title: A Randomized, Double-Blind, Factorial, Parallel-Group, Active and Placebo-Controlled, Multicenter Dose-Ranging Study to Evaluate the Efficacy, Safety and Tolerability of Six Dose Combinations of Solifenacin Succinate and Mirabegron Compared to Mirabegron and Solifenacin Succinate Monotherapies in the Treatment of Overactive Bladder.

acronym: Symphony

summary: The purpose of this study is to examine how well two medicines in combination (solifenacin succinate and mirabegron) work in the treatment of bladder problems over a 12-week period.

ReferenceCitation: Abrams P, Kelleher C, Staskin D, Rechberger T, Kay R, Martina R, Newgreen D, Paireddy A, van Maanen R, Ridder A. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015 Mar;67(3):577-88. doi: 10.1016/j.eururo.2014.02.012. Epub 2014 Feb 19.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Europe B.V.

location_country:
Denmark
Poland
Portugal
Belarus
Romania
Italy
Russian Federation
Netherlands
Spain
Finland
United Kingdom
Ukraine
Sweden
Hungary
France
Belgium
Norway
Germany
Slovakia
Czechia


type: EudraCT Number

title: A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

summary:
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.

In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.

Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.

Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

ReferenceCitation: Jouneau S, Crestani B, Thibault R, Lederlin M, Vernhet L, Valenzuela C, Wijsenbeek M, Kreuter M, Stansen W, Quaresma M, Cottin V. Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis. Respir Res. 2020 Nov 25;21(1):312. doi: 10.1186/s12931-020-01528-4.

ReferenceCitation: Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6). pii: 2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun.

ReferenceCitation: Richeldi L, Kolb M, Jouneau S, Wuyts WA, Schinzel B, Stowasser S, Quaresma M, Raghu G. Efficacy and safety of nintedanib in patients with advanced idiopathic pulmonary fibrosis. BMC Pulm Med. 2020 Jan 8;20(1):3. doi: 10.1186/s12890-019-1030-4.

ReferenceCitation: Kreuter M, Koegler H, Trampisch M, Geier S, Richeldi L. Differing severities of acute exacerbations of idiopathic pulmonary fibrosis (IPF): insights from the INPULSIS® trials. Respir Res. 2019 Apr 11;20(1):71. doi: 10.1186/s12931-019-1037-7.

ReferenceCitation: Xu Z, Li H, Wen F, Bai C, Chen P, Fan F, Hu N, Stowasser S, Kang J. Subgroup Analysis for Chinese Patients Included in the INPULSIS(®) Trials on Nintedanib in Idiopathic Pulmonary Fibrosis. Adv Ther. 2019 Mar;36(3):621-631. doi: 10.1007/s12325-019-0887-1. Epub 2019 Feb 7.

ReferenceCitation: Costabel U, Behr J, Crestani B, Stansen W, Schlenker-Herceg R, Stowasser S, Raghu G. Anti-acid therapy in idiopathic pulmonary fibrosis: insights from the INPULSIS® trials. Respir Res. 2018 Sep 3;19(1):167. doi: 10.1186/s12931-018-0866-0.

ReferenceCitation: Collard HR, Richeldi L, Kim DS, Taniguchi H, Tschoepe I, Luisetti M, Roman J, Tino G, Schlenker-Herceg R, Hallmann C, du Bois RM. Acute exacerbations in the INPULSIS trials of nintedanib in idiopathic pulmonary fibrosis. Eur Respir J. 2017 May 19;49(5). pii: 1601339. doi: 10.1183/13993003.01339-2016. Print 2017 May.

ReferenceCitation: Paterniti MO, Bi Y, Rekić D, Wang Y, Karimi-Shah BA, Chowdhury BA. Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2017 Sep;14(9):1395-1402. doi: 10.1513/AnnalsATS.201606-458OC.

ReferenceCitation: Rinciog C, Watkins M, Chang S, Maher TM, LeReun C, Esser D, Diamantopoulos A. A Cost-Effectiveness Analysis of Nintedanib in Idiopathic Pulmonary Fibrosis in the UK. Pharmacoeconomics. 2017 Apr;35(4):479-491. doi: 10.1007/s40273-016-0480-2.

ReferenceCitation: Kolb M, Richeldi L, Behr J, Maher TM, Tang W, Stowasser S, Hallmann C, du Bois RM. Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume. Thorax. 2017 Apr;72(4):340-346. doi: 10.1136/thoraxjnl-2016-208710. Epub 2016 Sep 26.

ReferenceCitation: Corte T, Bonella F, Crestani B, Demedts MG, Richeldi L, Coeck C, Pelling K, Quaresma M, Lasky JA. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res. 2015 Sep 24;16:116. doi: 10.1186/s12931-015-0276-5.

ReferenceCitation: Richeldi L, du Bois RM, Raghu G, Azuma A, Brown KK, Costabel U, Cottin V, Flaherty KR, Hansell DM, Inoue Y, Kim DS, Kolb M, Nicholson AG, Noble PW, Selman M, Taniguchi H, Brun M, Le Maulf F, Girard M, Stowasser S, Schlenker-Herceg R, Disse B, Collard HR; INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014 May 29;370(22):2071-82. doi: 10.1056/NEJMoa1402584. Epub 2014 May 18. Erratum in: N Engl J Med. 2015 Aug 20;373(8):782.

ReferenceCitation: Richeldi L, Cottin V, Flaherty KR, Kolb M, Inoue Y, Raghu G, Taniguchi H, Hansell DM, Nicholson AG, Le Maulf F, Stowasser S, Collard HR. Design of the INPULSIS™ trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med. 2014 Jul;108(7):1023-30. doi: 10.1016/j.rmed.2014.04.011. Epub 2014 Apr 29.

lead_sponsor: Boehringer Ingelheim

location_country:
United Kingdom
Ireland
Italy
Australia
Czech Republic
United States
France
China
India
Belgium
Israel
Germany
Japan

location_facility: 1199.32.33003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10018 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10028 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81011 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39009 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81010 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39006B Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39012 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10016 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10013 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.32001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39011 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10029 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10019 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.97002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.32005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39006A Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81012 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.32002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10021 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10015 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10022 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.32004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10009 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10033 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.35301 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10023 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10025 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10024 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39010 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39008 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10038 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10020 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81009 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.91005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.42003 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.97001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33007 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.39005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.61005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44005 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.42002 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10034 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.97004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.10001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44009 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.33004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.86004 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.44006 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.42001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.49001 Boehringer Ingelheim Investigational Site

location_facility: 1199.32.81001 Boehringer Ingelheim Investigational Site

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


acronym: GALLIUM

title: A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders

lead_sponsor: Hoffmann-La Roche

source: euctr

study_start_date_type: Actual

ReferenceCitation: Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2022 Oct 4. pii: S2152-2650(22)01685-8. doi: 10.1016/j.clml.2022.09.003. [Epub ahead of print]

ReferenceCitation: Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.

ReferenceCitation: Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trněný M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcγ receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.

ReferenceCitation: Davies A, Trask P, Demeter J, Florschütz A, Hänel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.

ReferenceCitation: Klanova M, Oestergaard MZ, Trněný M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.

ReferenceCitation: Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.

ReferenceCitation: Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptáčník V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8. Erratum in: Lancet Oncol. 2019 Apr 29;:.

ReferenceCitation: Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Dürig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.

