title: A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]

summary: The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

family: Singh

full_name: Dave Singh

given: Dave

family: Wedzicha

full_name: Jadwiga A. Wedzicha

given: Jadwiga A.

family: Siddiqui

full_name: Salman Siddiqui

given: Salman

family: de la Hoz

full_name: Alberto de la Hoz

given: Alberto

family: Xue

full_name: Wenqiong Xue

given: Wenqiong

family: Magnussen

full_name: Helgo Magnussen

given: Helgo

family: Miravitlles

full_name: Marc Miravitlles

given: Marc

family: Chalmers

full_name: James D. Chalmers

given: James D.

family: Calverley

full_name: Peter M. A. Calverley

given: Peter M. A.

currency_apc_doaj: GBP

journal_name: Respiratory Research

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: University of Dundee - Discovery Research Portal

repositories_institution: University of Dundee - Discovery Research Portal

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(®)/DYNAGITO(®) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.

family: Buhl

full_name: Roland Buhl

given: Roland

family: Vogelmeier

full_name: Claus F. Vogelmeier

given: Claus F.

family: Anzueto

full_name: Antonio Anzueto

given: Antonio

title: Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO®/DYNAGITO® Trials

ReferenceCitation: Ferguson GT, Buhl R, Bothner U, Hoz A, Voß F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.

ReferenceCitation: Calverley PMA, Anzueto AR, Carter K, Grönke L, Hallmann C, Jenkins C, Wedzicha J, Rabe KF. Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial. Lancet Respir Med. 2018 May;6(5):337-344. doi: 10.1016/S2213-2600(18)30102-4. Epub 2018 Apr 5.

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

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title: Brentuximab Vedotin Associated With Chemotherapy in Untreated Patients With Stage I/II Unfavourable Hodgkin Lymphoma. A Randomized Phase II LYSA-FIL-EORTC Intergroup Study

acronym: BREACH

summary: This study aims to evaluate the efficacy of brentuximab vedotin + AVD combination (doxorubicine, vinblastine, dacarbazine) in patients with Hodgkin lymphoma stage I / II with an unfavorable diagnosis, assessed by the negativity of PET (positron emission tomography ) after two cycles of chemotherapy.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Netherlands Croatia France Belgium Denmark

location_facility: Centre Hospitalier de Versailles - André Mignot

location_facility: Erasmus MC Cancer Institute - location Daniel den Hoed

location_facility: Academisch Medisch Centrum - Universiteit van Amsterdam

location_facility: Radboud University Medical Center Nijmegen

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: Other Identifier

type: Registry Identifier

title: A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 In Completely Resected Non-Small Cell Lung Cancer

summary: The purpose of this study is to find out whether it is better to receive a new drug, MEDI4736, or better to receive no further treatment after surgery (and possibly chemotherapy) for lung cancer.

enrollment_type: Anticipated

lead_sponsor: Canadian Cancer Trials Group

location_country:
Italy
Brazil
United States
Netherlands
Spain
France
Bulgaria
Japan
Poland
Romania
Hungary
Australia
Singapore
New Zealand
China
Canada
Korea, Republic of
Taiwan
Ukraine

location_facility: Hematology and Oncology Associates of NEPA

location_facility: Sir run run shaw hospital School of Medicine

location_facility: Spitalul de Psihiatrie Dr. Constantin Gorgos

location_facility: PO A Perrino ASL Brindisi - UOC Oncologia Medica

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Dnipropetrovsk City Clinical Hospital No.4

location_facility: Azienda Ospedaliera di Rilievo Nazionale

location_facility: Ospedale S. Paolo - U.O. di Oncologia Medica

location_facility: Hospital Evangelico de Cachoeiro de Itapemirim

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: National Hospital Organization Kinki-Chuo

location_facility: Complejo Asistencial Universitario de Leon

location_facility: Thunder Bay Regional Health Sciences Centre/Thunder

location_facility: AOU Policlinico Vittorio Emanuele UOC di Oncologia

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Annemasse - Centre Hospitalier Alpes Leman

location_facility: CHUM-Centre Hospitalier de l'Universite de Montreal

location_facility: Liverpool Cancer Therapy Centre, Liverpool Hospital

location_facility: Frankston Hospital - Peninsula Oncology Centre

location_facility: Vinnytsia Regional Clinical Oncology Dispensary

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Centro de Oncologia e Radioterapia (COR) Mae de Deus

