title: Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

summary:
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
To evaluate the effects of alirocumab on other lipid parameters.

ReferenceType: result

ReferenceCitation: Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi: 10.1056/NEJMoa1501031. Epub 2015 Mar 15.

ReferenceCitation: Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

ReferenceCitation: Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

repositories_concat: PubMed Central;www.repositoriosalud.es

ReferenceCitation: Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. Erratum In: J Clin Lipidol. 2020 Sep - Oct;14(5):742.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan-Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.

ReferenceCitation: Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

location_country:
Finland
Germany
Poland
Argentina
Chile
Canada
France
Czech Republic
Colombia
Portugal
Hungary
Denmark
United States
Ukraine
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Spain
South Africa
Bulgaria
Russian Federation
Israel

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summary: This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Katakami N, Felip E, Spigel DR, Kim JH, Olivo M, Guo M, Nokihara H, Yang JC, Iannotti N, Satouchi M, Barlesi F. A randomized, open-label, multicenter, phase 3 study to compare the efficacy and safety of eribulin to treatment of physician's choice in patients with advanced non-small cell lung cancer. Ann Oncol. 2017 Sep 1;28(9):2241-2247. doi: 10.1093/annonc/mdx284.

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 OAI-PMH doi match)

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

lead_sponsor: Eisai Inc.

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

summary: The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.

primary_purpose: Supportive Care

ReferenceType: background

ReferenceCitation: Platzbecker U, Symeonidis A, Oliva EN, Goede JS, Delforge M, Mayer J, Slama B, Badre S, Gasal E, Mehta B, Franklin J. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. Leukemia. 2017 Sep;31(9):1944-1950. doi: 10.1038/leu.2017.192. Epub 2017 Jun 19.

lead_sponsor: Amgen

location_country: Germany Italy Switzerland Austria Belgium Spain Greece Czechia France


title: A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment

summary: The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Portugal
United Kingdom
Japan
Switzerland
Austria
Belgium
United States
Spain
Canada
Puerto Rico
France

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location_facility: 1220.7.3301 Boehringer Ingelheim Investigational Site

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location_facility: 1220.7.8108 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.0016 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.8107 Boehringer Ingelheim Investigational Site

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location_facility: 1220.7.0029 Boehringer Ingelheim Investigational Site

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location_facility: 1220.7.0077 Boehringer Ingelheim Investigational Site

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location_facility: 1220.7.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3411 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.7.4905 Boehringer Ingelheim Investigational Site

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location_facility: 1220.7.0101 Boehringer Ingelheim Investigational Site

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location_facility: 1220.7.3501 Boehringer Ingelheim Investigational Site

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location_facility: 1220.7.3403 Boehringer Ingelheim Investigational Site


acronym: LUX-Head & Neck 2

summary: This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

ReferenceCitation: Burtness B, Haddad R, Dinis J, Trigo J, Yokota T, de Souza Viana L, Romanov I, Vermorken J, Bourhis J, Tahara M, Martins Segalla JG, Psyrri A, Vasilevskaya I, Nangia CS, Chaves-Conde M, Kiyota N, Homma A, Holeckova P, Del Campo JM, Asarawala N, Nicolau UR, Rauch D, Even C, Wang B, Gibson N, Ehrnrooth E, Harrington K, Cohen EEW; LUX-Head & Neck 2 investigators. Afatinib vs Placebo as Adjuvant Therapy After Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA Oncol. 2019 Aug 1;5(8):1170-1180. doi: 10.1001/jamaoncol.2019.1146.

oa_colors: green other

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Burtness B, Bourhis JP, Vermorken JB, Harrington KJ, Cohen EE. Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial. Trials. 2014 Nov 29;15:469. doi: 10.1186/1745-6215-15-469.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

repository_institution: Université de Lausanne - SERVAL

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

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

unpaywall_oa_status: gold

publisher_dissemination: Springer

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status: Terminated

title: A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma

source: euctr

location_country:
Finland
Germany
Argentina
Australia
Brazil
Japan
Chile
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Ukraine
India
Belgium
Egypt
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Spain
Greece
Russian Federation
Israel

status_simplified: Unknown


title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection

summary: The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

ReferenceCitation: Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourliere M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Bocher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naive HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repositories_concat: closed

ReferenceCitation: Dieterich D, Nelson M, Soriano V, Arasteh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon alpha-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

oa_host_type: closed

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Ferenci P, Asselah T, Foster GR, Zeuzem S, Sarrazin C, Moreno C, Ouzan D, Maevskaya M, Calinas F, Morano LE, Crespo J, Dufour JF, Bourliere M, Agarwal K, Forton D, Schuchmann M, Zehnter E, Nishiguchi S, Omata M, Kukolj G, Datsenko Y, Garcia M, Scherer J, Quinson AM, Stern JO; STARTVerso1 Study Group. STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection. J Hepatol. 2015 Jun;62(6):1246-55. doi: 10.1016/j.jhep.2014.12.024. Epub 2015 Jan 2.

oa_host_type: repository

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_institution: University of Bern - Bern Open Repository and Information System

unpaywall_oa_status: green

location_country:
Germany
Portugal
United Kingdom
Romania
Japan
Switzerland
Austria
Belgium
Spain
Russian Federation
France

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title: A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.

summary: The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).

design_allocation: Non-Randomized

ReferenceCitation: Tourian KA, Pitrosky B, Padmanabhan SK, Rosas GR. A 10-month, open-label evaluation of desvenlafaxine in outpatients with major depressive disorder. Prim Care Companion CNS Disord. 2011;13(2):PCC.10m00977. doi: 10.4088/PCC.10m00977blu.

lead_sponsor: Pfizer

location_country:
Finland
Germany
Lithuania
Poland
Slovakia
United States
Latvia
South Africa
Former Serbia and Montenegro
Estonia
France

location_facility: Psychoneurological hospital of Jelgava, Dept No12

location_facility: Riga Mental Health Care Center, Dept of Psychiatry

location_facility: Pivotal Research Centers 13128 North 94th Drive, Suite 200

location_facility: The George Washington University Medical Center

location_facility: Capital Clinical Research Associates, LLP

location_facility: Kolin Research Group 1065 West Morse Blvd. Suite 202

location_facility: Praxis für Psychiatrie, Dr. Alexander Schulze

location_facility: California Clinical Trials Medical Group, Inc.

location_facility: Specjalistyczny Psychiatryczny ZOZ w Lodzi

location_facility: Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje

location_facility: UCSD Department of Psychiatry Psychopharmacology Research

location_facility: Southeastern Pennsylvania Medical Institute

location_facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu

location_facility: Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych

location_facility: Inventiva Biomedical and Sport Research Sp. z o.o.

location_facility: Atlanta Institute of Medicine & Research

location_facility: Poradnia Zdrowia Psychicznego w Chelmnie

location_facility: Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse

location_facility: Nemocnica s poliklinikou Liptovsky Mikulas

location_facility: Viljandi Hospital Foundation Psychiatric Clinic

location_facility: Turku Psychiatric Services Aurakatu 14 B 3 Krs

location_facility: SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy

location_facility: Psychiatrische Praxis Dr. Hans-Peter Wunderlich


acronym: ADVANCE

lead_sponsor: Astellas Pharma Inc

summary: The purpose of this study is to focus on potential differences in the occurrence of new-onset Diabetes Mellitus (a glucose metabolism disorder) when two different regimens of immunosuppressive treatment are compared.

ReferenceCitation: Mourad G, Glyda M, Albano L, Viklicky O, Merville P, Tyden G, Mourad M, Lohmus A, Witzke O, Christiaans MHL, Brown MW, Undre N, Kazeem G, Kuypers DRJ; Advagraf-based immunosuppression regimen examining new onset diabetes mellitus in kidney transplant recipients (ADVANCE) study investigators. Incidence of Posttransplantation Diabetes Mellitus in De Novo Kidney Transplant Recipients Receiving Prolonged-Release Tacrolimus-Based Immunosuppression With 2 Different Corticosteroid Minimization Strategies: ADVANCE, A Randomized Controlled Trial. Transplantation. 2017 Aug;101(8):1924-1934. doi: 10.1097/TP.0000000000001453.

title: Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study

primary_purpose: Prevention

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

location_country:
Finland
Germany
Poland
Australia
Czechia
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Switzerland
Latvia
Romania
Belgium
Estonia
Italy
Norway
Netherlands
Mexico
Korea, Republic of
Spain
Russian Federation
Sweden

ipd_sharing: Yes


title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy, Safety and Immunogenicity of Neovacs' TNFα-Kinoid in Adult Subjects With Crohn's Disease

summary:
The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising.

The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.

lead_sponsor: Neovacs

location_country:
Germany
Hungary
Romania
Netherlands
Belgium
Croatia
Bulgaria
Czech Republic
France

location_facility: Clinic of Gastroenterology/ University Hospital Varna

location_facility: Klinik für Innere Medizin II Abteilung Gastroenterologie, Hepatologie, Infektiologie

location_facility: Universitätsklinik und Poliklinik für Innere Medizin I

location_facility: Abteilung Innere Medizin Evangelisches Krankenhaus Kalk gGmbH

location_facility: Fővárosi Önkormányzat Péterfy Sándor utcai Kórháza

location_facility: I. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf

location_facility: Gastroenterologische Gemeinschaftspraxis im Ärztehaus am Ev. Krankenhaus Herne

location_facility: Medical Institute- Ministry of Interior Clinic of Gastroenterology

location_facility: Internistische Gemeinschaftspraxis für Verdauungs- und Stoffwechselkrankheiten

location_facility: University Multiprofile Hospital St. Georgi

location_facility: Free University Medical Centre in Amsterdam (VUMC)

location_facility: Hamburgisches Forschungsinstitut für CED

location_facility: Klinik mit Schwerpunkt Gastroenterologie, Campus Charité Mitte

location_facility: Klinik für Allg. Innere Medizin, Gastroenterologie und Diabetologie, Kliniken-Essen-Mitte/Evang. Huyssenstiftung

intervention_type: Biological


title: OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

acronym: OASIS

summary: Study will evaluate the safety and potential benefit of talactoferrin (recombinant human lactoferrin) as an addition to the standard care for severe sepsis.

status: Suspended

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Vincent JL, Marshall JC, Dellinger RP, Simonson SG, Guntupalli K, Levy MM, Singer M, Malik R; Oral tAlactoferrin in Severe sepsIS Study Investigators. Talactoferrin in Severe Sepsis: Results From the Phase II/III Oral tAlactoferrin in Severe sepsIS Trial. Crit Care Med. 2015 Sep;43(9):1832-8. doi: 10.1097/CCM.0000000000001090.

lead_sponsor: Agennix

location_country:
Germany
Israel
United Kingdom
Denmark
Netherlands
Belgium
United States
Spain
Canada
France

location_facility: Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Queen Elizabeth II Health Sciences Center

location_facility: Hospital Universitari de Tarragona Joan XXIII

location_facility: Klinikum der Friedrich-Schiller-Universität Jena

location_facility: University of Oklahoma Health Science Center

location_facility: Klinikum der Johann-Wolfgang Goethe-Universität


acronym: SAILING

lead_sponsor: ViiV Healthcare

summary: ING111762 is a 48 week, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will be conducted in at least 688 HIV-1 infected antiretroviral experienced, integrase-naïve subjects. Subjects will be randomized 1:1 to receive GSK1349572 50 mg once daily or raltegravir (RAL) 400 mg twice daily, each added to an investigator selected background regimen consisting of at least one fully active agent plus no more than one second single agent which may or may not be active. Antiviral activity, safety, pharmacokinetics (PK), and development of viral resistance will be evaluated.

ReferenceCitation: Cahn P, Pozniak AL, Mingrone H, Shuldyakov A, Brites C, Andrade-Villanueva JF, Richmond G, Buendia CB, Fourie J, Ramgopal M, Hagins D, Felizarta F, Madruga J, Reuter T, Newman T, Small CB, Lombaard J, Grinsztejn B, Dorey D, Underwood M, Griffith S, Min S; extended SAILING Study Team. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet. 2013 Aug 24;382(9893):700-8. doi: 10.1016/S0140-6736(13)61221-0. Epub 2013 Jul 3. Erratum In: Lancet. 2014 Jan 4;383(9911):30.

sponsor_collaborators:
ViiV Healthcare
Shionogi
GlaxoSmithKline

title: A Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered With an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral-Experienced Adults

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

location_country:
Poland
Argentina
Australia
Brazil
Chile
Canada
France
Hungary
United States
Romania
Belgium
Italy
United Kingdom
Netherlands
Mexico
Spain
Greece
South Africa
Taiwan
Russian Federation

collaborators: Shionogi GlaxoSmithKline


acronym: SABRINA

lead_sponsor: Hoffmann-La Roche

summary: This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.

ReferenceCitation: Davies A, Merli F, Mihaljevic B, Mercadal S, Siritanaratkul N, Solal-Celigny P, Boehnke A, Berge C, Genevray M, Zharkov A, Dixon M, Brewster M, Barrett M, MacDonald D. Efficacy and safety of subcutaneous rituximab versus intravenous rituximab for first-line treatment of follicular lymphoma (SABRINA): a randomised, open-label, phase 3 trial. Lancet Haematol. 2017 Jun;4(6):e272-e282. doi: 10.1016/S2352-3026(17)30078-9. Epub 2017 May 2.

ReferenceCitation: Davies A, Merli F, Mihaljevic B, Siritanaratkul N, Solal-Celigny P, Barrett M, Berge C, Bittner B, Boehnke A, McIntyre C, Macdonald D. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomised phase 3 study. Lancet Oncol. 2014 Mar;15(3):343-52. doi: 10.1016/S1470-2045(14)70005-1. Epub 2014 Feb 10.

ReferenceCitation: Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Public Library of Science

ReferenceCitation: Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.

evidence: open (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

location_facility: Clinical Center Vojvodine; Clinic for Hematology

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Hematologia

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

location_facility: Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: Fundeni Clinical Inst. ; Hematology Dept

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

location_facility: Specialised Hospital For Treatment Of Hematological Diseases; Hematology

location_facility: Centre de sante et de services sociaux Rimouski Neigette

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: New Cross Hospital; Dept. Of Haematology

location_facility: Haematology Research Center; Haematology

location_facility: National Cancer Inst. ; Dept. of Chemotherapy

location_facility: University Clinic for Hematology; HSCT Department

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Research Inst. of Hematology & Blood Transfusion ; Hematology

location_facility: Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.

location_facility: Ospedale S. Eugenio; Divisione Di Ematologia

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie

location_facility: King Edward VIII; Department of Haematology

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

location_facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

location_facility: Pinderfields General Hospital; Dept of Haematology

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Uni Degli Studi Di Genova; 1A Divisione Di Ematologia

location_facility: Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

location_facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

location_facility: Hospital Universitario Puerta del Mar; Servicio de Hematologia

location_facility: Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

location_facility: Bilim University School of Medicine; Hematology

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Ospedale Di Vicenza; Nefrologia, Ematologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia

location_facility: CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

location_facility: Hopital Henri Mondor; Hematologie Clinique

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: Hospital Universitario de la Princesa; Servicio de Hematologia

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

location_facility: Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie

location_facility: Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

location_facility: Gold Coast Hospital; Haematology Department

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

location_facility: Siriraj Hospital; Division of Hematology, Department of Medicine

location_facility: Derriford Hospital; Department of Haematology

location_facility: Helsinki University Central Hospital; Dept of Oncology

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

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: University Clinical Center Sarajevo, Clinic for Hematology

location_facility: Centre hospitalier regional de Trois-Rivieres

location_facility: Odense Universitetshospital; Hæmatologisk Afdeling

location_facility: Singapore General Hospital; Department of Haematology

location_facility: Ampang Hospital; Department of Haematology

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay

location_facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

location_facility: Azienda Ospedaliera Ospedale S.Carlo; Ematologia

location_facility: Hospital del Mar; Servicio de Hematologia

location_facility: Hospital General De Culiacan; Servicio De Hematologia

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: National Cancer Centre; Medical Oncology

location_facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

location_facility: Ninewells Hospital & Medical School; Ward 34

location_facility: University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology

location_facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

location_facility: University Hospital Center Zagreb; Haematology Department

location_facility: Caritas Kilinik St. Theresia; Abt. Innere Medizin

location_facility: Centre Hospitalier Universitaire de Sherbrooke

location_facility: AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Institute of Hematology and Transfusiology

location_facility: Vejle Hospital; Dept of Medicine, Division of Hematology

location_facility: Centro de Estudios Clinicos de Queretaro (CECLIQ)

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

location_facility: Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia

location_facility: Canterbury Health Laboratories; Haematology

location_facility: Istanbul University Cerrahpasa Medical Faculty; Hematology Department

location_facility: Herlev Uni Hospital; Hæmatologisk Afdeling L 121

location_facility: Aarhus Universitetshospital, Hæmatologisk Afdeling R

location_facility: Chemotherapy and Immunotherapy Clinic Medulla

location_facility: University Malaya Medical Center; Hematology Unit of Department of Internal Medicine

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

location_facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

location_facility: Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)

location_facility: University Clinic of Hematology Skopje, Hospital Care Department

title: A Two-Stage Phase III, International, Multi-Center, Randomized, Controlled, Open-Label Study to Investigate the Pharmacokinetics, Efficacy and Safety of Rituximab SC in Combination With CHOP or CVP Versus Rituximab IV in Combination With CHOP or CVP in Patients With Previously Untreated Follicular Lymphoma Followed by Maintenance Treatment With Either Rituximab SC or Rituximab IV

location_country: Macedonia, The Former Yugoslav Republic of


title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

acronym: DESKTOPIII

summary: It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.

primary_purpose: Other

ReferenceCitation: Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgaard BJ, Selle F, Guyon F, Pomel C, Lecuru F, Zang R, Avall-Lundqvist E, Kim JW, Ponce J, Raspagliesi F, Kristensen G, Classe JM, Hillemanns P, Jensen P, Hasenburg A, Ghaem-Maghami S, Mirza MR, Lund B, Reinthaller A, Santaballa A, Olaitan A, Hilpert F, du Bois A; DESKTOP III Investigators. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer. N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294. Erratum In: N Engl J Med. 2022 Feb 17;386(7):704.

evidence: open (via free article)

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Bommert M, Harter P, Heitz F, du Bois A. When should Surgery be used for Recurrent Ovarian Carcinoma? Clin Oncol (R Coll Radiol). 2018 Aug;30(8):493-497. doi: 10.1016/j.clon.2018.04.006. Epub 2018 May 7.

lead_sponsor: AGO Study Group

collaborators: Grupo Español de Investigación en Cáncer de Ovario

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Sweden
Austria
Belgium
Korea, Republic of
China
Spain
France

location_facility: Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe

location_facility: Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie

location_facility: Insitut Jean Godinot, Service Rubis - Oncologie Médicale

location_facility: ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona

location_facility: Zhejiang Cancer Hospital, Gynecology Oncology

location_facility: Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology

location_facility: Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde

location_facility: Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre

location_facility: University College London Hospital, Cancer clinical trails unit

location_facility: Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology

location_facility: Suzhou Municipal Hospital, Gynecologic and Obstetrics

location_facility: Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg

location_facility: Fudan University Cancer Hospital, Gynecologic Oncology

location_facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie

location_facility: St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre

location_facility: Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe

location_facility: Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: Istituto Europeo di Oncologia, Divisione di Ginecologia

location_facility: Karolinska University Hospital, Oncology

location_facility: Hospital Universitari i Politècnic la Fe, Oncology

location_facility: Seoul National University Hospital, Department of Obstetrics and Gynecology

location_facility: Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe

location_facility: Fudan University Zhongshan Hospital, Obstetrics and Gynecology

location_facility: Klinikum Dritter Orden, Gynäkologie und Geburtshilfe

location_facility: Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung

location_facility: Hospital de la Santa Creu i Sant Pau, Oncology

location_facility: Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology

location_facility: Nottingham University Hospital, City Campus, Oncology

location_facility: Norfolk & Norwich University Hospital,Obstetrics & Gynaecology

location_facility: Royal Surrey Country Hospital,St Lukes Cancer Centre

location_facility: Northampton General Hospital, Gynaecological Oncology

location_facility: Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe

location_facility: Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik

location_facility: Fondazione IRCCS Istituto Nazionale Tumori di Milano

location_facility: Birmingham City Hospital, Cancer Research Team

location_facility: Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology

location_facility: HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie

location_facility: Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre

location_facility: Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe

location_facility: East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology

location_facility: Linköping University Hospital, Department of Obstetrics and Gynecology

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde

location_facility: Klinikum Fürth, Frauenklinik Nathanstift

location_facility: Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House

location_facility: Ringshospitalet Copenhagen University Hospital; Oncology

location_facility: Odense University Hospital, Gynaecology and Obstetrics

location_facility: Centre Hospitalier Universitaire Charles-Nicolle

location_facility: Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology

location_facility: Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik

location_facility: ICO Badalona - H. U. Germans Trias i Pujol

location_facility: Istituto Nazionale Tumori di Napoli, Gynecologic Oncology

location_facility: Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre

location_facility: Gynecologic Clinic of the Ernst-Moritz-Arndt-University

location_facility: Fundación Instituto Valenciano de Oncologia

location_facility: Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica

intervention_type: Procedure


acronym: LUX-Breast 1

summary: To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

ReferenceCitation: Harbeck N, Huang CS, Hurvitz S, Yeh DC, Shao Z, Im SA, Jung KH, Shen K, Ro J, Jassem J, Zhang Q, Im YH, Wojtukiewicz M, Sun Q, Chen SC, Goeldner RG, Uttenreuther-Fischer M, Xu B, Piccart-Gebhart M; LUX-Breast 1 study group. Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):357-366. doi: 10.1016/S1470-2045(15)00540-9. Epub 2016 Jan 26.

location_facility: Vitebsk Regional Clinical Oncology Dispensary

location_facility: Complejo Hospitalario Universitario Insular - Materno Infantil

location_facility: Ziemia Lubelska Oncological Center, Lublin

location_facility: Instituto Português de Oncologia de Coimbra Francisco Gentil

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: Instituto Clínico Oncológico del Sur - ICOS

location_facility: Riga East Univ. Hospital, Oncology Centre

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: N. N. Alexandrov National Cancer Center of Belarus

location_facility: Klinikum der Universität München - Campus Innenstadt

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: POKO Policlinic Dept. of Clinical Oncology

location_facility: Cancer Care Associates Medical Group, Inc

location_facility: Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

location_facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern

location_facility: Centro de Referência da Saude da Mulher-Hosp Perola Byington

location_facility: CHUC, EPE - CHC-Maternidade Bissaya Barreto

location_facility: Universitätsfrauenklinik am Klinikum Südstadt

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: National Institute of Oncology, Bratislava

location_facility: St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov

location_facility: The Third Affiliated Hospital of Harbin Medical University

location_facility: GUZ "Regional Clinical Oncology Dispensary"

location_facility: Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

location_facility: P. Stradins Clinical Univ. Hospital, Oncology Clinic

location_facility: Provincial Specialist M. Kopernik Hospital

location_facility: Cancer Hospital of Chinese Academy of Medical Science

location_facility: Osaka Medical Center for Cancer and Cardiovascular Diseases

location_facility: Hammoud Hospital University Medical Centre (HHUMC)

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Centro de Pesquisas Clínicas em Oncología

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.

location_facility: St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

location_facility: Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim

location_facility: Instituto Medico de Asistencia e Investigaciones S. A.

location_facility: Máxima Medisch Centrum, locatie Eindhoven

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc

location_facility: Public Health Inst. Minsk City Clinical Oncology Dispensary

location_facility: DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU

location_facility: Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD

location_facility: CHU de Quebec-Universite Laval Research Centre

location_facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

location_facility: Koo Foundation Sun Yet-Sen Cancer Center

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: The Chaim Sheba Medical Center Tel Hashomer

location_facility: Central Coast Medical Oncology Corporation

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

location_facility: Wojewodzki Specialist Hospital No. 4, Bytom

location_facility: N.A. Semashko Central Clinical Hospital, Moscow

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie

title: LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Slovenia
Belarus
Lithuania
Portugal
Slovakia
United States
Latvia
Sri Lanka
India
Lebanon
Belgium
China
Peru
Egypt
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel