title: Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

acronym: CYPIDES

summary: The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

status: Recruiting

lead_sponsor: Orion Corporation, Orion Pharma

location_country:
United States
Finland
France
United Kingdom

location_facility: The Rutherford Cancer Centre, North East

location_facility: Institut de cancérologie Strasbourg Europe

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: University of Maryland Marlene and Stewart Greenebaum Cancer Center

location_facility: University at Buffalo, Kaleida Health Great Lakes Cancer Care Collaborative

location_facility: The Rutherford Cancer Centre, North West

status_simplified: Ongoing


title: A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

acronym: TRANSPORT

summary: The primary objective of the study was to evaluate the efficacy of lumacaftor in combination with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12:CD010966. doi: 10.1002/14651858.CD010966.pub3.

name: Department of Women's and Children's Health; University of Liverpool; Liverpool UK

family: Southern

full_name: Kevin W Southern

given: Kevin W

sequence: additional

family: Murphy

full_name: Jared Murphy

given: Jared

family: Sinha

full_name: Ian P Sinha

given: Ian P

name: Department of Biostatistics; University of Liverpool; Liverpool UK

family: Nevitt

full_name: Sarah J Nevitt

given: Sarah J

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Cochrane Database of Systematic Reviews

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Flume PA, Suthoff ED, Kosinski M, Marigowda G, Quittner AL. Measuring recovery in health-related quality of life during and after pulmonary exacerbations in patients with cystic fibrosis. J Cyst Fibros. 2019 Sep;18(5):737-742. doi: 10.1016/j.jcf.2018.12.004. Epub 2018 Dec 23.

family: Flume

full_name: Patrick A. Flume

given: Patrick A.

sequence: first

family: Suthoff

full_name: Ellison D. Suthoff

given: Ellison D.

family: Kosinski

full_name: Mark Kosinski

given: Mark

family: Marigowda

full_name: Gautham Marigowda

given: Gautham

family: Quittner

full_name: Alexandra L. Quittner

given: Alexandra L.

journal_name: Journal of Cystic Fibrosis

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: McColley SA, Konstan MW, Ramsey BW, Stuart Elborn J, Boyle MP, Wainwright CE, Waltz D, Vera-Llonch M, Marigowda G, Jiang JG, Rubin JL. Lumacaftor/Ivacaftor reduces pulmonary exacerbations in patients irrespective of initial changes in FEV(1). J Cyst Fibros. 2019 Jan;18(1):94-101. doi: 10.1016/j.jcf.2018.07.011. Epub 2018 Aug 23.

family: McColley

full_name: Susanna A. McColley

given: Susanna A.

family: Konstan

full_name: Michael W. Konstan

given: Michael W.

family: Ramsey

full_name: Bonnie W. Ramsey

given: Bonnie W.

family: Stuart Elborn

full_name: J. Stuart Elborn

given: J.

family: Boyle

full_name: Michael P. Boyle

given: Michael P.

family: Wainwright

full_name: Claire E. Wainwright

given: Claire E.

family: Waltz

full_name: David Waltz

given: David

family: Vera-Llonch

full_name: Montserrat Vera-Llonch

title: Lumacaftor/Ivacaftor reduces pulmonary exacerbations in patients irrespective of initial changes in FEV1

ReferenceCitation: Elborn JS, Ramsey BW, Boyle MP, Konstan MW, Huang X, Marigowda G, Waltz D, Wainwright CE; VX-809 TRAFFIC and TRANSPORT study groups. Efficacy and safety of lumacaftor/ivacaftor combination therapy in patients with cystic fibrosis homozygous for Phe508del CFTR by pulmonary function subgroup: a pooled analysis. Lancet Respir Med. 2016 Aug;4(8):617-626. doi: 10.1016/S2213-2600(16)30121-7. Epub 2016 Jun 10.

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Wainwright CE, Elborn JS, Ramsey BW, Marigowda G, Huang X, Cipolli M, Colombo C, Davies JC, De Boeck K, Flume PA, Konstan MW, McColley SA, McCoy K, McKone EF, Munck A, Ratjen F, Rowe SM, Waltz D, Boyle MP; TRAFFIC Study Group; TRANSPORT Study Group. Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR. N Engl J Med. 2015 Jul 16;373(3):220-31. doi: 10.1056/NEJMoa1409547. Epub 2015 May 17.

repository_institution: The University of Queensland - Queensland's institutional digital repository

title: Lumacaftor–Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR

location_country:
Austria
United States
Germany
France
Australia
Belgium
Spain
Denmark
Canada
United Kingdom


title: Effects of a Partially Supervised Conditioning Program in CF: an International Multi-centre, Randomized Controlled Trial

acronym: ACTIVATE-CF

summary: Physical activity and exercise have become an accepted and valued component of Cystic Fibrosis care. Regular physical activity and exercise can slow the rate of decline of pulmonary function, improve physical fitness, and enhance quality of life. However, motivating people to be more active is challenging. Supervised exercise programs are expensive and labor intensive, and adherence falls off significantly once supervision ends. Unsupervised or partially supervised programs are less costly and more flexible, but compliance can be more problematic. The primary objective of this study is to evaluate the effects of a 12-months partially supervised exercise intervention along with regular motivation on forced expiratory volume in 1 second (FEV1) in a large international group of cystic fibrosis patients. Secondary endpoints include patient reported quality of life, as well as levels of anxiety and depression, and control of blood sugar. A total of 292 patients with cystic fibrosis 12 years and older with a FEV1 ≥35% predicted will be recruited. Following baseline assessments (2 visits) patients will be randomized into an intervention and a control group. Thereafter, they will be seen every 3 months for assessments in their centre for one year (4 follow-up visits). Along with individual counseling to increase vigorous physical activity by at least 3 hours per week on each clinic visit, the intervention group will document daily exercise and inactivity time and will receive a step counter and they will record their progress with a web-based program. They will also receive monthly phone calls from the study staff. After 6 months, they will continue with the step counter and web-based program for a further 6 months. The control group will receive access to this intervention after 12 months of standardized care. Should this relatively simple program prove successful, this will be made available on a wider scale internationally.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Hebestreit H, Lands LC, Alarie N, Schaeff J, Karila C, Orenstein DM, Urquhart DS, Hulzebos EHJ, Stein L, Schindler C, Kriemler S, Radtke T; ACTIVATE-CF Study Working Group. Effects of a partially supervised conditioning programme in cystic fibrosis: an international multi-centre randomised controlled trial (ACTIVATE-CF): study protocol. BMC Pulm Med. 2018 Feb 8;18(1):31. doi: 10.1186/s12890-018-0596-6.

ReferenceCitation: Hebestreit H, Kriemler S, Schindler C, Stein L, Karila C, Urquhart DS, Orenstein DM, Lands LC, Schaeff J, Eber E, Radtke T; ACTIVATE-CF Study Working Group. Effects of a Partially Supervised Conditioning Program in Cystic Fibrosis: An International Multicenter Randomized Controlled Trial (ACTIVATE-CF). Am J Respir Crit Care Med. 2021 Nov 4. doi: 10.1164/rccm.202106-1419OC. [Epub ahead of print]

name: University Hospitals Würzburg, Würzburg, Germany;

family: Hebestreit

full_name: Helge Hebestreit

given: Helge

name: University of Zurich, 27217, Zurich, Switzerland

family: Kriemler

full_name: Susi Kriemler

given: Susi

name: Universitat Basel, 27209, Basel, Switzerland

name: Swiss Tropical and Public Health Institute, Basel, Switzerland

family: Schindler

full_name: Christian Schindler

given: Christian

name: Hannover Medical School, 9177, Hannover, Germany

family: Stein

full_name: Lothar Stein

given: Lothar

name: Hopital universitaire Necker-Enfants malades, 246596, Paris, France

family: Karila

full_name: Chantal Karila

given: Chantal

name: Royal Hospital for Sick Children, Edinburgh, United Kingdom of Great Britain and Northern Ireland

family: Urquhart

full_name: Don S Urquhart

given: Don S

name: Univ. of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States

family: Orenstein

full_name: David M. Orenstein

given: David M.

