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 Magalhães 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.

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

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

lead_sponsor_type: academique


type: Other Identifier

type: EudraCT Number

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.

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: 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.

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.

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.

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.

lead_sponsor: Janssen Research & Development, LLC

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

intervention_type: Other

lead_sponsor_type: industriel

status_simplified: Completed


ipd_sharing: Yes

status: Active, not recruiting

primary_purpose: Other

acronym: ENESTfreedom

intervention_type: Drug

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.

study_completion_date_type: Anticipated

lead_sponsor: Novartis Pharmaceuticals

source: euctr

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

location_facility: Oregon Health and Science University SC-6

location_facility: Florida Cancer Specialists FL Cancer Specialists

location_facility: Cancer Centers of the Carolinas Cancer Centers of Carolinas (3

location_facility: Sarah Cannon Research Institute Sarah Cannon Research

location_facility: H Lee Moffitt Cancer Center and Research Institute SC - 5

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

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.

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.

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.

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.

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


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.

status: Terminated

ReferenceType: background

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.

lead_sponsor: CTI BioPharma

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

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

status_simplified: Unknown


acronym: NEMO

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

lead_sponsor: Pfizer

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, Bozón 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.

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

location_facility: UT Southwestern University Hospital- St. Paul

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

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

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

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: Hospital Regional Universitario de Malaga Hospital General

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

location_facility: Karmanos Cancer Institute of Farmington Hills

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

location_facility: Radboud University Nijmegen Medical Centre

location_facility: UT Southwestern Medical Center at Dallas

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

location_facility: Klinikum Mannheim Universitätsklinikum gGmbH

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

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

location_facility: Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH

location_facility: Centro de Investigación Clínica ? Clínica Viedma

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

location_facility: Penn State Milton S. Hershey Medical Center

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

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

location_facility: Azienza Ospedaliera Universitaria Senese

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Kaiser Permanente Northwest Region Oncology/Hematology

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: St James s Institute of Clinical Oncology

location_facility: Istituto Dermopatico dell'Immacolata IRCCS

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

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

location_facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden

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

location_facility: Institut für Diagnostische und Interventionelle Radiologie Frankfurt

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

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Cancer Center Associates - Medical Oncology

location_facility: Centre Hospitalier Universitaire Vaudois

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

location_facility: Centre Hospitalier Universitaire Hopitaux de Rouen

location_facility: The Ohio State University Martha Morehouse Medical Plaza

location_facility: Fundacion Instituto Valenciano de Oncologia

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

location_facility: Ryazan Regional Clinical Oncology Dispensary

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

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

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

location_facility: IRCCS Giovanni Paolo II Istituto Oncologico

location_facility: Baskent University Medical Faculty Ankara Hospital

location_facility: Centre Hospitalier Universitaire Ambroise Pare

location_facility: Alberta Health Services - Cross Cancer Institute

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Hospital Universitario Vall d'Hebrón - PPDS

location_facility: Harry and Jeannette Weinberg Cancer Institute @Franklin Square

location_facility: UT Southwestern University Hospital - Zale Lipshy

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

location_facility: The Ohio State University James Cancer Hospital

location_facility: Severance Hospital Yonsei University Health System - PPDS

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

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: McGill University Health Center / Royal Victoria Hospital

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

location_facility: Medizinische Hochschule Hannover (Hannover Medical School)

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


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

ReferenceCitation: Zhu Z, Turner NC, Loi S, André F, Martin M, Diéras 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.

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.

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, Diéras 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.

ReferenceCitation: Zheng J, Yu Y, Durairaj C, Diéras 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.

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, Diéras 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: Diéras 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.

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: Diéras 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.

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, Diéras 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.

ReferenceCitation: Turner NC, Finn RS, Martin M, Im SA, DeMichele A, Ettl J, Diéras 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, Diéras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936.

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

location_facility: Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik

location_facility: Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily

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

location_facility: UCLA Santa Monica Medical Center and Orthopaedic Hospital

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

location_facility: Cancer Specialists of North Florida - St. Augustine

location_facility: Southern California Permanente Medical Group

location_facility: James Graham Brown Cancer Center and University Hospital

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

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Walter Reed National Military Medical Center

location_facility: Gasthuis Zusters Antwerpen - Campus Sint- Augustinus

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

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

location_facility: Southlake Regional Health Centre- Stronach Regional Cancer Centre

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

location_facility: Torrance Health Association, DBa Torrance Memorial Physician Network

location_facility: The University of Texas MD Anderson Cancer Center

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

location_facility: Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen

location_facility: Bendigo Health Care Group, The Bendigo Hospital Campus

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: Whittingham Cancer Center @ Norwalk Hospital

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

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

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

location_facility: Edinburgh Cancer Centre, Western General Hospital

location_facility: UCLA West Medical Pharmacy; Drug Management Only

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: TRIO-US Central Administration: Regulatory Management Only

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Institut Curie, Departement d'Oncologie Medicale

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

location_facility: Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie

location_facility: QEII Health Sciences Centre, Victoria General Site

location_facility: Memorial Breast Cancer Center at Memorial Hospital West

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

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

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Cancer Specialist of North Florida, Pharmacy

location_facility: State Budget Medical Institution Republican Clinical Oncology

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

location_facility: Hiroshima City Hiroshima Citizens Hospital

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

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

location_facility: Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet

location_facility: University of Maryland, Greenebaum Cancer Center

location_facility: Országos Onkológiai Intézet, Nuklearis Medicina Osztaly

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

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

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

location_facility: Breast Cancer, University of Munich, Grosshadern Hospital

location_facility: Sylvester Comprehensive Cancer Center Plantation

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

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

location_facility: The West Clinic, PC dba West Cancer Centre

location_facility: Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly

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

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

location_facility: Smilow Cancer Hospital at Yale New Haven

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

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

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Central Coast Medical Oncology Corporation

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: City Oncology Centre of Central Municipal Clinical Hospital

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

location_facility: Cancer Specialists of North Florida-Southpoint

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

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: UCLA West Medical Pharmacy: Drug Management Only

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

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Mercy Clinic St. Louis Cancer and Breast Institute

location_facility: Regulatory Management Only: TRIO-US Central Administration

location_facility: Országos Onkológiai Intézet "B" Belgyogyaszati osztaly

location_facility: Seoul National University Bundang Hospital

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

location_facility: State Budget Healthcare Institution Moscow City Oncology Hospital

location_facility: Instituto Catalan de Oncologia L'Hospitalet

location_facility: Memorial Cancer Institute at Memorial Hospital West

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Regional Budgetary Healthcare Institution Kursk Regional Clinical

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Fundacion de Alcorcon

location_facility: National Hospital Organization Osaka National Hospital

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

location_facility: SBHI of Republic of Bashkortostan Emergency Hospital

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

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

location_facility: The University of Texas MD Anderson Cancer Center.

location_facility: Memorial Breast Cancer Center at Memorial Regional Hospital

location_facility: Centro Oncologico MD Anderson Internacional España

location_facility: Carle Foundation Hospital DBA Carle Cancer Center

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

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Hospital Madrid Universitario Sanchinarro

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

location_facility: US Oncology Investigational Products Center

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

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

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Administrative Address: UCLA Hematology/Oncology

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

location_facility: St. Mary's Hospital Regional Cancer Center

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.


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, Sengeløv 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.

lead_sponsor: Ipsen

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

location_facility: Urology and Urological Oncology Department and Clinic

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu


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

lead_sponsor: Boehringer Ingelheim

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, Pagès 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.

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.

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

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

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: The University of Texas MD Anderson Cancer Center

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

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

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

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

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: University Hospital Plzen, Plzen-Lochotin

location_facility: ASST Grande Ospedale Metropolitano Niguarda

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

location_facility: Japanese Red Cross Nagoya Daini Hospital

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

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

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

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Hospital Central de Salud Zenón Santillan

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: National Hospital Organization Nagoya Medical Center

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

location_facility: City Hospital Torun, Department of Hematology

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

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

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

location_facility: Centre Hospitalier Universitaire de Liège

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


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.

lead_sponsor: Hoffmann-La Roche

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

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

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

location_facility: Nuovo Ospedale Civile S.Agostino - Estense

location_facility: New York University Medical Center;Child Study Center

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

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

location_facility: Medical Research Group of Central Florida

location_facility: Groupe Hospitalier Sud - Hôpital Xavier Arnozan

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

location_facility: Inha University Hospital; Pulmonary Medicine

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo

location_facility: Memory Enhancement Center of America, Inc.

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

location_facility: Artemis Institute for Clinical Research, LLC

location_facility: Hospital Perpetuo Socorro, Servicio de Geriatria

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

location_facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

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

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital General Universitario de Elche; Servicio de Farmacia

location_facility: University of North Texas Health Science Center

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

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

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

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Seoul National University Bundang Hospital

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

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

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

location_facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog

location_facility: Alzheimer's Research & Clinical Programs

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Toronto Memory Program (Neurology Research Inc.)


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.

ipd_sharing: No

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

location_country: France Spain Belgium

location_facility: Complejo Hospitalario Santiago de Compostela

location_facility: Centre Hospitalier Universitaire de Liege


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

location_facility: Ospedale Civile Maggiore Verona Borgo Trento

location_facility: Azienda Ospedaliera S.Anna e S.Sebastiano

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Hopital du Nord - CH Bourrely St. Antoine

location_facility: Institut de Cardiologie du Quebec - Hopital Laval

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Escorts Heart Institute and Research Center

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

intervention_type: Procedure


title: Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
To evaluate the effects of alirocumab on other lipid parameters.

ReferenceType: result

ReferenceCitation: Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi: 10.1056/NEJMoa1501031. Epub 2015 Mar 15.

ReferenceCitation: Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

ReferenceCitation: Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov - Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. Erratum in: J Clin Lipidol. 2020 Sep - Oct;14(5):742.

ReferenceCitation: Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan - Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. Epub 2016 Oct 24.

lead_sponsor: Sanofi

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
South Africa
Poland
Portugal
Russian Federation
Argentina
Israel
Mexico
Norway
Sweden
Canada
Hungary
Germany
Bulgaria
Denmark
Finland
Czech Republic
France
Chile
Colombia
Netherlands

location_facility:
Investigational Site Number 616008
Investigational Site Number 056002
Investigational Site Number 840027
Investigational Site Number 152008
Investigational Site Number 276009
Investigational Site Number 840006
Investigational Site Number 616009
Investigational Site Number 643006
Investigational Site Number 032001
Investigational Site Number 170003
Investigational Site Number 620005
Investigational Site Number 710009
Investigational Site Number 840022
Investigational Site Number 840058
Investigational Site Number 620006
Investigational Site Number 840028
Investigational Site Number 826021
Investigational Site Number 826014
Investigational Site Number 840110
Investigational Site Number 840200
Investigational Site Number 840182
Investigational Site Number 840040
Investigational Site Number 840129
Investigational Site Number 840165
Investigational Site Number 840094
Investigational Site Number 643012
Investigational Site Number 710007
Investigational Site Number 840091
Investigational Site Number 056005
Investigational Site Number 380010
Investigational Site Number 276013
Investigational Site Number 840053
Investigational Site Number 840055
Investigational Site Number 100014
Investigational Site Number 840013
Investigational Site Number 840224
Investigational Site Number 100013
Investigational Site Number 170005
Investigational Site Number 376002
Investigational Site Number 528011
Investigational Site Number 724005
Investigational Site Number 170004
Investigational Site Number 840246
Investigational Site Number 276019
Investigational Site Number 124013
Investigational Site Number 826024
Investigational Site Number 840162
Investigational Site Number 710010
Investigational Site Number 348013
Investigational Site Number 528004
Investigational Site Number 528006
Investigational Site Number 724003
Investigational Site Number 752006
Investigational Site Number 826008
Investigational Site Number 826001
Investigational Site Number 528013
Investigational Site Number 840077
Investigational Site Number 840018
Investigational Site Number 643009
Investigational Site Number 528001
Investigational Site Number 528005
Investigational Site Number 578003
Investigational Site Number 840184
Investigational Site Number 380007
Investigational Site Number 840045
Investigational Site Number 840212
Investigational Site Number 276012
Investigational Site Number 840117
Investigational Site Number 124001
Investigational Site Number 840158
Investigational Site Number 208001
Investigational Site Number 250007
Investigational Site Number 616013
Investigational Site Number 724004
Investigational Site Number 642001
Investigational Site Number 250004
Investigational Site Number 710011
Investigational Site Number 724008
Investigational Site Number 124011
Investigational Site Number 348011
Investigational Site Number 840076
Investigational Site Number 124006
Investigational Site Number 208003
Investigational Site Number 250001
Investigational Site Number 056004
Investigational Site Number 124022
Investigational Site Number 250005
Investigational Site Number 484008
Investigational Site Number 840153
Investigational Site Number 840113
Investigational Site Number 250003
Investigational Site Number 250012
Investigational Site Number 840175
Investigational Site Number 840059
Investigational Site Number 826010
Investigational Site Number 840104
Investigational Site Number 100005
Investigational Site Number 840084
Investigational Site Number 840070
Investigational Site Number 840151
Investigational Site Number 032008
Investigational Site Number 710008
Investigational Site Number 484003
Investigational Site Number 840061
Investigational Site Number 348009
Investigational Site Number 826007
Investigational Site Number 032004
Investigational Site Number 840202
Investigational Site Number 840004
Investigational Site Number 376003
Investigational Site Number 348003
Investigational Site Number 826019
Investigational Site Number 276007
Investigational Site Number 642004
Investigational Site Number 840244
Investigational Site Number 840180
Investigational Site Number 203006
Investigational Site Number 840241
Investigational Site Number 276005
Investigational Site Number 840155
Investigational Site Number 840164
Investigational Site Number 100015
Investigational Site Number 840033
Investigational Site Number 246001
Investigational Site Number 840150
Investigational Site Number 100009
Investigational Site Number 840120
Investigational Site Number 124027
Investigational Site Number 840093
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Investigational Site Number 826025
Investigational Site Number 276003
Investigational Site Number 710006
Investigational Site Number 840122
Investigational Site Number 484001
Investigational Site Number 840181
Investigational Site Number 348008
Investigational Site Number 616007
Investigational Site Number 826004
Investigational Site Number 276014
Investigational Site Number 840207
Investigational Site Number 752002
Investigational Site Number 840046
Investigational Site Number 826023
Investigational Site Number 840026
Investigational Site Number 840096
Investigational Site Number 124002
Investigational Site Number 840002
Investigational Site Number 840170
Investigational Site Number 840003
Investigational Site Number 276001
Investigational Site Number 840168
Investigational Site Number 840105
Investigational Site Number 826011
Investigational Site Number 124005
Investigational Site Number 246003
Investigational Site Number 840041
Investigational Site Number 616010
Investigational Site Number 840073
Investigational Site Number 376004
Investigational Site Number 276015
Investigational Site Number 032006
Investigational Site Number 840047
Investigational Site Number 032010
Investigational Site Number 826012
Investigational Site Number 208002
Investigational Site Number 840001
Investigational Site Number 840221
Investigational Site Number 840083
Investigational Site Number 380009
Investigational Site Number 840159
Investigational Site Number 826006
Investigational Site Number 276011
Investigational Site Number 840086
Investigational Site Number 528002
Investigational Site Number 840020
Investigational Site Number 246002
Investigational Site Number 840152
Investigational Site Number 380006
Investigational Site Number 124009
Investigational Site Number 250008
Investigational Site Number 276008
Investigational Site Number 124015
Investigational Site Number 616001
Investigational Site Number 840031
Investigational Site Number 100001
Investigational Site Number 804002
Investigational Site Number 616018
Investigational Site Number 484004
Investigational Site Number 528007
Investigational Site Number 840209
Investigational Site Number 276004
Investigational Site Number 578002
Investigational Site Number 484010
Investigational Site Number 203007
Investigational Site Number 840087
Investigational Site Number 484009
Investigational Site Number 616004
Investigational Site Number 100007
Investigational Site Number 840038
Investigational Site Number 642005
Investigational Site Number 840007
Investigational Site Number 840194
Investigational Site Number 616003
Investigational Site Number 642002
Investigational Site Number 840011
Investigational Site Number 710005
Investigational Site Number 840097
Investigational Site Number 804005
Investigational Site Number 203004
Investigational Site Number 840072
Investigational Site Number 840068
Investigational Site Number 124018
Investigational Site Number 170001
Investigational Site Number 724006
Investigational Site Number 840090
Investigational Site Number 804011
Investigational Site Number 840154
Investigational Site Number 840075
Investigational Site Number 840193
Investigational Site Number 840092
Investigational Site Number 124003
Investigational Site Number 752003
Investigational Site Number 840166
Investigational Site Number 484002
Investigational Site Number 840065
Investigational Site Number 840214
Investigational Site Number 840177
Investigational Site Number 152006
Investigational Site Number 578004
Investigational Site Number 710003
Investigational Site Number 276006
Investigational Site Number 578005
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Investigational Site Number 032007
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Investigational Site Number 826013
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Investigational Site Number 724007
Investigational Site Number 643008
Investigational Site Number 620001
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Investigational Site Number 620002
Investigational Site Number 528008
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Investigational Site Number 840111
Investigational Site Number 752001
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Investigational Site Number 208004
Investigational Site Number 152004
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Investigational Site Number 250014
Investigational Site Number 710001
Investigational Site Number 804012
Investigational Site Number 804008
Investigational Site Number 380001
Investigational Site Number 804014
Investigational Site Number 826005
Investigational Site Number 840204
Investigational Site Number 250002
Investigational Site Number 840021
Investigational Site Number 804001
Investigational Site Number 840039
Investigational Site Number 124008
Investigational Site Number 152007
Investigational Site Number 276010
Investigational Site Number 826009
Investigational Site Number 246004
Investigational Site Number 840161
Investigational Site Number 208005
Investigational Site Number 348002
Investigational Site Number 804016
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 528009
Investigational Site Number 100012
Investigational Site Number 348007
Investigational Site Number 840023
Investigational Site Number 643005
Investigational Site Number 804003
Investigational Site Number 840163
Investigational Site Number 578001
Investigational Site Number 840074
Investigational Site Number 348006
Investigational Site Number 724001
Investigational Site Number 804013
Investigational Site Number 710004
Investigational Site Number 840149
Investigational Site Number 124007
Investigational Site Number 376005
Investigational Site Number 840167
Investigational Site Number 752004
Investigational Site Number 710002
Investigational Site Number 840190
Investigational Site Number 528012
Investigational Site Number 840052
Investigational Site Number 840101
Investigational Site Number 170008
Investigational Site Number 056001
Investigational Site Number 840049
Investigational Site Number 643004
Investigational Site Number 100008
Investigational Site Number 840079
Investigational Site Number 348001
Investigational Site Number 804010
Investigational Site Number 826003
Investigational Site Number 840108
Investigational Site Number 840005
Investigational Site Number 840067
Investigational Site Number 528010
Investigational Site Number 643014
Investigational Site Number 348004
Investigational Site Number 840222
Investigational Site Number 840095
Investigational Site Number 380005
Investigational Site Number 840103


summary: This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

ReferenceCitation: Katakami N, Felip E, Spigel DR, Kim JH, Olivo M, Guo M, Nokihara H, Yang JC, Iannotti N, Satouchi M, Barlesi F. A randomized, open-label, multicenter, phase 3 study to compare the efficacy and safety of eribulin to treatment of physician's choice in patients with advanced non-small cell lung cancer. Ann Oncol. 2017 Sep 1;28(9):2241-2247. doi: 10.1093/annonc/mdx284.

lead_sponsor: Eisai Inc.

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
Russian Federation
Australia
United Kingdom
Korea, Republic of
United States
France
Singapore
Japan
Germany


title: A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

summary: The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.

primary_purpose: Supportive Care

ReferenceCitation: Platzbecker U, Symeonidis A, Oliva EN, Goede JS, Delforge M, Mayer J, Slama B, Badre S, Gasal E, Mehta B, Franklin J. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. Leukemia. 2017 Sep;31(9):1944-1950. doi: 10.1038/leu.2017.192. Epub 2017 Jun 19.

lead_sponsor: Amgen

location_country: Spain Greece Austria Italy Switzerland France Belgium Germany Czechia


title: A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment

summary: The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

location_country:
Portugal
Spain
United Kingdom
Austria
Canada
Switzerland
Puerto Rico
United States
France
Belgium
Japan
Germany

location_facility: 1220.7.8121 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4911 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8108 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3205 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8112 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3501 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8125 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4901 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8101 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0095 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0034 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3201 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8107 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8105 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0027 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3203 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8111 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1004 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4107 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3407 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3311 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8117 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0087 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0012 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4108 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8114 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3410 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1006 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8126 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0082 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3305 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4409 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4410 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0101 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4913 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1007 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3303 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3206 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3207 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8109 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3308 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0063 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0039 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0071 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4302 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0062 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8124 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3409 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8104 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4404 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0091 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1012 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3411 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3318 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3301 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3316 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8106 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8123 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3505 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4903 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3506 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3502 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8110 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0029 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4303 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3317 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8116 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3509 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4918 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8113 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4101 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1014 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8119 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8115 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0009 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0016 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8118 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3412 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3315 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8102 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0013 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3408 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0058 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1010 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1011 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3503 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4407 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3304 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0085 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3302 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8122 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3204 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4907 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0077 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.1016 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3202 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3310 Boehringer Ingelheim Investigational Site


acronym: LUX-Head & Neck 2

title: A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma

ReferenceCitation: Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA Oncol. 2019 Aug 1;5(8):1170-1180. doi: 10.1001/jamaoncol.2019.1146.

ReferenceCitation: Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen EE. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials. 2014 Nov 29;15:469. doi: 10.1186/1745-6215-15-469.

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summary: This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.