title: A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

ReferenceCitation: de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAF(V600) wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.

location_country:
Poland
Brazil
Spain
Greece
Italy
Australia
Netherlands
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
Belgium
Germany

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

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

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Johannes Wesling Klinikum Minden; Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Copernicus Podmiot Medyczny Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria - Polo Oncologico

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie

location_facility: Hopital Charles Nicolle; Dermatologie Serv.

location_facility: M.D Anderson Cancer Center; Uni of Texas At Houston

location_facility: University of Michigan; Michigan Institute for Clinical and Health Research (MICHR)

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: Amphia Ziekenhuis, locatie Langendijk;Oncology

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Massachusetts General Hospital;Hematology/ Oncology

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: TriHealth Hatton Institute; Surgical Education

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: University of California at Irvine Medical Center; Department of Oncology

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

location_facility: Dartmouth-Hitchcock Medical Center; Hematology/Oncology

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology

location_facility: Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

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

location_facility: Pecsi Tudomanyegyetem AOK; Borgyogyaszati Klinika

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

location_facility: Western General Hospital; Edinburgh Cancer Center

location_facility: Hopital l Archet 2; Ginestriere, Service de; Dermatologie

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: A.O. Universitaria Policlinico Di Modena; Ematologia

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

location_facility: Thomas Jefferson University Hospital;Medical Oncology

location_facility: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen

location_facility: A.O.U. Cons. Policlinico Bari - Consorzlale Policlinico; Scienze Biomediche e Oncologia Umana

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Centre Hospitalier Le Mans; Dermatologie

location_facility: Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

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

location_facility: University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Universitatsklinikum Essen; Klinik für Dermatologie

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

summary: This is a Phase III, multicenter, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.


ipd_sharing: Yes

status: Active, not recruiting

primary_purpose: Treatment

intervention_type: Drug

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)

study_completion_date_type: Anticipated

lead_sponsor: Daiichi Sankyo, Inc.

type: EudraCT Number

type: Registry Identifier

type: Other Identifier

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

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. Review.

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.

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.

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.

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.

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/

enrollment_type: Actual

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

location_facility: The Regents of the University of California

location_facility: University of Louisville Research Foundation

location_facility: Washington University School of Medicine

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: The University of Texas Health Science Center at Tyler

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

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Nottingham University Hospitals City Campus

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Sylvester Comprehensive Cancer Center - Deerfield Beach

location_facility: Innovative Clinical Research Institute, LLC

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

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Seoul National University Bundang Hospital

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: The Methodist Hospital Research Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Providence Regional Medical Center - Everett

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.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)

summary: This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of 2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK) inhibitor.

design_allocation: Non-Randomized

ipd_sharing_description: Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.

lead_sponsor: Incyte Corporation

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
United States
France
Israel
Belgium
Germany
Czechia

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Chu de Clermont - Ferrand- Hospital Estaing

location_facility: Hospital General Universitari Vall D Hebron

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Yakima Valley Memorial Hospital/North Star

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie

location_facility: University College London Hospitals (Uclh)

location_facility: Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies

location_facility: Nu-Med Centrum Diagnostykii I Terapii Onkologicznej

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Beskidzkie Centrum Onkologii Im.Jana Pawla Ii

location_facility: University of Alabama At Birmingham Comprehensive Cancer Center

location_facility: Hospital Universitario Y Politecnic La Fe

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Chru Hopitaux de Tours, Hospital Bretonneau

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

location_facility: Odense Universitetshospital (Ouh) (Odense University Hospital)


status: Completed

acronym: SUSTAIN 10

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

study_completion_date_type: Actual

lead_sponsor: Novo Nordisk A/S

ReferenceType: result

ReferenceCitation: Capehorn MS, Catarig AM, Furberg JK, Janez A, Price HC, Tadayon S, Vergès 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.

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jódar E. Once-Weekly Semaglutide Reduces HbA(1c) 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.

