CSG Investigational Site (#158)
CSG Investigational Site (#707)
CSG Investigational Site (#157)
CSG Investigational Site (#653)
CSG Investigational Site (#508)
CSG Investigational Site (#803)
CSG Investigational Site (#139)
CSG Investigational Site (#202)
CSG Investigational Site (#127)
CSG Investigational Site (#200)
CSG Investigational Site (#751)
CSG Investigational Site (#601)
CSG Investigational Site (#134)
CSG Investigational Site (#102)
CSG Investigational Site (#125)
CSG Investigational Site (#119)
CSG Investigational Site (#116)
CSG Investigational Site (#112)
CSG Investigational Site (#133)
CSG Investigational Site (#110)
CSG Investigational Site (#149)
CSG Investigational Site (#207)

status_simplified: Unknown


lead_sponsor: Grünenthal GmbH

summary: Tapentadol has already been studied in adults. This study is needed to find out if tapentadol works and is safe to use in children and adolescents with long-term pain.

title: An Open-label Trial, Enrolling Subjects Aged 6 Years to Less Than 18 Years Suffering From Pain Requiring Prolonged Release Opioid Treatment, to Evaluate the Safety and Efficacy of Tapentadol PR Versus Morphine PR, Followed by an Open-label Extension

ipd_sharing_description: Information available on the Grünenthal Web Site (see URL below for details)

location_country:
Germany
Italy
Portugal
Hungary
United Kingdom
Belgium
Spain
Chile
Bulgaria
France


title: A Randomized, Double-Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia

summary: The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

ReferenceCitation: Arnold LM, Whitaker S, Hsu C, Jacobs D, Merante D. Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study. Curr Med Res Opin. 2019 Oct;35(10):1825-1835. doi: 10.1080/03007995.2019.1629757. Epub 2019 Jul 9.

publisher_dissemination: Informa

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.

sponsor_collaborators:
Daiichi Sankyo, Inc.
Syneos Health

location_country:
Finland
Germany
Norway
Denmark
Sweden
Netherlands
United States
Czechia
Canada
Serbia
France


summary: The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

ReferenceCitation: Chen P, Sohn W, Narayanan A, Gisleskog PO, Melhem M. Bridging adults and paediatrics with secondary hyperparathyroidism receiving haemodialysis: a pharmacokinetic-pharmacodynamic analysis of cinacalcet. Br J Clin Pharmacol. 2019 Jun;85(6):1312-1325. doi: 10.1111/bcp.13900. Epub 2019 Apr 25.

ReferenceCitation: Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.

title: A Randomized, Open-label, Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Secondary Hyperparathyroidism and Chronic Kidney Disease Receiving Dialysis

location_country:
Germany
Italy
Lithuania
Poland
Portugal
New Zealand
Slovakia
Hungary
Belgium
United States
Spain
Greece
Czechia
Ukraine
Russian Federation
France


title: Study MEA117106: Mepolizumab vs. Placebo as add-on Treatment for Frequently Exacerbating COPD Patients

summary:
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group trial evaluating mepolizumab 100 mg against placebo given every 4 weeks through subcutaneous (SC) injection.

In severe COPD patients, sputum eosinophils levels are elevated similar as those seen in severe asthmatics. It is hypothesized that the reduction of eosinophils with mepolizumab in COPD patients would translate into a reduction of COPD exacerbations. The study will determine the reduction in exacerbations in subjects who are above and below the baseline blood eosinophil count of at least 150 cells/microlitres. The study will evaluate the efficacy and safety of mepolizumab on the frequency of moderate and severe exacerbations in COPD subjects at high risk of exacerbations, despite the use of optimized standard of care background therapy.

Overall in this study, a total of 800 subjects will be randomised in 1:1 ratio to receive placebo or mepolizumab (100 milligram (mg)) administered SC. The total duration of this study will be approximately 62 weeks, consisting of a 1 to 2 week screening period, 52-week treatment period and 8-week follow-up period.

ReferenceCitation: Pavord ID, Chapman KR, Bafadhel M, Sciurba FC, Bradford ES, Schweiker Harris S, Mayer B, Rubin DB, Yancey SW, Paggiaro P. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO. Int J Chron Obstruct Pulmon Dis. 2021 Jun 16;16:1755-1770. doi: 10.2147/COPD.S294333. eCollection 2021.