name: Montreal Children’s Hospital – McGill University Health Centre, Montreal, Quebec, Canada

family: Lands

full_name: Larry C Lands

given: Larry C

name: Unversity Hospitals Würzburg, Würzburg, Germany

family: Schaeff

full_name: Jonathan Schaeff

given: Jonathan

name: Medical University of Graz, Department of Pediatrics and Adolescent Medicine, Graz, Austria

family: Eber

full_name: Ernst Eber

given: Ernst

name: University of Zurich, Epidemiology, Biostatistics and Prevention Institute, Zurich, Switzerland

family: Radtke

full_name: Thomas Radtke

given: Thomas

name: on behalf of the ACTIVATE-CF Study Working Group

journal_name: American Journal of Respiratory and Critical Care Medicine

publisher: American Thoracic Society

publisher_dissemination: American Thoracic Society

publisher_group: American Thoracic Society

publisher_normalized: American Thoracic Society

lead_sponsor: Wuerzburg University Hospital

location_country:
Austria
Switzerland
Netherlands
Germany
France
United States
United Kingdom
Canada

location_facility: Montreal Children's Hospital, McGill University Health Centre - Glen Site

location_facility: Christiane Herzog CF-Zentrum, Goethe Universität

location_facility: Klinik und Poliklinik für Kinderheilkunde - Universitäts-Mukoviszidose-Centrum

location_facility: Hôpital Calmette, Service Pneumologie-immuno-allergologie boulevard du Pr Leclercq

location_facility: CF Zentrum Hamburg-Altona, Kinderarztpraxis Runge, Sextro,Held

location_facility: Hôpital Necker, Service : Pneumologie et allergologie pédiatriques

location_facility: Pediatric Pulmonology and CF centre, Children´s Hospital, Ruhr University

location_facility: QuartierBleu, Praxis für Pneumologie am Lindenhofspital

location_facility: Praxis für Lungen- und Bronchialheilkunde

location_facility: Zentrum für Kinder- und Jugendmedizin, Pädiatrische Pneumologie, Allergologie und Mukoviszidose

location_facility: Inselspital, Universitätsklinik für Kinderheilkunde, Pneumologie

location_facility: UniversitätsSpital, Klinik für Pneumologie

location_facility: CF- Ambulanz, Kinderklinik, Pädiatrische Pneumologie, Allergologie und Neonatologie

location_facility: Hôpital Renée Sabran, Service : Maladies respiratoires

location_facility: University Medical Center, Child Development & Exercise Center, Wilhelmina Children's Hospital

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Tübingen

location_facility: Hôpital Maison Blanche, Service : Maladies respiratoires

location_facility: Klinik für Kinder- und Jugendmedizin / Universitätsklinikum

location_facility: Hôpital Jeanne de Flandre, Service: Pneumologie et allergologie pédiatriques

location_facility: Mukoviszidose-Ambulanz, Universitätsklinik für Kinder- und Jugendheilkunde,

location_facility: Cystische Fibrose Zentrum für Kinder, Jugendliche und Erwachsene

location_facility: Hôpital Arnaud de Villeneuve, Service: Maladies respiratoires

intervention_type: Behavioral

lead_sponsor_type: academique

status_simplified: Completed


ReferenceCitation: Carol H, Szymanska B, Evans K, Boehm I, Houghton PJ, Smith MA, Lock RB. The anti-CD19 antibody-drug conjugate SAR3419 prevents hematolymphoid relapse postinduction therapy in preclinical models of pediatric acute lymphoblastic leukemia. Clin Cancer Res. 2013 Apr 1;19(7):1795-805. doi: 10.1158/1078-0432.CCR-12-3613. Epub 2013 Feb 20. Erratum in: Clin Cancer Res. 2013 Jun 1;19(11):3108.

family: Carol

full_name: Hernan Carol

given: Hernan

family: Szymanska

full_name: Barbara Szymanska

given: Barbara

family: Evans

full_name: Kathryn Evans

given: Kathryn

family: Boehm

full_name: Ingrid Boehm

given: Ingrid

family: Houghton

full_name: Peter J. Houghton

given: Peter J.

family: Smith

full_name: Malcolm A. Smith

given: Malcolm A.

family: Lock

full_name: Richard B. Lock

given: Richard B.

journal_name: Clinical Cancer Research

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via free pdf)

license_normalized: no license

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

publisher: American Association for Cancer Research (AACR)

title: The Anti-CD19 Antibody–Drug Conjugate SAR3419 Prevents Hematolymphoid Relapse Postinduction Therapy in Preclinical Models of Pediatric Acute Lymphoblastic Leukemia

intervention_type: Drug

status: Terminated

lead_sponsor: Sanofi

location_country:
United States
France

acronym: MYRALL

location_facility:
Investigational Site Number 840004
Investigational Site Number 840001
Investigational Site Number 840003
Investigational Site Number 840006
Investigational Site Number 250004
Investigational Site Number 250005
Investigational Site Number 250002
Investigational Site Number 250006
Investigational Site Number 250008
Investigational Site Number 840002
Investigational Site Number 250001

type: Other Identifier

type: EudraCT Number

source: euctr

title: Phase II Two Stage Finding Run-in Study of SAR3419, An Anti-CD19 Antibody-Maytansine Conjugate, Administered as a Single Agent by Intravenous Infusion in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

summary:
Primary Objective:

Participants achieving an Objective Response Rate

Secondary Objectives:

Response duration
Progression Free Survival
Minimal residual disease
Safety
Pharmacokinetics

lead_sponsor_type: industriel

status_simplified: Unknown


intervention_type: Dietary Supplement

lead_sponsor: Acrotech Biopharma LLC

location_country:
United States
Hungary
France
Czechia

location_facility: Fakultní nemocnice Královské Vinohrady - FNKV

location_facility: University of Debrecen Medical and Health Science Center

location_facility: Centre Lutte Contre le Cancer Val d'Aurelle (CRLC)

location_facility: Centre Régional de Lutte Contre le Cancer Alexis Vautrin

title: Phase 2 Study of Pralatrexate in Female Patients With Previously-treated Advanced or Metastatic Breast Cancer

summary: The purpose of this study is to determine the efficacy (ability to provide a beneficial treatment of the disease) of pralatrexate for the treatment of female patients with advanced or metastatic breast cancer who have failed prior chemotherapy. Patients will receive vitamin B12 and folic acid supplementation.


title: CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.

summary: The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Gerckens U, Tamburino C, Bleiziffer S, Bosmans J, Wenaweser P, Brecker S, Guo J, Linke A. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J. 2017 Sep 21;38(36):2729-2738. doi: 10.1093/eurheartj/ehx295.

name: Department of Cardiology, University of Rostock, Ernst-Heydemann- Straße, 618057 Rostock, Germany

family: Gerckens

full_name: Ulrich Gerckens

given: Ulrich

name: Cardiology Unit, Ferrarotto Hospital, University of Catania, Via Salvatore Citelli, 6, 95124 Catania CT, Italy

family: Tamburino

full_name: Corrado Tamburino

given: Corrado

name: Department of Cardiovascular Surgery, German Heart Centre, Lazarettstraße 36, 80636 Munich, Germany

family: Bleiziffer

full_name: Sabine Bleiziffer

given: Sabine

name: Cardiovascular Diseases Department, University Hospital Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium

family: Bosmans

full_name: Johan Bosmans

given: Johan

name: Department of Cardiology, University Hospital Bern, Freiburgstrasse 8, 3010 Bern, Switzerland

family: Wenaweser

full_name: Peter Wenaweser

given: Peter

name: Cardiology Clinical Academic Group, St. George’s Hospital, Blackshaw Rd, London SW17 0QT, UK

family: Brecker

full_name: Stephen Brecker

given: Stephen

name: Coronary and Structural Heart, Medtronic, 8200 Coral Sea Street NE, Mounds View, MN 55112 USA

family: Guo

full_name: Jia Guo

given: Jia

name: Department of Internal Medicine and Cardiology, University of Leipzig Heart Centre, Strümpellstraße 39, 04289 Leipzig, Germany

family: Linke

full_name: Axel Linke

given: Axel

journal_name: European Heart Journal

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: St George's University of London - St George's Online Research Archive

repositories:
PubMed Central
irua
openaccess.sgul.ac.uk

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Bleiziffer S, Bosmans J, Brecker S, Gerckens U, Wenaweser P, Tamburino C, Linke A; ADVANCE Study Investigators. Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study. Clin Res Cardiol. 2017 Oct;106(10):784-795. doi: 10.1007/s00392-017-1120-3. Epub 2017 May 8. Erratum in: Clin Res Cardiol. 2017 Jul 4;:.

ReferenceCitation: Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.

ReferenceCitation: Barbanti M, Schiltgen M, Verdoliva S, Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Gulino S, Tamburino C, Linke A; ADVANCE Study Investigators. Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study). Am J Cardiol. 2016 Mar 1;117(5):820-7. doi: 10.1016/j.amjcard.2015.11.066. Epub 2015 Dec 13.

