lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.

ReferenceCitation: Coon CD, Schlichting M, Zhang X. Interpreting Within-Patient Changes on the EORTC QLQ-C30 and EORTC QLQ-LC13. Patient. 2022 Nov;15(6):691-702. doi: 10.1007/s40271-022-00584-w. Epub 2022 Jun 30.

ReferenceCitation: Hrinczenko B, Iannotti N, Goel S, Spigel D, Safran H, Taylor MH, Bennouna J, Wong DJ, Kelly K, Verschraegen C, Bajars M, Manitz J, Ruisi M, Gulley JL. Long-term avelumab in advanced non-small-cell lung cancer: summaries and post hoc analyses from JAVELIN Solid Tumor. Future Oncol. 2022 Apr;18(11):1333-1342. doi: 10.2217/fon-2021-0930. Epub 2022 Feb 11.

repository_institution: University of California - eScholarship University of California

publisher_dissemination: Future Science Ltd

ReferenceCitation: Park K, Ozguroglu M, Vansteenkiste J, Spigel D, Yang JC, Bajars M, Ruisi M, Manitz J, Barlesi F. Impact of subsequent immune checkpoint inhibitor treatment on overall survival with avelumab vs docetaxel in platinum-treated advanced NSCLC: Post hoc analyses from the phase 3 JAVELIN Lung 200 trial. Lung Cancer. 2021 Apr;154:92-98. doi: 10.1016/j.lungcan.2021.01.026. Epub 2021 Feb 6.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Aix-Marseille Université

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

repositories:
HAL
LIRIAS (KU Leuven)

repositories_concat: HAL;LIRIAS (KU Leuven)

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

ReferenceCitation: Barlesi F, Vansteenkiste J, Spigel D, Ishii H, Garassino M, de Marinis F, Ozguroglu M, Szczesna A, Polychronis A, Uslu R, Krzakowski M, Lee JS, Calabro L, Aren Frontera O, Ellers-Lenz B, Bajars M, Ruisi M, Park K. Avelumab versus docetaxel in patients with platinum-treated advanced non-small-cell lung cancer (JAVELIN Lung 200): an open-label, randomised, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1468-1479. doi: 10.1016/S1470-2045(18)30673-9. Epub 2018 Sep 24. Erratum In: Lancet Oncol. 2018 Nov;19(11):e581.

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Seconda Università degli Studi di Napoli

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Oncosinos - Clínica de Oncologia - Hospital Regina

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Liga Norte-Rio-Grandense Contra o Câncer

location_facility: Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Health Pharma Professional Research S.A. de C.V.

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: SHBI Moscow Clinical Scientific Center of Department of Healthcare of Moscow

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: University Clinic for Pulmonary Diseases

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

location_facility: University of Texas Health Science Center at Tyler

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: St. Petersburg SHI "City Clinical Oncology Dispensary"

location_facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital

location_facility: Fundacion Cardioinfantil Instituto de Cardiologia

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

location_facility: The Center for Cancer and Blood Disorders

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

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Azienda Ospedaliera Istituti Ospitalieri di Cremona

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Penn State Univ. Milton S. Hershey Medical Center

location_facility: IOS - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 5 SUM

location_facility: Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz

location_facility: Nemocnica s poliklinikou Sv. Jakuba, n.o. Bardejov

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

location_facility: CIEC - Centro Internacional de Estudios Clínicos

location_facility: Spitalul Clinic Municipal "Dr. Gavril Curteanu" Oradea

location_facility: Hematology Oncology Associates of Rockland

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Bezmi Alem Foundation University Medical Faculty Hospital

location_facility: Centro de Investigacion Clinica Chapultepec S.A. de C.V.

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo

location_facility: Hospital Universitario Materno-Infantil de Canarias

location_facility: Oaxaca Site Management Organization S.C.

location_facility: University of Pretoria Oncology Department

location_facility: Institute of Biomedical Research and Innovation Hospital

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: IPS IMAT- Instituto Medico de Alta Tecnologia - Oncomedica S.A.

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Hospital General Universitario de Alicante

location_facility: Seoul National University Bundang Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto

location_facility: Instituto de Terapias Oncologicas Providencia

location_facility: Clínica Universitaria Privada Reina Fabiola

location_facility: FSBHI Clinical research institute of phthisiopulmonology

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Konya Necmettin Erbakan University Meram Faculty of Medicine

location_facility: Phylasis Clinicas Research S de RL de CV

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

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Cenantron - Centro Avançado de Tratamento Oncológico S/C Ltda

location_facility: Centro de Oncologia e Investigacion Buenos Aires

location_facility: Centro Oncologico Riojano Integral (Cori)

location_facility: Marmara University Pendik Research and Training Center

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

location_facility: Complex Oncological Center - Plovdiv, EOOD

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: Centro de Investigaciones Clinicas Viña del Mar

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Ustredna vojenska nemocnica SNP Ruzomberok- Fakultna nemocnica

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia

location_facility: Instituto Nacional de Cancerologia E.S.E.

location_facility: Clinical Hospital Centar "Sestre Milosrdnice"

location_facility: SHI "Republican Clinical Oncological Dispensary of HM RT"

location_facility: Azienda Ospedaliero Universitaria Pisana

title: A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

location_country:
Poland
Argentina
Australia
Brazil
Japan
Turkey
Croatia
Chile
Czechia
France
Colombia
Slovakia
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Peru
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


type: EudraCT Number

title: An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection

summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Asselah T, Shafran S, Bourgeois S, Lai CL, Cramp M, Mathurin P, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in HCV Infected Patients Previously Treated With Placebo: Results of the Deferred Treatment Study (GS-US-342-1446 Study) [Abstract SAT-279]. J Hepatology 2016;64:S827-8.

ReferenceType: derived

ReferenceCitation: Asselah T, Shafran SD, Bourgeois S, Lai CL, Mathurin P, Willems B, Nguyen MH, Davis MN, Huang KC, Svarovskaia E, Osinusi A, McNally J, Brainard DM, Shaikh OS, Tran TT. Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. J Viral Hepat. 2019 Oct;26(10):1229-1232. doi: 10.1111/jvh.13159. Epub 2019 Aug 4.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ipd_sharing: Yes

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
United Kingdom
Hong Kong
Belgium
United States
Canada
Puerto Rico
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase IIb, Multicentre, Randomised, Double-blinded, Placebo-controlled, Multi-dose and Multi-injection, Parallel Groups Study to Evaluate the Efficacy and the Safety of Ovasave in Patients With Active Refractory Crohn's Disease

summary:
The investigational product, named Ovasave (Ova-Treg), is a cell-based therapy, consisting of an autologous antigen-specific regulatory type 1 T lymphocyte expanded population administered via the intravenous route as an infusion.

The study is a multicenter, randomised, double-blinded, placebo-controlled, multi-dose and multi-injection study; followed with a 16-week phase with either the possibility for an open-label treatment part or a safety follow-up part with no injection.

Then, the patients will be followed in an additional long-term safety follow-up, of maximum duration of 3 years from the first administration.

status: Terminated

design_allocation: Randomized

ReferenceCitation: Desreumaux P, Foussat A, Allez M, Beaugerie L, Hebuterne X, Bouhnik Y, Nachury M, Brun V, Bastian H, Belmonte N, Ticchioni M, Duchange A, Morel-Mandrino P, Neveu V, Clerget-Chossat N, Forte M, Colombel JF. Safety and efficacy of antigen-specific regulatory T-cell therapy for patients with refractory Crohn's disease. Gastroenterology. 2012 Nov;143(5):1207-1217.e2. doi: 10.1053/j.gastro.2012.07.116. Epub 2012 Aug 8.

lead_sponsor: TxCell

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
France

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

status_simplified: Unknown


lead_sponsor: Takeda

summary: The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.

ReferenceCitation: Dimopoulos MA, Spicka I, Quach H, Oriol A, Hajek R, Garg M, Beksac M, Bringhen S, Katodritou E, Chng WJ, Leleu X, Iida S, Mateos MV, Morgan G, Vorog A, Labotka R, Wang B, Palumbo A, Lonial S; TOURMALINE-MM4 study group. Ixazomib as Postinduction Maintenance for Patients With Newly Diagnosed Multiple Myeloma Not Undergoing Autologous Stem Cell Transplantation: The Phase III TOURMALINE-MM4 Trial. J Clin Oncol. 2020 Dec 1;38(34):4030-4041. doi: 10.1200/JCO.20.02060. Epub 2020 Oct 6. Erratum In: J Clin Oncol. 2022 Mar 10;40(8):919.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_normalized: University of Melbourne - Minerva Access

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

repository_institution: Spanish National Research Council (CSIC) - DIGITAL.CSIC

repository_normalized: DIGITAL.CSIC (Spain)

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

repositories: University of Melbourne - Minerva Access

repositories_concat: DIGITAL.CSIC (Spain);PubMed Central;University of Melbourne - Minerva Access;ddd.uab.cat

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Hospital Y Clinica OCA Sociedad Anonima de Capital Variable

location_facility: Hospital Universitario HM Sanchinarro CIOCC

location_facility: James Lind Centro de Investigación del Cáncer

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: University of Athens Medical School - Regional General Hospital Alexandra

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz

location_facility: Beijing Chaoyang Hospital Capital Medical University

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: State Medical and Preventive Treatment Institution Kirov Regional Clinical Oncology Dispensary

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine

location_facility: Second Hospital of Shanxi Medical University

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Instituto Joinvilense de Hematologia E Oncologia

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: American Oncology Partners of Maryland, PA

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

location_facility: Gemeinschaftspraxis Dr. med. R. Schlag & Dr. med. B. Schottker & Dr. med. J. Haas

location_facility: Klinika Hematologii, Szpital Uniwersytecki Nr 2 im. Jana Biziela w Bydgoszczy

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Russian Research Institute of Hematology and Blood Transfusion

location_facility: MTZ Clinical Research Sp z o o - PRATIA - PPDS

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Clinical Hospital Center ''Bezanijska Kosa''

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

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: Schwarzwald Baar Klinkum Villingen-Schwenningen GmbH

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Internistisch Hamatologische und Internistische Praxis

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Shengjing Hospital of China Medical University

location_facility: Maharaj Nakorn Chiang Mai Chiang Mai University

location_facility: Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" (CEMIC)

location_facility: Saint Agnes Hospital - Baltimore - Hunt - PPDS

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: North County Oncology Medical Clinic Inc

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

location_facility: Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: National Hospital Organization Mito Medical Center

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: Instituto Nacional de Cancerologia Colombia

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Complejo Asistencial Universitario de Salamanca H. Clinico

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Oaxaca Site management Organization (OSMO) - PPDS

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Centro de Investigacion Farmaceutica Especializada de Occidente, SC - PPDS

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Mae de Deus Center Hospital Giovanni Battista

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Severance Hospital Yonsei University Health System - PPDS

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

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Hospital Das Clinicas Da Universidade Federal de Goias

location_facility: John H. Stroger Jr. Hospital of Cook County

location_facility: Klinikum rechts der Isar der Technischen Universitat Munchen

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Groupe Hospitalier Necker Enfants Malades

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

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

location_facility: Global Cancer Research Institute (GCRI), Inc.

location_facility: Gemeinschaftspraxis fur Hamatologie und Onkologie

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Praxis Pihusch Medizinisches Versorgungszentrum GbR

location_facility: Hospital de Base Da Faculdade de Medicina de Sao Jose Do Rio Preto

location_facility: Nara Hospital Kinki University Faculty of Medicine

location_facility: Centro Hospitalar do Porto - Hospital de Santo Antonio

location_facility: Japanese Red Cross Nagoya Daiichi Hospital

location_facility: Central Coast Medical Oncology Corporation

location_facility: Aarhus Universitetshospital Århus Sygehus

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: Siouxland Hematology - Oncology Associates LLP

location_facility: Centro Internacional de Estudios Clinicos

location_facility: University Clinical Center of Serbia - PPDS

location_facility: Medizinische Universitat Wien (Medical University of Vienna)

location_facility: Stavropol Regional Clinical Oncology Centre Pyatigorsk Affiliate

location_facility: Fundação Antônio Prudente - AC Camargo Câncer Center

location_facility: Winship Cancer Institute, Emory University

location_facility: Del-pesti Centrumkorhaz- Orszagos Hematologiai és Infektologiai Intezet

location_facility: Hamatologische Onkologische Gemeinschaftspraxis Dr. Brudler, Dr. Heinrich, Dr. Bangerter

location_facility: Medizinisches Versorgungszentrum Onkologischer Schwerpunkt

location_facility: W VA University Mary Babb Randolph Cancer Center

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino

title: A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation

type: Registry Identifier

source: euctr

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
Canada
Serbia
France
Colombia
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel


title: Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)

summary: This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.

status: Recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Manetti L, Deutschbein T, Schopohl J, Yuen KCJ, Roughton M, Kriemler-Krahn U, Tauchmanova L, Maamari R, Giordano C. Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study. Pituitary. 2019 Oct;22(5):542-551. doi: 10.1007/s11102-019-00984-6.

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repository_institution: PubMed Central - Europe PMC

repositories_concat: PubMed Central;iris.unipa.it

publisher_dissemination: Springer-Nature

lead_sponsor: RECORDATI GROUP

location_country:
Germany
Italy
Colombia
Israel
United Kingdom
Romania
Sweden
Netherlands
Lebanon
United States
Canada
France

location_facility: Swedish Medical Center Dept.ofSeattle Neuroscience(2)

location_facility: LifeBridge Heath Cardiovascular Institute, Sinai Hospital SC - SOM230B2410

location_facility: University of Southern California CSOM230B2410 - SC

location_facility: R. I. Hospital Medical Oncology Clinical Research SC

location_facility: Massachusetts General Hospital SC - SOM230B2410

status_simplified: Ongoing


acronym: CONNECT

lead_sponsor: Biogen

summary: The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric subjects with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306.

ReferenceCitation: Vermersch P, Scaramozza M, Levin S, Alroughani R, Deiva K, Pozzilli C, Lyons J, Mokliatchouk O, Pultz J, N'Dure F, Liu S, Badwan R, Branco F, Hood-Humphrey V, Franchimont N, Hanna J, Maghzi AH. Effect of Dimethyl Fumarate vs Interferon beta-1a in Patients With Pediatric-Onset Multiple Sclerosis: The CONNECT Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2230439. doi: 10.1001/jamanetworkopen.2022.30439.

oa_colors: green gold

evidence: oa journal (via doaj)

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: American Medical Association

location_facility:
Researh Site
Research Site
Resaerch Site
Resaeach Site

status: Active, not recruiting

title: Open-Label, Randomized, Multicenter, Multiple-Dose,Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

location_country:
Germany
Italy
Poland
Hungary
Israel
Denmark
Kuwait
Sweden
United Kingdom
Belgium
United States
Spain
Turkey
Czechia
Bulgaria
Canada
Serbia
France


title: ADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)

acronym: EASE LID 3

summary:
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance.

In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.

ReferenceCitation: Hauser RA, Mehta SH, Kremens D, Chernick D, Formella AE. Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson's Disease and Dyskinesia. Neurol Ther. 2021 Dec;10(2):739-751. doi: 10.1007/s40120-021-00256-1. Epub 2021 May 22.

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Mehta SH, Pahwa R, Tanner CM, Hauser RA, Johnson R. Effects of Gocovri (Amantadine) Extended Release Capsules on Non-Motor Symptoms in Patients with Parkinson's Disease and Dyskinesia. Neurol Ther. 2021 Jun;10(1):307-320. doi: 10.1007/s40120-021-00246-3. Epub 2021 Apr 17.

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

repositories_concat: California Digital Library - eScholarship;PubMed Central

repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Elmer LW, Juncos JL, Singer C, Truong DD, Criswell SR, Parashos S, Felt L, Johnson R, Patni R. Pooled Analyses of Phase III Studies of ADS-5102 (Amantadine) Extended-Release Capsules for Dyskinesia in Parkinson's Disease. CNS Drugs. 2018 Apr;32(4):387-398. doi: 10.1007/s40263-018-0498-4. Erratum In: CNS Drugs. 2018 Apr 10;:

lead_sponsor: Adamas Pharmaceuticals, Inc.

location_country:
Germany
Austria
United States
Spain
France


acronym: AMARANTH

lead_sponsor: AstraZeneca

summary: The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the hypothesis that lanabecestat is a disease-modifying treatment for participants with early Alzheimer´s disease, defined as the continuum of participants with mild cognitive impairment (MCI) due to Alzheimer´s disease and participants diagnosed with mild dementia of the Alzheimer´s type, as measured by change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) score at week 104 in each of the 2 lanabecestat treatment groups compared with placebo.

ReferenceCitation: Wessels AM, Lines C, Stern RA, Kost J, Voss T, Mozley LH, Furtek C, Mukai Y, Aisen PS, Cummings JL, Tariot PN, Vellas B, Dupre N, Randolph C, Michelson D, Andersen SW, Shering C, Sims JR, Egan MF. Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. Alzheimers Dement. 2020 Nov;16(11):1483-1492. doi: 10.1002/alz.12164. Epub 2020 Oct 13.

ReferenceCitation: Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988. Erratum In: JAMA Neurol. 2020 Sep 1;77(9):1179.

evidence: open (via free pdf)

repository_institution: The University of Arizona - UA Campus Repository

repositories_concat: PubMed Central;repository.arizona.edu

ReferenceCitation: Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjall S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053. doi: 10.3233/JAD-160701.

publisher_dissemination: IOS Press

sponsor_collaborators:
AstraZeneca
Eli Lilly and Company

location_facility: University of Texas Health Services Center - Houston

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

location_facility: Instituto de Neurologia Dra. Ivonne Fraga

location_facility: Territory Neurology & Research Institute

location_facility: Australian Alzheimer's Research Foundation

location_facility: Quillen College of Medicine, East TN State University

location_facility: Fundacion ACE-Institut Catala de Neurociences Aplicades

location_facility: Alzheimer's Disease and Memory Disorders Center

location_facility: Centro de Atencion Especializada (CAE) OROITU

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Fondazione San Raffaele Giglio di Cefalu

location_facility: The Florey Institute of Neuroscience and Mental Health

location_facility: NZOZ Wielospecjalistyczna Poradnia Lekarska

location_facility: Tokyo Women's Medical University Hospital

location_facility: True North Clinical Research Halifax, LLC

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Kyoto Prefectural University of Medicine

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Alzheimer's Research and Treatment Center

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Allied Biomedical Research Institute, Inc.

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

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

location_facility: Gemeinschaftspraxis Dr. R. Ehret & Dr. W. von Pannwitz

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Neurology Specialists of Monmouth County

location_facility: Università Politecnica delle Marche Torrette

location_facility: Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policinico

location_facility: The Multiple Sclerosis Center of Atlanta

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: Seoul National University Bundang Hospital

location_facility: Institute for Neurodegenerative Disorders

location_facility: IRCCS San Giovanni di Dio Fatebenefratelli

location_facility: Gemeinschaftspraxis für Neurologie Prof. Gereon Nelles

location_facility: Ospedale San Giovanni Calibita Fatebenefratelli

location_facility: National Institute for Longevity Sciences NCGG

location_facility: Azienda Ospedaliera Citta della Salute della Scienza Torino

location_facility: Del-pesti Centrumkorház - Orszagos Hematologiai és Infektologiai Intezet

location_facility: Collaborative Neuroscience Network - CNS

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: CSSS-Institut Universitaire Gériatric de Sherbrooke

location_facility: Nuovo Ospedale Civile Sant'Agostino Estense

location_facility: Dip.to Med. Sperimentale -Polic.Umberto I -Univ. La Sapienza

location_facility: PTE KK Pszichiatriai es Pszichoterapias Klinika

title: A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease (The AMARANTH Study)

type: Other Identifier

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Romania
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Canada
Puerto Rico
France


summary: This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).

ReferenceCitation: Aoki FY, Sitar DS. Clinical pharmacokinetics of amantadine hydrochloride. Clin Pharmacokinet. 1988 Jan;14(1):35-51. doi: 10.2165/00003088-198814010-00003.

ReferenceCitation: Colosimo C, Martinez-Martin P, Fabbrini G, Hauser RA, Merello M, Miyasaki J, Poewe W, Sampaio C, Rascol O, Stebbins GT, Schrag A, Goetz CG. Task force report on scales to assess dyskinesia in Parkinson's disease: critique and recommendations. Mov Disord. 2010 Jul 15;25(9):1131-42. doi: 10.1002/mds.23072.

ReferenceCitation: da Silva-Junior FP, Braga-Neto P, Sueli Monte F, de Bruin VM. Amantadine reduces the duration of levodopa-induced dyskinesia: a randomized, double-blind, placebo-controlled study. Parkinsonism Relat Disord. 2005 Nov;11(7):449-52. doi: 10.1016/j.parkreldis.2005.05.008. Epub 2005 Sep 9.

ReferenceCitation: Dallos V, Heathfield K, Stone P, Allen FA. Use of amantadine in Parkinson's disease. Results of a double-blind trial. Br Med J. 1970 Oct 3;4(5726):24-6. doi: 10.1136/bmj.4.5726.24.

ReferenceCitation: Del Sorbo F, Albanese A. Levodopa-induced dyskinesias and their management. J Neurol. 2008 Aug;255 Suppl 4:32-41. doi: 10.1007/s00415-008-4006-5.

ReferenceCitation: Encarnacion EV, Hauser RA. Levodopa-induced dyskinesias in Parkinson's disease: etiology, impact on quality of life, and treatments. Eur Neurol. 2008;60(2):57-66. doi: 10.1159/000131893. Epub 2008 May 15.

ReferenceCitation: Factor SA, Molho ES. Transient benefit of amantadine in Parkinson's disease: the facts about the myth. Mov Disord. 1999 May;14(3):515-7. doi: 10.1002/1531-8257(199905)14:33.0.co;2-z. No abstract available.

ReferenceCitation: Goetz CG, Nutt JG, Stebbins GT. The Unified Dyskinesia Rating Scale: presentation and clinimetric profile. Mov Disord. 2008 Dec 15;23(16):2398-403. doi: 10.1002/mds.22341.

ReferenceCitation: Goetz CG, Tilley BC, Shaftman SR, Stebbins GT, Fahn S, Martinez-Martin P, Poewe W, Sampaio C, Stern MB, Dodel R, Dubois B, Holloway R, Jankovic J, Kulisevsky J, Lang AE, Lees A, Leurgans S, LeWitt PA, Nyenhuis D, Olanow CW, Rascol O, Schrag A, Teresi JA, van Hilten JJ, LaPelle N; Movement Disorder Society UPDRS Revision Task Force. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008 Nov 15;23(15):2129-70. doi: 10.1002/mds.22340.

ReferenceCitation: Goetz CG, Stebbins GT, Chung KA, Hauser RA, Miyasaki JM, Nicholas AP, Poewe W, Seppi K, Rascol O, Stacy MA, Nutt JG, Tanner CM, Urkowitz A, Jaglin JA, Ge S. Which dyskinesia scale best detects treatment response? Mov Disord. 2013 Mar;28(3):341-6. doi: 10.1002/mds.25321. Epub 2013 Feb 6.

ReferenceCitation: Hayden FG, Gwaltney JM Jr, Van de Castle RL, Adams KF, Giordani B. Comparative toxicity of amantadine hydrochloride and rimantadine hydrochloride in healthy adults. Antimicrob Agents Chemother. 1981 Feb;19(2):226-33. doi: 10.1128/AAC.19.2.226.

ReferenceCitation: Jackson G, Stanley E, Lee Muldoon R. Chemoprophylaxis of viral respiratory diseases. Bulletin Pan Am Health Org. 1967; 147: 595-603.

ReferenceCitation: Luginger E, Wenning GK, Bosch S, Poewe W. Beneficial effects of amantadine on L-dopa-induced dyskinesias in Parkinson's disease. Mov Disord. 2000 Sep;15(5):873-8. doi: 10.1002/1531-8257(200009)15:53.0.co;2-i.

ReferenceCitation: Ory-Magne F, Corvol JC, Azulay JP, Bonnet AM, Brefel-Courbon C, Damier P, Dellapina E, Destee A, Durif F, Galitzky M, Lebouvier T, Meissner W, Thalamas C, Tison F, Salis A, Sommet A, Viallet F, Vidailhet M, Rascol O; NS-Park CIC Network. Withdrawing amantadine in dyskinetic patients with Parkinson disease: the AMANDYSK trial. Neurology. 2014 Jan 28;82(4):300-7. doi: 10.1212/WNL.0000000000000050. Epub 2013 Dec 26.

ReferenceCitation: Paci C, Thomas A, Onofrj M. Amantadine for dyskinesia in patients affected by severe Parkinson's disease. Neurol Sci. 2001 Feb;22(1):75-6. doi: 10.1007/s100720170054.

ReferenceCitation: Parkes JD, Zilkha KJ, Marsden P, Baxter RC, Knill-Jones RP. Amantadine dosage in treatment of Parkinson's disease. Lancet. 1970 May 30;1(7657):1130-3. doi: 10.1016/s0140-6736(70)91211-0. No abstract available.

ReferenceCitation: Sawada H, Oeda T, Kuno S, Nomoto M, Yamamoto K, Yamamoto M, Hisanaga K, Kawamura T; Amantadine Study Group. Amantadine for dyskinesias in Parkinson's disease: a randomized controlled trial. PLoS One. 2010 Dec 31;5(12):e15298. doi: 10.1371/journal.pone.0015298.

ReferenceCitation: Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson's disease. A community-based study. Brain. 2000 Nov;123 ( Pt 11):2297-305. doi: 10.1093/brain/123.11.2297.

ReferenceCitation: Schwab RS, Poskanzer DC, England AC Jr, Young RR. Amantadine in Parkinson's disease. Review of more than two years' experience. JAMA. 1972 Nov 13;222(7):792-5. doi: 10.1001/jama.222.7.792. No abstract available.

ReferenceCitation: Snow BJ, Macdonald L, Mcauley D, Wallis W. The effect of amantadine on levodopa-induced dyskinesias in Parkinson's disease: a double-blind, placebo-controlled study. Clin Neuropharmacol. 2000 Mar-Apr;23(2):82-5. doi: 10.1097/00002826-200003000-00004.

ReferenceCitation: Spencer TJ, Biederman J, Ciccone PE, Madras BK, Dougherty DD, Bonab AA, Livni E, Parasrampuria DA, Fischman AJ. PET study examining pharmacokinetics, detection and likeability, and dopamine transporter receptor occupancy of short- and long-acting oral methylphenidate. Am J Psychiatry. 2006 Mar;163(3):387-95. doi: 10.1176/appi.ajp.163.3.387.

ReferenceCitation: Swanson JM, Volkow ND. Pharmacokinetic and pharmacodynamic properties of stimulants: implications for the design of new treatments for ADHD. Behav Brain Res. 2002 Mar 10;130(1-2):73-8. doi: 10.1016/s0166-4328(01)00433-8.

ReferenceCitation: Thomas A, Iacono D, Luciano AL, Armellino K, Di Iorio A, Onofrj M. Duration of amantadine benefit on dyskinesia of severe Parkinson's disease. J Neurol Neurosurg Psychiatry. 2004 Jan;75(1):141-3.

ReferenceCitation: Tyrrell DA, Bynoe ML, Hoorn B. Studies on the antiviral activity of 1-adamantanamine. Br J Exp Pathol. 1965 Aug;46(4):370-5. No abstract available.

ReferenceCitation: Verhagen Metman L, Del Dotto P, van den Munckhof P, Fang J, Mouradian MM, Chase TN. Amantadine as treatment for dyskinesias and motor fluctuations in Parkinson's disease. Neurology. 1998 May;50(5):1323-6. doi: 10.1212/wnl.50.5.1323.

ReferenceCitation: Metman LV, Del Dotto P, LePoole K, Konitsiotis S, Fang J, Chase TN. Amantadine for levodopa-induced dyskinesias: a 1-year follow-up study. Arch Neurol. 1999 Nov;56(11):1383-6. doi: 10.1001/archneur.56.11.1383.

ReferenceCitation: Volkow ND, Wang GJ, Fowler JS, Gatley SJ, Logan J, Ding YS, Hitzemann R, Pappas N. Dopamine transporter occupancies in the human brain induced by therapeutic doses of oral methylphenidate. Am J Psychiatry. 1998 Oct;155(10):1325-31. doi: 10.1176/ajp.155.10.1325.

ReferenceCitation: Wolf E, Seppi K, Katzenschlager R, Hochschorner G, Ransmayr G, Schwingenschuh P, Ott E, Kloiber I, Haubenberger D, Auff E, Poewe W. Long-term antidyskinetic efficacy of amantadine in Parkinson's disease. Mov Disord. 2010 Jul 30;25(10):1357-63. doi: 10.1002/mds.23034.

ReferenceCitation: Wright Willis A, Evanoff BA, Lian M, Criswell SR, Racette BA. Geographic and ethnic variation in Parkinson disease: a population-based study of US Medicare beneficiaries. Neuroepidemiology. 2010;34(3):143-51. doi: 10.1159/000275491. Epub 2010 Jan 15.

ReferenceCitation: Hauser RA, Pahwa R, Tanner CM, Oertel W, Isaacson SH, Johnson R, Felt L, Stempien MJ. ADS-5102 (Amantadine) Extended-Release Capsules for Levodopa-Induced Dyskinesia in Parkinson's Disease (EASE LID 2 Study): Interim Results of an Open-Label Safety Study. J Parkinsons Dis. 2017;7(3):511-522. doi: 10.3233/JPD-171134.

oa_colors: green other

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

unpaywall_oa_status: bronze

title: Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)

location_country:
Germany
Austria
United States
Spain
Canada
France


summary: The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

ReferenceType: result

ReferenceCitation: Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.

ReferenceCitation: Mangia, A., Roberts, SK., Pianko, S., Thompson, A at al. Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks Compared to Sofosbuvir with Ribavirin for 24 Weeks in Genotype 3 HCV Infected Patients: The Randomized Controlled Phase 3 ASTRAL-3 Study. Hepatology 2015; 62: 1 (SUPPL) 338A.

ReferenceCitation: Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, Lawitz E, Thompson A, Shiffman ML, Cooper C, Towner WJ, Conway B, Ruane P, Bourliere M, Asselah T, Berg T, Zeuzem S, Rosenberg W, Agarwal K, Stedman CA, Mo H, Dvory-Sobol H, Han L, Wang J, McNally J, Osinusi A, Brainard DM, McHutchison JG, Mazzotta F, Tran TT, Gordon SC, Patel K, Reau N, Mangia A, Sulkowski M; ASTRAL-2 Investigators; ASTRAL-3 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015 Dec 31;373(27):2608-17. doi: 10.1056/NEJMoa1512612. Epub 2015 Nov 17.

evidence: open (via free article)

repository_institution: Queen Mary University of London - Queen Mary Research Online

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12.

publisher_dissemination: Elsevier

title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection

location_country:
Germany
Italy
New Zealand
United Kingdom
Australia
United States
Canada
Puerto Rico
France


summary: The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

ReferenceCitation: Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16.

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

repositories_institution: Queen Mary University of London - Queen Mary Research Online

ReferenceCitation: Feld JJ, Agarwal K, Hezode C, Asselah T, Ruane PJ, Gruener N, et al. A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naive and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without Cirrhosis: Results of the ASTRAL-1 Study. J Hepatol 2015;62(6) Suppl:1379A-1380A.

title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

publications_result: Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6.

location_country:
Germany
Italy
United Kingdom
Belgium
United States
China
Canada
Puerto Rico
France


title: JUNIPER: A Randomized Phase 3 Study of Abemaciclib Plus Best Supportive Care Versus Erlotinib Plus Best Supportive Care in Patients With Stage IV NSCLC With a Detectable KRAS Mutation Who Have Progressed After Platinum-Based Chemotherapy

acronym: JUNIPER

summary: The main purpose of this study is to evaluate how safe and effective the study drug known as abemaciclib is in participants with lung cancer.

ReferenceCitation: Goldman JW, Mazieres J, Barlesi F, Dragnev KH, Koczywas M, Goskel T, Cortot AB, Girard N, Wesseler C, Bischoff H, Nadal E, Park K, Lu S, Taus A, Cobo M, Estrem ST, Wijayawardana SR, Turner K, Oakley GJ 3rd, Hurt KC, Chiang AY, Hossain AM, John WJ, Paz-Ares L. A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER. Front Oncol. 2020 Oct 26;10:578756. doi: 10.3389/fonc.2020.578756. eCollection 2020.

repository_institution: Universitat Pompeu Fabra - Repositori digital de la UPF

publisher_dissemination: Frontiers

ReferenceCitation: Goldman JW, Shi P, Reck M, Paz-Ares L, Koustenis A, Hurt KC. Treatment Rationale and Study Design for the JUNIPER Study: A Randomized Phase III Study of Abemaciclib With Best Supportive Care Versus Erlotinib With Best Supportive Care in Patients With Stage IV Non-Small-Cell Lung Cancer With a Detectable KRAS Mutation Whose Disease Has Progressed After Platinum-Based Chemotherapy. Clin Lung Cancer. 2016 Jan;17(1):80-4. doi: 10.1016/j.cllc.2015.08.003. Epub 2015 Aug 18.

oa_host_type: publisher

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Poland
Argentina
Japan
Brazil
Turkey
Canada
France
United States
Ukraine
Romania
China
Puerto Rico
Italy
Austria
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: Oklahoma Cancer Specialists & Research Institute, LLC

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: Metro-West and Greater Boston CNS Research

location_facility: Chattanooga Oncology Hematology Associates

location_facility: UCLA Department of Medicine-Hematology/Oncology

location_facility: Volgograd regional clinical oncology dispensary

location_facility: Loma Linda University School of Medicine

location_facility: Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo

location_facility: Central Coast Medical Oncology Corporation

location_facility: Republic clinical oncology dispensary of MoH of Bashkortostan Republic

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Russian oncological scientific centre n.a. N.N. Blokhin of RAMS

location_facility: Fundação Antonio Prudente - Hospital do Câncer A.C Camargo

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Providence Cancer Center Oncology Hematology Care

location_facility: Saint-Petersburg city clinical oncology dispensary

location_facility: St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)


lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The purpose of this study was to determine if eculizumab is safe and could be used to prevent delayed graft function (DGF) following kidney transplantation.

sponsor_collaborators: CTI Clinical Trial and Consulting Services

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multi-center Study of Eculizumab for the Prevention of Delayed Graft Function After Kidney Transplantation in Adult Subjects at Increased Risk of Delayed Graft Function.

primary_purpose: Prevention

location_country:
Germany
Italy
Australia
Brazil
United States
Spain
Czechia
Canada
France


title: Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

summary:
Primary Objective:

To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).

Secondary Objectives:

To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.

To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:

Systemic exposure
Anti-drug antibodies
Biomarkers

ReferenceCitation: Tohda Y, Nakamura Y, Fujisawa T, Ebisawa M, Msihid J, Djandji M, Ortiz B, Jacob-Nara JA, Deniz Y, Rowe PJ, Ishida M, Arima K. Efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma recruited from Japanese centers in the phase 3 LIBERTY ASTHMA TRAVERSE study. Allergol Int. 2023 Jan;72(1):89-99. doi: 10.1016/j.alit.2022.07.008. Epub 2022 Sep 13.

ReferenceCitation: Lugogo N, Mohan A. Are We Poised to Change the Trajectory of Maintenance Oral Corticosteroid Use in Severe Asthma in the Age of Biologics? Chest. 2022 Jul;162(1):4-5. doi: 10.1016/j.chest.2022.04.004. No abstract available.

ReferenceCitation: Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

ReferenceCitation: Sher LD, Wechsler ME, Rabe KF, Maspero JF, Daizadeh N, Mao X, Ortiz B, Mannent LP, Laws E, Ruddy M, Pandit-Abid N, Jacob-Nara JA, Gall R, Rowe PJ, Deniz Y, Lederer DJ, Hardin M. Dupilumab Reduces Oral Corticosteroid Use in Patients With Corticosteroid-Dependent Severe Asthma: An Analysis of the Phase 3, Open-Label Extension TRAVERSE Trial. Chest. 2022 Jul;162(1):46-55. doi: 10.1016/j.chest.2022.01.071. Epub 2022 Feb 22.

ReferenceCitation: Wechsler ME, Ford LB, Maspero JF, Pavord ID, Papi A, Bourdin A, Watz H, Castro M, Nenasheva NM, Tohda Y, Langton D, Cardona G, Domingo C, Park HS, Chapman KR, Mao X, Zhang Y, Khan AH, Deniz Y, Rowe PJ, Kapoor U, Khokhar FA, Mannent LP, Ruddy M, Laws E, Amin N, Hardin M. Long-term safety and efficacy of dupilumab in patients with moderate-to-severe asthma (TRAVERSE): an open-label extension study. Lancet Respir Med. 2022 Jan;10(1):11-25. doi: 10.1016/S2213-2600(21)00322-2. Epub 2021 Sep 28.

oa_host_type: repository

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

repository_normalized: HAL

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

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

repositories_concat: HAL

unpaywall_oa_status: green

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

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Canada
France
Colombia
Hungary
Denmark
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility:
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lead_sponsor: Boehringer Ingelheim

summary: Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

ReferenceCitation: Eikelboom JW, van Ryn J, Reilly P, Hylek EM, Elsaesser A, Glund S, Pollack CV, Weitz JI. Dabigatran Reversal With Idarucizumab in Patients With Renal Impairment. J Am Coll Cardiol. 2019 Oct 8;74(14):1760-1768. doi: 10.1016/j.jacc.2019.07.070.

ReferenceCitation: Glund S, Coble K, Gansser D, Stangier J, Hoermann K, Pollack CV, Reilly P. Pharmacokinetics of idarucizumab and its target dabigatran in patients requiring urgent reversal of the anticoagulant effect of dabigatran. J Thromb Haemost. 2019 Aug;17(8):1319-1328. doi: 10.1111/jth.14476. Epub 2019 Jun 18.

ReferenceCitation: Van der Wall SJ, Lopes RD, Aisenberg J, Reilly P, van Ryn J, Glund S, Elsaesser A, Klok FA, Pollack CV Jr, Huisman MV. Idarucizumab for Dabigatran Reversal in the Management of Patients With Gastrointestinal Bleeding. Circulation. 2019 Feb 5;139(6):748-756. doi: 10.1161/CIRCULATIONAHA.118.036710. Erratum In: Circulation. 2019 Feb 5;139(6):e36.

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Royle G, Sellke FW, Stangier J, Steiner T, Verhamme P, Wang B, Young L, Weitz JI. Idarucizumab for Dabigatran Reversal - Full Cohort Analysis. N Engl J Med. 2017 Aug 3;377(5):431-441. doi: 10.1056/NEJMoa1707278. Epub 2017 Jul 11.

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

ReferenceCitation: Pollack CV Jr, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kamphuisen PW, Kreuzer J, Levy JH, Sellke FW, Stangier J, Steiner T, Wang B, Kam CW, Weitz JI. Idarucizumab for Dabigatran Reversal. N Engl J Med. 2015 Aug 6;373(6):511-20. doi: 10.1056/NEJMoa1502000. Epub 2015 Jun 22.

ReferenceCitation: Pollack CV Jr, Reilly PA, Bernstein R, Dubiel R, Eikelboom J, Glund S, Huisman MV, Hylek E, Kam CW, Kamphuisen PW, Kreuzer J, Levy JH, Sellke F, Stangier J, Steiner T, Wang B, Weitz JI. Design and rationale for RE-VERSE AD: A phase 3 study of idarucizumab, a specific reversal agent for dabigatran. Thromb Haemost. 2015 Jul;114(1):198-205. doi: 10.1160/TH15-03-0192. Epub 2015 May 28.

publisher_dissemination: Georg Thieme

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: National Hospital Organization Takasaki General Medical Center

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

location_facility: The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow

location_facility: National Hospital Organization Kagoshima Medical Center

location_facility: Japanese Red Cross Nagoya Daini Hospital

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

location_facility: Emergency Department, John Radcliffe Hospital, Oxford

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

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

location_facility: Westmead Hospital-Clinical Haematology Dept

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: CHLO, EPE - Hospital S. Francisco Xavier

location_facility: Memorial Hermann Hospital - Texas Medical Center

location_facility: Our Lady of the Lake Regional Medical Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: University of Florida College of Medicine

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: Oslo Universitetssykehus HF, Ullevål sykehus

location_facility: TYKS, Akuutti sisätautihoito ASIS, Turku

location_facility: Hospital General Universitario de Alicante

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Hospital Regional Universitario de Málaga

location_facility: Baptist Health Center for Clinical Research

location_facility: Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Military Medical Academy n.a. S. M. Kirov, St. Petersburg

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: HUS, Kirurginen päivystysosasto P1P, Meilahti, Helsinki

location_facility: Stefan Kardynal Wyszynski Reg.Hosp,Cardiol&IntensUnit,Lublin

location_facility: Texas Health Research and Education Institute

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

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia

location_facility: National Cerebral and Cardiovascular Center

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia

title: A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Colombia
Portugal
Hong Kong
Denmark
United States
India
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: Efficacy and Safety of New Generation Drug Eluting Stents Associated With an Ultra Short Duration of Dual Antiplatelet Therapy. Design of the Short Duration of Dual antiplatElet Therapy With SyNergy II Stent in Patients Older Than 75 Years Undergoing Percutaneous Coronary Revascularization.

acronym: SENIOR

summary: The main objective of the SENIOR study is to establish the efficacy and safety of the everolimus eluting stent with a biodegradable abluminal polymer (SYNERGY II) associated with a short dual antiplatelet therapy (DAPT) in patients ≥75 years old, suffering from stable angina, silent ischemia (1 month DAPT) or acute coronary syndromes (6 months DAPT) related to significant coronary artery disease and requiring percutaneous coronary intervention. The primary end point is to demonstrate that SYNERGY II in patients ≥75 years old is associated with a lower rate of the composite rate of major cardiovascular and cerebrovascular events (all-cause death, myocardial infarction, stroke, ischemia-driven target lesion revascularization) and a similar risk of stent thrombosis than bare metal stent at one year.

status: Unknown status

ReferenceCitation: Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrie D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR; SENIOR investigators. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet. 2018 Jan 6;391(10115):41-50. doi: 10.1016/S0140-6736(17)32713-7. Epub 2017 Nov 1.

ipd_sharing: No

lead_sponsor: Ceric Sàrl

sponsor_collaborators:
Ceric Sàrl
Boston Scientific; Pr Olivier Varenne

location_country: Macedonia, The Former Yugoslav Republic of

location_facility: Heary Center - Satakunta Centyral Hospital

location_facility: Hospital Universitario virgen de la arrixaca

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: University Clinic of Cardiology - Medical Faculty

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Hospital Universati Germans Trias i Pujol

location_facility: Hospital universitario Marquès de Valdecilla

location_facility: Centre hospitalier universitaire vaudois

location_facility: Pauls Stradins Clinical University Hospital

intervention_type: Procedure


title: Maximizing CRT Delivery by Using Multipolar Coronary Sinus Lead Family ACUITY® X4

summary:
The objective of this study is to collect clinical data on safety and performance of ACUITY X4® leads when used in a standard clinical setting.

It is a prospective, non-randomized, observational multicenter study evaluating standard of care.

For Post Market Clinical Follow up (PMCF) purposes the 3 month implant success rate, adverse events and basic parameters of the lead will be assessed. The cohort of subjects included in this evaluation will be the first 200 subjects which are indicated for PMCF in Rally X4 to receive an ACUITY X4® lead implant.

