title: A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia Gravis

summary: The primary objective is to evaluate whether IGIV-C improves MG symptoms as compared to placebo in subjects with MG.

ReferenceCitation: Dalakas MC, Meisel A. Immunomodulatory effects and clinical benefits of intravenous immunoglobulin in myasthenia gravis. Expert Rev Neurother. 2022 Apr;22(4):313-318. doi: 10.1080/14737175.2022.2057223. Epub 2022 Apr 5.

repository_institution: Oxford - Oxford Academix

publisher_dissemination: Informa

lead_sponsor: Grifols Therapeutics LLC

location_country:
Germany
Lithuania
Poland
Hungary
Belgium
United States
Czechia
Canada
Estonia
France

location_facility: CHU Nice - Hôpital de l'Archet 1, Ctre de Réf Maladies Neuromusculaires et SLA

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet, Neurologiai Osztaly

location_facility: CHU de Toulouse - Hôpital Purpan, Service de Neurologie Générale

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Houston Methodist Neurological Institute

location_facility: CHU Strasbourg - Nouvel Hôpital Civil, Clinique Neurologique

location_facility: University Health Network (UHN) - Toronto General Hospital

location_facility: Krankenhaus Martha-Maria Halle-Doelau, Klinik fuer Neurologie

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: London Health Sciences Centre - University Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: III Szpital Miejski w Lodzi im. Dr K. Jonschera

location_facility: Uniwersyteckie Centrum Kliniczne, Dept of Neurology

location_facility: Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii Klinicznej

location_facility: Pest Megyei Flor Ferenc Korhaz, Neurologia es Stroke Osztaly

location_facility: University of Florida Health Science Center

location_facility: Fakultni nemocnice Brno, Dept of Neurologicka klinika

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Hopital Neurologique Pierre Wertheimer, Neuro-musculaire - Electromyographie

location_facility: Universitaetsklinikum Koeln, Neurologie und Psychiatrie

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny, Dept of Neurology

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Klinik und Poliklinik fuer Neurologie

location_facility: Ohio State University Wexner Medical Center

location_facility: Universitaetsklinikum Jena, Klinik fuer Neurologie


study_start_date_type: Actual

intervention_type: Drug

acronym: Basket

lead_sponsor: Hoffmann-La Roche

summary: The primary efficacy objective for this study is to evaluate non-progression rate (NPR) at 18 weeks in participants with advanced solid tumors treated with atezolizumab, defined as the percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1, or according to disease-specific criteria for prostate cancer and malignant pleural mesothelioma.

ReferenceType: derived

ReferenceCitation: Tabernero J, Andre F, Blay JY, Bustillos A, Fear S, Ganta S, Jaeger D, Maio M, Mileshkin L, Melero I. Phase II multicohort study of atezolizumab monotherapy in multiple advanced solid cancers. ESMO Open. 2022 Apr;7(2):100419. doi: 10.1016/j.esmoop.2022.100419. Epub 2022 Mar 16.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: gold

publisher_dissemination: Elsevier

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

location_facility: Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Now. Tkanek Miekkich,Kosci i Czer.

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Chemotherapie & Infektionskrankhei

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Haukeland Universitetssjukehus; Klinisk forskningspost

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: St James' Hospital; Cancer Clinical Trials Office

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Sarah Cannon Cancer Center and Research Institute

location_facility: Uniklinik-Eppendorf; Zentren F. Innere Medizin-Klinik U. Poliklinik

location_facility: LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed

status: Completed

title: An Open-Label, Multicohort, Phase II Study of Atezolizumab in Advanced Solid Tumors

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

study_completion_date_type: Actual

location_country:
Finland
Germany
Ireland
Italy
Poland
Norway
United Kingdom
Denmark
Brazil
Netherlands
Austria
Switzerland
United States
Spain
Turkey
Canada
Russian Federation
France

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: PTC Therapeutics

summary: This is an open-label extension study for participants who completed a Phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.

location_facility: University of Cologne Children's Hospital

location_facility: Hospital de Sabadell, Consorci Sanitari Parc Tauli

location_facility: Hospital Regional Universitario de Malaga

location_facility: University of Toronto Hospital for Sick Children

location_facility: University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Szpital Dzieciecy Polanki im Macieja Plazynskiego w Gdansku

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: New York University Langone Medical Center

location_facility: University of Texas Health Science Center

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

location_facility: Azienda Ospedaliero Universitaria Ospedall Riuniti di Acona-Umberto I G.M. Lancisi G. Salesi

location_facility: University Multiprofile Hospital for Active Treatment Aleksandrovska EAD

location_facility: Children's Hospital and Research Center at Oakland

location_facility: Ann and Robert H. Lurie Children's Hospital of Chicago

location_facility: Ippokratio General Hospital Of Thessaloniki

location_facility: Hopital Universitaire des Enfants Reine Fabiola

status: Terminated

title: Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Cystic Fibrosis

location_country:
Germany
Italy
Poland
Israel
Argentina
United Kingdom
Australia
Brazil
Netherlands
Belgium
United States
Spain
Greece
Bulgaria
Canada
France

status_simplified: Unknown


type: Other Identifier

title: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Duvortuxizumab, A Humanized CD19 x CD3 Dual-Affinity Re-Targeting (DART®) Protein in Subjects With Relapsed or Refractory B-cell Malignancies

summary: The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to participants with relapsed or refractory B-cell malignancies [diffuse-large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL)].

design_allocation: Non-Randomized

lead_sponsor: Janssen Research & Development, LLC

location_country:
France
Belgium
United States
Spain
Israel


title: Amplatzer™Amulet™ Observational Post-Market Study

acronym: Amulet™PMS

summary: This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

study_type: Observational

time_perspective: Prospective

ReferenceCitation: De Caterina AR, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Fischer S, Lund J, Montorfano M, Gage R, Lam SCC, Berti S. Gender difference in left atrial appendage occlusion outcomes: Results from the Amplatzer Amulet Observational Study. Int J Cardiol Heart Vasc. 2021 Jul 26;35:100848. doi: 10.1016/j.ijcha.2021.100848. eCollection 2021 Aug.

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

repository_institution: University of Turku - UTUPub

repositories_concat: PubMed Central;www.utupub.fi

ReferenceCitation: Piayda K, Hellhammer K, Nielsen-Kudsk JE, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Gage R, Zeus T. Clinical outcomes of patients undergoing percutaneous left atrial appendage occlusion in general anaesthesia or conscious sedation: data from the prospective global Amplatzer Amulet Occluder Observational Study. BMJ Open. 2021 Mar 24;11(3):e040455. doi: 10.1136/bmjopen-2020-040455.

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

ReferenceCitation: Aminian A, De Backer O, Nielsen-Kudsk JE, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Lam SCC, Freixa X, Gage R, Diener HC, Schmidt B. Incidence and clinical impact of major bleeding following left atrial appendage occlusion: insights from the Amplatzer Amulet Observational Post-Market Study. EuroIntervention. 2021 Oct 20;17(9):774-782. doi: 10.4244/EIJ-D-20-01309.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Tarantini G, D'Amico G, Schmidt B, Mazzone P, Berti S, Fischer S, Lund J, Montorfano M, Della Bella P, Lam SCC, Cruz-Gonzalez I, Gage R, Zhao H, Omran H, Odenstedt J, Nielsen-Kudsk JE. The Impact of CHA2DS2-VASc and HAS-BLED Scores on Clinical Outcomes in the Amplatzer Amulet Study. JACC Cardiovasc Interv. 2020 Sep 28;13(18):2099-2108. doi: 10.1016/j.jcin.2020.06.003.

oa_host_type: closed

repositories_concat: closed

lead_sponsor: Abbott Medical Devices

location_country:
Finland
Germany
Ireland
Italy
Poland
Israel
Norway
Denmark
Australia
Sweden
Netherlands
United Kingdom
Belgium
Spain
Chile
France

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH

location_facility: The Cardinal Stefan Wyszynski Institute of Cardiology

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Charité - Universitätsmedizin Berlin (CBF)

location_facility: Internistische Klinik Dr. Müller, München-Thalkirchen

location_facility: Azienda Ospedaliera S. Anna e S. Sebastiano

location_facility: Zentrum fur Herzgesundheit/Kardiologie am Alice Hospital Darmstadt

location_facility: Nuovo Ospedale Civile Sant'Agostino Estense

location_facility: Ospedale dell'Angelo and Ospedale SS Giovanni e Paolo Venezia

location_facility: Ospedale del Cuoro Fondazione C. N. R. Regione Toscana G. Monasterio

location_facility: Cardiac Arrhythmia Research Center, Centro Cardiologico Monzino, Unveristiy of Milan

intervention_type: Device


title: An Open-Label, Multicenter, Phase 1 Study of Ramucirumab Plus Pembrolizumab in Patients With Locally Advanced and Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma, Non-Small Cell Lung Cancer, Transitional Cell Carcinoma of the Urothelium, or Biliary Tract Cancer

summary: The main purpose of this study is to evaluate the safety and preliminary efficacy of the combination of the study drug known as ramucirumab plus pembrolizumab in participants with locally advanced and unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, non-small cell lung cancer (NSCLC), transitional cell carcinoma of the urothelium, or biliary tract cancer (BTC).

