acronym: SOTA-EMPA

lead_sponsor: Lexicon Pharmaceuticals

summary: The purpose of the study is to demonstrate the superiority of sotagliflozin versus placebo on hemoglobin A1c (HbA1c) reduction in participants with type 2 diabetes (T2D) who have inadequate glycemic control on a DPP4(i) with or without metformin.

sponsor_collaborators:
Lexicon Pharmaceuticals
Sanofi

location_facility:
Investigational Site Number 8408005
Investigational Site Number 7248003
Investigational Site Number 1248007
Investigational Site Number 7248007
Investigational Site Number 2508001
Investigational Site Number 7248006
Investigational Site Number 8408009
Investigational Site Number 8408082
Investigational Site Number 4848005
Investigational Site Number 8408012
Investigational Site Number 1248011
Investigational Site Number 2038007
Investigational Site Number 6438011
Investigational Site Number 8268003
Investigational Site Number 7038001
Investigational Site Number 2038010
Investigational Site Number 2038011
Investigational Site Number 2508004
Investigational Site Number 8268002
Investigational Site Number 3808005
Investigational Site Number 8408027
Investigational Site Number 8408011
Investigational Site Number 3808010
Investigational Site Number 2038003
Investigational Site Number 2038008
Investigational Site Number 4848003
Investigational Site Number 4288002
Investigational Site Number 7038002
Investigational Site Number 2508007
Investigational Site Number 7248002
Investigational Site Number 8408061
Investigational Site Number 8408041
Investigational Site Number 4848002
Investigational Site Number 2038001
Investigational Site Number 3808001
Investigational Site Number 8408060
Investigational Site Number 3808002
Investigational Site Number 4848001
Investigational Site Number 8408004
Investigational Site Number 2038009
Investigational Site Number 8408051
Investigational Site Number 8408018
Investigational Site Number 8408047
Investigational Site Number 8268006
Investigational Site Number 8408006
Investigational Site Number 8408074
Investigational Site Number 2508002
Investigational Site Number 7038005
Investigational Site Number 7248001
Investigational Site Number 8408037
Investigational Site Number 2038013
Investigational Site Number 6438007
Investigational Site Number 4288007
Investigational Site Number 4288005
Investigational Site Number 8408052
Investigational Site Number 8408026
Investigational Site Number 8408028
Investigational Site Number 1248001
Investigational Site Number 8408069
Investigational Site Number 3808011
Investigational Site Number 6438014
Investigational Site Number 7248009
Investigational Site Number 8268005
Investigational Site Number 1248003
Investigational Site Number 7038008
Investigational Site Number 6438010
Investigational Site Number 8408022
Investigational Site Number 7038004
Investigational Site Number 8408056
Investigational Site Number 8408064
Investigational Site Number 6438001
Investigational Site Number 8408039
Investigational Site Number 8408017
Investigational Site Number 1248008
Investigational Site Number 8408068
Investigational Site Number 4288008
Investigational Site Number 7038009
Investigational Site Number 3808003
Investigational Site Number 8408035
Investigational Site Number 8408036
Investigational Site Number 3808007
Investigational Site Number 8408031
Investigational Site Number 8408079
Investigational Site Number 8408001
Investigational Site Number 8408008
Investigational Site Number 1248005
Investigational Site Number 8408007
Investigational Site Number 2508006
Investigational Site Number 8408053
Investigational Site Number 4288004
Investigational Site Number 6438008
Investigational Site Number 8408032
Investigational Site Number 8408072
Investigational Site Number 1008004
Investigational Site Number 8408002
Investigational Site Number 2038004
Investigational Site Number 3808008
Investigational Site Number 8408049
Investigational Site Number 8408044
Investigational Site Number 6438002
Investigational Site Number 4288003
Investigational Site Number 2038002
Investigational Site Number 6438013
Investigational Site Number 8268001
Investigational Site Number 1008007
Investigational Site Number 8268007
Investigational Site Number 8408010
Investigational Site Number 1248009
Investigational Site Number 1008001
Investigational Site Number 8408029
Investigational Site Number 2038006
Investigational Site Number 4848007
Investigational Site Number 1008003
Investigational Site Number 1248010
Investigational Site Number 8408040
Investigational Site Number 4288006
Investigational Site Number 8408054
Investigational Site Number 4848011
Investigational Site Number 8408042
Investigational Site Number 3808006
Investigational Site Number 8408038
Investigational Site Number 8408067
Investigational Site Number 4288001
Investigational Site Number 7038007
Investigational Site Number 1008012
Investigational Site Number 1248002
Investigational Site Number 8408016
Investigational Site Number 6438012
Investigational Site Number 8408019
Investigational Site Number 2038005
Investigational Site Number 6438009
Investigational Site Number 7248008
Investigational Site Number 1008011
Investigational Site Number 7248004
Investigational Site Number 1008008
Investigational Site Number 8408013
Investigational Site Number 7248005
Investigational Site Number 1008002
Investigational Site Number 2508005
Investigational Site Number 3808004
Investigational Site Number 8408045
Investigational Site Number 6438015
Investigational Site Number 4848012
Investigational Site Number 1008010
Investigational Site Number 1248004
Investigational Site Number 8408003
Investigational Site Number 8408059
Investigational Site Number 6438003
Investigational Site Number 7038003
Investigational Site Number 6438005
Investigational Site Number 2508003
Investigational Site Number 8268008
Investigational Site Number 7038006
Investigational Site Number 8268004
Investigational Site Number 3808009
Investigational Site Number 7248010
Investigational Site Number 6438006
Investigational Site Number 1008005
Investigational Site Number 1008006
Investigational Site Number 8408033

