title: A Phase 3 Open-label Safety Study of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen in HIV-1 Positive Patients With Mild to Moderate Renal Impairment

summary: The primary objective of this study is to evaluate the effect of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) tablet on renal parameters at Week 24 in treatment-naive and treatment-experienced HIV-positive, adults with mild to moderate renal impairment.

ReferenceCitation: Pozniak A, Arribas JR, Gathe J, Gupta SK, Post FA, Bloch M, Avihingsanon A, Crofoot G, Benson P, Lichtenstein K, Ramgopal M, Chetchotisakd P, Custodio JM, Abram ME, Wei X, Cheng A, McCallister S, SenGupta D, Fordyce MW; GS-US-292-0112 Study Team. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2016 Apr 15;71(5):530-7. doi: 10.1097/QAI.0000000000000908.

repository_institution: PubMed Central - Europe PMC

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repository_institution: Indiana University - IUScholarWorks

repositories_concat: PubMed Central;scholarworks.iupui.edu

ReferenceCitation: Post FA, Tebas P, Clarke A, Cotte L, Short WR, Abram ME, Jiang S, Cheng A, Das M, Fordyce MW. Brief Report: Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Adults With Renal Impairment: 96-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. J Acquir Immune Defic Syndr. 2017 Feb 1;74(2):180-184. doi: 10.1097/QAI.0000000000001186.

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

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Australia
Netherlands
Mexico
United States
Spain
Thailand
Dominican Republic
France

location_facility: The Kansas City Care Clinic (KC Free Health Clinic)

location_facility: Long Beach Education and Research Consultants

location_facility: HIV-NAT, Thai Red Cross AIDS Research Centre

location_facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca

location_facility: Germans Trias i Pujol University Hospital

location_facility: Chelsea and Westminster NHS Foundation Trust Hospital

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Instituto Dominicano de Estudios Virologicos (IDEV)

location_facility: Faculty of Medicine Ramathibodi Hospital, Mahidol University

location_facility: North Shore University Hospital/Division of Infectious Diseases

location_facility: Desert Medical Group Inc. dba Desert Oasis Healthcare Medical Group

location_facility: University of PA HIV Clinical Trials Unit

location_facility: Clinical Research Infectious Diseases Department- Alfred Hospital

location_facility: Maricopa Integrated Health System - McDowell Clinic

location_facility: Community Research Initiative of New England

location_facility: Department of Preventive and Social Medicine, Faculty of Medicine, Siriraj Hospital

location_facility: LA Gay & Lesbian Center - Jeffrey Goodman Special Care Clinic

location_facility: North Texas Infectious Diseases Consultants, PA

location_facility: GHPS Service des maladies infectieuses et tropicales pavillon Laveran unité de recherche clinique

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Brighton & Sussex University Hospitals NHS Trust

location_facility: Central Manchester University Hospitals NHS foundation Trust


title: Master Study for the MRI Compatibility of the Solia S and Solia T Pacing Lead, the Linoxsmart ProMRI and Linoxsmart ProMRI DF4 ICD (Implantable Cardioverter-defibrillator) Lead and the Corox ProMRI OTW Coronary Sinus Lead in Combination With the Ilesto/Iforia ICD or the Evia/Entovis Triple Chamber Pacemaker

summary: This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

lead_sponsor: Biotronik SE & Co. KG

location_country:
Germany
Hungary
Australia
Switzerland
Austria
Canada
Czech Republic
France

location_facility: CHUS - Centre hospitalier universitaire de Sherbrooke

location_facility: Schwarzwald Baar Klinikum Villingen Schwenningen

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Completed


title: Intensive Enteral Nutrition in Association With Corticosteroids in Severe Acute Alcoholic Hepatitis: a Multicenter, Randomized, Controlled Trial

summary: To evaluate the effect of an intensive enteral nutrition (compared to clinical routine) in association with corticosteroïds in patients with severe acute alcoholic hepatitis.

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Moreno C, Deltenre P, Senterre C, Louvet A, Gustot T, Bastens B, Hittelet A, Piquet MA, Laleman W, Orlent H, Lasser L, Serste T, Starkel P, De Koninck X, Negrin Dastis S, Delwaide J, Colle I, de Galocsy C, Francque S, Langlet P, Putzeys V, Reynaert H, Degre D, Trepo E. Intensive Enteral Nutrition Is Ineffective for Patients With Severe Alcoholic Hepatitis Treated With Corticosteroids. Gastroenterology. 2016 Apr;150(4):903-10.e8. doi: 10.1053/j.gastro.2015.12.038. Epub 2016 Jan 5.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

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

host_type: repository

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

repository_normalized: irua

version: acceptedVersion

unpaywall_oa_status: bronze

publisher_dissemination: Elsevier

lead_sponsor: Erasme University Hospital

location_country: Belgium France

location_facility:
Hôpital Ambroise Paré
CHU Saint-Pierre
Cliniques universitaires Saint-Luc
AZ VUB
AZ Brugge
CHR Saint Joseph-Warquignies
Erasme University Hospital
Hôpital de Jolimont
Hôpitaux Iris-Sud
UZ Gent
Hôpital Saint-Joseph
UZ Antwerpen
CHU Caen
KU Leuven
ULG Sart Tilman
CHU Brugmann
CHR La Citadelle
Hôpital Ottignies
CHU Lille

intervention_type: Dietary Supplement

lead_sponsor_type: academique


title: A Double-blind, Randomized, Placebo and Ezetimibe-controlled, Multicenter Study to Evaluate Safety and Efficacy of Lipid Lowering Monotherapy With AMG 145 in Subjects With a 10-Year Framingham Risk Score of 10% or Less

summary: The primary objective was to evaluate the effect of 12 weeks of evolocumab subcutaneous (SC) monotherapy every 2 weeks (Q2W) and monthly (QM), compared with placebo and ezetimibe, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in adults with a 10-year Framingham risk score of 10% or less.

study_start_date_type: Actual

ReferenceType: background

ReferenceCitation: Koren MJ, Lundqvist P, Bolognese M, Neutel JM, Monsalvo ML, Yang J, Kim JB, Scott R, Wasserman SM, Bays H; MENDEL-2 Investigators. Anti-PCSK9 monotherapy for hypercholesterolemia: the MENDEL-2 randomized, controlled phase III clinical trial of evolocumab. J Am Coll Cardiol. 2014 Jun 17;63(23):2531-2540. doi: 10.1016/j.jacc.2014.03.018. Epub 2014 Mar 29.

ReferenceCitation: Daviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16.

ReferenceCitation: Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20.

ReferenceCitation: Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7.

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.

ReferenceCitation: Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932.

ReferenceCitation: Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21.

ReferenceCitation: Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1.

ReferenceCitation: Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2.

ReferenceCitation: Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16.

ReferenceCitation: May HT, Muhlestein JB, Ma Y, Lopez JAG, Coll B, Nelson J. Effects of Evolocumab on the ApoA1 Remnant Ratio: A Pooled Analysis of Phase 3 Studies. Cardiol Ther. 2019 Jun;8(1):91-102. doi: 10.1007/s40119-019-0133-6. Epub 2019 Mar 9.

lead_sponsor: Amgen

location_country:
Denmark
Australia
Belgium
United States
Korea, Republic of
South Africa
Turkey
Taiwan
Canada
France

intervention_type: Drug


acronym: ARISE

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary:
This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid lipase deficiency (LAL-D) (cholesteryl ester storage disease [CESD]).

Late-onset LAL-D is an underappreciated cause of cirrhosis, liver failure and dyslipidemia. There is currently no standard treatment for LAL-D other than supportive care. Enzyme replacement therapy may be a potential new treatment option for LAL-D participants.

ReferenceCitation: Wilson DP, Friedman M, Marulkar S, Hamby T, Bruckert E. Sebelipase alfa improves atherogenic biomarkers in adults and children with lysosomal acid lipase deficiency. J Clin Lipidol. 2018 May-Jun;12(3):604-614. doi: 10.1016/j.jacl.2018.02.020. Epub 2018 Mar 9.

ReferenceCitation: Burton BK, Balwani M, Feillet F, Baric I, Burrow TA, Camarena Grande C, Coker M, Consuelo-Sanchez A, Deegan P, Di Rocco M, Enns GM, Erbe R, Ezgu F, Ficicioglu C, Furuya KN, Kane J, Laukaitis C, Mengel E, Neilan EG, Nightingale S, Peters H, Scarpa M, Schwab KO, Smolka V, Valayannopoulos V, Wood M, Goodman Z, Yang Y, Eckert S, Rojas-Caro S, Quinn AG. A Phase 3 Trial of Sebelipase Alfa in Lysosomal Acid Lipase Deficiency. N Engl J Med. 2015 Sep 10;373(11):1010-20. doi: 10.1056/NEJMoa1501365.