ReferenceCitation: Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Tamburino C, Linke A; ADVANCE Study Investigators. The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients. J Am Coll Cardiol. 2015 Jul 21;66(3):209-217. doi: 10.1016/j.jacc.2015.05.025.

journal_name: Journal of the American College of Cardiology

location_country:
Italy
Switzerland
Netherlands
France
Greece
Israel
Belgium
Portugal
Denmark
Germany
United Kingdom
Colombia

location_facility: Azienda Ospedaliere Spedali Civili di Brescia

location_facility: Policlinico Vittorio Emanuele, P.O. Ferrarotto


ReferenceCitation: Diéras V, Bonnefoi H, Alba E, Awada A, Coudert B, Pivot X, Gligorov J, Jager A, Zambelli S, Lindeman GJ, Charpentier E, Emmons GT, Garcia-Ribas I, Paridaens R, Verweij J. Iniparib administered weekly or twice-weekly in combination with gemcitabine/carboplatin in patients with metastatic triple-negative breast cancer: a phase II randomized open-label study with pharmacokinetics. Breast Cancer Res Treat. 2019 Sep;177(2):383-393. doi: 10.1007/s10549-019-05305-w. Epub 2019 Jun 6.

family: Diéras

full_name: Véronique Diéras

given: Véronique

family: Bonnefoi

full_name: Hervé Bonnefoi

given: Hervé

family: Alba

full_name: Emilio Alba

given: Emilio

family: Awada

full_name: Ahmad Awada

given: Ahmad

family: Coudert

full_name: Bruno Coudert

given: Bruno

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Gligorov

full_name: Joseph Gligorov

given: Joseph

family: Jager

full_name: Agnes Jager

given: Agnes

family: Zambelli

full_name: Stefania Zambelli

given: Stefania

family: Lindeman

full_name: Geoffrey J. Lindeman

given: Geoffrey J.

family: Charpentier

full_name: Eric Charpentier

given: Eric

family: Emmons

full_name: Gary T. Emmons

given: Gary T.

family: Garcia-Ribas

full_name: Ignacio Garcia-Ribas

given: Ignacio

family: Paridaens

full_name: Robert Paridaens

given: Robert

family: Verweij

full_name: Jaap Verweij

given: Jaap

journal_name: Breast Cancer Research and Treatment

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

location_country: Italy Netherlands France Belgium Australia Spain

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 380004

location_facility: Sanofi-Aventis Investigational Site Number 724004

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 250002

location_facility: Sanofi-Aventis Investigational Site Number 380003

location_facility: Sanofi-Aventis Investigational Site Number 036001

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 724002

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 036002

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 250003

title: Multicenter, Randomized, Open Label Study Evaluating a Poly(ADP-ribose) Polymerase-1(PARP-1) Inhibitor, SAR240550 (BSI-201), Administered Twice Weekly or Weekly, in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (mTNBC)

summary:
Primary Objective:

To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a 60min intravenous (IV) infusion twice weekly or weekly, in combination with gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative Breast Cancer (mTNBC).

Secondary Objectives:

To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR), partial response (PR) and stable disease (SD) lasting at least 24 weeks;
To assess Progression-free survival (PFS) and the overall survival (OS);
To assess the safety profile of each schedule of iniparib;
To assess the biological activity in tumor tissue (substudy);
To evaluate the pharmacokinetic (PK) profile of iniparib (substudy);
To characterize molecular and biological profile of tumors (substudy);
To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood mononuclear cells (PBMC) (substudy).


title: Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal cancer.

ReferenceType: result

ReferenceCitation: Garufi C, Focan C, Tumolo S, et al.: Time finding study of chronomodulated irinotecan (I), fluorouracil (F), leucovorin (L) and oxaliplatin (O) (chronoIFLO) against metastatic colorectal cancer: results from randomized EORTC 05011 trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-2566, 2007.

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

location_country: Italy Belgium France Portugal

location_facility: Azienda Ospedale S. Luigi at University of Torino

location_facility: Centre Hospital Regional Universitaire de Limoges

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc

location_facility: Centre Hospitalier Notre Dame - Reine Fabiola


title: An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies

summary:
The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML).

The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).

design_allocation: Non-Randomized

lead_sponsor: Bayer

location_facility:
Thomas Jefferson University
Montefiore Medical Center
Memorial Sloan-Kettering Cancer Center
Institut Gustave Roussy
Vanderbilt University Medical Center


title: Open-Label, Exploratory Study to Evaluate the Effects of QR-010 on Nasal Potential Difference in Subjects With CF With the ΔF508 CFTR Mutation

summary: Exploratory proof of concept study to determine whether intranasal administration of QR-010 in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation, can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).

ReferenceCitation: Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27. Review.

name: Gene Medicine Group, Nuffield Division of Clinical Laboratory Science, Radcliffe Department of Medicine, University of Oxford, Oxford, UK

family: Miah

full_name: Kamran M. Miah

given: Kamran M.

family: Hyde

full_name: Stephen C. Hyde

given: Stephen C.

family: Gill

full_name: Deborah R. Gill

given: Deborah R.

journal_name: Expert Review of Respiratory Medicine

oa_host_type: repository

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

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

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: ProQR Therapeutics

location_country:
United States
Belgium
France

location_facility: Cincinnati Childrens Hospital Medical Center


title: A Multi-Center, Open-Label, Extension Study of RO5045337 (MDM2 Antagonist) Administered Orally in Patients Treated With RO5045337 on Previous Roche-Sponsored Phase 1 Cancer Studies

summary: This open-label, extension study is designed to provide continuing treatment with RO5045337 to participants who have completed parent studies NO21279 (NCT00623870), NO21280 (NCT00559533), NP25299 (NCT01164033), NP28021 (NCT01605526) or NP28023 (NCT01635296). Participants are eligible to participate in this study if they have completed required Phase 1 study assessments for primary objectives of respective parent protocol and are having evidence of clinical benefit (as defined by the parent protocol). Participants will continue the most similar dose and formulation available (which does not exceed the maximum tolerated dose [MTD] or the maximum safely administered dose for that formulation during Phase 1) and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from the parent clinical study protocol.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Canada
France

location_facility: Cancer Therapy & Research Ctr; Dept Institute for Drug Development

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Princess Margaret Hospital, Medical Oncology & Haematology


summary: This is an observational study assessing patient satisfaction following at least 5 years of BOTOX® treatment for glabellar lines.

time_perspective: Cross-Sectional

ReferenceCitation: Trindade de Almeida A, Carruthers J, Cox SE, Goldman MP, Wheeler S, Gallagher CJ. Patient satisfaction and safety with aesthetic onabotulinumtoxinA after at least 5 years: a retrospective cross-sectional analysis of 4,402 glabellar treatments. Dermatol Surg. 2015 Jan;41 Suppl 1:S19-28. doi: 10.1097/DSS.0000000000000275.

lead_sponsor: Allergan

location_country:
Brazil
United States
France
Australia
Canada

intervention_type: Biological


title: A Phase 1, Pharmacologic and Pharmacodynamic Study of MM-121 in Combination With Multiple Anticancer Therapies in Patients With Advanced Solid Tumors

summary: To evaluate the safety and tolerability of escalating doses of MM-121 + certain anticancer therapies

lead_sponsor: Merrimack Pharmaceuticals


title: Stenting in the Treatment of Large, Wide-necked or Recurring Intracranial Aneurysms

acronym: STAT

summary: The STAT trial aims at comparing coiling versus coiling plus stenting in patients with aneurysms prone to recurrence, that is large aneurysms or recurring aneurysms after previous coiling or wide-necked aneurysms. The primary hypothesis is that the use of stenting in addition to coiling decreases the recurrence rate from 33% to 20% at 12 months as compared to coiling alone.

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Naggara O, Darsaut T, Trystram D, Tselikas L, Raymond J. Unruptured intracranial aneurysms: why we must not perpetuate the impasse for another 25 years. Lancet Neurol. 2014 Jun;13(6):537-8. doi: 10.1016/S1474-4422(14)70091-2.

family: Naggara

full_name: Olivier Naggara

given: Olivier

family: Darsaut

full_name: Tim Darsaut

given: Tim

family: Trystram

full_name: Denis Trystram

given: Denis

family: Tselikas

full_name: Lambros Tselikas

given: Lambros

family: Raymond

full_name: Jean Raymond

given: Jean

journal_name: The Lancet Neurology

ReferenceCitation: Darsaut TE, Raymond J; STAT Collaborative Group. The design of the STenting in Aneurysm Treatments (STAT) trial. J Neurointerv Surg. 2012 May;4(3):178-81. doi: 10.1136/neurintsurg-2011-010065. Epub 2011 Jun 23.

full_name: Tim E Darsaut

given: Tim E

journal_name: Journal of NeuroInterventional Surgery

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

lead_sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

location_country: Canada France

location_facility: Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: CHRU de Brest (Brest University Hospital)

intervention_type: Device


title: A Phase 1 Study Of Neratinib In Combination With Temsirolimus In Subjects With Solid Tumors

summary: The primary purpose of this study is to identify the maximum tolerated dose(s) (MTD) of neratinib in combination with temsirolimus in subjects with solid tumors. This study will also include a preliminary evaluation of efficacy, and assessment of pharmacokinetic (PK) parameters of the combination.

ReferenceCitation: Gandhi L, Bahleda R, Tolaney SM, Kwak EL, Cleary JM, Pandya SS, Hollebecque A, Abbas R, Ananthakrishnan R, Berkenblit A, Krygowski M, Liang Y, Turnbull KW, Shapiro GI, Soria JC. Phase I study of neratinib in combination with temsirolimus in patients with human epidermal growth factor receptor 2-dependent and other solid tumors. J Clin Oncol. 2014 Jan 10;32(2):68-75. doi: 10.1200/JCO.2012.47.2787. Epub 2013 Dec 9.

name: Leena Gandhi, Sara M. Tolaney, James M. Cleary, and Geoffrey I. Shapiro, Dana-Farber Cancer Institute; Eunice L. Kwak, Massachusetts General Hospital; Shuchi S. Pandya, Beth Israel Deaconess Medical Center, Boston; Anna Berkenblit and Mizue Krygowski, Aveo Pharmaceuticals; Revathi Ananthakrishnan and Kathleen W. Turnbull, Inventiv Health, Cambridge, MA; Rastislav Bahleda, Antoine Hollebecque, and Jean-Charles Soria, Insitut Gussav Roussy, Villejuif, France; Richat Abbas and Yali Liang, Pfizer,...

family: Gandhi

full_name: Leena Gandhi

given: Leena

family: Bahleda

full_name: Rastislav Bahleda

given: Rastislav

family: Tolaney

full_name: Sara M. Tolaney

given: Sara M.

family: Kwak

full_name: Eunice L. Kwak

given: Eunice L.

family: Cleary

full_name: James M. Cleary

given: James M.

family: Pandya

full_name: Shuchi S. Pandya

given: Shuchi S.

family: Hollebecque

full_name: Antoine Hollebecque

given: Antoine

family: Abbas

full_name: Richat Abbas

given: Richat

family: Ananthakrishnan

full_name: Revathi Ananthakrishnan

given: Revathi

family: Berkenblit

full_name: Anna Berkenblit

given: Anna

family: Krygowski

full_name: Mizue Krygowski

given: Mizue

family: Liang

full_name: Yali Liang

given: Yali

family: Turnbull

full_name: Kathleen W. Turnbull

given: Kathleen W.

family: Shapiro

full_name: Geoffrey I. Shapiro

given: Geoffrey I.

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Phase I Study of Neratinib in Combination With Temsirolimus in Patients With Human Epidermal Growth Factor Receptor 2–Dependent and Other Solid Tumors

lead_sponsor: Puma Biotechnology, Inc.

location_facility:
Institut Gustave Roussy
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana Farber Cancer Institute


title: A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)

summary: The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.

lead_sponsor: Eisai Inc.


title: A Three-period Multicenter Study, With a Randomized-withdrawal, Double-blinded, Placebo-controlled Design in Period 2 to Evaluate the Clinical Efficacy, Safety, and Tolerability of MAS825 in NLRC4-GOF Patients

acronym: MAS NLRC4-GOF

summary: This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF

ipd_sharing: Yes

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:
Italy
France
Japan
Czechia
United States


title: A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)

acronym: TURANDOT II

summary: Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

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

lead_sponsor: Shire

location_country:
Australia
Belgium
Russian Federation
France
Poland
Slovakia
Canada
Korea, Republic of
South Africa
Netherlands
Bulgaria
Hungary
Germany
United States
Italy
Austria
Serbia
Czechia
Israel
New Zealand
Spain

location_facility: Weill Cornell Medical College of Cornell University

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: The Oregon Clinic-West Hills Gastroenterology Associates, P.C.

location_facility: Milan University, Humanitas Clinical Institute

location_facility: Hamilton Health Sciences Corp, McMaster Univ Medical Centre

location_facility: Baylor College Of Medicine - Baylor Medical Center

location_facility: London Health Sciences Centre - University Hospital

location_facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Azienda Ospedaliera Universitaria, Policlinico Tor Vergata

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Clinical Hospital Centre Bezanijska Kosa

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: Medical Research Center of Connecticut, LLC

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)

location_facility: St. Petersburg State Medical Academy for Postgraduate Education

location_facility: Centro Medico Teknon-Institut de la Macula i de la Retina

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Klinika Chorob Wewnetrznych I Gastroenterologii

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica

location_facility: UCSD Altman Clinical and Translational Research Institute

location_facility: Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem

location_facility: University Medical Center Groningen (UMCG)

location_facility: Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica

location_facility: Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.

location_facility: Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1

location_facility: Universita' degli Studi "Magna Graecia" di Catanzaro

location_facility: Hepato-Gastroenterologie HK s.r.o. Poliklinika III

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED


title: Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies

summary: The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

primary_purpose: Prevention

ReferenceCitation: Dagnew AF, Ilhan O, Lee WS, Woszczyk D, Kwak JY, Bowcock S, Sohn SK, Rodriguez Macías G, Chiou TJ, Quiel D, Aoun M, Navarro Matilla MB, de la Serna J, Milliken S, Murphy J, McNeil SA, Salaun B, Di Paolo E, Campora L, López-Fauqued M, El Idrissi M, Schuind A, Heineman TC, Van den Steen P, Oostvogels L; Zoster-039 study group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis. Lancet Infect Dis. 2019 Sep;19(9):988-1000. doi: 10.1016/S1473-3099(19)30163-X. Epub 2019 Aug 6. Erratum in: Lancet Infect Dis. 2020 Jan;20(1):e1.

family: Dagnew

full_name: Alemnew F Dagnew

given: Alemnew F

family: Ilhan

full_name: Osman Ilhan

given: Osman

family: Lee

full_name: Won-Sik Lee

given: Won-Sik

family: Woszczyk

full_name: Dariusz Woszczyk

given: Dariusz

full_name: Jae-Yong Kwak

given: Jae-Yong

family: Bowcock

full_name: Stella Bowcock

given: Stella

family: Sohn

full_name: Sang Kyun Sohn

given: Sang Kyun

family: Rodriguez Macías

full_name: Gabriela Rodriguez Macías

given: Gabriela

family: Chiou

full_name: Tzeon-Jye Chiou

given: Tzeon-Jye

family: Quiel

full_name: Dimas Quiel

given: Dimas

family: Aoun

full_name: Mickael Aoun

given: Mickael

family: Navarro Matilla

full_name: Maria Belen Navarro Matilla

given: Maria Belen

family: de la Serna

full_name: Javier de la Serna

given: Javier

family: Milliken

full_name: Samuel Milliken

given: Samuel

family: Murphy

full_name: John Murphy

given: John

family: McNeil

full_name: Shelly A McNeil

given: Shelly A

family: Salaun

full_name: Bruno Salaun

given: Bruno

family: Di Paolo

full_name: Emmanuel Di Paolo

given: Emmanuel

family: Campora

full_name: Laura Campora

given: Laura

family: López-Fauqued

full_name: Marta López-Fauqued

given: Marta

family: El Idrissi

full_name: Mohamed El Idrissi

given: Mohamed

family: Schuind

full_name: Anne Schuind

given: Anne

family: Heineman

full_name: Thomas C Heineman

given: Thomas C

location_country:
Finland
Belgium
Australia
Russian Federation
Taiwan
Pakistan
France
Panama
Poland
Canada
Korea, Republic of
Sweden
Hong Kong
Singapore
United States
United Kingdom
Italy
Czechia
New Zealand
Spain
Turkey


title: A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or Other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir Plus Emtricitabine/Tenofovir DF or Efavirenz/Emtricitabine/Tenofovir DF) Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults With eGFR ≥70 mL/Min

summary: The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).

lead_sponsor: Gilead Sciences

location_country:
France
Ireland
Belgium
Spain
United Kingdom


title: A Phase Ib Dose-finding Study of BYL719 Plus Everolimus and BYL719 Plus Everolimus Plus Exemestane in Patients With Advanced Solid Tumors, With Dose-expansion Cohorts in Renal Cell Cancer (RCC), Pancreatic Neuroendocrine Tumors (pNETs), and Advanced Breast Cancer (BC) Patients.

summary:
Dose escalation part: to determine the highest dose of alpelisib administered on a daily basis when given in combination with daily everolimus or in combination with daily everolimus and exemestane.

Dose expansion part: To describe safety and tolerability of the alpelisib and everolimus or alpelisib, everolimus and exemestane combinations.

