ReferenceCitation: Pascual-Figal D, Wachter R, Senni M, Bao W, Noè A, Schwende H, Butylin D, Prescott MF; TRANSITION Investigators. NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study. JACC Heart Fail. 2020 Oct;8(10):822-833. doi: 10.1016/j.jchf.2020.05.012. Epub 2020 Aug 12.

family: Pascual-Figal

full_name: Domingo Pascual-Figal

given: Domingo

family: Wachter

full_name: Rolf Wachter

given: Rolf

family: Senni

full_name: Michele Senni

given: Michele

family: Bao

full_name: Weibin Bao

given: Weibin

family: Noè

full_name: Adele Noè

given: Adele

family: Schwende

full_name: Heike Schwende

given: Heike

family: Butylin

full_name: Dmytro Butylin

given: Dmytro

family: Prescott

full_name: Margaret F. Prescott

given: Margaret F.

family: Gniot

full_name: Jacek Gniot

given: Jacek

family: Mozheiko

full_name: Maria Mozheiko

given: Maria

family: Lelonek

full_name: Malgorzata Lelonek

given: Malgorzata

family: Dominguez

full_name: Antonio Reyes Dominguez

given: Antonio Reyes

family: Horacek

full_name: Thomas Horacek

given: Thomas

family: Garcia del Rio

full_name: Enrique Garcia del Rio

given: Enrique

family: Kobalava

full_name: Zhanna Kobalava

given: Zhanna

family: Mueller

full_name: Christian Eugen Mueller

given: Christian Eugen

family: Cavusoglu

full_name: Yuksel Cavusoglu

given: Yuksel

family: Straburzynska-Migaj

full_name: Ewa Straburzynska-Migaj

given: Ewa

family: Slanina

full_name: Miroslav Slanina

given: Miroslav

family: vom Dahl

full_name: Juergen vom Dahl

given: Juergen

family: Ryding

full_name: Alisdair Ryding

given: Alisdair

family: Moriarty

full_name: Andrew Moriarty

given: Andrew

family: Robles

full_name: Manuel Beltran Robles

given: Manuel Beltran

family: Villota

full_name: Julio Nunez Villota

given: Julio Nunez

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

ReferenceCitation: Senni M, Wachter R, Witte KK, Straburzynska-Migaj E, Belohlavek J, Fonseca C, Mueller C, Lonn E, Chakrabarti A, Bao W, Noe A, Schwende H, Butylin D, Pascual-Figal D; TRANSITION Investigators. Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed (de novo) heart failure: a subgroup analysis of the TRANSITION study. Eur J Heart Fail. 2020 Feb;22(2):303-312. doi: 10.1002/ejhf.1670. Epub 2019 Dec 9.

name: Cardiology Division, Cardiovascular DepartmentPapa Giovanni XXIII Hospital Bergamo Italy

name: Clinic and Policlinic for CardiologyUniversity Hospital Leipzig Leipzig Germany

name: Clinic for Cardiology and PneumologyUniversity Medicine Göttingen, Germany and German Cardiovascular Research Center, partner site Göttingen Göttingen Germany

name: Leeds Institute of Cardiovascular and Metabolic MedicineUniversity of Leeds Leeds UK

name: 1st Department of CardiologyUniversity of Medical Sciences Poznan Poland

name: General Teaching HospitalCharles University in Prague Prague Czech Republic

name: Heart Failure Unit, Internal Medicine Department, Hospital de São Francisco Xavier, CHLO, NOVA Medical School, Faculdade de Ciências MédicasUniversidade Nova de Lisboa Lisbon Portugal

name: University Hospital BaselUniversity of Basel Basel Switzerland

name: McMaster University and Hamilton Health Sciences Hamilton ON Canada

name: Novartis Pharmaceuticals Hyderabad India

name: Novartis Pharmaceuticals Corporation East Hanover NJ USA

name: Cardiology DepartmentHospital Universitario Virgen de la Arrixaca, Universidad de Murcia Murcia Spain

name: on behalf of the TRANSITION Investigators

title: Initiation of sacubitril/valsartan shortly after hospitalisation for acutely decompensated heart failure in patients with newly diagnosed ( de novo ) heart failure: a subgroup analysis of the TRANSITION study

ReferenceCitation: Wachter R, Senni M, Belohlavek J, Straburzynska-Migaj E, Witte KK, Kobalava Z, Fonseca C, Goncalvesova E, Cavusoglu Y, Fernandez A, Chaaban S, Bøhmer E, Pouleur AC, Mueller C, Tribouilloy C, Lonn E, A L Buraiki J, Gniot J, Mozheiko M, Lelonek M, Noè A, Schwende H, Bao W, Butylin D, Pascual-Figal D; TRANSITION Investigators. Initiation of sacubitril/valsartan in haemodynamically stabilised heart failure patients in hospital or early after discharge: primary results of the randomised TRANSITION study. Eur J Heart Fail. 2019 Aug;21(8):998-1007. doi: 10.1002/ejhf.1498. Epub 2019 May 27.

name: Clinic and Policlinic for CardiologyUniversity Hospital Leipzig, and Clinic for Cardiology, University Medicine Göttingen and German Cardiovascular Research Center, Partner Site Göttingen Germany

name: Cardiology DivisionCardiovascular Department, Papa Giovanni XXIII Hospital Bergamo Italy

name: First Department of CardiologyUniversity of Medical Sciences Poznan Poland

name: Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds Leeds UK

name: Peoples' Friendship University of Russia (RUDN University) Moscow Russia

name: Heart Failure Unit, Internal Medicine DepartmentHospital de São Francisco Xavier, CHLO, NOVA Medical School, Faculdade de Ciências Médicas, Universidade Nova de Lisboa Lisbon Portugal

name: Odd. Srdcovehozlyhavania a Transplantacie Bratislava Slovakia

name: Eskişehir Osmangazi University Medical Faculty Eskişehir Turkey

name: Sanatorio Modelo Quilmes Buenos Aires Argentina

name: Hammoud Hospital University Medical Center Saida Lebanon

name: Innlandet Hospital Trust Lillehammer Norway

name: Cardiology DivisionCliniques Universitaires Saint‐Luc Brussels Belgium

name: University Hospital Basel, University of Basel Basel Switzerland

name: Department of CardiologyAmiens University Hospital Amiens France

name: McMaster University and Hamilton Health Sciences Hamilton Canada

name: King Faisal Specialist Hospital Riyadh Saudi Arabia

name: SP ZOZ Szpital Specjalistyczny Pulawy Poland

name: Yaroslavl Regional Hospital of Veterans of Wars Yaroslavl Russia

name: Department of Noninvasive CardiologyMedical University of Lodz Lodz Poland

name: Novartis Pharmaceuticals East Hanover NJ USA

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

ReferenceCitation: Pascual-Figal D, Wachter R, Senni M, Belohlavek J, Noè A, Carr D, Butylin D. Rationale and design of TRANSITION: a randomized trial of pre-discharge vs. post-discharge initiation of sacubitril/valsartan. ESC Heart Fail. 2018 Apr;5(2):327-336. doi: 10.1002/ehf2.12246. Epub 2017 Dec 14.

name: Heart Failure and Heart Transplantation Unit, Cardiology Department; Virgen de la Arrixaca University Hospital, Universidad de Murcia; Ctra. Madrid-Cartagena s/n 30120 Murcia Spain

name: Clinic and Policlinic for Cardiology; University Hospital Leipzig; Germany

name: Cardiology Division, Cardiovascular Department; Hospital Papa Giovanni XXIII-Bergamo; Bergamo Italy

name: Complex Cardiovascular Centre, General Teaching Hospital; Charles University; Prague Czech Republic

location_country:
Italy
Sweden
Saudi Arabia
Switzerland
Lebanon
Spain
Germany
France
Czechia
Poland
Slovakia
Norway
Belgium
Argentina
Russian Federation
Portugal
Turkey
Canada
United Kingdom

title: A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)

summary: To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.


type: EudraCT Number

title: A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (Anti-PD-1 Monoclonal Antibody) and in Combination With Both Nivolumab and Ipilimumab (Anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

summary: The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
United States
Sweden
Germany
Finland
France
Poland
Norway
Australia
Spain
Canada

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

acronym: CheckMate 274

summary: The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

ReferenceType: derived

ReferenceCitation: Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442. Erratum in: N Engl J Med. 2021 Aug 26;385(9):864.

name: From the Memorial Sloan Kettering Cancer Center (D.F.B), Weill Cornell Medical College (S.F.S.), and Icahn School of Medicine at Mount Sinai (M.D.G.) — all in New York; Radboud University, Nijmegen, the Netherlands (J.A.W.); the Department of Urology, Technical University Munich, Munich, Germany (J.E.G.); Nectarie Oncology Center, Craiova, Romania (M.S.); Hospital Universitario Virgen del Rocío, Seville (B.P.V.), and Ramon y Cajal University Hospital, Madrid (P.G.) — both in Spain; Niigata University...

family: Bajorin

full_name: Dean F. Bajorin

given: Dean F.

sequence: first

family: Witjes

full_name: J. Alfred Witjes

given: J. Alfred

sequence: additional

family: Gschwend

full_name: Jürgen E. Gschwend

given: Jürgen E.

family: Schenker

full_name: Michael Schenker

given: Michael

family: Valderrama

full_name: Begoña P. Valderrama

given: Begoña P.