ReferenceCitation: Burton BK, Feillet F, Furuya KN, Marulkar S, Balwani M. Sebelipase alfa in children and adults with lysosomal acid lipase deficiency: Final results of the ARISE study. J Hepatol. 2022 Mar;76(3):577-587. doi: 10.1016/j.jhep.2021.10.026. Epub 2021 Nov 10.

oa_host_type: closed

repositories_concat: closed

ReferenceCitation: Valayannopoulos V, Malinova V, Honzik T, Balwani M, Breen C, Deegan PB, Enns GM, Jones SA, Kane JP, Stock EO, Tripuraneni R, Eckert S, Schneider E, Hamilton G, Middleton MS, Sirlin C, Kessler B, Bourdon C, Boyadjiev SA, Sharma R, Twelves C, Whitley CB, Quinn AG. Sebelipase alfa over 52 weeks reduces serum transaminases, liver volume and improves serum lipids in patients with lysosomal acid lipase deficiency. J Hepatol. 2014 Nov;61(5):1135-42. doi: 10.1016/j.jhep.2014.06.022. Epub 2014 Jun 30.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: University of California - eScholarship University of California

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central

unpaywall_oa_status: hybrid

title: A Multicenter, Randomized, Placebo-controlled Study of SBC-102 in Patients With Lysosomal Acid Lipase Deficiency

source: euctr

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Australia
Japan
Mexico
United States
Spain
Turkey
Croatia
Czechia
Russian Federation
France


type: Other Identifier

type: EudraCT Number

title: An Open-Label, Four-Part, Phase I/II Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the MEK Inhibitor GSK1120212, BRAF Inhibitor GSK2118436 and the Anti-EGFR Antibody Panitumumab in Combination in Subjects With BRAF-mutation V600E Positive Colorectal Cancer and in Subjects With CRC With Secondary Resistance to Prior Anti-EGFR Therapy

summary: This was a four part, phase I/II study aimed to evaluate the safety, tolerability and efficacy of combination of an anti-EGFR antibody panitumumab (P) either with a BRAF inhibitor (dabrafenib (D); GSK2118436) alone or with the combination of a BRAF inhibitor and a MEK inhibitor (trametinib (T); GSK1120212) in patients with BRAF-mutant V600E advanced or mCRC. The goal was to: 1) Determine RP2R/MTD for doublet (D+P) and triplet (D+T+P) combinations in Part 1; 2) Assess clinical activity for these combinations in Part 2; 3) Determine RP2R/MTD for double (T+P) combination in Part 4A, and assess clinical activity of this combination in two patient populations in Part 4B (patients with BRAF-V600E mutation-positive advanced or metastatic CRC and patients with advanced or metastatic CRC with secondary resistance to anti-EGFR therapy).

ipd_sharing: Yes

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
United Kingdom
Japan
Netherlands
Belgium
United States
Spain
France


title: A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

summary: This Phase IIa international multicenter, open-label, uncontrolled study will evaluate the safety and pharmacokinetics of rituximab (MabThera/Rituxan) in pediatric participants with severe granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). Participants will receive rituximab 375 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8, 15 and 22.

design_allocation: Non-Randomized

ReferenceCitation: Melega S, Brogan P, Cleary G, Hersh AO, Kasapcopur O, Rangaraj S, Yeung RSM, Zeft A, Cooper J, Pordeli P, Kirchner P, Lehane PB. Evaluation of Serious Infection in Pediatric Patients with Low Immunoglobulin Levels Receiving Rituximab for Granulomatosis with Polyangiitis or Microscopic Polyangiitis. Rheumatol Ther. 2022 Apr;9(2):721-734. doi: 10.1007/s40744-022-00433-0. Epub 2022 Mar 12.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

license: cc-by

license_normalized: cc-by

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: Brogan P, Yeung RSM, Cleary G, Rangaraj S, Kasapcopur O, Hersh AO, Li S, Paripovic D, Schikler K, Zeft A, Bracaglia C, Eleftheriou D, Pordeli P, Melega S, Jamois C, Gaudreault J, Michalska M, Brunetta P, Cooper JC, Lehane PB; PePRS Study Group. Phase IIa Global Study Evaluating Rituximab for the Treatment of Pediatric Patients With Granulomatosis With Polyangiitis or Microscopic Polyangiitis. Arthritis Rheumatol. 2022 Jan;74(1):124-133. doi: 10.1002/art.41901. Epub 2021 Dec 5.

oa_host_type: repository

unpaywall_oa_status: green

publisher_dissemination: Wiley

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
United Kingdom
United States
Turkey
Canada
Serbia
France

location_facility: Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie

location_facility: Alder Hey Children s Hospital; Department of Pediatrics

location_facility: The Hospital for Sick Children Research Institute

location_facility: The Cleveland Clinic Foundation; Rheumatic and Immunologic Diseases

location_facility: University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit

location_facility: Children's and Women's Health Center / BC Children's Hospital

location_facility: Univ. Di Padova - Dip. Di Pediatria - Unita' Reumatol. Pediatrica

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS

location_facility: University of Utah; Immunology/Rheumatology/Allergy

location_facility: Universitätsklinikum für Kinder und Jugendmedizin Hamburg

location_facility: Hacettepe University, School of Medicine; Pediatrics Department

location_facility: Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina

location_facility: COLUMBIA PRESBYTERIAN MEDICAL CENTER, Research Pharmacy, William Black Medical Research Building

location_facility: Great Ormond Street Children's Hospital; Centre of Paediatric & Adolescent Rheumatology

location_facility: KfH-Nierenzentrum fur Kinder und Jugendliche

location_facility: Istanbul University, Cerrahpasa Medical Faculty; Pediatrics Department


acronym: Phase I study of LDK378 in pediatric malignancies with a genetic alteration in ALK

summary: The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.

ReferenceCitation: Fischer M, Moreno L, Ziegler DS, Marshall LV, Zwaan CM, Irwin MS, Casanova M, Sabado C, Wulff B, Stegert M, Wang L, Hurtado FK, Branle F, Geoerger B, Schulte JH. Ceritinib in paediatric patients with anaplastic lymphoma kinase-positive malignancies: an open-label, multicentre, phase 1, dose-escalation and dose-expansion study. Lancet Oncol. 2021 Dec;22(12):1764-1776. doi: 10.1016/S1470-2045(21)00536-2. Epub 2021 Nov 12.

ReferenceCitation: Brivio E, Zwaan CM. ALK inhibition in two emblematic cases of pediatric inflammatory myofibroblastic tumor: Efficacy and side effects. Pediatr Blood Cancer. 2019 May;66(5):e27645. doi: 10.1002/pbc.27645. Epub 2019 Jan 29.

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

repository_institution: Erasmus University Rotterdam - EUR Research Repository

location_facility: St Jude s Childrens Research Hospital Dept of Oncology

location_facility: Texas Children's Hospital Dept of Oncology

location_facility: Cincinnati Children s Hospital Medical Center Dept of Oncology

location_facility: Dana Farber Cancer Institute Dept of Onc

title: A Phase I, Open-label, Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

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

ipd_sharing: No


summary: This open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. Participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (BID), 720 mg BID, or 480 mg BID, depending on the last dose in the antecedent protocol. Treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the Medical Monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the Sponsor to terminate the study, whichever occurred first.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hadassah University Hospital - Ein Kerem

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

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"; Chemotherapy Departement

location_facility: University of Pennsylvania Health System

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

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Cancercare Langenhoven Drive Oncology Centre

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

location_facility: Mary Crowley Medical Research Center; Oncology

location_facility: University of Chicago Medical Center; Medicine, Section of Pulmonary

location_facility: Hospital General Universitario de Valencia

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Chaim Sheba Medical Center; Allergy and Clinical Immunology Unit

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Moscow city oncology hospital #62 of Moscow Healthcare Department

location_facility: Massachusetts General Hospital Cancer Center

location_facility: Hospital Regional Universitario de Malaga; Oncologia

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

location_facility: Hospital General Universitario Santa Lucia

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Siouxland Regional Cancer Center d/b/a June E. Nylen Cancer Center

location_facility: New York University Medical Center PRIME

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

location_facility: University General Hospital of Heraklion

location_facility: SBIH " Clinical Oncological Dispensary # 1"; Chemotherapy department #1 and #2

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

location_facility: Debreceni Egyetem Klinikai Központ; Bőrgyógyászati Klinika

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

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

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

location_facility: Kyungpook National University Chilgok Hospital

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Azienda Ospedaliero Universitaria Pisana

title: An Open-Label, Extension (Rollover) Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol

location_country:
Germany
New Zealand
Brazil
Bosnia and Herzegovina
Croatia
Canada
Serbia
France
Belarus
Portugal
Hungary
United States
Romania
Belgium
Egypt
Italy
Cyprus
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
South Africa
Russian Federation
Israel


title: A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ISIS 420915 in Patients With Familial Amyloid Polyneuropathy (NEURO-TTR Study)

summary: The purpose of this study is to evaluate the efficacy and safety of inotersen given for 65 weeks in participants with Familial Amyloid Polyneuropathy (FAP).

