title: Dose Optimization Study of Idelalisib in Follicular Lymphoma

summary: The primary objective of this study is to establish a safe and effective dosing regimen of idelalisib in participants with relapsed or refractory follicular lymphoma (FL) who have no other therapeutic options.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Gilead Sciences

location_country:
Italy
United States
France
Czechia
Poland
Israel
Romania
Australia
Spain
Canada
United Kingdom

location_facility: Centre Hospitalier Lyon Sud-Pavillon Marcel Berard

location_facility: Samodzielny Publizny Szpital Kliniczny nr 1 w Lubllinie

location_facility: Fakulni newmcince v Motole, Onkologicka klinika 2. LF UK a FN Motol

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Dipartimento di Ematologia ed Oncoematolgia - S.C Ematolgia

location_facility: Centrum Onkologii Instytut im.Marii Sklodowskiej Curie

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

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Klinika Hematologii Nowotworow Kriwi i Transplantacji Szpiku

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Hospital General Universiario Gregorio Maranon

location_facility: St. Luke's Mountain States Tumor Institute-Boise

location_facility: Institutul Oncologic, Prof.Dr. Ion Chiricuta-Cluj-Napoca

location_facility: Northeren NSW Local Health District, The Tweed Hospital

location_facility: Fondazione Policlinico Tor Vergata-UOC Patologie Linfoproliferative

location_facility: University Hospitals Birmhingam NHS Foundation Trust

location_facility: A.S.U. Integrata Santa Maria della Misericordia

location_facility: East Kent Hospitals University NHS Foundation Trust

location_facility: Instituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Dipartimento di Oncologia Medica

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Wojewodzki Szpital Specjalistyczny w Legniicy

location_facility: Azienda Ospedaliera Vito Fazzi Unita Operativa di Ematologia

location_facility: Azienda Ospedaliera Cardinale G Panico di Tricase-Unita Operativa Complessa di Ematologia e TMO

location_facility: Centre Hospitalier Universaitaire de Poit iers-Pole Regional de Cancerlogie

location_facility: Azienda Unita Sanitaria Locale di Ravenna, U.O di Ematologia

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitire (CHU) de Dijon

location_facility: Centre de recherche du CHU de Quebec Hopital Enfant-Jesus

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: The Hillingdon Hospitals NHS Foundation Trust

location_facility: SCDU Ematologia e Terapie Cellulari Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris" Baia Mare

location_facility: London North West University Healthcare NHS Trust

location_facility: Ospedale Policlinico San Martino IRCCS-Clinica Ematologica

location_facility: Torbay and South Devon NHS Foundation Trust

location_facility: Centre Hospitalier de Tours-Hopital Bretoneau Centre Regional de Cancerologie Henry Kaplan

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: Institut Catala d'Oncologia Hospital Universitari de Bellvitge

location_facility: Centro Integral Oncologico Clara Campal (CIOCC)

location_facility: Hospital Genereal Universitario Morales Meseguer

location_facility: Centre Hospitalier d'Avignon-Hopital Henri Duffaut

location_facility: Hospital Clinico Universitario Lozano Blesa


design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

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

lead_sponsor: Novo Nordisk A/S

enrollment_type: Actual

primary_purpose: Treatment

location_country:
Italy
United States
Netherlands
France
Australia
New Zealand
Turkey
Canada

ipd_sharing: Yes

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome.

summary: This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.

lead_sponsor_type: industriel

status_simplified: Completed


title: ARMOR3-SV: A Phase 3, Randomized, Open Label, Multi-Center, Controlled Study of Galeterone Compared to Enzalutamide in Men Expressing Androgen Receptor Splice Variant-7 mRNA (AR-V7) Metastatic (M1) Castrate Resistant Prostate Cancer (CRPC)

summary: The purpose of this study is to compare galeterone to enzalutamide in men expressing androgen receptor spice variant-7 mRNA (AR-V7) in metastatic (M1) castrate resistant prostate cancer (CRPC).

status: Terminated

ReferenceType: derived

ReferenceCitation: Aragon-Ching JB. The promising role of poly(ADP-ribose) polymerase inhibitors in prostate cancer. Asian J Androl. 2016 Jul-Aug;18(4):592-3. doi: 10.4103/1008-682X.172821.

apc_source: doaj

family: Aragon-Ching

full_name: JeannyB Aragon-Ching

given: JeannyB

sequence: first

bso_classification: Medical research

currency_apc_doaj: CNY

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Asian Journal of Andrology

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Medknow

publisher_dissemination: Medknow

publisher_group: Medknow

publisher_normalized: Medknow

lead_sponsor: Novus Therapeutics, Inc

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

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Jules Bordet Institute Clinique d'Oncologie Medicale

location_facility: Instituto Catalan de Oncologia (Hospital Durans i Reynals)

location_facility: Hospital Clínic i Provincial de Barcelona-Oncology

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Walter Reed National Military Medical Center

location_facility: University of Colorado Cancer Center Anschultz Cancer Pavilion

location_facility: University of Maryland Greenenbaum Cancer Center

location_facility: Texas Oncology/Baylor University Medical Center

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Service de Médecine Interne Onco-Hématologie

location_facility: Hospital Clinico Universitario de Navarra

location_facility: Clinique Victor Hugo Centre Jean Bernard

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Guy's and St. Thomas' NHS Foundation Trust

location_facility: Unidad Cnio Ibima de Investigacion en Prostata

location_facility: Ashford Cancer Centre/Adelaide Cancer Centre Research

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: The University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

location_facility: St. George Private Hospital, Oncology Day Care Centre

location_facility: University of North Carolina Lineberger Cancer Center

location_facility: Unità Operativa di Oncologia Ospedale Civile degli Infe

location_facility: University of Florida Health Cancer Center

location_facility: Centro Oncologico c/o Presidio Ospedaliero San Donato - Arezzo

location_facility: University of Surrey Post Graduate Medical Hospital

location_facility: Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: Urology Cancer Center and GU Research Network

location_facility: Centre Hospitalier De I'Universite de Montreal

status_simplified: Unknown


title: A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

summary: The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

ReferenceCitation: Greulich T, Kostikas K, Gaga M, Aalamian-Mattheis M, Lossi NS, Patalano F, Nunez X, Pagano VA, Fogel R, Vogelmeier CF, Clemens A. Indacaterol/glycopyrronium reduces the risk of clinically important deterioration after direct switch from baseline therapies in patients with moderate COPD: a post hoc analysis of the CRYSTAL study. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1229-1237. doi: 10.2147/COPD.S159732. eCollection 2018.

family: Greulich

full_name: Timm Greulich

given: Timm

family: Kostikas

full_name: Konstantinos Kostikas

given: Konstantinos

sequence: additional

family: Gaga

full_name: Mina Gaga

given: Mina

family: Aalamian-Mattheis

full_name: Maryam Aalamian-Mattheis

given: Maryam

family: Lossi

full_name: Nadine S Lossi

given: Nadine S

family: Patalano

full_name: Francesco Patalano

given: Francesco

family: Nunez

full_name: Xavier Nunez

given: Xavier

family: Pagano

full_name: Veronica A. Pagano

given: Veronica A.

family: Fogel

full_name: Robert Fogel

given: Robert

family: Vogelmeier

full_name: Claus Vogelmeier

given: Claus

family: Clemens

full_name: Andreas Clemens

given: Andreas

currency_apc_doaj: USD

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Vogelmeier CF, Gaga M, Aalamian-Mattheis M, Greulich T, Marin JM, Castellani W, Ninane V, Lane S, Nunez X, Patalano F, Clemens A, Kostikas K; CRYSTAL study investigators. Efficacy and safety of direct switch to indacaterol/glycopyrronium in patients with moderate COPD: the CRYSTAL open-label randomised trial. Respir Res. 2017 Jul 18;18(1):140. doi: 10.1186/s12931-017-0622-x.

full_name: Claus F. Vogelmeier

given: Claus F.

