title: A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)

acronym: NALA

summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

ReferenceCitation: Dai MS, Feng YH, Chen SW, Masuda N, Yau T, Chen ST, Lu YS, Yap YS, Ang PCS, Chu SC, Kwong A, Lee KS, Ow S, Kim SB, Lin J, Chung HC, Ngan R, Kok VC, Rau KM, Sangai T, Ng TY, Tseng LM, Bryce R, Bebchuk J, Chen MC, Hou MF. Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens. Breast Cancer Res Treat. 2021 Oct;189(3):665-676. doi: 10.1007/s10549-021-06313-5. Epub 2021 Sep 23.

ReferenceCitation: Saura C, Oliveira M, Feng YH, Dai MS, Chen SW, Hurvitz SA, Kim SB, Moy B, Delaloge S, Gradishar W, Masuda N, Palacova M, Trudeau ME, Mattson J, Yap YS, Hou MF, De Laurentiis M, Yeh YM, Chang HT, Yau T, Wildiers H, Haley B, Fagnani D, Lu YS, Crown J, Lin J, Takahashi M, Takano T, Yamaguchi M, Fujii T, Yao B, Bebchuk J, Keyvanjah K, Bryce R, Brufsky A; NALA Investigators. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial. J Clin Oncol. 2020 Sep 20;38(27):3138-3149. doi: 10.1200/JCO.20.00147. Epub 2020 Jul 17.

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

lead_sponsor: Puma Biotechnology, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Singapore
Sweden
Brazil
Canada
Switzerland
Germany
Denmark
Taiwan
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner

location_facility: Emory University Winship Cancer Institute

location_facility: Hospital Cervesi di Cattolica, Department of Oncology

location_facility: Scientific Institute of Romagna of the Study and Treatment of Cancer

location_facility: University of California San Diego Moores Cancer Center

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Instituto de Pesquisas Clinicas para Estudos Multicentricos Hospital Geral de Caxias do Sul, Universidade de Caxias do Sul (IPCEM)

location_facility: Institut Jules Bordet - Medical Oncology

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin Russian Academy of Medical Sciences

location_facility: Orebro University Hospital, Department of Oncology

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.

location_facility: University of California San Diego Medical Center - Hillcrest

location_facility: North Shore Oncology-Hematology Associates, Ltd.

location_facility: University Hospitals Case Medical Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Icon Singapore Oncology Consultants Farrer Park Medical Clinic

location_facility: Taichung Veterans General Hospital, Breast Center

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station

location_facility: Hospital Infermi Rimini, Unit of Oncology

location_facility: University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology

location_facility: Queen Mary Hospital, Department of Clinical Oncology

location_facility: Maastricht University Medical Centre (MUMC)

location_facility: University Hospital Quiron Madrid, Department of Oncology

location_facility: Instituto Brasileiro de Controle Do Câncer IBCC

location_facility: Instituto Joinvillense de Hematologia e Oncologia

location_facility: Hospital Clinico Universitario de Valencia, Servicio de Oncologia

location_facility: Queen Mary Hospital, Department of Oncology

location_facility: Kaplan Medical Center, Department of Oncology

location_facility: Maroondah Hospital, Maroondah Breast Clinic

location_facility: Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility

location_facility: Gustave Roussy Oncology Institute, Department of Medicine

location_facility: IRCCS - Hospital San Raffaele, Department of Medical Oncology

location_facility: North Shore Hematology Oncology Association PC

location_facility: Cancer Center of Santa Barbara Sansum Clinic

location_facility: University Hospitals Cleveland Medical Center

location_facility: Abbotsford Regional Hospital and Cancer Care Centre

location_facility: Chi Mei Medical Center - LiouYing Branch

location_facility: National Cancer Institute - IRCCS "Fondazione G. Pascale"

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto, Hospital de Base

location_facility: Hospital Do Cancer A C Camargo - Hospital

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: University Hospital Virgen del Rocio, Servicio de Oncologia

location_facility: Cancer Care Associates Medical Group, Inc

location_facility: Centro de Investigação Clinica, Hospital da Luz

location_facility: University Hospital Motol, Comprehensive Oncology Center

location_facility: University Hospital Clinic San Carlos, Servicio de Oncologia Medica

location_facility: Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia

location_facility: University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology

location_facility: COIBA Centro de Oncología e Investigación Buenos Aires

location_facility: Queen Mary Hospital, Department of Surgery

location_facility: Hospital Son Llatzer, Servicio de Oncologia

location_facility: Otto von Guericke University of Magdeburg

location_facility: Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement

location_facility: Hospital de Cancer de Barretos - Hospital

location_facility: Hospital Desio and Vimercate, Department of Medical Oncology

location_facility: Clinic Sainte Anne, Center for Radiotherapy

location_facility: Sourasky Medical Center, Department of Oncology

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology

location_facility: Calderdale Royal Hospital, Macmillan Unit

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Caner Center

location_facility: Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia

location_facility: Gleneagles Medical Centre, Center for Medical Oncology

location_facility: Sunnybrook Health Sciences Center, Odette Cancer Center

location_facility: Compassionate Cancer Care Medical Group Inc.

location_facility: Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Hospital Sacro Cuore Don Calabria, Department of Medical Oncology

location_facility: Uppsala University Hospital, Department of Oncology

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Nottingham City Hospital Campus, Department of Oncology

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

location_facility: Hospital Papa Giovanni XXIII, Department of Medical Oncology

location_facility: University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta

location_facility: Institute of Cancer Research and Treatment

location_facility: AZ Damiaan General Hospital, Sint-Jozef Oncology Center

location_facility: Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás

location_facility: Helsinki University Central Hospital, Department of Oncology

location_facility: Federal State Government-Financed Institution: City Clinical Hospital #40

location_facility: The Cancer Institute at University of Maryland St. Joseph Medical Center

location_facility: Queen Elizabeth Hospital, Department of Clinical Oncology

location_facility: National Cancer Centre Singapore, Department of Medical Oncology

location_facility: University of Texas Southwestern Medical Center

location_facility: Hakuaikai Medical Corporation Sagara Hospital


type: Other Identifier

type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.

ReferenceCitation: Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.

ReferenceCitation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.

ReferenceCitation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.

ReferenceCitation: Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.

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

ReferenceCitation: Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Ureña-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.

ReferenceCitation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.

ReferenceCitation: Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.

lead_sponsor: Amgen

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus

summary:
This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE). This study will also investigate the safety and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses will be conducted. These are to monitor the pharmacodynamic effect and safety following 2 weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184 following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d, 400 mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength will be administered orally up to 12 weeks.

Subjects who complete the study will participate in the study for approximately 21 weeks.

status: Terminated

ReferenceType: derived

ReferenceCitation: Kahl L, Patel J, Layton M, Binks M, Hicks K, Leon G, Hachulla E, Machado D, Staumont-Sallé D, Dickson M, Condreay L, Schifano L, Zamuner S, van Vollenhoven RF; JAK115919 Study Team. Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus. Lupus. 2016 Nov;25(13):1420-1430. doi: 10.1177/0961203316640910. Epub 2016 Jul 11.

ipd_sharing: Yes

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Hong Kong
Spain
Greece
Estonia
Argentina
Sweden
Hungary
Korea, Republic of
France
Chile
Peru
South Africa
Romania
Germany
Czechia

status_simplified: Unknown


type: Other Grant/Funding Number

type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Phase II/III Randomized, Double-Blind, Placebo-Controlled, Cognitive Endpoint, Multi-Center Study of Potential Disease Modifying Therapies in Individuals at Risk for and With Dominantly Inherited Alzheimer's Disease

acronym: DIAN-TU

summary: The purpose of this study is to assess the safety, tolerability, biomarker and cognitive efficacy of investigational products in subjects who are known to have an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive impairment and improves disease-related biomarkers.

status: Recruiting

study_completion_date_type: Anticipated

enrollment_type: Anticipated

ReferenceCitation: Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11. Erratum in: N Engl J Med. 2012 Aug 23;367(8):780.

ReferenceCitation: Farlow M, Arnold SE, van Dyck CH, Aisen PS, Snider BJ, Porsteinsson AP, Friedrich S, Dean RA, Gonzales C, Sethuraman G, DeMattos RB, Mohs R, Paul SM, Siemers ER. Safety and biomarker effects of solanezumab in patients with Alzheimer's disease. Alzheimers Dement. 2012 Jul;8(4):261-71. doi: 10.1016/j.jalz.2011.09.224. Epub 2012 Jun 5.

ReferenceCitation: Bateman RJ, Benzinger TL, Berry S, Clifford DB, Duggan C, Fagan AM, Fanning K, Farlow MR, Hassenstab J, McDade EM, Mills S, Paumier K, Quintana M, Salloway SP, Santacruz A, Schneider LS, Wang G, Xiong C; DIAN-TU Pharma Consortium for the Dominantly Inherited Alzheimer Network. The DIAN-TU Next Generation Alzheimer's prevention trial: Adaptive design and disease progression model. Alzheimers Dement. 2017 Jan;13(1):8-19. doi: 10.1016/j.jalz.2016.07.005. Epub 2016 Aug 29.

ReferenceCitation: Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS, Althage MC, Belyew S, Benzinger TL, Brooks WS, Buckles VD, Cairns NJ, Clifford D, Danek A, Fagan AM, Farlow M, Fox N, Ghetti B, Goate AM, Heinrichs D, Hornbeck R, Jack C, Jucker M, Klunk WE, Marcus DS, Martins RN, Masters CM, Mayeux R, McDade E, Morris JC, Oliver A, Ringman JM, Rossor MN, Salloway S, Schofield PR, Snider J, Snyder P, Sperling RA, Stewart C, Thomas RG, Xiong C, Bateman RJ. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013 Oct;169(10):737-43. doi: 10.1016/j.neurol.2013.07.017. Epub 2013 Sep 6. Review.

ReferenceCitation: Wang G, Berry S, Xiong C, Hassenstab J, Quintana M, McDade EM, Delmar P, Vestrucci M, Sethuraman G, Bateman RJ; Dominantly Inherited Alzheimer Network Trials Unit. A novel cognitive disease progression model for clinical trials in autosomal-dominant Alzheimer's disease. Stat Med. 2018 Sep 20;37(21):3047-3055. doi: 10.1002/sim.7811. Epub 2018 May 14.

ReferenceCitation: Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001.

ReferenceCitation: Grill JD, Bateman RJ, Buckles V, Oliver A, Morris JC, Masters CL, Klunk WE, Ringman JM; Dominantly Inherited Alzheimer's Network. A survey of attitudes toward clinical trials and genetic disclosure in autosomal dominant Alzheimer's disease. Alzheimers Res Ther. 2015 Jul 22;7(1):50. doi: 10.1186/s13195-015-0135-0. eCollection 2015.

ReferenceCitation: McDade E, Bateman RJ. Stop Alzheimer's before it starts. Nature. 2017 Jul 12;547(7662):153-155. doi: 10.1038/547153a.

ReferenceCitation: McDade E, Wang G, Gordon BA, Hassenstab J, Benzinger TLS, Buckles V, Fagan AM, Holtzman DM, Cairns NJ, Goate AM, Marcus DS, Morris JC, Paumier K, Xiong C, Allegri R, Berman SB, Klunk W, Noble J, Ringman J, Ghetti B, Farlow M, Sperling RA, Chhatwal J, Salloway S, Graff-Radford NR, Schofield PR, Masters C, Rossor MN, Fox NC, Levin J, Jucker M, Bateman RJ; Dominantly Inherited Alzheimer Network. Longitudinal cognitive and biomarker changes in dominantly inherited Alzheimer disease. Neurology. 2018 Oct 2;91(14):e1295-e1306. doi: 10.1212/WNL.0000000000006277. Epub 2018 Sep 14.

ReferenceCitation: Ryman DC, Acosta-Baena N, Aisen PS, Bird T, Danek A, Fox NC, Goate A, Frommelt P, Ghetti B, Langbaum JB, Lopera F, Martins R, Masters CL, Mayeux RP, McDade E, Moreno S, Reiman EM, Ringman JM, Salloway S, Schofield PR, Sperling R, Tariot PN, Xiong C, Morris JC, Bateman RJ; Dominantly Inherited Alzheimer Network. Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis. Neurology. 2014 Jul 15;83(3):253-60. doi: 10.1212/WNL.0000000000000596. Epub 2014 Jun 13. Review.

ReferenceCitation: Weng H, Bateman R, Morris JC, Xiong C. Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostat Epidemiol. 2017;1(1):59-77. doi: 10.1080/24709360.2017.1331822. Epub 2017 Jun 13.

ipd_sharing_description: Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention [CAP REF].

lead_sponsor: Washington University School of Medicine

location_country:
Brazil
Spain
Ireland
Italy
Australia
Mexico
Argentina
Canada
Netherlands
United Kingdom
Puerto Rico
United States
France
Colombia
Japan
Germany

location_facility: The McCuster Foundation of Alzheimer's Disease Research

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

location_facility: University of California San Diego Medical Center

location_facility: University of Puerto Rico, School of Medicine

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Hospital Clínic I Provincial de Barcelona

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Grupo de Neurociencias Sede de la Universidad de Antioquia

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

lead_sponsor_type: academique

status_simplified: Ongoing


title: A Pivotal Phase 2b/3, Multicentre, Randomised, Open, Controlled Study on the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Non-Infected Hypotrophic Non-Union Fractures

summary:
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite.

Non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. Various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009).

This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority design.

lead_sponsor: Bone Therapeutics S.A

location_country: Netherlands France Belgium

location_facility:
Investigating site BE08
Investigating site BE02
Investigating site FR03
Investigating site NL02
Investigating site BE03
Investigating site FR01
Investigating site BE06
Investigating site BE09
Investigating site BE07
Investigating site BE04
Investigating site BE01
Investigating site FR04
Investigating site FR02
Investigating site BE05
Investigating site NL01
Investigating site FR06

intervention_type: Procedure


title: Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis

summary: This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15 milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a follow-up visit around 14 weeks after the last infusion. A total of approximately 294 eligible subjects will be randomised from approximately 37 centers worldwide. The primary objective is to assess the effect of ozanezumab on the physical function and survival of ALS subjects over a treatment period of 48 weeks. Function will be measured using the ALS Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of other clinical outcomes associated with ALS (respiratory function, muscle strength, progression free survival and overall survival) in support of the primary objective. Quality of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole) will also be assessed.

ReferenceCitation: Meininger V, Genge A, van den Berg LH, Robberecht W, Ludolph A, Chio A, Kim SH, Leigh PN, Kiernan MC, Shefner JM, Desnuelle C, Morrison KE, Petri S, Boswell D, Temple J, Mohindra R, Davies M, Bullman J, Rees P, Lavrov A; NOG112264 Study Group. Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 Mar;16(3):208-216. doi: 10.1016/S1474-4422(16)30399-4. Epub 2017 Jan 28.

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


title: Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma

summary: Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.

ReferenceCitation: Chesney J, Puzanov I, Collichio F, Singh P, Milhem MM, Glaspy J, Hamid O, Ross M, Friedlander P, Garbe C, Logan TF, Hauschild A, Lebbé C, Chen L, Kim JJ, Gansert J, Andtbacka RHI, Kaufman HL. Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of Talimogene Laherparepvec in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced, Unresectable Melanoma. J Clin Oncol. 2018 Jun 10;36(17):1658-1667. doi: 10.1200/JCO.2017.73.7379. Epub 2017 Oct 5.

ReferenceCitation: Puzanov I, Milhem MM, Minor D, Hamid O, Li A, Chen L, Chastain M, Gorski KS, Anderson A, Chou J, Kaufman HL, Andtbacka RH. Talimogene Laherparepvec in Combination With Ipilimumab in Previously Untreated, Unresectable Stage IIIB-IV Melanoma. J Clin Oncol. 2016 Aug 1;34(22):2619-26. doi: 10.1200/JCO.2016.67.1529. Epub 2016 Jun 13.

ReferenceCitation: Chesney J, Puzanov I, Collichio F, Milhem MM, Hauschild A, Chen L, Sharma A, Garbe C, Singh P, Mehnert JM. Patterns of response with talimogene laherparepvec in combination with ipilimumab or ipilimumab alone in metastatic unresectable melanoma. Br J Cancer. 2019 Aug;121(5):417-420. doi: 10.1038/s41416-019-0530-6. Epub 2019 Jul 29.

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

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Germany
United States
France


title: A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation

acronym: VENTURE-AF

summary: The purpose of this exploratory study is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.

ReferenceCitation: Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ, Ma CS, Hess S, Wells DS, Juang G, Vijgen J, Hügl BJ, Balasubramaniam R, De Chillou C, Davies DW, Fields LE, Natale A; VENTURE-AF Investigators. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14.

lead_sponsor: Janssen Scientific Affairs, LLC

location_country:
United Kingdom
United States
France
Belgium
Germany


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

acronym: RA-BEACON

summary: The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).

ReferenceCitation: Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.

ReferenceCitation: Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.

ReferenceCitation: Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8. Erratum in: Arthritis Res Ther. 2020 Jul 2;22(1):166.

ReferenceCitation: Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum in: J Rheumatol. 2019 Dec;46(12):1648-1649.

ReferenceCitation: Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.

ReferenceCitation: Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20. Review.

ReferenceCitation: Genovese MC, Kremer JM, Kartman CE, Schlichting DE, Xie L, Carmack T, Pantojas C, Sanchez Burson J, Tony HP, Macias WL, Rooney TP, Smolen JS. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018 May 1;57(5):900-908. doi: 10.1093/rheumatology/kex489.

ReferenceCitation: Smolen JS, Kremer JM, Gaich CL, DeLozier AM, Schlichting DE, Xie L, Stoykov I, Rooney T, Bird P, Sánchez Bursón JM, Genovese MC, Combe B. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis. 2017 Apr;76(4):694-700. doi: 10.1136/annrheumdis-2016-209821. Epub 2016 Oct 31.

ReferenceCitation: Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, Beattie SD, Koch AE, Cardillo TE, Rooney TP, Macias WL, de Bono S, Schlichting DE, Smolen JS. Baricitinib in Patients with Refractory Rheumatoid Arthritis. N Engl J Med. 2016 Mar 31;374(13):1243-52. doi: 10.1056/NEJMoa1507247.

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.

lead_sponsor: Eli Lilly and Company

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Poland
Austria
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Canada
Switzerland
Germany
Denmark
Greece
Korea, Republic of
France
Netherlands

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


title: A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

source: euctr

ReferenceCitation: Pierce CM, Zhang MH, Jonsson B, Iorga D, Cheruvu N, Balagtas CC, Steinhorn RH. Efficacy and Safety of IV Sildenafil in the Treatment of Newborn Infants with, or at Risk of, Persistent Pulmonary Hypertension of the Newborn (PPHN): A Multicenter, Randomized, Placebo-Controlled Trial. J Pediatr. 2021 Oct;237:154-161.e3. doi: 10.1016/j.jpeds.2021.05.051. Epub 2021 May 27.

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

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
Canada
Sweden
United States
France
Belgium
Norway
Germany

location_facility: Riley Hospital for Children at IU Health

location_facility: OU Follow-Up Program, PREMIEr Clinic, Children's Hospital

location_facility: Henry Zarrow Neonatal Intensive Care Unit, Children's Hospital at Saint Francis

location_facility: Hôpital de la Conception Assistance Publique-Hôpitaux de Marseille

location_facility: Centre Hospitalier et Regional de Lille - Hopital Jeanne de Flandre

location_facility: Neonatologia Fondazione IRCCS Policlinico San Matteo

location_facility: Indiana University Health Methodist Hospital

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Centre Hospitalier et Régional de Lille,

location_facility: University of California Davis Medical Center

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: OU Neonatal Intensive Care Unit at Children's Hospital

location_facility: Great Ormond Street Hospital NHS Foundation Trust

location_facility: Glenfield Hospital, University Hospitals of Leicester NHS Trust

summary: This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.


title: A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors

summary: To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
Canada
Switzerland
United States
France

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: The Ohio State University Wexner Medical Center

location_facility: University Of Texas Medical Branch Of Galveston


title: A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

lead_sponsor: AstraZeneca

ReferenceCitation: Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5.

location_country:
Poland
Spain
Italy
Canada
Hungary
United States
France
Germany
Czechia

summary: The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period


title: Interventional, Prospective, Multicenter, Randomized, Parallel-arm Study to Compare the Effectiveness of Peripheral Nerve Stimulation (PNS) Utilizing a Subcutaneous Lead Implant Technique (SQS) Plus Optimized Medical Management (OMM) Versus OMM Alone in Patients Suffering From Back Pain Due to Failed Back Surgery Syndrome (FBSS)

summary: The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).

ReferenceCitation: Eldabe S, Kern M, Peul W, Green C, Winterfeldt K, Taylor RS. Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial. Trials. 2013 Jun 25;14:189. doi: 10.1186/1745-6215-14-189.

lead_sponsor: MedtronicNeuro

location_country:
Spain
United Kingdom
Austria
Australia
Netherlands
Switzerland
France
Israel
Belgium
Germany

location_facility: Clinique Mutualiste de la porte de l'Orient

location_facility: Märkische Kliniken GmbH / Marienhospital Letmathe

intervention_type: Other


title: A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

acronym: CONCERTO

summary: This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

ReferenceCitation: Comi G, Dadon Y, Sasson N, Steinerman JR, Knappertz V, Vollmer TL, Boyko A, Vermersch P, Ziemssen T, Montalban X, Lublin FD, Rocca MA, Volkinshtein R, Rubinchick S, Halevy N, Filippi M. CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis. Mult Scler. 2022 Apr;28(4):608-619. doi: 10.1177/13524585211032803. Epub 2021 Aug 11.

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Montenegro
Poland
Austria
Russian Federation
Israel
Slovakia
Bosnia and Herzegovina
Canada
Hungary
North Macedonia
Germany
Bulgaria
Moldova, Republic of
Belarus
Greece
Georgia
Estonia
Latvia
Korea, Republic of
France

location_facility:
Teva Investigational Site 59045
Teva Investigational Site 10307
Teva Investigational Site 59061
Teva Investigational Site 87003
Teva Investigational Site 30028
Teva Investigational Site 54045
Teva Investigational Site 81016
Teva Investigational Site 30040
Teva Investigational Site 61016
Teva Investigational Site 35077
Teva Investigational Site 54046
Teva Investigational Site 50125
Teva Investigational Site 62013
Teva Investigational Site 10324
Teva Investigational Site 33015
Teva Investigational Site 10315
Teva Investigational Site 55007
Teva Investigational Site 63024
Teva Investigational Site 31032
Teva Investigational Site 81018
Teva Investigational Site 60009
Teva Investigational Site 53072
Teva Investigational Site 11016
Teva Investigational Site 54048
Teva Investigational Site 30027
Teva Investigational Site 87001
Teva Investigational Site 32177
Teva Investigational Site 34011
Teva Investigational Site 32179
Teva Investigational Site 52037
Teva Investigational Site 32193
Teva Investigational Site 10319
Teva Investigational Site 80023
Teva Investigational Site 65010
Teva Investigational Site 53078
Teva Investigational Site 68012
Teva Investigational Site 50136
Teva Investigational Site 63030
Teva Investigational Site 55005
Teva Investigational Site 10323
Teva Investigational Site 10311
Teva Investigational Site 52038
Teva Investigational Site 31034
Teva Investigational Site 58072
Teva Investigational Site 10308
Teva Investigational Site 63027
Teva Investigational Site 69006
Teva Investigational Site 59058
Teva Investigational Site 68010
Teva Investigational Site 59041
Teva Investigational Site 51045
Teva Investigational Site 33014
Teva Investigational Site 59048
Teva Investigational Site 33016
Teva Investigational Site 50124
Teva Investigational Site 65011
Teva Investigational Site 58089
Teva Investigational Site 50147
Teva Investigational Site 32198
Teva Investigational Site 10346
Teva Investigational Site 52036
Teva Investigational Site 30024
Teva Investigational Site 58080
Teva Investigational Site 33013
Teva Investigational Site 61019
Teva Investigational Site 61026
Teva Investigational Site 32183
Teva Investigational Site 30034
Teva Investigational Site 32184
Teva Investigational Site 30025
Teva Investigational Site 10338
Teva Investigational Site 30029
Teva Investigational Site 68009
Teva Investigational Site 50139
Teva Investigational Site 58115
Teva Investigational Site 10343
Teva Investigational Site 55008
Teva Investigational Site 53064
Teva Investigational Site 52047
Teva Investigational Site 34019
Teva Investigational Site 11015
Teva Investigational Site 59049
Teva Investigational Site 59038
Teva Investigational Site 59057
Teva Investigational Site 81014
Teva Investigational Site 32195
Teva Investigational Site 59059
Teva Investigational Site 65012
Teva Investigational Site 52042
Teva Investigational Site 58075
Teva Investigational Site 52049
Teva Investigational Site 31031
Teva Investigational Site 68013
Teva Investigational Site 32201
Teva Investigational Site 52048
Teva Investigational Site 61022
Teva Investigational Site 63026
Teva Investigational Site 50137
Teva Investigational Site 59040
Teva Investigational Site 32182
Teva Investigational Site 10348
Teva Investigational Site 69009
Teva Investigational Site 81019
Teva Investigational Site 53068
Teva Investigational Site 50146
Teva Investigational Site 61024
Teva Investigational Site 32190
Teva Investigational Site 61027
Teva Investigational Site 53066
Teva Investigational Site 58116
Teva Investigational Site 34016
Teva Investigational Site 60010
Teva Investigational Site 35075
Teva Investigational Site 61015
Teva Investigational Site 34010
Teva Investigational Site 80021
Teva Investigational Site 58082
Teva Investigational Site 68008
Teva Investigational Site 56006
Teva Investigational Site 59062
Teva Investigational Site 60011
Teva Investigational Site 52046
Teva Investigational Site 10341
Teva Investigational Site 32200
Teva Investigational Site 61014
Teva Investigational Site 10332
Teva Investigational Site 50144
Teva Investigational Site 10340
Teva Investigational Site 52043
Teva Investigational Site 37023
Teva Investigational Site 58073
Teva Investigational Site 58085
Teva Investigational Site 87002
Teva Investigational Site 35079
Teva Investigational Site 30035
Teva Investigational Site 52039
Teva Investigational Site 54043
Teva Investigational Site 10318
Teva Investigational Site 32203
Teva Investigational Site 35073
Teva Investigational Site 31039
Teva Investigational Site 52044
Teva Investigational Site 58083
Teva Investigational Site 53073
Teva Investigational Site 10350
Teva Investigational Site 68011
Teva Investigational Site 53063
Teva Investigational Site 53079
Teva Investigational Site 50132
Teva Investigational Site 50134
Teva Investigational Site 53069
Teva Investigational Site 53076
Teva Investigational Site 50149
Teva Investigational Site 10317
Teva Investigational Site 32181
Teva Investigational Site 50140
Teva Investigational Site 61018
Teva Investigational Site 53074
Teva Investigational Site 30026
Teva Investigational Site 50131
Teva Investigational Site 10334
Teva Investigational Site 10330
Teva Investigational Site 59042
Teva Investigational Site 54049
Teva Investigational Site 32173
Teva Investigational Site 53065
Teva Investigational Site 50135
Teva Investigational Site 59052
Teva Investigational Site 61025
Teva Investigational Site 58074
Teva Investigational Site 50127
Teva Investigational Site 30031
Teva Investigational Site 32185
Teva Investigational Site 61017
Teva Investigational Site 66002
Teva Investigational Site 59044
Teva Investigational Site 32175
Teva Investigational Site 30037
Teva Investigational Site 54042
Teva Investigational Site 80020
Teva Investigational Site 50126
Teva Investigational Site 70005
Teva Investigational Site 31033
Teva Investigational Site 52041
Teva Investigational Site 70006
Teva Investigational Site 52040
Teva Investigational Site 59063
Teva Investigational Site 50138
Teva Investigational Site 50208
Teva Investigational Site 50142
Teva Investigational Site 50133
Teva Investigational Site 58088
Teva Investigational Site 58078
Teva Investigational Site 32176
Teva Investigational Site 30032
Teva Investigational Site 61021
Teva Investigational Site 31036
Teva Investigational Site 59054
Teva Investigational Site 81015
Teva Investigational Site 51046
Teva Investigational Site 58086
Teva Investigational Site 10329
Teva Investigational Site 11013
Teva Investigational Site 10325
Teva Investigational Site 32174
Teva Investigational Site 10316
Teva Investigational Site 32194
Teva Investigational Site 54044
Teva Investigational Site 10313
Teva Investigational Site 59046
Teva Investigational Site 59060
Teva Investigational Site 32202
Teva Investigational Site 10335
Teva Investigational Site 32196
Teva Investigational Site 51044
Teva Investigational Site 70008
Teva Investigational Site 53085
Teva Investigational Site 63029
Teva Investigational Site 11014
Teva Investigational Site 59039
Teva Investigational Site 53080
Teva Investigational Site 58084
Teva Investigational Site 10310
Teva Investigational Site 81017
Teva Investigational Site 62012
Teva Investigational Site 30039
Teva Investigational Site 58076
Teva Investigational Site 58081
Teva Investigational Site 50129
Teva Investigational Site 59053
Teva Investigational Site 32191
Teva Investigational Site 50128
Teva Investigational Site 10345
Teva Investigational Site 50143
Teva Investigational Site 53084
Teva Investigational Site 53081
Teva Investigational Site 34013
Teva Investigational Site 10349
Teva Investigational Site 10339
Teva Investigational Site 63025
Teva Investigational Site 69008
Teva Investigational Site 31030
Teva Investigational Site 53067
Teva Investigational Site 32189
Teva Investigational Site 59051
Teva Investigational Site 52050
Teva Investigational Site 30023
Teva Investigational Site 10342
Teva Investigational Site 54041
Teva Investigational Site 51043
Teva Investigational Site 32188
Teva Investigational Site 32199
Teva Investigational Site 10347
Teva Investigational Site 63028
Teva Investigational Site 80024
Teva Investigational Site 59050
Teva Investigational Site 54047
Teva Investigational Site 52034
Teva Investigational Site 34017
Teva Investigational Site 55006
Teva Investigational Site 58087
Teva Investigational Site 32197
Teva Investigational Site 53071
Teva Investigational Site 10309
Teva Investigational Site 52045
Teva Investigational Site 34015
Teva Investigational Site 53083
Teva Investigational Site 50148
Teva Investigational Site 50130
Teva Investigational Site 31035
Teva Investigational Site 30030
Teva Investigational Site 56005
Teva Investigational Site 53070
Teva Investigational Site 10331
Teva Investigational Site 58077
Teva Investigational Site 31037
Teva Investigational Site 50141
Teva Investigational Site 32186
Teva Investigational Site 37024
Teva Investigational Site 35076
Teva Investigational Site 59043
Teva Investigational Site 59055
Teva Investigational Site 58079
Teva Investigational Site 52035


title: Phase I Study of the Combination of Trastuzumab Emtansine (T-DM1) and Capecitabine in HER2-Positive Metastatic Breast Cancer and HER2-Positive Locally Advanced/Metastatic Gastric Cancer Patients, Followed by a Randomized, Open-Label Phase II Study of Trastuzumab Emtansine and Capecitabine Versus Trastuzumab Emtansine Alone in HER2-Positive Metastatic Breast Cancer

lead_sponsor: Hoffmann-La Roche

design_allocation: Non-Randomized

ReferenceCitation: Cortés J, Diéras V, Lorenzen S, Montemurro F, Riera-Knorrenschild J, Thuss-Patience P, Allegrini G, De Laurentiis M, Lohrisch C, Oravcová E, Perez-Garcia JM, Ricci F, Sakaeva D, Serpanchy R, Šufliarský J, Vidal M, Irahara N, Wohlfarth C, Aout M, Gelmon K. Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial. JAMA Oncol. 2020 Aug 1;6(8):1203-1209. doi: 10.1001/jamaoncol.2020.1796.

location_country:
Brazil
Portugal
Serbia
Greece
Italy
Russian Federation
Spain
Argentina
Canada
France
Germany
Slovakia

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Faculdade de Medicina de Sao Jose do Rio Preto - FAMERP*X*

location_facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)

location_facility: Philipps-Universität Marburg; Klinik für Innere Med.; Schwerpunkt Hämatologie/Onkologie/Immunologie

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

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

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

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

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Fakultna nemocnica Trencín; Onkologicke odd.

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Instituto Oncologico de Ribeirao Preto - INORP

location_facility: University Hospital of Patras Medical Oncology

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Onkologische Schwerpunktpraxis Bielefeld; Haemotologie & Internistische onkologie

location_facility: Klinik Fulda, Medizinisches Versorgungszentrum Osthessen GmbH

summary: This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.


status: Active, not recruiting

acronym: ENESTop

title: A Phase II, Single Arm, Open Label Study of Treatment-free Remission in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients After Achieving Sustained MR4.5 on Nilotinib

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Mahon FX, Boquimpani C, Kim DW, Benyamini N, Clementino NCD, Shuvaev V, Ailawadhi S, Lipton JH, Turkina AG, De Paz R, Moiraghi B, Nicolini FE, Dengler J, Sacha T, Takahashi N, Fellague-Chebra R, Acharya S, Wong S, Jin Y, Hughes TP. Treatment-Free Remission After Second-Line Nilotinib Treatment in Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Single-Group, Phase 2, Open-Label Study. Ann Intern Med. 2018 Apr 3;168(7):461-470. doi: 10.7326/M17-1094. Epub 2018 Feb 20.

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

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

location_country:
Poland
Brazil
Spain
Greece
Russian Federation
Australia
Mexico
Argentina
Canada
United Kingdom
Korea, Republic of
United States
France
Israel
Singapore
Belgium
Japan
Germany

location_facility: USC Kenneth Norris Comprehensive Cancer Center USC

summary: A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.


acronym: ROMULUS

title: A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

lead_sponsor: Genentech, Inc.

ReferenceCitation: Shi R, Lu T, Ku G, Ding H, Saito T, Gibiansky L, Agarwal P, Li X, Jin JY, Girish S, Miles D, Li C, Lu D. Asian race and origin have no clinically meaningful effects on polatuzumab vedotin pharmacokinetics in patients with relapsed/refractory B-cell non-Hodgkin lymphoma. Cancer Chemother Pharmacol. 2020 Sep;86(3):347-359. doi: 10.1007/s00280-020-04119-8. Epub 2020 Aug 8.

ReferenceCitation: Lu T, Gibiansky L, Li X, Li C, Shi R, Agarwal P, Hirata J, Miles D, Chanu P, Girish S, Jin JY, Lu D. Exposure-safety and exposure-efficacy analyses of polatuzumab vedotin in patients with relapsed or refractory diffuse large B-cell lymphoma. Leuk Lymphoma. 2020 Dec;61(12):2905-2914. doi: 10.1080/10428194.2020.1795154. Epub 2020 Jul 24.

ReferenceCitation: Morschhauser F, Flinn IW, Advani R, Sehn LH, Diefenbach C, Kolibaba K, Press OW, Salles G, Tilly H, Chen AI, Assouline S, Cheson BD, Dreyling M, Hagenbeek A, Zinzani PL, Jones S, Cheng J, Lu D, Penuel E, Hirata J, Wenger M, Chu YW, Sharman J. Polatuzumab vedotin or pinatuzumab vedotin plus rituximab in patients with relapsed or refractory non-Hodgkin lymphoma: final results from a phase 2 randomised study (ROMULUS). Lancet Haematol. 2019 May;6(5):e254-e265. doi: 10.1016/S2352-3026(19)30026-2. Epub 2019 Mar 29.

location_country:
Italy
Netherlands
Canada
United States
France
Germany

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: Oncology & Hematolgy Associates of SW Va Inc. - Roanoke

location_facility: Florida Cancer Specialists - Fort Myers (Colonial Center Dr)

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

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

location_facility: Yakima Valley Memorial Hospital/North Star Lodge

location_facility: Hematology Oncology Associates; Carol G. Simon Ctr

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

location_facility: Univ of Michigan Med School; Hematology Oncology

location_facility: Universitätsmedizin Johannes Gutenberg Universität; Klinik u. Poliklinik f. Neurologie

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Georgetown University Medical Center Lombardi Cancer Center

summary: This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).


title: MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects With Severe Refractory Asthma

summary: This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects with severe refractory asthma. The study consists of four phases, OCS Optimisation Phase (Week -8 to Week 0), and the double-blind treatment period divided into an Induction Phase (Week 0 to Week 4), OCS Reduction Phase (Week 5 upto Week 20) followed by Maintenance Phase (Week 20 to Week 24). During the Optimisation Phase the investigator will adjust the OCS (prednisone/prednisolone) dose according to the Optimisation titration schedule based on a review of Asthma Control Questionnaire (ACQ)-5 score and exacerbation. In the Induction Phase subjects will be randomized 1:1 (approximately 60 per arm) to receive either mepolizumab (100 mg) administered subcutaneously (SC) or placebo every 4 weeks in addition to their existing maintenance asthma therapy with the lowest dose of OCS from Optimisation Phase. The Induction Phase will allow sufficient time for those subjects randomised to the mepolizumab arm to achieve a decrease in the eosinophilic inflammation prior to the reduction in OCS. During the Reduction Phase, subjects will continue receiving 100 mg mepolizumab/placebo every 4 weeks and the OCS dose reduction will be done every 4 weeks using the reduction titration schedule based on a review of eDiary parameters recorded by the subject, the subjects' exacerbation history, and a review of the signs and symptoms of adrenal insufficiency. In the Maintenance Phase subjects will be maintained without any further OCS dose adjustment. Subjects who complete the 24 week double-blind period and meet the eligibility criteria, will be offered the opportunity to participate in an open label extension (OLE) study otherwise they will return for a Follow-up Visit 12 weeks after their last dose of double blind study treatment. At each clinic visit, adverse events, safety labs, spirometery parameters and exacerbations will be assessed. The pharmacokinetic samples will be collected in the beginning of the treatment, prior to last dose, at the end of study (exit visit) and the follow up.

ReferenceCitation: Casale TB, Burnette A, Bourdin A, Howarth P, Hahn B, Stach-Klysh A, Khurana S. Oral corticosteroid-sparing effects of mepolizumab in severe eosinophilic asthma: evidence from randomized controlled trials and real-world studies. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107313. doi: 10.1177/17534666221107313.

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150-300 cells/μL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

ReferenceCitation: Keene ON. Strategies for composite estimands in confirmatory clinical trials: Examples from trials in nasal polyps and steroid reduction. Pharm Stat. 2019 Jan;18(1):78-84. doi: 10.1002/pst.1909. Epub 2018 Oct 29.

ReferenceCitation: Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.

ReferenceCitation: Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8.

location_country:
Poland
United Kingdom
Australia
Netherlands
Canada
Czech Republic
United States
France
Mexico
Germany


title: Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793

summary: This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

ReferenceType: result

ReferenceCitation: Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
United Kingdom
Greece
Canada
United States
France
South Africa
Germany

location_facility:
Site Reference ID/Investigator# 84175
Site Reference ID/Investigator# 84394
Site Reference ID/Investigator# 84185
Site Reference ID/Investigator# 84397
Site Reference ID/Investigator# 84400
Site Reference ID/Investigator# 84374
Site Reference ID/Investigator# 84182
Site Reference ID/Investigator# 84382
Site Reference ID/Investigator# 84381
Site Reference ID/Investigator# 84186
Site Reference ID/Investigator# 84383
Site Reference ID/Investigator# 84380
Site Reference ID/Investigator# 84393
Site Reference ID/Investigator# 84398
Site Reference ID/Investigator# 84375
Site Reference ID/Investigator# 84378
Site Reference ID/Investigator# 84180
Site Reference ID/Investigator# 84376
Site Reference ID/Investigator# 84179
Site Reference ID/Investigator# 84391
Site Reference ID/Investigator# 84173
Site Reference ID/Investigator# 84373
Site Reference ID/Investigator# 84399
Site Reference ID/Investigator# 84377
Site Reference ID/Investigator# 84395
Site Reference ID/Investigator# 84181
Site Reference ID/Investigator# 84177
Site Reference ID/Investigator# 84183
Site Reference ID/Investigator# 84379
Site Reference ID/Investigator# 84388
Site Reference ID/Investigator# 84386
Site Reference ID/Investigator# 84392
Site Reference ID/Investigator# 84385
Site Reference ID/Investigator# 84390
Site Reference ID/Investigator# 84174
Site Reference ID/Investigator# 84176
Site Reference ID/Investigator# 84178
Site Reference ID/Investigator# 84389
Site Reference ID/Investigator# 84187


title: Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors

summary: This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients participated in only either part 1 or part 2 of the study.

ReferenceCitation: Hargrave DR, Bouffet E, Tabori U, Broniscer A, Cohen KJ, Hansford JR, Geoerger B, Hingorani P, Dunkel IJ, Russo MW, Tseng L, Dasgupta K, Gasal E, Whitlock JA, Kieran MW. Efficacy and Safety of Dabrafenib in Pediatric Patients with BRAF V600 Mutation-Positive Relapsed or Refractory Low-Grade Glioma: Results from a Phase I/IIa Study. Clin Cancer Res. 2019 Dec 15;25(24):7303-7311. doi: 10.1158/1078-0432.CCR-19-2177.

ReferenceCitation: Kieran MW, Geoerger B, Dunkel IJ, Broniscer A, Hargrave D, Hingorani P, Aerts I, Bertozzi AI, Cohen KJ, Hummel TR, Shen V, Bouffet E, Pratilas CA, Pearson ADJ, Tseng L, Nebot N, Green S, Russo MW, Whitlock JA. A Phase I and Pharmacokinetic Study of Oral Dabrafenib in Children and Adolescent Patients with Recurrent or Refractory BRAF V600 Mutation-Positive Solid Tumors. Clin Cancer Res. 2019 Dec 15;25(24):7294-7302. doi: 10.1158/1078-0432.CCR-17-3572. Epub 2019 Sep 10.

ReferenceCitation: Wang J, Yao Z, Jonsson P, Allen AN, Qin ACR, Uddin S, Dunkel IJ, Petriccione M, Manova K, Haque S, Rosenblum MK, Pisapia DJ, Rosen N, Taylor BS, Pratilas CA. A Secondary Mutation in BRAF Confers Resistance to RAF Inhibition in a BRAF(V600E)-Mutant Brain Tumor. Cancer Discov. 2018 Sep;8(9):1130-1141. doi: 10.1158/2159-8290.CD-17-1263. Epub 2018 Jun 7.

location_country:
Denmark
Spain
Italy
United Kingdom
Australia
Canada
United States
France
Israel
Germany


title: Osteonecrosis of the Jaw (ONJ) Case Registry

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Schiodt M, Vadhan-Raj S, Chambers MS, Nicolatou-Galitis O, Politis C, Coropciuc R, Fedele S, Jandial D, Zhang J, Ma H, Saunders DP. A multicenter case registry study on medication-related osteonecrosis of the jaw in patients with advanced cancer. Support Care Cancer. 2018 Jun;26(6):1905-1915. doi: 10.1007/s00520-017-4003-2. Epub 2017 Dec 23.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

location_country:
Denmark
Spain
Greece
Italy
United Kingdom
Finland
Canada
United States
France
Belgium
Germany


title: A Phase 3, Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of Dexamethasone Plus MLN9708 or Physicians Choice of Treatment Administered to Patients With Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

summary: The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.

ReferenceCitation: Sanchorawala V, Palladini G, Kukreti V, Zonder JA, Cohen AD, Seldin DC, Dispenzieri A, Jaccard A, Schönland SO, Berg D, Yang H, Gupta N, Hui AM, Comenzo RL, Merlini G. A phase 1/2 study of the oral proteasome inhibitor ixazomib in relapsed or refractory AL amyloidosis. Blood. 2017 Aug 3;130(5):597-605. doi: 10.1182/blood-2017-03-771220. Epub 2017 May 26. Erratum in: Blood. 2020 Mar 26;135(13):1071.

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Denmark
Brazil
Spain
Greece
Italy
Australia
Netherlands
Canada
United Kingdom
Korea, Republic of
United States
France
Israel
Germany
Czechia

location_facility: Centre Hospitalier et Universitaire de Limoges

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

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Royal Free and University College Medical School

location_facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

location_facility: Fondazione IRCCS Policlinico San Matteo di Pavia

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: Severance Hospital at Yonsei University Health System - PPDS

location_facility: Hospital Universitario Clementino Fraga Filho (UFRJ)

location_facility: University of Texas Southwestern Medical Center

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Arhus Universitetshospital Arhus Sygehus

location_facility: Hadasit Medical Research Services and Development Ltd

location_facility: Institute of Hematology "Seragnoli" University of Bologna


title: A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period

summary: The purpose of this study is to evaluate the safety, tolerability and efficacy of NRL001 in the treatment of faecal incontinence, compared against placebo

lead_sponsor: Norgine

location_country:
Poland
Spain
Italy
United Kingdom
Czech Republic
Sweden
Hungary
France
Germany

location_facility: Centrum Medyczne, Wyzszej Szkoly Informatycznej

location_facility: Lecznica Prosen SMO Private Medical Health Care Centre

location_facility: Polyclinic for Outpatients, Szakrendelo Intezet

location_facility: Unita Operativa Complessa Gastroenteroloogia A

location_facility: University of Szeged, Albert Szent-Gyorgyi Clinical Center, Faculty of Medicine

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Chu Nantes - Hotel Dieu - Institut Des Maladies De L'Appareil Digestif (IMAD)

location_facility: Fakultni Nemocnice Na Bulovce, Gynekologicko-Porodnicka Klinika

location_facility: Unita Operativa Complessa Patologia Chirurgica A Indirizzo Gastroenterologico

location_facility: Hospital Clinico Universtiaria Lozana Blesa

location_facility: Seconda Unita Operativa Di Chirurgia Generale

location_facility: Chu Lyon Groupement Hospitalier Edouard Herriot

location_facility: Osrodek Badawczo - Leczniczy Zbigniew Zegota


title: A Randomized, Controlled, Open-Label, Multicenter Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, Versus Temsirolimus in Subjects With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib versus temsirolimus in patients with relapsed or refractory mantle cell lymphoma who received at least 1 prior chemotherapy regimen.

ReferenceCitation: Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

ReferenceCitation: Dreyling M, Jurczak W, Jerkeman M, Silva RS, Rusconi C, Trneny M, Offner F, Caballero D, Joao C, Witzens-Harig M, Hess G, Bence-Bruckler I, Cho SG, Bothos J, Goldberg JD, Enny C, Traina S, Balasubramanian S, Bandyopadhyay N, Sun S, Vermeulen J, Rizo A, Rule S. Ibrutinib versus temsirolimus in patients with relapsed or refractory mantle-cell lymphoma: an international, randomised, open-label, phase 3 study. Lancet. 2016 Feb 20;387(10020):770-8. doi: 10.1016/S0140-6736(15)00667-4. Epub 2015 Dec 7. Erratum in: Lancet. 2016 Feb 20;387(10020):750.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
United Kingdom
Ukraine
Belgium
Czechia
Poland
Portugal
Russian Federation
Mexico
Sweden
Brazil
Canada
Hungary
Germany
Taiwan
Ireland
Korea, Republic of
France
Chile
Colombia
Netherlands


title: A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

summary: CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

ReferenceCitation: Bissonnette R, Luger T, Thaçi D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.

ipd_sharing: Undecided

location_country:
Poland
United Kingdom
Italy
Austria
Canada
Switzerland
Vietnam
United States
France
Singapore
Japan
Germany
Bulgaria
Slovakia
Czechia


title: An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis

acronym: ENVISION

summary: The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

lead_sponsor: Knopp Biosciences

location_country:
Spain
Ireland
United Kingdom
Australia
Netherlands
Canada
Sweden
United States
France
Belgium
Germany

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Johns Hopkins University School of Medicine

location_facility: Washington University School of Medicine

location_facility: University of Miami Miller School of Medicine

location_facility: Barrow Neurological Institute - St. Joseph's Hospital

location_facility: Research Foundation of the State University of New York

location_facility: Newcastle University Hospital - Clinical Ageing Research Unit

location_facility: University of Texas Health Sciences Center

location_facility: University of South Florida Medical Center

location_facility: Sheffield Institute for Transnational Neuroscience

location_facility: Sunnybrook and Women's College and Health Sciences Centre

location_facility: University of California at San Francisco - Fresno

location_facility: Walton Centre for Neurology & Neurosurgery


title: Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial

summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.

ReferenceCitation: Davies MJ, Bain SC, Atkin SL, Rossing P, Scott D, Shamkhalova MS, Bosch-Traberg H, Syrén A, Umpierrez GE. Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Diabetes Care. 2016 Feb;39(2):222-30. doi: 10.2337/dc14-2883. Epub 2015 Dec 17.

ReferenceCitation: Zobel EH, von Scholten BJ, Goldman B, Persson F, Hansen TW, Rossing P. Pleiotropic effects of liraglutide in patients with type 2 diabetes and moderate renal impairment: Individual effects of treatment. Diabetes Obes Metab. 2019 May;21(5):1261-1265. doi: 10.1111/dom.13638. Epub 2019 Feb 22.

ReferenceCitation: Kim JD, Park CY, Cha BY, Ahn KJ, Kim IJ, Park KS, Lee HW, Min KW, Won JC, Chung MY, Kim JT, Kang JG, Park SW. Comparison of Adherence to Glimepiride/Metformin Sustained Release Once-daily Versus Glimepiride/Metformin Immediate Release BID Fixed-combination Therapy Using the Medication Event Monitoring System in Patients With Type 2 Diabetes. Clin Ther. 2018 May;40(5):752-761.e2. doi: 10.1016/j.clinthera.2018.04.002. Epub 2018 May 3.

lead_sponsor: Novo Nordisk A/S

location_country:
Poland
United Kingdom
Russian Federation
Ukraine
United States
France


title: A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Who Have Fallen Recently and Have Muscle Weakness

summary: LY2495655 is an investigational drug being tested for muscle wasting.

ReferenceCitation: Becker C, Lord SR, Studenski SA, Warden SJ, Fielding RA, Recknor CP, Hochberg MC, Ferrari SL, Blain H, Binder EF, Rolland Y, Poiraudeau S, Benson CT, Myers SL, Hu L, Ahmad QI, Pacuch KR, Gomez EV, Benichou O; STEADY Group. Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):948-57. doi: 10.1016/S2213-8587(15)00298-3. Epub 2015 Oct 27.

location_country:
Australia
Argentina
Sweden
United States
France
Germany

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: Biological


title: A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

summary: This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.

ReferenceCitation: Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709.

lead_sponsor: Humanigen, Inc.

location_country:
Poland
United Kingdom
Australia
Ukraine
United States
France


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Tabalumab in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma

summary: The purpose of this study is to evaluate an investigational drug called tabalumab in participants with Multiple Myeloma (MM) who have tried at least one other therapy in the past. Tabalumab will be given in combination with standard doses of two other drugs that are often used to treat MM. Study doctors will collect information about the effectiveness and side effects of this therapy.

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

location_country:
Poland
Taiwan
Brazil
Spain
Greece
Italy
Netherlands
United Kingdom
Canada
Korea, Republic of
United States
France
Turkey
Mexico
Germany


title: A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.

location_country:
Poland
Spain
United Kingdom
Russian Federation
Puerto Rico
United States
France
Israel
Belgium


title: An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib

acronym: DASCERN

summary: The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

ReferenceCitation: Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G. Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7.

location_country:
Poland
Brazil
Spain
Italy
Austria
Argentina
Canada
Thailand
Hungary
Korea, Republic of
United States
France
China
Belgium
Czechia

location_facility: Institute of Oncology Hematology Biomedical Research

location_facility: University Of Southern California University Hospital

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Kaiser Permanente Oncology Clinical Trials


title:
EFFECT OF V0251 IN ACUTE VERTIGO.
 A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.

lead_sponsor: Pierre Fabre Medicament

location_country:
Spain
Czech Republic
Hungary
France
Germany

location_facility: Pécsi Tudományegyetem Általános Orvostudományi Kar

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Complejo Hospitalario de Pontevedra- Montecelo

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

summary: Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.


acronym: POSTURE

title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS

lead_sponsor: Amgen

ReferenceCitation: Gladman DD, Kavanaugh A, Gómez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.

ReferenceCitation: Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.

ReferenceCitation: Taylor PC, van der Heijde D, Landewé R, McCue S, Cheng S, Boonen A. A Phase III Randomized Study of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Active Ankylosing Spondylitis. J Rheumatol. 2021 Aug;48(8):1259-1267. doi: 10.3899/jrheum.201088. Epub 2021 Feb 15.

location_country:
Poland
Spain
United Kingdom
Austria
Australia
Estonia
Canada
Netherlands
Russian Federation
Sweden
Hungary
United States
France
Romania
Germany
Bulgaria
Slovakia
Czechia

location_facility: Nizhniy Novgorod State Medical Academy of Roszdrav

location_facility: MUDr. Zuzana Cizmarikova, s.r.o., Reumatologick ambulancia

location_facility: Clinic: University of Calgary Heritage Medical Research Clinic (HMRC),Teaching Research and Wellness (TRW)

location_facility: Diagnostic and Consulting Center Sv. Pantaleymon

location_facility: University of Utah Hospitals and Clinics

location_facility: IPROS - CHR ORLEANS - Hôpital de la Source

location_facility: Federal State Budget Institution "Rheumatology Research Institute RAMS"

location_facility: NZOZ Osteo-Medic sc A. Racewicz J. Supronik

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: The Arthritis Program Research Group Inc.

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: Fakultni Thomayerova nemocnice s poliklinikou - Klinicko-farmakologicka jednotka

location_facility: Cividino Medicine Professional Corporation

location_facility: Centrum fur innovative Diagnostik und Therapie Rheumatologie Immunologie GmbH

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

location_facility: National Multiprofile Transport Hospital Tzar Boris III

location_facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: Departmental Hospital at Smolensk Station RZhD JSC

location_facility: Sf Apostol Andrei Emergency Clinical County Hospital

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela Travesía de la Choupana s/n

location_facility: Cristei R. Rodica - Private Medical Practice

location_facility: NZOZ NASZ LEKARZ Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna

summary: Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.


title: A Phase 2 Study of LY2157299 Monohydrate Monotherapy or LY2157299 Monohydrate Plus Lomustine Therapy Compared to Lomustine Monotherapy in Patients With Recurrent Glioblastoma

summary: The purpose of the study is to see whether treatment with LY2157299 on its own, LY2157299 plus lomustine therapy or lomustine plus placebo can help participants with brain cancer

ReferenceCitation: Smith CL, Thomas Z, Enas N, Thorn K, Lahn M, Benhadji K, Cleverly A. Leveraging historical data into oncology development programs: Two case studies of phase 2 Bayesian augmented control trial designs. Pharm Stat. 2020 May;19(3):276-290. doi: 10.1002/pst.1990. Epub 2020 Jan 5.

ReferenceCitation: Brandes AA, Carpentier AF, Kesari S, Sepulveda-Sanchez JM, Wheeler HR, Chinot O, Cher L, Steinbach JP, Capper D, Specenier P, Rodon J, Cleverly A, Smith C, Gueorguieva I, Miles C, Guba SC, Desaiah D, Lahn MM, Wick W. A Phase II randomized study of galunisertib monotherapy or galunisertib plus lomustine compared with lomustine monotherapy in patients with recurrent glioblastoma. Neuro Oncol. 2016 Aug;18(8):1146-56. doi: 10.1093/neuonc/now009. Epub 2016 Feb 21.

lead_sponsor: Eli Lilly and Company

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

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


title: A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

acronym: ALCANZA

summary: The purpose of this study is to determine objective response rate (ORR), lasting at least 4 months (ORR4), with brentuximab vedotin in participants with cluster of differentiation antigen 30 positive (CD30+) cutaneous T-cell lymphoma [mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) ]compared to that achieved with therapy in the control arm.

ReferenceCitation: Horwitz SM, Scarisbrick JJ, Dummer R, Whittaker S, Duvic M, Kim YH, Quaglino P, Zinzani PL, Bechter O, Eradat H, Pinter-Brown L, Akilov OE, Geskin L, Sanches JA, Ortiz-Romero PL, Weichenthal M, Fisher DC, Walewski J, Trotman J, Taylor K, Dalle S, Stadler R, Lisano J, Bunn V, Little M, Prince HM. Randomized phase 3 ALCANZA study of brentuximab vedotin vs physician's choice in cutaneous T-cell lymphoma: final data. Blood Adv. 2021 Dec 14;5(23):5098-5106. doi: 10.1182/bloodadvances.2021004710.

ReferenceCitation: Kim YH, Prince HM, Whittaker S, Horwitz SM, Duvic M, Bechter O, Sanches JA, Stadler R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown LC, Ortiz-Romero PL, Akilov OE, Trotman J, Taylor K, Weichenthal M, Walewski J, Fisher D, McNeeley M, Gru AA, Brown L, Palanca-Wessels MC, Lisano J, Onsum M, Bunn V, Little M, Trepicchio WL, Dummer R. Response to brentuximab vedotin versus physician's choice by CD30 expression and large cell transformation status in patients with mycosis fungoides: An ALCANZA sub-analysis. Eur J Cancer. 2021 May;148:411-421. doi: 10.1016/j.ejca.2021.01.054. Epub 2021 Mar 29.

ReferenceCitation: Valipour A, Jäger M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7:CD008946. doi: 10.1002/14651858.CD008946.pub3.

ReferenceCitation: Dummer R, Prince HM, Whittaker S, Horwitz SM, Kim YH, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Eradat H, Pinter-Brown L, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Huen A, Walewski J, Wang Y, Lisano J, Richhariya A, Feliciano J, Zhu Y, Bunn V, Little M, Zagadailov E, Dalal MR, Duvic M. Patient-reported quality of life in patients with relapsed/refractory cutaneous T-cell lymphoma: Results from the randomised phase III ALCANZA study. Eur J Cancer. 2020 Jul;133:120-130. doi: 10.1016/j.ejca.2020.04.010. Epub 2020 Jun 2.

ReferenceCitation: Prince HM, Kim YH, Horwitz SM, Dummer R, Scarisbrick J, Quaglino P, Zinzani PL, Wolter P, Sanches JA, Ortiz-Romero PL, Akilov OE, Geskin L, Trotman J, Taylor K, Dalle S, Weichenthal M, Walewski J, Fisher D, Dréno B, Stadler R, Feldman T, Kuzel TM, Wang Y, Palanca-Wessels MC, Zagadailov E, Trepicchio WL, Zhang W, Lin HM, Liu Y, Huebner D, Little M, Whittaker S, Duvic M; ALCANZA study group. Brentuximab vedotin or physician's choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomised, phase 3, multicentre trial. Lancet. 2017 Aug 5;390(10094):555-566. doi: 10.1016/S0140-6736(17)31266-7. Epub 2017 Jun 7.

location_country:
Poland
Brazil
Spain
Italy
Austria
Australia
United Kingdom
Switzerland
United States
France
Belgium
Germany


title: Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects

acronym: REPLACE

summary: The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.

lead_sponsor: Janssen-Cilag International NV

location_country:
Spain
United Kingdom
Austria
France
Belgium
Germany