ReferenceCitation: Fankhauser M, Bechmann N, Lauseker M, Goncalves J, Favier J, Klink B, William D, Gieldon L, Maurer J, Spöttl G, Rank P, Knösel T, Orth M, Ziegler CG, Aristizabal Prada ET, Rubinstein G, Fassnacht M, Spitzweg C, Grossman AB, Pacak K, Beuschlein F, Bornstein SR, Eisenhofer G, Auernhammer CJ, Reincke M, Nölting S. Synergistic Highly Potent Targeted Drug Combinations in Different Pheochromocytoma Models Including Human Tumor Cultures. Endocrinology. 2019 Nov 1;160(11):2600-2617. doi: 10.1210/en.2019-00410.

name: Medizinische Klinik und Poliklinik IV, Klinikum der Universität, LMU München, Munich, Germany

family: Fankhauser

full_name: Maria Fankhauser

given: Maria

name: Institute for Clinical Chemistry and Laboratory Medicine, University Hospital Carl Gustav Carus at Technische Universität Dresden, Dresden, Germany

family: Bechmann

full_name: Nicole Bechmann

given: Nicole

name: Institute for Medical Information Sciences, Biometry, and Epidemiology, Campus Grosshadern, Ludwig-Maximilians-University of Munich, Munich, Germany

family: Lauseker

full_name: Michael Lauseker

given: Michael

name: Institut National de la Santé et de la Recherche Médicale, UMR970, Paris-Cardiovascular Research Center, Equipe Labellisée par la Ligue contre le Cancer, Paris, France

name: Université Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Paris, France

name: Université Paris Diderot, Sorbonne Paris Cité, Paris, France

family: Goncalves

full_name: Judith Goncalves

given: Judith

family: Favier

full_name: Judith Favier

name: Institute for Clinical Genetics, Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany

name: National Center of Genetics, Laboratoire National de Santé, Dudelange, Luxembourg

name: German Cancer Consortium, Dresden, Germany

family: Klink

full_name: Barbara Klink

given: Barbara

family: William

full_name: Doreen William

given: Doreen

name: German Cancer Research Center, Heidelberg, Germany

name: Core Unit for Molecular Tumor Diagnostics, National Center for Tumor Diseases, Heidelberg, Germany

family: Gieldon

full_name: Laura Gieldon

family: Maurer

full_name: Julian Maurer

given: Julian

family: Spöttl

full_name: Gerald Spöttl

given: Gerald

family: Rank

full_name: Petra Rank

given: Petra

name: Institute of Pathology, Ludwig-Maximilians-University, Munich, Germany

family: Knösel

full_name: Thomas Knösel

given: Thomas

name: Department of Radiation Oncology, University Hospital, LMU Munich, Munich, Germany

family: Orth

full_name: Michael Orth

name: Department of Medicine III, University Hospital Carl Gustav Carus Dresden, Dresden, Germany

family: Ziegler

full_name: Christian G Ziegler

given: Christian G

family: Aristizabal Prada

full_name: Elke Tatjana Aristizabal Prada

given: Elke Tatjana

family: Rubinstein

full_name: German Rubinstein

given: German

name: Department of Medicine I, Division of Endocrinology and Diabetology, University Hospital, University of Würzburg, Würzburg, Germany

family: Fassnacht

full_name: Martin Fassnacht

given: Martin

family: Spitzweg

full_name: Christine Spitzweg

given: Christine

name: Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, United Kingdom

name: Royal Free Hospital ENETS Centre of Excellence, London, United Kingdom

family: Grossman

full_name: Ashley B Grossman

given: Ashley B

name: Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland

family: Pacak

full_name: Karel Pacak

given: Karel

name: Klinik für Endokrinologie, Diabetologie und Klinische Ernährung, Universitätsspital Zürich, Zurich, Switzerland

family: Beuschlein

full_name: Felix Beuschlein

given: Felix

family: Bornstein

full_name: Stefan R Bornstein

given: Stefan R

family: Eisenhofer

full_name: Graeme Eisenhofer

given: Graeme

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country:
Italy
United States
Hong Kong
Netherlands
France
Hungary
Spain
Germany
United Kingdom

location_facility: Memorial Sloan Kettering Cancer Center SC - BYL719Z2102


lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Netherlands
France
Romania
Australia
Russian Federation
Spain
United States

acronym: MAGNITUDE

location_facility: Hospital Of The University Of Pennsylvania

title: A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin

summary: The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3


title: A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema

acronym: TRANSFORM

summary: To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.

ReferenceCitation: Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hübner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.

name: Royal Brompton Hospital and Imperial College London, London, United Kingdom

name: Sherwood Forest Hospitals, NHS Foundation Trust, Nottinghamshire, United Kingdom

family: Kemp

full_name: Samuel V. Kemp

given: Samuel V.

name: Department of Pulmonary Diseases, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands

family: Slebos

full_name: Dirk-Jan Slebos

given: Dirk-Jan

name: Department of Thoracic Surgery, West of Scotland Regional Heart & Lung Centre, Golden Jubilee National Hospital, West Dunbartonshire, Scotland, United Kingdom

family: Kirk

full_name: Alan Kirk

given: Alan

name: Department of Cardiothoracic Surgery, University Hospital of Wales, Cardiff, United Kingdom

family: Kornaszewska

full_name: Malgorzata Kornaszewska

given: Malgorzata

name: Department of Pulmonology, AZ Delta, Menen, Belgium

family: Carron

full_name: Kris Carron

given: Kris

name: Department of Pulmonary Diseases, Skane University Hospital, Lund, Sweden

family: Ek

full_name: Lars Ek

given: Lars

name: Department of Pulmonary Diseases, Uppsala University Hospital, Uppsala, Sweden

family: Broman

full_name: Gustav Broman

given: Gustav

family: Hillerdal

full_name: Gunnar Hillerdal

given: Gunnar

name: Service de Pneumologie A, Hôpital Bichat, Paris, France

family: Mal

full_name: Herve Mal

given: Herve

name: Clinique Universitaire de Pneumologie, Pôle Thorax et Vaisseaux, CHU Grenoble Alpes, Grenoble, France

family: Pison

full_name: Christophe Pison

given: Christophe

family: Briault

full_name: Amandine Briault

given: Amandine

family: Downer

full_name: Nicola Downer

given: Nicola

name: Department of Interventional Pneumology, Ruhrlandklinik, West German Lung Center, University Clinic Essen, Essen, Germany

family: Darwiche

full_name: Kaid Darwiche

given: Kaid

name: Sheffield Teaching Hospitals, NHS Foundation Trust, Sheffield, United Kingdom

family: Rao

full_name: Jagan Rao

given: Jagan

name: Charité Universitätsmedizin Berlin, Medizinische Klinik m. Schw. Infektiologie und Pneumologie, Campus Virchow, Berlin, Germany

family: Hübner

full_name: Ralf-Harto Hübner

given: Ralf-Harto

family: Ruwwe-Glosenkamp

full_name: Christof Ruwwe-Glosenkamp

given: Christof

name: Service de Pneumologie et Réanimation, Unité d’Endoscopie Bronchique, Groupe Hospitalier Pitié Salpétrière, Paris, France

family: Trosini-Desert

full_name: Valéry Trosini-Desert

given: Valéry

name: Department of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg and Translational Lung Research Center Heidelberg, Heidelberg, Germany

family: Eberhardt

full_name: Ralf Eberhardt

given: Ralf

family: Herth

full_name: Felix J. Herth

given: Felix J.

name: Department of Pulmonary Diseases, Ghent University Hospital, Ghent, Belgium; and

family: Derom

full_name: Eric Derom

given: Eric

family: Malfait

full_name: Thomas Malfait

family: Shah

full_name: Pallav L. Shah

given: Pallav L.

family: Garner

full_name: Justin L. Garner

given: Justin L.

name: Université Côte d’Azur, Centre Hospitalier Universitaire de Nice, FHU OncoAge, Service de Pneumologie, Nice, France

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

location_country:
Sweden
Netherlands
France
Belgium
Germany
United Kingdom

location_facility: West of Scotland Regional Heart & Lung Centre - Golden Jubilee National Hospital

location_facility: The Royal Brompton Hospital & Harefield NHS Foundation Trust

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Thoraxklinik am Universitäts Klinikum Heidelberg


title: A Multicenter, Open-Label, Long-Term Safety Extension of Phase II Studies ABE4869g and ABE4955g in Patients With Mild to Moderate Alzheimer's Disease

summary: This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term safety and tolerability of crenezumab in participants with mild to moderate Alzheimer's disease who have participated in and completed the treatment period of the Phase II Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on study treatment is 144 weeks.

lead_sponsor: Genentech, Inc.

location_country:
United States
France
Spain
Germany
United Kingdom
Canada

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: University of California Davis Medical System

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

location_facility: Great Western Hosp.; Kingshill Research Ctr

location_facility: CHU de Limoges Hopital Dupuytren; Service de Medecine Geriatrique

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: West London Research Unit; Brentford Lodge

location_facility: Florida Atlantic University; College of Medicine

location_facility: University of British Columbia Hospital; Division of Neurology

location_facility: Univ of CA San Diego; Neurosciences Comp.Alzheimer's

location_facility: Hospital de Cruces; Servicio de Neurologia

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Universitätsklinik Tübingen; Psychiatrie und Psychotherapie

location_facility: Zentralinstitut fuer Seelische Gesundheit

location_facility: Investigational Drug Service; Univ of Rochester Medical Ctr

location_facility: Clinical Neuroscience Research Associates, Inc.

