title: A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

acronym: PREVENT

summary: The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

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: derived

ReferenceCitation: Braun J, Blanco R, Marzo-Ortega H, Gensler LS, van den Bosch F, Hall S, Kameda H, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Shete A, Richards HB, Haemmerle S, Deodhar A. Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT. Arthritis Res Ther. 2021 Sep 4;23(1):231. doi: 10.1186/s13075-021-02613-9.

family: Braun

full_name: Jürgen Braun

given: Jürgen

sequence: first

family: Blanco

full_name: Ricardo Blanco

given: Ricardo

sequence: additional

family: Marzo-Ortega

full_name: Helena Marzo-Ortega

given: Helena

family: Gensler

full_name: Lianne S. Gensler

given: Lianne S.

family: van den Bosch

full_name: Filip van den Bosch

given: Filip

family: Hall

full_name: Stephen Hall

given: Stephen

family: Kameda

full_name: Hideto Kameda

given: Hideto

family: Poddubnyy

full_name: Denis Poddubnyy

given: Denis

family: van de Sande

full_name: Marleen van de Sande

given: Marleen

family: Wiksten

full_name: Anna S. Wiksten

given: Anna S.

family: Porter

full_name: Brian O. Porter

given: Brian O.

family: Shete

full_name: Abhijit Shete

given: Abhijit

family: Richards

full_name: Hanno B. Richards

given: Hanno B.

family: Haemmerle

full_name: Sibylle Haemmerle

given: Sibylle

family: Deodhar

full_name: Atul Deodhar

given: Atul

bso_classification: Medical research

currency_apc_doaj: GBP

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Arthritis Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: Ghent University - Ghent University Academic Bibliography

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

ReferenceCitation: Deodhar A, Blanco R, Dokoupilová E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.

name: Oregon Health & Science University  Portland

name: Hospital University Marqués de Valdecilla IDIVAL  Santander Spain

name: Medical Plus, s.r.o., Uherské Hradiště, Czech Republic University of Veterinary and Pharmaceutical Sciences  Brno Czech Republic

name: Monash University  Melbourne Victoria Australia

name: Altoona Center for Clinical Research  Duncansville Pennsylvania

name: Charité Universitätsmedizin  Berlin Germany

name: Amsterdam UMC University of Amsterdam Amsterdam Rheumatology and Immunology Center  Amsterdam The Netherlands

name: Rheumazentrum Ruhrgebiet, Herne, Germany, and Ruhr‐University Bochum  Bochum Germany

title: Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo‐Controlled Phase III Study

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:
Australia
Belgium
Russian Federation
France
Japan
Poland
Norway
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
Spain
Turkey


type: Other Identifier

type: EudraCT Number

title: monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

acronym: monarcHER

summary: The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, Ricci F, Im SA, Kim SB, Johnston SR, Chan A, Goel S, Catron K, Chapman SC, Price GL, Yang Z, Gainford MC, André F. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):763-775. doi: 10.1016/S1470-2045(20)30112-1. Epub 2020 Apr 27. Erratum in: Lancet Oncol. 2021 Mar;22(3):e92. Lancet Oncol. 2021 Nov;22(11):e472.

family: Tolaney

full_name: Sara M Tolaney

given: Sara M

family: Wardley

full_name: Andrew M Wardley

given: Andrew M

family: Zambelli

full_name: Stefania Zambelli

given: Stefania

family: Hilton

full_name: John F Hilton

given: John F

family: Troso-Sandoval

full_name: Tiffany A Troso-Sandoval

given: Tiffany A

family: Ricci

full_name: Francesco Ricci

given: Francesco

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Kim

full_name: Sung-Bae Kim

given: Sung-Bae

family: Johnston

full_name: Stephen RD Johnston

given: Stephen RD

family: Chan

full_name: Arlene Chan

given: Arlene

family: Goel

full_name: Shom Goel

given: Shom

family: Catron

full_name: Kristen Catron

given: Kristen

family: Chapman

full_name: Sonya C Chapman

given: Sonya C

family: Price

full_name: Gregory L Price

given: Gregory L

family: Yang

full_name: Zhengyu Yang

given: Zhengyu

family: Gainford

full_name: M Corona Gainford

given: M Corona

family: André

full_name: Fabrice André

given: Fabrice

journal_name: The Lancet Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

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:
Italy
Brazil
Mexico
Germany
France
Korea, Republic of
Greece
Belgium
Argentina
Australia
Spain
United States
United Kingdom
Canada

location_facility: The Center for Cancer and Blood Disorders

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: Universitair Ziekenhuis Leuven - Gasthuisberg

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: North Shore Hematology Oncology Associates

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: Fundação Antonio Prudente - Hospital do Câncer A.C Camargo

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: Instituto COI de Pesquisa Educação e Gestão

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized Phase 3 Single Blind Study of Temozolomide Plus Radiation Therapy Combined With Nivolumab or Placebo in Newly Diagnosed Adult Subjects With MGMT-Methylated (Tumor O6-methylguanine DNA Methyltransferase) Glioblastoma

summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.

ReferenceCitation: Woroniecka K, Fecci PE. Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma. Neuro Oncol. 2020 Sep 29;22(9):1233-1234. doi: 10.1093/neuonc/noaa170.

name: Preston Robert Tisch Brain Tumor Center and Department of Pathology

family: Woroniecka

full_name: Karolina Woroniecka

given: Karolina

name: Department of Neurosurgery, Duke University Medical Center, Durham, North Carolina

family: Fecci

full_name: Peter E Fecci

given: Peter E

journal_name: Neuro-Oncology

oa_host_type: repository

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Japan
Poland
Israel
Norway
Australia
Belgium
Russian Federation
Spain
Denmark
Canada
United Kingdom

location_facility: Johns Hopkins University School Of Medicine

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Washington University School OF Medicine-Siteman Cancer Center

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: University Of Texas Southwestern Medical Center

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote

location_facility: Preston Robert Tisch Brain Tumor Center at Duke University

location_facility: Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main

location_facility: The Regents of the University of California, San Francisco

location_facility: Montreal Neurological Institute and Hospital

location_facility: The Ohio State University Wexner Medical Center

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

location_facility: Erlanger Oncology & Hematology - Univ. of TN

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

intervention_type: Other


title: AdreView™ Myocardial Imaging for Risk Evaluation - A Multicentre Trial to Guide ICD Implantation in NYHA Class II & III Heart Failure Patients With 25%≤LVEF≤35%

acronym: ADMIRE-ICD

summary: This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in New York Health Association (NYHA) class II and III heart failure participants with 25%<=left ventricular ejection fraction (LVEF)<=35%, and in particular, for identifying participants who are at low risk for sudden cardiac death and who would not benefit, or may suffer harm, from implantation of an ICD device.

status: Terminated

primary_purpose: Prevention

lead_sponsor: GE Healthcare

location_country:
Italy
United States
Netherlands
France
Czechia
Poland
Hungary
Spain
Germany
Canada

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Venezia Mestre - Azienda ULSS 12 "Veneziana"

location_facility: Institut Universitaire De Cardiologie Et De Pneumologie De Quebec

location_facility: CHU Clermont-Ferrand, 63003 Montalembert

location_facility: Cardiology Physicians PA/Red Clay Research, LLC

location_facility: Area Cardiologia Critica - IRCCS Centro Cardiologico Mozino

location_facility: Regions Hospital and Regions Heart Center Clinic

location_facility: Vascular Biology and Hypertension Program, University of Alabama at Birmingham

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Hospital Clinico Universitario San Carlos

location_facility: Veterans Affairs North Texas Healthcare System

location_facility: Kliniken Maria Hilf GmbH, Klinik fur Nuklearmedizin

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità, Dipartimento Cardiologico, Cardiologia 1

location_facility: Comprehensive Cardiovascular Medical Group

location_facility: Dolnośląski Szpital Specjalistyczny im. T. Marciniaka Centrum Medycyny Ratunkowej

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: CIUSSS de L'Estrie - CHUS Hopital Fleurimont

location_facility: Debreceni Egyetem, Kardiologia Intezet and ScanoMed Nuclear Medicine Institute

location_facility: Varosmajori Sziv es Ergyogyaszati Klinika

location_facility: Ospedale dell'Angelo, 30174, Venezia Mestre

location_facility: Klinik & Poliklinik fur Nuklearmedizin, LMU, Campus Grobhader

location_facility: Azienda Ospedaliera Universitaria G. Martino

location_facility: VA Connecticut Healthcare System (VACHS)

location_facility: Azienda Ospedaliero-Universitaria Federico II Dipartimento ad Attivita Integrata di Cardiologia,Cardiochirurgia ed Emergenze Cardiovascolari

location_facility: University of Florida Health Jacksonville

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont Kardiológia Osztály/Nuklearis Medicina Osztaly

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Hospital General Universitario de Valencia

location_facility: Department of Cardiology, K-14 (Henry Ford Health System)