ReferenceCitation: Herbst RS, Arkenau HT, Bendell J, Arrowsmith E, Wermke M, Soriano A, Penel N, Santana-Davila R, Bischoff H, Chau I, Mi G, Wang H, Rasmussen E, Ferry D, Chao BH, Paz-Ares L. Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC. J Thorac Oncol. 2021 Feb;16(2):289-298. doi: 10.1016/j.jtho.2020.10.004. Epub 2020 Oct 15.

oa_colors: green hybrid

evidence: open (via crossref license)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery

unpaywall_oa_status: hybrid

ReferenceCitation: Herbst RS, Arkenau HT, Santana-Davila R, Calvo E, Paz-Ares L, Cassier PA, Bendell J, Penel N, Krebs MG, Martin-Liberal J, Isambert N, Soriano A, Wermke M, Cultrera J, Gao L, Widau RC, Mi G, Jin J, Ferry D, Fuchs CS, Petrylak DP, Chau I. Ramucirumab plus pembrolizumab in patients with previously treated advanced non-small-cell lung cancer, gastro-oesophageal cancer, or urothelial carcinomas (JVDF): a multicohort, non-randomised, open-label, phase 1a/b trial. Lancet Oncol. 2019 Aug;20(8):1109-1123. doi: 10.1016/S1470-2045(19)30458-9. Epub 2019 Jul 10.

repository_institution: The University of Manchester - Research Explorer

repository_normalized: Pure (Denmark)

version: submittedVersion

repositories_concat: Pure (Denmark)

ReferenceCitation: Arkenau HT, Martin-Liberal J, Calvo E, Penel N, Krebs MG, Herbst RS, Walgren RA, Widau RC, Mi G, Jin J, Ferry D, Chau I. Ramucirumab Plus Pembrolizumab in Patients with Previously Treated Advanced or Metastatic Biliary Tract Cancer: Nonrandomized, Open-Label, Phase I Trial (JVDF). Oncologist. 2018 Dec;23(12):1407-e136. doi: 10.1634/theoncologist.2018-0044. Epub 2018 May 31.

oa_colors: green other

evidence: open (via free article)

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Merck Sharp & Dohme LLC

location_country:
Germany
United Kingdom
Japan
United States
Spain
France

location_facility: Florida Cancer Specialists and Research Institute

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.


acronym: VALOR

lead_sponsor: UCB BIOSCIENCES, Inc.

summary: Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion.

sponsor_collaborators:
UCB BIOSCIENCES, Inc.
Pharmaceutical Research Associates

title: A Double-blind, Randomized, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

design_allocation: Randomized

location_country:
Germany
Poland
Australia
Brazil
Japan
Czechia
France
Portugal
Slovakia
Hungary
United States
Romania
Belgium
China
Italy
Mexico
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Israel


title: A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Crohn's Disease

summary: This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension. Participants who complete the Double-Blind Phase will be eligible to enroll in the optional Open-Label Extension for an additional 44 weeks. Participants who complete Week 52 assessments will be eligible to enter the Extended Treatment Phase to continue treatment with andecaliximab for an additional 156 weeks.

ReferenceType: result

ReferenceCitation: Schreiber S, Siegel CA, Friedenberg KA, Younes ZH, Seidler U, Bhandari BR, Wang K, Wendt E, McKevitt M, Zhao S, Sundy JS, Lee SD, Loftus EV. A Phase 2, Randomized, Placebo-Controlled Study Evaluating Matrix Metalloproteinase-9 Inhibitor, Andecaliximab, in Patients With Moderately to Severely Active Crohn's Disease. J Crohns Colitis. 2018 Aug 29;12(9):1014-1020. doi: 10.1093/ecco-jcc/jjy070.

evidence: open (via page says license)

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
Poland
New Zealand
Hungary
United Kingdom
Australia
United States
Spain
South Africa
Czechia
Canada
France

location_facility: Ibd Clinical And Research Centre-Iscare Ivf

location_facility: Gastroenterology/Colorectal Medicine & Genetics

location_facility: The Medical University of Bialystok Clinical

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Gastroenterology Associates Of Tidewater

location_facility: Digestive Health Specialists of The Southeast

location_facility: Capital and Coast District Health board-Wellington hospital

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Ertan Digestive Disease Center of Excellence, UTH/MH-TMC

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Medical Diagnostic Center (MDC)-Indiana University (IU) Health University Hospital

location_facility: Washington University School of Medicine

location_facility: Debreceni Egyeterm Orvos es Egeszsegtudomanyi Centrum

location_facility: Gastroenterology Associates Of Central Georgia, LLC

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Norfolk and Norwich University Hospital Nhs Foundation Trust

location_facility: Gastroenterology Research of San Antonio

location_facility: Premier Medical Group Of The Hudson Valley


acronym: L-MIND

lead_sponsor: MorphoSys AG

summary: This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).

ReferenceCitation: Salles G, Duell J, Gonzalez Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, Andre M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

version: acceptedVersion

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

repository_normalized: HAL

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

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - CHU de Clermont-Ferrand

repositories_concat: HAL

ReferenceCitation: Duell J, Maddocks KJ, Gonzalez-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, Andre M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repositories_concat: PubMed Central;diposit.ub.edu

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Duell J, Obr A, Augustin M, Endell J, Liu H, Geiger S, Silverman IM, Ambarkhane S, Rosenwald A. CD19 expression is maintained in DLBCL patients after treatment with tafasitamab plus lenalidomide in the L-MIND study. Leuk Lymphoma. 2022 Feb;63(2):468-472. doi: 10.1080/10428194.2021.1986219. Epub 2021 Nov 15. No abstract available.

oa_host_type: publisher

ReferenceCitation: Cherng HJ, Westin JR. Broadening the MIND: Tafasitamab and Lenalidomide versus Synthetic Controls. Clin Cancer Res. 2022 Sep 15;28(18):3908-3910. doi: 10.1158/1078-0432.CCR-22-1626.

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Nowakowski GS, Yoon DH, Peters A, Mondello P, Joffe E, Fleury I, Greil R, Ku M, Marks R, Kim K, Zinzani PL, Trotman J, Huang D, Waltl EE, Winderlich M, Kurukulasuriya NC, Ambarkhane S, Hess G, Salles G. Improved Efficacy of Tafasitamab plus Lenalidomide versus Systemic Therapies for Relapsed/Refractory DLBCL: RE-MIND2, an Observational Retrospective Matched Cohort Study. Clin Cancer Res. 2022 Sep 15;28(18):4003-4017. doi: 10.1158/1078-0432.CCR-21-3648.

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

ReferenceCitation: Zinzani PL, Rodgers T, Marino D, Frezzato M, Barbui AM, Castellino C, Meli E, Fowler NH, Salles G, Feinberg B, Kurukulasuriya NC, Tillmanns S, Parche S, Dey D, Fingerle-Rowson G, Ambarkhane S, Winderlich M, Nowakowski GS. RE-MIND: Comparing Tafasitamab + Lenalidomide (L-MIND) with a Real-world Lenalidomide Monotherapy Cohort in Relapsed or Refractory Diffuse Large B-cell Lymphoma. Clin Cancer Res. 2021 Nov 15;27(22):6124-6134. doi: 10.1158/1078-0432.CCR-21-1471. Epub 2021 Aug 25.

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

location_facility: The Royal Bournemouth & Christchurch Hospitals

location_facility: St. Mary's Hospital And Regional Medical Center

location_facility: Charleston Hematology Oncology Associates

location_facility: Centre Hospitalier Universitaire (CHU) de Liege

location_facility: Az Ospedaliera Santa Maria Facolta di Medicina e Chirurgia

location_facility: Tor Vergata University Department Of Hematology

location_facility: Institut Catala D'Oncologia-Hospital Duran Y Reynals

location_facility: St. Joseph Mercy Hospital Cancer Care Center

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)

location_facility: AZ Groeninge-Campus Maria's Voorzienigheid

location_facility: Azienda Ospedaliera Univerisitaria Policlinico Consorziale Di Bari UOC Ematologia con Trapianto

location_facility: Cancer Care - Torrance Memorial Physician Network

location_facility: Azienda Ospedaliero - Universitaria Policlinico di Modena Dip di Medicina Diagnostica, Clinica e di Sanità Pubblica

location_facility: Szpital Wojewodzk I w Opolu SP ZOZ Oddzial Hematologii i Onkologii Hematologicznej

location_facility: Ist.Ematologia E Oncologia Medica L.E A.Seragnoli Azienda Ospedaliero-Universitaria, Policlinico S.Orsola-Malpighi

location_facility: Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)

location_facility: ZNA Middelheim dep Klinische studies Hematologie

location_facility: Hospital Universitari Germans Trias i Pujol (HUGTP)

location_facility: Hospital Universitario Quiron Salud Madrid

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmimsko

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Poznaniu im. prof. Ludwika Bierkowskiego

location_facility: Central Coast Medical Oncology Corporation

location_facility: Universitatsklinikum Essen, Abteilung Haematologie

location_facility: The Newcastle Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

location_facility: Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen

location_facility: National Institute of Oncology Hematological Department

location_facility: Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica

location_facility: Royal Liverpool University Hospital - Liverpool University Hospitals NHS Foundation Trust

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: Klinikum Nuernberg Nord Medizinische Klinik 5 Hamatologie

location_facility: Hospital Universitario Fundacion Jimenez Diaz Servicio de Hematologia Unidad de Linformas Oncohealth Institute

location_facility: Semmelweis Egyetem I. Sz. Belgyogyaszati Klinika-Semmelweis University

location_facility: Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie

location_facility: A.O.U. Citta della Salute e della Scienza di Torino

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Klinika Nowotworow Ukladu Chlonnego Ul.

location_facility: CHU De Clermont Ferrand - Hopital Estaing Service Hematologie Clinique Et Thrapie Cellulaire

location_facility: University Hospital Olomouc Hematoonkologicka klinika

location_facility: Hospital Universitario Virgen del Rocio, Hospital de la Mujer Servicio de Hematologia

location_facility: Hopital Universitaire Necker Enfants Malades Service de Hematologie Adultes

title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)

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


title: An Open Label Phase II Study of Tipifarnib in Advanced Non-Hematological Malignancies With HRAS Mutations

summary: Phase II study to investigate the antitumor activity in terms of objective response rate (ORR) of tipifarnib in subjects with advanced tumors that carry HRAS mutations and for whom there is no standard curative therapy available. Note; Only cohort 2 (Head & Neck SCC) and cohort 3 (Other SCC) are currently open

ReferenceCitation: Ho AL, Brana I, Haddad R, Bauman J, Bible K, Oosting S, Wong DJ, Ahn MJ, Boni V, Even C, Fayette J, Flor MJ, Harrington K, Kim SB, Licitra L, Nixon I, Saba NF, Hackenberg S, Specenier P, Worden F, Balsara B, Leoni M, Martell B, Scholz C, Gualberto A. Tipifarnib in Head and Neck Squamous Cell Carcinoma With HRAS Mutations. J Clin Oncol. 2021 Jun 10;39(17):1856-1864. doi: 10.1200/JCO.20.02903. Epub 2021 Mar 22. Erratum In: J Clin Oncol. 2021 Oct 1;39(28):3192.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

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

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: University of Strathclyde - Strathprints: The University of Strathclyde institutional repository

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ipd_sharing: Undecided

lead_sponsor: Kura Oncology, Inc.

location_country:
Germany
Italy
United Kingdom
Netherlands
Belgium
United States
Korea, Republic of
Spain
Greece
France

location_facility: Oklahoma University Health Sciences Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Hospital Universitario Virgen de la Rocio

location_facility: Wihship Cancer Institute of Emory University

location_facility: START, Centro Integral Oncologico Clara Campal

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: University of Michigan Comprehensive Cancer Center


lead_sponsor: Celgene

summary: The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2-) Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor (AI).

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Centre Rene Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

location_facility: Universitatsklinikum Hamburg-Eppendorf / IVDP

location_facility: Hamatologisch Onkologische Praxis Eppendorf

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Clinique Sainte Elisabeth - Service d'Oncologie

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

location_facility: Hospital Clinico Universitario Virgen de La Victoria

title: A Phase 2, Randomized, Open-label, Two-arm Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women With ER+, HER2- Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor

location_country:
Germany
Italy
Belgium
United States
Spain
France


title: An Open-label Phase 1b Study of PF-04449913 (Glasdegib) in Combination With Azacitidine in Patients With Previously Untreated Higher-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia

acronym: BRIGHT 1012

summary: This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.

ReferenceCitation: Sekeres MA, Schuster M, Joris M, Krauter J, Maertens J, Breems D, Gyan E, Kovacsovics T, Verma A, Vyas P, Wang ES, Ching K, O'Brien T, Gallo Stampino C, Ma WW, Kudla A, Chan G, Zeidan AM. A phase 1b study of glasdegib + azacitidine in patients with untreated acute myeloid leukemia and higher-risk myelodysplastic syndromes. Ann Hematol. 2022 Aug;101(8):1689-1701. doi: 10.1007/s00277-022-04853-4. Epub 2022 Apr 30.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

publisher_dissemination: Springer-Nature

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.

lead_sponsor: Pfizer

location_country:
Germany
United Kingdom
Belgium
United States
Canada
France

location_facility: University of Alabama at Birmingham the Kirklin Clinic

location_facility: CHU de Tours-Hopital Bretonneau-Centre Regional de cancerologie Henry Kaplan

location_facility: Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie

location_facility: Hopital Saint-Louis (AP-HP) - Service Hematologie Senior

location_facility: Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg

location_facility: Smilow Cancer Center at Yale New Haven Hospital

location_facility: The Newcastle Hospitals NHS Foundation Trust

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Duke University Health System: Adult Bone Marrow Transplant Clinic

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: University of Washington Medical Center (UWMC)

location_facility: Duke University Health System, Duke University Hospital

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Stony Brook University Hospital Cancer Center


title: A Randomised Phase II Trial of Imatinib Alternating With Regorafenib Compared to Imatinib Alone for the First Line Treatment of Advanced Gastrointestinal Stromal Tumour (GIST)

acronym: ALT GIST

summary: An open label randomised trial for adults with histologically confirmed measurable metastatic GIST who have received no other treatment for metastatic disease. The study aims to determine if an alternating regimen of imatinib and regorafenib has sufficient activity and safety in comparison to imatinib alone to warrant further evaluation as a first line treatment for metastatic GIST.

status: Active, not recruiting

study_completion_date_type: Anticipated

lead_sponsor: Australasian Gastro-Intestinal Trials Group

collaborators: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Finland
Slovakia
Norway
Singapore
United Kingdom
Australia
Sweden
Netherlands
Spain
France

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Netherlands Cancer Institute -Antoni Van Leeuwenhoek

location_facility: Nottingham University Hospitals NHS Trust - Nottingham City Hospital

location_facility: ICO L'Hospitalet - Hospital Duran i Reynals

location_facility: University Hospital Birmingham - Queen Elizabeth Hospital

status_simplified: Ongoing


title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.

summary: This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.

ReferenceCitation: Li CSW, Sweeney K, Cronenberger C. Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin(R)) in patients with advanced non-squamous non-small cell lung cancer. Cancer Chemother Pharmacol. 2020 Mar;85(3):487-499. doi: 10.1007/s00280-019-03946-8. Epub 2019 Nov 26.

