title: A Randomized, Double-blind Study To Evaluate the Efficacy and Safety of Cabozantinib (XL184) at 60 mg/Day Compared to a 140 mg/Day in Progressive, Metastatic Medullary Thyroid Cancer Patients

acronym: EXAMINER

summary: The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events compared to the PFS, ORR and adverse events found in previous clinical trials of 140 mg.

ReferenceCitation: Capdevila J, Klochikhin A, Leboulleux S, Isaev P, Badiu C, Robinson B, Hughes BGM, Keam B, Parnis F, Elisei R, Gajate P, Gan HK, Kapiteijn E, Locati L, Mangeshkar M, Faoro L, Krajewska J, Jarzab B. A Randomized, Double-Blind Noninferiority Study to Evaluate the Efficacy of the Cabozantinib Tablet at 60 mg Per Day Compared with the Cabozantinib Capsule at 140 mg Per Day in Patients with Progressive, Metastatic Medullary Thyroid Cancer. Thyroid. 2022 May;32(5):515-524. doi: 10.1089/thy.2022.0027.

repository_institution: Leiden University - Leiden Repository

repository_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: Mary Ann Liebert Inc

lead_sponsor: Exelixis

location_country:
Italy
Poland
Hungary
Israel
Romania
Australia
Sweden
Netherlands
Korea, Republic of
Spain
Croatia
Canada
Russian Federation
France


type: EudraCT Number

title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

acronym: SYNERGY

summary:
The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing multiple sclerosis (MS) when used concurrently with Avonex.

Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulovic J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: publishedVersion

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Deutscher Arzte-Verlag GmbH

lead_sponsor: Biogen

location_country:
Italy
Poland
Hungary
United Kingdom
Netherlands
United States
Spain
Serbia
Canada
Czech Republic
Russian Federation
France

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Azienda Ospedaliera S. Antonio Abate di Gallarate

location_facility: Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku

location_facility: Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari

location_facility: M.A.- Lek A.M.Maciejowscy Spolka Cywilna

location_facility: Multiple Sclerosis Center of North Eastern New York

location_facility: Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization

location_facility: Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego

location_facility: Michigan Institute For Neurological Disorders

location_facility: OMRF Multiple Sclerosis Center of Excellence

location_facility: Fondazione Istituto San Raffaele G. Giglio di Cefalù

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku

location_facility: Nemocnice Jihlava Prispevkova Organizace

location_facility: Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet

location_facility: Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele

location_facility: Republican Clinical Hospital For Rehabilitation Treatment

location_facility: Krajska Zdravotni a.s. Nemocnice Teplice Oz

location_facility: City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


study_start_date_type: Actual

lead_sponsor: AstraZeneca

summary: Olaparib Monotherapy in Patients with BRCA Mutated Ovarian Cancer following First Line Platinum Based Chemotherapy.

ReferenceCitation: DiSilvestro P, Banerjee S, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, McNamara J, Lowe ES, Ah-See ML, Moore KN; SOLO1 Investigators. Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. J Clin Oncol. 2023 Jan 20;41(3):609-617. doi: 10.1200/JCO.22.01549. Epub 2022 Sep 9.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_concat: PubMed Central;pure.ed.ac.uk

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

publisher_dissemination: Wiley

ReferenceCitation: Banerjee S, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Holmes E, Lowe ES, DiSilvestro P. Maintenance olaparib for patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (SOLO1/GOG 3004): 5-year follow-up of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2021 Dec;22(12):1721-1731. doi: 10.1016/S1470-2045(21)00531-3. Epub 2021 Oct 26. Erratum In: Lancet Oncol. 2021 Dec;22(12):e539.

version: acceptedVersion

ReferenceCitation: Friedlander M, Moore KN, Colombo N, Scambia G, Kim BG, Oaknin A, Lisyanskaya A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley WH, Liu J, Mathews C, Selle F, Lortholary A, Lowe ES, Hettle R, Flood E, Parkhomenko E, DiSilvestro P. Patient-centred outcomes and effect of disease progression on health status in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation receiving maintenance olaparib or placebo (SOLO1): a randomised, phase 3 trial. Lancet Oncol. 2021 May;22(5):632-642. doi: 10.1016/S1470-2045(21)00098-X. Epub 2021 Apr 13.

ReferenceCitation: Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, Lisyanskaya A, Floquet A, Leary A, Sonke GS, Gourley C, Banerjee S, Oza A, Gonzalez-Martin A, Aghajanian C, Bradley W, Mathews C, Liu J, Lowe ES, Bloomfield R, DiSilvestro P. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2018 Dec 27;379(26):2495-2505. doi: 10.1056/NEJMoa1810858. Epub 2018 Oct 21.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

host_type: publisher

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

sponsor_collaborators:
AstraZeneca
GOG Foundation
Myriad Genetic Laboratories, Inc.
Merck Sharp & Dohme LLC

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Obstetris and Gynecology Hospital of Fudan University

location_facility: SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii

location_facility: University of Texas Health Science Center of Houston

location_facility: Nancy N. & J.C. Lewis Cancer and Research Pavillion

location_facility: First affiliated hospital college of XianJiaotong University

location_facility: St.Petersburg City Oncology Dispensary, Dept. Gynecology

location_facility: St. Vincent Hospital & Health Care Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Istituto Nazionale Per Cura Tumori - Milano

location_facility: Netherlands Cancer Institute Antoni van Leeuwenhoek Hospital

location_facility: City Hospital, Birmingham, Cancer Trials Team

location_facility: Walter Reed National Military Medical Center

location_facility: Szpital Specjalistyczny im. Swietej Rodziny SPZOZ

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alagre

location_facility: Cancer Research UK and UCL Cancer Trials Centre

location_facility: Udmurtia Republic Clinical Oncology Center

location_facility: The Tumor Hospital affiliated to China Medical Science Insti

location_facility: State Institution of Heath Omsk Regional Oncology Dispensary

location_facility: Istituto Regina Elena-Polo Oncologico Ifo

location_facility: Washington University School of Medicine

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Peggy and Charles Stephenson Cancer Center

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Innowacyjna Medycyna

location_facility: Royal Marsden Hospital and Institute of Cancer Research

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: Wojewódzki Szpital Specjalistyczny w Olsztynie

location_facility: West China Hospital Affiliated to Sichuan University

location_facility: Chemotherapy Department, Russian Cancer Research Centre

location_facility: The First Affiliated Hospital of Soochow Universit

location_facility: Shanghai Cancer Hospital of Fudan University

location_facility: University of Mississippi Medical Center

location_facility: Cleveland Clinic Cancer Center at Fairview Hospital

location_facility: Istituto Nazionale Tumori Fondazione Pascale

location_facility: The Tumour Hospital of Harbin Medical University

location_facility: Women's Hospital, Zhejaing University School of Medicine

status: Active, not recruiting

title: A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

source: euctr

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.

study_completion_date_type: Anticipated

location_country:
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Japan
Netherlands
United States
China
Korea, Republic of
Spain
Canada
Russian Federation
France

ipd_sharing: Yes

status_simplified: Ongoing


title: A Phase 3, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab Versus Ipilimumab Monotherapy in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

summary: The purpose of this study is to show that Nivolumab and/or Nivolumab in combination with Ipilimumab will extend progression free survival and overall survival compared to Ipilimumab alone.

ReferenceCitation: Mantia CM, Werner L, Stwalley B, Ritchings C, Tarhini AA, Atkins MB, McDermott DF, Regan MM. Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 Feb 1;32(1):35-44. doi: 10.1097/CMR.0000000000000793.

oa_colors: green hybrid

evidence: open (via page says license)

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Wolchok JD, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Butler MO, Hill A, Marquez-Rodas I, Haanen JBAG, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bas T, Ritchings C, Larkin J, Hodi FS. Long-Term Outcomes With Nivolumab Plus Ipilimumab or Nivolumab Alone Versus Ipilimumab in Patients With Advanced Melanoma. J Clin Oncol. 2022 Jan 10;40(2):127-137. doi: 10.1200/JCO.21.02229. Epub 2021 Nov 24.

license: cc-by

license_normalized: cc-by

repository_institution: Swansea University - Cronfa

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Zurich - Zurich Open Repository and Archive

repositories_concat: LIRIAS (KU Leuven);PubMed Central;cronfa.swan.ac.uk;www.zora.uzh.ch

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

ReferenceCitation: Hodi FS, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Cowey CL, Lao CD, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hill A, Hogg D, Marquez-Rodas I, Jiang J, Rizzo J, Larkin J, Wolchok JD. Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1480-1492. doi: 10.1016/S1470-2045(18)30700-9. Epub 2018 Oct 22. Erratum In: Lancet Oncol. 2018 Dec;19(12):e668. Lancet Oncol. 2018 Nov;19(11):e581.

ReferenceCitation: Wolchok JD, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao CD, Wagstaff J, Schadendorf D, Ferrucci PF, Smylie M, Dummer R, Hill A, Hogg D, Haanen J, Carlino MS, Bechter O, Maio M, Marquez-Rodas I, Guidoboni M, McArthur G, Lebbe C, Ascierto PA, Long GV, Cebon J, Sosman J, Postow MA, Callahan MK, Walker D, Rollin L, Bhore R, Hodi FS, Larkin J. Overall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2017 Oct 5;377(14):1345-1356. doi: 10.1056/NEJMoa1709684. Epub 2017 Sep 11. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.

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

ReferenceCitation: Long GV, Weber JS, Larkin J, Atkinson V, Grob JJ, Schadendorf D, Dummer R, Robert C, Marquez-Rodas I, McNeil C, Schmidt H, Briscoe K, Baurain JF, Hodi FS, Wolchok JD. Nivolumab for Patients With Advanced Melanoma Treated Beyond Progression: Analysis of 2 Phase 3 Clinical Trials. JAMA Oncol. 2017 Nov 1;3(11):1511-1519. doi: 10.1001/jamaoncol.2017.1588.

ReferenceCitation: Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, Rutkowski P, Grob JJ, Cowey CL, Lao C, Wagstaff J, Callahan MK, Postow MA, Smylie M, Ferrucci PF, Dummer R, Hill A, Taylor F, Sabater J, Walker D, Kotapati S, Abernethy A, Long GV. Health-related quality of life results from the phase III CheckMate 067 study. Eur J Cancer. 2017 Sep;82:80-91. doi: 10.1016/j.ejca.2017.05.031. Epub 2017 Jun 23.

ReferenceCitation: Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med. 2015 Jul 2;373(1):23-34. doi: 10.1056/NEJMoa1504030. Epub 2015 May 31. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.

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

location_facility: California Pacific Medical Center Research Institute

location_facility: Comprehensive Cancer Center At Desert Regional Medical Ctr


acronym: Tremelimumab

lead_sponsor: MedImmune LLC

summary: This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.

ReferenceCitation: Baverel P, Roskos L, Tatipalli M, Lee N, Stockman P, Taboada M, Vicini P, Horgan K, Narwal R. Exposure-Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status. Clin Transl Sci. 2019 Sep;12(5):450-458. doi: 10.1111/cts.12633. Epub 2019 Apr 12.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: gold

ReferenceCitation: Maio M, Scherpereel A, Calabro L, Aerts J, Perez SC, Bearz A, Nackaerts K, Fennell DA, Kowalski D, Tsao AS, Taylor P, Grosso F, Antonia SJ, Nowak AK, Taboada M, Puglisi M, Stockman PK, Kindler HL. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Lancet Oncol. 2017 Sep;18(9):1261-1273. doi: 10.1016/S1470-2045(17)30446-1. Epub 2017 Jul 17.

title: A Phase 2b, Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Second- or Third-line Treatment of Subjects With Unresectable Pleural or Peritoneal Malignant Mesothelioma

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:
Germany
Poland
Australia
Canada
France
Hungary
Denmark
United States
Romania
Belgium
Italy
United Kingdom
Sweden
Netherlands
Korea, Republic of
Spain
South Africa
Russian Federation
Israel


summary: This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM Custom Fenestrated Stent Graft in patients with a short infrarenal neck of <15mm or juxta-renal abdominal aortic aneurysms who, in the opinion of the treating physician, are anatomically suitable for the AnacondaTM Custom Fenestrated Stent Graft and for whom a customised medical device is required.

status: Terminated

study_type: Observational

time_perspective: Prospective

lead_sponsor: Vascutek Ltd.

location_country:
Germany
Italy
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Monaco
Canada
France

location_facility: Medical Care Centre for Vascular Diseases

location_facility: Imperial (St Mary's / Charing X) Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervel

status_simplified: Unknown


title: A Phase 3, Open-Label Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-Suppressed, HIV-1 Positive Subjects

summary: The primary objective of this study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-containing fixed dose combination (FDC) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically suppressed HIV-infected participants as determined by having HIV-1 RNA < 50 copies/mL at Week 48.

ReferenceType: result

ReferenceCitation: Mills A, Arribas JR, Andrade-Villanueva J, DiPerri G, Van Lunzen J, Koenig E, Elion R, Cavassini M, Madruga JV, Brunetta J, Shamblaw D, DeJesus E, Orkin C, Wohl DA, Brar I, Stephens JL, Girard PM, Huhn G, Plummer A, Liu YP, Cheng AK, McCallister S; GS-US-292-0109 team. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study. Lancet Infect Dis. 2016 Jan;16(1):43-52. doi: 10.1016/S1473-3099(15)00348-5. Epub 2015 Nov 2.

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

repositories_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Vandercam B, de Wet J, Rockstroh J, Lazzarin A, Rijnders B, Podzamczer D, Thalme A, Stoeckle M, Porter D, Liu HC, Cheng A, Quirk E, SenGupta D, Cao H. Switching from tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e195-e204. doi: 10.1016/S2352-3018(17)30031-0. Epub 2017 Mar 2.

ReferenceCitation: Brown T, Yin MT, Gupta S, Katlama C, et al. Switching from TDF to TAF in HIV-infected adults with low BMD: a pooled analysis. 24th Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2017; poster presentation: abstract #683.

ReferenceCitation: Podzamczer D, Viciana P, Rijnders B, Shalit P, et al. Switching from Tenofovir disoproxil fumarate to tenofovir alafenamide in patients with high risk for chronic kidney disease. 8th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 9th Teacher Meeting of AIDS Research Network 2016; poster presentation: abstract #P-188.

ReferenceCitation: Orkin C, Rjinders B, Stephan C, McKellar M, et al. Switching from boosted atazanavir (ATV) plus FTC/TDF to a TAF-based single tablet regimen (STR): Week 48 data in virologically suppressed adults. Annual Conference of the British Association for Sexual Health and HIV (BASHH) 2016; poster presentation: abstract # P045.

ReferenceCitation: Mills A, Andrade J, Koenig E, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 13th Congress for Infectious Diseases and Tropical Medicine (KIT) 2016; poster presentation: abstract #eP-038.

ReferenceCitation: Overton ET, Shalit P, Crofoot G, Benson P, et al. Switch from TDF regimens to E/C/F/TAF is associated with improved bone mineral density (BMD), decreased serum PTH and decreased bone turnover biomarkers. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract #PW-027.

ReferenceCitation: Huhn G, Rijnders B, Thompson M, Tebas P, et al. Switching from TDF to TAF in patients with high risk for CKD. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; oral presentation: https://www.natap.org/2016/HIV/062116_01.htm.

ReferenceCitation: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 23rd Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2016, poster presentation: abstract #496.

ReferenceCitation: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 25th International HIV Drug Resistance Workshop - Informed Horizons, LLC 2016; poster presentation: abstract #33.

ReferenceCitation: Mills A, Andrade J, Di Perri G, Van Lunzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 8th Biennial Conference on HIV Pathogenesis and Treatment and Prevention of the International AIDS Society (IAS) 2015; oral presentation: abstract #TUAB0102.

ReferenceCitation: Shamblaw D, Van Lunzen J, Orkin C, Bloch M, eta al. Switching from Atripla (ATR) to a tenofovir alafenamide (TAF)-based single tablet regimen: week 48 data in virologically suppressed adults. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) 2015; oral presentation; https://natap.org/2015/ICAAC/ICAAC_13.htm.

ReferenceCitation: Thompson M, Morales-Ramirez J, Mcdonald C, Rachlis A, et al. Switching from a tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): Week 48 data in HIV-1 infected virologically suppressed adults. Spring Conference of the Society for Healthcare Epidemiology of America (SHEA) 2015; oral presentation: abstract #725.

ReferenceCitation: Rijnders B, Stephan C, Lazzarin A, Squires K, et al. Switching from ritonavir or cobicistat boosted atazanavir (ATV) plus emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) to a tenofovir alafenamide (TAF)-based single tablet regimen (STR): week 48 data in virologically suppressed adults. 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #577.

ReferenceCitation: Lutz T, Benson P, Goffard J-C, Haubrich R, et al. Patient reported outcomes (PRO) over 48 weeks in a randomized, open-label trial of patients with HIV switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (E/C/F/TAF). 15th European AIDS Conference (EACS) and 17th International Workshop on Co-morbidities and Adverse Drug Reactions in HIV 2015; poster presentation: abstract #324.

ReferenceCitation: Viciana P, Mills A, Andrade J, Diperri G, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: data in virologically suppressed adults through 48 weeks of treatment. 7th National Congress of the AIDS Study Group (GESIDA) and Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) held jointly with the 8th Teacher Meeting of AIDS Research Network 2015; oral presentation: abstract #PO-08.

ReferenceCitation: Mills A, Andrade-Villanueva J, DiPerri G, Van Luzen J, et al. Switching from a tenofovir disoproxil fumarate (TDF)-based regimen to a tenofovir alafenamide (TAF)-based regimen: Data in virologically suppressed adults through 48 weeks of treatment. 8th Annual International AIDS Society meeting 2015; oral presentation: abstract #839.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #209.

ReferenceCitation: Stellbrink H, Gandhi-Patel B, Zhong L, Das M, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #205.

ReferenceCitation: Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 15th Congress on Infectious Diseases and Tropical Medicine - German Society for Infectious Diseases (DPID) held jointly with the 29th Annual Meeting of the German Society for Pediatric Infectiology (DGPI) 2020; poster presentation: abstract #A-343.

ReferenceCitation: Gupta SK, Post FA, Arribas JR, Eron JJ Jr, Wohl DA, Clarke AE, Sax PE, Stellbrink HJ, Esser S, Pozniak AL, Podzamczer D, Waters L, Orkin C, Rockstroh JK, Mudrikova T, Negredo E, Elion RA, Guo S, Zhong L, Carter C, Martin H, Brainard D, SenGupta D, Das M. Renal safety of tenofovir alafenamide vs. tenofovir disoproxil fumarate: a pooled analysis of 26 clinical trials. AIDS. 2019 Jul 15;33(9):1455-1465. doi: 10.1097/QAD.0000000000002223.

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

version: submittedVersion

repositories_concat: PubMed Central;scholarworks.iupui.edu

repositories_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

ReferenceCitation: Hermansson L, Yilmaz A, Price RW, Nilsson S, McCallister S, Makadzange T, Das M, Zetterberg H, Blennow K, Gisslen M. Plasma concentration of neurofilament light chain protein decreases after switching from tenofovir disoproxil fumarate to tenofovir alafenamide fumarate. PLoS One. 2019 Dec 11;14(12):e0226276. doi: 10.1371/journal.pone.0226276. eCollection 2019.

repository_institution: Chalmers University of Technology - Chalmers Research

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

repositories_institution: Chalmers University of Technology - Chalmers Research

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Stellbrink H-J, Post FA, Podzamczer D, Arribas J, et al. Safety and efficacy of switching from tenofovir disoproxil fumarate to tenofovir alafenamide in people with HIV aged 50 years and older. 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE9-50.

ReferenceCitation: Pepperrell T, Hughes S, Gotham D, Pozniak A, et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate - is there a true difference in safety? 17th European AIDS Conference of the European AIDS Clinical Society (EACS) 2019; poster presentation: abstract #PE3-8.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs. tenofovir DF in women: pooled analysis of 7 clinical trials. 9th Edition International Workshop on HIV and Women - Virology Education 2019; poster presentation: abstract #21.

ReferenceCitation: Dejesus E, Federico Andrade Villanueva J, Ramon Arribas Lopez J, Brinson C, et al. Tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in hispanic/latinx and black participants: efficacy, bone and renal safety results from a pooled analysis of 7 clinical trials. IDWeek Meeting of the Infectious Diseases Society of America (IDSA) 2019; poster presentation: abstract #318.

ReferenceCitation: Walmsley S, Andany N, Brar I, Brinson C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. 28th Annual Canadian Conference on HIV/AIDS Research - Canadian Association for HIV Research (CAHR) 2019; poster presentation: abstract #CSP9.04.

ReferenceCitation: Kim YS, Oka S, Chetchotisakd P, Clarke A, Supparatpinyo K, Avihingsanon A, Ratanasuwan W, Kiertiburanakul S, Ruxrungtham K, Yang S, Guo S, Liu Y, Das M, Tran D, McColl D, Corales R, Nguyen C, Piontkowsky D. Efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide in Asian participants with human immunodeficiency virus 1 infection: A sub-analysis of phase 3 clinical trials. HIV Res Clin Pract. 2019 Jun;20(3):73-81. doi: 10.1080/15284336.2019.1589232. Epub 2019 Jul 8.

ReferenceCitation: Hermansson L, Price RW, Yilmaz A, Nilsson S, et al. Effect on plasma NFL, a marker or neuronal injury, after switching from TDF to TAF. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; oral presentation: abstract #127.

ReferenceCitation: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide VS tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2019; poster presentation: abstract #519.

ReferenceCitation: Orkin C, Castelli F, Yazdanpanah Y, Rockstroh J, et al. Cardiovascular disease risk assessments and fasting lipid changes in virologically suppressed patients randomized to switch to tenofovir alafenamide versus continuing tenofovir disoproxil fumarate. 22nd International AIDS Conference - International AIDS Society 2018; poster presentation: abstract #TUPEB104.

ReferenceCitation: Brown TT, Yin MT, Gupta SK, Short WR, et al. Combined effects of bisphosphonates & TDF->TAF switch in HIV+ adults with low BMD. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2018; poster presentation: abstract #724.

ReferenceCitation: DeJesus E, Haas B, Segal-Maurer S, Ramgopal MN, Mills A, Margot N, Liu YP, Makadzange T, McCallister S. Superior Efficacy and Improved Renal and Bone Safety After Switching from a Tenofovir Disoproxil Fumarate- to a Tenofovir Alafenamide-Based Regimen Through 96 Weeks of Treatment. AIDS Res Hum Retroviruses. 2018 Apr;34(4):337-342. doi: 10.1089/AID.2017.0203. Epub 2018 Mar 20.

ReferenceCitation: Goldstein D, Ward D, Brinson C, Crofoot G, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-Infected virologically-suppressed adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A90.

ReferenceCitation: Ward D, Thompson M, Goldstein D, Brinson C, et al. Week 96 efficacy and safety of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in older, HIV-infected treatment-naïve adults. Annual Meeting of the American Geriatrics Society (AGS) 2017; poster presentation: abstract #A91.

ReferenceCitation: Choe S, Podzamvzer D, Tashima K, McNicholl I, and McCallister S. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). Midyear Clinical Meeting of the American Society of Health-System Pharmacists (ASHP) 2017; poster presentation: abstract #7-068.

ReferenceCitation: Yin M, Gupta S, Nguyen-Cleary T, Mora M, and Das M. Switching from TDF to TAF in HIV-infected adults with low BMD: A pooled analysis. Congress on HIV and Hepatitis in the Americas - ViiV Healthcare UK Limited 2017; poster presentation: abstract #P021.

ReferenceCitation: Podzamczer D, Tashima K, Daar E, McGowan J, et al. Utilizing phase 3 clinical trial data to assess adverse event (AE) frequency of a potentially interacting medication (PIM) amlodipine with elvitegravir/cobicistat (EVG/COBI). International Congress of Drug Therapy in HIV Infection - International AIDS Society 2016; poster presentation: abstract #P314.

ReferenceCitation: Dejesus E, Haas B, Segal-Maurer S, Ramgopal M, et al. Superior efficacy and improved renal and bone safety after switching from a tenofovir disoproxil fumarate (TDF) regimen to a tenofovir alafenamide (TAF) based regimen through 96 weeks (W96) of treatment. 56th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held Jointly with the 2016 Annual Meeting on Microbe - American Society for Microbiology (ASM) 2016; poster presentation: abstract # LB-087.

ReferenceCitation: Viciana P, Rijnders B, Shalit P, Liu Y et al. Cambio desde TDF a TAF en pacientes en alto riesgo de erc. 18th Congress of the Andalusian Society of Infectious Diseases (SAID) 2016; poster presentation: abstract #P-070.

publications_result: Abram M, Margot NA, Cox S, Ram RR, et al. Pooled week-48 analysis of HIV-1 drug resistance in E/C/F/TAF (Genvoya) phase 3 studies. 25th International HIV Drug Resistance Workshop - Informed Horizons, LLC 2016; poster presentation: abstract #33.

publications_result: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs tenofovir DF in women: pooled analysis of 7 clinical trials. Annual Meeting of the American Pharmacists Association (APhA) - Virtual 2020; poster presentation: abstract #209.

publications_result: Thompson M, Brar I, Brinson C, Creticos C, et al. Tenofovir alafenamide vs. tenofovir DF in women: pooled analysis of 7 clinical trials. 9th Edition International Workshop on HIV and Women - Virology Education 2019; poster presentation: abstract #21.

publications_result: Brown TT, Yin MT, Gupta SK, Short WR, et al. Combined effects of bisphosphonates & TDF->TAF switch in HIV+ adults with low BMD. Annual Conference on Retroviruses and Opportunistic Infections (CROI) - CROI Foundation 2018; poster presentation: abstract #724.

publications_result: Yin M, Gupta S, Nguyen-Cleary T, Mora M, and Das M. Switching from TDF to TAF in HIV-infected adults with low BMD: A pooled analysis. Congress on HIV and Hepatitis in the Americas - ViiV Healthcare UK Limited 2017; poster presentation: abstract #P021.

publications_result: Viciana P, Rijnders B, Shalit P, Liu Y et al. Cambio desde TDF a TAF en pacientes en alto riesgo de erc. 18th Congress of the Andalusian Society of Infectious Diseases (SAID) 2016; poster presentation: abstract #P-070.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

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

location_facility: SMZ Baumgartner Hoehe - Otto-Wagner-Spital

location_facility: São Paulo Secretaria da Saúde - Centro de Referência e Treinamento em DST/AIDS

location_facility: Servico De Doencas Infecciosas - Hospital De Sao Joao

location_facility: Yale University HIV Clinical Trials Program

location_facility: Instituto De Pesquisa Clinica Evandro Chagas - Fundação Oswaldo Cruz

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Beth Israel Medical Center- Division of Infectious Diseases

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

location_facility: Tarrant County Infectious Disease Associates

location_facility: Siriraj HospitalDepartment of Preventive and Social Medicine, Faculty of Medicine

location_facility: Kaiser Permanente Medical Center, Clinical Trials Unit

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

location_facility: São Paulo Secretaria da Saúde - Instituto De Infectologia Emilio Ribas

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

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Onze Lieve Vrouwe Gasthuis, Afdeling Infectieziekten

location_facility: Fondazione Centro San Raffaele del Monte Tabor

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Comprensorio Amedeo Di Savoia Birago Di Vische

location_facility: Infectious Disease Research Institute Inc.

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

location_facility: North Shore University Hospital, Divison of Infectious Diseases

location_facility: McGill University Health Centre (MUHC) - Montral Chest Institute

location_facility: Istituto Nazionale Malattie Infettive "Lazzaro Spallanzani" IRCCS

location_facility: Broward Health/Comprehensive Care Center

location_facility: University of Cologne, Department of Internal Medicine

location_facility: University of California, Davis Medical Center

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Community Research Initiative of New England

location_facility: Winnipeg Regional Health Authority - Health Sciences Centre Winnipeg

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

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Azienda Ospedaliera Luigi Sacco 1° Divisione Malattie Infettive

location_facility: Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: La Playa Medical Group and Clinical Research

location_facility: University Health Network, Toronto General Hospital

location_facility: Instituto Dominicano de Estudios Virologicos - IDEV

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: George Washington University Medical Faculty Associates

location_facility: Chelsea and Westminster Hospital Foundation Trust

location_facility: Universitätsklinik für Infektiologie, Universitätsspital Bern

location_facility: University of NC AIDS Clinical Trials Unit

location_facility: Infektio Research GmbH / Infektiologikum Frankfurt

location_facility: University of Hawaii - Hawaii Center for AIDS

location_facility: Michael Keith Wensley, MD, Inc., A Medical Corporation


title: A Randomized, Double-blind, Double-dummy, Multi-center Study to Assess Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Emergency Presentation at the Hospital Because of Worsening Chronic Heart Failure With Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone Versus Eplerenone

acronym: ARTS-HF

summary: To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.

ReferenceCitation: Filippatos G, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Kim SY, Nowack C, Palombo G, Kolkhof P, Kimmeskamp-Kirschbaum N, Pieper A, Pitt B. A randomized controlled study of finerenone vs. eplerenone in patients with worsening chronic heart failure and diabetes mellitus and/or chronic kidney disease. Eur Heart J. 2016 Jul 14;37(27):2105-14. doi: 10.1093/eurheartj/ehw132. Epub 2016 Apr 29.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

evidence: oa repository (semantic scholar lookup)

publisher_dissemination: Oxford University Press

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

ReferenceCitation: Pitt B, Anker SD, Bohm M, Gheorghiade M, Kober L, Krum H, Maggioni AP, Ponikowski P, Voors AA, Zannad F, Nowack C, Kim SY, Pieper A, Kimmeskamp-Kirschbaum N, Filippatos G. Rationale and design of MinerAlocorticoid Receptor antagonist Tolerability Study-Heart Failure (ARTS-HF): a randomized study of finerenone vs. eplerenone in patients who have worsening chronic heart failure with diabetes and/or chronic kidney disease. Eur J Heart Fail. 2015 Feb;17(2):224-32. doi: 10.1002/ejhf.218.

repository_institution: University of Michigan - Deep Blue

lead_sponsor: Bayer

location_country:
Finland
Germany
Poland
Australia
Turkey
Czechia
Canada
France
Lithuania
Portugal
Hungary
Denmark
United States
Italy
Norway
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Israel


type: Other Identifier

title: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

summary: The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

status: Enrolling by invitation

enrollment_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC.

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Colombia
Portugal
Hungary
United States
Ukraine
Belgium
China
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

location_facility: St Bartholomew's Hospital - Dept of Haematology

location_facility: Adventist Health Care Limited trading as San Clinical Trials Unit

location_facility: Weill Medical College of Cornell University

location_facility: Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: University College London Hospitals NHSFT

location_facility: St. Joseph Hospital Center for Cancer Prevention and Treatment

location_facility: Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku

location_facility: University Hospitals Birmingham NHS Trust,

location_facility: Hopital Haut Leveque Service Maladie Du Sang

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Fundacion Oftalmologica de Santander - FOSCAL

location_facility: Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

location_facility: Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika

location_facility: University of California San Diego Medical Center

location_facility: Universitätsklinikum Heidelberg Med. Klinik IV

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie

location_facility: The First Affliated Hospital of Soochow University

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: University of Pennsylvania Medical Center

location_facility: Semmelweis Egyetem, I. Belgyogyaszati Klinika

location_facility: Tangdu hospital the Fourth Military Medical

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany

location_facility: Sahlgrenska University hospital, Hematology Dept

location_facility: Universitätsklinikum Essen; Klinik f. Hämatologie- Germany

location_facility: A.O.Citta della Salute e della Scienza di Torino

location_facility: DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

location_facility: Hospital Clinico Universitario Salamanca

location_facility: Laiko General Hospital - 1st department of Internal Medicine

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Federal Center of Heart, Blood and Endocrinology

location_facility: Khmelnitskiy Regional Hospital, Hematology Department

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika

location_facility: Vinnytsya Regional Clinical Hospital named after M.I.Pirogov

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: The Ohio State University- James Cancer Hospital

location_facility: Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

location_facility: Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany

location_facility: Louisville Oncology Suburban - Norton Cancer Institute

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

location_facility: Karmanos Cancer Institute - Wayne State University

location_facility: HOPITAL SAINT LOUIS - Hematology / Oncology

location_facility: Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus

location_facility: 'G. Papanikolaou' Hospital of Thessaloniki

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

location_facility: State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine

location_facility: Republican Hospital named by V.A.Baranova

location_facility: University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research

location_facility: Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

location_facility: Nottingham University Hospitals NHS Trust

location_facility: MD Anderson Cancer Center - University of Texas


title: BENEFIT 11 a Long-term Follow-up Study of the BENEFIT (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment, 304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

summary: This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.