title: A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Compared to Empagliflozin, and Placebo in Participants With Type 2 Diabetes Who Have Inadequate Glycemic Control on Dipeptidyl Peptidase 4 Inhibitor (DPP4(i)) With or Without Metformin

ipd_sharing_description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

location_country:
Italy
Slovakia
United Kingdom
Mexico
United States
Latvia
Spain
Czechia
Bulgaria
Canada
Russian Federation
France


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Hoffmann-La Roche

summary: This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

ReferenceType: derived

ReferenceCitation: Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2022 Feb;191(3):565-576. doi: 10.1007/s10549-021-06450-x. Epub 2021 Dec 3.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

location_facility: Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology

location_facility: PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax

location_facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

location_facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology

location_facility: National Hospital Organization Osaka National Hospital

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Dicle Uni Medical Faculty; Internal Medicine

location_facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

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

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients

location_facility: Hospital de Donostia; Servicio de Oncologia

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Hosp Provincial D. Centenarios; Oncology Dept

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Sakarya University Medical School; Medical Oncology

location_facility: Kinki University Hospital, Faculty of Medicine; Surgery

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

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

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr

location_facility: Agioi Anargyroi; 3Rd Dept. of Medical Oncology

location_facility: Vall d?Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter.

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: USC Norris Cancer Center; USC Oncology Hematology Newport Beach

location_facility: Hospital Clinico Universitario; Oncologia

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hospital Clinic Barcelona; Servicio de oncologia

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Seoul National University Bundang Hospital

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: National Cancer Institute MOH of Ukraine

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

location_facility: University Hospital coventry; Oncology Department

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy

location_facility: National Cancer Centre; Medical Oncology

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

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Kaiser Permanente - San Francisco (2238 Geary)

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e

location_facility: Showa University Hospital; Breast Surgery

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Instituto Regional de Enfermedades Neoplasicas - IREN Norte

location_facility: PHI University Clinic of Radiotherapy and Oncology; Breast malignancy

location_facility: Medipol University Medical Faculty; Oncology Department

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: FSI Rostov research oncological institute of MoH and SD of RF; PAD

status: Completed

title: A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Argentina
Australia
Brazil
Costa Rica
Japan
Turkey
Chile
Czechia
Canada
France
Slovenia
Hungary
United States
Ukraine
North Macedonia
India
Belgium
Peru
Italy
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Eli Lilly and Company

summary:
The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis.

Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.

ReferenceCitation: Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Dec;12(12):2765-2779. doi: 10.1007/s13555-022-00828-5. Epub 2022 Oct 18.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: gold

ReferenceCitation: Silverberg JI, Simpson EL, Wollenberg A, Bissonnette R, Kabashima K, DeLozier AM, Sun L, Cardillo T, Nunes FP, Reich K. Long-term Efficacy of Baricitinib in Adults With Moderate to Severe Atopic Dermatitis Who Were Treatment Responders or Partial Responders: An Extension Study of 2 Randomized Clinical Trials. JAMA Dermatol. 2021 Jun 1;157(6):691-699. doi: 10.1001/jamadermatol.2021.1273.

evidence: open (via free pdf)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher_dissemination: American Medical Association

ReferenceCitation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

sponsor_collaborators:
Eli Lilly and Company
Incyte Corporation

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Aarhus Universitehospital Marselisborg Centret

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: Byramjee Jeejeebhoy Medical College & Civil Hospital

location_facility: Dr. D. Y. Patil Medical College & Hospital

location_facility: Russian state medical-stomatological university n.a. Evdokimov

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Severance Hospital Yonsei University Health System

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: Kyoto Prefectural University of Medicine

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: KH Hietzing mit neurologischem Zentrum Rosenhügel

location_facility: CHUV Centre Hospitalier Universitaire Vaudois

location_facility: Universität Leipzig - Universitätsklinikum

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus

location_facility: Ordensklinikum Linz GmbH - Elisabethinen

location_facility: Miejski Szpital Zespolony w Olsztynie Klinika Dermatologii

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Queen's Square Dermatology and Allergology

