acronym: RE-DUAL PCI

lead_sponsor: Boehringer Ingelheim

summary:
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.

ReferenceCitation: Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.

repository_institution: Aalborg Universitet - VBN Forskningsportal

repository_institution: Uppsala University - Uppsala University Publications

repositories:
DiVA.org
PubMed Central
Pure (Denmark)

repositories_concat: DiVA.org;PubMed Central;Pure (Denmark)

repositories_institution: Aalborg Universitet - VBN Forskningsportal

ReferenceCitation: De Caterina R, Procopio A, Lopez Sendon JL, Raev D, Mehta SR, Opolski G, Oldgren J, Steg PG, Hohnloser SH, Lip GYH, Kimura T, Kleine E, Ten Berg JM, Bhatt DL, Miede C, Nordaby M, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Comparison of Dabigatran Plus a P2Y12 Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI. Am J Med. 2020 Nov;133(11):1302-1312. doi: 10.1016/j.amjmed.2020.03.045. Epub 2020 May 7.

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

repositories_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

ReferenceCitation: Berry NC, Mauri L, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM, Cannon CP. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008349. doi: 10.1161/CIRCINTERVENTIONS.119.008349. Epub 2020 Apr 7.

ReferenceCitation: Hohnloser SH, Steg PG, Oldgren J, Nickenig G, Kiss RG, Ongen Z, Navarro Estrada JL, Oude Ophuis T, Lip GYH, Nordaby M, Kleine E, Ten Berg JM, Bhatt DL, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1553-1561. doi: 10.1016/j.jcin.2019.05.050.

ReferenceCitation: Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.

repository_institution: University of Birmingham - University of Birmingham Research Portal

ReferenceCitation: Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Westküstenkliniken Brunsbüttel und Heide gGmbH

location_facility: INCOR e Hospital das Clínicas da Universidade de São Paulo

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin

location_facility: Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens

location_facility: North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep

location_facility: Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce

location_facility: Bayview Physicians Services PC dba Cardiovascular Associates

location_facility: Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb

location_facility: Mission Cardiovascular Research Institute

location_facility: Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary

location_facility: MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Centro Especializado en Terapia Endovascular (CETEN)

location_facility: Carl-von-Basedow Klinikum Saalekreis gGmgH

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi

location_facility: Asklepios Klinik Langen-Seligenstadt GmbH

location_facility: Novant Health Heart and Vascular Institute

location_facility: City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

location_facility: General Hospital Izola, Cardiology Department

location_facility: Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk

location_facility: Richmond Cardiology Associates Research, LLC

location_facility: City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia

location_facility: University of Utah Health Sciences Center

location_facility: Instituto de Cardiologia Rio Grande do Sul

location_facility: Univ. of Szeged, 2nd Dept. of Internal Med., Haematology

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: University Hospital of Thessaloniki AHEPA

location_facility: Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Tokyo Women's Medical University Hospital

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Independent Public Healthcare, Dept. of Cardiology, Pulawy

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow

location_facility: State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

location_facility: Oslo Universitetssykehus HF, Ullevål sykehus

location_facility: Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

location_facility: Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center

location_facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto

location_facility: City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method

location_facility: Kansas City Veterans Administration Medical Center

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Istanbul Universitesi Kardiyoloji Enstitusu

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk

location_facility: National Hospital Organization Saitama National Hospital

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Hippokration Hospital, Univ Clinic of Cardiology

location_facility: Hospitals of Pardubice Region, Internal Department, Svitavy

location_facility: Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali

location_facility: Prince of Wales Hosp, Dept of Med & Therapeutics

location_facility: Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola

location_facility: General Hospital of Attica "Sismanoglio - Amalia Fleming"

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

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH

location_facility: University of Florida College of Medicine

location_facility: Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi

location_facility: Central Hospital of Medical Academy, Warsaw

location_facility: Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali

location_facility: General Hospital of Athens Konstantopoulio-Agia Olga

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Kardiocentrum Nitra,Internal Medicine Dept, Nitra

location_facility: Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw

location_facility: HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept

location_facility: Shri Krishna Hrudayalaya and Critical Care

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

location_facility: Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb

location_facility: Bacs-Kiskun Megyei Onkormanyzat Hospital

location_facility: Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)

location_facility: Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad

location_facility: MHAT "Deva Maria", Dept. of Cardiology, Burgas

location_facility: B and M Patel Cardiac Centre, Shree Krishna Hospital,

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Thunder Bay Regional Health Science Centre

location_facility: Irmandade da Santa Casa de Misericordia de Curitiba

location_facility: University General Hospital of Heraklion

location_facility: Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol

location_facility: Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

location_facility: General Hospital of Chios, Department of Cardiology

location_facility: Instituto Cardiovascular de Buenos Aires

title: A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
France
Slovenia
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
United States
India
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

acronym: ALLAY-LID-I

summary: This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

study_start_date_type: Actual

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Adamas Pharmaceuticals, Inc.

location_country:
Germany
United States
Spain
Canada
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

acronym: ALLAY-LID-II

summary: The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

location_facility:
Hospital General de Cataluna
Hospital de la Santa Creu i Sant Pau


acronym: PERLES

lead_sponsor: Pierre Fabre Medicament

summary: The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.

status: Completed

title: PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

type: EudraCT Number

source: euctr

location_country:
Germany
Italy
Spain
Czech Republic
France

status_simplified: Completed


type: Other Identifier

title: Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceType: derived

ReferenceCitation: Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: Erasmus University Rotterdam - EUR Research Repository

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central;pure.eur.nl

unpaywall_oa_status: bronze

publisher_dissemination: American Society of Hematology

ReferenceCitation: Plesner T, Dimopoulos MA, Oriol A, San-Miguel J, Bahlis NJ, Rabin N, Suzuki K, Yoon SS, Ben-Yehuda D, Cook G, Goldschmidt H, Grosicki S, Qin X, Fastenau J, Garvin W, Carson R, Renaud T, Gries KS. Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial. Br J Haematol. 2021 Jul;194(1):132-139. doi: 10.1111/bjh.17435. Epub 2021 Apr 6.