ReferenceType: result

ReferenceCitation: Benson MD, Waddington-Cruz M, Berk JL, Polydefkis M, Dyck PJ, Wang AK, Plante-Bordeneuve V, Barroso FA, Merlini G, Obici L, Scheinberg M, Brannagan TH 3rd, Litchy WJ, Whelan C, Drachman BM, Adams D, Heitner SB, Conceicao I, Schmidt HH, Vita G, Campistol JM, Gamez J, Gorevic PD, Gane E, Shah AM, Solomon SD, Monia BP, Hughes SG, Kwoh TJ, McEvoy BW, Jung SW, Baker BF, Ackermann EJ, Gertz MA, Coelho T. Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):22-31. doi: 10.1056/NEJMoa1716793.

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

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

repositories_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Karam C, Brown D, Yang M, Done N, Zhu JJ, Greatsinger A, Bozas A, Vera-Llonch M, Signorovitch J. Long-term treatment effects of inotersen on health-related quality of life in patients with hATTR amyloidosis with polyneuropathy: Analysis of the open-label extension of the NEURO-TTR trial. Muscle Nerve. 2022 Oct;66(4):438-446. doi: 10.1002/mus.27675. Epub 2022 Aug 4.

ReferenceCitation: Karam C, Brown D, Yang M, Done N, Dieye I, Bozas A, Vera Llonch M, Signorovitch J. Factors associated with increased health-related quality-of-life benefits in hereditary transthyretin amyloidosis polyneuropathy patients treated with inotersen. Muscle Nerve. 2022 Sep;66(3):319-328. doi: 10.1002/mus.27668. Epub 2022 Jul 15.

ReferenceCitation: Yarlas A, Lovley A, McCausland K, Brown D, Vera-Llonch M, Conceicao I, Karam C, Khella S, Obici L, Waddington-Cruz M. Early Data on Long-term Impact of Inotersen on Quality-of-Life in Patients with Hereditary Transthyretin Amyloidosis Polyneuropathy: Open-Label Extension of NEURO-TTR. Neurol Ther. 2021 Dec;10(2):865-886. doi: 10.1007/s40120-021-00268-x. Epub 2021 Aug 5.

ReferenceCitation: Yarlas A, Lovley A, Brown D, Kosinski M, Vera-Llonch M. Responder analysis for neuropathic impairment and quality-of-life assessment in patients with hereditary transthyretin amyloidosis with polyneuropathy in the NEURO-TTR study. J Neurol. 2022 Jan;269(1):323-335. doi: 10.1007/s00415-021-10635-1. Epub 2021 Jun 14.

ReferenceCitation: Yu RZ, Wang Y, Norris DA, Kim TW, Narayanan P, Geary RS, Monia BP, Henry SP. Immunogenicity Assessment of Inotersen, a 2'-O-(2-Methoxyethyl) Antisense Oligonucleotide in Animals and Humans: Effect on Pharmacokinetics, Pharmacodynamics, and Safety. Nucleic Acid Ther. 2020 Oct;30(5):265-275. doi: 10.1089/nat.2020.0867. Epub 2020 Aug 19.

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Dyck PJB, Kincaid JC, Wiesman JF, Polydefkis M, Litchy WJ, Mauermann ML, Ackermann EJ, Guthrie S, Pollock M, Jung SW, Baker BF, Dyck PJ. mNIS+7 and lower limb function in inotersen treatment of hereditary transthyretin-mediated amyloidosis. Muscle Nerve. 2020 Oct;62(4):502-508. doi: 10.1002/mus.27022. Epub 2020 Aug 13.

ReferenceCitation: Dyck PJB, Coelho T, Waddington Cruz M, Brannagan TH 3rd, Khella S, Karam C, Berk JL, Polydefkis MJ, Kincaid JC, Wiesman JF, Litchy WJ, Mauermann ML, Ackermann EJ, Baker BF, Jung SW, Guthrie S, Pollock M, Dyck PJ. Neuropathy symptom and change: Inotersen treatment of hereditary transthyretin amyloidosis. Muscle Nerve. 2020 Oct;62(4):509-515. doi: 10.1002/mus.27023. Epub 2020 Aug 7.

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

ReferenceCitation: Coelho T, Yarlas A, Waddington-Cruz M, White MK, Sikora Kessler A, Lovley A, Pollock M, Guthrie S, Ackermann EJ, Hughes SG, Karam C, Khella S, Gertz M, Merlini G, Obici L, Schmidt HH, Polydefkis M, Dyck PJB, Brannagan Iii TH, Conceicao I, Benson MD, Berk JL. Inotersen preserves or improves quality of life in hereditary transthyretin amyloidosis. J Neurol. 2020 Apr;267(4):1070-1079. doi: 10.1007/s00415-019-09671-9. Epub 2019 Dec 18.

ReferenceCitation: Pinto MV, Dyck PJB, Gove LE, McCauley BM, Ackermann EJ, Hughes SG, Waddington-Cruz M, Dyck PJ. Kind and distribution of cutaneous sensation loss in hereditary transthyretin amyloidosis with polyneuropathy. J Neurol Sci. 2018 Nov 15;394:78-83. doi: 10.1016/j.jns.2018.08.031. Epub 2018 Aug 30.

ReferenceCitation: Waddington-Cruz M, Ackermann EJ, Polydefkis M, Heitner SB, Dyck PJ, Barroso FA, Wang AK, Berk JL, Dyck PJB, Monia BP, Hughes SG, Tai L, Jesse Kwoh T, Jung SW, Coelho T, Benson MD, Gertz MA. Hereditary transthyretin amyloidosis: baseline characteristics of patients in the NEURO-TTR trial. Amyloid. 2018 Sep;25(3):180-188. doi: 10.1080/13506129.2018.1503593. Epub 2018 Aug 31.

repository_institution: University of Illinois at Chicago - INDIGO

location_country:
Germany
Italy
Portugal
New Zealand
United Kingdom
Argentina
Brazil
United States
Spain
France

location_facility: UKM; Universitätsklinikum Münster, Klinik für Transplantationsmedizin

location_facility: University College London - National Amyloidosis Centre

location_facility: Federal University of Rio de Janeiro - University Hospital

location_facility: Johns Hopkins University Bayview Medical Center

location_facility: Universita Degli Studi Di Messina - Azienda Ospedaliera Universitaria Policlinico "Gaetano Martino"

location_facility: CHU Bicetre Aphp French Referral Center for FAP/Cornamyl Network

location_facility: CHU Henri Mondor - Department of Neurology

location_facility: Boston University School of Medicine - Amyloid Treatment & Research Program

location_facility: CHP-HGSA, Unidade Clinica de Paramiloidose

location_facility: Columbia University Medical Center - The Neurological Institute

location_facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche - Fondazione IRCCS Policlinico San Matteo


summary: The purpose of this study is to allow continued use of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs (CD&MA) study and are benefiting from the treatment as judged by the investigator

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

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 https://www.clinicalstudydatarequest.com/.

location_country:
Italy
Slovakia
Hungary
Hong Kong
Israel
Singapore
Sweden
Netherlands
Austria
United Kingdom
United States
Korea, Republic of
Spain
Canada
Russian Federation
France


title: A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin

summary: To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.

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

oa_host_type: publisher

publisher_dissemination: Oxford University Press

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

repositories_concat: PubMed Central;www.repositoriosalud.es

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

evidence: open (via page says license)

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

repository_institution: Imperial College London - Spiral

version: submittedVersion

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Farnier M, Jones P, Severance R, Averna M, Steinhagen-Thiessen E, Colhoun HM, Du Y, Hanotin C, Donahue S. Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial. Atherosclerosis. 2016 Jan;244:138-46. doi: 10.1016/j.atherosclerosis.2015.11.010. Epub 2015 Nov 14.

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Robinson JG, Colhoun HM, Bays HE, Jones PH, Du Y, Hanotin C, Donahue S. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies. Clin Cardiol. 2014 Oct;37(10):597-604. doi: 10.1002/clc.22327. Epub 2014 Sep 30.

repository_institution: University of Dundee - Discovery Research Portal

location_country:
Germany
Italy
United Kingdom
Australia
Mexico
United States
Spain
Canada
France


title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 232 in Adult Subjects With Advanced Solid Tumors or Multiple Myeloma

summary: First in human, open-label, sequential dose escalation and expansion study of AMG 232 in subjects with advanced solid tumors or multiple myeloma

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
United States
Netherlands
France

location_facility:
Research Site
Greenville Hospital System


title: A Phase Ib/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients With BRAF Mutant Metastatic Colorectal Cancer

summary: This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer

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

location_country:
Germany
Italy
Norway
Australia
Japan
Netherlands
Belgium
United States
Korea, Republic of
Spain
Canada
France

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: University of Utah - Huntsman Cancer Institute - PPDS

location_facility: Redwood Health Center - ARUP Lab Draw Location

location_facility: Sir Mortimer B. Davis Jewish General Hospital

location_facility: Pharmacy of National Cancer Center Hospital East

location_facility: UCLA University of California Los Angeles

location_facility: Smilow Cancer Hospital Care Center at North Haven

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Ospedaliero Universitaria di Modena Policlinico

location_facility: UCLA Santa Monica Medical Center & Orthopaedic Hospital

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Westwood Bowyer Clinic, Peter Morton Medical Building

location_facility: Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON


title: A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR Mutation

acronym: KONTINUE

summary: The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).