family: Tomita

full_name: Yoshihiko Tomita

given: Yoshihiko

family: Bamias

full_name: Aristotelis Bamias

given: Aristotelis

family: Lebret

full_name: Thierry Lebret

given: Thierry

family: Shariat

full_name: Shahrokh F. Shariat

given: Shahrokh F.

family: Park

full_name: Se Hoon Park

given: Se Hoon

family: Ye

full_name: Dingwei Ye

given: Dingwei

family: Agerbaek

full_name: Mads Agerbaek

given: Mads

family: Enting

full_name: Deborah Enting

given: Deborah

family: McDermott

full_name: Ray McDermott

given: Ray

family: Gajate

full_name: Pablo Gajate

given: Pablo

family: Peer

full_name: Avivit Peer

given: Avivit

family: Milowsky

full_name: Matthew I. Milowsky

given: Matthew I.

family: Nosov

full_name: Alexander Nosov

given: Alexander

family: Neif Antonio

full_name: João Neif Antonio

given: João

suffix: Jr.

family: Tupikowski

full_name: Krzysztof Tupikowski

given: Krzysztof

family: Toms

full_name: Laurence Toms

given: Laurence

family: Fischer

full_name: Bruce S. Fischer

given: Bruce S.

family: Qureshi

location_country:
Peru
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Switzerland
Netherlands
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Universitatsklinikum Giessen Und Marburg

location_facility: Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: Univ Klinikum Der Ernst-Moritz-Arndt-Univ Greifswald

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Fundacion Oftalmologica De Santander - Foscal

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: Centre Hospitalier De L'Universite De Montreal

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: Erlanger Oncology & Hematology - Univ. of TN

location_facility: Ibcc - Inst. Bras. De Controle De Cancer

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: University Of California San Francisco-Fresno

location_facility: Azienda Ospedaliera S. Camillo Forlanini

location_facility: Centre integre universitaire de sante et de service sociaux de l'estrie - CHUS

location_facility: Cancer & Hematology Centers Of Western Michigan

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Arcispedale S. Maria Nuova - A.O. Reggio Emilia

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: University of Pittsburgh Cancer Institute Cancer Services

location_facility: Hospital General Universitari Vall D'Hebron

location_facility: Administradora Del Country S.A. - Clinica Del Country


title: A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

acronym: ReGIFT

summary: The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).

status: Completed

study_completion_date_type: Actual

primary_purpose: Prevention

lead_sponsor: Quark Pharmaceuticals

location_country:
Brazil
Netherlands
Germany
France
Czechia
Belgium
Argentina
Australia
Spain
United States
Canada

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Centre Hospitalier - Universitaire de Liège

location_facility: Medizinische Hochschule Hannover, Klinik für Nieren und Hochdruckerkrankungen

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Fundação Oswaldo Ramos - Hospital do Rim

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: University of Florida Health, Shands Hospital

location_facility: Integris Nazih Zuhdi Transplant Institute

location_facility: University Hospital Schleswig Holstein, Campus Kiel

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: New York - Presbyterian Hospital / Weill Cornell Medical Center

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

location_facility: Centre Hospitalier Universitaire de Rangueil

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum (CVK)

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Instituto de Nefrología Trasplante Renal y Renopancreatico

intervention_type: Other

status_simplified: Completed


lead_sponsor: Bayer

location_country:
Italy
United States
Netherlands
Finland
France
Poland
Belgium
Australia
Russian Federation
Spain
Turkey
Canada
United Kingdom
Korea, Republic of

acronym: Phase II anetumab ravtansine as 2nd line treatment for malignant pleural mesothelioma (MPM)

source: euctr

title: A Randomized, Open-label, Active-controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients With Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Platinum/Pemetrexed-based Chemotherapy

summary:
The main purpose of the 15743 study is to assess efficacy and safety of anetumab ravtansine versus vinorelbine in progression free survival in patients with stage IV mesothelin overexpressing malignant pleural mesothelioma (MPM).

210 eligible patients will be randomized to receive either anetumab ravtansine every three weeks or weekly vinorelbine.

Treatment will continue until centrally confirmed disease progression or until another criterion is met for withdrawal from the study. Patients will enter follow up phase to capture safety and endpoint data as required.

Efficacy will be measured by evaluating progression free survival from randomization. Radiological tumor assessments will be performed at defined time points until the patient's disease progresses.

Blood samples will be collected for safety, pharmacokinetic and biomarker analysis. Archival or fresh biopsy tissue may also be collected for central pathology review and biomarkers.


type: Other Identifier

title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of JNJ-61186372, a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

acronym: CHRYSALIS

summary: The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
United States
Spain
France
Japan
Australia
China
Canada
United Kingdom
Korea, Republic of
Taiwan

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

location_facility: National Hospital Organization Kyushu Cancer Center

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

location_facility: Sanford Cancer Center - Sanford Hematology Oncology

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

location_facility: Union Hospital Tongji Medical College of Huazhong University of Science and Technology

location_facility: University of Michigan - Rogel Cancer Center

location_facility: Beijing Shijitan Hospital, Capital Medical University

location_facility: Sir Bobby Robson Unit, Northern Centre for Cancer Care

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: The First Bethune Hospital of Jilin University

location_facility: Langone Health at NYC University, NYU School of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital of NanChang University

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: The first affiliated hospital of xiamen university


title: A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

summary: The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.

ReferenceType: result

ReferenceCitation: Daar ES, DeJesus E, Ruane P, Crofoot G, Oguchi G, Creticos C, Rockstroh JK, Molina JM, Koenig E, Liu YP, Custodio J, Andreatta K, Graham H, Cheng A, Martin H, Quirk E. Efficacy and safety of switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide from boosted protease inhibitor-based regimens in virologically suppressed adults with HIV-1: 48 week results of a randomised, open-label, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2018 Jul;5(7):e347-e356. doi: 10.1016/S2352-3018(18)30091-2. Epub 2018 Jun 18.

family: Daar

full_name: Eric S Daar

given: Eric S

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Ruane

full_name: Peter Ruane

given: Peter

family: Crofoot

full_name: Gordon Crofoot

given: Gordon

family: Oguchi

full_name: Godson Oguchi

given: Godson

family: Creticos

full_name: Catherine Creticos

given: Catherine

family: Rockstroh

full_name: Jürgen K Rockstroh

given: Jürgen K

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Koenig

full_name: Ellen Koenig

given: Ellen

family: Liu

full_name: Ya-Pei Liu

given: Ya-Pei

family: Custodio

full_name: Joseph Custodio

given: Joseph

family: Andreatta

full_name: Kristen Andreatta

given: Kristen

family: Graham

full_name: Hiba Graham

given: Hiba

family: Cheng

full_name: Andrew Cheng

given: Andrew

family: Martin

full_name: Hal Martin

given: Hal

family: Quirk

full_name: Erin Quirk

given: Erin

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet HIV

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Andreatta K, Willkom M, Martin R, Chang S, Wei L, Liu H, Liu YP, Graham H, Quirk E, Martin H, White KL. Switching to bictegravir/emtricitabine/tenofovir alafenamide maintained HIV-1 RNA suppression in participants with archived antiretroviral resistance including M184V/I. J Antimicrob Chemother. 2019 Dec 1;74(12):3555-3564. doi: 10.1093/jac/dkz347. Erratum in: J Antimicrob Chemother. 2019 Dec 1;74(12):3646-3647.

name: Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404, USA

family: Willkom

full_name: Madeleine Willkom

given: Madeleine

full_name: Ross Martin

given: Ross

family: Chang

full_name: Silvia Chang

given: Silvia

family: Wei

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

location_country:
Italy
United States
Germany
Dominican Republic
France
Belgium
Australia
Puerto Rico
Spain
Canada
United Kingdom


title: COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention

acronym: COBRA-REDUCE

summary: The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.

ReferenceCitation: Colleran R, Joner M, Cutlip D, Urban P, Maeng M, Jauhar R, Barakat M, Michel JM, Mehran R, Kirtane AJ, Maillard L, Kastrati A, Byrne RA; COBRA-REDUCE investigators. Design and rationale of a randomized trial of COBRA PzF stenting to REDUCE duration of triple therapy (COBRA-REDUCE). Cardiovasc Revasc Med. 2021 Jan 22. pii: S1553-8389(21)00051-8. doi: 10.1016/j.carrev.2021.01.022. [Epub ahead of print]

family: Colleran

full_name: Róisín Colleran

given: Róisín

family: Joner

full_name: Michael Joner

given: Michael

family: Cutlip

full_name: Donald Cutlip

given: Donald

family: Urban

full_name: Philip Urban

given: Philip

family: Maeng

full_name: Michael Maeng

family: Jauhar

full_name: Rajiv Jauhar

given: Rajiv

family: Barakat

full_name: Mark Barakat

given: Mark

family: Michel

full_name: Jonathan M. Michel

given: Jonathan M.

family: Mehran

full_name: Roxana Mehran

given: Roxana

family: Kirtane

full_name: Ajay J. Kirtane

given: Ajay J.

family: Maillard

full_name: Luc Maillard

given: Luc

family: Kastrati

full_name: Adnan Kastrati

given: Adnan

family: Byrne

full_name: Robert A. Byrne

given: Robert A.

