title: A 12-month Prospective, Randomized, Interventional, Global, Multi-center, Activecontrolled Study Comparing Sustained Benefit of Two Treatment Paradigms (Erenumab qm vs. Oral Prophylactics) in Adult Episodic Migraine Patients

summary: The primary objective is to demonstrate the superiority of subcutaneous erenumab compared to oral prophylactic(s) on sustained benefit defined as % subjects completing one-year on the randomized treatment and achieving at least a 50% reduction from baseline in monthly migraine days at month 12.

ipd_sharing_description:
Data sharing for this study is the responsibility of Novartis. 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: Amgen

location_country:
Italy
Austria
Netherlands
Spain
Germany
Finland
France
Czechia
Greece
Israel
Poland
Slovakia
Ireland
Argentina
Belgium
Portugal
United States
United Kingdom

location_facility: Navy Hospital of Athens "NNA" Main Centre

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: University Hospital of North Midlands NHS Trust

location_facility: Aeginition Hospital of Athens, University of Athens

location_facility: Centro Hospitalar do Porto Hospital Geral de Santo Antonio Serviço de Neurologia

location_facility: Hopital Lariboisiere Centre d Urgence des Cephalees

location_facility: New England Regional Headache Center, Inc

location_facility: Policl.Universit.Campus Bio-Medico Università Campus Bio-Med U.O.C.Area di Oncologia Medica

location_facility: A O Perugia Osp S Maria Misericordia Loc S Andrea d Fratte

location_facility: 401 Army General Hospital of Athens Main Centre

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Neurologische Gemeinschaftspraxis Klemt & Bauersachs

location_facility: ASST degli Spedali Civili di Brescia Univ degli Studi

location_facility: Azienda Ospedaliera Sant'Andrea - Università La Sapienza

location_facility: Euromedica General Clinic of Thessaloniki Neurology Dept

location_facility: General Hospital of Patra O AGIOS ANDREAS Neurology Clinic

location_facility: Ordensklinikum Linz Barmherzigen Schwestern

location_facility: Neurologicka a algeziologicka ambulancia SANERA s r o

location_facility: Canisius Wilhelmina Hospital Dept of Neurology C-70

location_facility: Neurologische Gemeinschaftpraxis im Bienenkorbhaus

location_facility: Texas Institute for Neurological Disorders

location_facility: Jessa Ziekenhuis- Campus Virga Jesse Dienst Gastro-entrologie

location_facility: Hull and amp East Yorkshire Hospitals NHS Trust

location_facility: New England Institute for Neurology and Headache

location_facility: IDIM Instituto de Investigaciones Metabolicas

location_facility: Tel Aviv Sourasky Medical Center Ichilov

location_facility: Hopital Charles Nicolle Departement de Neurologie

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hospital Clinico Universitario Lozano Blesa


title: A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

summary: This is a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Undecided

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:
United States
Netherlands
Germany
France
Czechia
Japan
Poland
Slovakia
Hungary
Belgium
Argentina
Russian Federation
Spain
Turkey
Denmark
Canada
United Kingdom

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)

summary: This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).

ReferenceType: background

ReferenceCitation: Wine JJ. Cystic fibrosis: How do CFTR mutations cause cystic fibrosis? Curr Biol. 1995 Dec 1;5(12):1357-9. Review.

ReferenceCitation: Lewis PA. The epidemiology of cystic fibrosis. In: Hodson ME, Geddes DM. Cystic Fibrosis 2nd edition, Arnold, London 2000; 1a: 2-12.

ReferenceCitation: Dodge JA, Morison S, Lewis PA, Coles EC, Geddes D, Russell G, Littlewood JM, Scott MT. Incidence, population, and survival of cystic fibrosis in the UK, 1968-95. UK Cystic Fibrosis Survey Management Committee. Arch Dis Child. 1997 Dec;77(6):493-6.

ReferenceCitation: Lucotte G, Hazout S, De Braekeleer M. Complete map of cystic fibrosis mutation DF508 frequencies in Western Europe and correlation between mutation frequencies and incidence of disease. Hum Biol. 1995 Oct;67(5):797-803.

ReferenceCitation: Bossi A, Battistini F, Braggion C, Magno EC, Cosimi A, de Candussio G, Gagliardini R, Giglio L, Giunta A, Grzincich GL, La Rosa M, Lombardo M, Lucidi V, Manca A, Mastella G, Moretti P, Padoan R, Pardo F, Quattrucci S, Raia V, Romano L, Salvatore D, Taccetti G, Zanda M. [Italian Cystic Fibrosis Registry: 10 years of activity]. Epidemiol Prev. 1999 Jan-Mar;23(1):5-16. Italian.

ReferenceCitation: Yamashiro Y, Shimizu T, Oguchi S, Shioya T, Nagata S, Ohtsuka Y. The estimated incidence of cystic fibrosis in Japan. J Pediatr Gastroenterol Nutr. 1997 May;24(5):544-7.

ReferenceCitation: Imaizumi Y. Incidence and mortality rates of cystic fibrosis in Japan, 1969-1992. Am J Med Genet. 1995 Aug 28;58(2):161-8.

ReferenceCitation: Boat TF, Welsh MJ, Beaudet AL. Cystic fibrosis, in the metabolic basis of inherited disease (7th edn). McGraw-Hill, New York,1995.

ReferenceCitation: Wood RE, Boat TF, Doershuk CF. Cystic fibrosis. Am Rev Respir Dis. 1976 Jun;113(6):833-78. Review.

ReferenceCitation: Rommens JM, Iannuzzi MC, Kerem B, Drumm ML, Melmer G, Dean M, Rozmahel R, Cole JL, Kennedy D, Hidaka N, et al. Identification of the cystic fibrosis gene: chromosome walking and jumping. Science. 1989 Sep 8;245(4922):1059-65.

ReferenceCitation: Riordan JR, Rommens JM, Kerem B, Alon N, Rozmahel R, Grzelczak Z, Zielenski J, Lok S, Plavsic N, Chou JL, et al. Identification of the cystic fibrosis gene: cloning and characterization of complementary DNA. Science. 1989 Sep 8;245(4922):1066-73. Erratum in: Science 1989 Sep 29;245(4925):1437.

ReferenceCitation: Anderson MP, Gregory RJ, Thompson S, Souza DW, Paul S, Mulligan RC, Smith AE, Welsh MJ. Demonstration that CFTR is a chloride channel by alteration of its anion selectivity. Science. 1991 Jul 12;253(5016):202-5.

ReferenceCitation: Trapnell BC, Chu CS, Paakko PK, Banks TC, Yoshimura K, Ferrans VJ, Chernick MS, Crystal RG. Expression of the cystic fibrosis transmembrane conductance regulator gene in the respiratory tract of normal individuals and individuals with cystic fibrosis. Proc Natl Acad Sci U S A. 1991 Aug 1;88(15):6565-9.

ReferenceCitation: Høiby N. Microbiology of lung infections in cystic fibrosis patients. Acta Paediatr Scand 1982; 301: 33-54.

ReferenceCitation: Moss RB, Babin S, Hsu YP, Blessing-Moore J, Lewiston NJ. Allergy to semisynthetic penicillins in cystic fibrosis. J Pediatr. 1984 Mar;104(3):460-6.

ReferenceCitation: Hodson ME, Gallagher CG, Govan JR. A randomised clinical trial of nebulised tobramycin or colistin in cystic fibrosis. Eur Respir J. 2002 Sep;20(3):658-64.

ReferenceCitation: Ramsey BW, Dorkin HL, Eisenberg JD, Gibson RL, Harwood IR, Kravitz RM, Schidlow DV, Wilmott RW, Astley SJ, McBurnie MA, et al. Efficacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med. 1993 Jun 17;328(24):1740-6.

ReferenceCitation: Ramsey BW, Pepe MS, Quan JM, Otto KL, Montgomery AB, Williams-Warren J, Vasiljev-K M, Borowitz D, Bowman CM, Marshall BC, Marshall S, Smith AL. Intermittent administration of inhaled tobramycin in patients with cystic fibrosis. Cystic Fibrosis Inhaled Tobramycin Study Group. N Engl J Med. 1999 Jan 7;340(1):23-30.

ReferenceCitation: Gilligan PH. Microbiology of airway disease in patients with cystic fibrosis. Clin Microbiol Rev. 1991 Jan;4(1):35-51. Review.