Study endpoints:

Phrenic Nerve Stimulation (PNS) related CFR through 6 months post-implant (Defined as: rate of freedom from loss of function or operative system revision due to unacceptable PNS threshold) Lead-related Complication-Free Rate (CFR) from Implant through 3 months post-implant.

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
ICON plc

location_country:
Finland
Germany
Ireland
Colombia
Italy
Portugal
Israel
Hong Kong
Denmark
Japan
Singapore
Netherlands
Austria
Belgium
Switzerland
United Kingdom
Spain
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Guidant Europe SA / NV a Boston Scientific Company

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Azienda Ospedaliera Spedale Sant'Anna di Como

location_facility: Centre Hospitalier Régional Universitaire de Lille

intervention_type: Device


lead_sponsor: Hoffmann-La Roche

summary: This is a multicenter, open-label, dose-finding study of venetoclax administered orally in combination with rituximab (R) or obinutuzumab (G) and standard doses of cyclophosphamide, doxorubicin, vincristine and oral prednisone (CHOP) in participants with Non-Hodgkin's Lymphoma (NHL). The study consisted of 2 stages: a dose-finding Phase Ib stage and a Phase II expansion stage. In the Phase I portion of the study, participants were randomized to one of 2 treatment arms venetoclax in combination with R-CHOP (Arm A) and venetoclax in combination with G-CHOP (Arm B) and explored the doses of venetoclax in combination with R-CHOP and G-CHOP. The maximum tolerated dose (MTD) of venetoclax in combination with R-CHOP and G-CHOP was determined during the dose-finding stage. For the Phase II portion of the study, the venetoclax dose for venetoclax + R-CHOP was on a non-continuous dosing schedule as determined by the Phase Ib portion of the study based on safety and tolerability observed in participants treated in the dose escalation portion of the study. On 17 July 2016, Roche/Genentech as the sponsor of Study BO21005 (Goya study), a Phase III study that evaluated G CHOP versus R-CHOP in 1L DLBCL, informed through a press release that the primary endpoint of investigator-assessed PFS was not met. Given these results, Arm B (venetoclax + G-CHOP) was not expanded in Phase II in patients who are first-line with DLBCL.

ReferenceCitation: Zelenetz AD, Salles G, Mason KD, Casulo C, Le Gouill S, Sehn LH, Tilly H, Cartron G, Chamuleau MED, Goy A, Tam CS, Lugtenburg PJ, Petrich AM, Sinha A, Samineni D, Herter S, Ingalla E, Szafer-Glusman E, Klein C, Sampath D, Kornacker M, Mobasher M, Morschhauser F. Venetoclax plus R- or G-CHOP in non-Hodgkin lymphoma: results from the CAVALLI phase 1b trial. Blood. 2019 May 2;133(18):1964-1976. doi: 10.1182/blood-2018-11-880526. Epub 2019 Mar 8.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Samineni D, Huang W, Gibiansky L, Ding H, Zhang R, Li C, Sinha A, Rajwanshi R, Humphrey K, Bazeos A, Salem AH, Miles D. Population Pharmacokinetics and Exposure-Response Analyses for Venetoclax in Combination with R-CHOP in Relapsed/Refractory and Previously Untreated Patients with Diffuse Large B Cell Lymphoma. Adv Ther. 2022 Jan;39(1):598-618. doi: 10.1007/s12325-021-01919-z. Epub 2021 Nov 25.

ReferenceCitation: Morschhauser F, Feugier P, Flinn IW, Gasiorowski R, Greil R, Illes A, Johnson NA, Larouche JF, Lugtenburg PJ, Patti C, Salles GA, Trneny M, de Vos S, Mir F, Samineni D, Kim SY, Jiang Y, Punnoose E, Sinha A, Clark E, Spielewoy N, Humphrey K, Bazeos A, Zelenetz AD. A phase 2 study of venetoclax plus R-CHOP as first-line treatment for patients with diffuse large B-cell lymphoma. Blood. 2021 Feb 4;137(5):600-609. doi: 10.1182/blood.2020006578. Erratum In: Blood. 2021 Apr 1;137(13):1844.

sponsor_collaborators:
Hoffmann-La Roche
AbbVie

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Hackensack University Medical Center; WFAN - Imus Pediatric Center

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

location_facility: Hopital Henri Mondor, Unite Hemopathies lymphoides

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

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Centre Hospitalier Départemental Les Oudairies

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

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals; Hematology

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Uni of Rochester Medical Center; Wilmot Cancer Center, Pharmacy Department

location_facility: Azienda Ospedaliero Universitaria Pisana; U.O. Farmaceutica

location_facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

location_facility: Debreceni Egyetem; Belgyogyaszati Klinika Hematologiai Tanszek

location_facility: BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency

title: A Phase Ib/II, Open-Label Study Evaluating the Safety, Efficacy and Pharmacokinetics of GDC-0199 (ABT-199) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL

location_country:
Italy
Hungary
Australia
Netherlands
Austria
United States
Spain
Czechia
Canada
France


title: BRF117277: A Phase II, Open-Label, Multicentre Study of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain

summary: This is a multi-cohort, open label, Phase II study with Dabrafenib (GSK2118436) and Trametinib (GSK1120212) combination therapy in subject with BRAF mutation-positive melanoma that has metastasized to the brain. This study will evaluate the safety and efficacy of 4 cohorts. Cohorts will consist of; V600 E, D, K, R mutations, metastases to the brain, symptomatic and asymptomatic, with or without prior local (brain) therapy, with or without prior local (brain) therapy, and range of ECOG scores from 0-2.

design_allocation: Non-Randomized

ReferenceCitation: Syeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.

version: acceptedVersion

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Davies MA, Saiag P, Robert C, Grob JJ, Flaherty KT, Arance A, Chiarion-Sileni V, Thomas L, Lesimple T, Mortier L, Moschos SJ, Hogg D, Marquez-Rodas I, Del Vecchio M, Lebbe C, Meyer N, Zhang Y, Huang Y, Mookerjee B, Long GV. Dabrafenib plus trametinib in patients with BRAFV600-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial. Lancet Oncol. 2017 Jul;18(7):863-873. doi: 10.1016/S1470-2045(17)30429-1. Epub 2017 Jun 4.

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

repository_normalized: dnet

repositories:
PubMed Central
dnet

repositories_concat: PubMed Central;dnet

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Australia
United States
Spain
Canada
France