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

ipd_sharing: No

lead_sponsor: CeloNova BioSciences, Inc.

location_country:
Italy
Switzerland
Germany
France
Belgium
Denmark
United States
Latvia

location_facility: Sentara Heart Hospital (Sentara Cardiovascular Research Institute)

location_facility: Paula Stradins Clinical University Hospital

location_facility: Rutgers Robert Wood Johnson Medical Schoo

location_facility: Institut Lorrain du Coeur et Vaisseaux, CHU Nancy-Barbois

location_facility: University of Maryland St. Joseph Medical Center

intervention_type: Device


ReferenceCitation: Rosenstock J, Marquard J, Laffel LM, Neubacher D, Kaspers S, Cherney DZ, Zinman B, Skyler JS, George J, Soleymanlou N, Perkins BA. Empagliflozin as Adjunctive to Insulin Therapy in Type 1 Diabetes: The EASE Trials. Diabetes Care. 2018 Dec;41(12):2560-2569. doi: 10.2337/dc18-1749. Epub 2018 Oct 4.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Marquard

full_name: Jan Marquard

given: Jan

family: Laffel

full_name: Lori M. Laffel

given: Lori M.

family: Neubacher

full_name: Dietmar Neubacher

given: Dietmar

family: Kaspers

full_name: Stefan Kaspers

given: Stefan

family: Cherney

full_name: David Z. Cherney

given: David Z.

family: Zinman

full_name: Bernard Zinman

given: Bernard

family: Skyler

full_name: Jay S. Skyler

given: Jay S.

family: George

full_name: Jyothis George

given: Jyothis

family: Soleymanlou

full_name: Nima Soleymanlou

given: Nima

family: Perkins

full_name: Bruce A. Perkins

given: Bruce A.

journal_name: Diabetes Care

evidence: open (via free pdf)

license_normalized: no license

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Greece
Romania
Australia
Russian Federation
France
Poland
Norway
Canada
South Africa
Sweden
Netherlands
Hungary
Ireland
Portugal
United States
Germany
United Kingdom
Italy
Mexico
Czechia
New Zealand
Spain
Latvia

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Richmond Road and Diagnostic Treatment Centre

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: SC Pelican Impex SRL, Cabinet Nr. 201, Diabetes Dept.

location_facility: Policlinic No. 1 of Russian Academy of Sciences, St. Petersburg

location_facility: Independent Public Clin.Hosp.no1Lublin,Dep.Internal Diseases

location_facility: A. Lucenko's Internist & Endocrinologist Doctor's Practice

location_facility: Clínica EndocrInol en Diabetes Obesidad y Tiroides (DOT)

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: AIDIN VK s.r.o.,Department Diabetology, Hranice

location_facility: Applied Medical Informatics Research INC.

location_facility: Endo-Diabesidad-Clínica Durán & Asociados

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Diabetes-Klinik Bad Mergentheim GmbH & Co. KG

location_facility: Medical Academy named after I. Mechnikov, St. Petersburg

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: City Hospital Saint Elizaveta, Dept. Endocrinology

location_facility: University of Maryland School of Medicine

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: Diabetes Endocrinology Research Center of Western New York

location_facility: DiaGolfova s.r.o., Department Diabetology, Prague

location_facility: Oslo Universitetssykehus HF, Lipidklinikken

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: University Diabetes and Endocrine Consultants

location_facility: NorCal Endocrinology and Internal Medicine

location_facility: Milan Kvapil s.r.o.,Diabetology ambulance,Prague

location_facility: Eagle's Landing Diabetes and Endocrinology

location_facility: Endocrine-Diabetes Care and Resource Center

location_facility: Witold Chodzko Institute Rural Medic,Dep.Diabetology,Lublin

location_facility: Clinical Research Center Medicome, Oswiecim

location_facility: Milit. Cent. Emerg. Univ. Hosp. Dr. Davila, Met. Dis. Dept.

location_facility: Institut für Diabetesforschung Münster GmbH

location_facility: Osp. S. Giovanni Calibita Fatebenefratelli

location_facility: Solutions Through Advanced Research, Inc.

location_facility: Strand Physician Specialists dba Carolina Health Specialists

location_facility: Zala Country Hospital, Diabetic Outpatient Clinic

location_facility: CRU Hungary Ltd, Private Practice, Miskolc

location_facility: Diabetes and Endocrinology Consultants, PC

location_facility: Clinique des maladies Lipidiques de Quebec

location_facility: Instituto Jaliscience de Inv. en Diabetes y Obesidad, S.C.

location_facility: General Hopsital of Thessaloniki "Ippokrateio"

location_facility: John Muir Physician Network Clinical Research Center

location_facility: H. Santo António - Centro Hospitalar do Porto

location_facility: VSV Centrs, Stalte Private Practice, Talsi

location_facility: Desert Endocrinology Clinical Research Center

location_facility: P. Stradins Clinical University Hospital, Riga

location_facility: APDP - Associação Protectora dos Diabéticos de Portugal

location_facility: Dace Teterovska Doctor's Practice in Endocrinology,Ogre

location_facility: "Korgialeneio-Benakeio" Hellenic Red Cross Hospital

location_facility: HUS, Lihavuustutkimusyksikkö Biomedicum Helsinki

location_facility: SC Medical Centre "Sanatatea Ta" SRL, Bucharest

title: A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group, Efficacy, Safety and Tolerability Trial of Once Daily, Oral Doses of Empagliflozin as Adjunctive to Insulin Therapy Over 26 Weeks in Patients With Type 1 Diabetes Mellitus (EASE-3)

summary: The study will investigate the efficacy, safety, tolerability and Pharmacokinetic(PK) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin


ReferenceCitation: Vancheri C, Kreuter M, Richeldi L, Ryerson CJ, Valeyre D, Grutters JC, Wiebe S, Stansen W, Quaresma M, Stowasser S, Wuyts WA; INJOURNEY Trial Investigators. Nintedanib with Add-on Pirfenidone in Idiopathic Pulmonary Fibrosis. Results of the INJOURNEY Trial. Am J Respir Crit Care Med. 2018 Feb 1;197(3):356-363. doi: 10.1164/rccm.201706-1301OC.

name: Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy

family: Vancheri

full_name: Carlo Vancheri

given: Carlo

name: Center for Interstitial and Rare Lung Diseases, Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany, Member of the German Center for Lung Research

family: Kreuter

full_name: Michael Kreuter

given: Michael

name: Catholic University of the Sacred Heart, Rome, Italy

family: Richeldi

full_name: Luca Richeldi

given: Luca

name: University of British Columbia, Vancouver, British Columbia, Canada

family: Ryerson

full_name: Christopher J. Ryerson

given: Christopher J.

name: Assistance Publique-Hôpitaux de Paris, Avicenne Hospital University, Bobigny, France

family: Valeyre

full_name: Dominique Valeyre

given: Dominique

name: Interstitial Lung Diseases Center of Excellence, Department of Pulmonology, St. Antonius Hospital, Nieuwegein, the Netherlands

name: Division of Heart & Lungs, University Medical Center Utrecht, Utrecht, the Netherlands

family: Grutters

full_name: Jan C. Grutters

given: Jan C.

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany

family: Wiebe

full_name: Sabrina Wiebe

given: Sabrina

name: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany; and

family: Stansen

full_name: Wibke Stansen

given: Wibke

family: Quaresma

full_name: Manuel Quaresma

given: Manuel

family: Stowasser

full_name: Susanne Stowasser

given: Susanne

name: Unit for Interstitial Lung Diseases, Department of Respiratory Medicine, University Hospitals Leuven, Leuven, Belgium

family: Wuyts

full_name: Wim A. Wuyts

given: Wim A.

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

location_country:
Italy
United States
Netherlands
France
Germany
Canada

acronym:
Safety, tolerability and PK of nintedanib in combination with pirfenidone in IPF

 Innocuité, tolérance et PK du nintedanib combiné avec la pirfénidone dans la PFI

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

title: A Twelve Week, Open-label, Randomised, Parallel-group Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of Oral Nintedanib in Combination With Oral Pirfenidone, Compared to Treatment With Nintedanib Alone, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
This is a phase IV, twelve week, open label, randomized, parallel group study to assess safety and tolerability of combined treatment with nintedanib and pirfenidone.

A secondary objective is to assess the exposure based on PK trough concentration values to nintedanib either given alone or in combination with pirfenidone and to assess the exposure of pirfenidone when combined with nintedanib.


