title: A Multicenter, Controlled, Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145

summary: This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

ReferenceCitation: Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. Review.

ReferenceType: result

ReferenceCitation: Sattar N, Toth PP, Blom DJ, Koren MJ, Soran H, Uhart M, Elliott M, Cyrille M, Somaratne R, Preiss D. Effect of the Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor Evolocumab on Glycemia, Body Weight, and New-Onset Diabetes Mellitus. Am J Cardiol. 2017 Nov 1;120(9):1521-1527. doi: 10.1016/j.amjcard.2017.07.047. Epub 2017 Jul 31.

family: Sattar

full_name: Naveed Sattar

given: Naveed

family: Toth

full_name: Peter P. Toth

given: Peter P.

family: Blom

full_name: Dirk J. Blom

given: Dirk J.

family: Koren

full_name: Michael J. Koren

given: Michael J.

family: Soran

full_name: Handrean Soran

given: Handrean

family: Uhart

full_name: Magdalena Uhart

given: Magdalena

family: Elliott

full_name: Mary Elliott

given: Mary

family: Cyrille

full_name: Marcoli Cyrille

given: Marcoli

family: Somaratne

full_name: Ransi Somaratne

given: Ransi

family: Preiss

full_name: David Preiss

given: David

journal_name: The American Journal of Cardiology

version: acceptedVersion

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Hovingh GK, Raal FJ, Dent R, Stefanutti C, Descamps O, Masana L, Lira A, Bridges I, Coll B, Sullivan D. Long-term safety, tolerability, and efficacy of evolocumab in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Nov - Dec;11(6):1448-1457. doi: 10.1016/j.jacl.2017.09.003. Epub 2017 Sep 22.

family: Hovingh

full_name: G. Kees Hovingh

given: G. Kees

family: Raal

full_name: Frederick J. Raal

given: Frederick J.

family: Dent

full_name: Ricardo Dent

given: Ricardo

family: Stefanutti

full_name: Claudia Stefanutti

given: Claudia

family: Descamps

full_name: Olivier Descamps

given: Olivier

family: Masana

full_name: Luis Masana

given: Luis

family: Lira

full_name: Armando Lira

given: Armando

family: Bridges

full_name: Ian Bridges

given: Ian

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

name: Institute of Cardiovascular Science; University College London; London UK

name: Department of Cardiology, Division Heart and Lungs; UMC Utrecht; Utrecht Netherlands

name: Department of Clinical Pharmacology and Therapeutics; University College London Hospital; London UK

name: Department of Non-communicable Disease Epidemiology; London School of Hygiene & Tropical Medicine; London UK

name: The Department of Medicine (Cardiology) and the Department of Preventive Medicine; Northwestern University Feinberg School of Medicine; Chicago Illinois USA

name: Medicines Discovery Catapult; Alderly Edge UK

name: Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC); VA Boston Healthcare System; Boston Massachusetts USA

repository_institution: University College London - UCL Discovery

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

ReferenceCitation: Sabatine MS, Giugliano RP, Wiviott SD, Raal FJ, Blom DJ, Robinson J, Ballantyne CM, Somaratne R, Legg J, Wasserman SM, Scott R, Koren MJ, Stein EA; Open-Label Study of Long-Term Evaluation against LDL Cholesterol (OSLER) Investigators. Efficacy and safety of evolocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1500-9. doi: 10.1056/NEJMoa1500858. Epub 2015 Mar 15.

repository_institution: University of Cape Town - Open University of Cape Town

title: Efficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events

location_country:
Australia
Belgium
Russian Federation
Denmark
Taiwan
France
Japan
Poland
Norway
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Hungary
United States
Germany
United Kingdom
Italy
Austria
Czechia
New Zealand
Spain


type: EudraCT Number

title: A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib

summary: The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kiura K, Imamura F, Kagamu H, Matsumoto S, Hida T, Nakagawa K, Satouchi M, Okamoto I, Takenoyama M, Fujisaka Y, Kurata T, Ito M, Tokushige K, Hatano B, Nishio M. Phase 3 study of ceritinib vs chemotherapy in ALK-rearranged NSCLC patients previously treated with chemotherapy and crizotinib (ASCEND-5): Japanese subset. Jpn J Clin Oncol. 2018 Apr 1;48(4):367-375. doi: 10.1093/jjco/hyy016.

family: Kiura

full_name: Katsuyuki Kiura

given: Katsuyuki

sequence: first

name: Osaka International Cancer Institute, Osaka

family: Imamura

full_name: Fumio Imamura

given: Fumio

sequence: additional

name: Niigata University Medical and Dental Hospital, Niigata

family: Kagamu

full_name: Hiroshi Kagamu

given: Hiroshi

name: National Cancer Center Hospital East, Kashiwa

family: Matsumoto

full_name: Shingo Matsumoto

given: Shingo

family: Hida

full_name: Toyoaki Hida

given: Toyoaki

family: Nakagawa

full_name: Kazuhiko Nakagawa

given: Kazuhiko

family: Satouchi

full_name: Miyako Satouchi

given: Miyako

name: Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka

family: Okamoto

full_name: Isamu Okamoto

given: Isamu

family: Takenoyama

full_name: Mitsuhiro Takenoyama

given: Mitsuhiro

family: Fujisaka

full_name: Yasuhito Fujisaka

given: Yasuhito

name: Kansai Medical University Hospital, Osaka

family: Kurata

full_name: Takayasu Kurata

given: Takayasu

family: Ito

full_name: Masayuki Ito

given: Masayuki

family: Tokushige

full_name: Kota Tokushige

given: Kota

family: Hatano

full_name: Ben Hatano

given: Ben

name: The Cancer Institute Hospital of JFCR, Tokyo, Japan

family: Nishio

full_name: Makoto Nishio

given: Makoto

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Japanese Journal of Clinical Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Shaw AT, Kim TM, Crinò L, Gridelli C, Kiura K, Liu G, Novello S, Bearz A, Gautschi O, Mok T, Nishio M, Scagliotti G, Spigel DR, Deudon S, Zheng C, Pantano S, Urban P, Massacesi C, Viraswami-Appanna K, Felip E. Ceritinib versus chemotherapy in patients with ALK-rearranged non-small-cell lung cancer previously given chemotherapy and crizotinib (ASCEND-5): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):874-886. doi: 10.1016/S1470-2045(17)30339-X. Epub 2017 Jun 9.

family: Shaw

full_name: Alice T Shaw

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:
Italy
United States
Hong Kong
Lebanon
Netherlands
Germany
Spain
Switzerland
France
Japan
Israel
Singapore
Ireland
Belgium
Russian Federation
Portugal
Turkey
Canada
United Kingdom
Korea, Republic of

location_facility: University of Iowa Hospitals and Clinics Comprehensive Cancer Center

location_facility: Oklahoma Cancer Specialists and Research Institute SC-2

location_facility: Texas Oncology Cancer Care and Research Center

location_facility: Loyola University Medical Center /Cardinal Bernardin Cancer SC

location_facility: Virginia Cancer Specialists SC Virginia Cancer Specialists


title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Positive, Antiretroviral Treatment-Naïve Adults

summary: The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15. Erratum in: Lancet. 2016 Apr 30;387(10030):1816.

family: Sax

full_name: Paul E Sax

given: Paul E

family: Wohl

full_name: David Wohl

given: David

family: Yin

full_name: Michael T Yin

given: Michael T

family: Post

full_name: Frank Post

given: Frank

family: DeJesus

full_name: Edwin DeJesus

given: Edwin

family: Saag

full_name: Michael Saag

given: Michael

family: Pozniak

full_name: Anton Pozniak

given: Anton

family: Thompson

full_name: Melanie Thompson

given: Melanie

family: Podzamczer

full_name: Daniel Podzamczer

given: Daniel

family: Molina

full_name: Jean Michel Molina

given: Jean Michel

family: Oka

full_name: Shinichi Oka

given: Shinichi

family: Koenig

full_name: Ellen Koenig

given: Ellen

family: Trottier

full_name: Benoit Trottier

given: Benoit

family: Andrade-Villanueva

full_name: Jaime Andrade-Villanueva

given: Jaime

family: Crofoot

full_name: Gordon Crofoot

given: Gordon

family: Custodio

full_name: Joseph M Custodio

given: Joseph M

family: Plummer

full_name: Andrew Plummer

given: Andrew

family: Zhong

full_name: Lijie Zhong

given: Lijie

family: Cao

full_name: Huyen Cao

given: Huyen

family: Martin

full_name: Hal Martin

given: Hal

family: Callebaut

full_name: Christian Callebaut

given: Christian

family: Cheng

full_name: Andrew K Cheng

given: Andrew K

family: Fordyce

full_name: Marshall W Fordyce

given: Marshall W

ReferenceCitation: Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for 144 weeks. J Clin Virol. 2018 Jun;103:37-42. doi: 10.1016/j.jcv.2018.03.012. Epub 2018 Apr 2.

ReferenceCitation: Arribas JR, Thompson M, Sax PE, Haas B, McDonald C, Wohl DA, DeJesus E, Clarke AE, Guo S, Wang H, Callebaut C, Plummer A, Cheng A, Das M, McCallister S. Brief Report: Randomized, Double-Blind Comparison of Tenofovir Alafenamide (TAF) vs Tenofovir Disoproxil Fumarate (TDF), Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine (E/C/F) for Initial HIV-1 Treatment: Week 144 Results. J Acquir Immune Defic Syndr. 2017 Jun 1;75(2):211-218. doi: 10.1097/QAI.0000000000001350.

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

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

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

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Margot N, Cox S, Das M, McCallister S, Miller MD, Callebaut C. Infrequent development of drug resistance in HIV-1-infected treatment-naive subjects after 96 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate. Antivir Ther. 2017;22(5):443-446. doi: 10.3851/IMP3125. Epub 2017 Jan 11.

ReferenceCitation: Margot NA, Kitrinos KM, Fordyce M, McCallister S, Miller MD, Callebaut C. Rare emergence of drug resistance in HIV-1 treatment-naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide. HIV Clin Trials. 2016 Mar;17(2):78-87. doi: 10.1080/15284336.2016.1142731.

title: Rare emergence of drug resistance in HIV-1 treatment -naïve patients after 48 weeks of treatment with elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide

ReferenceCitation: Funderburg NT, McComsey GA, Kulkarni M, Bannerman T, Mantini J, Thornton B, Liu HC, Zhang Y, Song Q, Fang L, Dinoso J, Cheng A, McCallister S, Fordyce MW, Das M. Equivalent Decline in Inflammation Markers with Tenofovir Disoproxil Fumarate vs. Tenofovir Alafenamide. EBioMedicine. 2016 Nov;13:321-327. doi: 10.1016/j.ebiom.2016.10.009. Epub 2016 Oct 11.

ReferenceCitation: Wohl D, Oka S, Clumeck N, Clarke A, Brinson C, Stephens J, Tashima K, Arribas JR, Rashbaum B, Cheret A, Brunetta J, Mussini C, Tebas P, Sax PE, Cheng A, Zhong L, Callebaut C, Das M, Fordyce M; GS-US-2,92-01040111 and Study Team. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. J Acquir Immune Defic Syndr. 2016 May 1;72(1):58-64. doi: 10.1097/QAI.0000000000000940.

title: Brief Report

ReferenceCitation: Custodio JM, Garner W, Callebaut C, Fordyce M, Plummer A, Zhong L, et al. The Pharmacokinetics of Tenofovir and Tenofovir Diphosphate Following Administration of Tenofovir Alafenamide vs Tenofovir Disoproxil Fumarate [Oral Abstract #6]. The 16th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy. Washington DC, USA, May 26-28, 2015.

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

location_country:
Italy
Sweden
Mexico
Netherlands
Dominican Republic
France
Puerto Rico
Portugal
United States
United Kingdom
Canada

location_facility: University of Hawaii - Hawaii Center for AIDS

location_facility: Saint Louis Hospital of Infectious Diseases

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

location_facility: North Texas Infectious Diseases Consultants

location_facility: North Shore University Hospital - Division of Infectious Diseases

location_facility: Archet 1 CHU de Nice, Department of Infectiology

location_facility: East Carolina University The Brody School of Medicine

location_facility: University Health Network/Toronto General Hospital

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: Kaiser Permanente - Los Angeles Medical Center

location_facility: Carolinas Medical Center Myer's Park Clinic

location_facility: Insituto Nacional De Enfermedades Respiratorias "Ismael Cosio Villegas"

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Tarrant County Infectious Disease Associates

location_facility: University of North Carolina AIDS Clinical Trials Unit

location_facility: La Playa Medical Group and Clinical Research

location_facility: Brownlee Centre, Gartnavel General Hospital

location_facility: Infectious Disease Specialist of Atlanta

location_facility: University Hospital of Montpellier (CHU-Gui de Chauliac)

location_facility: Community Research Initiative of New England

location_facility: Centro Hospitalar do Porto - Hospital Joaquim Urbano

location_facility: Serviço de Doenças Infecciosas, HUC-CHUC, EPE

location_facility: Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center

location_facility: University of Southern California AIDS Clinical Trials Group

location_facility: University of California, Davis Medical Center

location_facility: Karolinska University Hospital, Huddinge

location_facility: Rush University Medical Center, Section of Infectious Diseases

location_facility: Infectious Disease Research Institute Inc.

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

location_facility: Instituto Dominicano de Estudios Virologicos--IDEV

location_facility: Universitaria di Bologna-Policlicnico S' Orsola Malpighi

location_facility: Research Institute of McGill University Health Care

location_facility: St. Joseph's Comprehensive Research Institute


intervention_type: Drug

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

location_country:
Italy
Netherlands
France
Poland
Belgium
Spain
Denmark
Germany
United Kingdom

acronym: EORTC protocol 1209-EnTF

location_facility: Hopitaux Universitaires Bordet-Erasme - Institut Jules Bordet

location_facility: Assitance Publique - Hopitaux de Paris - Hopital Saint-Louis

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Maria Sklodowska-Curie Memorial Cancer Centre

location_facility: Radboud University Medical Center Nijmegen

location_facility: NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

location_facility: Assistance Publique - Hopitaux de Paris - La Pitié Salpétrière

source: euctr

title: A Phase II Study Exploring the Safety and Efficacy of Nintedanib (BIBF1120) as Second Line Therapy for Patients With Either Differentiated or Medullary Thyroid Cancer Progressing After First Line Therapy.

summary:
For the treatment of thyroid cancer with the so called targeted therapy the angiogenesis pathway has several potential targets. The Receptors for Vascular endothelial growth factor (VEGF) and especially VEGFR-2 is considered to be crucial for the initiation of the formation as well as the maintenance of tumor vasculature.

In thyroid cancer these VEGF receptors (VEGFR-1, VEGFR-2), VEGF itself and receptors of the fibroblast growth factor (FGF) and for the platelet-derived growth factor (PDGF) are often overexpressed. Other cells as pericytes and smooth muscle cells that are also involved in tumor angiogenesis express these receptors as well.

Inhibitors of the VEGFR or PDGFR pathway have been tested in thyroid cancer with positive results. However there is no treatment that is generally considered as standard of care for patients with differentiated thyroid cancer (DTC) or medullar thyroid cancer (MTC) who have progressed on one line of therapy. The classical cytotoxic chemotherapy has not shown a clinically meaningful benefit yet.

Nintedanib is a triple angiogenesis inhibitor which inhibits receptors of VEGF, FGF and PDGF. Therefore it might act not only on endothelial cells but also on pericytes and smooth muscle cells. Nintedanib also interacts with other kinases such as RET. Because of this multi-kinase activity rationale exists to investigate the effect in MTC and DTC.

Because it targets these three major angiogenesis signaling pathways it might prevent further tumor growth and related tumor escape mechanisms. Therefore nintedanib may be active in patients who have progressed on agents that target only one pathway.

lead_sponsor_type: industriel

status_simplified: Completed


title: An Open-label Phase IIIb Study of Riociguat in Patients With In-operable CTEPH, or Recurrent or Persisting PH After Surgical Treatment Who Are Not Satisfactorily Treated and Cannot Participate in Any Other CTEPH Trial

acronym: EAS

summary: The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

status: No longer available

study_type: Expanded Access

ReferenceCitation: McLaughlin VV, Jansa P, Nielsen-Kudsk JE, Halank M, Simonneau G, Grünig E, Ulrich S, Rosenkranz S, Gómez Sánchez MA, Pulido T, Pepke-Zaba J, Barberá JA, Hoeper MM, Vachiéry JL, Lang I, Carvalho F, Meier C, Mueller K, Nikkho S, D'Armini AM. Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm Med. 2017 Dec 28;17(1):216. doi: 10.1186/s12890-017-0563-7.

family: McLaughlin

full_name: Vallerie V. McLaughlin

given: Vallerie V.

family: Jansa

full_name: Pavel Jansa

given: Pavel

family: Nielsen-Kudsk

full_name: Jens E. Nielsen-Kudsk

given: Jens E.

family: Halank

full_name: Michael Halank

given: Michael

family: Simonneau

full_name: Gérald Simonneau

given: Gérald

family: Grünig

full_name: Ekkehard Grünig

given: Ekkehard

family: Ulrich

full_name: Silvia Ulrich

given: Silvia

family: Rosenkranz

full_name: Stephan Rosenkranz

given: Stephan

family: Gómez Sánchez

full_name: Miguel A. Gómez Sánchez

given: Miguel A.

family: Pulido

full_name: Tomás Pulido

given: Tomás

family: Pepke-Zaba

full_name: Joanna Pepke-Zaba

given: Joanna

family: Barberá

full_name: Joan Albert Barberá

given: Joan Albert

family: Hoeper

full_name: Marius M. Hoeper

given: Marius M.

family: Vachiéry

full_name: Jean-Luc Vachiéry

given: Jean-Luc

family: Lang

full_name: Irene Lang

given: Irene

family: Carvalho

full_name: Francine Carvalho

given: Francine

family: Meier

full_name: Christian Meier

family: Mueller

full_name: Katharina Mueller

given: Katharina

family: Nikkho

full_name: Sylvia Nikkho

given: Sylvia

family: D’Armini

full_name: Andrea M. D’Armini

given: Andrea M.

currency_apc_doaj: GBP

journal_name: BMC Pulmonary Medicine

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country:
Italy
Austria
United States
Sweden
Switzerland
Mexico
Netherlands
Germany
Spain
United Kingdom
France
Japan
Belgium
Russian Federation
Portugal
Turkey
Denmark
Canada
Czech Republic
Colombia


type: Other Identifier

title: A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

summary:
Primary Objective:

- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

- To compare the treatments/regimens on:

The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,
Body weight,
Self-Monitored Glucose profiles,
Fasting Plasma Glucose (FPG),
Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),
Daily doses of insulins,
Safety and tolerability.

ReferenceCitation: Rosenstock J, Guerci B, Hanefeld M, Gentile S, Aronson R, Tinahones FJ, Roy-Duval C, Souhami E, Wardecki M, Ye J, Perfetti R, Heller S; GetGoal Duo-2 Trial Investigators. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care. 2016 Aug;39(8):1318-28. doi: 10.2337/dc16-0014. Epub 2016 May 23.

family: Rosenstock

full_name: Julio Rosenstock

given: Julio

family: Guerci

full_name: Bruno Guerci

given: Bruno

family: Hanefeld

full_name: Markolf Hanefeld

given: Markolf

family: Gentile

full_name: Sandro Gentile

given: Sandro

family: Aronson

full_name: Ronnie Aronson

given: Ronnie

family: Tinahones

full_name: Francisco J. Tinahones

given: Francisco J.

family: Roy-Duval

full_name: Christine Roy-Duval

given: Christine

family: Souhami

full_name: Elisabeth Souhami

given: Elisabeth

family: Wardecki

full_name: Marek Wardecki

given: Marek

family: Ye

full_name: Jenny Ye

given: Jenny

family: Perfetti

full_name: Riccardo Perfetti

given: Riccardo

family: Heller

full_name: Simon Heller

given: Simon

journal_name: Diabetes Care

oa_host_type: publisher

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Tabák ÁG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.

family: Tabák

full_name: Ádám G. Tabák

given: Ádám G.

family: Anderson

full_name: John Anderson

given: John

family: Aschner

full_name: Pablo Aschner

given: Pablo

family: Liu

full_name: Minzhi Liu

given: Minzhi

family: Saremi

full_name: Aramesh Saremi

given: Aramesh

family: Stella

full_name: Peter Stella

given: Peter

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

name: Dallas Diabetes Research Center at Medical City; Dallas Texas

name: Metabolic Institute of America; Tarzana California

name: Hospital Clinic of Barcelona; Barcelona Spain

name: Centro Investigación Biomédica en Red en Diabetes y Enfermeades Metabólicas (CIBERDEM); Madrid Spain

name: Clinic University Hospital of Valencia; Valencia Spain

name: University of Bari Aldo Moro; Bari Italy

name: BDM Consulting, Inc.; Somerset New Jersey

name: St Josef Hospital, Ruhr-University Bochum; Bochum Germany

location_country:
Italy
Chile
United Kingdom
Mexico
Germany
France
Poland
Lithuania
Romania
Hungary
Latvia
Russian Federation
Spain
Estonia
United States
Czech Republic
Canada
Ukraine

location_facility:
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title: A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection

summary: The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

ReferenceCitation: Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naïve patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. eCollection 2016.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Austria
Netherlands
Spain
Germany
France
Romania
Hungary
Ireland
Russian Federation
Portugal
United States
United Kingdom
Canada

location_facility: 1241.20.00003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.40003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35102 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00033 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00022 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00024 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35302 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00018 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35301 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35104 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.36001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.36002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00019 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49012 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00014 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.40002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00032 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49013 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49011 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35303 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.40001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00016 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35103 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00026 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.43003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00020 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33009 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35105 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00009 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00015 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00012 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00031 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00017 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00013 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35101 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49014 Boehringer Ingelheim Investigational Site


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease

summary: The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 weeks.

ReferenceType: background

ReferenceCitation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25. Review.

lead_sponsor: Amgen

location_country:
Austria
United States
Switzerland
Netherlands
Germany
France
Czechia
Hungary
Belgium
Denmark
Canada
United Kingdom

location_facility:
Hospital
Research Site


title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

summary: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

ReferenceCitation: Klijn SL, Fenwick E, Kroep S, Johannesen K, Malcolm B, Kurt M, Kiff C, Borrill J. What Did Time Tell Us? A Comparison and Retrospective Validation of Different Survival Extrapolation Methods for Immuno-Oncologic Therapy in Advanced or Metastatic Renal Cell Carcinoma. Pharmacoeconomics. 2021 Mar;39(3):345-356. doi: 10.1007/s40273-020-00989-1. Epub 2021 Jan 11.

family: Klijn

full_name: Sven L. Klijn

given: Sven L.

family: Fenwick

full_name: Elisabeth Fenwick

family: Kroep

full_name: Sonja Kroep

given: Sonja

family: Johannesen

full_name: Kasper Johannesen

given: Kasper

family: Malcolm

full_name: Bill Malcolm

given: Bill

family: Kurt

full_name: Murat Kurt

given: Murat

family: Kiff

full_name: Christopher Kiff

given: Christopher

family: Borrill

full_name: John Borrill

journal_name: PharmacoEconomics

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

name: Evidence Synthesis, Modeling, & Communications, Evidera, Inc., Bethesda, MD 20814, USA

family: Ambavane

full_name: Apoorva Ambavane

given: Apoorva

name: Health Economics Outcomes Research, Bristol-Myers Squibb, Princeton, NJ 08540, USA

family: Yang

full_name: Shuo Yang

given: Shuo

name: Department of Internal Medicine – Medical Oncology, Georgetown-Lombardi Comprehensive Cancer Center, Washington, DC 20007-2113, USA

family: Atkins

full_name: Michael B Atkins

given: Michael B

family: Rao

full_name: Sumati Rao

given: Sumati

name: Evidence Synthesis, Modeling, & Communications, Evidera, Inc., Waltham, MA 20814, USA

family: Shah

full_name: Anshul Shah

given: Anshul

name: Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA 02215, USA

family: Regan

full_name: Meredith M Regan

given: Meredith M

name: Department of Medicine, Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA 02215, USA

family: McDermott

full_name: David F McDermott

given: David F

name: Massachusetts General Hospital Cancer Center, Boston, MA 02214, USA

family: Michaelson

full_name: M Dror Michaelson

given: M Dror

journal_name: Immunotherapy

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Shah R, Botteman M, Solem CT, Luo L, Doan J, Cella D, Motzer RJ. A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC). Clin Genitourin Cancer. 2019 Oct;17(5):356-365.e1. doi: 10.1016/j.clgc.2019.05.010. Epub 2019 May 31.

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

ReferenceCitation: Escudier B, Motzer RJ, Sharma P, Wagstaff J, Plimack ER, Hammers HJ, Donskov F, Gurney H, Sosman JA, Zalewski PG, Harmenberg U, McDermott DF, Choueiri TK, Richardet M, Tomita Y, Ravaud A, Doan J, Zhao H, Hardy H, George S. Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025. Eur Urol. 2017 Sep;72(3):368-376. doi: 10.1016/j.eururo.2017.03.037. Epub 2017 Apr 12.

ReferenceCitation: Escudier B, Sharma P, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Gurney H, Donskov F, Peltola K, Wagstaff J, Gauler TC, Ueda T, Zhao H, Waxman IM, Motzer RJ; CheckMate 025 investigators. CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma. Eur Urol. 2017 Dec;72(6):962-971. doi: 10.1016/j.eururo.2017.02.010. Epub 2017 Mar 3. Erratum in: Eur Urol. 2018 Jan 3;:.

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Cella D, Grünwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6. Erratum in: Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Japan
Poland
Norway
Argentina
Canada
Sweden
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain

location_facility: Euromedica General Clinic of Thessaloniki

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: University Of Michigan Comprehensive Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: Ucsf Helen Diller Family Comprehensive Cancer Center

location_facility: Lakeridge Health Oshawa-Durham Regional Cancer Centre

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University Of Iowa Hospitals And Clinics


title: A Randomised, Double-Blind, Placebo-Controlled Proof Of Concept Study Of Maintenance Therapy With Tasquinimod In Patients With Metastatic Castrate-Resistant Prostate Cancer Who Are Not Progressing After A First Line Docetaxel Based Chemotherapy

summary: The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.

status: Terminated

ReferenceCitation: Fizazi K, Ulys A, Sengeløv L, Moe M, Ladoire S, Thiery-Vuillemin A, Flechon A, Guida A, Bellmunt J, Climent MA, Chowdhury S, Dumez H, Matouskova M, Penel N, Liutkauskiene S, Stachurski L, Sternberg CN, Baton F, Germann N, Daugaard G. A randomized, double-blind, placebo-controlled phase II study of maintenance therapy with tasquinimod in patients with metastatic castration-resistant prostate cancer responsive to or stabilized during first-line docetaxel chemotherapy. Ann Oncol. 2017 Nov 1;28(11):2741-2746. doi: 10.1093/annonc/mdx487.

family: Fizazi

full_name: K. Fizazi

given: K.

family: Ulys

full_name: A. Ulys

given: A.

family: Sengeløv

full_name: L. Sengeløv

given: L.

family: Moe

full_name: M. Moe

given: M.

family: Ladoire

full_name: S. Ladoire

given: S.

family: Thiery-Vuillemin

full_name: A. Thiery-Vuillemin

family: Flechon

full_name: A. Flechon

family: Guida

full_name: A. Guida

family: Bellmunt

full_name: J. Bellmunt

given: J.

family: Climent

full_name: M.A. Climent

family: Chowdhury

full_name: S. Chowdhury

family: Dumez

full_name: H. Dumez

given: H.

family: Matouskova

full_name: M. Matouskova

family: Penel

full_name: N. Penel

given: N.

family: Liutkauskiene

full_name: S. Liutkauskiene

family: Stachurski

full_name: L. Stachurski

family: Sternberg

full_name: C.N. Sternberg

family: Baton

full_name: F. Baton

given: F.

family: Germann

full_name: N. Germann

family: Daugaard

full_name: G. Daugaard

given: G.

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

location_country:
Italy
France
Czechia
Lithuania
Poland
Hungary
Belgium
Spain
Denmark
Germany
United Kingdom

location_facility: Urology and Urological Oncology Department and Clinic

location_facility: Wojewódzki Szpital Specjalistyczny we Wrocławiu


title: A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma

summary: This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

family: Schadendorf

full_name: Dirk Schadendorf

given: Dirk

family: Robert

full_name: Caroline Robert

given: Caroline

family: Dummer

full_name: Reinhard Dummer

given: Reinhard

family: Flaherty

full_name: Keith T. Flaherty

given: Keith T.

family: Tawbi

full_name: Hussein A. Tawbi

given: Hussein A.

family: Menzies

full_name: Alexander M. Menzies

given: Alexander M.

family: Banerjee

full_name: Hiya Banerjee

given: Hiya

family: Lau

full_name: Mike Lau

given: Mike

family: Long

full_name: Georgina V. Long

given: Georgina V.

journal_name: European Journal of Cancer

repositories_institution: University of Zurich - Zurich Open Repository and Archive

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Syeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.

family: Syeda

full_name: Mahrukh M Syeda

given: Mahrukh M

family: Wiggins

full_name: Jennifer M Wiggins

given: Jennifer M

family: Corless

full_name: Broderick C Corless

given: Broderick C

full_name: Georgina V Long

given: Georgina V

full_name: Keith T Flaherty

given: Keith T

family: Nathan

full_name: Paul D Nathan

given: Paul D

ReferenceCitation: Robert C, Grob JJ, Stroyakovskiy D, Karaszewska B, Hauschild A, Levchenko E, Chiarion Sileni V, Schachter J, Garbe C, Bondarenko I, Gogas H, Mandalá M, Haanen JBAG, Lebbé C, Mackiewicz A, Rutkowski P, Nathan PD, Ribas A, Davies MA, Flaherty KT, Burgess P, Tan M, Gasal E, Voi M, Schadendorf D, Long GV. Five-Year Outcomes with Dabrafenib plus Trametinib in Metastatic Melanoma. N Engl J Med. 2019 Aug 15;381(7):626-636. doi: 10.1056/NEJMoa1904059. Epub 2019 Jun 4.

name: From Institut Gustave Roussy and Paris-Sud-Paris-Saclay University, Villejuif (C.R.), Aix-Marseille University, Marseille (J.J.G.), and Assistance Publique–Hôpitaux de Paris Dermatology and Clinical Investigation Center, Unité 976, Université de Paris, Hôpital Saint-Louis, Paris (C.L.) — all in France; Moscow City Oncology Hospital, Moscow (D. Stroyakovskiy), and the Petrov Research Institute of Oncology, St. Petersburg (E.L.) — both in Russia; Przychodnia Lekarska Komed, Konin (B.K.), the University of...

ReferenceCitation: Long GV, Grob JJ, Nathan P, Ribas A, Robert C, Schadendorf D, Lane SR, Mak C, Legenne P, Flaherty KT, Davies MA. Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials. Lancet Oncol. 2016 Dec;17(12):1743-1754. doi: 10.1016/S1470-2045(16)30578-2. Epub 2016 Nov 16.

ReferenceCitation: Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, Garbe C, Jouary T, Hauschild A, Grob JJ, Chiarion-Sileni V, Lebbe C, Mandalà M, Millward M, Arance A, Bondarenko I, Haanen JB, Hansson J, Utikal J, Ferraresi V, Kovalenko N, Mohr P, Probachai V, Schadendorf D, Nathan P, Robert C, Ribas A, DeMarini DJ, Irani JG, Swann S, Legos JJ, Jin F, Mookerjee B, Flaherty K. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015 Aug 1;386(9992):444-51. doi: 10.1016/S0140-6736(15)60898-4. Epub 2015 May 31.

ReferenceCitation: Schadendorf D, Amonkar MM, Stroyakovskiy D, Levchenko E, Gogas H, de Braud F, Grob JJ, Bondarenko I, Garbe C, Lebbe C, Larkin J, Chiarion-Sileni V, Millward M, Arance A, Mandalà M, Flaherty KT, Nathan P, Ribas A, Robert C, Casey M, DeMarini DJ, Irani JG, Aktan G, Long GV. Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma. Eur J Cancer. 2015 May;51(7):833-40. doi: 10.1016/j.ejca.2015.03.004. Epub 2015 Mar 17.