ReferenceCitation: Condreay LD, Gao C, Bradford E, Yancey SW, Ghosh S. No genetic associations with mepolizumab efficacy in COPD with peripheral blood eosinophilia. Respir Med. 2019 Aug;155:26-28. doi: 10.1016/j.rmed.2019.07.004. Epub 2019 Jul 5.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Pavord ID, Chanez P, Criner GJ, Kerstjens HAM, Korn S, Lugogo N, Martinot JB, Sagara H, Albers FC, Bradford ES, Harris SS, Mayer B, Rubin DB, Yancey SW, Sciurba FC. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. 2017 Oct 26;377(17):1613-1629. doi: 10.1056/NEJMoa1708208. Epub 2017 Sep 11.

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 Oxford - Oxford University Research Archive (ORA)

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

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

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

location_country:
Italy
Poland
Norway
Australia
Sweden
Mexico
Belgium
United States
Spain
Greece
Czechia
Canada
Estonia
Peru
Russian Federation
France


acronym: Simplify 2

lead_sponsor: Sierra Oncology LLC - a GSK company

summary:
This study is to determine the efficacy of momelotinib (MMB) versus best available therapy (BAT) in anemic or thrombocytopenic adults with primary myelofibrosis (PMF), or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) who were treated with ruxolitinib as measured by splenic response rate at Week 24 (SRR24).

Participants will be randomized to receive either MMB or BAT for 24 weeks during the randomized treatment phase, after which they will be eligible to receive MMB in an extended treatment phase for up to an additional 204 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 subjects planning to continue treatment with MMB following the end of the study, the End of Treatment, 30-day, 12-Week, and survival follow-up visits are not required.

ReferenceCitation: Harrison CN, Vannucchi AM, Platzbecker U, Cervantes F, Gupta V, Lavie D, Passamonti F, Winton EF, Dong H, Kawashima J, Maltzman JD, Kiladjian JJ, Verstovsek S. Momelotinib versus best available therapy in patients with myelofibrosis previously treated with ruxolitinib (SIMPLIFY 2): a randomised, open-label, phase 3 trial. Lancet Haematol. 2018 Feb;5(2):e73-e81. doi: 10.1016/S2352-3026(17)30237-5. Epub 2017 Dec 20.

title: A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis Who Were Treated With Ruxolitinib

location_country:
Germany
France
Italy
United Kingdom
United States
Spain
Canada
Israel


title: PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246

summary: The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.

ReferenceCitation: Lehmann S, Bykov VJ, Ali D, Andren O, Cherif H, Tidefelt U, Uggla B, Yachnin J, Juliusson G, Moshfegh A, Paul C, Wiman KG, Andersson PO. Targeting p53 in vivo: a first-in-human study with p53-targeting compound APR-246 in refractory hematologic malignancies and prostate cancer. J Clin Oncol. 2012 Oct 10;30(29):3633-9. doi: 10.1200/JCO.2011.40.7783. Epub 2012 Sep 10.

ReferenceCitation: Deneberg S, Cherif H, Lazarevic V, Andersson PO, von Euler M, Juliusson G, Lehmann S. An open-label phase I dose-finding study of APR-246 in hematological malignancies. Blood Cancer J. 2016 Jul 15;6(7):e447. doi: 10.1038/bcj.2016.60. No abstract available.

lead_sponsor: Aprea Therapeutics

location_country:
Germany
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
France

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Massey Cancer Center, Virginia Commonwealth University

location_facility: Institut Català d'Oncologia, Hospital Germans Trias i Pujol

location_facility: UPMC Hillman Cancer Center, Magee-Womens Hospital

location_facility: Edinburgh Cancer Research Centre, The University of Edinburgh

location_facility: Bristol Haematology & Oncology Centre, University Hospitals Bristol

location_facility: Imperial College London, Hammersmith Hospital Campus

location_facility: Cambridge Cancer Trials Centre, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

location_facility: The Clatterbridge Cancer Center NHS Foundation Trust

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Medische oncologie, Universitair Ziekenhuis Gent

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: University of Texas Southwestern Medical Center

location_facility: Parkland, UT Southwestern Medical Center


title: A Prospective, Longitudinal, Multinational, Observational Study to Describe Patterns of Care and Outcomes of Men Who Are at High Risk for Poor Clinical Outcomes After Experiencing Biochemical Failure Following Definitive Prostate Cancer Therapy, Men With Castration-Resistant Prostate Cancer and Men With Metastatic Prostate Cancer at Initial Diagnosis

acronym: ASPIRE-PCa

summary: The purpose of this study is to describe patterns in disease management and to describe clinical outcomes, as well as to identify factors influencing physician treatment decisions including reason(s) for treatment choices and trigger(s) for treatment changes and to document healthcare resource utilization used to manage treatment-related complications.

time_perspective: Prospective

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Germany
New Zealand
Argentina
Algeria
Australia
Brazil
Thailand
Canada
France
Colombia
Indonesia
Lebanon
Peru
Oman
Egypt
Philippines
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Israel


summary:
Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE).