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

publisher_dissemination: Wiley

ReferenceCitation: Avet-Loiseau H, San-Miguel J, Casneuf T, Iida S, Lonial S, Usmani SZ, Spencer A, Moreau P, Plesner T, Weisel K, Ukropec J, Chiu C, Trivedi S, Amin H, Krevvata M, Ramaswami P, Qin X, Qi M, Sun S, Qi M, Kobos R, Bahlis NJ. Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR. J Clin Oncol. 2021 Apr 1;39(10):1139-1149. doi: 10.1200/JCO.20.01814. Epub 2021 Jan 29.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: PubMed Central;sdu.dk

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Mateos MV, Spencer A, Nooka AK, Pour L, Weisel K, Cavo M, Laubach JP, Cook G, Iida S, Benboubker L, Usmani SZ, Yoon SS, Bahlis NJ, Chiu C, Ukropec J, Schecter JM, Qin X, O'Rourke L, Dimopoulos MA. Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies. Haematologica. 2020 Jan 31;105(2):468-477. doi: 10.3324/haematol.2019.217448. Print 2020.

oa_colors: green gold

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331. doi: 10.1056/NEJMoa1607751.

publisher_dissemination: Massachusetts Medical Society

location_country:
Germany
Poland
Israel
United Kingdom
Denmark
Australia
Japan
Netherlands
Sweden
Belgium
United States
Korea, Republic of
Spain
Greece
Taiwan
Canada
Russian Federation
France


lead_sponsor: CTI BioPharma

summary: Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.

ReferenceType: background

ReferenceCitation: Mascarenhas J, Hoffman R, Talpaz M, Gerds AT, Stein B, Gupta V, Szoke A, Drummond M, Pristupa A, Granston T, Daly R, Al-Fayoumi S, Callahan JA, Singer JW, Gotlib J, Jamieson C, Harrison C, Mesa R, Verstovsek S. Pacritinib vs Best Available Therapy, Including Ruxolitinib, in Patients With Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):652-659. doi: 10.1001/jamaoncol.2017.5818.

ReferenceCitation: Verstovsek S, Mesa R, Talpaz M, Kiladjian JJ, Harrison CN, Oh ST, Vannucchi AM, Rampal R, Scott BL, Buckley SA, Craig AR, Roman-Torres K, Mascarenhas JO. Retrospective analysis of pacritinib in patients with myelofibrosis and severe thrombocytopenia. Haematologica. 2022 Jul 1;107(7):1599-1607. doi: 10.3324/haematol.2021.279415.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repositories_concat: PubMed Central;digitalcommons.wustl.edu

ReferenceCitation: Tremblay D, Mesa R, Scott B, Buckley S, Roman-Torres K, Verstovsek S, Mascarenhas J. Pacritinib demonstrates spleen volume reduction in patients with myelofibrosis independent of JAK2V617F allele burden. Blood Adv. 2020 Dec 8;4(23):5929-5935. doi: 10.1182/bloodadvances.2020002970.

location_facility: Haematology and Oncology Clinics of Australia

location_facility: George Washington University- Medical Faculty Associates

location_facility: SCRI- Florida Cancer Specialists South Region

location_facility: Auckland District Health Board, Auckland City Hospital

location_facility: Investigative Clinical Research of Indiana

location_facility: SZTE II. sz Belgyogyoszati Klinika es Kardiologiai Kozpont

location_facility: Russian Research Institute of Hematology and Transfusiology

location_facility: Texas Onocolgy-Baylor Sammons Cancer Center

location_facility: Hematology-Oncology Associates of Northern Jersey

location_facility: Military Medical Academy n.a. S.M. Kirov

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőint

location_facility: Klinik I fur Innere Medizin, Universitat Koln

location_facility: Washington University School of Medicine Division of Oncology

location_facility: University of Debrecen, Belgyogyaszati Intezet

location_facility: SCRI - Florida Cancer Specialists North Region

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Siouxland Hematology-Oncology Associates, L.L.P (SHOA)

location_facility: University of Iowa Hospitals and Clinics

location_facility: Froedtert Hospital and the Medical College of Wisconsin

title: A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

location_country:
Germany
New Zealand
Hungary
United Kingdom
Australia
Netherlands
Belgium
United States
Czechia
Canada
Russian Federation
France


title: A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

summary: This is a multi-center, randomized, double-blinded, placebo controlled trial.

ReferenceCitation: Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, Andre F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022 Mar 10;386(10):942-950. doi: 10.1056/NEJMoa2114663.

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

evidence: open (via free pdf)

publisher_dissemination: Springer-Nature

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Pare L, Martinez D, Chic N, Martinez-Saez O, Braso-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum In: J Clin Oncol. 2021 Nov 1;39(31):3525. J Clin Oncol. 2023 Apr 20;41(12):2299-2301.

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

oa_host_type: publisher

repositories_concat: closed

publisher_dissemination: Future Science Ltd

ReferenceCitation: Hortobagyi GN. Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial. Breast Cancer Res. 2018 Oct 19;20(1):123. doi: 10.1186/s13058-018-1050-7.

license: cc-by

license_normalized: cc-by

ReferenceCitation: Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155. Erratum In: Ann Oncol. 2019 Nov 1;30(11):1842.

evidence: open (via crossref license)

ReferenceCitation: Janni W, Alba E, Bachelot T, Diab S, Gil-Gil M, Beck TJ, Ryvo L, Lopez R, Tsai M, Esteva FJ, Aunon PZ, Kral Z, Ward P, Richards P, Pluard TJ, Sutradhar S, Miller M, Campone M. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018 Jun;169(3):469-479. doi: 10.1007/s10549-017-4658-x. Epub 2018 Feb 5.

ReferenceCitation: Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, Andre F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. doi: 10.1056/NEJMoa1609709. Epub 2016 Oct 7. Erratum In: N Engl J Med. 2018 Dec 27;379(26):2582.

repository_institution: University of Padua - Padua Research Archive

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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Finland
Germany
Ireland
Argentina
Australia
Brazil
Thailand
Turkey
Czechia
Canada
France
Hungary
Denmark
United States
Lebanon
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility: Mercy Clinic Oklahoma Communities Mercy Oncology

location_facility: City of Hope National Medical Center SC-5

location_facility: The Ohio State University Comprehensive Cancer Center Ohio State-2

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Dana Farber Cancer Institute Dana Farber-9

location_facility: Rocky Mountain Cancer Centers RMCC - Aurora

location_facility: UC Davis Comprehensive Cancer Center SC-2

location_facility: Glendale-Adventist Medical Center Dept of Oncology

location_facility: Utah Cancer Specialists Utah Cancer Specialists (11)

location_facility: NYU Langone Medical Center CV Research center SC-2

location_facility: Ingalls Memorial Hospital Ingalls Mem Hosp

location_facility: Moanalua Medical Center. Attn: Oncology Dept

location_facility: The Angeles Clinic and Research Institute SC-3

location_facility: Virginia Cancer Specialists Fairfax Northern Virginia

location_facility: Center for Cancer and Blood Disorders SC

location_facility: Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp. Onc Dept

location_facility: Oncology Hematology Care Inc Oncology Hematology Care (3)

location_facility: University of Illinois Cancer Center at Chicago

location_facility: Vanderbilt University Medical Center SC-4

location_facility: Richardson Hematology Oncology Associates

location_facility: University of Texas MD Anderson Cancer Center UT MDAnderson

location_facility: Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology

location_facility: Penn State University Milton S Hershey Medical Center SC-3

location_facility: Georgia Cancer Specialists Georgia Cancer Spec

location_facility: Saint Luke's Hospital/Marion Bloch Neuroscience Institute Oncology Dept

location_facility: Northwest Medical Specialties Dept of Onc

location_facility: Cooper Cancer Center Cooper Cancer Center

location_facility: Florida Cancer Specialists FL Cancer Specialists

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Colorado School of Medicine Onc Dept.

location_facility: Virginia Piper Cancer Institute, Allina Health

location_facility: Florida Cancer Research Institute Dept of Oncology


title: Efficacy, Immunogenicity, and Safety Study of Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (Cdiffense™)

summary:
The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need.

Primary objective:

To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection.

Secondary Objectives:

Efficacy:

To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days.
To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections.

Immunogenicity:

To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60.

Safety:

To describe the safety profile of all participants who received at least 1 injection.

primary_purpose: Prevention

ReferenceCitation: de Bruyn G, Gordon DL, Steiner T, Tambyah P, Cosgrove C, Martens M, Bassily E, Chan ES, Patel D, Chen J, Torre-Cisneros J, Fernando De Magalhaes Francesconi C, Gesser R, Jeanfreau R, Launay O, Laot T, Morfin-Otero R, Oviedo-Orta E, Park YS, Piazza FM, Rehm C, Rivas E, Self S, Gurunathan S. Safety, immunogenicity, and efficacy of a Clostridioides difficile toxoid vaccine candidate: a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2021 Feb;21(2):252-262. doi: 10.1016/S1473-3099(20)30331-5. Epub 2020 Sep 15.

oa_host_type: closed

publisher_dissemination: Elsevier

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi Pasteur, a Sanofi Company

location_country:
Finland
Germany
Poland
Australia
Brazil
Costa Rica
Japan
Thailand
Canada
France
Colombia
Denmark
United States
Dominican Republic
Peru
Puerto Rico
Philippines
Guatemala
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Panama
Taiwan
Sweden

location_facility:
Investigational Site 183
Investigational Site 465
Investigational Site 171
Investigational Site 163
Investigational Site 022
Investigational Site 463
Investigational Site 044
Investigational Site 091
Investigational Site 030
Investigational Site 454
Investigational Site 084
Investigational Site 438
Investigational Site 099
Investigational Site 069
Investigational Site 086
Investigational Site 223
Investigational Site 427
Investigational Site 404
Investigational Site 442
Investigational Site 408
Investigational Site 247
Investigational Site 456
Investigational Site 215
Investigational Site 401
Investigational Site 244
Investigational Site 466
Investigational Site 295
Investigational Site 418
Investigational Site 051
Investigational Site 334
Investigational Site 364
Investigational Site 040
Investigational Site 006
Investigational Site 276
Investigational Site 332
Investigational Site 061
Investigational Site 450
Investigational Site 409
Investigational Site 347
Investigational Site 413
Investigational Site 461
Investigational Site 441
Investigational Site 013
Investigational Site 457
Investigational Site 055
Investigational Site 439
Investigational Site 324
Investigational Site 114
Investigational Site 506
Investigational Site 407
Investigational Site 187
Investigational Site 180
Investigational Site 443
Investigational Site 363
Investigational Site 229
Investigational Site 077
Investigational Site 468
Investigational Site 010
Investigational Site 544
Investigational Site 419
Investigational Site 355
Investigational Site 529
Investigational Site 075
Investigational Site 283
Investigational Site 425
Investigational Site 049
Investigational Site 429
Investigational Site 202
Investigational Site 459
Investigational Site 543
Investigational Site 428
Investigational Site 277
Investigational Site 050
Investigational Site 293
Investigational Site 445
Investigational Site 453
Investigational Site 104
Investigational Site 088
Investigational Site 035
Investigational Site 464
Investigational Site 523
Investigational Site 119
Investigational Site 452
Investigational Site 161
Investigational Site 411
Investigational Site 232
Investigational Site 281
Investigational Site 437
Investigational Site 152
Investigational Site 504
Investigational Site 189
Investigational Site 455
Investigational Site 421
Investigational Site 326
Investigational Site 012
Investigational Site 057
Investigational Site 193
Investigational Site 242
Investigational Site 460
Investigational Site 325
Investigational Site 230
Investigational Site 149
Investigational Site 129
Investigational Site 329
Investigational Site 292
Investigational Site 194
Investigational Site 415
Investigational Site 003
Investigational Site 351
Investigational Site 151
Investigational Site 031
Investigational Site 020
Investigational Site 146
Investigational Site 426
Investigational Site 467
Investigational Site 517
Investigational Site 175
Investigational Site 528
Investigational Site 458
Investigational Site 352
Investigational Site 271
Investigational Site 356
Investigational Site 156
Investigational Site 135
Investigational Site 083
Investigational Site 534
Investigational Site 095
Investigational Site 176
Investigational Site 112
Investigational Site 221
Investigational Site 196
Investigational Site 365
Investigational Site 009
Investigational Site 451
Investigational Site 203
Investigational Site 101
Investigational Site 158
Investigational Site 354
Investigational Site 503
Investigational Site 190
Investigational Site 446
Investigational Site 294
Investigational Site 469
Investigational Site 546
Investigational Site 047
Investigational Site 412
Investigational Site 284
Investigational Site 002
Investigational Site 245
Investigational Site 403
Investigational Site 143
Investigational Site 275
Investigational Site 540
Investigational Site 201
Investigational Site 080

intervention_type: Biological

lead_sponsor_type: academique


title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure

acronym: COMMANDER HF

summary: The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.

ReferenceCitation: Ferreira JP, Cleland JG, Lam CSP, Anker SD, Mehra MR, van Veldhuisen DJ, Byra WM, La Police DA, Pitt B, Greenberg B, Zannad F. Heart failure re-hospitalizations and subsequent fatal events in coronary artery disease: insights from COMMANDER-HF, EPHESUS, and EXAMINE. Clin Res Cardiol. 2021 Oct;110(10):1554-1563. doi: 10.1007/s00392-021-01830-1. Epub 2021 Mar 8.

oa_host_type: repository

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

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

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

repository_normalized: HAL

version: submittedVersion

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

unpaywall_oa_status: green

ReferenceCitation: Ferreira JP, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, La Police DA, Anker SD, Mehra MR, Leroy C, Eschwege V, Toussaint-Hacquard M, Rossignol P, Greenberg B, Zannad F. Impact of Geographic Region on the COMMANDER-HF Trial. JACC Heart Fail. 2021 Mar;9(3):201-211. doi: 10.1016/j.jchf.2020.11.007. Epub 2021 Feb 3.

license: publisher-specific-oa

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

ReferenceCitation: Cunningham JW, Ferreira JP, Deng H, Anker SD, Byra WM, Cleland JGF, Gheorghiade M, Lam CSP, La Police D, Mehra MR, Neaton JD, Spiro TE, van Veldhuisen DJ, Greenberg B, Zannad F. Natriuretic Peptide-Based Inclusion Criteria in a Heart Failure Clinical Trial: Insights From COMMANDER HF. JACC Heart Fail. 2020 May;8(5):359-368. doi: 10.1016/j.jchf.2019.12.009. Epub 2020 Mar 11.

ReferenceCitation: Mehra MR, Vaduganathan M, Fu M, Ferreira JP, Anker SD, Cleland JGF, Lam CSP, van Veldhuisen DJ, Byra WM, Spiro TE, Deng H, Zannad F, Greenberg B. A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial. Eur Heart J. 2019 Nov 21;40(44):3593-3602. doi: 10.1093/eurheartj/ehz427.

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

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

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Greenberg B, Neaton JD, Anker SD, Byra WM, Cleland JGF, Deng H, Fu M, La Police DA, Lam CSP, Mehra MR, Nessel CC, Spiro TE, van Veldhuisen DJ, Vanden Boom CM, Zannad F. Association of Rivaroxaban With Thromboembolic Events in Patients With Heart Failure, Coronary Disease, and Sinus Rhythm: A Post Hoc Analysis of the COMMANDER HF Trial. JAMA Cardiol. 2019 Jun 1;4(6):515-523. doi: 10.1001/jamacardio.2019.1049.

ReferenceCitation: Zannad F, Anker SD, Byra WM, Cleland JGF, Fu M, Gheorghiade M, Lam CSP, Mehra MR, Neaton JD, Nessel CC, Spiro TE, van Veldhuisen DJ, Greenberg B; COMMANDER HF Investigators. Rivaroxaban in Patients with Heart Failure, Sinus Rhythm, and Coronary Disease. N Engl J Med. 2018 Oct 4;379(14):1332-1342. doi: 10.1056/NEJMoa1808848. Epub 2018 Aug 27.

sponsor_collaborators:
Janssen Research & Development, LLC
Bayer

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
United States
Latvia
Ukraine
Romania
China
Malaysia
Estonia
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Greece
South Africa
Bulgaria
Russian Federation
Sweden


acronym: ENESTfreedom

lead_sponsor: Novartis Pharmaceuticals

summary: The main purpose of the study was to investigate whether nilotinib treatment can be safely suspended with no recurrence of CML in selected patients who responded optimally on this treatment

location_facility:
Novartis Investigative Site
Cancer Center of Kansas SC

title: A Single-arm, Multicenter, Nilotinib Treatment-free Remission Study in Patients With BCR-ABL1 Positive Chronic Myelogenous Leukemia in Chronic Phase Who Have Achieved Durable Minimal Residual Disease (MRD) Status on First Line Nilotinib Treatment.

primary_purpose: Other

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

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

location_country:
Germany
Ireland
Poland
Argentina
Japan
France
Colombia
Hungary
Denmark
United States
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Sweden

status_simplified: Ongoing


title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).

summary: This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.

ReferenceCitation: Mackay AJ, Kostikas K, Roche N, Frent SM, Olsson P, Pfister P, Gupta P, Patalano F, Banerji D, Wedzicha JA. Impact of baseline symptoms and health status on COPD exacerbations in the FLAME study. Respir Res. 2020 Apr 22;21(1):93. doi: 10.1186/s12931-020-01354-8.

repository_institution: ZB MED - Informationszentrum Lebenswissenschaften - PUBLISSO-Fachrepositorium Lebenswissenschaften

repositories_concat: PubMed Central;frl.publisso.de

ReferenceCitation: Wedzicha JA, Singh D, Tsiligianni I, Jenkins C, Fucile S, Fogel R, Shen S, Goyal P, Mezzi K, Kostikas K. Treatment response to indacaterol/glycopyrronium versus salmeterol/fluticasone in exacerbating COPD patients by gender: a post-hoc analysis in the FLAME study. Respir Res. 2019 Jan 8;20(1):4. doi: 10.1186/s12931-019-0972-7.

repository_institution: Imperial College London - Spiral

repositories_concat: PubMed Central;spiral.imperial.ac.uk

repositories_institution:
Imperial College London - Spiral
PubMed Central - Europe PMC

ReferenceCitation: Frent SM, Chapman KR, Larbig M, Mackay A, Fogel R, Gutzwiller FS, Shen S, Patalano F, Banerji D, Kostikas K, Wedzicha JA. Capturing Exacerbations of Chronic Obstructive Pulmonary Disease with EXACT. A Subanalysis of FLAME. Am J Respir Crit Care Med. 2019 Jan 1;199(1):43-51. doi: 10.1164/rccm.201801-0038OC.

publisher_dissemination: American Thoracic Society

ReferenceCitation: Anzueto AR, Kostikas K, Mezzi K, Shen S, Larbig M, Patalano F, Fogel R, Banerji D, Wedzicha JA. Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study. Respir Res. 2018 Jun 20;19(1):121. doi: 10.1186/s12931-018-0830-z.

ReferenceCitation: Roche N, Chapman KR, Vogelmeier CF, Herth FJF, Thach C, Fogel R, Olsson P, Patalano F, Banerji D, Wedzicha JA. Blood Eosinophils and Response to Maintenance Chronic Obstructive Pulmonary Disease Treatment. Data from the FLAME Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1189-1197. doi: 10.1164/rccm.201701-0193OC.

ReferenceCitation: Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.

repository_institution: The University of Manchester - Research Explorer

repositories:
LIRIAS (KU Leuven)
Pure (Denmark)
spiral.imperial.ac.uk

repositories_concat: LIRIAS (KU Leuven);Pure (Denmark);spiral.imperial.ac.uk

location_country:
Finland
Germany
Poland
Argentina
Japan
Thailand
Turkey
Croatia
Chile
Canada
Serbia
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Latvia
Iceland
India
Romania
Belgium
China
Estonia
Philippines
Italy
Guatemala
Norway
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden


title: A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

summary: Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.

ReferenceCitation: Mesa RA, Vannucchi AM, Mead A, Egyed M, Szoke A, Suvorov A, Jakucs J, Perkins A, Prasad R, Mayer J, Demeter J, Ganly P, Singer JW, Zhou H, Dean JP, Te Boekhorst PA, Nangalia J, Kiladjian JJ, Harrison CN. Pacritinib versus best available therapy for the treatment of myelofibrosis irrespective of baseline cytopenias (PERSIST-1): an international, randomised, phase 3 trial. Lancet Haematol. 2017 May;4(5):e225-e236. doi: 10.1016/S2352-3026(17)30027-3. Epub 2017 Mar 20.

ReferenceCitation: Tremblay D, Mesa R, Scott B, Buckley S, Roman-Torres K, Verstovsek S, Mascarenhas J. Pacritinib demonstrates spleen volume reduction in patients with myelofibrosis independent of JAK2V617F allele burden. Blood Adv. 2020 Dec 8;4(23):5929-5935. doi: 10.1182/bloodadvances.2020002970.

location_country:
Germany
Italy
New Zealand
Hungary
United Kingdom
Australia
Netherlands
Belgium
United States
Czechia
Russian Federation
France

location_facility:
CTI Investigational Site 31001
CTI Investigational Site 61002
CTI Investigational Site 36008
CTI Investigational Site 61003
CTI Investigational Site 44002
CTI Investigational Site 61004
CTI Investigational Site 33008
CTI Investigational Site 33005
CTI Investigational Site 33012
CTI Investigational Site 33006
CTI Investigational Site 44008
CTI Investigational Site 36005
CTI Investigational Site 39003
CTI Investigational Site 70010
CTI Investigational Site 70002
CTI Investigational Site 49002
CTI Investigational Site 64004
CTI Investigational Site 33002
CTI Investigational Site 32004
CTI Investigational Site 32005
CTI Investigational Site 10003
CTI Investigational Site 42001
CTI Investigational Site 70006
CTI Investigational Site 31002
CTI Investigational Site 64001
CTI Investigational Site 61006
CTI Investigational Site 49007
CTI Investigational Site 10001
CTI Investigational Site 33003
CTI Investigational Site 42003
CTI Investigational Site 70001
CTI Investigational Site 44004
CTI Investigational Site 36007
CTI Investigational Site 44006
CTI Investigational Site 70005
CTI Investigational Site 44001
CTI Investigational Site 33004
CTI Investigational Site 36003
CTI Investigational Site 33011
CTI Investigational Site 61005
CTI Investigational Site 49009
CTI Investigational Site 44005
CTI Investigational Site 64003
CTI Investigational Site 42004
CTI Investigational Site 36006
CTI Investigational Site 10002
CTI Investigational Site 44007
CTI Investigational Site 42002
CTI Investigational Site 44003
CTI Investigational Site 49001
CTI Investigational Site 33010
CTI Investigational Site 64002
CTI Investigational Site 36001
CTI Investigational Site 70004
CTI Investigational Site 70009
CTI Investigational Site 31004
CTI Investigational Site 39006
CTI Investigational Site 33001
CTI Investigational Site 70007
CTI Investigational Site 36002
CTI Investigational Site 70011
CTI Investigational Site 39005
CTI Investigational Site 39001
CTI Investigational Site 32001
CTI Investigational Site 33007
CTI Investigational Site 39008
CTI Investigational Site 70008
CTI Investigational Site 39002
CTI Investigational Site 49008
CTI Investigational Site 36004
CTI Investigational Site 49003
CTI Investigational Site 32003
CTI Investigational Site 31003
CTI Investigational Site 39004
CTI Investigational Site 33009
CTI Investigational Site 10004
CTI Investigational Site 61001
CTI Investigational Site 32002
CTI Investigational Site 49005
CTI Investigational Site 49006
CTI Investigational Site 49004


acronym: NEMO

lead_sponsor: Pfizer

summary: Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival

ReferenceCitation: Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozon V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. doi: 10.1016/S1470-2045(17)30180-8. Epub 2017 Mar 9.

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

location_facility: Adana Ba?kent Hastanesi K??la Yerle?kesi

location_facility: The Ohio State University Martha Morehouse Medical Plaza

location_facility: Institut für Diagnostische und Interventionelle Radiologie Frankfurt

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Centro de Investigación Clínica ? Clínica Viedma

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: IRCCS Az. Osp. Universitaria San Martino- IST

location_facility: Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH

location_facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Kaiser Permanente Northwest Region Oncology/Hematology

location_facility: Harry and Jeannette Weinberg Cancer Institute @Franklin Square

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Alberta Health Services - Cross Cancer Institute

location_facility: UT Southwestern University Hospital - Zale Lipshy

location_facility: Karmanos Cancer Institute of Farmington Hills

location_facility: A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro

location_facility: St. Luke's University Hospital - Bethlehem Campus

location_facility: Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

location_facility: St James s Institute of Clinical Oncology

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: Centre Hospitalier Universitaire Ambroise Pare

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: St. Luke's Cancer Center - Anderson Campus

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: UT Southwestern Medical Center at Dallas

location_facility: McGill University Health Center / Royal Victoria Hospital

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

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

location_facility: Medizinische Hochschule Hannover (Hannover Medical School)

location_facility: Fundacion Instituto Valenciano de Oncologia

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Centre Hospitalier Universitaire Hopitaux de Rouen

location_facility: UT Southwestern University Hospital- St. Paul

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano

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

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: The Ohio State University James Cancer Hospital

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Istituto Dermopatico dell'Immacolata IRCCS

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

location_facility: Azienza Ospedaliera Universitaria Senese

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Baskent University Medical Faculty Ankara Hospital

location_facility: St. Luke's Cancer Center - Allentown Campus

location_facility: Cancer Center Associates - Medical Oncology

title: The NEMO Trial (NRAS Melanoma and MEK Inhibitor):A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma

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.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Slovakia
Hungary
Switzerland
United States
Belgium
Italy
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Israel


summary: The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

ReferenceCitation: Zhu Z, Turner NC, Loi S, Andre F, Martin M, Dieras V, Gelmon KA, Harbeck N, Zhang C, Cao JQ, Yan Z, Lu DR, Wei P, VanArsdale TL, Rejto PA, Huang X, Rugo HS, Loibl S, Cristofanilli M, Finn RS, Liu Y. Comparative biomarker analysis of PALOMA-2/3 trials for palbociclib. NPJ Precis Oncol. 2022 Aug 16;6(1):56. doi: 10.1038/s41698-022-00297-1.

ReferenceCitation: Gelmon K, Walshe JM, Mahtani R, Joy AA, Karuturi M, Neven P, Lu DR, Kim S, Schnell P, Bananis E, Schwartzberg L. Efficacy and safety of palbociclib in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2. Breast. 2021 Oct;59:321-326. doi: 10.1016/j.breast.2021.07.017. Epub 2021 Jul 28.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: Iwata H, Umeyama Y, Liu Y, Zhang Z, Schnell P, Mori Y, Fletcher O, Marshall JC, Johnson JG, Wood LS, Toi M, Finn RS, Turner NC, Bartlett CH, Cristofanilli M. Evaluation of the Association of Polymorphisms With Palbociclib-Induced Neutropenia: Pharmacogenetic Analysis of PALOMA-2/-3. Oncologist. 2021 Jul;26(7):e1143-e1155. doi: 10.1002/onco.13811. Epub 2021 Jun 7.

publisher_dissemination: Oxford University Press

ReferenceCitation: Finn RS, Rugo HS, Gelmon KA, Cristofanilli M, Colleoni M, Loi S, Schnell P, Lu DR, Theall KP, Mori A, Gauthier E, Bananis E, Turner NC, Dieras V. Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. Oncologist. 2021 May;26(5):e749-e755. doi: 10.1002/onco.13684. Epub 2021 Mar 10.

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Zheng J, Yu Y, Durairaj C, Dieras V, Finn RS, Wang DD. Impact of Dose Reduction on Efficacy: Implications of Exposure-Response Analysis of Palbociclib. Target Oncol. 2021 Jan;16(1):69-76. doi: 10.1007/s11523-020-00771-5.

ReferenceCitation: Finn RS, Cristofanilli M, Ettl J, Gelmon KA, Colleoni M, Giorgetti C, Gauthier E, Liu Y, Lu DR, Zhang Z, Bartlett CH, Slamon DJ, Turner NC, Rugo HS. Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials. Breast Cancer Res Treat. 2020 Nov;184(1):23-35. doi: 10.1007/s10549-020-05782-4. Epub 2020 Aug 11.

ReferenceCitation: Huang Bartlett C, Mardekian J, Cotter MJ, Huang X, Zhang Z, Parrinello CM, Bourla AB. Concordance of real-world versus conventional progression-free survival from a phase 3 trial of endocrine therapy as first-line treatment for metastatic breast cancer. PLoS One. 2020 Apr 21;15(4):e0227256. doi: 10.1371/journal.pone.0227256. eCollection 2020.

ReferenceCitation: Ettl J, Im SA, Ro J, Masuda N, Colleoni M, Schnell P, Bananis E, Lu DR, Cristofanilli M, Rugo HS, Finn RS. Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies. Breast Cancer Res. 2020 Mar 12;22(1):27. doi: 10.1186/s13058-020-01263-0.

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

repository_institution: Seoul National University - Seoul National University Open Repository

ReferenceCitation: Rugo HS, Finn RS, Gelmon K, Joy AA, Harbeck N, Castrellon A, Mukai H, Walshe JM, Mori A, Gauthier E, Lu DR, Bananis E, Martin M, Dieras V. Progression-free Survival Outcome Is Independent of Objective Response in Patients With Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer Treated With Palbociclib Plus Letrozole Compared With Letrozole: Analysis From PALOMA-2. Clin Breast Cancer. 2020 Apr;20(2):e173-e180. doi: 10.1016/j.clbc.2019.08.009. Epub 2019 Sep 5.

ReferenceCitation: Dieras V, Harbeck N, Joy AA, Gelmon K, Ettl J, Verma S, Lu DR, Gauthier E, Schnell P, Mori A, Rugo HS, Finn RS. Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial. Oncologist. 2019 Dec;24(12):1514-1525. doi: 10.1634/theoncologist.2019-0019. Epub 2019 Jun 19.

repository_institution: University of California - eScholarship University of California

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Masuda N, Mukai H, Inoue K, Rai Y, Ohno S, Mori Y, Hashigaki S, Muramatsu Y, Umeyama Y, Iwata H, Toi M. Neutropenia management with palbociclib in Japanese patients with advanced breast cancer. Breast Cancer. 2019 Sep;26(5):637-650. doi: 10.1007/s12282-019-00970-7. Epub 2019 May 24. Erratum In: Breast Cancer. 2019 Jun 5;:

ReferenceCitation: Im SA, Mukai H, Park IH, Masuda N, Shimizu C, Kim SB, Im YH, Ohtani S, Huang Bartlett C, Lu DR, Iyer S, Mori Y, Mori A, Gauthier E, Finn RS, Toi M. Palbociclib Plus Letrozole as First-Line Therapy in Postmenopausal Asian Women With Metastatic Breast Cancer: Results From the Phase III, Randomized PALOMA-2 Study. J Glob Oncol. 2019 May;5:1-19. doi: 10.1200/JGO.18.00173.

ReferenceCitation: Mukai H, Shimizu C, Masuda N, Ohtani S, Ohno S, Takahashi M, Yamamoto Y, Nishimura R, Sato N, Ohsumi S, Iwata H, Mori Y, Hashigaki S, Muramatsu Y, Nagasawa T, Umeyama Y, Lu DR, Toi M. Palbociclib in combination with letrozole in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients. Int J Clin Oncol. 2019 Mar;24(3):274-287. doi: 10.1007/s10147-018-1353-9. Epub 2018 Dec 4.

ReferenceCitation: Rugo HS, Turner NC, Finn RS, Joy AA, Verma S, Harbeck N, Masuda N, Im SA, Huang X, Kim S, Sun W, Iyer S, Schnell P, Bartlett CH, Johnston S. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018 Sep;101:123-133. doi: 10.1016/j.ejca.2018.05.017. Epub 2018 Jul 25.

ReferenceCitation: Dieras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;escholarship.org

repositories_institution: California Digital Library - eScholarship

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

ReferenceCitation: Rugo HS, Dieras V, Gelmon KA, Finn RS, Slamon DJ, Martin M, Neven P, Shparyk Y, Mori A, Lu DR, Bhattacharyya H, Bartlett CHUANG, Iyer S, Johnston S, Ettl J, Harbeck N. Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial. Ann Oncol. 2018 Apr 1;29(4):888-894. doi: 10.1093/annonc/mdy012.

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

repositories_concat: LIRIAS (KU Leuven);PubMed Central;dnet;escholarship.org;mediatum.ub.tum.de

ReferenceCitation: Turner NC, Finn RS, Martin M, Im SA, DeMichele A, Ettl J, Dieras V, Moulder S, Lipatov O, Colleoni M, Cristofanilli M, Lu DR, Mori A, Giorgetti C, Iyer S, Bartlett CH, Gelmon KA. Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Ann Oncol. 2018 Mar 1;29(3):669-680. doi: 10.1093/annonc/mdx797.

ReferenceCitation: Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: MI "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly,

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen

location_facility: Mercy Clinic St. Louis Cancer and Breast Institute

location_facility: Institut Curie, Departement d'Oncologie Medicale

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Centro Oncologico MD Anderson Internacional España

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: The Mark M. Connolly Center for Cancer and Specialty Care

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie

location_facility: University Hospital Carl Gustav Carus - Department for Obstetrics and Gynecology.

location_facility: UCLA Santa Monica Medical Center and Orthopaedic Hospital

location_facility: Memorial Cancer Institute at Memorial Hospital West

location_facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine

location_facility: City Oncology Centre of Central Municipal Clinical Hospital

location_facility: Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Słomian

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Edinburgh Cancer Centre, Western General Hospital

location_facility: QEII Health Sciences Centre, Victoria General Site

location_facility: Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care

location_facility: Municipal Medical Institution "Makiivka City Hospital No.2 of Donetsk Region"

location_facility: McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre

location_facility: US Oncology Investigational Products Center

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers

location_facility: Sylvester Comprehensive Cancer Center Plantation

location_facility: Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily

location_facility: Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly

location_facility: Republican Clinical Hospital n.a. G.G. Kuvatov

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Regional Municipal Establishment "Sumy Regional Clinical Oncology Dispensary", Thoracic Department

location_facility: Non-State Health Care agency "Road Clinical Hospital of PLC" Russian Railways

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

location_facility: State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine

location_facility: Breast Cancer, University of Munich, Grosshadern Hospital

location_facility: St. Mary's Hospital Regional Cancer Center

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: James Graham Brown Cancer Center and University Hospital

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Walter Reed National Military Medical Center

location_facility: UCLA West Medical Pharmacy; Drug Management Only

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine",

location_facility: Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D.

location_facility: Administrative Address: UCLA Hematology/Oncology

location_facility: Országos Onkológiai Intézet "B" Belgyogyaszati osztaly

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Carle Foundation Hospital DBA Carle Cancer Center

location_facility: Southlake Regional Health Centre- Stronach Regional Cancer Centre

location_facility: Országos Onkológiai Intézet, Nuklearis Medicina Osztaly

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: University of Maryland, Greenebaum Cancer Center

location_facility: Instituto Catalan de Oncologia L'Hospitalet

location_facility: Memorial Breast Cancer Center at Memorial Hospital West

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department

location_facility: Hospital Universitario Fundacion de Alcorcon

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

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Whittingham Cancer Center @ Norwalk Hospital

location_facility: Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department

location_facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

location_facility: Bendigo Health Care Group, The Bendigo Hospital Campus

location_facility: Hospital Madrid Universitario Sanchinarro

location_facility: Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik

location_facility: State Budget Healthcare Institution Moscow City Oncology Hospital

location_facility: Cancer Specialist of North Florida, Pharmacy

location_facility: Institut de Cancérologie de l'Ouest-Rene Gauducheau

location_facility: Municipal Non-profit Enterprise "Regional Centre of Oncology"

location_facility: Seoul National University Bundang Hospital

location_facility: Saint Francis Medical Center, Saint Francis Cancer Treatment Center

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: State Budget Healthcate Institution "Leningrad Region Oncology Dispensary"

location_facility: University of California San Francisco - Helen Diller Family Comprehensive Cancer Center

location_facility: Regulatory Management Only: TRIO-US Central Administration

location_facility: UCLA West Medical Pharmacy: Drug Management Only

location_facility: Mercy Hospital St. Louis - David C. Pratt Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: TRIO-US Central Administration: Regulatory Management Only

location_facility: Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen

location_facility: The West Clinic, PC dba West Cancer Centre

location_facility: SBHI of Republic of Bashkortostan Emergency Hospital

location_facility: The Research And Development Office, The Christie NHS Foundation Trust

location_facility: Institut de Cancerologie de l'Ouest- Paul Papin

location_facility: Southern California Permanente Medical Group

location_facility: Memorial Breast Cancer Center at Memorial Regional Hospital

location_facility: State Budget Medical Institution Republican Clinical Oncology

location_facility: Gasthuis Zusters Antwerpen - Campus Sint- Augustinus

location_facility: The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Altalanos Orvostudomanyi Kar

location_facility: Grand Hopital de Charleroi / Service d'Hematologie et Oncologie

location_facility: Central Coast Medical Oncology Corporation

location_facility: Torrance Health Association, DBa Torrance Memorial Physician Network

location_facility: Regional Budgetary Healthcare Institution Kursk Regional Clinical

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: Cancer Specialists of North Florida - St. Augustine

location_facility: Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ.

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong

location_facility: GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan

location_facility: MI "Dnipropetrovsk City Multidisciplinary Clinical Hospital No.4" of the Dnipropetrovsk City Council

location_facility: The University of Texas MD Anderson Cancer Center.

location_facility: Cancer Specialists of North Florida-Southpoint

location_facility: Saint-Petersburg State Budget Healthcare Institution (SBHCI)

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Gynakologie und Geburtshilfe

location_facility: Center Hospitalier Affilie Universitaire de Quebec, Universite Laval, Hopital du Saint Sacrement

location_facility: Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet

title: A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

location_country:
Germany
Ireland
Italy
Poland
Hungary
United Kingdom
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
Canada
Ukraine
Russian Federation
France


title: A Randomised, Double-Blind, Placebo-Controlled Proof Of Concept Study Of Maintenance Therapy With Tasquinimod In Patients With Metastatic Castrate-Resistant Prostate Cancer Who Are Not Progressing After A First Line Docetaxel Based Chemotherapy

summary: The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.

ReferenceCitation: Fizazi K, Ulys A, Sengelov L, Moe M, Ladoire S, Thiery-Vuillemin A, Flechon A, Guida A, Bellmunt J, Climent MA, Chowdhury S, Dumez H, Matouskova M, Penel N, Liutkauskiene S, Stachurski L, Sternberg CN, Baton F, Germann N, Daugaard G. A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy. Ann Oncol. 2017 Nov 1;28(11):2741-2746. doi: 10.1093/annonc/mdx487.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Ipsen

location_country:
Germany
Italy
Lithuania
Poland
Hungary
United Kingdom
Denmark
Belgium
Spain
Czechia
France

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu

location_facility: Urology and Urological Oncology Department and Clinic


summary: To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy

ReferenceCitation: Hagege A, Ambrosetti D, Boyer J, Bozec A, Doyen J, Chamorey E, He X, Bourget I, Rousset J, Saada E, Rastoin O, Parola J, Luciano F, Cao Y, Pages G, Dufies M. The Polo-like kinase 1 inhibitor onvansertib represents a relevant treatment for head and neck squamous cell carcinoma resistant to cisplatin and radiotherapy. Theranostics. 2021 Sep 21;11(19):9571-9586. doi: 10.7150/thno.61711. eCollection 2021.

publisher_dissemination: Ivyspring International Publisher

location_facility: Hospital Central de Salud Zenón Santillan

location_facility: Reg. Specialist Hospital of M. Kopernik, Dept. Haematology

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Med. Klinik m.S. Hämatologie und Onkologie

location_facility: Univ. of Szeged, 2nd Dept. of Internal Med., Haematology

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Japanese Red Cross Nagoya Daini Hospital

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

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: St. Luke's Hospital Association of Duluth, Inc.

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: University Hospital Plzen, Plzen-Lochotin

location_facility: Chonnam National University Hwasun Hospital

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: City Hospital Torun, Department of Hematology

location_facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

location_facility: Regional Clinical Hospital 'The Badge of Honor Order'

location_facility: Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António

title: A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy

ipd_sharing_description:
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

location_country:
Finland
Germany
Poland
Argentina
Japan
Brazil
Czechia
Canada
France
Portugal
Hungary
United States
India
Belgium
Italy
Norway
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation

ipd_sharing: No


title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of RO4602522 Added to Background Alzheimer's Disease Therapy in Patients With Moderate Severity Alzheimer's Disease

acronym: MAyflOwer RoAD

summary: This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in participants with moderate severity Alzheimer's disease. Participants who are taking background therapy of acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4 months before screening will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.

ReferenceCitation: Nave S, Doody RS, Boada M, Grimmer T, Savola JM, Delmar P, Pauly-Evers M, Nikolcheva T, Czech C, Borroni E, Ricci B, Dukart J, Mannino M, Carey T, Moran E, Gilaberte I, Muelhardt NM, Gerlach I, Santarelli L, Ostrowitzki S, Fontoura P. Sembragiline in Moderate Alzheimer's Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD). J Alzheimers Dis. 2017;58(4):1217-1228. doi: 10.3233/JAD-161309.

license: unspecified-oa

license_normalized: unspecified-oa

publisher_dissemination: IOS Press

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Sweden
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: Institut Universitaire de gériatrie de Sherbrooke; Service de gériatrie/pavillon Argyll

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Inha University Hospital; Pulmonary Medicine

location_facility: New York University Medical Center;Child Study Center

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Artemis Institute for Clinical Research, LLC

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Advanced Research Center, Inc.;In-Patient Unit

location_facility: Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Medical Research Group of Central Florida

location_facility: Comprehensive Clinical Development, Inc.- St. Petersburg, FL

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog

location_facility: West London Cognitive Disorders Treatment and Research Unit; Lakeside Metal Health Unit

location_facility: University of North Texas Health Science Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Alzheimer's Research & Clinical Programs

location_facility: Hospital Perpetuo Socorro, Servicio de Geriatria

location_facility: Hospital General Universitario de Elche; Servicio de Farmacia

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: Nuovo Ospedale Civile S.Agostino - Estense

location_facility: Seoul National University Bundang Hospital

location_facility: Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo

location_facility: Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Groupe Hospitalier Sud - Hôpital Xavier Arnozan

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hospital Universitario Clínico San Carlos


title: cAlprotectin and hsCRP as Markers of a New Diagnostic-therapeutic strAtegy That Assesses muCosal Activity to individuaLize Treatment and Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants

acronym: ADACAL

summary: This study will test that individualized treatment in patients with Crohn's Disease in remission or mild clinical activity under immunosuppressants may improve prognosis, rather than just treating flares.

lead_sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

collaborators:
Abbott
TFS Trial Form Support

location_country: Spain Belgium France

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Complejo Hospitalario Santiago de Compostela


title: More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges

acronym: MORE-CRT

summary: This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.

ReferenceCitation: Boriani G, Connors S, Kalarus Z, Lemke B, Mullens W, Osca Asensi J, Raatikainen P, Gazzola C, Farazi TG, Leclercq C. Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial. JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11.

lead_sponsor: Abbott Medical Devices

location_country:
Finland
Germany
Italy
Poland
India
Israel
United Kingdom
Netherlands
Switzerland
Belgium
Spain
Canada
France

location_facility: Hopital du Nord - CH Bourrely St. Antoine

location_facility: Escorts Heart Institute and Research Center

location_facility: Institut de Cardiologie du Quebec - Hopital Laval

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Azienda Ospedaliera S.Anna e S.Sebastiano

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: Ospedale Civile Maggiore Verona Borgo Trento

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

intervention_type: Procedure