acronym: CUPISCO

summary: This study will compare the efficacy and safety of molecularly-guided therapy versus standard platinum-containing chemotherapy in participants with poor-prognosis cancer of unknown primary site (CUP; non-specific subset) who have achieved disease control after 3 cycles of first-line platinum based induction chemotherapy.

sponsor_collaborators:
Hoffmann-La Roche
Foundation Medicine, Inc.

location_facility: Tampere University Hospital; Dept of Oncology

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

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Severance Hospital, Yonsei University Health System; Oncology

location_facility: Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: James Lind Centro de Investigación Del Cáncer

location_facility: Budapesti Uzsoki Utcai Kórház; Onkoradiológiai Osztály

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Hospital Sant Joan Despi- Moises Broggi; Servicio de Oncologia

location_facility: U. O. Oncologia Medica, Ospedale Santa Chiara

location_facility: Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Chaim Sheba medical center, Oncology division

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: Institut Paoli-Calmettes; Oncologie Medicale 1

location_facility: North Estonia Medical Centre, Oncology and hematology Clinic; Department of Chemotherapy

location_facility: Universitätsklinikum Augsburg; II. Med. Klinik

location_facility: Istanbul University Cerrahpa?a-Cerrahpa?a Medical Faculty; Medikal Onkoloji Departmani

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

location_facility: Western General Hospital; Edinburgh Cancer Center

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

location_facility: Onkologisches Zentrum - Onkologie Dachau

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Theagenio Anticancer Hospital; 3Rd Oncology Clinic

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

location_facility: Inst. Nacional de Cancerologia; Clinica de Seno

location_facility: Arcispedale Santa Maria Nuova; Oncologia

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

location_facility: Bács-Kiskun Vármegyei Oktatókórház; Onkoradiológiai Központ

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: CRLCC-Francois Baclesse; Oncologie Médicale

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

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

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Universitätsklinikum Jena, Klinik für Innere Medizin II; Hämatologie und Internistische Onkologie

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

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

location_facility: Klinikum der LMU München, Campus Großhadern, Krebszentrum München; Comprehensive Cancer Center LMU

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Universitätsklinikum Düsseldorf; Klinik für Hämatologie, Onkologie und Klinische Immunologie

location_facility: Royal United Hospital; Oncology Department

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

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

location_facility: Universitätsklinikum Heidelberg;Innere Medizin V, Hämatologie/Onkologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

location_facility: Hammersmith Hospital; Garry Weston Centre

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

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

location_facility: Aarhus Universitetshospital; Afdeling for Eksperimentel Klinisk Onkologi

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: RED-Oncology GmbH; Dres.Gerdt Hübner/Clemens Engels (Oldenburg)/Yael Bonnin-Gruber (Eutin)

location_facility: Universitätsklinikum Frankfurt, UCT; Universitäres Centrum für Tumorerkrankungen

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Universitätsklinikum Münster, Medizinische Klinik A, Translationale Onkologie

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

location_facility: Policlinico Univ. - A.O. Mater Domini; U.O. Di Oncoematologia

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

location_facility: Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie

title: A Phase II, Randomized, Active-Controlled, Multi-Center Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Guided by Genomic Profiling Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site Who Have Received Three Cycles of Platinum Doublet Chemotherapy

location_country:
Finland
Germany
Ireland
Poland
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
France
Colombia
Portugal
Hungary
Denmark
Switzerland
Latvia
Romania
Peru
Estonia
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Bulgaria
Israel


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Daiichi Sankyo, Inc.

summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.

ReferenceType: derived

ReferenceCitation: Rugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: California Digital Library - eScholarship

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

ReferenceCitation: Bardia A, Harnden K, Mauro L, Pennisi A, Armitage M, Soliman H. Clinical Practices and Institutional Protocols on Prophylaxis, Monitoring, and Management of Selected Adverse Events Associated with Trastuzumab Deruxtecan. Oncologist. 2022 Aug 5;27(8):637-645. doi: 10.1093/oncolo/oyac107.

repositories_concat: PubMed Central

publisher_dissemination: Oxford University Press

ReferenceCitation: Modi S. Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study. Future Oncol. 2021 Sep 1;17(26):3415-3423. doi: 10.2217/fon-2021-0427. Epub 2021 Jul 15.

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nd

license_normalized: cc-by-nd

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

ReferenceCitation: Yin O, Iwata H, Lin CC, Tamura K, Watanabe J, Wada R, Kastrissios H, AbuTarif M, Garimella T, Lee C, Zhang L, Shahidi J, LaCreta F. Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan. Clin Pharmacol Ther. 2021 Oct;110(4):986-996. doi: 10.1002/cpt.2291. Epub 2021 Jun 10.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.

oa_colors: green other

evidence: open (via free article)

version: acceptedVersion

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

repository_institution: Yonsei University Medical Library - YUHSpace

version: submittedVersion

repository_institution: University of California - eScholarship University of California

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
Daiichi Sankyo, Inc.
AstraZeneca
Daiichi Sankyo Co., Ltd.

location_facility: University of Louisville Research Foundation

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: The Regents of the University of California

location_facility: Providence Regional Medical Center - Everett

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: Seoul National University Bundang Hospital

location_facility: Washington University School of Medicine

location_facility: The Methodist Hospital Research Institute

location_facility: Innovative Clinical Research Institute, LLC

location_facility: Sylvester Comprehensive Cancer Center - Deerfield Beach

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists

location_facility: Nottingham University Hospitals City Campus

location_facility: Kyungpook National University Chilgok Hospital

status: Active, not recruiting

title: A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)

primary_purpose: Treatment

type: EudraCT Number

type: Registry Identifier

type: Other Identifier

source: euctr

enrollment_type: Actual

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Italy
United Kingdom
Japan
Belgium
United States
Korea, Republic of
Spain
Canada
France

study_type: Interventional

ipd_sharing: Yes

collaborators:
AstraZeneca
Daiichi Sankyo Co., Ltd.

