title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors

summary: This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

ReferenceCitation: Dikranian AH, Gonzalez-Gay MA, Wellborne F, Álvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1). pii: e002103. doi: 10.1136/rmdopen-2021-002103.

ReferenceCitation: Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.

ReferenceCitation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3). pii: e001395. doi: 10.1136/rmdopen-2020-001395.

ReferenceCitation: Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.

ReferenceCitation: Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.

ReferenceCitation: Mariette X, Chen C, Biswas P, Kwok K, Boy MG. Lymphoma in the Tofacitinib Rheumatoid Arthritis Clinical Development Program. Arthritis Care Res (Hoboken). 2018 May;70(5):685-694. doi: 10.1002/acr.23421. Epub 2018 Apr 2.

ReferenceCitation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.

ReferenceCitation: Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.

ReferenceCitation: Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum in: Ann Rheum Dis. 2017 Mar;76(3):611.

ReferenceCitation: Strand V, Burmester GR, Zerbini CA, Mebus CA, Zwillich SH, Gruben D, Wallenstein GV. Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial. Arthritis Care Res (Hoboken). 2015 Apr;67(4):475-83. doi: 10.1002/acr.22453.

ReferenceCitation: Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.

ReferenceCitation: Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C; ORAL Step investigators. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. 2013 Feb 9;381(9865):451-60. doi: 10.1016/S0140-6736(12)61424-X. Epub 2013 Jan 5.

lead_sponsor: Pfizer

location_country:
Taiwan
Brazil
Spain
Ireland
Austria
Australia
Italy
Canada
Korea, Republic of
United States
France
Puerto Rico
Belgium
Germany


title: A Randomised, Open-label, Multi-centre, 2-stage, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC) in Comparison With LDAC Alone in Patients Aged ≥ 60 With Newly Diagnosed Acute Myeloid Leukaemia (AML)

summary: The purpose of this study is to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in AML patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Quintás-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Australia
United States
France
Romania
Japan
Germany

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.

ReferenceType: background

ReferenceCitation: van Lunzen J, Maggiolo F, Arribas JR, Rakhmanova A, Yeni P, Young B, Rockstroh JK, Almond S, Song I, Brothers C, Min S. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial. Lancet Infect Dis. 2012 Feb;12(2):111-8. doi: 10.1016/S1473-3099(11)70290-0. Epub 2011 Oct 20.

lead_sponsor: ViiV Healthcare

location_country:
Spain
Italy
Russian Federation
United States
France
Germany


title: Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled

acronym: LANCELOT

summary:
Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

Plasma glucose (fasting, nocturnal) over time,
Changes from baseline in HbA1c over time,
Percentage of patients who reach the target of HbA1c <7 and <6.5,
Use of prandial insulin as rescue medication at month 6,
Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
Daily dose of insulin,
Change in body weight from baseline,
Evolution of 8-point plasma-glucose (PG) profiles,
Overall safety,
Patient reported outcomes (treatment satisfaction).

ReferenceCitation: Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11:CD005613. doi: 10.1002/14651858.CD005613.pub4.

ReferenceCitation: Home PD, Bolli GB, Mathieu C, Deerochanawong C, Landgraf W, Candelas C, Pilorget V, Dain MP, Riddle MC. Modulation of insulin dose titration using a hypoglycaemia-sensitive algorithm: insulin glargine versus neutral protamine Hagedorn insulin in insulin-naïve people with type 2 diabetes. Diabetes Obes Metab. 2015 Jan;17(1):15-22. doi: 10.1111/dom.12329. Epub 2014 Jul 12.

lead_sponsor: Sanofi

location_country:
Kuwait
Poland
Brazil
Romania
Italy
Russian Federation
United Arab Emirates
Czech Republic
Switzerland
Thailand
Sweden
Korea, Republic of
France
Mexico
Netherlands
Slovakia
Egypt

location_facility:
Investigational Site Number 250-003
Investigational Site Number 643-002
Investigational Site Number 643-007
Investigational Site Number 703003
Investigational Site Number 642003
Investigational Site Number 784-001
Investigational Site Number 703008
Investigational Site Number 250-005
Investigational Site Number 250-002
Investigational Site Number 528004
Investigational Site Number 528006
Investigational Site Number 528005
Investigational Site Number 528001
Investigational Site Number 642001
Investigational Site Number 484008
Investigational Site Number 076-005
Investigational Site Number 764003
Investigational Site Number 616002
Investigational Site Number 642011
Investigational Site Number 642009
Investigational Site Number 484003
Investigational Site Number 410005
Investigational Site Number 764001
Investigational Site Number 703001
Investigational Site Number 076-003
Investigational Site Number 703004
Investigational Site Number 642004
Investigational Site Number 203006
Investigational Site Number 203005
Investigational Site Number 076-006
Investigational Site Number 643-003
Investigational Site Number 643-001
Investigational Site Number 484001
Investigational Site Number 764004
Investigational Site Number 752002
Investigational Site Number 642010
Investigational Site Number 203008
Investigational Site Number 756001
Investigational Site Number 703007
Investigational Site Number 643-006
Investigational Site Number 484005
Investigational Site Number 203002
Investigational Site Number 528002
Investigational Site Number 616001
Investigational Site Number 410001
Investigational Site Number 410006
Investigational Site Number 642007
Investigational Site Number 203007
Investigational Site Number 484009
Investigational Site Number 616004
Investigational Site Number 642005
Investigational Site Number 616003
Investigational Site Number 642002
Investigational Site Number 410004
Investigational Site Number 203004
Investigational Site Number 703006
Investigational Site Number 203011
Investigational Site Number 764002
Investigational Site Number 752003
Investigational Site Number 484002
Investigational Site Number 414001
Investigational Site Number 250-006
Investigational Site Number 076-002
Investigational Site Number 203009
Investigational Site Number 076-004
Investigational Site Number 250-004
Investigational Site Number 752001
Investigational Site Number 203010
Investigational Site Number 528003
Investigational Site Number 643-005
Investigational Site Number 410002
Investigational Site Number 380001
Investigational Site Number 642008
Investigational Site Number 764005
Investigational Site Number 076-001
Investigational Site Number 643-004
Investigational Site Number 250-001
Investigational Site Number 076-007
Investigational Site Number 818001
Investigational Site Number 642012
Investigational Site Number 703005
Investigational Site Number 752004
Investigational Site Number 203001
Investigational Site Number 764006
Investigational Site Number 703002
Investigational Site Number 410003
Investigational Site Number 203003


title: A Multi-center, Randomized, Open Label, Controlled Study to Compare the Sustained Virological Response During Treatment With Neoral or Tacrolimus in Maintenance Liver Transplant Recipients Treated With Pegylated Interferon and Ribavirin for Recurrent Hepatitis C

acronym: SUSTAIN

summary: This study will assess the rates of Sustained Virological Response following anti-viral therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with recurrent Hepatitis C and treated with Neoral or tacrolimus.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Brazil
Belgium
Spain
Italy
Russian Federation
United Kingdom
Canada
Switzerland
Korea, Republic of
United States
France
Colombia
Germany


ipd_sharing: Yes

acronym: GALACCTIC

intervention_type: Other

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma

lead_sponsor: Astellas Pharma Inc

type: EudraCT Number

source: euctr

study_start_date_type: Actual

ReferenceCitation: Fassnacht M, Berruti A, Baudin E, Demeure MJ, Gilbert J, Haak H, Kroiss M, Quinn DI, Hesseltine E, Ronchi CL, Terzolo M, Choueiri TK, Poondru S, Fleege T, Rorig R, Chen J, Stephens AW, Worden F, Hammer GD. Linsitinib (OSI-906) versus placebo for patients with locally advanced or metastatic adrenocortical carcinoma: a double-blind, randomised, phase 3 study. Lancet Oncol. 2015 Apr;16(4):426-35. doi: 10.1016/S1470-2045(15)70081-1. Epub 2015 Mar 18.