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: Royal Sussex County Hospital, CIRU Level 5

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Alzheimers Disease & Memory Disorders Center; Department of Neurology Baylor College of Medicine

location_facility: Litwin Zucker Research Ctr.; Feinstein Inst. Med. Rsch.

location_facility: Memory Enhancement Center of America, Inc.

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: University of Rochester Medical Center; Monroe Community Hospital

location_facility: Clinica Ruber, 4 planta; Servicio de Neurologia

location_facility: Univ Berlin; Klin fur Psychi & Psycho Charite

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: The National Hospital for Neurology & Neurosurgery; Dementia Research Center

location_facility: Miami Jewish Health Systems; Clinical Research

location_facility: University of California Los Angeles (UCLA)

location_facility: Moorgreen Hospital; Memory Assessment & Rsch Ctr


title: Assessment of the Safety and Efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the Treatment of Single de Novo Bifurcation Lesions in Native Coronary Arteries

acronym: BIPAX

summary: The purpose of this trial is to assess the safety and efficacy of the Nile PAX® Drug Eluting Coronary Bifurcation Stent System for the treatment of single de novo bifurcation lesions in native coronary arteries with a main branch reference vessel diameter of 2.5-3.5 mm and side branch reference vessel diameter of 2.0-3.0 mm.

lead_sponsor: MINVASYS

location_country: Italy Brazil Netherlands France Bulgaria Poland Spain

location_facility: Karol Marcinkowski University of Medical Sciences

location_facility: Instituto Dante Pazzanese de Cardiologia


title: Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex)

acronym: POINT X

summary: This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).

ReferenceCitation: Warwick D, Arner M, Pajardi G, Reichert B, Szabo Z, Masmejean EH, Fores J, Chapman DS, Gerber RA, Huard F, Seghouani A, Szczypa PP; POINT X Investigators. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol. 2015 Feb;40(2):124-32. doi: 10.1177/1753193413519926. Epub 2014 Jan 26.

name: National Institute of Health Research Wellcome Trust Clinical Research Facility, University Hospital Southampton, NHS Foundation Trust, UK

family: Warwick

full_name: D. Warwick

given: D.

name: Department of Hand Surgery Södersjukhuset and Department of Clinical Science & Education, Karolinska Institutet, Stockholm, Sweden

family: Arner

full_name: M. Arner

given: M.

name: San Giuseppe MultiMedica University Hospital and Università degli Studi di Milano, Milan, Italy

family: Pajardi

full_name: G. Pajardi

given: G.

name: Department for Plastic, Reconstructive & Hand Surgery, Nuremberg Hospital, Nuremberg, Germany

family: Reichert

full_name: B. Reichert

given: B.

name: Traumatology & Hand Surgery Department, BAZ University County Teaching Hospital, Miskolc, Hungary

family: Szabo

full_name: Z. Szabo

given: Z.

name: Hand Surgery Unit, Georges-Pompidou European Hospital (HEGP), Assistance Publique-Hôpitaux de Paris (AP-HP), Paris-Descartes University, Sorbonne Paris Cité, Paris Cedex, France

family: Masmejean

full_name: E. H. Masmejean

given: E. H.

name: Traumatología y Cirugía Ortopédica, Barcelona, Spain

family: Fores

full_name: J. Fores

given: J.

name: Specialty Care Biostatistics, Pfizer Inc, New York, NY, USA

family: Chapman

full_name: D. S. Chapman

given: D. S.

name: Medicines Development Group, Pfizer Inc, Groton, CT, USA

family: Gerber

full_name: R. A. Gerber

given: R. A.

name: Pfizer Global Research and Development, Paris, France

family: Huard

full_name: F. Huard

given: F.

family: Seghouani

full_name: A. Seghouani

given: A.

name: Medical Affairs, Pfizer Ltd, Tadworth Surrey, UK

family: Szczypa

full_name: P. P. Szczypa

given: P. P.

journal_name: Journal of Hand Surgery (European Volume)

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

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: Collagenase clostridium histolyticum in patients with Dupuytren’s contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes

lead_sponsor: Pfizer

location_country:
Italy
Sweden
France
Hungary
Spain
Denmark
Germany
United Kingdom


title: Multicentre Paediatric Disease Registry in Essential Thrombocythaemia

summary: The aim of this study is to evaluate the progression of ET in children (aged 6-17years inclusive) over a period of 5 years maximum. The study will also assess how children are diagnosed, treatment options for those children with symptoms and events related to their ET and the outcomes of those treatments.

location_country:
Italy
Switzerland
France
Czechia
Greece
Spain
Germany
United Kingdom

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Hospital Universitario Virgen de la Arrixac

location_facility: Chairmen of Pediatric Hamatooncology Outpatient Clinic. Hospital San Gerardo

location_facility: Paediatric Clinic University Hospital Olomouc

location_facility: Centre Hospitalier Lyon Sud - service Hématologie

location_facility: Department of Cellular Biotechnologies and Hematology. Sapienza University

location_facility: Hamatology Unit. Paediatric Department. University of Torino

location_facility: Servicio de Transfusión, Hospital Universitario Niño Jesús

location_facility: Department of Oncology, Pausilipon Hospital, AORN Santobono

location_facility: Klinikum Chemnitz GmbH, Klinik für Kinder-und Jugendmedizin

location_facility: Practicen Hospitalier , Institute d'Hematologie et Oncologie Pediatrique

location_facility: Zentrum für Kinder- und Jugendmedizin Klinik II / III

location_facility: Leitender Arzt, Pädiatrische Hämatologie/Onkologie Kinderspital

location_facility: Complexo Hospitalario Universitario, Santiago

location_facility: Jefe de Servicio Oncología Y Hematología Pediátricas

location_facility: Clinic of Paediatric haematology and oncology University Hospital Motol

location_facility: Children's Clinic, Royal Berkshire Hospital

location_facility: Dipartimento di Biomedicina dell'Eta Evolutiva. University of Bari

location_facility: Paediatric Oncology Unit, Hopital Cote De Nacre

location_facility: Pediatric Hamatology Unit. Department of Hematology and Oncology. G Gaslini Children's hospital. Largo

location_facility: Department Haematology, Hospital Ramon y Caja

location_facility: Sección de Hematología Pediátrica. Hospital de la Santa Creu i Sant Pau

location_facility: Servicio de Hematología Clínica, Hospital Sant Joan de Déu Barcelona


lead_sponsor: H. Lundbeck A/S

location_country:
Italy
Hong Kong
France
Poland
Thailand
Belgium
Germany
Taiwan

title: A Randomised, Double-blind, Parallel-Group, Fixed Dose Study Exploring the Efficacy and Safety of Lu AE58054 as Augmentation Therapy to Risperidone in Patients With Schizophrenia

summary: The objective of this study is to explore the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia.


title: Phase II Study of GW786034 in Patients With Relapsed or Refractory Soft Tissue Sarcoma

summary: The purpose of this study is to evaluate the activity and tolerability of pazopanib in subjects with advanced and/or metastatic soft tissue sarcoma who have relapsed following standard therapies or for whom no standard therapy exists and to characterize the pharmacokinetics of pazopanib in this subject population.

ReferenceCitation: Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schöffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY. Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: a phase II study from the European organisation for research and treatment of cancer-soft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol. 2009 Jul 1;27(19):3126-32. doi: 10.1200/JCO.2008.21.3223. Epub 2009 May 18.

ReferenceCitation: Sleijfer S, Gorlia T, Lamers C, Burger H, Blay JY, Le Cesne A, Scurr M, Collin F, Pandite L, Marreaud S, Hohenberger P. Cytokine and angiogenic factors associated with efficacy and toxicity of pazopanib in advanced soft-tissue sarcoma: an EORTC-STBSG study. Br J Cancer. 2012 Aug 7;107(4):639-45. doi: 10.1038/bjc.2012.328. Epub 2012 Jul 17.

ReferenceCitation: Kasper B, Sleijfer S, Litière S, Marreaud S, Verweij J, Hodge RA, Bauer S, Kerst JM, van der Graaf WTA. Long-term responders and survivors on pazopanib for advanced soft tissue sarcomas: subanalysis of two European Organisation for Research and Treatment of Cancer (EORTC) clinical trials 62043 and 62072. Ann Oncol. 2014 Mar;25(3):719-724. doi: 10.1093/annonc/mdt586. Epub 2014 Feb 6.

family: Kasper

full_name: B. Kasper

family: Sleijfer

full_name: S. Sleijfer

given: S.

family: Litière

full_name: S. Litière

family: Marreaud

full_name: S. Marreaud

family: Verweij

full_name: J. Verweij

family: Hodge

full_name: R.A. Hodge

family: Bauer

full_name: S. Bauer

family: Kerst

full_name: J.M. Kerst

family: van der Graaf

full_name: W.T.A. van der Graaf

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: GlaxoSmithKline

location_country:
Netherlands
France
Hungary
Belgium
United Kingdom


title: Open Label Phase II Study On STI571 (Glivec) Administered As A Daily Oral Treatment In Gliomas

summary:
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and slow the growth of the tumor.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have gliomas.

ReferenceCitation: Raymond E, Brandes AA, Dittrich C, Fumoleau P, Coudert B, Clement PM, Frenay M, Rampling R, Stupp R, Kros JM, Heinrich MC, Gorlia T, Lacombe D, van den Bent MJ; European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. Phase II study of imatinib in patients with recurrent gliomas of various histologies: a European Organisation for Research and Treatment of Cancer Brain Tumor Group Study. J Clin Oncol. 2008 Oct 1;26(28):4659-65. doi: 10.1200/JCO.2008.16.9235.

name: From the Service Inter Hospitalier de Cancérologie, Beaujon University Hospital, Clichy; Centre Georges-François Leclerc, Dijon; Antoine Lacassagne Center, Nice, France; Bellaria and Maggiore Hospitals, Azienda Unità Sanitaria Locale of Bologna, Bologna, Italy; Applied Cancer Research-Institute for Translational Research; Ludwig Boltzmann-Institute for Applied Cancer Reearch; Kaiser Franz Josef Spital, Vienna, Austria; Leuven Cancer Institute, University Hospital Leuven, Leuven; European Organisation for...

family: Raymond

full_name: Eric Raymond

family: Brandes

full_name: Alba A. Brandes

given: Alba A.

family: Dittrich

full_name: Christian Dittrich

given: Christian

family: Fumoleau

full_name: Pierre Fumoleau

given: Pierre

family: Coudert

full_name: Bruno Coudert

given: Bruno

family: Clement

full_name: Paul M.J. Clement

given: Paul M.J.

family: Frenay

full_name: Marc Frenay

given: Marc

family: Rampling

full_name: Roy Rampling

given: Roy

family: Stupp

full_name: Roger Stupp

given: Roger

family: Kros

full_name: Johan M. Kros

given: Johan M.

family: Heinrich

full_name: Michael C. Heinrich

given: Michael C.

family: Gorlia

full_name: Thierry Gorlia

given: Thierry

family: Lacombe

full_name: Denis Lacombe

given: Denis

family: van den Bent

full_name: Martin J. van den Bent

given: Martin J.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Phase II Study of Imatinib in Patients With Recurrent Gliomas of Various Histologies: A European Organisation for Research and Treatment of Cancer Brain Tumor Group Study

ReferenceCitation: Raymond E, Brandes A, Van Oosterom A, et al.: Multicentre phase II study of imatinib mesylate in patients with recurrent glioblastoma: an EORTC: NDDG/BTG Intergroup study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1501, 2004.

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

location_country:
Italy
Austria
Switzerland
Netherlands
France
Belgium
United Kingdom

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center


title: An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

summary: The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Austria
Sweden
France
Poland
Spain
Germany
United Kingdom

location_facility: Ospedale Niguarda-Ca Granda, Dept. of Internal Medicine Padiglione Brera

location_facility: Hospital Doce de Octubre, Servicio de Microbiologia Y Enfermadades Infecciosas

location_facility: Johann Wolfgang Goethe Universitat, Medizinische Klinik III

location_facility: Hospital Gregorio Maranon, Servicio de Enfermadades Infecciosas

location_facility: Hopital Necker Enfants Malades, Service d"Hematologie

location_facility: LMU Munchen, Hamatopoetische Zell - Transplantation

location_facility: Universitat Wurzburg, Institut fur Molekulare und Infectionsbiologie

location_facility: Uniklinik Mainz, III. Medizinische Klinik

location_facility: Hopital Saint Louis, Service D'Hematologie/Greffe de Moelle

location_facility: Royal Free Hospital, Dept. of Haematological Oncology

location_facility: Hopital Henri Mondor, Dervice d'Hematologie Clinique

location_facility: Institute of Haematology and Blood Transfusion

location_facility: Huddinge University Hospital, Dept. of Transplantation Surgery/Immunology

location_facility: Klinikum der Stadt, Medizinische Klinik A

location_facility: Hospital Clinic I Provencial, Servicio Enfermadades Infecciosas

location_facility: Medizinische Klinik und Poliklinik II, Abt. Hamatologie und Onkologie


title: An Open-Label, Non-Comparative Study of FK463 for the Treatment of Invasive Aspergillosis

summary: The purpose of the study is to evaluate the safety and efficacy of FK463 in patients with proven or probable invasive infections due to Aspergillus species.

ReferenceCitation: Denning DW, Marr KA, Lau WM, Facklam DP, Ratanatharathorn V, Becker C, Ullmann AJ, Seibel NL, Flynn PM, van Burik JA, Buell DN, Patterson TF. Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. J Infect. 2006 Nov;53(5):337-49. Epub 2006 May 6.

ReferenceCitation: Kontoyiannis DP, Ratanatharathorn V, Young JA, Raymond J, Laverdière M, Denning DW, Patterson TF, Facklam D, Kovanda L, Arnold L, Lau W, Buell D, Marr KA. Micafungin alone or in combination with other systemic antifungal therapies in hematopoietic stem cell transplant recipients with invasive aspergillosis. Transpl Infect Dis. 2009 Feb;11(1):89-93. doi: 10.1111/j.1399-3062.2008.00349.x. Epub 2008 Oct 8.

family: Kontoyiannis

full_name: D.P. Kontoyiannis

family: Ratanatharathorn

full_name: V. Ratanatharathorn

given: V.

family: Young

full_name: J.-A. Young

full_name: J. Raymond

given: J.

family: Laverdière

full_name: M. Laverdière

given: M.

family: Denning

full_name: D.W. Denning

family: Patterson

full_name: T.F. Patterson

family: Facklam

full_name: D. Facklam

given: D.

family: Kovanda

full_name: L. Kovanda

given: L.

family: Arnold

full_name: L. Arnold

family: Lau

full_name: W. Lau

given: W.

family: Buell

full_name: D. Buell

family: Marr

full_name: K.A. Marr

journal_name: Transplant Infectious Disease

location_facility: Hopital Necker Enfants Malades, Service d'Hematologie

location_facility: Hospital Clinic I provencial, Servicio Enfermadades Infecciosas

location_facility: Hospital Doce de Octubre, Servicio de Microbiologia y Enfermadades Infecciosas

location_facility: Hopital Henri Mondor, Service d'Hematologie Clinique


title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

summary: The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

primary_purpose: Other

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
United States
Netherlands
Spain
France
Japan
Poland
Portugal
Germany
Taiwan

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Centre for Rheumatology, Immunology and Arthritis

location_facility: REUMED Zespol Poradni Specjalistycznych Filia nr 2

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'

location_facility: Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

intervention_type: Other


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

summary: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

study_start_date_type: Anticipated

status: Not yet recruiting

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
United States
Netherlands
Spain
Germany
France
Japan
Poland
Argentina
Australia
Russian Federation
China
Turkey
Denmark
Canada
Korea, Republic of
Taiwan

location_facility: Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico

location_facility: Research Center of Neurology; Neurology Department #5

location_facility: University of California Irvine - Manchester Pavilion

location_facility: University at Buffalo / SUNY; UBMD Neurology

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Tianjin Medical University General Hospital

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: International University of Health and Welfare Narita Hospital; Neurology

location_facility: Pusan National University Yangsan Hospital

location_facility: Beijing Tiantan Hospital,Capital Medical University

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

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: St. Josef-Hospital, Klinik für Neurologie

location_facility: Box Hill Hospital; Department of Neurology

location_facility: A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: Washington University School of Medicine; Department of Neurology

location_facility: Nagasaki Kawatana Medical Center; Neurology

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

location_facility: The First Hospital of Shanxi Medical University

location_facility: Tokyo Women's Medical University Hospital; Neurology

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Universitätsklinikum Essen (AöR); Klinik für Neurologie

location_facility: Ohio State University Wexner Medical Center

location_facility: Klinika Neurologii Dorosłych, Uniwersyteckie Centrum Kliniczne

location_facility: A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit

location_facility: The First Affiliated Hospital Of Shandong First Medical University

location_facility: Clinica Universitaria Navarra; Servicio Neurologia

location_facility: University of Florida Jacksonville Physicians Inc. (UFJPI)

location_facility: Tokyo Medical And Dental University, Medical Hospital; Neurology

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Osaka Toneyama Medical Center; Neurology

location_facility: Xuanwu Hospital, Capital Medical University

location_facility: Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie

location_facility: Hospital de Donostia Unidad Demencias; Consultas de Neurología

location_facility: Hopital Timone Adultes; Neurologie Mal Neuro Musculaires

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Sapporo Medical University Hospital; Neurology

location_facility: Aarhus Universitetshospital; Neurologisk Klinik

location_facility: Taipei Veterans General Hospital-Neurology

location_facility: West China Hospital - Sichuan University

location_facility: Dokkyo Medical University Saitama Medical Center; Neurology

location_facility: University of Iowa Hospitals & Clinics; Department of Neurology

location_facility: National Center of Social Significant Disease

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Kyungpook National University Chilgok Hospital

