summary: This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).

ReferenceCitation: Verset G, Borbath I, Karwal M, Verslype C, Van Vlierberghe H, Kardosh A, Zagonel V, Stal P, Sarker D, Palmer DH, Vogel A, Edeline J, Cattan S, Kudo M, Cheng AL, Ogasawara S, Daniele B, Chan SL, Knox JJ, Qin S, Siegel AB, Chisamore M, Hatogai K, Wang A, Finn RS, Zhu AX. Pembrolizumab Monotherapy for Previously Untreated Advanced Hepatocellular Carcinoma: Data from the Open-Label, Phase II KEYNOTE-224 Trial. Clin Cancer Res. 2022 Jun 13;28(12):2547-2554. doi: 10.1158/1078-0432.CCR-21-3807.

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

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven);PubMed Central;archive.ugent.be;dipot.ulb.ac.be;figshare.com

repositories_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Association for Cancer Research

location_facility: Norrlands Universitetssjukhus ( Site 0687)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0676)

location_facility: Zhongshan Hospital affiliated to Fudan University ( Site 0153)

location_facility: National Taiwan University Hospital ( Site 0330)

location_facility: Hospital Universitario Puerta de Hierro ( Site 0678)

location_facility: Maharaj Nakorn Chiangmai Hospital ( Site 0353)

location_facility: Shalimov s NI of Surgery and Transplantation ( Site 0781)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0779)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 0606)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0469)

location_facility: Saitama Medical University Hospital ( Site 0104)

location_facility: The University of Tokyo Hospital ( Site 0105)

location_facility: The University of Arizona Cancer Center - North Campus ( Site 0039)

location_facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 0335)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0540)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 0665)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0118)

location_facility: City Clinical Oncology Center ( Site 0646)

location_facility: Bezmialem Vakif University School of Medicine ( Site 0732)

location_facility: Kings College Hospital NHS Foundation Trust ( Site 0758)

location_facility: Hospital Universitario La Paz ( Site 0677)

location_facility: Yokohama City University Medical Center ( Site 0110)

location_facility: Adnan Menderes University Medical Faculty ( Site 0737)

location_facility: City of Hope Medical Center ( Site 0027)

location_facility: Casa de Saude Santa Marcelina ( Site 0821)

location_facility: Hospital Universitario de Donostia ( Site 0671)

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino ( Site 0542)

location_facility: Universitaetsklinikum Tuebingen ( Site 0466)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0332)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 0661)

location_facility: Sahlgrenska Universitetssjukhuset ( Site 0691)

location_facility: Tallaght University Hospital ( Site 0499)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0483)

location_facility: Hospital Britanico de Buenos Aires ( Site 0792)

location_facility: Toranomon Hospital Kajigaya ( Site 0109)

location_facility: Konya Necmettin Erbakan University Medical Faculty ( Site 0736)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0757)

location_facility: Hospital Universitario Miguel Servet-Gastroenterology ( Site 0682)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0461)

location_facility: Vanderbilt Ingram Cancer Center ( Site 0006)

location_facility: Privolzhsky District Medical Center ( Site 0655)

location_facility: Universitaetsklinikum Koeln ( Site 0463)

location_facility: Medical Center Dobrobut Clinic ( Site 0785)

location_facility: City Clinical Hospital 1 na. NI. Pirogov ( Site 0662)

location_facility: Massachusetts General Hospital ( Site 0062)

location_facility: Fujian Provincial Cancer Hospital ( Site 0165)

location_facility: Zhongshan Hospital Fudan University ( Site 0193)

location_facility: Hospital Universitario Austral ( Site 0795)

location_facility: Staedtisches Klinikum Dresden ( Site 0471)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0826)

location_facility: Hospital Universitario Virgen del Rocio ( Site 0670)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 0042)

location_facility: Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek ( Site 0481)

location_facility: West China Hospital of Sichuan University ( Site 0162)

location_facility: Seoul National University Bundang Hospital ( Site 0313)

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University ( Site 0157)

location_facility: University Malaya Medical Centre ( Site 0288)

location_facility: National Medical Research Radiological Centre ( Site 0660)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 0711)

location_facility: SLK-Kliniken Heilbronn GmbH ( Site 0460)

location_facility: Altay Regional Oncology Dispensary ( Site 0919)

location_facility: National Cheng Kung University Hospital ( Site 0334)

location_facility: Hiroshima University Hospital ( Site 0117)

location_facility: Baskent Unv. Adana Uyg. ve Arast. Hastanesi ( Site 0733)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 0271)

location_facility: Peking University People's Hospital ( Site 0191)

location_facility: Regional Oncology Center of Kharkiv ( Site 0777)

location_facility: Siberian Clinical Center of FMBA ( Site 0918)

location_facility: Hospital Central de Asturias ( Site 0667)

location_facility: University of Cincinnati Medical Center ( Site 0084)

location_facility: Fundación favaloro para la Docencia e Investigación Médica ( Site 0808)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0730)

location_facility: Musashino Red Cross Hospital ( Site 0107)

location_facility: Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0982)

location_facility: Aarhus Universitets hospital ( Site 0420)

location_facility: Hospital de Cancer de Pernambuco ( Site 0815)

location_facility: Universitaetsklinikum Wuerzburg ( Site 0468)

location_facility: Medizinische Hochschule Hannover ( Site 0458)

location_facility: Institut Kanser Negara - National Cancer Institute ( Site 0294)

location_facility: Royal Prince Alfred Hospital AW ( Site 0225)

location_facility: Oslo Universitetssykehus HF. Ulleval ( Site 0433)

location_facility: Taipei Veterans General Hospital ( Site 0331)

location_facility: The Third Xiangya Hospital of Central South University ( Site 0167)

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0174)

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello ( Site 0547)

location_facility: Nottingham University Hospitals NHS Trust ( Site 0756)

location_facility: MI Odessa Regional Oncological Centre ( Site 0776)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0820)

location_facility: Anhui Provincil Hospital South District ( Site 0181)

location_facility: Baylor Scott & White Medical Center - Temple ( Site 0089)

location_facility: CHUV (centre hospitalier universitaire vaudois) ( Site 0712)

location_facility: Gulhane Egitim ve Arastirma Hastanesi ( Site 0741)

location_facility: Azienda Ospedaliero Universitaria Pisana ( Site 0546)

location_facility: Wakayama Medical University Hospital ( Site 0115)

location_facility: Saga-Ken Medical Centre Koseikan ( Site 0120)

location_facility: University Hospital Antwerp (UZA) ( Site 0374)

location_facility: Banner MD Anderson Cancer Center ( Site 0026)

location_facility: Inonu University Faculty of Medicine ( Site 0729)

location_facility: A O U Policlinico di Modena ( Site 0548)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0824)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0657)

location_facility: Charite - Campus Virchow Klinikum ( Site 0457)

location_facility: Samara Regional Clinical Oncology Center ( Site 0656)

location_facility: North Shore-Long Island Jewish Health System ( Site 0068)

location_facility: University Medical Center New Orleans ( Site 0014)

location_facility: Indiana University Simon Cancer Center ( Site 0075)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0211)

location_facility: China Medical University Hospital ( Site 0333)

location_facility: SZTE Szent-Gyorgyi Albert Klinikai Kozpont ( Site 0482)

location_facility: Universitaetsklinikum Frankfurt ( Site 0467)

location_facility: Universal Clinic Oberig-Oncology Center ( Site 0786)

location_facility: Hospital Universitari Parc Tauli ( Site 0681)

location_facility: St Vincents Hospital Melbourne ( Site 0227)

location_facility: Southern Medical University Nanfang Hospital ( Site 0172)

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba ( Site 0813)

location_facility: Japanese Red Cross Osaka Hospital ( Site 0113)

location_facility: Hospital Universitari Vall d Hebron ( Site 0674)

location_facility: Cambridge University Hospitals NHS Trust ( Site 0755)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 0750)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 0751)

location_facility: Haddassah Medical Organization - Ein Kerem ( Site 0519)

location_facility: Henry Ford Hospital-GI/Hepatology Research ( Site 0047)

location_facility: Princess Alexandra Hospital ( Site 0228)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 0549)

location_facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 0112)

location_facility: Road Hospital JSC Russian railways ( Site 0649)

location_facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 0484)

location_facility: James Graham Brown Cancer Center ( Site 0088)

location_facility: Karolinska Universitetssjukhuset, Huddinge ( Site 0689)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0208)

location_facility: McGill University Health Centre ( Site 0207)

location_facility: Hopital Claude Huriez CHRU LILLE ( Site 0440)

location_facility: St Vincent's University Hospital ( Site 0498)

location_facility: Seoul National University Hospital ( Site 0312)

location_facility: Fudan University Shanghai Cancer Center ( Site 0161)

location_facility: Osaka Metropolitan University Hospital. ( Site 0114)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0156)

location_facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 0470)

location_facility: AOU di Bologna Policliico S. Orsola-Malpighi ( Site 0541)

location_facility: Hospital Universiti Sains Malaysia ( Site 0295)

location_facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 0754)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie ( Site 0620)

location_facility: Namik Kemal Universitesi Tip Fakultesi ( Site 0738)

location_facility: Kanazawa University Hospital ( Site 0111)

location_facility: The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 0315)

location_facility: Kagawa Prefectural Central Hospital ( Site 0122)

location_facility: Istituto Tumori Giovanni Paolo II ( Site 0543)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0828)

location_facility: Severance Hospital Yonsei University Health System ( Site 0309)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0648)

location_facility: Virginia Mason Medical Center ( Site 0028)

location_facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0802)

location_facility: Miami Valley Hospital South ( Site 0093)

location_facility: Hunan Provincial People Hospital ( Site 0192)