A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.

ReferenceCitation: Klein G, Delmar P, Voyle N, Rehal S, Hofmann C, Abi-Saab D, Andjelkovic M, Ristic S, Wang G, Bateman R, Kerchner GA, Baudler M, Fontoura P, Doody R. Gantenerumab reduces amyloid-beta plaques in patients with prodromal to moderate Alzheimer's disease: a PET substudy interim analysis. Alzheimers Res Ther. 2019 Dec 12;11(1):101. doi: 10.1186/s13195-019-0559-z.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

version: submittedVersion

repositories_concat: PubMed Central;digitalcommons.wustl.edu

location_facility: Sussex Partnership NHS Foundation Trust; Cognitive Treatment and Research unit

location_facility: Charing Cross Hospital; Dept of Neurosciences

location_facility: California Neuroscience Research Medical Group, Inc

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: MBAL St. Marina; First Neurology Department

location_facility: Policlínica Guipuzkoa; Servicio de Neurología

location_facility: Royal Adelaide Hospital; Memory Trials Centre

location_facility: Australian Alzheimer's Research Foundation

location_facility: Juntendo University Urayasu Hospital; Neurology

location_facility: IRCCS "Centro S. Giovanni di Dio" Fatebenefratelli -UO Alzheimer

location_facility: National Hospital Organization Chiba-east Hospital; Neurology

location_facility: Semmelweis University; Department of Neurology

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Hopital Pierre Wertheimer; Laboratoire De Neuro Psychologie

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Hopital la Grave; Gerontopole - Centre de Recherche Clinique

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

location_facility: Saint Petersburg State Institution of Healthcare City Geriatric Medico-Social Center

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Klinikum rechts der Isar der TU München; Klinikapotheke

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata; Neurologia

location_facility: Alzheimer's Research and Treatment Center

location_facility: Miami Jewish Health Systems; Clinical Research

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: KAROLINSKA UNI HOSPITAL, HUDDINGE; Mottagning Kognitiv Forskning, M54

location_facility: Ewha Womans University Mokdong Hospital; Dept of Neurology

location_facility: Hospital General Universitario de Elche; Servicio de Neurología

location_facility: CHU Rennes - hopital Hotel Dieu; Consultation Memoire - Gerontologie

location_facility: Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus

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

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Hyogo Brain and Heart Center at Himeji; Department of Aging Brain and Cognitive Disorders

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Medical Corporation Hakuyokai Kashiwado Hospital

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Inha University Hospital; Neurology Department

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: University of Utah, Center for Alzheimer's Care Imaging & Research

location_facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research

location_facility: Erasmus Mc - Locatie Centrum; Dept of Neurology

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: Shonan Kamakura General Hospital; Neurology

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Jewish General Hospital / McGill University

location_facility: ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

location_facility: Fukuoka University Hospital; Neurology and Health Care

location_facility: Shizuoka City Shimizu Hospital; Neurology

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: Irccs Multimedica Santa Maria; Unita' Di Neurologia

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Nuovo Ospedale Civile S. Agostino-Estense; Clinica Neurologica - Dipartimento di Neuroscienze

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Territory Neurology and Research Institute

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: Seoul National University Bundang Hospital; Neurology Department

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: Dokuz Eylul University Medicine Faculty; Noroloji Departmani

location_facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

location_facility: Neuropsychiatric Research; Center of Southwest Florida

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Efficacy and Safety Study of Gantenerumab in Patients With Mild Alzheimer's Disease; Part II: Open-Label Extension For Participating Patients

location_country:
Finland
Germany
Argentina
Australia
Japan
Turkey
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Bulgaria
Russian Federation
Sweden


acronym: ERA 223

lead_sponsor: Bayer

summary: To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.

ReferenceType: result

ReferenceCitation: Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nole F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6. Erratum In: Lancet Oncol. 2019 Oct;20(10):e559.