name: on behalf of the CRYSTAL study investigators

family: Marin

full_name: Jose M. Marin

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

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

repository_institution: University of Zaragoza Repository - Zaguan

location_country:
Greece
Romania
Belgium
Russian Federation
Denmark
France
Poland
Lithuania
Slovakia
Norway
Slovenia
Sweden
Hungary
Ireland
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Spain
Estonia
Latvia


title: A Multicentre, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)

acronym: BORA

summary: The purpose of this study is to characterize the safety profile of benralizumab administration in asthma patients who have completed one of the three predecessor studies: D3250C00017, D3250C00018 or D3250C00020.

primary_purpose: Other

ReferenceCitation: Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Brooks L, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Benralizumab for adolescent patients with severe, eosinophilic asthma: Safety and efficacy after 3 years of treatment. J Allergy Clin Immunol. 2021 Jul;148(1):266-271.e2. doi: 10.1016/j.jaci.2021.02.009. Epub 2021 Feb 17.

family: Busse

full_name: William W. Busse

given: William W.

family: Bleecker

full_name: Eugene R. Bleecker

given: Eugene R.

family: FitzGerald

full_name: J. Mark FitzGerald

given: J. Mark

family: Ferguson

full_name: Gary T. Ferguson

given: Gary T.

family: Barker

full_name: Peter Barker

given: Peter

family: Brooks

full_name: Laura Brooks

given: Laura

family: Olsson

full_name: Richard F. Olsson

given: Richard F.

family: Martin

full_name: Ubaldo J. Martin

given: Ubaldo J.

family: Goldman

full_name: Mitchell Goldman

given: Mitchell

journal_name: Journal of Allergy and Clinical Immunology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Busse WW, Bleecker ER, FitzGerald JM, Ferguson GT, Barker P, Sproule S, Olsson RF, Martin UJ, Goldman M; BORA study investigators. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial. Lancet Respir Med. 2019 Jan;7(1):46-59. doi: 10.1016/S2213-2600(18)30406-5. Epub 2018 Nov 8. Erratum in: Lancet Respir Med. 2019 Jan;7(1):e1.

full_name: William W Busse

given: William W

full_name: Eugene R Bleecker

given: Eugene R

full_name: J Mark FitzGerald

given: J Mark

full_name: Gary T Ferguson

given: Gary T

family: Sproule

full_name: Stephanie Sproule

given: Stephanie

full_name: Richard F Olsson

given: Richard F

full_name: Ubaldo J Martin

given: Ubaldo J

family: Yañez

full_name: Anahí Yañez

given: Anahí

family: Fernández

full_name: Marcelo Fernández

given: Marcelo

family: Tolcachier

location_country:
Peru
Romania
Australia
Russian Federation
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
South Africa
Chile
Sweden
Vietnam
Philippines
Bulgaria
Germany
United States
United Kingdom
Brazil
Czechia
Spain
Turkey


ReferenceType: background

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545. Review.

ReferenceCitation: Facon T, Lee JH, Moreau P, Niesvizky R, Dimopoulos M, Hajek R, Pour L, Jurczyszyn A, Qiu L, Klippel Z, Zahlten-Kumeli A, Osman M, Paiva B, San-Miguel J. Carfilzomib or bortezomib with melphalan-prednisone for transplant-ineligible patients with newly diagnosed multiple myeloma. Blood. 2019 May 2;133(18):1953-1963. doi: 10.1182/blood-2018-09-874396. Epub 2019 Feb 28.

ReferenceCitation: Rosenthal A, Luthi J, Belohlavek M, Kortüm KM, Mookadam F, Mayo A, Fonseca R, Bergsagel PL, Reeder CB, Mikhael JR, Stewart AK. Carfilzomib and the cardiorenal system in myeloma: an endothelial effect? Blood Cancer J. 2016 Jan 15;6:e384. doi: 10.1038/bcj.2015.112.

family: Rosenthal

full_name: A Rosenthal

given: A

family: Luthi

full_name: J Luthi

given: J

family: Belohlavek

full_name: M Belohlavek

given: M

family: Kortüm

full_name: K M Kortüm

given: K M

family: Mookadam

full_name: F Mookadam

given: F

family: Mayo

full_name: A Mayo

family: Fonseca

full_name: R Fonseca

given: R

family: Bergsagel

full_name: P L Bergsagel

given: P L

family: Reeder

full_name: C B Reeder

given: C B

family: Mikhael

full_name: J R Mikhael

given: J R

family: Stewart

full_name: A K Stewart

given: A K

currency_apc_doaj: GBP

journal_name: Blood Cancer Journal

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

lead_sponsor: Amgen

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Bulgaria
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

acronym: CLARION

location_facility: National Hospital Organization Disaster Medical Center

location_facility: University Hospital Ostrava, Clinic of Hematooncology of UHO and MFUO

location_facility: Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: UO Clinica Ematologica, IRCCS A.O.U. San Martino

location_facility: Bekes County Pandy Kalman Hospital 1st Department of Internal Medicine, Hematology

location_facility: Iasi Regional Institute for Oncology, Medical Hematology Department

location_facility: CHR de La Citadelle (ENG: Citadelle Regional Hospital Center)

location_facility: Ein Kerem Hospital, Department of Hematology

location_facility: Targu-Mures County Emergency Clinical Hospital, Clinic of Hematology and Bone Marrow Transplantation

location_facility: Independent Public Healthcare Facility University Hospital

location_facility: Universitari i Politècnic la Fe de Valencia Consulta Externa de Hematología

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina", Varna

location_facility: Kaposi Mor County Teaching Hospital, 2nd Department of Internal Medicine, Hematology

location_facility: Ospedali Riuniti di Ancona Umberto I, G.M. Lancisi, G. Salesi

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Oncology and Hematology Clinic

location_facility: Institute on Hematology & Blood Diseases Hospital Chinese Academy of Medical Scicnces & Peking Union Medical University

location_facility: Medical University of Innsbruck, University Clinic for Internal Medicine V

location_facility: Institution of the Russian Academy of Medical Sciences Russian Oncological Research Center n.a. N.N.Blokhin under the Russian Academy of Medical Sciences

location_facility: Consultorio Privado del Dr. Guillermo Jose Ruiz y Arguelles

location_facility: National Institute of Oncology, Department of Oncology, Internal Medicine "A" and Hematology

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: University Hospital Brno, Hospital Pharmacy - Department of Dilution of Cytostasis

location_facility: University Hospital Brno, Department of Internal Hematology and Oncology

location_facility: Institute of Blood Pathology and Transfusion Medicine

location_facility: Maria Sklodowska-Curie Institute of Oncology

location_facility: University of Debrecen, Medical and Health Science Center, Institute for Medicine, Chair of Hematology

location_facility: Bacs-Kiskun County Teaching Hospital, II. Department of Internal Medicine

location_facility: State Higher Educational Institution St. Petersburg Pavlov State Medical University

location_facility: Ulm University Hospital, Center for Internal Medicine, Clinic of Internal Medicine III

location_facility: Ankara University Medical Faculty, Cebeci Research and Application Hospital, Hematology Department

location_facility: National Hospitalization Organization Kyushu Cancer Center

location_facility: National Center for Global Health and Medicine

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Vrije Universiteit Medisch Centrum (VUMC), Department of Hematology

location_facility: Kharkiv Regional Clinical Oncology Center, Department of Hematology

location_facility: Medical Center of the University of Pecs, 1st Clinic for Internal Medicine

location_facility: Beijing Chao Yang Hospital, Capital Medical University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: A. Novak Zakarpattia Regional Clinical Hospital

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital

location_facility: Kyiv Center for Bone Marrow Transplantation

location_facility: Fundacion Centro Oncologieo de Integracion Regional - COIR

location_facility: CHRU Hopital Huriez, Departement of Hematology

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: City Clinical Hospital #31, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders

location_facility: National Hospital Organization Okayama Medical Center

location_facility: University Hospital Kralovske Vinohrady - Internal Hematology Clinic

location_facility: Brasov County Emergency Clinical Hospital, Hematology Department

location_facility: The First Affiliated Hospital of the Fourth Military Medical University of PLA

location_facility: Johannes Gutenberg-University Mainz, Medical Clinic and Policlinic III

location_facility: Chonnam National University Hwasun Hospital

location_facility: Ludwig Maximilians University Hospital - Medical Clinic III

location_facility: Centro de educacion medica c investigacioncs clinicas "Norberto Quimo' (CEMIC)

location_facility: The First Affiliated Hospital of Soochow University

location_facility: The First Affiliated Hospital of College of Medicine, Zhejiang University - Dr. Jie Jin

location_facility: State Medical Institution: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia

location_facility: Singapore Oncology Consultants, Gleneagles Hospital

location_facility: University of Athens, Alexandra Hospital

location_facility: AO Città della Salute e della Scienza di Torino, Division of Hematology

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases, Sofia, Hematology Clinic

location_facility: Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice

location_facility: "Prof. Dr. Ion Chiricuta" Institut of Oncology, Hematology Department

location_facility: Fundeni Clinical Institute, Hematology Department

location_facility: Group Practice for Hematology and Oncology

location_facility: General University Hospital Prague, 1st Department of Medicine - Department of Hematology

location_facility: Arkhangelsk Regional Clinical Hospital, Department of internal diseases #2

location_facility: Military Medical Academy - Multiprofile Hospital for Active Treatment, Sofia, Hematology and Oncology Clinic

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4, Hematology Centre

location_facility: Bucharest Emergency University Hospital, Hematology Department

location_facility: The Royal Wolverhampton Hospitals NHS Trust, New Cross Hospital

location_facility: California Cancer Associates for Research & Excellence, Inc. (cCARE)

location_facility: Centre Hospitalier Regional Universitaire de Nimes, Groupe Hospitalo-Universitaire Caremeau

location_facility: Hopital Saini Louis, Service d'immuno-Hematologie

location_facility: St. Istvan and St. Laszlo Hospital of Budapest, Department of Haematology and Stem-cell Transplant

location_facility: State Medical Institution: Republican Hospital n a.V.A. Baranov, Department of Hematology

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

location_facility: University College London, Cancer Centre

location_facility: Seoul National University Bundang Hospital

location_facility: Independent Public Teaching Hospital No.1 in Lublin, Dept. of Hematology-Oncology

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical-Hospital

location_facility: University Hospital Olomouc, 3rd Clinic of Internal Medicine, Nephrology, Rheumatology and Endocrinology

location_facility: Centre Hospitalier Lyon Sud, Service d'hématologie Clinique

location_facility: Isala Clinics in Zwolle, Department of Oncology

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv, Hematology Clinic

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Royal North Shore Hospital, Haematology Department

location_facility: Nicolaus Copernicus Municipal Specialist Hospital, Department of Hematology

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: Khmelnytskyi Regional Hospital, Hematology Department

location_facility: St. Antonius Ziekenhuis, Department of Hematology

location_facility: Maggiore della Carita Hospital of Novara

location_facility: Local NHS of Piacenza Hospital Guglielmo da Saliceto Department Oncology-Hematology, Unit of Hema

location_facility: O.F. Herbachevskyi Regional Clinical Hospital, Hematology Center

location_facility: City Clinical Hospital N.A.S.P. Botkin, Department of Bone Marrow Transplantation and Intensive Chemotherapy for Patients with Myeloproliferative Disorders

location_facility: Rambam Medical Center, Department of Hematology

location_facility: M.I. Pyrohov Vinnytsya Regional Clinical Hospital, Hematology Department

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Independent Public Healthcare Facility Municipal Hospital Group, Department of Hematology

location_facility: Paoli Calmettes Institute, Department ofHematology 2

location_facility: Independent Public Healthcare Facility of the Ministry of Internal Affairs & Warminsko-Mazurskie Oncology Centre in Olsztyn

location_facility: Coltea Clinical Hospital, Hematology Department

location_facility: Saint Joseph Clinic Arlon, Department of Hematology

location_facility: Stiftungsklinikum Mittelrhein GmbH, Clinic of Internal Medicine

location_facility: Fujian Medical University Union Hospital

location_facility: Federal State Institution: Russian Research Institute of Hematology and Blood Transfusion under the Federal Agency for High-Tech Medical Care

location_facility: Oxford University Hospitals NHS Trust, Churchill Hospital

location_facility: Marmara University Pendik Training and Research Hospital

location_facility: The Federal State Budget Institute The Nikiforov Russian Center of Emergency and Radiation Medicine the Ministry of Russian

title: A Randomized, Open-label Phase 3 Study of Carfilzomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma

summary: The primary objective was to compare the progression-free survival of transplant ineligible patients newly diagnosed with multiple myeloma who were treated with carfilzomib, melphalan and prednisone (CMP) or with Velcade® (bortezomib), melphalan and prednisone (VMP).


ReferenceCitation: von Minckwitz G, Huang CS, Mano MS, Loibl S, Mamounas EP, Untch M, Wolmark N, Rastogi P, Schneeweiss A, Redondo A, Fischer HH, Jacot W, Conlin AK, Arce-Salinas C, Wapnir IL, Jackisch C, DiGiovanna MP, Fasching PA, Crown JP, Wülfing P, Shao Z, Rota Caremoli E, Wu H, Lam LH, Tesarowski D, Smitt M, Douthwaite H, Singel SM, Geyer CE Jr; KATHERINE Investigators. Trastuzumab Emtansine for Residual Invasive HER2-Positive Breast Cancer. N Engl J Med. 2019 Feb 14;380(7):617-628. doi: 10.1056/NEJMoa1814017. Epub 2018 Dec 5.

name: From the German Breast Group, Neu-Isenburg (G.M., S.L., H.H.F., P.W.), the Center for Hematology and Oncology Bethanien, Frankfurt (S.L.), the AGO-B and HELIOS Klinikum Berlin-Buch, Berlin (M.U.), the National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg (A.S.), Evangelische Kliniken Gelsenkirchen, Gelsenkirchen (H.H.F.), the Arbeitsgemeinschaft Gynäkologische Onkologie – Breast and Sana Klinikum Offenbach, Offenbach (C.J.), the Department of...

family: von Minckwitz

full_name: Gunter von Minckwitz

given: Gunter

family: Huang

full_name: Chiun-Sheng Huang

given: Chiun-Sheng

family: Mano

full_name: Max S. Mano

given: Max S.

family: Loibl

full_name: Sibylle Loibl

given: Sibylle

family: Mamounas

full_name: Eleftherios P. Mamounas

given: Eleftherios P.

family: Untch

full_name: Michael Untch

given: Michael

family: Wolmark

full_name: Norman Wolmark

given: Norman

family: Rastogi

full_name: Priya Rastogi

given: Priya

family: Schneeweiss

full_name: Andreas Schneeweiss

given: Andreas

family: Redondo

full_name: Andres Redondo

given: Andres

family: Fischer

full_name: Hans H. Fischer

given: Hans H.

family: Jacot

full_name: William Jacot

given: William

family: Conlin

full_name: Alison K. Conlin

given: Alison K.

family: Arce-Salinas

full_name: Claudia Arce-Salinas

given: Claudia

family: Wapnir

full_name: Irene L. Wapnir

given: Irene L.

family: Jackisch

full_name: Christian Jackisch

given: Christian

family: DiGiovanna

full_name: Michael P. DiGiovanna

given: Michael P.

family: Fasching

full_name: Peter A. Fasching

given: Peter A.

family: Crown

full_name: John P. Crown

given: John P.

family: Wülfing

full_name: Pia Wülfing

given: Pia

family: Shao

full_name: Zhimin Shao

given: Zhimin

family: Rota Caremoli

full_name: Elena Rota Caremoli

given: Elena

family: Wu

full_name: Haiyan Wu

given: Haiyan

family: Lam

full_name: Lisa H. Lam

given: Lisa H.

family: Tesarowski

full_name: David Tesarowski

given: David

location_country:
Peru
Guatemala
Greece
Belgium
Taiwan
France
Panama
Argentina
Canada
Colombia
South Africa
Sweden
Hong Kong
Switzerland
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

location_facility: Aultman Hospital; Aultman Hospital Cancer Center

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

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

location_facility: St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP

location_facility: Universitätsklinikum Ulm Am Michelsberg; Frauenklinik

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Hospital Angeles Metropolitano; Room 220