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Poland
United Kingdom
Italy
Australia
Netherlands
Canada
United States
France
Germany

location_facility: CHRU Lille, Clinique Endocrinologique Marc Linquette

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach

location_facility: TGen Clinical Research Service at Scottsdale Healthcare

location_facility: Royal North Shore Hospital Department of Endocrinology

location_facility: University of Colorado Denver Cancer Center

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

summary: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens


title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

summary: The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

lead_sponsor: MacroGenics

location_country:
Poland
Romania
Spain
Italy
United Kingdom
Mexico
Netherlands
Finland
Ukraine
France
United States
India
Israel
Belgium
Germany
Czechia

location_facility: B. P. Poddar Hospital & Medical Research Limited

location_facility: Ukrainian Children Specialized Clinical Hospital

location_facility: Clinical Innovations Inc. Research Facility

location_facility: Regional Clinical Endocrinology Dispensary of MoH Ukraine

location_facility: University of Missouri - Columbia, Cosmopolitan Diabetes and Endocrinology

location_facility: U.O. di Malattie Metaboliche e Diabetologia

location_facility: Institutul National De Diabet, Nutritie si Boli Metabolice

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: Centro Especializado en Diabetes, Obesidad y Prevención de Enfermedades Cardiovasculares, S.C.

location_facility: East Carolina University, Brody School of Medicine

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital Civil

location_facility: Ivano-Frankivsk State Regional Pediatric Clinical Hospital

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: CHU de Brest Hôpital de la Cavale Blanche

location_facility: Donetsk Regional Children Clinical Hospital

location_facility: I. Detska interni klinika,Fakultni nemocnice Brno Detska nemocnice

location_facility: Maryland Diabetes & Endocrine Associates

location_facility: The Safra Children's Hospital, The Chaim Sheba Medical Center

location_facility: Hospital Universitario Principe de Asturias

location_facility: Klinika deti a dorostu FN Kralovske Vinohrady

location_facility: Virginia Commonwealth University-Division of Pediatric Endocrinology & Metabolism

location_facility: Herz und Diabeteszentrum Nordrhein-Westfallen

location_facility: John H Stoger Jr. Hospital of Cook County, Cook County Hospital

location_facility: University of Bristol Henery Wellcome laboratories for Integrative Neuroscience and Endocrinology,

location_facility: Institute of Endocrinology and Metabolism named after V.Komisarenko of AMS Ukraine

location_facility: Diabetes-Thyroid-Hormone Research Institute Pvt. Ltd.

location_facility: Maulana Azad Medical College and Associated Hospitals

location_facility: Wojewódzki Specjalistyczny Szpital Dzieciecy

location_facility: Centrum diabetologie, Institut klinicke a experimentalni mediciny

location_facility: Detska klinika, Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 4

location_facility: Queens Medical Centre, Diabetes and Endocrinology Unit

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr1 we Wroclawiu

location_facility: Kings College, Clinical Research Unit, Department of Diabetes and Endocrinology

location_facility: Pediatricka klinika UK 2.LF a FN Motol, Fakultni nemocnice v Motole

location_facility: Struttura Complessa di Pediatria, Azienda Ospedaliero-Universitaria di Modena,

location_facility: University Diabetes & Endocrine Consultants

location_facility: Diabetes and Glandular Disease Research Associates, PA

location_facility: Kharkiv Regional Clinical Children Hospital, Department of Endocrinology

location_facility: Sheffield Children's Hospital NHS Foundation Trust

location_facility: Children's Hospitals and Clinics of Minnesota

location_facility: Hospital y Clinica OCA / Monterrey International Research Center

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Samodzielny Publiczny Dzieciecy Szpital Kliniczny w Warszawie-Filia


title: A Prospective, Multi-center Trial of NovoTTF-100A Together With Temozolomide Compared to Temozolomide Alone in Patients With Newly Diagnosed GBM.

summary: The study is a prospective, randomly controlled pivotal trial, designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed GBM patients. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

enrollment_type: Anticipated

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Salzberg M, Kirson E, Palti Y, Rochlitz C. A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors. Onkologie. 2008 Jul;31(7):362-5. doi: 10.1159/000137713. Epub 2008 Jun 24.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Kirson ED, Schneiderman RS, Dbalý V, Tovarys F, Vymazal J, Itzhaki A, Mordechovich D, Gurvich Z, Shmueli E, Goldsher D, Wasserman Y, Palti Y. Chemotherapeutic treatment efficacy and sensitivity are increased by adjuvant alternating electric fields (TTFields). BMC Med Phys. 2009 Jan 8;9:1. doi: 10.1186/1756-6649-9-1.

ReferenceCitation: Ram Z, Kim CY, Hottinger AF, Idbaih A, Nicholas G, Zhu JJ. Efficacy and Safety of Tumor Treating Fields (TTFields) in Elderly Patients with Newly Diagnosed Glioblastoma: Subgroup Analysis of the Phase 3 EF-14 Clinical Trial. Front Oncol. 2021 Sep 27;11:671972. doi: 10.3389/fonc.2021.671972. eCollection 2021. Erratum in: Front Oncol. 2022 Apr 12;12:902929.

ReferenceCitation: Kim CY, Paek SH, Nam DH, Chang JH, Hong YK, Kim JH, Kim OL, Kim SH. Tumor treating fields plus temozolomide for newly diagnosed glioblastoma: a sub-group analysis of Korean patients in the EF-14 phase 3 trial. J Neurooncol. 2020 Feb;146(3):399-406. doi: 10.1007/s11060-019-03361-2. Epub 2020 Feb 4.

ReferenceCitation: Ballo MT, Urman N, Lavy-Shahaf G, Grewal J, Bomzon Z, Toms S. Correlation of Tumor Treating Fields Dosimetry to Survival Outcomes in Newly Diagnosed Glioblastoma: A Large-Scale Numerical Simulation-Based Analysis of Data from the Phase 3 EF-14 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Aug 1;104(5):1106-1113. doi: 10.1016/j.ijrobp.2019.04.008. Epub 2019 Apr 23.

ReferenceCitation: Toms SA, Kim CY, Nicholas G, Ram Z. Increased compliance with tumor treating fields therapy is prognostic for improved survival in the treatment of glioblastoma: a subgroup analysis of the EF-14 phase III trial. J Neurooncol. 2019 Jan;141(2):467-473. doi: 10.1007/s11060-018-03057-z. Epub 2018 Dec 1.

ReferenceCitation: Taphoorn MJB, Dirven L, Kanner AA, Lavy-Shahaf G, Weinberg U, Taillibert S, Toms SA, Honnorat J, Chen TC, Sroubek J, David C, Idbaih A, Easaw JC, Kim CY, Bruna J, Hottinger AF, Kew Y, Roth P, Desai R, Villano JL, Kirson ED, Ram Z, Stupp R. Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Apr 1;4(4):495-504. doi: 10.1001/jamaoncol.2017.5082.

ReferenceCitation: Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum in: JAMA. 2018 May 1;319(17):1824.

ReferenceCitation: Kesari S, Ram Z; EF-14 Trial Investigators. Tumor-treating fields plus chemotherapy versus chemotherapy alone for glioblastoma at first recurrence: a post hoc analysis of the EF-14 trial. CNS Oncol. 2017 Jul;6(3):185-193. doi: 10.2217/cns-2016-0049. Epub 2017 Apr 12.

