title: Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations

summary: This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.

time_perspective: Retrospective

ReferenceCitation: Halmos B, Tan EH, Soo RA, Cadranel J, Lee MK, Foucher P, Hsia TC, Hochmair M, Griesinger F, Hida T, Kim E, Melosky B, Märten A, Carcereny E. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: Results from a global real-world study (RealGiDo). Lung Cancer. 2019 Jan;127:103-111. doi: 10.1016/j.lungcan.2018.10.028. Epub 2018 Nov 2.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Taiwan
Spain
Italy
Austria
Canada
Korea, Republic of
United States
France
Singapore
Mexico
Japan
Germany

location_facility: Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Organización para Cuidado Integral en Oncología S.A de C.V

location_facility: Grzegorz Czyzewicz Specialised Medical Practice, Cracow

location_facility: Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland


type: EudraCT Number

title: Phase IIa, Open Label, Dose Ascending Study to Determine the Maximum Tolerated Dose, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Lanreotide PRF in Subjects With Acromegaly Previously Treated and Controlled With Either Octreotide LAR or Lanreotide Autogel

summary: The objectives of the protocol is to determine the maximum tolerated dose and to investigate the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Neggers S, Badiu C, Biagetti B, Durand-Gasselin L, Petit A, Petrossians P, Regnault B, Rich D, Shafigullina Z, Shustov S, Vydrych A. Pharmacological and safety profile of a prolonged-release lanreotide formulation in acromegaly. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1551-1560. doi: 10.1080/17512433.2021.1986004. Epub 2021 Nov 8.

lead_sponsor: Ipsen

location_country:
Poland
Romania
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Lithuania
France
Belgium
Germany
Czechia

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Endocrinological Research Center Ministry of Health Russian Federation

location_facility: Szpital Bielanski im. ks. Jerzego Popieluszki SPZOZ

location_facility: Fakultní nemocnice Hradec Králové (University Hospital Hradec)

location_facility: Vilnius University hospital Santariskiu Klinikos

location_facility: Szpital Kliniczny im. H. Święcickiego UM w Poznaniu

location_facility: AO Città della Salute e della Scienza di Torino

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: IRCCS AOU San Martino-IST, University of Genova

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: Lithuanian University of Health Sciences (LUHS) Kauno klinikos

location_facility: Erasmus University Medical Centre Rotterdam

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 2A Multicentre, Randomised, Double Blind, Placebo-Controlled, Parallel-Group Safety and Tolerability Study of PQ912 in Subjects With Early Alzheimer's Disease

acronym: SAPHIR

summary: The aim of this study is to evaluate the safety, tolerability and preliminary efficacy of PQ912 in subjects with Mild Cognitive Impairment (MCI) due to Alzheimers Disease (AD) or mild dementia due to AD.

design_allocation: Randomized

ReferenceCitation: Scheltens P, Hallikainen M, Grimmer T, Duning T, Gouw AA, Teunissen CE, Wink AM, Maruff P, Harrison J, van Baal CM, Bruins S, Lues I, Prins ND. Safety, tolerability and efficacy of the glutaminyl cyclase inhibitor PQ912 in Alzheimer's disease: results of a randomized, double-blind, placebo-controlled phase 2a study. Alzheimers Res Ther. 2018 Oct 12;10(1):107. doi: 10.1186/s13195-018-0431-6.

lead_sponsor: Vivoryon Therapeutics N.V.

location_country: Spain Netherlands Finland Sweden France Belgium Germany

location_facility: Universitätsmedizin Göttingen / Klinik für Psychiatrie und Psychotherapie

location_facility: Universitätsmedizin Rostock / Zentrum für Nervenheilkunde/ Klinik für Psychosomatik und Psychotherapeutische Medizin

location_facility: Universitätsklinikum Halle (Saale) Klinik und Poliklinik für Psychiatrie, Psychotherapie und Psychosomatik

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS)

location_facility: Fundació ACE. Institut Català de Neurociències Aplicades

location_facility: Verksamheten för neuropsykiatri Sahlgrenska universitetssjukhuset

location_facility: Hôpital La Grave / Centre de Recherche Clinique

location_facility: Universitätsklinikum Magdeburg / Institut für Kognitive Neurologie und Demenzforschung

location_facility: Klinikum rechts der Isar der TU München / Klinik für Psychiatrie und Psychotherapie

location_facility: Ziekenhuis Netwerk Antwerpen / Geheugenkliniek

location_facility: CHU François Mitterand (Centre Mémoire Ressources Recherche (CMRR))

location_facility: Universitätsklinikum Münster / Klinik für Allgemeine Neurologie

location_facility: Hospital de la Santa Creu i Sant Pau, Neurology Department, Memory Unit

intervention_type: Other


title: Assessing Standard oF Care and Clinical Outcomes UsiNg the EDWARDS INTUITY VAlve SysTem in a European multI-center, Active, pOst-market surveillaNce Study.

acronym: FOUNDATION

summary:
The purpose of this active post-market surveillance study is to confirm the safety and effectiveness of the EDWARDS INTUITY Valve System in the study population.

The objective is to evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR. The AVR surgical approach is either full or partial sternotomy or a right anterior thoracotomy.

study_type: Observational

time_perspective: Prospective

ReferenceType: result

ReferenceCitation: Young C, Laufer G, Kocher A, Solinas M, Alamanni F, Polvani G, Podesser BK, Aramendi JI, Arribas J, Bouchot O, Livi U, Massetti M, Terp K, Giot C, Glauber M. One-year outcomes after rapid-deployment aortic valve replacement. J Thorac Cardiovasc Surg. 2018 Feb;155(2):575-585. doi: 10.1016/j.jtcvs.2017.09.133. Epub 2017 Oct 31.

lead_sponsor: Edwards Lifesciences

location_country:
Denmark
Spain
Italy
Austria
Netherlands
United Kingdom
Switzerland
France
Germany

location_facility: Westdeutsches Herzcentrum Uniklinik Essen

location_facility: G. Pasquinucci Heart Hospital - "G.Monasterio" Foundation

location_facility: Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia"

location_facility: Università Cattolica del Sacro Cuore Policlinico

location_facility: Universitätsklinik Für Herz und Gefässchirurgie

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Herz- und Gefäß-Klinik GmbH Bad Neustadt

location_facility: Klinisshe Abteiluing Für Herz-thoraxchirurgie


title: A Randomized Phase II, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of INC280 in Adult Patients With Advanced Hepatocellular Carcinoma After Progression or Intolerance to Sorafenib Treatment

summary:
This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib.

Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding.

Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).

status: Withdrawn

study_completion_date_type: Anticipated

lead_sponsor: Novartis Pharmaceuticals

location_country:
Hong Kong
Spain
Australia
Switzerland
United States
France
Germany

location_facility: Massachusetts General Hospital Mass General Hospital

status_simplified: Unknown


title: An Open-label, International, Multicenter, Interventional Study Exploring the Efficacy of Once-daily Oral Rivaroxaban (BAY 59-7939) for the Treatment of Left Atrial/Left Atrial Appendage Thrombus in Subjects With Nonvalvular Atrial Fibrillation or Atrial Flutter

acronym: X-TRA

summary: A study for subjects with atrial fibrillation (AF) or atrial flutter who are diagnosed with left atrial (LA) or left atrial appendage (LAA) thrombus. The study will assign subjects to rivaroxaban for treatment of thrombi. The study will measure thrombus outcomes based on echo image and common clinical outcomes such as bleeding and stroke or thromboembolism.