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: University of Florida; Davis Cancer Pavilion and Shands Medical Plaza

location_facility: Houston Methodist Hospital Outpatient Center

location_facility: McGill University Health Centre - Glen Site

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

location_facility: Universitätsfrauen- und Poliklinik am Klinikum Suedstadt

location_facility: Nstituto Nacional de Ciancias Medicas Y Nutricion, Salvador Zubir

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: UPCO - Unidade de Pesquisas Clínicas em Oncologia

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: Joe Arrington Cancer Research & Treatment Center

location_facility: Hospital Nacional Guillermo Almenara Irigoyen; Oncology

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis; Dres. Schlag & Schöttker

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Medical University of South Carolina; Hollings Cancer Center

location_facility: Evangelische Kliniken Gelsenkirchen GmbH; Brustzentrum

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie PD Dr. Bauer, Dr. Kremers

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Ohio State University, Arthur James Cancer Hospital

location_facility: Klinikum Esslingen; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Leeds Teaching Hosp NHS Trust;St James's Institute of Onc

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Hospital Universitario Dr. Peset; Servicio de Oncologia

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Fairview Hospital; Cleveland Clinic Cancer Center

location_facility: Batte Cancer Center - Carolinas Medical Center

location_facility: Charing Cross Hospital; Medical Oncology.

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

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Washington Cancer Institute; Washington Hospital Center

location_facility: Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

location_facility: Marien-Hospital Witten; Frauenklinik Brustzentrum

location_facility: US oncology research at Minnesota Oncology

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Rocky Mountain Cancer Centers - Colorado Springs (Circle)

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Fondazione Del Piemonte Per L'oncologia IRCC Di Candiolo

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Klinikum Kassel GmbH; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Klinikum der Universität München; Frauenklinik - Onkologie II

location_facility: Centre Hospitalier Fleyriat; Oncologie/Hematologie

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Med Star Franklin Square Medical Center/Weinburg Cancer Institute

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: Lake Health/University Hospitals - Mentor Campus

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

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Gemeinschaftspraxis Dr. Kronawitter und Dr. Jung

location_facility: Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Harbin Medical University Cancer Hospital

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

location_facility: PeaceHealth St. John Medical Center - Lower Columbia Cancer Center

location_facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology

location_facility: Luisenkrankenhaus GmbH & Co. KG., Brustzentrum

location_facility: Mercy Medical Center; Medical Oncology & Hematology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Chang Gung Medical Foundation - Linkou; Dept of Surgery

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: HELIOS Klinikum Berlin-Buch; Klinik für Gynäkologie und Geburtshilfe

location_facility: Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: The Ottawa Hospital; Division of Infectious Diseases

location_facility: Taichung Veterans General Hospital; Dept of Surgery

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: Bradford Royal Infirmary; Dept of Medical Oncology C/O Ward15

location_facility: Uni of Pittsburgh; Magee-Women'S Hospital

location_facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

location_facility: Todd Cancer Institute at Long Beach Memorial Medical Center

location_facility: Kimmel Cancer Center Thomas Jefferson University

location_facility: St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Tom Baker Cancer Centre; Dept of Medicine

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

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Centre Val Aurelle Paul Lamarque; Recherche Clinique

title: A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy

summary: This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.


title: A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

summary: A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.

study_completion_date_type: Anticipated

ReferenceCitation: Maerevoet M, Zijlstra JM, Follows G, Casasnovas RO, Vermaat JSP, Kalakonda N, Goy A, Choquet S, Van Den Neste E, Hill B, Thieblemont C, Cavallo F, De la Cruz F, Kuruvilla J, Hamad N, Jaeger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Schuster M, Egyed M, Offner F, Vassilakopoulos TP, Samal P, Ku M, Ma X, Corona K, Chamoun K, Shah J, Shacham S, Kauffman MG, Canales M. Survival among patients with relapsed/refractory diffuse large B cell lymphoma treated with single-agent selinexor in the SADAL study. J Hematol Oncol. 2021 Jul 16;14(1):111. doi: 10.1186/s13045-021-01122-1.

family: Maerevoet

full_name: Marie Maerevoet

given: Marie

family: Zijlstra

full_name: Josee M. Zijlstra

given: Josee M.

family: Follows

full_name: George Follows

given: George

family: Casasnovas

full_name: Rene-Olivier Casasnovas

given: Rene-Olivier

family: Vermaat

full_name: J. S. P. Vermaat

given: J. S. P.

family: Kalakonda

full_name: Nagesh Kalakonda

given: Nagesh

family: Goy

full_name: Andre Goy

given: Andre

family: Choquet

full_name: Sylvain Choquet

given: Sylvain

family: Van Den Neste

full_name: Eric Van Den Neste

given: Eric

family: Hill

full_name: Brian Hill

given: Brian

family: Thieblemont

full_name: Catherine Thieblemont

given: Catherine

family: Cavallo

full_name: Federica Cavallo

given: Federica

family: De la Cruz

full_name: Fatima De la Cruz

given: Fatima

family: Kuruvilla

full_name: John Kuruvilla

given: John

family: Hamad

full_name: Nada Hamad

given: Nada

family: Jaeger

full_name: Ulrich Jaeger

given: Ulrich

family: Caimi

full_name: Paolo Caimi

given: Paolo

family: Gurion

full_name: Ronit Gurion

given: Ronit

family: Warzocha

full_name: Krzysztof Warzocha

given: Krzysztof

family: Bakhshi

full_name: Sameer Bakhshi

given: Sameer

family: Sancho

full_name: Juan-Manuel Sancho

given: Juan-Manuel

family: Schuster

full_name: Michael Schuster

given: Michael

family: Egyed

full_name: Miklos Egyed

given: Miklos

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Shah J, Shacham S, Kauffman M, Daniele P, Tomaras D, Tremblay G, Casasnovas RO, Maerevoet M, Zijlstra J, Follows G, P Vermaat JS, Kalakonda N, Goy AH, Choquet S, Den Neste EV, Hill BT, Thieblemont C, Cavallo F, la Cruz F, Kuruvilla J, Hamad N, Bouabdallah R, Jäger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Schuster M, Egyed M, Offner F, Vasilakopoulos TP, Samal P, Nagy A, Ku M, Canales Albendea MÁ. Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma. Future Oncol. 2021 Apr;17(11):1295-1310. doi: 10.2217/fon-2020-0946. Epub 2021 Feb 2.

name: Karyopharm Therapeutics, Inc., Newton, MA 02459, USA

name: Health Economics, Purple Squirrel Economics, Montreal, QC H3J 1M1, Canada

name: Clinical Hematology, CHU Dijon Bourgogne, Dijon, 21079, France

name: Hématologie, Institut Jules Bordet, Brussels, 1000, Belgium

name: Department of Hematology, Amsterdam UMC, Amsterdam, 1105 AZ, The Netherlands

name: Haematology, Addenbrooke’s Hospital, Cambridge, CB2 0QQ, UK

name: Hematology, Leiden University Medical Center, Leiden, 2333 ZA, The Netherlands

name: Institute of Translational Medicine, University of Liverpool, Liverpool, L3 9TA, UK

name: John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ 07601, USA

name: Service d'Hématologie clinique, Hôpital Pitié-Salpêtrière, Paris, 75013, France

name: Faculté de médecine et médecine dentaire, Université catholique de Louvain, Ottignies-Louvain-la-Neuve, 1348, Belgium

name: Hematology & Medical Oncology, Cleveland Clinic, Cleveland, OH 44106, USA

name: Hémato-Oncologie, Hôpital Saint-Louis, Paris, 75010, France

name: Divisione di Ematologia, University of Turin, Turin, 10138, Italy

name: Facultativo Especialista de Área de Hematología, Hospital Universitario Virgen del Rocío, Sevilla, 41013, Spain

name: Cancer Clinical Research Unit, University Health Network Research, Toronto, ON, Canada

name: Haematology Clinical Trials Unit, St Vincent’s Hospital, Melbourne, 3065, Australia

name: Hematology, Institut Paoli-Calmettes, Marseille, 13009, France

name: Department of Clinical Hematology & Hemostaseology, Medical University of Vienna, Vienna, 1090, Austria

name: Department of Medicine, UH Cleveland Medical Center, Cleveland, OH 44106, USA

name: Hematology, Tel Aviv University, Tel Aviv, 69978, Israel

name: Institute of Hematology & Blood Transfusion, Warsaw, 02-776, Poland

name: Department of Medical Oncology, Institute Rotary Cancer Hospital, New Delhi, 110029, India

name: Department of Clinical Hematology, Germans Trias i Pujol Hospital, Barcelona, 08916, Spain

name: Hematology, Stony Brook University, NY 11794, USA

name: Department of Haematology, Somogy County Kaposi Mór Hospital, Kaposvár, 7400, Hungary

name: Department of Clinical Hematology, Ghent University Hospital, Ghent, 9000, Belgium

name: Faculty of Medicine, National & Kapodistrian University of Athens, Athens, 10679, Greece

name: IMS & SUM Hospital, Bhubaneswar, Odisha, India

name: Hematology, Semmelweis University, Budapest, 1085, Hungary

name: Department of Haematology, St Vincent’s Hospital, Melbourne, VIC, 3065, Australia

name: Servicio de Hematología, Hospital Universitario La Paz, Madrid, 28046, Spain

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

ReferenceCitation: Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, Hamad N, Zijlstra JM, Bakhshi S, Bouabdallah R, Choquet S, Gurion R, Hill B, Jaeger U, Sancho JM, Schuster M, Thieblemont C, De la Cruz F, Egyed M, Mishra S, Offner F, Vassilakopoulos TP, Warzocha K, McCarthy D, Ma X, Corona K, Saint-Martin JR, Chang H, Landesman Y, Joshi A, Wang H, Shah J, Shacham S, Kauffman M, Van Den Neste E, Canales MA. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e511-e522. doi: 10.1016/S2352-3026(20)30120-4.

location_country:
Italy
Austria
India
Serbia
Netherlands
Germany
France
Bulgaria
Greece
Israel
Poland
Hungary
Australia
Belgium
New Zealand
Spain
United States
United Kingdom
Canada

location_facility: Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie

location_facility: Medical University of Vienna (MUW) Department of Medicine I

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Netaji Subhas Chandra Bose Cancer Research Institute

location_facility: Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg

location_facility: Princess Royal University Hospital (PRUH)

location_facility: University Hospital for Active Treatment Dr. Georgi Stranski

location_facility: Klinički centar Srbije Klinika za hematologiju

location_facility: Charite Universitatsmedizin Berlin (Virchow Campus)

location_facility: Department of clinical hematology ,university hospital Ioannina

location_facility: Klinički centar Niš Klinika za hematologiju

location_facility: Netaji Subhas Chandra Bose Cancer Research Hospital

location_facility: Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

location_facility: Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii

location_facility: Semmelweis University Department of Medicine and Oncology

location_facility: LKH Leoben Department for Haemato-Oncology

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: National & Kapodistrian University of Athens, Attiko University Hospital

location_facility: Boca Raton Cancer Research Medical Center

location_facility: Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: National & Kapodistrian University of Athens, Laiko General Hospital

location_facility: New York Presbyterian Hospital/ Cornell Medical College

location_facility: Klinicko Bolnick Centar Zemun Odeljenje hematologije

location_facility: Military Medical Institute Hematology and Internal Medicine Clinic

location_facility: University Hospitals Seidman Cancer Center

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases EAD

location_facility: Memorial Provincial Specialist Hospital in Lodz

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

location_facility: Nil Ratan Sircar Medical College and Hospital

location_facility: Virginia Mason Hospital & Medical Center

location_facility: Chu Dijon-Bourgogne - Hematologie Clinique

location_facility: Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)

location_facility: Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin

location_facility: Sir Mortimer B Davis Jewish General Hospital/McGill University

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Institute of Medical Sciences & SUM Hospital

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa

location_facility: Maria Sklodowska Curie National Research Institute

location_facility: Gemeinschaftspraxis Haematologie and Onkologie-Dresden

location_facility: Unite Hemopathies Lymphoides Chu Henri Mondor

location_facility: Hôpital Necker Service d'Hématologie Adult

location_facility: AOU Maggiore della Carità SCDU Ematologia

location_facility: Haematology Department and HCT Unit G.Papanicolaou Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza

location_facility: Medizinische Universität Innsbruck für Innere Medizin

location_facility: Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Hematology Department Laiko General Hospital

location_facility: Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital

location_facility: Institut za onkologiju i radiologiju Srbije

location_facility: Città della Salute e della Scienza di Torino

location_facility: Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály

location_facility: SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale

location_facility: IRCH, All India Institute of Medical Sciences

location_facility: University of Massachusetts Medical School

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: Liverpool Hospital, Ingham Institute of Medical Research

location_facility: Martin-Luther-University Halle-Wittenberg Department of Oncology

location_facility: Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS

location_facility: Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego

location_facility: Krankenhaus Barmherzigen Schwestern Linz

location_facility: Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie

location_facility: Hematology Department St John's Cancer Centre

location_facility: Second Depth of Internal Medicine, Attiko University Hospital

location_facility: Hematology Clinic,General Hospital of Athens,G. Gennimatos

location_facility: LUMC (leidse universitair medisch centrum)

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

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

location_facility: University of California Los Angeles (UCLA)

location_facility: Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences

location_facility: Hospitla Universitari Germans Trias i Pujol - ICO


title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Waldenström Macroglobulinemia

summary: The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.

status: Active, not recruiting

ReferenceCitation: Owen RG, McCarthy H, Rule S, D'Sa S, Thomas SK, Tournilhac O, Forconi F, Kersten MJ, Zinzani PL, Iyengar S, Kothari J, Minnema MC, Kastritis E, Aurran-Schleinitz T, Cheson BD, Walter H, Greenwald D, Chen DY, Frigault MM, Hamdy A, Izumi R, Patel P, Wei H, Lee SK, Mittag D, Furman RR. Acalabrutinib monotherapy in patients with Waldenström macroglobulinemia: a single-arm, multicentre, phase 2 study. Lancet Haematol. 2020 Feb;7(2):e112-e121. doi: 10.1016/S2352-3026(19)30210-8. Epub 2019 Dec 19. Erratum in: Lancet Haematol. 2021 Apr;8(4):e249.

family: Owen

full_name: Roger G Owen

given: Roger G

family: McCarthy

full_name: Helen McCarthy

given: Helen

family: Rule

full_name: Simon Rule

given: Simon

family: D'Sa

full_name: Shirley D'Sa

given: Shirley

family: Thomas

full_name: Sheeba K Thomas

given: Sheeba K

family: Tournilhac

full_name: Olivier Tournilhac

given: Olivier

family: Forconi

full_name: Francesco Forconi

given: Francesco

family: Kersten

full_name: Marie José Kersten

given: Marie José

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Iyengar

full_name: Sunil Iyengar

given: Sunil

family: Kothari

full_name: Jaimal Kothari

given: Jaimal

family: Minnema

full_name: Monique C Minnema

given: Monique C

family: Kastritis

full_name: Efstathios Kastritis

given: Efstathios

family: Aurran-Schleinitz

full_name: Thérèse Aurran-Schleinitz

given: Thérèse

family: Cheson

full_name: Bruce D Cheson

given: Bruce D

family: Walter

full_name: Harriet Walter

given: Harriet

family: Greenwald

full_name: Daniel Greenwald

given: Daniel

family: Chen

full_name: Dih-Yih Chen

given: Dih-Yih

family: Frigault

full_name: Melanie M Frigault

given: Melanie M

family: Hamdy

full_name: Ahmed Hamdy

given: Ahmed

family: Izumi

full_name: Raquel Izumi

given: Raquel

family: Patel

full_name: Priti Patel

given: Priti

family: Wei

full_name: Helen Wei

family: Lee

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.

location_country:
Italy
Netherlands
France
Greece
Spain
United States
United Kingdom


title: A Multicenter, Global, Observational Study to Collect Information on Safety and to Document the Drug Utilization of Tecfidera™ (Dimethyl Fumarate) When Used in Routine Medical Practice in the Treatment of Multiple Sclerosis (ESTEEM)

acronym: ESTEEM

summary: The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.

study_type: Observational

time_perspective: Prospective

lead_sponsor: Biogen

location_country:
Australia
Denmark
France
Poland
Slovakia
Norway
Argentina
Canada
Switzerland
Netherlands
Hungary
Ireland
Puerto Rico
Portugal
United States
Germany
United Kingdom
Italy
Austria
Czechia
New Zealand
Spain

location_facility:
Research site
Research Site
Research Sites

status_simplified: Ongoing


ReferenceCitation: Kater AP, Wu JQ, Kipps T, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, Owen C, Robak T, de la Serna J, Jaeger U, Cartron G, Montillo M, Dubois J, Eldering E, Mellink C, Van Der Kevie-Kersemaekers AM, Kim SY, Chyla B, Punnoose E, Bolen CR, Assaf ZJ, Jiang Y, Wang J, Lefebure M, Boyer M, Humphrey K, Seymour JF. Venetoclax Plus Rituximab in Relapsed Chronic Lymphocytic Leukemia: 4-Year Results and Evaluation of Impact of Genomic Complexity and Gene Mutations From the MURANO Phase III Study. J Clin Oncol. 2020 Dec 1;38(34):4042-4054. doi: 10.1200/JCO.20.00948. Epub 2020 Sep 28.

name: Department of Hematology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Academic Medical Center, on behalf of Hovon Chronic Lymphocytic Leukemia Working Group, Amsterdam, the Netherlands

family: Kater

full_name: Arnon P. Kater

given: Arnon P.

family: Wu

full_name: Jenny Qun Wu

given: Jenny Qun

name: University of California School of Medicine, San Diego, CA

family: Kipps

full_name: Thomas Kipps

given: Thomas

family: Eichhorst

full_name: Barbara Eichhorst

given: Barbara

name: St James’s University Hospital, Leeds, United Kingdom

family: Hillmen

full_name: Peter Hillmen

given: Peter

name: The John Curtin School of Medical Research, Australian National University, Canberra, Australia

family: D’Rozario

full_name: James D’Rozario

given: James

name: Segal Cancer Center, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada

family: Assouline

full_name: Sarit Assouline

given: Sarit

name: University of Calgary, Calgary, Alberta, Canada

family: Owen

full_name: Carolyn Owen

given: Carolyn

name: Medical University of Lodz, Copernicus Memorial Hospital, Lodz, Poland

family: Robak

full_name: Tadeusz Robak

given: Tadeusz

name: Hospital Universitario 12 de Octubre, Madrid, Spain

family: de la Serna

full_name: Javier de la Serna

given: Javier

name: Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria

family: Jaeger

full_name: Ulrich Jaeger

given: Ulrich

name: Department of Clinical Hematology, University Hospital Montpellier, Montpellier, France

family: Cartron

full_name: Guillaume Cartron

given: Guillaume

name: Department of Hematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy

family: Montillo

full_name: Marco Montillo

given: Marco

family: Dubois

full_name: Julie Dubois

given: Julie

family: Eldering

full_name: Eric Eldering

given: Eric

family: Mellink

full_name: Clemens Mellink

given: Clemens

family: Van Der Kevie-Kersemaekers

full_name: Anne-Marie Van Der Kevie-Kersemaekers

given: Anne-Marie

family: Kim

full_name: Su Young Kim

given: Su Young

family: Chyla

full_name: Brenda Chyla

given: Brenda

family: Punnoose

full_name: Elizabeth Punnoose

given: Elizabeth

family: Bolen

full_name: Christopher R. Bolen

given: Christopher R.

family: Assaf

full_name: Zoe June Assaf

given: Zoe June

family: Jiang

full_name: Yanwen Jiang

given: Yanwen

family: Wang

full_name: Jue Wang

given: Jue

name: Roche Products Limited, Welwyn Garden City, United Kingdom

family: Lefebure

full_name: Marcus Lefebure

given: Marcus

name: Royal Melbourne Hospital, Peter MacCallum Cancer Centre and University of Melbourne, Melbourne, Victoria, Australia

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Kater AP, Seymour JF, Hillmen P, Eichhorst B, Langerak AW, Owen C, Verdugo M, Wu J, Punnoose EA, Jiang Y, Wang J, Boyer M, Humphrey K, Mobasher M, Kipps TJ. Fixed Duration of Venetoclax-Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Eradicates Minimal Residual Disease and Prolongs Survival: Post-Treatment Follow-Up of the MURANO Phase III Study. J Clin Oncol. 2019 Feb 1;37(4):269-277. doi: 10.1200/JCO.18.01580. Epub 2018 Dec 3.

name: Amsterdam Universitair Medische Centra, University of Amsterdam, Amsterdam, the Netherlands

name: Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia

name: University of Cologne, Cologne, Germany;

name: Erasmus MC University Medical Center, Rotterdam, the Netherlands

ReferenceCitation: Seymour JF, Kipps TJ, Eichhorst B, Hillmen P, D'Rozario J, Assouline S, Owen C, Gerecitano J, Robak T, De la Serna J, Jaeger U, Cartron G, Montillo M, Humerickhouse R, Punnoose EA, Li Y, Boyer M, Humphrey K, Mobasher M, Kater AP. Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. N Engl J Med. 2018 Mar 22;378(12):1107-1120. doi: 10.1056/NEJMoa1713976.

name: From the Peter MacCallum Cancer Centre, Royal Melbourne Hospital, and University of Melbourne, Melbourne, VIC (J.F.S.), and the John Curtin School of Medical Research, Australian National University, Canberra, ACT (J.D.) — all in Australia; the University of California School of Medicine, San Diego (T.J.K.), and Genentech, South San Francisco (E.A.P., Y.L., M. Mobasher) — both in California; University Hospital Cologne and the Center for Integrated Oncology Cologne–Bonn, Cologne, Germany (B.E.); St....

title: Venetoclax–Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia

ReferenceCitation: Jones AK, Freise KJ, Agarwal SK, Humerickhouse RA, Wong SL, Salem AH. Clinical Predictors of Venetoclax Pharmacokinetics in Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma Patients: a Pooled Population Pharmacokinetic Analysis. AAPS J. 2016 Sep;18(5):1192-1202. doi: 10.1208/s12248-016-9927-9. Epub 2016 May 27.

title: Clinical Predictors of Venetoclax Pharmacokinetics in Chronic Lymphocytic Leukemia and Non-Hodgkin’s Lymphoma Patients: a Pooled Population Pharmacokinetic Analysis

location_country:
Italy
Austria
United States
Sweden
Netherlands
Spain
Germany
France
Czechia
Poland
Hungary
Australia
Belgium
New Zealand
Russian Federation
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: North-West Federal Medical Research Center n.a. V.A. Almazov

location_facility: Saskatoon City Hospital;Saskatchewan Cancer Centre

location_facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

location_facility: Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

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

location_facility: Centre Hospitalier Départemental Les Oudairies

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

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: SP ZOZ Zespol Szpitali Miejskich w Chorzowie

location_facility: University of California San Diego Medical Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino; Radiology

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Albert Schweitzer Ziekenhuis, Dordwijk; Internal Medicine, Hemato-Oncology

location_facility: Perlmutter Cancer Center NYU Langone Health

location_facility: Memorial Sloan Kettering Cancer Center; Clinical Trials Office

location_facility: Cliniques Universitaires Saint-Luc; Hematology

location_facility: Hospital Clinic i Provincial de Barcelona; Hematology

location_facility: Azienda Ospedaliero Universitaria San Martino

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

location_facility: Seoul National University Bundang Hospital

location_facility: Asst Grande Ospedale Metropolitano Niguarda; SC Farmacia Ospedale

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

location_facility: BHI of Omsk region Clinical Oncology Dispensary

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

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Huntsman Cancer Institute; University of Utah

location_facility: CHU Nantes - Hôtel Dieu; Service Assistance Medicale à la Procreation

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

title: A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab

summary: The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).


title: COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection

acronym: COMBI-AD

summary: This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Robert

full_name: Caroline Robert

given: Caroline

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Flaherty

full_name: Keith T. Flaherty

given: Keith T.

family: Tawbi

full_name: Hussein A. Tawbi

given: Hussein A.

family: Menzies

full_name: Alexander M. Menzies

given: Alexander M.

family: Banerjee

full_name: Hiya Banerjee

given: Hiya

family: Lau

full_name: Mike Lau

given: Mike

family: Long

full_name: Georgina V. Long

given: Georgina V.

journal_name: European Journal of Cancer

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Zurich - Zurich Open Repository and Archive

version: acceptedVersion

ReferenceCitation: Dummer R, Hauschild A, Santinami M, Atkinson V, Mandalà M, Kirkwood JM, Chiarion Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Gasal E, Tan M, Long GV, Schadendorf D. Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma. N Engl J Med. 2020 Sep 17;383(12):1139-1148. doi: 10.1056/NEJMoa2005493. Epub 2020 Sep 2.

name: From University Hospital Zurich Skin Cancer Center, Zurich, Switzerland (R.D.); University Hospital Schleswig-Holstein, Kiel (A. Hauschild), University Hospital Essen, Essen (D.S.), and German Cancer Consortium, Heidelberg (D.S.) — all in Germany; Fondazione IRCCS Istituto Nazionale dei Tumori, Milan (M.S.), Papa Giovanni XXIII Cancer Center Hospital, Bergamo (M.M.), and the Melanoma Oncology Unit, Veneto Oncology Institute–IRCCS, Padua (V.C.S.) — all in Italy; Princess Alexandra Hospital, Gallipoli...

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Santinami

full_name: Mario Santinami

given: Mario

family: Atkinson

full_name: Victoria Atkinson

given: Victoria

family: Mandalà

full_name: Mario Mandalà

family: Kirkwood

full_name: John M. Kirkwood

given: John M.

family: Chiarion Sileni

full_name: Vanna Chiarion Sileni

given: Vanna

family: Larkin

full_name: James Larkin

given: James

ReferenceCitation: Dummer R, Brase JC, Garrett J, Campbell CD, Gasal E, Squires M, Gusenleitner D, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Flaherty K, Larkin J, Robert C, Kefford R, Kirkwood JM, Hauschild A, Schadendorf D, Long GV. Adjuvant dabrafenib plus trametinib versus placebo in patients with resected, BRAF(V600)-mutant, stage III melanoma (COMBI-AD): exploratory biomarker analyses from a randomised, phase 3 trial. Lancet Oncol. 2020 Mar;21(3):358-372. doi: 10.1016/S1470-2045(20)30062-0. Epub 2020 Jan 30.

title: Adjuvant dabrafenib plus trametinib versus placebo in patients with resected, BRAFV600-mutant, stage III melanoma (COMBI-AD): exploratory biomarker analyses from a randomised, phase 3 trial

ReferenceCitation: Schadendorf D, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Lesimple T, Plummer R, Schachter J, Dasgupta K, Manson S, Koruth R, Mookerjee B, Kefford R, Dummer R, Kirkwood JM, Long GV. Patient-reported outcomes in patients with resected, high-risk melanoma with BRAF(V600E) or BRAF(V600K) mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 May;20(5):701-710. doi: 10.1016/S1470-2045(18)30940-9. Epub 2019 Mar 27.

title: Patient-reported outcomes in patients with resected, high-risk melanoma with BRAFV600E or BRAFV600K mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial

ReferenceCitation: Hauschild A, Dummer R, Schadendorf D, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Haas T, Shilkrut M, Gasal E, Kefford R, Kirkwood JM, Long GV. Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma. J Clin Oncol. 2018 Dec 10;36(35):3441-3449. doi: 10.1200/JCO.18.01219. Epub 2018 Oct 22.

name: Axel Hauschild, University Hospital Schleswig-Holstein, Kiel; Dirk Schadendorf, University Hospital Essen, Essen; German Cancer Consortium, Heidelberg, Germany; Reinhard Dummer, University Hospital Zürich Skin Cancer Center, Zürich; Tomas Haas, Novartis AG, Basel, Switzerland; Mario Santinami, Fondazione Istituto Nazionale Tumori, Milan; Mario Mandalà, Papa Giovanni XXIII Cancer Center Hospital, Bergamo; Vanna Chiarion-Sileni, Veneto Institute of Oncology–Istituto di Ricovero e Cura a Carattere...

repository_institution: The University of Queensland - Queensland's institutional digital repository

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600–Mutant Stage III Melanoma

ReferenceCitation: Long GV, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma. N Engl J Med. 2017 Nov 9;377(19):1813-1823. doi: 10.1056/NEJMoa1708539. Epub 2017 Sep 10.

name: From the Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals (G.V.L.), and Macquarie University, Melanoma Institute Australia, University of Sydney, and Westmead Hospital (R.K.), Sydney, Princess Alexandra Hospital, Gallipoli Medical Research Foundation, University of Queensland, Brisbane (V.A.), and Alfred Hospital, Melbourne, VIC (A. Haydon) — all in Australia; University Hospital Schleswig-Holstein, Kiel (A. Hauschild), and University Hospital Essen, Essen, and...

repository_institution: Newcastle Univesity - Newcastle University ePrints

title: Adjuvant Dabrafenib plus Trametinib in Stage IIIBRAF-Mutated Melanoma

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

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

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Argentina
Canada
Sweden
Switzerland
Netherlands
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain


ReferenceCitation: Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol. 2021 Jul;22(7):1034-1046. doi: 10.1016/S1470-2045(21)00216-3. Epub 2021 Jun 15.

family: Pujade-Lauraine

full_name: Eric Pujade-Lauraine

given: Eric

family: Fujiwara

full_name: Keiichi Fujiwara

given: Keiichi

family: Ledermann

full_name: Jonathan A Ledermann

given: Jonathan A

family: Oza

full_name: Amit M Oza

given: Amit M

family: Kristeleit

full_name: Rebecca Kristeleit

given: Rebecca

family: Ray-Coquard

full_name: Isabelle-Laure Ray-Coquard

given: Isabelle-Laure

family: Richardson

full_name: Gary E Richardson

given: Gary E

family: Sessa

full_name: Cristiana Sessa

given: Cristiana

family: Yonemori

full_name: Kan Yonemori

given: Kan

full_name: Susana Banerjee

given: Susana

family: Leary

full_name: Alexandra Leary

given: Alexandra

family: Tinker

full_name: Anna V Tinker

given: Anna V

family: Jung

full_name: Kyung Hae Jung

given: Kyung Hae

family: Madry

full_name: Radoslaw Madry

given: Radoslaw

family: Park

full_name: Sang-Yoon Park

given: Sang-Yoon

family: Anderson

full_name: Charles K Anderson

given: Charles K

family: Zohren

full_name: Fabian Zohren

given: Fabian

family: Stewart

full_name: Ross A Stewart

given: Ross A

family: Wei

full_name: Caimiao Wei

given: Caimiao

family: Dychter

full_name: Samuel S Dychter

given: Samuel S

family: Monk

full_name: Bradley J Monk

given: Bradley J

journal_name: The Lancet Oncology

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:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Canada
Korea, Republic of
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
United States
United Kingdom
Italy
Austria
Czechia
Israel
Spain

location_facility: US Oncology Investigational Products Center

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: State Regional Budgetary Healthcare Institution "Regional clinical oncology dispensary"

location_facility: Oncology Pharmacy McGill University Health Centre

location_facility: British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior

location_facility: Hillcrest Hospital Hirsch Cancer Center Pharmacy

location_facility: Texas Oncology - San Antonio Medical Center

location_facility: Nottingham University Hospital NHS Trust

location_facility: State Budgetary Healthcare Institution of Nizhegorogsky region

location_facility: The University of Kansas Cancer Center and Medical Pavilion

location_facility: Federal State Budgetary Institution "Russian Cancer Research Center n.a. N.N. Blokhin"

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: McGill University Health Centre - Glen Site

location_facility: State Budgetary Healthcare Institution Pyatigorsk Oncology Dispensary

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: Fairview Hospital Moll Pavilion Cancer Center

location_facility: National Defense Medical College Hospital

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w

location_facility: Vseobecna fakultni nemocnice v Praze, Nemocnicni lekarna,

location_facility: Epic Pharmacy,Newcastle Private Hospital

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: Nova Scotia Health Authority, QEII Health Sciences Centre, Nova Scotia Cancer Centre

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Vseobecna fakultni nemocnice v Praze, Neurologicka klinika

location_facility: University College London Hospital NHS Foundation Trust

location_facility: Universitatsspital Zurich, Institut fur diagnostische und interventionelle Radiologie

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Onkologiai Kozpont

location_facility: Clinical Trial Pharmacy, Taipei Veterans General Hospital

location_facility: State Budget Institution of Healthcare Saint Petersburg Clinical Scientific - Practice Center

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

location_facility: Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

location_facility: The University of Pennsylvania Health System

location_facility: Institut Catala d'Oncologia - Hospital Duran y Reynalds

location_facility: Saitama Medical University International Medical Center

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: The Christie Hospital NHS Foundation Trust

location_facility: Norton Cancer Institute, Brownsboro Hospital Campus

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Texas Oncology -Fort Worth Cancer Center

location_facility: Poliambulatorio Specialistico Villa Salute

location_facility: Clinical Trial Pharmacy, Mackay Memorial Hospital

location_facility: The University of Kansas Clinical Research Center

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Norton Healthcare Pharmacy, Attn: Marlon Baranda, Pharm D

location_facility: Humanitas, Unita Operativa di Cardiologia 2

location_facility: University of California, Irvine/UC Irvine Health

location_facility: Clinical Trial Pharmacy, Keimyung University Dongsan Medical Center

location_facility: State Budgetary Healthcare Institution "Clinical oncology dispensary #1"

location_facility: Severance Hospital, Yonsei University Health System, Clinical Trial Pharmacy

location_facility: Spire Healthcare Limited (St. Anthony's Hospital)

location_facility: National Cancer Centre Singapore Pharmacy

location_facility: Luzerner Kantonsspital, Medizinische Onkologie, Studienzentrale Onkologie

location_facility: Guy's & St. Thomas' NHS Foundation Trust

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: Fondazione Poliambulanza Istituto Ospedelario

location_facility: Azienda Unita Sanitaria Locale di Piacenza

location_facility: Clinical Trial Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Ambulatorio dott. Francesco Cavanna, Medico Chirurgo

location_facility: The University of Kansas Cancer Center, CCP - North

location_facility: Samsung Medical Center Clinical Trial Pharmacy

location_facility: Orszagos Onkologiai Intezet, Gyogyszertar

location_facility: Vseobecna fakultni nemocnice v Praze, Fakultni poliklinika

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku, Apteka Szpitalna

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Apteka Szpitalna

location_facility: General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Department of Medical Oncology

location_facility: Center of Hope at Renown Regional Medical Center

location_facility: Krajska zdravotni a.s., Masarykova nemocnice v Usti nad Labem, o.z

location_facility: Norton Cancer Institute, Norton Healthcare Pavilion

location_facility: Congregazione delle Suore Infermiere dell'Addolorata

location_facility: Chemotherapy Pharmacy, Chang Gung Memorial Hospital - Linkou Branch

location_facility: lnstitut Catala d Oncologia de Girona. Hospital Universitario Dr. Josep Trueta

location_facility: Universitatsspital Zurich, Universitares Herzzentrum Zurich

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: State Budgetary Healthcare Institution "Orenburg Regional Clinical Oncological Dispensary"

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Keimyung University Dongsan Medical Center

location_facility: Universitaetsspital Zurich, Klinik fuer Gynakologie

location_facility: State Budgetary Healthcare Institution "Oncology Center #2" of the Ministry of Healthcare

location_facility: Centrum Onkologii, Instytut im. M. Sklodowskiej-Curie, Oddzial w Krakowie, Apteka Szpitalna

location_facility: Regione Lombardia, A O Istituti Ospitalieri di Cremona

location_facility: Servizio Sanitario Regionale Emilia-Romagna

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Department of Obstetrics and Gynecology, Haukeland University Hospital

location_facility: Fairview Hospital Moll Pavilion Pharmacy

location_facility: Investigational Drug Services, University of Pennsylvania

location_facility: Medizinische Universitat Graz, LKH-Univ. Klinikum Graz

location_facility: Universitatsspital Zurich, Clinical Trials Center

location_facility: Clinical Trial Pharmacy, National Cheng Kung University Hospital

location_facility: Nippon Medical School Musashikosugi Hospital

title: A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY OF AVELUMAB (MSB0010718C) ALONE OR IN COMBINATION WITH PEGYLATED LIPOSOMAL DOXORUBICIN VERSUS PEGYLATED LIPOSOMAL DOXORUBICIN ALONE IN PATIENTS WITH PLATINUM-RESISTANT/REFRACTORY OVARIAN CANCER

summary: A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian cancer.


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of the Safety and Tolerability of N-Acetylcysteine in Patients With Idiopathic Pulmonary Fibrosis With Background Treatment of Pirfenidone

summary: This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary fibrosis (IPF) receiving background pirfenidone therapy.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Austria
Sweden
France
Belgium
Denmark
Germany
United Kingdom


ReferenceCitation: Stenzl A, Dunshee C, De Giorgi U, Alekseev B, Iguchi T, Szmulewitz RZ, Flaig TW, Tombal B, Morlock R, Ivanescu C, Ramaswamy K, Saad F, Armstrong AJ. Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study. Eur Urol. 2020 Oct;78(4):603-614. doi: 10.1016/j.eururo.2020.03.019. Epub 2020 Apr 23.

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

family: Dunshee

full_name: Curtis Dunshee

given: Curtis

family: De Giorgi

full_name: Ugo De Giorgi

given: Ugo

family: Alekseev

full_name: Boris Alekseev

given: Boris

family: Iguchi

full_name: Taro Iguchi

given: Taro

family: Szmulewitz

full_name: Russell Z. Szmulewitz

given: Russell Z.

family: Flaig

full_name: Thomas W. Flaig

given: Thomas W.

family: Tombal

full_name: Bertrand Tombal

given: Bertrand

family: Morlock

full_name: Robert Morlock

given: Robert

family: Ivanescu

full_name: Cristina Ivanescu

given: Cristina

family: Ramaswamy

full_name: Krishnan Ramaswamy

given: Krishnan

family: Saad

full_name: Fred Saad

given: Fred

family: Armstrong

full_name: Andrew J. Armstrong

given: Andrew J.

journal_name: European Urology

oa_host_type: publisher

ReferenceCitation: Armstrong AJ, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore ND, Rosbrook B, Sugg J, Baron B, Chen L, Stenzl A. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019 Nov 10;37(32):2974-2986. doi: 10.1200/JCO.19.00799. Epub 2019 Jul 22.

name: Duke Cancer Institute Center for Prostate and Urologic Cancers, Durham, NC

family: Petrylak

full_name: Daniel P. Petrylak

given: Daniel P.

name: The University of Kansas Medical Center, Kansas City, KS

family: Holzbeierlein

full_name: Jeffrey Holzbeierlein

given: Jeffrey

family: Villers

full_name: Arnauld Villers

given: Arnauld

name: Monash Health, Melbourne, Victoria, Australia

family: Azad

full_name: Arun Azad

given: Arun

name: Hospital Clinic of Barcelona, Barcelona, Spain

family: Alcaraz

full_name: Antonio Alcaraz

given: Antonio

name: Hertzen Moscow Cancer Research Institute, Moscow, Russia

name: Osaka City University Graduate School of Medicine, Osaka, Japan

name: Carolina Urologic Research Center, Myrtle Beach, SC

name: Astellas Pharma, Leiden, the Netherlands

name: Eberhard Karls University of Tübingen, Tübingen, Germany

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

publisher_group: American Society of Clinical Oncology (ASCO)

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Finland
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Chile
Sweden
Netherlands
United States
Germany
United Kingdom
Italy
Israel
New Zealand
Spain

location_facility:
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title: A Multinational, Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

summary: The purpose of this study was to evaluate the efficacy of enzalutamide plus androgen deprivation therapy (ADT) as measured by radiographic progression-free survival (rPFS) based on central review. The study also evaluated the safety of enzalutamide plus ADT in mHSPC.