ReferenceCitation: Ramsey BW, Schaeffler BL, Montgomery AB, et al. Survival and lung function during two years of treatment with intermittent tobramycin solution for inhalation in CF patients. Presented at European Cystic Fibrosis Conference (June 1999), The Hague, The Netherlands.

ReferenceCitation: Van Dalfsen JM, Lin L, Burns JL, et al. Microbiology effect of 18 months of intermittent inhaled tobramycin in patients with CF. Presented at European Cystic Fibrosis Conference (June 1999), The Hague, The Netherlands.

ReferenceCitation: Lenoir G, Aryayev N, et al. Highly concentrated aerosolized Tobramycin in the treatment of patients with cystic fibrosis and Pseudomonas aeruginosa infection. Eur. Respir. J 2005:26 (suppl. 49) 620s.

ReferenceCitation: Chuchalin A, Gyurkovics K, et al. Long term administration of aerosolised tobramycin, in patients with cystic fibrosis. Eur. Respir. J.2005: 26 (suppl 49) 3942s.

ReferenceCitation: Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. Review.

ReferenceCitation: Pin I, Gibson PG, Kolendowicz R, Girgis-Gabardo A, Denburg JA, Hargreave FE, Dolovich J. Use of induced sputum cell counts to investigate airway inflammation in asthma. Thorax. 1992 Jan;47(1):25-9.

ReferenceCitation: Henry DA, Campbell ME, LiPuma JJ, Speert DP. Identification of Burkholderia cepacia isolates from patients with cystic fibrosis and use of a simple new selective medium. J Clin Microbiol. 1997 Mar;35(3):614-9. Erratum in: J Clin Microbiol 1999 Apr;37(4):1237.

ReferenceCitation: Bauernfeind A, Rotter K, Weisslein-Pfister C. Selective procedure to isolate haemophilus influenzae from sputa with large quantities of Pseudomonas aeruginosa. Infection. 1987 Jul-Aug;15(4):278-80.

ReferenceCitation: Johansen HK, Høiby N. Seasonal onset of initial colonisation and chronic infection with Pseudomonas aeruginosa in patients with cystic fibrosis in Denmark. Thorax. 1992 Feb;47(2):109-11.

ReferenceType: result

ReferenceCitation: Mazurek H, Chiron R, Kucerova T, Geidel C, Bolbas K, Chuchalin A, Blanco-Aparicio M, Santoro D, Varoli G, Zibellini M, Cicirello HG, Antipkin YG. Long-term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis. Pediatr Pulmonol. 2014 Nov;49(11):1076-89. doi: 10.1002/ppul.22989. Epub 2014 Jan 24.

name: Instytut Gruźlicy i Chorób Pluc; Oddzial Terenowy im. Jana i Ireny Rudników w Rabce-Zdrój; Klinika Pneumonologii i Mukowiscydozy; Rabka-Zdrój Poland

family: Mazurek

full_name: Henryk Mazurek

given: Henryk

sequence: first

name: Hôpital Arnaud de Villeneuve; Centre des Maladies Respiratoires; Montpellier France

family: Chiron

full_name: Raphaël Chiron

given: Raphaël

sequence: additional

name: Centrum Pro Cystickou Fibrosu; Pediatricka Klinika; Fakultní nemocnice v Motole; Praha Czech Republic

family: Kucerova

full_name: Tereza Kucerova

given: Tereza

name: Justus-Liebig Universität Gießen; Pädiatrische Pneumologie und Allergologie; Mukovizidose-Zentrum; Zentrum für Kinderheilkunde und Jugendmedizin; Gießen Germany

family: Geidel

full_name: Christian Geidel

given: Christian

name: Kaposi Mór Oktatókórház; Gyermekpulmonológiai Részleg; Mosdós Hungary

family: Bolbas

full_name: Katalin Bolbas

given: Katalin

name: Federal State Institution-Scientific Research Pulmonology Institute under the Roszdrav Laboratory of Cystic Fibrosis; Moscow Russia

family: Chuchalin

full_name: Alexander Chuchalin

given: Alexander

name: Complejo Hospitalario Universitario La Coruña; Servicio de Neumologia; A Coruña Spain

family: Blanco-Aparicio

full_name: Marina Blanco-Aparicio

given: Marina

name: Corporate Clinical Development; Chiesi Farmaceutici, S.p.A.; Parma Italy

family: Santoro

full_name: Debora Santoro

given: Debora

family: Varoli

full_name: Guido Varoli

given: Guido

family: Zibellini

full_name: Marco Zibellini

given: Marco

name: Chiesi Pharmaceuticals, Inc.; Rockville Maryland

family: Cicirello

full_name: Helen G. Cicirello

given: Helen G.

name: Institute of Pediatrics; Obstetrics and Gynecology; Department of Respiratory Diseases and Ecological Problems of Children's Health; Kyiv Ukraine

family: Antipkin

full_name: Yuriy G. Antipkin

given: Yuriy G.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Pediatric Pulmonology

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Chiesi Farmaceutici S.p.A.

location_country: Ukraine France Poland

location_facility: Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii

location_facility: Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2

location_facility: Donetsk Regional Children Clinical Hospital

location_facility: Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy

location_facility: Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny

location_facility: Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj

location_facility: Lviv Regional Children Specialized Clinical Hospital

location_facility: Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine

location_facility: I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy

location_facility: Zaporizhya Regional Clinical Children Hospital

location_facility: Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

location_facility: Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires

location_facility: Odesa Regional Children Clinical Hospital

location_facility: Klinika Pediatrii Instytut Matki I Dziecka

location_facility: Simferopol Central District Clinical Hospital

location_facility: Dnipropetrovsk City Children Clinical Hospital # 2

location_facility: Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine


title: A Multicentre Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis

summary: This is a Phase 2, multicenter, randomized, double-blind, parallel group, placebo-controlled study to investigate the safety, tolerability, efficacy and dose-response of GSK2831781 in participants with moderate to severe active ulcerative colitis. The study consists of a 5-week screening window, 10-week Induction Phase, 30-week double-blind Extended Treatment Phase (ETP) with 42-week Follow-Up Phase. Non-Responders identified following the Week 10 assessment will be allocated to open label treatment, consisting of Induction (Weeks 12 to 22), an Open label ETP (Weeks 22 to 42) and a follow-Up to Week 54.

status: Terminated

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
South Africa
India
Serbia
Netherlands
France
Czechia
Bulgaria
Japan
Poland
Slovakia
Russian Federation
Estonia
United States
United Kingdom
Ukraine

status_simplified: Unknown


type: EudraCT Number

title: Intra-articular Treatment With MEN16132 in Patients With Symptomatic Primary Osteoarthritis of the Knee: A Randomized, Multi-centre, Double Blind, Placebo Controlled, Five Parallel Group, Dose Finding Study

acronym: ALBATROSS

summary: The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.

lead_sponsor: Menarini Group

location_country: Italy Germany France Spain

location_facility: Department of Rheumatology, Purpan University Hospital

location_facility: Servicio de Reumatologia, Corporacio Sanitaria Parc Tauli, Hospital de Sabadell

location_facility: Klinik für Rheumatologie und Klinische Immunologie, Charité - Campus Charité Mitte

location_facility: Servicio de Reumatologia, Hospital Universitario La Paz

location_facility: Dipartimento di Medicina Interna Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara Pisa

location_facility: Centre Hospitalier Régional - Hôpital Porte Madeleine

location_facility: ClinPharm International, Prüfzentrum Leipzig

location_facility: ClinPharm International, Prüfzentrum Dresden

location_facility: ClinPharm International, Prüfzentrum Bochum

location_facility: Rheumatologie/Immunologie - Rheumazentrum, Krankenhaus Doberan

location_facility: Servizio di Reumatologia, Ospedale Privato Accreditato Nigrisoli

location_facility: Medizinische Klinik 3, Universität Erlangen-Nürnberg

location_facility: Servicio de Reumatologia, Hospital de Basurto

location_facility: Servicio de Reumatologia, Hospital Universitario Virgen Macarena

location_facility: Istituto di Reumatologia, "Policlinico Le Scotte" Università degli Studi di Siena

location_facility: Dipartimento di Biomedicina - SOD Reumatologia - Azienda Ospedaliera Universitaria Careggi


type: Other Identifier

title: Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse

acronym: ISAKIDS

summary:
Primary Objective:

To evaluate the anti-leukemic activity of isatuximab in combination with standard chemotherapies in pediatric participants of ages 28 days to less than 18 years with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML)

Secondary Objectives:

Safety and tolerability assessments
Assessment of infusion reactions (IRs)
Pharmacokinetics (PK) of isatuximab
Minimal residual disease
Overall response rate
Overall survival
Event free survival
Duration of response
Relationship between clinical effects and CD38 receptor density and occupancy

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

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

lead_sponsor: Sanofi

location_country:
Italy
United States
Brazil
Peru
Sweden
Mexico
Netherlands
Germany
Finland
France
Czechia
Greece
Norway
Hungary
Belgium
Argentina
Portugal
Denmark
Canada
Korea, Republic of

location_facility:
Investigational Site Number :4840001
Investigational Site Number :0560001
Investigational Site Number :2500005
Investigational Site Number :5280001
Investigational Site Number :3480001
Investigational Site Number :0320005
Investigational Site Number :2500001
Investigational Site Number :4100002
Investigational Site Number :7520001
Investigational Site Number :0760004
Investigational Site Number :0320002
Investigational Site Number :3800003
Investigational Site Number :0760009
Investigational Site Number :8400003
Investigational Site Number :0320001
Investigational Site Number :6040001
Investigational Site Number :4100001
Investigational Site Number :2760005
Investigational Site Number :2460001
Investigational Site Number :8400002
Investigational Site Number :2030002
Investigational Site Number :0320003
Investigational Site Number :4100004
Investigational Site Number :2500004
Investigational Site Number :4840005
Investigational Site Number :1240001
Investigational Site Number :0760013
Investigational Site Number :2030001
Investigational Site Number :0760007
Investigational Site Number :5780001
Investigational Site Number :2080001
Investigational Site Number :6200001
Investigational Site Number :6040002
Investigational Site Number :8400004
Investigational Site Number :3000001
Investigational Site Number :0320004
Investigational Site Number :2500003
Investigational Site Number :6200002
Investigational Site Number :2760001
Investigational Site Number :3480002
Investigational Site Number :2760006
Investigational Site Number :3800004
Investigational Site Number :0760006
Investigational Site Number :0760001
Investigational Site Number :5780002
Investigational Site Number :0760010
Investigational Site Number :2760004
Investigational Site Number :2760003
Investigational Site Number :2500002
Investigational Site Number :0320006
Investigational Site Number :8400001
Investigational Site Number :4100003
Investigational Site Number :6200003
Investigational Site Number :1240003
Investigational Site Number :3800001
Investigational Site Number :3800002
Investigational Site Number :3800005

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Rab MAE, Van Oirschot BA, Kosinski PA, Hixon J, Johnson K, Chubukov V, Dang L, Pasterkamp G, Van Straaten S, Van Solinge WW, Van Beers EJ, Kung C, Van Wijk R. AG-348 (Mitapivat), an allosteric activator of red blood cell pyruvate kinase, increases enzymatic activity, protein stability, and ATP levels over a broad range of PKLR genotypes. Haematologica. 2021 Jan 1;106(1):238-249. doi: 10.3324/haematol.2019.238865.

family: Rab

full_name: Minke A.E. Rab

given: Minke A.E.

family: Van Oirschot

full_name: Brigitte A. Van Oirschot

given: Brigitte A.

family: Kosinski

full_name: Penelope A. Kosinski

given: Penelope A.

family: Hixon

full_name: Jeffrey Hixon

given: Jeffrey

family: Johnson

full_name: Kendall Johnson

given: Kendall

family: Chubukov

full_name: Victor Chubukov

given: Victor

family: Dang

full_name: Lenny Dang

given: Lenny

family: Pasterkamp

full_name: Gerard Pasterkamp

given: Gerard

family: Van Straaten

full_name: Stephanie Van Straaten

given: Stephanie

family: Van Solinge

full_name: Wouter W. Van Solinge

given: Wouter W.

family: Van Beers

full_name: Eduard J. Van Beers

given: Eduard J.

family: Kung

full_name: Charles Kung

given: Charles

family: Van Wijk

full_name: Richard Van Wijk

given: Richard

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: publisher-specific license

license_normalized: publisher-specific

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Ferrata Storti Foundation (Haematologica)

design_allocation: Non-Randomized

status: Active, not recruiting

lead_sponsor: Agios Pharmaceuticals, Inc.

location_country:
Italy
Brazil
Switzerland
Netherlands
Spain
Germany
France
Czechia
Japan
Korea, Republic of
Thailand
Ireland
Portugal
Turkey
Denmark
United States
United Kingdom
Canada

location_facility: Indiana Hemophilia & Thrombosis Center Inc.

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Hospital Central da Faculdade de Medicina - USP

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Htal Clínico Universitario Virgen de la Arrixaca.

location_facility: Wayne State University School of Medicine

location_facility: Kansai Medical University, Dep. of Pediatrics, Hirakata Hospital

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Manchester University NHS Foundation Trust

location_facility: Charite - UB - CVK - Medizinische Klinik

location_facility: The Royal Liverpool and Broadgreen University

location_facility: Hacettepe University Faculty of Medicine

location_facility: UCSF Benioff Children's Hospital, Oakland

location_facility: Università della Campania "Luigi Vanvitelli"

location_facility: CHU Hopitaux de Bordeaux - Hôpital Saint-André

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

ipd_sharing: No

source: euctr

title: An Open-Label, Multicenter, Extension Study of AG-348 in Adult Subjects With Pyruvate Kinase Deficiency Previously Enrolled in AG-348 Studies

summary: This is a multicenter, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of treatment with AG-348 in participants who were previously enrolled in Study AG348-C-006 or Study AG348-C-007.


intervention_type: Procedure

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
France
Australia
Spain
United States

location_facility: University of Iowa Hospitals and Clinics; Investigational Drug Services

location_facility: University of Kansas Clinical Research Center; Clinical Trials Office

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Hospital Universitario Virgen del Rocío; Servicio de Neuropediatra

location_facility: ASST Papa Giovanni XXIII; Dipartimento Interaziendale di Farmacia Clinica

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: UCLA Jonsson Comprehensive Cancer Center

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

title: A Phase Ib/II Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission

summary: This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).


title: Vascular-Targeted Photodynamic Therapy Using WST11 in Patients With Localized Prostate Cancer

summary:
The aim of this trial is to determine the optimal treatment conditions to achieve prostate cancer tumour ablation and to assess the effects of WST11-mediated Vascular-Targeted Photodynamic therapy (VTP) treatment in patients with localized prostate cancer.

The secondary objectives are to assess the safety and quality of life following WST11-mediated VTP treatment,to assess the effects,safety and quality of life following a second WST11-mediated VTP treatment; and to explore optimisation techniques to reduce the duration of the VTP procedure.

ReferenceCitation: Azzouzi AR, Barret E, Moore CM, Villers A, Allen C, Scherz A, Muir G, de Wildt M, Barber NJ, Lebdai S, Emberton M. TOOKAD(®) Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer. BJU Int. 2013 Oct;112(6):766-74. doi: 10.1111/bju.12265.

family: Azzouzi

full_name: Abdel-Rahmène Azzouzi

given: Abdel-Rahmène

name: Institut Mutualiste Montsouris (IMM); Paris; France

family: Barret

full_name: Eric Barret

given: Eric

name: University College London Hospital; London; UK

family: Moore

full_name: Caroline M. Moore

given: Caroline M.

name: University Hospital of Lille; Lille; France

family: Villers

full_name: Arnaud Villers

given: Arnaud

family: Allen

full_name: Clare Allen

given: Clare

name: Plant Sciences; Weizmann Institute of Science; Rehovot; Israel

family: Scherz

full_name: Avigdor Scherz

given: Avigdor

family: Muir

full_name: Gordon Muir

given: Gordon

name: Catharina Hospital; Eindhoven; The Netherlands

family: de Wildt

full_name: Michel de Wildt

given: Michel

family: Barber

full_name: Neil J. Barber

given: Neil J.

family: Lebdai

full_name: Souhil Lebdai

given: Souhil

family: Emberton

full_name: Mark Emberton

given: Mark

journal_name: BJU International

title: TOOKAD®Soluble vascular-targeted photodynamic (VTP) therapy: determination of optimal treatment conditions and assessment of effects in patients with localised prostate cancer

ReferenceCitation: Azzouzi AR, Lebdai S, Benzaghou F, Stief C. Vascular-targeted photodynamic therapy with TOOKAD® Soluble in localized prostate cancer: standardization of the procedure. World J Urol. 2015 Jul;33(7):937-44. doi: 10.1007/s00345-015-1535-2. Epub 2015 Mar 19.

full_name: Abdel-Rahmene Azzouzi

given: Abdel-Rahmene

family: Benzaghou

full_name: Fawzi Benzaghou

given: Fawzi

family: Stief

full_name: Christian Stief

given: Christian

journal_name: World Journal of Urology

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

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

license: implied-oa

license_normalized: implied-oa

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Azzouzi AR, Barret E, Bennet J, Moore C, Taneja S, Muir G, Villers A, Coleman J, Allen C, Scherz A, Emberton M. TOOKAD® Soluble focal therapy: pooled analysis of three phase II studies assessing the minimally invasive ablation of localized prostate cancer. World J Urol. 2015 Jul;33(7):945-53. doi: 10.1007/s00345-015-1505-8. Epub 2015 Feb 25.