ReferenceCitation: Dangas GD, Tijssen JGP, Wöhrle J, Søndergaard L, Gilard M, Möllmann H, Makkar RR, Herrmann HC, Giustino G, Baldus S, De Backer O, Guimarães AHC, Gullestad L, Kini A, von Lewinski D, Mack M, Moreno R, Schäfer U, Seeger J, Tchétché D, Thomitzek K, Valgimigli M, Vranckx P, Welsh RC, Wildgoose P, Volkl AA, Zazula A, van Amsterdam RGM, Mehran R, Windecker S; GALILEO Investigators. A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. N Engl J Med. 2020 Jan 9;382(2):120-129. doi: 10.1056/NEJMoa1911425. Epub 2019 Nov 16.

name: From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers–University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) — both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of...

family: Dangas

full_name: George D. Dangas

given: George D.

family: Tijssen

full_name: Jan G.P. Tijssen

given: Jan G.P.

family: Wöhrle

full_name: Jochen Wöhrle

given: Jochen

family: Søndergaard

full_name: Lars Søndergaard

given: Lars

family: Gilard

full_name: Martine Gilard

given: Martine

family: Möllmann

full_name: Helge Möllmann

given: Helge

family: Makkar

full_name: Raj R. Makkar

given: Raj R.

family: Herrmann

full_name: Howard C. Herrmann

given: Howard C.

family: Giustino

full_name: Gennaro Giustino

given: Gennaro

family: Baldus

full_name: Stephan Baldus

given: Stephan

family: De Backer

full_name: Ole De Backer

given: Ole

family: Guimarães

full_name: Ana H.C. Guimarães

given: Ana H.C.

family: Gullestad

full_name: Lars Gullestad

family: Kini

full_name: Annapoorna Kini

given: Annapoorna

family: von Lewinski

full_name: Dirk von Lewinski

given: Dirk

family: Mack

full_name: Michael Mack

family: Moreno

full_name: Raúl Moreno

given: Raúl

family: Schäfer

full_name: Ulrich Schäfer

given: Ulrich

family: Seeger

full_name: Julia Seeger

given: Julia

family: Tchétché

full_name: Didier Tchétché

given: Didier

family: Thomitzek

full_name: Karen Thomitzek

given: Karen

family: Valgimigli

full_name: Marco Valgimigli

given: Marco

family: Vranckx

full_name: Pascal Vranckx

given: Pascal

family: Welsh

full_name: Robert C. Welsh

given: Robert C.

family: Wildgoose

full_name: Peter Wildgoose

given: Peter

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

repository_institution: University of Bern - Bern Open Repository and Information System

repository_institution: University of Southampton - ePrints Soton

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Piayda K, Zeus T, Sievert H, Kelm M, Polzin A. Subclinical leaflet thrombosis. Lancet. 2018 Mar 10;391(10124):937-938. doi: 10.1016/S0140-6736(18)30534-8.

title: Subclinical leaflet thrombosis

ReferenceCitation: Windecker S, Tijssen J, Giustino G, Guimarães AH, Mehran R, Valgimigli M, Vranckx P, Welsh RC, Baber U, van Es GA, Wildgoose P, Volkl AA, Zazula A, Thomitzek K, Hemmrich M, Dangas GD. Trial design: Rivaroxaban for the prevention of major cardiovascular events after transcatheter aortic valve replacement: Rationale and design of the GALILEO study. Am Heart J. 2017 Feb;184:81-87. doi: 10.1016/j.ahj.2016.10.017. Epub 2016 Oct 31.

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Germany
France
Czechia
Poland
Norway
Belgium
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

title: Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes

summary:
To assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE).

To assess the primary bleeding events (PBE) of the rivaroxaban-based strategy compared to an antiplatelet-based strategy, following TAVR.


title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Cinryze® (C1 Esterase Inhibitor [Human]) for the Treatment of Acute Antibody-mediated Rejection in Kidney Transplant Patients

summary: The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft in kidney transplant recipients as measured by the proportion of participants with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.

status: Terminated

ipd_sharing: Yes

ipd_sharing_description: Shire provides access to the de-identified individual participant data for eligible studies to aid qualified researchers in addressing legitimate scientific objectives. These IPDs will be provided following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Shire

location_country:
United States
Netherlands
France
Spain
Germany
Canada

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Providence Health Care Research Institute

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire de Bicêtre

location_facility: Washington University School of Medicine

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: University of Pennsylvania Health System

location_facility: University Of Colorado School Of Medicine

location_facility: Kidney Transplant Research Office at UCLA

location_facility: INTEGRIS Nazih Zuhdi Transplant Institute

location_facility: University of Utah Health Sciences Center

status_simplified: Unknown


title: Glycemic Control and Treatment Satisfaction Using Finesse Versus Pen for Initiating Bolus Insulin Dosing in Type 2 Diabetes Mellitus Patients Not Achieving Glycemic Targets on Basal Insulin With/Without Anti-Hyperglycemic Agents

summary: To compare glycemic control and treatment satisfaction using a novel bolus insulin patch (Finesse) versus a pen for initiating and managing bolus insulin dosing in patients with T2DM not achieving glycemic targets on basal insulin with/without anti-hyperglycemic agents.

lead_sponsor: Calibra Medical, Inc.

location_country:
Germany
United States
United Kingdom
France

location_facility: Texas Diabetes & Endocrinology, P.A.- Austin

location_facility: Royal United Hospital, Diabetes & Lipid Research Wolfson Centre

location_facility: University Diabetes and Endocrine Consultants

location_facility: Diabetes Zentrum und Praxis Prof. Pfutzner Parcusstr.

location_facility: Iowa Diabetes and Endocrinology Research Center

location_facility: Hopital Lariboisiere, Centre Universitaire du Diabete et de ses Complications

location_facility: BAG Unterm Heilig Kreuz Unterm Heilig Kreuz

location_facility: Diabetes Research Institute Mills-Peninsula Health Service

location_facility: Leicester General Hospital Leicester Diabetes Centre

location_facility: Rocky Mountain Diabetes and Osteoporosis Center PA

location_facility: Advanced Metabolic Care & Research Institute, Inc. (AMCR)

location_facility: Ninewells Hospital & Medical School Diabetes Support Unit

location_facility: John H. Stroger, Jr. Hospital of Cook County Diabetes Center

location_facility: Park Nicollet Institute International Diabetes Center

location_facility: Forth Valley Royal Hospital Dept. of Diabetes

location_facility: Diabetes & Glandular Disease Clinic, P.A.

location_facility: Lapeyronie Hospital, University Hospital Montpellier

location_facility: Northwestern University The Feinberg School of Medicine

location_facility: Royal Blackburn Hospital, East Lancashire Hospitals NHS Trust


title: Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.

lead_sponsor: Arena Pharmaceuticals

location_country:
Romania
Australia
Belgium
Russian Federation
Ukraine
France
Poland
Lithuania
Canada
Korea, Republic of
Bulgaria
Hungary
Germany
United Kingdom
United States
Austria
Czechia
Israel
New Zealand
Spain
Latvia

location_facility:
Arena 1130
Arena 1414
Arena 1405
Arena 1443
Arena 1486
Arena 1116
Arena 1406
Arena 1131
Arena 1128
Arena 1428
Arena 1465
Arena 1407
Arena 1421
Arena 1436
Arena 1704
Arena 1446
Arena 1127
Arena 1424
Arena 1605
Arena 1206
Arena 1492
Arena 1493
Arena 1417
Arena 1469
Arena 1480
Arena 1470
Arena 1498
Arena 1113
Arena 1455
Arena 1477
Arena 1102
Arena 1411
Arena 1138
Arena 1451
Arena 1204
Arena 1101
Arena 1142
Arena 1473
Arena 1703
Arena 1607
Arena 1430
Arena 1111
Arena 1420
Arena 1500
Arena 1112
Arena 1121
Arena 1137
Arena 1490
Arena 1459
Arena 1133
Arena 1454
Arena 1466
Arena 1464
Arena 1456
Arena 1118
Arena 1457
Arena 1495
Arena 1471
Arena 1506
Arena 1491
Arena 1458
Arena 1489
Arena 1143
Arena 1304
Arena 1105
Arena 1615
Arena 1462
Arena 1437
Arena 1481
Arena 1484
Arena 1448
Arena 1416
Arena 1302
Arena 1419
Arena 1409
Arena 1108
Arena 1705
Arena 1475
Arena 1408
Arena 1141
Arena 1106
Arena 1601
Arena 1504
Arena 1303
Arena 1109
Arena 1202
Arena 1115
Arena 1438
Arena 1423
Arena 1497
Arena 1114
Arena 1444
Arena 1614
Arena 1431
Arena 1610
Arena 1460
Arena 1479
Arena 1119
Arena 1208
Arena 1445
Arena 1604
Arena 1139
Arena 1403
Arena 1505
Arena 1706
Arena 1702
Arena 1472
Arena 1107
Arena 1501
Arena 1136
Arena 1425
Arena 1441
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Arena 1418
Arena 1432
Arena 1103
Arena 1209
Arena 1117
Arena 1422
Arena 1410
Arena 1433
Arena 1474
Arena 1123
Arena 1478
Arena 1476
Arena 1494
Arena 1210


lead_sponsor: ImmuPharma

location_country:
United States
France
Czechia
Poland
Hungary
Puerto Rico
Germany
Mauritius

acronym: LUPUZOR

location_facility: University of Debrecen Medical Center Department of Clinical Immunology

location_facility: Arthritis and Rheumatic Disease Specialties

location_facility: Egyesitett Szt.István és Szt. László Kórház

location_facility: Clinic for Rheumatology and Internal Medicine

title: A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus

summary: This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.


title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas

summary: This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.