lead_sponsor_type: industriel

status_simplified: Ongoing


acronym: SUSTAIN 10

lead_sponsor: Novo Nordisk A/S

summary: This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

ReferenceType: result

ReferenceCitation: Capehorn MS, Catarig AM, Furberg JK, Janez A, Price HC, Tadayon S, Verges B, Marre M. Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10). Diabetes Metab. 2020 Apr;46(2):100-109. doi: 10.1016/j.diabet.2019.101117. Epub 2019 Sep 17.

oa_host_type: closed

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: Springer-Nature

status: Completed

title: Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

study_completion_date_type: Actual

location_country:
Germany
Finland
Italy
Poland
Slovenia
Hungary
United Kingdom
Sweden
Spain
Czechia
Bulgaria
France

status_simplified: Completed


title: A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1+GEM vs GEM Alone in Patients With Measurable Locally Advanced/Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

summary: The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.

lead_sponsor: SynCore Biotechnology Co., Ltd.

location_country:
France
Hungary
United States
Korea, Republic of
Taiwan
Russian Federation
Israel

location_facility: Budget Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"

location_facility: Dél-pesti Centrumkórház - Országos Hematológia és Infektológia Intézet

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)

location_facility: Chang Gung Medical Foundation - Kaohsiung Branch

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: Clinique Sainte Anne/Strasbourg Oncologie Leberale

location_facility: Investigator Clinical Research Centers of Indiana

location_facility: Federal State Budgetary Scientific Institution "Russian Oncological Scientific Center named after N.N.Blokhin"

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: State Budgetary Healthcare Institution Leningrad Regional Oncology Center

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: North Mississippi Hematology & Oncology Associates, Ltd.

location_facility: Chonnam National University Hwasun Hospital

location_facility: Southeast Nebraska Cancer Center (SNCC) - Central Clinic - Main Clinic

location_facility: Guthrie - Corning Hospital - Guthrie Cancer Center

location_facility: John B. Amos Cancer Center / IACT Health

location_facility: State Budget Healthcare Institution "Orenburg Region Clinical Oncological Dispensary"

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: The Center for Cancer and Blood Disorders

location_facility: Bács-Kiskun Megyei Kórház Onkoradiológiai Központ

location_facility: Kursk State Clinical Oncology Dispensary

location_facility: Pécsi Tudomány Egyetem Onkoterápiás Intézet


title: An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices

summary: An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.

study_type: Observational

time_perspective: Prospective

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

lead_sponsor: Amgen

location_country:
Finland
Germany
Italy
Poland
Portugal
United Kingdom
Sweden
Netherlands
Austria
Switzerland
Greece
Czechia
France

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: Centre Hospitalier Universitaire Dieu Angers

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: Szpital Kliniczny im H Swiecickiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

location_facility: Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova

location_facility: Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I

location_facility: Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

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

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: Centro Hospitalar do Porto EPE - Hospital de Santo Antonio

location_facility: St James University Hospital, St James Institute of Oncology

location_facility: Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo

location_facility: Centro Hospitalar de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Centre Hospitalier Universitaire de Nice

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

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Azienda Ospedaliero Universitaria di Modena

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

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: Instituto Oncologico Della Svizzera Italiana

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

location_facility: Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo


title: Real-world Use of Carfilzomib Among Multiple Myeloma Patients in Europe Who Have Received at Least One Prior Therapy.

summary:
With the recent addition of carfilzomib as a treatment option for multiple myeloma, no data is available yet on how the drug is being used outside of the clinical trial setting.

This study will therefore provide essential data to demonstrate the real world utilization of carfilzomib in routine clinical practice, including dosage, administration schedule, regimen, duration of treatment and reason for discontinuation in Europe.

time_perspective: Other

ReferenceType: background

ReferenceCitation: Leleu X, Katodritou E, Kuehr T, Terpos E, Caers J, Zambello R, Brescianini A, Liang T, Wetten S, Badelita SN. Real-world use of carfilzomib combined with lenalidomide and dexamethasone in patients with multiple myeloma in Europe and Israel. EJHaem. 2022 Nov 6;4(1):174-183. doi: 10.1002/jha2.595. eCollection 2023 Feb.

ReferenceCitation: Terpos E, Zambello R, Leleu X, Kuehr T, Badelita SN, Katodritou E, Brescianini A, Liang T, Wetten S, Caers J. Real-World Use and Effectiveness of Carfilzomib Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma in Europe. Cancers (Basel). 2022 Oct 28;14(21):5311. doi: 10.3390/cancers14215311.

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

location_country: Italy Israel Norway Romania Netherlands Austria Belgium Greece Czechia Bulgaria France

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Azienda Ospedaliera Universitaria Ospedale San Giovanni di Dio e Ruggi D Aragona

location_facility: Targu-Mures County Emergency Clinical Hospital

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

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli

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

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: General Hospital of Patras Agios Andreas

location_facility: Azienda Ospedaliero Universitaria Integrata di Udine

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Azienda Ospedaliera Brotzu Presidio Ospedaliero A Businco Centro di Riferimento Oncologico Regionale

location_facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carola Davila"

location_facility: Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Algemeen Ziekenhuis Nikolaas Campus Sint-Niklaas

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: University of Athens School of Medicine Alexandra Hospital

location_facility: Centres Hospitaliers Jolimont - Hopital de Jolimont

location_facility: Special Anticancer Hospital of Piraeus Metaxa

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Presidio Ospedaliero San Giuseppe Moscati

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Azienda Unita Sanitaria Locale Toscana Centro

location_facility: Profesor Dr Ion Chiricuta Institut of Oncology

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

location_facility: Centre Hospitalier Wallonie Picarde - site imc

location_facility: Spitalul Clinic Dr Gavril Curteanu Oradea

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: General Hospital of Athens Georgios Gennimatas

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: Groupe Hospitalo Universitaire de Nimes - Hopital Caremeau

location_facility: Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: University General Hospital of Evros-Alexandroupolis District

location_facility: Azienda Ospedaliera di Alessandro Manzoni Lecco

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

summary: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

status: Terminated

ReferenceCitation: Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16.

evidence: open (via free pdf)

ReferenceCitation: Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA.

ReferenceCitation: Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA.

ReferenceCitation: Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.

ReferenceCitation: Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3 and STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6.

ReferenceCitation: Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.

ipd_sharing: No

lead_sponsor: Gilead Sciences

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Canada
France
Portugal
Hong Kong
Switzerland
United States
India
Belgium
Malaysia
Puerto Rico
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Intermountain Liver Disease and Transplant Center

location_facility: South Florida Center of Gastroenterology, PA

location_facility: Rutgers New Jersey Medical School- Doctors Office Center

location_facility: Tulane University Health Sciences Center

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Greenville Health System - Gastroenterology and Liver Center

location_facility: University of Minnesota Medical Center - Fairview

location_facility: Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

location_facility: Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)

location_facility: William Osler Health System-Brampton Civic Hospital

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)

location_facility: Baylor College of Medicine - Advanced Liver Therapies

location_facility: CHOP_Complejo Hospitalrio Universitario de Pontevedra

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: IRCCS Ospedale Casa Sollievo Della Soferrenza

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: American Research Corporation, The Texas Liver Institute

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: University of California San Francisco (UCSF)

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: Keimyung University Dongsan Medical Center

location_facility: Universitatsklinikum Frankfurt der Goethe-Universitat

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine

location_facility: Gastroenterologisch- Hepatologisches Zentrum Kiel

location_facility: Southern Therapy and Advanced Research LLC (STAR)

location_facility: UF Health Jacksonville-Gastroenterology Emerson

location_facility: National Health Insurance Service- Ilsan Hospital

location_facility: Walter Reed National Military Medical Center

location_facility: Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E

location_facility: University of Buffalo, Clinical and Translational Research Center

location_facility: Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP

location_facility: Indiana University Health - University Hospital

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Banner University Medical Center-Phoenix

location_facility: St. Joseph's Hospital and Medical Center

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: Uniklinikum des Saarlandes- Klinik fur Innere Medizin II

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

location_facility: Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii

location_facility: Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease

location_facility: Toronto Center for Liver Diseases (TCLD), Toronto General Hospital

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Hospital de Clínicas de Porto Alegre - HCPA/UFRGS

location_facility: Kansas City Gastroenterology and Hepatology

location_facility: Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik III

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: CHU de Limoges- Hopital Dupuytren- Federation Hepatologie

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)

location_facility: Northwell Health - Sandra Atlas Bass Center for Liver Diseases

location_facility: Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)

location_facility: University of Calgary Liver Unit (Heritage Medical Research Clinic)

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP

location_facility: University of California, Davis Medical Center

location_facility: Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

location_facility: Kawasaki Medical School General Medical Center

location_facility: National Center for Global Health and Medicine Hospital

location_facility: Centre Hospitalier Regional Universitaire- Hopital Claude Huriez

location_facility: National Cheng Kung University Hospitalv

location_facility: Duke University Medical Center - Duke South Clinics

location_facility: The University of Chicago Medical Center

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute

location_facility: Huron Gastroenterology Associates/Center for Digestive Care

location_facility: University of North Carolina at Chapel Hill / UNC School of Medicine

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: University of California San Diego (UCSD)

location_facility: California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant

location_facility: The University of Vermont Medical Center

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital

location_facility: Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Phylasis Clinicas Research S. de RL de CV.

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie

location_facility: University of Iowa Hospitals and Clinics

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)

location_facility: Institute of Post Graduate Medical Education and Research / SSKM Hospital

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Baylor Scott & White All Saints Medical Center

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Centre Hospitalier Universitaire d'Angers

status_simplified: Unknown


title: A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine

acronym: ADVOCATE

summary: The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with cyclophosphamide followed by azathioprine, or in combination with rituximab.

ReferenceCitation: Harigai M, Kaname S, Tamura N, Dobashi H, Kubono S, Yoshida T. Efficacy and safety of avacopan in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis: A subanalysis of a randomized Phase 3 study. Mod Rheumatol. 2023 Mar 2;33(2):338-345. doi: 10.1093/mr/roac037.

evidence: open (via crossref license)

ReferenceCitation: Soulsby WD. Journal Club Review of "Avacopan for the Treatment of ANCA-Associated Vasculitis". ACR Open Rheumatol. 2022 Jul;4(7):558-561. doi: 10.1002/acr2.11412. Epub 2022 Feb 15.

ReferenceCitation: Jayne DRW, Merkel PA, Schall TJ, Bekker P; ADVOCATE Study Group. Avacopan for the Treatment of ANCA-Associated Vasculitis. N Engl J Med. 2021 Feb 18;384(7):599-609. doi: 10.1056/NEJMoa2023386.

repository_institution: University of Cambridge - Apollo

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

ReferenceCitation: Merkel PA, Jayne DR, Wang C, Hillson J, Bekker P. Evaluation of the Safety and Efficacy of Avacopan, a C5a Receptor Inhibitor, in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis Treated Concomitantly With Rituximab or Cyclophosphamide/Azathioprine: Protocol for a Randomized, Double-Blind, Active-Controlled, Phase 3 Trial. JMIR Res Protoc. 2020 Apr 7;9(4):e16664. doi: 10.2196/16664.

publisher_dissemination: JMIR Publications

lead_sponsor: ChemoCentryx

location_country:
Germany
Ireland
New Zealand
Australia
Japan
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Spain
Sweden


title: A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

acronym: BEACON CRC

summary: This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

ReferenceCitation: Stintzing S, Seufferlein T, Rose C, Reichenbach F, Luftner D. Encorafenib in Combination With Cetuximab After Systemic Therapy in Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: German Health Technology Assessment-Driven Analyses From the BEACON CRC Study. Clin Colorectal Cancer. 2022 Sep;21(3):244-251. doi: 10.1016/j.clcc.2022.04.002. Epub 2022 May 5.