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Hospital Universitario Infanta Sofia; Servicio de Neurologia

location_facility: CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE

location_facility: St. Marianna University School of Medicine Hospital

location_facility: Novosibirsk State Regional Clinical Hospital

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie

location_facility: MUCH - Montreal Neurological Institute & Hospital

location_facility: Xiangya Hospital Central South University

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Neurologia

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Samara Regional Clinical Hospital named after V.D. Seredavina


title: A Randomized Phase 3 Double-Blinded Study Comparing the Efficacy and Safety of Niraparib to Placebo in Participants With Either HER2-Negative BRCA-Mutated or Triple-Negative Breast Cancer With Molecular Disease Based on Presence of Circulating Tumor DNA After Definitive Therapy (ZEST)

acronym: ZEST

summary: This is a multicenter, multi-cohort, phase 3, double-blinded, placebo-controlled study to assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy. Participants who have completed definitive therapy at any time in the past are eligible for ctDNA monitoring and potential enrollment onto the trial.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Italy
Brazil
United States
South Africa
Netherlands
Finland
France
Japan
Poland
Norway
Ireland
Argentina
Russian Federation
Spain
Canada
United Kingdom


title: LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC

summary: The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

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

lead_sponsor: Loxo Oncology, Inc.

location_country:
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Singapore
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Sotiria Thoracic Diseases Hospital of Athens

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: COT - Centro Oncológico do Triângulo S.A.

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II

location_facility: Beijing Peking Union Medical College Hospital

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

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

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Stockton Hematology Oncology Medical Group

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Grupo COI - Clínicas Oncológicas Integradas

location_facility: Tang Du Hospital, The Second Teaching Hospital of FMMU

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Wojewodzki Zespol Specjalistyczny Chorob Pluc

location_facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

location_facility: University clinic of Sumy State University

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Klinik Floridsdorf - Abteilung für INNERE MEDIZIN UND PNEUMOLOGIE

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: City Hospital, Nottingham University Hospitals

location_facility: Rashtrasant Tukdoji Regional Cancer Hospital and Research Centre (RSTRCH)

location_facility: National medical research center of oncology n. a. N. N. Petrov

location_facility: Izmir Katip Celebi University Training and Research Hospital Oncology

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Xiangya Hospital, Central South University

location_facility: Seoul National University Bundang Hospital

location_facility: Pan American Center for Oncology Trials, LLC

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: National Taiwan University Cancer Centre

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

location_facility: Charité-Campus Benjamin Franklin-Hematology and Oncology

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Southern Medical University Nanfang Hospital

location_facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

location_facility: Ballarat Health Services - Base Hospital

location_facility: Harbin Medical University Cancer Hospital

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Inonu University Medical Faculty Oncology

location_facility: Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: University General Hospital of Heraklion

location_facility: Universitair Medisch Centrum St Radboud Nijmegen

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch


title: A 2-year Extension Study to Evaluate Long-term Effectiveness of Mavenclad® in Participants Who Have Completed Trial MS700568_0022 (MAGNIFY MS) (Magnify MS Extension)

summary: The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).

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

location_country:
Italy
Austria
Sweden
Germany
Finland
France
Czechia
Poland
Israel
Hungary
Australia
Spain
Canada
United Kingdom

location_facility: IRCSS Neuromed Istituto Neurologico Mediterraneo

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo

location_facility: Children's Hospital, London Health Sciences Centre- Pediatrics

location_facility: Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach

location_facility: CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie

location_facility: Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 7 SUM

location_facility: Akademiskt Specialist Centrum - Centrum för Neurologi,

location_facility: Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"

location_facility: Hospital Universitario Puerta de Hierro Majadahonda


title: A Phase II, Open-label, Single-arm Study of Berzosertib (M6620) in Combination With Topotecan in Participants With Relapsed Platinum-resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

summary: The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
Spain
France
Japan
Belgium
China
United States

location_facility: CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie

location_facility: Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil - Service de Pneumologie

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

location_facility: Institut Jules Bordet - Department of Institut Jules Bordet

location_facility: Osaka Medical and Pharmaceutical University Hospital

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

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology

location_facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie


lead_sponsor: MEI Pharma, Inc.

location_country:
Italy
Netherlands
France
Japan
Poland
Hungary
Belgium
Spain
United States
Korea, Republic of
Taiwan

acronym: The COASTAL Study

location_facility: CHU de Bordeaux - Maladies Du Sang, Centre François Magendie

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: U.O. Ematologia - Azienda Ospedaliero-Universitaria Careggi

location_facility: National University Corporation Tohoku University Hospital

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Kobe City Medical Center General Hospital

location_facility: UO di Ematologia "L.e A.Seragnoli" Policlinico Sant'Orsola Malpighi

location_facility: Centre Henri Becquerel, Service d'Hematologie

location_facility: UO Ematologia, Ospedale Civile S.Maria delle Croci

location_facility: Mercy Clinic Cancer & Hematology - Chub O'Reilly Cancer Center

location_facility: UO Ematologia 1 Azienda ULSS 3 Serenissima, Distertto del veneziano - Ospedale dell'Angelo di Mestre

location_facility: Centre Hospitalier De Dunkerque - Service d'hématologie

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: The Oncology Institute of Hope and Innovation

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: UO Ematologia, Ospedale Infermi di Rimini AUSL Romagna

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

ipd_sharing: No

title: A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME- 401) in Combination With Rituximab Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non Hodgkin's Lymphoma (iNHL) - The COASTAL Study

summary: This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.


title: A Three-arm, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Two Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) Who Have Refractory Partial-onset Seizures

summary:
This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures.

The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week 18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had completed the core phase] and Post Extension phase [from end of Extension phase to end of study].

ReferenceCitation: Curatolo P, Franz DN, Lawson JA, Yapici Z, Ikeda H, Polster T, Nabbout R, de Vries PJ, Dlugos DJ, Fan J, Ridolfi A, Pelov D, Voi M, French JA. Adjunctive everolimus for children and adolescents with treatment-refractory seizures associated with tuberous sclerosis complex: post-hoc analysis of the phase 3 EXIST-3 trial. Lancet Child Adolesc Health. 2018 Jul;2(7):495-504. doi: 10.1016/S2352-4642(18)30099-3. Epub 2018 May 24.

family: Curatolo

full_name: Paolo Curatolo

given: Paolo

family: Franz

full_name: David N Franz

given: David N

family: Lawson

full_name: John A Lawson

given: John A

family: Yapici

full_name: Zuhal Yapici

given: Zuhal

family: Ikeda

full_name: Hiroko Ikeda

given: Hiroko

family: Polster

full_name: Tilman Polster

given: Tilman

family: Nabbout

full_name: Rima Nabbout

given: Rima

family: de Vries

full_name: Petrus J de Vries

given: Petrus J

family: Dlugos

full_name: Dennis J Dlugos

given: Dennis J

family: Fan

full_name: Jenna Fan

given: Jenna

family: Ridolfi

full_name: Antonia Ridolfi

given: Antonia

family: Pelov

full_name: Diana Pelov

given: Diana

family: Voi

full_name: Maurizio Voi

given: Maurizio

family: French

full_name: Jacqueline A French

given: Jacqueline A

journal_name: The Lancet Child & Adolescent Health

ReferenceCitation: French JA, Lawson JA, Yapici Z, Ikeda H, Polster T, Nabbout R, Curatolo P, de Vries PJ, Dlugos DJ, Berkowitz N, Voi M, Peyrard S, Pelov D, Franz DN. Adjunctive everolimus therapy for treatment-resistant focal-onset seizures associated with tuberous sclerosis (EXIST-3): a phase 3, randomised, double-blind, placebo-controlled study. Lancet. 2016 Oct 29;388(10056):2153-2163. doi: 10.1016/S0140-6736(16)31419-2. Epub 2016 Sep 6.

ReferenceCitation: Goyer I, Dahdah N, Major P. Use of mTOR inhibitor everolimus in three neonates for treatment of tumors associated with tuberous sclerosis complex. Pediatr Neurol. 2015 Apr;52(4):450-3. doi: 10.1016/j.pediatrneurol.2015.01.004. Epub 2015 Jan 14.

title: Use of mTOR Inhibitor Everolimus in Three Neonates for Treatment of Tumors Associated With Tuberous Sclerosis Complex

location_country:
Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
Netherlands
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Mexico
Spain
Turkey

location_facility: Washington University School of Medicine SC-2

location_facility: Cincinnati Children's Hospital Medical Center SC

location_facility: University of California at Los Angeles SC

location_facility: Oregon Health and Science University SC - 3

location_facility: The University of Texas Medical School-Houston SC

location_facility: Texas Scottish Rite Hospital for Children Texas Scottish