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: All India Institue of Medical Sciences (AIIMS)

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: SZTE AOK Borgyogyaszati es Allergologiai Klinika

location_facility: Instituto de Neumonología y Dermatología

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

location_facility: Medical Corporation Soleil Miyata Dermatology Clinic

location_facility: CEDIC-Centro de Investigaciones Clinicas

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Universitätsklinikum Aachen AöR - Klinik für Dermatologie und Allergologie - Hautklinik

location_facility: Azienda Ospedaliera Universitaria Ospedale San Martino di Genova

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

title: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients With Atopic Dermatitis

type: Other Identifier

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

location_country:
Germany
Poland
Argentina
Australia
Japan
Czechia
France
Hungary
Denmark
Switzerland
India
Italy
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

ipd_sharing: Yes


title: A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane

acronym: CONTESSA

summary: CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled.

status: Terminated

ipd_sharing: Undecided

ipd_sharing_description: Currently under evaluation by the organization

lead_sponsor: Odonate Therapeutics, Inc.

location_country:
Germany
Poland
Australia
Thailand
Czechia
Canada
France
Hungary
United States
Ukraine
Belgium
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Cancer Treatment Centers of America - Philadelphia

location_facility: University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation

location_facility: Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )

location_facility: Hospital Teresa Herrera Materno-Infantil (CHUAC)

location_facility: Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie

location_facility: Mammazentrum HH am Krankenhaus Jerusalem

location_facility: Sarah Cannon Research Institute at Tennessee Oncology

location_facility: Stanford Cancer Center / Cancer Clinical Trials

location_facility: Communal Non-Profit Enterprise "Regional Center of Oncology"

location_facility: John Hopkins Singapore International Medical Centre

location_facility: University of North Carolina Lineberger Cancer Center

location_facility: St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum

location_facility: Sarah Cannon Research Institute - Florida Cancer Specialists

location_facility: S.C. Oncologia/Az. Osp.Ra. S Maria Terni

location_facility: Royal Cornwall Hospital Oncology Trials, Sunrise Centre

location_facility: LMU Klinikum der Universität München Breast Cancer

location_facility: Westside Surgical Hospital and Breast Center

location_facility: Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre

location_facility: Mercy Hospital St. Louis, David C. Pratt Cancer Center

location_facility: San Luis Obispo Oncology & Hematology Health Center

location_facility: Arizona Oncology Associates, P.C. - HOPE

location_facility: Arzt der Studienzentrale Universitätsklinikum Erlangen

location_facility: Cancer Care - Torrance Memorial Physician Network

location_facility: University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

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

location_facility: Oncology Hematology West, P.C. dba Nebraska Cancer Specialists

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: California Cancer Associates for Research and Excellence

location_facility: Central City Clinical Hospital, City Oncology Center

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: New Mexico Cancer Care Alliance - Southwest Gynecology Oncology

location_facility: Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"

location_facility: Hospices Civils de Lyon Sud Oncologie Medicale

location_facility: Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs

location_facility: Forrest General Cancer Center/Hattiesburg Clinic

location_facility: Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii

location_facility: Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut

location_facility: InVO - Institut für Versorgungsforschung

location_facility: Hospital Universitario Ramon y Cajal Servicio de Oncologia

location_facility: Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center

location_facility: Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad

location_facility: Onkologicka Klinika (Fakultni Nemocnice v Motole)

location_facility: Washington University School of Medicine

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

location_facility: Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie

location_facility: Florida Cancer Specialists and Research Institute - Panhandle Region

location_facility: Ospedale San Raffaele - Medical Oncology Dept.

location_facility: New Jersey Hematology Oncology Associates

location_facility: Texas Oncology - Dallas Presbyterian Hospital

location_facility: University of Pécs Department of Oncotherapy

location_facility: Centre Hospitalier Regional et Universitaire de Tours CHRU

location_facility: Center Hospitalier de Montreal CHUM McPeak Sirois

location_facility: Dnipropetrovsk City Multifield Clinical Hospital #4

location_facility: QEII Health Sciences Centre - Nova Scotia Cancer Centre

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Cancer Treatment Centers of America - Western Regional Medical Center

location_facility: Hematology Oncology Associates of Central New York, P.C.

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania

location_facility: Clinique Sainte Anne - Strasbourg Oncologie Liberale

location_facility: Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation

location_facility: CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: University of Maryland - Greenebaum Comprehensive Cancer Center

location_facility: Regional Cancer Care Associates, LLC-Sparta

location_facility: Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde

location_facility: NH Hospital a.s. Nemocnice Hořovice Onkologie

location_facility: Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik

location_facility: Centre François Baclesse Service the Recherche Clinique

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Cancer Research Collaboration and Breast Link

location_facility: Virginia Piper Cancer Institute, Allina Health

status_simplified: Unknown


acronym: SCORED

summary: The primary objective of the study was to compare the effect of sotagliflozin to placebo on total occurrences of cardiovascular (CV) death, hospitalization for heart failure [HHF], and urgent visit for heart failure [HF] in participants with type 2 diabetes, cardiovascular risk factors, and moderate to severely impaired renal function.

ReferenceCitation: Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kosiborod MN, Cherney DZI, Dwyer JP, Scirica BM, Bailey CJ, Diaz R, Ray KK, Udell JA, Lopes RD, Lapuerta P, Steg PG; SCORED Investigators. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139. doi: 10.1056/NEJMoa2030186. Epub 2020 Nov 16.

oa_colors: green other

evidence: open (via free article)

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

repository_institution: Imperial College London - Spiral

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repository_institution: Aston University - Aston Publications Explorer

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Cefalo CMA, Cinti F, Moffa S, Impronta F, Sorice GP, Mezza T, Pontecorvi A, Giaccari A. Sotagliflozin, the first dual SGLT inhibitor: current outlook and perspectives. Cardiovasc Diabetol. 2019 Feb 28;18(1):20. doi: 10.1186/s12933-019-0828-y.

repository_institution: PubMed Central - Europe PMC

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

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Investigational Site Number 0360001
Investigational Site Number 1520010

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes, Cardiovascular Risk Factors and Moderately Impaired Renal Function

primary_purpose: Prevention

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.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Turkey
Chile
Czechia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Ukraine
North Macedonia
India
Romania
Belgium
China
Peru
Estonia
Puerto Rico
Italy
Guatemala
Norway
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Georgia
Russian Federation
Israel


title: A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects With High-Risk Smoldering Multiple Myeloma

summary: The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Hungary
Denmark
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Spain
Greece
Russian Federation
Israel

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

location_facility: Centro de Atención e Investigación Clínica en Oncología

location_facility: ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Universitaetsklinikum Heidelberg Medizinische Klinik V

location_facility: Semmelweis Egyetem, I. Belgyogyaszati Klinika

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Semmelweis Egyetem I.Belgyogyaszati Klinika

location_facility: Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Università di Roma 'La Sapienza' - Ospedale Umberto 1°

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Nizhniy Novgorod Region Clinical Hospital

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

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: Clinical Research Center sp. z o.o MEDIC-R s.k.

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Tom Baker Cancer Center, University of Calgary

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Universidade Federal de Goias - Hospital das Clinicas da UFG

location_facility: Ankara Numune Egitim ve Arastirma Hastanesi

location_facility: Hospital Privado - Centro Medico de Cordoba

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Szent László Telephely

location_facility: On Dokuz Mayis University Medical Faculty Department of Hematology

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Centro de Investigación Farmacéutica Especializada

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia

location_facility: Oslo University Hospital HF Ullevål sykehus

location_facility: A.O.U. Città della Salute e della Scienza di Torino- Divisione di Ematologia

location_facility: National Hospital Organization Sendai Medical Center

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

status_simplified: Ongoing


summary: The purpose of this study is to show that subcutaneous (SC) administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 (Dara SC) is non-inferior to intravenous (IV) administration of daratumumab (Dara IV) in terms of the overall response rate (ORR) and maximum trough concentration (Ctrough).

ReferenceCitation: Usmani SZ, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis NJ, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Lantz K, O'Rourke L, Heuck C, Delioukina M, Qin X, Nnane I, Qi M, Mateos MV. Final analysis of the phase III non-inferiority COLUMBA study of subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma. Haematologica. 2022 Oct 1;107(10):2408-2417. doi: 10.3324/haematol.2021.279459.

license: publisher-specific license

license_normalized: publisher-specific

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

repository_normalized: DIGITAL.CSIC (Spain)

repositories:
DIGITAL.CSIC (Spain)
PubMed Central

repositories_concat: DIGITAL.CSIC (Spain);PubMed Central

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Iida S, Ishikawa T, Min CK, Kim K, Yeh SP, Usmani SZ, Mateos MV, Nahi H, Heuck C, Qin X, Parasrampuria DA, Gries KS, Qi M, Bahlis N, Ito S. Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study. Ann Hematol. 2021 Apr;100(4):1065-1077. doi: 10.1007/s00277-021-04405-2. Epub 2021 Feb 18.

