title: A Randomized, Multi-Center Cross-Over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-Positive Early Breast Cancer (EBC)

acronym: PrefHER

summary: This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.

primary_purpose: Health Services Research

ReferenceCitation: Pivot X, Verma S, Fallowfield L, Müller V, Lichinitser M, Jenkins V, Sánchez Muñoz A, Machackova Z, Osborne S, Gligorov J; PrefHer Study Group. Efficacy and safety of subcutaneous trastuzumab and intravenous trastuzumab as part of adjuvant therapy for HER2-positive early breast cancer: Final analysis of the randomised, two-cohort PrefHer study. Eur J Cancer. 2017 Nov;86:82-90. doi: 10.1016/j.ejca.2017.08.019. Epub 2017 Sep 28.

ReferenceCitation: Gligorov J, Curigliano G, Müller V, Knoop A, Jenkins V, Verma S, Osborne S, Lauer S, Machackova Z, Fallowfield L, Pivot X. Switching between intravenous and subcutaneous trastuzumab: Safety results from the PrefHer trial. Breast. 2017 Aug;34:89-95. doi: 10.1016/j.breast.2017.05.004. Epub 2017 May 23.

ReferenceCitation: De Cock E, Pivot X, Hauser N, Verma S, Kritikou P, Millar D, Knoop A. A time and motion study of subcutaneous versus intravenous trastuzumab in patients with HER2-positive early breast cancer. Cancer Med. 2016 Mar;5(3):389-97. doi: 10.1002/cam4.573. Epub 2016 Jan 25.

ReferenceCitation: Pivot X, Gligorov J, Müller V, Curigliano G, Knoop A, Verma S, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study. Ann Oncol. 2014 Oct;25(10):1979-1987. doi: 10.1093/annonc/mdu364. Epub 2014 Jul 28.

ReferenceCitation: Pivot X, Gligorov J, Müller V, Barrett-Lee P, Verma S, Knoop A, Curigliano G, Semiglazov V, López-Vivanco G, Jenkins V, Scotto N, Osborne S, Fallowfield L; PrefHer Study Group. Preference for subcutaneous or intravenous administration of trastuzumab in patients with HER2-positive early breast cancer (PrefHer): an open-label randomised study. Lancet Oncol. 2013 Sep;14(10):962-70. doi: 10.1016/S1470-2045(13)70383-8. Epub 2013 Aug 19.

location_country:
Denmark
Poland
Spain
Italy
Russian Federation
United Kingdom
Canada
Switzerland
Sweden
France
Turkey
Germany

intervention_type: Device


type: Other Identifier

type: EudraCT Number

title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)

summary: This study (UNITI-1) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to placebo over 8 weeks, in patients with moderately to severely active Crohn's disease who have either failed or could not tolerate at least one TNF-antagonist medications in the past (specifically, infliximab, adalimumab, or certolizumab pegol).

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Kowalski K, Sandborn WJ, Feagan B. Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease. Clin Ther. 2022 Oct;44(10):1336-1355. doi: 10.1016/j.clinthera.2022.08.010. Epub 2022 Sep 21.

ReferenceCitation: Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.

ReferenceCitation: Narula N, Aruljothy A, Wong ECL, Homenauth R, Alshahrani AA, Marshall JK, Reinisch W. The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies. United European Gastroenterol J. 2021 Jun;9(5):581-589. doi: 10.1002/ueg2.12094. Epub 2021 Jun 2.

ReferenceCitation: Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum in: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

ReferenceCitation: Li K, Friedman JR, Chan D, Pollack P, Yang F, Jacobstein D, Brodmerkel C, Gasink C, Feagan BG, Sandborn WJ, Rutgeerts P, De Hertogh G. Effects of Ustekinumab on Histologic Disease Activity in Patients With Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1019-1031.e7. doi: 10.1053/j.gastro.2019.06.037. Epub 2019 Jul 4.

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

ReferenceCitation: Rutgeerts P, Gasink C, Chan D, Lang Y, Pollack P, Colombel JF, Wolf DC, Jacobstein D, Johanns J, Szapary P, Adedokun OJ, Feagan BG, Sandborn WJ. Efficacy of Ustekinumab for Inducing Endoscopic Healing in Patients With Crohn's Disease. Gastroenterology. 2018 Oct;155(4):1045-1058. doi: 10.1053/j.gastro.2018.06.035. Epub 2018 Aug 29.

ReferenceCitation: Adedokun OJ, Xu Z, Gasink C, Jacobstein D, Szapary P, Johanns J, Gao LL, Davis HM, Hanauer SB, Feagan BG, Ghosh S, Sandborn WJ. Pharmacokinetics and Exposure Response Relationships of Ustekinumab in Patients With Crohn's Disease. Gastroenterology. 2018 May;154(6):1660-1671. doi: 10.1053/j.gastro.2018.01.043. Epub 2018 Feb 1.

ReferenceCitation: Hibi T, Imai Y, Murata Y, Matsushima N, Zheng R, Gasink C. Efficacy and safety of ustekinumab in Japanese patients with moderately to severely active Crohn's disease: a subpopulation analysis of phase 3 induction and maintenance studies. Intest Res. 2017 Oct;15(4):475-486. doi: 10.5217/ir.2017.15.4.475. Epub 2017 Oct 23.

ReferenceCitation: Feagan BG, Sandborn WJ, Gasink C, Jacobstein D, Lang Y, Friedman JR, Blank MA, Johanns J, Gao LL, Miao Y, Adedokun OJ, Sands BE, Hanauer SB, Vermeire S, Targan S, Ghosh S, de Villiers WJ, Colombel JF, Tulassay Z, Seidler U, Salzberg BA, Desreumaux P, Lee SD, Loftus EV Jr, Dieleman LA, Katz S, Rutgeerts P; UNITI-IM-UNITI Study Group. Ustekinumab as Induction and Maintenance Therapy for Crohn's Disease. N Engl J Med. 2016 Nov 17;375(20):1946-1960.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Serbia
Spain
United Kingdom
United States
South Africa
Belgium
Iceland
Japan
Poland
Austria
Australia
Israel
Brazil
Canada
Hungary
Germany
Denmark
Ireland
New Zealand
Czech Republic
Korea, Republic of
France
Netherlands

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Single Arm, Open-label, Phase II, Multicentre Study, to Assess the Safety of Vismodegib (GDC-0449) in Patient With Locally Advanced or Metastatic Basal Cell Carcinoma (BCC)

summary: This single-arm, open-label, multi-center study will evaluate the safety and efficacy of vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma. Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or unacceptable toxicity.

study_start_date_type: Actual

design_allocation: Non-Randomized

ReferenceCitation: Bossi P, Peris K, Calzavara-Pinton P, Queirolo P, Alfieri S, Palla M, Rossi MT, Spagnolo F, Tambone S, Astolfi C, Ascierto PA. Cohort analysis of safety and efficacy of vismodegib in Italian patients from the Phase II, multicenter STEVIE study. Future Oncol. 2020 Jun;16(16):1091-1100. doi: 10.2217/fon-2019-0664. Epub 2020 May 6.

ReferenceCitation: Basset-Séguin N, Hauschild A, Kunstfeld R, Grob J, Dréno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Meyer N, Guillot B, Dummer R, Arenberger P, Fife K, Raimundo A, Dika E, Dimier N, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma: Primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017 Nov;86:334-348. doi: 10.1016/j.ejca.2017.08.022. Epub 2017 Nov 5.

ReferenceCitation: Basset-Seguin N, Hauschild A, Grob JJ, Kunstfeld R, Dréno B, Mortier L, Ascierto PA, Licitra L, Dutriaux C, Thomas L, Jouary T, Meyer N, Guillot B, Dummer R, Fife K, Ernst DS, Williams S, Fittipaldo A, Xynos I, Hansson J. Vismodegib in patients with advanced basal cell carcinoma (STEVIE): a pre-planned interim analysis of an international, open-label trial. Lancet Oncol. 2015 Jun;16(6):729-36. doi: 10.1016/S1470-2045(15)70198-1. Epub 2015 May 13.

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Belgium
Romania
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Ireland
New Zealand
Finland
France
Colombia
Netherlands

location_facility: Universitätsklinikum Würzburg; Klinik und Poliklinik für Dermatologie Venerologie u. Allergologie

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH; Klinik für Dermatologie und Allergologie

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

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Fundacion Hospital de Alcorcon; Servicio de Dermatologia

location_facility: Addenbrookes Hospital; Cambridge Cancer Trials Centre, S4 Box 279

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

location_facility: National Specialized Hospital for Active Oncology Treatment; Dermatology Clinic

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

location_facility: Cork University Hospital; Dermatology Dept

location_facility: Helsinki University Central Hospital; Skin & Allergy Hospital

location_facility: Fondazione Ptv Policlinico Tor Vergata; Dermatologia

location_facility: Klinikum Nürnberg Nord; Hautklinik; Klinik für Dermatologie

location_facility: Universitätsspital Zürich; Dermatologische Klinik

location_facility: Klinikum rechts der Isar der TU München; Klinik & Poliklinik für Dermatologie und Allergologie

location_facility: Klinikum Mannheim Klinik fuer Dermatologie, Venerologie und Allergologie

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Dermatologia

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Dermatologia

location_facility: LKH Salzburg; Universitätsklinik für Dermatologie

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Centre Hospitalier Lyon Sud; Dermatologie

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

location_facility: Hopital Saint Andre CHU De Bordeaux; Dermatologie

location_facility: Istituto Dermatologico San Gallicano IRCCS; Dermatologia Oncolgica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

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

location_facility: Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin.Kozp.

