acronym: PNEU-WAY

summary: This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.

ReferenceCitation: Mohapi L, Pinedo Y, Osiyemi O, Supparatpinyo K, Ratanasuwan W, Molina JM, Dagan R, Tamms G, Sterling T, Zhang Y, Pedley A, Hartzel J, Kan Y, Hurtado K, Musey L, Simon JK, Buchwald UK; V114-018 (PNEU-WAY) study group. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV. AIDS. 2022 Mar 1;36(3):373-382. doi: 10.1097/QAD.0000000000003126.

publisher_dissemination: Wolters Kluwer Health

location_facility: Siriraj Hosp (Prev&Social Med). ( Site 0183)

location_facility: Research Institute for Health. ( Site 0182)

location_facility: Triple O Research Institute, P.A. ( Site 0011)

location_facility: Chris Hani Baragwanath Hospital ( Site 0122)

location_facility: The Crofoot Research Center, Inc. ( Site 0002)

location_facility: Investigaciones Medicas en Salud - INMENSA ( Site 0041)

location_facility: Saint Hope Foundation, Inc. ( Site 0009)

title: A Phase 3, Multicenter, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Adults Infected With HIV (PNEU-WAY)

location_country:
United States
Thailand
South Africa
Peru
France


study_start_date_type: Actual

intervention_type: Biological

lead_sponsor: Baxalta now part of Shire

summary: The purpose of the study is to acquire additional data on safety, tolerability and immunogenicity of HyQvia in pediatric (age two to <18 years) patients with Primary Immunodeficiency Diseases (PIDD)

sponsor_collaborators: Baxalta Innovations GmbH, now part of Shire

location_facility: Hospices Civils de Lyon - Hôpitaux Est - IHOP

location_facility: United St. Istvan and St. Laszlo Hospital

location_facility: University Hospital of Wales Heath Park Clinical Research Facility

location_facility: The Great North Children's Hospital Royal Victoria Infirmary

location_facility: Univerzitna Nemocnica Klinika detí a dorastu

location_facility: Dept. of Pediatric Oncology/Hematology/Immunology-Skånes Universitetssjukhus

location_facility: Groupe Hospitalier Pellegrin - Hôpital des Enfants

location_facility: General Hospital of Thessaloniki Ippokrateio

location_facility: General Hospital of Thessaloniki Papageorgiou

location_facility: Fakultni nemocnice Brno Odd. Detska klinika

status: Completed

title: Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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.

design_allocation: Non-Randomized

study_completion_date_type: Actual

location_country:
Slovakia
Hungary
United Kingdom
Denmark
Sweden
Greece
Czechia
France

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


type: Other Identifier

title: Phase I, International, Multicentre, Open-label, Non-randomised, Non-comparative Study of Intravenously Administered S64315, a Mcl-1 Inhibitor, in Patients With Acute Myeloid Leukaemia (AML) or Myelodysplastic Syndrome (MDS)

summary: The CL1-64315-001 study is a phase I, international, multicentre, open-label, non-randomised, non-comparative study. This study is designed in two parts: one part for dose escalation, one part for dose expansion.

ipd_sharing_description:
Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

sponsored by Servier
with a first patient enrolled as of 1 January 2004 onwards
for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

lead_sponsor: Institut de Recherches Internationales Servier

location_country:
United States
Spain
Australia
France

location_facility: The University of Texas MD Anderson Cancer Center, Department of Leukemia, Division of Cancer Medicine

location_facility: Hôpital Saint-Antoine Département d'Hematologie Clinique et de Thérapie cellulaire

location_facility: Hospital Universitario Vall d' Hebron/VHIO Hematology Department

location_facility: Patient Care Location: Smilow Cancer Hospital at Yale

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Royal Melbourne Hospital, Department of Clinical Haematology and BMT Service

location_facility: Institut Paoli-Calmettes Departement d'Hématologie

location_facility: The Alfred Hospital Department of Haematology

location_facility: Hospital Universitario La Fe Hematology Department

intervention_type: Drug


title: VMI-CFA Study: Physician-initiated Trial Investigating the Efficacy of the Vascular Mimetic Implant Supera Peripheral Stent System for the Treatment of the Common Femoral Artery

acronym: VMI-CFA

summary: The VMI-CFA study investigates the efficacy of the Supera Stent in the treatment of common femoral artery stenosis or occlusion. 100 patients will be included with a RF of 2 to 4. The lesion is located within the native CFA and treated with predillation prior to stenting with the Supera Peripheral Stent System. Patients will be invited for a follow-up visit at 1, 6, 12 and 24 month post procedure. The primary endpoint of the study is the primary patency at 12 months and periprocedural events up to 30 days post procedure. Secondary endpoints include technical success, primary patency rate at 1, 6 and 24 month, freedom from TLR at 1-, 6-, 12 and 24 month follow-up and clinical success at 1-, 6-, 12- and 24-month follow-up.

lead_sponsor: ID3 Medical

location_country: Belgium France

location_facility:
ZNA Stuivenberg
OLV Ziekenhuis Aalst
CHU de Clermont-Ferrand
Imelda Hospital
Clinique Rhone Durance
CHU de Nantes
AZ Sint-Blasius

intervention_type: Device


title: A Phase Ib/II, Open-label, Multi-center Study of INC280 in Combination With PDR001 or PDR001 Single Agent in Advanced Hepatocellular Carcinoma.

summary: The purpose of this study of capmatinib (INC280) and spartalizumab (PDR001) was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of spartalizumab administered intravenously (i.v.) as a single agent or in combination with capmatinib administered orally in adult patients with advanced hepatocellular carcinoma (HCC).

design_allocation: Randomized

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
Hong Kong
Korea, Republic of
China
Taiwan
Canada
France


title: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

summary: The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

ReferenceType: derived

ReferenceCitation: Tchetche D, Windecker S, Kasel AM, Schaefer U, Worthley S, Linke A, Abdel-Wahab M, Le Breton H, Sondergaard L, Spence MS, Petronio S, Baumgartner H, Hovorka T, Blanke P, Reichenspurner H. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC Cardiovasc Interv. 2019 Apr 8;12(7):673-680. doi: 10.1016/j.jcin.2019.01.231.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

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

repository_institution: University of Zurich - Zurich Open Repository and Archive

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Reichenspurner H, Schaefer A, Schafer U, Tchetche D, Linke A, Spence MS, Sondergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3127-3136. doi: 10.1016/j.jacc.2017.10.060.

oa_host_type: publisher

license: publisher-specific-oa

license_normalized: publisher-specific

repositories_concat: closed

ipd_sharing: No

lead_sponsor: Edwards Lifesciences

sponsor_collaborators:
Edwards Lifesciences
Medstar Health Research Institute
European Cardiovascular Research Center
University of British Columbia

location_country:
Germany
Italy
New Zealand
United Kingdom
Denmark
Australia
Netherlands
Switzerland
France

location_facility: LMU - Klinikum der Universitaet Muenchen

location_facility: Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH

location_facility: Erasmus University Medical Center Rotterdam

location_facility: Universitair Medical Center (UMC) Utrecht

location_facility: Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania


lead_sponsor: Hoffmann-La Roche

summary: This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics and activity of Selicrelumab administered in combination with Atezolizumab (ATZ) in participants with metastatic or locally advanced solid tumors. The study will be conducted in two Parts (I and II), with Part I divided into Parts IA and IB. All participants will be followed up for survival until death or loss of follow-up after the last visit or withdrawal of consent.