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 7 Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Fakultni nemocnice v Kralovske Vinohrady

location_facility: Instituti Clinici Scientifici Maugeri Spa Societa Benefit

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Dipartimento di Scienze Cardiovascolari, Respiratorie Neufrologiche e Geriatriche - Universita di Roma "La Sapienza"

location_facility: Semmelweis Egyetem Nuklearis Medicina Kozpont

location_facility: Hospital Universitario San Juan de Alicante

location_facility: Gottsegen Gyorgy Orszagos Kardiologiai Intezet

intervention_type: Device

status_simplified: Unknown


ReferenceCitation: Liu MC, Chipps B, Munoz X, Devouassoux G, Bergna M, Smith SG, Price RG, Galkin DV, Azmi J, Mouneimne D, Albers FC, Chapman KR. Benefit of switching to mepolizumab from omalizumab in severe eosinophilic asthma based on patient characteristics. Respir Res. 2021 May 10;22(1):144. doi: 10.1186/s12931-021-01733-9.

family: Liu

full_name: Mark C. Liu

given: Mark C.

family: Chipps

full_name: Bradley Chipps

given: Bradley

family: Munoz

full_name: Xavier Munoz

given: Xavier

family: Devouassoux

full_name: Gilles Devouassoux

given: Gilles

family: Bergna

full_name: Miguel Bergna

given: Miguel

family: Smith

full_name: Steven G. Smith

given: Steven G.

full_name: Robert G. Price

given: Robert G.

family: Galkin

full_name: Dmitry V. Galkin

given: Dmitry V.

family: Azmi

full_name: Jay Azmi

given: Jay

family: Mouneimne

full_name: Dalal Mouneimne

given: Dalal

family: Albers

full_name: Frank C. Albers

given: Frank C.

full_name: Kenneth R. Chapman

given: Kenneth R.

journal_name: Respiratory Research

publisher_normalized: Springer

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

lead_sponsor: GlaxoSmithKline

location_country:
United States
Sweden
Netherlands
Germany
France
Belgium
Argentina
Spain
Canada

source: euctr

title: A Multi-centre, Open Label, Single Arm, 32-week Treatment Study in Subjects With Severe Eosinophilic Asthma Not Optimally Controlled With Current Omalizumab Treatment Who Are Switched From Omalizumab to Mepolizumab 100mg Subcutaneous (Study Number 204471- the OSMO Study)

summary:
Mepolizumab is an anti-interleukin-5 ( IL-5) monoclonal antibody that neutralizes IL-5 and reduces eosinophil counts in both sputum and blood. Omalizumab an anti-immunoglobulin E (IgE) monoclonal antibody (mAb) is effective in the treatment of moderate to severe allergic asthma. The aim of this study is to investigate whether subjects not optimally controlled on their current omalizumab treatment, who are eligible for therapy with mepolizumab can be effectively and safely switched to treatment with mepolizumab to improve asthma control. The study will provide data on the efficacy, safety, immunogenicity, and tolerability of mepolizumab when switched directly from omalizumab without any wash-out. The learnings from this study may help guide physicians when substituting one biologic with another for the treatment of patients with severe eosinophilic asthma.

The study will be a multi-centre, open-label single arm trial. Patients with severe eosinophilic asthma who are receiving omalizumab, but are not optimally controlled will be eligible to participate. Subjects will remain on their current maintenance therapy including omalizumab throughout the run-in period for a minimum of one week and up to 4 weeks. At Visit 2 (week 0) subjects will discontinue their omalizumab treatment and be switched to mepolizumab 100 mg subcutaneous (SC) every 4 weeks for 28 weeks. The treatment period is 32 weeks, including an Exit Visit/Early Withdrawal Visit, 4 weeks following the subject's last dose of mepolizumab.

status_simplified: Completed


title: A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)

acronym: CheckMate 498

summary: The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.

title: Immuno-synergy? Neoantigen vaccines and checkpoint blockade in glioblastoma

location_facility: Johns Hopkins University School Of Medicine

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Washington University School OF Medicine-Siteman Cancer Center

location_facility: Columbia University Medical Center (Cumc)

location_facility: Centre hospitalier universitaire Vaudois (CHUV)

location_facility: University Of Texas Southwestern Medical Center

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote

location_facility: Preston Robert Tisch Brain Tumor Center at Duke University

location_facility: University Of Texas Md Anderson Cancer Ctr

location_facility: Emory University - Winship Cancer Institute

location_facility: Klinikum Der J. W. Goethe-Universitaet Frankfurt/Main

location_facility: The Regents of the University of California, San Francisco

location_facility: Montreal Neurological Institute and Hospital

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza

location_facility: Erlanger Oncology & Hematology - Univ. of TN

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

intervention_type: Radiation


title: A Randomized, Multi-center Phase III Study of Nivolumab Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (CheckMate 459: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 459)

summary: The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma.

location_country:
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Hong Kong
Switzerland
Singapore
China
United States
Germany
United Kingdom
Italy
Austria
Czechia
Israel
Spain

location_facility: Scott & White Memorial Hospital And Clinic

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Istituto Nazionale Per Lo Studio E La Cura

location_facility: Klinikum Der Johann Wolfgang Goethe-Universitat

location_facility: The University Of Texas Health Science Center

location_facility: British Columbia Cancer Agency-Vancouver Ctr


title: A Phase 2b Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

summary: A Phase 2b study to evaluate the efficacy and safety of brazikumab (MEDI2070) in participants with moderate to severe Crohn's disease who have failed or are intolerant to anti-tumor necrosis factor-alpha (anti-TNFα) therapy.

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Netherlands
Germany
France
Israel
Hungary
Belgium
Australia
Russian Federation
Spain
Canada

location_facility: University of Texas Health Science Center at Houston

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Clinical Research of West Florida - Corporate

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health


title: A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE

acronym: RE-EMBARK

summary: The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.

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

lead_sponsor: Pfizer

location_country:
Sweden
Netherlands
Germany
Finland
France
Czechia
Poland
Hungary
Belgium
Australia
Spain
United States
Taiwan
Colombia

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Oregon Health and Science University Research Pharmacy

location_facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob

location_facility: Diagnostic-Med Centrum Diagnostyki Radiologicznej

location_facility: Complejo Hospitalario Regional Virgen Macarena

location_facility: SANUS Szpital Specjalistyczny Sp. z o.o.

location_facility: Zaklad Radiologii i Diagnostyki Obrazowej

location_facility: Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1

location_facility: Northwestern University Clinical and Translational Sciences Institute (NUCATS)

location_facility: Complexo Hospitalario Universitario A Coruna

location_facility: Winthrop University Hospital, Clinical Trials Center

location_facility: Complejo Hospitalario Universitario Santiago

location_facility: VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont

location_facility: Samodzielny Publiczny Zespol Opieki Zdrowotnej

location_facility: Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

location_facility: Northwestern Medical Group; Division of Rheumatology

location_facility: Swedish Medical Center Investigational Drug Services Pharmacy

location_facility: Centro Integral de Reumatologia Reumalab S.A.S.

intervention_type: Biological


ReferenceCitation: Cortes J, Apperley J, Lomaia E, Moiraghi B, Undurraga Sutton M, Pavlovsky C, Chuah C, Sacha T, Lipton JH, Schiffer CA, McCloskey J, Hochhaus A, Rousselot P, Rosti G, de Lavallade H, Turkina A, Rojas C, Arthur CK, Maness L, Talpaz M, Mauro M, Hall T, Lu V, Srivastava S, Deininger M. Ponatinib dose-ranging study in chronic-phase chronic myeloid leukemia: a randomized, open-label phase 2 clinical trial. Blood. 2021 Nov 25;138(21):2042-2050. doi: 10.1182/blood.2021012082.

name: Georgia Cancer Center, Augusta, Georgia, United States

family: Cortes

full_name: Jorge Cortes

given: Jorge

name: Imperial College London, London, United Kingdom

family: Apperley

full_name: Jane F Apperley

given: Jane F

name: Almazov National Medical Research Centre, St. Petersburg, Russian Federation

family: Lomaia

full_name: Elza Lomaia

given: Elza

name: Hospital J.M. Ramos Mejia, Buenos Aires, Argentina

family: Moiraghi

full_name: Beatriz Moiraghi

given: Beatriz

family: Undurraga

full_name: Maria Soledad Undurraga

given: Maria Soledad

family: Pavlovsky

full_name: Carolina Pavlovsky

given: Carolina

name: Singapore General Hospital, Singapore, Singapore

family: Chuah

full_name: Charles Chuah

given: Charles

name: Jagiellonian University Hospital, Kraków, Poland

family: Sacha

full_name: Tomasz Sacha

given: Tomasz

name: Princess Margaret Hospital, Toronto, Canada

family: Lipton

full_name: Jeffrey H Lipton

given: Jeffrey H

name: Wayne State University School of Medicine, Bloomfield Hills, Michigan, United States

family: Schiffer

full_name: Charles A. Schiffer

given: Charles A.