ReferenceCitation: Shore N, Higano CS, George DJ, Sternberg CN, Saad F, Tombal B, Miller K, Kalinovsky J, Jiao X, Tangirala K, Sartor O. Concurrent or layered treatment with radium-223 and enzalutamide or abiraterone/prednisone: real-world clinical outcomes in patients with metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):680-688. doi: 10.1038/s41391-020-0236-0. Epub 2020 May 13.

ReferenceCitation: Matsubara N, Kimura G, Uemura H, Uemura H, Nakamura M, Nagamori S, Mizokami A, Kikukawa H, Hosono M, Kinuya S, Krissel H, Siegel J, Kakehi Y. A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study. Int J Clin Oncol. 2020 Apr;25(4):720-731. doi: 10.1007/s10147-019-01589-6. Epub 2019 Dec 10.

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

status: Active, not recruiting

title: A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Finland
Germany
Poland
Australia
Brazil
Japan
Canada
France
United States
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Spain
Russian Federation
Israel

status_simplified: Ongoing


title: A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER

acronym: ABRAZO

summary:
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; or
Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease

ReferenceCitation: Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke EM, Mina LA, Balmana J, Fasching PA, Hurvitz SA, Wardley AM, Chappey C, Hannah AL, Robson ME; ABRAZO Study Group. A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO). Clin Cancer Res. 2019 May 1;25(9):2717-2724. doi: 10.1158/1078-0432.CCR-18-1891. Epub 2018 Dec 18.

evidence: oa repository (via page says license)

publisher_dissemination: American Association for Cancer Research

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

lead_sponsor: Pfizer

sponsor_collaborators:
Pfizer
Myriad Genetic Laboratories, Inc.
Medivation, Inc.

location_country:
Germany
United Kingdom
United States
Spain
France

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: Kliniken Essen Mitte Klinik fuer Gynaekologie und Gynaekologische Onkologie

location_facility: g.SUND Gynaekologie Kompetenzzentrum Stralsund

location_facility: Memorial Breast Cancer Center at Memorial Hospital West

location_facility: Cambridge University Hospital NHS Foundation Trust

location_facility: Anne Arundel Medical Center (AAMC), Research Pharmacy

location_facility: University of California, San Francisco: Helen Diller Comprehensive Cancer Center

location_facility: IOZ Muenchen - lnerdisziplinaeres Onkologisches Zentrum

location_facility: University of Munich (LMU) Grosshadern Hospital

location_facility: Anne Arundel Medical Center (AAMC), Annapolis Oncology and Hematology

location_facility: Klinikum Mutterhaus Der Borromaeerinnen Ggmbh

location_facility: MD Anderson Cancer Center International Espana

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Memorial Sloan Kettering Rockville Centre

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer Care Associates

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Memorial Cancer Institute at Memorial Hospital West

location_facility: Hospital Universitario San Juan de Alicante

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins, Green Spring Station

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: UCLA West Medical Pharmacy Attn: Steven L. Wong, PharmD

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Memorial Sloan Kettering Evelyn H. Lauder Breast Center

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust


title: A Randomized, Double-blind, Placebo Controlled, 2-arm, Parallel-group, 26-week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in the Treatment of Subjects With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin Therapy

summary: The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) compared to placebo in the treatment of participants with Type 2 Diabetes Mellitus (T2DM), who have inadequate glycemic control on maximally or near-maximally effective doses of metformin and sitagliptin.

ReferenceCitation: Cai J, Delahanty LM, Akapame S, Slee A, Traina S. Impact of Canagliflozin Treatment on Health-Related Quality of Life among People with Type 2 Diabetes Mellitus: A Pooled Analysis of Patient-Reported Outcomes from Randomized Controlled Trials. Patient. 2018 Jun;11(3):341-352. doi: 10.1007/s40271-017-0290-4.

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

repositories_concat: PubMed Central;dash.harvard.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Australia
United States
Canada
France


acronym: TOWER Study

summary: The primary objective was to evaluate the effect of blinatumomab on overall survival when compared to standard of care (SOC) chemotherapy.

ReferenceCitation: Delea TE, Amdahl J, Boyko D, Hagiwara M, Zimmerman ZF, Franklin JL, Cong Z, Hechmati G, Stein A. Cost-effectiveness of blinatumomab versus salvage chemotherapy in relapsed or refractory Philadelphia-chromosome-negative B-precursor acute lymphoblastic leukemia from a US payer perspective. J Med Econ. 2017 Sep;20(9):911-922. doi: 10.1080/13696998.2017.1344127. Epub 2017 Jul 11.