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

repository_institution: University College London - UCL Discovery

ReferenceCitation: Lebdai S, Villers A, Barret E, Nedelcu C, Bigot P, Azzouzi AR. Feasibility, safety, and efficacy of salvage radical prostatectomy after Tookad® Soluble focal treatment for localized prostate cancer. World J Urol. 2015 Jul;33(7):965-71. doi: 10.1007/s00345-015-1493-8. Epub 2015 Jan 23.

location_facility: University College London Hospital (UCLH)


title: A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.

acronym: August III

summary: The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.

ReferenceCitation: van Vollenhoven RF, Wax S, Li Y, Tak PP. Safety and efficacy of atacicept in combination with rituximab for reducing the signs and symptoms of rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled pilot trial. Arthritis Rheumatol. 2015 Nov;67(11):2828-36. doi: 10.1002/art.39262.

family: van Vollenhoven

full_name: R. F. van Vollenhoven

given: R. F.

family: Wax

full_name: S. Wax

given: S.

family: Li

full_name: Y. Li

given: Y.

name: Academic Medical Center and University of Amsterdam, Amsterdam, The Netherlands, University of Cambridge, Cambridge, UK, and GlaxoSmithKlineStevenage UK

family: Tak

full_name: P. P. Tak

given: P. P.

journal_name: Arthritis & Rheumatology

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: Safety and Efficacy of Atacicept in Combination With Rituximab for Reducing the Signs and Symptoms of Rheumatoid Arthritis: A Phase II, Randomized, Double‐Blind, Placebo‐Controlled Pilot Trial

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Sweden
United Kingdom
France
Netherlands


title: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients With Moderate Alzheimer's Disease

summary: This Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate AD. The study consists of a screening period, a double-blind treatment period, an optional open-label extension (OLE) period, and a safety follow-up period. There may be up to three study cohorts.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)

lead_sponsor: Genentech, Inc.

location_country:
Spain
United States
France
Poland

location_facility: Alzheimer's Research and Treatment Center

location_facility: Empire Neurology PC; MS Center of Northeastern NY

location_facility: New Orleans Center for Clinical Research

location_facility: Brigham and Womens Hospital; Center for Alzheimer Research & Treatment

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Butler Hospital; Movement Disorders Program

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

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

location_facility: Stanford University; Stanford Clinical Cancer Ctr

location_facility: Neuropsychiatric Research; Center of Southwest Florida

location_facility: Southern Illinois University, School of Medicine

location_facility: Synexus Clinical Research US, Inc. - Orlando

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

location_facility: Advanced Memory Research Institute of NJ

location_facility: Rush University Medical Center - Chicago

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research


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: Eli Lilly and Company

location_country:
Italy
Austria
Brazil
India
Mexico
Spain
France
Czechia
Japan
Israel
Poland
Argentina
Australia
Belgium
China
Russian Federation
Denmark
Germany
United Kingdom
Turkey

acronym: JUVE-BASIS

location_facility: Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital

location_facility: Beijing Children's hospital, Capital Medical University

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Charité Universitätsmedizin Berlin Campus Buch

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Sri Ramachandra MedicaL College & Research Institute

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Hospital General de Niños Dr. Pedro de Elizalde

location_facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Hospital Univ. "Dr. José Eleuterio González"

location_facility: Morozovsky Children's City Clinical Hospital

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Children's Hospital of Soochow University

location_facility: Universidade Federal de São Paulo - Escola Paulista de Medicina

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

location_facility: Capitol Institute of Pediatrics Children'S Hospital

location_facility: Hospital Infantil Universitario Niño Jesús

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Niigata University Medical & Dental Hospital

location_facility: Hospices Civils de Lyon - Hôpital Femme Mère Enfant

location_facility: Saint-Petersburg State Pediatric Medical University

location_facility: Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze

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

location_facility: Children's Hospital of Chongqing Medical University

location_facility: Tokyo Women's Medical University Hospital

location_facility: CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

title: A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)

summary: The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.


acronym: JUVE-X

location_facility: Children's Hospital Capital Institute of Pediatrics

location_facility: Beijing Children's hospital, Capital Medical University

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Sri Ramachandra MedicaL College & Research Institute

location_facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

location_facility: Hospital General de Niños Dr. Pedro de Elizalde

location_facility: Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie

location_facility: ASST Spedali Civili - Università degli Studi

location_facility: Sanjay Gandhi Post Graduate Institute of Medical Sciences

location_facility: Instituto de Investigaciones Clínicas para la Salud

location_facility: Hospital Univ. "Dr. José Eleuterio González"

location_facility: Morozovsky Children's City Clinical Hospital

location_facility: Oxford University Hospitals - Nuffield Orthopaedic Centre

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty-Department of pediatric Rheumatology

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji

location_facility: Children's Hospital of Soochow University

location_facility: Great Ormond Street Hospital For Children NHS Foundation Trust

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: The Children's Hospital of Chongqing Medical University

location_facility: Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO

location_facility: Detska revmatologie, Detska klinika, Fakultni nemocnice Olomouc

title: A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)

summary: The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.


title: Phase III Study of Usefulness of Near Infrared Spectroscopy to Optimize Tissues Perfusion and Oxygenation in Severe Sepsis

acronym: OTO-STS

summary: The purpose of this study is to evaluate the usefulness of an optimization of muscle perfusion and oxygenation, as assessed by the NIRS technique, in critically ill patients with sepsis.

ReferenceCitation: Nardi O, Zavala E, Martin C, Nanas S, Scheeren T, Polito A, Borrat X, Annane D. Targeting skeletal muscle tissue oxygenation (StO(2)) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study). BMJ Open. 2018 Mar 19;8(3):e017581. doi: 10.1136/bmjopen-2017-017581.

family: Nardi

full_name: Olivier Nardi

given: Olivier

family: Zavala

full_name: Elizabeth Zavala

given: Elizabeth

family: Martin

full_name: Claude Martin

given: Claude

family: Nanas

full_name: Serafim Nanas

given: Serafim

family: Scheeren

full_name: Thomas Scheeren

given: Thomas

family: Polito

full_name: Andrea Polito

given: Andrea

family: Borrat

full_name: Xavi Borrat

given: Xavi

family: Annane

full_name: Djillali Annane

given: Djillali

currency_apc_doaj: GBP

journal_name: BMJ Open

license: cc-by-nc

license_normalized: cc-by-nc

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

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Targeting skeletal muscle tissue oxygenation (StO2) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study)

lead_sponsor: University of Versailles

location_country: Spain Germany France Greece

location_facility:
GERLACH Herwig
Hôpital Nord AP HM
University Hospital Rostock
Raymond Poincaré Hospital
CHU Tours
EZAVALA Elizabeth
NANAS Serafeim

intervention_type: Device

lead_sponsor_type: academique


summary: The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).

lead_sponsor: Eisai Limited

location_country:
United Kingdom
France

location_facility:
Centre Antoine Lacassagne
Hôpitaux Civils de Colmar
Aberdeen Royal Infirmary
Cookridge Hospital
CRLC Val d'Aurelle
Beatson Oncology Centre
Leicester Royal Infirmary


title: Irbesartan in the Treatment of Hypertensive Patients With Metabolic Syndrome

summary: The purpose of this clinical research study is to learn if irbesartan is superior to hydrochlorothiazide relative to effects on insulin sensitivity and glucose metabolism in hypertensive patients with metabolic syndrome.

ReferenceCitation: Parhofer KG, Birkeland KI, DeFronzo R, Del Prato S, Bhaumik A, Ptaszynska A. Irbesartan has no short-term effect on insulin resistance in hypertensive patients with additional cardiometabolic risk factors (i-RESPOND). Int J Clin Pract. 2010 Jan;64(2):160-8. doi: 10.1111/j.1742-1241.2009.02246.x. Epub 2009 Nov 19.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
France
Norway
Russian Federation
Spain
Germany


title: A Prospective, Multi-Center, Single Arm Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke: The EvaQ Study

acronym: EvaQ

summary: Assess the safety and efficacy of the Q Revascularization System to remove thrombi and emboli from the neurovasculature in patients experiencing an acute ischemic stroke

status: Enrolling by invitation

lead_sponsor: MIVI Neuroscience, Inc.

location_country:
United States
France

location_facility:
Hôpital Purpan
Cooper University Health Care
University at Buffalo Neurosurgery
CHU Pellegrin
CHU Urbains
University of South Florida
Baptist Memorial Hospital
CHU Bicetre Paris


title: Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS®

acronym: MOKHA

summary: This pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of patients suffering of knee osteoarthritis as revealed by using scientifically sound, objective measurements of biological and MRI-based imaging markers.

lead_sponsor: Fidia Farmaceutici s.p.a.

location_country: Belgium France

location_facility: Service de Rhumatologie CHU Dinant-Godinne (Site Godinne)

location_facility: Service de Rhumatologie CHR Metz Thionville Hôpital Bel Air

location_facility: Service de rhumatologie,RDC Hôpital Lariboisière


title: An Open Label, Multicenter, Dose Escalation and Expansion, Phase 1 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-Tumor Activity of RO7121661, a PD-1/TIM-3 Bispecific Antibody, in Patients With Advanced and/or Metastatic Solid Tumors

summary: This is a first-in-human, open-label, multicenter, Phase I multiple-ascending dose (MAD) study of single agent RO7121661, an anti PD-1 (programmed death-1) and TIM-3 (T-cell immunoglobulin and mucin domain 3) bispecific antibody, for participants with advanced and/or metastatic solid tumors. The study consists of 2 parts: Dose Escalation (Part A) and Expansion (Parts B1, B2, B3, B4, and B5). The Dose Escalation part will be conducted first to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) based on safety, tolerability, pharmacokinetic, and/or the pharmacodynamic profile of escalating doses of RO7121661. The Expansion part will enroll tumor-specific cohorts to evaluate anti-tumor activity of the MTD and/or RDE of RO7121661 from Part A (Q2W) and to confirm safety and tolerability in participants with selected tumor types.

location_country:
France
New Zealand
Spain
Denmark
United States
Korea, Republic of

location_facility: CHU Timone; Centre d'Essais Précoces en Cancérologie de Marseille (CEPCM)

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Severance Hospital, Yonsei University Health System

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

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

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Clinica Universitaria de Navarra; Servicio de oncología

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centre Leon Berard; Service Oncologie Medicale

location_facility: Auckland City Hospital; Clinical Oncology


title: A Phase II Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)

summary: This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with < 50% of tumor cells expressing PD-L1 by immunohistochemical (IHC) staining.

lead_sponsor: Transgene

location_country:
France
Hungary
Belgium
Denmark
United States

location_facility: Créteil Mulhouse Nashville Budapest Szekesfehervar Strasbourg Herlev Libramont Charlotte Rennes


title: Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations

summary: This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.

study_type: Observational

time_perspective: Retrospective

ReferenceCitation: Halmos B, Tan EH, Soo RA, Cadranel J, Lee MK, Foucher P, Hsia TC, Hochmair M, Griesinger F, Hida T, Kim E, Melosky B, Märten A, Carcereny E. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: Results from a global real-world study (RealGiDo). Lung Cancer. 2019 Jan;127:103-111. doi: 10.1016/j.lungcan.2018.10.028. Epub 2018 Nov 2.

family: Halmos

full_name: Balazs Halmos

given: Balazs

family: Tan

full_name: Eng-Huat Tan

given: Eng-Huat

family: Soo

full_name: Ross A. Soo

given: Ross A.

family: Cadranel

full_name: Jacques Cadranel

given: Jacques

family: Lee

full_name: Min Ki Lee

given: Min Ki

family: Foucher

full_name: Pascal Foucher

given: Pascal

family: Hsia

full_name: Te-Chun Hsia

given: Te-Chun

family: Hochmair

full_name: Maximilian Hochmair

given: Maximilian

family: Griesinger

full_name: Frank Griesinger

given: Frank

family: Hida

full_name: Toyoaki Hida

given: Toyoaki

family: Kim

full_name: Edward Kim

given: Edward

family: Melosky

full_name: Barbara Melosky

given: Barbara

family: Märten

full_name: Angela Märten

given: Angela

family: Carcereny

full_name: Enric Carcereny

given: Enric

journal_name: Lung Cancer

oa_host_type: publisher

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
Mexico
Germany
France
Japan
Korea, Republic of
Poland
Singapore
Spain
United States
Canada
Taiwan

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Organización para Cuidado Integral en Oncología S.A de C.V

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland

location_facility: Grzegorz Czyzewicz Specialised Medical Practice, Cracow

location_facility: Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz


title: Personalized CRT - Product Surveillance Registry (PSR)

summary: The purpose of this study is to evaluate the cardiac resynchronization therapy (CRT) response in a real-world patient population and evaluate options to address non-response and patient management.

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Italy
United States
Sweden
Serbia
Netherlands
Germany
France
Malaysia
Belgium
Spain
Canada
United Kingdom
Korea, Republic of


title: SOLAR: A Phase 2, Randomized, Open-label, Parallel-group, Active Comparator, Multi-center Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype

acronym: SOLAR

summary:
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype. Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells. The study will compare the effects of cobomarsen to vorinostat, a drug that has been approved for the treatment of CTCL in the United States and several other countries.

Participants in the clinical trial will be randomly assigned to receive either weekly doses of cobomarsen by injection into a vein or daily oral doses of vorinostat. Participants will continue on their assigned treatment as long as there is no evidence of progression of their cancer. The effects of treatment will be measured based on changes in skin lesion severity, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.

Participants assigned to receive vorinostat who experience progression of their disease during their participation in this study may have the option to be treated with cobomarsen in an open-label, crossover arm of the same study if they meet the entry criteria for that part of the study.

ReferenceCitation: Ganguly K, Kishore U, Madan T. Interplay between C-type lectin receptors and microRNAs in cellular homeostasis and immune response. FEBS J. 2021 Jul;288(14):4210-4229. doi: 10.1111/febs.15603. Epub 2020 Nov 7. Review.

name: Department of Innate Immunity ICMR‐National Institute for Research in Reproductive Health Mumbai India

family: Ganguly

full_name: Kasturi Ganguly

given: Kasturi

name: Biosciences College of Health Medicine and Life Sciences Brunel University London Uxbridge UK

family: Kishore

full_name: Uday Kishore

given: Uday

family: Madan

full_name: Taruna Madan

given: Taruna

bso_classification: Biology (fond.)

journal_name: The FEBS Journal

evidence: open (via free article)

title: Interplay between C‐type lectin receptors and microRNAs in cellular homeostasis and immune response

ReferenceCitation: Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7:CD008946. doi: 10.1002/14651858.CD008946.pub3.

name: Department of Dermatology, Venereology and Allergology; Johann Wolfgang Goethe-University Hospital; Frankfurt am Main Germany

name: Evidence-Based Medicine Frankfurt, Institute of General Practice; Goethe University; Frankfurt Germany

family: Valipour

full_name: Arash Valipour

given: Arash

name: Hautklinik; Städtisches Klinikum Karlsruhe; Karlsruhe Germany

family: Jäger

full_name: Manuel Jäger

given: Manuel

name: Department of Dermatology; University of California Davis; Sacramento CA USA

family: Wu

full_name: Peggy Wu

given: Peggy

name: Center for Evidence-Based Healthcare; Faculty of Medicine Carl Gustav Carus, Technischen Universität (TU) Dresden; Dresden Germany

family: Schmitt

full_name: Jochen Schmitt

given: Jochen

name: c/o Cochrane Skin Group; The University of Nottingham; Nottingham UK

family: Bunch

full_name: Charles Bunch

given: Charles

family: Weberschock

full_name: Tobias Weberschock

given: Tobias

journal_name: Cochrane Database of Systematic Reviews

oa_host_type: repository

title: Interventions for mycosis fungoides

lead_sponsor: miRagen Therapeutics, Inc.

location_country:
Italy
United States
France
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: Consorcio Hospital General Universitario Valencia

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Washington University School of Medicine

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: AOU Citta dell Salute e della Scienza di Torino

location_facility: Chao Family Comprehensive Cancer Center at University of California, Irvine

location_facility: Centre Hospitalier Universitaire de Rouen

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: University Hospitals of Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Guy's and St. Thomas' NHS Foundation Trust, Cancer Center


title: A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Glepaglutide in Patients With Short Bowel Syndrome (SBS)

acronym: EASE SBS 1

summary:
The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

lead_sponsor: Zealand Pharma

location_country:
Italy
United States
Netherlands
Germany
France
Poland
Belgium
Denmark
Canada
United Kingdom

location_facility: Vanderbilt University Medical Center, Nashville

location_facility: Division of Gastroenterology and Hepatology

location_facility: Wojewodzki Specjalistyczny Szpital im. M. Pirogowa w Lodzi

location_facility: University of Chicago Children's Hospital

location_facility: Azienda Ospedaliero Universitaria Federico II

location_facility: Universitätsklinikum Frankfurt - Med. Klinik I

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University Health Network - Toronto General Hospital

location_facility: Universitätsklinikum Tübingen - Innere Medizin I

location_facility: Szpital Skawina sp. z o.o. im. Stanley Dudricka


title: A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)

summary: The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.

lead_sponsor: Incyte Corporation

location_country:
Italy
Austria
France
Poland
Romania
Hungary
Spain
United States

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: California Cancer Associates for Research and Excellence, Inc.

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.

location_facility: Centrum Onkologii- Instytut im Marii Skłodowskiej Curie

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Clinical Emergency Hospital of Constanta

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti di Ancona

location_facility: Christiana Care Helen F. Graham Cancer Center

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc.

location_facility: Texas Oncology Surgical Specialists - Austin Central

location_facility: St. Joseph Health Medical Group - Annadel Medical Group

location_facility: Rocky Mountain Cancer Centers - Denver - Midtown


title: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.

acronym: FOUNDATION

summary:
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.

The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

ReferenceCitation: Young C, Laufer G, Kocher A, Solinas M, Alamanni F, Polvani G, Podesser BK, Aramendi JI, Arribas J, Bouchot O, Livi U, Massetti M, Terp K, Giot C, Glauber M. One-year outcomes after rapid-deployment aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Feb;155(2):575-585. doi: 10.1016/j.jtcvs.2017.09.133. Epub 2017 Oct 31.

family: Young

full_name: Christopher Young

given: Christopher

family: Laufer

full_name: Günther Laufer

given: Günther

family: Kocher

full_name: Alfred Kocher

given: Alfred

family: Solinas

full_name: Marco Solinas

given: Marco

family: Alamanni

full_name: Francesco Alamanni

given: Francesco

family: Polvani

full_name: Gianluca Polvani

given: Gianluca

family: Podesser

full_name: Bruno K. Podesser

given: Bruno K.

family: Aramendi

full_name: Jose Ignacio Aramendi

given: Jose Ignacio

family: Arribas

full_name: Jose Arribas

given: Jose

family: Bouchot

full_name: Olivier Bouchot

given: Olivier

family: Livi

full_name: Ugolino Livi

given: Ugolino

family: Massetti

full_name: Massimo Massetti

given: Massimo

family: Terp

full_name: Kim Terp

given: Kim

family: Giot

full_name: Christophe Giot

given: Christophe

family: Glauber

full_name: Mattia Glauber

given: Mattia

journal_name: The Journal of Thoracic and Cardiovascular Surgery

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

lead_sponsor: Edwards Lifesciences

location_country:
Italy
Austria
Switzerland
Netherlands
France
Spain
Denmark
Germany
United Kingdom

location_facility: Herz- und Gefäß-Klinik GmbH Bad Neustadt

location_facility: G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation

location_facility: Klinisshe Abteiluing Für Herz-thoraxchirurgie

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

location_facility: Università Cattolica del Sacro Cuore Policlinico

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Westdeutsches Herzcentrum Uniklinik Essen

location_facility: Universitätsklinik Für Herz und Gefässchirurgie


title: A Randomized Phase II, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of INC280 in Adult Patients With Advanced Hepatocellular Carcinoma After Progression or Intolerance to Sorafenib Treatment

summary:
This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib.

Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding.

Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).

status: Withdrawn

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Hong Kong
Switzerland
France
Australia
Spain
Germany

location_facility: Massachusetts General Hospital Mass General Hospital


title: Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

summary: The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

ReferenceCitation: Tassorelli C, Bragg S, Krege JH, Doty EG, Ardayfio PA, Ruff D, Dowsett SA, Schwedt T. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021 Nov 6;22(1):132. doi: 10.1186/s10194-021-01343-2.

family: Tassorelli

full_name: C Tassorelli

given: C

family: Bragg

full_name: S Bragg

given: S

family: Krege

full_name: JH Krege

given: JH

family: Doty

full_name: EG Doty

given: EG

family: Ardayfio

full_name: PA Ardayfio

given: PA

family: Ruff

full_name: D Ruff

given: D

family: Dowsett

full_name: SA Dowsett

given: SA

family: Schwedt

full_name: T Schwedt

given: T

journal_name: The Journal of Headache and Pain

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2021 Oct 13:3331024211048507. doi: 10.1177/03331024211048507. [Epub ahead of print]

name: Universitätsmedizin Greifswald, Greifswald, Germany

family: Reuter

full_name: Uwe Reuter

given: Uwe

name: Eli Lilly and Company, Indianapolis, IN, USA

full_name: John H Krege

given: John H

family: Lombard

full_name: Louise Lombard

given: Louise

family: Gomez Valderas

full_name: Elisa Gomez Valderas

given: Elisa

family: Krikke-Workel

full_name: Judith Krikke-Workel

given: Judith

family: Dell-Agnello

full_name: Grazia Dell-Agnello

given: Grazia

full_name: Sherie A Dowsett

given: Sherie A

name: Albert Einstein College of Medicine, Bronx, NY, USA

family: Buse

full_name: Dawn C Buse

given: Dawn C

journal_name: Cephalalgia

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

ReferenceCitation: Ashina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.

name: Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Medical and Health Sciences, University of Copenhagen, Copenhagen, Denmark

name: Department of Neurology, Charité-Universitätsmedizin Berlin, Berlin, Germany

name: StudyMetrix Research, St Peters, MO, USA

location_country:
Italy
Austria
India
Switzerland
Mexico
Netherlands
Germany
Spain
France
Czechia
Hungary
Belgium
Russian Federation
China
Denmark
United States
United Kingdom

location_facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Hospital Clínico Universitario de Valencia

location_facility: KH der Barmherzigen Schwestern Linz BetriebsGesmbH

location_facility: Rehabilitation & Neurological Services LLC

location_facility: Xuanwu Hospital-Capital Medical University

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

location_facility: First hospital affiliated to Zhengzhou University

location_facility: Synexus Thames Valley Clinical Research Centre

location_facility: Tianjin Medical University General Hospital

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Hospital Universitario La Fe de Valencia

location_facility: The First Affliated Hospital of Suzhou University

location_facility: Synexus Scotland Clinical Research Centre

location_facility: First Moscow State Medical University n.a. Sechenov

location_facility: Gemeinschaftspraxis für Neurologie und Psychiatrie

location_facility: Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology

location_facility: Center for Clinical and Basic Research -CCBR

location_facility: Saint Petersburg State Medical University n.a. Pavlov I.P.

location_facility: Fondazione Istituto Neurologico Nationale C. Mondino

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí S.C.

location_facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University

location_facility: No 1 Affiliate Hospital of Kunming Medical College

location_facility: Synexus Manchester Clinical Research Centre

location_facility: Synexus Lancashire Clinical Research Centre

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Centre Hospitalier Annecy Genevois - Site d'Annecy

location_facility: Synexus Merseyside Clinical Research Centre

location_facility: Mangala Hospitals & Mangala Kidney Foundation

location_facility: First Affiliated Hospital of Xi'an Jiaotong University

location_facility: The First Affiliated Hospital of Harbin Medical University

location_facility: Xiangya Hospital, Central South University

location_facility: George Washington University Medical Center

location_facility: Beijing Tiantan Hospital Affiliated to Capital Medical Univ

location_facility: Affiliated Hospital of Jiangsu University

location_facility: HuaShan Hospital Affiliated To Fudan University

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: UCSD Altman Clinical & Translational Research Institute (ACTRI)

location_facility: The First Affiliated Hospital Chongqing Medical University

location_facility: No.2 Hospital Affiliated to Jilin University

location_facility: Synexus Midlands Clinical Research Center

location_facility: Deenanth Mangeshkar Hospital and Research Centre

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

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: West China Hospital of Sichuan University

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Neurologicka ambulance, Neurologie Brno s.r.o.


intervention_type: Biological

location_country:
Italy
United States
Chile
Netherlands
Spain
Germany
France
Poland
Romania
Singapore
Belgium
Argentina
Australia
Puerto Rico
Denmark
Canada
United Kingdom

acronym: CheckMate 848

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Texas Oncology, PA - Central Austin Cancer Center

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: The University of Texas MD Anderson Cancer Center-merge

location_facility: Juravinski Cancer Center At Hamilton Health Sciences

title: A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

summary: The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)


title: A Placebo-controlled, Patient and Investigator Blinded, Randomized Parallel Cohort Study to Assess Pharmacodynamics, Pharmacokinetics, Safety, Tolerability and Preliminary Clinical Efficacy of VAY736 and CFZ533 in Patients With Systemic Lupus Erythematosus (SLE)

summary: This study is designed to evaluate the safety, tolerability, pharmacokinetics and therapeutic efficacy of treatment with either VAY736 or CFZ533 in patients with SLE to enable further development of these compounds as treatment in this disease population

location_country:
Spain
France
Czechia
Japan
Israel
Poland
Thailand
Hungary
Argentina
Australia
Russian Federation
China
Germany
Korea, Republic of
Taiwan


title: A Randomized, Open-label, Two-arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects With Unresectable Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer

summary: The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.

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

location_facility: The University Of Texas Md Anderson Cancer Center

intervention_type: Other


title: A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis

acronym: MIRCAST

summary:
Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.

A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.

However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.

MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:

Robotic Right Colectomy with ICA
Robotic Right Colectomy with ECA
Laparoscopic Right Colectomy with ICA
Laparoscopic Right Colectomy with ECA

All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.

status: Unknown status

ReferenceCitation: Gomez Ruiz M, Bianchi PP, Chaudhri S, Gerjy R, Gögenur I, Jayne D, Khan JS, Rautio T, Sánchez-Guillén L, Spinoglio G, Ulrich A, Rouanet P. Minimally invasive right colectomy anastomosis study (MIRCAST): protocol for an observational cohort study of surgical complications using four surgical techniques for anastomosis in patients with a right colon tumor. BMC Surg. 2020 Jul 13;20(1):151. doi: 10.1186/s12893-020-00803-x.

family: Gomez Ruiz

full_name: Marcos Gomez Ruiz

given: Marcos

family: Bianchi

full_name: Paolo Pietro Bianchi

given: Paolo Pietro

family: Chaudhri

full_name: Sanjay Chaudhri

given: Sanjay

family: Gerjy

full_name: Roger Gerjy

given: Roger

family: Gögenur

full_name: Ismail Gögenur

given: Ismail

family: Jayne

full_name: David Jayne

given: David

family: Khan

full_name: Jim S. Khan

given: Jim S.

family: Rautio

full_name: Tero Rautio

given: Tero

family: Sánchez-Guillén

full_name: Luis Sánchez-Guillén

given: Luis

family: Spinoglio

full_name: Giuseppe Spinoglio

given: Giuseppe

family: Ulrich

full_name: Alexis Ulrich

given: Alexis

family: Rouanet

full_name: Philippe Rouanet

given: Philippe

journal_name: BMC Surgery

repository_institution: University of Oulu - University of Oulu Repository - Jultika

lead_sponsor: Instituto de Investigación Marqués de Valdecilla

location_country:
Italy
Spain
Finland
Croatia
France
Greece
Portugal
Denmark
Germany
United Kingdom

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: ICM - Institut Régional du Cancer de Montpellier


ReferenceCitation: Colombo N, Dubot C, Lorusso D, Caceres MV, Hasegawa K, Shapira-Frommer R, Tewari KS, Salman P, Hoyos Usta E, Yañez E, Gümüş M, Olivera Hurtado de Mendoza M, Samouëlian V, Castonguay V, Arkhipov A, Toker S, Li K, Keefe SM, Monk BJ; KEYNOTE-826 Investigators. Pembrolizumab for Persistent, Recurrent, or Metastatic Cervical Cancer. N Engl J Med. 2021 Nov 11;385(20):1856-1867. doi: 10.1056/NEJMoa2112435. Epub 2021 Sep 18.

name: From the University of Milan–Bicocca and European Institute of Oncology IRCCS, Milan (N.C.), and Fondazione Policlinico Universitario A. Gemelli IRCCS and Catholic University of the Sacred Heart, Rome (D.L.) — both in Italy; Institut Curie Saint-Cloud, Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, Saint-Cloud, France (C.D.); Instituto de Oncología Ángel H. Roffo, Buenos Aires (M.V.C.); Saitama Medical University International Medical Center, Hidaka, Japan (K.H.); Ella Lemelbaum...

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Dubot

full_name: Coraline Dubot

given: Coraline

family: Lorusso

full_name: Domenica Lorusso

given: Domenica

family: Caceres

full_name: M. Valeria Caceres

given: M. Valeria

family: Hasegawa

full_name: Kosei Hasegawa

given: Kosei

family: Shapira-Frommer

full_name: Ronnie Shapira-Frommer

given: Ronnie

family: Tewari

full_name: Krishnansu S. Tewari

given: Krishnansu S.

family: Salman

full_name: Pamela Salman

given: Pamela

family: Hoyos Usta

full_name: Edwin Hoyos Usta

given: Edwin

family: Yañez

full_name: Eduardo Yañez

given: Eduardo

family: Gümüş

full_name: Mahmut Gümüş

given: Mahmut

family: Olivera Hurtado de Mendoza

full_name: Mivael Olivera Hurtado de Mendoza

given: Mivael

family: Samouëlian

full_name: Vanessa Samouëlian

given: Vanessa

family: Castonguay

full_name: Vincent Castonguay

given: Vincent

family: Arkhipov

full_name: Alexander Arkhipov

given: Alexander

family: Toker

full_name: Sarper Toker

given: Sarper

family: Li

full_name: Kan Li

given: Kan

family: Keefe

full_name: Stephen M. Keefe

given: Stephen M.

family: Monk

full_name: Bradley J. Monk

given: Bradley J.

journal_name: New England Journal of Medicine

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Chile
Peru
Mexico
Germany
France
Japan
Israel
Argentina
Australia
Russian Federation
Spain
Turkey
Canada
Korea, Republic of
Taiwan
Colombia
Ukraine

acronym: Trial of 1L Pembrolizumab Plus Chemotherapy in Persistent, Recurrent, or Metastatic Cervical Cancer

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1211)

location_facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1334)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 1095)

location_facility: MUSC Hollings Cancer Center ( Site 1819)

location_facility: St John of God Subiaco Hospital ( Site 1512)

location_facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 1157)

location_facility: Universitaetsklinikum Duesseldorf ( Site 1220)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 1731)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 1153)

location_facility: Centro Oncologico Riojano Integral ( Site 1004)

location_facility: Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)

location_facility: Groupe Hospitalier Broca Cochin Hotel Dieu ( Site 1183)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 1636)

location_facility: BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 1734)

location_facility: CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 1724)

location_facility: University of Oklahoma- Stephenson Oklahoma Cancer Center ( Site 1784)

location_facility: London Regional Cancer Program - London HSC ( Site 1723)

location_facility: Sociedad de Oncologia y Hematologia del Cesar Ltda. ( Site 1103)

location_facility: Texas Oncology-San Antonio Medical Center ( Site 8001)

location_facility: Instituto Medico Especializado Alexander Fleming ( Site 1009)

location_facility: Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 1457)

location_facility: Hadassah Medical Center. Ein Kerem ( Site 1367)

location_facility: Centro di Riferimento Oncologico de Aviano Istituto Nazionale Tumori ( Site 1243)

location_facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1456)

location_facility: Arizona Oncology Associates, PC- HAL ( Site 8005)

location_facility: University of the Ryukyus Hospital ( Site 1706)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 1489)

location_facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 1152)

location_facility: CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 1127)

location_facility: National Medical Research Center of Oncology n.a. N. N. Petrov ( Site 1348)

location_facility: Cancer Institute of New Jersey at University Hospital ( Site 1762)

location_facility: Instituto Nacional de Cancerologia. ( Site 1130)

location_facility: West Cancer Center - East Campus ( Site 1763)

location_facility: Monash Health-Monash Medical Centre ( Site 1519)

location_facility: Consultorio de Medicina Especializada del Sector Privado ( Site 1129)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 1703)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 1633)

location_facility: Universitatsklinikum Essen AoR ( Site 1213)

location_facility: Centro Estatal de Cancerologia de Chihuahua ( Site 1123)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1242)

location_facility: Municipal Clinical Oncology Center ( Site 1346)

location_facility: Hacettepe University Medical Faculty ( Site 1459)

location_facility: The Jikei University Kashiwa Hospital ( Site 1701)

location_facility: Instituto Cancerologico de Narino Ltda ( Site 1097)

location_facility: The Ottawa Hospital Cancer Centre ( Site 1736)

location_facility: National Cancer Center Hospital ( Site 1702)

location_facility: Seattle Cancer Care Alliance ( Site 1777)

location_facility: National Research Ogarev Mordovia State University ( Site 1347)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1345)

location_facility: National Cancer Center Hospital East ( Site 1704)

location_facility: Taipei Veterans General Hospital ( Site 1631)

location_facility: Keimyung University Dongsan Medical Center ( Site 1603)

location_facility: Iwate Medical University Hospital ( Site 1695)

location_facility: Princess Margaret Cancer Centre ( Site 1732)

location_facility: Gynoncological Practice Lueck. Schrader. Noeding ( Site 1224)

location_facility: The Jikei University Hospital ( Site 1697)

location_facility: Mater Misericordiae Ltd Mater Cancer Care Centre ( Site 1521)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1006)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 1721)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 1360)

location_facility: Hospital Nacional Arzobispo Loayza ( Site 1159)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 1212)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 1726)

location_facility: Medeniyet University Goztepe Egitim ve Arastırma Hast. Merdivenkoy ( Site 1458)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 1214)

location_facility: Columbia University Medical Center ( Site 1800)

location_facility: Seoul National University Hospital ( Site 1602)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1275)

location_facility: Novosibirsk Regional Clinical Oncology Dispensary ( Site 1358)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 1061)

location_facility: Saitama Medical University International Medical Center ( Site 1691)

location_facility: Akdeniz Universitesi Tip Fakultesi ( Site 1453)

location_facility: H. Lee Moffitt Cancer Center and Research Institute ( Site 1754)

location_facility: Hospital Universitario Virgen Macarena ( Site 1274)

location_facility: Medical Rehabilitation Center ( Site 1337)

location_facility: Hospital Nacional Maria Auxiliadora ( Site 1155)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 1484)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1698)

location_facility: Medical Centre LLC Oncolife ( Site 1485)

location_facility: Centro de Urologia Avanzada del Noreste S.A. de C.V. ( Site 1125)

location_facility: Policlinico Universitario -Agostino Gemelli ( Site 1241)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1487)

location_facility: Baskent Universitesi Ankara Hastanesi ( Site 1451)

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1245)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 1729)

location_facility: Georgia Cancer Center at Augusta University ( Site 1767)

location_facility: Istituto Europeo di Oncologia ( Site 1250)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1276)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 1185)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 1158)

location_facility: Washington University School of Medicine ( Site 1779)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 1700)

location_facility: Hospital de Oncologia Angel Roffo ( Site 1003)

location_facility: MI Odessa Regional Oncological Centre ( Site 1493)

location_facility: MD Anderson Cancer Center Madrid ( Site 1273)

location_facility: City Clinical Hosp.4 of DCC ( Site 1482)

location_facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 1730)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1768)

location_facility: Medical Care and Research S.A. de C.V. ( Site 1135)

location_facility: Rotkreuzklinikum Muenchen gGmbH. Studienzentrale Frauenklinik ( Site 1225)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 1452)

location_facility: Barbara Ann Karmanos Cancer Institute ( Site 1785)

location_facility: Centro Medico Monte Carmelo ( Site 1156)

location_facility: BC Cancer - Vancouver Center ( Site 1722)

location_facility: Taichung Veterans General Hospital ( Site 1634)

location_facility: Kaohsiung Veterans General Hospital ( Site 1632)

location_facility: Smilow Cancer Hospital at Yale New Haven ( Site 1809)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1331)

location_facility: Shaare Zedek Medical Center ( Site 1366)

location_facility: Instituto Clinico Oncologico del Sur ( Site 1062)

location_facility: China Medical University Hospital ( Site 1635)

location_facility: Sunnybrook Research Institute ( Site 1733)

type: Registry Identifier

title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.

The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator, or, 2) Overall Survival (OS).


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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Finland
Malaysia
Greece
Romania
Australia
Russian Federation
Denmark
Taiwan
Iceland
India
France
Japan
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
Chile
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Vietnam
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Lebanon
Czechia
Spain
Turkey

location_facility: USC Kenneth Norris Comprehensive Cancer Center

title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without Canakinumab as First Line Therapy for Locally Advanced or Metastatic Non-squamous and Squamous Non-small Cell Lung Cancer Subjects (CANOPY-1)

summary:
This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects.

The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.


location_country:
Jordan
Greece
Belgium
Australia
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Singapore
Hungary
China
Germany
United States
Italy
Brazil
Lebanon
Czechia
Israel
Spain

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

location_facility: Montefiore Medical Center Albert Einstein College of Med

location_facility: University of Cincinnati Cancer Institute

location_facility: Emory University School of Medicine/Winship Cancer Institute

title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Canakinumab in Combination With Docetaxel Versus Placebo in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancer (NSCLC) Previously Treated With PD-(L)1 Inhibitors and Platinum-based Chemotherapy (CANOPY 2)

summary: This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.


ReferenceCitation: Wiemer EAC, Wozniak A, Burger H, Smid M, Floris G, Nzokirantevye A, Sciot R, Sleijfer S, Schöffski P. Identification of microRNA biomarkers for response of advanced soft tissue sarcomas to eribulin: Translational results of the EORTC 62052 trial. Eur J Cancer. 2017 Apr;75:33-40. doi: 10.1016/j.ejca.2016.12.018. Epub 2017 Feb 16.

family: Wiemer

full_name: Erik A.C. Wiemer

given: Erik A.C.

family: Wozniak

full_name: Agnieszka Wozniak

given: Agnieszka

family: Burger

full_name: Herman Burger

given: Herman

family: Smid

full_name: Marcel Smid

given: Marcel

family: Floris

full_name: Giuseppe Floris

given: Giuseppe

family: Nzokirantevye

full_name: Axelle Nzokirantevye

given: Axelle

family: Sciot

full_name: Raf Sciot

given: Raf

family: Sleijfer

full_name: Stefan Sleijfer

given: Stefan

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

journal_name: European Journal of Cancer

ReferenceCitation: Schöffski P, Ray-Coquard IL, Cioffi A, Bui NB, Bauer S, Hartmann JT, Krarup-Hansen A, Grünwald V, Sciot R, Dumez H, Blay JY, Le Cesne A, Wanders J, Hayward C, Marreaud S, Ouali M, Hohenberger P; European Organisation for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG). Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol. 2011 Oct;12(11):1045-52. doi: 10.1016/S1470-2045(11)70230-3. Epub 2011 Sep 19. Erratum in: Lancet Oncol. 2015 Sep;16(9):e427.

family: Ray-Coquard

full_name: Isabelle Laure Ray-Coquard

given: Isabelle Laure

family: Cioffi

full_name: Angela Cioffi

given: Angela

family: Bui

full_name: Nguyen Bin Bui

given: Nguyen Bin

family: Bauer

full_name: Sebastian Bauer

given: Sebastian

family: Hartmann

full_name: Joerg Thomas Hartmann

given: Joerg Thomas

family: Krarup-Hansen

full_name: Anders Krarup-Hansen

given: Anders

family: Grünwald

full_name: Viktor Grünwald

given: Viktor

family: Dumez

full_name: Herlinde Dumez

given: Herlinde

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Wanders

full_name: Jantien Wanders

given: Jantien

family: Hayward

title: Phase II Study of E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma

summary: The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.


title: 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

summary: This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

location_country:
Italy
United States
Switzerland
France
Spain
Germany
United Kingdom
Canada

location_facility: Az. Osp. Di Bologna Polici. S. Orsola - Malpighi

location_facility: Azienda Ospedaliera di Padova - Universita degli Studi

location_facility: Klinikum der Humboldt Universitat Charite

location_facility: Ciutat Santitaria I Univessitaria de Bellvitge

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Azienda Opedaliera Careggi - Universita degli Studi