ReferenceCitation: Pilewski JM, De Boeck K, Nick JA, Tian S, DeSouza C, Higgins M, Moss RB. Long-Term Ivacaftor in People Aged 6 Years and Older with Cystic Fibrosis with Ivacaftor-Responsive Mutations. Pulm Ther. 2020 Dec;6(2):303-313. doi: 10.1007/s41030-020-00129-2. Epub 2020 Sep 23.

ReferenceCitation: Moss RB, Flume PA, Elborn JS, Cooke J, Rowe SM, McColley SA, Rubenstein RC, Higgins M; VX11-770-110 (KONDUCT) Study Group. Efficacy and safety of ivacaftor in patients with cystic fibrosis who have an Arg117His-CFTR mutation: a double-blind, randomised controlled trial. Lancet Respir Med. 2015 Jul;3(7):524-33. doi: 10.1016/S2213-2600(15)00201-5. Epub 2015 Jun 9.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Vertex Pharmaceuticals Incorporated

sponsor_collaborators:
Vertex Pharmaceuticals Incorporated
Cystic Fibrosis Foundation

location_country:
United States
United Kingdom
Belgium
France


title: A Phase 1 Study of LY3039478 in Patients With Advanced or Metastatic Cancer

summary: The purpose of this study is to find a recommended dose level of LY3039478 that can safely be taken by participants with advanced cancer or cancer that has spread to other parts of the body, including but not limited to lymphoma. The study will also explore changes to various markers in blood cells and tissue. Finally, the study will help to document any tumor activity this drug may have.

ReferenceCitation: Azaro A, Baldini C, Rodon J, Soria JC, Yuen E, Lithio A, Oakley G, Benhadji KA, Massard C. Phase 1 study of 2 high dose intensity schedules of the pan-Notch inhibitor crenigacestat (LY3039478) in combination with prednisone in patients with advanced or metastatic cancer. Invest New Drugs. 2021 Feb;39(1):193-201. doi: 10.1007/s10637-020-00944-z. Epub 2020 Sep 11.

ReferenceCitation: Mir O, Azaro A, Merchan J, Chugh R, Trent J, Rodon J, Ohnmacht U, Diener JT, Smith C, Yuen E, Oakley GJ 3rd, Le Cesne A, Soria JC, Benhadji KA, Massard C. Notch pathway inhibition with LY3039478 in soft tissue sarcoma and gastrointestinal stromal tumours. Eur J Cancer. 2018 Nov;103:88-97. doi: 10.1016/j.ejca.2018.08.012. Epub 2018 Sep 12.

ReferenceCitation: Massard C, Azaro A, Soria JC, Lassen U, Le Tourneau C, Sarker D, Smith C, Ohnmacht U, Oakley G, Patel BKR, Yuen ESM, Benhadji KA, Rodon J. First-in-human study of LY3039478, an oral Notch signaling inhibitor in advanced or metastatic cancer. Ann Oncol. 2018 Sep 1;29(9):1911-1917. doi: 10.1093/annonc/mdy244.

repository_institution: King's College London - Research Portal

repository_normalized: Pure (Denmark)

repositories_concat: Pure (Denmark)

lead_sponsor: Eli Lilly and Company

location_country:
Germany
United Kingdom
Denmark
United States
Spain
France

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 Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

summary: This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.

ReferenceCitation: Gavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21.

ReferenceCitation: Sheth S, Gao C, Mueller N, Angra N, Gupta A, Germa C, Martinez P, Soria JC. Durvalumab activity in previously treated patients who stopped durvalumab without disease progression. J Immunother Cancer. 2020 Aug;8(2):e000650. doi: 10.1136/jitc-2020-000650.

publisher_dissemination: British Medical Journal

ReferenceCitation: Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

repositories_institution: University of Illinois at Chicago - INDIGO

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Zajac M, Ye J, Mukhopadhyay P, Jin X, Ben Y, Antal J, Gupta AK, Rebelatto MC, Williams JA, Walker J. Optimal PD-L1-high cutoff for association with overall survival in patients with urothelial cancer treated with durvalumab monotherapy. PLoS One. 2020 Apr 27;15(4):e0231936. doi: 10.1371/journal.pone.0231936. eCollection 2020.

ReferenceCitation: Nordstrom BL, Oguz M, Chu BC, Ouwens M, Arkenau HT, Klein AB. Effectiveness of durvalumab versus chemotherapy in metastatic urothelial cancer: an observational, indirect comparison. J Comp Eff Res. 2020 Feb;9(3):191-199. doi: 10.2217/cer-2019-0163. Epub 2020 Jan 9.

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Antonia SJ, Balmanoukian A, Brahmer J, Ou SI, Hellmann MD, Kim SW, Ahn MJ, Kim DW, Gutierrez M, Liu SV, Schoffski P, Jager D, Jamal R, Jerusalem G, Lutzky J, Nemunaitis J, Calabro L, Weiss J, Gadgeel S, Bhosle J, Ascierto PA, Rebelatto MC, Narwal R, Liang M, Xiao F, Antal J, Abdullah S, Angra N, Gupta AK, Khleif SN, Segal NH. Clinical Activity, Tolerability, and Long-Term Follow-Up of Durvalumab in Patients With Advanced NSCLC. J Thorac Oncol. 2019 Oct;14(10):1794-1806. doi: 10.1016/j.jtho.2019.06.010. Epub 2019 Jun 20.

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

ReferenceCitation: Althammer S, Tan TH, Spitzmuller A, Rognoni L, Wiestler T, Herz T, Widmaier M, Rebelatto MC, Kaplon H, Damotte D, Alifano M, Hammond SA, Dieu-Nosjean MC, Ranade K, Schmidt G, Higgs BW, Steele KE. Automated image analysis of NSCLC biopsies to predict response to anti-PD-L1 therapy. J Immunother Cancer. 2019 May 6;7(1):121. doi: 10.1186/s40425-019-0589-x.

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

ReferenceCitation: Segal NH, Ou SI, Balmanoukian A, Fury MG, Massarelli E, Brahmer JR, Weiss J, Schoffski P, Antonia SJ, Massard C, Zandberg DP, Khleif SN, Xiao F, Rebelatto MC, Steele KE, Robbins PB, Angra N, Song X, Abdullah S, Butler M. Safety and efficacy of durvalumab in patients with head and neck squamous cell carcinoma: results from a phase I/II expansion cohort. Eur J Cancer. 2019 Mar;109:154-161. doi: 10.1016/j.ejca.2018.12.029. Epub 2019 Feb 4.

ReferenceCitation: Zajac M, Boothman AM, Ben Y, Gupta A, Jin X, Mistry A, Sabalos C, Nielsen A, Manriquez G, Barker C, Antal J, Wang P, Patil P, Schechter N, Rebelatto MC, Walker J. Analytical Validation and Clinical Utility of an Immunohistochemical Programmed Death Ligand-1 Diagnostic Assay and Combined Tumor and Immune Cell Scoring Algorithm for Durvalumab in Urothelial Carcinoma. Arch Pathol Lab Med. 2019 Jun;143(6):722-731. doi: 10.5858/arpa.2017-0555-OA. Epub 2018 Nov 20.

publisher_dissemination: Archives of Pathology and Laboratory Medicine

ReferenceCitation: Steele KE, Tan TH, Korn R, Dacosta K, Brown C, Kuziora M, Zimmermann J, Laffin B, Widmaier M, Rognoni L, Cardenes R, Schneider K, Boutrin A, Martin P, Zha J, Wiestler T. Measuring multiple parameters of CD8+ tumor-infiltrating lymphocytes in human cancers by image analysis. J Immunother Cancer. 2018 Mar 6;6(1):20. doi: 10.1186/s40425-018-0326-x.

ReferenceCitation: Powles T, O'Donnell PH, Massard C, Arkenau HT, Friedlander TW, Hoimes CJ, Lee JL, Ong M, Sridhar SS, Vogelzang NJ, Fishman MN, Zhang J, Srinivas S, Parikh J, Antal J, Jin X, Gupta AK, Ben Y, Hahn NM. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017 Sep 14;3(9):e172411. doi: 10.1001/jamaoncol.2017.2411. Epub 2017 Sep 14.

ReferenceCitation: Levy A, Massard C, Soria JC, Deutsch E. Concurrent irradiation with the anti-programmed cell death ligand-1 immune checkpoint blocker durvalumab: Single centre subset analysis from a phase 1/2 trial. Eur J Cancer. 2016 Nov;68:156-162. doi: 10.1016/j.ejca.2016.09.013. Epub 2016 Oct 17.

location_country:
Germany
Italy
United Kingdom
Belgium
United States
Korea, Republic of
Taiwan
Canada
France


summary: A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator

ReferenceCitation: Hida T, Satouchi M, Nakagawa K, Seto T, Matsumoto S, Kiura K, Nokihara H, Murakami H, Tokushige K, Hatano B, Nishio M. Ceritinib in patients with advanced, crizotinib-treated, anaplastic lymphoma kinase-rearranged NSCLC: Japanese subset. Jpn J Clin Oncol. 2017 Jul 1;47(7):618-624. doi: 10.1093/jjco/hyx045.

ReferenceCitation: Crino L, Ahn MJ, De Marinis F, Groen HJ, Wakelee H, Hida T, Mok T, Spigel D, Felip E, Nishio M, Scagliotti G, Branle F, Emeremni C, Quadrigli M, Zhang J, Shaw AT. Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol. 2016 Aug 20;34(24):2866-73. doi: 10.1200/JCO.2015.65.5936. Epub 2016 Jul 18.

repository_institution: University of Turin - Institutional Research Information System University of Turin

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: University of California at San Diego, Moores Cancer Ctr SC

location_facility: Stanford University Medical Center Stanford Cancer Center(2)

location_facility: University of California at Los Angeles Reg-5

location_facility: Sarah Cannon Research Institute Drug Ship - 4

location_facility: U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept of Oncology

location_facility: City of Hope National Medical Center Dept of Oncology 2

location_facility: University of Kansas Cancer Center DeptofUofKansas CancerCenter-2

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Massachusetts General Hospital Mass General

title: A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib

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


title: A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis

acronym: EYEGUARD™-A

summary: The purpose of this study is to evaluate the efficacy of gevokizumab in the treatment of active non-infectious intermediate, posterior, or pan- uveitis.

status: Terminated

lead_sponsor: XOMA (US) LLC

collaborators: Institut de Recherches Internationales Servier

location_country:
Germany
Poland
Argentina
Australia
Brazil
Armenia
Turkey
France
Portugal
United States
Tunisia
China
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

status_simplified: Unknown


title: A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study

acronym: eMESH 1

summary: Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

status: Unknown status

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Kips Bay Medical, Inc.

location_country:
Italy
United Kingdom
Netherlands
Switzerland
United States
Czech Republic
France

location_facility: Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research


title: Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

acronym: CAPTURE

summary:
To monitor post-market performance through evaluation of short and long-term performance via:

Efficacy
Safety
Patient reported outcomes

lead_sponsor: ASTORA Women's Health

location_country:
Germany
Slovenia
United Kingdom
United States
Spain
South Africa
Canada
France

location_facility: The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre

location_facility: German Pelvic Floor Center, St. Hedwig Hospital

location_facility: Hospital Clínico y Provincial de Barcelona

location_facility: Female Pelvic Medicine Institute of Virginia


title: A Large, International, Randomized, Placebo-controlled Trial to Assess the Impact of Dabigatran (a Direct Thrombin Inhibitor) and Omeprazole (a Proton-pump Inhibitor) in Patients Suffering Myocardial Injury After Noncardiac Surgery

acronym: MANAGE

summary: Patients who have myocardial injury after noncardiac surgery are at a higher risk of dying than those who do not. One in 10 patients with myocardial injury will die within 30 days of surgery. This risk of death exists up to one year after myocardial injury. There are currently no treatments or guidelines available for heart injury after surgery, but there is evidence that taking a blood-thinner can prevent some of the deaths, both in the short and long-term. The purpose of this trial is to test the effect of two drugs (dabigatran and omeprazole) that may prevent mortality, major cardiovascular complications and major upper gastrointestinal bleeding in patients who have had myocardial injury after noncardiac surgery.

ReferenceCitation: Duceppe E, Yusuf S, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Franzosi MG, Vincent J, Srinathan SK, Parlow J, Magloire P, Neary J, Rao M, Chaudhry NK, Mayosi B, de Nadal M, Popova E, Villar JC, Botto F, Berwanger O, Guyatt G, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Connolly SJ, Sharma M, Bangdiwala SI, Devereaux PJ. Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE). Can J Cardiol. 2018 Mar;34(3):295-302. doi: 10.1016/j.cjca.2018.01.020. Epub 2018 Feb 2.

ReferenceCitation: Lamy A, Tong W, Mian R, Vincent J, Szczeklik W, Biccard BM, Duceppe E, Franzosi MG, Srinathan SK, Meyhoff CS, Parlow J, Xavier D, Devereaux PJ. The Cost Implications of Dabigatran in Patients with Myocardial Injury After Non-Cardiac Surgery. Am J Cardiovasc Drugs. 2022 Jan;22(1):83-91. doi: 10.1007/s40256-021-00489-3. Epub 2021 Jul 26.

ReferenceCitation: Devereaux PJ, Duceppe E, Guyatt G, Tandon V, Rodseth R, Biccard BM, Xavier D, Szczeklik W, Meyhoff CS, Vincent J, Franzosi MG, Srinathan SK, Erb J, Magloire P, Neary J, Rao M, Rahate PV, Chaudhry NK, Mayosi B, de Nadal M, Iglesias PP, Berwanger O, Villar JC, Botto F, Eikelboom JW, Sessler DI, Kearon C, Pettit S, Sharma M, Connolly SJ, Bangdiwala SI, Rao-Melacini P, Hoeft A, Yusuf S; MANAGE Investigators. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial. Lancet. 2018 Jun 9;391(10137):2325-2334. doi: 10.1016/S0140-6736(18)30832-8. Erratum In: Lancet. 2018 Jul 7;392(10141):30.

lead_sponsor: Population Health Research Institute

location_country:
Germany
Poland
Argentina
Australia
Brazil
Czechia
Canada
France
Colombia
Denmark
United States
Kenya
India
Peru
Philippines
Italy
United Kingdom
Spain
South Africa

location_facility: Victoria Hospital, London Health Sciences Centre

location_facility: University Hospital, London Health Sciences Centre

location_facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

location_facility: Bispebjerg Hospital, University of Copenhagen

location_facility: M.S. Ramaiah Medical College & Hospitals

location_facility: Fundacion Cardioinfantil - Instituto de Cardiologia

location_facility: Klinikum der J. W. Goethe-Universität Frankfurt

location_facility: VA North Texas Health Care System Dallas VA Medical Center

location_facility: Clinica Parra - Centro de Investigaciones

location_facility: Zakład Opieki Zdrowotnej im. Jana Pawła II

location_facility: Belfast Health and Social Care Trust, Royal Victoria Hospital

location_facility: Queens University - Kingston General Hospital

location_facility: Centre Hospitalier Universitaire de Montreal - St. Luc Hospital

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Amrita Institute of Medical Sciences and Research Institute

location_facility: Hospital e Maternidade Celso Pierro - PUCCAMP

location_facility: Specjalistyczny Szpital im. E. Szczeklika

location_facility: Copenhagen University Hospital, Rigshospitalet

location_facility: Russell Halls Hospital, Dudley Group NHS

location_facility: IRCCS Istituto Ortopedico Galeazzi Milan

location_facility: Instituto Cardiovascular de Buenos Aires


title: The REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE) Post Approval Study

acronym: PSR-REVERSE

summary: The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.

lead_sponsor: Medtronic

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


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC)

acronym: FUSCIA

summary:
Primary Objective:

To assess the efficacy of SAR339658

Secondary Objective:

To assess the safety of SAR339658

lead_sponsor: Sanofi

location_country:
Germany
Italy
Poland
Austria
United States
Canada
France

location_facility:
Investigational Site Number 840065
Investigational Site Number 840089
Investigational Site Number 276005
Investigational Site Number 616007
Investigational Site Number 840051
Investigational Site Number 840001
Investigational Site Number 616004
Investigational Site Number 616008
Investigational Site Number 250006
Investigational Site Number 616001
Investigational Site Number 380003
Investigational Site Number 840034
Investigational Site Number 840059
Investigational Site Number 840048
Investigational Site Number 840019
Investigational Site Number 840070
Investigational Site Number 124002
Investigational Site Number 840003
Investigational Site Number 616006
Investigational Site Number 840074
Investigational Site Number 840038
Investigational Site Number 840064
Investigational Site Number 840088
Investigational Site Number 040003
Investigational Site Number 276007
Investigational Site Number 616005
Investigational Site Number 840071
Investigational Site Number 840046
Investigational Site Number 840068
Investigational Site Number 840060
Investigational Site Number 840061
Investigational Site Number 276001
Investigational Site Number 616002
Investigational Site Number 840024
Investigational Site Number 840078
Investigational Site Number 840045
Investigational Site Number 380006
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840053
Investigational Site Number 840005


title: A Multicenter, Two Stage, Phase II Study, Evaluating the Efficacy of Oral BEZ235 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumors (pNET) After Failure of mTOR Inhibitor Therapy.

summary:
This is a Phase II study in 2 stages, evaluating BEZ235 plus best supportive care (BSC) versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (pNET) after failure of mTOR inhibitor therapy.

Study design: This was a Phase II, two-stage, multicenter study, where Stage 1 was a single arm, open label design and Stage 2 was planned to be a randomized, double-blind study.

However, at the end of Stage 1, the futility was met and hence the Stage 2 was not initiated.

ReferenceCitation: Fazio N, Buzzoni R, Baudin E, Antonuzzo L, Hubner RA, Lahner H, DE Herder WW, Raderer M, Teule A, Capdevila J, Libutti SK, Kulke MH, Shah M, Dey D, Turri S, Aimone P, Massacesi C, Verslype C. A Phase II Study of BEZ235 in Patients with Everolimus-resistant, Advanced Pancreatic Neuroendocrine Tumours. Anticancer Res. 2016 Feb;36(2):713-9.

location_country:
Germany
Italy
United Kingdom
Netherlands
Austria
Belgium
United States
Spain
France

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC

location_facility: Dana Farber Cancer Institute GastrointestionalCancer Clinic


title: An Open-label, Multicenter, Single-arm Study to Evaluate the Reduction in Nonpsychotic Behavioral Side Effects in Subjects With Epilepsy Switching From Levetiracetam to Brivaracetam Due to Nonpsychotic Behavioral Side Effects Phase 3b

summary: Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.

ReferenceCitation: Yates SL, Fakhoury T, Liang W, Eckhardt K, Borghs S, D'Souza J. An open-label, prospective, exploratory study of patients with epilepsy switching from levetiracetam to brivaracetam. Epilepsy Behav. 2015 Nov;52(Pt A):165-8. doi: 10.1016/j.yebeh.2015.09.005. Epub 2015 Sep 29.

lead_sponsor: UCB Pharma SA

location_country:
Germany
United Kingdom
United States
Spain
France


title: Double-blind, Randomized, 8-week Placebo-controlled, and 16-week Open-label Extension Study Investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients With Diffuse Cutaneous Systemic Sclerosis

summary:
Primary Objective:

- To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse cutaneous systemic sclerosis.

Secondary Objectives:

To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin;
To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the modified Rodnan Skin Score (mRSS);
To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ);
To document long term safety of SAR100842 during the extension part.

ReferenceCitation: Allanore Y, Distler O, Jagerschmidt A, Illiano S, Ledein L, Boitier E, Agueusop I, Denton CP, Khanna D. Lysophosphatidic Acid Receptor 1 Antagonist SAR100842 for Patients With Diffuse Cutaneous Systemic Sclerosis: A Double-Blind, Randomized, Eight-Week Placebo-Controlled Study Followed by a Sixteen-Week Open-Label Extension Study. Arthritis Rheumatol. 2018 Oct;70(10):1634-1643. doi: 10.1002/art.40547. Epub 2017 Nov 6.

repository_institution: University of Michigan - Deep Blue

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country:
Italy
United Kingdom
Switzerland
United States
France

location_facility:
Investigational Site Number 840003
Investigational Site Number 826002
Investigational Site Number 826001
Investigational Site Number 840006
Investigational Site Number 756001
Investigational Site Number 250001
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840007
Investigational Site Number 840004
Investigational Site Number 840002
Investigational Site Number 380001
Investigational Site Number 840001


title: A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis

summary: The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.

ReferenceCitation: Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.

ReferenceCitation: Taylor CJ, Thieroff-Ekerdt R, Shiff S, Magnus L, Fleming R, Gommoll C. Comparison of two pancreatic enzyme products for exocrine insufficiency in patients with cystic fibrosis. J Cyst Fibros. 2016 Sep;15(5):675-80. doi: 10.1016/j.jcf.2016.02.010. Epub 2016 Mar 21.

lead_sponsor: Forest Laboratories

location_country:
Germany
Italy
Poland
United Kingdom
Belgium
Bulgaria
France

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino, Gastroenterologia Pediatrica E Fibrosi Cistica

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Centrum Zdrowia Matki, Dziecka i Mlodziezy

location_facility: University Federico II of Naples, Pediatrics Department

location_facility: Specialized Hospital for Active Treatment of Pulmological and Phtisiatric Disease

location_facility: Ruhr-Universitaet Bochum - St. Josef Hospital

location_facility: University Hospital Antwerp - Universitair Ziekenhuis Antwerpen (UZA)

location_facility: Universitätsklinikum Essen Zentrum f.Kinderheilkunde Klinik f.Kinderheilkunde III

location_facility: Universitatsklinikum Jena, Klinik fur Kinder und Jugendmedizin

location_facility: Sheffield Children's Hospital, The Academic Unit of Child Health

location_facility: Universitaetsklinik für Kinder- und Jugendmedizin Tuebingen

location_facility: Istituto Azienda Ospedaliera Universitaria

location_facility: Azienda Ospedaliero Universitaria, Ospedali Riuniti, Ospedale Pediatrico G. Salesi

location_facility: Wojewodzki Szpital Specjalistyczny im Kopernika

location_facility: Centrum Pulmonologii i Alergologii w Karpaczu

location_facility: ALERGOTEST s.c Specjalistyczne Centrum Medyczne

location_facility: Clinic of Genetic and Paediatric Diseases at UMHAT Sveti Georgi

location_facility: Universita degli Studi di Roma La Sapienza, Azienda Policlinico Umberto I, Dipartimento di Pediatria, Centro Fibrosi Cistica Regione Lazio

location_facility: Clinic of Paediatric Diseases at UMHAT Dr Georgi Stranski

location_facility: Specjalistyczny Zespot Opieki Zdrowotnej nad Matka i Dzieckiem Poradnia Leczenia Mukowiscydozy

location_facility: Azienda Ospedaliera Universitaria Integrata, Centro Fibrosi Cistica-Ospedale Civile Maggiore

location_facility: Universitair Ziekenhuis Gent, Centrum voor Mucoviscidose

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitaetsklinikum Essen gGmbH

location_facility: Multiprofile Clinic for Specialized Pediatric Clinic at MHAT Sveta Marina

location_facility: NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii

location_facility: Bambino Gesu Hospital, Cystic Fibrosis Unit

location_facility: Clinica di Malattie dell'Apparato Respiratorio


title: A Phase 2/3, Multicenter, Open-label Clinical Study to Assess the Safety and Efficacy of BAY86-6150 in Subjects With Hemophilia A or B With Inhibitors, Composed of 2 Parts (A & B). Part A: Sequential Cohorts of Four Dose Levels of the Modified rFVIIa BAY86-6150 Assessed in a Non-controlled Dose Response Design in Acutely Bleeding Subjects and for PK/ PD in an Intra-individual Crossover Design Compared With One Fixed Dose of Eptacog Alfa in Non-bleeding Subjects. Part B: Confirmatory Study to Further Investigate the Efficacy and Safety of BAY86-6150

summary:
Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability.

The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process.

The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months.

Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study.

Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.

lead_sponsor: Bayer

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Turkey
Chile
France
Colombia
Hungary
Denmark
United States
Ukraine
India
Romania
China
Italy
United Kingdom
Singapore
Sweden
Netherlands
Mexico
Korea, Republic of
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: A Multicenter, Open-label Study to Assess the Long-term Safety, Tolerability, and Efficacy of Evolocumab (AMG145) on LDL-C in Subjects With Severe Familial Hypercholesterolemia

acronym: TAUSSIG

summary: A study to assess the long term safety and tolerability of evolocumab (AMG 145) in adolescents and adults with severe familial hypercholesterolemia.

ReferenceCitation: Raal FJ, Hovingh GK, Blom D, Santos RD, Harada-Shiba M, Bruckert E, Couture P, Soran H, Watts GF, Kurtz C, Honarpour N, Tang L, Kasichayanula S, Wasserman SM, Stein EA. Long-term treatment with evolocumab added to conventional drug therapy, with or without apheresis, in patients with homozygous familial hypercholesterolaemia: an interim subset analysis of the open-label TAUSSIG study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):280-290. doi: 10.1016/S2213-8587(17)30044-X. Epub 2017 Feb 16.

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.

ReferenceCitation: Santos RD, Stein EA, Hovingh GK, Blom DJ, Soran H, Watts GF, Lopez JAG, Bray S, Kurtz CE, Hamer AW, Raal FJ. Long-Term Evolocumab in Patients With Familial Hypercholesterolemia. J Am Coll Cardiol. 2020 Feb 18;75(6):565-574. doi: 10.1016/j.jacc.2019.12.020.

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(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.

repository_institution: University College London - UCL Discovery

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

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

ReferenceCitation: Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.

lead_sponsor: Amgen

location_country:
Italy
New Zealand
Israel
Hong Kong
United Kingdom
Australia
Brazil
Japan
Lebanon
Belgium
Netherlands
United States
Spain
Greece
South Africa
Czechia
Canada
France

intervention_type: Biological


summary: This study assessed the safety and efficacy of escalating doses INC280 when added to gefitinib in patients with lung cancer that were known to have dysregulation of the c-MET pathway and who had failed after benefiting on a prior treatment with either gefitinib or erlotinib.