ReferenceCitation: Kappos L, Edan G, Freedman MS, Montalban X, Hartung HP, Hemmer B, Fox EJ, Barkhof F, Schippling S, Schulze A, Pleimes D, Pohl C, Sandbrink R, Suarez G, Wicklein EM; BENEFIT Study Group. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology. 2016 Sep 6;87(10):978-87. doi: 10.1212/WNL.0000000000003078. Epub 2016 Aug 10.

repository_institution: PubMed Central - Europe PMC

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

repositories_concat: LIRIAS (KU Leuven);PubMed Central;UCL Discovery;boris.unibe.ch;ganymedesd.lib.unideb.hu

location_country:
Finland
Germany
Poland
Canada
France
Slovenia
Czech Republic
Portugal
Hungary
Denmark
Switzerland
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Spain
Israel

intervention_type: Procedure


type: Other Grant/Funding Number

title: An International Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy Boost With Conventional External Beam Radiotherapy Boost After Lumpectomy for Breast Cancer in Women With a High Risk of Local Recurrence.

acronym: TARGIT-B

summary:
TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial.

Eligible patients are those with a higher risk of local recurrence after breast conserving surgery.

After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually.

The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.

status: Unknown status

lead_sponsor: University College, London

collaborators: National Institute for Health Research, United Kingdom

location_country:
Italy
United Kingdom
Switzerland
United States
China
Korea, Republic of
Saudi Arabia
Malaysia
South Africa
Spain
Thailand
France

location_facility: Helen Rey Breast Cancer Research Foundation

location_facility: Institut de Cancerologie de l'Ouest site René Gauducheau

location_facility: Centro Di Riferimento Oncologico Di Aviano

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: Memorial Health University Medical Center

location_facility: Hampshire Hospitals NHS Foundation Trust

intervention_type: Radiation

lead_sponsor_type: academique


summary: The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).

ReferenceCitation: Balasubramanian S, Hodkinson B, Schuster SJ, Fowler NH, Trotman J, Hess G, Cheson BD, Schaffer M, Sun S, Deshpande S, Vermeulen J, Salles G, Gopal AK. Identification of a genetic signature enriching for response to ibrutinib in relapsed/refractory follicular lymphoma in the DAWN phase 2 trial. Cancer Med. 2022 Jan;11(1):61-73. doi: 10.1002/cam4.4422. Epub 2021 Nov 17.

ReferenceCitation: Gopal AK, Schuster SJ, Fowler NH, Trotman J, Hess G, Hou JZ, Yacoub A, Lill M, Martin P, Vitolo U, Spencer A, Radford J, Jurczak W, Morton J, Caballero D, Deshpande S, Gartenberg GJ, Wang SS, Damle RN, Schaffer M, Balasubramanian S, Vermeulen J, Cheson BD, Salles G. Ibrutinib as Treatment for Patients With Relapsed/Refractory Follicular Lymphoma: Results From the Open-Label, Multicenter, Phase II DAWN Study. J Clin Oncol. 2018 Aug 10;36(23):2405-2412. doi: 10.1200/JCO.2017.76.8853. Epub 2018 May 31.

repository_institution: The University of Manchester - Research Explorer

repositories_concat: Pure (Denmark)

title: An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma

location_country:
Germany
Poland
United Kingdom
Australia
Belgium
United States
Spain
Russian Federation
France


summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

ReferenceCitation: Wang ML, Jurczak W, Jerkeman M, Trotman J, Zinzani PL, Belada D, Boccomini C, Flinn IW, Giri P, Goy A, Hamlin PA, Hermine O, Hernandez-Rivas JA, Hong X, Kim SJ, Lewis D, Mishima Y, Ozcan M, Perini GF, Pocock C, Song Y, Spurgeon SE, Storring JM, Walewski J, Zhu J, Qin R, Henninger T, Deshpande S, Howes A, Le Gouill S, Dreyling M; SHINE Investigators. Ibrutinib plus Bendamustine and Rituximab in Untreated Mantle-Cell Lymphoma. N Engl J Med. 2022 Jun 30;386(26):2482-2494. doi: 10.1056/NEJMoa2201817. Epub 2022 Jun 3.

oa_host_type: publisher

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Slovakia
Hungary
United States
Ukraine
Belgium
China
Puerto Rico
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


title: A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

summary: This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy and to explore the dose response of lecanemab using a composite clinical score (ADCOMS). BAN2401-G000-201 Core study is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. Any participant who completes the study treatment (Visit 42 [Week 79] of the Core study) or discontinues the Core Study will be eligible to participate in the Extension Phase, provided they meet the Extension Phase inclusion and exclusion criteria. Participants will receive 10 mg/kg biweekly for up to 60 months or until the drug is commercially available in the country, where the subject resides, or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. The Follow-up Visit in the Extension Phase will take place 3 months after the last dose of study drug.

ReferenceCitation: Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Abeta protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. doi: 10.1186/s13195-021-00813-8. Erratum In: Alzheimers Res Ther. 2022 May 21;14(1):70.

repository_institution: Uppsala University - Uppsala University Publications

repository_institution: KTH Royal Institute of Technology - KTH Publication Database DiVA

publisher_dissemination: Springer-Nature

lead_sponsor: Eisai Inc.

sponsor_collaborators:
Eisai Inc.
Biogen

location_country:
Germany
Italy
United Kingdom
Japan
Sweden
Netherlands
United States
Korea, Republic of
Spain
Canada
France

location_facility:
Facility #1
Facility #3
Eisai Trial Site #2
Facility #2
Eisai Trial Site #3
Facility #4
Eisai Trial Site #1


lead_sponsor: Merck Sharp & Dohme LLC

summary: The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).

ReferenceCitation: Komrokji R, Garcia-Manero G, Ades L, Prebet T, Steensma DP, Jurcic JG, Sekeres MA, Berdeja J, Savona MR, Beyne-Rauzy O, Stamatoullas A, DeZern AE, Delaunay J, Borthakur G, Rifkin R, Boyd TE, Laadem A, Vo B, Zhang J, Puccio-Pick M, Attie KM, Fenaux P, List AF. Sotatercept with long-term extension for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes: a phase 2, dose-ranging trial. Lancet Haematol. 2018 Feb;5(2):e63-e72. doi: 10.1016/S2352-3026(18)30002-4. Epub 2018 Jan 10.

location_facility: Institute Paoli-Calmettes Service Haematology

location_facility: Monter Cancer Center, North Shore LIJ Health Systems

location_facility: Columbia University Medical Center/New York-Presbyterian Hospital

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: Texas Oncology Round Rock Cancer Center - Round Rock

location_facility: The Cleveland Clinic Foundation Hematology and Medical Oncology Rm 35

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

title: An Open-label, Randomized, Phase 2, Parallel, Dose-Ranging, Multicenter Study of Sotatercept for the Treatment of Patients With Anemia and Low or Intermediate-1 Risk Myelodysplastic Syndromes or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

location_country:
United States
France


title: A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.

summary: This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

ReferenceCitation: Softeland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.

evidence: open (via free pdf)

publisher_dissemination: American Diabetes Association

lead_sponsor: Boehringer Ingelheim

sponsor_collaborators:
Boehringer Ingelheim
Eli Lilly and Company

location_country:
New Zealand
Norway
Australia
Brazil
United States
El Salvador
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: 1275.9.01001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01101 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88604 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01023 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33012 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01025 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01010 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01017 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01013 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01105 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01015 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88602 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01031 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01024 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88605 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01104 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82010 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01103 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01019 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34011 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88606 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01106 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01032 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01028 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01021 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01029 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01018 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01030 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88607 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01022 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01014 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01102 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01011 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88603 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01016 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01027 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34010 Boehringer Ingelheim Investigational Site


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens

ReferenceCitation: Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

evidence: oa repository (via page says license)

repositories_concat: PubMed Central;aacr.figshare.com

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Rizvi NA, Mazieres J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Mar;16(3):257-65. doi: 10.1016/S1470-2045(15)70054-9. Epub 2015 Feb 20.

repositories_concat: PubMed Central;cv43p508m

location_facility: University Hospitals Cleveland Medical Center

location_facility: Network Office of Research and Innovation

location_facility: University Of North Carolina At Chapel Hill

location_facility: University Of California Davis Medical Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute

title: A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

location_country:
United States
Italy
Germany
France


summary: The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

ReferenceCitation: Koroki Y, Taguri M, Matsubara N, Fizazi K. Estimation of Overall Survival with Subsequent Treatment Effect by Applying Inverse Probability of Censoring Weighting in the LATITUDE Study. Eur Urol Open Sci. 2022 Jan 6;36:51-58. doi: 10.1016/j.euros.2021.11.012. eCollection 2022 Feb.

ReferenceCitation: Baciarello G, Ozguroglu M, Mundle S, Leitz G, Richarz U, Hu P, Feyerabend S, Matsubara N, Chi KN, Fizazi K. Impact of abiraterone acetate plus prednisone in patients with castration-sensitive prostate cancer and visceral metastases over four years of follow-up: A post-hoc exploratory analysis of the LATITUDE study. Eur J Cancer. 2022 Feb;162:56-64. doi: 10.1016/j.ejca.2021.11.026. Epub 2021 Dec 23.

evidence: open (via crossref license)

ReferenceCitation: Azad AA, Armstrong AJ, Alcaraz A, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Rosbrook B, Lee HJ, Haas GP, Stenzl A. Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):274-282. doi: 10.1038/s41391-021-00436-y. Epub 2021 Aug 21.

ReferenceCitation: Feyerabend S, Saad F, Perualila NJ, Van Sanden S, Diels J, Ito T, De Porre P, Fizazi K. Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study. Target Oncol. 2019 Dec;14(6):681-688. doi: 10.1007/s11523-019-00685-x.

ReferenceCitation: Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, Sulur G, Luna Y, Li S, Mundle S, Chi KN. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 May;20(5):686-700. doi: 10.1016/S1470-2045(19)30082-8. Epub 2019 Apr 12.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

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

repositories_concat: HAL

ReferenceCitation: Li T, Franco-Villalobos C, Proskorovsky I, Sorensen SV, Tran N, Sulur G, Chi KN. Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration-naive prostate cancer: Results from LATITUDE. Cancer. 2019 Feb 15;125(4):626-632. doi: 10.1002/cncr.31847. Epub 2018 Dec 6.

ReferenceCitation: Chi KN, Protheroe A, Rodriguez-Antolin A, Facchini G, Suttman H, Matsubara N, Ye Z, Keam B, Damiao R, Li T, McQuarrie K, Jia B, De Porre P, Martin J, Todd MB, Fizazi K. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018 Feb;19(2):194-206. doi: 10.1016/S1470-2045(17)30911-7. Epub 2018 Jan 8.

ReferenceCitation: Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.

repository_institution: Tampere University - Tampere University Institutional Repository

title: A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
Denmark
Ukraine
Romania
Belgium
China
Malaysia
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel


title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study

acronym: ELEVATE

summary:
This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study.

This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

ReferenceCitation: Viel E, Eerdekens M, Kandaswamy P. Treatment Impact on Patient-Reported Outcomes in Peripheral Neuropathic Pain: Comparing Single Intervention With Topical High-Concentration Capsaicin to Daily Oral Pregabalin. Pain Physician. 2021 Sep;24(6):453-463.

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Finland
Germany
Poland
Armenia
Turkey
Czechia
France
Slovenia
Belarus
Portugal
Slovakia
Hungary
Romania
Belgium
Italy
United Kingdom
Austria
Spain
Greece
Bulgaria
Russian Federation
Sweden

location_facility: Site 202 Hippokration General Hospital of Athens

location_facility: Site 323 Ege University Medical Faculty Hospital

location_facility: Site 252 Instituto Portuges de Oncologic

location_facility: Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ

location_facility: Site 274 Saint-Petersburg State Medical University

location_facility: Site 278 Semashko Regional Clinical Hospital

location_facility: Site 326 Maramara University, Pendik Training and Research Hospital

location_facility: Site 104 Medical Center "Surb Nerses Mets"

location_facility: Site 121 Vitebsk Regional Clinical Hospital # 1

location_facility: Site 321 Hacettepe University Medical Faculty Hospital

location_facility: Site 324 Dokuz Eylul University Medical Faculty Hospital

location_facility: Site 325 Pamukkale University Medical Faculty Hospital

location_facility: Site 271 First Moscow State Medical University named after I.M. Sechenov

location_facility: Site 301 Hospital General Universitario de Alicante

location_facility: Site 103 Scientific research Institute of physiotherapy


intervention_type: Biological

lead_sponsor: Octapharma

summary: Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

location_facility: National Children's Specialized Hospital "OHMATDET"

location_facility: Hôtel-Dieu de Nantes, Centre Regional de Traitement de l'hemophilie

location_facility: Centro di Referimento per le Malattie Emorragiche e Trombotiche