ReferenceCitation: Reinmuth N, Bryl M, Bondarenko I, Syrigos K, Vladimirov V, Zereu M, Bair AH, Hilton F, Liau K, Kasahara K. PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin(R)), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study. BioDrugs. 2019 Oct;33(5):555-570. doi: 10.1007/s40259-019-00363-4.

ipd_sharing: Yes

location_country:
Germany
Poland
Australia
Brazil
Japan
Thailand
Turkey
Croatia
Chile
Czechia
France
Hungary
United States
Ukraine
India
Romania
Malaysia
Philippines
Italy
Netherlands
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation

location_facility: SBHI "Chelyabinsk Regional Clinical Hospital"

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: National Hospital Organization Kochi National Hospital

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH - Apotheke

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Kopernika w Lodzi,

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu Szpital Obserwacyjno-Zakazny

location_facility: Clinical Research Center, Phramongkutklao Hospital

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE/HSPE-FMO

location_facility: Centro Internacional de Estudios Clinicos (CIEC)

location_facility: P.A.Hertsen Moscow Oncology Research Institute - Branch of the National Medical Radiological

location_facility: SHI Oncology Dispensary #2 of Health Department of Krasnodar Region

location_facility: Semmelweis Egyetem Klinikai Pulmonologiai Klinikai Gyogyszertar

location_facility: Federal State Budgetary Institution of Healthcare "Clinical Hospital #

location_facility: Vincentius-Diakonissen-Kliniken gAG Klinik fuer Diagnostische und Interventionelle Radiologie

location_facility: Communal Non-Profit Enterprise "Regional Center of Oncology",

location_facility: Cardiac Services, John Flynn Private Hospital -

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Vinnytsia Regional Clinical Oncology Dispensary

location_facility: Road Clinical Hospital on the station Chelyabinsk of OJSC "RZD"

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Cardiologie

location_facility: SPb SBHI "City Clinical Oncology Dispensary"

location_facility: Stavropol Krai State Budget Healthcare Institute "Stavropol Regional Oncology Clinic"

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

location_facility: Ege Universitesi Tip Fakultesi lc Hastaliklari Anabilim Dali

location_facility: General Oncology Hospital of Kifissia "Ag. Anargiroi"

location_facility: LLC "Medical clinic "INNOVACIA", chemotherapy department

location_facility: Institut Fuer Versorgungsforschung In Der Onkologie

location_facility: Klinisch Chemisch en Hematologisch Laboratorium (KCHL)

location_facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi

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

location_facility: S.C. Oncologia Medica-Presidio Ospedaliero Sondrio

location_facility: Universitaetsklinikum des Saarlandes, Apotheke

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: Oncologia Medica, Fondazione Poliambulanza Instituto Ospedaliero

location_facility: Clinical hospital n.a. S.R. Mirotvortseva of SSMU

location_facility: Vivantes GmbH Apotheke des Humboldt-Klinikums

location_facility: Hospital Bruno Born (Sociedade Beneficencia e Caridade de Lajeado)

location_facility: Yildirim Beyazit Universitesi Tip Fakultesi Ataturk Egitim ve Arastirma Hastanesi

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Staedtisches Klinikum Braunschweig gGmbH Institut fuer Roentgendiagnostik und Nuklearmedizin

location_facility: Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital,

location_facility: "SAHI of Moscow ""Moscow City Oncology Hospital #62 of Health Department of Moscow"""

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Oncology Unit, Department of Medicine, Faculty of Medicine, Naresuan University

location_facility: SBHI "Regional clinical hospital #2" of MoH of Krasnodar Region

location_facility: SBHI of NNR Nizhniy Novgorod Regional Oncology Dispensary

location_facility: "Budgetary Healthcare Institution of Omsk Region ""Clinical Oncology Dispensary"""

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - Hospital Santa Rita

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Semmelweis Egyetem, Pulmonologiai Klinika

location_facility: Saratov scientific research institute of traumatology and orthopedics

location_facility: "RMI ""Sumy Reg. Clin. Oncology Dispensary"". oncothoracic dep.-nt. Surny State Univ.,

location_facility: Bradford Hill Centro de Investigaciones Clinicas

location_facility: Instituto Joinvillense de Hematologia e Oncologia SS Ltda - Clinica de Hematologia e Oncologia

location_facility: COT - Centro Oncologico do Triangulo Ltda

location_facility: Consorcio Hospital Universitario General De Valencia

location_facility: Oncosinos (Lessa Ferreira Servicos Oncologicos Ltda)

location_facility: Centrul Medical Pozimed, SC Pozitron Medical Investigation SRL

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: FSBI 'Scientific-Research Oncology Institute n.a. N.N.Petrov' of MoH of RF

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre - ISCMPA

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L., Oncologie Medicala

location_facility: Istanbul Universitesi Onkoloji Enstitusu

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Hospital da Cidade de Passo Fundo - HCPF

location_facility: National Hospital Organization Mito Medical Center

location_facility: SBHI of Stavropol Region "Essentuki Central City Hospital"

location_facility: Mahatma Gandhi Cancer Hospital And Research Institute

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Institute of Respiratory Diseases, SMS Medical College & Hospital

location_facility: Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie Szpital Wojewodzki w

location_facility: Instituto de Oncologia de Sorocaba - ONCO Clinicas Especializadas SC Ltda

location_facility: "SBHI ""Chelyabinsk Regional Clinical Oncology Dispensary"""

location_facility: Baskent Universitesi Tip Fakultesi Adana Hastanesi

location_facility: NHI Road clinical hospital at the st. Saratov II of OJSC Russian Railways

location_facility: University Hospital Centre "Sestre Milosrdnice"

location_facility: Wojewodzki Szpital Chorob Pluc im. dr Alojzego Pawelca

location_facility: Instituto COI de Pesquisa, Educacao e Gestao - COI Clinicas Barra Da Tijuca

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Spitalul Clinic Judetean Mures, sectia Clinica de Oncologie Medicala

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Center

location_facility: "RBHI ""Kursk Regional Clinical Oncology Dispensary"" of Healthcare Committee of Kursk Region"

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari

location_facility: Hospital Santa Izabel / Santa Casa de Misericordia da Bahia

location_facility: "Central City Clinical Hospital, City Oncology Center, SHEI ""Uzhhorod National University""

location_facility: Oncoclinic (Clinica de Oncologia e Atendimento de Urgencia Ltda)

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Hospital Universitario La Paz, Servicio de Oncologia

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: SBHI of Vladimir Region "Regional Clinical Oncology Dispensary"

location_facility: Csongrad Megyei Mellkasi Betegsegek Szakkorhaza

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto -

location_facility: Seoul National University Bundang Hospital

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH - Institut fuer Radiologie

location_facility: Institut fuer Diagnostische und Interventionelle Radiologie

location_facility: Medizinische Hochschule Hannover Zentralapotheke

location_facility: Sahyadri Clinical Research and Development Center (A Unit of Sahayadri hospitals Limited)

location_facility: Wojskowy Instytut Medyczny, Klinika Onkologii

location_facility: Staedtisches Klinikum Braunschweig gGmbH Apotheke

location_facility: MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC', Dep.-nt of Chemotherapy;

location_facility: National Hospital Organization Disaster Medical Center

location_facility: Hopital d'instruction des armees Sainte Anne

location_facility: Univ. of Athens Hosp. of Chest Diseases of Athens ''Sotiria''

location_facility: POIS Leipzig GbR, Pneumologisch/onkologisch/internistisches Studienzentrum

location_facility: Hiperdia Timisoara, Radiologie si imagistica medicala

location_facility: Privolzhskiy District Medical Center of Federal Biomedical Agency

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

location_facility: Matrai Gyogyintezet Pulmonologiai Osztaly

location_facility: Limited Liability Company "Common health"

location_facility: Diskapi Yildirim Beyazit Egitim ve Arastirma Hastanesi

location_facility: State Budget Healthcare Institution of Arkhangelsk Region

location_facility: Nemocnice Pelhrimov p.o, Radioterapeuticke oddeleni

location_facility: Universitaetsklinikum des Saarlandes - Klinik fuer Innere Medizin V - Pneumologie, Allergologie,

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

location_facility: MI 'Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council'

location_facility: Medical Oncology Unit, Department of Medicine, Phramongkutklao Hospital

location_facility: Poltava Reg. Clinical Oncology Dispensary of PRC, thoracic department, SHEI of Ukr.

location_facility: Petz Aladar Megyei Oktato Korhaz, Pulmonologiai Osztaly

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: "Municipal Institution ""Chernivtsi Regional Clinical Oncology Dispensary"",

location_facility: Universitaetsklinikum des Saarlandes - Klinik fuer Diagnostische und Interventionelle Radiologie

location_facility: S.G. Primushko Republican Clinical Oncology Dispensary

location_facility: Instituto Clínico Oncológico del Sur (ICOS)

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im.Eugenii i Janusza Zeylandow

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH

location_facility: UOSD Pneumologia Oncologica - Padiglione Flaiani

location_facility: Spitalul Clinic Judetean Mures, radiologie si imagistica medicala

location_facility: South Coast Radiology, John Flynn Private Hospital

location_facility: Centro de Investigaciones Clinicas Vina del Mar Ltda.

location_facility: Centre Hospitalier General De Mont De Marsan

location_facility: Centro de Pesquisa em Oncologia - Uniao Brasileira de Educacao e Assistencia

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz - Rendelointezet, Megyei Onkologiai Kozpont

location_facility: lnstituto do Cancer do Estado de Sao Paulo - Octavio Frias de -

location_facility: National Hospital Organization Oita Medical Center

location_facility: FSBI "N.N.Blokhin Russian Cancer Research Center" RAMS

location_facility: National Hospital Organization Mie Chuo Medical Center

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: SBEI HPE RyazSMU of MoH of Russia based on SBI of Ryazan Region

location_facility: Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz (ZRN Leipzig)

location_facility: Austin Health - Olivia Newton - John Cancer & Wellness Centre

location_facility: SBHI of Stavropol Region "Pyatigorsk Oncology Dispensary"

location_facility: Spitalul Clinic Judetean de Urgenta "Sf Apostol Andrei" Constanta Clinica Oncologie Medicala

location_facility: MRUKMED. Lekarz Beata Madej Mruk i Partner. Sp. p. Oddzial nr 1 w Rzeszowie


title: A Phase 3, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of LJPC-501 in Patients With Catecholamine-Resistant Hypotension (CRH)

summary: This is a Phase 3, double-blind, randomized study of LJPC-501 (angiotensin II) in adult patients diagnosed with catecholamine-resistant hypotension (CRH) conducted in multiple centers globally.

ReferenceCitation: Bellomo R, Forni LG, Busse LW, McCurdy MT, Ham KR, Boldt DW, Hastbacka J, Khanna AK, Albertson TE, Tumlin J, Storey K, Handisides D, Tidmarsh GF, Chawla LS, Ostermann M. Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1253-1261. doi: 10.1164/rccm.201911-2172OC.

repository_institution: Monash University - Monash University Research Portal

repository_institution: University of California - eScholarship University of California

publisher_dissemination: American Thoracic Society

ReferenceCitation: Bellomo R, Wunderink RG, Szerlip H, English SW, Busse LW, Deane AM, Khanna AK, McCurdy MT, Ostermann M, Young PJ, Handisides DR, Chawla LS, Tidmarsh GF, Albertson TE. Angiotensin I and angiotensin II concentrations and their ratio in catecholamine-resistant vasodilatory shock. Crit Care. 2020 Feb 6;24(1):43. doi: 10.1186/s13054-020-2733-x.

repository_institution: University of Ottawa - uO Research

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;escholarship.org;monash.edu;ruor.uottawa.ca

ReferenceCitation: Senatore F, Jagadeesh G, Rose M, Pillai VC, Hariharan S, Liu Q, McDowell TY, Sapru MK, Southworth MR, Stockbridge N. FDA Approval of Angiotensin II for the Treatment of Hypotension in Adults with Distributive Shock. Am J Cardiovasc Drugs. 2019 Feb;19(1):11-20. doi: 10.1007/s40256-018-0297-9. Erratum In: Am J Cardiovasc Drugs. 2019 Apr;19(2):227.

evidence: open (via free pdf)

ReferenceCitation: Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.

repository_institution: University of Newcastle, Australia - NOVA

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

ReferenceCitation: Schmull S, Wang Z, Gao L, Lv J, Li J, Xue S. Angiotensins and Their Receptors in Cardiac and Vascular Injury. Curr Hypertens Rev. 2016;12(3):170-180. doi: 10.2174/1573402112666160302101545.

location_country:
Finland
Germany
New Zealand
United Kingdom
Australia
Switzerland
Belgium
United States
Canada
France

location_facility: Montefiore Medical Center, Weiler Division

location_facility: Methodist Hospital, Indiana University Health Physicians

location_facility: University of California, Irvine Medical Center

location_facility: Virginia Commonwealth University Medical Center

location_facility: Joseph M. Still Research Foundation, Inc.

location_facility: Rutgers Robert Wood Johnson Medical Center

location_facility: Los Angeles County + University of Southern California Medical Center

location_facility: Norfolk and Norwich University Hospitals

location_facility: South Health Campus & Rockyview General Hospital

location_facility: John Peter Smith Hospital - JPS Health Network


title: A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab 70, 210, and 700 mg on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)

summary: The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

ReferenceCitation: Rooks D, Swan T, Goswami B, Filosa LA, Bunte O, Panchaud N, Coleman LA, Miller RR, Garcia Garayoa E, Praestgaard J, Perry RG, Recknor C, Fogarty CM, Arai H, Chen LK, Hashimoto J, Chung YS, Vissing J, Laurent D, Petricoul O, Hemsley S, Lach-Trifilieff E, Papanicolaou DA, Roubenoff R. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020836. doi: 10.1001/jamanetworkopen.2020.20836.

publisher_dissemination: American Medical Association

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Denmark
Australia
Japan
Switzerland
Belgium
United States
Korea, Republic of
Spain
Taiwan
Czechia
Russian Federation
France


summary: This three-cohort, multi-stage, randomized, Phase II, multicenter trial will evaluate the safety and tolerability and estimate the efficacy of cobimetinib plus paclitaxel versus placebo plus paclitaxel in Cohort I, of cobimetinib plus atezolizumab plus paclitaxel in Cohort II, and of cobimetinib plus atezolizumab plus nab-paclitaxel in Cohort III in participants with metastatic or locally advanced, triple-negative adenocarcinoma of the breast who have not received prior systemic therapy for metastatic breast cancer (MBC). Participants may continue on study treatment until the development of progressive disease (PD) or the loss of clinical benefit, unacceptable toxicity, and/or consent withdrawal. The Cohort I target sample size is 12 participants for the safety run-in stage and approximately 90 participants in the expansion stage. Each of Cohorts II and III will consist of a safety run-in stage of approximately 15 participants followed by an expansion stage of approximately 15 participants.

ReferenceCitation: Barteselli G, Goodman GR, Patel Y, Caro I, Xue C, McCallum S. Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies. Drug Saf. 2022 Dec;45(12):1491-1499. doi: 10.1007/s40264-022-01248-2. Epub 2022 Oct 30.

location_facility: Hospital Clinico San Carlos; Servicio de Nefrologia

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: Mercy Hospital, a Campus of Plantation General Hospital

location_facility: Organización Sanitaria Integrada Bilbao Basurto

location_facility: St John of God Murdoch Hospital; Oncology West

location_facility: Azienda Ospedaliero - Universitaria Pisana U.O. Oncologia Medica 2 Universitaria ? Polo Oncologico

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: National Cancer Center; Medical Oncology

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hosp. Regional Univ. de Malaga ? Hospital Materno Infantil; Hospital Materno Infantil de Malaga

location_facility: Azienda Ospedaliero Universitaria Seconda Università Degli Studi Di Napoli

location_facility: Yonsei University Health System/Severance Hospital

location_facility: Nottingham University Hospitals City Campus

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Fundacion Jimenez Diaz; Servicio de Oncologia

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Centro Di Riferimento Oncologico; SOC Oncologia Medica C

location_facility: Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer

location_facility: Pauls Stradins Clinical University Hospital

title: A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as First-Line Treatment for Patients With Metastatic Triple-Negative Breast Cancer

location_country:
Italy
Israel
United Kingdom
Romania
Australia
Belgium
United States
Korea, Republic of
Latvia
Spain
Taiwan
Czechia
France


summary: This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.

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

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Praxis für Ambulante Onkologie im Krankenhaus Jerusalem

location_facility: Cancerologia de Queretaro; Oncologia; Investigación

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Gifu University Hospital; Digestive Surgery

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: AUSL ? IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: West China Hospital, Sichuan University; Department of Breast

location_facility: Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)

location_facility: Zhejiang Cancer Hospital; Breast Surgery

location_facility: CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

location_facility: Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Centro de Investigación En Oncología Y Medicina Interna de La Clínica Santa Beatriz

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Clinique Armoricaine Radiologie; Cons Externes

location_facility: National Cancer Center Hospital East; Gastroenterology

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Studienzentrum UnterEms; Onkologische Schwerpunktpraxis Leer; Dr. med. Lothar Müller

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

title: A Single-Arm Open-Label Multi-Centre Extension Study of Pertuzumab Administered As a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Study

location_country:
Germany
Italy
Poland
Portugal
Japan
Costa Rica
Brazil
Mexico
Korea, Republic of
China
Spain
Peru
Ukraine
Russian Federation
France


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in this study may have already been treated prior for HCV or may have never received treatment for their HCV.

title: Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)

location_country: Australia France


title: A Phase 3 Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALN TTRSC in Patients With Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)

summary: The purpose of this study was to evaluate the safety and efficacy of revusiran (ALN-TTRSC) in patients with transthyretin (TTR) mediated Familial Amyloidotic Cardiomyopathy. Dosing has been discontinued; patients are being followed-up for safety.

ReferenceCitation: Judge DP, Kristen AV, Grogan M, Maurer MS, Falk RH, Hanna M, Gillmore J, Garg P, Vaishnaw AK, Harrop J, Powell C, Karsten V, Zhang X, Sweetser MT, Vest J, Hawkins PN. Phase 3 Multicenter Study of Revusiran in Patients with Hereditary Transthyretin-Mediated (hATTR) Amyloidosis with Cardiomyopathy (ENDEAVOUR). Cardiovasc Drugs Ther. 2020 Jun;34(3):357-370. doi: 10.1007/s10557-019-06919-4. Erratum In: Cardiovasc Drugs Ther. 2020 Jun 16;:

repository_institution: PubMed Central - Europe PMC

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Sweden
Belgium
United States
Spain
Canada
France


title: A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy

acronym: POSITIVE

summary: The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.

ReferenceType: background

ReferenceCitation: Brinton LA, Sherman ME, Carreon JD, Anderson WF. Recent trends in breast cancer among younger women in the United States. J Natl Cancer Inst. 2008 Nov 19;100(22):1643-8. doi: 10.1093/jnci/djn344. Epub 2008 Nov 11.

ReferenceCitation: Leclere B, Molinie F, Tretarre B, Stracci F, Daubisse-Marliac L, Colonna M; GRELL Working Group. Trends in incidence of breast cancer among women under 40 in seven European countries: a GRELL cooperative study. Cancer Epidemiol. 2013 Oct;37(5):544-9. doi: 10.1016/j.canep.2013.05.001. Epub 2013 Jun 12. Erratum In: Cancer Epidemiol. 2014 Feb;38(1):106. GRELL Working Group [added]; multiple investigator names added.

ReferenceCitation: Bentzon N, During M, Rasmussen BB, Mouridsen H, Kroman N. Prognostic effect of estrogen receptor status across age in primary breast cancer. Int J Cancer. 2008 Mar 1;122(5):1089-94. doi: 10.1002/ijc.22892.

ReferenceCitation: Anders CK, Hsu DS, Broadwater G, Acharya CR, Foekens JA, Zhang Y, Wang Y, Marcom PK, Marks JR, Febbo PG, Nevins JR, Potti A, Blackwell KL. Young age at diagnosis correlates with worse prognosis and defines a subset of breast cancers with shared patterns of gene expression. J Clin Oncol. 2008 Jul 10;26(20):3324-30. doi: 10.1200/JCO.2007.14.2471. Erratum In: J Clin Oncol. 2011 Sep 20;29(27):3721.

ReferenceCitation: Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: ETOP IBCSG Partners Foundation

collaborators: Alliance for Clinical Trials in Oncology

sponsor_collaborators: Alliance for Clinical Trials in Oncology

location_country:
Ireland
Australia
Japan
Canada
Serbia
France
Slovenia
Portugal
Hungary
Denmark
Switzerland
United States
Lebanon
Belgium
Italy
Norway
Netherlands
Austria
Korea, Republic of
Spain
Greece
Israel

location_facility: Univ. Klinik f. Frauenheilkunde Innsbruck

location_facility: Regional Hematology Oncology Practice Associates

location_facility: Smilow Cancer Hospital-Torrington Care Center

location_facility: Greenville Health System Cancer Institute-Greer

location_facility: Institute of Oncology Ljubljana - Medical Oncology Department

location_facility: Weill Medical College of Cornell University

location_facility: Women and Infants Hospital of Rhode Island

location_facility: Hennepin County Medical Center - Cancer Center

location_facility: Instituto Catalán de Oncología de Gerona Hospital

location_facility: Champalimaud Cancer Center - Breast Cancer Unit

location_facility: Smilow Cancer Hospital Care Center at Saint Francis

location_facility: Montefiore Medical Center - Moses Campus, 111 East 210th Street

location_facility: National Cancer Center for Global Medicine

location_facility: Social Medical Corporation Hakuaikai Sagara Hospital

location_facility: Brustzentrum Thurgau - Obstetrics and Gynecology

location_facility: UNC Lineberger Comprehensive Cancer Center

location_facility: Greenville Health System Cancer Institute-Seneca

location_facility: Abbott-Northwestern Hospital, 800 East 28th Street

location_facility: NorthShore University Health System - Glenbrook Hospital

location_facility: CHCVs Hôpital de Sion - Service d'oncologie ambulatoire

location_facility: Yale-New Haven Hospital North Haven Medical Center

location_facility: Montefiore Medical Center-Weiler Hospital

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Bon Secours Memorial Regional Medical Centre

location_facility: Istituto scientifico Romagnolo per lo studio e la cura

location_facility: Smilow Cancer Hospital Care Center-Trumbull

location_facility: IHA Hematology Oncology Consultants-Ann Arbor

location_facility: U.O Medicina Oncologica Ospedale di Carpi

location_facility: AO Universitaria Ospedale Di Circolo e Fondazione

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Greenville Health System Cancer Institute-Butternut

location_facility: NorthShore University HealthSystem-Evanston Hospital

location_facility: Norwegian Radium Hospital (Oslo University)

location_facility: Spital STS AG Onkologiezentrum Thun-Berner Oberland

location_facility: Smilow Cancer Hospital Care Center-Fairfield

location_facility: Cliniques Universitaires Saint-Luc Brussels

location_facility: Smilow Cancer Hospital-Waterbury Care Center

location_facility: Smilow Cancer Hospital-Orange Care Center

location_facility: Leiden University Medical Centre, Albinusdreef 2, Postbus 9600

location_facility: Greenville Health System Cancer Institute-Eastside

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: American University of Beirut Medical Center

location_facility: Huntsman Cancer Institute / University of Utah

location_facility: St Marianna University School of Medicine Hospital

location_facility: University of Colorado Cancer Centre - Anschutz Cancer Pavilion

location_facility: Dartmouth Hitchcock Medical Center/Norris Cotton Cancer Center

location_facility: Greenville Health System Cancer Institute-Faris

location_facility: Ospedale degli Infermi - S. C. Oncologia Medica

location_facility: Hospital Universitario Central de Asturias

location_facility: NorthShore Unversity Health System - Highland Park Hospital

location_facility: Montefiore Medical Center - Einstein Campus, 1695 Eastchester Road

location_facility: Univ. Klinik f. Frauenheilkunde u. Geburtshilfe

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

location_facility: Greenville Health System Cancer Institute-Spartanburg

location_facility: Bon Secours Saint Francis Medical Centre

location_facility: University General Hospital of Heraklion

location_facility: Salvatore Maugeri Foundation - Medical Oncology Unit

location_facility: Christiana Care Health System-Christiana Hospital

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: NHO Kyushu Cancer Centre, 3-1-1 Notame Minami-ku Fukuoka-shi

location_facility: Sanford USD Medical Centre - Sioux Falls

location_facility: University Hospital of Lausanne (CHUV) BH06 - Oncology Department

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre

location_facility: Laso General Hospital, First Department of Medical Oncology

location_facility: Hospital Universitario HM Sanchinarro - Centro Integral Oncologico Clara Campal (CIOCC)

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: Smilow Cancer Hospital-Derby Care Center

location_facility: Institute of Oncology & Radiology of Serbia

location_facility: Medical Oncology Hematology Consultants PA

location_facility: Hospital General Universitario de Valencia - Servico Oncologia

intervention_type: Other


title: The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

summary: The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.

ReferenceCitation: Gouni-Berthold I, Alexander VJ, Yang Q, Hurh E, Steinhagen-Thiessen E, Moriarty PM, Hughes SG, Gaudet D, Hegele RA, O'Dea LSL, Stroes ESG, Tsimikas S, Witztum JL; COMPASS study group. Efficacy and safety of volanesorsen in patients with multifactorial chylomicronaemia (COMPASS): a multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Diabetes Endocrinol. 2021 May;9(5):264-275. doi: 10.1016/S2213-8587(21)00046-2. Epub 2021 Mar 30.

lead_sponsor: Ionis Pharmaceuticals, Inc.

sponsor_collaborators:
Ionis Pharmaceuticals, Inc.
Akcea Therapeutics

location_country:
Germany
United Kingdom
Netherlands
United States
Canada
France


summary:
Evaluate the safety and efficacy of oral azacitidne (CC-486) twice daily (BID) in subjects with myelodysplastic syndromes who failed to achieve an objective response post injectable hypomethylating agent (iHMA) treatment

Reason for removing the combination arm: Due to difficulties with dose-finding, the durvalumab plus CC-486 combination arm was closed to enrollment.

Extension:

An Extension Phase (EP) has been added to allow subjects who are currently receiving oral azacitidine BID and who are demonstrating clinical benefit as assessed by the Investigator, to continue receiving oral azacitidine until the subject meets the criteria for study discontinuation.

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: King's College HospitalSchool of Medicine

location_facility: Hospital Universitario Virgen De La Victoria

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Medizinische Klinik III Klinikum der Universität München-Großhadern

location_facility: Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo

location_facility: Cancer Care Centers of South Texas - HOAST

location_facility: University of Iowa Hospitals and Clinics

location_facility: Institut Calatà d'Oncologia, L'Hospitalet

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

location_facility: Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital

location_facility: University of Miami Miller School of Medicine

title: A Phase 2, International, Multicenter, Randomized, Open-label, Parallel Group to Evaluate the Efficacy and Safety of Cc-486 (Oral Azacitidine) Alone in Combination With Durvalumab (MEDI4736) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve an Objective Response to Treatment With Azacitidine for Injection or Decitabine

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Belgium
United States
Spain
France


lead_sponsor: Amgen

summary: This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the absence of ITP rescue medications for the past 4 weeks.

ReferenceCitation: Tarantino MD, Despotovic J, Roy J, Grainger J, Cooper N, Beam D, Raj A, Maschan A, Kim J, Eisen M. Romiplostim treatment for children with immune thrombocytopenia: Results of an integrated database of five clinical trials. Pediatr Blood Cancer. 2020 Nov;67(11):e28630. doi: 10.1002/pbc.28630. Epub 2020 Sep 9.

ReferenceCitation: Grainger J, Bussel J, Tarantino M, Cooper N, Beam D, Despotovic J, Maschan A, Wang K, Eisen M, Bowers C. A single-arm, long-term efficacy and safety study of subcutaneous romiplostim in children with immune thrombocytopenia. Blood Adv. 2023 Feb 14;7(3):396-405. doi: 10.1182/bloodadvances.2021006014.

title: A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Poland
Hungary
Israel
United Kingdom
Australia
Brazil
Switzerland
Mexico
Belgium
United States
Spain
South Africa
Turkey
Czechia
Canada
Russian Federation
France


title: BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III

summary: BIOLUX P-III is a prospective, international, multi-centre, postmarket all-comers registry to collect clinical performance data on the Passeo-18 Lux paclitaxel releasing balloon catheter in the treatment of atherosclerotic disease of the infrainguinal arteries.

ReferenceCitation: Barry IP, Macarulay R, Brodmann M, Zeller T, Moscovic M, Dahm J, Troisi N, Tepe G, Wong J, Mwipatayi BP; BIOLUX P-III Global Registry Investigators. Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis. Cardiovasc Intervent Radiol. 2022 Jul;45(7):918-928. doi: 10.1007/s00270-022-03135-w. Epub 2022 Apr 20.

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

ReferenceCitation: Mwipatayi BP, Barry IP, Brodmann M, Zeller T, Varcoe RL, Moscovic M, Chian JWC, Christensen JK, Yahaya SA, Oshin OA, Tepe G; BIOLUX P-III Global Registry Investigators. Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis. Ann Vasc Surg. 2021 Aug;75:237-252. doi: 10.1016/j.avsg.2021.02.050. Epub 2021 Apr 5.

ReferenceCitation: Tepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry. Cardiovasc Intervent Radiol. 2021 Feb;44(2):207-217. doi: 10.1007/s00270-020-02663-7. Epub 2020 Oct 20. Erratum In: Cardiovasc Intervent Radiol. 2021 Jul;44(7):1155-1156.

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

repositories_concat: PubMed Central;air.unimi.it;sdu.dk

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

ReferenceCitation: Tepe G, Wang J, Corpataux JM, Pua U, Binkert CA, Moscovic M, Ghotbi R, Keirse K, Robertson D, Brodmann M. BIOLUX P-III Passeo-18 Lux All-Comers Registry: 24-Month Results in Below-the-Knee Arteries. Cardiovasc Intervent Radiol. 2021 Jan;44(1):10-18. doi: 10.1007/s00270-020-02586-3. Epub 2020 Sep 22. Erratum In: Cardiovasc Intervent Radiol. 2021 Aug;44(8):1307.

ReferenceCitation: Tepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, Nano G, Schroeder H, Binkert CA, Brodmann M. Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry. J Endovasc Ther. 2020 Apr;27(2):304-315. doi: 10.1177/1526602819898804. Epub 2020 Jan 28. Erratum In: J Endovasc Ther. 2021 Jun;28(3):489.

location_country: Finland Germany Italy Portugal Slovakia Singapore Denmark Australia Netherlands Austria Belgium Switzerland Latvia Spain Malaysia France

location_facility: Centre Hopsitalier Universitaire Vaudois

location_facility: Universitätsklinikum Giessen und Marburg GmbH

location_facility: P.Stradins Clinical University Hospital, Institute of Diagnostic

location_facility: Hospital. Universitario Germans Trias i Pujol

location_facility: Department Radiologie, Universitätsklinik für Radiodiagnostik

location_facility: Institute of Cardiovascular diseases Kosice, Dpt. of Angiology

location_facility: Department of Angiology at Universitats- Herzzentrum Freiburg


title: Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period

summary:
Primary Objective:

To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine.

Secondary Objectives:

To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study.

To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension.

To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

ReferenceCitation: Garg SK, Wernicke-Panten K, Rojeski M, Pierre S, Kirchhein Y, Jedynasty K. Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. Diabetes Technol Ther. 2017 Sep;19(9):516-526. doi: 10.1089/dia.2017.0117. Epub 2017 Aug 30. Erratum In: Diabetes Technol Ther. 2017 Dec;19(12):753.

lead_sponsor: Sanofi

location_country:
Germany
Poland
Hungary
Japan
United States
Spain
Russian Federation
France

location_facility:
Investigational Site Number 276005
Investigational Site Number 840028
Investigational Site Number 840012
Investigational Site Number 276003
Investigational Site Number 348010
Investigational Site Number 643007
Investigational Site Number 724004
Investigational Site Number 840029
Investigational Site Number 392001
Investigational Site Number 276006
Investigational Site Number 392004
Investigational Site Number 840003
Investigational Site Number 724001
Investigational Site Number 840038
Investigational Site Number 840036
Investigational Site Number 840020
Investigational Site Number 840018
Investigational Site Number 724005
Investigational Site Number 840049
Investigational Site Number 616003
Investigational Site Number 348005
Investigational Site Number 840013
Investigational Site Number 348001
Investigational Site Number 250002
Investigational Site Number 348003
Investigational Site Number 840051
Investigational Site Number 392006
Investigational Site Number 840062
Investigational Site Number 840002
Investigational Site Number 840037
Investigational Site Number 840023
Investigational Site Number 840014
Investigational Site Number 840039
Investigational Site Number 840040
Investigational Site Number 840043
Investigational Site Number 276008
Investigational Site Number 840060
Investigational Site Number 840054
Investigational Site Number 348007
Investigational Site Number 616002
Investigational Site Number 724003
Investigational Site Number 840021
Investigational Site Number 840041
Investigational Site Number 348011
Investigational Site Number 840026
Investigational Site Number 840009
Investigational Site Number 840030
Investigational Site Number 392005
Investigational Site Number 276002
Investigational Site Number 840022
Investigational Site Number 840059
Investigational Site Number 840048
Investigational Site Number 250005
Investigational Site Number 840006
Investigational Site Number 643006
Investigational Site Number 276007
Investigational Site Number 616005
Investigational Site Number 840046
Investigational Site Number 840057
Investigational Site Number 276001
Investigational Site Number 643002
Investigational Site Number 840050
Investigational Site Number 840033
Investigational Site Number 276004
Investigational Site Number 840045
Investigational Site Number 250003
Investigational Site Number 840004
Investigational Site Number 840042
Investigational Site Number 840016
Investigational Site Number 643005
Investigational Site Number 724002
Investigational Site Number 616004
Investigational Site Number 616001
Investigational Site Number 840034
Investigational Site Number 840007
Investigational Site Number 250001
Investigational Site Number 348002
Investigational Site Number 840019
Investigational Site Number 840031
Investigational Site Number 840027
Investigational Site Number 392002
Investigational Site Number 643001
Investigational Site Number 392003
Investigational Site Number 840061
Investigational Site Number 643004
Investigational Site Number 643003
Investigational Site Number 840011
Investigational Site Number 840005
Investigational Site Number 840015


title: A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ceralasertib in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.

summary: This is a modular, phase I/ phase 1 b, open-label, multicentre study of ceralasertib administered orally in combination with cytotoxic chemotherapy regimens and/or novel anti-cancer agents, to patients with advanced malignancies. The study design allows an investigation of optimal combination dose of ceralasertib with other anti-cancer treatments, with intensive safety monitoring to ensure the safety of the patients. The initial combination to be investigated is ceralasertib with carboplatin. The second combination to be investigated is ceralasertib with Olaparib. The third combination to be investigated is ceralasertib with durvalumab. The fourth module will investigate the effect of food on ceralasertib absorption and the effect of ceralasertib on ECG parameter. The fifth module to be investigated is ceralasertib with AZD5305.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Smith G, Alholm Z, Coleman RL, Monk BJ. DNA Damage Repair Inhibitors-Combination Therapies. Cancer J. 2021 Nov-Dec 01;27(6):501-505. doi: 10.1097/PPO.0000000000000561.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: AstraZeneca

location_country:
Hungary
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Spain
Canada
France


title: A Randomized, Multi-center, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

summary: The primary objective of this study is to evaluate the efficacy of ibrutinib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab based on the Independent Review Committee (IRC) assessment of progression free survival (PFS). Efficacy will be evaluated according to 2008 International Workshop for Chronic Lymphocytic Leukemia (IWCLL) criteria with the modification for treatment-related lymphocytosis, in subjects with treatment-naive CLL or SLL.

ReferenceCitation: Moreno C, Greil R, Demirkan F, Tedeschi A, Anz B, Larratt L, Simkovic M, Samoilova O, Novak J, Ben-Yehuda D, Strugov V, Gill D, Gribben JG, Hsu E, Lih CJ, Zhou C, Clow F, James DF, Styles L, Flinn IW. Ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab in first-line treatment of chronic lymphocytic leukaemia (iLLUMINATE): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):43-56. doi: 10.1016/S1470-2045(18)30788-5. Epub 2018 Dec 3. Erratum In: Lancet Oncol. 2019 Jan;20(1):e10.

ReferenceCitation: Moreno C, Greil R, Demirkan F, Tedeschi A, Anz B, Larratt L, Simkovic M, Novak J, Strugov V, Gill D, Gribben JG, Kwei K, Dai S, Hsu E, Dean JP, Flinn IW. First-line treatment of chronic lymphocytic leukemia with ibrutinib plus obinutuzumab versus chlorambucil plus obinutuzumab: final analysis of the randomized, phase III iLLUMINATE trial. Haematologica. 2022 Sep 1;107(9):2108-2120. doi: 10.3324/haematol.2021.279012.

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

repositories_concat: PubMed Central;ddd.uab.cat

ReferenceCitation: Burger JA, Robak T, Demirkan F, Bairey O, Moreno C, Simpson D, Munir T, Stevens DA, Dai S, Cheung LWK, Kwei K, Lal I, Hsu E, Kipps TJ, Tedeschi A. Up to 6.5 years (median 4 years) of follow-up of first-line ibrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma and high-risk genomic features: integrated analysis of two phase 3 studies. Leuk Lymphoma. 2022 Jun;63(6):1375-1386. doi: 10.1080/10428194.2021.2020779. Epub 2022 Jan 11.

ReferenceCitation: Allan JN, Shanafelt T, Wiestner A, Moreno C, O'Brien SM, Li J, Krigsfeld G, Dean JP, Ahn IE. Long-term efficacy of first-line ibrutinib treatment for chronic lymphocytic leukaemia in patients with TP53 aberrations: a pooled analysis from four clinical trials. Br J Haematol. 2022 Feb;196(4):947-953. doi: 10.1111/bjh.17984. Epub 2021 Dec 5.

repository_institution: California Digital Library - eScholarship

publisher_dissemination: Wiley

ReferenceCitation: Greil R, Tedeschi A, Moreno C, Anz B, Larratt L, Simkovic M, Gill D, Gribben JG, Flinn IW, Wang Z, Cheung LWK, Nguyen AN, Zhou C, Styles L, Demirkan F. Pretreatment with ibrutinib reduces cytokine secretion and limits the risk of obinutuzumab-induced infusion-related reactions in patients with CLL: analysis from the iLLUMINATE study. Ann Hematol. 2021 Jul;100(7):1733-1742. doi: 10.1007/s00277-021-04536-6. Epub 2021 May 20.

ipd_sharing_description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.

lead_sponsor: Pharmacyclics LLC.

location_country:
Italy
Poland
New Zealand
Israel
United Kingdom
Australia
Sweden
Austria
Belgium
United States
Spain
Turkey
Czechia
Canada
Russian Federation
France

location_facility:
Site Reference ID/Investigator# 0631
Site Reference ID/Investigator# 0581
Site Reference ID/Investigator# 0582
Site Reference ID/Investigator# 0608
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Site Reference ID/Investigator# 0875
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Site Reference ID/Investigator# 0864
Site Reference ID/Investigator# 0533
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Site Reference ID/Investigator# 0790
Site Reference ID/Investigator# 0573
Site Reference ID/Investigator #0503
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Site Reference ID/Investigator# 0559
Site Reference ID/Investigator# 0535
Site Reference ID/Investigator# 0769
Site Reference ID/Investigator# 662
Site Reference ID/Investigator# 0854
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Site Reference ID/Investigator# 0352
Site Reference ID/Investigator# 0524
Site Reference ID/Investigator# 0523


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Upper Respiratory Tract

summary: The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

ReferenceCitation: Chemaly RF, Dadwal SS, Bergeron A, Ljungman P, Kim YJ, Cheng GS, Pipavath SN, Limaye AP, Blanchard E, Winston DJ, Stiff PJ, Zuckerman T, Lachance S, Rahav G, Small CB, Mullane KM, Patron RL, Lee DG, Hirsch HH, Waghmare A, McKevitt M, Jordan R, Guo Y, German P, Porter DP, Gossage DL, Watkins TR, Marty FM, Chien JW, Boeckh M. A Phase 2, Randomized, Double-blind, Placebo-Controlled Trial of Presatovir for the Treatment of Respiratory Syncytial Virus Upper Respiratory Tract Infection in Hematopoietic-Cell Transplant Recipients. Clin Infect Dis. 2020 Dec 31;71(11):2777-2786. doi: 10.1093/cid/ciz1166.

location_country:
Germany
Israel
Singapore
United Kingdom
Australia
Brazil
Netherlands
Sweden
Switzerland
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Fundação Antonio Prudente - Hospital do Câncer AC Camargo

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Institut Universitaire du Cancer Oncopole

location_facility: Instituto Brasileiro de Controle do Câncer-IBCC

location_facility: Chang Gung Medical Foundation-LinKou Branch

location_facility: Fundacao Faculdade Regional Medicina de Sao Jose do Rio Preto

location_facility: New York Presbyterian Hospital Cornell Medical Center

location_facility: University of Massachusetts Memorial Cancer Center


title: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma

summary: The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

location_country:
United States
Spain
Germany
France

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

intervention_type: Biological


acronym: Long term Safety TOPAMAX monotherapy in pediatric patients

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.

title: A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent-Onset Epilepsy

primary_purpose: Health Services Research

location_country:
Germany
Poland
Russian Federation
Hungary
Argentina
Australia
Austria
Belgium
United States
South Africa
Taiwan
Canada
Philippines
France