ReferenceCitation: Johnson CN, Ahn JS, Buck IM, Chiarparin E, Day JEH, Hopkins A, Howard S, Lewis EJ, Martins V, Millemaggi A, Munck JM, Page LW, Peakman T, Reader M, Rich SJ, Saxty G, Smyth T, Thompson NT, Ward GA, Williams PA, Wilsher NE, Chessari G. A Fragment-Derived Clinical Candidate for Antagonism of X-Linked and Cellular Inhibitor of Apoptosis Proteins: 1-(6-[(4-Fluorophenyl)methyl]-5-(hydroxymethyl)-3,3-dimethyl-1 H,2 H,3 H-pyrrolo[3,2- b]pyridin-1-yl)-2-[(2 R,5 R)-5-methyl-2-([(3R)-3-methylmorpholin-4-yl]methyl)piperazin-1-yl]ethan-1-one (ASTX660). J Med Chem. 2018 Aug 23;61(16):7314-7329. doi: 10.1021/acs.jmedchem.8b00900. Epub 2018 Aug 9.

name: Astex Pharmaceuticals, 436 Cambridge Science Park, Milton Road, Cambridge CB4 0QA, United Kingdom

family: Johnson

full_name: Christopher N. Johnson

given: Christopher N.

family: Ahn

full_name: Jong Sook Ahn

given: Jong Sook

family: Buck

full_name: Ildiko M. Buck

given: Ildiko M.

family: Chiarparin

full_name: Elisabetta Chiarparin

given: Elisabetta

family: Day

full_name: James E. H. Day

given: James E. H.

family: Hopkins

full_name: Anna Hopkins

given: Anna

family: Howard

full_name: Steven Howard

given: Steven

family: Lewis

full_name: Edward J. Lewis

given: Edward J.

family: Martins

full_name: Vanessa Martins

given: Vanessa

family: Millemaggi

full_name: Alessia Millemaggi

given: Alessia

family: Munck

full_name: Joanne M. Munck

given: Joanne M.

family: Page

full_name: Lee W. Page

given: Lee W.

family: Peakman

full_name: Torren Peakman

given: Torren

family: Reader

full_name: Michael Reader

given: Michael

family: Rich

full_name: Sharna J. Rich

given: Sharna J.

family: Saxty

full_name: Gordon Saxty

given: Gordon

family: Smyth

full_name: Tomoko Smyth

given: Tomoko

family: Thompson

full_name: Neil T. Thompson

given: Neil T.

family: Ward

full_name: George A. Ward

given: George A.

family: Williams

full_name: Pamela A. Williams

given: Pamela A.

family: Wilsher

full_name: Nicola E. Wilsher

given: Nicola E.

family: Chessari

full_name: Gianni Chessari

given: Gianni

journal_name: Journal of Medicinal Chemistry

title: A Fragment-Derived Clinical Candidate for Antagonism of X-Linked and Cellular Inhibitor of Apoptosis Proteins: 1-(6-[(4-Fluorophenyl)methyl]-5-(hydroxymethyl)-3,3-dimethyl-1H,2H,3H-pyrrolo[3,2-b]pyridin-1-yl)-2-[(2R,5R)-5-methyl-2-([(3R)-3-methylmorpholin-4-yl]methyl)piperazin-1-yl]ethan-1-one (ASTX660)

location_country:
Italy
United States
France
Hungary
Belgium
Spain
Canada
United Kingdom

location_facility: Centre Antoine Lacassagne, Oncologie Médicale

location_facility: START- South Texas Accelerated Research Therapeutics

location_facility: CRU de Tours - Hôpital Bretonneau, Hématologie -Thérapy Cellulaire

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

location_facility: Institut Universitaire du Cancer - Oncopôle, Department d'Hématologie

location_facility: Emory University winship Cancer Institute

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

location_facility: Azienda Socio Santaria Territoriale Monza- Osperdale San Gerado

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház

location_facility: New York Presbyterian Hospital Columbia University Medical Center

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: The Christie NHS Foundation Trust, Christie Hospital

location_facility: Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne

location_facility: University of Oklahoma Stephenson Cancer Center

location_facility: University Hospitals of Leicester NHS Trust

location_facility: Beatson Cancer Center and University of Glasgow

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Semmelweis Egyetem - I. sz. Belgyógyászati Klinika

location_facility: University Hospital Southhampton NHS Foundation Trust - Somers Cancer Research

location_facility: New York University Langone Medical Center

location_facility: Dartmouth-Hitchcock Medical Center (DHMC)

location_facility: The Ohio State University and Wexner Medical Center, James Cancer Hospital

location_facility: Hospital Universitario Fundacion Jimenez Diaz Preview

location_facility: Churchill Hospital, Oxford University Hospital NHS Trust

location_facility: University of Washington, Seattle Cancer Care Alliance

location_facility: Summit Medical Group - Florham Park Campus/Atlantic Health


title: A Phase 3, Multi-National, Double-Blind, Randomized, Placebo-Controlled, Stratified, Parallel Group, Study to Evaluate the Safety, Tolerability and Efficacy of Tirasemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

acronym: VITALITY-ALS

summary: This study assessed the effect of tirasemtiv versus placebo on respiratory function in patients with ALS.

ReferenceCitation: Andrews JA, Cudkowicz ME, Hardiman O, Meng L, Bian A, Lee J, Wolff AA, Malik FI, Shefner JM. VITALITY-ALS, a phase III trial of tirasemtiv, a selective fast skeletal muscle troponin activator, as a potential treatment for patients with amyotrophic lateral sclerosis: study design and baseline characteristics. Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):259-266. doi: 10.1080/21678421.2018.1426770. Epub 2018 Feb 6. Erratum in: Amyotroph Lateral Scler Frontotemporal Degener. 2018 May;19(3-4):321.

name: Eleanor and Lou Gehrig ALS Center, Columbia University, New York, NY, USA,

family: Andrews

full_name: Jinsy A. Andrews

given: Jinsy A.

name: Department of Neurology, Massachussetts General Hospital, Boston, MA, USA,

family: Cudkowicz

full_name: Merit E. Cudkowicz

given: Merit E.

name: Biomedical Sciences Institute of Neurosciences, The University of Dublin, Dublin, Ireland,

family: Hardiman

full_name: Orla Hardiman

given: Orla

name: Cytokinetics, Inc, South San Francisco, CA, USA, and

family: Meng

full_name: Lisa Meng

given: Lisa

family: Bian

full_name: Amy Bian

given: Amy

family: Lee

full_name: Jacqueline Lee

given: Jacqueline

family: Wolff

full_name: Andrew A. Wolff

given: Andrew A.

family: Malik

full_name: Fady I. Malik

given: Fady I.

name: Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA

family: Shefner

full_name: Jeremy M. Shefner

given: Jeremy M.

journal_name: Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration

oa_host_type: repository

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

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Cytokinetics

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Ireland
Belgium
Portugal
Canada
United Kingdom

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Texas Health Science Center

location_facility: University of California Davis Medical Center

location_facility: Carol and Frank Morsini Center for Advanced Health Care - University of South Florida

location_facility: The Penn Comprehensive Neuroscience Center

location_facility: Charite Campus Virchow-Klinikum, Neurology Department

location_facility: Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"

location_facility: Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda

location_facility: Clinical Research Centre, Royal London Hospital

location_facility: West Virginia University Department of Neurology

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: Providence Brain and Spine Institute ALS Center

location_facility: George Washington University Medical Center

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Neurological Institute Columbia University Medical Center

location_facility: University of Ulm, Department of Neurology

location_facility: Hannover Medical School, Department of Neurology

location_facility: Montreal Neurological Institute and Hospital

location_facility: University of Michigan Hospital and Health System

location_facility: University of Colorado Hospital Anschutz Outpatient Pavilion

location_facility: University of Iowa Hospitals and Clinics

location_facility: The Ohio State University Wexner Medical Center

location_facility: St. Joseph's Hospital & Medical Center - Barrow Neurology Clinics

location_facility: University of Massachusetts Memorial Medical Center

location_facility: CHU de Quebec - Universite Laval Hopital de l'Enfant-Jesus

location_facility: Froedtert Memorial Lutheran Hospital, Department of Neurology

location_facility: Dartmouth Hitchcock Medical Center Dept of Neurology

location_facility: Neurosciences Institute: Neurology - Charlotte

location_facility: IRCCS Istituto Auxologico Italiano - U.O. Neurologia

location_facility: Hospital Santa Maria-Centro Hospitalar Lisboa Norte

location_facility: Clinical Research Centre, Beaumont Hospital


title: A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression

summary: The purpose of this study is to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms in participants with treatment-resistant depression (TRD) who are in stable remission after an induction and optimization course of intranasal esketamine plus an oral antidepressant.

ReferenceCitation: Doty RL, Popova V, Wylie C, Fedgchin M, Daly E, Janik A, Ochs-Ross R, Lane R, Lim P, Cooper K, Melkote R, Jamieson C, Singh J, Drevets WC. Effect of Esketamine Nasal Spray on Olfactory Function and Nasal Tolerability in Patients with Treatment-Resistant Depression: Results from Four Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Studies. CNS Drugs. 2021 Jul;35(7):781-794. doi: 10.1007/s40263-021-00826-9. Epub 2021 Jul 7.

family: Doty

full_name: Richard L. Doty

given: Richard L.

family: Popova

full_name: Vanina Popova

given: Vanina

family: Wylie

full_name: Crystal Wylie

given: Crystal

family: Fedgchin

full_name: Maggie Fedgchin

given: Maggie

family: Daly

full_name: Ella Daly

given: Ella

family: Janik

full_name: Adam Janik

given: Adam

family: Ochs-Ross

full_name: Rachel Ochs-Ross

given: Rachel

family: Lane

full_name: Rosanne Lane

given: Rosanne

family: Lim

full_name: Pilar Lim

given: Pilar

family: Cooper

full_name: Kim Cooper

given: Kim

family: Melkote

full_name: Rama Melkote

given: Rama

family: Jamieson

full_name: Carol Jamieson

given: Carol

family: Singh

full_name: Jaskaran Singh

given: Jaskaran

family: Drevets

full_name: Wayne C. Drevets

given: Wayne C.

journal_name: CNS Drugs

oa_colors: green hybrid

oa_host_type: publisher;repository

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Katz EG, Hough D, Doherty T, Lane R, Singh J, Levitan B. Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression. Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13.