ReferenceCitation: Kantarjian H, Stein A, Gokbuget N, Fielding AK, Schuh AC, Ribera JM, Wei A, Dombret H, Foa R, Bassan R, Arslan O, Sanz MA, Bergeron J, Demirkan F, Lech-Maranda E, Rambaldi A, Thomas X, Horst HA, Bruggemann M, Klapper W, Wood BL, Fleishman A, Nagorsen D, Holland C, Zimmerman Z, Topp MS. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017 Mar 2;376(9):836-847. doi: 10.1056/NEJMoa1609783.

ReferenceCitation: Dombret H, Topp MS, Schuh AC, Wei AH, Durrant S, Bacon CL, Tran Q, Zimmerman Z, Kantarjian H. Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2019 Sep;60(9):2214-2222. doi: 10.1080/10428194.2019.1576872. Epub 2019 Apr 5.

ReferenceCitation: Kuchimanchi M, Zhu M, Clements JD, Doshi S. Exposure-response analysis of blinatumomab in patients with relapsed/refractory acute lymphoblastic leukaemia and comparison with standard of care chemotherapy. Br J Clin Pharmacol. 2019 Apr;85(4):807-817. doi: 10.1111/bcp.13864. Epub 2019 Feb 18.

ReferenceCitation: Stein AS, Larson RA, Schuh AC, Stevenson W, Lech-Maranda E, Tran Q, Zimmerman Z, Kormany W, Topp MS. Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia. Blood Adv. 2018 Jul 10;2(13):1522-1531. doi: 10.1182/bloodadvances.2018019034.

ReferenceCitation: Topp MS, Zimmerman Z, Cannell P, Dombret H, Maertens J, Stein A, Franklin J, Tran Q, Cong Z, Schuh AC. Health-related quality of life in adults with relapsed/refractory acute lymphoblastic leukemia treated with blinatumomab. Blood. 2018 Jun 28;131(26):2906-2914. doi: 10.1182/blood-2017-09-804658. Epub 2018 May 8.

ReferenceCitation: Kantarjian HM, Zugmaier G, Bruggemann M, Wood BL, Horst HA, Zeng Y, Martinelli G. Impact of Blinatumomab Treatment on Bone Marrow Function in Patients with Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia. Cancers (Basel). 2021 Nov 9;13(22):5607. doi: 10.3390/cancers13225607.

ReferenceCitation: Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

ReferenceCitation: Jabbour E, Patel K, Jain N, Duose D, Luthra R, Short NJ, Zugmaier G, San Lucas A, Velasco K, Tran Q, Zaman F, Konopleva M, Kantarjian H. Impact of Philadelphia chromosome-like alterations on efficacy and safety of blinatumomab in adults with relapsed/refractory acute lymphoblastic leukemia: A post hoc analysis from the phase 3 TOWER study. Am J Hematol. 2021 Oct 1;96(10):E379-E383. doi: 10.1002/ajh.26281. Epub 2021 Jul 7. No abstract available.

ReferenceCitation: Wei AH, Ribera JM, Larson RA, Ritchie D, Ghobadi A, Chen Y, Anderson A, Dos Santos CE, Franklin J, Kantarjian H. Biomarkers associated with blinatumomab outcomes in acute lymphoblastic leukemia. Leukemia. 2021 Aug;35(8):2220-2231. doi: 10.1038/s41375-020-01089-x. Epub 2021 Feb 4.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;digitalcommons.wustl.edu

repositories_institution: Washington University School of Medicine - Digital Commons@Becker

ReferenceCitation: Rambaldi A, Huguet F, Zak P, Cannell P, Tran Q, Franklin J, Topp MS. Blinatumomab consolidation and maintenance therapy in adults with relapsed/refractory B-precursor acute lymphoblastic leukemia. Blood Adv. 2020 Apr 14;4(7):1518-1525. doi: 10.1182/bloodadvances.2019000874.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_concat: PubMed Central;air.unimi.it

title: A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study)

location_country:
Germany
Ireland
Poland
Australia
Turkey
Czechia
Canada
France
United States
Belgium
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-centre, Phase IIb Study to Assess Safety and Clinical Activity of Continued AFFITOPE® AD02 Vaccinations of Patients Who Participated in the AFFITOPE® AD02 Phase II Study AFF006.

summary: This is a follow-up study to assess safety and clinical activity of continued AFFITOPE® AD02 vaccinations in patients with Alzheimer's disease. Patients, who have already participated in AFF006 will be involved in 27 study sites in Europe. Duration of patient's participation in the clinical trial is 19 months.

lead_sponsor: Affiris AG

location_country:
Germany
Slovakia
Austria
Croatia
Czech Republic
France

location_facility: Centre Mémoire de Ressources et de Recherche, Service de Neurologie

location_facility: "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju

location_facility: Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie

location_facility: Arzneimittelforschung Leipzig GmbH, Studienzentrum

location_facility: Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München

location_facility: Christian Doppler Klinik, Univ. Klinik f. Neurologie

location_facility: MUW Klin. Pharmakologie und Klinik für Neurologie

location_facility: CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard

location_facility: University Hospital Motol, Clinic of Neurology

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie

location_facility: Opća bolnica Varaždin, Klinika za Neurologiju

location_facility: Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju

location_facility: Centre Hospitalier Universitaire (CHU) de Dijon

location_facility: Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie


title: A 24-week, Phase IIB, Randomized, Controlled, Parallel Group, Multi-center Study to Evaluate the Safety and Efficacy of GSK1278863 in Subjects With Anemia Associated With Chronic Kidney Diseases Who Are Not on Dialysis.

summary: This study will be conducted in approximately 228 subjects with anemia associated with CKD who are not on dialysis. Two groups of subjects will be enrolled into the study: Group 1: recombinant human erythropoietin (rhEPO) naive subjects; Group 2: rhEPO users, who are currently receiving rhEPO. Subjects who are rhEPO naive will be randomized to receive either GSK1278863 once daily (QD) or rhEPO in a 3:1 fashion; subjects who are receiving an rhEPO before enrolling (rhEPO users) will be randomized in a 1:1 fashion to GSK1278863 QD or to the control arm. For those randomized to the control arm, the decision around whether the subject requires rhEPO, the selection of the type of rhEPO (if needed) and the choice of rhEPO dose to achieve and maintain Hgb concentrations within the target range should be based on Investigator clinical judgment, with the historical rhEPO dose and the current Hgb value being considered. The study consists of a screening phase of at least 4 weeks, a 24-week treatment phase and a follow-up visit that will occur approximately 4 weeks after completing treatment. It is anticipated that the data generated will enable selection of the starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

location_country:
Germany
Poland
Hungary
United Kingdom
Denmark
Australia
Japan
Sweden
United States
Korea, Republic of
Spain
Czechia
Canada
Russian Federation
France


type: U.S. NIH Grant/Contract

type: Other Grant/Funding Number

title: Age of Blood in Children in Pediatric Intensive Care Units

acronym: ABC-PICU

summary: ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC storage duration in 1538 critically ill children. Laboratory and observational evidence points to serious concerns about the lack of safety and effectiveness of older RBCs, especially in more vulnerable populations. Physicians and institutions have been systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed high quality evidence to answer the question "do RBCs of reduced storage duration improve outcomes?" The ABC PICU Trial will conduct a RCT comparing development of New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of 17-21 days).

ReferenceCitation: Spinella PC, Tucci M, Fergusson DA, Lacroix J, Hebert PC, Leteurtre S, Schechtman KB, Doctor A, Berg RA, Bockelmann T, Caro JJ, Chiusolo F, Clayton L, Cholette JM, Guerra GG, Josephson CD, Menon K, Muszynski JA, Nellis ME, Sarpal A, Schafer S, Steiner ME, Turgeon AF; ABC-PICU Investigators, the Canadian Critical Care Trials Group, the Pediatric Acute Lung Injury and Sepsis Investigators Network, the BloodNet Pediatric Critical Care Blood Research Network, and the Groupe Francophone de Reanimation et Urgences P. Effect of Fresh vs Standard-issue Red Blood Cell Transfusions on Multiple Organ Dysfunction Syndrome in Critically Ill Pediatric Patients: A Randomized Clinical Trial. JAMA. 2019 Dec 10;322(22):2179-2190. doi: 10.1001/jama.2019.17478.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Tucci M, Lacroix J, Fergusson D, Doctor A, Hebert P, Berg RA, Caro J, Josephson CD, Leteurtre S, Menon K, Schechtman K, Steiner ME, Turgeon AF, Clayton L, Bockelmann T, Spinella PC; Canadian Critical Care Trials Group; Pediatric Critical Care Blood Research Network (BloodNet); Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial. Trials. 2018 Jul 28;19(1):404. doi: 10.1186/s13063-018-2809-y.