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0604)

location_facility: Universitatsklinikum Carl Gustav Carus ( Site 0459)

location_facility: Izerskie Centrum Pulmonologii i Chemioterapii IZER-MED Spolka z o.o. ( Site 0607)

location_facility: Regional Clinical Onco Dispensary_ State Medical University ( Site 0782)

location_facility: Odense Universitets Hospital ( Site 0422)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0164)

location_facility: MTZ Clinical Research Sp. z o. o. ( Site 0608)

location_facility: Instituto COI de Pesquisa Educacao e Gestao ( Site 0825)

location_facility: Beth Israel Deaconess Medical Ctr. ( Site 0033)

location_facility: Hospital Provincial del Centenario ( Site 0794)

location_facility: Blokhin National Medical Oncology ( Site 0645)

location_facility: University of Massachusetts Worcester ( Site 0017)

location_facility: Hadassah Medical-Clinical Research Department ( Site 0920)

location_facility: Clinica de Oncologia Reichow ( Site 0818)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 0102)

location_facility: Complejo Hospitalario Universitario de Santiago ( Site 0668)

location_facility: CI City Clinical Hospital # 3 ( Site 0783)

location_facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 0550)

title: A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Versus Placebo as Adjuvant Therapy in Participants With Hepatocellular Carcinoma and Complete Radiological Response After Surgical Resection or Local Ablation (KEYNOTE-937)

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
China
Malaysia
Italy
Norway
United Kingdom
Sweden
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


type: EudraCT Number

title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia

summary:
This is a study in adults with schizophrenia. The study tests whether a medicine called BI 425809 together with brain training improves mental abilities.

Participants take study medication once a day for 12 weeks. At the start of the study, the participants are put into 2 groups. It is decided by chance who gets into which group. One group gets BI 425809 tablets every day. The other group gets placebo tablets every day. Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study, all participants do brain training using a computer.

The doctors regularly test mental abilities of the participants. The results of the mental ability tests are compared between the groups. The doctors also check the general health of the patients.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Harvey PD, Bowie CR, McDonald S, Podhorna J. Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial. Clin Drug Investig. 2020 Apr;40(4):377-385. doi: 10.1007/s40261-020-00893-8.

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

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

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ipd_sharing: Yes

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
New Zealand
United Kingdom
Australia
United States
Canada
France

location_facility: Jerome Golden Center for Behavioral Health

location_facility: IUSMM Institut Universitaire en Sante Mentale de Montreal

location_facility: UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center

location_facility: BC Mental Health and Addictions Research Institute (University of British Columbia)

location_facility: Collaborative Neuroscience Network, LLC (CNS)

location_facility: Monash Alfred Psychiatry Research Centre

location_facility: Centre for Addiction and Mental Health (CAMH)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Phase IIa Randomized, Double Blind, Placebo Controlled, Multiple Dose Study on ABX464 in Combination With Methotrexate (MTX), in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have Inadequate Response to MTX or/and to Anti-Tnfα, or Intolerance to Anti-Tnfα

summary: This Phase IIa study aims at investigating the safety and tolerability of 2 dose-levels of ABX464 administered daily in combination with methotrexate (MTX) in patients with moderate to severe active Rheumatoid Arthritis (RA) who had an inadequate response to MTX or/and to one or more anti- tumor necrosis factor alpha (TNFα) therapies.

ReferenceCitation: Daien C, Krogulec M, Gineste P, Steens JM, Desroys du Roure L, Biguenet S, Scherrer D, Santo J, Ehrlich H, Durez P. Safety and efficacy of the miR-124 upregulator ABX464 (obefazimod, 50 and 100 mg per day) in patients with active rheumatoid arthritis and inadequate response to methotrexate and/or anti-TNFalpha therapy: a placebo-controlled phase II study. Ann Rheum Dis. 2022 May 31;81(8):1076-84. doi: 10.1136/annrheumdis-2022-222228. Online ahead of print.

evidence: open (via page says license)

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

repository_normalized: HAL

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

repositories:
HAL
PubMed Central

repositories_concat: HAL;PubMed Central

publisher_dissemination: British Medical Journal

ipd_sharing: No

lead_sponsor: Abivax S.A.

location_country: Poland Hungary Belgium Czechia France

location_facility: CMed Rehabilitációs és Diagnosztikai Központ


lead_sponsor: Enyo Pharma

summary: The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH

ReferenceCitation: Ratziu V, Harrison SA, Loustaud-Ratti V, Bureau C, Lawitz E, Abdelmalek M, Alkhouri N, Francque S, Girma H, Darteil R, Couchoux H, Wolf M, Sanyal A, Vonderscher J, Scalfaro P. Hepatic and renal improvements with FXR agonist vonafexor in individuals with suspected fibrotic NASH. J Hepatol. 2023 Mar;78(3):479-492. doi: 10.1016/j.jhep.2022.10.023. Epub 2022 Nov 9.

oa_host_type: repository

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Limoges

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repositories: HAL irua

repositories_concat: HAL;irua

repositories_pmh: HAL irua

unpaywall_oa_status: green

publisher_dissemination: Elsevier

location_facility:
ENYO PHARMA Investigative site 0403
ENYO PHARMA Investigative site 0304
ENYO PHARMA Investigative site 0416
ENYO PHARMA Investigative site 0101
ENYO PHARMA Investigative site 0423
ENYO PHARMA Investigative site 0412
ENYO PHARMA Investigative site 0105
ENYO PHARMA Investigative site 0206
ENYO PHARMA Investigative site 0408
ENYO PHARMA Investigative site 0410
ENYO PHARMA Investigative site 0422
ENYO PHARMA Investigative site 0302
ENYO PHARMA Investigative site 0414
ENYO PHARMA Investigative site 0415
ENYO PHARMA Investigative site 0204
ENYO PHARMA Investigative site 0420
ENYO PHARMA Investigative site 0104
ENYO PHARMA Investigative site 0305
ENYO PHARMA Investigative site 0404
ENYO PHARMA Investigative site 0401
ENYO PHARMA Investigative site 0421
ENYO PHARMA Investigative site 0207
ENYO PHARMA Investigative site 0406
ENYO PHARMA Investigative site 0402
ENYO PHARMA Investigative site 0103
ENYO PHARMA Investigative site
ENYO PHARMA Investigative site 0417
ENYO PHARMA Investigative site 0303
ENYO PHARMA Investigative site 0201
ENYO PHARMA Investigative site 0205
ENYO PHARMA Investigative site 0405
ENYO PHARMA Investigative site 0424
ENYO PHARMA Investigative site 0418
ENYO PHARMA Investigative site 0411
ENYO PHARMA Investigative site 0203
ENYO PHARMA Investigative site 0429
ENYO PHARMA Investigative site 0407
ENYO PHARMA Investigative site 0409
ENYO PHARMA Investigative site 0301
ENYO PHARMA Investigative site 0413
ENYO PHARMA Investigative site 0419
ENYO PHARMA Investigative site 0202

title: A Phase 2a, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis

source: euctr

location_country:
United Kingdom
Belgium
United States
Puerto Rico
France


title: An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

acronym: RAPTOR

summary: The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

status: Terminated

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Japan
Czechia
Canada
France
Slovakia
Hong Kong
Denmark
Switzerland
United States
China
Puerto Rico
Italy
United Kingdom
Austria
Spain
Taiwan
Russian Federation
Israel

status_simplified: Unknown


title: BRIEF: Bendamustine and Rituximab In Elderly Follicular: A Multicentric Phase II Study Evaluating the Benefit of a Short Induction Treatment by Bendamustine and Rituximab Followed by Maintenance Therapy With Rituximab In Elderly (≥ 60 Years Old) Patients With Untreated Follicular Lymphoma Patients, With an Intermediate or High FLIPI Score

acronym: BRIEF

summary:
The objective of this study is to evaluate the complete response rate after a short induction treatment with rituximab (375mg/m2)and bendamustine (90mg/m2)in In Elderly (≥ 60 years old) patients with untreated Follicular lymphoma, with an intermediate or high FLIPI score and without high tumor burden.