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

family: Katz

full_name: Eva G. Katz

given: Eva G.

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

name: Former employee of Janssen Research and Development, LLC Titusville New Jersey USA

family: Hough

full_name: David Hough

given: David

family: Doherty

full_name: Teodora Doherty

given: Teodora

name: Janssen Research & Development, LLC San Diego California USA

name: Neurocrine Biosciences San Diego California USA

title: Benefit–Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment‐Resistant Depression

ReferenceCitation: Daly EJ, Trivedi MH, Janik A, Li H, Zhang Y, Li X, Lane R, Lim P, Duca AR, Hough D, Thase ME, Zajecka J, Winokur A, Divacka I, Fagiolini A, Cubala WJ, Bitter I, Blier P, Shelton RC, Molero P, Manji H, Drevets WC, Singh JB. Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2019 Sep 1;76(9):893-903. doi: 10.1001/jamapsychiatry.2019.1189.

name: Department of  Neuroscience, Janssen Research and Development LLC, Titusville, New Jersey

name: Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas

name: Department of Neuroscience, Janssen Research and Development LLC, San Diego, California

name: Department of Clinical Biostatistics, Janssen Research and Development LLC, Fremont, California

name: Department of Clinical Biostatistics, Janssen Research and Development LLC, Raritan, New Jersey

name: Department of Clinical Biostatistics, Janssen Research and Development LLC, Titusville, New Jersey

name: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia

name: Department of Psychiatry, Rush University Medical Center, Chicago, Illinois

name: Department of Psychiatry, University of Connecticut Health, Farmington

name: Institute of Living, Hartford, Connecticut

name: Private practice, Prague, Czech Republic

name: Department of Molecular Medicine, Division of Psychiatry, University of Siena, Siena, Italy

name: Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland

name: Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary

name: Departments of Psychiatry and Cellular/Molecular Medicine, University of Ottawa, Ottawa, Ontario, Canada

name: Department of Psychiatry, University of Alabama School of Medicine, Birmingham

name: Department of Psychiatry, Clinica Universidad de Navarra, Pamplona, Spain

location_country:
Brazil
United States
Sweden
Mexico
Germany
France
Czechia
Poland
Slovakia
Hungary
Belgium
Spain
Estonia
Canada
Turkey


title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

acronym: TITAN

summary: The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

ReferenceCitation: Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Özgüroğlu M, Juárez Soto Á, Merseburger AS, Uemura H, Ye D, Given R, Basch E, Miladinovic B, Lopez-Gitlitz A, Chi KN. Apalutamide plus Androgen Deprivation Therapy for Metastatic Castration-Sensitive Prostate Cancer: Analysis of Pain and Fatigue in the Phase 3 TITAN Study. J Urol. 2021 Oct;206(4):914-923. doi: 10.1097/JU.0000000000001841. Epub 2021 May 27.

name: Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah

family: Agarwal

full_name: Neeraj Agarwal

given: Neeraj

name: Janssen Research & Development, Horsham, Pennsylvania

family: McQuarrie

full_name: Kelly McQuarrie

given: Kelly

family: Bjartell

full_name: Anders Bjartell

given: Anders

name: Guy’s, King’s, and St Thomas’ Hospitals, and Sarah Cannon Research Institute, London, United Kingdom

family: Chowdhury

full_name: Simon Chowdhury

given: Simon

name: Liga Norte Riograndense Contra O Câncer, Natal, Brazil

family: Pereira de Santana Gomes

full_name: Andrea J. Pereira de Santana Gomes

given: Andrea J.

family: Chung

full_name: Byung Ha Chung

given: Byung Ha

name: Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey

family: Özgüroğlu

full_name: Mustafa Özgüroğlu

given: Mustafa

family: Soto

full_name: Álvaro Juárez Soto

given: Álvaro Juárez

name: University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany

family: Merseburger

full_name: Axel S. Merseburger

given: Axel S.

name: Kindai University Faculty of Medicine, Osaka, Japan

family: Uemura

full_name: Hirotsugu Uemura

given: Hirotsugu

name: Fudan University Shanghai Cancer Center, Shanghai, China

family: Ye

full_name: Dingwei Ye

given: Dingwei

name: Urology of Virginia, Eastern Virginia Medical School, Norfolk, Virginia

family: Given

full_name: Robert Given

given: Robert

name: University of North Carolina, Chapel Hill, North Carolina

family: Basch

full_name: Ethan Basch

given: Ethan

name: Janssen Research & Development, San Diego, California

family: Miladinovic

full_name: Branko Miladinovic

given: Branko

name: Janssen Research & Development, Los Angeles, California

family: Lopez-Gitlitz

full_name: Angela Lopez-Gitlitz

given: Angela

name: BC Cancer, Vancouver, British Columbia, Canada

family: Chi

full_name: Kim N. Chi

given: Kim N.

journal_name: Journal of Urology

evidence: open (via page says license)

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Chi KN, Chowdhury S, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juárez A, Merseburger AS, Özgüroğlu M, Uemura H, Ye D, Brookman-May S, Mundle SD, McCarthy SA, Larsen JS, Sun W, Bevans KB, Zhang K, Bandyopadhyay N, Agarwal N. Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study. J Clin Oncol. 2021 Jul 10;39(20):2294-2303. doi: 10.1200/JCO.20.03488. Epub 2021 Apr 29.

name: BC Cancer and Vancouver Prostate Centre, Vancouver, BC, Canada

name: Guy's and St Thomas' Hospitals, London, United Kingdom

name: Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea

name: Liga Norte Riograndense Contra O Cancer, Natal, Brazil

name: Urology of Virginia, Eastern Virginia Medical School, Norfolk, VA

name: Istanbul University–Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey

name: Kindai University Hospital Faculty of Medicine, Osaka, Japan

name: Ludwig-Maximilians-University (LMU), Munich, Germany

name: Janssen Research & Development, Spring House, PA

name: Janssen Research & Development, Los Angeles, CA

name: Janssen Research & Development, Horsham, PA

name: Janssen Research & Development, San Diego, CA

name: Huntsman Cancer Institute, University of Utah, Salt Lake City, UT

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Uemura H, Koroki Y, Iwaki Y, Imanaka K, Kambara T, Lopez-Gitlitz A, Smith A, Uemura H. Skin rash following Administration of Apalutamide in Japanese patients with Advanced Prostate Cancer: an integrated analysis of the phase 3 SPARTAN and TITAN studies and a phase 1 open-label study. BMC Urol. 2020 Sep 2;20(1):139. doi: 10.1186/s12894-020-00689-0. Erratum in: BMC Urol. 2020 Oct 22;20(1):166.

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

ReferenceCitation: Agarwal N, McQuarrie K, Bjartell A, Chowdhury S, Pereira de Santana Gomes AJ, Chung BH, Özgüroğlu M, Juárez Soto Á, Merseburger AS, Uemura H, Ye D, Given R, Cella D, Basch E, Miladinovic B, Dearden L, Deprince K, Naini V, Lopez-Gitlitz A, Chi KN; TITAN investigators. Health-related quality of life after apalutamide treatment in patients with metastatic castration-sensitive prostate cancer (TITAN): a randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2019 Nov;20(11):1518-1530. doi: 10.1016/S1470-2045(19)30620-5. Epub 2019 Sep 29.

ReferenceCitation: Chi KN, Agarwal N, Bjartell A, Chung BH, Pereira de Santana Gomes AJ, Given R, Juárez Soto Á, Merseburger AS, Özgüroğlu M, Uemura H, Ye D, Deprince K, Naini V, Li J, Cheng S, Yu MK, Zhang K, Larsen JS, McCarthy S, Chowdhury S; TITAN Investigators. Apalutamide for Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2019 Jul 4;381(1):13-24. doi: 10.1056/NEJMoa1903307. Epub 2019 May 31.

name: From BC Cancer and Vancouver Prostate Centre, Vancouver, Canada (K.N.C.); Huntsman Cancer Institute, University of Utah, Salt Lake City (N.A.); Skåne University Hospital, Lund University, Malmö, Sweden (A.B.); Yonsei University College of Medicine and Gangnam Severance Hospital, Seoul, South Korea (B.H.C.); Liga Norte Riograndense Contra o Câncer, Natal, Brazil (A.J.P.S.G.); Urology of Virginia, Eastern Virginia Medical School, Norfolk (R.G.); Hospital Universitario de Jerez de la Frontera, Cadiz, Spain ...

location_country:
Romania
Australia
Russian Federation
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Sweden
Hungary
China
United States
Germany
United Kingdom
Brazil
Mexico
Czechia
Israel
Spain
Turkey