ReferenceCitation: Meletath SK, Pavlick D, Brennan T, Hamilton R, Chmielecki J, Elvin JA, Palma N, Ross JS, Miller VA, Stephens PJ, Snipes G, Rajaram V, Ali SM, Melguizo-Gavilanes I. Personalized Treatment for a Patient With a BRAF V600E Mutation Using Dabrafenib and a Tumor Treatment Fields Device in a High-Grade Glioma Arising From Ganglioglioma. J Natl Compr Canc Netw. 2016 Nov;14(11):1345-1350.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

lead_sponsor: NovoCure Ltd.

location_country:
Spain
Italy
Austria
Canada
Czech Republic
Switzerland
Sweden
Korea, Republic of
United States
France
Israel
Germany

location_facility: Seoul National University Hospital (SNUH)

location_facility: Hospital Universitari de Bellvitge-ICO Duran i Reynals

location_facility: Washington University School of Medicine, Division of Oncology

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

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: New Jersey Neuroscience Center - JFK Medical Center

location_facility: The University of Texas Health Science Center at Houston (UTHSC)

location_facility: Mount Sinai Medical Center, Department of Neurosurgery

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Chungnam National University Hospital (CNUH)

location_facility: Hospital of the University of Pennsylvania

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Yonsei University Severance Hospital (YUHS)

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Az. Ospedaliero-Universitaria - Ospedali Riuniti

location_facility: (CHUS) Centre Hospitalier Universitaire de Sherbrooke, Service de Neurochirurgie

location_facility: Hospital 12 de Octubre, Servicio de Oncología Médica

location_facility: Istituti Fisioterapici Ospitalieri - Istituto Nazionale dei Tumori Regina Elena

location_facility: Centre Hospitalier Universitaire Vaudois (CHUV)

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hôpital Saint André Centre Hospitalier Universitaire (CHU) des Hôpitaux de Bordeaux

location_facility: Centre Hospitalo-Universitaire de Toulouse Purpan

location_facility: The Ohio State University Arthur G. James Cancer Hospital and Solove Research Institute

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Seoul National University Bundang Hospital (SNUBH)

location_facility: University of California San Diego Moores Cancer Center (UCSD)

location_facility: University of Kentucky, Markey Cancer Center

location_facility: McGill - Gerald Bronfman Centre for Clinical Research in Oncology -

location_facility: Emory University, Winship Cancer Institute

location_facility: University Hospital of Schleswig-Holstein

intervention_type: Device


acronym: ORIGIN

title: A Phase 3, Multicenter, Randomized, Openlabel, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) Versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients With B-Cell Chronic Lymphocytic Leukemia (The Origin Trial)

lead_sponsor: Celgene

ReferenceType: result

ReferenceCitation: Chanan-Khan A, Egyed M, Robak T, Martinelli de Oliveira FA, Echeveste MA, Dolan S, Desjardins P, Blonski JZ, Mei J, Golany N, Zhang J, Gribben JG. Randomized phase 3 study of lenalidomide versus chlorambucil as first-line therapy for older patients with chronic lymphocytic leukemia (the ORIGIN trial). Leukemia. 2017 May;31(5):1240-1243. doi: 10.1038/leu.2017.47. Epub 2017 Jan 31.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Slovakia
Brazil
Canada
Hungary
Bulgaria
Denmark
New Zealand
France
Chile
Colombia
Netherlands

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos

location_facility: Klinicka bolnica Dubrava Klinika za unutarnje bolesti Odjel za Hematologiju

location_facility: Herlev University Hospital Dep of hematology

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: BIOCANCER - Centro de Pesquisa e Tratamento do Câncer S/A

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Specjalistyczny Szpital miejski im. Kopernika

location_facility: Pro Onco Centro de Tratamento Oncologico

location_facility: Spitalul Clinic Judetean de Urgenta Sf Spiridon Iasi

location_facility: University hospital Sveti Georgi Hematology Clinic

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Regional Health Authority B-Saint John Regional Hospital

location_facility: Instituto Portugues Oncologia do Porto Francisco Gentil EPE

location_facility: Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: St. Bartholomew's and The Royal London Hospital

location_facility: Szegedi TudomanyegyetemII Belgyogyaszati Klinika

location_facility: Central Texas Veterans Health Care System

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: Centro de Estudos e Pesquisas de Hematologia e Oncologia da Faculdade de Medicina do ABC

location_facility: IRCSS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Klinika Chorob wewnetrznych i Hematologii

location_facility: Floyd Memorial Cancer Center of Indiana, a division of Floyd Memorial Hospital and Health Services

location_facility: GUZ Nizhegorodskaya Regional Clinical Hospital

location_facility: Russian Academy of Medical Sciences Institution

location_facility: Komarom-Esztergom Megye Onkormanyzat Szent Borbala Korhaza

location_facility: MHAT Georgi Stranski PlevenHematology Clinic

location_facility: Instituto Estadual Arthur de Siqueira Cavalcanti - HEMORIO

location_facility: Instituto de Ensino e Pesquisa Sao Lucas

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Wojewodzki Szpital Specjalistczny im. Mikolaja Kopernika

location_facility: Medical University of Vienna Internalmedicine 1, Hematology

location_facility: Spitalul Clinic Municipal de Urgenta Timisoara

location_facility: Fundação Antonio Prudente - AC Camargo Câncer center

location_facility: GUS Leningrad Regional Clinical Hospital

location_facility: Instituto Clinico Oncologico del Sur ICOS

location_facility: National Specialized Hospital for Active Treatment of Hematology Diseases

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Hospital General Universitario Morales Messeguer

location_facility: Azienda Ospedaliero Universitaria di Modena

summary: The purpose of this study is to determine the safety and efficacy of lenalidomide as a first line therapy in treating patients with B-cell Chronic Lymphocytic Leukemia. This study will compare the effects (good and bad) of lenalidomide with chlorambucil.


title: A Global, Multi-center, Open-label, Phase 2 Study of AGS-1C4D4 Given in Combination With Gemcitabine in Subjects With Metastatic Pancreatic Cancer

summary: A study to evaluate AGS-1C4D4 administered in combination with Gemcitabine chemotherapy in subjects with Metastatic Pancreatic Cancer.

ReferenceCitation: Wolpin BM, O'Reilly EM, Ko YJ, Blaszkowsky LS, Rarick M, Rocha-Lima CM, Ritch P, Chan E, Spratlin J, Macarulla T, McWhirter E, Pezet D, Lichinitser M, Roman L, Hartford A, Morrison K, Jackson L, Vincent M, Reyno L, Hidalgo M. Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer. Ann Oncol. 2013 Jul;24(7):1792-1801. doi: 10.1093/annonc/mdt066. Epub 2013 Feb 28.

location_country:
Spain
Russian Federation
Canada
United States
France

location_facility: Saint Petersburg State Healthcare Institution "Municipal Clinical Oncology Dispensary"

location_facility: Kaiser Permanente Northwest Region Oncology Hematology

location_facility: Vanderbilt University Medical Center, Div. of Medical Oncology

location_facility: Palm Beach Institute of Hematology and Oncology

location_facility: State Healthcare Institution of Omsk Region "Clinical Oncologic Dispensary"

location_facility: State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"

location_facility: Clinical Oncology Dispensary of Republic of Tatarstan

location_facility: Hospital Clinic i Provincial de Barcelona, Servicio de Oncologia

location_facility: Alan B. Pearson Regional Cancer Center Lynchburg Hematology Oncology Clinic

location_facility: State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"

location_facility: Hospital Virgen de la Salud, Servicio Oncologia

location_facility: Medical Radiology Research Center of Russian Medical Academy

location_facility: Hôpital du Haut Lèvêque, Service d'Hepato Gastroentérologie

location_facility: University of California San Diego Medical Center

location_facility: State Healthcare Institution "Leningrad Regional Oncologic Dispensary"

location_facility: Non-state Healthcare Institution N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway"

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Centre Régional de Lutte Contre le Cancer-Centre Oscar Lambret

intervention_type: Biological


title: Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic NSCLC

summary: The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.

ReferenceCitation: Jänne PA, Smith I, McWalter G, Mann H, Dougherty B, Walker J, Orr MC, Hodgson DR, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios CH, Franke FA, Crinò L, Smith P. Impact of KRAS codon subtypes from a randomised phase II trial of selumetinib plus docetaxel in KRAS mutant advanced non-small-cell lung cancer. Br J Cancer. 2015 Jul 14;113(2):199-203. doi: 10.1038/bjc.2015.215. Epub 2015 Jun 30.

ReferenceCitation: Jänne PA, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios C, Franke FA, Grinsted L, Zazulina V, Smith P, Smith I, Crinò L. Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: a randomised, multicentre, placebo-controlled, phase 2 study. Lancet Oncol. 2013 Jan;14(1):38-47. doi: 10.1016/S1470-2045(12)70489-8. Epub 2012 Nov 28.

location_country:
Brazil
Spain
Italy
Mexico
Canada
Hungary
United States
France
Peru
Belgium
Bulgaria
Czechia


title: A Double Blind Randomized Placebo-Controlled Parallel Group Dose-Ranging Study of Oral COL-144 in the Acute Treatment of Migraine

lead_sponsor: Eli Lilly and Company

type: Other Identifier

ReferenceCitation: Färkkilä M, Diener HC, Géraud G, Láinez M, Schoenen J, Harner N, Pilgrim A, Reuter U; COL MIG-202 study group. Efficacy and tolerability of lasmiditan, an oral 5-HT(1F) receptor agonist, for the acute treatment of migraine: a phase 2 randomised, placebo-controlled, parallel-group, dose-ranging study. Lancet Neurol. 2012 May;11(5):405-13. doi: 10.1016/S1474-4422(12)70047-9. Epub 2012 Mar 28.