ReferenceCitation: Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. doi: 10.1016/j.esmoop.2022.100477. Epub 2022 May 30.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. doi: 10.1200/JCO.20.02088.

oa_colors: green hybrid

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories: University of Melbourne - Minerva Access

repositories_concat: LIRIAS (KU Leuven);PubMed Central;UCL Discovery;University of Melbourne - Minerva Access

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Melbourne - Minerva Access

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. doi: 10.1056/NEJMoa1908075. Epub 2019 Sep 30.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

ReferenceCitation: Van Cutsem E, Huijberts S, Grothey A, Yaeger R, Cuyle PJ, Elez E, Fakih M, Montagut C, Peeters M, Yoshino T, Wasan H, Desai J, Ciardiello F, Gollerkeri A, Christy-Bittel J, Maharry K, Sandor V, Schellens JHM, Kopetz S, Tabernero J. Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study. J Clin Oncol. 2019 Jun 10;37(17):1460-1469. doi: 10.1200/JCO.18.02459. Epub 2019 Mar 20.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repositories_concat: LIRIAS (KU Leuven);PubMed Central;University of Melbourne - Minerva Access;dnet;irua;repositori.upf.edu

repositories_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

repositories_institution: University of Antwerp - Institutional Repository University of Antwerp

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

sponsor_collaborators:
Pfizer
Merck KGaA, Darmstadt, Germany
Pierre Fabre Medicament
Ono Pharmaceutical Co. Ltd

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Hungary
Denmark
United States
Ukraine
Belgium
Italy
Norway
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Innere Medizin II

location_facility: Imaging Department of Meir Medical Center

location_facility: SC Farmacia Aziendale - ASST Cremona, Ospedale di Cremona

location_facility: The University of Kansas Cancer Center, Investigational Drug Services

location_facility: Hospital Evangelico de Cachoeiro de Itapemirim

location_facility: Centre Hospitalier de l'Ardenne - Site de Libramont

location_facility: Kyivska klinichna likarnia na zaliznychnomu transporti No3 filii Tsentr okhorony zdorov'ia PAT

location_facility: Servizio di Farmacia - IRCCS Ospedale San Raffaele

location_facility: U.O. di Oncologia ed Ematologia, Istituto Clinico HUMANITAS

location_facility: Mt. Scopus Department of Medical Imaging of Hadassah Medical Organization,

location_facility: Praxis fuer Augenheilkunde Dr. Edmund Meyer-Schwickerath

location_facility: CLINICA PERGAMINO S.A. (Centro de Investigacion Pergamino S.A.)

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Gemeinschaftspraxis fuer Radiologie und Nuklearmedizin, Standort Worms

location_facility: Institut f. Pathologie - Ruhr-Universitaet Bochum, Prof. Dr. med. Andrea Tannapfel

location_facility: Centro de Pesquisa Clínica de Oncologia e Hematologia - Hospital Mãe de Deus/AESC

location_facility: Radiologie im Israelitischen Krankenhaus

location_facility: Komumalnyi zaklad, Dnipropetrovska miska bahatoprofilna klinichna likarnia Nº4

location_facility: Radiologia AOU di Cagliari Presidio Duilio Casula Monserrato

location_facility: Farmacia Central da Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Tsentralna miska klinichna likarnia, Miskyi onkolohichnyi tsentr

location_facility: Dipartimento Neuromuscoloscheletrico e Organi di Senso, "Oncologia Oculare Unit"

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: Unita di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini

location_facility: Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser, viddilennia khimioterapii

location_facility: Chonnam National University Hwasun Hospital

location_facility: Mehmet F. Hepgur, MD - Broward Health Medical Center

location_facility: Centre Hospitalier National d'Opthalmologie des Quinze-Vingts (CHNO des XV-XX)

location_facility: ASST Bergamo Ovest, Ospedale Treviglio Caravaggio di Trevigl

location_facility: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers

location_facility: CHU Toulouse-Institut Inuversitaire du Cancer Toulouse

location_facility: DVNZ "Uzhhorodskyi natsionalnyi universytet"

location_facility: Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Augenheilkunde und Optometrie

location_facility: U.O. Oculistica, Istituto Clinico HUMANITAS

location_facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

location_facility: Oculistica AOU di Cagliari Presidio San Giovanni di Dio

location_facility: CENANTRON - Centro Avancado de Tratamento Oncologic

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

location_facility: IRCCS Ospedale San Raffaele - U.O. di Medicina Oncologica

location_facility: Sylvester Comprehensive Cancer Center/UMHC

location_facility: Washington University Infusion Center Pharmacy

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kliniken Maria Hilf GmbH - Franziskuskrankenhaus

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Nemocnicni lekarna - Usek klinickych studii

location_facility: Cleveland Clinic Taussig Cancer Institute

location_facility: Centre Ophtalmologique - Pole Vision - Clinique Val d'Ouest

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Ein-Karem Department of Medical Imaging of Hadassah Medical Organization, Hadassah Medical Center,

location_facility: AOU Universita degli Studi della Campania L. Vanvitelli - DAI di Medicina Interna e Specialistica

location_facility: Izmir Medical Park Hospital - Medical Oncology

location_facility: Oftalmologia Diagnostica de Sorocaba (ODS)

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Clinica Oculistica - Azienda Ospedaliera di Padova

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

location_facility: Osaka University Hospital Laboratory for Clinical Investigation

location_facility: SC di Radiologia, Dipartimento Interaziendale integrato Diagnostica per Immagini

location_facility: Superare Centro de Infusion S.A. de C.V.