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Universitätsklinikum Hamburg-Eppendorf Zentrum f.Innere Medizin Klinik f.Dermatologie

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: LKH Graz; Abteilung für allgemeine Dermatologie

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: I.R.S.T. Srl - Meldola - FC; Day Hospital Oncologico

location_facility: Fakultni Thomayerova Nemocnice; Onkologicke Oddeleni

location_facility: Hospital Reina Sofia; Servicio de dermatología

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Dermatologie

location_facility: Dokuz Eylul University Medicine Faculty; Dermatology

location_facility: Universitätsmedizin Greifswald; Klinik für MKG-Chirurgie und Plastische Operationen

location_facility: Istituto Dermopatico dell'Immacolata (IDI)-IRCCS; IV Divisione Oncologica e Dermatologia Oncologica

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Elbekliniken Buxtehude; Klinik für Dermatologie

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Università di Brescia; Dipartimento di Dermatologia

location_facility: Uni Schleswig-Holstein; Klinik für Dermatologie, Allergologie und Venerologie (Hautklinik)

location_facility: Gazi Universitesi Tip Facultesi; Dept. of Dermatology

location_facility: IRCCS Istituto Clinico Humanitas; Farmacia

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Hôpital Larrey Université Paul Sabatier; Service Dermatologie

location_facility: Universitätsklinikum Marburg Klinik f. Dermatologie

location_facility: Universitätsklinikum Magdeburg; Hautklinik; Klinik für Dermatologie und Venerologie

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Laiko General Hospital; 1St Pathological Clinic

location_facility: CMAX A division of IDT Australia Limited

location_facility: District Oncology Dispensary; Department for Oncology and Dermatology

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Waitemata District Health; General Surgery

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Inst. Nacional de Cancerologia; Clinica de Seno

location_facility: Semmelweis Egyetem; Bor-, Nemikortani es Boronkologiai Klinika

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hospital General Universitario de Guadalajara; Servicio de Dermatologia

location_facility: Ankara Numune Training and Research Hospital; Dermatology

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hospital Clinic i Provincial; Servicio de dermatología

location_facility: Hospital Universitario Miguel Servet; Servicio Dermatologia

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie; Klinika Onkologiczna

location_facility: Charité Campus Mitte; Hauttumorcentrum Charité (HTCC); Klinik für Dermatologie, Venerologie und Alle

location_facility: Andreas Syggros Hospital; 1st University Dermatology Clinic; Oncology Department

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Dermatologia

location_facility: Maastricht University Medical Centre; Dermatologie

location_facility: Clinica Universitaria de Navarra; Servicio de Dermatologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Klinikum der LMU München; Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: University General Hospital of loannina; Dermatology and Venereal Diseases Clinic

location_facility: Fakultní nemocnice Ostrava; Kožní oddělení

location_facility: Azienda Ospedaliera Umberto I; Clinica Dermatologica

location_facility: Hospital Universitario del Sureste; Servicio de Dermatologia

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Ospedale San Salvatore (ASL-01); Dip. di Dermatologia U.O.S. di Dermatologia Oncol

location_facility: UNI-Klinikum Campus Kiel Klinik f.Dermatologie Tagesklinik f.Dermatologie

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Hospital Univ. Central de Asturias; Servicio de Dermatologia

location_facility: Klinikum d.Stadt Ludwigshafen Hautklinik

location_facility: Skånes Onkologiska Klinik, Universitetssjukhuset

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: S.C. Life Search S.R.L; Medical Oncology Clinic

location_facility: Oslo Universitetssykehus HF; Radiumhospitalet

location_facility: Centre de Recherche Dermatologique du Quebec Metropolitain (CRDQ)

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Klinikum Dortmund gGmbH Klinikzentrum Mitte

location_facility: Western Infirmary; Division of Cardiovascular and Medical Sciences

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

location_facility: Klinik der Uni zu Köln; Klinik & Poliklinik fuer Dermatologie & Venerologie

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Inst. de Oncologia Angel H. Roffo ; Servicio de Oncologia

location_facility: Universitätsklinikum Münster; Klinik für Hautkrankheiten; Allgemeine Dermatologie und Venerologie

location_facility: Hospital General Universitario J.M Morales Meseguer; Servicio de Dermatologia

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Hospital Universitario Virgen de las Nieves; Servicio de Oncologia

location_facility: Policlinico Sant'Orsola Malpighi; U.O. Dermatologia

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

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie


acronym: PROSELICA

title: Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

lead_sponsor: Sanofi

source: euctr

ReferenceCitation: Meisel A, de Wit R, Oudard S, Sartor O, Stenner-Liewen F, Shun Z, Foster M, Ozatilgan A, Eisenberger M, de Bono JS. Neutropenia, neutrophilia, and neutrophil-lymphocyte ratio as prognostic markers in patients with metastatic castration-resistant prostate cancer. Ther Adv Med Oncol. 2022 Jun 1;14:17588359221100022. doi: 10.1177/17588359221100022. eCollection 2022.

ReferenceCitation: Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.

ReferenceCitation: Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Macé S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.

ReferenceCitation: Eisenberger M, Hardy-Bessard AC, Kim CS, Géczi L, Ford D, Mourey L, Carles J, Parente P, Font A, Kacso G, Chadjaa M, Zhang W, Bernard J, de Bono J. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017 Oct 1;35(28):3198-3206. doi: 10.1200/JCO.2016.72.1076. Epub 2017 Aug 15.

ReferenceCitation: Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91.

location_country:
Spain
United Kingdom
United States
Peru
Romania
Belgium
South Africa
Poland
Russian Federation
Australia
Argentina
Tunisia
Turkey
Brazil
Canada
Hungary
Germany
Taiwan
Korea, Republic of
France
Chile
Netherlands

location_facility:
Investigational Site Number 056002
Investigational Site Number 826003
Investigational Site Number 840006
Investigational Site Number 643006
Investigational Site Number 032001
Investigational Site Number 840012
Investigational Site Number 032003
Investigational Site Number 152005
Investigational Site Number 643010
Investigational Site Number 056005
Investigational Site Number 643007
Investigational Site Number 642003
Investigational Site Number 840013
Investigational Site Number 036013
Investigational Site Number 616005
Investigational Site Number 036010
Investigational Site Number 604002
Investigational Site Number 724005
Investigational Site Number 158002
Investigational Site Number 840024
Investigational Site Number 528004
Investigational Site Number 724003
Investigational Site Number 826001
Investigational Site Number 788002
Investigational Site Number 643009
Investigational Site Number 158001
Investigational Site Number 528005
Investigational Site Number 528001
Investigational Site Number 276012
Investigational Site Number 124001
Investigational Site Number 056007
Investigational Site Number 788003
Investigational Site Number 724004
Investigational Site Number 076009
Investigational Site Number 250007
Investigational Site Number 642001
Investigational Site Number 250004
Investigational Site Number 724008
Investigational Site Number 604007
Investigational Site Number 250005
Investigational Site Number 250001
Investigational Site Number 792001
Investigational Site Number 604003
Investigational Site Number 056004
Investigational Site Number 250003
Investigational Site Number 604001
Investigational Site Number 036012
Investigational Site Number 036016
Investigational Site Number 616002
Investigational Site Number 642009
Investigational Site Number 056009
Investigational Site Number 410005
Investigational Site Number 036009
Investigational Site Number 826007
Investigational Site Number 032004
Investigational Site Number 036008
Investigational Site Number 840004
Investigational Site Number 826002
Investigational Site Number 056011
Investigational Site Number 348003
Investigational Site Number 276007
Investigational Site Number 642004
Investigational Site Number 840025
Investigational Site Number 076015
Investigational Site Number 276005
Investigational Site Number 056013
Investigational Site Number 076002
Investigational Site Number 276003
Investigational Site Number 056010
Investigational Site Number 826004
Investigational Site Number 642013
Investigational Site Number 076007
Investigational Site Number 124002
Investigational Site Number 840002
Investigational Site Number 792002
Investigational Site Number 840003
Investigational Site Number 276001
Investigational Site Number 036015
Investigational Site Number 840014
Investigational Site Number 124005
Investigational Site Number 604006
Investigational Site Number 076012
Investigational Site Number 840001
Investigational Site Number 788004
Investigational Site Number 826006
Investigational Site Number 643003
Investigational Site Number 276011
Investigational Site Number 528002
Investigational Site Number 840020
Investigational Site Number 032002
Investigational Site Number 152001
Investigational Site Number 250008
Investigational Site Number 616001
Investigational Site Number 276008
Investigational Site Number 410001
Investigational Site Number 276004
Investigational Site Number 348005
Investigational Site Number 642007
Investigational Site Number 616004
Investigational Site Number 642005
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Investigational Site Number 348004
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summary:
Primary Objective:

- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m² (Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants with metastatic castration resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing regimen.

Secondary Objectives:

To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was better tolerated than Cabazitaxel 25 mg/m².

To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:

Progression Free Survival (PFS) defined as the first occurrence of any of the following events: tumor progression per Response Evaluation Criteria In Solid Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or death due to any cause;
PSA Progression;
Pain progression;
Tumor response in participants with measurable disease (RECIST 1.1);
PSA response;
Pain response in participants with stable pain at baseline.
To compare Health-related Quality of Life (HRQoL).
To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.


title: A Randomized, Double Blind Study of the Safety and Efficacy of GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily Both Administered With Fixed-dose Dual Nucleoside Reverse Transcriptase Inhibitor Therapy Over 96 Weeks in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects

summary: The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg once daily versus RAL 400mg twice daily over 48 weeks; non-inferiority will also be tested at Week 96. Both GSK1349572 and RAL will be given in combination with fixed-dose dual NRTI therapy (ABC/3TC or TDF/FTC). This study will be conducted in HIV-1 infected ART-naïve adult subjects.

ReferenceType: background

ReferenceCitation: Brinson C, Walmsley S, Arasteh K, et al. Dolutegravir treatment response and safety by key subgroups in treatment naive HIV-infected individuals. Published at: Conference on Retroviruses and Opportunistic Infections - 20th Annual; March 3-6, 2013; Atlanta, GA.

ReferenceCitation: Raffi F, Rachlis A, Stellbrink HJ, Hardy WD, Torti C, Orkin C, Bloch M, Podzamczer D, Pokrovsky V, Pulido F, Almond S, Margolis D, Brennan C, Min S; SPRING-2 Study Group. Once-daily dolutegravir versus raltegravir in antiretroviral-naive adults with HIV-1 infection: 48 week results from the randomised, double-blind, non-inferiority SPRING-2 study. Lancet. 2013 Mar 2;381(9868):735-43. doi: 10.1016/S0140-6736(12)61853-4. Epub 2013 Jan 8.

ReferenceCitation: Raffi F, Jaeger H, Quiros-Roldan E, Albrecht H, Belonosova E, Gatell JM, Baril JG, Domingo P, Brennan C, Almond S, Min S; extended SPRING-2 Study Group. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naive adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2013 Nov;13(11):927-35. doi: 10.1016/S1473-3099(13)70257-3. Epub 2013 Sep 25.

lead_sponsor: ViiV Healthcare

location_country:
Spain
Italy
Russian Federation
Australia
United Kingdom
Canada
United States
France
Germany

intervention_type: Other


title: A Randomized, Double-blind Study of the Effect of Avastin Plus Gemcitabine and Erlotinib Compared With Placebo Plus Gemcitabine and Erlotinib on Overall Survival in Patients With Metastatic Pancreatic Cancer

summary: This study will evaluate efficacy, safety and tolerability of Avastin versus placebo added to a chemotherapeutic regimen in patients with metastatic pancreatic cancer. The anticipated time of study treatment is until confirmed evidence of disease progression, and the target sample size is 500+ individuals.

location_country:
Spain
Italy
United Kingdom
Peru
Belgium
South Africa
Poland
Austria
Australia
Israel
Sweden
Singapore
Canada
China
Germany
Taiwan
New Zealand
Finland
Czech Republic
France
Netherlands


title: A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY

summary: The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.

ReferenceCitation: Kang YK, Yau T, Park JW, Lim HY, Lee TY, Obi S, Chan SL, Qin S, Kim RD, Casey M, Chen C, Bhattacharyya H, Williams JA, Valota O, Chakrabarti D, Kudo M. Randomized phase II study of axitinib versus placebo plus best supportive care in second-line treatment of advanced hepatocellular carcinoma. Ann Oncol. 2015 Dec;26(12):2457-63. doi: 10.1093/annonc/mdv388. Epub 2015 Sep 18.

ipd_sharing: Yes

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Taiwan
Hong Kong
United Kingdom
Italy
Hungary
Korea, Republic of
United States
France
China
Belgium
Japan
Germany
Slovakia

location_facility: Hospital of the University of Pennsylvania

location_facility: Istituto di Ematologia ed Oncologia Medica, Lorenzo ed Ariosto Seragnoli,

location_facility: University of California Irvine Medical Center

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria aile Scotte

location_facility: Alta Bates Summit Comprehensive Cancer Center

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Royal Liverpool and Broadgreen University Hospital

location_facility: Bichat-Beaujon Service Inter Hospitalier De Cancerologie

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: Unita Operativa Oncologia Medica IRCCS Fondazione Salvatore Maugeri

location_facility: Klinikum der Ludwig-Maximilians-Universitaet , Campus Grosshadern

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

location_facility: Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

location_facility: CHRU Montpellier-Hopital Saint Eloi - Departement Oncologie Medicale

location_facility: National Cancer Center/ Center for Liver Cancer

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Aichi Cancer Center Central Hospital, Diagnostic and Interventional Radiology

location_facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

location_facility: Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University

location_facility: Florida Hospital Transplant Center, Liver Unit

location_facility: Moffitt Cancer Center & Research Institute

location_facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. E A. Seragnoli"

location_facility: Centre Hospitalier Universitaire d'Amiens

location_facility: Semmelweis Egyetem I.sz. Belgyógyászati Klinika


title: A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

lead_sponsor: Celgene

ReferenceType: result

ReferenceCitation: Czuczman MS, Trněný M, Davies A, Rule S, Linton KM, Wagner-Johnston N, Gascoyne RD, Slack GW, Brousset P, Eberhard DA, Hernandez-Ilizaliturri FJ, Salles G, Witzig TE, Zinzani PL, Wright GW, Staudt LM, Yang Y, Williams PM, Lih CJ, Russo J, Thakurta A, Hagner P, Fustier P, Song D, Lewis ID. A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. Clin Cancer Res. 2017 Aug 1;23(15):4127-4137. doi: 10.1158/1078-0432.CCR-16-2818. Epub 2017 Apr 5.

ReferenceCitation: Hernandez-Ilizaliturri FJ, Deeb G, Zinzani PL, Pileri SA, Malik F, Macon WR, Goy A, Witzig TE, Czuczman MS. Higher response to lenalidomide in relapsed/refractory diffuse large B-cell lymphoma in nongerminal center B-cell-like than in germinal center B-cell-like phenotype. Cancer. 2011 Nov 15;117(22):5058-66. doi: 10.1002/cncr.26135. Epub 2011 Apr 14.

location_country:
Spain
Italy
Austria
Australia
United Kingdom
United States
France
Sweden
Czechia

location_facility: Providence St Joseph Medical Center/Cancer Center

location_facility: Hosptial Clinico Universitario de Salamanca

location_facility: Royal Mardsen Hospital - Fulham (Satellite Site)

location_facility: Royal Devon and Exeter Hospital Haematology Department

location_facility: Clinica Ematologica, A.O.U. San Martino di Genova

location_facility: Policlinico Tor Vergata (Universta Tor Vergata)

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The Christie Foundation Trust, I'st Floor, Haemotology Oncology Outpatients, Lymphoma Team

location_facility: Universita Federico II di Napoli Nuovo Policlinico

location_facility: Azienda Ospedaliera di Perugai Ospedale S. Maria della Miseri

location_facility: Washington University Siteman Cancer Center

location_facility: Istituto di Ematologica Istituto di Ematologica " L.e. A. Seragnoli' Azienda Ospedaliera Universitaria Policlinico

location_facility: CHU de Grenoble-Hopital Albert Michallon

location_facility: University of Michigan, Comprehensive Cancer Center

location_facility: Southhampton University Hospital NHS Trust

summary: The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.


status: Terminated

primary_purpose: Prevention

intervention_type: Biological

acronym: PREVENT

title: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence

lead_sponsor: Janssen Biotech, Inc.

ReferenceCitation: Regueiro M, Feagan BG, Zou B, Johanns J, Blank MA, Chevrier M, Plevy S, Popp J, Cornillie FJ, Lukas M, Danese S, Gionchetti P, Hanauer SB, Reinisch W, Sandborn WJ, Sorrentino D, Rutgeerts P; PREVENT Study Group. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection. Gastroenterology. 2016 Jun;150(7):1568-1578. doi: 10.1053/j.gastro.2016.02.072. Epub 2016 Mar 3.

location_country:
Poland
United Kingdom
Austria
Australia
Netherlands
Canada
Czech Republic
New Zealand
Hungary
United States
France
Israel
Belgium
Germany

summary: REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.

status_simplified: Unknown


title: AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

acronym: AMBITION

summary: The purpose of this study is to compare the two treatment strategies; first-line combination therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil) in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first clinical failure event.

ReferenceCitation: Kuwana M, Blair C, Takahashi T, Langley J, Coghlan JG. Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis. Ann Rheum Dis. 2020 May;79(5):626-634. doi: 10.1136/annrheumdis-2019-216274. Epub 2020 Mar 11. Erratum in: Ann Rheum Dis. 2020 Sep;79(9):e118.

ReferenceCitation: White RJ, Vonk-Noordegraaf A, Rosenkranz S, Oudiz RJ, McLaughlin VV, Hoeper MM, Grünig E, Ghofrani HA, Chakinala MM, Barberà JA, Blair C, Langley J, Frost AE. Clinical outcomes stratified by baseline functional class after initial combination therapy for pulmonary arterial hypertension. Respir Res. 2019 Sep 12;20(1):208. doi: 10.1186/s12931-019-1180-1.

ReferenceCitation: Coghlan JG, Galiè N, Barberà JA, Frost AE, Ghofrani HA, Hoeper MM, Kuwana M, McLaughlin VV, Peacock AJ, Simonneau G, Vachiéry JL, Blair C, Gillies H, Miller KL, Harris JHN, Langley J, Rubin LJ; AMBITION investigators. Initial combination therapy with ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH): subgroup analysis from the AMBITION trial. Ann Rheum Dis. 2017 Jul;76(7):1219-1227. doi: 10.1136/annrheumdis-2016-210236. Epub 2016 Dec 30.

ReferenceCitation: Galiè N, Barberà JA, Frost AE, Ghofrani HA, Hoeper MM, McLaughlin VV, Peacock AJ, Simonneau G, Vachiery JL, Grünig E, Oudiz RJ, Vonk-Noordegraaf A, White RJ, Blair C, Gillies H, Miller KL, Harris JH, Langley J, Rubin LJ; AMBITION Investigators. Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension. N Engl J Med. 2015 Aug 27;373(9):834-44. doi: 10.1056/NEJMoa1413687.

ReferenceCitation: Peacock AJ, Zamboni W, Vizza CD. Ambrisentan for the treatment of adults with pulmonary arterial hypertension: a review. Curr Med Res Opin. 2015;31(9):1793-807. doi: 10.1185/03007995.2015.1074890. Epub 2015 Aug 27. Review.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Greece
Austria
Australia
Italy
Canada
Netherlands
United Kingdom
Sweden
United States
France
Belgium
Japan
Germany


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9350-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

lead_sponsor: Gilead Sciences

ReferenceCitation: Gallant JE, Koenig E, Andrade-Villanueva J, Chetchotisakd P, DeJesus E, Antunes F, Arastéh K, Moyle G, Rizzardini G, Fehr J, Liu Y, Zhong L, Callebaut C, Szwarcberg J, Rhee MS, Cheng AK. Cobicistat versus ritonavir as a pharmacoenhancer of atazanavir plus emtricitabine/tenofovir disoproxil fumarate in treatment-naive HIV type 1-infected patients: week 48 results. J Infect Dis. 2013 Jul;208(1):32-9. doi: 10.1093/infdis/jit122. Epub 2013 Mar 26.

ReferenceCitation: Gallant JE, Koenig E, Andrade-Villanueva JF, Chetchotisakd P, DeJesus E, Antunes F, Arastéh K, Rizzardini G, Fehr J, Liu HC, Abram ME, Cao H, Szwarcberg J. Brief Report: Cobicistat Compared With Ritonavir as a Pharmacoenhancer for Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate: Week 144 Results. J Acquir Immune Defic Syndr. 2015 Jul 1;69(3):338-40. doi: 10.1097/QAI.0000000000000598.

ReferenceCitation: Gallant J, Moyle G, Berenguer J, Shalit P, Cao H, Liu YP, Myers J, Rosenblatt L, Yang L, Szwarcberg J. Atazanavir Plus Cobicistat: Week 48 and Week 144 Subgroup Analyses of a Phase 3, Randomized, Double-Blind, Active-Controlled Trial. Curr HIV Res. 2017;15(3):216-224. doi: 10.2174/1570162X14666161021102728.

location_country:
Denmark
Brazil
Portugal
Spain
Dominican Republic
Austria
Australia
Italy
Canada
Mexico
Netherlands
Switzerland
Thailand
Puerto Rico
United States
France
United Kingdom
Belgium
Germany

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: University of California, Davis Medical Center

location_facility: Infectious Disease Research Institute Inc.

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: University of Cologne, Department of Internal Medicine

location_facility: George Washington University Medical Faculty Associates

location_facility: Universitätsklinik für Infektiologie, Universitätsspital Bern

location_facility: Instituto De Pesquisa Clinica Evandro Chagas

location_facility: Community Research Initiative of New England

location_facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

location_facility: Johns Hopkins University School of Medicine

location_facility: Broward Health/Comprehensive Care Center

location_facility: Centre François Magendie, Hôpital du Haut Lévêque

location_facility: La Playa Medical Group and Clinical Research

location_facility: Tarrant County Infectious Disease Associates

location_facility: Service des Maladies Infectieuses, CHU de Caen

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: Maharaj Nakorn Chiang Mai University, Faculty of Medicine, Department of Medicine

location_facility: Division of Infectious Diseases, Thomas Jefferson University

location_facility: Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde

location_facility: Istituto Nazionale Malattie Infettive Lazzaro Spallanzani

location_facility: East Carolina University, The Brody School of Medicine

location_facility: Instituto Dominicano de Estudios Virologicos - IDEV

location_facility: Hopital Saint Antoine, Service De Maladies Infectieuses

location_facility: Brasilmed Assistencia Medica E Pesquisas

location_facility: Division of Infectious Diseases and Hospital Hygiene; University Hospital of Zurich

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Serviço de Doenças Infecciosas, Hospital de São João

location_facility: Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic

location_facility: HIV-NAT, Thai Red Cross AIDS Research Center and Faculty of Medicine Chulalongkorn University

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Instituto de Investigacion Clentifica del Sur

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Kaiser Permanente Medical Center, Clinical Trials Unit

location_facility: University of South Florida HIV Clinical Research Unit / Hillsborough County Health Department

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: Hopital Sainte Marguerite Service d'Immuno-Hématologie Clinique -CISIH

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Immunodeficiency Service, McGill University Health Centre (MUHC) - Montreal Chest Institute

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: University Health Network, Toronto General Hospital

location_facility: Infektio Research GmbH / Infektiologikum Frankfurt

summary:
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults.

Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

ReferenceCitation: DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial. Lancet. 2012 Jun 30;379(9835):2429-2438. doi: 10.1016/S0140-6736(12)60918-0.

ReferenceCitation: Rockstroh JK, DeJesus E, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Plummer A, Abram M, Cheng AK, Fordyce MW, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results. J Acquir Immune Defic Syndr. 2013 Apr 15;62(5):483-6. doi: 10.1097/QAI.0b013e318286415c.

ReferenceCitation: Clumeck N, Molina JM, Henry K, Gathe J, Rockstroh JK, DeJesus E, Wei X, White K, Fordyce MW, Rhee MS, Szwarcberg J; GS-236-0103 Study Team. A randomized, double-blind comparison of single-tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus emtricitabine/tenofovir DF for initial treatment of HIV-1 infection: analysis of week 144 results. J Acquir Immune Defic Syndr. 2014 Mar 1;65(3):e121-4. doi: 10.1097/QAI.0000000000000089.

location_country:
Denmark
Portugal
United Kingdom
Italy
Austria
Australia
Mexico
Canada
Netherlands
Switzerland
Thailand
Sweden
Puerto Rico
United States
France
Belgium
Germany

location_facility: Department of Dermatology, Division of Immunology, Allergy & Inf. Diseases; Medical University Vienna

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: Department of Infectious Diseases, Saint-Louis hospital

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Hôpital de la Croix Rousse - Maladies Infectieuses et Tropicales

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Interne Lungenabteilung, SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: Nicholaos C. Bellos, MD, PA (Southwest Infectious Disease Clinical Research, Inc.)

location_facility: University of California, Davis Medical Center

location_facility: Infectious Disease Research Institute Inc.

location_facility: Garden State Infectious Diseases Associates, PA

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

location_facility: University of Cologne, Department of Internal Medicine

location_facility: Dr. Joseph C. Gathe MD (Therapeutic Concepts, PA)

location_facility: Klinikum der Goethe-Universitaet, Medizinische Klinik II, Schwerpunkt HIV, Haus 68

location_facility: George Washington University Medical Faculty Associates

location_facility: Trinity Health and Wellness Center/AIDS Arms, Inc.

location_facility: St. Mary's Hospital, London (Imperial College, London)

location_facility: Yale University HIV Clinical Trials Program

location_facility: University Medical Center Hamburg-Eppendorf, Infectious Diseases Unit

location_facility: Broward Health/Comprehensive Care Center

location_facility: Erasmus MC, Internal Medicine, Section of Infectious Diseases

location_facility: La Playa Medical Group and Clinical Research

location_facility: National Institute for Infectious Diseases "L. Spallanzani" IRCCS

location_facility: Tarrant County Infectious Disease Associates

location_facility: Service des Maladies Infectieuses, CHU de Caen

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: Division of Infectious Diseases, Thomas Jefferson University

location_facility: Unidad de VIH, Hospital Civil de Guadalajara, Fray Antonio Alcalde

location_facility: Clinical Alliance for Research & Education, Infectious Diseases (CARE-ID)

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Hopital Saint Antoine, Service De Maladies Infectieuses

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: CHU Gui de Chauliac, Maladies Infectieuses Dpt

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Melbourne Health - Royal Melbourne Hospital Campus (Sexual Health Clinic)

location_facility: STAR Health Care Center (SUNY Downstate)

location_facility: University of Bonn, Dep. of Internal Medicine I, HIV-Outpatient Clinic

location_facility: National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales

location_facility: Division of Infectious Diseases, St. Louis University Medical Center

summary: To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.


title: SCOT Registry: Small Cell Lung Cancer Treatment and Outcome

acronym: SCOT

summary:
The registry is an international, multicenter, observational registry of newly diagnosed patients with SCLC.

Data will be entered into an electronic CRF (eCRF) via Internet access. Treatment plan remains the responsibility of the patient's physician and data collected in this registry will reflect a "real world" approach of the diagnosis and treatment of patients with SCLC.

Approximately 60 centres in 13 countries will take part in this registry. It is expected that about 500 patients will be recruited during a period of 6 to 9 months according to the feasibility.

study_type: Observational

time_perspective: Prospective

location_country:
Poland
Slovenia
Greece
Austria
Estonia
Italy
Lithuania
Czech Republic
Netherlands
Spain
Hungary
Korea, Republic of
France
Germany


intervention_type: Radiation

title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Bevacizumab, Temozolomide and Radiotherapy, Followed by Bevacizumab and Temozolomide Versus Placebo, Temozolomide and Radiotherapy Followed by Placebo and Temozolomide in Patients With Newly Diagnosed Glioblastoma

ReferenceCitation: Hagiwara A, Schlossman J, Shabani S, Raymond C, Tatekawa H, Abrey LE, Garcia J, Chinot O, Saran F, Nishikawa R, Henriksson R, Mason WP, Wick W, Cloughesy TF, Ellingson BM. Incidence, molecular characteristics, and imaging features of "clinically-defined pseudoprogression" in newly diagnosed glioblastoma treated with chemoradiation. J Neurooncol. 2022 Sep;159(3):509-518. doi: 10.1007/s11060-022-04088-3. Epub 2022 Jul 17.

ReferenceCitation: Jiguet-Jiglaire C, Boissonneau S, Denicolai E, Hein V, Lasseur R, Garcia J, Romain S, Appay R, Graillon T, Mason W, Carpentier AF, Brandes AA, Ouafik L', Wick W, Baaziz A, Gigan JP, Argüello RJ, Figarella-Branger D, Chinot O, Tabouret E. Plasmatic MMP9 released from tumor-infiltrating neutrophils is predictive for bevacizumab efficacy in glioblastoma patients: an AVAglio ancillary study. Acta Neuropathol Commun. 2022 Jan 3;10(1):1. doi: 10.1186/s40478-021-01305-4.

ReferenceCitation: Chinot OL, Nishikawa R, Mason W, Henriksson R, Saran F, Cloughesy T, Garcia J, Revil C, Abrey L, Wick W. Upfront bevacizumab may extend survival for glioblastoma patients who do not receive second-line therapy: an exploratory analysis of AVAglio. Neuro Oncol. 2016 Sep;18(9):1313-8. doi: 10.1093/neuonc/now046. Epub 2016 Mar 22.

ReferenceCitation: Saran F, Chinot OL, Henriksson R, Mason W, Wick W, Cloughesy T, Dhar S, Pozzi E, Garcia J, Nishikawa R. Bevacizumab, temozolomide, and radiotherapy for newly diagnosed glioblastoma: comprehensive safety results during and after first-line therapy. Neuro Oncol. 2016 Jul;18(7):991-1001. doi: 10.1093/neuonc/nov300. Epub 2016 Jan 24.

ReferenceCitation: Taphoorn MJ, Henriksson R, Bottomley A, Cloughesy T, Wick W, Mason WP, Saran F, Nishikawa R, Hilton M, Theodore-Oklota C, Ravelo A, Chinot OL. Health-Related Quality of Life in a Randomized Phase III Study of Bevacizumab, Temozolomide, and Radiotherapy in Newly Diagnosed Glioblastoma. J Clin Oncol. 2015 Jul 1;33(19):2166-75. doi: 10.1200/JCO.2014.60.3217. Epub 2015 May 26.

ReferenceCitation: Chinot OL, Wick W, Mason W, Henriksson R, Saran F, Nishikawa R, Carpentier AF, Hoang-Xuan K, Kavan P, Cernea D, Brandes AA, Hilton M, Abrey L, Cloughesy T. Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.

ReferenceCitation: Chinot OL, Macdonald DR, Abrey LE, Zahlmann G, Kerloëguen Y, Cloughesy TF. Response assessment criteria for glioblastoma: practical adaptation and implementation in clinical trials of antiangiogenic therapy. Curr Neurol Neurosci Rep. 2013 May;13(5):347. doi: 10.1007/s11910-013-0347-2. Review.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Poland
Hong Kong
Portugal
Russian Federation
Australia
Israel
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Greece
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Ausl Di Bologna-Ospedale Bellaria;U.O. Oncologia Medica

location_facility: Sarah Cannon Cancer Center and Research Institute

location_facility: Catharina Ziekenhuis; Dept of Internal Medicin

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Russian Research Oncology Center n.a. N.N. Blokhin of the RAMS; Department of Neurosurgery

location_facility: Chonnam National University Hwasun Hospital

location_facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Saitama Medical University International Medical Center; Clinical and Medical Oncology

location_facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

location_facility: Scientific Research Neurosurgery Institute; Dept. of Neurooncology

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Chaim Sheba MC; Pediatric Hematology Oncology

location_facility: Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie

location_facility: Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

location_facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet

location_facility: Kyorin University Hospital; Neurosurgery

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

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Kumamoto University Hospital; Neurosurgery

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: University Hospital of Larissa; Oncology

location_facility: Hiroshima University Hospital; Neurosurgery

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: Royal Melbourne Hospital; Hematology and Medical Oncology

location_facility: VU MEDISCH CENTRUM; Dept. of Medical Oncology

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Cancer Centre of Southeastern Ontario; Kingston General Hospital

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Waikato Hospital; Regional Cancer Center

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie; Klinika Neurochirurgii i Neurochirurgii Dzi

location_facility: Norrlands Universitetssjukhus; Cancer Centrum

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: BC Cancer Agency, Vancouver Clinic; Dept. of Medical Oncology

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Hong Kong Sanatorium & Hospital; Comprehensive Oncology Centre

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Centre Val Aurelle Paul Lamarque; Medecine B3

location_facility: Universitatsklinikum Heidelberg; Abteilung Neuroonkologie

location_facility: The Royal Marsden NHS Foundation Trust; Oncology

location_facility: Northern Centre for Cancer Care;Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Samsung Medical Center; Neurosurgery Department

location_facility: Institution of Higher Professional Learning Military; Neurooncology

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház; Neurosurgery

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Prince of Wales Hospital; Department of Medical Oncology

location_facility: North Shore Private Hospital; Northern Specialist Centre

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Kyungpook National University Hosital; Neuro Sugery

location_facility: University of Alabama At Birmingham; Neuro-Oncology

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Pusan National University Hospital; Neuro Sugery

location_facility: Hadassah Hebrew University Hospital; Leslie and Michael Gaffin Center for Neuro-Oncology

location_facility: Calvary North Adelaide; North Adeliade Oncology Centre

location_facility: Az. Osp. S. Maria; Dept. Di Oncologia Medica

location_facility: Oncology-Evanston Nthwest Healthcare Kellogg Cancer Care Ctr

location_facility: Ospedale di Treviso, Universita di Padova; Neurosurgery Dept

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Nottingham City Hospital; Dept of Haematology

location_facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

location_facility: National Cancer Centre; Neurosurgery Dept

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Hôpital Central; Departement de Neuro-Oncologie

location_facility: Ottawa Hospital Regional Cancer Centre; Neuro-Oncology

location_facility: Utrecht University Medical Centre; Dept of Medical Oncology and UPC

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727

location_facility: Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Institut Bergonie; Gastro Enterologie Oncologie

location_facility: National Cancer Center Hospital; Neurosurgery

location_facility: Queen Elizabeth Medical Centre; Neurosurgery

location_facility: Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie

location_facility: Justus-Liebig-Universität Giessen; Neurochirurgische Klinik

location_facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Neurochirurgie

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Institut Oncologic Prof. Dr. Alexandru Trestioreanu; Departament Radioterapie

summary: This 2 arm study investigated the efficacy and safety of the addition of bevacizumab to the current standard of care (multimodality therapy of concurrent radiotherapy plus temozolomide followed by adjuvant temozolomide) as compared to the current standard of care alone. Participants were randomly assigned to either the bevacizumab (10 milligrams per kilogram (mg/kg) intravenously [IV] once every 2 week [q2w]) or the placebo arm, in combination with radiation therapy (total dose 60 Gray [Gy], administered as 2 Gy fractions, 5 days/week) plus temozolomide (75 milligrams per meter squared [mg/m^2] oral administration [po] daily) for 6 weeks. After a 4 week treatment break, participants continued to receive bevacizumab (10 mg/kg IV q2w) or placebo, plus temozolomide (150-200 mg/m^2 po daily on days 1-5 of each 4 week cycle) for 6 cycles of maintenance treatment or until disease progression or unacceptable toxicity, whichever occured first. Following the maintenance phase, bevacizumab (15 mg/kg iv every 3 weeks [q3w]) or placebo monotherapy continued. The time on study treatment was until disease progression.


acronym: SEARCH

title: A Phase III Randomized, Placebo Controlled, Double Blind Trial of Sorafenib Plus Erlotinib vs. Sorafenib Plus Placebo as First Line Systemic Treatment for Hepatocellular Carcinoma (HCC)

lead_sponsor: Bayer

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Israel
Singapore
Brazil
Canada
China
Germany
Bulgaria
Taiwan
Greece
New Zealand
Korea, Republic of
France
Chile
Colombia

summary: This is a randomized trial to evaluate the clinical benefit of sorafenib 400 mg twice daily and erlotinib 150 mg once a day versus sorafenib 400 mg twice daily and placebo erlotinib once daily in subjects with unresectable advanced or metastatic Child-Pugh A HCC. Patients who are candidates for potentially curative intervention (i.e. surgical resection or local ablation) are not eligible for this study.


title: Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome

summary: The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome

ReferenceCitation: Sharma A, Hagström E, Wojdyla DM, Neely ML, Harrington RA, Wallentin L, Alexander JH, Goodman SG, Lopes RD; Apixaban for Prevention of Acute Ischemic Safety Events APPRAISE-2 Steering Committee and Investigators. Clinical consequences of bleeding among individuals with a recent acute coronary syndrome: Insights from the APPRAISE-2 trial. Am Heart J. 2019 Sep;215:106-113. doi: 10.1016/j.ahj.2019.05.004. Epub 2019 May 11.

ReferenceCitation: Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.

ReferenceCitation: Sherwood MW, Lopes RD, Sun JL, Liaw D, Harrington RA, Wallentin L, Laskowitz DT, James SK, Goodman SG, Darius H, Lewis BS, Gibson CM, Pieper KS, Alexander JH. Apixaban following acute coronary syndromes in patients with prior stroke: Insights from the APPRAISE-2 trial. Am Heart J. 2018 Mar;197:1-8. doi: 10.1016/j.ahj.2017.09.020. Epub 2017 Oct 24.

ReferenceCitation: Guimarães PO, Lopes RD, Stevens SR, Zimerman A, Wruck L, James SK, Haque G, Giraldez RRCV, Alexander JH, Alexander KP. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection. J Am Heart Assoc. 2017 Apr 24;6(4). pii: e005490. doi: 10.1161/JAHA.117.005490.

ReferenceCitation: Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FWA, De Caterina R, Ogawa H, Wallentin L, Alexander JH. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):777-787. doi: 10.1016/j.jacc.2015.06.027.

ReferenceCitation: Khan R, Lopes RD, Neely ML, Stevens SR, Harrington RA, Diaz R, Cools F, Jansky P, Montalescot G, Atar D, Lopez-Sendon J, Flather M, Liaw D, Wallentin L, Alexander JH, Goodman SG; Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE)-2 Steering Committee and Investigators. Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome. Heart. 2015 Sep;101(18):1475-84. doi: 10.1136/heartjnl-2014-307346. Epub 2015 Jun 24.

ReferenceCitation: Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.

ReferenceCitation: Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699-708. doi: 10.1056/NEJMoa1105819. Epub 2011 Jul 24.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
Romania
South Africa
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
New Zealand
Finland
Czech Republic
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Cardiology Partners Clinical Research Institute

location_facility: Central Cardiovascular Institute Of San Antonio

location_facility: Indian River Cardiovascular Associates, Inc

location_facility: Methodist Debakey Heart & Vascular Center

location_facility: Texas Health Research & Education Institute

location_facility: Melbourne Internal Medicine Associates (Mima)

location_facility: Alta Pharmaceutical Research Center, Inc.

location_facility: Washington University School Of Medicine

location_facility: University Of Oklahoma Health Sciences Center

location_facility: Great Lakes Heart & Vascular Institute, Pc

location_facility: Sendara Cardiovasular Research Institute

location_facility: University Of Mississippi Medical Center

location_facility: East Carolina Heart Institute At East Carolina University

location_facility: The University Of North Carolina At Chapel Hill

location_facility: Jacksonville Center For Clinical Research

location_facility: Wheaton Franciscan Healthcare St. Joseph

location_facility: Richard M. Kastelic M.D. & Associates, P.C.

location_facility: Alegent Health Clinic Heart & Vascular Specialists

location_facility: Cardiovascular Specialist Of South Florida

location_facility: Bermisa Family Practice & Research Center

location_facility: Dr Kiran C Patel Research Institute At Pepin Heart Hospital

location_facility: Cardiology Assoicates, Pc/Black Hills Clinical Research Ctr

location_facility: Louisiana State University Health Sciences Center-Shreveport

location_facility: The Heart And Vascular Institute Of Florida

location_facility: Centex Research, Pineloch Medical Clinic

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: Thoracic And Cardiovascular Healthcare Foundation

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: Cincinnati Veterans Affairs Medical Center

location_facility: Cardiovascular Research Institute Of Dallas

location_facility: Cardiology Associates Of Southeastern Ohio

location_facility: Cardiovascular Physicians Of North Atlanta

location_facility: Miami Cardiology Clinical Research, L.L.C.

location_facility: Virgina Commonwealth Universitymedical Center

location_facility: Consultants In Cardiovascular Diseases, Inc.


acronym: EMILIA

title: A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

ReferenceCitation: Diéras V, Miles D, Verma S, Pegram M, Welslau M, Baselga J, Krop IE, Blackwell K, Hoersch S, Xu J, Green M, Gianni L. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017 Jun;18(6):732-742. doi: 10.1016/S1470-2045(17)30312-1. Epub 2017 May 16. Erratum in: Lancet Oncol. 2017 Aug;18(8):e433. Erratum in: Lancet Oncol. 2018 Dec;19(12):e667.

ReferenceCitation: Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, Pegram M, Oh DY, Diéras V, Guardino E, Fang L, Lu MW, Olsen S, Blackwell K; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012 Nov 8;367(19):1783-91. doi: 10.1056/NEJMoa1209124. Epub 2012 Oct 1. Erratum in: N Engl J Med. 2013 Jun 20;368(25):2442.

ReferenceCitation: Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236. Review.

location_country:
Spain
Italy
United Kingdom
United States
Philippines
Poland
Hong Kong
Portugal
Slovenia
Russian Federation
India
Mexico
Singapore
Sweden
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Germany
Bulgaria
Denmark
Taiwan
New Zealand
Finland
Korea, Republic of
France
Colombia

summary: This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up, withdrawal of consent, or study termination.


acronym: Not applicable

title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Lu AA21004 in Patients With Generalized Anxiety Disorder

lead_sponsor: H. Lundbeck A/S

ReferenceCitation: Baldwin DS, Loft H, Florea I. Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. Int Clin Psychopharmacol. 2012 Jul;27(4):197-207. doi: 10.1097/YIC.0b013e3283530ad7.

ReferenceCitation: Christensen MC, Loft H, Florea I, McIntyre RS. Efficacy of vortioxetine in working patients with generalized anxiety disorder. CNS Spectr. 2019 Apr;24(2):249-257. doi: 10.1017/S1092852917000761. Epub 2017 Oct 30. Erratum in: CNS Spectr. 2019 Apr;24(2):275.

location_country:
Russian Federation
Estonia
Argentina
Finland
Hungary
Costa Rica
Chile
France
Peru
Colombia
South Africa

summary: The study will evaluate the long-term maintenance of efficacy of Lu AA21004 in patients with Generalized Anxiety Disorder (GAD) who responded to acute treatment with Lu AA21004.


status: Active, not recruiting

title: A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib

study_completion_date_type: Anticipated

ReferenceCitation: Gore L, Kearns PR, de Martino ML, Lee, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. doi: 10.1200/JCO.2017.75.9597. Epub 2018 Mar 2.

location_country:
Brazil
Romania
Spain
Italy
Russian Federation
Australia
Netherlands
Argentina
Canada
United Kingdom
Korea, Republic of
United States
France
India
Singapore
Mexico
South Africa
Germany

location_facility: Children's Healthcare Of Atlanta - Egleston

location_facility: Jonathan Jaques Children'S Cancer Center

location_facility: Hospital Nacional Profesor Alejandro Posadas

location_facility: Children's Healthcare of Atlanta - Egleston Hospital

location_facility: Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca

summary: The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

status_simplified: Ongoing


title: A Randomised, Double-Blind, Single Dose, One-Day Early Administration, Multicentre Study Comparing the Efficacy and Safety of Acyclovir Lauriad® 50 mg Muco-adhesive Buccal Tablet to Matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients.

acronym: LIP

summary: To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.

lead_sponsor: Onxeo

location_country:
Poland
United Kingdom
Australia
Czech Republic
United States
France
Germany

location_facility: General Teaching Hospital, Dep. Of Dermatology

location_facility: Hôpital L'Archet 2, Service de Dermatologie

location_facility: Service de Stomatologie et chirurgie Maxilo-Faciale.Hôpital de la pitié Salpétrière

location_facility: Central military hospital Dept. of Dermatology

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Nasz Lekarz" Praktyka Grupowa Lekarzy Rodzinnych z Przychodnią Specjalistyczną

location_facility: Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczna Przychodnia Lekarska Medikard

location_facility: University Hospital Bulovka 3rd Clinic of Inf. Diseases

location_facility: Specjalistyczne Gabinety Lekarskie Dermed

location_facility: NZOZ Praktyka Lekarska Iga Gilas - Mirkiewicz

location_facility: Klinik und Poliklinik für Dermatologie des Universitätsklinikums Bonn

location_facility: University Hospital Bulovka Dept. of Dermatology

location_facility: Hopital Fournier, Service de dermatologie

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej GCP Dobra Praktyka Lekarska

location_facility: Charité Universitätsmedizin Berlin Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Naukowo-Badawczy i Naukowo-Dydaktyczny Ośrodek Dermatologii Estetycznej, Dermatochirurgii i Fotodermatologii

location_facility: Hôpital St Jacques Service de Dermatologie

location_facility: Clinvest, a Division of Banyan Group, Inc.,

location_facility: Hôpital Saint Louis Paris, Service de Dermatologie 1

location_facility: Katedra i Klinika Dermatologii Collegium Medicum


title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)

ReferenceCitation: Assael BM, Pressler T, Bilton D, Fayon M, Fischer R, Chiron R, LaRosa M, Knoop C, McElvaney N, Lewis SA, Bresnik M, Montgomery AB, Oermann CM; AZLI Active Comparator Study Group. Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial. J Cyst Fibros. 2013 Mar;12(2):130-40. doi: 10.1016/j.jcf.2012.07.006. Epub 2012 Sep 15.

location_country:
Denmark
Portugal
Spain
Ireland
Austria
Italy
Netherlands
United Kingdom
Switzerland
United States
France
Belgium
Germany

summary: The purpose of this study was to assess the comparative safety and effectiveness of aztreonam for inhalation solution versus tobramycin inhalation solution in adult and pediatric patients with cystic fibrosis (CF) and pulmonary Pseudomonas aeruginosa (PA) infection.


title: An Observational Follow-Up Study Of Patients Previously Enrolled In Exubera Controlled Clinical Trials

acronym: FUSE

summary: In studies of Exubera in persons with diabetes, lung cancer occurred in a few more people who were taking Exubera than in people who were taking other diabetes medicines. All subjects diagnosed with lung cancer had a history of smoking and the number of lung cancer cases observed fell within the expected range based on population-based data. There is currently not enough information to determine if any of the observed lung cancer cases were related to Exubera use, therefore, the study is being conducted to further investigate whether Exubera use makes the appearance of lung cancer more likely.

ReferenceCitation: Gatto NM, Koralek DO, Bracken MB, Duggan WT, Lem J, Klioze S, Koch GG, Wise RA, Cohen RB, Jackson NC. Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results. Diabetes Care. 2019 Sep;42(9):1708-1715. doi: 10.2337/dc18-2529. Epub 2019 Jul 22.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Portugal
Austria
Australia
Argentina
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Germany
Denmark
Greece
Estonia
Finland
France
Netherlands


title: A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Impact of Diamyd on the Progression of Diabetes in Patients Newly Diagnosed With Type 1 Diabetes Mellitus (EU)

summary: The purpose of this study is to determine whether Diamyd (rhGAD65 formulated in alum) is effective in preserving the body's own insulin producing capacity in patients recently diagnosed with type 1 diabetes.

ReferenceCitation: Tavira B, Cheramy M, Axelsson S, Åkerman L, Ludvigsson J, Casas R. Effect of simultaneous vaccination with H1N1 and GAD-alum on GAD(65)-induced immune response. Diabetologia. 2017 Jul;60(7):1276-1283. doi: 10.1007/s00125-017-4263-x. Epub 2017 Mar 29.

ReferenceCitation: Ludvigsson J, Chéramy M, Axelsson S, Pihl M, Akerman L, Casas R; Clinical GAD-Study Group in Sweden. GAD-treatment of children and adolescents with recent-onset type 1 diabetes preserves residual insulin secretion after 30 months. Diabetes Metab Res Rev. 2014 Jul;30(5):405-14. doi: 10.1002/dmrr.2503.

ReferenceCitation: Ludvigsson J, Krisky D, Casas R, Battelino T, Castaño L, Greening J, Kordonouri O, Otonkoski T, Pozzilli P, Robert JJ, Veeze HJ, Palmer J, Samuelsson U, Elding Larsson H, Åman J, Kärdell G, Neiderud Helsingborg J, Lundström G, Albinsson E, Carlsson A, Nordvall M, Fors H, Arvidsson CG, Edvardson S, Hanås R, Larsson K, Rathsman B, Forsgren H, Desaix H, Forsander G, Nilsson NÖ, Åkesson CG, Keskinen P, Veijola R, Talvitie T, Raile K, Kapellen T, Burger W, Neu A, Engelsberger I, Heidtmann B, Bechtold S, Leslie D, Chiarelli F, Cicognani A, Chiumello G, Cerutti F, Zuccotti GV, Gomez Gila A, Rica I, Barrio R, Clemente M, López Garcia MJ, Rodriguez M, Gonzalez I, Lopez JP, Oyarzabal M, Reeser HM, Nuboer R, Stouthart P, Bratina N, Bratanic N, de Kerdanet M, Weill J, Ser N, Barat P, Bertrand AM, Carel JC, Reynaud R, Coutant R, Baron S. GAD65 antigen therapy in recently diagnosed type 1 diabetes mellitus. N Engl J Med. 2012 Feb 2;366(5):433-42. doi: 10.1056/NEJMoa1107096.

lead_sponsor: Diamyd Therapeutics AB

location_country:
Slovenia
Italy
Spain
Netherlands
United Kingdom
Finland
Sweden
France
Germany

location_facility: Barn och ungdomsmedicinska kliniken, Centralsjukhuset

location_facility: Centre for Diabetes and Metabolic Medicine (DMM), Barts and The London School of Medicine and Dentistry

location_facility: Drottning Silvias Barnsjukhus, Barn- och ungdomssjukvården

location_facility: Reparto di Pediatria, Ospedale S. Raffaele

location_facility: Klinik und Poliklinik fȕr Kinder und Jugendliche der Universität Leipzig

location_facility: Hospital Materno-Infantil Vírgen del Camino

location_facility: CHU Montpellier Hôpital Arnaud de Villeneuve, Service de Pédiatrie 1

location_facility: Barn- och ungdomskliniken, NU-sjukvården/NÄL

location_facility: Turun yliopistollinen keskussairaala, Lastentautien Klinikka

location_facility: Unità Operativa di Pediatria, Policlinico

location_facility: Hospital Materno-Infantil Vírgen del Rocío

location_facility: Tampereen yliopistollinen sairaala, Lasten klinikka

location_facility: Barn- och ungdomskliniken, Vrinnevi sjukhus

location_facility: Barn- och ungdomskliniken, Uddevalla Sjukhus

location_facility: Hôpital Necker, Clinique Robert Debré, Diabète de l'Enfant et de l'Adolescent,

location_facility: Barn- och ungdomskliniken, Länssjukhuset Ryhov

location_facility: Hospital Materno-Infantil Clínico de Valencia

location_facility: Barn- och ungdomskliniken, Universitetssjukhuset

location_facility: Helsingin yliopistollinen keskussairaala, Lasten ja nuorten sairaala

location_facility: Hopital Robert Debré, Service d'Endocrinologie

location_facility: Universitätsklinik fȕr Kinder- und Jugendmedizin, Tȕbingen

location_facility: Barn- och ungdomskliniken, Centrallasarettet

location_facility: Azienda Ospedaliero, Universitaria di Parma, Pediatria

location_facility: University Medical Centre Ljubljana, Department of Pediatric Endocrinology

location_facility: Campus Bio-Medico, Dipartimento di Diabetologia e Endocrinologia

location_facility: Haga Ziekenhuis, Lokatie Juliana Kinderziekenhuis

location_facility: Meander Medisch Centrum, Lokatie Elisabeth

location_facility: Diabetologia - Dipartimento Scienze Pediatriche, Ospedale Infantile, Regina Margherita

location_facility: Maternal & Child Health Sciences, University of Dundee

location_facility: Kuopion yliopistollinen sairaala, Lasten klinikka

location_facility: Oulun yliopistollinen sairaala, Lasten ja nuorten klinikka

location_facility: Barn- och ungdomskliniken, Centralsjukhuset

location_facility: CHU Timone Enfants, Service de pédiatrie multidisciplinaire

location_facility: Hôpital Pellegrin Enfants, Service d'endocrinologie pédiatrique

location_facility: Centre Hospitalier Universitaire de Besançon

location_facility: Diabetologia - Dipartimento Clinica Pediatrica, Ospedale Luigi Sacco

location_facility: Struttura Complessa di Diabetologia, Ospedale S. Michele

location_facility: Charité Campus Virchow Childrens Hospital

location_facility: Hôpital des Enfants, Gastroentero-nutrition-diabétologie pédiatrique

location_facility: Seinäjoen keskussairaala, Lastentautien poliklinikka

location_facility: Barn- och ungdomscentrum, Universitetssjukhuset MAS

location_facility: Clinica Pediatrica, Università di Genova


title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults

ReferenceCitation: Molina JM, Lamarca A, Andrade-Villanueva J, Clotet B, Clumeck N, Liu YP, Zhong L, Margot N, Cheng AK, Chuck SL; Study 145 Team. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. Lancet Infect Dis. 2012 Jan;12(1):27-35. doi: 10.1016/S1473-3099(11)70249-3. Epub 2011 Oct 18.

location_country:
Portugal
Spain
Italy
United Kingdom
Australia
Mexico
Canada
Netherlands
Switzerland
Puerto Rico
United States
France
Belgium
Germany

location_facility: Washington University School of Medicine

location_facility: Hopital Purpan - Service of Infectious Diseases

location_facility: Henry Ford Hospital Div of Infectious Disease

location_facility: Infectious Disease Specialists of Atlanta (IDSA)

location_facility: Southwest Infectious Disease Clinical Research

location_facility: University of Puerto Rico, School of Medicine, Proyecto ACTU

location_facility: Complexo Hospitalario Xeral-Cies (Chuvi) Vigo

location_facility: Instituto de Investigacion Cientifica del Sur

location_facility: Community Research Initiative of New England

location_facility: University of Maryland, Institute of Human Virology

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMYNSZ)

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Imperial College Healthcare NHS Trust, St. Mary's Campus

location_facility: University of Medicine and Dentistry of New Jersey; University Hospital Infectious Disease Practice

location_facility: Ambulanzzentrum am Universitatsklinikum Hamburg Eppendorf

location_facility: Tarrant County Infectious Disease Associates

location_facility: Canadian Immunodeficiency Research Collaborative (CIRC) Inc.

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University Hospital of Montpellier - Gui de Chauliac

location_facility: University of Texas Health Science Center at Houston

location_facility: Treasure Coast Infectious Disease Consultants

location_facility: University of Manitoba - Health Sciences Centre

location_facility: Hospital General Universitario de Alicante

location_facility: Thomas Jefferson University Jefferson Alumni Hall

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Universita La Sapienza Policlinico Umberto I

location_facility: The George Washington University Medical Center

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: University of Southern California, AIDS Clinical Trials Unit

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

location_facility: Brody School of Medicine at East Carolina University

location_facility: Hopital Saint Antoine - Infectious Desease Department

location_facility: Royal Free and University College Medical School

location_facility: Hawaii AIDS Clinical Research Program HACRP

location_facility: Hopital de Bicentre - Service de medecine Interne et Immunologie

location_facility: Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani I.R.C.C.S.

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: The Emory Clinic, Inc., Division of Infectious Diseases

location_facility: University of North Carolina/ School of Medicine Division of Infectious Diseases/ AIDS Clinical Trials Unit

location_facility: University of Kentucky Healthcare/Bluegrass Care Clinic

location_facility: Hospital General Universitario del Elche

location_facility: AIDS Healthcare Foundation-Research Center

location_facility: Immunodeficiency Service, McGill University Health Centre (MUHC)

location_facility: University Health Network, Toronto General Hospital

location_facility: Hopital Pitie Salpetriere - Infectious Deseases Department

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: North Texas Infectious Disease Consultants

summary:
The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents.

Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).


title: A Multinational, Randomized, Double-blind Placebo Controlled Study of AVE8062 (25 mg/m2) Administered Every 3 Weeks in Patients With Advanced-stage Soft Tissue Sarcoma, Treated With Cisplatin (75 mg) After Failure of Anthracycline and Ifosfamide Chemotherapies.

summary:
The primary objective of the study is to compare the progression-free survival (PFS) in the 2 treatment arms

The secondary objectives of the study are :

To compare the overall survival in the 2 treatment arms
To compare the objective response rate in the 2 treatment arms
To assess the safety profile of AVE8062 (in combination with the background cisplatin therapy)
To assess the pharmacokinetics of AVE8062 and its main metabolite, RPR258063, using a population approach, in all patients enrolled in selected centers.

ReferenceCitation: Blay JY, Pápai Z, Tolcher AW, Italiano A, Cupissol D, López-Pousa A, Chawla SP, Bompas E, Babovic N, Penel N, Isambert N, Staddon AP, Saâda-Bouzid E, Santoro A, Franke FA, Cohen P, Le-Guennec S, Demetri GD. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015 May;16(5):531-40. doi: 10.1016/S1470-2045(15)70102-6. Epub 2015 Apr 8.

location_country:
Brazil
Serbia
Spain
Italy
United Kingdom
Hungary
France
United States
India
Belgium

location_facility:
Investigational Site Number 250003
Investigational Site Number 250012
Investigational Site Number 380002
Investigational Site Number 840001
Investigational Site Number 076003
Investigational Site Number 826003
Investigational Site Number 250010
Investigational Site Number 250008
Investigational Site Number 380001
Investigational Site Number 891002
Investigational Site Number 380003
Investigational Site Number 891001
Investigational Site Number 250002
Investigational Site Number 840004
Investigational Site Number 826002
Investigational Site Number 056005
Investigational Site Number 356005
Investigational Site Number 348002
Investigational Site Number 076008
Investigational Site Number 076006
Investigational Site Number 250006
Investigational Site Number 250005
Investigational Site Number 840007
Investigational Site Number 076005
Investigational Site Number 724001
Investigational Site Number 076004
Investigational Site Number 380004
Investigational Site Number 724003
Investigational Site Number 076002
Investigational Site Number 826001
Investigational Site Number 076007
Investigational Site Number 056001
Investigational Site Number 840002
Investigational Site Number 348001
Investigational Site Number 724004
Investigational Site Number 076009
Investigational Site Number 250007
Investigational Site Number 356004
Investigational Site Number 840005
Investigational Site Number 840003
Investigational Site Number 356003
Investigational Site Number 250004
Investigational Site Number 250009
Investigational Site Number 250001
Investigational Site Number 056004


title: A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen

summary: This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

ReferenceCitation: Michaelson MD, Oudard S, Ou YC, Sengeløv L, Saad F, Houede N, Ostler P, Stenzl A, Daugaard G, Jones R, Laestadius F, Ullèn A, Bahl A, Castellano D, Gschwend J, Maurina T, Chow Maneval E, Wang SL, Lechuga MJ, Paolini J, Chen I. Randomized, placebo-controlled, phase III trial of sunitinib plus prednisone versus prednisone alone in progressive, metastatic, castration-resistant prostate cancer. J Clin Oncol. 2014 Jan 10;32(2):76-82. doi: 10.1200/JCO.2012.48.5268. Epub 2013 Dec 9.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Poland
Portugal
Australia
Israel
Sweden
Slovakia
Brazil
Canada
China
Germany
Denmark
Taiwan
Finland
Czech Republic
Korea, Republic of
France