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

location_country: Spain Finland France Belgium Germany

summary: The purpose of this study is to evaluate the efficacy and safety of a range of oral doses of COL-144 in treating migraine headache, in order to select a dose or doses for further evaluation.


title: A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects With Castration Resistant Prostate Cancer That Have Received Prior Treatment With Docetaxel

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Trump D. Commentary on: "Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): A multicentre, randomised, double-blind, phase 3 trial." Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR, CA184-043 Investigators. Departments of Urology and Immunology and Mayo Clinic Comprehensive Cancer Center, Mayo Clinic, Rochester, MN, USA, Electronic address: kwon.eugene@mayo.edu; Johns Hopkins Sidney Kimmel Comprehensive Cancer Center and Brady Urological Institute, Baltimore, MD, USA; Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA; Institut Gustave Roussy, University of Paris-Sud, Villejuif, France; Institut Gustave Roussy, Villejuif, France; VU University Medical Centre, Amsterdam, Netherlands; Vienna General Hospital, Medical University Vienna, Vienna, Austria; Institut Bergonié, Bordeaux, France; CHU Caremeau, Nimes, France; Centro Médico Austral, Buenos Aires, Argentina; Centre Jean Perrin, Clermont-Ferrand, France; St John of God Hospital, Subiaco, WA, Australia; University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy; Hospital de Caridade de Ijuí, Ijuí, Brazil; Nottingham University Hospital, Nottingham, UK; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA; Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands; Institute of Oncology Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, Romania; Hospital Británico de Buenos Aires, Buenos Aires, Argentina; Herlev Hospital, Herlev, Denmark; Odense University Hospital, Odense, Denmark; University of Texas MD Anderson Cancer Center, Houston,. Urol Oncol. 2016 May;34(5):249-50. doi: 10.1016/j.urolonc.2015.03.013. Epub 2015 Apr 20.

ReferenceCitation: Kwon ED, Drake CG, Scher HI, Fizazi K, Bossi A, van den Eertwegh AJ, Krainer M, Houede N, Santos R, Mahammedi H, Ng S, Maio M, Franke FA, Sundar S, Agarwal N, Bergman AM, Ciuleanu TE, Korbenfeld E, Sengeløv L, Hansen S, Logothetis C, Beer TM, McHenry MB, Gagnier P, Liu D, Gerritsen WR; CA184-043 Investigators. Ipilimumab versus placebo after radiotherapy in patients with metastatic castration-resistant prostate cancer that had progressed after docetaxel chemotherapy (CA184-043): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2014 Jun;15(7):700-12. doi: 10.1016/S1470-2045(14)70189-5. Epub 2014 May 13.

ReferenceCitation: Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13. Review.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Romania
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Mexico
Brazil
Canada
Hungary
Germany
Denmark
Greece
Ireland
Czech Republic
France
Chile
Colombia
Netherlands

location_facility: Siouxland Hematology-Oncology Assoc., Llp

location_facility: Suburban Hematology-Oncology Associates, Pc

location_facility: The Bunting-Blaustein Cancer Research Building

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: Kansas City Veterans Affairs Medical Center

location_facility: University Of Iowa Hospitals And Clinics

location_facility: Associates In Hematology & Oncology, P.C.

location_facility: St. Luke'S Hospital & Health Network Laboratory

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: The Center For Cancer And Blood Disorders

location_facility: Mid-Illinois Hematology & Oncology Associates, Ltd

location_facility: St Johns Medical Research Institute, Inc.

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: The University Of Texas Md Anderson Cancer Center

summary: The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia

acronym: COMORBID©

summary: Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.

ReferenceCitation: Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Büttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.

ReferenceCitation: Porst H, Gacci M, Büttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.

location_country:
Portugal
Greece
Italy
Russian Federation
Canada
United States
France
Mexico
Germany

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


title: CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil

acronym: CONCERT

summary: The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.

lead_sponsor: Medivation, Inc.

location_country:
United Kingdom
Italy
Australia
New Zealand
Finland
Sweden
United States
France
Belgium
Germany


title: A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multi-centre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 in Patients With Gastroesophageal Reflux Disease (GERD) Who Are Partial Responders to Proton Pump Inhibitor (PPI) Treatment

summary: The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors

lead_sponsor: Addex Pharma S.A.

location_country:
Netherlands
Switzerland
United States
France
Germany


title: Solifenacin in the Treatment of Urgency Symptoms of Overactive Bladder in a Rising Dose, Randomized, Placebo-controlled, Double-blind Trial

acronym: SUNRISE

summary: Prospective, double-blind, double-randomised, 2-arm parallel group study. Optimal dose increase. Primary efficacy assessment of OAB symptoms by patient diaries.

ReferenceCitation: Cardozo L, Hessdörfer E, Milani R, Arañó P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.

location_country:
Poland
Portugal
Spain
Greece
Italy
Russian Federation
United Kingdom
Czech Republic
Hungary
France
Belgium
Germany
Slovakia
Egypt


title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

summary: Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients had achieved complete response with first-line rituximab-chemotherapy

primary_purpose: Prevention

ReferenceCitation: Witzig TE, Tobinai K, Rigacci L, Ikeda T, Vanazzi A, Hino M, Shi Y, Mayer J, Costa LJ, Bermudez Silva CD, Zhu J, Belada D, Bouabdallah K, Kattan JG, Kuruvilla J, Kim WS, Larouche JF, Ogura M, Ozcan M, Fayad L, Wu C, Fan J, Louveau AL, Voi M, Cavalli F. Adjuvant everolimus in high-risk diffuse large B-cell lymphoma: final results from the PILLAR-2 randomized phase III trial. Ann Oncol. 2018 Mar 1;29(3):707-714. doi: 10.1093/annonc/mdx764.

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

location_country:
Saudi Arabia
Italy
Spain
Venezuela
United States
Peru
Japan
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Singapore
Slovakia
Egypt
Brazil
Lebanon
Canada
Switzerland
Hungary
China
Germany
Greece
New Zealand
Thailand
Korea, Republic of
France
Colombia

location_facility: South Texas Oncology and Hematology, PA South Texas Oncology (2)

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisMedicalCenter(4)

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

location_facility: University of Pittsburgh Medical Center SC-3

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (3)

location_facility: Baylor College of Medicine Dept.of Baylor College of Med.

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: University of Vermont Office of Clinical Trials Res.

location_facility: Rush University Medical Center Div. of Hematology & Oncology

location_facility: Indiana University Hospital IU Cancer Center

location_facility: Medical University of South Carolina -Hollings Cancer Center MUSC/HCC (2)

location_facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson (18)

location_facility: Blue Ridge Research Center at Roanoke Neurological Center SC

location_facility: Wake Forest University Baptist Medical Center Dept. of WFUHS

location_facility: Texas A&M HealthSciencesCtr-Scott & White Memorial Hospital CenterForCancerPrevention&Care

location_facility: Washington University School of Medicine Div. of Medical Oncology

location_facility: Mayo Clinic - Rochester Dept. of MayoClinic-Rochester

location_facility: Denver Health & Hospital Authority CACZ885M2301

location_facility: University of Tennessee Cancer Institute SC-2

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD

location_facility: University of Virginia Health Systems SC-2

location_facility: Dartmouth Hitchcock Medical Center Dartmouth

location_facility: Waukesha Memorial Hospital Cancer Center Dept.ofWaukeshaMemorialHosp.

location_facility: Tulane University Health Sciences Center Office of Clinical Research


title: A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone

acronym: REGAL

summary: The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.