ReferenceCitation: Lip GY, Hammerstingl C, Marin F, Cappato R, Meng IL, Kirsch B, Morandi E, van Eickels M, Cohen A. Rationale and design of a study exploring the efficacy of once-daily oral rivaroxaban (X-TRA) on the outcome of left atrial/left atrial appendage thrombus in nonvalvular atrial fibrillation or atrial flutter and a retrospective observational registry providing baseline data (CLOT-AF). Am Heart J. 2015 Apr;169(4):464-71.e2. doi: 10.1016/j.ahj.2014.12.020. Epub 2015 Jan 6.

lead_sponsor: Bayer

location_country:
Poland
Russian Federation
Ukraine
France
Turkey
Germany
Bulgaria


title: An Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 18 Years of Age or Older With Solid Tumours Receiving Chemotherapy

summary: The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine in adults with solid tumours undergoing chemotherapy.

study_start_date_type: Actual

primary_purpose: Prevention

ReferenceType: background

ReferenceCitation: Vink P, Delgado Mingorance I, Maximiano Alonso C, Rubio-Viqueira B, Jung KH, Rodriguez Moreno JF, Grande E, Marrupe Gonzalez D, Lowndes S, Puente J, Kristeleit H, Farrugia D, McNeil SA, Campora L, Di Paolo E, El Idrissi M, Godeaux O, López-Fauqued M, Salaun B, Heineman TC, Oostvogels L; Zoster-028 Study Group. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in patients with solid tumors, vaccinated before or during chemotherapy: A randomized trial. Cancer. 2019 Apr 15;125(8):1301-1312. doi: 10.1002/cncr.31909. Epub 2019 Feb 1. Erratum in: Cancer. 2020 Jun 15;126(12):2941.

ipd_sharing: Yes

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
United Kingdom
Canada
Korea, Republic of
France
Czechia

intervention_type: Biological


title: A Phase IB, Open-Label Study Evaluating the Safety and Pharmacokinetics of Venetoclax (GDC-0199, ABT-199) in Combination With Bendamustine+Rituximab (BR) or Bendamustine+Obinutuzumab (BG) in Patients With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia

summary: This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with first-line (1L)/previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). The study will explore two venetoclax combination regimens in participants with 1L CLL: BR+venetolax (V) and BG+V. Participants with R/R CLL will be administered BR+V.

design_allocation: Non-Randomized

lead_sponsor: Genentech, Inc.

location_country:
Germany
United States
France

location_facility: Apotheke des Universitätsklinikums Freiburg

location_facility: University of California San Diego Medical Center

location_facility: Ingalls Hospital; Cancer Clinical Trials

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III


title: A Randomized, Open-label, Two-arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects With Unresectable Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer

summary: The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. Review.

lead_sponsor: Bristol-Myers Squibb

location_country:
Poland
Taiwan
Hong Kong
Spain
Italy
Russian Federation
Korea, Republic of
United States
France
Singapore
Japan
Germany

location_facility: The University Of Texas Md Anderson Cancer Center


title: 12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

summary: This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

ReferenceCitation: Trenkwalder C, Stocchi F, Poewe W, Dronamraju N, Kenney C, Shah A, von Raison F, Graf A. Mavoglurant in Parkinson's patients with l-Dopa-induced dyskinesias: Two randomized phase 2 studies. Mov Disord. 2016 Jul;31(7):1054-8. doi: 10.1002/mds.26585. Epub 2016 May 23.

location_country:
Spain
Italy
Canada
Hungary
United States
France
Germany


title: Perceval S Valve Clinical Trial for Extended CE Mark

acronym: CAVALIER

summary: The primary objective of this clinical investigation is to assess the safety and effectiveness of the Perceval S valve at 12 months after implantation when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

status: Terminated

ReferenceCitation: Fischlein T, Meuris B, Folliguet T, Hakim-Meibodi K, Misfeld M, Carrel T, Zembala M, Cerutti E, Asch FM, Haverich A; CAVALIER Trial Investigators. Midterm outcomes with a sutureless aortic bioprosthesis in a prospective multicenter cohort study. J Thorac Cardiovasc Surg. 2022 Dec;164(6):1772-1780.e11. doi: 10.1016/j.jtcvs.2020.12.109. Epub 2021 Jan 13.

lead_sponsor: Corcym S.r.l

location_country:
Poland
United Kingdom
Austria
Netherlands
Switzerland
France
Belgium
Germany

location_facility: Inselspital, Universitätsklinik für Herz- und Gefässchirurgie

location_facility: RHÖN Klinikum AG, Herz- und Gefäß-Klinik GmbH

location_facility: Academic Medical Center, Division of Cardio-thoracic Surgery

intervention_type: Device


type: Other Identifier

title: A Post-Market, Open Observational Long-term Effectiveness Follow-up Study of Participants With Drug-resistant Epilepsy With Partial-onset Seizures Previously Enrolled in a Randomized Controlled Trial (E-100: PuLsE) Comparing Best Medical Practice With or w/o Adjunctive Vagus Nerve Stimulation Therapy

acronym: PuLsE 2

summary: This is a post-market, open observational long-term effectiveness follow-up study of participants with drug-resistant epilepsy with partial-onset seizures previously enrolled in a randomized controlled trial (PuLsE) comparing Best Medical Practice with or without adjunctive Vagus Nerve Stimulation Therapy.

lead_sponsor: Cyberonics, Inc.

location_country:
United Kingdom
Italy
Netherlands
Canada
France
Belgium
Germany

location_facility: Azienda Ospedialiera "Bianchi Melacrino Morelli"

location_facility: Hopital Roger Salengro Service de Neurologie

location_facility: Hopital Neurologique Unite d' epileptologie

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Universitatsklinl Erlangen Zentrum fur Epilepsie

location_facility: QE2 Health Sciences Centre Department of Neurology


title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..

summary: A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

lead_sponsor: AstraZeneca

location_country:
Denmark
Poland
United Kingdom
Russian Federation
France
Sweden
Bulgaria


title: A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

summary: This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

lead_sponsor: Grifols Therapeutics LLC

location_country: Serbia Spain Austria Australia France Slovakia

location_facility: Neurology Clinic Hospital with Policlinic of F.D. Roosevelt

location_facility: Clinical Center Niš, Center of Radiology

location_facility: Hospital General Vall d'Hebron, Barcelona

location_facility: Heidelberg Repatriation Hospital, Melbourne

location_facility: Christian-Doppler-Klinik Salzburg,Universitätsklinik für Neurologie

location_facility: Clinical Center of Serbia, Clinic for Vascular and Endovascular Surgery

location_facility: Special Hospital for Cerebrovascular Diseases "Sveti Sava"

location_facility: Radiology Clinic, University Hospital Martin

location_facility: Clinical Center Kragujevac, Center for Radiology Diagnostic

location_facility: Neurology Clinic, Faculty Hospital Nitra

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: I. Neurology Clinic, University Hospital Bratislava

location_facility: Neurology Clinic, Central Military Faculty Hospital

location_facility: Clinical Center of Vojvodina, Center for Radiology

location_facility: Hospital Universitario Germans Trias i Pujol


title: A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multicentre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 for the Prevention of Migraine

summary: Evaluation of ADX10059 to prevent migraine attacks

enrollment_type: Anticipated

lead_sponsor: Addex Pharma S.A.

location_country:
United Kingdom
Austria
France
Belgium
Germany

location_facility:
Hamburg
Lille
06
Freiburg
Manchester
Leipzig
Cardiff
Paris
Liège
Berkshire
Bochum
Itzehoe
Wilrijk
05
Wiesbaden
Berlin Hellersdorf 11
Münster
Dreseden
Magdeburg
Görlitz
Göppingen
02
Frankfurt
Sint-Truiden
Liverpool
24
10
28
Nice
Toulouse


title: A Double Blind, Within Patient, Placebo Controlled Trial to Assess the Efficacy of Juvista (Avotermin) in Conjunction With Scar Revision Surgery for the Improvement of Disfiguring Scars.

acronym: Revise

summary: This trial is to determine whether Juvista can prevent scar formation or improve the appearance of scars following scar revision surgery. The trial will involve comparing Juvista to placebo.

lead_sponsor: Renovo

location_country:
Denmark
Poland
Spain
Italy
Latvia
United Kingdom
Hungary
United States
France
Germany

location_facility: Samodzielny Publiczny Zespół Zakładów Opieki Zdrowotnej Zachodniopomorski

location_facility: Hospital de la Santa Creu I Sant Pau, Departamento Cirugía Plástica

location_facility: Fondazione S. Maugeri, U.O. DI CHIRURGIA PLASTICA E RICOSTRUTTIVA

location_facility: Chirurgia Plastica, Umberto I Policlinico di Roma

location_facility: Hospital Clinic, Departament o Cirugia plástica

location_facility: St Josef und St Elisabeth Hospital, Klinik fur Dermatologie und Allergologie, Gundrunstrasse 56

location_facility: Wojewódzki Szpital Specjalistyczny im. Ludwika Rydygiera, os. Złotej Jesieni 1

location_facility: Klinkia Chirurgii Plastycznej, Akademickie Centrum Kliniczne

location_facility: Fővárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelőintézet

location_facility: Unfallkrankenhaus Berlin, Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Warener Strasse 7

location_facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ

location_facility: Klinikum Offenbach GmbH - Chirurgische Klinik III, Starkenburgring 66

location_facility: Chirurgia Plastica e Ricostruttiva, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Magyarországi Református Egyház Bethesda Gyermekkórháza Égéssérült Gyermekeket Ellátó Országos Központ

location_facility: Paula Stradina Clinical University Hospital

location_facility: Hospital de Conxo-Complejo Hospitalario Universitario de Santiago de Compostela, Servicio de Cirugía plástica

location_facility: Friedrich-Schiller-Universität Jena, Klinik für Dermatologie, Erfurter Strasse 35

location_facility: Krankenhaus Barmherzige Brüder Regensburg

location_facility: Hospital Universitario Nuestra Señora del Perpetuo Socorro

location_facility: Kenézy Kórház Rendelőintézet Egészségügyi Szolgáltató Kft.

location_facility: Universitätsklinikum Schleswig-Holstein- Campus Lübec Plastische Chirurgie, Handchirurgie, Ratzeburger Allee 160

location_facility: Sollorod Privethospital, Primary Clinic, Hjortholmsvej 2C

location_facility: Hôpital Emile Muller, Service de chirurgie plastique

location_facility: Queen Victoria Hospital (QVH) NHS Foundation Trust

location_facility: Wojskowy Instytut Medyczny Kliniczny Oddział Chirurgii Plastycznej,

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Renovo Clinical Trials Unit, 48 Grafton Street

location_facility: Ospedale di Circolo di Varese "Fondazione Macchi", Chirurgia Plastica


title: Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naive Patients With HER2-Positive Breast Cancer

lead_sponsor: Cephalon, Inc.

source: euctr

location_country: Spain Italy Austria France Belgium Germany

location_facility:
Teva Investigational Site 16
Teva Investigational Site 11
Teva Investigational Site 26
Teva Investigational Site 14
Teva Investigational Site 2
Teva Investigational Site 27
Teva Investigational Site 15
Teva Investigational Site 25
Teva Investigational Site 34
Teva Investigational Site 1
Teva Investigational Site 33
Teva Investigational Site 8
Teva Investigational Site 3
Teva Investigational Site 32
Teva Investigational Site 9
Teva Investigational Site 5
Teva Investigational Site 21
Teva Investigational Site 20
Teva Investigational Site 29
Teva Investigational Site 4
Teva Investigational Site 23
Teva Investigational Site 30

summary: To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.


title: Phase II Study of E7389 Administered as an IV Bolus Infusion Day 1 and Day 8 Every 3 Weeks in Pre-Treated Patients With Advanced and/or Metastatic Soft Tissue Sarcoma

lead_sponsor: Eisai Inc.

ReferenceCitation: Wiemer EAC, Wozniak A, Burger H, Smid M, Floris G, Nzokirantevye A, Sciot R, Sleijfer S, Schöffski P. Identification of microRNA biomarkers for response of advanced soft tissue sarcomas to eribulin: Translational results of the EORTC 62052 trial. Eur J Cancer. 2017 Apr;75:33-40. doi: 10.1016/j.ejca.2016.12.018. Epub 2017 Feb 16.

ReferenceCitation: Schöffski P, Ray-Coquard IL, Cioffi A, Bui NB, Bauer S, Hartmann JT, Krarup-Hansen A, Grünwald V, Sciot R, Dumez H, Blay JY, Le Cesne A, Wanders J, Hayward C, Marreaud S, Ouali M, Hohenberger P; European Organisation for Research and Treatment of Cancer (EORTC) Soft Tissue and Bone Sarcoma Group (STBSG). Activity of eribulin mesylate in patients with soft-tissue sarcoma: a phase 2 study in four independent histological subtypes. Lancet Oncol. 2011 Oct;12(11):1045-52. doi: 10.1016/S1470-2045(11)70230-3. Epub 2011 Sep 19. Erratum in: Lancet Oncol. 2015 Sep;16(9):e427.

location_country: Denmark Poland France Belgium Germany

summary: The purpose of this study is to evaluate the therapeutic activity and safety of E7389 in patients with advanced/metastatic soft tissue sarcoma who have failed standard chemotherapy.


title: 12-month Open Label, Randomized, Multicenter Study Evaluating Efficacy, Safety and Tolerability of Oral AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), vs. Mycophenolic Acid Plus Tacrolimus in de Novo Renal Transplant Recipients

summary: This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.

location_country:
Spain
Italy
United Kingdom
Canada
Switzerland
United States
France
Germany

location_facility: Azienda Ospedaliera di Padova - Universita degli Studi

location_facility: Ciutat Santitaria I Univessitaria de Bellvitge

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Azienda Opedaliera Careggi - Universita degli Studi

location_facility: Az. Osp. Di Bologna Polici. S. Orsola - Malpighi

location_facility: Klinikum der Humboldt Universitat Charite


title: Protocol H7T-MC-TABL(a) PRasugrel IN Comparison to Clopidogrel for Inhibition of PLatelet Activation and AggrEgation (PRINCIPLE) - TIMI 44

acronym: PRINCIPLE

summary: The purpose of this study is to provide information of the relative potency of prasugrel and clopidogrel on platelet function studies, inflammation, and myocyte necrosis in subjects undergoing elective percutaneous coronary intervention (PCI).

lead_sponsor: Eli Lilly and Company

location_country:
Germany
United States
Israel
France

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


title: An Open-label, Non-Comparative Trial to Evaluate the Safety, Efficacy and Pharmacokinetics of Faslodex (Fulvestrant) in Girls With Progressive Precocious Puberty Associated With McCune-Albright Syndrome

acronym: FMAS

summary: The purpose of this study is to evaluate the safety, effectiveness and pharmacokinetics of a study drug called Faslodex (fulvestrant) in the treatment of progressive precocious puberty (early puberty) in girls with McCune-Albright syndrome (MAS).

status: Active, not recruiting

ReferenceCitation: Sims EK, Garnett S, Guzman F, Paris F, Sultan C, Eugster EA; Fulvestrant McCune-Albright study group. Fulvestrant treatment of precocious puberty in girls with McCune-Albright syndrome. Int J Pediatr Endocrinol. 2012 Sep 22;2012(1):26. doi: 10.1186/1687-9856-2012-26.

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:
United States
France

status_simplified: Ongoing


title: A Phase 2 Open-label Trial to Evaluate Safety, Efficacy, Tolerability, and Pharmacodynamics of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs, and a PD-1 Inhibitor in Chronic Hepatitis B Patients

summary: The purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis B surface antigen (HBsAg) levels at follow-up (FU) Week 24.

status: Recruiting

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/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

lead_sponsor: Janssen Research & Development, LLC

location_country:
Taiwan
Spain
Italy
Russian Federation
United Kingdom
Canada
France
Turkey
Czechia

location_facility: St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Imperial College London and Imperial College Healthcare NHS Trust

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma

location_facility: Fondazione IRCCS Cà Granda, Ospedale Policlinico di Milano

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Clinical Infectious Diseases Hospital n. a. S.P. Botkin


title: A Three-period Multicenter Study, With a Randomized-withdrawal, Double-blinded, Placebo-controlled Design in Period 2 to Evaluate the Clinical Efficacy, Safety, and Tolerability of MAS825 in NLRC4-GOF Patients

acronym: MAS NLRC4-GOF

summary: This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF

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:
Spain
Italy
Canada
United States
France
Turkey
Japan
Czechia


title: Limiting AKI Progression In Sepsis (LAPIS): A Phase 4, Multicenter, Randomized Controlled Trial of Biomarker-guided Delivery of Kidney-sparing Care Measures in Sepsis Subjects at Risk of Developing AKI

acronym: LAPIS

summary:
Biomarkers that provide an early indicator of kidney stress could be useful in clinical practice to detect silent episodes of acute kidney injury (AKI) or for early identification of subjects at risk of AKI. Two urinary biomarkers have been identified as early indicators of AKI. The NephroCheck® test is a commercially available test that uses these biomarkers, and this study assesses the use of these in reducing negative clinical outcomes for patients with sepsis-associated AKI. The study will enroll subjects diagnosed with sepsis, including septic shock, who will be randomly assigned to either receive NephroCheck®-guided kidney-sparing and fast-tracking interventions; or to receive current Standard of Care assessment and treatment.

NOTE: Participants are no longer being recruited to this study.

primary_purpose: Diagnostic

ReferenceCitation: Molinari L, Heskia F, Peerapornratana S, Ronco C, Guzzi L, Toback S, Birch R, Beyhaghi H, Kwan T, Kampf JP, Yealy DM, Kellum JA; Sapphire and Protocolized Care for Early Septic Shock (ProCESS) Investigators. Limiting Acute Kidney Injury Progression In Sepsis: Study Protocol and Trial Simulation. Crit Care Med. 2021 Oct 1;49(10):1706-1716. doi: 10.1097/CCM.0000000000005061.

lead_sponsor: BioMérieux

location_country:
Germany
United States
France
Belgium

location_facility: Brigham and Womens Hospital, 75 Francis Street

location_facility: Memorial Sloan Kettering Cancer Center, 1275 York Avenue

location_facility: University Clinic Heidelberg, Klinik für Anaesthesiologie, Im Neuenheimer Feld 110

location_facility: Universitatsklinikum Leipzig, Klinik und Poliklinik für Anästhesiologie und Intensivtherapie, Liebigstraße 20

location_facility: AZ Sint-Jan Brugge-Oostende, Intensieve Zorgen, Ruddershove 10

location_facility: Centre Hospitalier de Béthune, Service de Réanimation et Surveillance continue, 27 rue Delbecque

location_facility: Universitatsklinikum Munster, Albert-Schweitzer-Campus 1

location_facility: Hopital Cochin, 27 Rue Du Faubourg Saint Jacques

location_facility: CHRU Dijon Complexe Du Bocage, Department Infectiologie, 14 rue Gaffarel

location_facility: LSU Health Sciences Center, 1541 Kings Highway

location_facility: Hôpital Erasme, Soins Intensifs, Route de Lennik 808


title: A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis

acronym: LANDMARK

summary:
The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.

This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)

The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

ReferenceCitation: Kawashima H, Soliman O, Wang R, Ono M, Hara H, Gao C, Zeller E, Thakkar A, Tamburino C, Bedogni F, Neumann FJ, Thiele H, Abdel-Wahab M, Morice MC, Webster M, Rosseel L, Mylotte D, Onuma Y, Wijns W, Baumbach A, Serruys PW. Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial. Am Heart J. 2021 Feb;232:23-38. doi: 10.1016/j.ahj.2020.11.001. Epub 2020 Nov 6.

ReferenceCitation: Kawashima H, Wang R, Mylotte D, Jagielak D, De Marco F, Ielasi A, Onuma Y, den Heijer P, Terkelsen CJ, Wijns W, Serruys PW, Soliman O. Quantitative Angiographic Assessment of Aortic Regurgitation after Transcatheter Aortic Valve Implantation among Three Balloon-Expandable Valves. Glob Heart. 2021 Mar 19;16(1):20. doi: 10.5334/gh.959.

ipd_sharing: No

lead_sponsor: Meril Life Sciences Pvt. Ltd.

location_country:
Croatia
Poland
Portugal
Belarus
Slovenia
Greece
Austria
Netherlands
New Zealand
Spain
Hungary
France
Germany
Slovakia

location_facility: Asklepios Kliniken Hamburg Gmbh Lohmuehlenstrasse 5

location_facility: University Herzentrum Division of Cardiology and Angiology II,University Heart Center Freiburg, Südring 15

location_facility: Centro Hospital Lisboa Central E.P.E. - Santa Marta

location_facility: Uniwersytecki Szpital Kliniczny (USK) Curie-Skłodowskiej 58

location_facility: Republican Scientific-Practical Centre "Cardiology"

location_facility: University hospital Banska Bystrica Námestie Ludvíka Svobodu 1

location_facility: Virgen de la Arrixaca University Hospital

location_facility: Hospital Cliinico Univertistario de Valladolid

location_facility: Centro Hospitalar Lisboa Ocidental EPE- Hospital Santa Cruz, Av. Prof. Dr. Reinaldo dos Santos

location_facility: Hospital de Santa Maria, Av. Prof. Egas Moniz MB

location_facility: Hospital Universitario de Gran Canaria Dr Negrin

location_facility: University Hospital Dubrava Avenija Gojka Šuška 6

location_facility: Hospital Universitari Son Espases Carretera de Valldemossa

location_facility: Technology University Dresden Fetscherstraße 76

location_facility: Centre Hospitalier Universitaire De Rennes


title: MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalised for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated With Zinforo (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting

summary: MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

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

lead_sponsor: Pfizer

location_country:
Brazil
Spain
Italy
Greece
Russian Federation
France
Colombia

location_facility: Asst Spedali Civili Brescia and Universita Degli Studi di Brescia

location_facility: Croix-Rousse hospital, Hospices Civils de Lyon

location_facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa

location_facility: Aou Citta Della Salute E Della Scienza Scdu Malattie Infettive 2

location_facility: AHEPA General University Hospital of Thessaloniki

location_facility: E.S.E. Hospital Universitario San Jorge de Pereira

location_facility: Republican Clinical Hospital named after G.G. Kuvatova

location_facility: BUZ UR First Republican Clinical Hospital under the Ministry of Healthcare of Udmurt Republic UR

location_facility: AORN Ospedali dei Colli - Ospedale Monaldi


title: A Phase 1b Open-Label Study Assessing the Pharmacokinetics, Tolerability, and Safety of Oral Trimetazidine in Subjects With Acute-on-Chronic Liver Failure

acronym: TRUST

summary: The study will assess the pharmacokinetics (PK), tolerability, and safety of oral trimetazidine administered to subjects with AD (ACLF Grade 0) or with ACLF Grade 1 or 2.

status: Suspended

primary_purpose: Other

lead_sponsor: Martin Pharmaceuticals

location_country: Spain Austria France Belgium Germany

location_facility: Universitätsklinikum Halle Klinik und Poliklinik für Innere Medizin I

location_facility: Hospital Marques de Valdecilla Santander


title: An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizumab (Anti-PD-L1), Administered Intravenously, in Participants With Advanced and/or Metastatic Solid Tumors

lead_sponsor: Hoffmann-La Roche

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Poland
Taiwan
Spain
United Kingdom
Russian Federation
New Zealand
Switzerland
Korea, Republic of
United States
France
Israel
Singapore
Belgium
Turkey
Germany

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

location_facility: Istanbul University Cerrahpaşa-Cerrahpaşa Medical Faculty; Medikal Onkoloji Departmani

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Hopital Timone Adultes; Oncologie Medicale Et Usp

location_facility: University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center

location_facility: Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz

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: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: National Cancer Centre; Medical Oncology

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Auckland City Hospital; Clinical Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: Hôpitaux Universit. de Genève Médecine Oncologie; Oncologie

location_facility: Goztepe Prof.Dr. Suleyman Yalcin City Hospital; Clinical Oncology

location_facility: Universitätsklinikum Essen; Innere Klinik (Tumorforschung)

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Royal Marsden Hospital; Institute of Cancer Research

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

location_facility: Seoul National University Bundang Hospital

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

summary: This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on patients with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.


title: A Phase Ib/II Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Patients With Relapsed and Refractory Multiple Myeloma

location_country: Denmark Poland Spain Netherlands Sweden France Norway Germany Czechia

location_facility: Uniwersytet Medyczny im.Karola Marcinkowskiego w Poznaniu

location_facility: Univerzita Karlova v Praze a Vseobecna fakultni nemocnice v Praze - 1; Lekarska Fakulta - I

location_facility: Fakultni nemocnice Ostrava; Klinika hematoonkologie

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia

location_facility: Universitätsklinikum Tübingen Medizinische UNI-Klinik und Poliklinik Abt. Innere Medizin II

location_facility: Medical University School; Dept. of Haematology

location_facility: UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

location_facility: Oslo University Hospital HF, Rikshospitalet

location_facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

summary: This open-label, randomized, multicenter, triple-arm Phase Ib/II study is designed to assess the efficacy, safety, tolerability, and pharmacokinetics of cobimetinib administered as a single agent (Arm A), cobimetinib plus venetoclax (Arm B), and cobimetinib plus venetoclax plus atezolizumab (Arm C) in participants with relapsed and refractory multiple myeloma. Two successive cohorts will evaluate the safety of cobimetinib plus venetoclax and that of cobimetinib plus venetoclax plus atezolizumab in the selected population during the safety run-in phase of the study. Once the dose levels have demonstrated acceptable safety during this phase, randomization will begin for all treatment arms (Arms A, B, and C).


title: Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

acronym: PIPACRegis

summary: Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

status: Unknown status

ReferenceCitation: Graversen M, Detlefsen S, Bjerregaard JK, Pfeiffer P, Mortensen MB. Peritoneal metastasis from pancreatic cancer treated with pressurized intraperitoneal aerosol chemotherapy (PIPAC). Clin Exp Metastasis. 2017 Jun;34(5):309-314. doi: 10.1007/s10585-017-9849-7. Epub 2017 May 17.

ReferenceCitation: Grass F, Vuagniaux A, Teixeira-Farinha H, Lehmann K, Demartines N, Hübner M. Systematic review of pressurized intraperitoneal aerosol chemotherapy for the treatment of advanced peritoneal carcinomatosis. Br J Surg. 2017 May;104(6):669-678. doi: 10.1002/bjs.10521. Review.

ReferenceCitation: Hübner M, Teixeira Farinha H, Grass F, Wolfer A, Mathevet P, Hahnloser D, Demartines N. Feasibility and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy for Peritoneal Carcinomatosis: A Retrospective Cohort Study. Gastroenterol Res Pract. 2017;2017:6852749. doi: 10.1155/2017/6852749. Epub 2017 Feb 26.

ReferenceCitation: Teixeira Farinha H, Grass F, Kefleyesus A, Achtari C, Romain B, Montemurro M, Demartines N, Hübner M. Impact of Pressurized Intraperitoneal Aerosol Chemotherapy on Quality of Life and Symptoms in Patients with Peritoneal Carcinomatosis: A Retrospective Cohort Study. Gastroenterol Res Pract. 2017;2017:4596176. doi: 10.1155/2017/4596176. Epub 2017 Feb 21.

ReferenceCitation: Tempfer CB, Hartmann F, Hilal Z, Rezniczek GA. Intraperitoneal cisplatin and doxorubicin as maintenance chemotherapy for unresectable ovarian cancer: a case report. BMC Cancer. 2017 Jan 6;17(1):26. doi: 10.1186/s12885-016-3004-8.

ReferenceCitation: Girshally R, Demtröder C, Albayrak N, Zieren J, Tempfer C, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) as a neoadjuvant therapy before cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. World J Surg Oncol. 2016 Sep 27;14(1):253.

ReferenceCitation: Graversen M, Pfeiffer P, Mortensen MB. [Treatment of peritoneal carcinomatosis with pressurized intraperitoneal aerosol chemotherapy]. Ugeskr Laeger. 2016 May 23;178(21). pii: V11150928. Review. Danish.

ReferenceCitation: Robella M, Vaira M, De Simone M. Safety and feasibility of pressurized intraperitoneal aerosol chemotherapy (PIPAC) associated with systemic chemotherapy: an innovative approach to treat peritoneal carcinomatosis. World J Surg Oncol. 2016 Apr 29;14:128. doi: 10.1186/s12957-016-0892-7.

ReferenceCitation: Tempfer CB, Rezniczek GA, Ende P, Solass W, Reymond MA. Pressurized Intraperitoneal Aerosol Chemotherapy with Cisplatin and Doxorubicin in Women with Peritoneal Carcinomatosis: A Cohort Study. Anticancer Res. 2015 Dec;35(12):6723-9.

ReferenceCitation: Nadiradze G, Giger-Pabst U, Zieren J, Strumberg D, Solass W, Reymond MA. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with Low-Dose Cisplatin and Doxorubicin in Gastric Peritoneal Metastasis. J Gastrointest Surg. 2016 Feb;20(2):367-73. doi: 10.1007/s11605-015-2995-9. Epub 2015 Oct 28.

ReferenceCitation: Demtröder C, Solass W, Zieren J, Strumberg D, Giger-Pabst U, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy with oxaliplatin in colorectal peritoneal metastasis. Colorectal Dis. 2016 Apr;18(4):364-71. doi: 10.1111/codi.13130.

ReferenceCitation: Hübner M, Teixeira H, Boussaha T, Cachemaille M, Lehmann K, Demartines N. [PIPAC--Pressurized intraperitoneal aerosol chemotherapy. A novel treatment for peritoneal carcinomatosis]. Rev Med Suisse. 2015 Jun 17;11(479):1325-30. French.

ReferenceCitation: Odendahl K, Solass W, Demtröder C, Giger-Pabst U, Zieren J, Tempfer C, Reymond MA. Quality of life of patients with end-stage peritoneal metastasis treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC). Eur J Surg Oncol. 2015 Oct;41(10):1379-85. doi: 10.1016/j.ejso.2015.06.001. Epub 2015 Jun 21.

ReferenceCitation: Tempfer CB, Solass W, Buerkle B, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in a woman with pseudomyxoma peritonei: A case report. Gynecol Oncol Rep. 2014 Oct 18;10:32-5. doi: 10.1016/j.gore.2014.10.001. eCollection 2014 Dec.

ReferenceCitation: Giger-Pabst U, Solass W, Buerkle B, Reymond MA, Tempfer CB. Low-dose pressurized intraperitoneal aerosol chemotherapy (PIPAC) as an alternative therapy for ovarian cancer in an octogenarian patient. Anticancer Res. 2015 Apr;35(4):2309-14.

ReferenceCitation: Tempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18.

ReferenceCitation: Sabaila A, Fauconnier A, Huchon C. [Pressurized intraperitoneal aerosol chemotherapy (PIPAC): a new way of administration in peritoneal carcinomatosis of ovarian cancer]. Gynecol Obstet Fertil. 2015 Jan;43(1):66-7. doi: 10.1016/j.gyobfe.2014.11.012. Epub 2014 Dec 15. French.

ReferenceCitation: Tempfer CB, Solass W, Reymond MA. Pressurized intraperitoneal chemotherapy (PIPAC) in women with gynecologic malignancies: a review. Wien Med Wochenschr. 2014 Dec;164(23-24):519-28. doi: 10.1007/s10354-014-0312-y. Epub 2014 Sep 24. Review.

ReferenceCitation: Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.

ReferenceCitation: Solass W, Kerb R, Mürdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.

ReferenceCitation: Kurtz F, Struller F, Horvath P, Solass W, Bösmüller H, Königsrainer A, Reymond MA. Feasibility, Safety, and Efficacy of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) for Peritoneal Metastasis: A Registry Study. Gastroenterol Res Pract. 2018 Oct 24;2018:2743985. doi: 10.1155/2018/2743985. eCollection 2018.

ipd_sharing_description: Requests can be addressed to the Scientific Advisory Board, AnInstitut für Qualitässicherung in der operativen Medizin gGmbH, Leipziger Str. 44, 39120 MAGDEBURG, Germany

lead_sponsor: Sabine Rhode

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Russian Federation
Argentina
Switzerland
France
Singapore
Belgium
Germany

location_facility:
SALK - Salzburger Landeskliniken
University Hospital Tübingen
Hospital de Pilar
University Hospital Odense
IRCC Torino Candiolo
F. Łukaszczyk Oncology Centre
Gersten Institute for Cancer Research
Roffo Cancer Institute
Peter MacCallum Cancer Centre
Centre du Cancer
National University Hospital
University Hospital Lausanne CHUV
University Hospital Gent (UZ Gent)
Hospices civils de Lyon
Centre Hospitalier Universitaire

intervention_type: Combination Product


title: A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Subjects (Part I), and After Multiple Dose Regimens in Subjects With Chronic Hepatitis B (Part II)

summary: The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).

ReferenceCitation: Zoulim F, Lenz O, Vandenbossche JJ, Talloen W, Verbinnen T, Moscalu I, Streinu-Cercel A, Bourgeois S, Buti M, Crespo J, Manuel Pascasio J, Sarrazin C, Vanwolleghem T, Shukla U, Fry J, Yogaratnam JZ. JNJ-56136379, an HBV Capsid Assembly Modulator, Is Well-Tolerated and Has Antiviral Activity in a Phase 1 Study of Patients With Chronic Infection. Gastroenterology. 2020 Aug;159(2):521-533.e9. doi: 10.1053/j.gastro.2020.04.036. Epub 2020 Apr 25.

ReferenceCitation: Vandenbossche J, Jessner W, van den Boer M, Biewenga J, Berke JM, Talloen W, De Zwart L, Snoeys J, Yogaratnam J. Pharmacokinetics, Safety and Tolerability of JNJ-56136379, a Novel Hepatitis B Virus Capsid Assembly Modulator, in Healthy Subjects. Adv Ther. 2019 Sep;36(9):2450-2462. doi: 10.1007/s12325-019-01017-1. Epub 2019 Jul 2. Erratum in: Adv Ther. 2020 Mar 4;:.

lead_sponsor: Janssen Sciences Ireland UC

location_country:
Taiwan
Romania
Spain
Georgia
France
Malaysia
Belgium
Germany
Bulgaria
Moldova, Republic of


acronym: ENTERPRISE

title: A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)

lead_sponsor: Takeda

type: Registry Identifier

ReferenceCitation: Schwartz DA, Peyrin-Biroulet L, Lasch K, Adsul S, Danese S. Efficacy and Safety of 2 Vedolizumab Intravenous Regimens for Perianal Fistulizing Crohn's Disease: ENTERPRISE Study. Clin Gastroenterol Hepatol. 2022 May;20(5):1059-1067.e9. doi: 10.1016/j.cgh.2021.09.028. Epub 2021 Sep 29.

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.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Netherlands

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Hospital Universitario y Politecnico La Fe

summary: The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).


title: A Prospective, Multi-center Study to Evaluate the Safety and Performance of the Hyperion™ ASD and PDA Closure Systems.

summary: The purpose of this study is to determine the safety, performance and efficacy of the Hyperion™ Occluder Systems during treatment of ASD and PDA patients.

lead_sponsor: European Cardiovascular Research Center

location_country: Germany Algeria France China

location_facility: Hôpital cardiologique Haut-Leveque (CHU Bordeaux)

location_facility: Centre Médico-chirurgical infantile Bou Ismail


title: A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection

summary: The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C Virus (HCV) infection.

ReferenceCitation: Asselah T, Moreno C, Sarrazin C, Gschwantler M, Foster GR, Craxí A, Buggisch P, Ryan R, Lenz O, Scott J, Van Dooren G, Lonjon-Domanec I, Schlag M, Buti M. An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1). PLoS One. 2016 Jul 18;11(7):e0158526. doi: 10.1371/journal.pone.0158526. eCollection 2016.

lead_sponsor: Janssen-Cilag International NV

location_country:
Saudi Arabia
Spain
Austria
United Kingdom
France
Belgium
Germany


title: Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.

summary: The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).

ReferenceCitation: Pavlovic N, Chierchia GB, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Dekker L, Scazzuso F, Packer DL, de Asmundis C, Pitschner HF, Piazza FD, Kaplon RE, Kuniss M; Cryo-FIRST Investigators. Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms. Am Heart J. 2021 Dec;242:103-114. doi: 10.1016/j.ahj.2021.08.007. Epub 2021 Sep 8.

lead_sponsor: Medtronic Cardiac Rhythm and Heart Failure

location_country: Croatia Italy Australia Netherlands Argentina France Belgium Norway Germany

location_facility: Klinicki bolnicki centar Sestre Milosrdnice

location_facility: Heart Rhythm Management Centre, UZ Brussels - VUB Brussel


title: An Exploratory Phase II, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Pertuzumab and Herceptin (Trastuzumab) in Patients With HER2-Positive Metastatic Breast Cancer

summary: This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840 milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab will be administered at the same schedule the participant was following before entry into the study. An additional cohort of participants at certain centers will receive pertuzumab monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks. These participants may have trastuzumab added to the regimen in the event of progression during single-agent pertuzumab treatment.

location_country:
United Kingdom
Italy
Spain
Canada
France


title: A Multi-center, Open-label Phase IB Study of Escalating Doses of RO5045337, an Oral Small Molecule MDM2 Antagonist, in Combination With Doxorubicin in Patients With Soft Tissue Sarcoma

summary: This multicenter, open-label, Phase 1b study will evaluate the safety, pharmacokinetics and efficacy of RO5045337 in combination with doxorubicin in patients with soft tissue sarcoma. Cohorts of patients will receive escalating doses of RO5045337 orally on Days 1-5 (1-3) of each 28-day cycle in combination with doxorubicin 60 mg/m2 intravenously on Day 1 of each cycle for up to 6 cycles.


title: A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

summary: The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.

lead_sponsor: Biogen

location_country: Denmark Sweden France Czechia


ipd_sharing: Undecided

title: A Long-Term, Open-Label, Safety and Efficacy Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Patients With Cystinosis

lead_sponsor: Horizon Pharma USA, Inc.

ReferenceCitation: Dohil R, Fidler M, Barshop BA, Gangoiti J, Deutsch R, Martin M, Schneider JA. Understanding intestinal cysteamine bitartrate absorption. J Pediatr. 2006 Jun;148(6):764-9.

ReferenceCitation: Fidler MC, Barshop BA, Gangoiti JA, Deutsch R, Martin M, Schneider JA, Dohil R. Pharmacokinetics of cysteamine bitartrate following gastrointestinal infusion. Br J Clin Pharmacol. 2007 Jan;63(1):36-40.

ReferenceCitation: Levtchenko EN, van Dael CM, de Graaf-Hess AC, Wilmer MJ, van den Heuvel LP, Monnens LA, Blom HJ. Strict cysteamine dose regimen is required to prevent nocturnal cystine accumulation in cystinosis. Pediatr Nephrol. 2006 Jan;21(1):110-3. Epub 2005 Oct 27.

ReferenceCitation: Langman CB, Greenbaum LA, Grimm P, Sarwal M, Niaudet P, Deschenes G, Cornelissen EA, Morin D, Cochat P, Elenberg E, Hanna C, Gaillard S, Bagger MJ, Rioux P. Quality of life is improved and kidney function preserved in patients with nephropathic cystinosis treated for 2 years with delayed-release cysteamine bitartrate. J Pediatr. 2014 Sep;165(3):528-33.e1. doi: 10.1016/j.jpeds.2014.05.013. Epub 2014 Jun 16.

location_country:
Netherlands
United States
France

location_facility: Radboud University Nijmegen Medical Center

location_facility: California Pacific Medical Center (CPMC) Research Institute

location_facility: Hôpital Arnaud Villeneuve - CHU Montpellier

location_facility: Texas Children's Hospital/Baylor University

location_facility: Ann & Robert H. Lurie Children's Hospital of Chicago

summary: Cystinosis is an inherited disease that if untreated, results in kidney failure as early as the first decade of life. The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release) which must be taken every six hours for the rest of the patient's life to prevent complications of cystinosis. Cysteamine bitartrate delayed-release capsules (RP103) is a formulation of cysteamine bitartrate that is being studied to see if it can be given less frequently, once every 12 hours, and have similar results to four times a day Cystagon®.


acronym: TENPIN

title: Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients

lead_sponsor: Astellas Pharma Inc

ReferenceCitation: Saliba F, Pascher A, Cointault O, Laterre PF, Cervera C, De Waele JJ, Cillo U, Langer RM, Lugano M, Göran-Ericzon B, Phillips S, Tweddle L, Karas A, Brown M, Fischer L; TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators; TENPIN Liver Transplant European Study Into the Prevention of Fungal Infection Investigators. Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients. Clin Infect Dis. 2015 Apr 1;60(7):997-1006. doi: 10.1093/cid/ciu1128. Epub 2014 Dec 17.

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Portugal
Romania
Saudi Arabia
Ireland
Austria
Italy
Russian Federation
Spain
United Kingdom
Sweden
Hungary
France
Belgium
Germany

summary: Prevention of invasive fungal infection in high risk patients following liver transplant.


acronym: AS703026 in Hematological Malignancies

title: Phase II Trial With Safety-Run-In of MEK Inhibitor MSC1936369B in Subjects With Poor Prognosis Acute Myeloid Leukemia and Other Hematological Malignancies

lead_sponsor: EMD Serono

location_country:
United States
France

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: CHU du Haut-Leveque, Service des Maladies du Sang Unite de Recherche Clinique

location_facility: Hospital Edouard Herriot, Service d'Hematologie Clinique

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Hospital Saint Louis, Service des Maladies du Sang

location_facility: Hospital Hotel Dieu, Service D'Hematologie

summary:
This is an open-label, multi-center, dose-escalation trial of pimasertib (MSC1936369B) in blood and bone marrow cancers. The trial will be conducted in two parts:

Part 1 (safety run-in period): Will determine the maximum tolerated dose (MTD) of the study drug in subjects with advanced hematological malignancies.

Part 2: Will assess the anti-leukemic activity of the study drug in older subjects with newly diagnosed poor prognosis acute myeloid leukemia (AML) who are not candidates for intensive chemotherapy.


title: A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies

summary: Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing

lead_sponsor: Clavis Pharma

location_country:
United Kingdom
Italy
United States
France
Norway
Germany

location_facility: University Hospital Benjamin Franklin Med.Clinic III

location_facility: Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata

location_facility: Hematology Service, Hôpital Beaujon and Hôpital Avicenne

location_facility: Institute for Drug Development (IDD), Cancer Therapy and Research Center, 7979 Wurzbach Rd.

location_facility: Westfälische Wilhelms-Universität Münster Medizinische Klinik und Polikinik Innere Medizin A

location_facility: Mew York Medical College, Division of Oncology

location_facility: Department of Hematology, Ullevål University Hospital, University of Oslo

location_facility: Centre Hospitalier Universitaire, CHU de Lyon, Service d'Hematologie Clinique

location_facility: Centre Hospitalier Universitaire CHU de Toulouse, Hopital Purpan

location_facility: Institute of Hematology & Medical Oncology L and A Serágnoli University of Bologna

location_facility: Department of Internal Medicine Klinikum der Johann Wolfgang Goethe-Universität Medizinische Klinik II


title: Phase II, Placebo Controlled, Parallel Group, Double Blind, Randomised, Multicentre Trial Comparing the Anastrozole (Arimidex®) Placebo Combination to the Anastrozole - ZD1839 (Iressa™) Combination as Neoadjuvant Treatment in Postmenopausal Women With Stage I-IIIB Breast Cancer and Oestrogen Receptor (ER) and/or Progesterone (PgR) Positive Tumours

summary: The purpose of this study is to compare the changes in a proliferation biomarker in subjects receiving Anastrozole or Anastrozole/ZD1839 combination.

lead_sponsor: AstraZeneca

location_country:
Portugal
Spain
United Kingdom
Czech Republic
Hungary
France
Sweden


title: A Prospective Multicenter, Parallel Group Study With A Single Blind Phase And A Double Blind Randomised Phase, To Evaluate The Efficacy And Satisfaction Of Viagra (Sildenafil Citrate) High Dose (100mg) Titration Compared With 50mg Dose, In Men With Erectile Dysfunction

summary: To evaluate the efficacy of Viagra dose titration to 100mg versus 50mg in men with erectile dysfunction, based on responses to the IIEF questionnaire as measured at the beginning and at the end of double blind treatment, comparing the group titrated to 100mg vs. the group maintained on 50mg.

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

location_country:
Spain
Italy
Greece
Russian Federation
United Kingdom
Canada
Israel
France


title: An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

summary: The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

time_perspective: Other

lead_sponsor: Exactech

location_country:
United States
Italy
United Kingdom
France

location_facility: Hospital for Joint Diseases - NYU Langone Health

location_facility: Gloucester Royal Hospital Foundation Trust

location_facility: UF Health Orthopaedics and Sports Medicine Institute

location_facility: Steadman Hawkins Clinic of the Carolinas

location_facility: Orthopaedic and Spine Center of the Rockies

location_facility: Southeastern Sports Medicine and Orthopedics

location_facility: Yeovil District Hospital NHS Foundation Trust


title: A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing the Safety and Assessor Blinded Efficacy of Upadacitinib to Dupilumab in Subjects With Moderate to Severe Atopic Dermatitis (Level-Up)

acronym: Level Up

summary:
Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed.

Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide.

Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days.