name: John Theurer Cancer Center at Hackensack Meridian Health, Hackensack, New Jersey, United States

family: McCloskey

full_name: James McCloskey

given: James

name: Universitätsklinikum Jena, Jena, Germany

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

name: Centre Hospitalier de Versailles, Le Chesnay, France

family: Rousselot

full_name: Philippe Rousselot

given: Philippe

name: IRCCS/Irst "Dino Amadori", Meldola, Italy

family: Rosti

full_name: Gianantonio Rosti

given: Gianantonio

name: Guy's and St Thomas' NHS Foundation trust, London, United Kingdom

family: de Lavallade

full_name: Hugues de Lavallade

given: Hugues

name: National Research Center for Hematology, Moscow, Russian Federation

family: Turkina

full_name: Anna Turkina

given: Anna

name: Centro de Investigaciones Clinicas Vina del Mar, Valparaíso, Chile

family: Rojas

full_name: Christine Rojas

given: Christine

name: Royal North Shore Hospital, Sydney, Australia

family: Arthur

full_name: Christopher Arthur

given: Christopher

name: University of Nebraska Medical Center, Omaha, Nebraska, United States

family: Maness

full_name: Lori J Maness

given: Lori J

name: University of Michigan, Ann Arbor, Michigan, United States

family: Talpaz

full_name: Moshe Talpaz

given: Moshe

name: Memorial Sloan Kettering Cancer Center, New York, New York, United States

family: Mauro

full_name: Michael J Mauro

given: Michael J

suffix: MD

name: Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, United States

family: Hall

full_name: Tracey Hall

given: Tracey

name: Millennium Pharmaceuticals, Inc., Cambridge, MA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, United States

family: Lu

full_name: Vickie Lu

given: Vickie

family: Srivastava

full_name: Shouryadeep Srivastava

given: Shouryadeep

name: The University of Utah, Salt Lake City, Utah, United States

family: Deininger

full_name: Michael W Deininger

title: Ponatinib Dose-Ranging Study in Chronic-Phase Chronic Myeloid Leukemia: A Randomized, Open-Label Phase 2 Clinical Trial

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Australia
Russian Federation
Denmark
Taiwan
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Sweden
Hong Kong
Switzerland
Singapore
Portugal
United States
Germany
United Kingdom
Italy
Czechia
Spain

location_facility: Center Hospitalier Universitaire d'Angers

location_facility: Centre Hospitalier Universitaire de Nantes Hotel Dieu

location_facility: FGU Russian Scientific Research Institute of Hematology and Transfusiology

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil

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

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire de Nice Hopital l'Archet

location_facility: Centre Hospitalier Universitaire de Nancy Hopital de Brabois

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: AOUI - Ospedale Policlinico "Giambattista Rossi" di Borgo Roma

location_facility: Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: Cleveland Clinic Taussig Cancer Institute Main Campus

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Azienda Sanitaria Locale di Pescara Ospedale Civile Dello Spirito Santo

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: NewYork-Presbyterian Weill Cornell Medical Center

location_facility: Hospital Clinic i Provincial de Barcelona

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

location_facility: Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Hospital Universitario de Gran Canaria Doctor Nergrin

location_facility: GBUZ Moscow Clinical Scientific Center DZM

location_facility: Memorial Sloan-Kettering Cancer Center - New York

location_facility: Hospital General de Agudo Jose Maria Ramos Mejia

location_facility: Emory University Winship Cancer Institute

location_facility: Royal Liverpool University Hospital NHS Trust

location_facility: Ustav Hematologie a Krevni Transfuze Praha

location_facility: Azienda Ospedaliera San Gerardo di Monza

location_facility: Centre de Lutte Contre le Cancer - Institut Bergonie

title: A Randomized, Open-label, Phase 2 Trial of Ponatinib in Patients With Resistant Chronic Phase Chronic Myeloid Leukemia to Characterize the Efficacy and Safety of a Range of Doses

summary: The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by <=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months.


ReferenceCitation: Jones RL, Wagner AJ, Kawai A, Tamura K, Shahir A, Van Tine BA, Martín-Broto J, Peterson PM, Wright J, Tap WD. Prospective Evaluation of Doxorubicin Cardiotoxicity in Patients with Advanced Soft-tissue Sarcoma Treated in the ANNOUNCE Phase III Randomized Trial. Clin Cancer Res. 2021 Jul 15;27(14):3861-3866. doi: 10.1158/1078-0432.CCR-20-4592. Epub 2021 Feb 25.

family: Jones

full_name: Robin L. Jones

given: Robin L.

family: Wagner

full_name: Andrew J. Wagner

given: Andrew J.

family: Kawai

full_name: Akira Kawai

given: Akira

family: Tamura

full_name: Kazuo Tamura

given: Kazuo

family: Shahir

full_name: Ashwin Shahir

given: Ashwin

family: Van Tine

full_name: Brian A. Van Tine

given: Brian A.

family: Martín-Broto

full_name: Javier Martín-Broto

given: Javier

family: Peterson

full_name: Patrick M. Peterson

given: Patrick M.

family: Wright

full_name: Jennifer Wright

given: Jennifer

family: Tap

full_name: William D. Tap

given: William D.

journal_name: Clinical Cancer Research

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Association for Cancer Research (AACR)

ReferenceCitation: Tap WD, Wagner AJ, Schöffski P, Martin-Broto J, Krarup-Hansen A, Ganjoo KN, Yen CC, Abdul Razak AR, Spira A, Kawai A, Le Cesne A, Van Tine BA, Naito Y, Park SH, Fedenko A, Pápai Z, Soldatenkova V, Shahir A, Mo G, Wright J, Jones RL; ANNOUNCE Investigators. Effect of Doxorubicin Plus Olaratumab vs Doxorubicin Plus Placebo on Survival in Patients With Advanced Soft Tissue Sarcomas: The ANNOUNCE Randomized Clinical Trial. JAMA. 2020 Apr 7;323(13):1266-1276. doi: 10.1001/jama.2020.1707.

name: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York

name: Department of Medicine, Weill Cornell Medical College, New York, New York

name: Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts

name: University Hospitals Leuven, Department of General Medical Oncology, Leuven Cancer Institute, Leuven, Belgium

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

name: Medical Oncology Department in University Hospital Virgen del Rocio and Institute of Biomedicine of Sevilla (IBIS) (HUVR, CSIC, University of Sevilla), Sevilla, Spain

family: Martin-Broto

full_name: Javier Martin-Broto

name: University of Copenhagen, Copenhagen, Denmark

family: Krarup-Hansen

full_name: Anders Krarup-Hansen

given: Anders

name: Stanford University, Stanford, California

family: Ganjoo

full_name: Kristen N. Ganjoo

given: Kristen N.

name: Division of Medical Oncology, Center for Immuno-oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan

name: National Yang-Ming University School of Medicine, Taipei, Taiwan

family: Yen

full_name: Chueh-Chuan Yen

given: Chueh-Chuan

name: Princess Margaret Cancer Center, Toronto, Ontario, Canada

family: Abdul Razak

full_name: Albiruni R. Abdul Razak

given: Albiruni R.

family: Spira

full_name: Alexander Spira

given: Alexander

name: National Cancer Center Hospital, Tokyo, Japan

name: Institut Gustave Roussy, Villejuif, France

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

name: Department of Internal Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri

name: National Cancer Center Hospital East, Kashiwa, Japan

name: Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea

name: Blokhin Cancer Research Center, Moscow, Russian Federation

name: Magyar Honvedseg Eu Kp, Budapest, Hungary

name: Eli Lilly and Company, Indianapolis, Indiana

name: Eli Lilly and Company, Windlesham, United Kingdom

name: Sarcoma Unit, Royal Marsden NHS Foundation Trust and Institute of Cancer Research, London, United Kingdom

ReferenceCitation: Tobias A, O'brien MP, Agulnik M. Olaratumab for advanced soft tissue sarcoma. Expert Rev Clin Pharmacol. 2017 Jul;10(7):699-705. doi: 10.1080/17512433.2017.1324295. Epub 2017 May 5. Review.

name: Rosalind Franklin University of Medicine and Science, North Chicago, IL, USA

name: Division of Hematology/Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

location_country:
Finland
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Fairfax Northern Virginia Hematology Oncology, PC

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: Moffitt Cancer Center & Research Institute

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

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: Pennsylvania Oncology Hematology Associates

location_facility: University of Florida School of Medicine

title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Doxorubicin Plus Olaratumab Versus Doxorubicin Plus Placebo in Patients With Advanced or Metastatic Soft Tissue Sarcoma

summary: The main purpose of this study is to evaluate the efficacy of the combination of doxorubicin plus the study drug known as olaratumab versus doxorubicin plus placebo in participants with advanced or metastatic soft tissue sarcoma.


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Subjects With Active Radiographic Axial Spondyloarthritis

summary: The purpose of this study is to assess the efficacy of ustekinumab, in adult anti-TNF(alpha) refractory participants with active radiographic axial spondyloarthritis (AxSpA), as measured by the reduction in signs and symptoms of radiographic AxSpA.