ReferenceCitation: Batchelor TT, Mulholland P, Neyns B, Nabors LB, Campone M, Wick A, Mason W, Mikkelsen T, Phuphanich S, Ashby LS, Degroot J, Gattamaneni R, Cher L, Rosenthal M, Payer F, Jürgensmeier JM, Jain RK, Sorensen AG, Xu J, Liu Q, van den Bent M. Phase III randomized trial comparing the efficacy of cediranib as monotherapy, and in combination with lomustine, versus lomustine alone in patients with recurrent glioblastoma. J Clin Oncol. 2013 Sep 10;31(26):3212-8. doi: 10.1200/JCO.2012.47.2464. Epub 2013 Aug 12.

location_country:
United Kingdom
Austria
Australia
Netherlands
Canada
Czech Republic
United States
France
Belgium
Germany


status: Terminated

title: A Double-Blind, Placebo-Controlled, Randomized, Multi-Center, Dose-Finding Study of SLV320, a Selective A1 Adenosine Receptor Antagonist, to Evaluate the Effect on Renal Function and Safety in Subjects Hospitalized With Acute Decompensated Heart Failure and Renal Dysfunction (Reno-Defend 1)

lead_sponsor: Solvay Pharmaceuticals

type: Other Grant/Funding Number

ReferenceCitation: Pang PS, Mehra M, Maggioni AP, Filippatos G, Middlebrooks J, Turlapaty P, Kazei D, Gheorghiade M; RENO-DEFEND Investigators. Rationale, design, and results from RENO-DEFEND 1: a randomized, dose-finding study of the selective A1 adenosine antagonist SLV320 in patients hospitalized with acute heart failure. Am Heart J. 2011 Jun;161(6):1012-23.e3. doi: 10.1016/j.ahj.2011.03.004.

location_country:
Denmark
Poland
Italy
Russian Federation
Canada
Ukraine
United States
Chile
France
Romania
Germany

summary: The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

status_simplified: Unknown


title: A Phase II Study of Oral Panobinostat in Adult Patients With Relapsed/Refractory Classical Hodgkins Lymphoma After High-dose Chemotherapy With Autologous Stem Cell Transplant

ReferenceCitation: Chari A, Cho HJ, Dhadwal A, Morgan G, La L, Zarychta K, Catamero D, Florendo E, Stevens N, Verina D, Chan E, Leshchenko V, Laganà A, Perumal D, Mei AH, Tung K, Fukui J, Jagannath S, Parekh S. A phase 2 study of panobinostat with lenalidomide and weekly dexamethasone in myeloma. Blood Adv. 2017 Aug 21;1(19):1575-1583. doi: 10.1182/bloodadvances.2017007427. eCollection 2017 Aug 22.

ReferenceCitation: Harrison SJ, Hsu AK, Neeson P, Younes A, Sureda A, Engert A, Prince HM, Li M, Savage P, Bugarini R, Williams D, Squier M, Ritchie DS. Early thymus and activation-regulated chemokine (TARC) reduction and response following panobinostat treatment in patients with relapsed/refractory Hodgkin lymphoma following autologous stem cell transplant. Leuk Lymphoma. 2014 May;55(5):1053-60. doi: 10.3109/10428194.2013.820287. Epub 2013 Aug 5.

location_country:
Brazil
Spain
Italy
United Kingdom
Australia
New Zealand
United States
France
Israel
Malaysia
Belgium
Singapore
Germany

location_facility: Karmanos Cancer Institute Div.of Hematology/Oncology

location_facility: Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5)

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(2)

location_facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(5)

location_facility: Georgia Regents University Cancer Clinical Research Unit

location_facility: Dana Farber Cancer Institute Hematology / Oncology

location_facility: The Methodist Hospital Cell & Gene Therapy Clinic

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept. of Hematology (2)

location_facility: University of Pennsylvania Medical Center Dept of UPenn Med Ctr (3)

location_facility: Rush University Medical Center Divisionof Hem/Onc Research(2)

location_facility: West Virginia University/ Mary Babb Randolph Cancer Center

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)

summary: This study evaluated the efficacy of oral panobinostat in participants with refractory/relapsed classical Hodgkins lymphoma (HL) who have received prior treatment with high dose chemotherapy and autologous stem cell transplant. Safety of panobinostat also was assessed. Other markers that may correlate with efficacy or safety were explored.


title: A Phase 2, 12 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Proof Of Concept Study Evaluating The Efficacy And Safety Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis/Painful Bladder Syndrome.

summary: The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency. At the same time assess the drug's safety and tolerability.

ReferenceCitation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7:CD013325. doi: 10.1002/14651858.CD013325.pub2.

ReferenceCitation: Nickel JC, Crossland A, Davis E, Haab F, Mills IW, Rovner E, Scholfield D, Crook T. Investigation of a Ca2+ channel α2δ ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol. 2012 Sep;188(3):817-23. doi: 10.1016/j.juro.2012.05.010. Epub 2012 Jul 19.

location_country:
Denmark
Finland
Canada
United States
France
Germany


title: Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

acronym: SIRFLOX

summary:
This study is a randomized multi-center trial that will assess the effect of adding Selective Internal Radiation Therapy (SIRT), using SIR-Spheres microspheres®, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.

ReferenceCitation: van Hazel GA, Heinemann V, Sharma NK, Findlay MP, Ricke J, Peeters M, Perez D, Robinson BA, Strickland AH, Ferguson T, Rodríguez J, Kröning H, Wolf I, Ganju V, Walpole E, Boucher E, Tichler T, Shacham-Shmueli E, Powell A, Eliadis P, Isaacs R, Price D, Moeslein F, Taieb J, Bower G, Gebski V, Van Buskirk M, Cade DN, Thurston K, Gibbs P. SIRFLOX: Randomized Phase III Trial Comparing First-Line mFOLFOX6 (Plus or Minus Bevacizumab) Versus mFOLFOX6 (Plus or Minus Bevacizumab) Plus Selective Internal Radiation Therapy in Patients With Metastatic Colorectal Cancer. J Clin Oncol. 2016 May 20;34(15):1723-31. doi: 10.1200/JCO.2015.66.1181. Epub 2016 Feb 22. Erratum in: J Clin Oncol. 2016 Nov 20;34(33):4059.

ReferenceCitation: Wolstenholme J, Fusco F, Gray AM, Moschandreas J, Virdee PS, Love S, Van Hazel G, Gibbs P, Wasan HS, Sharma RA. Quality of life in the FOXFIRE, SIRFLOX and FOXFIRE-global randomised trials of selective internal radiotherapy for metastatic colorectal cancer. Int J Cancer. 2020 Aug 15;147(4):1078-1085. doi: 10.1002/ijc.32828. Epub 2020 Jan 9.

ReferenceCitation: Wasan HS, Gibbs P, Sharma NK, Taieb J, Heinemann V, Ricke J, Peeters M, Findlay M, Weaver A, Mills J, Wilson C, Adams R, Francis A, Moschandreas J, Virdee PS, Dutton P, Love S, Gebski V, Gray A; FOXFIRE trial investigators; SIRFLOX trial investigators; FOXFIRE-Global trial investigators, van Hazel G, Sharma RA. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials. Lancet Oncol. 2017 Sep;18(9):1159-1171. doi: 10.1016/S1470-2045(17)30457-6. Epub 2017 Aug 3.

ReferenceCitation: Virdee PS, Moschandreas J, Gebski V, Love SB, Francis EA, Wasan HS, van Hazel G, Gibbs P, Sharma RA. Protocol for Combined Analysis of FOXFIRE, SIRFLOX, and FOXFIRE-Global Randomized Phase III Trials of Chemotherapy +/- Selective Internal Radiation Therapy as First-Line Treatment for Patients With Metastatic Colorectal Cancer. JMIR Res Protoc. 2017 Mar 28;6(3):e43. doi: 10.2196/resprot.7201.

ReferenceCitation: Gibbs P, Gebski V, Van Buskirk M, Thurston K, Cade DN, Van Hazel GA; SIRFLOX Study Group. Selective Internal Radiation Therapy (SIRT) with yttrium-90 resin microspheres plus standard systemic chemotherapy regimen of FOLFOX versus FOLFOX alone as first-line treatment of non-resectable liver metastases from colorectal cancer: the SIRFLOX study. BMC Cancer. 2014 Dec 1;14:897. doi: 10.1186/1471-2407-14-897.

lead_sponsor: Sirtex Medical

location_country:
Poland
Spain
Italy
Australia
New Zealand
Switzerland
United States
France
Israel
Belgium
Germany

location_facility: Centre Hospitalier General de Longjumeau

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Praxis fur Hamatologie und Internnistische Onkologie

location_facility: Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie

location_facility: Gemeinschaftspraxis Hamatologie und internistische Onkologie

location_facility: Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik

location_facility: Imelda Ziekenhuis GI Clinical Research Centre

location_facility: Hospitalier Universitaire de Grenoble C.H.U.

location_facility: Florida International University College of Medicine Practice

location_facility: OL Vrouw Ziekenhuis Aalst Gastro-Enterologie

location_facility: Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin

location_facility: Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl

location_facility: Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Schwerpunktspraxis fur Hamatologie und Internistische Onkologie

location_facility: Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie

location_facility: Hospital de Navarra, Servicio de Ongoligia, Planta Baja

location_facility: Braxiskooperation Bonn, Fachartze fur Innere Medizin

location_facility: VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel

location_facility: Schwerpunktpraxis fur Hamatologie und Onkologie

location_facility: Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr

location_facility: Institut Jules Bordet - Centre de Tumeurs d'ULB


title: Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822

summary: This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.

lead_sponsor: Hoffmann-La Roche

location_country:
Brazil
Hong Kong
Italy
Austria
Australia
Argentina
Canada
Switzerland
Thailand
Hungary
France
Israel
Singapore
Mexico
Germany
Bulgaria
Slovakia


title: Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

summary: This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

ReferenceCitation: Rosenstock J, Balas B, Charbonnel B, Bolli GB, Boldrin M, Ratner R, Balena R; T-emerge 2 Study Group. The fate of taspoglutide, a weekly GLP-1 receptor agonist, versus twice-daily exenatide for type 2 diabetes: the T-emerge 2 trial. Diabetes Care. 2013 Mar;36(3):498-504. doi: 10.2337/dc12-0709. Epub 2012 Nov 8.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
South Africa
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Mexico
Sweden
Brazil
Canada
Switzerland
Guatemala
Germany
Denmark
Greece
New Zealand
Finland
Thailand
Korea, Republic of
France


title: Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study

summary:
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML.

The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

status: Unknown status

ReferenceCitation: Stone RM, Mazzola E, Neuberg D, Allen SL, Pigneux A, Stuart RK, Wetzler M, Rizzieri D, Erba HP, Damon L, Jang JH, Tallman MS, Warzocha K, Masszi T, Sekeres MA, Egyed M, Horst HA, Selleslag D, Solomon SR, Venugopal P, Lundberg AS, Powell B. Phase III open-label randomized study of cytarabine in combination with amonafide L-malate or daunorubicin as induction therapy for patients with secondary acute myeloid leukemia. J Clin Oncol. 2015 Apr 10;33(11):1252-7. doi: 10.1200/JCO.2014.57.0952. Epub 2015 Mar 2.

ReferenceCitation: Lindsley RC, Mar BG, Mazzola E, Grauman PV, Shareef S, Allen SL, Pigneux A, Wetzler M, Stuart RK, Erba HP, Damon LE, Powell BL, Lindeman N, Steensma DP, Wadleigh M, DeAngelo DJ, Neuberg D, Stone RM, Ebert BL. Acute myeloid leukemia ontogeny is defined by distinct somatic mutations. Blood. 2015 Feb 26;125(9):1367-76. doi: 10.1182/blood-2014-11-610543. Epub 2014 Dec 30.

lead_sponsor: Antisoma Research

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Canada
Hungary
Germany
Taiwan
Estonia
Ecuador
Czech Republic
Korea, Republic of
France
Chile

location_facility: State Higher Educational Instution Rostov State

location_facility: Univ of Southern California Comprehensive Cancer Center

location_facility: Chang Gung Memorial Hospital Kao Hsiung Branch

location_facility: Northshore Hospital - Monter Cancer Center

location_facility: Nicolaus Copernicus Provincial Specialist Hospital in Lodz

location_facility: Federal Center of Heart, Blood and Endocrinology

location_facility: Public Institution 'Cherkasy Regional Oncology Center'

location_facility: Ivano-Frankivsk State Medical University

location_facility: State Medical Institution Republican Hospital n.a. V.A. Baranov

location_facility: Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant

location_facility: Poznan Stare Miasto Health Care Facility

location_facility: Institute of Haematology and Blood Transfusion Prague

location_facility: Chinese Medical University Hospital (CMUH)

location_facility: Sibiu County Clinical Hospital, Internal Clinic II

location_facility: Hospital General de Agudos "Dr. Teodoro Alvarez"

location_facility: State Medical Institution Sverdlovsk Regional Clinical Hospital #1

location_facility: The Blood and Marrow Transplant Group of GA

location_facility: Municipal Medical Institution Municipal Hospital #1

location_facility: Dnipropetrovsk City General Clinical Hospital #4

location_facility: State Medical Institution Territorial Clinical Oncological Center

location_facility: State Medical Institution Irkutsk Regional Clinical Hospital

location_facility: University of Colorado Health Sciences Center

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Independent Public University Hospital No. 1 in Wroclaw

location_facility: State Institution Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences

location_facility: M.I. Pyrohov Vinnytsya Regional Clinical Hospital

location_facility: Markische Kliniken GmbH Klinikim Ludenscheid

location_facility: Moscow State Medical Institution Municipal

location_facility: Winship Cancer Institute, Emory University

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government

location_facility: University Hospital Kralovske Vinohrady Prague

location_facility: National Taiwan University Hospital (NTUH)

location_facility: O.F. Herbachevsky Zhytomyr Regional Clinical Hospital

location_facility: Academic Clinical Centre - Teaching Hospital of the Medical University of Gdansk

location_facility: State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development

location_facility: Colentina Clinical Hospital, Internal Medicine Department

location_facility: Università degli Studi di Roma "La Sapienza"

location_facility: Institute of Hematology and Transfusiology

location_facility: Dr. Constantin Opris County Emergency Hospital, Internal Medicine Department

location_facility: Brasov County Emergency Clinical Hospital

location_facility: Janusz Korczak Provincial Specialist Hospital

location_facility: State Medical Institution Territorial Clinical Hospital #1

location_facility: State Institution 'Institute of Blood Pathology and Transfusion Medicine under the UAMS'

location_facility: National Cheng Kung University Hospital (NCKUH)

location_facility: Teaching Hospital of the Medical University in Bialystok

location_facility: Northwestern University School of Medicine

location_facility: Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó

location_facility: State Medical Institution Leningrad Regional Clinical Hospital

location_facility: Veterans General Hospital Taipei (VGH-TP)


title: An International, Randomized, Double-Blinded, Phase 3 Efficacy Study of XL184 Versus Placebo in Subjects With Unresectable, Locally Advanced, or Metastatic Medullary Thyroid Cancer

acronym: EXAM

summary:
The purpose of this research study is to evaluate the progression-free survival (PFS) with XL184 as compared with placebo (an inactive substance) in subjects with unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC). Subjects will be randomized to receive XL184 or placebo in a 2:1 ratio. XL184 is an investigational drug that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

The Clinical Steering Committee for this study, comprised of study doctors who specialize in medullary thyroid cancer, has provided guidance regarding the design of the study. The committee includes: Douglas Ball, MD, Barry Nelkin, PhD, Martin Schlumberger, MD and Steven Sherman, MD.

ReferenceCitation: Schlumberger M, Elisei R, Müller S, Schöffski P, Brose M, Shah M, Licitra L, Krajewska J, Kreissl MC, Niederle B, Cohen EEW, Wirth L, Ali H, Clary DO, Yaron Y, Mangeshkar M, Ball D, Nelkin B, Sherman S. Overall survival analysis of EXAM, a phase III trial of cabozantinib in patients with radiographically progressive medullary thyroid carcinoma. Ann Oncol. 2017 Nov 1;28(11):2813-2819. doi: 10.1093/annonc/mdx479.

ReferenceCitation: Elisei R, Schlumberger MJ, Müller SP, Schöffski P, Brose MS, Shah MH, Licitra L, Jarzab B, Medvedev V, Kreissl MC, Niederle B, Cohen EE, Wirth LJ, Ali H, Hessel C, Yaron Y, Ball D, Nelkin B, Sherman SI. Cabozantinib in progressive medullary thyroid cancer. J Clin Oncol. 2013 Oct 10;31(29):3639-46. doi: 10.1200/JCO.2012.48.4659. Epub 2013 Sep 3. Erratum in: J Clin Oncol. 2014 Jun 10;32(17):1864.

lead_sponsor: Exelixis

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
United States
Peru
Belgium
Poland
Portugal
Austria
Russian Federation
India
Israel
Sweden
Brazil
Canada
Switzerland
Germany
Denmark
Greece
Korea, Republic of
France
Chile
Netherlands

location_facility: Indo-American Cancer Institute and Research Center

location_facility: Washington University School of Medicine

location_facility: Hospital of the University of Pennsylvania

location_facility: Deenanath Mangeshkar Hospital & Research Center

location_facility: University of Alabama at Birmingham, Comprehensive Cancer Center

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen

location_facility: University of Arkansas for Medical Sciences

location_facility: SEAROC Cancer Institute, S.K. Soni Hospital

location_facility: Vermont Cancer Center at Fletcher Allen Health Care

location_facility: H. Lee Moffet Cancer Center and Research Institute

location_facility: Netaji Subhash Chandra Bose Cancer Hospital Research Institute

location_facility: Capitol Comprehensive Cancer Care Clinic and Research Institute

location_facility: Klinik fuer Nuklearmedizin des Universitaetsklinikums Essen

location_facility: Ohio State University, James Cancer Hospital

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: TGEN Clinical Research Service at Scottsdale Healthcare


title: Maintenance of Response After Open-Label Treatment With Atomoxetine Hydrochloride in Adult Outpatients With Attention-Deficit/Hyperactivity Disorder (ADHD): A Placebo-Controlled, Randomized Withdrawal Study

ReferenceCitation: Tanaka Y, Escobar R, Upadhyaya HP. Assessment of effects of atomoxetine in adult patients with ADHD: consistency among three geographic regions in a response maintenance study. Atten Defic Hyperact Disord. 2017 Jun;9(2):113-120. doi: 10.1007/s12402-016-0212-7. Epub 2017 Jan 6.

ReferenceCitation: Upadhyaya H, Tanaka Y, Lipsius S, Kryzhanovskaya LA, Lane JR, Escobar R, Trzepacz PT, Allen AJ. Time-to-onset and -resolution of adverse events before/after atomoxetine discontinuation in adult patients with ADHD. Postgrad Med. 2015;127(7):677-85. doi: 10.1080/00325481.2015.1083394. Epub 2015 Sep 2.

ReferenceCitation: Upadhyaya H, Adler LA, Casas M, Kutzelnigg A, Williams D, Tanaka Y, Arsenault J, Escobar R, Allen AJ. Baseline characteristics of European and non-European adult patients with attention deficit hyperactivity disorder participating in a placebo-controlled, randomized treatment study with atomoxetine. Child Adolesc Psychiatry Ment Health. 2013 May 6;7(1):14. doi: 10.1186/1753-2000-7-14.

location_country:
Portugal
Spain
Italy
Austria
Netherlands
United Kingdom
Finland
Switzerland
Sweden
France
Belgium
Germany

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

summary: LYDO is a multi-center study that will enroll approximately 1925 adult outpatients with Attention Deficit/Hyperactivity Disorder (ADHD). Patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. Those patients that meet the response criteria will continue the blind phase of the study up to a year. During that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).


acronym: EXPAND

title: Open-label, Randomized, Controlled, Multicenter Phase III Study Investigating Cetuximab in Combination With Capecitabine (Xeloda, X) and Cisplatin (P) Versus XP Alone as First-line Treatment for Subjects With Advanced Gastric Adenocarcinoma Including Adenocarcinoma of the Gastroesophageal Junction

lead_sponsor: Merck KGaA, Darmstadt, Germany

location_country:
Spain
Italy
United Kingdom
Romania
Belgium
Japan
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Brazil
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Czech Republic
Korea, Republic of
France
Chile

location_facility:
Research site
Research Site

summary:
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) [XP] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).

Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.


title: A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes

summary: This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

ReferenceCitation: Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31. Erratum In: Drugs Aging. 2021 Apr 23;:

ReferenceCitation: Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. Epub 2016 Aug 29. Erratum in: Ann Oncol. 2018 Apr 1;29(4):1076.

lead_sponsor: Bausch Health Americas, Inc.

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

location_facility:
Salix Investigational Site
Pfizer Investigational Site


title: A Phase IA/II, Multi-center, Open-label Study of HCD122 Administered Intravenously Once Weekly for Four Weeks in Adult Patients With Advanced Non-Hodgkin's or Hodgkin's Lymphoma Who Have Progressed After at Least Two Prior Therapies (CHIR-12.12-LYM-01)

design_allocation: Non-Randomized

location_country:
Hong Kong
United Kingdom
Italy
Australia
Canada
Korea, Republic of
United States
France
Singapore
Belgium
Germany

location_facility: St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2)

location_facility: Wake Forest University Baptist Medical Center Dept. of Industry Research (2)

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(3)

summary: This study is to evaluate the highest tolerated dose, safety and activity of HCD122 in adults with non-Hodgkin's or Hodgkin's lymphoma who have received at least two prior therapies.


acronym: ASTER

title: Protocol for a Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week Treatment, Adaptive Proof-of-principle Study of Twice Daily Oral Dosing of a Novel PDE4 Inhibitor (ASP9831) in Subjects With Non-alcoholic Steatohepatitis (NASH)

location_country:
Belgium
United Kingdom
Czech Republic
Switzerland
France
Romania
Germany

summary: The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period


acronym: 48-week comparison of Tiotropium/Salmeterol Inhalation Powder with the individual components

title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)

lead_sponsor: Boehringer Ingelheim

location_country:
Denmark
Greece
Austria
Estonia
Italy
Canada
Finland
Latvia
Lithuania
Netherlands
Hungary
Sweden
Korea, Republic of
United States
France
Belgium
Germany
Slovakia

location_facility: 1184.14.3302A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37201 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.45001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01010 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01015 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01011 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01012 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.43001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303C Boehringer Ingelheim Investigational Site

location_facility: 1184.14.35801 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37103 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37102 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01018 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.42103 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01009 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37101 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.32001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01017 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.39001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.45002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.32004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01020 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37202 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3301A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.36002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3303B Boehringer Ingelheim Investigational Site

location_facility: 1184.14.82003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01022 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49004 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01019 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02010 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.3304A Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01005 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01021 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31001 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.37003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01013 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01007 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.35802 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.31002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.01014 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02003 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.46002 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.30006 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.49008 Boehringer Ingelheim Investigational Site

location_facility: 1184.14.02002 Boehringer Ingelheim Investigational Site

summary: The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined by the SGRQ and the effect on COPD exacerbations.


title: A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A β-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults

summary: To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.

lead_sponsor: Pfizer

location_country:
United Kingdom
Italy
Netherlands
Finland
United States
France
India
Belgium
Norway
Germany


title: Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi

acronym: VITAL

summary: The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.

ReferenceCitation: Kovanda LL, Desai AV, Lu Q, Townsend RW, Akhtar S, Bonate P, Hope WW. Isavuconazole Population Pharmacokinetic Analysis Using Nonparametric Estimation in Patients with Invasive Fungal Disease (Results from the VITAL Study). Antimicrob Agents Chemother. 2016 Jul 22;60(8):4568-76. doi: 10.1128/AAC.00514-16. Print 2016 Aug.

ReferenceCitation: Thompson GR 3rd, Rendon A, Ribeiro Dos Santos R, Queiroz-Telles F, Ostrosky-Zeichner L, Azie N, Maher R, Lee M, Kovanda L, Engelhardt M, Vazquez JA, Cornely OA, Perfect JR. Isavuconazole Treatment of Cryptococcosis and Dimorphic Mycoses. Clin Infect Dis. 2016 Aug 1;63(3):356-62. doi: 10.1093/cid/ciw305. Epub 2016 May 11.

ReferenceCitation: Marty FM, Ostrosky-Zeichner L, Cornely OA, Mullane KM, Perfect JR, Thompson GR 3rd, Alangaden GJ, Brown JM, Fredricks DN, Heinz WJ, Herbrecht R, Klimko N, Klyasova G, Maertens JA, Melinkeri SR, Oren I, Pappas PG, Ráčil Z, Rahav G, Santos R, Schwartz S, Vehreschild JJ, Young JH, Chetchotisakd P, Jaruratanasirikul S, Kanj SS, Engelhardt M, Kaufhold A, Ito M, Lee M, Sasse C, Maher RM, Zeiher B, Vehreschild MJGT; VITAL and FungiScope Mucormycosis Investigators. Isavuconazole treatment for mucormycosis: a single-arm open-label trial and case-control analysis. Lancet Infect Dis. 2016 Jul;16(7):828-837. doi: 10.1016/S1473-3099(16)00071-2. Epub 2016 Mar 9.

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Brazil
Russian Federation
Australia
Lebanon
Argentina
Canada
Mexico
Thailand
Korea, Republic of
United States
Chile
France
India
Belgium
Israel
Germany
South Africa
Egypt

location_facility: Regional Infection Diseases Infusion Center Inc.

location_facility: University of California at San Francisco

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Hadassah Universtiy Hospital - Ein Kerem

location_facility: Hamilton Health Sciences - Henderson Site

location_facility: Republican Hospital named after V.A. Baranov

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: University of California Davis Health System

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Hospital de Clinicas da FMUSP - Ribeirao Preto

location_facility: Hospital Universitario Clementino Fraga Filho

location_facility: Upstate Infectious Diseases Association LLP

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: University of Pittsburgh Medical Center Health System

location_facility: American University of Beirut Medical Center

location_facility: Wayne State University School of Medicine

location_facility: Soonchunhyang University Bucheon Hospital

location_facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital Nuestra Senora de la Misericordia

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: University of Chicago, Division of Infectious Diseases

location_facility: Tata Memorial Hopital, Department of Anesthesia

location_facility: State Institution "Hematology Research Center" RAMS

location_facility: Fred Hutchinson Cancer Research Center, Clinical Research

location_facility: Hospital Central Dr Ignacio Morones Prieto

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: University Of Colorado Health Sciences Center

location_facility: Shirdi Sai Baba Cancer Hospital K. M. C. Hospital

location_facility: Deenanath Mangeshkar Hospital & Research Centre


title: A Phase III Randomised Study Comparing Concomitant Radiochemotherapy With Cisplatin and Docetaxel as Induction Versus Consolidation Treatment in Patients With Locally Advanced Unresectable Non-small Cell Lung Cancer.

summary: The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.

lead_sponsor: European Lung Cancer Working Party

location_country: France Spain Greece Belgium

location_facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

location_facility: Department of Pneumology Centre Hospitalier de Mouscron

location_facility: Service de Pneumologie Centre Hospitalier Intercommunal le Raincy-Montfermeil

location_facility: Department of Pneumology Hospital Ixelles-Molière

location_facility: Service de Pneumologie Centre Hospitalier de Douai

location_facility: Department of Pneumology RHMS Hôpital de la Madeleine

location_facility: Department of Pneumology CHR St Joseph-Warquignies

location_facility: Department of Pneumology Clinique Saint-Luc

location_facility: Service de Pneumologie Hôpital de Hayange

location_facility: Department of Pneumology Hôpital Saint-Joseph


title: Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study

lead_sponsor: Pharmaxis

ReferenceCitation: Daviskas E, Anderson SD. Hyperosmolar agents and clearance of mucus in the diseased airway. J Aerosol Med. 2006 Spring;19(1):100-9. Review.

ReferenceCitation: Daviskas E, Anderson SD, Gomes K, Briffa P, Cochrane B, Chan HK, Young IH, Rubin BK. Inhaled mannitol for the treatment of mucociliary dysfunction in patients with bronchiectasis: effect on lung function, health status and sputum. Respirology. 2005 Jan;10(1):46-56.

ReferenceCitation: Daviskas E, Robinson M, Anderson SD, Bye PT. Osmotic stimuli increase clearance of mucus in patients with mucociliary dysfunction. J Aerosol Med. 2002 Fall;15(3):331-41. Review.

ReferenceCitation: Robinson M, Bye PT. Mucociliary clearance in cystic fibrosis. Pediatr Pulmonol. 2002 Apr;33(4):293-306. Review.

ReferenceCitation: Daviskas E, Anderson SD, Eberl S, Chan HK, Young IH. The 24-h effect of mannitol on the clearance of mucus in patients with bronchiectasis. Chest. 2001 Feb;119(2):414-21.

ReferenceCitation: Robinson M, Daviskas E, Eberl S, Baker J, Chan HK, Anderson SD, Bye PT. The effect of inhaled mannitol on bronchial mucus clearance in cystic fibrosis patients: a pilot study. Eur Respir J. 1999 Sep;14(3):678-85.

ReferenceCitation: Daviskas E, Anderson SD, Eberl S, Chan HK, Bautovich G. Inhalation of dry powder mannitol improves clearance of mucus in patients with bronchiectasis. Am J Respir Crit Care Med. 1999 Jun;159(6):1843-8.

ReferenceCitation: Daviskas E, Anderson SD, Brannan JD, Chan HK, Eberl S, Bautovich G. Inhalation of dry-powder mannitol increases mucociliary clearance. Eur Respir J. 1997 Nov;10(11):2449-54.

ReferenceCitation: Jaques A, Daviskas E, Turton JA, McKay K, Cooper P, Stirling RG, Robertson CF, Bye PTP, LeSouëf PN, Shadbolt B, Anderson SD, Charlton B. Inhaled mannitol improves lung function in cystic fibrosis. Chest. 2008 Jun;133(6):1388-1396. doi: 10.1378/chest.07-2294. Epub 2008 Mar 13.

ReferenceCitation: Nevitt SJ, Thornton J, Murray CS, Dwyer T. Inhaled mannitol for cystic fibrosis. Cochrane Database Syst Rev. 2020 May 1;5:CD008649. doi: 10.1002/14651858.CD008649.pub4.

ReferenceCitation: Aitken ML, Bellon G, De Boeck K, Flume PA, Fox HG, Geller DE, Haarman EG, Hebestreit HU, Lapey A, Schou IM, Zuckerman JB, Charlton B; CF302 Investigators. Long-term inhaled dry powder mannitol in cystic fibrosis: an international randomized study. Am J Respir Crit Care Med. 2012 Mar 15;185(6):645-52. doi: 10.1164/rccm.201109-1666OC. Epub 2011 Dec 28.

location_country:
Netherlands
Argentina
Canada
United States
France
Belgium
Germany

location_facility: Batchelor Children's Research Institute - University of Miami

location_facility: Clinica Universitaria Privada Reina Fabiola - Universidad Cotolica de Cordoba

location_facility: Central Connecticut Cystic Fibrosis Center

location_facility: Louisiana State University Health Sciences Center

location_facility: Hospital de Ninos Dr Ricardo Gutierrez, Pediatria

location_facility: Christus Santa Rosa Children's Hospital Cystic Fibrosis Center

location_facility: Hospital de Ninos del la Santisima Trinidad

location_facility: University of Munich Medizinischen Klinik Innenstadt

location_facility: Universitats Kinderklinik Tubungen Wurzburg

location_facility: Nebraska Medical Center - Nebraska Regional CF Center

location_facility: Hospital Interzonal Dr Jose Penna Bahia Blanca

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Gral. de Ninos Pedro de Elizalde

location_facility: The Toledo Hospital and Toledo Childrens Hospital

location_facility: Hospital de Ninos Superiora Sor Maria Ludovica de La Plata

summary: The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis. Previous studies have demonstrated improvements in lung function, mucociliary clearance, changes in physical properties of mucus, 24 hour sputum weight and quality of life. The results of this study are to further investigate and confirm these findings in addition to examine the effect on antibiotic use and chest infections. It is hypothesised that inhaled mannitol will have beneficial effects compared to a control treatment. An open label phase of 26 weeks duration will follow the blinded 26 week phase. During the open label phase all subjects will receive active treatment.