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

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

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.

status_simplified: Completed


title: Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS): Prospective Observational Cohort of Patients With Moderate-to-severe SLE to Characterize Cross-sectional and Longitudinal Disease Activity, Treatment Patterns and Effectiveness, Outcomes and Comorbidities, Healthcare Resource Utilization, and the Impact of SLE on Quality of Life by Type I Interferon Expression

acronym: SPOCS

summary: SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient-journey regarding clinical features, disease progression and treatment patterns, SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU) in a general population of moderate-to-severe SLE patients.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Hammond ER, Tummala R, Berglind A, Syed F, Wang X, Desta B, Nab H. Study protocol for the international Systemic Lupus Erythematosus Prospective Observational Cohort Study (SPOCS): understanding lupus and the role of type I interferon gene signature. BMJ Open. 2020 Sep 1;10(9):e036563. doi: 10.1136/bmjopen-2019-036563.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Germany

intervention_type: Other


title: A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or 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:
Taiwan
Russian Federation
Hungary
Korea, Republic of
United States
Israel
France

location_facility: The Center for Cancer and Blood Disorders

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

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

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: John B. Amos Cancer Center / IACT Health

location_facility: Kursk State Clinical Oncology Dispensary

location_facility: Investigator Clinical Research Centers of Indiana

location_facility: Chonnam National University Hwasun Hospital

location_facility: Clinique Sainte Anne/Strasbourg Oncologie Leberale

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

location_facility: North Mississippi Hematology & Oncology Associates, Ltd.

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

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: Arkhangelsk Clinical Oncological Dispensary

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

location_facility: Pécsi Tudomány Egyetem Onkoterápiás Intézet

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

location_facility: Guthrie - Corning Hospital - Guthrie Cancer Center

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

location_facility: Chang Gung Medical Foundation - Kaohsiung Branch

location_facility: State Budgetary Healthcare Institution Leningrad Regional Oncology Center

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: Bács-Kiskun Megyei Kórház Onkoradiológiai Központ


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.

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

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

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito

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

location_facility: Azienda Ospedaliera Universitaria Federico II

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

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

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

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

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Azienda Ospedaliero Universitaria Careggi

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

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

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo

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

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing

location_facility: Centre Hospitalier Universitaire Dieu Angers

location_facility: Instituto Oncologico Della Svizzera Italiana

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

location_facility: Centro Hospitalar Universitario de Coimbra

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

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

location_facility: Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I

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

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Azienda Ospedaliero Universitaria di Modena

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


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

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

location_facility: Groupe Hospitalo Universitaire de Nimes - Hopital Caremeau

location_facility: Theagenion Cancer Hospital of Thessaloniki

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: Presidio Ospedaliero San Giuseppe Moscati

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

location_facility: Spitalul Judetean de Urgenta Dr Constantin Opris Baia Mare

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

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

location_facility: Universitaetsklinikum Allgemeines Krankenhaus Wien

location_facility: Centre Hospitalier Regional Universitaire de Limoges - Hopital Dupuytren

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Targu-Mures County Emergency Clinical Hospital

location_facility: Azienda Ospedaliero Universitaria Integrata di Udine

location_facility: General Hospital of Patras Agios Andreas

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: Spitalul Clinic Dr Gavril Curteanu Oradea

location_facility: General Hospital of Athens Georgios Gennimatas

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Azienda Ospedaliera di Alessandro Manzoni Lecco

location_facility: Centres Hospitaliers Jolimont - Hopital de Jolimont

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

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

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

location_facility: Profesor Dr Ion Chiricuta Institut of Oncology

location_facility: Centre Hospitalier Universitaire de Reims - Hopital Robert Debre

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

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

location_facility: General University Hospital of Patras Panagia i Voithia

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: University of Athens School of Medicine Alexandra Hospital

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

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: Special Anticancer Hospital of Piraeus Metaxa

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: University General Hospital of Evros-Alexandroupolis District

location_facility: Centre Hospitalier Wallonie Picarde - site imc

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello

location_facility: Azienda Unita Sanitaria Locale Toscana Centro

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: Algemeen Ziekenhuis Nikolaas Campus Sint-Niklaas


status: Terminated

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

lead_sponsor: Gilead Sciences

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.

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.

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

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

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

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: The University of Chicago Medical Center

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research

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

location_facility: Walter Reed National Military Medical Center

location_facility: University of California, Davis Medical Center

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

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

location_facility: University of California, San Francisco-Liver Clinic

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

location_facility: Centre Hospitalier Regional Universitaire- Hopital Claude Huriez

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

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

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

location_facility: Tokyo Womens Medical University Hospital

location_facility: American Research Corporation, The Texas Liver Institute

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Southern Therapy and Advanced Research LLC (STAR)

location_facility: Carolinas HealthCare System Center for Liver Disease

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: National Health Insurance Service- Ilsan Hospital

location_facility: University of Massachusetts Medical School

location_facility: Baylor College of Medicine - Advanced Liver Therapies

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

location_facility: University of Florida Hepatology Research at CTRB

location_facility: NorthShore University HealthSystem - Glenbrook ACC

location_facility: Universitatsklinikum Frankfurt der Goethe-Universitat

location_facility: South Florida Center of Gastroenterology, PA

location_facility: Medical University of South Carolina, University Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Institute of Post Graduate Medical Education and Research (IPGMER)

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

location_facility: William Osler Health System-Brampton Civic Hospital

location_facility: Greenville Health System Gastroenterology and Liver Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology

location_facility: Groupe Hospitalier Universitaire La Pitie Salpetriere

location_facility: Southern District Health Board - Dunedin Hospital

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Abertawe Bro Morgannwg University Health Board

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

location_facility: Duke University Medical Center - Duke South Clinics

location_facility: Hospital Universitario Puerto de Hierro Majadahonda

location_facility: Indianapolis Gastroenterology Research Foundation

location_facility: Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center

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

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: University of Buffalo, Clinical and Translational Research Center

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

location_facility: University Hospitals Cleveland Medical Center

location_facility: Rutgers New Jersey Medical School- Doctors Office Center

location_facility: Island View Gastroenterology Associates- Ventura

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: University of Colorado Denver and Hospital

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: The University of Vermont Medical Center

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: Indiana University Health - University Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Tulane University Health Sciences Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik III

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

location_facility: Penn State University, The Milton S. Hershey Medical Center

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Louisville Clinical Trials Unit

location_facility: Global Clinical Reseaech Services PVT LTD

location_facility: University of Manitoba, Health Sciences Centre, John Buhler Research Centre

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

location_facility: Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil

location_facility: University of California, San Diego (Altman Clinical and Translational Research Center)

location_facility: King's College Hospital NHS Foundation Trust

location_facility: CHOP_Complejo Hospitalario Universitario de Pntevedra

location_facility: CHU de Limoges- Hopital Dupuytren- Federation Hepatologie

location_facility: Department of Hepatology PGIMER Chandigarh

location_facility: Gastrointestinal Specialists of Georgia, PC

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

location_facility: Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals

location_facility: St. Joseph's Hospital and Medical Center

location_facility: London Health Sciences Centre - University Hospital

location_facility: NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill

location_facility: Kawasaki Medical School General Medical Center

location_facility: Huntington Medical Research Institutes (HMRI) Liver Center

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

location_facility: Intermountain Liver Disease and Transplant Clinic

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

status_simplified: Unknown


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.

ipd_sharing: No

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

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

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

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

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: The University of Chicago Medical Center

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

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

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

location_facility: Walter Reed National Military Medical Center

location_facility: University of California, Davis Medical Center

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

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

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

location_facility: Vanderbilt University Medical Center - Digestive Disease Center

location_facility: Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin

location_facility: Banner University Medical Center-Phoenix

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

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

location_facility: Centre Hospitalier Regional Universitaire- Hopital Claude Huriez

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

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

location_facility: Centre Hospitalier Universitaire de Toulouse- Hopital Purpan

location_facility: American Research Corporation, The Texas Liver Institute

location_facility: Southern Therapy and Advanced Research LLC (STAR)

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Baylor Scott & White All Saints Medical Center

location_facility: National Health Insurance Service- Ilsan Hospital

location_facility: Baylor College of Medicine - Advanced Liver Therapies

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

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Universitatsklinikum Frankfurt der Goethe-Universitat

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Kagoshima University Medical And Dental Hospital

location_facility: IRCCS Ospedale Casa Sollievo Della Soferrenza

location_facility: South Florida Center of Gastroenterology, PA

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

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

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

location_facility: William Osler Health System-Brampton Civic Hospital

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: CHOP_Complejo Hospitalrio Universitario de Pontevedra

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Kansas City Gastroenterology and Hepatology

location_facility: Greenville Health System - Gastroenterology and Liver Center

location_facility: Swedish Organ Transplant and Liver Center

location_facility: Duke University Medical Center - Duke South Clinics

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

location_facility: Abertawe Bro Morgannwg University Health Board

location_facility: National Cheng Kung University Hospitalv

location_facility: Indianapolis Gastroenterology Research Foundation

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

location_facility: University of California San Francisco (UCSF)

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: University of Minnesota Medical Center - Fairview

location_facility: University of Buffalo, Clinical and Translational Research Center

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

location_facility: Rutgers New Jersey Medical School- Doctors Office Center

location_facility: Gastroenterologisch- Hepatologisches Zentrum Kiel

location_facility: Northwestern Memorial Hospital; Clinical Research Unit

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Centre Hospitalier Universitaire Estaing

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: The University of Vermont Medical Center

location_facility: Icahn School of Medicine at Mount Sinai Beth Israel

location_facility: Indiana University Health - University Hospital

location_facility: University of California San Diego (UCSD)

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Intermountain Liver Disease and Transplant Center

location_facility: Schiff Center for Liver Diseases/University of Miami

location_facility: Tulane University Health Sciences Center

location_facility: Keimyung University Dongsan Medical Center

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

location_facility: University of Iowa Hospitals and Clinics

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

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

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Uniklinik RWTH Aachen, Medizinische Klinik III

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

location_facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Huron Gastroenterology Associates/Center for Digestive Care

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: Uniklinikum des Saarlandes- Klinik fur Innere Medizin II

location_facility: Ditmanson Medical Foundation Chia-Yi Christian Hospital

location_facility: UF Health Jacksonville-Gastroenterology Emerson

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

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

location_facility: National Hospital Organization Osaka National Hospital

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

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: National Center for Global Health and Medicine Hospital

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


title: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF LORLATINIB (PF-06463922) MONOTHERAPY VERSUS CRIZOTINIB MONOTHERAPY IN THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED ALK-POSITIVE NON-SMALL CELL LUNG CANCER

summary: A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population

ReferenceCitation: Solomon BJ, Bauer TM, Ignatius Ou SH, Liu G, Hayashi H, Bearz A, Penkov K, Wu YL, Arrieta O, Jassem J, Calella AM, Peltz G, Polli A, Thurm H, Mok T. Post Hoc Analysis of Lorlatinib Intracranial Efficacy and Safety in Patients With ALK-Positive Advanced Non-Small-Cell Lung Cancer From the Phase III CROWN Study. J Clin Oncol. 2022 Nov 1;40(31):3593-3602. doi: 10.1200/JCO.21.02278. Epub 2022 May 23.

ReferenceCitation: Solomon BJ, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Shaw AT. Plain language summary of the CROWN study comparing lorlatinib with crizotinib for people with untreated non-small cell lung cancer. Future Oncol. 2021 Dec 1;17(34):4649-4656. doi: 10.2217/fon-2021-0904. Epub 2021 Sep 29.

ReferenceCitation: Shaw AT, Bauer TM, de Marinis F, Felip E, Goto Y, Liu G, Mazieres J, Kim DW, Mok T, Polli A, Thurm H, Calella AM, Peltz G, Solomon BJ; CROWN Trial Investigators. First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med. 2020 Nov 19;383(21):2018-2029. doi: 10.1056/NEJMoa2027187.

ReferenceCitation: Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, Dietrich J, James LP, Clancy JS, Chen J, Martini JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 rearrangement: an international, multicentre, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. doi: 10.1016/S1470-2045(17)30680-0. Epub 2017 Oct 23.

ReferenceCitation: Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10.

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

lead_sponsor: Pfizer

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Turkey
Mexico
Singapore
Canada
China
Germany
Taiwan
Korea, Republic of
France
Netherlands

location_facility: Sahyadri Clinical Research and Development Centre

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: National Hospital Organization, Yamaguchi-Ube Medical Center

location_facility: The University of Hong Kong, Department of Medicine

location_facility: RBHI Kursk Regional Clinical Oncology Dispensary

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Private Medical Institution "Euromedservice"

location_facility: Division of Medical Oncology, Severance Hospital, Yonsei University Health System

location_facility: Groupe Hospitalier Bichat Claude Bernard, AP-HP

location_facility: Universitatsklinikum Regensburg, Institut fur Rontgendiagnostik

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas

location_facility: The University of Hong Kong, Department of Clinical Oncology

location_facility: The Affiliated Hospital of Military Medical Sciences

location_facility: Wakayama Medical University Department of Pulmonary Medicine and Oncology

location_facility: Srinivasam Cancer Care Multispeciality Hospitals India Pvt Ltd

location_facility: Uberortliche Radiologische Gemeinschaftspraxis Dr. med. Marc Amler

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Hopital Haut-Léveque-Centre François Magendie

location_facility: University of Rochester Cancer Center Pharmacy

location_facility: AOU Policlinico Vittorio Emanuele-P.O.G. Rodolico

location_facility: Médicos Especialistas en Cancer S.C. / San Peregrino.

location_facility: Technische Universitat Dresden , Medizinische Fakultat Carl Gustav Carus

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: FSBI "N.N.Blokhin Medical Research Center of Oncology"

location_facility: Azienda Ospedaliero-Universitaria di Parma

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

location_facility: Bendigo Day Surgery Collection Centre and Laboratory

location_facility: LEC at SBIH "Saint-Petersburg Clinical Research Practical Center of specialized types of

location_facility: The William P. Beetham Eye Institute, Joslin Diabetes Center

location_facility: Universitatsklinikum Regensburg, Klinik und Poliklinik fur Innere Medizin II

location_facility: Fakultni nemocnice Olomouc, Klinika plicnich nemoci a tuberkulozy

location_facility: Universitätsklinikum des Saarlandes, Innere Medizin V

location_facility: Bendigo Medical Imaging, Bendigo Hospital

location_facility: Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne

location_facility: Department of Respiratory,the First Affiliated Hospital of College of Medicine, Zhejiang University

location_facility: The Catholic University of Korea, St. Vincents Hospital

location_facility: Heart of England NHS Foundation Trust, Birmingham Heartlands Hospital

location_facility: Azienda Ospedaliera Dei Colli Ospedale Monaldi

location_facility: Marmara Univ Pendik Training and Research Hospital

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Grand Hopital de Charleroi - Site Notre Dame

location_facility: Budgetary Healthcare Institution Omsk Region "Clinical Oncological Dispensary"

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Azienda Ospedaliera di Perugia - Ospedale S. M. Misericordia

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Institut Catala d'Oncologia L'Hospitalet


title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study

acronym: CARAVAGGIO

summary: Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study

status: Unknown status

ReferenceCitation: Becattini C, Bauersachs R, Maraziti G, Bertoletti L, Cohen A, Connors JM, Manfellotto D, Sanchez A, Brenner B, Agnelli G. Renal function and clinical outcome of patients with cancer-associated venous thromboembolism randomized to receive apixaban or dalteparin. Results from the Caravaggio trial. Haematologica. 2022 Jul 1;107(7):1567-1576. doi: 10.3324/haematol.2021.279072.

ReferenceCitation: Giustozzi M, Connors JM, Ruperez Blanco AB, Szmit S, Falvo N, Cohen AT, Huisman M, Bauersachs R, Dentali F, Becattini C, Agnelli G. Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study. J Thromb Haemost. 2021 Nov;19(11):2751-2759. doi: 10.1111/jth.15461. Epub 2021 Jul 29.

ReferenceCitation: Agnelli G, Becattini C, Meyer G, Muñoz A, Huisman MV, Connors JM, Cohen A, Bauersachs R, Brenner B, Torbicki A, Sueiro MR, Lambert C, Gussoni G, Campanini M, Fontanella A, Vescovo G, Verso M; Caravaggio Investigators. Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. N Engl J Med. 2020 Apr 23;382(17):1599-1607. doi: 10.1056/NEJMoa1915103. Epub 2020 Mar 29.

lead_sponsor: Fadoi Foundation, Italy

location_country:
Poland
Portugal
Spain
Italy
United Kingdom
Netherlands
United States
France
Israel
Belgium
Germany

location_facility: University of North Carolina at Chapel Hill

location_facility: AO Ospedale di Circolo e Fondazione Macchi

location_facility: Department of Internal Medicine - University of Perugia

location_facility: CH de Vendée Centre Hospitalier Départemental

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Staten Island University Hospital/Northwell Health

location_facility: Ospedale Buon Consiglio Fatebenefratelli

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: Ospedale Sacro Cuore-Don Calabria di Negrar-Verona.

location_facility: Medical Centre for Postgraduate Education - ECZ-Otwock

location_facility: Ospedale Sacro Cuore di Gesù Fatebenefratelli

location_facility: Centre Hospitalier Universitaire Lyon-Sud

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand

location_facility: Jacksonville Center for Clinical Research

location_facility: AO di Rilievo Nazione Antonio Cardarelli

location_facility: Centre Hospitalier Emile Roux Le Puy-en-Velay

location_facility: Centre Hospitalier Universitaire Dijon Bourgogne

location_facility: Istituto Nazionale Tumori - IRCCS Fondazione Pascale

location_facility: Hôpital des armées HIA Clermont Tonnerre

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Centre Hospitalier Universitaire Grenoble Alpes


title: Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen

acronym: MASTER DAPT

summary:
The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube).

This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.

ReferenceType: background

ReferenceCitation: Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29.

ReferenceCitation: Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group . 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29.

ReferenceCitation: Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016

ReferenceCitation: Smits PC, Frigoli E, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iñiguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Paradies V, Kala P, Kedev S, Al Mafragi A, Dewilde W, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk. J Am Coll Cardiol. 2022 Sep 27;80(13):1220-1237. doi: 10.1016/j.jacc.2022.07.016.

ReferenceCitation: Valgimigli M, Frigoli E, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Delorme L, Kala P, Kedev S, Abhaichand RK, Velchev V, Dewilde W, Podolec J, Leibundgut G, Topic D, Schultz C, Stankovic G, Lee A, Johnson T, Tonino PAL, Klotzka A, Lesiak M, Lopes RD, Smits PC, Heg D; MASTER DAPT Investigators. Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. J Am Coll Cardiol. 2022 Aug 23;80(8):766-778. doi: 10.1016/j.jacc.2022.04.065.

ReferenceCitation: Valgimigli M, Smits PC, Frigoli E, Bongiovanni D, Tijssen J, Hovasse T, Mafragi A, Ruifrok WT, Karageorgiev D, Aminian A, Garducci S, Merkely B, Routledge H, Ando K, Diaz Fernandez JF, Cuisset T, Nesa Malik FT, Halabi M, Belle L, Din J, Beygui F, Abhyankar A, Reczuch K, Pedrazzini G, Heg D, Vranckx P; MASTER DAPT Investigators. Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis. Eur Heart J. 2022 Sep 1;43(33):3100-3114. doi: 10.1093/eurheartj/ehac284.

ReferenceCitation: Smits PC, Frigoli E, Tijssen J, Jüni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iñiguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial. Circulation. 2021 Oct 12;144(15):1196-1211. doi: 10.1161/CIRCULATIONAHA.121.056680. Epub 2021 Aug 29.

ReferenceCitation: Valgimigli M, Frigoli E, Heg D, Tijssen J, Jüni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stanković G, Iñiguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.

ReferenceCitation: Vlieger S, Danzi GB, Kauer F, Oemrawsingh RM, Stojkovic S, IJsselmuiden AJJ, Routledge H, Laanmets P, Roffi M, Fröbert O, Baello P, Wlodarczak A, Puentes A, Polad J, Hildick-Smith D. One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: a propensity-matched analysis of two international all-comers registries. Coron Artery Dis. 2021 Aug 1;32(5):391-396. doi: 10.1097/MCA.0000000000000958.

ReferenceCitation: Frigoli E, Smits P, Vranckx P, Ozaki Y, Tijssen J, Jüni P, Morice MC, Onuma Y, Windecker S, Frenk A, Spaulding C, Chevalier B, Barbato E, Tonino P, Hildick-Smith D, Roffi M, Kornowski R, Schultz C, Lesiak M, Iñiguez A, Colombo A, Alasnag M, Mullasari A, James S, Stankovic G, Ong PJL, Rodriguez AE, Mahfoud F, Bartunek J, Moschovitis A, Laanmets P, Leonardi S, Heg D, Sunnåker M, Valgimigli M. Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. Am Heart J. 2019 Mar;209:97-105. doi: 10.1016/j.ahj.2018.10.009. Epub 2018 Nov 22.

ipd_sharing: Undecided

lead_sponsor: ECRI bv

location_country:
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Belgium
Japan
Czechia
Poland
Slovenia
Austria
Australia
Argentina
India
Israel
Singapore
Sweden
Bahrain
Bangladesh
Switzerland
Hungary
North Macedonia
Germany
Bulgaria
Denmark
Estonia
Vietnam
Korea, Republic of
France
Netherlands

location_facility: St.Marianna University School of Medicine

location_facility: Japan Red Cross Nagoya Daini Hospital (2nd)

location_facility: Japan Red Cross Nagoya Daiichi Hospital (1st)

location_facility: Second university of Naples Monaldi Hospital


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. 2022 Apr 28. pii: roac037. doi: 10.1093/mr/roac037. [Epub ahead of print]

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.

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.

lead_sponsor: ChemoCentryx

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

intervention_type: Biological


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.

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.

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.

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.

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

location_facility: Washington University School of Medicine

location_facility: Inonu Universitesi Turgut Ozal Medical Center

location_facility: Centre Hospitalier Regional (CHR) - Verviers

location_facility: LMU Klinikum der Universitaet Muenchen, Campus Grosshadern

location_facility: HKS Kardiologische Praxis am Israelitischen Krankenhaus

location_facility: Smilow Cancer Hospital Care Center at North Haven

location_facility: Smilow Cancer Hospital at Yale - New Haven

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

location_facility: SC Farmacia - Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Hospital Clinico Universitario de Valencia

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

location_facility: Colosseum Øyelegesenter C/O LB Holdings AS

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

location_facility: Osaka University Hospital Laboratory for Clinical Investigation

location_facility: Praxis fuer Augenheilkunde Dr. Edmund Meyer-Schwickerath

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

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

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

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

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

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Inland Imaging, LLC Holy Family Hospital

location_facility: Oculistica - ASST Cremona, Ospedale di Cremona

location_facility: The Christie NHS Foundation Trust - Christie Hospital

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

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

location_facility: SC Oncologia Medica 1, SS Oncologia Medica Gastroenterologica

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

location_facility: University of Wisconsin Clinical Science Center

location_facility: Universitaetsklinikum Hamburg Eppendorf, Klinik fuer Augenheilkunde

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC

location_facility: Imperial College Healthcare NHS Trust, Charing Cross Hospital

location_facility: University of Colorado Hospital Inpatient Pavillion'

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

location_facility: Wojewodzki Szpital Zespolony, Oddzial Onkologiczny

location_facility: Seoul National University Bundang Hospital

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

location_facility: ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld

location_facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Instituto de Ensino e Pesquisa São Lucas - Pharmacy

location_facility: Hospital Evangelico de Cachoeiro de Itapemirim

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

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

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

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

location_facility: Dipartimento Interaziendale Farmaceutico - AOU Policlinico di Modena

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

location_facility: The University of Texas MD Anderson Cancer Center

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

location_facility: SC oncologia Medica I - Azienda Ospedaliero Universitaria Careggi

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

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: Universitaetsklinikum Hamburg Eppendorf, Zentrum fuer Radiologie und Endoskopie

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

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

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

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

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

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

location_facility: Kliniken Maria Hilf GmbH; Klinik fuer Radiologie

location_facility: Lukaskrankenhaus Neuss; Zentrale Apotheke

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Medeniyet University Goztepe Training and Research Hospital

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

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

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

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

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

location_facility: Radiologia AOU di Cagliari Presidio Duilio Casula Monserrato

location_facility: UPCO - Unidade de Pesquisas Clinicas em Oncologia

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

location_facility: Klinikum Wels-Grieskirchen GmbH, Institut fuer Nuklearmedizin

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

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

location_facility: Medical Oncology Associates, PS DBA Summit Cancer Centers

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: SC Oncologia - ASST Cremona, Ospedale di Cremona

location_facility: Izmir Medical Park Hospital - Medical Oncology

location_facility: Centro de Pesquisas Clínicas em Oncologia

location_facility: SSM Health Saint Louis University Hospital

location_facility: Consultorio Medico de Oftalmologia - Dr. Ricardo Tres

location_facility: The University of Kansas Clinical Research Center

location_facility: Zala Megyei Szent Rafael Korhaz - Onkologiai Osztaly

location_facility: Rabin Medical Center, Beilinson Hospital

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

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

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

location_facility: Radiologie im Israelitischen Krankenhaus

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

location_facility: Oftalmolohycheskyi tsentr "Vzghliad" MTs

location_facility: Maastricht University Medical Center (MUMC)

location_facility: Unita di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini

location_facility: Gemeinschaftspraxis fuer Radiologie und Nuklearmedizin, Standort Worms

location_facility: Consulta Dr. Juan Carlos Castillo Dominguez

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

location_facility: Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser, viddilennia khimioterapii

location_facility: U.O.C. Farmacia Clinica - Fondazione PTV Policlinico Tor Vergata

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

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

location_facility: Imaging Department of Meir Medical Center

location_facility: Divisione Anatomia Patologica Presidio San Giovanni di Dio

location_facility: Oftalmologia Diagnostica de Sorocaba (ODS)

location_facility: Clinica Oculistica - Azienda Ospedaliera di Padova

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

location_facility: U.O. Oculistica, Istituto Clinico HUMANITAS

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

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

location_facility: Nemocnicni lekarna - Usek klinickych studii

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: St. Marianna University School of Medicine Hospital

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

location_facility: Sylvester Comprehensive Cancer Center/UMHC

location_facility: Pharmacy of Rabin Medical Center, Beilinson Hospital

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

location_facility: CEMES Centro Medico Especializado em Oftalmologia

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

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

location_facility: AOU Universita degli Studi della Campania L. Vanvitelli

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

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

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: Tsentralna miska klinichna likarnia, Miskyi onkolohichnyi tsentr

location_facility: University of Iowa Hospitals and Clinics

location_facility: Tel Aviv Sourasky Medical Center - Oncology

location_facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

location_facility: Memorial Sloan Kettering: Rockefeller Outpatient Pavilion

location_facility: Regional Budgetary Healthcare Institution Kursk Regional Clinical

location_facility: National Hospital Organization Osaka National Hospital

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

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

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

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

location_facility: University of Colorado Cancer Center - Anschutz Cancer Pavilion

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

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

location_facility: University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital

location_facility: CENANTRON - Centro Avancado de Tratamento Oncologic

location_facility: Monash Health Translation Precinct - Monash Health

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

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

location_facility: University of Colorado Denver CTO (CTRC)

location_facility: Komumalnyi zaklad, Dnipropetrovska miska bahatoprofilna klinichna likarnia Nº4

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: DVNZ "Uzhhorodskyi natsionalnyi universytet"

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

location_facility: Centre Hospitalier Universitaire (CHU) de Liege

location_facility: University Hospital Gasthuisberg (UZ Leuven)

location_facility: The Barzilai Medical Center - Oncology Institute

location_facility: Hospital General Universitario de Valencia

location_facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust

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

location_facility: Augenarzt Praxis Dr. med. Petra Huelsmann

location_facility: Servizio di Farmacia - IRCCS Ospedale San Raffaele

location_facility: Oleksandrivska klinichna likarnia mista Kyieva

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

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

location_facility: Kliniken Essen Mitte / Knappschaftskrankenhaus

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

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Oculistica AOU di Cagliari Presidio San Giovanni di Dio

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

location_facility: CHU Toulouse-Institut Inuversitaire du Cancer Toulouse

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Cleveland Clinic Taussig Cancer Institute

location_facility: Farmacia AOU di Cagliari Presidio Duilio Casula Monserrato

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

location_facility: Washington University Infusion Center Pharmacy

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

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

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

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Centro Oncologico Riojano Integral - CORI

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

location_facility: Klinikum Wels-Grieskirchen GmbH, Apotheke

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

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

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

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

location_facility: Servizio Farmacia - Istituto Oncologico Veneto I.R.C.C.S

location_facility: TOV "Zakarpatskyi Tsentr Mikrokhirurhii Oka"

location_facility: SC di Oftalmologia - AOU Policlinico di Modena

location_facility: Eye Care Centre, Vancouver General Hospital

location_facility: Kliniken Maria Hilf GmbH - Franziskuskrankenhaus

location_facility: ASST Bergamo Ovest, Ospedale Treviglio Caravaggio di Trevigl


title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib Versus Best Available Therapy in Patients With Corticosteroid-refractory Acute Graft vs. Host Disease After Allogeneic Stem Cell Transplantation

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Zeiser R, von Bubnoff N, Butler J, Mohty M, Niederwieser D, Or R, Szer J, Wagner EM, Zuckerman T, Mahuzier B, Xu J, Wilke C, Gandhi KK, Socié G; REACH2 Trial Group. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. N Engl J Med. 2020 May 7;382(19):1800-1810. doi: 10.1056/NEJMoa1917635. Epub 2020 Apr 22.

ReferenceCitation: Jagasia M, Zeiser R, Arbushites M, Delaite P, Gadbaw B, Bubnoff NV. Ruxolitinib for the treatment of patients with steroid-refractory GVHD: an introduction to the REACH trials. Immunotherapy. 2018 Apr;10(5):391-402. doi: 10.2217/imt-2017-0156. Epub 2018 Jan 10.

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

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

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Japan
Czechia
Hong Kong
Austria
Australia
Russian Federation
Israel
Turkey
Norway
Canada
Germany
Bulgaria
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

summary: To evaluate the safety and efficacy of ruxolitinib compared to Best Available Therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation