acronym: VITAL

lead_sponsor: Novartis Pharmaceuticals

summary: This is a randomized, parallel-arm, open-label, multi-centre, Phase II study to determine the efficacy and safety of lapatinib in combination with vinorelbine or capecitabine in women with ErbB2 overexpressing metastatic breast cancer (MBC) who have received no more than one chemotherapeutic regimen in the metastatic setting.

ReferenceCitation: Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

repository_institution: UWA - UWA Profiles and Research Repository

ReferenceCitation: Janni W, Sarosiek T, Karaszewska B, Pikiel J, Staroslawska E, Potemski P, Salat C, Brain E, Caglevic C, Briggs K, Mahood K, DeSilvio M, Marini L, Papadimitriou C. Final overall survival analysis of a phase II trial evaluating vinorelbine and lapatinib in women with ErbB2 overexpressing metastatic breast cancer. Breast. 2015 Dec;24(6):769-73. doi: 10.1016/j.breast.2015.08.005. Epub 2015 Sep 16.

title: A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer

location_country: Germany Italy Poland Mexico Spain Greece Chile Bulgaria Serbia France


type: Other Identifier

title: A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients With Major Depressive Disorder and Associated Painful Physical Symptoms

summary: The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.

ReferenceType: derived

ReferenceCitation: Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Marangell LB. A randomized placebo-controlled trial of duloxetine in patients with major depressive disorder and associated painful physical symptoms. Curr Med Res Opin. 2011 Oct;27(10):1849-58. doi: 10.1185/03007995.2011.609539. Epub 2011 Aug 12.

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Romania
Sweden
United States
Puerto Rico
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.

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


study_start_date_type: Actual

lead_sponsor: Grünenthal GmbH

summary:
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in subjects suffering from severe chronic low back pain (LBP) who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinical effectiveness trial designed to establish a link between anticipated clinical outcomes and the clinical practice by means of selected measures of clinical and subject-reported outcome.

The trial will compare the effectiveness of previous analgesic treatment (either WHO Step I or Step II analgesics or no regular analgesics) with that of tapentadol hydrochloride prolonged release (PR) treatment during defined periods of evaluation.

ReferenceType: result

ReferenceCitation: Steigerwald I, Muller M, Davies A, Samper D, Sabatowski R, Baron R, Rozenberg S, Szczepanska-Szerej A, Gatti A, Kress HG. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study. Curr Med Res Opin. 2012 Jun;28(6):911-36. doi: 10.1185/03007995.2012.679254. Epub 2012 May 9.

location_facility:
Site 8
Site 3
Site 7
Site 5
Site 4
Site 2
Site 1
Site 6

title: An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Uncontrolled Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics.

type: EudraCT Number

source: euctr

ipd_sharing_description: Information available on the Grünenthal Web Site

location_country:
Germany
Italy
Poland
United Kingdom
Switzerland
Austria
Spain
Croatia
France

ipd_sharing: Yes


acronym: BOOST™

lead_sponsor: Novo Nordisk A/S

summary:
This trial is conducted in Europe, Oceania, and the United States of America (USA).

The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin detemir (IDet) plus insulin aspart in patients with type 1 diabetes (main period) followed by the extension period comparing the long-term safety of NN5401 plus insulin aspart with insulin detemir plus insulin aspart.

The main period is registered internally at Novo Nordisk as NN5401-3594 while the extension period is registered as NN5401-3645.

ReferenceCitation: Hirsch IB, Franek E, Mersebach H, Bardtrum L, Hermansen K. Safety and efficacy of insulin degludec/insulin aspart with bolus mealtime insulin aspart compared with standard basal-bolus treatment in people with Type 1 diabetes: 1-year results from a randomized clinical trial (BOOST(R) T1). Diabet Med. 2017 Feb;34(2):167-173. doi: 10.1111/dme.13068. Epub 2016 Feb 19.

ReferenceCitation: Hirsch IB, Bode B, Courreges JP, Dykiel P, Franek E, Hermansen K, King A, Mersebach H, Davies M. Insulin degludec/insulin aspart administered once daily at any meal, with insulin aspart at other meals versus a standard basal-bolus regimen in patients with type 1 diabetes: a 26-week, phase 3, randomized, open-label, treat-to-target trial. Diabetes Care. 2012 Nov;35(11):2174-81. doi: 10.2337/dc11-2503. Epub 2012 Aug 28.

title: NN5401-3594: A 26-week, Open-labelled, Two-arm, Parallel, Randomised Trial Comparing Efficacy and Safety of NN5401 Once Daily Plus Insulin Aspart vs. Basal-bolus Treatment With Insulin Detemir Plus Insulin Aspart in Subjects With Type 1 Diabetes / NN5401-3645: An Extension Trial Comparing Safety and Efficacy of NN5401 Plus Meal-time Insulin Aspart for the Remaining Meals With Insulin Detemir Plus Meal-time Insulin Aspart in Type 1 Diabetes (BOOST™: T1)

location_country:
France
Poland
United Kingdom
Denmark
Australia
Romania
United States
Puerto Rico
Russian Federation
Israel


summary: This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

ReferenceCitation: Brand-Staufer B, Carcao M, Kerlin BA, Will A, Williams M, Tornoe CW, Sandberg Lundblad M, Nugent D. Pharmacokinetic characterization of recombinant factor XIII (FXIII)-A2 across age groups in patients with FXIII A-subunit congenital deficiency. Haemophilia. 2015 May;21(3):380-385. doi: 10.1111/hae.12616. Epub 2015 Jan 21.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Wiley

ReferenceCitation: Kerlin B, Brand B, Inbal A, Halimeh S, Nugent D, Lundblad M, Tehranchi R. Pharmacokinetics of recombinant factor XIII at steady state in patients with congenital factor XIII A-subunit deficiency. J Thromb Haemost. 2014 Dec;12(12):2038-43. doi: 10.1111/jth.12739. Epub 2014 Oct 25.

publisher_dissemination: Elsevier

title: A Multi-Centre, Open-Label, Single-Arm, and Multiple Dosing Trial on Safety of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Subjects With Congenital Factor XIII Deficiency

primary_purpose: Prevention

type: Registry Identifier

location_country:
Finland
Germany
Italy
Israel
United Kingdom
Japan
Switzerland
Austria
United States
Spain
Canada
France


title: A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio

summary: This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.

ReferenceCitation: Marcellin P, Cooper C, Balart L, Larrey D, Box T, Yoshida E, Lawitz E, Buggisch P, Ferenci P, Weltman M, Labriola-Tompkins E, Le Pogam S, Najera I, Thomas D, Hooper G, Shulman NS, Zhang Y, Navarro MT, Lim CY, Brunda M, Terrault NA, Yetzer ES. Randomized controlled trial of danoprevir plus peginterferon alfa-2a and ribavirin in treatment-naive patients with hepatitis C virus genotype 1 infection. Gastroenterology. 2013 Oct;145(4):790-800.e3. doi: 10.1053/j.gastro.2013.06.051. Epub 2013 Jun 26.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

unpaywall_oa_status: bronze

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Australia
Austria
United States
Canada
France


summary: The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.

location_facility: Cancer Care Associates Medical Group Dept. of CCA

location_facility: Central Coast Medical Oncology Corporation

location_facility: UCLA/ University of California Los Angeles Div. of Hematology/Oncology

location_facility: Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care

location_facility: UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr

location_facility: Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)

location_facility: Northwest Cancer Specialists Northwest Office (2)

location_facility: Comprehensive Blood and Cancer Center Dept CBCC (3)

location_facility: Texas Oncology, P.A. Dept. of Texas Oncology

location_facility: Fairfax Northern Virginia Hematology Oncology Fairfax NVH

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: Texas Oncology, P.A. Presbyterian Hospital

location_facility: Texas Oncology, P.A. Texas Oncology - Sammons

title: A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer

design_allocation: Non-Randomized

location_country:
Finland
Italy
United Kingdom
United States
Spain
Taiwan
Canada
France


intervention_type: Biological

lead_sponsor: AbbVie (prior sponsor, Abbott)

summary: This study will evaluate how well adalimumab works in the short and long term in patients with axial spondyloarthritis who are not diagnosed as having either ankylosing spondylitis or psoriatic arthritis.

ReferenceCitation: van der Heijde D, Sieper J, Maksymowych WP, Lambert RG, Chen S, Hojnik M, Anderson JK, Pangan AL. Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial. Arthritis Res Ther. 2018 Mar 27;20(1):61. doi: 10.1186/s13075-018-1556-5.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

evidence: oa repository (via pmcid lookup)

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

ReferenceCitation: van der Heijde D, Sieper J, Maksymowych WP, Brown MA, Lambert RG, Rathmann SS, Pangan AL. Spinal inflammation in the absence of sacroiliac joint inflammation on magnetic resonance imaging in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2014 Mar;66(3):667-73. doi: 10.1002/art.38283.

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Queensland University of Technology - QUT ePrints

repositories_concat: PubMed Central;eprints.qut.edu.au

unpaywall_oa_status: hybrid

ReferenceCitation: Sieper J, van der Heijde D, Dougados M, Mease PJ, Maksymowych WP, Brown MA, Arora V, Pangan AL. Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1). Ann Rheum Dis. 2013 Jun;72(6):815-22. doi: 10.1136/annrheumdis-2012-201766. Epub 2012 Jul 7.

location_facility:
Site Reference ID/Investigator# 21229
Site Reference ID/Investigator# 21246
Site Reference ID/Investigator# 21282
Site Reference ID/Investigator# 21224
Site Reference ID/Investigator# 21228
Site Reference ID/Investigator# 26882
Site Reference ID/Investigator# 21227
Site Reference ID/Investigator# 26544
Site Reference ID/Investigator# 21223
Site Reference ID/Investigator# 21241
Site Reference ID/Investigator# 21243
Site Reference ID/Investigator# 22342
Site Reference ID/Investigator# 21263
Site Reference ID/Investigator# 21230
Site Reference ID/Investigator# 21249
Site Reference ID/Investigator# 21266
Site Reference ID/Investigator# 21264
Site Reference ID/Investigator# 21248
Site Reference ID/Investigator# 21245
Site Reference ID/Investigator# 27382
Site Reference ID/Investigator# 26883
Site Reference ID/Investigator# 21281
Site Reference ID/Investigator# 22343
Site Reference ID/Investigator# 21225
Site Reference ID/Investigator# 21231
Site Reference ID/Investigator# 21284
Site Reference ID/Investigator# 21250
Site Reference ID/Investigator# 21265
Site Reference ID/Investigator# 21283
Site Reference ID/Investigator# 21226
Site Reference ID/Investigator# 21267
Site Reference ID/Investigator# 26582
Site Reference ID/Investigator# 21289
Site Reference ID/Investigator# 21262
Site Reference ID/Investigator# 21247
Site Reference ID/Investigator# 21222
Site Reference ID/Investigator# 21285
Site Reference ID/Investigator# 21261

title: A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Axial Spondyloarthritis

location_country:
France
Germany
United Kingdom
Australia
Netherlands
Belgium
United States
Spain
Canada
Czech Republic


title: A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)

summary: This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).

lead_sponsor: ThromboGenics

location_country:
Germany
Italy
United Kingdom
Belgium
United States
France

location_facility: Universität Lübeck Universitätsklinikum Schleswig-Holstein

location_facility: University of Milan Department of Clinical Science "Luigi Sacco"

location_facility: Augenklinik der Ludwig Maximilians Universität München

location_facility: Wolverhampton Eye Infirmary New Cross Hospital

location_facility: Centre Ophtalmologique d'Imagerie et de Laser

location_facility: Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg

location_facility: Allegheny Ophthalmic & Orbital Associates, PC

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology


lead_sponsor: Bayer

summary: Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

ReferenceCitation: Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.

ReferenceCitation: Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1.

ReferenceCitation: Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.

oa_colors: green other

repositories_concat: PubMed Central

ReferenceCitation: Simonneau G, D'Armini AM, Ghofrani HA, Grimminger F, Jansa P, Kim NH, Mayer E, Pulido T, Wang C, Colorado P, Fritsch A, Meier C, Nikkho S, Hoeper MM. Predictors of long-term outcomes in patients treated with riociguat for chronic thromboembolic pulmonary hypertension: data from the CHEST-2 open-label, randomised, long-term extension trial. Lancet Respir Med. 2016 May;4(5):372-80. doi: 10.1016/S2213-2600(16)30022-4. Epub 2016 Apr 8.

ReferenceCitation: Ghofrani HA, D'Armini AM, Grimminger F, Hoeper MM, Jansa P, Kim NH, Mayer E, Simonneau G, Wilkins MR, Fritsch A, Neuser D, Weimann G, Wang C; CHEST-1 Study Group. Riociguat for the treatment of chronic thromboembolic pulmonary hypertension. N Engl J Med. 2013 Jul 25;369(4):319-29. doi: 10.1056/NEJMoa1209657.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

location_facility: Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

title: Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Slovakia
Denmark
Switzerland
United States
Belgium
China
Italy
United Kingdom
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


acronym: STARTT

lead_sponsor: Amgen

summary: The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

ReferenceCitation: Bhandari M, Schemitsch EH, Karachalios T, Sancheti P, Poolman RW, Caminis J, Daizadeh N, Dent-Acosta RE, Egbuna O, Chines A, Miclau T. Romosozumab in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture: A Randomized Phase-2 Study. J Bone Joint Surg Am. 2020 Aug 19;102(16):1416-1426. doi: 10.2106/JBJS.19.01008.

sponsor_collaborators:
Amgen
UCB Pharma

title: A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail

location_country:
Germany
Poland
New Zealand
Australia
Canada
France
Lithuania
Slovakia
Hungary
Hong Kong
Denmark
United States
Latvia
India
Romania
Estonia
Italy
Norway
United Kingdom
Mexico
Greece
Bulgaria
Russian Federation


summary: This study assessed the efficacy and safety of first-line RAD001 followed by second-line sunitinib versus the opposite sequence: first-line sunitinib followed by second-line RAD001 for the treatment of patients with MRCC.

ReferenceCitation: Voss MH, Chen D, Reising A, Marker M, Shi J, Xu J, Ostrovnaya I, Seshan VE, Redzematovic A, Chen YB, Patel P, Han X, Hsieh JJ, Hakimi AA, Motzer RJ. PTEN Expression, Not Mutation Status in TSC1, TSC2, or mTOR, Correlates with the Outcome on Everolimus in Patients with Renal Cell Carcinoma Treated on the Randomized RECORD-3 Trial. Clin Cancer Res. 2019 Jan 15;25(2):506-514. doi: 10.1158/1078-0432.CCR-18-1833. Epub 2018 Oct 16.

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Knox JJ, Barrios CH, Kim TM, Cosgriff T, Srimuninnimit V, Pittman K, Sabbatini R, Rha SY, Flaig TW, Page RD, Beck JT, Cheung F, Yadav S, Patel P, Geoffrois L, Niolat J, Berkowitz N, Marker M, Chen D, Motzer RJ. Final overall survival analysis for the phase II RECORD-3 study of first-line everolimus followed by sunitinib versus first-line sunitinib followed by everolimus in metastatic RCC. Ann Oncol. 2017 Jun 1;28(6):1339-1345. doi: 10.1093/annonc/mdx075. Erratum In: Ann Oncol. 2018 Nov 1;29(11):2269.

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: Yonsei University Medical Library - YUHSpace

repositories_concat: PubMed Central;ir.ymlib.yonsei.ac.kr

ReferenceCitation: Motzer RJ, Barrios CH, Kim TM, Falcon S, Cosgriff T, Harker WG, Srimuninnimit V, Pittman K, Sabbatini R, Rha SY, Flaig TW, Page R, Bavbek S, Beck JT, Patel P, Cheung FY, Yadav S, Schiff EM, Wang X, Niolat J, Sellami D, Anak O, Knox JJ. Phase II randomized trial comparing sequential first-line everolimus and second-line sunitinib versus first-line sunitinib and second-line everolimus in patients with metastatic renal cell carcinoma. J Clin Oncol. 2014 Sep 1;32(25):2765-72. doi: 10.1200/JCO.2013.54.6911. Epub 2014 Jul 21.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_facility: Loyola University Medical Center /Cardinal Bernardin Cancer Cardinal Bernardin Cancer (3)

location_facility: University of Oklahoma Health Sciences Center Dept of OHSC

location_facility: University of Colorado Dept. of Anschutz Cancer (2)

location_facility: The West Clinic Dept. of the West Clinic

location_facility: Billings Clinic Dept of Billings Clinic(2)

location_facility: Highlands Oncology Group HighlandsOncGrp-Bentonville(2)

location_facility: Hackensack University Medical Center DeptofHackensackUniv.MedCtr.

location_facility: University of North Carolina Dept. of LinbergerCancerCtr(3)

location_facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando

location_facility: VA Maryland Health Care Dept.of GreenbaumCancerCent(7)

location_facility: NorthwesternUniv.Med.School/Robert H. Lurie Comp.Cancer Ctr Dept.ofNorthwesternMemHospital

location_facility: Georgia Health Sciences University Dept. of MCG

location_facility: University Cancer & Blood Center, LLC Dept of NE GCC (2)

location_facility: University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.

location_facility: Crescent City Research Consortium, LLC SC

location_facility: East Texas Medical Center Cancer Institute

location_facility: University of Alabama at Birmingham/ Kirklin Clinic Comprehensive CancerCenter (1)

location_facility: Memorial Sloan Kettering Cancer Center Dept. of MSKCC

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (5)

location_facility: St. Luke's Hospital and Health Network St Luke's Hospital (2)

location_facility: University of California at Los Angeles Dept. of UCLA (3)

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

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

location_facility: SUNY - Upstate Medical University Div. of Hematology-Oncology

location_facility: Georgetown University/Lombardi Cancer Center Dept.of Lombardi Cancer Ctr (2

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

title: An Open-label, Multicenter Phase II Study to Compare the Efficacy and Safety of RAD001 as First-line Followed by Second-line Sunitinib Versus Sunitinib as First-line Followed by Second-line RAD001 in the Treatment of Patients With Metastatic Renal Cell Carcinoma.

location_country:
Germany
Argentina
Australia
Brazil
Thailand
Turkey
Canada
France
Hong Kong
Denmark
United States
Peru
Italy
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan


summary: The purpose of this study is to determine the potential of denosumab to treat Hypercalcemia of Malignancy in patients with elevated serum calcium who do not respond to recent treatment with intravenous bisphosphonates by lowering corrected serum calcium </= 11.5 mg/dL (2.9 millimoles /L) by day 10.

ReferenceCitation: Hu MI, Glezerman I, Leboulleux S, Insogna K, Gucalp R, Misiorowski W, Yu B, Ying W, Jain RK. Denosumab for patients with persistent or relapsed hypercalcemia of malignancy despite recent bisphosphonate treatment. J Natl Cancer Inst. 2013 Sep 18;105(18):1417-20. doi: 10.1093/jnci/djt225. Epub 2013 Aug 29.

evidence: open (via page says license)

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Oxford University Press

title: A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium Despite Recent Treatment With IV Bisphosphonates

location_country:
Italy
Poland
United States
Canada
France


acronym: β-SPECIFIC 3

summary: This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.

ReferenceCitation: Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat NM, Horneff G, Kasapcopur O, Schneider R, Anton J, Barash J, Berner R, Corona F, Cuttica R, Fouillet-Desjonqueres M, Fischbach M, Foster HE, Foell D, Radominski SC, Ramanan AV, Trauzeddel R, Unsal E, Levy J, Vritzali E, Martini A, Lovell DJ; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials. Ann Rheum Dis. 2018 Dec;77(12):1710-1719. doi: 10.1136/annrheumdis-2018-213150. Epub 2018 Sep 29.

repository_institution: University of Bristol - Bristol Research

repository_institution: Newcastle Univesity - Newcastle University ePrints

publisher_dissemination: British Medical Journal

ReferenceCitation: Grom AA, Ilowite NT, Pascual V, Brunner HI, Martini A, Lovell D, Ruperto N; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group; Leon K, Lheritier K, Abrams K. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab. Arthritis Rheumatol. 2016 Jan;68(1):218-28. doi: 10.1002/art.39407.

sponsor_collaborators: Pediatric Rheumatology International Trials Organization

title: An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Canada
France
Hungary
Switzerland
United States
Belgium
Peru
Italy
United Kingdom
Sweden
Netherlands
Austria
Spain
Greece
Russian Federation
Israel


title: A Randomized, Double-blind, Placebo Controlled, Withdrawal Study of Flare Prevention of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

acronym: β-SPECIFIC 2

summary: This two-part study assessed the sustained efficacy of canakinumab in the double-blind Part II and the ability to taper steroids in the open label Part I.

repositories_institution: Newcastle Univesity - Newcastle University ePrints

repositories_institution: University of Bristol - Bristol Research

ReferenceCitation: Brachat AH, Grom AA, Wulffraat N, Brunner HI, Quartier P, Brik R, McCann L, Ozdogan H, Rutkowska-Sak L, Schneider R, Gerloni V, Harel L, Terreri M, Houghton K, Joos R, Kingsbury D, Lopez-Benitez JM, Bek S, Schumacher M, Valentin MA, Gram H, Abrams K, Martini A, Lovell DJ, Nirmala NR, Ruperto N; Pediatric Rheumatology International Trials Organization (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy. Arthritis Res Ther. 2017 Jan 23;19(1):13. doi: 10.1186/s13075-016-1212-x.

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

repository_institution: Utrecht University - Utrecht University Repository

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

ReferenceCitation: Ruperto N, Brunner HI, Quartier P, Constantin T, Wulffraat N, Horneff G, Brik R, McCann L, Kasapcopur O, Rutkowska-Sak L, Schneider R, Berkun Y, Calvo I, Erguven M, Goffin L, Hofer M, Kallinich T, Oliveira SK, Uziel Y, Viola S, Nistala K, Wouters C, Cimaz R, Ferrandiz MA, Flato B, Gamir ML, Kone-Paut I, Grom A, Magnusson B, Ozen S, Sztajnbok F, Lheritier K, Abrams K, Kim D, Martini A, Lovell DJ; PRINTO; PRCSG. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis. N Engl J Med. 2012 Dec 20;367(25):2396-406. doi: 10.1056/NEJMoa1205099.

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Canada
France
Hungary
Switzerland
United States
Belgium
Peru
Italy
Norway
Sweden
Netherlands
Spain
South Africa
Israel

location_facility: New England Medical Center - Department of Allergy

location_facility: Arkansas Children's Hospital Research Inst


acronym: MOVE

summary: This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.

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: Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Germany
Italy
Norway
Denmark
Mexico
United States
Spain
Greece
Croatia
Czechia
Canada
France


acronym: β-SPECIFIC 1

summary: This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

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

repositories_institution: Utrecht University - Utrecht University Repository

sponsor_collaborators: International Maternal Pediatric Adolescent AIDS Clinical Trials Group

sponsor_collaborators: Southwest Pediatric Nephrology Study Group

location_facility: Tufts New England Medical Center-Dept. of Allergy

status: Terminated

title: A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Canada
France
Hungary
Denmark
Switzerland
United States
Belgium
Peru
Italy
Norway
United Kingdom
Sweden
Netherlands
Spain
Greece
South Africa
Israel

status_simplified: Unknown


title: A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease

summary: This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

location_country:
Germany
Italy
Poland
Slovakia
United Kingdom
Argentina
Romania
Australia
Mexico
United States
Spain
Canada
France


lead_sponsor: R-Pharm

summary: The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.

ReferenceCitation: McMeekin S, Dizon D, Barter J, Scambia G, Manzyuk L, Lisyanskaya A, Oaknin A, Ringuette S, Mukhopadhyay P, Rosenberg J, Vergote I. Phase III randomized trial of second-line ixabepilone versus paclitaxel or doxorubicin in women with advanced endometrial cancer. Gynecol Oncol. 2015 Jul;138(1):18-23. doi: 10.1016/j.ygyno.2015.04.026. Epub 2015 Apr 26.

location_facility: St. Vincent Hospital And Health Care Center, Inc.

location_facility: Peggy And Charles Stephenson Oklahoma Cancer Center

location_facility: Pennsylvania Oncology Hematology Associates

location_facility: Tennessee Gynecologic Oncology Group, Llc

location_facility: Hematology And Oncology Specialists, Llc

location_facility: Magee-Womens Hospital Of Upmc Laboratory

title: A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy

location_country:
Argentina
Australia
Brazil
Canada
France
Czech Republic
Hungary
Denmark
United States
Belgium
Peru
Italy
Norway
United Kingdom
Mexico
Spain
Greece
Russian Federation
Sweden


title: Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple Sclerosis

summary: To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12, 16, 20, and 24 weeks compared to placebo.

location_country:
Germany
Poland
Slovakia
Hungary
Israel
Romania
United States
Czechia
Bulgaria
Ukraine
Serbia
Russian Federation
France


title: A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

acronym: AQUARIUS

summary: The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

ReferenceCitation: Puri R, Nissen SE, Menon V, Shao M, Hsu A, Bakris GL, Kastelein JJ, Williams B, Armbrecht J, Brunel P, Kataoka Y, Nicholls SJ. Effects of aliskiren in diabetic and non-diabetic patients with coronary artery disease: Insights from AQUARIUS. Atherosclerosis. 2015 Dec;243(2):553-9. doi: 10.1016/j.atherosclerosis.2015.10.019. Epub 2015 Oct 20.

ReferenceCitation: Nicholls SJ, Bakris GL, Kastelein JJ, Menon V, Williams B, Armbrecht J, Brunel P, Nicolaides M, Hsu A, Hu B, Fang H, Puri R, Uno K, Kataoka Y, Bash D, Nissen SE. Effect of aliskiren on progression of coronary disease in patients with prehypertension: the AQUARIUS randomized clinical trial. JAMA. 2013 Sep 18;310(11):1135-44. doi: 10.1001/jama.2013.277169.

publisher_dissemination: American Medical Association

sponsor_collaborators:
Novartis Pharmaceuticals
The Cleveland Clinic

location_country:
Germany
Italy
Poland
Hungary
Argentina
Australia
Belgium
United States
Spain
Canada
France


lead_sponsor: Eisai Inc.

summary: The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.

title: A Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

location_country:
Germany
Poland
Australia
Serbia
France
Montenegro
Hungary
Slovakia
Denmark
Switzerland
India
Italy
United Kingdom
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Sweden


lead_sponsor: Ipsen

summary: The primary purpose of this extension study was to assess the long term safety of patients with nonfunctioning enteropancreatic neuroendocrine tumour (NET), who were treated with open label lanreotide Autogel (120 mg every 28 days) and who participated in a previous study, 2-55-52030-726 (NCT00353496).

ReferenceCitation: Caplin ME, Pavel M, Cwikla JB, Phan AT, Raderer M, Sedlackova E, Cadiot G, Wolin EM, Capdevila J, Wall L, Rindi G, Langley A, Martinez S, Gomez-Panzani E, Ruszniewski P; CLARINET Investigators. Anti-tumour effects of lanreotide for pancreatic and intestinal neuroendocrine tumours: the CLARINET open-label extension study. Endocr Relat Cancer. 2016 Mar;23(3):191-9. doi: 10.1530/ERC-15-0490. Epub 2016 Jan 7.

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repositories_concat: PubMed Central;publicatt.unicatt.it

publisher_dissemination: Bioscientifica

ReferenceCitation: Caplin ME, Pavel M, Phan AT, Cwikla JB, Sedlackova E, Thanh XT, Wolin EM, Ruszniewski P; CLARINET Investigators. Lanreotide autogel/depot in advanced enteropancreatic neuroendocrine tumours: final results of the CLARINET open-label extension study. Endocrine. 2021 Feb;71(2):502-513. doi: 10.1007/s12020-020-02475-2. Epub 2020 Oct 14.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery

repositories_concat: PubMed Central;UCL Discovery

location_facility: Zaklad Diagnosttyki Radiologicznej, Centralny Szpital Klincny

title: Open Label Extension Study of Lanreotide Autogel 120 mg in Patients With Non-functioning Entero-pancreatic Endocrine Tumour

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

location_country:
Italy
Poland
Slovakia
United Kingdom
Belgium
United States
Spain
Czechia
France


title: A Pivotal Phase II, Multicenter, Single-arm, Two-cohort Trial Evaluating the Efficacy and Safety of GDC-0449 in Patients With Advanced Basal Cell Carcinoma

summary: This was a Phase II, single-arm, two-cohort multicenter clinical trial evaluating the efficacy and safety of vismodegib (GDC-0449) in patients with advanced basal cell carcinoma. All patients received vismodegib until evidence of progression, intolerable toxicities most probably attributable to vismodegib, or withdrawal from the study.

ReferenceCitation: Sekulic A, Migden MR, Basset-Seguin N, Garbe C, Gesierich A, Lao CD, Miller C, Mortier L, Murrell DF, Hamid O, Quevedo JF, Hou J, McKenna E, Dimier N, Williams S, Schadendorf D, Hauschild A; ERIVANCE BCC Investigators. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017 May 16;17(1):332. doi: 10.1186/s12885-017-3286-5. Erratum In: BMC Cancer. 2019 Apr 18;19(1):366.

repository_normalized: qucosa

repositories:
PubMed Central
qucosa

repositories_concat: PubMed Central;qucosa

ReferenceCitation: Chang AL, Arron ST, Migden MR, Solomon JA, Yoo S, Day BM, McKenna EF, Sekulic A. Safety and efficacy of vismodegib in patients with basal cell carcinoma nevus syndrome: pooled analysis of two trials. Orphanet J Rare Dis. 2016 Sep 1;11(1):120. doi: 10.1186/s13023-016-0506-z.

repositories_concat: California Digital Library - eScholarship;PubMed Central

ReferenceCitation: Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, Solomon JA, Yoo S, Arron ST, Friedlander PA, Marmur E, Rudin CM, Chang AL, Low JA, Mackey HM, Yauch RL, Graham RA, Reddy JC, Hauschild A. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012 Jun 7;366(23):2171-9. doi: 10.1056/NEJMoa1113713.

lead_sponsor: Genentech, Inc.

location_country:
Germany
United Kingdom
Australia
Belgium
United States
France


title: Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration

summary:
The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.

The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

lead_sponsor: Jazz Pharmaceuticals

sponsor_collaborators:
Jazz Pharmaceuticals
The Leukemia and Lymphoma Society

location_country:
United States
Canada
Poland
France

location_facility: North Shore LIJ Center for Advanced Medicine Monter Cancer Center

location_facility: Service d'Hématologie CHU Toulouse-Hôpital Purpan

location_facility: Oncology and Hematology at Lehigh Valley

location_facility: The Cancer Center, Hackensack University Medical Center

location_facility: Cancer Therapy and Research Center at The University of TX Health Science Center

location_facility: Maine General Medical Center Harold Alfond Center for Cancer Care

location_facility: Service des Maladies du Sang Hopital Haut-Leveque

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Service d'Hématologie et Médecine Interne CHU de Nancy-Hôpital de Brabois

location_facility: Texas Tech University Health Sciences Center

location_facility: University of Louisville Brown Cancer Center

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika

location_facility: University of Chicago Medical Center Section of Hematology/Oncology

location_facility: Service des Maladies du Sang CHU de Lille, Hopital Claude Huriez

location_facility: Blumenthal Cancer Center/Mecklenburg Medical Group

location_facility: Vancouver General Hospital/ British Columbia Cancer Agency


title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma

summary: This is a phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI

lead_sponsor: NantCell, Inc.

location_country:
Italy
Poland
India
Hungary
Hong Kong
Singapore
United States
Spain
Russian Federation
France


title: Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)

summary:
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients; or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced patients.

A secondary objective is to investigate antiviral activity, potential drug-drug interactions and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for treatment-naïve patients.

ReferenceCitation: Berger KL, Lagace L, Triki I, Cartier M, Marquis M, Lawetz C, Bethell R, Scherer J, Kukolj G. Viral resistance in hepatitis C virus genotype 1-infected patients receiving the NS3 protease inhibitor Faldaprevir (BI 201335) in a phase 1b multiple-rising-dose study. Antimicrob Agents Chemother. 2013 Oct;57(10):4928-36. doi: 10.1128/AAC.00822-13. Epub 2013 Jul 22.

publisher_dissemination: American Society for Microbiology

ReferenceCitation: Manns MP, Bourliere M, Benhamou Y, Pol S, Bonacini M, Trepo C, Wright D, Berg T, Calleja JL, White PW, Stern JO, Steinmann G, Yong CL, Kukolj G, Scherer J, Boecher WO. Potency, safety, and pharmacokinetics of the NS3/4A protease inhibitor BI201335 in patients with chronic HCV genotype-1 infection. J Hepatol. 2011 Jun;54(6):1114-22. doi: 10.1016/j.jhep.2010.08.040. Epub 2010 Nov 11.

lead_sponsor: Boehringer Ingelheim

location_country:
United States
Spain
Germany
France

location_facility: 1220.2.17 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.14 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3302A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.11 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.10 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49006 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.12 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49002 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49003 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49004 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.34001 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.15 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.49005 Boehringer Ingelheim Investigational Site

location_facility: 1220.2.3303A Boehringer Ingelheim Investigational Site


title: A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis.

summary: The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.

ReferenceCitation: Mukherjee A, Tsuchiwata S, Nicholas T, Cook JA, Modesto I, Su C, D'Haens GR, Sandborn WJ. Exposure-Response Characterization of Tofacitinib Efficacy in Moderate to Severe Ulcerative Colitis: Results From Phase II and Phase III Induction and Maintenance Studies. Clin Pharmacol Ther. 2022 Jul;112(1):90-100. doi: 10.1002/cpt.2601. Epub 2022 Apr 27.

ReferenceCitation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2023 Jan 5;29(1):51-61. doi: 10.1093/ibd/izac061.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Vong C, Martin SW, Deng C, Xie R, Ito K, Su C, Sandborn WJ, Mukherjee A. Population Pharmacokinetics of Tofacitinib in Patients With Moderate to Severe Ulcerative Colitis. Clin Pharmacol Drug Dev. 2021 Mar;10(3):229-240. doi: 10.1002/cpdd.899. Epub 2021 Jan 29.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:

repositories_concat: PubMed Central;eprint.ncl.ac.uk

ReferenceCitation: Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panes J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

repositories:
LIRIAS (KU Leuven)
PubMed Central
pdfs.semanticscholar.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;pdfs.semanticscholar.org

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Sandborn WJ, Panes J, Zhang H, Yu D, Niezychowski W, Su C. Correlation Between Concentrations of Fecal Calprotectin and Outcomes of Patients With Ulcerative Colitis in a Phase 2 Trial. Gastroenterology. 2016 Jan;150(1):96-102. doi: 10.1053/j.gastro.2015.09.001. Epub 2015 Sep 12.

ReferenceCitation: Panes J, Su C, Bushmakin AG, Cappelleri JC, Mamolo C, Healey P. Randomized trial of tofacitinib in active ulcerative colitis: analysis of efficacy based on patient-reported outcomes. BMC Gastroenterol. 2015 Feb 5;15:14. doi: 10.1186/s12876-015-0239-9.

ReferenceCitation: Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, Niezychowski W; Study A3921063 Investigators. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012 Aug 16;367(7):616-24. doi: 10.1056/NEJMoa1112168.

location_country:
France
Italy
Poland
Slovakia
Hungary
Israel
Denmark
United Kingdom
Brazil
Netherlands
Mexico
Belgium
Sweden
Spain
South Africa
Chile
Czech Republic


title: A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

summary: The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.

ReferenceCitation: Thertulien R, Manikhas GM, Dirix LY, Vermorken JB, Park K, Jain MM, Jiao JJ, Natarajan J, Parekh T, Zannikos P, Staddon AP. Effect of trabectedin on the QT interval in patients with advanced solid tumor malignancies. Cancer Chemother Pharmacol. 2012 Feb;69(2):341-50. doi: 10.1007/s00280-011-1697-6. Epub 2011 Jul 8.

lead_sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

location_country:
India
Belgium
United States
Korea, Republic of
Spain
Russian Federation
France


summary: The purpose of this study is to determine the safety and efficacy of oral lenvatinib in participants with medullary thyroid cancer (MTC) or radioiodine (131 I)-refractory/resistant differentiated thyroid cancer (DTC), unresectable differentiated thyroid cancers, stratified by Histology.

title: Phase II, Multicenter, Open-label, Single Arm Trial to Evaluate the Safety and Efficacy of Oral E7080 in Medullary and Iodine-131 Refractory, Unresectable Differentiated Thyroid Cancers, Stratified by Histology

location_country:
Italy
Poland
United Kingdom
Australia
United States
France


acronym: Not available

lead_sponsor: Puma Biotechnology, Inc.

summary: This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.

ReferenceCitation: Martin M, Bonneterre J, Geyer CE Jr, Ito Y, Ro J, Lang I, Kim SB, Germa C, Vermette J, Wang K, Wang K, Awada A. A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer. Eur J Cancer. 2013 Dec;49(18):3763-72. doi: 10.1016/j.ejca.2013.07.142. Epub 2013 Aug 15.

location_facility: Hospital Universitario Dr. Josep Trueta Servicio de Oncologia

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Klinicko Bolnicki Centar (KBC) Bezanijska Kosa (Medical Centre ''Bezanijska Kosa'' (MCBK))

location_facility: Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center

location_facility: Palm Beach Institute of Hematology & Oncology

location_facility: National Hospital Organization Osaka National Hospital

location_facility: St. Petersburg State Medical University I.P.Pavlov of Roszdrav

location_facility: Institute for Oncology Department for Medical Oncology

location_facility: Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku Specjalistyczny Szpital Onkologiczn

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly

location_facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"

location_facility: Istituto Regina Elena, Struttura Complessa Oncologia Medica A

location_facility: Russian Oncology Research Centre of RAMS

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Institut Jules Bordet Unite du Chimiotherapie

location_facility: The Center for Cancer and Blood Disorders

location_facility: Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-budai Egyesitett Korhazai, Onkologia

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Hospital Germans Trias i Pujol Servicio de Oncologia

location_facility: Centro Hospitalario de Jaen Servicio de Oncologia

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: Centre Oscar Lambret Departement de senologie

location_facility: Allegheny General Hospital Allegheny Cancer Center

location_facility: Hospital Universitario Miguel Servet Servicio de Oncologia

location_facility: GVI Oncology Trial Unit Room 110 Panorama Medical Centre

location_facility: East Texas Medical Center Cancer Institute, Tyler Hematology Oncology

location_facility: Kantonsspital Winterthur Medizinische Onkologie

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: SIH Oncology Dispensary # 2 Of Department of Public Health

location_facility: Hospital Central de Asturias Servicio de Oncologia, Planta Baja Oeste, Edificio Principal

location_facility: Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement

location_facility: Centrum Onkologii Ziemi Lubelskiej im. SW. Jana z Dukli

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: University of Tennessee Cancer Institute

location_facility: SIH Leningrad Regional Oncology Dispensary

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: Cancer Care Specialists Of Central Illinois

location_facility: Universitaetsklinikum Hamburg-Eppendorf Klinik und Poliklinik fuer Gynaekologie

location_facility: Scientific Research Institute of Oncology N.N. Petrov

location_facility: Hospital Mutua de Terrassa Servicio de Oncologia

location_facility: Institut Gustave ROUSSY Service de Pathologie mammaire

location_facility: CHU de Poitiers Service d'oncologie medicale

location_facility: Thompson Cancer Survival Center Thompson Oncology Group

location_facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases

location_facility: Oca Hospital / Monterrey International Research Center

location_facility: Medical Oncology Royal Adelaide Hospital

location_facility: Fakultni nemocnice Olomouc Klinika onkologie

location_facility: Department of Clinical Oncology, Tuen Mun Hospital

location_facility: AKH Wien Universitaetsklinik fuer Innere Medizin I Klinische Abteilung für Onkologie

location_facility: Ospedale Misericordia e Dolce c/o UO Oncologia Medica

location_facility: Hospital San Pedro de Alcantara Servicio de Oncologia

location_facility: Cancer Care Network of South Texas-HOAST

location_facility: University of Oklahoma Health Sciences Center Dept. of Hematology Oncology

location_facility: Abteilung fuer Onkologie Departement für Innere

location_facility: Centro Oncologico M.D. Anderson Internacional

location_facility: Division of Medical Oncology, Department of Medicine

location_facility: The Royal Marsden NHS Foundation Trust & Institute of Cancer Research

location_facility: Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Onkologii i Radioterapii

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

location_facility: Interdistrict Dispensary for Oncology Diseases -Internal Unit- Department Oncotherapy and Palliative Care

location_facility: Owsley Brown Frazier Cancer Center (OBFCC)

location_facility: Tokyo Metropolitan Cancer&Infectious disease Ctr Komagome Hp

location_facility: Hospital Provincial (Reina Sofia) Servicio de Oncologia

location_facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research Department of Medical Oncology

location_facility: Szegedi Tudomanyegyetem Onkoterapias Klinika

location_facility: Hospital Clinico Universitario de Valencia Servicio de Hematologia y Oncologia

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center

location_facility: Ryazan State Medical University I.P.Pavlov of Federal Agency in Healthcare and Social Development

location_facility: Complejo Hospitalario U. de A Coruña Hospital Teresa Herrera Servicio de Oncologia

location_facility: Instituto Valenciano de Oncologia Servicio de Oncologia

location_facility: Szpital Uniwersytecki w Krakowie Oddzial KIiniczny Kliniki Onkologii

location_facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD, Dept. of Chemotherapy

location_facility: Corporacio Sanitaria Parc Tauli Servicio de Oncologia

location_facility: Nationales Centrum fuer Tumorerkrankungen Sektion Gynaekologische Onkologie

location_facility: Yonsei University Health System - Severance Hospital

location_facility: Hospital General Universitario de Alicante Servicio de Oncologia

location_facility: Hospital Gregorio Marañon Servicio de Oncologia

location_facility: MetroHealth Medical Center, Cancer Care Center

location_facility: Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly

title: A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer

location_country:
Germany
Poland
Taiwan
Australia
Japan
Thailand
Croatia
Czechia
Canada
Serbia
France
Slovenia
Hungary
Hong Kong
Switzerland
United States
Romania
Belgium
Puerto Rico
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Jordan
Bulgaria
Russian Federation


title: Effect of LY450139 a y-Secretase Inhibitor, on the Progression of Alzheimer's Disease as Compared With Placebo

summary:
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some patients. The buildup of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some patients. In this trial, patients who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all patients could eventually receive active drug. Each patient's participation could last approximately 2 years. Patients taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All patients who completed this study had the option to continue receiving semagacestat by participating in an open label study.

Preliminary results from this study (LFBC) (and another similar study LFAN [NCT00594568]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. LFBC, LFAN and open label LFBF (NCT01035138) have been amended to continue collecting safety data, including cognitive scores, for at least seven months. The CT-Registry will reflect results of analyses from the original protocol in addition to those from the amended protocol.

ReferenceCitation: Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.

evidence: open (via page says Open Access)

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

repository_institution: Indiana University - IUScholarWorks

publisher_dissemination: IOS Press

ReferenceCitation: Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.

repository_institution: California Digital Library - eScholarship

lead_sponsor: Eli Lilly and Company

location_country:
Germany
Italy
Hungary
Romania
Japan
Brazil
Mexico
United States
China
Korea, Republic of
Turkey
Taiwan
Ukraine
Bulgaria
Canada
Serbia
Russian Federation
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: An Open-label, Randomized, Multicenter, Active-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C

summary: This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis

enrollment_type: Anticipated

ReferenceCitation: Pianko S, Zeuzem S, Chuang WL, Foster GR, Sarin SK, Flisiak R, Lee CM, Andreone P, Piratvisuth T, Shah S, Sood A, George J, Gould M, Komolmit P, Thongsawat S, Tanwandee T, Rasenack J, Li Y, Pang M, Yin Y, Feutren G, Jacobson IM; B2202 Study Team. Randomized trial of albinterferon alfa-2b every 4 weeks for chronic hepatitis C virus genotype 2/3. J Viral Hepat. 2012 Sep;19(9):623-34. doi: 10.1111/j.1365-2893.2012.01586.x. Epub 2012 Mar 21.

lead_sponsor: Novartis

sponsor_collaborators:
Novartis
Human Genome Sciences Inc.

location_country:
Germany
Italy
Poland
India
United Kingdom
Australia
Spain
Thailand
Greece
Taiwan
Canada
France

location_facility:
Novartis Investigative Site
Novartis Investigative site


title: A Multicenter, Randomized, Double-Blind, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin Added to Insulin Monotherapy or to Insulin in Combination With Metformin in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Insulin Alone or on Insulin in Combination With Metformin

summary: The purpose of this study is to compare the effects of saxagliptin with those of placebo as add-on therapy to insulin and insulin with metformin in improving glycemic control at 24 and 52 weeks.

ReferenceCitation: Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.

ReferenceCitation: Cook W, Minervini G, Bryzinski B, Hirshberg B. Saxagliptin efficacy and safety in patients with type 2 diabetes mellitus stratified by cardiovascular disease history and cardiovascular risk factors: analysis of 3 clinical trials. Postgrad Med. 2014 Oct;126(6):19-32. doi: 10.3810/pgm.2014.10.2818.

publisher_dissemination: Informa

ReferenceCitation: Barnett AH, Charbonnel B, Li J, Donovan M, Fleming D, Iqbal N. Saxagliptin add-on therapy to insulin with or without metformin for type 2 diabetes mellitus: 52-week safety and efficacy. Clin Drug Investig. 2013 Oct;33(10):707-17. doi: 10.1007/s40261-013-0107-8.

publisher_dissemination: Springer

ReferenceCitation: Barnett AH, Charbonnel B, Donovan M, Fleming D, Chen R. Effect of saxagliptin as add-on therapy in patients with poorly controlled type 2 diabetes on insulin alone or insulin combined with metformin. Curr Med Res Opin. 2012 Apr;28(4):513-23. doi: 10.1185/03007995.2012.665046. Epub 2012 Mar 1.

lead_sponsor: AstraZeneca

location_country:
Poland
India
Hungary
United Kingdom
Mexico
United States
South Africa
Canada
Russian Federation
France

location_facility: Panhandle Family Care Assoc. & Coastal Palms Res. Grp Inc.


title: Phase II Randomised, Double Blind, Multicentre Study to Assess the Efficacy of AZD2281 in the Treatment of Patients With Platinum Sensitive Relapsed Serous Ovarian Cancer Following Treatment With Two or More Platinum Containing Regimens

summary: The primary purpose of this study to determine if AZD2281 is effective and well tolerated in maintaining the improvement in your cancer after previous platinum-based chemotherapy

status: Active, not recruiting

study_completion_date_type: Anticipated

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

oa_host_type: repository

repositories_institution: University College London - UCL Discovery

unpaywall_oa_status: green

ReferenceCitation: Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Bennett B, Parry D, Spencer S, Mann H, Matulonis U. Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. Br J Cancer. 2016 Nov 22;115(11):1313-1320. doi: 10.1038/bjc.2016.348. Epub 2016 Nov 8.

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Edinburgh - Edinburgh Research Explorer

repositories_concat: LIRIAS (KU Leuven);PubMed Central;UCL Discovery;University of Melbourne - Minerva Access;pure.ed.ac.uk;scholarworks.iupui.edu

repositories_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

ReferenceCitation: Ledermann JA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Rowe P, Lowe E, Hodgson D, Sovak MA, Matulonis U. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016 Nov;17(11):1579-1589. doi: 10.1016/S1470-2045(16)30376-X. Epub 2016 Sep 9.

ReferenceCitation: Matulonis UA, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Parry D, Grinsted L, Ledermann JA. Olaparib maintenance therapy in patients with platinum-sensitive, relapsed serous ovarian cancer and a BRCA mutation: Overall survival adjusted for postprogression poly(adenosine diphosphate ribose) polymerase inhibitor therapy. Cancer. 2016 Jun 15;122(12):1844-52. doi: 10.1002/cncr.29995. Epub 2016 Apr 8.

ReferenceCitation: Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott CL, Meier W, Shapira-Frommer R, Safra T, Matei D, Fielding A, Spencer S, Dougherty B, Orr M, Hodgson D, Barrett JC, Matulonis U. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol. 2014 Jul;15(8):852-61. doi: 10.1016/S1470-2045(14)70228-1. Epub 2014 May 31. Erratum In: Lancet Oncol. 2015 Apr;16(4):e158.

ReferenceCitation: Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med. 2012 Apr 12;366(15):1382-92. doi: 10.1056/NEJMoa1105535. Epub 2012 Mar 27.

ReferenceCitation: Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

location_country:
Germany
Poland
Israel
United Kingdom
Romania
Australia
Netherlands
Austria
Belgium
United States
Spain
Czechia
Ukraine
Canada
Estonia
Russian Federation
France


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone

summary: This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Guatemala
Brazil
Costa Rica
Mexico
United States
Canada
Puerto Rico
France


lead_sponsor: Translational Research in Oncology

summary: This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.

location_facility: Wake Forest University Baptist Medical Center

location_facility: Central Coast Medical Oncology Corporation

location_facility: Hematology and Oncology Specialists, LLC

location_facility: Centre Hospitalier Départemental Les Oudairies

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Hospital Universitario Virgen Macarena de Sevilla

location_facility: Winship Cancer Institute Emory University School of Medicine

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: North Valley Hematology/Oncology Medical Group

title: A Randomized, Double-blind, Placebo Controlled, Multi-center, Phase II Study of Adding AMG 479, a Fully Human Monoclonal Antibody Against Insulin-like Growth Factor Type 1 Receptor (IGF-1R) to First Line Chemotherapy in Patients With Optimally Debulked ( < 1 cm ) Epithelial Ovarian Cancer

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


title: Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions

summary: Our hypothesis is that the addition of ShearWave Elastography (SWE) to a conventional breast ultrasound examination provides useful information for the radiologist when imaging lesions in the breast, as compared to conventional grayscale ultrasound alone.

study_type: Observational

time_perspective: Cross-Sectional

ReferenceCitation: Cosgrove DO, Berg WA, Dore CJ, Skyba DM, Henry JP, Gay J, Cohen-Bacrie C; BE1 Study Group. Shear wave elastography for breast masses is highly reproducible. Eur Radiol. 2012 May;22(5):1023-32. doi: 10.1007/s00330-011-2340-y. Epub 2011 Dec 31.

ReferenceCitation: Berg WA, Cosgrove DO, Dore CJ, Schafer FK, Svensson WE, Hooley RJ, Ohlinger R, Mendelson EB, Balu-Maestro C, Locatelli M, Tourasse C, Cavanaugh BC, Juhan V, Stavros AT, Tardivon A, Gay J, Henry JP, Cohen-Bacrie C; BE1 Investigators. Shear-wave elastography improves the specificity of breast US: the BE1 multinational study of 939 masses. Radiology. 2012 Feb;262(2):435-49. doi: 10.1148/radiol.11110640.

lead_sponsor: SuperSonic Imagine

location_country:
Germany
Italy
United Kingdom
United States
France

location_facility: Northwestern Memorial Hospital, Dept. of Radiology

location_facility: Thomas Jefferson Medical Center, Department of Radiology

location_facility: Yale Medical Center, Department of Diagnostic Radiology

location_facility: University of Southern California - LAC+USC Medical Center, OPD Rm 3P61


title: A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).

summary: The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

ReferenceCitation: Fleischmann R, Goldman JA, Leirisalo-Repo M, Zanetakis E, El-Kadi H, Kellner H, Bolce R, DeHoratius R, Wang J, Decktor D. Infliximab efficacy in rheumatoid arthritis after an inadequate response to etanercept or adalimumab: results of a target-driven active switch study. Curr Med Res Opin. 2014 Nov;30(11):2139-49. doi: 10.1185/03007995.2014.942416. Epub 2014 Jul 30.

lead_sponsor: Centocor Ortho Biotech Services, L.L.C.

sponsor_collaborators:
Centocor Ortho Biotech Services, L.L.C.
Schering-Plough

location_country:
Finland
Germany
Israel
United Kingdom
Netherlands
Austria
United States
Spain
Canada
France


acronym: PROGRESS

lead_sponsor: Abbott

summary: The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

ReferenceCitation: Reynes J, Trinh R, Pulido F, Soto-Malave R, Gathe J, Qaqish R, Tian M, Fredrick L, Podsadecki T, Norton M, Nilius A. Lopinavir/ritonavir combined with raltegravir or tenofovir/emtricitabine in antiretroviral-naive subjects: 96-week results of the PROGRESS study. AIDS Res Hum Retroviruses. 2013 Feb;29(2):256-65. doi: 10.1089/aid.2011.0275. Epub 2012 Aug 3.

publisher_dissemination: Mary Ann Liebert Inc

ReferenceCitation: Reynes J, Lawal A, Pulido F, Soto-Malave R, Gathe J, Tian M, Fredrick LM, Podsadecki TJ, Nilius AM. Examination of noninferiority, safety, and tolerability of lopinavir/ritonavir and raltegravir compared with lopinavir/ritonavir and tenofovir/ emtricitabine in antiretroviral-naive subjects: the progress study, 48-week results. HIV Clin Trials. 2011 Sep-Oct;12(5):255-67. doi: 10.1310/hct1205-255.

sponsor_collaborators:
Abbott
Merck Sharp & Dohme LLC

location_facility:
Site Reference ID/Investigator# 8052
Site Reference ID/Investigator# 8063
Site Reference ID/Investigator# 7963
Site Reference ID/Investigator# 7693
Site Reference ID/Investigator# 8425
Site Reference ID/Investigator# 7959
Site Reference ID/Investigator# 8393
Site Reference ID/Investigator# 8051
Site Reference ID/Investigator# 8431
Site Reference ID/Investigator# 8221
Site Reference ID/Investigator# 8433
Site Reference ID/Investigator# 7713
Site Reference ID/Investigator# 8424
Site Reference ID/Investigator# 7831
Site Reference ID/Investigator# 7821
Site Reference ID/Investigator# 8099
Site Reference ID/Investigator# 8396
Site Reference ID/Investigator# 7695
Site Reference ID/Investigator# 7690
Site Reference ID/Investigator# 8395
Site Reference ID/Investigator# 11461
Site Reference ID/Investigator# 11102
Site Reference ID/Investigator# 7960
Site Reference ID/Investigator# 7689
Site Reference ID/Investigator# 8426
Site Reference ID/Investigator# 8050
Site Reference ID/Investigator# 8403
Site Reference ID/Investigator# 8429
Site Reference ID/Investigator# 8432
Site Reference ID/Investigator# 7789
Site Reference ID/Investigator# 7700
Site Reference ID/Investigator# 7698
Site Reference ID/Investigator# 8402
Site Reference ID/Investigator# 7692
Site Reference ID/Investigator# 7691
Site Reference ID/Investigator# 8394
Site Reference ID/Investigator# 7697

title: A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

location_country:
Italy
Poland
United States
Spain
Canada
Puerto Rico
France


title: A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

acronym: ASPIRE

summary:
The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia

The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.

ReferenceCitation: Kane JM, Sanchez R, Baker RA, Eramo A, Peters-Strickland T, Perry PP, Johnson BR, Tsai LF, Carson WH, McQuade RD, Fleischhacker WW. Patient-Centered Outcomes with Aripiprazole Once-Monthly for Maintenance Treatment in Patients with Schizophrenia: Results From Two Multicenter, Randomized, Double-Blind Studies. Clin Schizophr Relat Psychoses. 2015 Summer;9(2):79-87. doi: 10.3371/CSRP.KASA.022015. Epub 2015 Feb 24.

publisher_dissemination: Longdom Group

ReferenceCitation: Fleischhacker WW, Sanchez R, Perry PP, Jin N, Peters-Strickland T, Johnson BR, Baker RA, Eramo A, McQuade RD, Carson WH, Walling D, Kane JM. Aripiprazole once-monthly for treatment of schizophrenia: double-blind, randomised, non-inferiority study. Br J Psychiatry. 2014 Aug;205(2):135-44. doi: 10.1192/bjp.bp.113.134213. Epub 2014 Jun 12.

publisher_dissemination: Royal College of Psychiatrists

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Italy
Poland
Hungary
Austria
Belgium
United States
Korea, Republic of
Thailand
South Africa
Croatia
Chile
Bulgaria
Estonia
Puerto Rico
France


summary:
The purpose of this study is to identify the highest tolerable dose of neratinib (HKI-272) in combination with vinorelbine and to assess the safety of the combination of the two drugs as well as to obtain preliminary information on whether the combination of the two drugs has any effect on solid tumors.

The study will be conducted in two parts. In the first part, testing will be done on up to 12 subjects to determine the highest tolerable dose of HKI-272 and vinorelbine in patients with advanced solid tumors. In the second part of the study, approximately 60 additional subjects with metastatic ErbB-2-positive breast cancer, with no prior exposure to lapatinib, are planned to be added to better define the tolerability and preliminary activity of HKI-272 in combination with vinorelbine. Up to 20 additional subjects with ErbB-2-positive breast cancer with prior lapatinib exposure are also planned to be enrolled in part 2 for exploratory analyses.

ReferenceCitation: Awada A, Dirix L, Manso Sanchez L, Xu B, Luu T, Dieras V, Hershman DL, Agrapart V, Ananthakrishnan R, Staroslawska E. Safety and efficacy of neratinib (HKI-272) plus vinorelbine in the treatment of patients with ErbB2-positive metastatic breast cancer pretreated with anti-HER2 therapy. Ann Oncol. 2013 Jan;24(1):109-16. doi: 10.1093/annonc/mds284. Epub 2012 Sep 11.

license: publisher-specific-oa

license_normalized: publisher-specific

location_facility: Hospital 12 de Octubre, Servicio de Oncologia Medica

location_facility: Hospital Arnau de Vilanova, Servicio de Oncologia Medica

location_facility: Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center

location_facility: Centrum Onkologii Ziemii Lubelskiej, Oddział Chemioterapii

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Cancer Hospital, Chinese Academy of Medical Sciences

location_facility: Onkologiska Kliniken Universitetssjukhuset i Lund

location_facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army

location_facility: Chinese People's Liberation Army General Hospital

location_facility: St.-Augustinus Hospital Oncology Department

location_facility: Wojskowy Instytut Medyczny, Klinika Onkologii

location_facility: Hematology Oncology Associates of Rockland

location_facility: Guy's and St. Thomas' NHS Foundation Trust, Guy's Hospital

location_facility: Martini Ziekenhuis / Afdeling Interne Geneeskunde

location_facility: Institut Curie, Département d'Oncologie Médicale

title: A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer

location_country:
Poland
United Kingdom
Hong Kong
Sweden
Netherlands
Belgium
United States
China
Spain
Taiwan
France


lead_sponsor: UCB Pharma

summary: Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.

ReferenceCitation: Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.

title: An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization.

location_country:
Germany
Italy
Hungary
United States
Spain
France


acronym: PROCLAIM

summary: This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.

ReferenceCitation: Govindan R, Senan S, Dickgreber N, Provencio M, Wu YL, Syrigos K, Parente B, Wilson M, Ziemiecki R, Chouaki N, Hossain A, San Antonio B, Winfree K, Vokes EE. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer. Curr Med Res Opin. 2019 Oct;35(10):1761-1767. doi: 10.1080/03007995.2019.1623185. Epub 2019 Jul 5.

ReferenceCitation: Brade AM, Wenz F, Koppe F, Lievens Y, San Antonio B, Iscoe NA, Hossain A, Chouaki N, Senan S. Radiation Therapy Quality Assurance (RTQA) of Concurrent Chemoradiation Therapy for Locally Advanced Non-Small Cell Lung Cancer in the PROCLAIM Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):927-934. doi: 10.1016/j.ijrobp.2018.04.015. Epub 2018 Apr 12.

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: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Turkey
Canada
France
Portugal
United States
India
Belgium
China
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan


summary:
This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β [anti-IL-1β] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies or newly identified patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease.

The duration of this study was 6 months with a maximum duration of 2 years

ReferenceCitation: Kuemmerle-Deschner JB, Hachulla E, Cartwright R, Hawkins PN, Tran TA, Bader-Meunier B, Hoyer J, Gattorno M, Gul A, Smith J, Leslie KS, Jimenez S, Morell-Dubois S, Davis N, Patel N, Widmer A, Preiss R, Lachmann HJ. Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes. Ann Rheum Dis. 2011 Dec;70(12):2095-102. doi: 10.1136/ard.2011.152728. Epub 2011 Aug 21.

location_facility: Rush-Presbyterian St. Lukes Medical Center

title: An Open-label, Long-term Safety and Efficacy Study of ACZ885 (Anti-interleukin-1β Monoclonal Antibody) Administered for at Least 6 Months in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

location_country:
Germany
Italy
India
United Kingdom
Belgium
United States
Spain
Turkey
France


lead_sponsor: AbbVie (prior sponsor, Abbott)

summary: This study is being conducted to compare the efficacy of ABT-874 versus Methotrexate in subjects with moderate to severe plaque psoriasis.

ReferenceCitation: Inzinger M, Weger W, Salmhofer W, Wolf P. Differential response of chronic plaque psoriasis to briakinumab vs. ustekinumab. Acta Derm Venereol. 2012 Jul;92(4):357-8. doi: 10.2340/00015555-1243. No abstract available.

ReferenceCitation: Reich K, Langley RG, Papp KA, Ortonne JP, Unnebrink K, Kaul M, Valdes JM. A 52-week trial comparing briakinumab with methotrexate in patients with psoriasis. N Engl J Med. 2011 Oct 27;365(17):1586-96. doi: 10.1056/NEJMoa1010858.

location_facility:
Site Reference ID/Investigator# 11864
Site Reference ID/Investigator# 8024
Site Reference ID/Investigator# 13481
Site Reference ID/Investigator# 8185
Site Reference ID/Investigator# 8022
Site Reference ID/Investigator# 13422
Site Reference ID/Investigator# 8027
Site Reference ID/Investigator# 8551
Site Reference ID/Investigator# 10203
Site Reference ID/Investigator# 13461
Site Reference ID/Investigator# 8034
Site Reference ID/Investigator# 13104
Site Reference ID/Investigator# 8020
Site Reference ID/Investigator# 13163
Site Reference ID/Investigator# 11001
Site Reference ID/Investigator# 12763
Site Reference ID/Investigator# 8032
Site Reference ID/Investigator# 8023
Site Reference ID/Investigator# 13161
Site Reference ID/Investigator# 13223
Site Reference ID/Investigator# 8363
Site Reference ID/Investigator# 8019
Site Reference ID/Investigator# 8033
Site Reference ID/Investigator# 9583
Site Reference ID/Investigator# 12381
Site Reference ID/Investigator# 8021
Site Reference ID/Investigator# 13462
Site Reference ID/Investigator# 10702
Site Reference ID/Investigator# 8030
Site Reference ID/Investigator# 11661
Site Reference ID/Investigator# 12401
Site Reference ID/Investigator# 11161
Site Reference ID/Investigator# 8035
Site Reference ID/Investigator# 11701
Site Reference ID/Investigator# 11504
Site Reference ID/Investigator# 9904
Site Reference ID/Investigator# 10963
Site Reference ID/Investigator# 8362
Site Reference ID/Investigator# 11841
Site Reference ID/Investigator# 8025
Site Reference ID/Investigator# 11381
Site Reference ID/Investigator# 13221
Site Reference ID/Investigator# 8026

title: A Phase 3, Multicenter, Randomized, Double-blind Study Comparing the Safety Efficacy of ABT-874 to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis

location_country:
Finland
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
Canada
France