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

repository_normalized: HAL

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

repository_institution: Université de Lille (University Of Lille) - LillOA

repository_normalized: LillOA (Lille Open Archive)

repositories:
HAL
LillOA (Lille Open Archive)
PubMed Central

repositories_concat: HAL;LillOA (Lille Open Archive);PubMed Central

lead_sponsor: Washington University School of Medicine

collaborators: National Heart, Lung, and Blood Institute (NHLBI)

collaborators: Canadian Institutes of Health Research (CIHR)

collaborators: Ministere de la Sante et des Services Sociaux

location_country:
France
Italy
United States
Canada
Israel

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: James Whitcomb Riley Hospital for Children

location_facility: Centre Hospitalier de I'Universite Laval

location_facility: Hôpital Universitaire Necker - Enfants Malades

location_facility: The Children's Hospital and University of Colorado Denver School of Medicine

lead_sponsor_type: academique

appel_a_projets: PHRCN

region: Hauts-de-France

nom_etablissement: CHR LILLE

type_etablissement: CH

acronyme: ABC-PICU

titre: Effet de la durée d'entreposage des concentrés érythrocytaires sur la morbidité des enfants transfusés en réanimation pédiatrique

discipline_principale: autre

nom_porteur: LETEURTRE

prenom_porteur: Stéphane


acronym: LIRA-LIXI™

lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in Europe. The aim of the trial is to investigate the efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes (T2DM).

ReferenceCitation: Nauck M, Rizzo M, Johnson A, Bosch-Traberg H, Madsen J, Cariou B. Once-Daily Liraglutide Versus Lixisenatide as Add-on to Metformin in Type 2 Diabetes: A 26-Week Randomized Controlled Clinical Trial. Diabetes Care. 2016 Sep;39(9):1501-9. doi: 10.2337/dc15-2479. Epub 2016 Jun 16.

publisher_dissemination: American Diabetes Association

ReferenceCitation: Hunt B, Vega-Hernandez G, Valentine WJ, Kragh N. Evaluation of the long-term cost-effectiveness of liraglutide vs lixisenatide for treatment of type 2 diabetes mellitus in the UK setting. Diabetes Obes Metab. 2017 Jun;19(6):842-849. doi: 10.1111/dom.12890. Epub 2017 Feb 23.

title: Efficacy and Safety of Liraglutide Versus Lixisenatide as add-on to Metformin in Subjects With Type 2 Diabetes

location_country:
Finland
Germany
Italy
Lithuania
Hungary
United Kingdom
Latvia
Czech Republic
France


title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

acronym: STARSHINE

summary: To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

ReferenceCitation: Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.

ReferenceCitation: Cummings JL, Atri A, Ballard C, Boneva N, Frolich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

ReferenceCitation: Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

lead_sponsor: H. Lundbeck A/S

sponsor_collaborators:
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.

location_country:
Germany
Italy
Poland
Argentina
Denmark
Romania
Belgium
United States
Spain
South Africa
Chile
Czechia
Ukraine
Bulgaria
Canada
France


title: Efficacy, Safety and Tolerability of Multiple Doses of Oral Cebranopadol in Subjects With Moderate to Severe Chronic Pain Due to Diabetic Peripheral Neuropathy.

summary:
The purpose of this trial is to evaluate if cebranopadol is safe and can decrease pain in patients when compared to placebo (a tablet that does not contain active product) and when compared to a marketed product containing pregabalin (Lyrica®). Furthermore, this trial will be undertaken to find out if the patient's general health and well-being improves under trial treatment.

The concentrations of cebranopadol in the blood will be investigated to get a better understanding of how it is absorbed from the gut, distributed and broken down in the body, and eliminated from the body.

lead_sponsor: Tris Pharma, Inc.

location_country:
Germany
Italy
Denmark
Netherlands
Austria
United States
Spain
France


title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma

acronym: AUGMENT

summary: This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

ReferenceCitation: Morschhauser F, Fowler NH, Feugier P, Bouabdallah R, Tilly H, Palomba ML, Fruchart C, Libby EN, Casasnovas RO, Flinn IW, Haioun C, Maisonneuve H, Ysebaert L, Bartlett NL, Bouabdallah K, Brice P, Ribrag V, Daguindau N, Le Gouill S, Pica GM, Martin Garcia-Sancho A, Lopez-Guillermo A, Larouche JF, Ando K, Gomes da Silva M, Andre M, Zachee P, Sehn LH, Tobinai K, Cartron G, Liu D, Wang J, Xerri L, Salles GA; RELEVANCE Trial Investigators. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma. N Engl J Med. 2018 Sep 6;379(10):934-947. doi: 10.1056/NEJMoa1805104.

