ReferenceCitation: Danese S, Colombel JF, Lukas M, Gisbert JP, D'Haens G, Hayee B, Panaccione R, Kim HS, Reinisch W, Tyrrell H, Oh YS, Tole S, Chai A, Chamberlain-James K, Tang MT, Schreiber S; GARDENIA Study Group. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study. Lancet Gastroenterol Hepatol. 2021 Nov 16. pii: S2468-1253(21)00294-6. doi: 10.1016/S2468-1253(21)00294-6. [Epub ahead of print]

family: Danese

full_name: Silvio Danese

given: Silvio

family: Colombel

full_name: Jean-Frederic Colombel

given: Jean-Frederic

family: Lukas

full_name: Milan Lukas

given: Milan

family: Gisbert

full_name: Javier P Gisbert

given: Javier P

family: D'Haens

full_name: Geert D'Haens

given: Geert

family: Hayee

full_name: Bu'hussain Hayee

given: Bu'hussain

family: Panaccione

full_name: Remo Panaccione

given: Remo

full_name: Hyun-Soo Kim

given: Hyun-Soo

family: Reinisch

full_name: Walter Reinisch

given: Walter

family: Tyrrell

full_name: Helen Tyrrell

given: Helen

family: Oh

full_name: Young S Oh

given: Young S

family: Tole

full_name: Swati Tole

given: Swati

family: Chai

full_name: Akiko Chai

given: Akiko

family: Chamberlain-James

full_name: Kirsten Chamberlain-James

given: Kirsten

family: Tang

full_name: Meina Tao Tang

given: Meina Tao

family: Schreiber

full_name: Stefan Schreiber

given: Stefan

family: Aboo

full_name: Nazimuddin Aboo

given: Nazimuddin

family: Ahmad

full_name: Tariq Ahmad

given: Tariq

family: Aldeguer Mante

full_name: Xavier Aldeguer Mante

given: Xavier

family: Allez

full_name: Matthieu Allez

given: Matthieu

family: Almer

full_name: Sven Almer

given: Sven

family: Altwegg

full_name: Romain Altwegg

given: Romain

family: Andreu Garcia

full_name: Montserrat Andreu Garcia

given: Montserrat

family: Arasaradnam

full_name: Ramesh Arasaradnam

given: Ramesh

family: Ardizzone

full_name: Sandro Ardizzone

given: Sandro

journal_name: The Lancet Gastroenterology & Hepatology

ReferenceCitation: Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22.

name: The Etrolizumab Global Steering Committee

title: Etrolizumab for the Treatment of Ulcerative Colitis and Crohn’s Disease: An Overview of the Phase 3 Clinical Program

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Italy
Austria
South Africa
Sweden
Switzerland
Netherlands
Spain
Germany
France
Czechia
Israel
Norway
Hungary
Belgium
Romania
Singapore
Portugal
Canada
United Kingdom
Korea, Republic of

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Asst Fatebenefratelli Sacco (Fatebenefratelli)

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

location_facility: Hospital da Senhora da Oliveira Guimarães

location_facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft

location_facility: IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz es Szakrendelo

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

location_facility: CHA Bundang Medical Centre; CHA university

location_facility: Universitätsklinikum Freiburg; Innere Medizin I; Hämatologie, Onkologie und Stammzelltransplantation

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Fundacion Hospital de Alcorcon; Servicio de Digestivo

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Chaim Sheba Medical Center; Pediatrics B North and Pediatric Endocrinology Unit

location_facility: Complejo Hospitalario Universitario de Ferrol

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: GZA Ziekenhuizen - Campus Sint-Vincentius

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Universitair Ziekenhuis Brussel; Neurology

location_facility: Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

location_facility: Kyungpook National University Chilgok Hospital

location_facility: University of Calgary; Heritage Medical Research Clinic

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Markhot Ferenc Oktato Korhaz es Rendelointezet

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

title: Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

summary: This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then once every 8 weeks [Q8W]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.


intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

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

lead_sponsor: Pfizer

enrollment_type: Actual

primary_purpose: Treatment

location_country:
United States
Germany
France
Greece
Belgium
Spain
Canada
United Kingdom

location_facility: University of California, San Francisco Medical Center

location_facility: TU Dresden Medizinische Fakultat, Medizinische Klinik und Poliklinik I

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Hospital Clinico Universitario de Valencia

location_facility: NY Presbyterian - Weill Cornell Medical Center

location_facility: Emory University, Winship Cancer Institute

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: General Hospital of Athens "Evangelismos"

ipd_sharing: Yes

study_completion_date_type: Actual

type: EudraCT Number

type: Other Identifier

source: euctr

title: A Multicenter Phase 2 Study of Single-agent Filanesib (ARRY-520) in Patients With Advanced Multiple Myeloma

summary:
The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study.

Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.

lead_sponsor_type: industriel

status_simplified: Completed


title: Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

summary: This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

design_allocation: Randomized

ReferenceType: background

ReferenceCitation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.

ReferenceCitation: Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). Published by: European Organisation for Research and Treatment of Cancer, Brussels 2001.

ipd_sharing: Undecided

lead_sponsor: Symphogen A/S

location_country:
Italy
Austria
Germany
France
Poland
Hungary
Belgium
Russian Federation
Spain
United States

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Washington University School of Medicine

location_facility: Seconda Università degli Studi di Napoli

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Hematology - Oncology Associates of Treasure Coast

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

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

location_facility: St. Petersburg SHI "City Clinical Oncology Dispensary"

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca' Granda

location_facility: SMZ Süd - Kaiser Franz Josef Spital Wien

intervention_type: Other


title: Double-Blind, Randomized, Placebo-Controlled, Multi-Centre Study to Investigate the Efficacy and Safety of GLPG0634 in Subjects With Active Crohn's Disease With Evidence of Mucosal Ulceration

summary:
180 patients suffering from active Crohn's disease with evidence of mucosal ulceration will be evaluated for improvement of disease activity (efficacy) when taking GLPG0634 or matching placebo once daily for 20 weeks in addition to their stable background treatment.
During the course of the study, patients will also be examined for any side effects that may occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood and stool (Pharmacodynamics) will be determined. Also, the effects GLPG0634 administration on subjects' quality of life will be evaluated.

ReferenceType: derived

ReferenceCitation: Vermeire S, Schreiber S, Petryka R, Kuehbacher T, Hebuterne X, Roblin X, Klopocka M, Goldis A, Wisniewska-Jarosinska M, Baranovsky A, Sike R, Stoyanova K, Tasset C, Van der Aa A, Harrison P. Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial. Lancet. 2017 Jan 21;389(10066):266-275. doi: 10.1016/S0140-6736(16)32537-5. Epub 2016 Dec 15.

family: Vermeire

full_name: Séverine Vermeire

given: Séverine

sequence: first

sequence: additional

family: Petryka

full_name: Robert Petryka

given: Robert

family: Kuehbacher

full_name: Tanja Kuehbacher

given: Tanja

family: Hebuterne

full_name: Xavier Hebuterne

family: Roblin

full_name: Xavier Roblin

family: Klopocka

full_name: Maria Klopocka

given: Maria

family: Goldis

full_name: Adrian Goldis

given: Adrian

family: Wisniewska-Jarosinska

full_name: Maria Wisniewska-Jarosinska

family: Baranovsky

full_name: Andrey Baranovsky

given: Andrey

family: Sike

full_name: Robert Sike

family: Stoyanova

full_name: Kremena Stoyanova

given: Kremena

family: Tasset

full_name: Chantal Tasset

given: Chantal

family: Van der Aa

full_name: Annegret Van der Aa

given: Annegret

family: Harrison

full_name: Pille Harrison

given: Pille

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Lancet

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Galapagos NV

location_country:
United Kingdom
France
Poland
Romania
Hungary
Belgium
Russian Federation
Germany
Czech Republic

location_facility: Lille Regional University Hospital Center

location_facility: Interdisciplinary Crohn Colitis Center Rhein Main

location_facility: Saint Etienne University Hospital Center

location_facility: Maternal, Pediatric and Adolescent Healtcare Centre, Gastroenterology Diagnostic Facility for Adults

location_facility: Institute of Clinical and Experimental Medicine

location_facility: Clinical Hospital of Ministry of Internal Affairs and Administration

location_facility: Mechnikov North-Western State Medical University

location_facility: Internal Medicine Group Practice Oldenburg

location_facility: Outpatient Clinic of Internal Medicine and Gastroenterology

location_facility: Vladimirsky Regional Clinical Research Institute

location_facility: Semashko Nizhny Novgorod Regional Clinical Hospital

location_facility: A.N. Ryzhikh State Research Center for Coloproctology

location_facility: University of Debrecen, Medical and Health Science Center


ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

name: Clinical Pharmacology Genentech Inc. South San Francisco CA USA

family: Shemesh

full_name: Colby S. Shemesh

given: Colby S.

family: Chan

full_name: Phyllis Chan

given: Phyllis

name: Clinical Science Genentech Inc. South San Francisco CA USA

family: Legrand

full_name: Fatema A. Legrand

given: Fatema A.

name: Biomarkers Genentech Inc. South San Francisco CA USA

family: Shames

full_name: David S. Shames

given: David S.

family: Das Thakur

full_name: Meghna Das Thakur

given: Meghna

name: Safety Science F. Hoffmann‐La Roche Ltd. Shanghai China

family: Shi

full_name: Jane Shi

given: Jane

name: Safety Science Roche Products Ltd. Welwyn Garden City United Kingdom

family: Bailey

full_name: Lorna Bailey

given: Lorna

family: Vadhavkar

full_name: Shweta Vadhavkar

given: Shweta

name: Biometrics Genentech Inc. South San Francisco CA USA

family: He

full_name: Xian He

given: Xian

family: Zhang

full_name: Wei Zhang

given: Wei

name: Clinical Pharmacology Genentech‐Roche Marseille France

family: Bruno

full_name: René Bruno

given: René

currency_apc_doaj: USD

journal_name: Pharmacology Research & Perspectives

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Pan‐cancer population pharmacokinetics and exposure‐safety and ‐efficacy analyses of atezolizumab in patients with high tumor mutational burden

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Bosnia and Herzegovina
Hong Kong
Netherlands
Switzerland
Germany
United Kingdom
France
Bulgaria
Japan
Georgia
Singapore
Belgium
Australia
Spain
Turkey
United States
Slovenia
Canada

acronym: BIRCH

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Ohio State University; B406 Starling-Loving Hall

location_facility: Research institute for Clinical Medicine

location_facility: Uni of Maryland; Greenebaum Cancer Center

location_facility: University Clinical Center Sarajevo;Clinic for Pulmonary disease

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: National Cancer Center Hospital; Thoracic Medical Oncology

location_facility: CHU Limoges - Dupuytren; Oncologie Thoracique Cutanee

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hopital Augustin Morvan; Oncologie Thoracique

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: University Clinical Centre of the Republic of Srpska

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Osaka International Cancer Institute; Thoracic Oncology

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Thoracic Oncology

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: National Cancer Centre; Medical Oncology

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

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

location_facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie

location_facility: Northwestern University; Robert H. Lurie Comp Can Ctr

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Klinikum Nuernberg Nord; Medizinische Klinik 3, Schwerpunkt Pneumologie, Allergologie, Schlafmedizin

location_facility: Washington University School of Medicine

location_facility: Toranomon Hospital; Respiratory Medicine

location_facility: Kansai Medical university Hospital; Thoracic Oncology

location_facility: National Hospital Organization Kyushu Medical Center; Respiratory Internal Medicine

location_facility: ICO Badalona - Hospital Germans Trias i Pujol

location_facility: Academ Ziekenhuis Groningen; Medical Oncology

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Chemotherapy and Immunotherapy Clinic Medulla

location_facility: Sendai Kousei Hospital; Pulmonary Medicine

location_facility: Kyoto University Hospital, Respiratory Medicine

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hopital Arnaud De Villeneuve; Maladies Respiratoires

location_facility: University of Virginia; Office of Sponsored Programs

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: University Clinical Center Sarajevo;Institute of oncology

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

location_facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Huntsman Cancer Institute; University of Utah

location_facility: Sir Charles Gairdner Hospital; Medical Oncology

location_facility: Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

location_facility: Emory Uni - Winship Cancer Center; Hematology/Oncology

location_facility: Kitasato University Hospital; Respiratory Medicine

location_facility: Specialized Hospital for Active Treatment of Oncology

location_facility: Fox Chase Cancer Center; Hematology/Oncology

location_facility: Ege University School of Medicine; Chest Diseases Department

location_facility: Yokohama Municipal Citizen'S Hospital; Respiratory Medicine

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Barts & London School of Med; Medical Oncology

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: Ankara Ataturk Chest Diseases Training and Research Hospital

title: A Phase II, Multicenter, Single-Arm Study OF Atezolizumab In Patients With PD-L1-Positive Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

summary: This multicenter, single-arm study will evaluate the efficacy and safety of Atezolizumab in participants with PD-L1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive Atezolizumab 1200 milligrams (mg) intravenously every 3 weeks as long as participants are experiencing clinical benefit as assessed by the investigator, that is , in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2

summary: The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.

lead_sponsor: Bausch Health Americas, Inc.

location_country:
United States
Mexico
France
Poland
Greece
Hungary
Russian Federation
Germany
Latvia
Canada


title: A Multicenter, Phase 2, Single Arm, Two Cohort Study Evaluating the Efficacy, Safety, and Pharmacokinetics of AMG337 in Subjects With MET Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma or Other MET Amplified Solid Tumors

summary: This is a multi-centre Phase 2 study. The study will evaluate the activity and safety of AMG 337 in patients who have MET amplified gastric, gastroesophageal junction or esophageal adenocarcinoma or other MET amplified solid tumors. The study is designed to estimate the objective response rate of AMG 337 by tumor type.

status: Terminated

lead_sponsor: Amgen

location_country:
Italy
Austria
United States
Chile
Peru
Germany
France
Czechia
Greece
Poland
Hungary
Australia
Belgium
Russian Federation
Spain
Canada
United Kingdom
Korea, Republic of

status_simplified: Unknown


ReferenceCitation: Antonia S, Goldberg SB, Balmanoukian A, Chaft JE, Sanborn RE, Gupta A, Narwal R, Steele K, Gu Y, Karakunnel JJ, Rizvi NA. Safety and antitumour activity of durvalumab plus tremelimumab in non-small cell lung cancer: a multicentre, phase 1b study. Lancet Oncol. 2016 Mar;17(3):299-308. doi: 10.1016/S1470-2045(15)00544-6. Epub 2016 Feb 6.

family: Antonia

full_name: Scott Antonia

given: Scott

family: Goldberg

full_name: Sarah B Goldberg

given: Sarah B

family: Balmanoukian

full_name: Ani Balmanoukian

given: Ani

family: Chaft

full_name: Jamie E Chaft

given: Jamie E

family: Sanborn

full_name: Rachel E Sanborn

given: Rachel E

family: Gupta

full_name: Ashok Gupta

given: Ashok

family: Narwal

full_name: Rajesh Narwal

given: Rajesh

family: Steele

full_name: Keith Steele

given: Keith

family: Gu

full_name: Yu Gu

given: Yu

family: Karakunnel

full_name: Joyson J Karakunnel

given: Joyson J

family: Rizvi

full_name: Naiyer A Rizvi

given: Naiyer A

journal_name: The Lancet Oncology

oa_host_type: repository

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

repository_institution: PubMed Central - Europe PMC

version: acceptedVersion

lead_sponsor: MedImmune LLC

location_country:
Italy
France
Belgium
Australia
Spain
United States
United Kingdom
Korea, Republic of
Taiwan

title: A Phase 1b Open-label Study to Evaluate the Safety and Tolerability of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer

summary: The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).


title: European Registry of Anti-epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS).

summary: This is a registry study, where sites will enter patients with LGS who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). This will include patients who are started on rufinamide. Patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. Upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. On each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, AEs (including suicidal-related events), and healthcare resource utilisation.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Nikanorova M, Brandt C, Auvin S, McMurray R. Real-world data on rufinamide treatment in patients with Lennox-Gastaut syndrome: Results from a European noninterventional registry study. Epilepsy Behav. 2017 Nov;76:63-70. doi: 10.1016/j.yebeh.2017.08.026. Epub 2017 Sep 15.

family: Nikanorova

full_name: Marina Nikanorova

given: Marina

family: Brandt

full_name: Christian Brandt

given: Christian

family: Auvin

full_name: Stéphane Auvin

given: Stéphane

family: McMurray

full_name: Rob McMurray

given: Rob

journal_name: Epilepsy & Behavior

title: Real-world data on rufinamide treatment in patients with Lennox–Gastaut syndrome: Results from a European noninterventional registry study

lead_sponsor: Eisai Limited

location_country:
Italy
Austria
Sweden
France
Spain
Denmark
Germany
United Kingdom


title: EPidemiological Study In Patients With Recently DiagnosEd PSOriasis: Clinical Assessment and Psychosocial Impact of This Disease

acronym: EPIDEPSO

summary: The purpose of this study is to explore the impact of plaque psoriasis on the different dimensions of patient life including psychological disorders, different types of addictions, and their consequences on health-related quality of life and socioeconomic parameters at baseline (cross-sectional part) and during the initial years of the psoriasis disease (longitudinal part).