ReferenceCitation: Deodhar A, Gensler LS, Sieper J, Clark M, Calderon C, Wang Y, Zhou Y, Leu JH, Campbell K, Sweet K, Harrison DD, Hsia EC, van der Heijde D. Three Multicenter, Randomized, Double-Blind, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis. Arthritis Rheumatol. 2019 Feb;71(2):258-270. doi: 10.1002/art.40728. Epub 2018 Dec 29.

name: Oregon Health & Science University Portland

family: Deodhar

full_name: Atul Deodhar

given: Atul

family: Gensler

full_name: Lianne S. Gensler

given: Lianne S.

name: Charite Universitatsmedizin Berlin Berlin Germany

family: Sieper

full_name: Joachim Sieper

given: Joachim

name: Janssen Research & Development, LLC Spring House Pennsylvania

family: Clark

full_name: Michael Clark

given: Michael

family: Calderon

full_name: Cesar Calderon

given: Cesar

family: Wang

full_name: Yuhua Wang

given: Yuhua

family: Zhou

full_name: Yiying Zhou

given: Yiying

family: Leu

full_name: Jocelyn H. Leu

given: Jocelyn H.

family: Campbell

full_name: Kim Campbell

given: Kim

family: Sweet

full_name: Kristen Sweet

given: Kristen

family: Harrison

full_name: Diane D. Harrison

given: Diane D.

name: Hospital of the University of Pennsylvania Philadelphia

family: Hsia

full_name: Elizabeth C. Hsia

given: Elizabeth C.

name: Leiden University Medical Center Leiden The Netherlands

family: Heijde

full_name: Désirée Heijde

given: Désirée

family: Ariel

full_name: Frederico Ariel

given: Frederico

family: Asnal

full_name: Cecilia Adma Asnal

given: Cecilia Adma

family: Berman

full_name: Alberto Berman

given: Alberto

family: Citera

full_name: Gustavo Citera

given: Gustavo

family: Rodriguez

full_name: Graciela Rodriguez

given: Graciela

family: Savio

full_name: Veronica Gabriela Savio

given: Veronica Gabriela

family: Bird

full_name: Paul Bird

given: Paul

family: Griffiths

full_name: Hedley Griffiths

given: Hedley

family: Nicholls

full_name: David Nicholls

given: David

family: Rischmueller

full_name: Maureen Rischmueller

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

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Three Multicenter, Randomized, Double‐Blind, Placebo‐Controlled Studies Evaluating the Efficacy and Safety of Ustekinumab in Axial Spondyloarthritis

location_country:
Brazil
Mexico
Spain
Germany
France
Bulgaria
Czechia
Korea, Republic of
Poland
Hungary
Belgium
Argentina
Russian Federation
Portugal
United States
United Kingdom
Canada
Taiwan
Ukraine


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function

summary: The purpose of this study is to evaluate the efficacy and safety of VX-661 in combination with ivacaftor (IVA, VX-770) and IVA monotherapy in participants with Cystic Fibrosis (CF) who are heterozygous for F508del-CFTR allele and a second allele with a CFTR mutation predicted to have residual function.

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Rowe SM, Daines C, Ringshausen FC, Kerem E, Wilson J, Tullis E, Nair N, Simard C, Han L, Ingenito EP, McKee C, Lekstrom-Himes J, Davies JC. Tezacaftor-Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis. N Engl J Med. 2017 Nov 23;377(21):2024-2035. doi: 10.1056/NEJMoa1709847. Epub 2017 Nov 3.

family: Rowe

full_name: Steven M. Rowe

given: Steven M.

family: Daines

full_name: Cori Daines

given: Cori

family: Ringshausen

full_name: Felix C. Ringshausen

given: Felix C.

family: Kerem

full_name: Eitan Kerem

given: Eitan

family: Wilson

full_name: John Wilson

given: John

family: Tullis

full_name: Elizabeth Tullis

given: Elizabeth

family: Nair

full_name: Nitin Nair

given: Nitin

family: Simard

full_name: Christopher Simard

given: Christopher

family: Han

full_name: Linda Han

given: Linda

family: Ingenito

full_name: Edward P. Ingenito

given: Edward P.

family: McKee

full_name: Charlotte McKee

given: Charlotte

family: Lekstrom-Himes

full_name: Julie Lekstrom-Himes

given: Julie

family: Davies

full_name: Jane C. Davies

given: Jane C.

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

repository_institution: The University of Arizona - UA Campus Repository

repository_institution: Queen's University Belfast - Research Portal

title: Tezacaftor–Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Israel
Belgium
Australia
Canada
United Kingdom


ReferenceCitation: Werth VP, Joly P, Mimouni D, Maverakis E, Caux F, Lehane P, Gearhart L, Kapre A, Pordeli P, Chen DM; PEMPHIX Study Group. Rituximab versus Mycophenolate Mofetil in Patients with Pemphigus Vulgaris. N Engl J Med. 2021 Jun 17;384(24):2295-2305. doi: 10.1056/NEJMoa2028564. Epub 2021 May 19.

name: From the Perelman School of Medicine, University of Pennsylvania, and the Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia (V.P.W.); the Department of Dermatology, Rouen University Hospital and INSERM 1234, Normandie Université, Rouen (P.J.), and the Department of Dermatology, Groupe Hospitalier Paris Seine-Saint-Denis, Assistance Publique–Hôpitaux de Paris and INSERM Unité Mixte de Recherche 1125, Bobigny (F.C.) — all in France; the Sackler School of Medicine, Tel Aviv...

family: Werth

full_name: Victoria P. Werth

given: Victoria P.

family: Joly

full_name: Pascal Joly

given: Pascal

family: Mimouni

full_name: Daniel Mimouni

given: Daniel

family: Maverakis

full_name: Emanual Maverakis

given: Emanual

family: Caux

full_name: Frédéric Caux

given: Frédéric

family: Lehane

full_name: Patricia Lehane

given: Patricia

family: Gearhart

full_name: Liudmila Gearhart

given: Liudmila

family: Kapre

full_name: Audrey Kapre

given: Audrey

family: Pordeli

full_name: Pooneh Pordeli

given: Pooneh

family: Chen

full_name: Diana M. Chen

given: Diana M.

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
United States
Germany
France
Israel
Argentina
Australia
Spain
Turkey
Canada
Ukraine

acronym: PEMPHIX

location_facility: Massachusetts General Hospital Dermatology

location_facility: Centro Clinico per le genodermatosi Dipartimento di Dermatologia dell'Immacolata - IRCCS

location_facility: University of Arizona Medical Research Office

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Wake Forest Baptist Hospital Center for Dermatology Research

location_facility: Rambam Medical Centre; Dept. of Dermatology

location_facility: S.C. Dermatologia 2 - Ambulatorio Malattie Rare

location_facility: Los Angeles Biomedical Research Institute

location_facility: Territorial Medical Association "Dermatovenerologia"

location_facility: Rabin Medical Centre; Dept. of Dermatology

location_facility: Karadeniz Teknik Üniversitesi Tıp Fakültesi Farabi Hastanesi

location_facility: Celal Bayar University Medical Faculty Hafsa Sultan Hospital

location_facility: Les Hospices Civils de Lyon Dermatologie inflammatoire et médecine interne

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR, Hautklinik und Poliklinik

location_facility: Università di Parma Clinica Dermatologica

location_facility: Kompetenzzentrum Fragile Haut Klinik fur Dermatologie und Venerologie

location_facility: Faculdade de Medicina de Botucatu - Hospital das Clínicas

location_facility: Department of Dermatology Avicenne Hospital & University

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Clinica Dermatologica

location_facility: Gülhane Military Medical Academy in Ankara

location_facility: Klinik und Poliklinik für Dermatologie und Venerologie Universitätsklinikum Köln

location_facility: U.O. Dermatologia Dipartimento Malattie Infettive Fondazione IRCCS Policlinico San Matteo

location_facility: Gaziantep University Medical Faculty Sahinbey Hospital

location_facility: Ambulatorio di Malattie Rare e Immunopatologia Cutanea

location_facility: Santa Casa de São Paulo Hospital Central X

title: A Randomized, Double-Blind, Double-Dummy, Active-Comparator, Multicenter Study to Evaluate the Efficacy and Safety of Rituximab Versus MMF in Patients With Pemphigus Vulgaris

summary:
This is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study to evaluate the efficacy and safety of rituximab compared with MMF in participants with moderate-to-severely active PV requiring 60-120 milligrams per day (mg/day) oral prednisone or equivalent. Participants must have a confirmed diagnosis of PV within the previous 24 months (by skin or mucosal biopsy and immunohistochemistry) and evidence of active disease at screening.

Approximately 135 participants will be enrolled at up to 60 centers worldwide. Participants will be randomized in a 1:1 ratio to receive either rituximab plus MMF placebo or rituximab placebo plus MMF. Randomization will be stratified by duration of illness.

The study will consist of three periods: a screening period of up to 28 days, a 52-week double-blind treatment period, and a 48-week safety follow up period that begins at the time of study treatment completion or discontinuation.


title: Retrospective Data Collection: Post Study Treatment Anticancer Therapy From All Randomized Patients Involved in IMELDA MO22223

summary: This study aims to understand better the effective results from the IMELDA MO22223 P-trial (NCT00929240) and see if the anti-cancer therapies given during its follow-up time after study treatments were terminated possibly had an effect on efficacy results.

study_type: Observational

time_perspective: Retrospective

location_country: Italy Brazil India France Spain Turkey

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

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

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

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

location_facility: Chg de Chartres Hopital Louis Pasteur; Pneumologie

location_facility: Complejo Hospitalario la Mancha Centro;Servicio Oncologia

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

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Hospital Virgen de los Lirios; Servicio de Oncologia

location_facility: Università Federico II; Dip. Di Endocrinologia ed Oncologia Molecolare e Clinica

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

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

location_facility: Centre Bourgogne, Service de Radiotherapie

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept


ReferenceCitation: Schott AF, Goldstein LJ, Cristofanilli M, Ruffini PA, McCanna S, Reuben JM, Perez RP, Kato G, Wicha M. Phase Ib Pilot Study to Evaluate Reparixin in Combination with Weekly Paclitaxel in Patients with HER-2-Negative Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 15;23(18):5358-5365. doi: 10.1158/1078-0432.CCR-16-2748. Epub 2017 May 24.

family: Schott

full_name: Anne F. Schott

given: Anne F.

family: Goldstein

full_name: Lori J. Goldstein

given: Lori J.

family: Cristofanilli

full_name: Massimo Cristofanilli

given: Massimo

family: Ruffini

full_name: Pier Adelchi Ruffini

given: Pier Adelchi

family: McCanna

full_name: Susan McCanna

given: Susan

family: Reuben

full_name: James M. Reuben

given: James M.

family: Perez

full_name: Raymond P. Perez

given: Raymond P.

family: Kato

full_name: Giraldo Kato

given: Giraldo

family: Wicha

full_name: Max Wicha

given: Max

oa_colors: green hybrid

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

publisher_dissemination: American Association for Cancer Research

title: Phase Ib Pilot Study to Evaluate Reparixin in Combination with Weekly Paclitaxel in Patients with HER-2–Negative Metastatic Breast Cancer

lead_sponsor: Dompé Farmaceutici S.p.A

location_country:
Italy
France
Czechia
Poland
Belgium
Spain
United States

acronym: FRIDA

location_facility: Hematology and Oncology Associates of Northeast PA

location_facility: Azienda Ospedaliera, Ospedale San Carlo Borromeo

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

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

location_facility: Complejo Hospitalario Universitario La Coruña

location_facility: Mid Illinois Hematology & Oncology Associates, Ltd.

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: Mrukmed. Lekarz Beata Madej Mruk i Partner. Spólka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro

location_facility: Northside Hospital, Inc.-Georgia Cancer Specialists

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: CBCC Global Research a Comprehensive Blood and Cancer Center

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Centre hospitalier de Saint-Brieuc, Yves Le Foll

location_facility: Fakultní nemocnice v Motole, Onkologická klinika 2. LF UK a FN Motol

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Azienda Ospedaliero - Universitaria, Policlinico Vittorio Emanuele

location_facility: Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

location_facility: Centro Oncológico Regional de Galicia, Servicio de Oncologia Medica

location_facility: Azienda Opspedaliero Universitaria Santa Maria della Misericordia

ipd_sharing: No

title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of Paclitaxel in Combination With Reparixin Compared to Paclitaxel Alone as Front-line Therapy for Metastatic Triple- Negative Breast Cancer (FRIDA)

summary:
The Objectives of this study:

The primary objective of the study was to evaluate progression-free survival (PFS) (defined as the number of days between the date of randomization and the date of clinical disease progression (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, as assessed by Independent Radiology Review, or death for any cause, whichever occured first) in patients with metastatic triple-negative breast cancer (TNBC) treated with the combination of paclitaxel and orally administered reparixin compared to paclitaxel alone.

The secondary objectives were:

To determine overall survival (OS).
To evaluate objective response rates (ORR).
To determine median PFS (mPFS).
To assess the safety of the combination of paclitaxel and orally administered reparixin (referred to as combination treatment).


title: A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma

acronym: ARTEMIS

summary:
This study was originally designed as a multicenter, double-blind, randomized, parallel-group study, using a placebo control or amatuximab 5 milligrams per kilogram (mg/kg), administered weekly, designed to evaluate the safety and efficacy of amatuximab in combination with pemetrexed and cisplatin in participants with unresectable Malignant Pleural Mesothelioma (MPM) who have not received prior systemic therapy.

Per a business decision made by the Sponsor, participants who were randomized to amatuximab and were still on active treatment at the time of the protocol amendment may have consented to continue to receive weekly treatment with amatuximab until disease progression or intolerable toxicity at the discretion of the principal investigator. Participants randomized to placebo or who were in follow-up at the time of the amendment have been discontinued from the study.

lead_sponsor: Morphotek

location_country:
Italy
United States
France
Australia
Germany
United Kingdom


ReferenceCitation: Gadelha M, Bex M, Colao A, Pedroza García EM, Poiana C, Jimenez-Sanchez M, Yener S, Mukherjee R, Bartalotta A, Maamari R, Raverot G. Evaluation of the Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Inadequately Controlled With First-Generation Somatostatin Analogs. Front Endocrinol (Lausanne). 2020 Feb 3;10:931. doi: 10.3389/fendo.2019.00931. eCollection 2019.

family: Gadelha

full_name: Mônica Gadelha

given: Mônica

family: Bex

full_name: Marie Bex

given: Marie

family: Colao

full_name: Annamaria Colao

given: Annamaria

family: Pedroza García

full_name: Elier Mitsael Pedroza García

given: Elier Mitsael

family: Poiana

full_name: Catalina Poiana

given: Catalina

family: Jimenez-Sanchez

full_name: Marisela Jimenez-Sanchez

given: Marisela

family: Yener

full_name: Serkan Yener

given: Serkan

family: Mukherjee

full_name: Rishav Mukherjee

given: Rishav

family: Bartalotta

full_name: Amy Bartalotta

given: Amy

family: Maamari

full_name: Ricardo Maamari

given: Ricardo

family: Raverot

full_name: Gérald Raverot

given: Gérald

bso_classification: Biology (fond.)

currency_apc_doaj: USD

journal_name: Frontiers in Endocrinology

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

publisher: Frontiers Media SA

publisher_dissemination: Frontiers

publisher_group: Frontiers

publisher_normalized: Frontiers

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Brazil
Mexico
France
Bulgaria
Malaysia
Portugal
Romania
Hungary
Belgium
Argentina
China
Turkey
United Kingdom
Colombia

title: A Phase IIIb Multicenter, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues

summary: This is a phase IIIb multicenter, open-label; single arm study to evaluate the efficacy and safety of pasireotide LAR 40 mg and 60 mg in patients with inadequately controlled acromegaly with maximal approved doses of first generation somatostatin analogues. The study will enroll inadequately controlled patients by high doses (maximal approved) of first-generation somatostatin analogues given for at least 3 months. Patients will receive pasireotide LAR 40 mg or 60 mg during the 36 week core study phase. Patients who have completed all visits of core phase and have completed all the assessments at the core phase completion visit can move into the 32-week extension phase. Patients can continue with study treatment until pasireotide LAR is commercially available and reimbursed in their respective country or until the end of the extension phase whichever occurs first.


status: Recruiting

lead_sponsor: Bayer

enrollment_type: Anticipated

primary_purpose: Other

location_country:
Finland
Belgium
Australia
Russian Federation
Taiwan
France
Japan
Poland
Norway
Canada
Korea, Republic of
Chile
Sweden
Singapore
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Israel
Spain

acronym: Radium-223 dichloride long-term follow-up program

title: A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride

summary: Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .


lead_sponsor: Prothena Biosciences Ltd.

location_country:
Italy
Austria
United States
Netherlands
Germany
France
Poland
Greece
Israel
Australia
Belgium
Spain
Denmark
Canada
United Kingdom

acronym: VITAL

location_facility: Hospital of the University of Pennsylvania

location_facility: Universitatsklinik fur Innere Medizin 1 Kinische Abteilung fur Onkologie Aligemeines Krankenhaus - Universitatskliniken

location_facility: University of Texas; MD Anderson Cancer Center

location_facility: Hospital Universitario Puerta de Hierro - Maiadahonda

location_facility: University of North Carolina Chapel Hill Comprehensive Cancer Center

location_facility: Radiant Research Northwestern University

location_facility: Policlinico S.Orsola Malpighi, Unita' Operativa di Ematologia

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: John Hopkins University School of Medicine

location_facility: Froedtert & Medical College of Wisconsin, Cancer Center-Froedtert Hospital

location_facility: University of Pittsburg - Hillman Cancer Center

location_facility: Sylvester Cancer Center, University of Miami

location_facility: The Royal Free London NHS Foundation Trust-The Royal Free Hospital

location_facility: Winship Cancer Institute of Emory University

location_facility: NNUH NHS Foundation Trust - Norfolk and Norwich University Hospital

location_facility: Amyloidosis Clinic Cnr Darcy Road and Bridge St. Westmead

location_facility: Columbia University - College of Physicians & Surgeons

location_facility: University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: University of Calgary-Southern Alberta Cancer Research Institute

location_facility: Princess Margaret Cancer Research Centre

location_facility: The University of Queensland-Princess Alexandra Hospital (PAH)

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis

summary: This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.


title: A Phase IIb, Double Blind Randomized, Controlled Clinical Trial, to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) - Aramchol 005 Study

summary:
This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic.

Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1.

The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

ReferenceCitation: Ratziu V, de Guevara L, Safadi R, Poordad F, Fuster F, Flores-Figueroa J, Arrese M, Fracanzani AL, Ben Bashat D, Lackner K, Gorfine T, Kadosh S, Oren R, Halperin M, Hayardeny L, Loomba R, Friedman S; ARREST investigator study group, Sanyal AJ. Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2021 Oct;27(10):1825-1835. doi: 10.1038/s41591-021-01495-3. Epub 2021 Oct 7.

family: Ratziu

full_name: V. Ratziu

given: V.

family: de Guevara

full_name: L. de Guevara

given: L.

family: Safadi

full_name: R. Safadi

given: R.

family: Poordad

full_name: F. Poordad

given: F.

family: Fuster

full_name: F. Fuster

family: Flores-Figueroa

full_name: J. Flores-Figueroa

given: J.

family: Arrese

full_name: M. Arrese

given: M.

family: Fracanzani

full_name: Anna L. Fracanzani

given: Anna L.

family: Ben Bashat

full_name: D. Ben Bashat

given: D.

family: Lackner

full_name: K. Lackner

given: K.

family: Gorfine

full_name: T. Gorfine

given: T.

family: Kadosh

full_name: S. Kadosh

given: S.

family: Oren

full_name: R. Oren

family: Halperin

full_name: M. Halperin

family: Hayardeny

full_name: L. Hayardeny

family: Loomba

full_name: R. Loomba

family: Friedman

full_name: S. Friedman

family: Abdelmalek

full_name: M. Abdelmalek

family: Angelico

full_name: F. Angelico

full_name: M. Angelico

family: Arancibia

full_name: J. P. Arancibia

given: J. P.

family: Bardou-Jacquet

full_name: E. Bardou-Jacquet

given: E.

family: Barrera

full_name: F. Barrera

location_country:
Italy
Chile
Hong Kong
Mexico
Germany
France
Lithuania
Israel
Georgia
Romania
United States

location_facility: County Hospital Mures-Gastroenterology Department

location_facility: Azienda Ospidaliera Universitaria Seconda Universita di Napoli

location_facility: Centre Hospitalier Universitaire (CHU) d'Angers

location_facility: Consultorio Medico del Dr. Mauricio Castillo Barradas

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne

location_facility: Vilinius University Hospital Santariskiu Klinikos

location_facility: University of California Department of Medicine Division of Gastroenterology

location_facility: Pontificia Universidad Catolica de Chile

location_facility: Policlinico Univestitario Campus Biomedico

location_facility: Azienda Ospedaliera di Rilievo Nazionale "A.Cardarelli"

location_facility: CHU Centre Hospiatalier Universitaire de Rennes

location_facility: The National Institute for Infectious Diseases "Prof. Dr. Matei Bals", Clinical Department for Adults II

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Profil Institue for Clinical Research Inc.

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Unidad de Hígado Hospital Universitario Dr. José Eleuterio González

location_facility: Universitat Leipzig Medizinische Fakultat

location_facility: Gastroenterology Consultants of San Antonio

location_facility: San Joseph Service Hepato Gastro Entrologie

location_facility: "Ospedale Cristo Re" dell'Istituto Figlie di N.S. al Monte Calvario

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Instituto de Ciencias Medicas y de la Nutricion Salvador Zubiran


title: A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

summary:
This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.

The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer

ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

family: Burris

full_name: Howard A. Burris

given: Howard A.

family: Chan

full_name: Arlene Chan

given: Arlene

family: Bardia

full_name: Aditya Bardia

given: Aditya

family: Thaddeus Beck

full_name: J. Thaddeus Beck

family: Sohn

full_name: Joohyuk Sohn

given: Joohyuk

family: Neven

full_name: Patrick Neven

given: Patrick

family: Tripathy

full_name: Debu Tripathy

given: Debu

family: Im

full_name: Seock-Ah Im

given: Seock-Ah

family: Chia

full_name: Stephen Chia

given: Stephen

family: Esteva

full_name: Francisco J. Esteva

given: Francisco J.

family: Hart

full_name: Lowell Hart

given: Lowell

family: Zarate

full_name: Juan Pablo Zarate

given: Juan Pablo

family: Ridolfi

full_name: Antonia Ridolfi

given: Antonia

family: Lorenc

full_name: Karen Rodriguez Lorenc

given: Karen Rodriguez

family: Yardley

full_name: Denise A. Yardley

given: Denise A.

journal_name: British Journal of Cancer

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Paré L, Martinez D, Chic N, Martínez-Sáez O, Brasó-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum in: J Clin Oncol. 2021 Nov 1;39(31):3525.

name: Department of Medical Oncology, Hospital Clínic of Barcelona, Barcelona, Spain

name: SOLTI Breast Cancer Research Group, Barcelona, Spain

name: Translational Genomics and Targeted Therapies in Solid Tumors, Institut D'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain

name: Department of Medicine, University of Barcelona, Barcelona, Spain

name: Institute of Oncology (IOB) Quiron, Barcelona, Spain

family: Prat

full_name: Aleix Prat

given: Aleix

name: Novartis Institutes for BioMedical Research, Cambridge, MA

family: Chaudhury

full_name: Anwesha Chaudhury

given: Anwesha

family: Solovieff

full_name: Nadia Solovieff

given: Nadia

family: Paré

full_name: Laia Paré

given: Laia

family: Martinez

full_name: Débora Martinez

given: Débora

family: Chic

name: Novartis Pharmaceuticals Corporation, East Hanover, NJ

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

name: Department of Medical Oncology, Sarah Cannon Research Institute & Tennessee Oncology PLLC, Nashville, TN 37203, USA

ReferenceCitation: Im SA, Lu YS, Bardia A, Harbeck N, Colleoni M, Franke F, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva-Vazquez R, Jung KH, Chakravartty A, Hughes G, Gounaris I, Rodriguez-Lorenc K, Taran T, Hurvitz S, Tripathy D. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019 Jul 25;381(4):307-316. doi: 10.1056/NEJMoa1903765. Epub 2019 Jun 4.

name: From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) — all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical...

ReferenceCitation: Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018 Jul;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4. Epub 2018 May 24.

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:
Malaysia
Greece
Belgium
Australia
Russian Federation
Taiwan
India
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
United Arab Emirates
Saudi Arabia
Hong Kong
Switzerland
Bulgaria
Singapore
Hungary
Portugal
Germany
United States
Italy
Brazil
Lebanon
Mexico
Spain
Turkey

location_facility: Methodist Hospital / Methodist Cancer Center Dept of Oncology

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3

location_facility: NorthWest Georgia Oncology Centers NW Georgia Oncology

location_facility: University of Texas MD Anderson Cancer Center SC-5

location_facility: Tennessee Oncology Tennessee Oncology (3)

location_facility: Comprehensive Cancer Center at Saint Joseph Hospital SC

location_facility: Penn State University Milton S Hershey Medical Center

location_facility: Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc

location_facility: Washington University School of Medicine SC

location_facility: Cancer Therapy and Research Center UT Health Science Center SC-4

location_facility: Northwest Medical Specialties Dept of Onc

location_facility: Duke University Medical Center Duke (SC)

location_facility: Comprehensive Blood and Cancer Center SC-2

location_facility: The Center for Cancer and Blood Disorders SC

location_facility: University of California at Los Angeles Dept of Onc

location_facility: Moanalua Medical Center. Attn: Oncology Dept SC

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Dept of Onc.

location_facility: University of Michigan Comprehensive Cancer Center Onc Dept


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

acronym: MONARCH 3

summary: The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

ReferenceType: result

ReferenceCitation: Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.

name: Matthew P. Goetz, Mayo Clinic, Rochester, MN; Masakazu Toi, Kyoto University, Kyoto, Japan; Mario Campone, Institut de Cancerologie de l’Ouest, Angers Cedex; Olivier Trédan, Centre Léon Bérard, Lyon; Nawel Bourayou, Eli Lilly, Paris, France; Joohyuk Sohn, Yonsei Cancer Center, Seoul; In Hae Park, National Cancer Center, Goyangsi, South Korea; Shani Paluch-Shimon, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel; Jens Huober, University of Ulm, Ulm, Germany; Shin-Cheh Chen, Chang Gung University...

family: Goetz

full_name: Matthew P. Goetz

given: Matthew P.

family: Toi

full_name: Masakazu Toi

given: Masakazu

family: Campone

full_name: Mario Campone

given: Mario

family: Sohn

family: Paluch-Shimon

full_name: Shani Paluch-Shimon

given: Shani

family: Huober

full_name: Jens Huober

given: Jens

family: Park

full_name: In Hae Park

given: In Hae

family: Trédan

full_name: Olivier Trédan

given: Olivier

family: Chen

full_name: Shin-Cheh Chen

given: Shin-Cheh

family: Manso

full_name: Luis Manso

given: Luis

family: Freedman

full_name: Orit C. Freedman

given: Orit C.

family: Garnica Jaliffe

full_name: Georgina Garnica Jaliffe

given: Georgina

family: Forrester

full_name: Tammy Forrester

given: Tammy

family: Frenzel

full_name: Martin Frenzel

given: Martin

family: Barriga

full_name: Susana Barriga

given: Susana

family: Smith

full_name: Ian C. Smith

given: Ian C.

family: Bourayou

full_name: Nawel Bourayou

given: Nawel

family: Di Leo

full_name: Angelo Di Leo

given: Angelo

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Johnston S, Martin M, Di Leo A, Im SA, Awada A, Forrester T, Frenzel M, Hardebeck MC, Cox J, Barriga S, Toi M, Iwata H, Goetz MP. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019 Jan 17;5:5. doi: 10.1038/s41523-018-0097-z. eCollection 2019.

family: Johnston

full_name: Stephen Johnston

family: Martin

full_name: Miguel Martin

given: Miguel

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

ReferenceCitation: Takahashi M, Tokunaga E, Mori J, Tanizawa Y, van der Walt JS, Kawaguchi T, Goetz MP, Toi M. Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Breast Cancer. 2021 Oct 18. doi: 10.1007/s12282-021-01295-0. [Epub ahead of print]

ReferenceCitation: Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, André VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.

location_country:
Greece
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Slovakia
Canada
Korea, Republic of
Sweden
Netherlands
Puerto Rico
United States
Germany
United Kingdom
Italy
Austria
Mexico
Israel
New Zealand
Spain
Turkey

location_facility: California Cancer Associates Research and Excellence (cCARE)

location_facility: Scott & White Memorial Hosptial & Clinic

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: North Valley Hematology/Oncology Medical Group

location_facility: TRIO - Translational Research in Oncology-US, Inc.

location_facility: Kaiser Permanente / Central Interstate Medical Office

location_facility: Walter Reed National Military Medical Center IRB

location_facility: Central Coast Medical Oncology Corporation

location_facility: St Mary's Hospital Regional Cancer Center


title: A DB Four-Arm, Parallel Group, Proof of Concept, Dose-Finding Adaptive Phase 2a/2b RCT to Investigate the Safety, Tolerability and Efficacy and Effect on QoL of Human Recombinant Alkaline Phosphatase in Patients With Sepsis-Associated AKI

acronym: STOP-AKI

summary: The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.

ReferenceCitation: Pickkers P, Mehta RL, Murray PT, Joannidis M, Molitoris BA, Kellum JA, Bachler M, Hoste EAJ, Hoiting O, Krell K, Ostermann M, Rozendaal W, Valkonen M, Brealey D, Beishuizen A, Meziani F, Murugan R, de Geus H, Payen D, van den Berg E, Arend J; STOP-AKI Investigators. Effect of Human Recombinant Alkaline Phosphatase on 7-Day Creatinine Clearance in Patients With Sepsis-Associated Acute Kidney Injury: A Randomized Clinical Trial. JAMA. 2018 Nov 20;320(19):1998-2009. doi: 10.1001/jama.2018.14283.

name: Department of Intensive Care Medicine, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands

family: Pickkers

full_name: Peter Pickkers

given: Peter

name: Department of Medicine, University of California, San Diego, Medical Center

family: Mehta

full_name: Ravindra L. Mehta

given: Ravindra L.

name: School of Medicine, University College Dublin, Dublin, Ireland

family: Murray

full_name: Patrick T. Murray

given: Patrick T.

name: Department of Internal Medicine, Division of Intensive Care and Emergency Medicine, Medical University Innsbruck, Innsbruck, Austria

family: Joannidis

full_name: Michael Joannidis

given: Michael

family: Molitoris

full_name: Bruce A. Molitoris

given: Bruce A.

name: Department of Critical Care Medicine, Center for Critical Care Nephrology, University of Pittsburgh, Pittsburgh, Pennsylvania

family: Kellum

full_name: John A. Kellum

given: John A.

name: Department of General and Surgical Critical Care Medicine, Medical University Innsbruck, Innsbruck, Austria

family: Bachler

full_name: Mirjam Bachler

given: Mirjam

name: Intensive Care, Ghent University, Ghent, Belgium

name: Clinical Research Foundation Flanders, Brussels, Belgium

family: Hoste

full_name: Eric A. J. Hoste

given: Eric A. J.

name: Intensive Care, Canisius Wilhelmina Hospital, Nijmegen, the Netherlands

family: Hoiting

full_name: Oscar Hoiting

given: Oscar

name: Internal Medicine, Eastern Idaho Regional Medical Center, Idaho Falls

family: Krell

full_name: Kenneth Krell

given: Kenneth

name: Guy’s and St Thomas’ Hospital, King’s College London, London, United Kingdom

family: Ostermann

full_name: Marlies Ostermann

given: Marlies

name: Intensive Care, Jeroen Bosch Hospital, ‘s-Hertogenbosch, the Netherlands

family: Rozendaal

full_name: Wim Rozendaal

given: Wim

name: Division of Anesthesia and Intensive Care Medicine, Helsinki University Central Hospital, Helsinki, Finland

family: Valkonen

full_name: Miia Valkonen

given: Miia

name: Division of Critical Care, University College London Hospitals National Institute for Health Research Biomedical Research Centre, London, United Kingdom

name: Bloomsbury Institute of Intensive Care Medicine, University College Hospital, London, United Kingdom.

family: Brealey

full_name: David Brealey

given: David

name: Intensive Care, Medisch Spectrum Twente, Enschede, the Netherlands

family: Beishuizen

full_name: Albertus Beishuizen

given: Albertus

name: Faculté de Médecine, Service de Réanimation, Université de Strasbourg, Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg, France

family: Meziani

full_name: Ferhat Meziani

given: Ferhat

name: Department of Critical Care Medicine, Center for Critical Care Nephrology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania

family: Murugan

full_name: Raghavan Murugan

given: Raghavan

name: Department of Intensive Care, Erasmus Medical Centre, Rotterdam, the Netherlands

family: de Geus

full_name: Hilde de Geus

given: Hilde

name: Unité Mixte de Recherche INSERM 1160, University Paris 7 Denis Diderot, Paris, France

name: Department of Anaesthesiology and Critical Care, Hôpital Lariboisière, Assistance Publique—Hôpitaux de Paris, Paris, France

family: Payen

full_name: Didier Payen

given: Didier

name: Clinical Department, AM-Pharma BV, Bunnik, the Netherlands

family: van den Berg

full_name: Erik van den Berg

given: Erik

family: Arend

full_name: Jacques Arend

given: Jacques

journal_name: JAMA

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

ReferenceCitation: Peters E, Mehta RL, Murray PT, Hummel J, Joannidis M, Kellum JA, Arend J, Pickkers P. Study protocol for a multicentre randomised controlled trial: Safety, Tolerability, efficacy and quality of life Of a human recombinant alkaline Phosphatase in patients with sepsis-associated Acute Kidney Injury (STOP-AKI). BMJ Open. 2016 Sep 27;6(9):e012371. doi: 10.1136/bmjopen-2016-012371.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

title: Study protocol for a multicentre randomised controlled trial:Safety,Tolerability, efficacy and quality of lifeOf a human recombinant alkalinePhosphatase in patients with sepsis-associatedAcuteKidneyInjury (STOP-AKI)

location_country:
Austria
Netherlands
Germany
Finland
France
Czechia
Ireland
Belgium
Spain
United States
United Kingdom

location_facility: Universitätsklinikum Hamburg Eppendorf Department Intensive Care Medicine

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Universitätsklinik für Allgemeine und Chirurgische Intensivmedizin

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Hospital Universitario Germans Trias i Pujol Medicina Intensiva Hospital General,

location_facility: Universitatsklinikum Jena - Klinik für Anästhesiologie und Intensivmedzin

location_facility: Tampa General Hospital, Division Emergency Medicine

location_facility: University Hospital Frankfurt, Anaesthesia, Intensive Care Medicine & Pain Therapy

location_facility: Universitätsklinikum Schleswig-Holstein - Klinik für Anästhesiologie und Operative Intensivmedizin

location_facility: Helios Klinikum Erfurt -Klinik fur Anaesthesie, Intensivmedizin und Schmerztherapie

location_facility: Centre Hospitalier Victor Dupouy - hopital

location_facility: Hospital Universitario 12 de Octubre, Unidad de Cuidados Intensivos Hospital General

location_facility: University of Texas Houston Medical School

location_facility: Royal Surrey County Hospital - Intensive Care Unit

location_facility: Universitätsmedizin Greifswald Klinik für Anästhesiologie, IntensivmedizinNotfallmedizin und Schmerzmedizin

location_facility: Medizinische Hochschule Hannover Hospital - Zentrum Innere Medizin - Klinik fuer Pneumologie


title: A Phase III, Open Label, Randomized Study of AZD9291 Versus Platinum-Based Doublet Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose Tumours Harbour a T790M Mutation Within the Epidermal Growth Factor Receptor Gene (AURA3).