ReferenceCitation: Menzies AM, Ashworth MT, Swann S, Kefford RF, Flaherty K, Weber J, Infante JR, Kim KB, Gonzalez R, Hamid O, Schuchter L, Cebon J, Sosman JA, Little S, Sun P, Aktan G, Ouellet D, Jin F, Long GV, Daud A. Characteristics of pyrexia in BRAFV600E/K metastatic melanoma patients treated with combined dabrafenib and trametinib in a phase I/II clinical trial. Ann Oncol. 2015 Feb;26(2):415-21. doi: 10.1093/annonc/mdu529. Epub 2014 Nov 18.

ReferenceCitation: Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, Garbe C, Jouary T, Hauschild A, Grob JJ, Chiarion Sileni V, Lebbe C, Mandalà M, Millward M, Arance A, Bondarenko I, Haanen JB, Hansson J, Utikal J, Ferraresi V, Kovalenko N, Mohr P, Probachai V, Schadendorf D, Nathan P, Robert C, Ribas A, DeMarini DJ, Irani JG, Casey M, Ouellet D, Martin AM, Le N, Patel K, Flaherty K. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014 Nov 13;371(20):1877-88. doi: 10.1056/NEJMoa1406037. Epub 2014 Sep 29.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

title: Combined BRAF and MEK Inhibition versus BRAF Inhibition Alone in Melanoma

location_country:
Italy
United States
Sweden
Netherlands
Germany
France
Greece
Argentina
Australia
Russian Federation
Spain
Canada
United Kingdom
Ukraine


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

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

Primary Objective of the study:

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

Secondary Objectives:

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

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

family: Robinson

full_name: Jennifer G. Robinson

given: Jennifer G.

family: Farnier

full_name: Michel Farnier

given: Michel

family: Krempf

full_name: Michel Krempf

family: Bergeron

full_name: Jean Bergeron

given: Jean

family: Luc

full_name: Gérald Luc

given: Gérald

family: Averna

full_name: Maurizio Averna

given: Maurizio

family: Stroes

full_name: Erik S. Stroes

given: Erik S.

family: Langslet

full_name: Gisle Langslet

given: Gisle

family: Raal

full_name: Frederick J. Raal

given: Frederick J.

family: El Shahawy

full_name: Mahfouz El Shahawy

given: Mahfouz

family: Koren

full_name: Michael J. Koren

given: Michael J.

family: Lepor

full_name: Norman E. Lepor

given: Norman E.

family: Lorenzato

full_name: Christelle Lorenzato

given: Christelle

family: Pordy

full_name: Robert Pordy

given: Robert

family: Chaudhari

full_name: Umesh Chaudhari

given: Umesh

family: Kastelein

full_name: John J.P. Kastelein

given: John J.P.

journal_name: New England Journal of Medicine

oa_host_type: repository

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events

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

name: Li Ka Shing Knowledge Institute; St Michael's Hospital; University of Toronto; Toronto ON Canada

family: Leiter

full_name: L. A. Leiter

given: L. A.

name: Department of Clinical Endocrinology and Nutrition (IBIMA); Hospital Virgen de la Victoria; University of Málaga; CIBER Fisiopatología de la Obesidad y Nutrición (CIBERobn); Instituto de Salud Carlos III; Málaga Spain

family: Tinahones

full_name: F. J. Tinahones

given: F. J.

name: Sidney Kimmel Medical College; Thomas Jefferson University; Philadelphia PA USA

family: Karalis

full_name: D. G. Karalis

given: D. G.

name: Biostatistics and Programming Department; Sanofi, Chilly-Mazarin France

name: Regeneron Pharmaceuticals, Inc.; Tarrytown NY USA

name: Baylor College of Medicine; Houston TX USA

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

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

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

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

location_facility:
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Investigational Site Number 276009
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Investigational Site Number 528012
Investigational Site Number 643012
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Investigational Site Number 840180
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Investigational Site Number 616003
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summary: This is a randomized, open-label, multicenter, Phase 3 study, comparing efficacy and safety of eribulin with TPC in subjects with advanced and disease progression following at least two prior regimens for advanced disease, which should have included a platinum-based regimen.

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

family: Katakami

full_name: N. Katakami

given: N.

family: Felip

full_name: E. Felip

given: E.

family: Spigel

full_name: D.R. Spigel

family: Kim

full_name: J.-H. Kim

family: Olivo

full_name: M. Olivo

given: M.

family: Guo

full_name: M. Guo

family: Nokihara

full_name: H. Nokihara

given: H.

family: Yang

full_name: J. C.-H. Yang

family: Iannotti

full_name: N. Iannotti

family: Satouchi

full_name: M. Satouchi

family: Barlesi

full_name: F. Barlesi

given: F.

title: A randomized, open-label, multicenter, phase 3 study to compare the efficacy and safety of eribulin to treatment of physician’s choice in patients with advanced non-small cell lung cancer

lead_sponsor: Eisai Inc.

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


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

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

primary_purpose: Supportive Care

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

location_country: Italy Austria Switzerland France Czechia Greece Belgium Spain Germany


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

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

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

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