location_facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

location_facility: Centre de traitement de l'hemophilie, Hôpital Bicêtre

location_facility: Scientific Research Institute of Mother and Child Health Care

location_facility: Great Ormond Street Hospital for Children

location_facility: Christian Medical College & Hospital, Dept of Haematology

location_facility: Kasturba Medical College, Dr. TMA Pai Hospital

location_facility: Unitat d'hemofilia, Hospital Universitari Vall d'Hebron

location_facility: Institut für Experimentelle Hämatologie und Transfusionsmedizin (IHT)

location_facility: Sahyadri Speciality Hospital, Haematology & BMT Unit

location_facility: Haemophilia Centre, University Clinical Centre

location_facility: Institute of Haematology and Transfusiology

location_facility: Institute of Blood Pathology and Transfusion Medicine

location_facility: Republican Scientific Practical Center for Pediatric Oncology and Hematology

title: Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A

location_country:
Germany
Belarus
Italy
Moldova, Republic of
India
Poland
Portugal
Slovenia
United Kingdom
United States
Spain
Morocco
Ukraine
Canada
Georgia
Russian Federation
France


title: A Phase IIb, Multi-National, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) (BENEFIT-ALS)

summary: The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

lead_sponsor: Cytokinetics

location_country:
Ireland
Germany
United Kingdom
Netherlands
United States
Spain
Canada
France

location_facility: Hennepin County Medical Center - Berman Center for Research

location_facility: West Virginia University Department of Neurology

location_facility: Carolinas Medical Center Department of Neurology

location_facility: Univ. of Toronto - Sunnybrook Health Sciences Centre

location_facility: Hôpital Notre Dame (CHUM) Centre Hospitalier de l'Universite de Montreal

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: University of Massachusetts Medical School

location_facility: Indiana University Department of Neurology

location_facility: California Pacific Medical Center Forbes Norris MDA/ALS Research Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Mayo Clinic Florida Department of Neurology

location_facility: Barts and the London MND & the Centre Royal London Hospital

location_facility: Wake Forest University, School of Medicine

location_facility: Ohio State University Department of Neurology

location_facility: Sheffield Institute for Translational Neuroscience


title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3

summary:
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

ReferenceCitation: Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Dec;11(6):2027-2042. doi: 10.1007/s13555-021-00618-5. Epub 2021 Oct 2.

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

repositories_concat: PubMed Central;ddd.uab.cat

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

ReferenceCitation: McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.

ReferenceCitation: Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.

ReferenceCitation: Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
Italy
Poland
Hungary
Australia
Belgium
United States
Latvia
Greece
Canada
Russian Federation
France


lead_sponsor: Novartis Pharmaceuticals

summary: This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.

location_facility: Ann & Robert H. Lurie Children Dept of Oncology

location_facility: Cincinnati Children's Hospital Medical Center Division of Hema/Onco.

location_facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept Onc

location_facility: Children's Hospital of Pittsburgh Dept of Oncology

location_facility: Seattle Cancer Care Alliance Dept Oncology

location_facility: Columbia University Medical Center- New York Presbyterian Dept of Oncology

location_facility: University of Texas/MD Anderson Cancer Center SC-3

title: A Phase II, Multi-center, Open-label, Single-arm Study of the Efficacy and Safety of Oral LDE225 in Patients With Hh-pathway Activated Relapsed Medulloblastoma

design_allocation: Non-Randomized

location_country:
Germany
Italy
United Kingdom
Australia
Brazil
Netherlands
Sweden
Switzerland
United States
Spain
Canada
Russian Federation
France


title: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma

summary: The purpose of this study is to evaluate the safety, pharmacokinetics (study of what the body does to a drug), and pharmacodynamics (study of what a drug does to the body) of JNJ-42756493, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in adult participants with advanced or refractory solid tumors or lymphoma.

ReferenceCitation: Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B, Gazzah A, Zhong B, Platero SJ, Smit JW, Stuyckens K, Chatterjee-Kishore M, Rodon J, Peddareddigari V, Luo FR, Soria JC. Phase I Dose-Escalation Study of JNJ-42756493, an Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors. J Clin Oncol. 2015 Oct 20;33(30):3401-8. doi: 10.1200/JCO.2014.60.7341. Epub 2015 Aug 31.

ReferenceCitation: Valade E, Dosne AG, Xie H, Kleiman R, Li LY, Perez-Ruixo JJ, Ouellet D. Assessment of the effect of erdafitinib on cardiac safety: analysis of ECGs and exposure-QTc in patients with advanced or refractory solid tumors. Cancer Chemother Pharmacol. 2019 Sep;84(3):621-633. doi: 10.1007/s00280-019-03896-1. Epub 2019 Jul 6.

ReferenceCitation: Bahleda R, Italiano A, Hierro C, Mita A, Cervantes A, Chan N, Awad M, Calvo E, Moreno V, Govindan R, Spira A, Gonzalez M, Zhong B, Santiago-Walker A, Poggesi I, Parekh T, Xie H, Infante J, Tabernero J. Multicenter Phase I Study of Erdafitinib (JNJ-42756493), Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced or Refractory Solid Tumors. Clin Cancer Res. 2019 Aug 15;25(16):4888-4897. doi: 10.1158/1078-0432.CCR-18-3334. Epub 2019 May 14.

location_country:
United States
Spain
France


summary:
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer.

Moreover, the study also aimed to investigate the efficacy and safety of second line treatment with everolumus plus examestane in participants whose disease progressed during everolimus plus letrozole therapy.

ReferenceCitation: Royce M, Bachelot T, Villanueva C, Ozguroglu M, Azevedo SJ, Cruz FM, Debled M, Hegg R, Toyama T, Falkson C, Jeong J, Srimuninnimit V, Gradishar WJ, Arce C, Ridolfi A, Lin C, Cardoso F. Everolimus Plus Endocrine Therapy for Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: A Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):977-984. doi: 10.1001/jamaoncol.2018.0060.

publisher_dissemination: American Medical Association

location_facility: Breastlink Medical Group Dept. of BreastlinkResearchGrp

location_facility: Saint Barnabas Medical Center CancerCenter of Saint Barnabas

location_facility: St. Francis Health Comprehensive Cancer Center

location_facility: University of Alabama Comprehensive Cancer Center SC-2

location_facility: Columbia University Medical Center- New York Presbyterian Columbia

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

location_facility: Oncology Specialists, SC Advocate Medical Group-Niles

title: An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer

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

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

location_country:
Portugal
Hungary
Argentina
United Kingdom
Japan
Brazil
Netherlands
United States
Korea, Republic of
Spain
Thailand
Turkey
France