summary: A Phase III, Open Label, Randomized Study of Osimertinib versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene

ReferenceCitation: Papadimitrakopoulou VA, Mok TS, Han JY, Ahn MJ, Delmonte A, Ramalingam SS, Kim SW, Shepherd FA, Laskin J, He Y, Akamatsu H, Theelen WSME, Su WC, John T, Sebastian M, Mann H, Miranda M, Laus G, Rukazenkov Y, Wu YL. Osimertinib versus platinum-pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor: AURA3 overall survival analysis. Ann Oncol. 2020 Nov;31(11):1536-1544. doi: 10.1016/j.annonc.2020.08.2100. Epub 2020 Aug 27.

family: Papadimitrakopoulou

full_name: V.A. Papadimitrakopoulou

family: Mok

full_name: T.S. Mok

family: Han

full_name: J.-Y. Han

family: Ahn

full_name: M.-J. Ahn

family: Delmonte

full_name: A. Delmonte

given: A.

family: Ramalingam

full_name: S.S. Ramalingam

family: Kim

full_name: S.W. Kim

family: Shepherd

full_name: F.A. Shepherd

family: Laskin

full_name: J. Laskin

given: J.

family: He

full_name: Y. He

given: Y.

family: Akamatsu

full_name: H. Akamatsu

given: H.

family: Theelen

full_name: W.S.M.E. Theelen

family: Su

full_name: W.-C. Su

family: John

full_name: T. John

given: T.

family: Sebastian

full_name: M. Sebastian

given: M.

family: Mann

full_name: H. Mann

family: Miranda

full_name: M. Miranda

family: Laus

full_name: G. Laus

given: G.

family: Rukazenkov

full_name: Y. Rukazenkov

family: Wu

full_name: Y.-L. Wu

journal_name: Annals of Oncology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Osimertinib versus platinum–pemetrexed for patients with EGFR T790M advanced NSCLC and progression on a prior EGFR-tyrosine kinase inhibitor: AURA3 overall survival analysis

ReferenceCitation: Papadimitrakopoulou VA, Han JY, Ahn MJ, Ramalingam SS, Delmonte A, Hsia TC, Laskin J, Kim SW, He Y, Tsai CM, Hida T, Maemondo M, Kato T, Jenkins S, Patel S, Huang X, Laus G, Markovets A, Thress KS, Wu YL, Mok T. Epidermal growth factor receptor mutation analysis in tissue and plasma from the AURA3 trial: Osimertinib versus platinum-pemetrexed for T790M mutation-positive advanced non-small cell lung cancer. Cancer. 2020 Jan 15;126(2):373-380. doi: 10.1002/cncr.32503. Epub 2019 Nov 26.

name: The University of Texas MD Anderson Cancer Center Houston Texas

full_name: Vassiliki A. Papadimitrakopoulou

given: Vassiliki A.

name: Center for Lung Cancer National Cancer Center Goyang Republic of Korea

full_name: Ji‐Youn Han

name: Samsung Medical Center School of Medicine Sungkyunkwan University Seoul Republic of Korea

name: Winship Cancer Institute Emory University Atlanta Georgia

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS Meldola Italy

name: China Medical University Taichung City Taiwan

name: British Columbia Cancer Agency Vancouver British Columbia Canada

name: Asan Medical Center University of Ulsan College of Medicine Seoul Republic of Korea

name: Daping Hospital Third Military Medical University Chongqing China

name: Taipei Veterans General Hospital Taipei Taiwan

name: Iwate Medical University School of Medicine Iwate Japan

name: Precision Medicine, R&D Oncology AstraZeneca Cambridge United Kingdom

name: Global Medicines Development AstraZeneca Cambridge United Kingdom

name: Translational Medicine, Oncology AstraZeneca Boston Massachusetts

name: Oncology Translational Sciences, Innovative Medicines and Early Development Biotech Unit AstraZeneca Waltham Massachusetts

name: Guangdong General HospitalGuangdong Academy of Medical Sciences Guangzhou China

name: State Key Laboratory of South China Department of Clinical Oncology Chinese University of Hong Kong Hong Kong China

title: Epidermal growth factor receptor mutation analysis in tissue and plasma from the AURA3 trial: Osimertinib versus platinum‐pemetrexed for T790M mutation‐positive advanced non–small cell lung cancer

ReferenceCitation: Wu YL, Ahn MJ, Garassino MC, Han JY, Katakami N, Kim HR, Hodge R, Kaur P, Brown AP, Ghiorghiu D, Papadimitrakopoulou VA, Mok TSK. CNS Efficacy of Osimertinib in Patients With T790M-Positive Advanced Non-Small-Cell Lung Cancer: Data From a Randomized Phase III Trial (AURA3). J Clin Oncol. 2018 Sep 10;36(26):2702-2709. doi: 10.1200/JCO.2018.77.9363. Epub 2018 Jul 30.

name: Yi-Long Wu, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China; Myung-Ju Ahn, Sungkyunkwan University School of Medicine; Hye Ryun Kim, Yonsei University College of Medicine, Seoul; Ji-Youn Han, National Cancer Center, Goyang, Republic of Korea; Marina Chiara Garassino, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy; Nobuyuki Katakami, Institute of Biomedical Research and Innovation, Kobe, Japan; Rachel Hodge, Paramjit Kaur, Andrew P. Brown, and Dana...

publisher_group: American Society of Clinical Oncology (ASCO)

title: CNS Efficacy of Osimertinib in Patients With T790M-Positive Advanced Non–Small-Cell Lung Cancer: Data From a Randomized Phase III Trial (AURA3)

ReferenceCitation: Lee CK, Novello S, Rydén A, Mann H, Mok T. Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial. J Clin Oncol. 2018 Jun 20;36(18):1853-1860. doi: 10.1200/JCO.2017.77.2293. Epub 2018 May 7.

name: Chee Khoon Lee, St George Hospital, Kogarah, New South Wales, Australia; Silvia Novello, University of Turin, Turin, Italy; Anna Rydén, AstraZeneca Gothenburg, Mölndal, Sweden; Helen Mann, AstraZeneca R&D, Cambridge, United Kingdom; and Tony Mok, Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong, Special Administrative Region, People's Republic of China.

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

title: Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non–Small-Cell Lung Cancer: The AURA3 Trial

ReferenceCitation: Akamatsu H, Katakami N, Okamoto I, Kato T, Kim YH, Imamura F, Shinkai M, Hodge RA, Uchida H, Hida T. Osimertinib in Japanese patients with EGFR T790M mutation-positive advanced non-small-cell lung cancer: AURA3 trial. Cancer Sci. 2018 Jun;109(6):1930-1938. doi: 10.1111/cas.13623. Epub 2018 May 31.

name: Third Department of Internal Medicine; Wakayama Medical University; Wakayama Japan

name: Institute of Biomedical Research and Innovation; Kobe Japan

name: Research Institute for Diseases of the Chest; Graduate School of Medical Sciences; Kyushu University; Fukuoka Japan

name: Kanagawa Cardiovascular and Respiratory Center; Yokohama Japan

name: Graduate School of Medicine; Kyoto University; Kyoto Japan

name: Osaka International Cancer Institute; Osaka Japan

name: Yokohama City University Medical Center; Yokohama Japan

name: Aichi Cancer Center Hospital; Nagoya Japan

repository_institution: Kyoto University - Kyoto University Research Information Repository

ReferenceCitation: Mok TS, Wu Y-L, Ahn M-J, Garassino MC, Kim HR, Ramalingam SS, Shepherd FA, He Y, Akamatsu H, Theelen WS, Lee CK, Sebastian M, Templeton A, Mann H, Marotti M, Ghiorghiu S, Papadimitrakopoulou VA; AURA3 Investigators. Osimertinib or Platinum-Pemetrexed in EGFR T790M-Positive Lung Cancer. N Engl J Med. 2017 Feb 16;376(7):629-640. doi: 10.1056/NEJMoa1612674. Epub 2016 Dec 6.

repository_institution: Queensland University of Technology - QUT ePrints

title: Osimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer

ReferenceCitation: Soria JC, Wu YL, Nakagawa K, Kim SW, Yang JJ, Ahn MJ, Wang J, Yang JC, Lu Y, Atagi S, Ponce S, Lee DH, Liu Y, Yoh K, Zhou JY, Shi X, Webster A, Jiang H, Mok TS. Gefitinib plus chemotherapy versus placebo plus chemotherapy in EGFR-mutation-positive non-small-cell lung cancer after progression on first-line gefitinib (IMPRESS): a phase 3 randomised trial. Lancet Oncol. 2015 Aug;16(8):990-8. doi: 10.1016/S1470-2045(15)00121-7. Epub 2015 Jul 6.

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

location_country:
Italy
United States
Sweden
Hong Kong
Mexico
Netherlands
Germany
Spain
France
Japan
Hungary
Australia
Russian Federation
China
Canada
United Kingdom
Korea, Republic of
Taiwan