location_facility: Jewish General Hospital / McGill University

location_facility: Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed

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

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

location_facility: Hopital Saint Louis, Service D Oncologie Medicale

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

title: An Open-Label, Multicenter, Dose-Escalation Phase IB Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Selicrelumab (CD40 Agonist) in Combination With Atezolizumab (Anti PD-L1) in Patients With Locally Advanced and/or Metastatic Solid Tumors

location_country:
Denmark
Netherlands
United States
Spain
Canada
France


title: A Phase 3, Single-Blind Study to Evaluate the Effect of Eleclazine (GS-6615) on Shortening of the QT Interval, Safety, and Tolerability in Subjects With Long QT Syndrome Type 3

summary: The primary objective of this study is to evaluate the effect of oral eleclazine on mean daytime QTcF interval after 24 weeks of treatment with elecalzine in participants with long QT syndrome Type 3. During the single-blind treatment period (24 weeks), participants will receive eleclazine and/or eleclazine placebo. Following the single-blind treatment period, participants who have not permanently discontinued study drug will be eligible, at the discretion of the investigator, to continue receiving eleclazine during an open-label extension (OLE) phase.

status: Terminated

lead_sponsor: Gilead Sciences

location_country:
Germany
France
Italy
United Kingdom
Netherlands
United States
Canada
Israel

location_facility: Groupe Hospitalier Bichat Claude Bernard

location_facility: Barts and The London School of Medicine and Dentistry

status_simplified: Unknown


acronym: TOLEDO

lead_sponsor: Britannia Pharmaceuticals Ltd.

summary:
The primary objective of the trial was to investigate the efficacy of apomorphine continuous subcutaneous infusion compared to placebo in Parkinson's Disease patients with motor fluctuations not well controlled on medical treatment.

The secondary objective of the study was to investigate the safety and tolerability of apomorphine continuous subcutaneous therapy.

ReferenceCitation: Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Lockhart D, Staines H, Lees A. Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study. Parkinsonism Relat Disord. 2021 Feb;83:79-85. doi: 10.1016/j.parkreldis.2020.12.024. Epub 2021 Jan 12.

license: cc-by

license_normalized: cc-by

license: cc-by-nc

license_normalized: cc-by-nc

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

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

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories_concat: UCL Discovery;pure.rug.nl

ReferenceCitation: Katzenschlager R, Poewe W, Rascol O, Trenkwalder C, Deuschl G, Chaudhuri KR, Henriksen T, van Laar T, Spivey K, Vel S, Staines H, Lees A. Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial. Lancet Neurol. 2018 Sep;17(9):749-759. doi: 10.1016/S1474-4422(18)30239-4. Epub 2018 Jul 25.

oa_host_type: repository

license_normalized: no license

version: submittedVersion

unpaywall_oa_status: green

location_facility: Newcastle University, Clinical Ageing Research Unit (CARU)

location_facility: Neurologisches Fachkrankenhausfür Bewegungsstörungen / Parkinson

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Klinikum Bremerhaven-Reinkenheide gGmbH, Neurologische Klinik

location_facility: CHU Toulouse, Hôpital Purpan, Centre d'Investigation Clinique

location_facility: Schön Klinik München Schwabing / Neurologie und Klinische Neurophysiologie

location_facility: Donauspital / SMZ-Ost, Abteilung für Neurologie, Sekretariat (Stock 1, Ebene 4)

location_facility: Medizinische Universität Graz / Univ. Klinik für Neurologie

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Bispebjerg University Hospital, Movement Disorder Centre

title: Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment

location_country:
Germany
United Kingdom
Denmark
Netherlands
Austria
Spain
France


title: A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects

summary: This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

ReferenceCitation: Molina JM, Orkin C, Iser DM, Zamora FX, Nelson M, Stephan C, Massetto B, Gaggar A, Ni L, Svarovskaia E, Brainard D, Subramanian GM, McHutchison JG, Puoti M, Rockstroh JK; PHOTON-2 study team. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet. 2015 Mar 21;385(9973):1098-106. doi: 10.1016/S0140-6736(14)62483-1. Epub 2015 Feb 4.

repository_institution: University of Milano-Bicocca - BOA - Bicocca Open Archive

ReferenceCitation: Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.

oa_colors: green other

evidence: open (via free article)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: The Pennsylvania State University - CiteSeer X

repository_normalized: CiteSeerX

evidence: oa repository (via pmcid lookup)

repositories:
CiteSeerX
PubMed Central

repositories_concat: CiteSeerX;PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

location_country:
Germany
Italy
United Kingdom
Australia
Spain
France


title: A Phase 1b Study Combining Ibrutinib With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With CD20-Positive B-Cell Non Hodgkin Lymphoma (NHL)

summary: The purpose of this study is to identify if, and at what dose, ibrutinib may be administered with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) and to document responses of this combination in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL).

ReferenceCitation: Younes A, Thieblemont C, Morschhauser F, Flinn I, Friedberg JW, Amorim S, Hivert B, Westin J, Vermeulen J, Bandyopadhyay N, de Vries R, Balasubramanian S, Hellemans P, Smit JW, Fourneau N, Oki Y. Combination of ibrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for treatment-naive patients with CD20-positive B-cell non-Hodgkin lymphoma: a non-randomised, phase 1b study. Lancet Oncol. 2014 Aug;15(9):1019-26. doi: 10.1016/S1470-2045(14)70311-0. Epub 2014 Jul 17.

oa_host_type: closed

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC.

location_country:
United States
France


title: A Randomized, Double-blind, Placebo Controlled Study to Assess Efficacy, Safety and Tolerability of LCQ908 in Subjects With Familial Chylomicronemia Syndrome

summary: The purpose of this study is to determine whether LCQ908 is effective and safe in lowering triglycerides in subjects with Familial Chylomicronemia Syndrome (FCS) (Hyperlipoproteinemia [HLP] type I). Data from this study will be used to support a registration submission of LCQ908 20 mg and 40 mg as treatment of chylomicronemia in subjects with FCS (HLP Type 1).

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


type: Registry Identifier

title: A Phase 1/2 Study of Brentuximab Vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

summary: The purpose of this study is to assess the safety and pharmacokinetics, and determine the pediatric maximum tolerated dose and/or or recommended phase 2 dose of brentuximab vedotin.

ReferenceType: result

ReferenceCitation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.

ReferenceCitation: Suri A, Mould DR, Song G, Kinley J, Venkatakrishnan K. Population Pharmacokinetics of Brentuximab Vedotin in Adult and Pediatric Patients With Relapsed/Refractory Hematologic Malignancies: Model-Informed Hypothesis Generation for Pediatric Dosing Regimens. J Clin Pharmacol. 2020 Dec;60(12):1585-1597. doi: 10.1002/jcph.1682. Epub 2020 Jun 28.

repositories_concat: PubMed Central

publisher_dissemination: Wiley

ReferenceCitation: Locatelli F, Mauz-Koerholz C, Neville K, Llort A, Beishuizen A, Daw S, Pillon M, Aladjidi N, Klingebiel T, Landman-Parker J, Medina-Sanson A, August K, Sachs J, Hoffman K, Kinley J, Song S, Song G, Zhang S, Suri A, Gore L. Brentuximab vedotin for paediatric relapsed or refractory Hodgkin's lymphoma and anaplastic large-cell lymphoma: a multicentre, open-label, phase 1/2 study. Lancet Haematol. 2018 Oct;5(10):e450-e461. doi: 10.1016/S2352-3026(18)30153-4.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Germany
Italy
United Kingdom
Netherlands
Mexico
United States
Spain
France


title: An Open-label, Single-arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AUY922 in Combination With Trastuzumab Standard Therapy as Second-line Treatment in Patients With HER2-positive Advanced Gastric Cancer

summary: This study will assess the safety and efficacy of AUY922, when administered, in combination with trastuzumab in adult patients with HER2+ advanced gastric cancer, who have received trastuzumab plus chemotherapy in the first line.

location_country:
Germany
Italy
Japan
Belgium
United States
Korea, Republic of
Spain
France

location_facility: University of Texas/MD Anderson Cancer Center UT SC

location_facility: University of California at Los Angeles UCLA LeConte Location


title: A Multicenter, Open-label, Dose Ranging Study to Determine the Pharmacokinetics and Pharmacodynamics of Mepolizumab Administered Intravenously or Subcutaneously to Adult Asthmatic Subjects With Elevated Blood Eosinophil Levels

summary: A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as safety/tolerability assessments will be collected throughout the study

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:
United States
Estonia
Germany
France


title: A Longitudinal 2-year Bone Marrow Study of Eltrombopag Olamine (SB-497115-GR) in Previously Treated Adults, With Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

summary: A open-label, multi-center 2-year safety study to ascertain the baseline levels of bone marrow fibers in previously treated adults with chronic immune (idiopathic) thrombocytopenic purpura (ITP) and to evaluate the long-term effect of eltrombopag on bone marrow fibers. The study will also describe the long-term safety and tolerability of oral eltrombopag treatment in subjects with chronic ITP.

ReferenceCitation: Wong RS, Bakshi K, Brainsky A. Thrombophilia in patients with chronic immune thrombocytopenia. Scand J Clin Lab Invest. 2015 Jan;75(1):13-7. doi: 10.3109/00365513.2014.962597. Epub 2014 Oct 9.

publisher_dissemination: Informa

location_country:
Germany
Italy
India
Hungary
Hong Kong
United States
Korea, Republic of
Pakistan
Czech Republic
Russian Federation
France


title: A Phase 1/2, Multiple-Dose, Dose-Escalation Study to Assess the Safety, Efficacy, and Pharmacokinetics of Intravenous CNTO 328, an Anti-Interleukin 6 (IL-6) Monoclonal Antibody, in Subjects With Solid Tumors

summary: The purpose of this study is to determine the recommended dose of siltuximab monotherapy, in participants with solid malignant (cancerous) tumors (a mass in a specific area) and to estimate the clinical benefit of siltuximab monotherapy in participants with ovarian cancer and with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant tumors.

lead_sponsor: Centocor, Inc.

location_country:
United Kingdom
Belgium
United States
Spain
France


title: A Multicenter Phase II Clinical Trial of Neoadjuvant Trabectedin (Yondelis) in Patients With Localized Myxoid / Round Cell Liposarcoma

summary: The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).

ReferenceCitation: Gronchi A, Bui BN, Bonvalot S, Pilotti S, Ferrari S, Hohenberger P, Hohl RJ, Demetri GD, Le Cesne A, Lardelli P, Perez I, Nieto A, Tercero JC, Alfaro V, Tamborini E, Blay JY. Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. Ann Oncol. 2012 Mar;23(3):771-776. doi: 10.1093/annonc/mdr265. Epub 2011 Jun 3.

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

location_country:
United States
Germany
France


title: A Ph I/IIa Rand Placebo Ctrl, S-Blind Multictr Dose-Esc Study of SC Intermittent Interleukin-7 CYT107 in Chronically HIV-Infected Pts With CD4 T Lymphocyte Counts 101-400 Cells-/mm(3) and Plasma HIV RNA Less Than 50 Copies/mL After at Least 12 M of HAART

summary:
This study will evaluate the safety of a new experimental drug, IL-7, in people with HIV infection. Animal studies have shown that IL-7 can improve the function and number of infection-fighting cells called T lymphocytes, or T cells. If this study shows that IL-7 is safe, additional studies will be done to see if it can improve the function or numbers of T-cells in HIV-infected persons.

HIV-infected persons who have been receiving HAART therapy for at least 12 months before enrolling in the study and have been stable on this treatment for at least 3 months before enrollment may be eligible for this study.

Participants have about 10 clinic visits over 3 months. They receive three injections of IL-7, one injection a week for 3 consecutive weeks. The injections are given as a shot under the skin in the arm or leg. On the day of each injection, the participant stays in the clinic for up to 8 hours or longer for observation and collection of blood samples. Three additional visits (one every 3 months) may be scheduled.

During the study visits the following may be done:

Medical history, physical examination, blood tests every visit.
Electrocardiogram (EKG) at study days 0 (day of first dose), 1, 7 (day of second dose), 14 (day of third dose) and 21.
Chest x-ray study on day 21.
Blood sample collections at frequent intervals during the first 96 hours after the first dose administration. A catheter (thin plastic tube) may be put into a vein in the arm and left in place to allow several blood samples to be drawn without repeated needle sticks.
Urine tests several times during the study.

ReferenceType: background

ReferenceCitation: Stebbing J, Gazzard B, Douek DC. Where does HIV live? N Engl J Med. 2004 Apr 29;350(18):1872-80. doi: 10.1056/NEJMra032395. No abstract available.

ReferenceCitation: Battegay M, Nuesch R, Hirschel B, Kaufmann GR. Immunological recovery and antiretroviral therapy in HIV-1 infection. Lancet Infect Dis. 2006 May;6(5):280-7. doi: 10.1016/S1473-3099(06)70463-7.

ReferenceCitation: Douek DC, Picker LJ, Koup RA. T cell dynamics in HIV-1 infection. Annu Rev Immunol. 2003;21:265-304. doi: 10.1146/annurev.immunol.21.120601.141053. Epub 2001 Dec 19.

lead_sponsor: Cytheris SA

location_country:
United States
Italy
Canada
France

location_facility: Hopital Henri Mendor-Service d'Immunologie Clinique

location_facility: National Institutes of Health Clinical Center, 9000 Rockville Pike


title: An Open Label, Single Arm, Phase 1b/2 Study With Pharmacokinetic Sampling to Evaluate LY2181308 in Patients With Advanced Hepatocellular Carcinoma

summary: The primary objective of this study is to estimate the time to progressive disease for patients with advanced hepatocellular cancer who receive LY2181308.

status: Withdrawn

study_completion_date_type: Anticipated

enrollment_type: Anticipated

lead_sponsor: Eli Lilly and Company

location_country:
United States
Spain
Germany
France

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


title: Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.

ReferenceCitation: Lutz MP, Van Cutsem E, Wagener T, Van Laethem JL, Vanhoefer U, Wils JA, Gamelin E, Koehne CH, Arnaud JP, Mitry E, Husseini F, Reichardt P, El-Serafi M, Etienne PL, Lingenfelser T, Praet M, Genicot B, Debois M, Nordlinger B, Ducreux MP; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Docetaxel plus gemcitabine or docetaxel plus cisplatin in advanced pancreatic carcinoma: randomized phase II study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group. J Clin Oncol. 2005 Dec 20;23(36):9250-6. doi: 10.1200/JCO.2005.02.1980.

ReferenceCitation: Lutz MP, Ducreux M, Wagener T, et al.: Docetaxel/gemcitabine or docetaxel/cisplatin in advanced pancreatic carcinoma: a randomized phase II study of the EORTC-GI group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-498, 2002.

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

location_country:
Germany
Poland
United Kingdom
Netherlands
Belgium
Turkey
Egypt
France

location_facility: Universitaetsklinik und Strahlenklinik - Essen

location_facility: Hermann-Holthusen Institute for Radiotherapy

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Dokuz Eylul University School of Medicine


title: The CROCO Study: CROhn's Disease COhort Study

acronym: CROCO

summary: The investigators propose to create a prospective Crohn Disease cohort, where patients receiving the most up-to-date therapies with a treat-to-target strategy, will be closely followed to characterize the progression of Crohn Disease by measuring the Lémann Index over time. The goal of the CROCO Study - "Crohn's Disease Cohort Study" is to promote a greater understanding of the long-term evolution of Crohn Disease , to describe prospectively the impact of different therapeutic strategies and develop accurate predictors of bowel disease damage and disability.

status: Recruiting

primary_purpose: Diagnostic

lead_sponsor: GLSMED Learning Health S.A.

sponsor_collaborators:
GLSMED Learning Health S.A.
AbbVie

location_country:
Italy
Cyprus
Portugal
United Kingdom
Denmark
Romania
Malta
Belgium
Spain
Czechia
France

location_facility: Hull University Teaching Hospitals NHS Trust

location_facility: IBD Clinical and Research Clinic, ISCARE

location_facility: Claude Huriez Hospital, Lille University

location_facility: Instituto Portugues de Oncologia de Lisboa

location_facility: Hospital Alvaro Cunqueiro - Área Sanitária de Vigo

intervention_type: Diagnostic Test

status_simplified: Ongoing


title: A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer naïve to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06A.

summary:
This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment.

With protocol amendment 5 (effective: 17-November-2023), enrollment in study arms "Pembrolizumab plus MK-4830 plus Chemotherapy" and "Pembrolizumab plus MK-4830 plus lenvatinib" is discontinued.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Italy
Norway
Singapore
Japan
Brazil
Switzerland
Korea, Republic of
Thailand
Turkey
Chile
Taiwan
France

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (

location_facility: Taichung Veterans General Hospital-Radiation Oncology ( Site 2008)

location_facility: Hopital Claude Huriez - CHU de Lille ( Site 1100)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1200)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 2006)

location_facility: Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 2801)

location_facility: Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 2804)

location_facility: Pitie Salpetriere University Hospital ( Site 1102)

location_facility: Saitama Prefectural Cancer Center ( Site 1703)

location_facility: Taipei Veterans General Hospital ( Site 2005)

location_facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 1402)

location_facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan ( Site 1104)

location_facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)

location_facility: Faculty of Medicine Siriraj Hospital ( Site 2102)

location_facility: I.E.U. Medical Point Hastanesi-Oncology ( Site 1406)

location_facility: National Cancer Center Hospital East ( Site 1701)

location_facility: Hôpitaux Universitaires de Genève (HUG) ( Site 2702)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1206)

location_facility: Kantonsspital Graubünden-Medizin ( Site 2700)

location_facility: Ankara City Hospital-Medical Oncology ( Site 1405)

location_facility: National Cancer Center Hospital ( Site 1700)

location_facility: Universitaetsklinikum Duesseldorf ( Site 2802)

location_facility: Aichi Cancer Center Hospital ( Site 1702)

location_facility: Asan Medical Center-Department of Oncology ( Site 1901)

location_facility: National Taiwan University Hospital ( Site 2000)

location_facility: Atatürk Üniversitesi-onkoloji ( Site 1416)

location_facility: Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 1410)

location_facility: Liga Norte Riograndense Contra o Câncer ( Site 2303)

location_facility: Chang Gung Memorial Hospital at Kaohsiung ( Site 2003)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 2806)

location_facility: China Medical University Hospital ( Site 2007)

location_facility: Oslo universitetssykehus, Radiumhospitalet ( Site 2501)

location_facility: Hospital Nossa Senhora da Conceição ( Site 2301)

location_facility: National Cheng Kung University Hospital ( Site 2001)

location_facility: National University Hospital ( Site 1800)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 1900)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1403)


title: An Open-label, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MEDI9253, a Recombinant Newcastle Disease Virus Encoding Interleukin-12, in Combination With Durvalumab in Participants With Select Advanced/Metastatic Solid Tumors

summary: Study D7880C00001 is a first-in-human (FIH), Phase 1, open-label, multicenter, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of MEDI9253 in combination with durvalumab in adult participants with select advanced/metastatic solid tumors.

status: Active, not recruiting

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca


title: A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants With NHL and CLL

summary: The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-75348780 in participants with relapsed/ refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in Part A and to further characterize the safety at the RP2D(s) in Part B.

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: The University of Texas MD Anderson Cancer Center

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


title: Phase I/II, Open-Label Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Durvalumab Monotherapy or in Combination With Tremelimumab in Pediatric Patients With Advanced Solid Tumors and Hematological Malignancies.

summary: The purpose of the study is to determine the recommended dose of durvalumab and tremelimumab (immunotherapy drugs) in pediatric patients with advanced solid and hematological cancers and expand in a second phase to test the efficacy of these drugs once this dose is determined.

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

location_country:
Germany
Italy
United Kingdom
Netherlands
United States
Spain
France


title: FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System

summary:
Prospective, single-arm, multi-center, interventional post-market study. After signing informed consent, eligible subjects will be implanted with the CE marked Evolut™ PRO system.

The investigation purpose is to evaluate the acute and long term clinical performance and safety of Evolut™ PRO in a routine hospital setting in patients with symptomatic native aortic valve stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement within the approved intended use in local geography.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Manoharan G, Grube E, Van Mieghem NM, Brecker S, Fiorina C, Kornowski R, Danenberg H, Ruge H, Thiele H, Lancellotti P, Sondergaard L, Tamburino C, Oh JK, Fan Y, Windecker S. Thirty-day clinical outcomes of the Evolut PRO self-expanding transcatheter aortic valve: the international FORWARD PRO study. EuroIntervention. 2020 Nov 20;16(10):850-857. doi: 10.4244/EIJ-D-20-00279.

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

publisher_dissemination: Europa Digital & Publishing

lead_sponsor: Medtronic Cardiovascular

location_country:
Finland
Germany
Italy
Slovenia
Israel
Norway
Denmark
United Kingdom
Netherlands
Austria
Belgium
Switzerland
Spain
France

location_facility: Deutsches Herzzentrum München Klinik an der TU München

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: The Royal Wolverhampton Hospitals NHS - New Cross Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

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

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

location_facility: AOU Presidio Gaspare Rodolico Policlinico


lead_sponsor: Novo Nordisk A/S

summary: This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A without inhibitors.

ReferenceCitation: Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J, Chowdary P. Long-term efficacy and safety of subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors. Blood Adv. 2022 Jun 14;6(11):3422-3432. doi: 10.1182/bloodadvances.2021006403.

oa_colors: green gold

evidence: open (via page says license)

repository_institution: Elsevier - Scopus

repository_normalized: Pure (Denmark)

repository_institution: Universidad Autónoma de Madrid - Biblos-e Archivo

repositories:
PubMed Central
Pure (Denmark)
repositorio.uam.es

unpaywall_oa_status: gold

publisher_dissemination: American Society of Hematology

ReferenceCitation: Shapiro AD, Angchaisuksiri P, Astermark J, Benson G, Castaman G, Chowdary P, Eichler H, Jimenez-Yuste V, Kavakli K, Matsushita T, Poulsen LH, Wheeler AP, Young G, Zupancic-Salek S, Oldenburg J. Subcutaneous concizumab prophylaxis in hemophilia A and hemophilia A/B with inhibitors: phase 2 trial results. Blood. 2019 Nov 28;134(22):1973-1982. doi: 10.1182/blood.2019001542.

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

title: A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

location_country:
Germany
Italy
United Kingdom
Japan
Sweden
United States
Spain
Thailand
Turkey
Ukraine
France


lead_sponsor: Sanofi

summary:
Primary Objective:

To describe the pharmacokinetic (PK) profile of sarilumab in patients aged 1-17 years with Systemic Juvenile Idiopathic Arthritis (sJIA) in order to identify the dose and regimen for adequate treatment of this population.

Secondary Objective:

To describe the pharmacodynamics (PD) profile, the efficacy, and the long term safety of sarilumab in patients with sJIA.

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number :6430065
Investigational Site Number :2460040
Investigational Site Number :7240053
Investigational Site Number :3720001
Investigational Site Number :2760060
Investigational Site Number :3800054
Investigational Site Number :1240110
Investigational Site Number :2500042
Investigational Site Number :1000001
Investigational Site Number :0320004
Investigational Site Number :2760064
Investigational Site Number :2760061
Investigational Site Number :1240112
Investigational Site Number :2760062
Investigational Site Number :7240052
Investigational Site Number :8260033
Investigational Site Number :2760063
Investigational Site Number :6430001
Investigational Site Number :6430063
Investigational Site Number :3800052
Investigational Site Number :2760065
Investigational Site Number :2500041
Investigational Site Number :8260034
Investigational Site Number :7240051
Investigational Site Number :2500040
Investigational Site Number :8260031
Investigational Site Number :6430062
Investigational Site Number :3800051
Investigational Site Number :7240050

title: An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase

location_country:
Finland
Germany
Ireland
Italy
United Kingdom
Argentina
Spain
Bulgaria
Canada
Russian Federation
France


title: A Phase 1b Study of LY3039478 in Combination With Other Anticancer Agents in Patients With Advanced or Metastatic Solid Tumors

summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.

ReferenceCitation: Massard C, Cassier PA, Azaro A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of crenigacestat (LY3039478) in combination with gemcitabine and cisplatin or gemcitabine and carboplatin in patients with advanced or metastatic solid tumors. Cancer Chemother Pharmacol. 2022 Oct;90(4):335-344. doi: 10.1007/s00280-022-04461-z. Epub 2022 Aug 28.

publisher_dissemination: Springer-Nature

ReferenceCitation: Azaro A, Massard C, Tap WD, Cassier PA, Merchan J, Italiano A, Anderson B, Yuen E, Yu D, Oakley G 3rd, Benhadji KA, Pant S. A phase 1b study of the Notch inhibitor crenigacestat (LY3039478) in combination with other anticancer target agents (taladegib, LY3023414, or abemaciclib) in patients with advanced or metastatic solid tumors. Invest New Drugs. 2021 Aug;39(4):1089-1098. doi: 10.1007/s10637-021-01094-6. Epub 2021 Mar 8.

location_country:
United States
Denmark
Spain
France

location_facility: University of Texas MD Anderson Cancer Center


title: Multicenter Randomized Controlled Trial Comparing Legflow - DCB (Cardionovum) Versus Bare Balloon Angioplasty for the Treatment of Atherosclerotic Disease in the Superficial Femoral & Popliteal Segment

summary: A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.

lead_sponsor: Cardionovum GmbH

sponsor_collaborators:
Cardionovum GmbH
Archer Research

location_country: Germany Belgium France

location_facility:
AZ Sint-Jan
ZNA Stuivenberg
UZ Leuven
CHU Cermont-Ferrand
ZOL (Ziekenhuis Oost-Limburg)
CH Mont-de-Marsan
CHU Bordeaux
Klinikum Arnsberg
Jessa hospital


acronym: iMATRIXcobi

lead_sponsor: Hoffmann-La Roche

summary: This open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of cobimetinib in pediatric and young adult participants with solid tumors with known or potential kinase pathway activation for which standard therapy has proven to be ineffective or intolerable or for which no curative standard-of-care treatment options exist. The study will be conducted in two stages: a dose-escalation stage and an expansion stage at the recommended dose.

ReferenceCitation: Trippett T, Toledano H, Campbell Hewson Q, Verschuur A, Langevin AM, Aerts I, Howell L, Gallego S, Rossig C, Smith A, Patel D, Pereira LR, Cheeti S, Musib L, Hutchinson KE, Devlin C, Bernardi R, Geoerger B. Cobimetinib in Pediatric and Young Adult Patients with Relapsed or Refractory Solid Tumors (iMATRIX-cobi): A Multicenter, Phase I/II Study. Target Oncol. 2022 May;17(3):283-293. doi: 10.1007/s11523-022-00888-9. Epub 2022 Jun 17.

location_facility: Great Ormond Street Hospital; Dept. Of Pediatric Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; Struttura Complessa di Pediatria Oncologica

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Hôpital de la Timone, Oncologie Pédiatrique

title: A Phase I/II, Multicenter, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Cobimetinib In Pediatric and Young Adult Patients With Previously Treated Solid Tumors

location_country:
Germany
Italy
France
United Kingdom
United States
Spain
Israel


title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-838, an Antibody Drug Conjugate, in Subjects With Relapsed and Refractory Multiple Myeloma

summary: This is a Phase 1/1b, open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and to determine the recommended Phase 2 dose of ABBV-838 in subjects with relapsed and refractory multiple myeloma.

ReferenceCitation: Vij R, Nath R, Afar DEH, Mateos MV, Berdeja JG, Raab MS, Guenther A, Martinez-Lopez J, Jakubowiak AJ, Leleu X, Weisel K, Wong S, Gulbranson S, Sheridan JP, Reddy A, Paiva B, Singhal A, San-Miguel JF, Moreau P. First-in-Human Phase I Study of ABBV-838, an Antibody-Drug Conjugate Targeting SLAMF7/CS1 in Patients with Relapsed and Refractory Multiple Myeloma. Clin Cancer Res. 2020 May 15;26(10):2308-2317. doi: 10.1158/1078-0432.CCR-19-1431. Epub 2020 Jan 22.

evidence: open (via free pdf)

publisher_dissemination: American Association for Cancer Research

ipd_sharing: Undecided

lead_sponsor: AbbVie

location_facility: Hospital Universitario de la Princesa /ID# 140881

location_facility: The Sarah Cannon Research Institute /ID# 135814

location_facility: Washington University School of Medicine /ID# 135708

location_facility: Hospital Clinico Universitario Salamanca /ID# 140880

location_facility: The University of Chicago Medical Center /ID# 139403

location_facility: CHU de la miletrie, Centre d'investigation clinique /ID# 147542

location_facility: Universitaetsklinikum Tuebingen /ID# 141074

location_facility: Universitaetsklinikum Wuerzburg /ID# 141533

location_facility: University of Michigan Medical Center /ID# 139402

location_facility: Universitaetsklinikum Schleswig-Holstein /ID# 141534

location_facility: Clinica Universitaria de Navarra /ID# 141411

location_facility: Hospital Universitario 12 de Octubre /ID# 140878

location_facility: Universitaetklinikum Dresden /ID# 141860

location_facility: Universitaetsklinikum Heidelberg /ID# 140046

location_facility: Hospital Clinic de Barcelona /ID# 141643

location_facility: CHU de Nantes, Hotel Dieu - HME /ID# 133633

location_facility: CHRU de Lille, Hopital Claude Huriez /ID# 133634


lead_sponsor: Celgene

summary:
Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT).

Objectives Primary Objective The primary objective is to assess the treatment effect on response rate (MDS: either complete remission [CR], partial remission [PR], or marrow CR; JMML: either clinical complete remission [cCR] or clinical partial remission [cPR]); at Cycle 3 Day 28 (each cycle is 28 days) and to compare against standard therapy using a matched-pairs analysis of historical data.

Secondary Objective The secondary objective is to further evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of azacitidine in this subject population.

Study Design This is a prospective, open-label, Phase 2 study consisting of 2 parallel experimental arms, one for each disease group: MDS and JMML. Each arm is designed based on Simon's Optimal 2 stage study design. The sample size has been calculated to allow evaluation of the response rate at 28 day-Cycle 3 Day 28 in each of the 2 disease groups. Each of the experimental arms will also individually be compared against a historical control arm using data retrospectively collected from the European Working Group of MDS in childhood (EWOG-MDS) registry by means of a matched-pairs analysis; matched for predefined subject baseline characteristics defined before any results from this study are known post Stage 1. If matched pair is not viable then other methodologies will be explored to evaluate and compare response rates reported in literature and also in registry database Twenty subjects with MDS and 35 JMML subjects evaluable for the primary endpoint (ie, subjects that receive at least 1 dose of investigational product [IP]) will be enrolled at approximately 45 centers in Europe. Each experimental arm has 1 interim analysis planned (at the end of Stage 1). If, during Stage 1 evaluation, less than 2 subjects are observed with a CR, PR, or marrow CR after 3 months of azacitidine in the first 9 subjects with MDS, then enrollment will be stopped. Similarly, if less than 3 subjects are observed with a cPR or cCR after 3 months of azacitidine in the first 18 subjects with JMML, then enrollment will be stopped.

ReferenceCitation: Niemeyer CM, Flotho C, Lipka DB, Stary J, Rossig C, Baruchel A, Klingebiel T, Micalizzi C, Michel G, Nysom K, Rives S, Schmugge Liner M, Zecca M, Schonung M, Baumann I, Nollke P, Benettaib B, Biserna N, Poon J, Simcock M, Patturajan M, Menezes D, Gaudy A, van den Heuvel-Eibrink MM, Locatelli F. Response to upfront azacitidine in juvenile myelomonocytic leukemia in the AZA-JMML-001 trial. Blood Adv. 2021 Jul 27;5(14):2901-2908. doi: 10.1182/bloodadvances.2020004144.

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: St. Anna Kinderkrebsforschung, CHILDREN'S CANCER RESEARCH INSTITUTE

location_facility: Hematology, Oncology and clinical immunology / Heinrich-Heine-University

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt/Main

title: A Phase 2, Multicenter, Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Azacitidine and to Compare Azacitidine to Historical Controls in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome or Juvenile Myelomonocytic Leukemia Before Hematopoietic Stem Cell Transplantation

location_country:
Germany
Ireland
Italy
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Czechia
France


title: A Phase IV, Prospective, Randomized, Exploratory, Multicenter, Eeva™ Trial (Time Lapse Eeva - TiLE)

acronym: TiLE

summary: The purpose of the study was to explore the added value of adjunctive use of Early Embryo Viability Assessment (Eeva) with morphological grading in identifying optimal embryos for transfer.

primary_purpose: Other

lead_sponsor: Merck KGaA, Darmstadt, Germany

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

location_facility: Birmingham Women's Health Care NHS Trust

location_facility: Montichiari Università degli studi di Bresca

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Laboratoire Alphabio & Institut de Médecine de la Reproducti


title: A Multiarm, Open-label, Phase 1b Study of MLN2480 (an Oral A-, B-, and CRAF Inhibitor) in Combination With MLN0128 (an Oral mTORC 1/2 Inhibitor), or Alisertib (an Oral Aurora A Kinase Inhibitor), or Paclitaxel, or Cetuximab, or Irinotecan, in Adult Patients With Advanced Nonhematologic Malignancies

summary: The primary purpose of this study is to determine the safety profile and the maximum tolerated doses (MTDs)/ potential recommended phase 2 doses (RP2Ds) of the combination treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 + cetuximab, and MLN2480 + irinotecan in participants with advanced nonhematologic malignancies.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
United States
Spain
United Kingdom
France

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Massachusetts General Hospital Cancer Center


title: Observational Multicenter Study in Ex-People Who INject Drugs (Ex-PWIDs) to Evaluate Efficacy, Safety, and Adherence to TElaprevir in Combination With Pegylated Interferon Alfa and Ribavirin in Genotype 1 ChRonic HepATitis C PatiEnts

acronym: INTEGRATE

summary: The purpose of this study is to collect information on the efficacy, safety and tolerability of telaprevir (in combination with other medications), in patients who have a history of intravenous drug use with genotype 1 chronic hepatitis C, under substitution therapy (eg., methadone, buprenorphine) and/or followed in addiction centres.

ReferenceCitation: Robaeys G, Christensen S, Lucidarme D, Arain A, Bruggmann P, Kunkel J, Keim S, Jakel M, DeMasi R, Liu C, Lonjon-Domanec I, Foster GR. Chronic Hepatitis C Treatment in Patients with Drug Injection History: Findings of the INTEGRATE Prospective, Observational Study. Infect Dis Ther. 2017 Jun;6(2):265-275. doi: 10.1007/s40121-017-0158-x. Epub 2017 May 5.

evidence: oa journal (via doaj)

repository_institution: Queen Mary University of London - Queen Mary Research Online

repositories_concat: PubMed Central;qmro.qmul.ac.uk

lead_sponsor: Janssen Pharmaceutica N.V., Belgium

location_country:
Germany
United Kingdom
Switzerland
Netherlands
Belgium
France


title: Direct Implantation of Rapamycin-Eluting Stents With Bio-Erodible Drug Carrier Technology Utilizing the Second Generation Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS)

acronym: DIRECT II

summary:
A prospective, randomized, active-control, multi-center clinical trial comparing the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) to that of the commercially available Resolute IntegrityTM Drug-Eluting Stent.

The study objective is to assess the safety and efficacy of the Svelte Drug-Eluting Coronary Stent Integrated Delivery System (IDS) compared to the Resolute IntegrityTM Drug-Eluting Stent in patients with single, never previously treated coronary artery lesions

lead_sponsor: Svelte Medical Systems, Inc.

location_country: Germany Sweden Netherlands Switzerland Belgium Czechia France

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Medizinisches Verzorgungszentrum Prof. Mathey, Prof. Schofer

location_facility: University Medical Center Utrecht, Department of Cardiology


title: Neo Randomized Heart Failure Study

summary: The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.

status: Unknown status

ReferenceCitation: Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.

ReferenceCitation: Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.

ReferenceCitation: Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.

repository_institution: Georg-August-Universität Göttingen - GoeScholar  The Publication Server of the Georg-August-Universität Göttingen

lead_sponsor: CVRx, Inc.

location_country: Germany Italy Canada France

location_facility: Azienda Ospedaliera Spedali Riuniti Di Bergamo

location_facility: Azienda Ospedaliero Universitaria Opedali

location_facility: University Hospital of Schleswig-Holstein, Kiel Campus

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Immanuel Hospital Bernau-Heart Center Brandenburg


title: Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD (The EFFORTLESS S-ICD Registry)

acronym: EFFORTLESS

summary: The EFFORTLESS ICD Registry is an observational, standard of care evaluation designed to demonstrate the early, mid and long-term clinical effectiveness the Boston Scientific S-ICD System. In addition, analysis of resource utilization and costs will be performed to document treatment costs for periods defined by Registry endpoints. Protocol 90904928 restricts enrolment to patients over 18 years of age while protocol 90904925 allows all patients to be included.

ReferenceCitation: Boersma L, Barr C, Knops R, Theuns D, Eckardt L, Neuzil P, Scholten M, Hood M, Kuschyk J, Jones P, Duffy E, Husby M, Stein K, Lambiase PD; EFFORTLESS Investigator Group. Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry: The EFFORTLESS Study. J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.

ReferenceCitation: Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA, Knops RE, Weiss R, Leon AR, Herre JM, Husby M, Stein KM, Lambiase PD. Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry. J Am Coll Cardiol. 2015 Apr 28;65(16):1605-1615. doi: 10.1016/j.jacc.2015.02.047.

ReferenceCitation: Lambiase PD, Barr C, Theuns DA, Knops R, Neuzil P, Johansen JB, Hood M, Pedersen S, Kaab S, Murgatroyd F, Reeve HL, Carter N, Boersma L; EFFORTLESS Investigators. Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.

repository_institution: Tilburg University - Research portal

repository_institution: Erasmus University Rotterdam - EUR Research Repository

repository_institution: Erasmus University, Rotterdam - RePub

evidence: oa repository (semantic scholar lookup)

lead_sponsor: Boston Scientific Corporation

location_country:
Germany
Italy
Portugal
New Zealand
United Kingdom
Denmark
Netherlands
Spain
Czechia
France

location_facility: Immanuel Klinikum Bernau Herzzentrum Brandenburg

location_facility: Ludwig-Maximilians-Universität München, Campus Großhadern

location_facility: Azienda Ospedaliero Universitaria Padova

location_facility: Azienda Ospedaliero Universitaria Pisana


title: A Phase IIa Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of AZD1386 After 3 Weeks of Treatment in Patients With Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)

acronym: AVANT

summary: The primary aim of this study is to investigate if AZD1386 is efficacious as an analgesic in patients with peripheral neuropathic pain. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain.

location_country:
Denmark
Canada
United Kingdom
France


title: International Report on Routine Practice of Sensor-enabled Pump Therapy

summary: The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.

ipd_sharing_description: Nørgaard K et al. Routine sensor-augmented pump therapy in type 1 diabetes: the INTERPRET study. Diabetes Technol Ther. 2013 Apr;15(4):273-80. doi: 10.1089/dia.2012.0288. Epub 2013 Feb 25.

lead_sponsor: Medtronic Diabetes

location_country: Slovenia Italy Lithuania Poland Slovakia Hungary Israel Denmark Sweden Austria Belgium Spain Serbia France

location_facility: Oddzial Kliniczny Kliniki Chorób Metabolicznych Sz

location_facility: LKH Salzburg/Universitätsklinikum der Paracelsus Med Privatuniversität/Innere Medizin I

location_facility: Klinika Chorób Dzieci Uniwersytecki Dzieciecy Szp


title: The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants

summary: The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.

ReferenceCitation: Laube M, Amann E, Uhlig U, Yang Y, Fuchs HW, Zemlin M, Mercier JC, Maier RF, Hummler HD, Uhlig S, Thome UH. Inflammatory Mediators in Tracheal Aspirates of Preterm Infants Participating in a Randomized Trial of Inhaled Nitric Oxide. PLoS One. 2017 Jan 3;12(1):e0169352. doi: 10.1371/journal.pone.0169352. eCollection 2017.

repository_institution: RWTH Aachen - RWTH Publications

repositories_institution:
PubMed Central - Europe PMC
RWTH Aachen - RWTH Publications

publisher_dissemination: Public Library of Science

ReferenceCitation: Durrmeyer X, Hummler H, Sanchez-Luna M, Carnielli VP, Field D, Greenough A, Van Overmeire B, Jonsson B, Hallman M, Mercier JC, Marlow N, Johnson S, Baldassarre J; European Union Nitric Oxide Study Group. Two-year outcomes of a randomized controlled trial of inhaled nitric oxide in premature infants. Pediatrics. 2013 Sep;132(3):e695-703. doi: 10.1542/peds.2013-0007. Epub 2013 Aug 12.

publisher_dissemination: American Academy of Pediatrics (AAP)

ReferenceCitation: Mercier JC, Hummler H, Durrmeyer X, Sanchez-Luna M, Carnielli V, Field D, Greenough A, Van Overmeire B, Jonsson B, Hallman M, Baldassarre J; EUNO Study Group. Inhaled nitric oxide for prevention of bronchopulmonary dysplasia in premature babies (EUNO): a randomised controlled trial. Lancet. 2010 Jul 31;376(9738):346-54. doi: 10.1016/S0140-6736(10)60664-2. Epub 2010 Jul 23.

ipd_sharing_description: Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT00551642) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

lead_sponsor: Mallinckrodt

location_country:
Finland
Italy
Germany
United Kingdom
Sweden
Netherlands
Belgium
Spain
France

location_facility: Astrid Lindgrens barnsjukjus, Karolinska Unviersritets sjukhuset-Solna

location_facility: Centre Hospitalier Intercommunal de Creteil

location_facility: Beatrix Children's Hospital, University Medical Center Groningen


title: A Phase Ib, Multi-center, Open-label, Dose-escalation Study of Oral LBH589 When Administered in Combination With Oral Lenalidomide & Dexamethasone in Adult Patients With Multiple Myeloma

summary: This study will evaluate the safety of LBH589 given in combination with lenalidomide and dexamethasone in adult patients with multiple myeloma

lead_sponsor: Novartis Pharmaceuticals

location_country:
United States
Spain
Australia
France

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

location_facility: St. Vincent's Comprehensive Cancer Center


title: A 5-Day, Double-Blind, Placebo-Controlled Multicenter Study of Oral YM087 (CI-1025) to Assess Efficacy and Safety in Patients With Euvolemic or Hypervolemic Hyponatremia

summary: Study of efficacy & safety of oral YM087 in subjects with euvolemic or hypervolemic hyponatremia

lead_sponsor: Cumberland Pharmaceuticals

sponsor_collaborators:
Cumberland Pharmaceuticals
Parke-Davis

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


title: An Open Label Study of the Safety of First-line Treatment With Avastin in Combination With Cisplatin-gemcitabine or Carboplatin-paclitaxel in Patients With Advanced or Recurrent Squamous Non-small Cell Lung Cancer, Who Are Considered to be at High Risk of Pulmonary Haemorrhage

summary: This single arm study will assess the feasibility of using Avastin plus platinum-based chemotherapy (cisplatin-gemcitabine or carboplatin-paclitaxel) in patients with advanced or recurrent squamous non-small cell lung cancer who have not received prior chemotherapy. Patients will receive preventive radiation, followed by one cycle of chemotherapy alone and 5 cycles of chemotherapy in combination with Avastin (15mg/kg iv on day 1 of each 3 weekly cycle), followed by Avastin alone for a maximum total treatment period with Avastin of 12 months. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

location_country:
Poland
Hungary
Israel
Australia
Belgium
Spain
Taiwan
Czech Republic
Russian Federation
France


title: A Multicentre, Stratified, Randomised, Double Blind, Parallel Group Trial to Evaluate Whether a Treatment Strategy Based on Aiming for Total Control Results in Better AHR Than a Treatment Strategy Based on Maintaining Well Control

summary: This double-blind, stratified, parallel group study is to determine whether aiming for 'Total control' results in better airway hyper-responsiveness than maintaining the treatment level at which 'Well-controlled' asthma was achieved. The primary endpoint is the mean change in PC20 methacholine. Well controlled subjects (as assessed after a 12 week run-in period) will enter a 24 week treatment period during which they will record PEF(Peak Expiratory Flow), symptoms, rescue beta2-agonist use over 24 hours, night time awakenings, asthma exacerbations, emergency visits due to asthma and Adverse Events. At every visit lung function measurements and airway hyper-responsiveness will be measured.

lead_sponsor: GlaxoSmithKline

location_country: Finland Germany Italy Sweden Netherlands Belgium Latvia Spain Estonia France


title: A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months

summary: This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.

lead_sponsor: AstraZeneca

location_country:
United States
France


title: A Phase II/III Study of the Safety and Efficacy of NC-503 in Patients Suffering From Secondary (AA) Amyloidosis

summary: The main objective of this study is to evaluate the safety and efficacy of NC-503 compared to placebo in patients with secondary (AA) amyloidosis using a composite assessment of clinical improvement/worsening of both renal and gastrointestinal functions.

ReferenceCitation: Safety, Tolerability and Pharmacokinetic Profile of FibrillexTM (Anti-AA Amyloid Agent) in Healthy and Renal Impaired Subjects. Garceau D., Gurbindo C., Laurin J. Neurochem Inc. Reference: Proceedings from the IXth International Symposium on Amyloidosis , 2001 (Budapest, Hungary)

ReferenceCitation: Dember LM, Hawkins PN, Hazenberg BP, Gorevic PD, Merlini G, Butrimiene I, Livneh A, Lesnyak O, Puechal X, Lachmann HJ, Obici L, Balshaw R, Garceau D, Hauck W, Skinner M; Eprodisate for AA Amyloidosis Trial Group. Eprodisate for the treatment of renal disease in AA amyloidosis. N Engl J Med. 2007 Jun 7;356(23):2349-60. doi: 10.1056/NEJMoa065644.

lead_sponsor: Bellus Health Inc. - a GSK company

collaborators: FDA Office of Orphan Products Development

location_country:
Finland
Italy
France
Lithuania
Poland
United Kingdom
Netherlands
United States
Spain
Turkey
Russian Federation
Israel

location_facility: Indiana University School of Medicine, Department of Pathology and Laboratory Medicine,

location_facility: Hospital Universitario Germans Trias I Pujol, Servicio de Reumatologia

location_facility: Heller Institute of Medical Research, Sheba Medical Center

location_facility: Marmara University Medical School Hospital, Department of Rheumatology

location_facility: Hospital Clinic I Provincial de Barcelona, Jefe del Departamento de Reumatologia

location_facility: University Hospital Groningen, Department of Medicine, Division of Rheumatology

location_facility: Hospital Clinico San Carlos de Madrid, Servicio de Reumatologia

location_facility: Okregowy Szpital Kolejowy, Zaklad Reumatologii

location_facility: Hôpital Cochin, Centre de Recherche et d'Explorations Fonctionnelles

location_facility: Ciutad Sanitària y Universitària de Bellvitge, Servicio de Reumatologia, Hospitalet de Llobregat

location_facility: Centre Hospitalier du Mans, Service de Rhumatologie

location_facility: Hôpital Claude Huriez, Service de médecine Interne, Clinique Médicale A

location_facility: Royal Free and University College Medical School, Department of Medicine, National Amyloidosis Centre

location_facility: Italian Group for Systemic Amyloidosis, Biotechnology Research Laboratories, IRCCS Policlinico San Matteo, Internal Medicine and Medical Oncology

location_facility: Istanbul Faculty of Medicine, Department of Internal Medicine, Division of Rheumatology


title: Gemtuzumab Ozogamicin (CMA-676) Followed or Not by Intensive Chemotherapy as Initial Treatment for Elderly Patients With Acute Myeloid Leukemia: An EORTC-LG Pilot Phase II Study

summary:
RATIONALE: Monoclonal antibodies such as gemtuzumab ozogamicin can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy uses different ways to stop cancer cells from dividing so they stop growing or die. Combining gemtuzumab ozogamicin with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of gemtuzumab ozogamicin with or without chemotherapy in treating older patients who have acute myeloid leukemia.

ReferenceCitation: Seedhouse CH, Grundy M, White P, Li Y, Fisher J, Yakunina D, Moorman AV, Hoy T, Russell N, Burnett A, Pallis M; National Cancer Research Network. Sequential influences of leukemia-specific and genetic factors on p-glycoprotein expression in blasts from 817 patients entered into the National Cancer Research Network acute myeloid leukemia 14 and 15 trials. Clin Cancer Res. 2007 Dec 1;13(23):7059-66. doi: 10.1158/1078-0432.CCR-07-1484.

ReferenceCitation: Amadori S, Suciu S, Willemze R, et al.: Up-front window trial of gemtuzumab ozogamicin (GO) in previously untreated elderly patients with AML: an EORTC leukemia group study. [Abstract] Blood 104 (11): A-877, 2004.

ReferenceCitation: Amadori S, Suciu S, Willemze R, Mandelli F, Selleslag D, Stauder R, Ho A, Denzlinger C, Leone G, Fabris P, Muus P, Vignetti M, Hagemeijer A, Beeldens F, Anak O, De Witte T; EORTC leukemia group; GIMEMA leukemia group. Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a phase II study (AML-15) of the EORTC and GIMEMA leukemia groups. Haematologica. 2004 Aug;89(8):950-6.

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

location_country: Germany Italy Netherlands Austria Belgium Croatia France

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore


title: TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.

ReferenceCitation: Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, Stein CA, Itri LM, Suciu S, Eggermont AM. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer. 2009 Jul;45(10):1807-14. doi: 10.1016/j.ejca.2009.04.016. Epub 2009 May 4.

ReferenceCitation: Keilholz U, Suciu S, Bedikian AY, et al.: LDH is a prognostic factor in stage IV melanoma patients (pts) but is a predictive factor only for bcl2 antisense treatment efficacy: re-analysis of GM301 and EORTC18951 randomized trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-8552, 485s, 2007.

ReferenceCitation: Keilholz U, Eggermont AM. The role of interleukin-2 in the management of stage IV melanoma: the EORTC melanoma cooperative group program. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S99-103.

ReferenceCitation: Schmidt H, Suciu S, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, von der Maase H, Eggermont AM, Keilholz U; American Joint Committee on Cancer Stage IV Melanoma; EORTC 18951. Pretreatment levels of peripheral neutrophils and leukocytes as independent predictors of overall survival in patients with American Joint Committee on Cancer Stage IV Melanoma: results of the EORTC 18951 Biochemotherapy Trial. J Clin Oncol. 2007 Apr 20;25(12):1562-9. doi: 10.1200/JCO.2006.09.0274.

ReferenceCitation: Punt CJ, Suciu S, Gore MA, Koller J, Kruit WH, Thomas J, Patel P, Lienard D, Eggermont AM, Keilholz U. Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group. Eur J Cancer. 2006 Nov;42(17):2991-5. doi: 10.1016/j.ejca.2006.08.012. Epub 2006 Oct 4.

ReferenceCitation: Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2005 Sep 20;23(27):6747-55. doi: 10.1200/JCO.2005.03.202.

ReferenceCitation: Keilholz U, Punt CJ, Gore M, et al.: Dacarbazine, cisplatin and interferon alpha with or without interleukin-2 in advanced melanoma: interim analysis of EORTC trial 18951. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2043, 530a, 1999.

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

location_country:
Germany
Italy
Portugal
United Kingdom
Netherlands
Austria
Belgium
Switzerland
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Instituto Portugues de Oncologia do Porto


title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Infigratinib in Children 3 to <18 Years of Age With Achondroplasia: PROPEL 3

summary: This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).

status: Enrolling by invitation

lead_sponsor: QED Therapeutics, Inc.

location_country:
Germany
Italy
Norway
Argentina
Singapore
Australia
United Kingdom
United States
Spain
Canada
France


title: A Phase 1/2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia

summary: This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R/R B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)

study_start_date_type: Anticipated

status: Not yet recruiting

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


title: A Phase 3, Randomized, Double-Blind, 52-Week, Placebo-Controlled, Efficacy and Safety Study of Povorcitinib in Participants With Nonsegmental Vitiligo

summary: This study is being conducted to determine the efficacy and safety of povorcitinib in participants with nonsegmental vitiligo.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Germany
Poland
Netherlands
Mexico
Belgium
United States
Spain
Canada
France

location_facility: Centre Hospitalier Universitaire (Chu) de Liege - Domaine Universitaire Du Sart Tilman

location_facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie

location_facility: Hopital Universitaire de Bruxelles (H.U.B)/ Academisch Ziekenhuis Brussel

location_facility: Instituto de Investigaciones Aplicadas A La Neurociencia A.C

location_facility: Emc Instytut Medyczny Spolka Akcyjna-Euromedicare Szpital Specjalistyczny Z Przychodnia

location_facility: Universite Catholique de Louvain (Ucl) - Cliniques Universitaires Saint-Luc

location_facility: Clinical Science Institute Clinical Research Specialists Inc

location_facility: Dermodent Centrum Medyczne Aldona Czajkowska Rafa¿ Czajkowski

location_facility: Hospital Universitario Fundacion Alcorcon

location_facility: Csk Mswia Centralny Szpital Kliniczny Mswia

location_facility: Clinical Research Partners Llc Crp Richmond Forest Avenue Office Building Location

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Katowicach

location_facility: International Clinical Research Tennessee Llc

location_facility: Clinica de Enfermedades Cronicas Y de Procedimientos Especiales (Cecype)

location_facility: Klinikum Der Johann Wolfgang Goethe-Universitaet Frankfurt

location_facility: Dermatologische Gemeinschaftspraxis Dres. Quist

location_facility: Sadick Dermatology Sadick Research Group

location_facility: Synexus Polska Sp. Z O.O. Oddzial W Warszawie

location_facility: Uva - Amc - Stichting Nederlands Instituut Voor Pigmentstoornissen (Snip) (Netherlands Institute For

location_facility: Dermapolis Medical Dermatology Center Dr N. Med. Edyta Gebska

location_facility: Universidad Autonoma de Nuevo Leon (Uanl) - Hospital Universitario Dr. Jose Eleuterio Gonzalez - Cen

location_facility: Hospital Universitario Germans Trias I Pujol

location_facility: Sutter Health Palo Alto Medical Foundation Pamf Sunnyvale Center

location_facility: Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie

location_facility: Dermatology Associates of Plymouth Meeting

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: Revival Research Institute, Llc Dermatology


title: A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC Injection in Adult Participants With Moderate to Severe Atopic Dermatitis

summary: This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

location_country:
Germany
Italy
Poland
Argentina
Japan
Mexico
United States
China
Korea, Republic of
Spain
Greece
Panama
Thailand
Czechia
Bulgaria
Canada
France