ReferenceCitation: Salloway S, Chalkias S, Barkhof F, Burkett P, Barakos J, Purcell D, Suhy J, Forrestal F, Tian Y, Umans K, Wang G, Singhal P, Budd Haeberlein S, Smirnakis K. Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease. JAMA Neurol. 2021 Nov 22. doi: 10.1001/jamaneurol.2021.4161. [Epub ahead of print]

name: Warren Alpert Medical School, Brown University, Providence, Rhode Island

family: Salloway

full_name: Stephen Salloway

given: Stephen

family: Chalkias

full_name: Spyros Chalkias

given: Spyros

name: Institutes of Healthcare Engineering and Neurology, University College London, London, United Kingdom

name: Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, the Netherlands

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

family: Burkett

full_name: Patrick Burkett

given: Patrick

name: California Pacific Medical Center, San Francisco

family: Barakos

full_name: Jerome Barakos

given: Jerome

family: Purcell

full_name: Derk Purcell

given: Derk

family: Suhy

full_name: Joyce Suhy

given: Joyce

family: Forrestal

full_name: Fiona Forrestal

given: Fiona

family: Tian

full_name: Ying Tian

given: Ying

family: Umans

full_name: Kimberly Umans

given: Kimberly

family: Wang

full_name: Guanfang Wang

given: Guanfang

family: Singhal

full_name: Priya Singhal

given: Priya

family: Budd Haeberlein

full_name: Samantha Budd Haeberlein

given: Samantha

family: Smirnakis

full_name: Karen Smirnakis

given: Karen

journal_name: JAMA Neurology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

lead_sponsor: Biogen

location_country:
Italy
Austria
United States
Spain
Germany
France
Japan
Australia
Portugal
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

acronym: ENGAGE

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Northeastern Pennsylvania Memory and Alzheimer's Center

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Seconda Università degli Studi di Napoli

location_facility: Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: The National Hospital for Neurology and Neurosurgery Centre

location_facility: University of Tennessee Medical Center. Knoxville

location_facility: Christian-Doppler-Klinik - Universitätsklinikum Salzburg

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona

location_facility: Institute for Neurodegenerative Disorders

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: National Clinical Research Inc.-Richmond

location_facility: Advanced Memory Research Institute of NJ, PC

location_facility: Alexian Brothers Neurosciences Institute

location_facility: California Neuroscience Research Medical Group Inc.

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: New York University Medical Center PRIME

location_facility: Hospital Professor Doutor Fernando Fonseca, E.P.E.

location_facility: Azienda Ospedaliera Ospedali Riuniti di Bergamo

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Groupe hospitalier Broca - La Rochefoucauld - La Collégiale

location_facility: Medical University of South Carolina (MUSC)

location_facility: Centro Hospitalar e Universitário de Coimbra E.P.E

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Jacksonville Center for Clinical Research

location_facility: ANI Neurology, PLLC d/b/a Alzheimer's Memory Center

location_facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin

location_facility: Central Coast Neurosciences Research, Gosford

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Torrance Clinical Research Institute, Inc.

location_facility: KARA Institute for Neurological Diseases

location_facility: St. Joseph's Hospital and Medical Center

title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease

summary: The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].


ReferenceCitation: Peipert JD, Efficace F, Pierson R, Loefgren C, Cella D, He J. Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia. J Geriatr Oncol. 2021 Sep 11. pii: S1879-4068(21)00208-3. doi: 10.1016/j.jgo.2021.09.007. [Epub ahead of print]

family: Peipert

full_name: John Devin Peipert

given: John Devin

family: Efficace

full_name: Fabio Efficace

given: Fabio

family: Pierson

full_name: Renee Pierson

given: Renee

family: Loefgren

full_name: Christina Loefgren

given: Christina

family: Cella

full_name: David Cella

given: David

family: He

full_name: Jianming He

given: Jianming

journal_name: Journal of Geriatric Oncology

location_country:
Sweden
Germany
France
Poland
Israel
Belgium
Australia
Russian Federation
Spain
Turkey
United States
United Kingdom
Korea, Republic of
Taiwan

title: A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus DACOGEN (Decitabine) Alone in Patients With AML Who Are Not Candidates for Intensive Chemotherapy

summary: The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.


ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Zhang J, Chiorean M, Vermeire S, Lee SD, Kühbacher T, Yacyshyn B, Cabell CH, Naik SU, Klassen P, Panés J. Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):550-561. doi: 10.1053/j.gastro.2019.10.035. Epub 2019 Nov 9.

family: Sandborn

full_name: William J. Sandborn

given: William J.

family: Peyrin-Biroulet

full_name: Laurent Peyrin-Biroulet

given: Laurent

family: Zhang

full_name: Jinkun Zhang

given: Jinkun

family: Chiorean

full_name: Michael Chiorean

given: Michael

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

family: Lee

full_name: Scott D. Lee

given: Scott D.

family: Kühbacher

full_name: Tanja Kühbacher

given: Tanja

family: Yacyshyn

full_name: Bruce Yacyshyn

given: Bruce

family: Cabell

full_name: Christopher H. Cabell

given: Christopher H.

family: Naik

full_name: Snehal U. Naik

given: Snehal U.

family: Klassen

full_name: Preston Klassen

given: Preston

family: Panés

full_name: Julián Panés

given: Julián

journal_name: Gastroenterology

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

location_facility:
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title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.


title: A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Systemic Lupus Erythematosus

summary: The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment regimen of anifrolumab versus placebo in adult participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE).

ReferenceCitation: Furie R, Morand EF, Askanase AD, Vital EM, Merrill JT, Kalyani RN, Abreu G, Pineda L, Tummala R. Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus. Lupus. 2021 Jul;30(8):1254-1263. doi: 10.1177/09612033211014267. Epub 2021 May 12.

name: Division of Rheumatology, Zucker School of Medicine at Hofstra/Northwell, Great Neck, NY, USA

family: Furie

full_name: Richard Furie

given: Richard

name: School of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia

family: Morand

full_name: Eric F Morand

given: Eric F

name: Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY, USA

family: Askanase

full_name: Anca D Askanase

given: Anca D

name: Leeds Institute for Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK

name: NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK

family: Vital

full_name: Edward M Vital

given: Edward M

name: Clinical Pharmacology Research Program, Oklahoma Medical Research Foundation, Oklahoma City, OK, USA

family: Merrill

full_name: Joan T Merrill

given: Joan T

name: BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA

family: Kalyani

full_name: Rubana N Kalyani

given: Rubana N

name: BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden

family: Abreu

full_name: Gabriel Abreu

given: Gabriel

family: Pineda

full_name: Lilia Pineda

given: Lilia

family: Tummala

full_name: Raj Tummala

given: Raj

journal_name: Lupus

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Furie R, Morand EF, Bruce IN, Isenberg D, van Vollenhoven R, Abreu G, Pineda L, Tummala R. What Does It Mean to Be a British Isles Lupus Assessment Group-Based Composite Lupus Assessment Responder? Post Hoc Analysis of Two Phase III Trials. Arthritis Rheumatol. 2021 Nov;73(11):2059-2068. doi: 10.1002/art.41778. Epub 2021 Sep 22.

name: Zucker School of Medicine at Hofstra/Northwell  Great Neck NY United States

name: Monash University  Melbourne VIC Australia

full_name: Eric F. Morand

given: Eric F.

name: Centre for Epidemiology Versus Arthritis The University of Manchester NIHR Manchester Biomedical Research Centre Manchester University Hospitals NHS Foundation Trust Manchester Academic Health Science Centre  Manchester United Kingdom

family: Bruce

full_name: Ian N Bruce

given: Ian N

name: Centre for Rheumatology University College London  London United Kingdom

name: Department of Rheumatology University College Hospital  London United Kingdom

family: Isenberg

full_name: David Isenberg

name: Department of Rheumatology, Amsterdam Rheumatology and Immunology Center  Amsterdam The Netherlands

family: van Vollenhoven

full_name: Ronald van Vollenhoven

given: Ronald

name: BioPharmaceuticals R&D AstraZeneca  Gothenburg Sweden

name: BioPharmaceuticals R&D AstraZeneca  Gaithersburg MD United States

journal_name: Arthritis & Rheumatology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: What Does it Mean to be a British Isles Lupus Assessment Group–Based Composite Lupus Assessment Responder? Post Hoc Analysis of 2 Phase 3 Trials

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

name: Dermatologist, Masters of Public Health Program; Harvard School of Public Health; Boston Massachusetts USA

family: Hannon

full_name: Cora W Hannon

given: Cora W

name: Department of Dermatology; Royal Victoria Hospital; Belfast UK

name: Department of Dermatology, Clinical Unit for Research Trials and Outcomes in Skin (CURTIS); Massachusetts General Hospital; Boston Massachusetts USA

name: Emory University Hospital; Emory Healthcare; Atlanta Georgia USA

name: Office of Research and Innovation; Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn; Dublin Ireland

ReferenceCitation: Morand EF, Furie R, Tanaka Y, Bruce IN, Askanase AD, Richez C, Bae SC, Brohawn PZ, Pineda L, Berglind A, Tummala R; TULIP-2 Trial Investigators. Trial of Anifrolumab in Active Systemic Lupus Erythematosus. N Engl J Med. 2020 Jan 16;382(3):211-221. doi: 10.1056/NEJMoa1912196. Epub 2019 Dec 18.

name: From the Centre for Inflammatory Disease, Monash University, Melbourne, VIC, Australia (E.F.M.); the Division of Rheumatology, Zucker School of Medicine at Hofstra–Northwell, Great Neck (R.F.), and the Department of Medicine, Division of Rheumatology, Columbia University College of Physicians and Surgeons, New York (A.D.A.) — both in New York; the First Department of Internal Medicine and Graduate School of Medical Science, University of Occupational and Environmental Health Japan, Kitakyushu (Y.T.); the...

repository_institution: The University of Manchester - Research Explorer

location_country:
Brazil
South Africa
Mexico
Germany
France
Bulgaria
Japan
Korea, Republic of
Lithuania
Belgium
Argentina
Russian Federation
Spain
United States
Canada


title: A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults

summary: The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.