ReferenceCitation: Wu YL, Zhang L, Kim DW, Liu X, Lee DH, Yang JC, Ahn MJ, Vansteenkiste JF, Su WC, Felip E, Chia V, Glaser S, Pultar P, Zhao S, Peng B, Akimov M, Tan DSW. Phase Ib/II Study of Capmatinib (INC280) Plus Gefitinib After Failure of Epidermal Growth Factor Receptor (EGFR) Inhibitor Therapy in Patients With EGFR-Mutated, MET Factor-Dysregulated Non-Small-Cell Lung Cancer. J Clin Oncol. 2018 Nov 1;36(31):3101-3109. doi: 10.1200/JCO.2018.77.7326. Epub 2018 Aug 29. Erratum In: J Clin Oncol. 2019 Jan 20;37(3):261.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

title: A Phase IB/II, Open Label, Multicenter Study of INC280 Administered Orally in Combination With Gefitinib in Adult Patients With EGFR Mutated, c-MET-amplified Non-small Cell Lung Cancer Who Have Progressed After EGFR Inhibitor Treatment

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:
Germany
Italy
Israel
Singapore
Australia
Japan
Netherlands
Belgium
Korea, Republic of
China
Spain
Thailand
Taiwan
France


title: The IN.PACT Global Clinical Study for the Treatment of Comprehensive Superficial Femoral and/or Popliteal Artery Lesions Using the IN.PACT Admiral™ Drug-Eluting Balloon.

summary: The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.

ReferenceCitation: Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.

ReferenceCitation: Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.

ReferenceCitation: Zeller T, Brodmann M, Ansel GM, Scheinert D, Choi D, Tepe G, Menk J, Micari A. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022 Dec 2;18(11):e940-e948. doi: 10.4244/EIJ-D-21-01098.

publisher_dissemination: Europa Digital & Publishing

ReferenceCitation: Torsello G, Stavroulakis K, Brodmann M, Micari A, Tepe G, Veroux P, Benko A, Choi D, Vermassen FEG, Jaff MR, Guo J, Dobranszki R, Zeller T; IN.PACT Global Investigators. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. J Endovasc Ther. 2020 Oct;27(5):693-705. doi: 10.1177/1526602820931477. Epub 2020 Jun 25.

repository_institution: Ghent University - Ghent University Academic Bibliography

repository_institution: Yonsei University Medical Library - YUHSpace

publisher_dissemination: SAGE Publications

ReferenceCitation: Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030.

ReferenceCitation: Reijnen MMPJ, van Wijck I, Zeller T, Micari A, Veroux P, Keirse K, Lee SW, Li P, Voulgaraki D, Holewijn S. Outcomes After Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Patients With Critical Limb Ischemia: A Post Hoc Analysis From the IN.PACT Global Study. J Endovasc Ther. 2019 Jun;26(3):305-315. doi: 10.1177/1526602819839044. Epub 2019 Apr 1.

repository_institution: University of Twente - University of Twente Research Information

ReferenceCitation: Tepe G, Micari A, Keirse K, Zeller T, Scheinert D, Li P, Schmahl R, Jaff MR; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study. JACC Cardiovasc Interv. 2019 Mar 11;12(5):484-493. doi: 10.1016/j.jcin.2018.12.004.

ReferenceCitation: Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. Erratum In: J Am Coll Cardiol. 2019 Feb 28;:

ReferenceCitation: Zeller T, Brodmann M, Micari A, Keirse K, Peeters P, Tepe G, Scheinert D, Jaff MR, Rocha-Singh KJ, Li P, Schmahl R, Ansel GM; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain. Circ Cardiovasc Interv. 2019 Jan;12(1):e007730. doi: 10.1161/CIRCINTERVENTIONS.118.007730. No abstract available.

ReferenceCitation: Banerjee S, Khalili H. Drug-Coated Balloon for Long Femoropopliteal Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007084. doi: 10.1161/CIRCINTERVENTIONS.118.007084. No abstract available.

ReferenceCitation: Scheinert D, Micari A, Brodmann M, Tepe G, Peeters P, Jaff MR, Wang H, Schmahl R, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease. Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.

ReferenceCitation: Ansel GM, Brodmann M, Keirse K, Micari A, Jaff MR, Rocha-Singh K, Fernandez EJ, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study. J Endovasc Ther. 2018 Dec;25(6):673-682. doi: 10.1177/1526602818803119. Epub 2018 Oct 3.

ReferenceCitation: Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.

repository_institution: University of Antwerp - Institutional Repository University of Antwerp

location_country:
Finland
Germany
Poland
Argentina
Australia
Czechia
Canada
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Switzerland
Belgium
Egypt
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Greece
Russian Federation
Israel

location_facility: City Clinical Hospital named after M.E. Zhadkevich

location_facility: Les Hospitaux Universitaires de Strasbourg

location_facility: Národný ústav srdcových a cievnych chorôb a.s. (NUSCH)

location_facility: Helsingin Seudun Yliopistollinen Keskussairaala

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 2

location_facility: Centre hospitalier universitaire Sherbrooke (CHUS)

location_facility: Stredoslovensky ustav srdcovych a cievnych chorob (SUSCCH)

location_facility: Východoslovenský ústav srdcových a cievnych chorôb, a.s.(VUSH)

location_facility: Ziekenhuis Oost Limburg - Campus St.-Jan

location_facility: Rabin Medical Center - Beilison Hospital


title: Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

acronym: RENEW

summary: Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System

ReferenceCitation: Hartman JE, Shah PL, Sciurba F, Herth FJF, Slebos DJ; RENEW Study Group. Endobronchial coils for emphysema: Dual mechanism of action on lobar residual volume reduction. Respirology. 2020 Nov;25(11):1160-1166. doi: 10.1111/resp.13816. Epub 2020 Apr 8.

repositories_concat: PubMed Central;pure.rug.nl

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

ReferenceCitation: Slebos DJ, Cicenia J, Sciurba FC, Criner GJ, Hartman JE, Garner J, Deslee G, Delage A, Jantz M, Marquette CH, Strange C, Hatipoglu U, Mehta AC, LaPrad AS, Schmid-Bindert G, Herth FJF, Shah PL; RENEW Study Group. Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema. Chest. 2019 May;155(5):928-937. doi: 10.1016/j.chest.2019.02.012. Epub 2019 Feb 21.

evidence: open (via crossref license, author manuscript)

license: publisher-specific-oa

license_normalized: publisher-specific

repository_institution: Temple University - TUScholarShare

ReferenceCitation: Sciurba FC, Criner GJ, Strange C, Shah PL, Michaud G, Connolly TA, Deslee G, Tillis WP, Delage A, Marquette CH, Krishna G, Kalhan R, Ferguson JS, Jantz M, Maldonado F, McKenna R, Majid A, Rai N, Gay S, Dransfield MT, Angel L, Maxfield R, Herth FJ, Wahidi MM, Mehta A, Slebos DJ; RENEW Study Research Group. Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial. JAMA. 2016 May 24-31;315(20):2178-89. doi: 10.1001/jama.2016.6261.

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

repository_normalized: HAL

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

publisher_dissemination: American Medical Association

ipd_sharing: Undecided

lead_sponsor: Boston Scientific Corporation

sponsor_collaborators:
Boston Scientific Corporation
PneumRx, Inc.

location_country:
Germany
United Kingdom
Netherlands
United States
Canada
France

location_facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)

location_facility: El Camino Hospital/Palo Alto Medical Foundation

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Pulmonary and Critical Care Associates of Baltimore

location_facility: Royal Brompton Hospital & Chelsea Westminster

location_facility: University of Wisconsin School of Medicine & Public Health

location_facility: Illinois Lung and Critical Care Institute

location_facility: University of Alabama Lung Health Center

location_facility: University of Texas Health Sciences Center at San Antonio

location_facility: New York Presbyterian Columbia University Medical Center

location_facility: University of Illinois Hospital and Health Center

location_facility: Yale University School of Medicine - Yale New Haven Hospital

location_facility: Emphysema COPD Research Center, University of Pittsburgh

location_facility: Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy

summary: The purpose of this study is to assess the efficacy of sirukumab as measured by the reduction of the signs and symptoms of rheumatoid arthritis (RA) in patients with active RA who are unresponsive or intolerant to treatment with anti-TNF-alpha agents.

ReferenceCitation: Aletaha D, Bingham CO 3rd, Tanaka Y, Agarwal P, Kurrasch R, Tak PP, Popik S. Efficacy and safety of sirukumab in patients with active rheumatoid arthritis refractory to anti-TNF therapy (SIRROUND-T): a randomised, double-blind, placebo-controlled, parallel-group, multinational, phase 3 study. Lancet. 2017 Mar 25;389(10075):1206-1217. doi: 10.1016/S0140-6736(17)30401-4. Epub 2017 Feb 16. Erratum In: Lancet. 2017 May 20;389(10083):1980.

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
GlaxoSmithKline

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Croatia
Canada
France
Lithuania
Portugal
United States
Belgium
Puerto Rico
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation


lead_sponsor: Novartis Pharmaceuticals

summary:
This was a multi-center, open-label, Phase Ib dose escalation /Phase II study in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The Phase Ib included three arms. Three different methods of administration and two different BYL719 formulations were studied to determine the MTD and/or RP2D of BYL719 in combination with cetuximab:

Arm A - film-coated whole tablets were orally administered to patients who were able to swallow the tablets; Arm B - a drinkable suspension prepared from crushed film-coated tablets was administered orally to patients with swallowing dysfunction Arm C - a suspension from a dispersible tablet administered via G-tube, in patients with swallowing dysfunction. Arm C was used to investigate the pharmacokinetics (PK), compared to Arm A (film coated tablet), and safety of the dispersible tablet of the dispersible tablet formulation of BYL719.

The Phase II investigated the clinical efficacy of BYL719 and consisted of an open label, randomized Phase II part investigating BYL719 in combination with cetuximab compared to cetuximab alone in patients resistant or intolerant to platinum and naïve to cetuximab (Scheme 1: Arm 1 and Arm 2), and a non-randomized Phase II part Scheme 2: Arm 3. In addition, patients who experienced disease progression in Arm 2 (cetuximab) were allowed to switch to the combination regimen (cross-over, Arm 2B). The safety of the BYL719 in combination with cetuximab was also further characterized in Arms 1, 2B and 3.

Patients were treated until progression of disease), unacceptable toxicity, or withdrawal of informed consent, whichever occurred first (except for phase II Arm 2 had the opportunity to crossover to the combination treatment (Arm 2B). In the follow-up period all patients had to complete the safety follow-up assessments within 30 days after the last dose of the study treatment. Patients who did not have disease progression at the time of discontinuation of study treatment were radiologically followed for disease status until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurred first. In addition, all patients enrolled in Phase II were followed for survival.

title: A Phase Ib Dose Escalation/Randomized Phase II, Multicenter, Open-label Study of BYL719 in Combination With Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

location_country:
Hong Kong
Singapore
Australia
Netherlands
United States
Korea, Republic of
Taiwan
Canada
France


title: An Open-Label Study of the Safety and Tolerability of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

summary: The purpose of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in a follow-up randomized withdrawal study.

location_country:
Italy
Poland
Colombia
New Zealand
Hungary
Singapore
Australia
Belgium
United States
Korea, Republic of
Spain
Iceland
South Africa
Ukraine
Canada
Estonia
Serbia
France

location_facility:
Forest Investigative Site 096
Forest Investigative Site 059
Forest Investigative Site 054
Forest Investigative Site 580
Forest Investigative Site 201
Forest Investigative Site 073
Forest Investigative Site 379
Forest Investigative Site 629
Forest Investigative Site 115
Forest Investigative Site 802
Forest Investigative Site 097
Forest Investigative Site 378
Forest Investigative Site 576
Forest Investigative Site 116
Forest Investigative Site 578
Forest Investigative Site 704
Forest Investigative Site 804
Forest Investigative Site 131
Forest Investigative Site 118
Forest Investigative Site 078
Forest Investigative Site 155
Forest Investigative Site 626
Forest Investigative Site 098
Forest Investigative Site 067
Forest Investigative Site 085
Forest Investigative Site 101
Forest Investigative Site 063
Forest Investigative Site 382
Forest Investigative Site 119
Forest Investigative Site 730
Forest Investigative Site 053
Forest Investigative Site 095
Forest Investigative Site 080
Forest Investigative Site 057
Forest Investigative Site 702
Forest Investigative Site 072
Forest Investigative Site 452
Forest Investigative Site 091
Forest Investigative Site 005
Forest Investigative Site 021
Forest Investigative Site 703
Forest Investigative Site 081
Forest Investigative Site 727
Forest Investigative Site 453
Forest Investigative Site 329
Forest Investigative Site 065
Forest Investigative Site 100
Forest Investigative Site 026
Forest Investigative Site 023
Forest Investigative Site 077
Forest Investigative Site 062
Forest Investigative Site 326
Forest Investigative Site 105
Forest Investigative Site 069
Forest Investigative Site 651
Forest Investigative Site 106
Forest Investigative Site 068
Forest Investigative Site 090
Forest Investigative Site 092
Forest Investigative Site 202
Forest Investigative Site 001
Forest Investigative Site 136
Forest Investigative Site 141
Forest Investigative Site 028
Forest Investigative Site 123
Forest Investigative Site 082
Forest Investigative Site 526
Forest Investigative Site 676
Forest Investigative Site 401
Forest Investigative Site 071
Forest Investigative Site 801
Forest Investigative Site 056
Forest Investigative Site 052
Forest Investigative Site 728
Forest Investigative Site 086
Forest Investigative Site 803
Forest Investigative Site 177
Forest Investigative Site 075
Forest Investigative Site 029
Forest Investigative Site 125
Forest Investigative Site 064
Forest Investigative Site 074
Forest Investigative Site 127
Forest Investigative Site 113
Forest Investigative Site 055
Forest Investigative Site 114
Forest Investigative Site 276
Forest Investigative Site 019
Forest Investigative Site 109
Forest Investigative Site 051
Forest Investigative Site 380
Forest Investigative Site 628
Forest Investigative Site 104
Forest Investigative Site 627
Forest Investigative Site 108
Forest Investigative Site 226
Forest Investigative Site 376
Forest Investigative Site 227
Forest Investigative Site 107
Forest Investigative Site 102
Forest Investigative Site 066
Forest Investigative Site 204
Forest Investigative Site 061
Forest Investigative Site 124
Forest Investigative Site 203
Forest Investigative Site 130
Forest Investigative Site 729
Forest Investigative Site 701
Forest Investigative Site 807
Forest Investigative Site 117
Forest Investigative Site 579
Forest Investigative Site 381
Forest Investigative Site 132
Forest Investigative Site 070
Forest Investigative Site 228
Forest Investigative Site 084
Forest Investigative Site 577
Forest Investigative Site 002


title: Multiple Phase 1/2 Cohorts of Nivolumab Monotherapy or Nivolumab Combination Regimens Across Relapsed/Refractory Hematologic Malignancies

summary: The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.

status: Active, not recruiting

ReferenceCitation: Lesokhin AM, Ansell SM, Armand P, Scott EC, Halwani A, Gutierrez M, Millenson MM, Cohen AD, Schuster SJ, Lebovic D, Dhodapkar M, Avigan D, Chapuy B, Ligon AH, Freeman GJ, Rodig SJ, Cattry D, Zhu L, Grosso JF, Bradley Garelik MB, Shipp MA, Borrello I, Timmerman J. Nivolumab in Patients With Relapsed or Refractory Hematologic Malignancy: Preliminary Results of a Phase Ib Study. J Clin Oncol. 2016 Aug 10;34(23):2698-704. doi: 10.1200/JCO.2015.65.9789. Epub 2016 Jun 6.

repository_institution: PubMed Central - Europe PMC

ReferenceCitation: Ansell SM, Lesokhin AM, Borrello I, Halwani A, Scott EC, Gutierrez M, Schuster SJ, Millenson MM, Cattry D, Freeman GJ, Rodig SJ, Chapuy B, Ligon AH, Zhu L, Grosso JF, Kim SY, Timmerman JM, Shipp MA, Armand P. PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. N Engl J Med. 2015 Jan 22;372(4):311-9. doi: 10.1056/NEJMoa1411087. Epub 2014 Dec 6.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Janssen, LP

location_country:
Italy
Poland
Belgium
United States
Greece
France

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: OHSU Center for Hematologic Malignancies

location_facility: Huntsman Cancer Institute At The Univ. Of Utah

location_facility: Division Of Hematology & Oncology Ctr. For Health Sciences

status_simplified: Ongoing


title: 2-part, Phase 2/3 Study to Assess the Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part A - Open-label, Single-arm, Multicenter Pilot Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia. Part B - Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 in Subjects With Homozygous Familial Hypercholesterolemia

acronym: TESLA

summary: A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

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.

ReferenceCitation: Raal FJ, Honarpour N, Blom DJ, Hovingh GK, Xu F, Scott R, Wasserman SM, Stein EA; TESLA Investigators. Inhibition of PCSK9 with evolocumab in homozygous familial hypercholesterolaemia (TESLA Part B): a randomised, double-blind, placebo-controlled trial. Lancet. 2015 Jan 24;385(9965):341-50. doi: 10.1016/S0140-6736(14)61374-X. Epub 2014 Oct 1.

ReferenceCitation: Stein EA, Honarpour N, Wasserman SM, Xu F, Scott R, Raal FJ. Effect of the proprotein convertase subtilisin/kexin 9 monoclonal antibody, AMG 145, in homozygous familial hypercholesterolemia. Circulation. 2013 Nov 5;128(19):2113-20. doi: 10.1161/CIRCULATIONAHA.113.004678. Epub 2013 Sep 6.

location_country:
Italy
New Zealand
Hong Kong
Netherlands
Lebanon
Belgium
United States
Spain
South Africa
Czechia
Canada
France


title: A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma

acronym: SOURCE

summary: This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.

ReferenceCitation: Jones RL, Chawla SP, Attia S, Schoffski P, Gelderblom H, Chmielowski B, Le Cesne A, Van Tine BA, Trent JC, Patel S, Wagner AJ, Chugh R, Heyburn JW, Weil SC, Wang W, Viele K, Maki RG. A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. Cancer. 2019 Jul 15;125(14):2445-2454. doi: 10.1002/cncr.32084. Epub 2019 Apr 29.

repositories_concat: PubMed Central;deepblue.lib.umich.edu

repositories_institution:
PubMed Central - Europe PMC
University of Michigan - Deep Blue

lead_sponsor: Morphotek

location_country:
Italy
Australia
Netherlands
Belgium
United States
France

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: The University of North Carolina at Chapel Hill