ReferenceCitation: Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trněný M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.

location_country:
Taiwan
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
Finland
Sweden
Hungary
United States
France
China
Israel
Belgium
Japan
Germany
Czechia

location_facility: Nagoya City University Hospital; Hematology and Oncology

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: Matsushita Memorial Hospital; hematology

location_facility: Hiroshima University Hospital; Hematology

location_facility: Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie

location_facility: Chu Estaing; Hematologie Clinique Adultes

location_facility: Chiba Cancer Center;Hematology and Oncology

location_facility: Western General Hospital; Department of Haematology

location_facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Aomori Prefectural Central Hospital; Hematology

location_facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

location_facility: Klinik der Uni zu Köln; Klinik für Innere Medizin

location_facility: Concord Repatriation General Hospital; Haematology

location_facility: The Regents of the University of California; Office of Research

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.

location_facility: St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Fundacion Hospital de Alcorcon; Servicio de Hematologia

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Harbin Medical University Cancer Hospital

location_facility: Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin

location_facility: Universitätsklinikum Jena; Klinik für Innere Medizin II

location_facility: Regional Clinical Hospital N.A. Semashko; Hematology

location_facility: University College Hospital; Macmillan Cancer Centre

location_facility: UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie

location_facility: Niigata Cancer Center Hospital; Internal Medicine

location_facility: Leicester Royal Infirmary; Dept of Haematology

location_facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: Gemeinschaftspraxis Dr. med. Holger Klaproth

location_facility: Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie

location_facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora

location_facility: HELIOS Klinikum Erfurt I.Medizinische Klinik

location_facility: Jichi Medical University Hospital; Hematology

location_facility: A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia

location_facility: Ospedale V. Cervello; U.O. Ematologia E Trapianti

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

location_facility: Hospital de Basurto; Servicio de Hematologia

location_facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Fujian Medical University Union Hospital

location_facility: Queen Elizabeth Hospital; Centre for Clinical Haematology

location_facility: Royal Cornwall Hospital; Haematology Clinic

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Hematologia

location_facility: Dr. Georges L. Dumont University Hospital Centre

location_facility: The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology

location_facility: Chaim Sheba Medical Center; Hematology BMT & CBB

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

location_facility: General Hospital of Chinese PLA; Department of Hematology

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Royal Bournemouth General Hospital; Haematology

location_facility: Tohoku University Hospital; Hematology and Immunology

location_facility: Velindre NHS Trust; Haematology Department

location_facility: Hyogo Cancer Center; Department of hematology

location_facility: Queen Alexandra Hospital; Haematology and Oncology Centre

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo

location_facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology

location_facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: Republican Clinical Hospital n.a. Baranov; Haematology

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

location_facility: National Cancer Center Hospital; Hematology

location_facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit

location_facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie

location_facility: Shikoku Cancer Center; Hematology and Oncology

location_facility: National Cancer Center Hospital East;Hematology

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster

location_facility: National Taiwan Universtiy Hospital; Division of Hematology

location_facility: Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie

location_facility: Aichi Cancer Center Hospital; Hematology and Cell Therapy

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: University Hospital, Kyoto Prefectural University of Medicine; Hematology

location_facility: James Paget Hospital; Haematology Department

location_facility: Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie

location_facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

location_facility: Fn Hr. Kralove; IV. Interni Hematologicka Klinika

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Hopital De La Conception; Hematologie Clinique

location_facility: Azienda Ospedaliera Universitaria di Modena

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Aberdeen Royal Infirmary; Haematology - Ward 16

location_facility: The Cancer Institute Hospital of JFCR; Hematology Oncology

location_facility: Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie

location_facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch

location_facility: Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Norfolk & Norwich Hospital; Dept of Haematology

location_facility: Peter MacCallum Cancer Centre; Department of Haematology

location_facility: Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II

location_facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)

location_facility: Princess Alexandra Hospital; Department of Haematology

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III

location_facility: St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie

location_facility: Semmelweis University, First Dept of Medicine

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Toronto East General Hospital; Haematology/Oncology

location_facility: Universität Tübingen; Med. Klinik; Innere Medizin I

location_facility: Kobe City Medical Center General Hospital; Hematology

location_facility: Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie

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

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz

location_facility: National Hospital Organization Kyushu Cancer Center; Hematology

location_facility: Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology

location_facility: Kent & Canterbury Hospital; Clinical Haematology

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: University of Szeged, II Dept of Internal Medicine

location_facility: Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation

location_facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

location_facility: Austin and Repatriation Medical Centre; Cancer Services

location_facility: Rambam Medical Center; Heamatology & Bone Marrow Transplantation

location_facility: University of Kansas; Medical Center & Medical pavilion

summary: This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response [CR] or partial response [PR]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.


title: A Phase III, Open-label Study of Once Daily BI 201335 240 mg for 24 Weeks in Combination With Pegylated interferon-a (PegIFN) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN / RBV Treatment

summary: The objective of this trial is to collect evidence for the safety and efficacy of 24 weeks of treatment with BI 201335 240 mg in combination with 24 or 48 weeks of Pegylated Interferon (PegIFN) and ribavirin (RBV) in treatment experienced patients who have been withdrawn from PegIFN and RBV treatment due to lack of efficacy in the 1220.7, 1220.30 and 1220.47 trials.

design_allocation: Non-Randomized

ReferenceCitation: Foster GR, Ferenci P, Asselah T, Mantry P, Dufour JF, Bourlière M, Forton D, Maevskaya M, Wright D, Yoshida EM, García-Samaniego J, Oliveira C, Wright M, Warner N, Sha N, Quinson AM, Stern JO. Open-label study of faldaprevir plus peginterferon and ribavirin in hepatitis C virus genotype 1-infected patients who failed placebo plus peginterferon and ribavirin. J Viral Hepat. 2016 Mar;23(3):227-31. doi: 10.1111/jvh.12485. Epub 2015 Nov 17.

location_country:
Taiwan
Portugal
Romania
Spain
United Kingdom
Austria
Russian Federation
Canada
Switzerland
Korea, Republic of
United States
France
Belgium
Japan
Germany

location_facility: 1220.48.3503 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3204 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0081 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8204 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0027 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0013 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3412 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0011 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0091 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0029 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1005 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1006 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3201 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8114 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.7001 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8206 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8802 China Medical University Hospital

location_facility: 1220.48.8207 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1007 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0078 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3203 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4404 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3303 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0018 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3502 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8119 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3316 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.7004 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0065 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8106 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4914 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1012 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0095 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4407 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3304 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8118 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3411 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0039 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0012 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1016 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4409 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3509 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8113 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4911 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0063 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3409 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3311 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8205 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8117 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3501 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0087 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3301 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8121 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8201 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3305 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3410 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0017 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0066 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.1009 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3312 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4302 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0058 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.8116 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0071 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4913 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.0023 Boehringer Ingelheim Investigational Site

location_facility: 1220.48.4901 Boehringer Ingelheim Investigational Site


title: Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa

summary:
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections. The Pa infection rate in CF patients increases with age and by age 18 years approximately 85% of CF patients in the US are infected. Liposomal amikacin for inhalation (Arikayce™) was developed as a possible treatment for chronic infection due to Pa in CF patients.

The purpose of this study is to determine whether Arikayce™ is effective in treating chronic lung infections caused by Pa in CF participants. The effectiveness, safety, and tolerability of Arikayce™ will be compared to Tobramycin TOBI®, an inhalation antibiotic already available for use.

ReferenceCitation: Bilton D, Pressler T, Fajac I, Clancy JP, Sands D, Minic P, Cipolli M, Galeva I, Solé A, Quittner AL, Liu K, McGinnis JP 2nd, Eagle G, Gupta R, Konstan MW; CLEAR-108 Study Group. Amikacin liposome inhalation suspension for chronic Pseudomonas aeruginosa infection in cystic fibrosis. J Cyst Fibros. 2020 Mar;19(2):284-291. doi: 10.1016/j.jcf.2019.08.001. Epub 2019 Aug 23.

lead_sponsor: Insmed Incorporated

location_country:
Denmark
Poland
Serbia
Spain
Greece
Austria
Ireland
Italy
Canada
Netherlands
United Kingdom
Sweden
Hungary
France
Belgium
Germany
Bulgaria
Slovakia


title: A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with upper limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

ReferenceCitation: Delafont B, Carroll K, Vilain C, Pham E. Investigation of mixed model repeated measures analyses and non-linear random coefficient models in the context of long-term efficacy data. Pharm Stat. 2018 Sep;17(5):515-526. doi: 10.1002/pst.1868. Epub 2018 May 20.

ipd_sharing: Yes

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Poland
Italy
Russian Federation
Hungary
France
United States
Belgium
Slovakia
Czechia

location_facility: Rancho Los Amigos National Rehabilitation Center

location_facility: Associated Neurologist of Southern CT, PT

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: National Institute for Medical Rehabilitation

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Centre Hospitalier Albert Chenevier-Hopital Henri Mondor

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: Southwestern Medical Center at Dallas University of Texas

location_facility: Parkinson's Disease & Movement Disorders Center of Boca Raton

intervention_type: Biological


title: A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression

summary: The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued duloxetine in the treatment of patients with treatment resistant depression (TRD).

lead_sponsor: Bristol-Myers Squibb

location_country:
Finland
Canada
United States
France
South Africa
Sweden

location_facility: Oregon Center For Clinical Investigations, Inc (Occi, Inc)

location_facility: Belmont Center For Comprehensive Treatment

location_facility: Comprehensive Clinical Development, Inc.

location_facility: Independent Psychiatric Consultants, Sc, Dba, Ipc Research

location_facility: Dean Foundation For Health Research & Education

location_facility: California Neuropsychopharmacology Clinical Research Inst.

location_facility: California Neuroscience Research Medical Group, Inc.

location_facility: Atlanta Institute Of Medicine & Research

location_facility: Collaborative Neuroscience Network, Inc.

location_facility: University Of South Carolina School Of Medicine

location_facility: K & S Professional Research Services, Llc

location_facility: Oregon Center For Clinical Investigations, Inc. (Occi, Inc)


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure

summary: The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.

ReferenceCitation: Teerlink JR, Felker GM, McMurray JJV, Ponikowski P, Metra M, Filippatos GS, Ezekowitz JA, Dickstein K, Cleland JGF, Kim JB, Lei L, Knusel B, Wolff AA, Malik FI, Wasserman SM; ATOMIC-AHF Investigators. Acute Treatment With Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: The ATOMIC-AHF Study. J Am Coll Cardiol. 2016 Mar 29;67(12):1444-1455. doi: 10.1016/j.jacc.2016.01.031.

lead_sponsor: Cytokinetics

location_country:
Poland
United Kingdom
Greece
Italy
Australia
Netherlands
Canada
Finland
Lithuania
Russian Federation
Hungary
United States
France
Belgium
Norway
Germany
Bulgaria
Slovakia
Czechia


title: Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)

acronym: IPOD-PD

summary: The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Verger C, Ronco C, Van Biesen W, Heaf J, Vrtovsnik F, Vera Rivera M, Puide I, Azar R, Gauly A, Atiye S, De Los Ríos T. Association of Prescription With Body Composition and Patient Outcomes in Incident Peritoneal Dialysis Patients. Front Med (Lausanne). 2021 Dec 24;8:737165. doi: 10.3389/fmed.2021.737165. eCollection 2021.

ReferenceCitation: Ronco C, Verger C, Crepaldi C, Pham J, De Los Ríos T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)†. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.

lead_sponsor: Fresenius Medical Care Deutschland GmbH

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Cuba
Venezuela
Belgium
Portugal
Austria
India
Israel
Turkey
Norway
Sweden
Bosnia and Herzegovina
Brazil
Switzerland
Germany
Denmark
Greece
Latvia
Estonia
Finland
Czech Republic
Korea, Republic of
France
Netherlands

location_facility: General Hospital of Athens G. Gennimatas

location_facility: General University Hospital of Thessaloniki "AHEPA"

location_facility: Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie

location_facility: AUB Quimper / Centre Hospitalier Laennec

location_facility: General University Hospital of Alexandroupolis

intervention_type: Other


title: Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Ireland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Presence Medical Group Hematology Oncology

location_facility: Southern Illinois University School Of Medicine

location_facility: Lynn Cancer Institute Center For Hematology-Oncology

location_facility: University Of Illinois At Chicago Medical Center

location_facility: Washington University School Of Medicine

location_facility: Oklahoma Oncology And Hematology, Pc Dba

location_facility: Wisconsin Institutes for Medical Research

location_facility: Texas Oncology, PA - South Austin Cancer Center


title: Studying Interventions for Managing Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase: The 5-Year Prospective Cohort Study (SIMPLICITY)

acronym: SIMPLICITY

summary: The purpose of this study is to better understand the use of tyrosine kinase inhibitors (TKI) in patients newly diagnosed with CML and their quality of life in a real-world setting.

time_perspective: Other

ReferenceCitation: Hehlmann R, Cortes JE, Zyczynski T, Gambacorti-Passerini C, Goldberg SL, Mauro MJ, Michallet M, Simonsson B, Williams LA, Gajavelli S, DeGutis I, Sen GP, Paquette RL. Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice: SIMPLICITY. Am J Hematol. 2019 Jan;94(1):46-54. doi: 10.1002/ajh.25306. Epub 2018 Oct 31.

location_country:
Spain
Italy
Russian Federation
Netherlands
Puerto Rico
United States
France
Germany

location_facility: City Hospital - West Virginia University Hospital East

location_facility: Texas Oncology-Odessa West Texas Cancer Center

location_facility: Tahoe Forest Health System Cancer Center

location_facility: Providence Cancer Center at Sacred Heart Medical Center

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: Texas Oncology-Midland Allison Cancer Center

location_facility: Medical Oncology and Blood Disorders, LLP

location_facility: Hematology And Medical Oncology Of Southern Palm Beach County

location_facility: Little Rock Hematology Oncology Associates

location_facility: Hematology and Oncology Associates of RI

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: St John's Clinic for Cancer and Hematology

location_facility: Signal Point Clinical Research Center, LLC

location_facility: Veterans Research Foundation of Pittsburgh

location_facility: Investigative Clinical Research of Indiana

location_facility: Swedish Cancer Institute-Eastside Hematology/Oncology

location_facility: Texas Oncology-Methodist Charlton Cancer Center

location_facility: Indiana Blood and Marrow Transplantation

location_facility: University of Louisville Hospital - Brown Cancer Center

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Washington Hospital Center, Washington Cancer Institute

location_facility: Hematology Oncology Associates of Fredricksburg


title: Randomized, Open Label, Multicenter Phase III Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 Tablets Versus Best Available Care (The RESPONSE Trial)

summary: This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea (HU).

ReferenceCitation: Kiladjian JJ, Zachee P, Hino M, Pane F, Masszi T, Harrison CN, Mesa R, Miller CB, Passamonti F, Durrant S, Griesshammer M, Kirito K, Besses C, Moiraghi B, Rumi E, Rosti V, Blau IW, Francillard N, Dong T, Wroclawska M, Vannucchi AM, Verstovsek S. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. Lancet Haematol. 2020 Mar;7(3):e226-e237. doi: 10.1016/S2352-3026(19)30207-8. Epub 2020 Jan 23.

ReferenceCitation: Kiladjian JJ, Guglielmelli P, Griesshammer M, Saydam G, Masszi T, Durrant S, Passamonti F, Jones M, Zhen H, Li J, Gadbaw B, Perez Ronco J, Khan M, Verstovsek S. Efficacy and safety of ruxolitinib after and versus interferon use in the RESPONSE studies. Ann Hematol. 2018 Apr;97(4):617-627. doi: 10.1007/s00277-017-3225-1. Epub 2018 Feb 2.

ReferenceCitation: Verstovsek S, Harrison CN, Kiladjian JJ, Miller C, Naim AB, Paranagama DC, Habr D, Vannucchi AM. Markers of iron deficiency in patients with polycythemia vera receiving ruxolitinib or best available therapy. Leuk Res. 2017 May;56:52-59. doi: 10.1016/j.leukres.2017.01.032. Epub 2017 Jan 31.

ReferenceCitation: Verstovsek S, Vannucchi AM, Griesshammer M, Masszi T, Durrant S, Passamonti F, Harrison CN, Pane F, Zachee P, Kirito K, Besses C, Hino M, Moiraghi B, Miller CB, Cazzola M, Rosti V, Blau I, Mesa R, Jones MM, Zhen H, Li J, Francillard N, Habr D, Kiladjian JJ. Ruxolitinib versus best available therapy in patients with polycythemia vera: 80-week follow-up from the RESPONSE trial. Haematologica. 2016 Jul;101(7):821-9. doi: 10.3324/haematol.2016.143644. Epub 2016 Apr 21.

ReferenceCitation: Vannucchi AM, Kiladjian JJ, Griesshammer M, Masszi T, Durrant S, Passamonti F, Harrison CN, Pane F, Zachee P, Mesa R, He S, Jones MM, Garrett W, Li J, Pirron U, Habr D, Verstovsek S. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med. 2015 Jan 29;372(5):426-35. doi: 10.1056/NEJMoa1409002.

lead_sponsor: Incyte Corporation

location_country:
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
Thailand
United Kingdom
Hungary
Korea, Republic of
United States
France
China
Turkey
Belgium
Japan
Germany


summary: This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

location_country:
Brazil
Spain
Italy
Austria
United Kingdom
Canada
Puerto Rico
United States
France
Mexico
Germany


type: Other Identifier

title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)

summary:
The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis.

This study is comprised of 2 periods:

Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).

Period 2: 48-week post-treatment follow-up

status: Terminated

lead_sponsor: Eli Lilly and Company

location_country:
Croatia
Spain
Lithuania
Ukraine
United States
Romania
Japan
South Africa
Poland
Russian Federation
Australia
Argentina
India
Mexico
Malaysia
Slovakia
Brazil
Sri Lanka
Hungary
Germany
Bulgaria
Taiwan
Greece
New Zealand
Korea, Republic of
France
Colombia

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.

status_simplified: Unknown


acronym: TEMPO 4/4

title: Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

ReferenceCitation: Bennett H, McEwan P, Hamilton K, O'Reilly K. Modelling the long-term benefits of tolvaptan therapy on renal function decline in autosomal dominant polycystic kidney disease: an exploratory analysis using the ADPKD outcomes model. BMC Nephrol. 2019 Apr 23;20(1):136. doi: 10.1186/s12882-019-1290-5.

ReferenceCitation: Thimmappa ND, Blumenfeld JD, Cerilles MA, Dunning A, Donahue SL, Bobb WO, Zhang HL, Prince MR. Cisterna chyli in autosomal dominant polycystic kidney disease. J Magn Reson Imaging. 2015 Jan;41(1):142-8. doi: 10.1002/jmri.24527. Epub 2014 Jan 27.

ReferenceCitation: Blumenfeld JD, Tepler J, Mauer A, Coller B, Bichet DG, Smith B. Tolvaptan inhibition of desmopressin effects on coagulation factors in a patient with decreased von Willebrand factor and polycystic kidney disease. Blood. 2011 Jul 14;118(2):474-6. doi: 10.1182/blood-2011-04-347328.

ipd_sharing_description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

location_country:
Poland
Romania
United Kingdom
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United States
France
Belgium
Germany

summary: To demonstrate whether tolvaptan modifies ADPKD progression as measured by changes from Baseline (from Study 156-04-251) in total kidney volume (TKV) and renal function.


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-α Inhibitors (FLEX V)

acronym: FLEX V

summary:
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors.

This study is comprised of 2 periods:

Period 1: 24-week blinded treatment

Period 2: 48-week post-treatment follow-up

ReferenceCitation: Schiff M, Combe B, Dörner T, Kremer JM, Huizinga TW, Veenhuizen M, Gill A, Komocsar W, Berclaz PY, Ortmann R, Lee C. Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study. RMD Open. 2015 Aug 12;1(1):e000037. doi: 10.1136/rmdopen-2014-000037. eCollection 2015.

location_country:
Poland
Taiwan
Brazil
Spain
Greece
Italy
Australia
Mexico
Argentina
New Zealand
Russian Federation
Korea, Republic of
United States
France
Malaysia
South Africa
Colombia
Japan
Germany


title: A Phase 3, Randomized, Double-Blind, Multicenter Trial Comparing Orteronel (TAK-700) Plus Prednisone With Placebo Plus Prednisone in Patients With Metastatic Castration-Resistant Prostate Cancer That Has Progressed During or Following Docetaxel-based Therapy.

lead_sponsor: Millennium Pharmaceuticals, Inc.

type: Registry Identifier

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

ReferenceCitation: Suri A, Chapel S, Lu C, Venkatakrishnan K. Physiologically based and population PK modeling in optimizing drug development: A predict-learn-confirm analysis. Clin Pharmacol Ther. 2015 Sep;98(3):336-44. doi: 10.1002/cpt.155. Epub 2015 Jul 14.

ReferenceCitation: Fizazi K, Jones R, Oudard S, Efstathiou E, Saad F, de Wit R, De Bono J, Cruz FM, Fountzilas G, Ulys A, Carcano F, Agarwal N, Agus D, Bellmunt J, Petrylak DP, Lee SY, Webb IJ, Tejura B, Borgstein N, Dreicer R. Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5. J Clin Oncol. 2015 Mar 1;33(7):723-31. doi: 10.1200/JCO.2014.56.5119. Epub 2015 Jan 26.

location_country:
Poland
Spain
Greece
Italy
Australia
Estonia
Canada
Finland
Hungary
United States
France
Belgium
Netherlands
Czechia

summary: This is a randomized, double-blind, multicenter, phase 3 study evaluating orteronel plus prednisone compared with placebo plus prednisone in men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed following Docetaxel-based therapy


title: A Phase III, Multi-Center, Randomized, 24 Week, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate Efficacy and Safety of RO4917838 in Stable Patients With Persistent, Predominant Negative Symptoms of Schizophrenia Treated With Antipsychotics Followed by a 28 Week, Double-Blind Treatment Period

summary: This multi-center, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 in participants with persistent, predominant negative symptoms of schizophrenia. Participants, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 56 weeks (treatment period 1 of 24 weeks and treatment period 2 of 32 weeks), followed by an optional treatment extension for up to 3 years. After 52 weeks, participants who were originally randomized to an active treatment will be randomly assigned to receive either placebo or continue on the originally assigned study treatment for 4 weeks washout period (Week 52 to Week 56) for the assessment of potential withdrawal effects in a blinded manner using participants staying on active treatment as a control. Participants initially randomized to placebo will remain on placebo. After 56 weeks, participants who were switched to placebo in the washout period will return to their blinded, active treatment arm.

ReferenceCitation: Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

ReferenceCitation: Bugarski-Kirola D, Blaettler T, Arango C, Fleischhacker WW, Garibaldi G, Wang A, Dixon M, Bressan RA, Nasrallah H, Lawrie S, Napieralski J, Ochi-Lohmann T, Reid C, Marder SR. Bitopertin in Negative Symptoms of Schizophrenia-Results From the Phase III FlashLyte and DayLyte Studies. Biol Psychiatry. 2017 Jul 1;82(1):8-16. doi: 10.1016/j.biopsych.2016.11.014. Epub 2016 Dec 15.

location_country:
Romania
United Kingdom
Russian Federation
Australia
Mexico
Finland
Argentina
Hungary
Korea, Republic of
United States
France
India
Colombia
Sweden

location_facility: Akademiska Sjukhuset; Psykosvård och rättspsykiatrisk vård

location_facility: Comprehensive Clinical Development- Cerritos CA

location_facility: Gujarat Institute of Psychological Research (GIPS)

location_facility: Cabinet Medical S.C. Lorentina 2102 S.R.L.; Psihiatrie

location_facility: Semmelweis Egyetem AOK; Pszichiatriai es Pszichoterapias Klinika

location_facility: Brij Psychiatry Hospital & Muskaan Research Centre; Maanav Health Foundation

location_facility: The Alfred Hospital; Monash Alfred Psychiatry Research Centre (MAP-RC)

location_facility: Spit Univ Urgenta Militar Dr. Carol Davila; Sectia Psihiatrie

location_facility: Centro de Asistencia e Investigación en Neurociencias

location_facility: Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai; Pszichiatriaci rehabilitacio

location_facility: Frankston Hospital; Mental Health Service

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Comunitara si Reintegrare Psihosociala

location_facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek

location_facility: GUZ Lipetsk Regional psychoneurological Hospital #1; Dispansary Department

location_facility: Centro de Investigaciones y Proyectos en Neurociencias CIPNA

location_facility: Facene Fund.Argentina Contra Enferm.Neur.Del Envejecimiento

location_facility: Dr. Kenessey Albert Hospital; Psychiatry I.

location_facility: Arkhangelsk Regional Clinical Psychiatric Hospital

location_facility: Spitalul de Psihiatrie Dr. Gh. Preda Sibiu;CSM Adulti Sibiu

location_facility: CHU Gabriel Montpied; Service de Psychiatrie

location_facility: R. K.Yadav Memorial Mental Health & De-Addiction Hospital

location_facility: Samvedna Hospitals; Samvedana Psychiatry and Sex Therapy Hospital

location_facility: Centro de Psiquiatria Biologica Professor Julio J. Herrera; Psiquiatria

location_facility: Scientifically Research Institute of Psychiatry of Ministry of Health of the Russian Federation

location_facility: Instituto de Neurociencias San Agustín S.A.

location_facility: Spitalul Universitar de Psihiatrie Socola

location_facility: Centro de Investigaciones del Sistema Nervioso Limitada - Gr

location_facility: Fundacion para el Estudio y Tratamiento des las Enfi Mentales

location_facility: Manav Neuropsychiatric Hospital Pvt. Ltd.

location_facility: CIAP - Centro de Investigacion y Asistencia en Psiquiatria

location_facility: University of Iowa College of Medicine; Psychiatry Research

location_facility: Central Moscow Regional Clinical Psychiatric Hospital

location_facility: Resolution Psicopharmacology Research Institute

location_facility: Spitalul Clinic Judetean de Urgenta Cluj; Sectia Clinica de Psihiatrie III

location_facility: St. Petersburg State Healthcare Institution "City Mental Hospital #3; I.I. Skvortsov-Stepanov

location_facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichatria II

location_facility: Karolinska Universitetssjukhuset Huddinge, Psykiatri Sydväst

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Sectia Clinica XIII Psihiatrie

location_facility: Spitalul Clinic Municipal Dr. Gavril Curteanu; Sectia Clinica Psihiatrie I

location_facility: Federal State Institution Moscow SRI of Psychiatry of Minzdravsocrazvitia

location_facility: Saint Petersburg Psychoneurological Research Institute of Roszdrav n.a. Bekhterev

location_facility: St. Petersburg GUZ City Psychiatric Hospital #6

location_facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaza; Pszichiatria I.

location_facility: City Psychiatric Hospital #2 of St. Nikolay Chudotvorets

location_facility: Hospital Lomas de San Luis Internacional

location_facility: Kemerovo Regional Clinical Psychiatric Hospital

location_facility: Centro de Investigacion Clinica Farmacologica en Psiquiatria

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: North Carolina Psychiatric Research Center

location_facility: Danderyds Sjukhus AB; PRIMA Vuxenpsykiatri

location_facility: Monash Medical Centre-Clayton Campus; School of Psychology and Psychiatry

location_facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia; Clinical III Psihiatrie

location_facility: Westmead Hospital; Department of Psychiatry

location_facility: Instituto de informacion e investigacion en salud mental AC

location_facility: Petz Aladar Megyei Oktato Korhaz; Pszichiatria I.

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

location_facility: Centro de Investigacion Medica S.C; Hospital Santa Cecilia de Monterrey S.A. de C.V.

location_facility: CHU Strasbourg Nouvel Hôpital Civil;Service de Psychiatrie I

location_facility: Hôpital de la Conception; Pôle Psychiatrique Centre

location_facility: Belmont Center for Comprehensive Treatment; Research

location_facility: Mhi City Clinical Hospital #2 Named After v.i. Razumousky

location_facility: Centre Hospitalier Universitaire Caen; Pôle Psychiatrie - Addictologie

location_facility: Spitalul Clinic Judetean Arad; Departamentul de Psihiatrie


title: A Prospective, Double-blind Randomized Phase III Study of 300 mg Versus 150 mg Erlotinib in Current Smokers With Locally Advanced or Metastatic NSCLC in Second-line Setting After Failure on Chemotherapy (CURRENTS)

summary: This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib [Tarceva] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

location_country: Denmark Spain Netherlands Switzerland France Turkey China Germany Egypt


title: A Randomized, Double-blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine

ReferenceCitation: Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

ReferenceCitation: Taniguchi H, Yoshino T, Yamaguchi K, Yamazaki K, Nixon AB, Tabernero J, Van Cutsem E, Robling KR, Abada PB, Hozak RR, Siegel R, Fill JA, Wijayawardana S, Walgren RA, Giles B, Jones A, Pitts KR, Drove N, Muro K. Clinical development and evaluation of a VEGF-D assay in plasma from patients with metastatic colorectal cancer in the RAISE study. Curr Med Res Opin. 2021 Oct;37(10):1769-1778. doi: 10.1080/03007995.2021.1940908. Epub 2021 Jul 28.

ReferenceCitation: Lim HH, Hopkins AM, Rowland A, Yuen HY, Karapetis CS, Sorich MJ. Effect of Early Adverse Events on Survival Outcomes of Patients with Metastatic Colorectal Cancer Treated with Ramucirumab. Target Oncol. 2019 Dec;14(6):743-748. doi: 10.1007/s11523-019-00683-z.

ReferenceCitation: Yoshino T, Portnoy DC, Obermannová R, Bodoky G, Prausová J, Garcia-Carbonero R, Ciuleanu T, García-Alfonso P, Cohn AL, Van Cutsem E, Yamazaki K, Lonardi S, Muro K, Kim TW, Yamaguchi K, Grothey A, O'Connor J, Taieb J, Wijayawardana SR, Hozak RR, Nasroulah F, Tabernero J. Biomarker analysis beyond angiogenesis: RAS/RAF mutation status, tumour sidedness, and second-line ramucirumab efficacy in patients with metastatic colorectal carcinoma from RAISE-a global phase III study. Ann Oncol. 2019 Jan 1;30(1):124-131. doi: 10.1093/annonc/mdy461.

ReferenceCitation: Grothey A, Yoshino T, Bodoky G, Ciuleanu T, Garcia-Carbonero R, García-Alfonso P, Van Cutsem E, Muro K, Mytelka DS, Li L, Lipkovich O, Hsu Y, Sashegyi A, Ferry D, Nasroulah F, Tabernero J. Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set. ESMO Open. 2018 Apr 24;3(3):e000347. doi: 10.1136/esmoopen-2018-000347. eCollection 2018.

ReferenceCitation: Tabernero J, Hozak RR, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Prausová J, Muro K, Siegel RW, Konrad RJ, Ouyang H, Melemed SA, Ferry D, Nasroulah F, Van Cutsem E. Analysis of angiogenesis biomarkers for ramucirumab efficacy in patients with metastatic colorectal cancer from RAISE, a global, randomized, double-blind, phase III study. Ann Oncol. 2018 Mar 1;29(3):602-609. doi: 10.1093/annonc/mdx767.

ReferenceCitation: Obermannová R, Van Cutsem E, Yoshino T, Bodoky G, Prausová J, Garcia-Carbonero R, Ciuleanu T, Garcia Alfonso P, Portnoy D, Cohn A, Yamazaki K, Clingan P, Lonardi S, Kim TW, Yang L, Nasroulah F, Tabernero J. Subgroup analysis in RAISE: a randomized, double-blind phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression. Ann Oncol. 2016 Nov;27(11):2082-2090. Epub 2016 Aug 29.

ReferenceCitation: Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Van Cutsem E, Grothey A, Prausová J, Garcia-Alfonso P, Yamazaki K, Clingan PR, Lonardi S, Kim TW, Simms L, Chang SC, Nasroulah F; RAISE Study Investigators. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015 May;16(5):499-508. doi: 10.1016/S1470-2045(15)70127-0. Epub 2015 Apr 12. Erratum in: Lancet Oncol. 2015 Jun;16(6):e262.

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
Italy
United States
Belgium
Japan
Romania
Czechia
Portugal
Slovenia
Austria
Australia
Argentina
Puerto Rico
India
Israel
Sweden
Brazil
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France
Netherlands

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: The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.


title: A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

acronym: HEPCAT

summary: The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

location_country:
Denmark
Italy
Australia
Argentina
Canada
Sweden
Puerto Rico
United States
France
Mexico
Germany

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: University Of North Carolina, Chapel Hill

location_facility: Instituto De Investigacion Cientifica Del Sur

location_facility: University Of California At San Francisco

location_facility: Alabama Liver & Digestive Specialists (Alds)

location_facility: Transplant Center And Hepatology Clinic, B-154

location_facility: Upper Delaware Valley Infectious Diseases, Pc


title: A Phase II Open Label, Roll Over Study of the Long Term Tolerability, Safety and Efficacy of Oral BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis

ReferenceCitation: Richeldi L, Kreuter M, Selman M, Crestani B, Kirsten AM, Wuyts WA, Xu Z, Bernois K, Stowasser S, Quaresma M, Costabel U. Long-term treatment of patients with idiopathic pulmonary fibrosis with nintedanib: results from the TOMORROW trial and its open-label extension. Thorax. 2018 Jun;73(6):581-583. doi: 10.1136/thoraxjnl-2016-209701. Epub 2017 Oct 9.

location_country:
Spain
Italy
United Kingdom
Belgium
Czechia
Portugal
Russian Federation
Australia
Argentina
Mexico
Brazil
Canada
Hungary
China
Germany
Bulgaria
Greece
Ireland
France
Chile
Netherlands

location_facility: QEII Health Sciences Centre (Dalhousie University)

location_facility: University Hospital of Heraklion, University Pulmonology Cl

location_facility: Centro Hospitalar Lisboa Norte Hospital Pulido Valente

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

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

location_facility: Scientific Research Institute of Pulmonology

location_facility: University of Pecs, 1st internal Med. Dept., Pulmonology

location_facility: Central Scientific Research Insitute of Tuberculosis

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

location_facility: Royal Perth Hospital-Lung Transplant Unit

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: Special. Hospital for Active Treatment, Sv. Sofia 2nd Clinic

summary:
The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).

As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.


title: A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy

summary: The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

ReferenceCitation: Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.

ReferenceCitation: Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, Pérol M. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy. ESMO Open. 2020 Jan;5(1). pii: e000567. doi: 10.1136/esmoopen-2019-000567.

ReferenceCitation: Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Pérol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.

ReferenceCitation: Garon EB, Cao D, Alexandris E, John WJ, Yurasov S, Perol M. A randomized, double-blind, phase III study of Docetaxel and Ramucirumab versus Docetaxel and placebo in the treatment of stage IV non-small-cell lung cancer after disease progression after 1 previous platinum-based therapy (REVEL): treatment rationale and study design. Clin Lung Cancer. 2012 Nov;13(6):505-9. doi: 10.1016/j.cllc.2012.06.007. Epub 2012 Jul 31.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Poland
Austria
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Taiwan
Greece
New Zealand
Korea, Republic of
France
Netherlands

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: A Prospective Open Randomized Trial on the Efficacy of Gonadotropin-releasing Hormone Agonist Depot-Triptorelin- to Prevent Chemotherapy Induced Premature Ovarian Failure in Lymphoma Patients.

acronym: Erasme-POF

summary:
Chemotherapy drugs like alkylating agents are frequently used in various combined regimens to treat neoplastic and benign diseases. These drugs are definitely associated with premature ovarian failure (POF), resulting in an important decrease of the long-term quality of life and an increase of morbidity. A recent study showed that the patients treated by alkylating agents had a 4.52 fold higher risk to lose their ovarian function compared with those who were treated by other agents. The rate of POF after treatment ranged from 40 to 80%, according to the age of the patients and the total doses administered.

Young women who experience POF have to face with the prospects of infertility and to consider years of hormonal replacement therapy. The possibility of minimizing gonadal damage by administering of protective therapy during chemotherapy represents an attractive option for these patients.

The aim of this study is to evaluate the protective effect on the ovarian function of the gonadotropin-releasing hormone agonist (GnRha) administered concomitantly to alkylating agents. Preliminary data in the literature on animals (rat and monkeys) are promising. Data in human are, however, highly controversial.

primary_purpose: Prevention

ReferenceCitation: Demeestere I, Brice P, Peccatori FA, Kentos A, Gaillard I, Zachee P, Casasnovas RO, Van Den Neste E, Dechene J, De Maertelaer V, Bron D, Englert Y. Gonadotropin-releasing hormone agonist for the prevention of chemotherapy-induced ovarian failure in patients with lymphoma: 1-year follow-up of a prospective randomized trial. J Clin Oncol. 2013 Mar 1;31(7):903-9. doi: 10.1200/JCO.2012.42.8185. Epub 2012 Nov 5.

lead_sponsor: Erasme University Hospital

location_country: France Italy Belgium

location_facility:
AZ-VUB
St Luc University
Henry-Mondor Hospital
St Louis Hospital
Instituto Europeo di oncologia
Algemeen Ziekenhuis Stuivenberg
Erasme Hospital
CHU Dijon
CHU Nancy
Hôpital Hotel Dieu
CHU St Antoine
Bordet
AZ St Jan
Centre Henri Beckerel
CHRU Lille

lead_sponsor_type: academique


title: A Phase II (BRF113710) Single-arm, Open-label Study of GSK2118436 in BRAF Mutant Metastatic Melanoma

summary: BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.

ReferenceType: background

ReferenceCitation: Ascierto PA, Minor D, Ribas A, Lebbe C, O'Hagan A, Arya N, Guckert M, Schadendorf D, Kefford RF, Grob JJ, Hamid O, Amaravadi R, Simeone E, Wilhelm T, Kim KB, Long GV, Martin AM, Mazumdar J, Goodman VL, Trefzer U. Phase II trial (BREAK-2) of the BRAF inhibitor dabrafenib (GSK2118436) in patients with metastatic melanoma. J Clin Oncol. 2013 Sep 10;31(26):3205-11. doi: 10.1200/JCO.2013.49.8691. Epub 2013 Aug 5.

ReferenceCitation: Hauschild A, Ascierto PA, Schadendorf D, Grob JJ, Ribas A, Kiecker F, Dutriaux C, Demidov LV, Lebbé C, Rutkowski P, Blank CU, Gutzmer R, Millward M, Kefford R, Haas T, D'Amelio A Jr, Gasal E, Mookerjee B, Chapman PB. Long-term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy: Analysis from phase 2 and 3 clinical trials. Eur J Cancer. 2020 Jan;125:114-120. doi: 10.1016/j.ejca.2019.10.033.

ReferenceCitation: Santiago-Walker A, Gagnon R, Mazumdar J, Casey M, Long GV, Schadendorf D, Flaherty K, Kefford R, Hauschild A, Hwu P, Haney P, O'Hagan A, Carver J, Goodman V, Legos J, Martin AM. Correlation of BRAF Mutation Status in Circulating-Free DNA and Tumor and Association with Clinical Outcome across Four BRAFi and MEKi Clinical Trials. Clin Cancer Res. 2016 Feb 1;22(3):567-74. doi: 10.1158/1078-0432.CCR-15-0321. Epub 2015 Oct 7.

ReferenceCitation: Ouellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17.

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Australia
United States
France
Germany


title: A Randomised Phase III Study of Elacytarabine vs. Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia

acronym: CLAVELA

summary: The purpose of the study is to assess the efficacy and safety of elacytarabine versus investigator's choice treatment in patients with relapsed or refractory acute myeloid leukemia (AML).

ReferenceCitation: Roboz GJ, Rosenblat T, Arellano M, Gobbi M, Altman JK, Montesinos P, O'Connell C, Solomon SR, Pigneux A, Vey N, Hills R, Jacobsen TF, Gianella-Borradori A, Foss Ø, Vetrhusand S, Giles FJ. International randomized phase III study of elacytarabine versus investigator choice in patients with relapsed/refractory acute myeloid leukemia. J Clin Oncol. 2014 Jun 20;32(18):1919-26. doi: 10.1200/JCO.2013.52.8562. Epub 2014 May 19.

lead_sponsor: Clavis Pharma

location_country:
Poland
Romania
Spain
Ireland
Italy
Australia
United Kingdom
Canada
United States
France
Belgium
Norway
Germany

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

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

location_facility: Gartnavel General Hospital: Beatson WOS Cancer Centre

location_facility: III. Medizinische Klinik und Poliklinik;Hämatologie, Onkologie und Pneumologie

location_facility: Rocky Mountain Blood and Bone Marrow Transplant Program

location_facility: Wake Forest University, Health Sciences Section on Hematology and Oncology

location_facility: Universitätsklinikum Ulm, Klinik für Innere Medizin III, Comprehensive Cancer Center Ulm (CCCU)

location_facility: Froedtert Hospital, Medical College of Wisconsin

location_facility: Christie Hospital, Haematology and Transplant Day Unit

location_facility: Evangelische Kliniken Johanniter- und Waldkrankenhaus Bonn GmbH

location_facility: Hospital Universitario La Fé, Servicio de Hematología

location_facility: The Blood and Marrow Transplant Group of GA

location_facility: Charité-Campus B. Franklin Med. Klinik Haematology

location_facility: UCLA School of Medicine, Division of Hematology/Oncology

location_facility: Universitätsklinikum Münster, Medisinische Klinik & Poliklinik A

location_facility: St. Spiridon" University Hospital, Hematology Department

location_facility: Heinrich-Heine Universität Düsseldorf, Klinik für Hämatologie/Onkolog. und Klin. Immunologie

location_facility: New York Presbyterian Hospital, Weill-Cornell Medical College

location_facility: Oncology Institute ,,Ion Chiricuta" Cluj Napoca , Hematology dept.

location_facility: USC/Norris Comprehensive Cancer Center and Hospital


title: A Multi-Centre, Randomized Study to Assess the Effects of Adaptive Servo Ventilation (ASV) on Survival and Frequency of Hospital Admissions in Patients With Heart Failure (HF) and Sleep Apnea (SA)-The ADVENT-HF Trial

acronym: ADVENT-HF

summary: Sleep Apnea (SA) is a disorder that causes pauses in breathing during sleep that expose the heart to oxygen deprivation. It is common in patients with heart failure (HF) where it is associated with increased risk of hospitalizations and death. It is not known however whether treating SA reduces these risks. This study is looking at whether a respiratory device known as Adaptive Servo Ventilation (ASV) can reduce the rate of cardiovascular hospitalizations and death in subjects with HF and SA. Study subjects will randomly receive either their regular medications OR their regular medications plus ASV. They will be followed for approximately 5 years and information relevant to their health will be collected and compared.

ReferenceCitation: Perger E, Inami T, Lyons OD, Alshaer H, Smith S, Floras JS, Logan AG, Arzt M, Duran Cantolla J, Delgado D, Fitzpatrick M, Fleetham J, Kasai T, Kimoff RJ, Leung RST, Lorenzi Filho G, Mayer P, Mielniczuk L, Morrison DL, Parati G, Parthasarathy S, Redolfi S, Ryan CM, Series F, Tomlinson GA, Woo A, Bradley TD; ADVENT-HF Investigators. Distinct Patterns of Hyperpnea During Cheyne-Stokes Respiration: Implication for Cardiac Function in Patients With Heart Failure. J Clin Sleep Med. 2017 Nov 15;13(11):1235-1241. doi: 10.5664/jcsm.6788. Erratum in: J Clin Sleep Med. 2018 Apr 15;14(4):703.

lead_sponsor: Toronto Rehabilitation Institute

location_country:
Brazil
Spain
Italy
United Kingdom
Canada
United States
France
Japan
Germany

location_facility: Glacier View Research Institute, Kalispell Regional Medical Center

location_facility: Pronto Socorro Cardiologico de Pernambuco

location_facility: Groupe Hospitalier Pitié-Salpêtrière Charles Foix, AP-HP

location_facility: Pole d'exploration de L' apnée du sommeil, Nouvelle Clinique Bel Air

location_facility: University of Arizona/Southern Arizona VA Health Care System

location_facility: Wissenschaftliches Institut Bethanien e.V.

location_facility: London Health Sciences Centre - Victoria Hospital

location_facility: University of Ottawa-Ottawa Heart Institute

location_facility: CDEC Brasil - Centro de Desenvolvimento em Estudos Clínicos Brasil

location_facility: Istituto Scientifico di Veruno, Istituti Clinici Scientifici Maugeri

location_facility: Istituto Scientifico di Montescano, Istituti Clinici Scientifici Maugeri (ICS Maugeri)

location_facility: Istituto Auxologico Italiano - Ospedale San Luca

location_facility: University Health Network/TRI/Mount Sinai

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: McGill University Health Centre, Glen Site

location_facility: Laboratoire d'Explorations Fonctionnelles Cardio-Respiratoires, Centre Hospitalier Universitaire de Grenoble

location_facility: The Sleep Disorders Centre -Nuffield House, Guy's Hospital

location_facility: McMaster University Medical Centre, Hamilton Health Sciences

location_facility: Kingston General Hospital Sleep Disorders Laboratory/Queen's University

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval

location_facility: Instituto do Coração do Hospital das Clínicas da FMUSP

intervention_type: Device


title: A Phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients With Metastatic Pancreatic Adenocarcinoma

summary: The purpose of this study is to determine whether CO-1.01 is safe and effective in the treatment of patients with metastatic pancreatic cancer and low hENT1 expression compared with gemcitabine.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Brazil
United Kingdom
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
Ukraine
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Instituto Especializado Alexander Fleming

location_facility: "Public Healthcare Institution ""Kharkiv Regional Clinical Oncology Center"", Abdominal Department

location_facility: Clinical Facility: Public Institution "Zaporizhya City Clinical Hospital #3", Regional Center of Hepatic, Biliary Tract and Pancreatic Surgery, Surgery Department #1

location_facility: Hôpital Saint André, Service d'Oncologie Médicale

location_facility: State Regional Diagnostics and Treatment Oncology Center, Chemotherapy Department

location_facility: National Cancer Institute, Department of Tumors of Abdominal Cavity and Retroperitoneum

location_facility: Centre Hospitalier Régional Universitaire Hôpital Saint Eloi

location_facility: Centre Regional de Lutte contre le Cancer Val d'Aurelle

location_facility: Mechnikov St. Petersburg State Medical Academy

location_facility: Institut Gustave-Roussy - Centre de Lutte Contre le Cancer

location_facility: Mykolayiv Regional Oncology Center, Surgery Department #1

location_facility: Beatson West of Scotland Cancer Centre, Cancer Research UK Clinical Trials Unit (CTU)

location_facility: Policlínica Privada Instituto de Medicina Nuclear

location_facility: Border Medical Oncology, Murray Valley Private Hospital

location_facility: Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk State Medical Academy, Department of Oncology and Medical Radiology

location_facility: Instituto Oncologico Veneto, Oncologia Medica 1

location_facility: Klinik der Otto-Von-Guericke-Universität Magdeburg

location_facility: Ludwig-Maximilians-Universität, Medizinische Klinik und Poliklinikversität München

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Southern Medical Day Oncology Care Centre

location_facility: Zakarpatya Regional Clinical Oncology Center, Chemotherapy Department

location_facility: Public Clinical Treatment and Prophylaxis Institution "Donetsk Regional Antitumor Center", Oncosurgery Department #6

location_facility: Medizinische Universitätsklinik Ulm, Abt. Innere Medizin I


acronym: INTENSE

title: An Exploratory Study to Compare the Efficacy and Safety of Micafungin as a Pre-emptive Treatment of Invasive Candidiasis Versus Placebo in High Risk Surgical Subjects - A Multicentre, Randomized, Double-blind Study

lead_sponsor: Astellas Pharma Inc

ReferenceCitation: White PL, Posso R, Parr C, Price JS, Finkelman M, Barnes RA. The Presence of (1→3)-β-D-Glucan as Prognostic Marker in Patients After Major Abdominal Surgery. Clin Infect Dis. 2021 Oct 5;73(7):e1415-e1422. doi: 10.1093/cid/ciaa1370.

ReferenceCitation: Knitsch W, Vincent JL, Utzolino S, François B, Dinya T, Dimopoulos G, Özgüneş İ, Valía JC, Eggimann P, León C, Montravers P, Phillips S, Tweddle L, Karas A, Brown M, Cornely OA. A randomized, placebo-controlled trial of preemptive antifungal therapy for the prevention of invasive candidiasis following gastrointestinal surgery for intra-abdominal infections. Clin Infect Dis. 2015 Dec 1;61(11):1671-8. doi: 10.1093/cid/civ707. Epub 2015 Aug 13.

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

location_country:
Denmark
Romania
Spain
Greece
Austria
Italy
United Kingdom
Finland
Switzerland
Hungary
France
Israel
Turkey
Belgium
Germany

summary: Subjects with intra-abdominal infection requiring surgery and Intensive Care Unit stay will be treated early with micafungin or placebo to determine the incidence and time to confirmation of fungal infection.


title: A Randomized, Controlled, Parallel Group, Double-blind, Multi-center, Phase II Study to Assess the Clinical- and Immunological Activity,as Well as the Safety and Tolerability of Different Doses/Formulations of AFFITOPE AD02 Administered Repeatedly to Patients With Early Alzheimer's Disease

lead_sponsor: Affiris AG

location_country:
Croatia
Austria
Czech Republic
France
Germany
Slovakia

location_facility: Centre Mémoire de Ressources et de Recherche, Service de Neurologie

location_facility: MUW Klin. Pharmakologie und Klinik für Neurologie

location_facility: Studienzentrum der PROSENEX, Ambulatoriumbetriebsges.m.b.H an der Confraternität - Privatklinik Josefstadt

location_facility: "BONIFARM" Poliklinika za kliničku farmakologiju i toksikologiju

location_facility: Opća bolnica Varaždin, Klinika za Neurologiju

location_facility: Universitätsklinikum Hamburg-Eppendorf, Klinik für Psychiatrie und Psychotherapie

location_facility: Klinikum Nürnberg Nord, Klinik f. Psychiatrie u. Psychotherapie

location_facility: Charite Universitätsmedizin Berlin, Klinik u. Hochschulambulanz f. Psychiatrie u. Psychotherapie

location_facility: Arzneimittelforschung Leipzig GmbH, Studienzentrum

location_facility: Klinik u. Poliklinik f. Psychiatrie u. Psychotherapie der TU München

location_facility: CMRR Hôpital Pellegrin, Bâtiment USN Tastet Girard

location_facility: Klinčki Bolnički Centar Zagreb (REBRO), Klinika za Neurologiju

location_facility: Centre Hospitalier Universitaire (CHU) de Dijon

location_facility: Christian Doppler Klinik, Univ. Klinik f. Neurologie

location_facility: Klinčki Bolnički Centar Rijeka, Klinika za Psihijatriju

location_facility: Zentralinstitut für Seelische Gesundheit, Abt. Gerontopsychiatrie

location_facility: University Hospital Motol, Clinic of Neurology

summary: This is a multiple vaccination study to find out if it is a safe treatment and what effects it has on the symptoms of early Alzheimer's disease in male and female patients aged 50 to 80 years. Approximately 40 study sites in Europe will be involved. Patients will be randomized to receive either AFFITOPE AD02 or placebo. Each patient's participation will last 1 year.


title: A Randomized, Placebo-controlled, Double-blinded Phase 2 Study of Second-line Treatment With OSI-906 in Patients With Advanced Hepatocellular Carcinoma (HCC) After Failure of First-line Treatment With Sorafenib

summary: This is a randomized, placebo-controlled, double-blind phase 2 study of OSI-906 or placebo at a continuous 150 mg twice daily (BID) dose.

ipd_sharing: No

ipd_sharing_description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

location_country:
Taiwan
Hong Kong
Spain
Italy
Korea, Republic of
United States
France
Singapore
Belgium
Germany

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: IRCCS Istituto Nazionale per lo studio e la cura dei tumori Fondazione G. Pascale-SSD Epatobiliare

location_facility: Ospedale Fatebenefratelli, Dipartimento Medicina Interna

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione ISMETT-Dipartimento di Epatologia e Gastroenterologia

location_facility: Chang Gung Medical Foundation LinKou Branch

location_facility: Fondazione Ca' Granda Ospedale Maggiore Policlinico, Divisione di Gastroenterologia I

location_facility: Hopital Jean Verdier - Dervice d'Hepato-Gastroenterologie

location_facility: Tulane University Health Services Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Seattle Cancer Care Alliance University of Washington