ReferenceCitation: Morales-Ramirez J, Bogner JR, Molina JM, Lombaard J, Dicker IB, Stock DA, DeGrosky M, Gartland M, Pene Dumitrescu T, Min S, Llamoso C, Joshi SR, Lataillade M. Safety, efficacy, and dose response of the maturation inhibitor GSK3532795 (formerly known as BMS-955176) plus tenofovir/emtricitabine once daily in treatment-naive HIV-1-infected adults: Week 24 primary analysis from a randomized Phase IIb trial. PLoS One. 2018 Oct 23;13(10):e0205368. doi: 10.1371/journal.pone.0205368. eCollection 2018.

family: Morales-Ramirez

full_name: Javier Morales-Ramirez

given: Javier

family: Bogner

full_name: Johannes R. Bogner

given: Johannes R.

family: Molina

full_name: Jean-Michel Molina

given: Jean-Michel

family: Lombaard

full_name: Johan Lombaard

given: Johan

family: Dicker

full_name: Ira B. Dicker

given: Ira B.

family: Stock

full_name: David A. Stock

given: David A.

family: DeGrosky

full_name: Michelle DeGrosky

given: Michelle

family: Gartland

full_name: Margaret Gartland

given: Margaret

family: Pene Dumitrescu

full_name: Teodora Pene Dumitrescu

given: Teodora

family: Min

full_name: Sherene Min

given: Sherene

family: Llamoso

full_name: Cyril Llamoso

given: Cyril

family: Joshi

full_name: Samit R. Joshi

given: Samit R.

family: Lataillade

full_name: Max Lataillade

given: Max

currency_apc_doaj: USD

journal_name: PLOS ONE

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: PubMed Central - Europe PMC

repository_institution: Ludwid Maxmilian's Universitat Munchen - Open access LMU

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

location_country:
Italy
United States
Chile
South Africa
Mexico
Germany
France
Poland
Argentina
Spain
Canada
United Kingdom


title: An Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma

summary: The purpose of this study is to assess overall response rate [ORR, including complete response (CR) and partial response (PR)], of daratumumab in participants with non-Hodgkin's lymphoma [a cancer of the lymph nodes (or tissues)-NHL] and to evaluate association between ORR and CD38 expression level in order to determine a threshold for CD38 expression level in each NHL subtype, above which daratumumab activity is enhanced in participants with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.

ReferenceCitation: Salles G, Gopal AK, Minnema MC, Wakamiya K, Feng H, Schecter JM, Wang M. Phase 2 Study of Daratumumab in Relapsed/Refractory Mantle-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma. Clin Lymphoma Myeloma Leuk. 2019 May;19(5):275-284. doi: 10.1016/j.clml.2018.12.013. Epub 2019 Jan 2.

family: Salles

full_name: Gilles Salles

given: Gilles

family: Gopal

full_name: Ajay K. Gopal

given: Ajay K.

family: Minnema

full_name: Monique C. Minnema

given: Monique C.

family: Wakamiya

full_name: Karen Wakamiya

given: Karen

family: Feng

full_name: Huaibao Feng

given: Huaibao

family: Schecter

full_name: Jordan M. Schecter

given: Jordan M.

family: Wang

full_name: Michael Wang

given: Michael

journal_name: Clinical Lymphoma Myeloma and Leukemia

location_country:
Netherlands
France
Belgium
Australia
Turkey
United States
Korea, Republic of


type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Randomized Phase III Trial Comparing Conventional-Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) With High-Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High-Dose Carboplatin and Etoposide (TI-CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

summary: This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.

ReferenceCitation: Tan YY, Al-Bubseeree B, Irvine D, MacDonald G, McQuaker G, Parker A, Waterston A, White J. High-Dose Chemotherapy in Relapsed or Refractory Metastatic Germ-Cell Cancer: The Scotland Experience. Clin Genitourin Cancer. 2019 Apr;17(2):125-131. doi: 10.1016/j.clgc.2018.11.013. Epub 2018 Nov 17.

family: Tan

full_name: Yun Yi Tan

given: Yun Yi

family: Al-Bubseeree

full_name: Bahaa Al-Bubseeree

given: Bahaa

family: Irvine

full_name: David Irvine

given: David

family: MacDonald

full_name: Graham MacDonald

given: Graham

family: McQuaker

full_name: Grant McQuaker

given: Grant

family: Parker

full_name: Anne Parker

given: Anne

family: Waterston

full_name: Ashita Waterston

given: Ashita

family: White

full_name: Jeff White

given: Jeff

journal_name: Clinical Genitourinary Cancer

lead_sponsor: Alliance for Clinical Trials in Oncology

location_country:
Italy
Switzerland
Netherlands
Germany
France
Ireland
Belgium
Australia
Spain
Denmark
United States
United Kingdom

location_facility: Vanderbilt University/Ingram Cancer Center

location_facility: Carolinas Medical Center/Levine Cancer Institute

location_facility: Prisma Health Cancer Institute - Eastside

location_facility: Duran i Reynals Hospital-Catalan Institute of Oncology

location_facility: Radboud University Nijmegen Medical Centre

location_facility: The Royal Marsden NHS Foundation Trust - Sutton

location_facility: Saint Joseph's Hospital/Children's Hospital-Tampa

location_facility: University of Oklahoma Health Sciences Center

location_facility: BI-LO Charities Children's Cancer Center

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: University of Florida Health Science Center - Gainesville

location_facility: Prisma Health Cancer Institute - Spartanburg

location_facility: Prisma Health Cancer Institute - Butternut

location_facility: Emory University Hospital/Winship Cancer Institute

location_facility: Children's Hospitals and Clinics of Minnesota - Minneapolis

location_facility: Hospital General Universitario Morales Meseguer

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: University of Pittsburgh Cancer Institute (UPCI)

location_facility: University of Berlin Charite Campus Benjamin Franklin

location_facility: Washington University School of Medicine

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Marshfield Medical Center-EC Cancer Center

location_facility: Hopital Tenon/Assistance Publique - Hopitaux de Paris

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Prisma Health Greenville Memorial Hospital

location_facility: USC / Norris Comprehensive Cancer Center

location_facility: University of Pennsylvania/Abramson Cancer Center

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: The Children's Hospital at TriStar Centennial

location_facility: Ohio State University Comprehensive Cancer Center

intervention_type: Procedure


title: T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry

acronym: T-STAR

summary: The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).

status: Withdrawn

study_type: Observational

time_perspective: Prospective

lead_sponsor: AstraZeneca

location_country:
Italy
United States
Netherlands
Spain
France
Russian Federation
China
Germany
Taiwan


ReferenceCitation: Matasar MJ, Capra M, Özcan M, Lv F, Li W, Yañez E, Sapunarova K, Lin T, Jin J, Jurczak W, Hamed A, Wang MC, Baker R, Bondarenko I, Zhang Q, Feng J, Geissler K, Lazaroiu M, Saydam G, Szomor Á, Bouabdallah K, Galiulin R, Uchida T, Soler LM, Cao A, Hiemeyer F, Mehra A, Childs BH, Shi Y, Zinzani PL. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):678-689. doi: 10.1016/S1470-2045(21)00145-5. Epub 2021 Apr 10. Erratum in: Lancet Oncol. 2021 Jun;22(6):e239.

family: Matasar

full_name: Matthew J Matasar

given: Matthew J

family: Capra

full_name: Marcelo Capra

given: Marcelo

family: Özcan

full_name: Muhit Özcan

given: Muhit

family: Lv

full_name: Fangfang Lv

given: Fangfang

family: Li

full_name: Wei Li

given: Wei

family: Yañez

full_name: Eduardo Yañez

given: Eduardo

family: Sapunarova

full_name: Katya Sapunarova

given: Katya

family: Lin

full_name: Tongyu Lin

given: Tongyu

family: Jin

full_name: Jie Jin

given: Jie

family: Jurczak

full_name: Wojciech Jurczak

given: Wojciech

family: Hamed

full_name: Aryan Hamed

given: Aryan

full_name: Ming-Chung Wang

given: Ming-Chung

family: Baker

full_name: Ross Baker

given: Ross

family: Bondarenko

full_name: Igor Bondarenko

given: Igor

family: Zhang

full_name: Qingyuan Zhang

given: Qingyuan

full_name: Jifeng Feng

given: Jifeng

family: Geissler

full_name: Klaus Geissler

given: Klaus

family: Lazaroiu

full_name: Mihaela Lazaroiu

given: Mihaela

family: Saydam

full_name: Guray Saydam

given: Guray

family: Szomor

full_name: Árpád Szomor

given: Árpád

family: Bouabdallah

full_name: Krimo Bouabdallah

given: Krimo

family: Galiulin

full_name: Rinat Galiulin

given: Rinat

family: Uchida

full_name: Toshiki Uchida

given: Toshiki

family: Soler

full_name: Lidia Mongay Soler

given: Lidia Mongay

family: Cao

full_name: Anjun Cao

given: Anjun

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Thailand
Argentina
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
Vietnam
Philippines
Bulgaria
Singapore
Hungary
Ireland
China
Portugal
Germany
United States
Italy
Austria
Brazil
Mexico
New Zealand
Spain
Turkey

location_facility:
MSK Bergen
MSK Westchester
MSK Commack
MSK Basking Ridge
MSK Rockville Centre
MSK Monmoth

title: A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Copanlisib in Combination With Rituximab in Patients With Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL) - CHRONOS-3

summary: The purpose of this study is to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.