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Sociedade Beneficencia e Cardade de Lajeado/Hospital Bruno Born

location_facility: Pharmacy of Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Oculistica - ASST Cremona, Ospedale di Cremona

location_facility: Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"

location_facility: Memorial Sloan Kettering: Rockefeller Outpatient Pavilion

location_facility: Centro de Pesquisas Clínicas em Oncologia

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna - Oncologia Medica

location_facility: The Christie NHS Foundation Trust - Christie Hospital

location_facility: Washington University School of Medicine

location_facility: AOU Universita degli Studi della Campania L. Vanvitelli

location_facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: SC Oncologia - ASST Cremona, Ospedale di Cremona

location_facility: Hospital Clinico Universitario de Valencia

location_facility: HKS Kardiologische Praxis am Israelitischen Krankenhaus

location_facility: SOD Radiodiagnostica 3 - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara

location_facility: State Budgetary Educational Institution of Higher Professional Education First Saint Petersburg

location_facility: Derzhavnyi zaklad, Dnipropetrovska medychna akademiia Ministerstva okhorony zdorovia Ukrainy

location_facility: Augenarzt-Gemeinschaftspraxis Dr.med.Andreas Kind & Dr.med. Ute Kariger-Schweigert

location_facility: UO Oncologia Medica 2 - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara

location_facility: Universitaetsklinikum Essen; Diagnostischeu. Interventionelle Radiologie u. Neuroradiologie

location_facility: Kliniken Maria Hilf GmbH; Klinik fuer Radiologie

location_facility: Divisione Anatomia Patologica Presidio San Giovanni di Dio

location_facility: Kliniken Essen Mitte / Knappschaftskrankenhaus

location_facility: Centre integre universitaire de sante et de services sociaux de l'Ouest-de-l'Ile-de-Montreal

location_facility: Consultorio Medico de Oftalmologia - Dr. Ricardo Tres

location_facility: Natsionalnyi medychnyi universytet imeni O.O Bohomltsia, kafedra onkolohii

location_facility: Cardiologia per i pazienti oncologici - Istituto Oncologico Veneto I.R.C.C.S

location_facility: University of Colorado Denver CTO (CTRC)

location_facility: Monash Health Translation Precinct - Monash Health

location_facility: The Barzilai Medical Center - Oncology Institute

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

location_facility: AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology

location_facility: Centro Oncologico Riojano Integral - CORI

location_facility: Federal State Budget Institution "N.N. Blokhin Russian Cancer Research Center" of the

location_facility: S.C. Radiologia diagnostica e interventistica - Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: UPCO - Unidade de Pesquisas Clinicas em Oncologia

location_facility: Giuliano Santos Borges - ME / Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai

location_facility: UO Oculistica - AOU Pisana, Stabilimento Ospedaliero di Cisanello

location_facility: Colosseum Øyelegesenter C/O LB Holdings AS

location_facility: Natsionalnyi medychnyi universytet imeni O.O Bohomltsia, kafedra oftalmolohii

location_facility: The University of Kansas Clinical Research Center

location_facility: Szpital Specjalistyczny im. L. Rydygiera w Krakowie Sp.z.o.o.

location_facility: Pharmacy of Rabin Medical Center, Beilinson Hospital

location_facility: U.O.S.D. Oncologia Medica, Dipartimento di Medicina - Fondazione PTV Policlinico Tor Vergata

location_facility: Zala Megyei Szent Rafael Korhaz - Onkologiai Osztaly

location_facility: Smilow Cancer Hospital at Yale - New Haven

location_facility: Central Adelaide Local Health Network Inc. operating as The Queen Elizabeth Hospital

location_facility: Klinikum Wels - Grieskirchen GmbH, Abteilung fuer Innere Medizin IV

location_facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

location_facility: Inonu Universitesi Turgut Ozal Medical Center

location_facility: Universitaetsklinikum Hamburg Eppendorf, Klinik fuer Augenheilkunde

location_facility: Smilow Cancer Hospital Care Center at North Haven

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: AOU Universita degli Studi della Campania L. Vanvitelli - U. Ma.Ca.

location_facility: U.O. Oncologia Medica 1 - Istituto Oncologico Veneto I.R.C.C.S

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: University of Wisconsin Clinical Science Center

location_facility: University Hospital Gasthuisberg (UZ Leuven)

location_facility: Augenarzt Praxis Dr. med. Petra Huelsmann

location_facility: Medeniyet University Goztepe Training and Research Hospital

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: SSM Health Saint Louis University Hospital

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

location_facility: Universitaetsklinikum Essen (AoeR), Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum

location_facility: SSD Day Hospital Oncologico - Dipartimento ad attivita integrata di Oncologia, Ematologia

location_facility: Centre Hospitalier Universitaire (CHU) de Liege

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Universitaetsklinikum Hamburg Eppendorf, Zentrum fuer Radiologie und Endoskopie

location_facility: CEPOS - Centro de Estudos e Pesquisas Oncologicas de Sorocaba

location_facility: Klinikum Wels-Grieskirchen GmbH, Institut fuer Radiologie I

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Oftalmolohycheskyi tsentr "Vzghliad" MTs

location_facility: SC oncologia Medica I - Azienda Ospedaliero Universitaria Careggi

location_facility: University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

location_facility: Dipartimento Interaziendale Farmaceutico - AOU Policlinico di Modena

location_facility: Central Adelaide Local Health Network Inc. operating as Royal Adelaide Hospital

location_facility: SC di Oftalmologia - AOU Policlinico di Modena

location_facility: University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital

location_facility: U.O.S.D. Patologie Retiniche - Fondazione PTV Policlinico Tor Vergata

location_facility: Eye Care Centre, Vancouver General Hospital

location_facility: CENOB - Centro de Oncologia da Bahia SS Ltda / Oncovida

location_facility: The University of Chicago Medicine Center for Advanced Care Orland Park

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: LMU Klinikum der Universitaet Muenchen, Campus Grosshadern

location_facility: CHU Toulouse - Purpan, hopital Pierre-Paul Riquet

location_facility: Inland Imaging, LLC Holy Family Hospital

location_facility: Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)

location_facility: University of Colorado Cancer Center - Anschutz Cancer Pavilion

location_facility: Centro Medico CAIPO (Centro para la Atención del paciente Oncológico)

location_facility: University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

location_facility: Keck Hospital of USC - Norris Healthcare Center (HC3)

location_facility: The Investigational Drug Pharmacy (IDS) in the Sidney Kimmel Cancer Center at Johns Hopkins

location_facility: University of Colorado Hospital Inpatient Pavillion'

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Oleksandrivska klinichna likarnia mista Kyieva

location_facility: Clinica di Oncologia Medica AOU di Cagliari Presidio Duilio Casula Monserrato

location_facility: Farmacia AOU di Cagliari Presidio Duilio Casula Monserrato

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: A. Tsyb Medical Radiological Research Center - branch of the

location_facility: UO Farmaceutica, Gestione del Farmaco - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara

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

location_facility: SC Oncologia Medica 1, SS Oncologia Medica Gastroenterologica

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital General Universitario de Valencia

location_facility: Imperial College Healthcare NHS Trust, Charing Cross Hospital

location_facility: Maastricht University Medical Center (MUMC)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Wojewodzki Szpital Zespolony, Oddzial Onkologiczny

location_facility: TOV "Zakarpatskyi Tsentr Mikrokhirurhii Oka"

location_facility: Evang. Krankenhaus Essen - Werden; Klinik fuer Augenheilkunde

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Hospitalier Regional (CHR) - Verviers

location_facility: FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC

location_facility: Fakultni nemocnice Olomouc, I. interni klinika - kardiologicka

location_facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust

location_facility: Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.

location_facility: CEMES Centro Medico Especializado em Oftalmologia

location_facility: Instituto de Ensino e Pesquisa São Lucas - Pharmacy

location_facility: Regional Budgetary Healthcare Institution Kursk Regional Clinical

location_facility: Centre hospitalier national d'ophtalmologie des Quinze-Vingts

location_facility: Medical Oncology Associates, PS DBA Summit Cancer Centers

location_facility: ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld

location_facility: Consulta Dr. Juan Carlos Castillo Dominguez

location_facility: Klinikum Wels-Grieskirchen GmbH, Institut fuer Nuklearmedizin

location_facility: Lukaskrankenhaus Neuss; Zentrale Apotheke


intervention_type: Biological

acronym: CASTING

lead_sponsor: Hoffmann-La Roche

summary: The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.

ReferenceCitation: Vermersch P, Oreja-Guevara C, Siva A, Van Wijmeersch B, Wiendl H, Wuerfel J, Buffels R, Kadner K, Kuenzel T, Comi G; CASTING Investigators. Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with suboptimal response to prior disease-modifying therapies: A primary analysis from the phase 3b CASTING single-arm, open-label trial. Eur J Neurol. 2022 Mar;29(3):790-801. doi: 10.1111/ene.15171. Epub 2021 Nov 25.

repository_institution: UHasselt - Document Server@UHasselt

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

location_facility: Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie

location_facility: Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt

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

location_facility: Cork University Hospital; Clinical Research Facility

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: Fakultni nemocnice Motol; Neurologicka klinika

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc

location_facility: PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge

location_facility: AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

location_facility: Fondazione Istituto S. Raffaele - Giglio; UO Neurologia

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: Odense Universitetshospital, Neurologisk Afdeling N

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz

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

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

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

location_facility: St. Josefs-Krankenhaus, Klinik für Neurologie

location_facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Sykehuset Buskerud HF; Nevrologisk avdeling

location_facility: Länssjukhuset Ryhov; Medicinkliniken / Neurologmottagningen

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

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

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

location_facility: Hospital General de Castellon; Servicio de Neurología

location_facility: Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla

location_facility: Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH

location_facility: Mersin University Medical Faculty; Neurology

location_facility: MultipEL Studies - Institut für klinische Studien

location_facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

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

location_facility: Universitätsklinikum Tübingen, Zentrum für Neurologie

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

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Hôpitaux Universitaires de strasbourg - hôpital civil

location_facility: Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico

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

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Hospital del Mar; Servicio de Neurologia

location_facility: Hacettepe University Medical Faculty; Neurology

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

location_facility: Fondation Rothschild; Service de Neurologie

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

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

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

location_facility: Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie

location_facility: AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla

location_facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

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

location_facility: Henriettenstiftung Hannover; Klinik fuer Neurologie und Klinische Neurophysiologie

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

location_facility: Hôpital Maison Blanche; Service de Neurologie

location_facility: East Tallinn Central Hospital; Neurology Department

location_facility: Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A

location_facility: Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

location_facility: Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie

location_facility: NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: Neurologische Klinik, Universitätsklinikum Heidelberg

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

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

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

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: Klinikum Grosshadern der LMU; Neuroimmunologie II

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

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

location_facility: AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

location_facility: Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito

location_facility: Hospital Universitario La Paz; Servicio de Neurologia

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

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla

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

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia

location_facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie

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

location_facility: Universitaetsklinikum Frankfurt; Klinik für Neurologie

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Hospital Universitario Central de Asturias; Servicio de Neurología

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia

title: An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment

location_country:
Finland
Germany
Ireland
Italy
Norway
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
Spain
Turkey
Czechia
Estonia
France


title: A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

acronym: CASCADE

summary: The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

lead_sponsor: Seagen Inc.

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Australia
Austria
Belgium
United States
Korea, Republic of
Spain
Luxembourg
Taiwan
Czechia
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza

location_facility: Florida Center for Cellular Therapy / Blood and Marrow Transplant Center

location_facility: Hopital Saint-Louis / Service d'Hematologie

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Florida Cancer Specialists - North Region

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie

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

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont

location_facility: Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

location_facility: Virginia Commonwealth University Medical Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: Ziekenhuis Netwerk Antwerpen Campus Stuivenberg

location_facility: Az Sint-Jane Brugge - Oostende Av - Campus Sint-Jan

location_facility: Soroka Medical Center, Dept. of Oncology

location_facility: Center Hospitalier Universitaire d' Angers

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: University of Arkansas for Medical Sciences

location_facility: Centre Hospitalier Victor Dupouy d'Argenteuil

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centre Hospitalier Universitaire Sart Tilman Liege

location_facility: Hopital d'Instruction des Armees - Percy

location_facility: University Hospitals of North Midlands NHS Trust

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Florida Cancer Specialists - South Region

location_facility: Cliniques Universitaires UCL de Mont-Goddine

location_facility: Centre Hospitalier Luxembourg - CHL Centre

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: Centre Hospitalier Universitaire Hopital Avicenne

