acronym: RE-COVER II

lead_sponsor: Boehringer Ingelheim

summary:
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

ReferenceCitation: Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.

ReferenceCitation: Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.

ReferenceCitation: Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.

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title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication

location_country:
Poland
New Zealand
Australia
Brazil
Thailand
Turkey
Canada
France
Czech Republic
Slovakia
Hungary
Denmark
United States
Ukraine
India
China
Malaysia
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


type: EudraCT Number

type: Other Identifier

title: AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS

acronym: POEM

summary: The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ipd_sharing: No

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: ViiV Healthcare

sponsor_collaborators:
ViiV Healthcare
Pfizer

location_country:
Germany
Italy
United Kingdom
Brazil
Belgium
United States
Spain
Greece
Canada
Puerto Rico
France

location_facility: George Washington University Medical Faculty Assoc

location_facility: University of California Irvine Medical Center

location_facility: Centro de Referencia e Treinamento DST/AIDS

location_facility: Azienda Ospedaliera San Giovanni Addolorata Presidia Santa Maria

location_facility: AOUP Paolo Giaccone, UOC Malattie Infettive

location_facility: Hospital Universitario Virgen de La Macarena

location_facility: Tarrant County Infectious Disease Associates

location_facility: Southern Illinois University School of Medicine

location_facility: Infectious Diseases Associates of Central Virginia

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Kaiser Permanente Northwest Region, Immune Deficiency Clinic

location_facility: UT Southwestern Medical Center HIV/AIDS Research Unit

location_facility: Istituto Nazionale Malattie Infettive INMI- "L. Spallanzani"- I.R.C.C.S.

location_facility: Yale University School of Medicine Aids Program

location_facility: University of Toledo: Health Sciences Campus

location_facility: Istituto Nazionale Malattie Infettive "L.Spallanzani"-IRCCS

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Universitaetsklinikum Carl Gustav Carus, Klinik und Poliklinik fuer Dermatologie

location_facility: Infectious Disease Research Institute, Inc

location_facility: 1 Divisione di Malattive Infettive e Servizio di Allergologia, Ospedale L. Sacco

location_facility: Azienda Ospedal Universitaria II Univ degli Studi di Napoli Servizio di Diagnosi e Terapia

location_facility: Ludwig-Maximilians-Universitaet, Klinikum Innenstadt, Medizinische Poliklinik

location_facility: Louisiana State University Health Sciences Center

location_facility: Ambulatorio Day Hospital Malattie Infettive

location_facility: Hospital Universitario Germans Tias I Pujol

location_facility: Hull & East Yorkshire Hospitals NHS Trust

location_facility: Dipartimento di Medicina Clinica Specialistica e Sperimentale

location_facility: University of British Columbia/ Downtown Infectious Diseases Clinic

location_facility: Ospedale Amedeo di Savoia, Clinica Universitaria di Malattie Infettive

location_facility: St. Joseph's Hospital Comprehensive Research Institute

location_facility: University of Oklahoma Health Sciences Center

location_facility: Michael E. DeBakey Veterans Affairs Medical Center

location_facility: Universita' di Roma La Sapienza, Dipartimento di Malattie Infettive e Tropicali

location_facility: The Ohio State University Medical Center

location_facility: Praxis Dr. Lothar Schneider Interne Medizin, HIV Schwerpunkt

location_facility: Universitaetsklinikum Mainz, I. Medizinische Klinik und Poliklinik,

location_facility: SOD Malattie Infettive, La Piastra dei Servizi

location_facility: A Professional Corporation, Research Department

location_facility: Marshall University Joan C. Edwards School of Medicine

location_facility: Mount Sinai Downtown Comprehensive Health Program

location_facility: Royal Free Hospital, Ian Charleson Day Centre

location_facility: ID Consultants Inc & Infectious Disease Research Corp.

location_facility: Michigan State University College of Osteopathic Medicine

location_facility: Tarrant County Infectious Disease Assocciates

location_facility: Azienda Sanitaria Locale Ospedale Civile dello Spirito Santo Presidio Ospedaliero

location_facility: Hôpital Haut - Leveque - Centre Francois Magendie

location_facility: Hospital of the J.W. Goethe University, Medical Clinic II

location_facility: Montgomery Infectious Disease Associates, P.A. (Private Practice)

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Universita'Cattolica del Sacro Cuore Policlinico Gemelli

location_facility: Arztpraxis fuer Innere Medizin Dr. Knechten

location_facility: Azienda Ospedaliero Universitaria Policlinico di Modena

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Kaiser Permanete of Colorado Rock Creek Medical Offices

location_facility: Hopital Jean Verdier, Unite de maladies infectieuses

location_facility: Hospital General Universitário de Alicante

location_facility: Universitaetsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

location_facility: Klinik I fuer Innere Medizin der Uni-Klinik Koeln

location_facility: Infectomed GbR Zentrum für medizinische Studien

location_facility: ifi-Institut am Allgemeines Krankenhaus St.Georg

location_facility: Centrum fuer interdisziplinaere Medizin Muenster GmbH

location_facility: Alta Bates Summit Medical Center East Bay AIDS Center

location_facility: Universitair Ziekenhuis Gasthuisberg, Inwendige Geneeskunde

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: University of Iowa Hospitals and Clinics

location_facility: Division of Infectious Diseases, George Washington University Medical Center

location_facility: University of South Carolina School of Medicine

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: South Florida Infectious Deisease and Tropical Medicine Center

location_facility: Universita' degli Studi di Milano, Dipartimento di scienza clinica Luigi Sacco

location_facility: San Francisco Veterans Affairs Medical Center

location_facility: Erie County Medical Center, HIV Services

location_facility: Clinic of Infectious and Tropical Diseases-University of Milan-San Paolo Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement

summary: The purpose of the study is to determine whether aripiprazole provides additional clinical benefit to patients with Bipolar I disorder when combined with lithium or valproate over 12 weeks.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Germany
Italy
Poland
Hungary
Romania
Austria
Spain
Greece
South Africa
Turkey
Czech Republic
Russian Federation
France


title: A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism

summary: The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

ReferenceType: derived

ReferenceCitation: Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Springer-Nature

ReferenceCitation: Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Georg Thieme

ReferenceCitation: Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

oa_colors: green other

evidence: open (via free article)

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

license: public-domain

license_normalized: public-domain

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Pfizer

location_country:
Germany
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Czech Republic
Portugal
Hong Kong
Denmark
United States
Ukraine
India
Romania
Puerto Rico
Philippines
Italy
Norway
Singapore
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Israel

location_facility: Anne Arundel Health System Research Institute, Inc.

location_facility: St. Francis Sleep Allergy & Lung Institute

location_facility: Amarillo Heart Clinical Research Institute Inc.

location_facility: Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group

location_facility: Internal Medical Associates Of Grand Island, P.C

location_facility: Charleston Hematology Oncology Associates, Pa

location_facility: Jobst Vascular Center At The Toledo Hospital

location_facility: Primary Care Of The Treasure Coast, Inc.

location_facility: Atlanta Institute For Medical Research, Inc

location_facility: Scripps Clinic/Scripps Health And Green Hospital


title: A Randomised, Double-Blind, Placebo-Controlled, Multi-centre, Phase III Study of Post-Operative Adjuvant Lapatinib or Placebo and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib or Placebo Monotherapy in High-Risk Subjects With Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN)

summary: This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.

ReferenceCitation: Harrington K, Temam S, Mehanna H, D'Cruz A, Jain M, D'Onofrio I, Manikhas G, Horvath Z, Sun Y, Dietzsch S, Dubinsky P, Holeckova P, El-Hariry I, Franklin N, Biswas-Baldwin N, Legenne P, Wissel P, Netherway T, Farrell J, Ellis C, Wang-Silvanto J, Amonkar M, Ahmed N, Santillana S, Bourhis J. Postoperative Adjuvant Lapatinib and Concurrent Chemoradiotherapy Followed by Maintenance Lapatinib Monotherapy in High-Risk Patients With Resected Squamous Cell Carcinoma of the Head and Neck: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study. J Clin Oncol. 2015 Dec 10;33(35):4202-9. doi: 10.1200/JCO.2015.61.4370. Epub 2015 Nov 2.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Ireland
Argentina
Thailand
Croatia
Canada
France
Czech Republic
Slovakia
Hungary
Hong Kong
United States
India
China
Estonia
Philippines
Italy
United Kingdom
Austria
Spain
Greece
Russian Federation


title: A Randomised, Multi-Centre, Phase IV, Double-Blind, Parallel Group Study Comparing the Effects of 52 Weeks Administration of AVANDAMET and Metformin Plus Sulphonylurea on Change in HbA1c From Baseline in Overweight Type 2 Diabetics Poorly Controlled on Metformin.

summary: This study compares the effects of Avandamet (rosiglitazone maleate/metformin) treatment and metformin plus sulphonylurea treatment in overweight people with type 2 diabetes.

location_country:
Germany
Ireland
Italy
Lithuania
United Kingdom
Netherlands
Mexico
Belgium
Switzerland
Spain
France


title: An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

summary: This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).

ReferenceType: result

ReferenceCitation: Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: Thomas Jefferson University - Jefferson Digital Commons

publisher_dissemination: Elsevier

ReferenceCitation: Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

repositories_concat: HAL

ReferenceCitation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.

lead_sponsor: UCB Pharma

location_country:
Finland
Germany
Poland
Czechia
Canada
Serbia
France
Hungary
Hong Kong
Switzerland
United States
Ukraine
Tunisia
Belgium
Italy
Norway
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel


title: An Open, Prospective, Randomised, Controlled, Multi-Center Study Comparing Fixed Dose vs Concentration Controlled Mycophenolate Mofetil Regimens for de Novo Patients Following Transplantation

summary: Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

ReferenceType: background

ReferenceCitation: van Gelder T, Hilbrands LB, Vanrenterghem Y, Weimar W, de Fijter JW, Squifflet JP, Hene RJ, Verpooten GA, Navarro MT, Hale MD, Nicholls AJ. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999 Jul 27;68(2):261-6. doi: 10.1097/00007890-199907270-00018.

ReferenceCitation: van Gelder T, Silva HT, de Fijter JW, Budde K, Kuypers D, Tyden G, Lohmus A, Sommerer C, Hartmann A, Le Meur Y, Oellerich M, Holt DW, Tonshoff B, Keown P, Campbell S, Mamelok RD. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation. 2008 Oct 27;86(8):1043-51. doi: 10.1097/TP.0b013e318186f98a.

ReferenceCitation: Hocker B, van Gelder T, Martin-Govantes J, Machado P, Tedesco H, Rubik J, Dehennault M, Garcia Meseguer C, Tonshoff B; FDCC Study Group. Comparison of MMF efficacy and safety in paediatric vs. adult renal transplantation: subgroup analysis of the randomised, multicentre FDCC trial. Nephrol Dial Transplant. 2011 Mar;26(3):1073-9. doi: 10.1093/ndt/gfq450. Epub 2010 Jul 28.

ReferenceCitation: van Gelder T, Tedesco Silva H, de Fijter JW, Budde K, Kuypers D, Arns W, Soulillou JP, Kanellis J, Zelvys A, Ekberg H, Holzer H, Rostaing L, Mamelok RD. Renal transplant patients at high risk of acute rejection benefit from adequate exposure to mycophenolic acid. Transplantation. 2010 Mar 15;89(5):595-9. doi: 10.1097/TP.0b013e3181ca7d84.

ReferenceCitation: van Schaik RH, van Agteren M, de Fijter JW, Hartmann A, Schmidt J, Budde K, Kuypers D, Le Meur Y, van der Werf M, Mamelok R, van Gelder T. UGT1A9 -275T>A/-2152C>T polymorphisms correlate with low MPA exposure and acute rejection in MMF/tacrolimus-treated kidney transplant patients. Clin Pharmacol Ther. 2009 Sep;86(3):319-27. doi: 10.1038/clpt.2009.83. Epub 2009 Jun 3.

lead_sponsor: Erasmus Medical Center

sponsor_collaborators:
Erasmus Medical Center
Hoffmann-La Roche

location_country:
Germany
Poland
Australia
Brazil
Canada
France
Lithuania
Denmark
Belgium
China
Estonia
Norway
United Kingdom
Venezuela
Netherlands
Austria
Spain
Taiwan
Sweden

location_facility: West China Hospital of Sichuan University

location_facility: Centre Hospitalier Regional Universitaire

location_facility: Surgical Clinic Of Tartu University Clinics

location_facility: Institute of Transplantology, Medical University of Warsaw

location_facility: Complejo Hospitalario Univeritario de Santiago

location_facility: Karolinska University Hospital, Huddinge


title: Comparison of the Efficacy and Safety of 160 mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma

summary: The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

lead_sponsor: AstraZeneca

location_country: Germany Italy India Hungary Canada France


title: Comparison of Inhaled Ciclesonide (640 mcg/Day) and Fluticasone Propionate (1000 mcg/Day) in Patients With Moderate and Severe Persistent Asthma

summary: The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

location_country:
Italy
United Kingdom
Netherlands
Switzerland
Belgium
Spain
France


title: A Multi-Center, Double-Blind, Randomized Study Comparing the Efficacy of Combination Therapy of Eprosartan Respectively Ramipril With Low-Dose Hydrochlorothiazide and Moxonidine on Blood Pressure Levels in Patients With Hypertension and Associated Diabetes Mellitus Type 2

summary: This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ.

lead_sponsor: Solvay Pharmaceuticals

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Sweden
Spain
Canada
France

location_facility:
Site 42
Site 26
Site 3
Site 7
Site 55
Site 51
Site 36
Site 40
Site 60
Site 58
Site 16
Site 12
Site 35
Site 27
Site 25
Site 46
Site 23
Site 53
Site 44
Site 31
Site 19
Site 39
Site 22
Site 15
Site 62
Site 4
Site 13
Site 45
Site 54
Site 17
Site 49
Site 34
Site 18
Site 20
Site 24
Site 47
Site 8
Site 33
Site 50
Site 61
Site 57
Site 2
Site 52
Site 28
Site 6
Site 29
Site 59
Site 30
Site 32
Site 37
Site 64
Site 11
Site 56
Site 43
Site 48
Site 10
Site 5
Site 38
Site 14
Site 21
Site 63
Site 9
Site 41


title: A Phase III Randomized, Open-Label Study of Docetaxel in Combination With CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane-Naïve Patients With Metastatic Hormone-Refractory Prostate Cancer With Pain

summary: The primary objective of this study is to compare the duration of survival between patients receiving docetaxel in combination with the GVAX® vaccine for prostate cancer versus patients receiving docetaxel and prednisone treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases with pain. Patients may have had up to one prior non-taxane chemotherapy treatment.

status: Terminated

study_completion_date_type: Anticipated

ReferenceCitation: Michael BD, Syndikus I, Clark A, Baborie A. Diffuse primary leptomeningeal melanocytosis in a patient receiving a novel cancer cell vaccine for prostate cancer. BMJ Case Rep. 2010 May 4;2010:bcr11.2009.2495. doi: 10.1136/bcr.11.2009.2495.

lead_sponsor: Cell Genesys

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

location_facility: Centre Regional de lutte contre le cancer Paul Papin

location_facility: Desert Hematology Oncology Medical Group

location_facility: Szpital Kliniczny Dzieciatka Jezus - Centrum Leczenia Obrazen

location_facility: Katedra i Klinika Onkologii i Radioterapli

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Centre Jean Perrin Centre Régional de lutte contre le cancer d'Auvergne

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Center for Oncology Research & Treatment, PA

location_facility: Peachtree Hematology & Oncology Consultants, PC

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Centre Hospitalier Universite de Sherbrooke

location_facility: Azienda Ospedaliero Universitaria (A.O.U.) Pisana-Ospedale S. Chiara

location_facility: Universitatsklinikum Carl Gustav Carus An Der

location_facility: Frederick Memorial Hospital Regional Cancer Therapy Center

location_facility: Presidio Ospedaliero di Sassari-Ospedale SS. Anunziata

location_facility: Wojewodzki Szpital Specjalistyczny Oddzial Urologii

location_facility: Seattle Cancer Care Alliance, Univ. of Washington

location_facility: Cancer Center and Department of Medicine

location_facility: Ziekenhuis Netwerk Antwerpen - AZ Middelheim

location_facility: Presbyterian Hospital Center for Cancer Research

location_facility: Kaiser Permanente Medical Group Dept. of Oncology Research

location_facility: Centre Rene Gauducheau - Site Hospitalier Nord

location_facility: Klinikum der Johann Wolfgang Goethe-Universitat

location_facility: Centre Antoine Lacassagne - Centre Regional de lutte contre le cancer

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Jupiter Hematology & Oncology Associates

location_facility: General Clinical Research Center University of Michigan

location_facility: Scunthorpe General Hospital, Dept of Oncology

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 Przemienienia Panskiego AM w Poznaniu

location_facility: Department of Oncology Hammersmith Hospital

location_facility: Rosemere Cancer Centre, Royal Preston Hospital

location_facility: Institut Jean Godinot, Oncologie Medicale

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej- Curie

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

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: North Shore Hematology Oncology Associates P.C.

location_facility: Wojewodzki Szpital Specjalistyczny w Siedlcach

location_facility: Urologische Klinik und Poliklinik der Johannes Gutenberg Universitat Mainz

location_facility: Azienda Ospedaliera Maggiore della Carita

location_facility: Centre Hospitalier de L'Universite de Montreal

status_simplified: Unknown


title: A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1

summary: The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.

ReferenceCitation: Neumann AU, Pianko S, Zeuzem S, Yoshida EM, Benhamou Y, Mishan M, McHutchison JG, Pulkstenis E, Mani Subramanian G. Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naive patients with genotype 1, chronic hepatitis C. J Hepatol. 2009 Jul;51(1):21-8. doi: 10.1016/j.jhep.2009.01.017. Epub 2009 Mar 11.

ReferenceCitation: Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naive patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17. doi: 10.1002/hep.22403.

lead_sponsor: Human Genome Sciences Inc.

location_country:
Germany
Poland
Israel
Romania
Australia
Canada
Czech Republic
France

location_facility: University of Bochum, Kliniken Bergmannsheil

location_facility: University of Paris, Hopital Pitie-Salpetriere

location_facility: Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"

location_facility: University of Hamburg, Hospital Hamburg Eppendorf

location_facility: Klinika Hepatologii i Nabytych Niedoborow Immunologicznych

location_facility: University of Toulouse, Clinique Dieulafoy

location_facility: Katedra i Oddzial Kliniczny Chorob Zakaznych

location_facility: McMaster Clinic - Hamilton General Hospital

location_facility: University of Creteil, Hopital Henri Mondor

location_facility: Institutul de Gastroenterologie si Hepatologie

location_facility: University of Berlin, Charite Campus Virchow Klinikum

location_facility: University of Lyon, Hopital de l'Hotel Dieu

location_facility: University of Lille, Hopital Claude Huriez

location_facility: University of Marseille, Hopital Saint Joseph

location_facility: Katedra i Klinika Chorob Zakaznych i Hepatologii

location_facility: University of Orleans, Hopital de la Source

location_facility: University of Paris, Hopital Saint-Antoine


title: A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)

summary: This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
United States
Thailand
Canada
Puerto Rico
France


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects

acronym: MOTIVATE 2

summary: Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.

ReferenceCitation: Lewis ME, Simpson P, Mori J, Jubb B, Sullivan J, McFadyen L, van der Ryst E, Craig C, Robertson DL, Westby M. V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1-infected, treatment-experienced persons receiving optimized background regimens. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211030380. doi: 10.1177/20402066211030380.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

publisher_dissemination: SAGE Publications

ReferenceCitation: Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a.

evidence: open (via page says license)

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Hardy WD, Gulick RM, Mayer H, Fatkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82.

ReferenceCitation: Fatkenheuer G, Nelson M, Lazzarin A, Konourina I, Hoepelman AI, Lampiris H, Hirschel B, Tebas P, Raffi F, Trottier B, Bellos N, Saag M, Cooper DA, Westby M, Tawadrous M, Sullivan JF, Ridgway C, Dunne MW, Felstead S, Mayer H, van der Ryst E; MOTIVATE 1 and MOTIVATE 2 Study Teams. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154.

ReferenceCitation: Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Canada
France


title: A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

summary: The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

oa_host_type: repository

unpaywall_oa_status: green

ReferenceCitation: Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.

ReferenceCitation: Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.

ReferenceCitation: Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.

lead_sponsor: R-Pharm

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Turkey
Croatia
Chile
Czechia
Canada
France
Portugal
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel


title: A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant

summary: The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

ReferenceCitation: Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roche HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. doi: 10.1200/JCO.2007.12.6557. Epub 2007 Oct 29.

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Canada
France
Hungary
United States
Belgium
China
Malaysia
Peru
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Sweden


title: SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke

summary: This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

ReferenceCitation: Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71. doi: 10.1056/NEJMoa070240.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Chile
Canada
France
Czech Republic
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
United States
Belgium
China
Philippines
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

lead_sponsor: Eisai Inc.

location_country:
Germany
Austria
United States
Spain
Canada
France

location_facility: New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates

location_facility: Georgia Oncology Partners Research & Education Foundation

location_facility: Coast Hematology and Oncology Associates

location_facility: Eastern Connecticut Hematology & Oncology

location_facility: Hospital Universitario La Fe Servicio de Oncologia

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: Tulane University Health Sciences Center

location_facility: Centre Hospitalier General de la Region Annecienne

location_facility: Medical Group of North County, Inc., San Diego Cancer Center

location_facility: Algoma Regional Cancer Program - Sault Area Hospital

location_facility: University of Cincinnati, Barrett Cancer Center

location_facility: Charite Universitatsklinikum der Humboldt-Universitat zu Berlin

location_facility: Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie

location_facility: Louisiana State University Health Sciences Center

location_facility: New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates

location_facility: Hospital de Sagunto Servicio de Oncologia

location_facility: Service de Pneumology, Hopital Adulte de Brabois

location_facility: Columbus Community Clinical Oncology Program

location_facility: Southern California Kaiser Permanente Medical Group

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: University of Oklahoma Health Sciences Center

location_facility: Pacific Coast Hematology/Oncology Medical Group, Inc.

location_facility: Kansas City Oncology and Hematology Group, Kansas City Cancer Centers

location_facility: New York Presbyterian Hospital, Weill Medical College of Cornell University

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: University of Medicine & Dentistry of NJ, School of Osteopathic Medicine

location_facility: Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.

location_facility: Montana Cancer & Infectious Disease Specialists

location_facility: Oncology/Hematology, Kaiser Permanente Northwest

location_facility: Hospital Arnau de Villanova, Servicio de Oncologia

location_facility: UCSF/Mount Zion Comprehensive Cancer Center

location_facility: Hematology Oncology Patient Enterprises, Center for Cancer Care

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Oncology/Hematology Associates of Central Illinois, P.C.

location_facility: Hematology & Oncology Associates of South Texas

location_facility: Metropolitan Hematology/Oncology Medical Group

location_facility: St. Luke's/Mountain State Tumor Institute (MSTI)

location_facility: Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque

location_facility: Oncology Hematology of Lehigh Valley, PC

location_facility: Northwest Carolina Oncology and Hematology, P.A.

location_facility: Hospital Clinico Universitario, Servicio Hematologia y Oncologia

location_facility: South Shore Hematology Oncology Associates, PC

location_facility: South Florida Oncology & Hematology Consultants

location_facility: Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach

location_facility: Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: Comprehensive Cancer Care Specialists of Boca Raton


title: Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.

enrollment_type: Anticipated

ReferenceCitation: Pettengell R, Schmitz N, Gisselbrecht C, Smith G, Patton WN, Metzner B, Caballero D, Tilly H, Walewski JA, Bence-Bruckler I, To B, Geisler CH, Schots R, Kimby E, Taverna CJ, Kozak T, Dreger P, Uddin R, Ruiz de Elvira C, Goldstone AH. Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the lymphoma working party of the European group for blood and marrow transplantation. J Clin Oncol. 2013 May 1;31(13):1624-30. doi: 10.1200/JCO.2012.47.1862. Epub 2013 Apr 1.

oa_host_type: publisher

evidence: open (via free pdf)

lead_sponsor: EBMT Solid Tumors Working Party

sponsor_collaborators:
EBMT Solid Tumors Working Party
Lymphoma Trials Office

location_country:
France
Germany
Poland
Portugal
New Zealand
Israel
United Kingdom
Denmark
Australia
Sweden
Switzerland
Austria
Belgium
Spain
Turkey
Canada
Czech Republic

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Singleton Hospital of the Swansea NHS Trust

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital

location_facility: Karolinska University Hospital - Huddinge

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Rotherham District General Hospital - NHS Trust

location_facility: Royal Liverpool and Broadgreen Hospitals NHS Trust

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Southampton University Hospital NHS Trust

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital Clinico Universitario de Valencia

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

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Clinical Trials and Research Unit of the University of Leeds

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Westmead Institute for Cancer Research at Westmead Hospital


title: Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia.

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

location_country: Portugal Belgium France

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Hopital Universitaire Des Enfants Reine Fabiola


title: IDA VS MTZ IN INDUCTION AND INTENSIFICATION TREATMENT OF AML OR MDS IN CHILDREN, A PHASE III RANDOMIZED STUDY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

ReferenceCitation: Brunet AS, Ploton C, Galambrun C, Pondarre C, Pages MP, Bleyzac N, Freydiere AM, Barbe G, Bertrand Y. Low incidence of sepsis due to viridans streptococci in a ten-year retrospective study of pediatric acute myeloid leukemia. Pediatr Blood Cancer. 2006 Nov;47(6):765-72. doi: 10.1002/pbc.20706.

ReferenceCitation: Entz-Werle N, Suciu S, van der Werff ten Bosch J, Vilmer E, Bertrand Y, Benoit Y, Margueritte G, Plouvier E, Boutard P, Vandecruys E, Ferster A, Lutz P, Uyttebroeck A, Hoyoux C, Thyss A, Rialland X, Norton L, Pages MP, Philippe N, Otten J, Behar C; EORTC Children Leukemia Group. Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogeneic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group report. Leukemia. 2005 Dec;19(12):2072-81. doi: 10.1038/sj.leu.2403932.

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

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).

summary: The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.

status: Recruiting

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Poland
Argentina
Australia
Brazil
Thailand
Turkey
Czechia
Canada
France
Slovakia
Hungary
China
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan

status_simplified: Ongoing


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

acronym: ARASTEP

summary:
Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer.

BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat.

In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments.

The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months.

To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells.

To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy.

During the study, the study team will:

take blood and urine samples.
measure PSA and testosterone levels in the blood samples
do physical examinations
check the participants' overall health
examine heart health using electrocardiogram (ECG)
check vital signs
check cancer status using PSMA PET/CT scans, CT, MRI and bone scans
take tumor samples (if required)
ask the participants if they have medical problems

About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

lead_sponsor: Bayer

location_country:
Finland
Germany
Poland
New Zealand
Australia
Brazil
Japan
Canada
France
Portugal
Denmark
United States
China
Italy
United Kingdom
Sweden
Austria
Spain
Israel

location_facility: Tokyo Medical and Dental University Hospital

location_facility: University of California Irvine Medical Center

location_facility: A.O. di Perugia - Ospedale Santa Maria della Misericordia - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Inst. de Assistência Médica ao Sérvidor Público Estadual

location_facility: Virgen del Rocio University Hospital - Oncology Department

location_facility: IRCCS Ist Nazionale Tumori GE - Oncologia Medica

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Skane University Hospital - Department of Urology

location_facility: Instituto do Câncer do Estado de São Paulo

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Tianjin Cancer Hospital, Airport Hospital

location_facility: UMass Memorial Medical Center - University Campus

location_facility: Medizinische Fakultät der Otto-von-Guericke Universität

location_facility: H. General Uiversitario Morales Meseguer - Department of Urology

location_facility: Centro Hospitalar Universitário de Lisboa Norte | Heart and Vessels Department

location_facility: Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department

location_facility: Hospital Universitario Virgen de la Victoria | Cardiology Department

location_facility: Barbara Ann Karmanos Cancer Institute - Detroit

location_facility: Bundaberg Hospital, Genesis Cancer Care - Bundaberg

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

location_facility: IRCCS Istituti Fisioterapici Ospitalieri - IFO

location_facility: IRCCS Centro di Riferimento Oncologico (CRO)

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: UCSF Med Center Helen Diller Family Comp Cancer Center

location_facility: South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department

location_facility: Assistência Multidisciplinar em Oncologia (AMO)

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Universitätsklinikum der Johann Wolfgang Goethe Universität

location_facility: Uniklinikum Salzburg - Landeskrankenhaus

location_facility: Ohio State University Wexner Medical Center

location_facility: Affiliated Hospital of Inner Mongolia Medical University

location_facility: Peking Union Medical College Hospital (PUMCH) - East Location

location_facility: Universitätsmedizin der Georg-August-Universität Göttingen

location_facility: Institut Gustave Roussy - Département de Médecine Oncologique

location_facility: Urology Austin, PLLC (an affiliate of Urology America)

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Ruijin Hosp. Shanghai Jiaotong Univ.School of Medicine

location_facility: A.O.U. di Bologna Policlinico S.Orsola Malpighi

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

location_facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS) - Hopital Fleurimont

location_facility: Johns Hopkins Univ School Med|Sidney Kimmel Comp Cancer Cntr

location_facility: Washington University School of Medicine

location_facility: Eastern Clinical Research Unit - Box Hill

location_facility: Associated Medical Professionals of NY, PLLC

location_facility: Hospital Moinhos de Vento-Centro Clínico

location_facility: ICANS - Institut de Cancérologie de Strasbourg Europe

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Uppsala Universitet - Akademiska Sjukhuset (Uppsala University Hospital)

location_facility: Colorado Urology (Colorado Clinical Research)

location_facility: The 1st Affiliated Hospital of Zhejiang University

location_facility: Wide Bay Hospital and Health Service - Hervey Bay Hospital

location_facility: Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Bedford Hospital - Bedfordshire Hospitals NHS Foundation Tru

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Universitätsklinikum Jena - Institut für Diagnostische und Interventionelle Radiologie, Kinderradiologie


title: A Randomized, Placebo-controlled, Double-blind, Multi-center, Phase III Trial to Assess the Efficacy and Safety of Trimodulin (BT588) in Adult Hospitalized Subjects With Severe Community-acquired Pneumonia (sCAP)

acronym: ESsCAPE

summary:
The main objective of the trial is to assess the efficacy and safety of trimodulin as adjunctive treatment to standard of care (SoC) compared to placebo plus SoC in adult hospitalized subjects with sCAP on invasive mechanical ventilation (IMV).

Other objectives are to determine detailed pharmacokinetic (PK) properties of trimodulin in a PK substudy and to determine its pharmacodynamic (PD) properties.

lead_sponsor: Biotest

location_country:
Germany
Argentina
Romania
Australia
Austria
Belgium
United States
Spain
South Africa
Czechia
Philippines
France

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: RYEXO Clinical Research Zuid Afrikaans Hospital

location_facility: Spitalul Universitar de Urgenta Bucuresti

location_facility: University of California San Francisco-Fresno

location_facility: West Visayas State University Medical Center

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Charité Universitätsmedizin Berlin - Campus Charité Mitte

location_facility: Hospital Universitario Clinico San Carlos


title: A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis

summary: The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.

status: Active, not recruiting

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Israel

location_facility: Justus-Liebig-Universität Gießen Zentrum für Kinderheilkunde und Jugendmedizin

location_facility: Children's Health Ireland at Temple Street

location_facility: St. Luke's Cystic Fibrosis Center of Idaho

location_facility: Uniklinikum Salzburg - Universitätsklinik für Pneumologie/Lungenheilkunde

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur

location_facility: Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: IRCCS Istituto Giannina Gaslini-Ospedale Pediatrico

location_facility: Providence Pediatric Pulmonary & Cystic Fibrosis Clinic

location_facility: General Hospital of Thessaloniki 'Hippokratio', 3rd Pediatrics Department of Aristotle University of Thessaloniki

location_facility: National Koranyi Institute for TBC and Pulmonology

location_facility: Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin (CF)

location_facility: Charite Paediatric Pulmonology Department

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena

location_facility: University of California San Francisco, Lung Transplant Program

location_facility: Johns Hopkins All Children's Hospital Outpatient Care Center

location_facility: Academisch Medisch Centrum (Academic Medical Centre)

location_facility: Albany Medical College, Pulmonary and Critical Care Medicine

location_facility: Atrium Health Levine Children's Hospital

location_facility: Joe DiMaggio Cystic Fibrosis & Pulmonary Center

location_facility: University Hospital Limerick (Pediatrics)

location_facility: Royal Papworth Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Intercommunal Creteil

location_facility: Azienda Ospedaliera di Verona - Ospedale Civile Maggiore

location_facility: Clinical Research Facility, Queen Elizabeth University Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: The University of Texas Southwestern Medical Center

location_facility: Schneider Children's Medical Center of Israel

location_facility: University of California Davis Medical Center

location_facility: Riley Hospital for Children at Indiana University Health

location_facility: Washington University School of Medicine / St. Louis Children's Hospital

location_facility: University Medical Center, Utrecht, Department of Pulmonology and Tuberculosis

location_facility: Mukoviszidose-Zentrum am Universitätsklinikum Jena, Klinik für Kinder- und Jugendmedizin

location_facility: University of Arkansas for Medical Sciences

location_facility: University of Oklahoma Health Sciences Center

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Royal Devon University Healthcare NHS Foundation Trust

location_facility: CF Therapeutics Development Center of Western New York

location_facility: Texas Children's Hospital - Baylor College of Medicine

location_facility: University of Miami Miller School of Medicine

location_facility: Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

location_facility: Spectrum Health Medical Group Adult Cystic Fibrosis Care Center

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme

location_facility: Massachusetts General Hospital Cystic Fibrosis Center Clinical Research Center

location_facility: Centro Regionale Fibrosi Cistica, A.O. Ospedale San Carlo

location_facility: Friedrich-Alexander University of Erlangen-Nuremberg, University Children's Hospital

location_facility: Universitair Ziekenhuis Brussel - Campus Jette

location_facility: ProMedica Toledo Hospital/Toledo Children's Hospital/Pediatric Pulmonary & Cystic Fibrosis Center

location_facility: Oslo University Hospital, Department of Paediatric Medicine

location_facility: Cardinal Glennon Children's Hospital - St. Louis University

location_facility: University of Calgary Medical Clinic of the Foothills Medical Centre

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital

location_facility: All Wales Adult Cystic Fibrosis Centre, University Hospital Llandough

location_facility: Banner University of Arizona Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM) Hotel-Dieu

location_facility: Hopital Foch (Suresnes), Hopital Foch, Adultes

location_facility: Lund University Skanes Universitetssjukhus

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

location_facility: Malattie Apparato Respiratorio 2 - Centro Fibrosi Cistica

location_facility: Sheba Medical Center - The Edmond and Lili Safra Children's Hospital

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Childrens Hospital University of Missouri Health Sciences Center

location_facility: Pediatric Hospital Polanki named of Maciej Płażyński

location_facility: Azienda Ospedaliero Universitaria Ospedale Riuniti

location_facility: Miller Children's Hospital / Long Beach Memorial

location_facility: Klinika Mukowiscydozy IMD Oddozial Chorob Pluc Szpzoz IM. Dzieci WarszaWY

location_facility: Vanderbilt University Medical Center, Nephrology Clinical Trials Center

location_facility: University Hospital and UW Health Clinics

location_facility: Institut Universitaire de Cardiologie et Pneumologie de Quebec - Universite Laval

location_facility: Ruhrlandklinik Westdeutsches Lungenzentrum am Klinikum Essen

location_facility: General Hospital of Thessaloniki "Papanikolaou"


acronym: JAVELIN Bladder Medley

lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.

sponsor_collaborators: Merck KGaA, Darmstadt, Germany; Gilead Sciences; Nektar Therapeutics

location_facility: Severance Hospital, Yonsei University Health System

location_facility: CRLCC Eugene Marquis - Service d'Oncologie médicale

location_facility: Azienda Ospedaliera San Camillo Forlanini - Dipartimento di Oncologia Medica

location_facility: CISSS de la Monteregie-Centre - Hospital Charles Le Moyne

location_facility: Centre Leon Berard - Service d'Oncologie Medicale

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS - Oncologia Medica

location_facility: Universitair Ziekenhuis Gent - Medical Oncology

location_facility: Chungnam National University Hospital - Department of Internal Medicine (Rheumatology)

location_facility: AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center

location_facility: Centre François Baclesse - Pathologies Gynecologiques

location_facility: William Osler Health System - Brampton Civic Hospital

location_facility: Universitaetsklinikum Tuebingen - Klinik fuer Urologie

location_facility: Hospital Clinic de Barcelona - Servicio de Oncologia

location_facility: Hôpital Cochin - Hematologie et Oncologie Médicale

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

location_facility: Ospedale San Raffaele - U.O. di Oncologia Medica

location_facility: Hospital General Universitario de Elche - Servicio de Oncologia

location_facility: Hospital del Mar - Servicio de Oncologia

location_facility: Multicare Health System Tacoma General Hospital

location_facility: Hospital Universitario Virgen del Rocio - Oncology Service

location_facility: Clinique Sainte-Anne - Service d'Oncologie Médicale

location_facility: Azienda Ospedaliera Universitaria Careggi - S.O.D. di Oncologia Medica

location_facility: IOV - Istituto Oncologico Veneto IRCCS - U.O. Oncologia Medica 1

location_facility: Universitaetsklinikum Essen - Westdeutsches Tumorzentrum

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

location_facility: Institut Jules Bordet - Medical Oncology

location_facility: Royal Preston Hospital - Rosemere Cancer Centre

location_facility: Hopital Caremeau - Service Hématologie Clinique/Oncologie Médicale

location_facility: ALTHAIA, Xarxa assistencial Universitaria de Manresa - Oncology Dept

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori - S.S. Oncologia Medica Genitourinaria

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

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale - Oncologia Medica A

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The Christie Hospital - Dept of Oncology

location_facility: Hospital Infanta Cristina - Unidad de Fase I

location_facility: ICO - Site Paul Papin - service d'oncologie medicale

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)

location_facility: Hospital Clinico Universitario de Valencia - Servicio de Hematologia y Oncologia Medica

location_facility: Seoul National University Bundang Hospital

location_facility: Universitaetsklinikum Frankfurt Goethe-Universitaet - Urologie und Kinderurologie2

location_facility: Universitaetsklinikum Wuerzburg - Klinik u. Poliklinik f. Urologie u. Kinderurologie

location_facility: Hospital Universitario Lucus Augusti - Oncology

location_facility: Humanitas Istituto Clinico Catanese - Oncologia Medica

location_facility: Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza - Dipartimento di Oncologia Medica

location_facility: Hospital Universitario Reina Sofia - Dept of Oncology

location_facility: Universitaetsklinikum Muenster - Klinik und Poliklinik fuer Urologie

location_facility: Hospital de la Santa Creu i Sant Pau - Dept of Oncology

location_facility: Hôpital de la Timone - service d'urologie

location_facility: Centre Hospitalier de l'Ardenne - PARENT

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS - Urologia

location_facility: Azienda Ospedaliera S. Maria Di Terni - S.C. Oncologia Medica

location_facility: Kliniken Maria Hilf GmbH - Klinik fuer Urologie

location_facility: Sjællands University Hospital - PARENT (Næstved)

location_facility: Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia

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

location_facility: Clinique Victor Hugo - Centre Jean Bernard - Service d'Oncologie Médical

location_facility: Institut Bergonié - Service d'Oncologie Médicale

location_facility: Ålborg Universitets Hospital - onkologisk afd

location_facility: Hôpital Henri Mondor - Service d'Oncologie Médicale

location_facility: ICO - Site René Gauducheau - Service d'Oncologie medicale

location_facility: AZ Groeninge - Campus Kennedylaan - account 2

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

title: A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor Agents as a Maintenance Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress With First Line Platinum-Containing Chemotherapy (JAVELIN Bladder Medley)

source: euctr

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

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Belgium
United States
Korea, Republic of
Spain
Greece
Taiwan
Canada
France


title: A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

summary: To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Argentina
Japan
Brazil
Turkey
Croatia
Canada
France
Slovenia
Portugal
Slovakia
United States
India
Romania
China
Estonia
Puerto Rico
Italy
United Kingdom
Mexico
Spain
Greece
South Africa
Bulgaria
Sweden