This short induction is followed by a rituximab (375mg/m2)maintenance/ Induction schedule:Rituximab+Bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, rituximab on day 22, Bendamustine on Day 29, Bendamustine on Day 30 Maintenance schedule: 12 infusions of rituximab, each 8 weeks

ReferenceCitation: Gyan E, Sonet A, Brice P, Anglaret B, Laribi K, Fruchart C, Tilly H, Araujo C, Soubeyran P, Gonzalez H, Morineau N, Nicolas-Virelizier E, Ghesquieres H, Salles B, Bouabdallah R, Orfeuvre H, Fahri J, Couturier O, Xerri L, Feugier P; Lymphoma Study Association (LYSA). Bendamustine and rituximab in elderly patients with low-tumour burden follicular lymphoma. Results of the LYSA phase II BRIEF study. Br J Haematol. 2018 Oct;183(1):76-86. doi: 10.1111/bjh.15513. Epub 2018 Aug 16.

oa_host_type: publisher

evidence: open (via free article)

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

lead_sponsor: The Lymphoma Academic Research Organisation

location_country: Belgium France

location_facility: CHU LIMOGES - Hôpital Universitaire Dupuytren

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Université Catholique de Louvain Saint Luc

location_facility: AZ Groeninge - Campus Maria's Voorzienigheid

location_facility: Centre Hospitalier de Wallonie Picarde - CHwapi

location_facility: CHU de Poitiers - Hôpital de la Milétrie

location_facility: Centre Hospitalier de la Région d'Annecy

location_facility: Université Libre de Bruxelles - Hôpital Erasme


title: An Open-Label, Multicenter, Phase 1/2 Study of RP1 as a Single Agent and in Combination With PD1 Blockade in Patients With Solid Tumors

acronym: IGNYTE

summary: RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ReferenceCitation: Thomas S, Kuncheria L, Roulstone V, Kyula JN, Mansfield D, Bommareddy PK, Smith H, Kaufman HL, Harrington KJ, Coffin RS. Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. J Immunother Cancer. 2019 Aug 10;7(1):214. doi: 10.1186/s40425-019-0682-1.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

unpaywall_oa_status: gold

ipd_sharing: Undecided

lead_sponsor: Replimune Inc.

location_country:
Germany
United Kingdom
United States
Spain
France

location_facility: Institut Catala D'Oncologia - Hospital Duran I

location_facility: University of Wisconsin-Carbone Cancer Center

location_facility: Sylvester Comprehensive Cancer Center- University of Miami

location_facility: Seattle Cancer Care Alliance- University of Washington

location_facility: Service de Dermatologie et Cancerologie Cutanee Hopital de la Timone

location_facility: James Graham Brown Cancer Center- University of Louisville

location_facility: New York University Clinical Cancer Center

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: University of Kiel (UKSH), Dep. of Dermatology

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: University of Iowa-Cancer Center Research

location_facility: Hospital General Universitario de Valencia

location_facility: University Hospital Essen, Klinik für Dermatologie

location_facility: Eccles Outpatient Care Center- Oncology Clinical Trials

location_facility: Intermountain Cancer Center- Saint George Cancer Center

intervention_type: Biological

status_simplified: Ongoing


title: A Randomized, Multicenter, Double-blind, Parallel-group, Active-control Study of the Efficacy and Safety of Sparsentan for the Treatment of Immunoglobulin A Nephropathy

acronym: PROTECT

summary: To determine the long-term (approximately 2 years) nephroprotective potential of treatment with sparsentan as compared to an angiotensin receptor blocker in patients with immunoglobulin A nephropathy (IgAN).

status: Active, not recruiting

lead_sponsor: Travere Therapeutics, Inc.

location_country:
Germany
Italy
Lithuania
Poland
Portugal
New Zealand
United Kingdom
Hong Kong
Australia
Belgium
United States
Korea, Republic of
Spain
Croatia
Taiwan
Czechia
Estonia
France


title: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

acronym: e-NOBORI

summary:
Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.

Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.

Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year

study_type: Observational

time_perspective: Prospective

ReferenceType: background

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ReferenceCitation: Detre KM, Holmes DR Jr, Holubkov R, Cowley MJ, Bourassa MG, Faxon DP, Dorros GR, Bentivoglio LG, Kent KM, Myler RK. Incidence and consequences of periprocedural occlusion. The 1985-1986 National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. Circulation. 1990 Sep;82(3):739-50. doi: 10.1161/01.cir.82.3.739.

ReferenceCitation: Holmes DR Jr, Holubkov R, Vlietstra RE, Kelsey SF, Reeder GS, Dorros G, Williams DO, Cowley MJ, Faxon DP, Kent KM, et al. Comparison of complications during percutaneous transluminal coronary angioplasty from 1977 to 1981 and from 1985 to 1986: the National Heart, Lung, and Blood Institute Percutaneous Transluminal Coronary Angioplasty Registry. J Am Coll Cardiol. 1988 Nov;12(5):1149-55. doi: 10.1016/0735-1097(88)92593-4.

ReferenceCitation: Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, et al. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. N Engl J Med. 1994 Aug 25;331(8):496-501. doi: 10.1056/NEJM199408253310802.

ReferenceCitation: Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.

ReferenceCitation: Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.

ReferenceCitation: Stettler C, Wandel S, Allemann S, Kastrati A, Morice MC, Schomig A, Pfisterer ME, Stone GW, Leon MB, de Lezo JS, Goy JJ, Park SJ, Sabate M, Suttorp MJ, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen MT, Cervinka P, Petronio AS, Nordmann AJ, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet. 2007 Sep 15;370(9591):937-48. doi: 10.1016/S0140-6736(07)61444-5.

ReferenceCitation: Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.

ReferenceCitation: Holmes DR Jr, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial: a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation. 2004 Feb 10;109(5):634-40. doi: 10.1161/01.CIR.0000112572.57794.22.

ReferenceCitation: Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation. 2003 Jan 7;107(1):38-42. doi: 10.1161/01.cir.0000047700.58683.a1.

ReferenceCitation: Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007 Feb;2(4):426-34.

ReferenceCitation: Ostojic M, Sagic D, Beleslin B, Jung R, Perisic Z, Jagic N, Nedeljkovic M, Mangovski L, Milosavljevic B, Stojkovic S, Orlic D, Antonic Z, Miloradovic V, Topic D, Paunovic D. First clinical comparison of Nobori -Biolimus A9 eluting stents with Cypher- Sirolimus eluting stents: Nobori Core nine months angiographic and one year clinical outcomes. EuroIntervention. 2008 Mar;3(5):574-9. doi: 10.4244/eijv3i5a103.

ReferenceCitation: Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30. doi: 10.1001/jama.293.17.2126.

ReferenceCitation: Chevalier B, Silber S, Park SJ, Garcia E, Schuler G, Suryapranata H, Koolen J, Hauptmann KE, Wijns W, Morice MC, Carrie D, van Es GA, Nagai H, Detiege D, Paunovic D, Serruys PW; NOBORI 1 Clinical Investigators. Randomized comparison of the Nobori Biolimus A9-eluting coronary stent with the Taxus Liberte paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the NOBORI 1 trial--Phase 2. Circ Cardiovasc Interv. 2009 Jun;2(3):188-95. doi: 10.1161/CIRCINTERVENTIONS.108.823443. Epub 2009 May 8.

ReferenceCitation: Jain AK, Meredith IT, Lotan C, Rothman MT, Pateraki S; E-Five Investigators. Real-world safety and efficacy of the endeavor zotarolimus-eluting stent: early data from the E-Five Registry. Am J Cardiol. 2007 Oct 22;100(8B):77M-83M. doi: 10.1016/j.amjcard.2007.08.026.

ReferenceCitation: Urban P, Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa JE, Wijns W, Berge C, Deme M, Stoll HP; e-Cypher Investigators. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry. Circulation. 2006 Mar 21;113(11):1434-41. doi: 10.1161/CIRCULATIONAHA.104.532242. Epub 2006 Mar 13.

ReferenceCitation: Stone GW. SPIRIT IV A Prospective, Randomized Trial Comparing an Everolimus Eluting Stent and a Paclitaxel Eluting Stent in Patients With Coronary Artery Disease One Year Clinical Results. 2009.

ReferenceCitation: Grube E, Spirit V registry: one-year follow-up. EuroIntervention 2009; 5

ReferenceCitation: Turco MA, Ormiston JA, Popma JJ, Mandinov L, O'Shaughnessy CD, Mann T, McGarry TF, Wu CJ, Chan C, Webster MW, Hall JJ, Mishkel GJ, Cannon LA, Baim DS, Koglin J. Polymer-based, paclitaxel-eluting TAXUS Liberte stent in de novo lesions: the pivotal TAXUS ATLAS trial. J Am Coll Cardiol. 2007 Apr 24;49(16):1676-83. doi: 10.1016/j.jacc.2007.01.069. Epub 2007 Apr 6.

ReferenceCitation: Rodriguez-Granillo GA, Valgimigli M, Garcia-Garcia HM, Ong AT, Aoki J, van Mieghem CA, Tsuchida K, Sianos G, McFadden E, van der Giessen WJ, van Domburg R, de Feyter P, Serruys PW. One-year clinical outcome after coronary stenting of very small vessels using 2.25 mm sirolimus- and paclitaxel-eluting stents: a comparison between the RESEARCH and T-SEARCH registries. J Invasive Cardiol. 2005 Aug;17(8):409-12.