ReferenceCitation: Usmani SZ, Mateos MV, Hungria V, Iida S, Bahlis NJ, Nahi H, Magen H, Cavo M, Hulin C, White D, De Stefano V, Fastenau J, Slavcev M, Heuck C, Qin X, Pei H, Masterson T, Lantz K, Gries KS. Greater treatment satisfaction in patients receiving daratumumab subcutaneous vs. intravenous for relapsed or refractory multiple myeloma: COLUMBA clinical trial results. J Cancer Res Clin Oncol. 2021 Feb;147(2):619-631. doi: 10.1007/s00432-020-03365-w. Epub 2020 Aug 27.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Mateos MV, Nahi H, Legiec W, Grosicki S, Vorobyev V, Spicka I, Hungria V, Korenkova S, Bahlis N, Flogegard M, Blade J, Moreau P, Kaiser M, Iida S, Laubach J, Magen H, Cavo M, Hulin C, White D, De Stefano V, Clemens PL, Masterson T, Lantz K, O'Rourke L, Heuck C, Qin X, Parasrampuria DA, Yuan Z, Xu S, Qi M, Usmani SZ. Subcutaneous versus intravenous daratumumab in patients with relapsed or refractory multiple myeloma (COLUMBA): a multicentre, open-label, non-inferiority, randomised, phase 3 trial. Lancet Haematol. 2020 May;7(5):e370-e380. doi: 10.1016/S2352-3026(20)30070-3. Epub 2020 Mar 23. Erratum In: Lancet Haematol. 2020 Oct;7(10):e710.

publisher_dissemination: Elsevier

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

location_facility: Ukrainian Medical Stomatological Academy, Poltava Regional Clinical Hospital

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: The Gordon & Leslie Diamond Health Care Center

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Kiev Marrow Transplantation Center, Bone Marrow Transplantation Department

location_facility: SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

location_facility: Kobe City Medical Center General Hospital

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

location_facility: Rambam Med.Center - Hematology Institute

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Nizhniy Novgorod Region Clinical Hospital

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

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

location_facility: S.P. Botkin Moscow City Clinical Hospital

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

location_facility: National Cancer Institute, Dept. of chemotherapy of hemoblastosis

location_facility: State Institution 'National Scientific Center for Radiation Medicine of NAMS of Ukraine'

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo

location_facility: Karolinska University Hospital, Huddinge

location_facility: Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

title: A Phase 3 Randomized, Multicenter Study of Subcutaneous vs. Intravenous Administration of Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma

location_country:
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Japan
Sweden
United States
Korea, Republic of
Spain
Greece
Taiwan
Czechia
Canada
Ukraine
Russian Federation
France


acronym: SURPASS

intervention_type: Biological

lead_sponsor: Novartis Pharmaceuticals

summary: The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

ReferenceCitation: Sieper J, Poddubnyy D. Twenty years of clinical trials in axial spondyloarthritis: what can we learn for the future? Curr Opin Rheumatol. 2021 Jul 1;33(4):363-369. doi: 10.1097/BOR.0000000000000804.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Baraliakos X, Ostergaard M, Gensler LS, Poddubnyy D, Lee EY, Kiltz U, Martin R, Sawata H, Readie A, Porter B; SURPASS Study Group. Comparison of the Effects of Secukinumab and Adalimumab Biosimilar on Radiographic Progression in Patients with Ankylosing Spondylitis: Design of a Randomized, Phase IIIb Study (SURPASS). Clin Drug Investig. 2020 Mar;40(3):269-278. doi: 10.1007/s40261-020-00886-7.

title: A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

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

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

location_country:
Finland
Germany
Poland
Argentina
Australia
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Slovakia
Denmark
United States
Romania
Belgium
Peru
Philippines
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


lead_sponsor: Celgene

summary: This study will assess the efficacy, safety and tolerability of pomalidomide in children and young adults aged 1 to < 21 years with recurrent or progressive primary brain tumors in one of four primary brain tumor types: high-grade glioma (HGG), medulloblastoma, ependymoma and diffuse intrinsic pontine glioma (DIPG).

ReferenceCitation: Fangusaro J, Cefalo MG, Garre ML, Marshall LV, Massimino M, Benettaib B, Biserna N, Poon J, Quan J, Conlin E, Lewandowski J, Simcock M, Jeste N, Hargrave DR, Doz F, Warren KE. Phase 2 Study of Pomalidomide (CC-4047) Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors. Front Oncol. 2021 Jun 8;11:660892. doi: 10.3389/fonc.2021.660892. eCollection 2021.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: Frontiers

ReferenceCitation: Fangusaro J, Mitchell DA, Kocak M, Robinson GW, Baxter PA, Hwang EI, Huang J, Onar-Thomas A, Dunkel IJ, Fouladi M, Warren KE. Phase 1 study of pomalidomide in children with recurrent, refractory, and progressive central nervous system tumors: A Pediatric Brain Tumor Consortium trial. Pediatr Blood Cancer. 2021 Feb;68(2):e28756. doi: 10.1002/pbc.28756. Epub 2020 Oct 7.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

location_facility: Ann and Robert H Lurie Childrens Hospital of Chicago

title: A PHASE 2 CLINICAL STUDY OF POMALIDOMIDE (CC-4047) MONOTHERAPY FOR CHILDREN AND YOUNG ADULTS WITH RECURRENT OR PROGRESSIVE PRIMARY BRAIN TUMORS

type: Registry Identifier

location_country:
Italy
United Kingdom
United States
Spain
France


lead_sponsor: CSL Behring

summary: This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).

ReferenceCitation: Viklicky O, Slatinska J, Novotny M, Hruba P. Developments in immunosuppression. Curr Opin Organ Transplant. 2021 Feb 1;26(1):91-96. doi: 10.1097/MOT.0000000000000844.

location_facility: University of Alabama Hospital (at Birmingham)

location_facility: Centre Regional Hospitalier Universitaire de Lille

title: A Double-blind, Randomized-withdrawal, Placebo-controlled Study to Evaluate the Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection in Adult Renal Transplant Recipients

location_country:
Germany
United Kingdom
Netherlands
Belgium
United States
Spain
France

ipd_sharing: No


title: An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 6 Years and Older With Moderate to Severe Plaque Psoriasis

acronym: STELARA

summary: The purpose of this study is to monitor the long-term safety of ustekinumab in pediatric participants (6 years to 17 years of age at the time of inclusion) with moderate to severe plaque psoriasis, through monitoring for the following adverse events potentially related to immune modulation: serious infections, malignancies and autoimmunity; and to monitor the long-term effects of ustekinumab on growth (weight, height, body mass index) and development (sexual maturity based on the Tanner Scale).

status: Recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Janssen-Cilag International NV

location_country:
Germany
Norway
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
Greece
Russian Federation
France

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Oslo universitetssykehus HF, Rikshospitalet

location_facility: Groupe Hospitalier Pellegrin CHU de Bordeaux

location_facility: Moscow Research-Practical Center of Dermatovenerology and Cosmetology

location_facility: Saint-Petersburg State Pediatric Medical Academy of RosZdrav

location_facility: FSBI 'Scientific Centre of Children Health' of the Russian Academy of Medical Sciences

location_facility: University Hospital for Skin and Venereal Diseases


title: Phase 1 / 2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects With Non-Small Cell Lung Cancer With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

acronym: SPARTA

summary:
To assess:

efficacy of APL-101 as monotherapy for the treatment of NSCLC harboring MET Exon 14 skipping mutations, NSCLC harboring MET amplification, solid tumors harboring MET amplification, solid tumors harboring MET fusion, primary CNS tumors harboring MET alterations, solid tumors harboring wild-type MET with overexpression of HGF and MET
efficacy of APL-101 as an add-on therapy to EGFR inhibitor for the treatment of NSCLC harboring EGFR activating mutations and developed acquired resistance with MET amplification and disease progression after documented CR or PR with 1st line EGFR inhibitors (EGFR-I)

design_allocation: Non-Randomized

lead_sponsor: Apollomics Inc.

location_country:
Finland
Italy
Hungary
Singapore
United Kingdom
Australia
United States
Spain
Taiwan
Canada
Puerto Rico
Russian Federation
France

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: West Virginia University Cancer Institute

location_facility: Centre d'Essais Precoces en Cancerologie de Marseille

location_facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

location_facility: Lady Davis Institute for Medical Research Jewish General Hospital

location_facility: Linkou Chang Gung Memorial Hospital (CGMHLK)

location_facility: UCSF - Helen Diller Family Comprehensive Cancer Center

location_facility: Cedars-Sinai Medical Center - Samuel Oschin Comprehensive Cancer Institute

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The Don & Sybil Harrington Cancer Center

location_facility: University of Southern California / Norris Comprehensive Cancer Center

location_facility: Washington University School of Medicine

location_facility: Private Medical Institution Euromedservice

location_facility: Hospital Universitario Central de Asturias

location_facility: McGill University Health Center - Research Institute

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: AOU Citta della Salute e della Scienza di Torino - Ospedale le Molinette

location_facility: Azienda Ospedaliero-Universitaria delle Marche

location_facility: Saint-Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)


title: A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy

summary: This is a Phase III, multicenter, double-blind, randomized study of pracinostat vs. placebo with azacitidine (AZA) as background therapy in patients ≥ 18 years of age with newly diagnosed acute myeloid leukemia (AML), excluding acute promyelocytic leukemia and cytogenetic low-risk AML, who are unfit to receive intensive remission induction chemotherapy due to age ≥ 75 years or comorbidities. Patients will be randomized in a 1:1 ratio to one of two groups: Group A (experimental group) to receive pracinostat plus AZA and Group B (control group) to receive placebo plus AZA. Randomization will be stratified by cytogenetic risk category (intermediate vs. unfavorable-risk, according to SWOG Cytogenetic Risk Category Definitions) and ECOG performance status (0-1 vs. 2). Treatments will be administered based on 28-day cycles, with pracinostat/placebo administered orally once every other day, 3 times a week for 3 weeks, followed by one week of no treatment and AZA administered for 7 days of each cycle. Study treatment should continue until there is documented disease progression, relapse from complete remission (CR), or non-manageable toxicity. A minimum of 6 cycles may be required to achieve a complete remission. Once permanently discontinued from study treatment, patients will enter the Long-term Follow-up phase of the study and will be followed for assessment of disease progression, if applicable, and survival every 3 months (±1 month) until death. The end of this study is defined when 390 events (deaths) have occurred and the study is unblinded for final overall survival analysis. Patients who are receiving study treatment at the end of the study may have the opportunity to continue to receive the study drugs to which they were randomized to (Post- Study Observation Period), until the Sponsor informs the Investigators of the appropriate course of action based on the study results. The Post-Study Observation Period is defined as the period starting from the end of the study for a maximum of 12 months.

lead_sponsor: Helsinn Healthcare SA

sponsor_collaborators:
Helsinn Healthcare SA
Clinipace Worldwide

location_country:
Germany
Italy
Poland
Hungary
Argentina
Romania
Australia
Brazil
United Kingdom
Austria
United States
Korea, Republic of
Spain
Taiwan
Czechia
France

location_facility: Ospedale la Maddalena, UO Oncoematologia e TMO

location_facility: Royal Devon & Exeter Hospital (Wonford site)

location_facility: Institute Nacional de Cancer Jose de Alencar Gomes da Silva-INCA

location_facility: Fondazione IRCCS policlinico San Matteo Pavia

location_facility: Austin Hospital, Clinical Trial Pharmacy

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Division of Hematology, National Taiwan University Hospital

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Dep. Of Haematology

location_facility: Specjalistyc:my Szpi tal im. dra Alfreda Sokolowskiego

location_facility: Ospedale San Raffaele-U.O. Ematologia e TMO

location_facility: Ce ntro de Pesquisas Hospital Amara l Ca rvalh o

location_facility: 10666 N.Torrey Pines-Scripps Cancer Center

location_facility: Wojewodzkie Wielospecjalistyczne Centrum onkologii I traumatologii

location_facility: University Hospital Cleveland Medical Center

location_facility: Gachon University Gil medical center, div hematology

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust

location_facility: Oklahoma cancer specialist and research institute

location_facility: Bradford Teaching Hospitals NHS Foundation trust

location_facility: Hospital Santa Casa de Belo Horizonte -Serviyo de Oncologia Clinica

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hematology and Oncology, Changhwa Christian Hospital

location_facility: CHU Amiens Picardie-Site Sud-Service d'Hematologie

location_facility: Charité-Universitätsmedizin - 1. Campus Mitte

location_facility: Haut-Leveque-Service d'hématologie clinique et de thérapie cellular

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Saint alphonsus Regional medical center-cancer care center

location_facility: Hosp.Universitario A Coruña-Hospital Teresa Herrera

location_facility: Seoul St.Mary Hospital, div hemato-oncology

location_facility: Barwon Health, University Hospital Geelong

location_facility: Liga Paranaense de Com bate ao Cancer - Hospital Erasto Gaertner

location_facility: koo-Foundation Sun Yat-Sen Cancer Center

location_facility: UMass Memorial medical center-university campus

location_facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: "Fakultni nemocnice Kralovske Vinohrady,

location_facility: Duke University Medical Center-2400 Pratt Street

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centro de Pesquisa Clinica do Hospital Santa Marcelina

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: St. Istvan & St. Laszlo Hospital, Deapartment of Hematology and Stem Cell Transplantation

location_facility: Hospital Universitario y Politecnico de La Fe

location_facility: CHU de Nice, Archet 1 Hospital-Hematology department

location_facility: Szabolcs-Szatmar-Bereg megyei Korhazak es Egyetemi Oktatokorhaz â€" Josa Andras Oktatokorhaz, Hematologiai Osztaly

location_facility: VA North texas Health Care sytem,Dallas VA Medical Center div. Hematology Oncology

location_facility: University of Arizona cancer center-north campus

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Pontchartrain Cancer Center (Research Location)

location_facility: The Northern hospital Pharmacy Department, Ground Floor

location_facility: Marien Hospital Herne-Universitätsklinikum der Ruhr-Universität Bochum

location_facility: Seoul National University Hospital, Div.Hematology/Oncology

location_facility: Arizona Oncology Associates, East Valley Cancer Center


lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA).