ReferenceCitation: Leonard JP, Trneny M, Izutsu K, Fowler NH, Hong X, Zhu J, Zhang H, Offner F, Scheliga A, Nowakowski GS, Pinto A, Re F, Fogliatto LM, Scheinberg P, Flinn IW, Moreira C, Cabecadas J, Liu D, Kalambakas S, Fustier P, Wu C, Gribben JG; AUGMENT Trial Investigators. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019 May 10;37(14):1188-1199. doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.

license: cc-by-nd

license_normalized: cc-by-nd

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_concat: PubMed Central;archive.ugent.be

lead_sponsor: Celgene

location_country:
Germany
Italy
Poland
Portugal
Israel
United Kingdom
Japan
Brazil
Belgium
United States
China
Spain
Turkey
Czechia
Puerto Rico
Russian Federation
France

location_facility: Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute

location_facility: Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: National University Corporation Tohoku University, Tohoku University Hospital

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi - Nesima

location_facility: Fakultni Nemocnice Ostrava, Klinika hematoonkologie,

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: North County Hematology Oncology (NCHO) - TRM, LLC.

location_facility: Fundação Antonio Prudente - AC Camargo Câncer center

location_facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Kobe City Medical Center General Hospital

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: A.O.U. di Bologna Policlinico S.Orsola-Malpighi

location_facility: Fujian Medical University Union Hospital

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Russian Academy of Medical Sciences Institution

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Florida Cancer Specialists North Region Sarah Cannon Research

location_facility: Southend University Hospital NHS Foundation Trust, Prittlewell Chase

location_facility: Onkologische Schwerpunktpraxis Leer - Emden

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

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

location_facility: The Third Xiangya hospital of central south university

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Klinkum der Stadt Villingen-Schwenningen GmbH

location_facility: University of Louisville, J.G. Brown Cancer Center

location_facility: Oncology Hematology Care Sarah Cannon Research

location_facility: The Ministry of Health and Social Development of the Tula region state institution Health Tula regio

location_facility: Associacao Educudora Sao Carlos AESC Hospital Giovanni Battista HGB Hospital Mae de Deus Center

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Centro di Riferimento Oncologico - IRCCS

location_facility: Hematology-Oncology Associates of Northern NJ

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

location_facility: Cukurova University Medical Faculty Balcali Hospital

location_facility: Sociedade Beneficente de Senhoras Hospital Sirio Libanes

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Nagoya Medical Center,Division of Hematology/Oncology

location_facility: Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Instytut Hematologii i Transfuzjologii w Warszawie

location_facility: Royal Liverpool University Hospital, Prescot Street

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: Central Coast Medical Oncology Corporation

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: Jiangsu Province Hospital The First Hospital affiliated with Nanjing Medical University

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia

location_facility: West China Hospital of Sichuan University

location_facility: IRCCS- Istituto Nazionale per lo Studio e la Cura dei Tumori, Fondazione "G. Pascale"

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Coborn Cancer Center at the St. Cloud Hospital

location_facility: Chinese Academy of Medical Sciences & Peking Union Medical College

location_facility: Hematology-Oncology Medical Group of Orange County, Inc.

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Mitchell Cancer Center, University of South Alabama

location_facility: Associacao Hospitalar Moinhos de Vento Hospital Moinhos de Vento

location_facility: St. Petersburg Pavlov State Medical University

location_facility: Fakultni nemocnice Hradec Kralove, IV.interni hematologicka klinika

location_facility: Hospital Dr. Amaral Carvalho/ Hospital Amaral Carvalho Jaú


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Inadequately Controlled Asthma and High Bronchodilator Reversibility

summary: The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

ReferenceCitation: Globe G, Wiklund I, Mattera M, Zhang H, Revicki DA. Evaluating minimal important differences and responder definitions for the asthma symptom diary in patients with moderate to severe asthma. J Patient Rep Outcomes. 2019 Apr 3;3(1):22. doi: 10.1186/s41687-019-0109-2.

lead_sponsor: Amgen

collaborators:
Kyowa Kirin Co., Ltd.
AstraZeneca

sponsor_collaborators:
Amgen
Kyowa Kirin Co., Ltd.
AstraZeneca

location_country:
Germany
Ireland
Italy
Poland
New Zealand
Hong Kong
Australia
United States
Korea, Republic of
Greece
Taiwan
Canada
Puerto Rico
Russian Federation
France