ReferenceCitation: Ong AT, van Domburg RT, Aoki J, Sonnenschein K, Lemos PA, Serruys PW. Sirolimus-eluting stents remain superior to bare-metal stents at two years: medium-term results from the Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registry. J Am Coll Cardiol. 2006 Apr 4;47(7):1356-60. doi: 10.1016/j.jacc.2005.05.102. Epub 2006 Mar 20.

ReferenceCitation: Galloe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR, Bligaard N, Saunamaki K, Junker A, Aaroe J, Abildgaard U, Ravkilde J, Engstrom T, Jensen JS, Andersen HR, Botker HE, Galatius S, Kristensen SD, Madsen JK, Krusell LR, Abildstrom SZ, Stephansen GB, Lassen JF; SORT OUT II Investigators. Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA. 2008 Jan 30;299(4):409-16. doi: 10.1001/jama.299.4.409.

ReferenceCitation: Kedhi E, Joesoef KS, McFadden E, Wassing J, van Mieghem C, Goedhart D, Smits PC. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): a randomised trial. Lancet. 2010 Jan 16;375(9710):201-9. doi: 10.1016/S0140-6736(09)62127-9. Epub 2010 Jan 7.

ReferenceCitation: Novack V, Cutlip D, Kleiman N, Pencina M, Mauri L, Yen CH, Berger P, Goldberg S, Kellett M, Waksman R, Hong M, Raizner AE, Cohen DJ. In-hospital and 1-year outcomes among unselected percutaneous coronary intervention patients treated with either sirolimus- or paclitaxel-eluting stents: results from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009 Aug;2(8):767-75. doi: 10.1016/j.jcin.2009.05.016.

ReferenceCitation: Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.

ReferenceCitation: Silber S, Albertsson P, Aviles FF, Camici PG, Colombo A, Hamm C, Jorgensen E, Marco J, Nordrehaug JE, Ruzyllo W, Urban P, Stone GW, Wijns W; Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Guidelines for percutaneous coronary interventions. The Task Force for Percutaneous Coronary Interventions of the European Society of Cardiology. Eur Heart J. 2005 Apr;26(8):804-47. doi: 10.1093/eurheartj/ehi138. Epub 2005 Mar 15.

ReferenceCitation: Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, Hartigan PM, Weintraub WS, O'Rourke RA, Dada M, Spertus JA, Chaitman BR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G, Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, Bates ER, McCallister B, Teo KK, Boden WE; COURAGE Investigators. Optimal medical therapy with or without percutaneous coronary intervention to reduce ischemic burden: results from the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial nuclear substudy. Circulation. 2008 Mar 11;117(10):1283-91. doi: 10.1161/CIRCULATIONAHA.107.743963. Epub 2008 Feb 11.

ReferenceCitation: Safian R.D. and Freed M., Complications. In: The Manual of Interventional Cardiology Jones & Bartlett Publishers, 2001. 381-467

ReferenceCitation: Tillmanns H, Waas W, Voss R, Grempels E, Holschermann H, Haberbosch W, Waldecker B. Gender differences in the outcome of cardiac interventions. Herz. 2005 Aug;30(5):375-89. doi: 10.1007/s00059-005-2716-3. English, German.

ReferenceCitation: Berger JS, Elliott L, Gallup D, Roe M, Granger CB, Armstrong PW, Simes RJ, White HD, Van de Werf F, Topol EJ, Hochman JS, Newby LK, Harrington RA, Califf RM, Becker RC, Douglas PS. Sex differences in mortality following acute coronary syndromes. JAMA. 2009 Aug 26;302(8):874-82. doi: 10.1001/jama.2009.1227.

ReferenceCitation: Briguori C, Airoldi F, Chieffo A, Carlino M, Montorfano M, Colombo A. Renal function and drug-eluting stent. Int J Cardiol. 2010 Jun 25;142(1):92-4. doi: 10.1016/j.ijcard.2008.11.138. Epub 2009 Jan 15.

ReferenceCitation: Latif F, Kleiman NS, Cohen DJ, Pencina MJ, Yen CH, Cutlip DE, Moliterno DJ, Nassif D, Lopez JJ, Saucedo JF; EVENT Investigators. In-hospital and 1-year outcomes among percutaneous coronary intervention patients with chronic kidney disease in the era of drug-eluting stents: a report from the EVENT (Evaluation of Drug Eluting Stents and Ischemic Events) registry. JACC Cardiovasc Interv. 2009 Jan;2(1):37-45. doi: 10.1016/j.jcin.2008.06.012.

ReferenceCitation: Rosenblum MA, Robbins MJ, Farkouh ME, Winston JA, Kim MC. Diminished benefits of drug-eluting stents versus bare metal stents in patients with severe renal insufficiency. Nephron Clin Pract. 2009;113(3):c198-202. doi: 10.1159/000232602. Epub 2009 Aug 12.

ReferenceCitation: Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schomig A; Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels. Eur Heart J. 2006 Feb;27(3):260-6. doi: 10.1093/eurheartj/ehi721. Epub 2006 Jan 9.

ReferenceCitation: Park SW, Lee CW, Hong MK, Kim JJ, Cho GY, Nah DY, Park SJ. Randomized comparison of coronary stenting with optimal balloon angioplasty for treatment of lesions in small coronary arteries. Eur Heart J. 2000 Nov;21(21):1785-9. doi: 10.1053/euhj.1999.1947.

ReferenceCitation: Ortolani P, Marzocchi A, Marrozzini C, Palmerini T, Saia F, Taglieri N, Aquilina M, Baldazzi F, Silenzi S, Cooke RM, Reggiani ML, Branzi A. Randomized comparative trial of a thin-strut bare metal cobalt-chromium stent versus a sirolimus-eluting stent for coronary revascularization. Catheter Cardiovasc Interv. 2007 May 1;69(6):790-8. doi: 10.1002/ccd.21011.

ReferenceCitation: Tanimoto S, Daemen J, Serruys PW. Update on stents: recent studies on the TAXUS stent system in small vessels. Vasc Health Risk Manag. 2007;3(4):481-90.

ReferenceCitation: Elezi S, Kastrati A, Pache J, Wehinger A, Hadamitzky M, Dirschinger J, Neumann FJ, Schomig A. Diabetes mellitus and the clinical and angiographic outcome after coronary stent placement. J Am Coll Cardiol. 1998 Dec;32(7):1866-73. doi: 10.1016/s0735-1097(98)00467-7.

ReferenceCitation: Stettler C, Allemann S, Egger M, Windecker S, Meier B, Diem P. Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials. Heart. 2006 May;92(5):650-7. doi: 10.1136/hrt.2005.070698. Epub 2005 Oct 26.

ReferenceCitation: Boccara F, Teiger E, Cohen A. Role of drug eluting stents in diabetic patients. Heart. 2006 May;92(5):579-81. doi: 10.1136/hrt.2005.082172. Epub 2006 Jan 31.

ReferenceCitation: Sukhija R, Mehta JL, Sachdeva R. Present status of coronary bifurcation stenting. Clin Cardiol. 2008 Feb;31(2):63-6. doi: 10.1002/clc.20177.

ReferenceCitation: Kim YH, Park SW, Lee SW, Park DW, Yun SC, Lee CW, Hong MK, Kim HS, Ko JK, Park JH, Lee JH, Choi SW, Seong IW, Cho YH, Lee NH, Kim JH, Chun KJ, Park SJ; Long-DES-II Study Investigators. Sirolimus-eluting stent versus paclitaxel-eluting stent for patients with long coronary artery disease. Circulation. 2006 Nov 14;114(20):2148-53. doi: 10.1161/CIRCULATIONAHA.106.666396. Epub 2006 Oct 23.

ReferenceCitation: Hannan EL, Wu C, Walford G, Culliford AT, Gold JP, Smith CR, Higgins RS, Carlson RE, Jones RH. Drug-eluting stents vs. coronary-artery bypass grafting in multivessel coronary disease. N Engl J Med. 2008 Jan 24;358(4):331-41. doi: 10.1056/NEJMoa071804.

ReferenceCitation: Nakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of left main coronary artery disease with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Oral Contributions Georgia World Congress Center, Room B315 Monday, March 15, 2010, 2:00 p.m.-2:12 p.m.). J Am Coll Cardiol 2010;55

ReferenceCitation: Lotan C, Almagor Y, Kuiper K, Suttorp MJ, Wijns W. Sirolimus-eluting stent in chronic total occlusion: the SICTO study. J Interv Cardiol. 2006 Aug;19(4):307-12. doi: 10.1111/j.1540-8183.2006.00151.x.

ReferenceCitation: Rahel BM, Suttorp MJ, Laarman GJ, Kiemeneij F, Bal ET, Rensing BJ, Ernst SM, ten Berg JM, Kelder JC, Plokker HW. Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study. Am Heart J. 2004 May;147(5):e22. doi: 10.1016/j.ahj.2003.11.023.