location_facility: Azienda USL di Piacenza, Ospedale Gugliemimo Salieto

location_facility: Stronach Regional Health Centre at Southlake

location_facility: Centre Hospitalier Regional Hopital de la Source

location_facility: The Affiliated Hospital Of Xuzhou Medical College

location_facility: Suporte Nutricional e Quimioterapia LTDA PRONUTRIR

location_facility: Istituti Fisioterapici Ospitalieri IFO Istituto

location_facility: Klinika Onkologii i Radioterapii Uniwersyteckie

location_facility: The Second Affiliated Hosp of Shantou Medical Colleg

location_facility: The Affiliated Hospital Of Qingdao University

location_facility: The Catholic University of Korea Bucheon

location_facility: Centre Hospitalier Intercommunal - Elbeuf

location_facility: Universita Federico II UOC Oncologia Medica

location_facility: Kinki University Hospital Faculty of Medicine

location_facility: Semmelweis University Pulmonology Department

location_facility: Hospital General Universitario de Valencia

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Chang-Gung Memorial Hospital - Kaohsiung

location_facility: Centre hospitalier universitaire de Montpellier

location_facility: U.O. di Oncologia Medica Azienda Ospedaliera G Rummo

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: The Second Xiangya Hospital of Central South Univer

location_facility: Centre Integre Universitaire De Sante Et De Services

location_facility: Hospital of the University of Occupational and

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: National Hospital Organization Kure Medical Center

location_facility: National Hospital Organization Yamaguchi

location_facility: UOC Oncologia Medica II Instituto Oncologio Veneto

location_facility: Royal Melbourne Hospital Research Foundation

location_facility: IRCCS Ospedale Oncologico Giovanni Paolo II

location_facility: Unita Sperimentazioni Cliniche Istituto per lo

location_facility: Samodzielny Publiczny Szpital Specjalistyczny

location_facility: Keimyung University Dongsan Medical Center

location_facility: Fondazione Salvatore Maugeri Oncologia Medica

location_facility: The People Hospital of Guangxi Zhuang Autonomous Reg

location_facility: Thonon-les-Bains - Hopital Georges Pianta

location_facility: OUC Oncologia Medica - Presidio Ospedaliero

location_facility: Dott. Fortunato Ciardiello,Cattedra Oncologia Medica

location_facility: Oncologia Medica IRCCS Arcispedale Maria

location_facility: Universitair medisch centrum Nijmegen st Radboud

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Azienda Ospedaliera di Perugia Santa Maria

location_facility: The Research Institute of the McGill University


title: Real-World Treatment Patterns, BRCA Testing Practices, Outcomes, and Health Care Utilization in Platinum-Sensitive Recurrent Serous Ovarian Cancer: A Multi-Country Retrospective Study

acronym: OSCA

summary: This study will be carried out as a retrospective, non-interventional observational review of medical records for patients in multiple countries with platinum-sensitive recurrent serous ovarian cancer. The objectives are to describe in a real-world population, treatment patterns, BRCA mutation testing and results, overall survival, health care utilization and also to estimate rates of selected treatment- and/or disease-related side effects

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

lead_sponsor: AstraZeneca

location_country:
Italy
Switzerland
Netherlands
Spain
Germany
France
Israel
Belgium
Australia
Portugal
Canada
United Kingdom
Korea, Republic of

intervention_type: Other

status_simplified: Completed


type: EudraCT Number

title: A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High Dose Therapy

summary: The purpose of this study is to compare the efficacy of daratumumab in combination with lenalidomide and dexamethasone to that of lenalidomide and dexamethasone in terms of progression-free survival (PFS) in participants with newly diagnosed multiple myeloma (a blood cancer of plasma cells) who are not candidates for high dose chemotherapy (treatment of disease, usually cancer, by chemical agents) and autologous stem cell transplant (ASCT).

ReferenceType: derived

ReferenceCitation: Facon T, Kumar SK, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Wang J, Van Rampelbergh R, Uhlar CM, Tromp B, Delioukina M, Vermeulen J, Usmani SZ. Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Nov;22(11):1582-1596. doi: 10.1016/S1470-2045(21)00466-6. Epub 2021 Oct 13.

family: Facon

full_name: Thierry Facon

given: Thierry

sequence: first

family: Kumar

full_name: Shaji K Kumar

given: Shaji K

sequence: additional

family: Plesner

full_name: Torben Plesner

given: Torben

family: Orlowski

full_name: Robert Z Orlowski

given: Robert Z

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Bahlis

full_name: Nizar Bahlis

given: Nizar

family: Basu

full_name: Supratik Basu

given: Supratik

family: Nahi

full_name: Hareth Nahi

given: Hareth

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Quach

full_name: Hang Quach

given: Hang

family: Goldschmidt

full_name: Hartmut Goldschmidt

given: Hartmut

family: O'Dwyer

full_name: Michael O'Dwyer

given: Michael

family: Perrot

full_name: Aurore Perrot

given: Aurore

family: Venner

full_name: Christopher P Venner

given: Christopher P

family: Weisel

full_name: Katja Weisel

given: Katja

family: Mace

full_name: Joseph R Mace

given: Joseph R

family: Raje

full_name: Noopur Raje

given: Noopur

family: Tiab

full_name: Mourad Tiab

given: Mourad

family: Macro

full_name: Margaret Macro

given: Margaret

family: Frenzel

full_name: Laurent Frenzel

given: Laurent

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Ahmadi

full_name: Tahamtan Ahmadi

given: Tahamtan

family: Wang

full_name: Jianping Wang

ReferenceCitation: Cavo M, San-Miguel JFF, Usmani SZ, Weisel KC, Dimopoulos MAA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria VTM, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar SK, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi NC. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, MAIA. Blood. 2021 Jul 21. pii: blood.2021011101. doi: 10.1182/blood.2021011101. [Epub ahead of print]

name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia, Bologna, Italy

name: Clínica Universidad de Navarra, Centro de Investigación Médica Aplicada (CIMA), Instituto de Investigación Sanitaria de Navarra, (IDISNA), CIBER-ONC number CB16/12/00369, Pamplona, Navarra, Spain

name: Levine Cancer Institute/Atrium Health, Charlotte, North Carolina, United States

name: University Medical Center Hamburg-Eppendorf, Hamburg, Germany

name: National and Kapodistrian University of Athens, Athens, Greece

name: Unite de Genomique du Myelome, IUC-Oncopole, Toulouse, France

name: Clinica Universidad de Navarra, Pamplona, Spain

name: Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, Canada

name: Centre Hospitalier Universitaire de Nantes, Nantes, France

name: Hospital Universitario de Salamanca, Instituto de Investigacion Biomedica de Salamanca, Instituto de Biologia Molecular y Celular del Cancer (Universidad de Salamanca-Consejo Superior de Investigacion, Salamanca, Spain

name: CHU Toulouse - IUCT Oncopole, Toulouse, France

name: Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

name: Centre Hospitalier Universitaire (CHU) Lille, Service des Maladies du Sang, University of Lille, Lille, France

name: Mayo Clinic, Rochester, Minnesota, United States

name: Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands

name: Erasmus MC Cancer Institute Rotterdam, Rotterdam, Netherlands

name: Alfred Hospital-Monash University, Melbourne, Australia

name: Janssen Research & Development, LLC, Spring House, Pennsylvania, United States

name: Janssen Pharmaceuticals, Belle Mead, New Jersey, United States

name: Janssen Global Medical Affairs, United States

name: Janssen Research & Development, Raritan, New Jersey, United States

name: Janssen Research & Development, LLC, Raritan, New Jersey, United States

name: Dana-Farber Cancer Institute, Boston, Massachusetts, United States

ReferenceCitation: San-Miguel JF, Avet-Loiseau H, Paiva B, Kumar SK, Dimopoulos MAA, Facon T, Mateos MV, Touzeau C, Jakubowiak AJ, Usmani SZ, Cook G, Cavo M, Quach H, Ukropec J, Ramaswami P, Pei H, Qi M, Sun S, Wang J, Krevvata M, DeAngelis N, Heuck C, Van Rampelbergh R, Kudva A, Kobos R, Qi M, Bahlis NJ. Sustained Minimal Residual Disease Negativity With Daratumumab in Newly Diagnosed Multiple Myeloma: MAIA and ALCYONE. Blood. 2021 Jul 16. pii: blood.2020010439. doi: 10.1182/blood.2020010439. [Epub ahead of print]

name: University of Chicago, Chicago, Illinois, United States

name: University of Leeds, Leeds, United Kingdom

name: St.Vincent's Hospital Melbourne and University of Melbourne, Fitzroy, Australia

name: Genmab, Harleysville, Pennsylvania, United States

name: Janssen Research & Development, LLC, Titusville, New Jersey, United States

name: Janssen, Titusville (Hopewell Township), New Jersey, United States

name: Janssen Research & Development, Beerse, Belgium

name: Janssen Research and Development, LLC., Spring House, Pennsylvania, United States

ReferenceCitation: Perrot A, Facon T, Plesner T, Usmani SZ, Kumar S, Bahlis NJ, Hulin C, Orlowski RZ, Nahi H, Mollee P, Ramasamy K, Roussel M, Jaccard A, Delforge M, Karlin L, Arnulf B, Chari A, He J, Ho KF, Van Rampelbergh R, Uhlar CM, Wang J, Kobos R, Gries KS, Fastenau J, Weisel K. Health-Related Quality of Life in Transplant-Ineligible Patients With Newly Diagnosed Multiple Myeloma: Findings From the Phase III MAIA Trial. J Clin Oncol. 2021 Jan 20;39(3):227-237. doi: 10.1200/JCO.20.01370. Epub 2020 Dec 16.

name: Hematology Department, Cancer University Institute Oncopole, Toulouse, France

name: Service des Maladies du Sang, Hôpital Claude Huriez, Lille, France

name: Vejle Hospital and University of Southern Denmark, Vejle, Denmark

name: Levine Cancer Institute/Atrium Health, Charlotte, NC

name: Department of Hematology, Mayo Clinic Rochester, Rochester, MN

name: University of Calgary, Arnie Charbonneau Cancer Research Institute, Calgary, AB, Canada

name: Department of Hematology, Hospital Haut Leveque, University Hospital, Pessac, France

name: Department of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX

name: Division of Hematology, Department of Medicine, Karolinska Institute, Karolinska University Hospital at Huddinge, Stockholm, Sweden

name: Princess Alexandra Hospital and University of Queensland, Brisbane, Australia

name: Oxford University Hospital and NIHR BRC Blood Theme, Oxford, United Kingdom

name: Centre Hospitalier Universitaire, Limoges, France

name: Department of Hematology, University Hospital Leuven, Belgium

name: Centre Hospitalier Lyon-Sud Hematologie (HCL), Pierre—Benite Cedex, France

name: Hematology/Oncology, Hopital Saint Louis, Paris, France

name: Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY

name: Janssen Research & Development, Raritan, NJ

name: Department of Oncology, Hematology, BMT with Department of Pneumology, University Medical Center Hamburg, Hamburg, Germany

publisher: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Facon T, Kumar S, Plesner T, Orlowski RZ, Moreau P, Bahlis N, Basu S, Nahi H, Hulin C, Quach H, Goldschmidt H, O'Dwyer M, Perrot A, Venner CP, Weisel K, Mace JR, Raje N, Attal M, Tiab M, Macro M, Frenzel L, Leleu X, Ahmadi T, Chiu C, Wang J, Van Rampelbergh R, Uhlar CM, Kobos R, Qi M, Usmani SZ; MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med. 2019 May 30;380(22):2104-2115. doi: 10.1056/NEJMoa1817249.

name: From University of Lille, Centre Hospitalier Universitaire (CHU) Lille, Service des Maladies du Sang, Lille (T.F.), Hematology Department, University Hospital Hôtel-Dieu, Nantes (P.M.), Department of Hematology, Hospital Haut Leveque, University Hospital, Pessac (C.H.), Hematology Department, University Hospital, Vandoeuvre lès Nancy (A.P.), Service d’Hématologie, CHU de Toulouse–Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse (M.A.), Department of Hematology, Vendée Hospital, La Roche...

location_country:
Austria
United States
Sweden
Netherlands
Germany
France
Israel
Ireland
Australia
Belgium
Denmark
Canada
United Kingdom


title: A Prospective Registry of Patients With a Confirmed Diagnosis of Adenocarcinoma of the Prostate Presenting With Metastatic Castrate-Resistant Prostate Cancer

summary: The purpose of this registry is to document the characteristics and management of patients with metastatic castrate resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used. Given the rapidly evolving landscape in mCRPC treatments, there is a need for a current and improved understanding of how these treatments fit into the current treatment paradigm for mCRPC, how they are combined and sequenced, and how their relative effectiveness profiles emerge outside of a clinical trial setting. This will be based on documentation and description of sequencing of treatment initiation, termination, and duration; relative effectiveness of treatments; defined medical resource utilization (MRU) and quality-of-life parameters and follow-up for survival.

time_perspective: Prospective

ReferenceCitation: Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaëth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S. Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry. Target Oncol. 2021 May;16(3):357-367. doi: 10.1007/s11523-021-00807-4. Epub 2021 Apr 7.

family: Bjartell

full_name: Anders Bjartell

given: Anders

family: Lumen

full_name: Nicolaas Lumen

given: Nicolaas

family: Maroto

full_name: Pablo Maroto

given: Pablo

family: Paiss

full_name: Thomas Paiss

given: Thomas

family: Gomez-Veiga

full_name: Francisco Gomez-Veiga

given: Francisco

family: Birtle

full_name: Alison Birtle

given: Alison

family: Kramer

full_name: Gero Kramer

given: Gero

family: Kalinka

full_name: Ewa Kalinka

given: Ewa

family: Spaëth

full_name: Dominique Spaëth

given: Dominique

family: Feyerabend

full_name: Susan Feyerabend

given: Susan

family: Matveev

full_name: Vsevolod Matveev

given: Vsevolod

family: Lefresne

full_name: Florence Lefresne

given: Florence

family: Lukac

full_name: Martin Lukac

given: Martin

family: Wapenaar

full_name: Robert Wapenaar

given: Robert

family: Costa

full_name: Luis Costa

given: Luis

family: Chowdhury

full_name: Simon Chowdhury

given: Simon

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Targeted Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

host_type: repository

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

ReferenceCitation: Chowdhury S, Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaëth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020 Jun;15(3):301-315. doi: 10.1007/s11523-020-00720-2.

repository_institution: Ghent University - Ghent University Academic Bibliography

location_country:
Luxembourg
Austria
Sweden
Switzerland
Spain
United Kingdom
France
Poland
Israel
Belgium
Russian Federation
Portugal
Turkey
Germany
Slovenia


title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma

summary: The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

ReferenceCitation: Wang M, Rule S, Zinzani PL, Goy A, Casasnovas O, Smith SD, Damaj G, Doorduijn J, Lamy T, Morschhauser F, Panizo C, Shah B, Davies A, Eek R, Dupuis J, Jacobsen E, Kater AP, Le Gouill S, Oberic L, Robak T, Covey T, Dua R, Hamdy A, Huang X, Izumi R, Patel P, Rothbaum W, Slatter JG, Jurczak W. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2018 Feb 17;391(10121):659-667. doi: 10.1016/S0140-6736(17)33108-2. Epub 2017 Dec 11.

family: Wang

full_name: Michael Wang

given: Michael

family: Rule

full_name: Simon Rule

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

family: Goy

full_name: Andre Goy

given: Andre

family: Casasnovas

full_name: Olivier Casasnovas

given: Olivier

family: Smith

full_name: Stephen D Smith

given: Stephen D

family: Damaj

full_name: Gandhi Damaj

given: Gandhi

family: Doorduijn

full_name: Jeanette Doorduijn

given: Jeanette

family: Lamy

full_name: Thierry Lamy

given: Thierry

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Panizo

full_name: Carlos Panizo

given: Carlos

family: Shah

full_name: Bijal Shah

given: Bijal

family: Davies

full_name: Andrew Davies

given: Andrew

family: Eek

full_name: Richard Eek

given: Richard

family: Dupuis

full_name: Jehan Dupuis

given: Jehan

family: Jacobsen

full_name: Eric Jacobsen

given: Eric

family: Kater

full_name: Arnon P Kater

given: Arnon P

family: Le Gouill

full_name: Steven Le Gouill

given: Steven

family: Oberic

full_name: Lucie Oberic

given: Lucie

family: Robak

full_name: Taduesz Robak

given: Taduesz

family: Covey

full_name: Todd Covey

given: Todd

family: Dua

full_name: Richa Dua

given: Richa

family: Hamdy

full_name: Ahmed Hamdy

given: Ahmed

family: Huang

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
Czechia
Poland
Belgium
Australia
Spain
United States
United Kingdom


ReferenceCitation: Chowdhury S, Oudard S, Uemura H, Joniau S, Dearden L, Capone C, Van Sanden S, Diels J, Hadaschik BA. Apalutamide Compared with Darolutamide for the Treatment of Non-metastatic Castration-Resistant Prostate Cancer: Efficacy and Tolerability in a Matching-Adjusted Indirect Comparison. Adv Ther. 2021 Nov 19. doi: 10.1007/s12325-021-01885-6. [Epub ahead of print]

family: Chowdhury

full_name: Simon Chowdhury

given: Simon

family: Oudard

full_name: Stephane Oudard

given: Stephane

family: Uemura

full_name: Hiroji Uemura

given: Hiroji

family: Joniau

full_name: Steven Joniau

family: Dearden

full_name: Lindsay Dearden

given: Lindsay

family: Capone

full_name: Camille Capone

given: Camille

family: Van Sanden

full_name: Suzy Van Sanden

given: Suzy

family: Diels

full_name: Joris Diels

given: Joris

family: Hadaschik

full_name: Boris A. Hadaschik

given: Boris A.

journal_name: Advances in Therapy

oa_host_type: publisher

ReferenceCitation: Fizazi K, Blue I, Nowak JT. Darolutamide and survival in nonmetastatic, castration-resistant prostate cancer: a patient perspective of the ARAMIS trial. Future Oncol. 2021 May;17(14):1699-1707. doi: 10.2217/fon-2020-1291. Epub 2021 Feb 8.

name: Institut Gustave Roussy, Villejuif, France

family: Fizazi

full_name: K Fizazi

given: K

family: Blue

full_name: Ian Blue

given: Ian

family: Nowak

full_name: Joel T Nowak

given: Joel T

journal_name: Future Oncology

evidence: open (via page says license)

license: cc-by-nd

license_normalized: cc-by-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Petrenciuc O, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide. N Engl J Med. 2020 Sep 10;383(11):1040-1049. doi: 10.1056/NEJMoa2001342.

name: From Institut Gustave Roussy, University of Paris-Saclay, Villejuif (K.F.), and Bayer Healthcare SAS, Loos (M.-A.L.B.) — both in France; Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and Tampere University, Tampere (T.L.T.), and Orion Pharma, Espoo (A.S., T.S.) — both in Finland; the National Cancer Institute, Vilnius (A.U.), and the Lithuanian University of Health Sciences, Medical Academy, Kaunas (M.J.) — both in Lithuania; Stradins Clinical University Hospital...

full_name: Karim Fizazi

given: Karim

family: Shore

full_name: Neal Shore

given: Neal

family: Tammela

full_name: Teuvo L. Tammela

given: Teuvo L.

family: Ulys

full_name: Albertas Ulys

given: Albertas

family: Vjaters

full_name: Egils Vjaters

given: Egils

repository_institution: Tampere University - Tampere University Institutional Repository

ReferenceCitation: Shore N, Zurth C, Fricke R, Gieschen H, Graudenz K, Koskinen M, Ploeger B, Moss J, Prien O, Borghesi G, Petrenciuc O, Tammela TL, Kuss I, Verholen F, Smith MR, Fizazi K. Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial. Target Oncol. 2019 Oct;14(5):527-539. doi: 10.1007/s11523-019-00674-0.

title: Evaluation of Clinically Relevant Drug–Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial

ReferenceCitation: Fizazi K, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Kappeler C, Snapir A, Sarapohja T, Smith MR; ARAMIS Investigators. Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2019 Mar 28;380(13):1235-1246. doi: 10.1056/NEJMoa1815671. Epub 2019 Feb 14.

name: From Institut Gustave Roussy, Université Paris-Sud, Villejuif, France (K.F.); Carolina Urologic Research Center, Myrtle Beach, SC (N.S.); Tampere University Hospital and University of Tampere, Tampere (T.L.T.), and Orion Pharma, Orion Corporation, Espoo (A.S., T.S.) — all in Finland; National Cancer Institute, Vilnius (A.U.), and Medical Academy, Lithuanian University of Health Sciences, Kaunas (M.J.) — both in Lithuania; Stradins Clinical University Hospital, Riga, Latvia (E.V.); N.N. Alexandrov...

location_country:
Peru
Finland
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
Spain
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
Colombia
South Africa
Sweden
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
Belarus
Estonia
Latvia

title: A Multinational, Randomised, Double-blind, Placebo-controlled, Phase III Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

summary: The purpose of this study is to assess the safety and efficacy of BAY1841788 (ODM-201) in patients with non-metastatic castration-resistant prostate cancer.