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Austria
South Africa
Netherlands
France
Greece
Israel
Norway
Ireland
Belgium
Russian Federation
Spain
United Kingdom


title: An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)

summary: The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).

ReferenceCitation: Ocean AJ, Pennington KL, Guarino MJ, Sheikh A, Bekaii-Saab T, Serafini AN, Lee D, Sung MW, Gulec SA, Goldsmith SJ, Manzone T, Holt M, O'Neil BH, Hall N, Montero AJ, Kauh J, Gold DV, Horne H, Wegener WA, Goldenberg DM. Fractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial. Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012 May 8.

ReferenceCitation: Gulec SA, Cohen SJ, Pennington KL, Zuckier LS, Hauke RJ, Horne H, Wegener WA, Teoh N, Gold DV, Sharkey RM, Goldenberg DM. Treatment of advanced pancreatic carcinoma with 90Y-Clivatuzumab Tetraxetan: a phase I single-dose escalation trial. Clin Cancer Res. 2011 Jun 15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28.

ReferenceCitation: Sharkey RM, Karacay H, Govindan SV, Goldenberg DM. Combination radioimmunotherapy and chemoimmunotherapy involving different or the same targets improves therapy of human pancreatic carcinoma xenograft models. Mol Cancer Ther. 2011 Jun;10(6):1072-81. doi: 10.1158/1535-7163.MCT-11-0115. Epub 2011 Apr 5.

ReferenceCitation: Tokh M, Bathini V, Saif MW. First-line treatment of metastatic pancreatic cancer. JOP. 2012 Mar 10;13(2):159-62. Review.

ReferenceCitation: Gold DV, Newsome G, Liu D, Goldenberg DM. Mapping PAM4 (clivatuzumab), a monoclonal antibody in clinical trials for early detection and therapy of pancreatic ductal adenocarcinoma, to MUC5AC mucin. Mol Cancer. 2013 Nov 20;12(1):143. doi: 10.1186/1476-4598-12-143.

ReferenceCitation: Gold DV, Gaedcke J, Ghadimi BM, Goggins M, Hruban RH, Liu M, Newsome G, Goldenberg DM. PAM4 enzyme immunoassay alone and in combination with CA 19-9 for the detection of pancreatic adenocarcinoma. Cancer. 2013 Feb 1;119(3):522-8. doi: 10.1002/cncr.27762. Epub 2012 Aug 16.

ReferenceCitation: Gold DV, Goggins M, Modrak DE, Newsome G, Liu M, Shi C, Hruban RH, Goldenberg DM. Detection of early-stage pancreatic adenocarcinoma. Cancer Epidemiol Biomarkers Prev. 2010 Nov;19(11):2786-94. doi: 10.1158/1055-9965.EPI-10-0667. Epub 2010 Sep 1.

ReferenceCitation: Gold DV, Goldenberg DM, Karacay H, Rossi EA, Chang CH, Cardillo TM, McBride WJ, Sharkey RM. A novel bispecific, trivalent antibody construct for targeting pancreatic carcinoma. Cancer Res. 2008 Jun 15;68(12):4819-26. doi: 10.1158/0008-5472.CAN-08-0232.

ReferenceCitation: Gold DV, Karanjawala Z, Modrak DE, Goldenberg DM, Hruban RH. PAM4-reactive MUC1 is a biomarker for early pancreatic adenocarcinoma. Clin Cancer Res. 2007 Dec 15;13(24):7380-7.

ReferenceCitation: Gold DV, Modrak DE, Ying Z, Cardillo TM, Sharkey RM, Goldenberg DM. New MUC1 serum immunoassay differentiates pancreatic cancer from pancreatitis. J Clin Oncol. 2006 Jan 10;24(2):252-8. Epub 2005 Dec 12.

ReferenceCitation: Gold DV, Modrak DE, Schutsky K, Cardillo TM. Combined 90Yttrium-DOTA-labeled PAM4 antibody radioimmunotherapy and gemcitabine radiosensitization for the treatment of a human pancreatic cancer xenograft. Int J Cancer. 2004 Apr 20;109(4):618-26.

ReferenceCitation: Gold DV, Schutsky K, Modrak D, Cardillo TM. Low-dose radioimmunotherapy ((90)Y-PAM4) combined with gemcitabine for the treatment of experimental pancreatic cancer. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3929S-37S.

ReferenceCitation: Cardillo TM, Blumenthal R, Ying Z, Gold DV. Combined gemcitabine and radioimmunotherapy for the treatment of pancreatic cancer. Int J Cancer. 2002 Jan 20;97(3):386-92.

ReferenceCitation: Cardillo TM, Ying Z, Gold DV. Therapeutic advantage of (90)yttrium- versus (131)iodine-labeled PAM4 antibody in experimental pancreatic cancer. Clin Cancer Res. 2001 Oct;7(10):3186-92.

ReferenceCitation: Gold DV, Cardillo T, Goldenberg DM, Sharkey RM. Localization of pancreatic cancer with radiolabeled monoclonal antibody PAM4. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):147-54.

ReferenceCitation: Gold DV, Cardillo T, Vardi Y, Blumenthal R. Radioimmunotherapy of experimental pancreatic cancer with 131I-labeled monoclonal antibody PAM4. Int J Cancer. 1997 May 16;71(4):660-7.

ReferenceCitation: Mariani G, Molea N, Bacciardi D, Boggi U, Fornaciari G, Campani D, Salvadori PA, Giulianotti PC, Mosca F, Gold DV, et al. Initial tumor targeting, biodistribution, and pharmacokinetic evaluation of the monoclonal antibody PAM4 in patients with pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5911s-5915s.

ReferenceCitation: Alisauskus R, Wong GY, Gold DV. Initial studies of monoclonal antibody PAM4 targeting to xenografted orthotopic pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5743s-5748s.

ReferenceCitation: Gold DV, Lew K, Maliniak R, Hernandez M, Cardillo T. Characterization of monoclonal antibody PAM4 reactive with a pancreatic cancer mucin. Int J Cancer. 1994 Apr 15;57(2):204-10.

lead_sponsor: Gilead Sciences

location_country:
Austria
United States
France
Poland
Israel
Belgium
Spain
Canada

location_facility: Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: The Ohio State University - Comprehensive Cancer Center

location_facility: University of Tennessee Medical Center, Cancer Institute

location_facility: Indiana University Health Goshen Center for Cancer Care

location_facility: Centre Hospitalier Université de Sherbrooke

location_facility: University of Pennsylvania Abramson Cancer Center

location_facility: Masonic Cancer Center, University of Minnesota

location_facility: Mountain States Tumor Institute at St. Luke's Regional Medical Center

location_facility: University of Mississippi Medical Center

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists

location_facility: The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

location_facility: University of Pittsburgh Medical Center/Hillman Cancer Center

location_facility: Centre Léon Bérard Cancerologie Medicale

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa

location_facility: University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center


title: A Prospective, Single-arm, Multicenter, Uncontrolled, Open-label Phase II Trial of Refametinib (BAY86-9766) in Combination With Sorafenib as First Line Treatment in Patients With RAS Mutant Hepatocellular Carcinoma (HCC)

summary:
This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement [modified response evaluation criteria in solid tumors (mRECIST)] assessed by external independent radiologists.

Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.

lead_sponsor: Bayer

location_country:
Belgium
Taiwan
France
Japan
Thailand
Korea, Republic of
Hong Kong
Switzerland
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Czechia
Israel
New Zealand
Spain
Turkey


title: A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

acronym: CELESTIAL

summary: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.

ReferenceCitation: Kelley RK, Miksad R, Cicin I, Chen Y, Klümpen HJ, Kim S, Lin ZZ, Youkstetter J, Hazra S, Sen S, Cheng AL, El-Khoueiry AB, Meyer T, Abou-Alfa GK. Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade. Br J Cancer. 2021 Oct 7. doi: 10.1038/s41416-021-01532-5. [Epub ahead of print]

family: Kelley

full_name: Robin Kate Kelley

given: Robin Kate

family: Miksad

full_name: Rebecca Miksad

given: Rebecca

family: Cicin

full_name: Irfan Cicin

given: Irfan

family: Chen

full_name: YenHsun Chen

given: YenHsun

family: Klümpen

full_name: Heinz-Josef Klümpen

given: Heinz-Josef

family: Kim

full_name: Stefano Kim

given: Stefano

family: Lin

full_name: Zhong-Zhe Lin

given: Zhong-Zhe

family: Youkstetter

full_name: Jillian Youkstetter

given: Jillian

family: Hazra

full_name: Saswati Hazra

given: Saswati

family: Sen

full_name: Suvajit Sen

given: Suvajit

family: Cheng

full_name: Ann-Lii Cheng

given: Ann-Lii

family: El-Khoueiry

full_name: Anthony B. El-Khoueiry

given: Anthony B.

family: Meyer

full_name: Tim Meyer

given: Tim

family: Abou-Alfa

full_name: Ghassan K. Abou-Alfa

given: Ghassan K.

journal_name: British Journal of Cancer

oa_colors: green hybrid

evidence: open (via crossref license)

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Trojan J, Mollon P, Daniele B, Marteau F, Martín L, Li Y, Xu Q, Piscaglia F, Zaucha R, Sarker D, Lim HY, Venerito M. Comparative Efficacy of Cabozantinib and Ramucirumab After Sorafenib for Patients with Hepatocellular Carcinoma and Alpha-fetoprotein ≥ 400 ng/mL: A Matching-Adjusted Indirect Comparison. Adv Ther. 2021 May;38(5):2472-2490. doi: 10.1007/s12325-021-01700-2. Epub 2021 Apr 6.

family: Trojan

full_name: Jörg Trojan

given: Jörg

family: Mollon

full_name: Patrick Mollon

given: Patrick

family: Daniele

full_name: Bruno Daniele

ReferenceCitation: Kelley RK, Ryoo BY, Merle P, Park JW, Bolondi L, Chan SL, Lim HY, Baron AD, Parnis F, Knox J, Cattan S, Yau T, Lougheed JC, Milwee S, El-Khoueiry AB, Cheng AL, Meyer T, Abou-Alfa GK. Second-line cabozantinib after sorafenib treatment for advanced hepatocellular carcinoma: a subgroup analysis of the phase 3 CELESTIAL trial. ESMO Open. 2020 Aug;5(4). pii: e000714. doi: 10.1136/esmoopen-2020-000714.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Abou-Alfa GK, Meyer T, Cheng AL, El-Khoueiry AB, Rimassa L, Ryoo BY, Cicin I, Merle P, Chen Y, Park JW, Blanc JF, Bolondi L, Klümpen HJ, Chan SL, Zagonel V, Pressiani T, Ryu MH, Venook AP, Hessel C, Borgman-Hagey AE, Schwab G, Kelley RK. Cabozantinib in Patients with Advanced and Progressing Hepatocellular Carcinoma. N Engl J Med. 2018 Jul 5;379(1):54-63. doi: 10.1056/NEJMoa1717002.

name: From Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (G.K.A.-A.); Royal Free Hospital and University College London, London (T.M.); National Taiwan University Hospital, Taipei (A.-L.C.), and the Department of Medical Oncology, Liouying Chi Mei Hospital, Tainan (Y.C.) — both in Taiwan; USC Norris Comprehensive Cancer Center, Los Angeles (A.B.E.-K.), UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco (A.P.V., R.K.K.), and Exelixis, Alameda (C.H., A.E.B.-H...

location_country:
Italy
United States
Hong Kong
Netherlands
Spain
Germany
France
Poland
Romania
Ireland
Belgium
Australia
New Zealand
Singapore
Turkey
Canada
United Kingdom
Korea, Republic of
Taiwan


title: A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

acronym: BRAVO

summary: The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice

ipd_sharing: No

lead_sponsor: Tesaro, Inc.

location_country:
Italy
United States
Netherlands
Spain
France
Poland
Greece
Israel
Hungary
Belgium
Portugal
Canada
United Kingdom
Iceland


title: Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes (SUSTAIN™ 3 - vs. QW GLP-1)

acronym: SUSTAIN™ 3

summary: This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

ReferenceCitation: Fonseca VA, Capehorn MS, Garg SK, Jódar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in insulin resistance are mediated primarily via weight loss in subjects with type 2 diabetes on semaglutide. J Clin Endocrinol Metab. 2019 Apr 2. pii: jc.2018-02685. doi: 10.1210/jc.2018-02685. [Epub ahead of print] Erratum in: J Clin Endocrinol Metab. 2020 Jan 1;105(1):.

ReferenceCitation: Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA(1C) ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.

ReferenceType: result

ReferenceCitation: Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

family: Ahmann

full_name: Andrew J. Ahmann

given: Andrew J.

family: Capehorn

full_name: Matthew Capehorn

given: Matthew

family: Charpentier

full_name: Guillaume Charpentier

given: Guillaume

family: Dotta

full_name: Francesco Dotta

given: Francesco

family: Henkel

full_name: Elena Henkel

given: Elena

family: Lingvay

full_name: Ildiko Lingvay

given: Ildiko

family: Holst

full_name: Anders G. Holst

given: Anders G.

family: Annett

full_name: Miriam P. Annett

given: Miriam P.

family: Aroda

full_name: Vanita R. Aroda

given: Vanita R.

journal_name: Diabetes Care

oa_colors: green other

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: Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.

name: Physicians East; Greenville North Carolina

family: Warren

full_name: Mark Warren

given: Mark

family: Chaykin

full_name: Louis Chaykin

given: Louis

name: University of Illinois College of Medicine at Peoria; Peoria Illinois

family: Trachtenbarg

full_name: David Trachtenbarg

given: David

family: Nayak

full_name: Gurudutt Nayak

given: Gurudutt

family: Wijayasinghe

full_name: Nelun Wijayasinghe

given: Nelun

name: L'Institut du Thorax, Department of Endocrinology; CHU de Nantes; Nantes France

family: Cariou

full_name: Bertrand Cariou

given: Bertrand

journal_name: Diabetes, Obesity and Metabolism

ReferenceCitation: Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.

name: Department of Quantitative Clinical Pharmacology; Novo Nordisk A/S; Søborg Denmark

name: Department of Clinical Pharmacology; Novo Nordisk A/S; Søborg Denmark

name: Department of Semaglutide Medical and Science, Global Development; Novo Nordisk A/S; Søborg Denmark

ReferenceCitation: Ahrén B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. Diabetes Obes Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.

name: Department of Clinical Sciences, Lund University; Lund Sweden

name: Weill Cornell Medical College Qatar; Doha Qatar

name: Department of Diabetes and Endocrinology, Centre Hospitalier Régional Gilles de Corbeil; Évry France

name: Endocrinology and Metabolism, Physicians East; Greenville North Carolina

name: Institute of Ageing and Chronic Disease, University of Liverpool; Liverpool UK

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

ReferenceCitation: DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.

name: Department of Endocrinology; Academic Medical Centre; Amsterdam The Netherlands

name: Profil Institute for Metabolic Research; Neuss Germany

name: Division of Diabetes Endocrinology & Metabolism; University of Nebraska Medical Center; Omaha Nebraska

name: School of Life and Health Sciences; Aston University; Birmingham UK

name: Director, Metabolic Studies; Catalina Research Institute; Chino, California

name: Section of Endocrinology and Metabolism, Health Sciences Centre; University of Manitoba; Winnipeg Canada

repository_institution: Aston University - Aston Publications Explorer

repositories_institution: Aston University - Aston Publications Explorer

ReferenceCitation: Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.

ReferenceCitation: Malkin SJP, Russel-Szymczyk M, Liidemann G, Volke V, Hunt B. Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes: A Long-Term Cost-Effectiveness Analysis in Estonia. Diabetes Ther. 2019 Feb;10(1):159-176. doi: 10.1007/s13300-018-0542-x. Epub 2018 Dec 7.

ReferenceCitation: Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jódar E, Mehta R, Woo V, Lingvay I. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4. Review.

repository_institution: University of Leicester - Leicester Research Archive

repositories_institution: University of Leicester - Leicester Research Archive

title: Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1–7 trials

ReferenceCitation: Overgaard RV, Lindberg SØ, Thielke D. Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23.

name: Department of Medical and Science; Novo Nordisk A/S; Søborg Denmark

name: Department of Global Medical Affairs; Novo Nordisk A/S; Søborg Denmark

ReferenceCitation: Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.

repositories:
PubMed Central
cronfa.swan.ac.uk
localhost

repositories_institution:
Swansea University - Cronfa
University of Toronto - TSpace

ReferenceCitation: Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. J Clin Endocrinol Metab. 2020 Dec 1;105(12). pii: dgaa577. doi: 10.1210/clinem/dgaa577.

name: University of Texas Southwestern Medical Center at Dallas, Dallas, Texas

name: Rotherham Institute for Obesity, Clifton Medical Centre, Doncaster Gate, Rotherham, UK

name: Novo Nordisk, Vandtårnsvej, Søborg, Denmark

name: Zedediah Consulting on behalf of DRG Abacus (part of Clarivate), Wokingham, UK

journal_name: The Journal of Clinical Endocrinology & Metabolism

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jódar E. Once-Weekly Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

title: Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2–4 and 10

ReferenceCitation: Husain M, Bain SC, Jeppesen OK, Lingvay I, Sørrig R, Treppendahl MB, Vilsbøll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.

name: Ted Rogers Centre for Heart ResearchToronto General Hospital Research Institute Toronto Canada

name: Swansea University Medical School, Diabetes Research Unit Cymru Swansea UK

name: UT Southwestern Medical Center, Internal Medicine and Population and Data Sciences Dallas Texas

name: Steno Diabetes Center CopenhagenGentofte Hospital, University of Copenhagen Copenhagen Denmark

repositories_institution:
PubMed Central - Europe PMC
Swansea University - Cronfa

ReferenceCitation: DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. J Clin Endocrinol Metab. 2020 Feb 1;105(2). pii: dgz072. doi: 10.1210/clinem/dgz072.

name: University of Nebraska Medical Center, Omaha, NE, US

name: L’Institut du Thorax, Department of Endocrinology, CHU Nantes, Nantes, France

name: Barbara Davis Center for Diabetes, University of Colorado Denver, Denver, CO, US

name: Tulane University Health Sciences Center, New Orleans, LA, US

repository_institution: CERN European Organization for Nuclear Research - Zenodo

repositories_institution: CERN European Organization for Nuclear Research - Zenodo

ReferenceCitation: Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Håkan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.

name: Diabetes Endocrinology and Metabolism Research Center, School of Medical Sciences, Örebro University Örebro Sweden

name: Department of Medicine IIICarl Gustav Carus University Hospital, Technische Universität Dresden Dresden Germany

name: Paul Langerhans Institute Dresden, Helmholtz Center Munich at Technische Universität Dresden Dresden Germany

name: Behavioral Diabetes Institute, University of California San Diego San Diego California

name: Southern New Hampshire Diabetes and Endocrinology Nashua New Hampshire

name: DaVita Medical GroupUniversity of Colorado School of Medicine Colorado Springs Colorado

name: Diabetes Research Centre, University of Leicester Leicester UK

title: Improved treatment satisfaction in patients with type 2 diabetes treated with once‐weekly semaglutide in the SUSTAIN trials

location_country:
Italy
Serbia
Switzerland
Netherlands
Germany
Finland
Croatia
France
Greece
Argentina
Puerto Rico
United States
United Kingdom


title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis

acronym: SPIRIT A1

summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Eli Lilly and Company

location_country:
United States
United Kingdom
Mexico
Netherlands
Germany
France
Poland
Hungary
Belgium
Argentina
Russian Federation
Spain
Canada
Czech Republic
Ukraine

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

summary: The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.

ReferenceCitation: Wilson WH, Wright GW, Huang DW, Hodkinson B, Balasubramanian S, Fan Y, Vermeulen J, Shreeve M, Staudt LM. Effect of ibrutinib with R-CHOP chemotherapy in genetic subtypes of DLBCL. Cancer Cell. 2021 Nov 3. pii: S1535-6108(21)00557-2. doi: 10.1016/j.ccell.2021.10.006. [Epub ahead of print]

family: Wilson

full_name: Wyndham H. Wilson

given: Wyndham H.

family: Wright

full_name: George W. Wright

given: George W.

family: Huang

full_name: Da Wei Huang

given: Da Wei

family: Hodkinson

full_name: Brendan Hodkinson

given: Brendan

family: Balasubramanian

full_name: Sriram Balasubramanian

given: Sriram

family: Fan

full_name: Yue Fan

given: Yue

family: Vermeulen

full_name: Jessica Vermeulen

given: Jessica

family: Shreeve

full_name: Martin Shreeve

given: Martin

family: Staudt

full_name: Louis M. Staudt

given: Louis M.

journal_name: Cancer Cell

ReferenceCitation: Younes A, Sehn LH, Johnson P, Zinzani PL, Hong X, Zhu J, Patti C, Belada D, Samoilova O, Suh C, Leppä S, Rai S, Turgut M, Jurczak W, Cheung MC, Gurion R, Yeh SP, Lopez-Hernandez A, Dührsen U, Thieblemont C, Chiattone CS, Balasubramanian S, Carey J, Liu G, Shreeve SM, Sun S, Zhuang SH, Vermeulen J, Staudt LM, Wilson W; PHOENIX investigators. Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2019 May 20;37(15):1285-1295. doi: 10.1200/JCO.18.02403. Epub 2019 Mar 22.

name: Memorial Sloan Kettering Cancer Center, New York, NY

family: Younes

full_name: Anas Younes

given: Anas

name: BC Cancer Agency, Vancouver, British Columbia, Canada

family: Sehn

full_name: Laurie H. Sehn

given: Laurie H.

name: University of Southampton, Southampton, United Kingdom

family: Johnson

full_name: Peter Johnson

given: Peter

name: “Seràgnoli” University of Bologna, Bologna, Italy

family: Zinzani

full_name: Pier Luigi Zinzani

given: Pier Luigi

name: Fudan University, Shanghai, People’s Republic of China

family: Hong

full_name: Xiaonan Hong

given: Xiaonan

name: Peking University Cancer Hospital, Beijing, People’s Republic of China

family: Zhu

full_name: Jun Zhu

given: Jun

name: Azienda Ospedaliera Ospedali Riuniti Villa Sofia–Cervello, Palermo, Italy

family: Patti

full_name: Caterina Patti

given: Caterina

name: Charles University, Hradec Králové, Czech Republic

name: University Hospital Hradec Králové, Hradec Králové, Czech Republic

family: Belada

full_name: David Belada

name: Regional Clinical Hospital, Nizhny Novgorod, Russian Federation

family: Samoilova

full_name: Olga Samoilova

given: Olga

name: University of Ulsan, Seoul, Republic of Korea

family: Suh

full_name: Cheolwon Suh

given: Cheolwon

name: Helsinki University Hospital, Helsinki, Finland

name: University of Helsinki, Helsinki, Finland

family: Leppä

full_name: Sirpa Leppä

given: Sirpa

name: Ondokuz Mayis University, Samsun, Turkey

name: Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada

name: Rabin Medical Center, Petah Tikva, Israel

name: China Medical University Hospital, Taichung, Republic of China

name: University Hospital Vall d’Hebron, Barcelona, Spain

name: University Hospital Essen, Essen, Germany

name: Diderot University, Sorbonne Paris-Cité, Paris, France

name: Santa Casa Medical School, São Paulo, Brazil

name: Janssen Research and Development, San Diego, CA

name: Janssen Research and Development, Spring House, PA

name: Janssen Research and Development, Raritan, NJ

name: Janssen Research and Development, Leiden, the Netherlands

name: National Cancer Institute, National Institutes of Health, Bethesda, MD

publisher: American Society of Clinical Oncology (ASCO)

title: Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non–Germinal Center B-Cell Diffuse Large B-Cell Lymphoma

location_country:
Finland
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
China
Germany
United States
United Kingdom
Brazil
Mexico
Czechia
Israel
Spain
Turkey


title: A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in the Treatment of Nosocomial Pneumonia Including Ventilator-Associated Pneumonia in Hospitalized Adults

summary: The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia

ReferenceCitation: Cheng K, Newell P, Chow JW, Broadhurst H, Wilson D, Yates K, Wardman A. Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme. Drug Saf. 2020 Aug;43(8):751-766. doi: 10.1007/s40264-020-00934-3.

family: Cheng

full_name: Karen Cheng

given: Karen

family: Newell

full_name: Paul Newell

given: Paul

family: Chow

full_name: Joseph W. Chow

given: Joseph W.

family: Broadhurst

full_name: Helen Broadhurst

given: Helen

family: Wilson

full_name: David Wilson

given: David

family: Yates

full_name: Katrina Yates

given: Katrina

family: Wardman

full_name: Angela Wardman

given: Angela

journal_name: Drug Safety

license: cc-by-nc

license_normalized: cc-by-nc

title: Safety Profile of Ceftazidime–Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme

ReferenceCitation: Tichy E, Torres A, Bassetti M, Kongnakorn T, Di Virgilio R, Irani P, Charbonneau C. Cost-effectiveness Comparison of Ceftazidime/Avibactam Versus Meropenem in the Empirical Treatment of Hospital-acquired Pneumonia, Including Ventilator-associated Pneumonia, in Italy. Clin Ther. 2020 May;42(5):802-817. doi: 10.1016/j.clinthera.2020.03.014. Epub 2020 Apr 27.

family: Tichy

full_name: Eszter Tichy

given: Eszter

family: Torres

full_name: Antoni Torres

given: Antoni

family: Bassetti

full_name: Matteo Bassetti

given: Matteo

family: Kongnakorn

full_name: Thitima Kongnakorn

given: Thitima

family: Di Virgilio

full_name: Roberto Di Virgilio

given: Roberto

family: Irani

full_name: Paurus Irani

given: Paurus

family: Charbonneau

full_name: Claudie Charbonneau

given: Claudie

journal_name: Clinical Therapeutics

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

ReferenceCitation: Stone GG, Bradford PA, Tawadrous M, Taylor D, Cadatal MJ, Chen Z, Chow JW. In Vitro Activity of Ceftazidime-Avibactam against Isolates from Respiratory and Blood Specimens from Patients with Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia, in a Phase 3 Clinical Trial. Antimicrob Agents Chemother. 2020 Apr 21;64(5). pii: e02356-19. doi: 10.1128/AAC.02356-19. Print 2020 Apr 21.

name: AstraZeneca Pharmaceuticals, Waltham, Massachusetts, USA

name: TaylorMade Health, Ltd, Warrington, United Kingdom

ReferenceCitation: Li J, Lovern M, Green ML, Chiu J, Zhou D, Comisar C, Xiong Y, Hing J, MacPherson M, Wright JG, Riccobene T, Carrothers TJ, Das S. Ceftazidime-Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups. Clin Transl Sci. 2019 Mar;12(2):151-163. doi: 10.1111/cts.12585. Epub 2018 Sep 28.

name: Quantitative Solutions Raleigh North Carolina USA

name: AstraZeneca Alderley Park Macclesfield UK

title: Ceftazidime‐Avibactam Population Pharmacokinetic Modeling and Pharmacodynamic Target Attainment Across Adult Indications and Patient Subgroups

ReferenceCitation: Nichols WW, Stone GG, Newell P, Broadhurst H, Wardman A, MacPherson M, Yates K, Riccobene T, Critchley IA, Das S. Ceftazidime-Avibactam Susceptibility Breakpoints against Enterobacteriaceae and Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2018 Oct 24;62(11). pii: e02590-17. doi: 10.1128/AAC.02590-17. Print 2018 Nov.

name: AstraZeneca, Waltham, Massachusetts, USA

name: AstraZeneca, Macclesfield, United Kingdom

name: Wright Dose Ltd., Altrincham, United Kingdom

ReferenceCitation: Stone GG, Newell P, Gasink LB, Broadhurst H, Wardman A, Yates K, Chen Z, Song J, Chow JW. Clinical activity of ceftazidime/avibactam against MDR Enterobacteriaceae and Pseudomonas aeruginosa: pooled data from the ceftazidime/avibactam Phase III clinical trial programme. J Antimicrob Chemother. 2018 Sep 1;73(9):2519-2523. doi: 10.1093/jac/dky204.

name: AstraZeneca Pharmaceuticals, 35 Gatehouse Drive, Waltham, MA 02451, USA

name: AstraZeneca Global Medicines Development, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK

name: AstraZeneca, 1800 Concord Pike, Wilmington, DE 19803, USA

name: AstraZeneca, 199 Liangjing Road, Shanghai 201203, China

ReferenceCitation: Torres A, Zhong N, Pachl J, Timsit JF, Kollef M, Chen Z, Song J, Taylor D, Laud PJ, Stone GG, Chow JW. Ceftazidime-avibactam versus meropenem in nosocomial pneumonia, including ventilator-associated pneumonia (REPROVE): a randomised, double-blind, phase 3 non-inferiority trial. Lancet Infect Dis. 2018 Mar;18(3):285-295. doi: 10.1016/S1473-3099(17)30747-8. Epub 2017 Dec 16.

location_country:
Peru
Romania
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Argentina
Slovenia
Korea, Republic of
South Africa
Vietnam
Philippines
Bulgaria
Hungary
China
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain
Turkey
Latvia


title: An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment

summary: The purpose of this study is to allow continued use of pasireotide in patients who are on pasireotide treatment in a Novartis-sponsored study and are benefiting from the treatment as judged by the investigator.

status: Active, not recruiting

lead_sponsor: RECORDATI GROUP

location_country:
Peru
Malaysia
Greece
Romania
Belgium
Russian Federation
Taiwan
India
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
Italy
Brazil
Mexico
Israel
Spain
Turkey

location_facility: Stanford Universtiy Medical Center Stanford Hospital & Clinics

location_facility: University of Michigan Comprehensive Cancer Center SC-2

location_facility: Swedish Cancer Institute Swedish Cancer Institute (SC)

location_facility: Cedars Sinai Medical Center Cedars Sinai 4

location_facility: Memorial Sloan-Kettering Cancer Center SC

status_simplified: Ongoing


lead_sponsor: Biota Scientific Management Pty Ltd

location_country:
United States
Peru
South Africa
United Kingdom
Mexico
Germany
France
Bulgaria
Hungary
Belgium
Australia
New Zealand
Estonia
Canada
Latvia
Colombia

acronym: Igloo

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Hometown Urgent Care & Occupational Health

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Columbia

location_facility: ABX-CRO advanced pharmaceuticals Forschungsqesellschaft mbH

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo

location_facility: Gemeinschaftspraxis Dres. Kleinecke-Pohl, Kirsch, Benner-Hemsen

location_facility: Diagnostic Consultative Center II - Sofia OOD

location_facility: University of Massachusetts Medical Center

location_facility: Bethesda Allergy, Asthma & Research Center, LLC

location_facility: DCT-Stone Oak, LLC dba Discovery Clinical Trials

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: San Diego Sports Medicine & Family Health Center

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Gemeinschaftspraxis Dr. med. Reinhold Jerwan-Keim, Renate Metz

location_facility: University of Pretoria Clinical Research Unit

location_facility: The Asthma & Allergy Center, P.C. master

location_facility: Gemeinschaftspraxis Dres. Hagemann, Duerfeld und Breiderhoff

location_facility: Syzygy Clinical Research Services Wilgers

location_facility: Jimboomba Junction Family Practice & Skin Cancer Clinic

location_facility: QUALICLINIC Eu-i Szolg. es Kutatasszervezo Kft

location_facility: Southeast Clinical Research, LLC - Parent

location_facility: CSALADGYOGYYASZ Szolgaltato es Oktato Bt.

location_facility: Synexus SA - Watermeyer Clinical Research Centre

location_facility: Facultad Mexicana de Medicina, Universidad La Salle A.C.

location_facility: Centro de Investigacion Clinica GRAMEL S.C

location_facility: Centro de Investigacion Clinica Acelerada, S.C.

location_facility: Phylasis Clinicas Research S de RL de CV

location_facility: Mexico Centre for Clinical Research S.A. de C.V

location_facility: DCT - FMC, LLC, d/b/a Discovery Clinical Trials

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada (CIMBYTA)

location_facility: Hospital de Especialidades Centro Medico Puerta de Hierro

location_facility: Clinique Medicale St-Louis (Recherche) Inc

location_facility: Centro de Investigaction y Transferencia en Salud del Tecnologico de Monterrey

location_facility: Synexus SA, Stanza Bopape Clinical Research Centre

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: Allergy Diagnostic & Clinical Research Unit

location_facility: Nucleo Victoria de Investigacion Clinica S.C.

location_facility: BRCR Medical Center, Inc DBA Boca Raton Clinical Research

location_facility: Institut fuer Praeventive Medizin Freiburg

location_facility: Clinexpert Egeszsegugyi Szolg. es Ker. Kft.

type: Other Grant/Funding Number

title: A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection

summary: This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.


title: A Phase IIIb, Multicenter, Multinational, Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Glycemic and Renal Efficacy of Once Daily Administration of Linagliptin 5 mg for 24 Weeks in Type 2 Diabetes Patients, With Micro- or Macroalbuminuria (30-3000mg/g Creatinine) on Top of Current Treatment With Angiotensin ConvEnzyme Inhibitor or Angiotensin Receptor Blocker - MARLINA (Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin)

summary: Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24 weeks of treatment.

ReferenceCitation: Siwy J, Klein T, Rosler M, von Eynatten M. Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase-4 Inhibition: A Hypothesis-Generating Analysis from the MARLINA-T2D Trial. Proteomics Clin Appl. 2019 Mar;13(2):e1800144. doi: 10.1002/prca.201800144. Epub 2019 Jan 28.

name: mosaiques‐diagnostics GmbH Rotenburger Str. 20 30659 Hannover Germany

family: Siwy

full_name: Justyna Siwy

given: Justyna

name: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Str. 65 88397 Biberach an der Riß Germany

family: Klein

full_name: Thomas Klein

given: Thomas

family: Rosler

full_name: Marcel Rosler

given: Marcel

name: Boehringer Ingelheim International GmbH. KG Binger Str. 173 55216 Ingelheim am Rhein Germany

family: Eynatten

full_name: Maximilian Eynatten

given: Maximilian

journal_name: PROTEOMICS – Clinical Applications

title: Urinary Proteomics as a Tool to Identify Kidney Responders to Dipeptidyl Peptidase‐4 Inhibition: A Hypothesis‐Generating Analysis from the MARLINA‐T2D Trial

ReferenceCitation: Groop PH, Cooper ME, Perkovic V, Hocher B, Kanasaki K, Haneda M, Schernthaner G, Sharma K, Stanton RC, Toto R, Cescutti J, Gordat M, Meinicke T, Koitka-Weber A, Thiemann S, von Eynatten M. Linagliptin and its effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: the randomized MARLINA-T2D trial. Diabetes Obes Metab. 2017 Nov;19(11):1610-1619. doi: 10.1111/dom.13041. Epub 2017 Jul 31.

name: Folkhälsan Institute of Genetics; Folkhälsan Research Center, Biomedicum Helsinki; Helsinki Finland

name: Abdominal Center Nephrology; University of Helsinki and Helsinki University Hospital; Helsinki Finland

name: Baker IDI Heart and Diabetes Institute; Melbourne Australia

family: Groop

full_name: Per-Henrik Groop

given: Per-Henrik

family: Cooper

full_name: Mark E. Cooper

given: Mark E.

name: The George Institute for Global Health, Faculty of Medicine; University of Sydney; Sydney Australia

family: Perkovic

full_name: Vlado Perkovic

given: Vlado

name: Institute of Nutritional Science; University of Potsdam; Potsdam Germany

name: Department of Histology and Embryology; Medical College, Jinan University; Guangzhou China

name: IFLb, Institut für Laboratoriumsmedizin Berlin GmbH; Berlin Germany

family: Hocher

full_name: Berthold Hocher

given: Berthold

name: Department of Diabetology and Endocrinology; Kanazawa Medical University; Kanazawa Japan

name: Division of Anticipatory Molecular Food Science and Technology; Medical Research Institute, Kanazawa Medical University; Kanazawa Japan

family: Kanasaki

full_name: Keizo Kanasaki

given: Keizo

name: Division of Metabolism and Biosystemic Science, Department of Medicine; Asahikawa Medical University; Asahikawa Japan

family: Haneda

full_name: Masakazu Haneda

given: Masakazu

name: Department of Internal Medicine; Rudolfstiftung Hospital; Vienna Austria

family: Schernthaner

full_name: Guntram Schernthaner

given: Guntram

name: Department of Medicine, Center for Renal Translational Medicine; University of California; San Diego California

family: Sharma

full_name: Kumar Sharma

given: Kumar

name: Joslin Diabetes Center; Harvard Medical School; Boston Massachusetts

family: Stanton

full_name: Robert C. Stanton

given: Robert C.

name: Department of Internal Medicine; University of Texas Southwestern Medical Center; Dallas Texas

family: Toto

full_name: Robert Toto

given: Robert

name: Boehringer Ingelheim France S.A.S; Reims France

family: Cescutti

full_name: Jessica Cescutti

given: Jessica

family: Gordat

full_name: Maud Gordat

given: Maud

name: Boehringer Ingelheim Pharma GmbH & Co. KG; Biberach Germany

family: Meinicke

full_name: Thomas Meinicke

family: Koitka-Weber

full_name: Audrey Koitka-Weber

given: Audrey

name: Boehringer Ingelheim Pharma GmbH & Co. KG; Ingelheim Germany

family: Thiemann

full_name: Sandra Thiemann

given: Sandra

family: von Eynatten

full_name: Maximilian von Eynatten

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

repository_normalized: HELDA - Digital Repository of the University of Helsinki

ReferenceCitation: Groop PH, Cooper ME, Perkovic V, Sharma K, Schernthaner G, Haneda M, Hocher B, Gordat M, Cescutti J, Woerle HJ, von Eynatten M. Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA-T2D™ trial. Diab Vasc Dis Res. 2015 Nov;12(6):455-62. doi: 10.1177/1479164115579002. Epub 2015 Jul 28.

name: Folkhälsan Institute of Genetics, Folkhälsan Research Center, Biomedicum Helsinki, Helsinki, Finland

name: Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland

name: Baker IDI Heart & Diabetes Institute, Melbourne, VIC, Australia

name: The George Institute for Global Health, University of Sydney, Sydney, NSW, Australia

name: Research Service and Division of Nephrology-Hypertension, Veterans Affairs San Diego Healthcare System, Veterans Medical Research Foundation, San Diego, CA, USA

name: Center for Renal Translational Medicine, Department of Medicine, University of California, San Diego, La Jolla, CA, USA

name: Department of Internal Medicine, Rudolfstiftung Hospital, Vienna, Austria

name: Division of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan

name: Institute of Nutritional Science, University of Potsdam, Potsdam, Germany

name: Boehringer Ingelheim, Ingelheim, Germany

title: Dipeptidyl peptidase-4 inhibition with linagliptin and effects on hyperglycaemia and albuminuria in patients with type 2 diabetes and renal dysfunction: Rationale and design of the MARLINA–T2D™ trial

location_country:
Vietnam
Philippines
Germany
Finland
France
Japan
Korea, Republic of
Spain
Denmark
United States
Canada
Taiwan

location_facility: Boehringer Ingelheim Investigational Site


title: A Multicenter Single-arm Extension Study to Describe the Long-term Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Bushinsky DA, Chertow GM, Cheng S, Deng H, Kopyt N, Martin KJ, Rastogi A, Ureña-Torres P, Vervloet M, Block GA. One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism. Nephrol Dial Transplant. 2020 Oct 1;35(10):1769-1778. doi: 10.1093/ndt/gfz039. Erratum in: Nephrol Dial Transplant. 2019 May 15;:1642.

name: Department of Medicine, Division of Nephrology, University of Rochester School of Medicine, Rochester, NY, USA

family: Bushinsky

full_name: David A Bushinsky

given: David A

name: Department of Medicine, Division of Nephrology, Stanford University, Stanford, CA, USA

family: Chertow

full_name: Glenn M Chertow

given: Glenn M

name: Clinical Development, Amgen Inc., Thousand Oaks, CA, USA

family: Cheng

full_name: Sunfa Cheng

given: Sunfa

name: Biostatistics, Amgen Inc., Thousand Oaks, CA, USA

family: Deng

full_name: Hongjie Deng

given: Hongjie

name: Department of Medicine, Division of Nephrology, Lehigh Valley Hospital, Allentown, PA, USA

family: Kopyt

full_name: Nelson Kopyt

given: Nelson

name: Department of Internal Medicine, Division of Nephrology, Saint Louis University School of Medicine, St Louis, MO, USA

family: Martin

full_name: Kevin J Martin

given: Kevin J

name: Department of Medicine, Division of Nephrology, University of California, Los Angeles, Los Angeles, CA, USA

family: Rastogi

full_name: Anjay Rastogi

given: Anjay

name: Department of Nephrology and Dialysis, Ramsay-Générale de Santé, Clinique du Landy, Saint Ouen, France and Necker Hospital, University of Paris Descartes, Paris, France

family: Ureña-Torres

full_name: Pablo Ureña-Torres

given: Pablo

name: Department of Nephrology and Amsterdam Cardiovascular Sciences, VU University Medical Center, Amsterdam, The Netherlands

family: Vervloet

full_name: Marc Vervloet

given: Marc

family: Block

full_name: Geoffrey A Block

given: Geoffrey A

journal_name: Nephrology Dialysis Transplantation

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Czechia
Poland
Israel
Hungary
Australia
Belgium
Russian Federation
Spain
Canada
United Kingdom


type: Registry Identifier

type: U.S. NIH Grant/Contract

title: A Pilot Trial of AVD and Brentuximab Vedotin (SGN-35) in the Treatment of Stage II-IV HIV-Associated Hodgkin Lymphoma

summary: This pilot phase I/II trial studies the side effects and the best dose of brentuximab vedotin when given together with combination chemotherapy and to see how well they work in treating patients with stage II-IV human immunodeficiency virus (HIV)-associated Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, called brentuximab, linked to a chemotherapy drug called vedotin. Brentuximab attaches to CD30-positive cancer cells in a targeted way and delivers vedotin to kill them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving brentuximab vedotin together with combination chemotherapy may kill more cancer cells.

ReferenceCitation: Rubinstein PG, Moore PC, Rudek MA, Henry DH, Ramos JC, Ratner L, Reid E, Sharon E, Noy A; AIDS Malignancy Consortium (AMC). Brentuximab vedotin with AVD shows safety, in the absence of strong CYP3A4 inhibitors, in newly diagnosed HIV-associated Hodgkin lymphoma. AIDS. 2018 Mar 13;32(5):605-611. doi: 10.1097/QAD.0000000000001729.

family: Rubinstein

full_name: Paul G. Rubinstein

given: Paul G.

family: Moore

full_name: Page C. Moore

given: Page C.

family: Rudek

full_name: Michelle A. Rudek

given: Michelle A.

family: Henry

full_name: David H. Henry

given: David H.

family: Ramos

full_name: Juan C. Ramos

given: Juan C.

family: Ratner

full_name: Lee Ratner

given: Lee

family: Reid

full_name: Erin Reid

given: Erin

family: Sharon

full_name: Elad Sharon

given: Elad

family: Noy

full_name: Ariela Noy

given: Ariela

journal_name: AIDS

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: National Cancer Institute (NCI)

location_country:
United States
France

location_facility: Louisiana State University Health Science Center

location_facility: Washington University School of Medicine

location_facility: Centre Hospitalier Universitaire (CHU) de Toulouse

location_facility: University of Miami Miller School of Medicine-Sylvester Cancer Center

location_facility: Montefiore Medical Center-Einstein Campus

location_facility: John H Stroger Jr Hospital of Cook County

location_facility: Siteman Cancer Center at Washington University

location_facility: UCLA / Jonsson Comprehensive Cancer Center

location_facility: University of California Davis Comprehensive Cancer Center

location_facility: Johns Hopkins University/Sidney Kimmel Cancer Center

location_facility: UCLA Center for Clinical AIDS Research and Education


title: A Randomized, Controlled Study of Sarilumab and Methotrexate (MTX) Versus Etanercept and MTX in Patients With Rheumatoid Arthritis (RA) and an Inadequate Response to 4 Months of Treatment With Adalimumab and MTX

acronym: RA-COMPARE

summary:
Primary Objective:

To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and MTX in participants with rheumatoid arthritis (RA) and an inadequate response to adalimumab and MTX by evaluation of the Disease Activity Score for 28 joints (DAS28).

Secondary Objectives:

To assess the signs and symptoms of RA in participants taking sarilumab in combination with MTX.

To assess the quality of life of participants with RA taking sarilumab in combination with MTX.

To assess the safety and tolerability of sarilumab in combination with MTX in participants with RA.

lead_sponsor: Sanofi

location_country:
Peru
Finland
Malaysia
Greece
Romania
Australia
Russian Federation
Taiwan
Ukraine
Ecuador
France
Poland
Lithuania
Thailand
Argentina
Korea, Republic of
Colombia
South Africa
Chile
Hungary
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Latvia

location_facility:
Investigational Site Number 218003
Investigational Site Number 158011
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Investigational Site Number 170040
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Investigational Site Number 840202
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Investigational Site Number 250007
Investigational Site Number 616056


title: An International Observational Prospective Study On Long-Term Response To Botulinum Toxin Type A (BoNT-A) Injections In Subjects Suffering From Idiopathic Cervical Dystonia (CD) - Pharmaco-Economic Impact

summary: The purpose of the study is to document long-term response in real-life practice after injection cycles with BoNT-A in subjects suffering from idiopathic cervical dystonia (Long-term clinical and pharmaco-economic data).

ReferenceCitation: Trosch RM, Misra VP, Maisonobe P, Om S. Impact of abobotulinumtoxinA on the clinical features of cervical dystonia in routine practice. Clin Park Relat Disord. 2020 Jun 15;3:100063. doi: 10.1016/j.prdoa.2020.100063. eCollection 2020.

family: Trosch

full_name: Richard M. Trosch

given: Richard M.

family: Misra

full_name: Vijay P. Misra

given: Vijay P.

family: Maisonobe

full_name: Pascal Maisonobe

given: Pascal

family: Om

full_name: Savary Om

given: Savary

journal_name: Clinical Parkinsonism & Related Disorders

repository_institution: Imperial College London - Spiral

lead_sponsor: Ipsen

location_country:
Jordan
Malaysia
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Poland
Thailand
Slovenia
Korea, Republic of
Turkey
Sweden
United Arab Emirates
Philippines
Singapore
Hungary
Algeria
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Lebanon
Mexico
Czechia
Israel
Estonia
Latvia

location_facility: Medical University of Vienna Spitalgasse 23

location_facility: Hospital General Dr. Santiago Ramón y Cajal

location_facility: State Federal Budgetary Institution Scientific Center of Neurology RAMS

location_facility: Istanbul University Cerrahpaşa Medical Faculty

location_facility: Pusan National University Yangsan Hospital

location_facility: National Rehabilitation center "Vaivari"

location_facility: Centro de Rehabilitación Integral de Querétaro

location_facility: State Institution "Interregional clinical diagnostic centre"

location_facility: P. Stradins Clinical University hospital

location_facility: CHRU Lyon Est Hôpital Neurologique et Neurochirurgical Pierre Wertheimer

location_facility: Hospital das Clínicas, Universidade Federal de Minas Gerais

location_facility: Tartu University Hospital, Neurology Clinic

location_facility: Spitalul Universitar de Urgenta Bucuresti, neurologie

location_facility: State Educational Institution of high professional education "St-Peterbusrg state medical university named after I.P. Pavlov of Roszdrav"

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Seoul National University Bundang Hospital

location_facility: Policlinico Umberto I, Università La Sapienza

location_facility: State Educational Institution of high professional education "Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky of the Ministry of Health and Social Development of Russia"

location_facility: Centre Hospitalier Universitaire Notre Dame de Secours

location_facility: Instituto Nacional de Neurología y Neurocirugía "Manuel Velasco Suárez"

location_facility: Department of Neurology 1st LF UK and VFN

location_facility: Spitalul Clinic Judetean de Urgenta Timisoara, neurologie II

location_facility: The Parkinson's and Movement Disorders Center

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro

location_facility: Parkinson's and Movement Disorders Center of Maryland

location_facility: Instituto de Medicina Física e Reabilitaçao

intervention_type: Biological