ReferenceCitation: Zaniboni A, Barone CA, Banzi MC, Bergamo F, Blasi L, Bordonaro R, Bartolomeo MD, Costanzo FD, Frassineti GL, Garufi C, Giuliani F, Latiano TP, Martinelli E, Personeni N, Racca P, Tamburini E, Tonini G, Besse MG, Spione M, Falcone A. Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer. Future Oncol. 2021 Jun;17(18):2315-2324. doi: 10.2217/fon-2020-1278. Epub 2021 Mar 5.

name: Fondazione Poliambulanza, Istituto Ospedaliero, Via Leonida Bissolati, 57, 25124, Brescia, Italy

family: Zaniboni

full_name: Alberto Zaniboni

given: Alberto

name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Via della Pineta Sacchetti, 217, 00168, Roma, Italy

family: Barone

full_name: Carlo Antonio Barone

given: Carlo Antonio

name: AUSL-IRCCS S. Maria Nuova, Viale Risorgimento, 80, 42123, Reggio Emilia, Italy

family: Banzi

full_name: Maria Chiara Banzi

given: Maria Chiara

name: Istituto Oncologico Veneto – IRCCS, Via Gattamelata, 64, 35128, Padova, Italy

family: Bergamo

full_name: Francesca Bergamo

given: Francesca

name: Azienda Ospedaliera “Civico-Di Cristina-Benefratelli”, Piazza Leotta Nicola, 4, 90127, Palermo, Italy

family: Blasi

full_name: Livio Blasi

given: Livio

name: Azienda Ospedaliera Garibaldi – Nesima, Via Palermo, 636, 95122, Catania, Italy

family: Bordonaro

full_name: Roberto Bordonaro

given: Roberto

name: Fondazione IRCCS – Istituto Nazionale dei Tumori, Via Giacomo Venezian, 1, 20133, Milano, Italy

family: Bartolomeo

full_name: Maria Di Bartolomeo

given: Maria Di

name: Azienda Ospedaliero-Universitaria Careggi, Largo Piero Palagi, 1, 50139, Firenze, Italy

family: Costanzo

full_name: Francesco Di Costanzo

given: Francesco Di

name: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via Piero Maroncelli, 40, 47014, Meldola (FC), Italy

family: Frassineti

full_name: Giovanni Luca Frassineti

given: Giovanni Luca

name: Azienda Ospedaliera San Camillo Forlanini, Circonvallazione Gianicolense, 87, 00152, Roma, Italy

family: Garufi

full_name: Carlo Garufi

given: Carlo

name: Medical Oncology Unit, IRCCS Istituto Tumori Giovanni Paolo II, Viale Orazio Flacco, 65, 70124, Bari, Italy

family: Giuliani

full_name: Francesco Giuliani

given: Francesco

name: Ospedale IRCSS Casa Sollievo della Sofferenza, Viale Cappuccini, 1, 71013, San Giovanni Rotondo (FG), Italy

family: Latiano

full_name: Tiziana Pia Latiano

given: Tiziana Pia

name: Università degli Studi della Campania “Luigi Vanvitelli”, Via Vico Luigi De Crecchio 6 - 80138, Napoli, Italy

family: Martinelli

full_name: Erika Martinelli

given: Erika

name: Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, Via Alessandro Manzoni, 56, 20089, Rozzano (Milan), Italy

name: Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini, 20090, Pieve Emanuele (Milan), Italy

family: Personeni

full_name: Nicola Personeni

given: Nicola

name: A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy

family: Racca

full_name: Patrizia Racca

given: Patrizia

name: Ospedale Infermi, Via le Luigi Settembrini, 2, 47923, Rimini, Italy

family: Tamburini

full_name: Emiliano Tamburini

given: Emiliano

name: Policlinico Universitario Campus Biomedico, Via Álvaro del Portillo, 20000128, Roma, Italy

family: Tonini

full_name: Giuseppe Tonini

given: Giuseppe

name: Medical Affairs, Servier Italia, Via Luca Passi, 85, 00166, Roma, Italy

family: Besse

full_name: Marie Georges Besse

given: Marie Georges

family: Spione

full_name: Mario Spione

given: Mario

name: Dipartimento di Ricerca Traslazionale, Università degli Studi di Pisa, Lungarno Antonio Pacinotti, 43, 56126, Pisa, Italy

family: Falcone

full_name: Alfredo Falcone

given: Alfredo

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Bachet JB, Wyrwicz L, Price T, Cremolini C, Phelip JM, Portales F, Ozet A, Cicin I, Atlan D, Becquart M, Vidot L, Mounedji N, Van Cutsem E, Taieb J, Falcone A. Safety, efficacy and patient-reported outcomes with trifluridine/tipiracil in pretreated metastatic colorectal cancer: results of the PRECONNECT study. ESMO Open. 2020 Jun;5(3):e000698. doi: 10.1136/esmoopen-2020-000698.

family: Bachet

full_name: Jean-Baptiste Bachet

given: Jean-Baptiste

family: Wyrwicz

full_name: Lucjan Wyrwicz

given: Lucjan

family: Price

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

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

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

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inserm

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country: Italy Brazil Croatia Bulgaria France Panama Poland Romania Ireland Belgium Australia Slovakia Portugal Turkey Slovenia Ukraine

location_facility: CHU Robert DEBRE service d'hepato-gastroenterologie / Cancérologie Digestive

location_facility: Fondazione Poliambulanza Istituto Ospedaliero Clinical Oncology

location_facility: Onkologicky ustav sv. Alzbety,s.r.o. Interna Klinika VSZ a SP a OUSA

location_facility: Bialostockie Centrum Onkologii im Marii Curie-Sklodowskiej Oddzial Onkologii Klinicznej im Dr Ewy Pileckiej z pododdzialem Chemioterapii Dziennej

location_facility: Ist.Tumori "Giovanni Paolo II" IRCCS Osp.Oncologico di Bari U.O.C. di Oncologia Medica

location_facility: Istituto Oncologico Veneto IOV - IRCCS Unità Operativa Complessa Oncologia Medica 1

location_facility: Arcispedale Santa Maria Nuova Unità di Oncologia

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori S.S. Oncologia Medica Gastrenterologia

location_facility: Istituto Clinico Humanitas I.R.C.C.S Dipartimento di Oncologia Medica ed Ematologia

location_facility: Klinicki bolnicki centar Zagreb Klinika za onkologiju

location_facility: Klinicki bolnicki centar Rijeka Klinika za radioterapiju i onkologiju

location_facility: Instituto Português de Oncologia de Coimbra Serviço de Oncologia Médica

location_facility: Specialized hospital for active treatment in oncology

location_facility: Centre de lutte contre le cancer Francois Baclesse UCP Digestif

location_facility: Azienda Ospedaliero-Universitaria Careggi Struttura Complessa Oncologia Medica

location_facility: Treatment-diagnostic Centre PJSC "House of medicine"

location_facility: Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive

location_facility: Centro Hospitalar de São João E.P.E. Serviço de Oncologia

location_facility: Hôpital Trousseau Hépato-gastroentérologie et cancérologie digestive

location_facility: Spitalul Clinic "Fundeni" Departament Oncologie Medicala - Gastroenterologie

location_facility: Hôpital Nord Franche-Comté - Site du Mittan Service d'oncologie médicale

location_facility: Universitair Ziekenhuis Antwerpen Oncologie

location_facility: Royal Brisbane & Women's Hospital Clinical Research Unit

location_facility: Hôpital Saint-Antoine Service d'Oncologie Médicale

location_facility: Erciyes University Mehmet Kemal Dedeman Hematology Oncology

location_facility: A.O.U. Seconda Università degli Studi di Napoli U.O.C. di Oncologia Medica e di Ematologia

location_facility: Kyiv City Clinical Oncological Centre Day care facility

location_facility: Wielkopolskie Centrum Onkologii im Marii Sklodowskiej-Curie Oddzial Chemioterapii

location_facility: The Queen Elizabeth Hospital Haematology and Oncology Unit

location_facility: Vychodoslovensky onkologicky ustav Oddelenie klinickej onkologie

location_facility: Hôpital Nord Pôle Digestif Urologie-Andrologie

location_facility: Hopital Privé Jean Mermoz Service de Gastro entérologie et d'Oncologie médicale

location_facility: CHD - Les Oudairies service d'hepato-gastroenterologie

location_facility: Hospital Mãe de Deus Centro Intergrado de Pesquisa

location_facility: Ospedale Civile Santo Spirito Struttura Complessa di Oncologia Medica

location_facility: CHU Toulouse Rangueil Oncologie médicale digestive

location_facility: Policlinico Universitario Campus Biomedico UOC di Oncologia Medica

location_facility: Hospital A C Camargo Unidade de Pesquisa Clínica

location_facility: CHU de Poitiers Pole Régional de Cancérologie

location_facility: Hopital Privé Les Bonnettes Pharmacie centrale

location_facility: IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia

location_facility: Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica

location_facility: A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2

location_facility: Azienda Ospedaliera "Civico-Di Cristina" - Ospedale Civico Oncologia Medica

location_facility: Hospital Garcia de Orta Serviço de Oncologia Médica

location_facility: Centre Eugène Marquis Service d'Oncologie Médicale

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: The Canberra Hospital Cancer,Ambulatory & Community Health Service (CACHS) Bldg 19

location_facility: Centro Hospitalar de Lisboa Norte E.P.E. - H. Santa Maria Serviço de Oncologia Médica

location_facility: Institut Sainte Catherine Institut Sainte Catherine

location_facility: Centre Antoine Lacassagne Dpt d'Oncologie Médicale

location_facility: Institutul Regional de Oncologie Iasi Clinica de Oncologie Medicala

location_facility: Cabrini Hospital Cabrini Haematology and Oncology Centre

location_facility: CHU Hôpital du Bocage/ François Mitterrand Hépato-gastroentérologie

location_facility: CHU de Grenoble Oncologie médicale Hépato-gastroentérologie - 7D

location_facility: AMO Assistencia Multidisciplinar em Oncologia GEM Assistencia Medica Especializada

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

location_facility: Centro Hospitalar e Universitário de Comibra E.P.E. Serviço de Oncologia Médica

location_facility: UZ Leuven Campus Gasthuisberg Digestieve Oncologie

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

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Gastroenterologii Onkologicznej

location_facility: Groupe Hospitalier Pitié Salpêtrière Service d'hépato-gastro-entérologie

location_facility: ARNAS - Azienda Ospedaliera Garibaldi - Nesima Struttura Complessa di Oncologia Medica

location_facility: Hôpital Universitaire Erasme Gastro-Entérologie

location_facility: St Vincent's Hospital The Kinghorn Cancer Centre

location_facility: Cliniques Universitaires St. Luc Oncologie médicale

location_facility: Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej

location_facility: St Vincent's Hospital (Melbourne) Cancer Centre

location_facility: Policlinico Universitario Agostino Gemelli U.O.C. di Oncologia Medica

location_facility: Ist.Scientifico Romagnolo per lo Studio e la Cura dei Tumori Department of Clinical Oncology

location_facility: A.O.U. Città della Salute e della Scienza di Torino S.C. Oncologia Medica 1 - Colo-Rectal Cancer Unit

location_facility: Franco-British Institue Department of Medical Oncology

location_facility: Military Medical Academy - MHAT Oncology clinic

location_facility: CHU de la Timone Hépato-Gastro-Entérologie

location_facility: Hacettepe University Faculty of Medicine

location_facility: Instituto Português de Oncologia do Porto Serviço de Oncologia Médica

location_facility: Gazi University Faculty of Medicine Medical Oncology Department

location_facility: Hôpital Haut-Lévèque Hépato-gastroentérologie et oncologie digestive

location_facility: Clinical and diagn.Centre of Medics-rey Inter. Group LLC - Hospital of Israeli Oncology "LISOD

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Ege University Faculty of Medicine Medical Oncology Department

title: An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)

summary:
The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).

Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.


title: A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients With Germline or Somatic BRCA1/2 Mutations.

summary: This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Gelmon KA, Fasching PA, Couch FJ, Balmaña J, Delaloge S, Labidi-Galy I, Bennett J, McCutcheon S, Walker G, O'Shaughnessy J; Collaborating Investigators. Clinical effectiveness of olaparib monotherapy in germline BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: phase IIIb LUCY interim analysis. Eur J Cancer. 2021 Jul;152:68-77. doi: 10.1016/j.ejca.2021.03.029. Epub 2021 Jun 1.

family: Gelmon

full_name: Karen A. Gelmon

given: Karen A.

sequence: first

family: Fasching

full_name: Peter A. Fasching

given: Peter A.

sequence: additional

family: Couch

full_name: Fergus J. Couch

given: Fergus J.

family: Balmaña

full_name: Judith Balmaña

given: Judith

family: Delaloge

full_name: Suzette Delaloge

given: Suzette

family: Labidi-Galy

full_name: Intidhar Labidi-Galy

given: Intidhar

family: Bennett

full_name: James Bennett

given: James

family: McCutcheon

full_name: Susan McCutcheon

given: Susan

family: Walker

full_name: Graham Walker

given: Graham

family: O'Shaughnessy

full_name: Joyce O'Shaughnessy

given: Joyce

family: Timcheva

full_name: Constanta Timcheva

given: Constanta

family: Tomova

full_name: Antoaneta Tomova

given: Antoaneta

family: Eisen

full_name: Andrea Eisen

given: Andrea

full_name: Karen Gelmon

given: Karen

family: Lemieux

full_name: Julie Lemieux

given: Julie

family: Bazan

full_name: Fernando Bazan

given: Fernando

family: Bourgeois

full_name: Hugues Bourgeois

given: Hugues

family: Chakiba

full_name: Camille Chakiba

given: Camille

family: Chehimi

full_name: Mohamad Chehimi

given: Mohamad

family: Dalenc

full_name: Florence Dalenc

given: Florence

family: De La Motte Rouge

full_name: Thibault De La Motte Rouge

given: Thibault

family: Frenel

full_name: Jean-Sébastien Frenel

given: Jean-Sébastien

family: Gonçalves

full_name: Anthony Gonçalves

given: Anthony

family: Hardy-Bessard

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

location_country:
Italy
United States
France
Bulgaria
Japan
Korea, Republic of
Poland
Hungary
Russian Federation
Spain
Turkey
Germany
United Kingdom
Canada
Taiwan


design_allocation: Randomized

intervention_type: Drug

status: Active, not recruiting

lead_sponsor: Hoffmann-La Roche

location_country:
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Canada
Korea, Republic of
Hong Kong
Switzerland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
New Zealand
Spain
Turkey

acronym: POLARIX

location_facility: Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis

location_facility: Barts Health NHS Trust; Bartholomew's H., King George V Building

location_facility: Pusan National University Yangsan Hospital; hemato-oncology

location_facility: CHRU DE STRASBOURG; Département d'Hématologie et Oncologie

location_facility: Universitätsspital Basel Gynäkologie - Onkologie

location_facility: L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard

location_facility: Univerzita Karlova v Praze 1. Lekarska Fakulta

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The University of Adelaide - The Queen Elizabeth Hospital (TQEH)

location_facility: Centre Hospitalier de La Cote Basque; Hematologie

location_facility: Ohio State University; B406 Starling-Loving Hall

location_facility: Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika

location_facility: China Medical University Hospital; Clinical Research Center Clinical Pharmacy

location_facility: Austin Hospital; Cancer Clinical Trials Centre

location_facility: Medical University of South Carolina Hospital

location_facility: Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

location_facility: Westmead Hospital; Outpatient Pharmacy University Clinic

location_facility: Seattle Cancer Care Alliance; Investigational Drug Service

location_facility: Northwest Cancer Specialists - Portland (SW Barnes Rd)

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Dana Farber Cancer Institute; Lymphoma Program

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

location_facility: Oncology/Hematology Care Clinical Trials LLC

location_facility: CHU Amiens - Hopital Sud; Hematologie Clinique et Therapie Cellulaire

location_facility: Texas Oncology San Antonio Medical Center

location_facility: Hopital Cantonal Universitaire De Geneve

location_facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III

location_facility: Gh Necker Enfants Malades; Hematologie Clinique

location_facility: Kaohsiung Medical University Hospital, Cancer Center

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

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Hospital of the University of Pennsylvania

location_facility: CIUSSS de l'Est-de-l'Ile-de-Montréal - Hôpital Maisonneuve-Rosemont

location_facility: Levine Cancer Institute - Clincal Trials Administration

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Centre Hospitalier de l'Universite de Montreal - Pavillon E (PEA)

location_facility: AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova

location_facility: Institut Gustave Roussy; Unite D'Hematologie

location_facility: Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP

location_facility: National Cancer Center; Medical Oncology

location_facility: Washington University; Wash Uni. Sch. Of Med

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

location_facility: Ronald Reagan UCLA Medical Center; Drug Information Center

location_facility: Hopital Pontchaillou; Hematologie Clinique

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Oncology Associates of Southwest Virginia, Inc.

location_facility: Shanghai East Hospital, Tongji University

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - s.c. Ematologia

location_facility: Emory University; Investigational Drug Service

location_facility: University of Pittsburgh Medical Center Cancer Center; Pharmacy

location_facility: Canterbury Health Laboratories; Immunology/Rheumatology

location_facility: Tennessee Oncology - Chattanooga; Tennessee Oncology - East Third Street

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Klinika Hematologii UM w Łodzi

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology

location_facility: InVO - Institut für Versorgungsforschung in der Onkologie GbR

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hôpital Saint-Louis; Service d'Hématologie

location_facility: Memorial Sloan Kettering Cancer Center - Commack

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

location_facility: Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica

location_facility: University of North Carolina at Chapel Hill

location_facility: University Hospitals Case Medical Center

location_facility: Centre Hospitalier de Quimper Cornouaille (CHIC); Médecine interne-Maladies du sang

location_facility: Roswell Park Cancer Institute; Grace Cancer Drug Center

location_facility: University of Louisville Hospital; The James Graham Brown Cancer Center

location_facility: CH Bretagne Atlantique; Médecine interne

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council

location_facility: Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Ankara University Faculty of Medicine Cebeci Hospital

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: McMaster University Medical Center, Juravinski Cancer Centre, Hamilton Health Sciences

location_facility: Kobe City Medical Center General Hospital

location_facility: Hôpital Albert Michallon; Hematologie Clinique

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Hopital Haut-Leveque - Centre Francois Magendie; Service d'Hematologie Clinique

location_facility: Fakultni Nemocnice Hradec Kralove (FNHK); IV. Interni Hematologicka Klinika

location_facility: Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

location_facility: SPZOZ Ministerstwa Spraw Wewnętrznych i Administracji w Poznaniu; Oddział Hematologii

location_facility: Memorial Sloan Kettering Cancer Center at Westchester

location_facility: University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Wiener Gesundheitsverbund - Klinik Ottakring

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: Fox Chase Cancer Center; Hematology/Oncology

location_facility: Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

location_facility: Khmelnytskyi Regional Hospital; Department of Hemathology

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich w Chorzowie

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

study_completion_date_type: Anticipated

type: EudraCT Number

source: euctr

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

summary: This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Phase Ib - II Study of Entospletinib (ENTO) in Newly Diagnosed Diffuse Large B Cell Lymphoma (DLBCL) Patients With aaIPI>=1 Treated by Rituximab, Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone (R-CHOP)

summary:
The primary objective of the phase Ib of the study is to determine the recommended phase 2 dose (RP2D) for entospletinib (ENTO) in patients treated with R-CHOP.

The primary objective of the phase II is to determine the complete metabolic response (CMR) rate by the Lugano classification 2014 (Deauville scale 1-3) at the end of treatment.

status: Terminated

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: Clinique Universite Catholique de Louvain Saint-Luc

status_simplified: Unknown


title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

acronym: AGILE

summary: Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.

ipd_sharing: Yes

location_country:
Italy
Austria
Brazil
Mexico
Netherlands
Germany
Spain
France
Czechia
Japan
Israel
Poland
Australia
Russian Federation
China
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Severance Hospital Yonsei University Health System

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Institut dHematologie de Basse Normandie

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

location_facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller

location_facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

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

location_facility: Oaxaca Site management Organization (OSMO) - PPDS

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Unicamp Universidade Estadual de Campinas

location_facility: Instituto do Cancer do Estado de Sao Paulo ICESP

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Nanfang Hospital Southern Medical University

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Centre Hospitalier de Versailles CHV Hopital Andre Mignot

location_facility: First Affiliated Hospital of Soochow University

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Hospital d Instructions des Armees Percy

location_facility: Kobe City Medical Center General Hospital

location_facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

location_facility: Peking University People's Hospital PKUPH

location_facility: Third Xiangya Hospital Central South University

location_facility: SPZOZ MSWiA w Poznaniu im.Prof Ludwika Bierkowskiego

location_facility: Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP

location_facility: Fujian Medical University Union Hospital

location_facility: ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Centro de Investigacion Clinica Chapultepec/Sanatorio de la Luz


title: A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

summary: This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.

status: Recruiting

design_allocation: Non-Randomized

enrollment_type: Anticipated

ipd_sharing: Undecided

lead_sponsor: Exelixis

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

location_facility:
Exelixis Clinical Site #44
Exelixis Clinical Site #106
Exelixis Clinical Site #45
Exelixis Clinical Site #4
Exelixis Clinical Site #86
Exelixis Clinical Site #19
Exelixis Clinical Site #3
Exelixis Clinical Site #58
Exelixis Clinical Site #123
Exelixis Clinical Site #75
Exelixis Clinical Site #13
Exelixis Clinical Site #7
Exelixis Clinical Site #48
Exelixis Clinical Site #77
Exelixis Clinical Site #81
Exelixis Clinical Site #122
Exelixis Clinical Site #112
Exelixis Clinical Site #8
Exelixis Clinical Site #90
Exelixis Clinical Site #119
Exelixis Clinical Site #39
Exelixis Clinical Site #98
Exelixis Clinical Site #101
Exelixis Clinical Site #60
Exelixis Clinical Site #14
Exelixis Clinical Site #30
Exelixis Clinical Site #9
Exelixis Clinical Site #5
Exelixis Clinical Site #22
Exelixis Clinical Site #34
Exelixis Clinical Site #65
Exelixis Clinical Site #87
Exelixis Clinical Site #94
Exelixis Clinical Site #111
Exelixis Clinical Site #28
Exelixis Clinical Site #105
Exelixis Clinical Site #6
Exelixis Clinical Site #83
Exelixis Clinical Site #50
Exelixis Clinical Site #103
Exelixis Clinical Site #107
Exelixis Clinical Site #96
Exelixis Clinical Site #31
Exelixis Clinical Site #118
Exelixis Clinical Site #66
Exelixis Clinical Site #110
Exelixis Clinical Site #2
Exelixis Clinical Site #56
Exelixis Clinical Site #79
Exelixis Clinical Site #25
Exelixis Clinical Site #97
Exelixis Clinical Site #68
Exelixis Clinical Site #33
Exelixis Clinical Site #63
Exelixis Clinical Site #26
Exelixis Clinical Site #16
Exelixis Clinical Site #93
Exelixis Clinical Site #41
Exelixis Clinical Site #20
Exelixis Clinical Site #92
Exelixis Clinical Site #80
Exelixis Clinical Site #76
Exelixis Clinical Site #24
Exelixis Clinical Site #71
Exelixis Clinical Site #116
Exelixis Clinical Site #89
Exelixis Clinical Site #69
Exelixis Clinical Site #74
Exelixis Clinical Site #40
Exelixis Clinical Site #104
Exelixis Clinical Site #43
Exelixis Clinical Site #114
Exelixis Clinical Site #18
Exelixis Clinical Site #102
Exelixis Clinical Site #29
Exelixis Clinical Site #23
Exelixis Clinical Site #100
Exelixis Clinical Site #54
Exelixis Clinical Site #84
Exelixis Clinical Site #12
Exelixis Clinical Site #47
Exelixis Clinical Site #11
Exelixis Clinical Site #46
Exelixis Clinical Site #55
Exelixis Clinical Site #52
Exelixis Clinical Site #15
Exelixis Clinical Site #78
Exelixis Clinical Site #85
Exelixis Clinical Site #124
Exelixis Clinical Site #82
Exelixis Clinical Site #88
Exelixis Clinical Site #72
Exelixis Clinical Site #32
Exelixis Clinical Site #99
Exelixis Clinical Site #120
Exelixis Clinical Site #51
Exelixis Clinical Site #49
Exelixis Clinical Site #36
Exelixis Clinical Site #10
Exelixis Clinical Site #117
Exelixis Clinical Site #115
Exelixis Clinical Site #59
Exelixis Clinical Site #121
Exelixis Clinical Site #53
Exelixis Clinical Site #67
Exelixis Clinical Site #42
Exelixis Clinical Site #38
Exelixis Clinical Site #108
Exelixis Clinical Site #17
Exelixis Clinical Site #1
Exelixis Clinical Site #21
Exelixis Clinical Site #61
Exelixis Clinical Site #95
Exelixis Clinical Site #70
Exelixis Clinical Site #73
Exelixis Clinical Site #35
Exelixis Clinical Site #91
Exelixis Clinical Site #109
Exelixis Clinical Site #113
Exelixis Clinical Site #27
Exelixis Clinical Site #37
Exelixis Clinical Site #57
Exelixis Clinical Site #64
Exelixis Clinical Site #62


type: Other Identifier

type: Registry Identifier

title: A Phase 2, Randomized, Open-Label Study Comparing Oral Ixazomib/Dexamethasone and Oral Pomalidomide/Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

summary:
The main aim of this study is to learn if ixazomib, given with dexamethasone, stops the cancer from getting worse in people with relapsed or refractory multiple myeloma. It will be compared to another medicine called pomalidomide, given with dexamethasone with people with the same condition. Relapsed means the previous cancer treatment stopped working, over time. Refractory means they did not respond to previous cancer treatment. Another aim is to check for side effects from the study medicines.

At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 treatments by chance.

Ixazomib capsules, given with dexamethasone tablets
Pomalidomide capsules, given with dexamethasone tablets

All participants will take their study medicine on specific days during a 28-day cycle.

The 1st dose of study medicines in each 28-day cycle will take place in the clinic, The other doses of the study medicines will be taken at home. This will happen for 6 cycles. After this, all study medicines will be taken at home.

After treatment, participants will visit the clinic every 12 weeks for a check-up.

If participants cannot attend their clinic for an important reason (for example, due to the COVID-19 pandemic), the clinic will make alternative arrangements using their local procedures.

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

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Czechia
Greece
Israel
Norway
Belgium
Australia
Russian Federation
Spain
Turkey
Denmark
Canada
United Kingdom

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: Centro Di Riferimento Oncologico Della Basilicata

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: Kirov Research Institute of Haematology and Blood Transfusion

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Universitari de Girona Dr Josep Trueta

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

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

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

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

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Bretagne Atlantique Vannes

location_facility: Oslo Universitetssykehus HF Rikshospitalet

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Fondazione del Piemonte per lOncologia (IRCCS)

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Gazi University Medical Faculty Gazi Hospital


ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3:CD013513. doi: 10.1002/14651858.CD013513.pub3.

name: Nuffield Department of Surgical Sciences; University of Oxford; Oxford UK

family: Chong

full_name: Lee-Yee Chong

given: Lee-Yee

name: Department of Otorhinolaryngology; Faculty of Medicine, Khon Kaen University; Khon Kaen Thailand

family: Piromchai

full_name: Patorn Piromchai

given: Patorn

name: National Institute for Health and Care Excellence; Manchester UK

family: Sharp

full_name: Steve Sharp

given: Steve

name: Department of Otolaryngology, Faculty of Medicine; Chulalongkorn University; Bangkok Thailand

family: Snidvongs

full_name: Kornkiat Snidvongs

given: Kornkiat

name: Cochrane ENT; Nuffield Department of Surgical Sciences, University of Oxford; Oxford UK

family: Webster

full_name: Katie E Webster

given: Katie E

name: Department of Medicine; Norwich Medical School, University of East Anglia; Norwich UK

family: Philpott

full_name: Carl Philpott

given: Carl

name: ENT Department; Guy's Hospital; London UK

family: Hopkins

full_name: Claire Hopkins

given: Claire

family: Burton

full_name: Martin J Burton

given: Martin J

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: University of East Anglia - UEA Digital Repository

version: acceptedVersion

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Biologics for chronic rhinosinusitis

ReferenceCitation: Harrison TW, Chanez P, Menzella F, Canonica GW, Louis R, Cosio BG, Lugogo NL, Mohan A, Burden A, McDermott L, Garcia Gil E, Zangrilli JG; ANDHI study investigators. Onset of effect and impact on health-related quality of life, exacerbation rate, lung function, and nasal polyposis symptoms for patients with severe eosinophilic asthma treated with benralizumab (ANDHI): a randomised, controlled, phase 3b trial. Lancet Respir Med. 2021 Mar;9(3):260-274. doi: 10.1016/S2213-2600(20)30414-8. Epub 2020 Dec 22. Erratum in: Lancet Respir Med. 2021 Jan 25;:.

family: Harrison

full_name: Tim W Harrison

given: Tim W

family: Chanez

full_name: Pascal Chanez

given: Pascal

family: Menzella

full_name: Francesco Menzella

given: Francesco

family: Canonica

full_name: Giorgio Walter Canonica

given: Giorgio Walter

family: Louis

full_name: Renaud Louis

given: Renaud

family: Cosio

full_name: Borja G Cosio

given: Borja G

family: Lugogo

full_name: Njira L Lugogo

given: Njira L

family: Mohan

full_name: Arjun Mohan

given: Arjun

family: Burden

full_name: Annie Burden

given: Annie

family: McDermott

full_name: Lawrence McDermott

given: Lawrence

family: Garcia Gil

full_name: Esther Garcia Gil

given: Esther

family: Zangrilli

full_name: James G Zangrilli

given: James G

family: Pohl

full_name: Wolfgang Pohl

given: Wolfgang

family: Voves

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
Finland
France
Norway
Belgium
Spain
Denmark
Canada
United Kingdom

title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3b Study to Evaluate the Safety and Efficacy of Benralizumab 30 mg sc in Patients With Severe Asthma Uncontrolled on Standard of Care Treatment

summary: The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.


title: Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study

acronym: POSE

summary: The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Kowark A, Berger M, Rossaint R, Schmid M, Coburn M; and the POSE-Study group. Association between benzodiazepine premedication and 30-day mortality rate: A propensity-score weighted analysis of the Peri-interventional Outcome Study in the Elderly (POSE). Eur J Anaesthesiol. 2021 Nov 24. doi: 10.1097/EJA.0000000000001638. [Epub ahead of print]

family: Kowark

full_name: Ana Kowark

given: Ana

family: Berger

full_name: Moritz Berger

given: Moritz

family: Rossaint

full_name: Rolf Rossaint

given: Rolf

family: Schmid

full_name: Matthias Schmid

given: Matthias

family: Coburn

full_name: Mark Coburn

given: Mark

journal_name: European Journal of Anaesthesiology

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Peri-interventional outcome study in the elderly in Europe: A 30-day prospective cohort study. Eur J Anaesthesiol. 2021 Nov 18. doi: 10.1097/EJA.0000000000001639. [Epub ahead of print]

lead_sponsor: Mark Coburn

location_country:
Austria
Serbia
Switzerland
Netherlands
North Macedonia
Spain
France
Poland
Greece
Israel
Georgia
Romania
Ireland
Belgium
Russian Federation
Portugal
Turkey
Denmark
Germany
Ukraine

location_facility: General Hospital of Volos "Achillopouleio"

location_facility: Clinical Center of Serbia, Cener for anaestesia , Department for digestive surgery

location_facility: Universitätsklinikum Schleswig-Holstein Campus Luebeck

location_facility: Clinic for orthopedics surgery and traumatology Clinical center of Serbia

location_facility: Centro Hospitalar Lisboa Norte - Hospital Santa Maria

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Department of Anesthesiology, University Hospital Aachen

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral

location_facility: Medical Corporation Evex, Tbilisi Referral Hospital

location_facility: University Hospital Knappschaftskrankenhaus Bochum

location_facility: Baskent University Konya Research Center

location_facility: Universitary General Hospital of Ciudad Real

location_facility: Centro Hospitalar e Universitario de Coimbra

location_facility: Acad. N. Kipshidze Central University Clinic

location_facility: Neurologic Hospital-Hospices Civils de Lyon

location_facility: Clinical Emergency Hospital of Bucharest

location_facility: University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Medical School, Aristotle University of Thessaloniki

location_facility: Marien Hospital Herne, UK der Ruhr-Universität Bochum

location_facility: Dokuz Eylul University Faculty of Medicine

location_facility: Emergency Center, Clinical Center of Serbia

location_facility: Klinikum der Ludwigs-Maximilians-Universität München (LMU)

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia

location_facility: University Clinic for Traumatology, Orthopedics, Anesthesia, Reanimation, and Intensive Care Medicine

location_facility: Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu"

location_facility: Ankara University Faculty of Medicine-Ibni Sina Hospital

location_facility: NN Blokhin National Medical Cancer Research Center

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital

location_facility: Medical Corporation Evex - Zugdidi Referral Hospital

location_facility: TR Ministry of Health Erzurum Palandoken State Hospital

location_facility: P.A. Herzen Moscow Cancer Research Institute

location_facility: Republic of Turkey Ministry of Health Tunceli State Hospital

location_facility: Saglik Bilimleri University Tepecik Education and Research Hospital

location_facility: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

location_facility: University Clinic for Gyn & Ob / Clinical Center Mother Teresa

location_facility: Istanbul University, Istanbul Faculty of Medicine

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: Urology Hospital, Clinical center of Serbia

location_facility: Huriez Hospital, University Hospital of Lille

location_facility: Kliniverbund St. Antonius und St. Josef GmbH

location_facility: Federal State Autonomous Institution N.N. Burdenko National medical research center of neurosurgery of the ministry of health of the Russian federation (N.N. Burdenko NMRCN)

location_facility: University Emergency Central Military Hospital

location_facility: University Hospital Carl Gustav Carus Dresden

intervention_type: Procedure

status_simplified: Completed


title: A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy

acronym: OReO

summary: The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer).

lead_sponsor: AstraZeneca

location_country:
Italy
Germany
France
Poland
Israel
Norway
Belgium
Spain
Denmark
Canada
United Kingdom


ReferenceCitation: Hartung HP; ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5). pii: e807. doi: 10.1212/NXI.0000000000000807. Print 2020 Sep.

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

currency_apc_doaj: USD

journal_name: Neurology - Neuroimmunology Neuroinflammation

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

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

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

title: Ocrelizumab shorter infusion

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Romania
Australia
Belgium
Denmark
Croatia
France
Poland
Slovakia
Kuwait
Norway
Argentina
Canada
Slovenia
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Spain
Turkey

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia

location_facility: UN Bratislava Nemocnica Ruzinov; Neurologicka klinika

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Neurologia

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Akershus universitetssykehus HF; Nevroklinikken S203

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

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich

location_facility: Gazi University Medical Faculty; Departmant of Neurology.

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Mustafa Kemal UTF; Department of norology

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: MultipEL Studies - Institut für klinische Studien

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika LF UK a UNB

location_facility: Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche

location_facility: CHU Hopital Gabriel Montpied; Service de Neurologie

location_facility: London Health Sciences Centre Uni Campus

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: Box Hill Hospital; Department of Neurology

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: HIA de Toulon hôpital militaire; Neurologie

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

location_facility: Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Luzerner Kantonsspital Luzern Medizin Neurologie

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Universitätsklinikum Essen (AöR); Klinik für Neurologie

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

location_facility: Ospedale Regionale di Lugano - Civico; Neurologia

location_facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie

location_facility: Rigshospitalet; Neurologisk Klinik Glostrup

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Centralsjukhuset; Neurologi och rehabiliteringskliniken

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research

location_facility: Hospital General Universitario de Alicante; Servicio de Neurología

location_facility: Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute

location_facility: Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: UBC Hospital; Div of Neurology, Dept of Medicine

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: VALEOMED Diagnosztikai Központ; VALEOMED Diagnosztikai Központ

location_facility: American University of Beirut - Medical Center

location_facility: Hospital General Universitario Morales Meseguer; Servicio de Neurología

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische

location_facility: Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica

location_facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

location_facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: Montreal Neurological Institute and Hospital

location_facility: Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Semmelweis Egyetem AOK; Neurologiai Klinika

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: Royal North Shore Hospital; Department of Neurology

location_facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: University of Maryland Medical Center; Department of Neurology

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Austin Hospital; Department of Neurology

location_facility: Hospital Garcia de Orta; Servico de Neurologia

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie

location_facility: Palo Alto Medical Foundation Research Center

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

location_facility: Istanbul University Istanbul Medical Faculty; Neurology

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Spitalul Clinic Judetean de Urgenta Mures

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

title: An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

summary:
This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.


title: An Open-Label, Multi-Centre, Safety Study of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.

acronym: STRONG

summary: To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Italy
United States
Netherlands
France
Korea, Republic of
Germany
United Kingdom
Canada

intervention_type: Biological


title: Strategic MAnagement to Optimize Response To Cardiac Resynchronization Therapy Registry (SMART Registry)

acronym: SMART Registry

summary:
To learn in a general Cardiac Resynchronization Therapy Defibrillators (CRT-D) population, which optimization techniques are used and how effective they are. It will compare 12-month response rates among different optimization methods and characterize which selected subject subgroups achieve better response than others.

A subset of SMART Registry subjects will contribute to the NG4 Post Market Clinical Follow Up (PMCF) Cohort whose objective is collecting data on the NG4 CRT-D features and device usage in a real world setting and monitor long term safety associated with these devices to support CE Mark.

lead_sponsor: Boston Scientific Corporation

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Spain
Germany
France
Czechia
Slovakia
Australia
Belgium
Portugal
Canada
United Kingdom

location_facility: Barwon Health Myers House Ground Floor Geelong Hospital

location_facility: Magna Graecia University AUO Mater Domini di Catanzaro

location_facility: Universitares Herzentrum Hamburg/Universitaetsklinik Eppendorf

location_facility: Royal Alexandra Hospital - Cardiology Research CK Hui Heart Centre

location_facility: IKEM - Institut klinicke a experimentalni mediciny

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Basildon and Thurrock University Hospitals NHS Foundation Trust

location_facility: North Florida/South Georgia Veterans Health System

location_facility: Ospedale Santa Maria della Misericordia di Rovigo

location_facility: Voc Cardiologia Ospedaliera Polocino di Bari

location_facility: Hospital Santa Maria (Centro Hospitalar de Lisboa Norte)

location_facility: Azienda Ospedaliero - Universitaria di Ferrara

location_facility: Comprehensive Cardiovascular Medical Group

location_facility: Columbia. University Medical Center/ NY Presbyterian Hospital

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Universität Mainz zentrum fur kardiologie

location_facility: Azienda Socio-Sanitaria Territoriale dei Sette Laghi

location_facility: The National Institute of Cardiovascular Diseases

location_facility: Allgemeines Krankenhaus der Stadt Wien, Univ.Klinik für Innere Medizin II

location_facility: Riverside Medical Center / Midwest Arrhythmia Consultants

location_facility: LHCH (Liverpool Heart and Chest Hospital)

location_facility: Western Connecticut Health Network/ Danbury Hospital

location_facility: Landeskrankenhaus Salzburg Universitätsklinikum der PMU

location_facility: The University of Illinois Medical Center

location_facility: Blackpool Teaching Hospitals NHS Foundation Trust'

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio

location_facility: Klinikum Links der Weser-Elektrophysiologie Bremen

location_facility: Midwest Cardiovascular Research Foundation

intervention_type: Device


title: Placebo-controlled, Double-blind, Randomized Study of Aerucin® as Adjunct Therapy to Antibiotics in the Treatment of P. Aeruginosa Pneumonia

summary: Prospective, double-blind, randomized assessment of the efficacy, safety and pharmacokinetic of Aerucin® as adjunct treatment (in addition to standard of care antibiotics) for pneumonia caused by P. aeruginosa.

lead_sponsor: Aridis Pharmaceuticals, Inc.

location_country:
Peru
Mexico
Spain
France
Czechia
Greece
Poland
Georgia
Hungary
Belgium
Australia
Russian Federation
Belarus
United States
Korea, Republic of
Taiwan
Ukraine

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

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: St. Petersburg State Healthcare Institution - City Hospital #26

location_facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Sotiria Hospital, General Hospital of Chest Diseases

location_facility: CHU de Nantes, Service d'Anesthesie, Reanimation Chirurgicale

location_facility: University Hospital of Larissa Medical School

location_facility: University of California, San Diego (UCSD) - Medical Center

location_facility: Hospital Universitario Joan XXIII de Tarragona

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Northwestern University Feinberg School of Medicine,

location_facility: Hospital Universitario "Dr. José Eleuterio González"

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej

location_facility: Hopital de la Salpetriere Service de Reanimation Medicale

location_facility: Hospital Universitario Central de Asturias

location_facility: Fakultni nemocnice Plzen Anesteziologicko-resuscitacni oddeleni

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: V.T. Zaitsev Institute of General and Emergency Surgery

location_facility: Municipal City Clinical Hospital of Urgent Medical Care

location_facility: "Acad. Z. Tskhakaia National Center of Western Georgia" Ltd.

location_facility: Washington University School of Medicine

location_facility: Hopital Pitie-Salpetriere - Service de pneumologie et reanimation medicale

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Republican Scientific and Practical Center of Pulmonology and Tuberculosis

location_facility: Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu

location_facility: North-Western State Medical University named after I.I. Mechnikov

location_facility: General Hospital of Larissa Koutlimpanio & Triantafyllio

location_facility: Hopital Pitie-Salpetriere - Service de Réanimation Chirurgicale Polyvalente

location_facility: Saint-Petersburg I.I. Dzhanelidze Research Institute Of Emergency Medicine

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Universite Libre de Bruxelles (ULB) - Hopital Erasme

location_facility: Florida Health Sciences Center/Tampa General Hospital/USF

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: City Hospital #40 of the Resort District

location_facility: University of Florida (UF) - Jacksonville


ReferenceType: background

ReferenceCitation: Attal M, Richardson PG, Rajkumar SV, San-Miguel J, Beksac M, Spicka I, Leleu X, Schjesvold F, Moreau P, Dimopoulos MA, Huang JS, Minarik J, Cavo M, Prince HM, Macé S, Corzo KP, Campana F, Le-Guennec S, Dubin F, Anderson KC; ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019 Dec 7;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. Epub 2019 Nov 14. Erratum in: Lancet. 2019 Dec 7;394(10214):2072.

ReferenceCitation: Bringhen S, Pour L, Vorobyev V, Vural F, Warzocha K, Benboubker L, Koh Y, Maisnar V, Karlin L, Pavic M, Campana F, Le Guennec S, Menas F, van de Velde H, Richardson PG. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis. Leuk Res. 2021 May;104:106576. doi: 10.1016/j.leukres.2021.106576. Epub 2021 Mar 29.

family: Bringhen

full_name: Sara Bringhen

given: Sara

family: Pour

full_name: Ludek Pour

given: Ludek

family: Vorobyev

full_name: Vladimir Vorobyev

given: Vladimir

family: Vural

full_name: Filiz Vural

given: Filiz

family: Warzocha

full_name: Krzysztof Warzocha

given: Krzysztof

family: Benboubker

full_name: Lotfi Benboubker

given: Lotfi

family: Koh

full_name: Youngil Koh

given: Youngil

family: Maisnar

full_name: Vladimir Maisnar

family: Karlin

full_name: Lionel Karlin

given: Lionel

family: Pavic

full_name: Michel Pavic

given: Michel

family: Campana

full_name: Frank Campana

given: Frank

family: Le Guennec

full_name: Solenn Le Guennec

given: Solenn

family: Menas

full_name: Fatima Menas

given: Fatima

family: van de Velde

full_name: Helgi van de Velde

given: Helgi

family: Richardson

full_name: Paul G. Richardson

given: Paul G.

journal_name: Leukemia Research

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Schjesvold FH, Richardson PG, Facon T, Alegre A, Spencer A, Jurczyszyn A, Sunami K, Frenzel L, Min CK, Guillonneau S, Lin PL, Le-Guennec S, Campana F, van de Velde H, Bensfia S, Bringhen S. Isatuximab plus pomalidomide and dexamethasone in elderly patients with relapsed/refractory multiple myeloma: ICARIA-MM subgroup analysis. Haematologica. 2021 Apr 1;106(4):1182-1187. doi: 10.3324/haematol.2020.253450.

family: Fredrik H. Schjesvold

full_name: Fredrik H. Schjesvold

family: Paul G. Richardson

family: Thierry Facon

full_name: Thierry Facon

family: Adrián Alegre

full_name: Adrián Alegre

family: Andrew Spencer

full_name: Andrew Spencer

family: Artur Jurczyszyn

full_name: Artur Jurczyszyn

family: Kazutaka Sunami

full_name: Kazutaka Sunami

family: Laurent Frenzel

publisher: Ferrata Storti Foundation (Haematologica)

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

location_country:
Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Slovakia
Norway
Canada
Korea, Republic of
Sweden
Hungary
Portugal
United States
Germany
United Kingdom
Italy
Czechia
New Zealand
Spain
Turkey

location_facility:
Investigational Site Number 3800009
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Investigational Site Number 1580001
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Investigational Site Number 0360002

title: A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

summary:
Primary Objective:

To demonstrate the benefit of isatuximab in combination with pomalidomide and low-dose dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to pomalidomide and low-dose dexamethasone in participants with refractory or relapsed and refractory multiple myeloma (MM).

Secondary Objectives:

To evaluate the Overall Response Rate (ORR) as per International Myeloma Working Group (IMWG) criteria in each arm.
To compare the Overall Survival (OS) between the two arms.
To evaluate the Time To Progression (TTP) in each arm.
To evaluate the PFS in high risk cytogenetic population in each arm.
To evaluate the Duration of Response (DOR) in each arm.
To evaluate the safety in both treatment arms.
To determine the Pharmacokinetic profile of isatuximab in combination with pomalidomide.
To evaluate the immunogenicity of isatuximab.
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status.


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

acronym: COMBI-i

summary: To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma

ReferenceCitation: Dummer R, Lebbé C, Atkinson V, Mandalà M, Nathan PD, Arance A, Richtig E, Yamazaki N, Robert C, Schadendorf D, Tawbi HA, Ascierto PA, Ribas A, Flaherty KT, Pakhle N, Campbell CD, Gusenleitner D, Masood A, Brase JC, Gasal E, Long GV. Combined PD-1, BRAF and MEK inhibition in advanced BRAF-mutant melanoma: safety run-in and biomarker cohorts of COMBI-i. Nat Med. 2020 Oct;26(10):1557-1563. doi: 10.1038/s41591-020-1082-2. Epub 2020 Oct 5.

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Lebbé

full_name: Celeste Lebbé

given: Celeste

family: Atkinson

full_name: Victoria Atkinson

given: Victoria

family: Mandalà

full_name: Mario Mandalà

given: Mario

family: Nathan

full_name: Paul D. Nathan

given: Paul D.

family: Arance

full_name: Ana Arance

given: Ana

family: Richtig

full_name: Erika Richtig

given: Erika

family: Yamazaki

full_name: Naoya Yamazaki

given: Naoya

family: Robert

full_name: Caroline Robert

given: Caroline

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Tawbi

full_name: Hussein A. Tawbi

given: Hussein A.

family: Ascierto

full_name: Paolo A. Ascierto

given: Paolo A.

family: Ribas

full_name: Antoni Ribas

given: Antoni

family: Flaherty

full_name: Keith T. Flaherty

given: Keith T.

family: Pakhle

full_name: Neha Pakhle

given: Neha

family: Campbell

full_name: Catarina D. Campbell

given: Catarina D.

family: Gusenleitner

full_name: Daniel Gusenleitner

given: Daniel

family: Masood

full_name: Aisha Masood

given: Aisha

family: Brase

full_name: Jan C. Brase

given: Jan C.

family: Gasal

full_name: Eduard Gasal

given: Eduard

family: Long

full_name: Georgina V. Long

given: Georgina V.

journal_name: Nature Medicine

publisher: Springer Science and Business Media LLC

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

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

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Chile
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain

location_facility: University of Pittsburgh Medical Center SC

location_facility: University of TX MD Anderson Cancer Center SC-2

location_facility: NYU Laura and Isaac Perlmutter Cancer Center SC

location_facility: University of Tennessee Medical Center SC

location_facility: California Cancer Associates for Research and Excellence SC-2


ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

name: Institute of General Practice and Evidence-Based Health Services Research; Medical University of Graz; Graz Austria

family: Semlitsch

full_name: Thomas Semlitsch

given: Thomas

name: Institute for General Practice; Goethe University; Frankfurt am Main Germany

family: Engler

full_name: Jennifer Engler

given: Jennifer

name: Institute of General Practice and Evidence-Based Health Services Research, Medical University of Graz; Graz, Austria / Institute of General Practice, Goethe University; Frankfurt am Main Austria

family: Siebenhofer

full_name: Andrea Siebenhofer

given: Andrea

name: Institute of General Practice and Evidence-Based Health Services Research / Institute for Medical Informatics, Statistics and Documentation; Medical University of Graz; Graz Austria

family: Jeitler

full_name: Klaus Jeitler

given: Klaus

family: Berghold

full_name: Andrea Berghold

name: Institute of General Practice and Evidence-Based Health Services Research / Department of Internal Medicine, Division of Endocrinology and Metabolism; Medical University of Graz; Graz Austria

family: Horvath

full_name: Karl Horvath

given: Karl

ReferenceCitation: Freemantle N, Mauricio D, Giaccari A, Bailey T, Roussel R, Franco D, Berthou B, Pilorget V, Westerbacka J, Bosnyak Z, Bonnemaire M, Cali AMG, Nguyên-Pascal ML, Penfornis A, Perez-Maraver M, Seufert J, Sullivan SD, Wilding J, Wysham C, Davies M. Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus. Curr Med Res Opin. 2020 Apr;36(4):571-581. doi: 10.1080/03007995.2019.1708287. Epub 2020 Jan 19.

name: Institute of Clinical Trials and Methodology, University College London, London, UK;

family: Freemantle

full_name: Nick Freemantle

given: Nick

name: Department of Endocrinology & Nutrition, Hospital de la Santa Creu i Sant Pau, CIBERDEM, Barcelona, Spain;

family: Mauricio

full_name: Didac Mauricio

given: Didac

name: Center for Endocrine and Metabolic Diseases, Fondazione Policlinico Universitario A. Gemelli IRCSS, Università Cattolica del Sacro Cuore, Rome, Italy;

family: Giaccari

full_name: Andrea Giaccari

family: Bailey

full_name: Timothy Bailey

given: Timothy

name: Department of Diabetology, Endocrinology, and Nutrition, Bichat Hospital, AP-HP, Paris, France;

name: INSERM U1138, Centre de Recherche des Cordeliers, Paris, France;

name: UFR de Médecine, Paris University, Paris, France;

family: Roussel

full_name: Ronan Roussel

given: Ronan

name: CPCLIN Clinical Research Center, São Paulo, Brazil;

family: Franco

full_name: Denise Franco

given: Denise

family: Berthou

full_name: Baptiste Berthou

given: Baptiste

family: Pilorget

full_name: Valerie Pilorget

given: Valerie

family: Westerbacka

full_name: Jukka Westerbacka

given: Jukka

family: Bosnyak

full_name: Zsolt Bosnyak

given: Zsolt

family: Bonnemaire

full_name: Mireille Bonnemaire

given: Mireille

family: Cali

full_name: Anna M. G. Cali

given: Anna M. G.

family: Nguyên-Pascal

full_name: My-Liên Nguyên-Pascal

given: My-Liên

name: Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes and Université Paris Sud, Paris, France;

family: Penfornis

full_name: Alfred Penfornis

given: Alfred

name: Servei d´Endocrinologia i Nutrició, Hospital Universitari Bellvitge, L’Hospitalet de Llobregat, IDIBELL, Barcelona, Spain;

family: Perez-Maraver

full_name: Manuel Perez-Maraver

given: Manuel

name: Faculty of Medicine, Division of Endocrinology and Diabetology, Department of Medicine II, University Hospital of Freiburg, University of Freiburg, Freiburg, Germany;

family: Seufert

full_name: Jochen Seufert

given: Jochen

name: The CHOICE Institute, School of Pharmacy, University of Washington, Seattle, WA, USA;

family: Sullivan

name: Obesity and Endocrinology Clinical Research, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK;

name: Diabetes and Endocrinology Center, Multicare Rockwood Clinic, Spokane, WA, USA;

name: Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK

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

repository_institution: University College London - UCL Discovery

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

location_country:
Brazil
France
Romania
Ireland
Spain
Germany
United Kingdom

location_facility:
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title: A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension

summary:
Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change

Secondary Objectives:

To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change.
To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events [as defined by the American Diabetes Association (ADA] Workgroup on Hypoglycemia).
Change in fasting plasma glucose (FPG).
Change in body weight.
Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc).
Change in hypoglycemic control subscale (HCS)
Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.