ReferenceCitation: Suttorp MJ, Laarman GJ, Rahel BM, Kelder JC, Bosschaert MA, Kiemeneij F, Ten Berg JM, Bal ET, Rensing BJ, Eefting FD, Mast EG. Primary Stenting of Totally Occluded Native Coronary Arteries II (PRISON II): a randomized comparison of bare metal stent implantation with sirolimus-eluting stent implantation for the treatment of total coronary occlusions. Circulation. 2006 Aug 29;114(9):921-8. doi: 10.1161/CIRCULATIONAHA.106.613588. Epub 2006 Aug 14.

ReferenceCitation: Nakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of chronic total occlusion: a comparison with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Poster Contributions Georgia World Congress Center, Hall B5 Monday, March 15, 2010, 9:30 a.m.-10:30 a.m. ). J Am Coll Cardiol 2010;55.

ReferenceCitation: Hamm CW, Braunwald E. A classification of unstable angina revisited. Circulation. 2000 Jul 4;102(1):118-22. doi: 10.1161/01.cir.102.1.118.

ReferenceCitation: Braunwald E. Unstable angina. A classification. Circulation. 1989 Aug;80(2):410-4. doi: 10.1161/01.cir.80.2.410. No abstract available.

ReferenceCitation: Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

ReferenceCitation: TIMI Study Group. The Thrombolysis in Myocardial Infarction (TIMI) trial. Phase I findings. N Engl J Med. 1985 Apr 4;312(14):932-6. doi: 10.1056/NEJM198504043121437. No abstract available.

lead_sponsor: Terumo Europe N.V.

location_country:
Germany
Ireland
Poland
Brazil
Malta
Chile
Czechia
Serbia
France
Slovenia
Belarus
Lithuania
Hungary
Denmark
Latvia
Ukraine
Indonesia
Romania
Estonia
Egypt
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Bangladesh
Taiwan
Bulgaria
Georgia
Russian Federation
Israel

location_facility: Hospital Universitario Dr. José Eleuterio Gonzalez

location_facility: Saratov Research Institute of science for cardiology

location_facility: National Institute of Cardiovascular Surgery AMS

location_facility: Gottsegen National Cardiology Institute (GOKI)

location_facility: Hospital Lomas de San Luis Internacional

location_facility: Fundação Bahiana de Cardiologia (MC Oliveira Prest

location_facility: National Heart Foundation Hospital & Research Institute

location_facility: Federal center of heart,blood and endocrinology diseases named by Almazov

location_facility: Uppsala Akademiska Sjukhus, Kardiologkliniken

location_facility: Republican Scientific and Practical Center of Cardiology

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Am Urban

location_facility: Szpital Klinicznk Przemienienia (University Hospital)

location_facility: Academian E.N Meshalkin State Research Institute of circulation Pathology

location_facility: Ev.Bethesda-Johanniter Klinikum Duisburg GmbH

location_facility: Institute for Cardiovascular Disease Dedinje

location_facility: Institut Hospitalier Jacques Cartier (ICPS Massy)

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hospital Cruz Vermelha Brasileira Filial do Paraná

location_facility: V Region (Hospital Gustavo Fricke, Hospital Van Buren, Clinica Reñaca)

location_facility: Hospital Santa Isabel-Sociedade Divina Providência

location_facility: Invasive Cardiology Laboratory of Clinics "Gailezers" of Riga's Eastern Clinical University Hospital

location_facility: State cardiovascular center based on regional clin

location_facility: Hospital Clínico Universitario de Salamanca

location_facility: Evangelisch Freikirchliches Krankenhaus und Herzze

location_facility: Uniklinik Schleswig-Holstein, Campus Kiel

location_facility: Irmandade da Santa Casa de Misericórdia de Marília

location_facility: Military Hospital N3 named by Vishnevsky

location_facility: Republican Clinical Medical Center (Presidential Hospital)

location_facility: Central Lasarettet i Västerås, Angio/PCI lab. Medi

location_facility: Clinique de l'Europe à Amiens (SAS Cardio Amiens)

location_facility: National Cardiovascular Center Harapan Kita

location_facility: Instituto Nacional De Cardiologia "Ignacio Chávez"

location_facility: Instituto do Coração do Triângulo Mineiro

location_facility: Instituto Cardiovascular de Linhares (Unicor)

location_facility: Central Clinical Hospital N°2 Russia Railways

location_facility: Hospital of Lithuania University of Health Science

location_facility: Frimley Park Hospital NHS Foundation Trust

location_facility: Hospital Beneficencia Portuguesa de Sao Paulo

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Friedrichs

location_facility: Vivantes Netzwerk für Gesundheit gmbH - Humboldt

location_facility: Hôpital Europeen Georges Pompidou (HEGP)

location_facility: Real e Benemérita Assoção Portuguesa de Beneficênc

location_facility: Royal Blackpool hospital (Lancashire Heart Centre)

location_facility: Southern Health and Social Care Trust Craigavon Ar

location_facility: Invasive Cardiology Laboratory of P. Stradins Clinical University Hospital

location_facility: Hospital Ana Costa (ENDOCOR Serviços Médicos Ltda)


title: A Phase III Randomized Study Evaluating the Efficacy and Safety of Continued and Re-induced Bevacizumab in Combination With Chemotherapy for Patients With Locally Recurrent or Metastatic Breast Cancer After First-line Chemotherapy and Bevacizumab Treatment

summary: This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

ReferenceCitation: Vrdoljak E, Marschner N, Zielinski C, Gligorov J, Cortes J, Puglisi F, Aapro M, Fallowfield L, Fontana A, Inbar M, Kahan Z, Welt A, Levy C, Brain E, Pivot X, Putzu C, Gonzalez Martin A, de Ducla S, Easton V, von Minckwitz G. Final results of the TANIA randomised phase III trial of bevacizumab after progression on first-line bevacizumab therapy for HER2-negative locally recurrent/metastatic breast cancer. Ann Oncol. 2016 Nov;27(11):2046-2052. doi: 10.1093/annonc/mdw316. Epub 2016 Aug 8.

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

version: acceptedVersion

repository_institution: University of Sussex - Sussex Research Online

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

version: submittedVersion

ReferenceCitation: von Minckwitz G, Puglisi F, Cortes J, Vrdoljak E, Marschner N, Zielinski C, Villanueva C, Romieu G, Lang I, Ciruelos E, De Laurentiis M, Veyret C, de Ducla S, Freudensprung U, Srock S, Gligorov J. Bevacizumab plus chemotherapy versus chemotherapy alone as second-line treatment for patients with HER2-negative locally recurrent or metastatic breast cancer after first-line treatment with bevacizumab plus chemotherapy (TANIA): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1269-78. doi: 10.1016/S1470-2045(14)70439-5. Epub 2014 Sep 28.

oa_host_type: closed

lead_sponsor: Hoffmann-La Roche

location_country: Germany Italy Slovakia Hungary Argentina Israel Brazil Switzerland Austria Spain Greece Croatia France


lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study to determine if the addition of daratumumab to bortezomib + lenalidomide + dexamethasone (VRd) will improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.

location_facility: Cancer & Hematology Centers of Western Michigan, PC

location_facility: Saint Luke's Hospital - Saint Luke's Cancer Specialists

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Centre Hospitalier Départmental La Roche sur Yon

location_facility: University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center

location_facility: The Gordon & Leslie Diamond Health Care Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

location_facility: Rambam Med.Center - Hematology Institute

location_facility: Albert Schweitzer ziekenhuis-lokatie Dordwijk

location_facility: National Hospital Organization Shibukawa Medical Center

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: Instituto Brasileiro de Controle do Cancer - Sao Camilo Oncologia

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

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

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Uniwersytecki Szpital Kliniczny w Poznaniu

location_facility: Universitaetsklinikum Tuebingen der Eberhard-Karls-Universitaet, Abteilung fuer Innere Medizin II,

location_facility: Ankara University School of Medicine, Cebeci Hospital

location_facility: Klinikum Großhadern der Ludwig-Maximilians-Universität

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: phase 3 - Hämatoonkologischer Studienkreis am Klinikum Aschaffenburg

location_facility: Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

title: A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

type: Other Identifier

location_country:
Germany
Poland
Israel
United Kingdom
Japan
Brazil
Netherlands
United States
Spain
Turkey
Czechia
Canada
France


title: A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment With the Nuvaira™ Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD)

summary: The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.

ReferenceCitation: Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Slebos DJ, Degano B, Valipour A, Shah PL, Deslee G, Sciurba FC; AIRFLOW-3 Trial Study Group. Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira(R) lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3). BMC Pulm Med. 2020 Feb 13;20(1):41. doi: 10.1186/s12890-020-1058-5.

repository_institution: Imperial College London - Spiral

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

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

ipd_sharing_description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

lead_sponsor: Nuvaira, Inc.

location_country:
Germany
United Kingdom
Netherlands
Austria
United States
France

location_facility: University of Alabama at Birmingham (UAB) Lung Health Center

location_facility: Medical University of South Carolina (MUSC)

location_facility: University Medical Center Groningen (UMCG)

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Ohio State University Wexner Medical Center

intervention_type: Device


title: 2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

summary: The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

ReferenceCitation: Chalasani NP, Porter K, Bhattacharya A, Book AJ, Neis BM, Xiong KM, Ramasubramanian TS, Edwards DK 5th, Chen I, Johnson S, Roberts LR, Kisiel JB, Reddy KR, Singal AG, Olson MC, Bruinsma JJ. Validation of a Novel Multitarget Blood Test Shows High Sensitivity to Detect Early Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2022 Jan;20(1):173-182.e7. doi: 10.1016/j.cgh.2021.08.010. Epub 2021 Aug 13.

ReferenceCitation: Chalasani NP, Ramasubramanian TS, Bhattacharya A, Olson MC, Edwards V DK, Roberts LR, Kisiel JB, Reddy KR, Lidgard GP, Johnson SC, Bruinsma JJ. A Novel Blood-Based Panel of Methylated DNA and Protein Markers for Detection of Early-Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2597-2605.e4. doi: 10.1016/j.cgh.2020.08.065. Epub 2020 Sep 2.

ipd_sharing_description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.

lead_sponsor: Exact Sciences Corporation

location_country:
Germany
Italy
United States
Spain
Thailand
Taiwan
France

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Methodist Healthcare University Hospital

location_facility: Hospital of the University of Pennsylvania

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Universidad Autonoma de Madrid - Hospital Universitario La Paz

intervention_type: Other


acronym: EPCORE™ NHL-1

lead_sponsor: Genmab

summary:
The trial is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). The trial consists of 3 parts:

a dose-escalation part (Phase 1, first-in-human (FIH))
an expansion part (Phase 2a)
a dose-optimization part (Phase 2a)

ReferenceType: result

ReferenceCitation: Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22.

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repositories_concat: PubMed Central;pure.eur.nl;sdu.dk

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.

repository_institution: University of Southampton - ePrints Soton

sponsor_collaborators: Genmab AbbVie

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia

location_facility: Plymouth University School of Medicine- Derriford Hospital

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Northside Hospital- The Blood Marrow Transplant Group

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Policlinico S. Orsola-Ematologia LA Seragnoli

location_facility: Keimyung University Dongsan Medical Center

location_facility: Klinik fur Innere Medizin Hamatologie and Onkologie

location_facility: Hospital Universitario Fundacin Jimnez Daz

location_facility: Der Universität Munchen Medizinische Klinik III LMU

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute

location_facility: Seoul National University Bundang Hospital

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Integrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: University of California at San Francisco

location_facility: Akademiska sjukhuset Uppsala University Hospital

title: A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

type: Registry Identifier

location_country:
Finland
Germany
Italy
Poland
United Kingdom
Singapore
Denmark
Australia
Sweden
Netherlands
United States
Korea, Republic of
Spain
Canada
France


title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events With Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients With History of Myocardial Infarction

acronym: PEGASUS

summary: This study is being carried out to see if a new drug called ticagrelor given twice daily in addition to the ASA therapy decreases the frequency of cardiovascular events (e.g., death from heart disease, heart attack, or stroke).

primary_purpose: Prevention

ReferenceCitation: Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Jensen EC, Magnani G, Bansilal S, Fish MP, Im K, Bengtsson O, Oude Ophuis T, Budaj A, Theroux P, Ruda M, Hamm C, Goto S, Spinar J, Nicolau JC, Kiss RG, Murphy SA, Wiviott SD, Held P, Braunwald E, Sabatine MS; PEGASUS-TIMI 54 Steering Committee and Investigators. Long-term use of ticagrelor in patients with prior myocardial infarction. N Engl J Med. 2015 May 7;372(19):1791-800. doi: 10.1056/NEJMoa1500857. Epub 2015 Mar 14.

oa_colors: green other

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repositories_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Bonaca MP, Im K, Magnani G, Bansilal S, Dellborg M, Storey RF, Bhatt DL, Steg PG, Cohen M, Johanson P, Braunwald E, Sabatine MS. Patient selection for long-term secondary prevention with ticagrelor: insights from PEGASUS-TIMI 54. Eur Heart J. 2022 Dec 21;43(48):5037-5044. doi: 10.1093/eurheartj/ehac402.

publisher_dissemination: Oxford University Press

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

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

repository_institution: The University of Sydney - The Sydney eScholarship Repository

repositories_concat: PubMed Central;ses.library.usyd.edu.au

ReferenceCitation: Bergmark BA, Bhatt DL, Steg PG, Budaj A, Storey RF, Gurmu Y, Kuder JF, Im K, Magnani G, Oude Ophuis T, Hamm C, Spinar J, Kiss RG, Van de Werf FJ, Montalescot G, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Long-Term Ticagrelor in Patients With Prior Coronary Stenting in the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2021 Sep 7;10(17):e020446. doi: 10.1161/JAHA.120.020446. Epub 2021 Aug 21.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repositories:
HAL
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: HAL;LIRIAS (KU Leuven);PubMed Central

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

ReferenceCitation: Magnani G, Ardissino D, Im K, Budaj A, Storey RF, Steg PG, Bhatt DL, Cohen M, Oude Ophius T, Goudev A, Parkhomenko A, Kamensky G, Angiolillo DJ, Lopez-Sendon J, Johanson P, Braunwald E, Sabatine MS, Bonaca MP. Predictors, Type, and Impact of Bleeding on the Net Clinical Benefit of Long-Term Ticagrelor in Stable Patients With Prior Myocardial Infarction. J Am Heart Assoc. 2021 Feb 16;10(4):e017008. doi: 10.1161/JAHA.120.017008. Epub 2021 Feb 9.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

ReferenceCitation: Furtado RHM, Venkateswaran RV, Nicolau JC, Gurmu Y, Bhatt DL, Storey RF, Steg PG, Magnani G, Goto S, Dellborg M, Kamensky G, Isaza D, Aylward P, Johanson P, Bonaca MP. Caffeinated Beverage Intake, Dyspnea With Ticagrelor, and Cardiovascular Outcomes: Insights From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015785. doi: 10.1161/JAHA.119.015785. Epub 2020 May 15.

ReferenceCitation: Gencer B, Li XS, Gurmu Y, Bonaca MP, Morrow DA, Cohen M, Bhatt DL, Steg PG, Storey RF, Johanson P, Wang Z, Hazen SL, Sabatine MS. Gut Microbiota-Dependent Trimethylamine N-oxide and Cardiovascular Outcomes in Patients With Prior Myocardial Infarction: A Nested Case Control Study From the PEGASUS-TIMI 54 Trial. J Am Heart Assoc. 2020 May 18;9(10):e015331. doi: 10.1161/JAHA.119.015331. Epub 2020 May 5.

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Furtado RHM, Nicolau JC, Magnani G, Im K, Bhatt DL, Storey RF, Steg PG, Spinar J, Budaj A, Kontny F, Corbalan R, Kiss RG, Abola MT, Johanson P, Jensen EC, Braunwald E, Sabatine MS, Bonaca MP. Long-term ticagrelor for secondary prevention in patients with prior myocardial infarction and no history of coronary stenting: insights from PEGASUS-TIMI 54. Eur Heart J. 2020 May 1;41(17):1625-1632. doi: 10.1093/eurheartj/ehz821.

ReferenceCitation: Dellborg M, Bonaca MP, Storey RF, Steg PG, Im KA, Cohen M, Bhatt DL, Oude Ophuis T, Budaj A, Hamm C, Spinar J, Kiss RG, Lopez-Sendon J, Kamensky G, Van de Werf F, Ardissino D, Kontny F, Montalescot G, Johanson P, Bengtsson O, Himmelmann A, Braunwald E, Sabatine MS. Efficacy and safety with ticagrelor in patients with prior myocardial infarction in the approved European label: insights from PEGASUS-TIMI 54. Eur Heart J Cardiovasc Pharmacother. 2019 Oct 1;5(4):200-206. doi: 10.1093/ehjcvp/pvz020.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris 1 Panthéon-Sorbonne

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UFC - Université de Franche-Comté

ReferenceCitation: Bonaca MP, Wiviott SD, Morrow DA, Steg PG, Hamm C, Bhatt DL, Storey RF, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Diaz R, Van de Werf F, Corbalan R, Goudev A, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Reduction in Subtypes and Sizes of Myocardial Infarction With Ticagrelor in PEGASUS-TIMI 54. J Am Heart Assoc. 2018 Nov 20;7(22):e009260. doi: 10.1161/JAHA.118.009260.

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

ReferenceCitation: Bansilal S, Bonaca MP, Cornel JH, Storey RF, Bhatt DL, Steg PG, Im K, Murphy SA, Angiolillo DJ, Kiss RG, Parkhomenko AN, Lopez-Sendon J, Isaza D, Goudev A, Kontny F, Held P, Jensen EC, Braunwald E, Sabatine MS, Oude Ophuis AJ. Ticagrelor for Secondary Prevention of Atherothrombotic Events in Patients With Multivessel Coronary Disease. J Am Coll Cardiol. 2018 Feb 6;71(5):489-496. doi: 10.1016/j.jacc.2017.11.050.

ReferenceCitation: Cavallari I, Morrow DA, Creager MA, Olin J, Bhatt DL, Steg PG, Storey RF, Cohen M, Scirica BS, Piazza G, Goodrich EL, Braunwald E, Sabatine MS, Bonaca MP. Frequency, Predictors, and Impact of Combined Antiplatelet Therapy on Venous Thromboembolism in Patients With Symptomatic Atherosclerosis. Circulation. 2018 Feb 13;137(7):684-692. doi: 10.1161/CIRCULATIONAHA.117.031062. Epub 2017 Oct 30.

ReferenceCitation: Bonaca MP, Storey RF, Theroux P, Steg PG, Bhatt DL, Cohen MC, Im K, Murphy SA, Magnani G, Ophuis TO, Rudah M, Parkhomenko A, Isaza D, Kamensky G, Goudev A, Montalescot G, Jensen EC, Johanson P, Braunwald E, Sabatine MS. Efficacy and Safety of Ticagrelor Over Time in Patients With Prior MI in PEGASUS-TIMI 54. J Am Coll Cardiol. 2017 Sep 12;70(11):1368-1375. doi: 10.1016/j.jacc.2017.07.768.

ReferenceCitation: Magnuson EA, Li H, Wang K, Vilain K, Shafiq A, Bonaca MP, Bhatt DL, Cohen M, Steg PG, Storey RF, Braunwald E, Sabatine MS, Cohen DJ; PEGASUS-TIMI 54 Trial Investigators. Cost-Effectiveness of Long-Term Ticagrelor in Patients With Prior Myocardial Infarction: Results From the PEGASUS-TIMI 54 Trial. J Am Coll Cardiol. 2017 Aug 1;70(5):527-538. doi: 10.1016/j.jacc.2017.05.063.

ReferenceCitation: Thomas MR, Angiolillo DJ, Bonaca MP, Ajjan RA, Judge HM, Rollini F, Franchi F, Ahsan AJ, Bhatt DL, Kuder JF, Steg PG, Cohen M, Muthusamy R, Sabatine MS, Storey RF. Consistent platelet inhibition with ticagrelor 60 mg twice-daily following myocardial infarction regardless of diabetes status. Thromb Haemost. 2017 May 3;117(5):940-947. doi: 10.1160/TH16-09-0703. Epub 2017 Mar 16.

repository_institution: University of Birmingham - University of Birmingham Research Portal

ReferenceCitation: Bonaca MP, Goto S, Bhatt DL, Steg PG, Storey RF, Cohen M, Goodrich E, Mauri L, Ophuis TO, Ruda M, Spinar J, Seung KB, Hu D, Dalby AJ, Jensen E, Held P, Morrow DA, Braunwald E, Sabatine MS. Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54). Circulation. 2016 Sep 20;134(12):861-71. doi: 10.1161/CIRCULATIONAHA.116.024637. Epub 2016 Aug 30.

ReferenceCitation: Bonaca MP, Bhatt DL, Oude Ophuis T, Steg PG, Storey R, Cohen M, Kuder J, Im K, Magnani G, Budaj A, Theroux P, Hamm C, Spinar J, Kiss RG, Dalby AJ, Medina FA, Kontny F, Aylward PE, Jensen EC, Held P, Braunwald E, Sabatine MS. Long-term Tolerability of Ticagrelor for the Secondary Prevention of Major Adverse Cardiovascular Events: A Secondary Analysis of the PEGASUS-TIMI 54 Trial. JAMA Cardiol. 2016 Jul 1;1(4):425-32. doi: 10.1001/jamacardio.2016.1017.

ReferenceCitation: Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.

ReferenceCitation: Bonaca MP, Bhatt DL, Storey RF, Steg PG, Cohen M, Kuder J, Goodrich E, Nicolau JC, Parkhomenko A, Lopez-Sendon J, Dellborg M, Dalby A, Spinar J, Aylward P, Corbalan R, Abola MTB, Jensen EC, Held P, Braunwald E, Sabatine MS. Ticagrelor for Prevention of Ischemic Events After Myocardial Infarction in Patients With Peripheral Artery Disease. J Am Coll Cardiol. 2016 Jun 14;67(23):2719-2728. doi: 10.1016/j.jacc.2016.03.524. Epub 2016 Apr 1.

ReferenceCitation: Bhatt DL, Bonaca MP, Bansilal S, Angiolillo DJ, Cohen M, Storey RF, Im K, Murphy SA, Held P, Braunwald E, Sabatine MS, Steg PG. Reduction in Ischemic Events With Ticagrelor in Diabetic Patients With Prior Myocardial Infarction in PEGASUS-TIMI 54. J Am Coll Cardiol. 2016 Jun 14;67(23):2732-2740. doi: 10.1016/j.jacc.2016.03.529. Epub 2016 Apr 1.

ReferenceCitation: Bonaca MP, Bhatt DL, Steg PG, Storey RF, Cohen M, Im K, Oude Ophuis T, Budaj A, Goto S, Lopez-Sendon J, Diaz R, Dalby A, Van de Werf F, Ardissino D, Montalescot G, Aylward P, Magnani G, Jensen EC, Held P, Braunwald E, Sabatine MS. Ischaemic risk and efficacy of ticagrelor in relation to time from P2Y12 inhibitor withdrawal in patients with prior myocardial infarction: insights from PEGASUS-TIMI 54. Eur Heart J. 2016 Apr 7;37(14):1133-42. doi: 10.1093/eurheartj/ehv531. Epub 2015 Oct 21.

ReferenceCitation: Bonaca MP, Bhatt DL, Braunwald E, Cohen M, Steg PG, Storey RF, Held P, Jensen EC, Sabatine MS. Design and rationale for the Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54 (PEGASUS-TIMI 54) trial. Am Heart J. 2014 Apr;167(4):437-444.e5. doi: 10.1016/j.ahj.2013.12.020. Epub 2014 Jan 6.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Czech Republic
Colombia
Slovakia
Hungary
United States
Ukraine
Romania
Belgium
China
Peru
Philippines
Italy
Norway
United Kingdom
Netherlands
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Sweden


title: An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies

summary: This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.

ReferenceCitation: Motzer RJ, Porta C, Vogelzang NJ, Sternberg CN, Szczylik C, Zolnierek J, Kollmannsberger C, Rha SY, Bjarnason GA, Melichar B, De Giorgi U, Grunwald V, Davis ID, Lee JL, Esteban E, Urbanowitz G, Cai C, Squires M, Marker M, Shi MM, Escudier B. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Mar;15(3):286-96. doi: 10.1016/S1470-2045(14)70030-0. Epub 2014 Feb 17.

repository_institution: PubMed Central - Europe PMC

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Canada
France
Czech Republic
Colombia
Slovakia
Hungary
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Saudi Arabia
Spain
Greece
Israel

location_facility: Cedars Sinai Medical Center Cedars Sinai Medical Ctr. (SC)

location_facility: St. Luke's Hospital and Health Network St Luke's

location_facility: Karmanos Cancer Institute Dept.of KarmanosCancerInst (5)

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

location_facility: Willamette Valley Clinical Studies Williamette Valley Cancer

location_facility: University of Texas Southwestern Medical Center UTSW

location_facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists

location_facility: Stanford University Medical Center Cancer Clinical Trials Office

location_facility: Moanalua Medical Center. Attn: Oncology Dept

location_facility: Cancer Centers of the Carolinas CC of C -Eastside

location_facility: University of Maryland Medical Center UMMC

location_facility: CINJ at Cooper University Hospital Cooper

location_facility: Medical University of South Carolina -Hollings Cancer Center Med Univ SC

location_facility: University of Kansas Cancer Center Univ of KS

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC

location_facility: Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

location_facility: Baylor Health Care System/Sammons Cancer Center Dept. of Sammons Cancer (4)

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

location_facility: University of California at Los Angeles UCLA (4)

location_facility: SUNY - Upstate Medical University Div. of Hematology-Oncology

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

location_facility: University of Virginia Health Systems Univ Virginia

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: University of Minnesota Medical Center - Fairview Univ of MN


title: PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY

acronym: PREVAIL

summary: The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

ReferenceCitation: Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

ReferenceCitation: Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.

ReferenceCitation: Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.

ReferenceCitation: Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. doi: 10.1016/j.eururo.2020.04.061. Epub 2020 Jun 9.

ReferenceCitation: Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.

evidence: open (via free pdf)

publisher_dissemination: American Medical Association

ReferenceCitation: Armstrong AJ, Lin P, Higano CS, Iversen P, Sternberg CN, Tombal B, Phung D, Parli T, Krivoshik A, Beer TM. Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial. Eur Urol Oncol. 2019 Nov;2(6):677-684. doi: 10.1016/j.euo.2018.11.005. Epub 2018 Dec 3.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Armstrong AJ, Lin P, Higano CS, Sternberg CN, Sonpavde G, Tombal B, Templeton AJ, Fizazi K, Phung D, Wong EK, Krivoshik A, Beer TM. Development and validation of a prognostic model for overall survival in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018 Nov 1;29(11):2200-2207. doi: 10.1093/annonc/mdy406.

ReferenceCitation: Rathkopf DE, Beer TM, Loriot Y, Higano CS, Armstrong AJ, Sternberg CN, de Bono JS, Tombal B, Parli T, Bhattacharya S, Phung D, Krivoshik A, Scher HI, Morris MJ. Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):694-701. doi: 10.1001/jamaoncol.2017.5808.

ReferenceCitation: Kim CS, Choi YD, Lee SE, Lee HM, Ueda T, Yonese J, Fukagai T, Chiong E, Lau W, Abhyankar S, Theeuwes A, Tombal B, Beer TM, Kimura G. Post hoc analyses of East Asian patients from the randomized placebo-controlled PREVAIL trial of enzalutamide in patients with chemotherapy-naive, metastatic castration-resistant prostate cancer. Medicine (Baltimore). 2017 Jul;96(27):e7223. doi: 10.1097/MD.0000000000007223.

ReferenceCitation: Devlin N, Herdman M, Pavesi M, Phung D, Naidoo S, Beer TM, Tombal B, Loriot Y, Ivanescu C, Parli T, Balk M, Holmstrom S. Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. Health Qual Life Outcomes. 2017 Jun 23;15(1):130. doi: 10.1186/s12955-017-0704-y.

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

ReferenceCitation: Bryce AH, Alumkal JJ, Armstrong A, Higano CS, Iversen P, Sternberg CN, Rathkopf D, Loriot Y, de Bono J, Tombal B, Abhyankar S, Lin P, Krivoshik A, Phung D, Beer TM. Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL. Prostate Cancer Prostatic Dis. 2017 Jun;20(2):221-227. doi: 10.1038/pcan.2016.71. Epub 2017 Jan 24.

ReferenceCitation: Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study. Eur Urol. 2017 Feb;71(2):151-154. doi: 10.1016/j.eururo.2016.07.032. Epub 2016 Jul 28.

repository_institution: University of California - eScholarship University of California

ReferenceCitation: Kim CS, Theeuwes A, Kwon DD, Choi YD, Chung BH, Lee HM, Lee KH, Lee SE. The PREVAIL trial of enzalutamide in men with chemotherapy-naive, metastatic castration-resistant prostate cancer: Post hoc analysis of Korean patients. Investig Clin Urol. 2016 May;57(3):174-83. doi: 10.4111/icu.2016.57.3.174. Epub 2016 May 10.

ReferenceCitation: Graff JN, Baciarello G, Armstrong AJ, Higano CS, Iversen P, Flaig TW, Forer D, Parli T, Phung D, Tombal B, Beer TM, Sternberg CN. Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL. Ann Oncol. 2016 Feb;27(2):286-94. doi: 10.1093/annonc/mdv542. Epub 2015 Nov 16.

ReferenceCitation: Loriot Y, Miller K, Sternberg CN, Fizazi K, De Bono JS, Chowdhury S, Higano CS, Noonberg S, Holmstrom S, Mansbach H, Perabo FG, Phung D, Ivanescu C, Skaltsa K, Beer TM, Tombal B. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015 May;16(5):509-21. doi: 10.1016/S1470-2045(15)70113-0. Epub 2015 Apr 14.

ReferenceCitation: Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, Iversen P, Bhattacharya S, Carles J, Chowdhury S, Davis ID, de Bono JS, Evans CP, Fizazi K, Joshua AM, Kim CS, Kimura G, Mainwaring P, Mansbach H, Miller K, Noonberg SB, Perabo F, Phung D, Saad F, Scher HI, Taplin ME, Venner PM, Tombal B; PREVAIL Investigators. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014 Jul 31;371(5):424-33. doi: 10.1056/NEJMoa1405095. Epub 2014 Jun 1.

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

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

repository_institution: Tampere University - Tampere University Institutional Repository

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

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

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.

collaborators: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

location_country:
Finland
Germany
Poland
Australia
Japan
Canada
France
Lithuania
Slovakia
Denmark
United States
Belgium
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Russian Federation
Israel

location_facility: Centre Hospitalier Universitaire de Liege-Urologie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Department of Urology, National University Hospital

location_facility: Anschutz Cancer Center Pavilion Pharmacy

location_facility: Hospital Universitario German Trias i Pujol

location_facility: MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor

location_facility: UROEXAM, spol. s r.o. urologicka ambulancia

location_facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden an der

location_facility: Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie

location_facility: North County Oncology Medical Clinic, Inc

location_facility: UZ Leuven - University Hospital Gasthuisberg

location_facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services

location_facility: MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Jewish Hospital & St. Mary's Healthcare, Inc.

location_facility: HIA Begin, Service de Medecine Interne et Oncologie

location_facility: Division of Oncourology, National Cancer Institute

location_facility: State Educational Institution of Higher Professional Education

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi

location_facility: Lynn Cancer Institute Center for Hematology Oncology

location_facility: University Hospitals Bristol NHS Foundation Trust

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

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Azienda USL8-Presidio Ospedaliero S.Donato

location_facility: University of Colorado Hospital, Anschutz Cancer Pavilion

location_facility: The University of Arizona Cancer Center-North Campus

location_facility: Kliniken Nordoberpfalz AG, Klinikum Weiden

location_facility: Russian Academy of Medical Sciences Institution

location_facility: Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging

location_facility: Universitaetsklinikum Mannheim, Klinik fuer Urologie

location_facility: Medical University of South Carolina - Urology Services

location_facility: Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Azienda Ospedaliera San. Camillo Forlanini

location_facility: Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Institut de Cancerologie Lucien Neuwirth

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: University Medical Center Groningen, Department of Urology

location_facility: Universitaetsklinikum Heidelberg, Klinik Fuer Urologie

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Clinical Investigations and Research Unit, Royal Sussex County Hospital

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Tom Baker Cancer Centre - Holy Cross Site

location_facility: London RegCancer Program, London Health Sciences Centre

location_facility: University of Queensland Centre for Clinical Research (UQCCR)

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Centre de recherche clinique el evaluative en oncologie (CRCEO)

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: University College London Hospital NHS Trust

location_facility: The Ottawa Hospital Cancer Centre, General Campus

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Niigata University Medical and Dental Hospital

location_facility: The University of Arizona Cancer Certer-North Campus

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

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

location_facility: Centre Jean Bernard - Clinique Victor Hugo

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica

location_facility: Lismore Base Hospital, Lismore Cancer Care and Haematology Unit

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

location_facility: Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare

location_facility: Centre Eugene Marquis-Service d'Oncologie Medicale

location_facility: Vrije Universiteit Medical Center, Department of Medical Oncology

location_facility: Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine

location_facility: Hematology / Oncology MUSC Hollings Cancer Center

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Oncology Eastern Clinical Research Unit (ECRU)

location_facility: Alberta Health Services - Cancer Care, Tom Baker Cancer Centre

location_facility: Royal North Shore Hospital, Department of Medical Oncology


lead_sponsor: Amgen

summary:
The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

ReferenceCitation: Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhomme C, Richardson G, Rincon DG, Coleman RL, Herzog TJ, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Tassoudji M, Navale L, Warner DJ, Oza AM. Anti-angiopoietin therapy with trebananib for recurrent ovarian cancer (TRINOVA-1): a randomised, multicentre, double-blind, placebo-controlled phase 3 trial. Lancet Oncol. 2014 Jul;15(8):799-808. doi: 10.1016/S1470-2045(14)70244-X. Epub 2014 Jun 17.

ReferenceCitation: Monk BJ, Poveda A, Vergote I, Raspagliesi F, Fujiwara K, Bae DS, Oaknin A, Ray-Coquard I, Provencher DM, Karlan BY, Lhomme C, Richardson G, Rincon DG, Coleman RL, Marth C, Brize A, Fabbro M, Redondo A, Bamias A, Ma H, Vogl FD, Bach BA, Oza AM. Final results of a phase 3 study of trebananib plus weekly paclitaxel in recurrent ovarian cancer (TRINOVA-1): Long-term survival, impact of ascites, and progression-free survival-2. Gynecol Oncol. 2016 Oct;143(1):27-34. doi: 10.1016/j.ygyno.2016.07.112. Epub 2016 Aug 18.

ReferenceCitation: Fujiwara K, Monk BJ, Lhomme C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30.

repository_institution: KU Leuven - Lirias

repositories_concat: LIRIAS (KU Leuven)

title: A Phase 3, Randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

location_country:
Poland
Australia
Brazil
Japan
Croatia
Chile
Canada
France
Czech Republic
Slovenia
Portugal
Hong Kong
Switzerland
United States
Latvia
India
Romania
Belgium
Malaysia
Peru
Estonia
Italy
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation
Israel