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

location_facility: County Durham and Darlington NHS Foundation Trust

location_facility: James P. Wilmot Cancer Center / University of Rochester Medical Center

location_facility: Shands Cancer Center / University of Florida

location_facility: Università degli Studi di Roma "La Sapienza, Policlinico Umberto I

location_facility: Debreceni Egyetem Orvos Ã©s Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: LSU Health Sciences Center / Feist Weiller Cancer Center

location_facility: LKH Salzburg, Universitatsklinikum der PMU

location_facility: Azienda Ospedaliero-Univesitaria San Luigi Gonzaga

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Intermountain Blood and Marrow Transplant/Acute Leukemia Program

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: Centre Hospitalier Universitaire de Poitiers


title: A Phase 3, Long-term Active Treatment Extension Study of Mongersen (GED-0301) in Subjects With Crohn's Disease

summary:
The purpose of this study is to assess long-term safety data of GED-0301 for a period of up to 208 weeks in adult subjects (i.e., ≥ 18 years of age) who participated in the core Phase 3 GED-0301-CD-002 and GED-0301-CD-003 studies and adolescent subjects (i.e., 12 to 17 years of age) who participated in the core Phase 3 GED-0301-CD-003 study. Although all subjects will receive active treatment, this study is double-blinded for the entire 208 weeks for the purpose of preserving the blind of the subject's treatment allocation in the initial, core Phase 3 GED-0301 study.

The GED-0301-CD-003 trial was not initiated; see detailed description.

lead_sponsor: Celgene

location_country:
Germany
Poland
Australia
Turkey
Croatia
Czechia
Canada
Serbia
France
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
Bulgaria
Russian Federation
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Texas Digestive Disease Consultants - Southlake

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: Klinikum Mannheim GmbH Universitaetsklinikum

location_facility: Kocaeli Derince Training and Research Hospital

location_facility: McGill University Health Centre Glen Site Royal Victoria Hospital

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: KH der Barmherzigen Brüder St.Veit an der Glan

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Universitaetsklinikum Schleswig Holstein Campus Kiel

location_facility: RCI Chernivtsi Regional Clinical Hospital Dept of Surgery Bukovinian SMU

location_facility: Toronto Digestive Disease Associates Inc

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Centre de sante et de services sociaux Champlain Charles Le Moyne

location_facility: University of Washington School of Medicine

location_facility: SPZOZ Uniwersytecki Szpital Kliniczny im. Wojskowej Akademii Medycznej - Centralny Szpital Weteranow

location_facility: CI Zaporizhzhia Regional Clinical Hospital of ZRC

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Nottingham University Hospitals Queens Medical Centre

location_facility: Texas Digestive Disease Consultants - Dallas

location_facility: Ukrainian-German Antiulcer Gastroenterological Center BYK-Kyiv LLC

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

location_facility: Hospital da Senhora da Oliveira Guimaraes

location_facility: McMaster University Health Sciences Center

location_facility: Praxis fuer Gastroenterologie Dr Ehehal Dr Helmstaedter

location_facility: Medizinisches Zentrum Klinikum Lueneburg

location_facility: Yeditepe University Medical School Hospital

location_facility: Atlanta Gastroenterology Associates, LLC

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

location_facility: FSBI Scientific Research Institute of Physyology and Basic Medicine under the SB of RAMS

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta

location_facility: Groupe Hospitalier Sud Hopital Haut Leveque USN

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Azienda Ospedaliera Universitaria Policlinico G Martino

location_facility: Crohn-Colitis Zentrum Bern Gemeinschaftspraxis Balsiger Seibold und Partner

location_facility: SI Republican Clinical Hospital of the MOHU Dept of Gastroenterology O.O.Bogomolets NMU

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Seoul National University Bundang Hospital

location_facility: Ternopil City Communal Emergency Medical Care Hospital

location_facility: Haydarpasa Numune Training and Research Hospital

location_facility: Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil GmbH

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej POLIMEDICA

location_facility: SEIHPE Rostov State Medical University of MoH of RF

location_facility: Pauls Stradins Clinical University Hospital

location_facility: London Health Science Center U. Hospital

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Indywidualna Praktyka Lekarska Maciej Zymla

location_facility: SBHI of NN region RCH of NN n.a. N.A.Semashko

location_facility: Gastroenterology Associates of Western Michigan PLC

location_facility: Gastroeneterologicka ambulancia MUDr. Peter Hegyi s.r.o.

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Szent Pantaleon Korhaz Rendelointezet Dunaujvaros

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Treatment-Diagnostic Center of Private Enterprise of PMF Atsynus

location_facility: CHA Bundang Medical Center CHA University

location_facility: NonState Healthcare Institution Central Clinical Hospital, Samara station JSC Russian Railways

location_facility: University of Texas Health Science Center at Houston

location_facility: University General Hospital of Alexandroupolis

location_facility: Charite Universitaetsmedizin Berlin Campus Benjamin Franklin

location_facility: Staedtisches Klinikum Braunschweig gGmbH Standort Salzdahlumer

location_facility: SBEIHPE Novosibirsk State Medical University


summary: The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

ReferenceCitation: Foster GR, Thompson AJ, Ruane PJ, Borgia SM, Dore G, Workowski K, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks for Patients with Genotype 3 HCV Infection and Cirrhosis: The POLARIS-3 Study [Abstract 258]. J Hepatology 2016;63 (1S):135A

ReferenceCitation: Jacobson IM, Lawitz E, Gane EJ, Willems BE, Ruane PJ, Nahass RG, Borgia SM, Shafran SD, Workowski KA, Pearlman B, Hyland RH, Stamm LM, Svarovskaia E, Dvory-Sobol H, Zhu Y, Subramanian GM, Brainard DM, McHutchison JG, Brau N, Berg T, Agarwal K, Bhandari BR, Davis M, Feld JJ, Dore GJ, Stedman CAM, Thompson AJ, Asselah T, Roberts SK, Foster GR. Efficacy of 8 Weeks of Sofosbuvir, Velpatasvir, and Voxilaprevir in Patients With Chronic HCV Infection: 2 Phase 3 Randomized Trials. Gastroenterology. 2017 Jul;153(1):113-122. doi: 10.1053/j.gastro.2017.03.047. Epub 2017 Apr 5.

repository_institution: Queen Mary University of London - Queen Mary Research Online

title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis

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/about/ethics-and-code-of-conduct/policies.

location_country:
Germany
New Zealand
United Kingdom
Australia
United States
Canada
Puerto Rico
France


title: An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

acronym: CheckMate 227

summary: The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

ReferenceCitation: Reck M, Ciuleanu TE, Lee JS, Schenker M, Audigier-Valette C, Zurawski B, Linardou H, Otterson GA, Salman P, Nishio M, de la Mora Jimenez E, Lesniewski-Kmak K, Albert I, Ahmed S, Syrigos K, Penrod JR, Yuan Y, Blum SI, Nathan FE, Sun X, Moreno-Koehler A, Taylor F, O'Byrne KJ. First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1. J Thorac Oncol. 2021 Apr;16(4):665-676. doi: 10.1016/j.jtho.2020.12.019. Epub 2021 Jan 21.

repository_institution: Queensland University of Technology - QUT ePrints

ReferenceCitation: Hellmann MD, Paz-Ares L, Bernabe Caro R, Zurawski B, Kim SW, Carcereny Costa E, Park K, Alexandru A, Lupinacci L, de la Mora Jimenez E, Sakai H, Albert I, Vergnenegre A, Peters S, Syrigos K, Barlesi F, Reck M, Borghaei H, Brahmer JR, O'Byrne KJ, Geese WJ, Bhagavatheeswaran P, Rabindran SK, Kasinathan RS, Nathan FE, Ramalingam SS. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019 Nov 21;381(21):2020-2031. doi: 10.1056/NEJMoa1910231. Epub 2019 Sep 28.

ReferenceCitation: Reck M, Schenker M, Lee KH, Provencio M, Nishio M, Lesniewski-Kmak K, Sangha R, Ahmed S, Raimbourg J, Feeney K, Corre R, Franke FA, Richardet E, Penrod JR, Yuan Y, Nathan FE, Bhagavatheeswaran P, DeRosa M, Taylor F, Lawrance R, Brahmer J. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: patient-reported outcomes results from the randomised, open-label, phase III CheckMate 227 trial. Eur J Cancer. 2019 Jul;116:137-147. doi: 10.1016/j.ejca.2019.05.008. Epub 2019 Jun 11.

repository_institution: Edith Cowan University - Research Online

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

ReferenceCitation: Hellmann MD, Ciuleanu TE, Pluzanski A, Lee JS, Otterson GA, Audigier-Valette C, Minenza E, Linardou H, Burgers S, Salman P, Borghaei H, Ramalingam SS, Brahmer J, Reck M, O'Byrne KJ, Geese WJ, Green G, Chang H, Szustakowski J, Bhagavatheeswaran P, Healey D, Fu Y, Nathan F, Paz-Ares L. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018 May 31;378(22):2093-2104. doi: 10.1056/NEJMoa1801946. Epub 2018 Apr 16.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

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

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Washington University School Of Medicine

location_facility: S.C. Di Oncologia Medica Azienda Ospedaliera Di Perugia

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

location_facility: Istituto Nazionale Tumori Fondazione Pascale


title: A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

summary: The purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

ReferenceCitation: Jha MK, Williamson DJ, Magharehabed G, Turkoz I, Daly EJ, Trivedi MH. Intranasal esketamine effectively treats treatment-resistant depression in adults regardless of baseline irritability. J Affect Disord. 2023 Jan 15;321:153-160. doi: 10.1016/j.jad.2022.10.020. Epub 2022 Oct 20.

ReferenceCitation: Chen G, Chen L, Zhang Y, Li X, Lane R, Lim P, Daly EJ, Furey ML, Fedgchin M, Popova V, Singh JB, Drevets WC. Relationship Between Dissociation and Antidepressant Effects of Esketamine Nasal Spray in Patients With Treatment-Resistant Depression. Int J Neuropsychopharmacol. 2022 Apr 19;25(4):269-279. doi: 10.1093/ijnp/pyab084.

ReferenceCitation: Jones RR, Freeman MP, Kornstein SG, Cooper K, Daly EJ, Canuso CM, Nicholson S. Efficacy and safety of esketamine nasal spray by sex in patients with treatment-resistant depression: findings from short-term randomized, controlled trials. Arch Womens Ment Health. 2022 Apr;25(2):313-326. doi: 10.1007/s00737-021-01185-6. Epub 2022 Jan 1.

ReferenceCitation: Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.

ReferenceCitation: Turkoz I, Daly E, Singh J, Lin X, Tymofyeyev Y, Williamson D, Salvadore G, Nash AI, Macaluso M, Wilkinson ST, Nelson JC. Treatment Response With Esketamine Nasal Spray Plus an Oral Antidepressant in Patients With Treatment-Resistant Depression Without Evidence of Early Response: A Pooled Post Hoc Analysis of the TRANSFORM Studies. J Clin Psychiatry. 2021 Jul 20;82(4):20m13800. doi: 10.4088/JCP.20m13800.

publisher_dissemination: Physicians Postgraduate Press, Inc

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.

ReferenceCitation: Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.

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.

ReferenceCitation: Saad Z, Hibar D, Fedgchin M, Popova V, Furey ML, Singh JB, Kolb H, Drevets WC, Chen G. Effects of Mu-Opiate Receptor Gene Polymorphism rs1799971 (A118G) on the Antidepressant and Dissociation Responses in Esketamine Nasal Spray Clinical Trials. Int J Neuropsychopharmacol. 2020 Dec 3;23(9):549-558. doi: 10.1093/ijnp/pyaa030.

ReferenceCitation: Fedgchin M, Trivedi M, Daly EJ, Melkote R, Lane R, Lim P, Vitagliano D, Blier P, Fava M, Liebowitz M, Ravindran A, Gaillard R, Ameele HVD, Preskorn S, Manji H, Hough D, Drevets WC, Singh JB. Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1). Int J Neuropsychopharmacol. 2019 Oct 1;22(10):616-630. doi: 10.1093/ijnp/pyz039.

location_country:
Slovakia
Hungary
Brazil
Mexico
Belgium
United States
Canada
Estonia
France