location_facility: Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants

location_facility: Tampa General Hospital Cardiac and Lung Transplant Clinic

location_facility: The University of Iowa Hospitals and Clinics

location_facility: Wake Forest University Baptist Medical Center

location_facility: Drexel University College of Medicine/ Drexel Adult Cystic Fibrosis Center

location_facility: Children's Speciality Services at North Druid Hills

location_facility: The University of Tennessee Medical Center

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Centre Hospitalier Universitaire De Nantes

location_facility: UCSF - Fresno, Community Regional Medical Center

location_facility: Universitaetsklinikum Tuebingen Klinik fuer Kinder- und Jugendmedizin

location_facility: Centre hospitalier universitaire de Nice, Pulmonology

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Charite Paediatric Pulmonology Department

location_facility: Massachusetts General Hospital Cystic Fibrosis Center

location_facility: Dell Children's Medical Center of Central Texas

location_facility: Children's Hospital of the King's Daughters

location_facility: Children's Hospital of Richmond at VCU, Children's Pavilion

location_facility: Centre Hospitalier Universitaire - Hopitaux de Rouen

location_facility: University of Mississippi Medical Center

location_facility: The University of Texas Health Science Center at San Antonio

location_facility: University of Oklahoma Health Sciences Center

location_facility: Centre Hospitalier Universitaire De Grenoble - Hopital Michallon

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: University of Utah / Primary Children's Medical Center

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: CHU de Montpellier - Hopital Arnaud de Villeneuve

location_facility: Klinikum Innenstadt, University of Munich

title: Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR Mutation

location_country:
United States
Germany
France


title: Strategic Management to Optimize Response To Cardiac Resynchronization Therapy

acronym: SMART CRT

summary: The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.

lead_sponsor: Boston Scientific Corporation

location_country:
Ireland
Germany
Italy
United Kingdom
Japan
Netherlands
Switzerland
United States
Spain
Canada
France

location_facility: Centre Hôpital Universitaire Rouen, Hôpital Charles Nicolle

location_facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec

location_facility: The International Heart Institute on Montana Foundation

location_facility: The Ohio Health Research Institute- Grant Medical Center

location_facility: University of Berlin, Charite Virchow Standort

location_facility: Virginia Commonwealth University Medical Center

location_facility: Trinity Health Michigan d/b/a Michigan Heart

location_facility: Novant Health Heart and Vascular Institute

location_facility: Azienda Sanitaria Universtitaria Integrata di Trieste

location_facility: Salinas Valley Memorial Healthcare System

location_facility: Foundation for Advancing Veterans' Health Research

location_facility: Cardiovascular Associates of the Delaware Valley

location_facility: Affinity Hospital, LLC d/b/a Granview Medical Center

location_facility: University of Arizona Sarver Heart Center

intervention_type: Device


acronym: PASSPORT

lead_sponsor: Biogen

summary:
The Primary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change from baseline in the PSP Rating Scale (PSPRS) at Week 52 and to assess the safety and tolerability of BIIB092, relative to placebo, by measuring the frequency of deaths, SAEs, AEs leading to discontinuation, and Grade 3 & 4 laboratory abnormalities.

The Secondary objective of the study is to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Movement Disorder Society (MDS)-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) at Week 52, to evaluate the efficacy of BIIB092, compared to placebo, as measured by a change in baseline in the Repeatable Battery for the Assessment of Neuropsychological Disease Severity (RBANS) at Week 52 and to assess the impact of BIIB092 on quality of life, relative to placebo, as measured by change from baseline on the Progressive Supranuclear Palsy Quality of Life scale (PSP-QoL) at Week 52.

ReferenceCitation: Jaeger J, Yang L, Li Y, Castrillo-Viguera C, Haeberlein SB, Dam T, O'Gorman J. Development of a cognitive composite for measuring change in progressive supranuclear palsy. Parkinsonism Relat Disord. 2021 Nov;92:94-100. doi: 10.1016/j.parkreldis.2021.10.007. Epub 2021 Oct 12.

ReferenceCitation: Dam T, Boxer AL, Golbe LI, Hoglinger GU, Morris HR, Litvan I, Lang AE, Corvol JC, Aiba I, Grundman M, Yang L, Tidemann-Miller B, Kupferman J, Harper K, Kamisoglu K, Wald MJ, Graham DL, Gedney L, O'Gorman J, Haeberlein SB; PASSPORT Study Group. Safety and efficacy of anti-tau monoclonal antibody gosuranemab in progressive supranuclear palsy: a phase 2, randomized, placebo-controlled trial. Nat Med. 2021 Aug;27(8):1451-1457. doi: 10.1038/s41591-021-01455-x. Epub 2021 Aug 12. Erratum In: Nat Med. 2023 Nov;29(11):2955-2956.

version: submittedVersion

repositories_concat: UCL Discovery

repositories_institution: University College London - UCL Discovery

location_facility:
Research Site
Research Name

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Intravenously Administered BIIB092 in Participants With Progressive Supranuclear Palsy

location_country:
Germany
Italy
United Kingdom
Australia
Japan
Austria
United States
Korea, Republic of
Spain
Greece
Canada
Russian Federation
France