There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

study_start_date_type: Anticipated

status: Not yet recruiting

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
South Africa
Czechia
Poland
Portugal
Australia
Argentina
Puerto Rico
Turkey
Mexico
Sweden
Slovakia
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Korea, Republic of
France
Netherlands

location_facility: Diagnostic consultative center Focus-5 /ID# 251269

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 251557

location_facility: Wiseman Dermatology Research /ID# 250219

location_facility: Zespół Naukowo-Leczniczy Iwolang /ID# 249598

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 249848

location_facility: Skin Care Research - Hollywood /ID# 250459

location_facility: Uludag University Medical Faculty /ID# 249864

location_facility: Treasure Valley Medical Research /ID# 250727

location_facility: Erciyes University Medical Fac /ID# 249863

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz /ID# 249549

location_facility: Bács-Kiskun Megyei Kórház Szegedi Tudományegyetem AOK Oktató Kórháza /ID# 249850

location_facility: Centre de recheche dermatologique du Quebec Metropolitain /ID# 250427

location_facility: Instituto de Neumonología y Dermatología /ID# 250088

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 249195

location_facility: Univerzitna nemocnica L. Pasteura Kosice /ID# 251790

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 250123

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 249560

location_facility: Great Ormond Street Hospital for Children /ID# 250507

location_facility: Medical Dermatology Specialist /ID# 250212

location_facility: Hospital dos Lusíadas Lisboa /ID# 251456

location_facility: Allergy Research Canada Inc. /ID# 250224

location_facility: Hospital Infantil de Mexico Federico Gomez /ID# 249644

location_facility: Modern Research Associates, PL /ID# 250688

location_facility: Azienda Ospedaliero Universitaria di Cagliari- Presidio Ospedaliero /ID# 250130

location_facility: Wuhan Integrated TCM & Western Medicine Hospital（Wuhan No.1 Hospital) /ID# 250019

location_facility: Bispebjerg and Frederiksberg Hospital /ID# 248902

location_facility: First OC Dermatology Research /ID# 250686

location_facility: International Clinical Research - Tennessee LLC /ID# 250724

location_facility: Korea University Ansan Hospital /ID# 249814

location_facility: Virginia Clinical Research, Inc. /ID# 249908

location_facility: Michigan Center for Research Company /ID# 250225

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 249679

location_facility: Randall Dermatology of West Lafayette /ID# 250234

location_facility: Oregon Dermatology and Research Center /ID# 250726

location_facility: Unidade Local de Saúde de Matosinhos, EPE /ID# 249197

location_facility: Derma-B Egeszsegugyi es Szolgaltato Kft. /ID# 249819

location_facility: IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 250558

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 249849

location_facility: Nemocnice AGEL Novy Jicin, a.s. /ID# 249873

location_facility: Cryptex Investigación Clínica S.A de C.V /ID# 249994

location_facility: National Taiwan University Hospital /ID# 249258

location_facility: Ambulatory for Specialized Medical Help - Individual Practice for Specialized Me /ID# 251272

location_facility: Duplicate_Allergy, Asthma & Immunology Associates, PC /ID# 250616

location_facility: California Dermatology Institute /ID# 250213

location_facility: Centrum Medyczne ALL-MED Badania Kliniczne /ID# 249630

location_facility: Centro Hospitalar Universitario do Porto, EPE - Hospital Santo Antonio /ID# 249191

location_facility: Poliklinika Bezrucova (Cliniq s.r.o.) /ID# 249746

location_facility: The Second Xiangya Hospital of Central South University /ID# 249657

location_facility: Brunswick Dermatology Center /ID# 250220

location_facility: Mid Yorkshire Hospitals NHS Trust /ID# 250508

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 250070

location_facility: Universitaetsklinikum Tuebingen /ID# 249552

location_facility: Karolinska University Hospital /ID# 250328

location_facility: Kyungpook National University Hospital /ID# 249855

location_facility: Ondokuz Mayis Universitesi Tip /ID# 249865

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 250322

location_facility: Vital Prospects Clinical Research Institute, PC /ID# 249840

location_facility: Oregon Medical Res Center PC /ID# 249666

location_facility: Diamond Clinic - Specjalistyczne Poradnie Lekarskie /ID# 249631

location_facility: Taichung Veterans General Hospital /ID# 249261

location_facility: Universitaetsklinikum Leipzig /ID# 249562

location_facility: Hospital Universitario Virgen Macarena /ID# 249603

location_facility: The First Affiliated Hospital of Fujian Medical University /ID# 249674

location_facility: Centro de Dermatologia de Monterrey /ID# 249126

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 250419

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 250124

location_facility: Universitaetsklinikum Muenster /ID# 249404

location_facility: UMHAT Dr Georgi Stranski EAD /ID# 251268

location_facility: Hospital Universitario Virgen de las Nieves /ID# 249785

location_facility: Huashan Hospital, Fudan University /ID# 250025

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 249547

location_facility: Azienda Ospedaliera di Perugia /ID# 251572

location_facility: Klinika Ambroziak Sp. z o.o. /ID# 249406

location_facility: Alliance Dermatology and MOHs /ID# 249671

location_facility: Pusan National University Hospital /ID# 249852

location_facility: Gaziantep University Şahinbey Research and Practice Hospital /ID# 249868

location_facility: Sapienza University of Rome - Polo Pontino /ID# 251571

location_facility: London North West University Healthcare NHS Trust /ID# 250097

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 251431

location_facility: The University of Hong Kong- Shenzhen Hospital /ID# 249436

location_facility: Kaohsiung Chang Gung Memorial Hospital /ID# 249260

location_facility: Sjællands Universitetshospital /ID# 248901

location_facility: Advanced Clinical Research Institute /ID# 250460

location_facility: Cabinet Medical de Dermatovenerologie Dr. Remus Orasan /ID# 249625

location_facility: Hangzhou First People's Hospital /ID# 249437

location_facility: Herlev and Gentofte Hospital /ID# 248900

location_facility: Clinical Research Puerto Rico /ID# 250394

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 250125

location_facility: Hospital da Senhora da Oliveira Guimaraes, EPE /ID# 249196

location_facility: Centro Hospitalar de Leiria, EPE /ID# 249194

location_facility: Instituto de Diagnostico ABC /ID# 250144

location_facility: The Second Affiliated Hospital of Guangzhou Medical University /ID# 249694

location_facility: Florida International Rsrch cr /ID# 249667

location_facility: Shanghai Skin Disease Hospital /ID# 249392

location_facility: Arlington Research Center, Inc /ID# 250468

location_facility: Taipei Medical University Shuang Ho Hospital /ID# 249256

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 251347

location_facility: Diagnostic consultative center Aleksandrovska /ID# 251137

location_facility: Universitaetsklinikum Freiburg /ID# 249555

location_facility: Universita degli Studi Gabriele dAnnunzio /ID# 251495

location_facility: University of Texas Health Science Center at Houston /ID# 250736

location_facility: The First Hospital of China Medical University /ID# 249638

location_facility: ASST Spedali civili di Brescia /ID# 250129

location_facility: KonKuk University Medical Center /ID# 249811

location_facility: Centrul Medical de Diagnostic si Tratament SRI /ID# 249688

location_facility: Arke SMO, S.A. de C.V. / Veracruz /ID# 250147

location_facility: Centro Hospitalar Universitario de Sao Joao, EPE /ID# 249192

location_facility: UBC Department of Dermatology and Skin Science The Skin Care Centre /ID# 250218

location_facility: Hospital Universitario Basurto /ID# 249784

location_facility: Akdeniz Universitesi Tip Fakul /ID# 249866

location_facility: Montefiore Medical Center - Moses Campus /ID# 251214

location_facility: Universitaetsklinikum Frankfurt /ID# 249544

location_facility: Royalderm Agnieszka Nawrocka /ID# 251432

location_facility: Antelope Valley Clinical Trials /ID# 249946

location_facility: Tianjin Medical University General Hospital /ID# 250246

location_facility: Hospital Garcia de Orta, EPE /ID# 251455

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 250128

location_facility: Skin Care Research - Boca Raton /ID# 250458

location_facility: Dermatology Hospital of Southern Medical University /ID# 250121

location_facility: NHS Greater Glasgow and Clyde /ID# 250068

location_facility: University of Utah Mid Valley Dermatology /ID# 250042

location_facility: Soonchunhyang University Hospital Bucheon /ID# 249812

location_facility: Linkou Chang Gung Memorial Hospital /ID# 249257

location_facility: Guangzhou First People's Hospital /ID# 249695

location_facility: Guys and St Thomas NHS Foundation Trust /ID# 250467

location_facility: Zhejiang Provincial People's Hospital /ID# 249653

location_facility: Military Medical Academy Multiprofile Hospital /ID# 251187

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 249818

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 251485

location_facility: CCA Braga - Hospital de Braga /ID# 250480

location_facility: Burke Pharmaceutical Research /ID# 249838

location_facility: Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 249548

location_facility: Fondazione Policlinico Universitario Agostino Gemelli /ID# 251494

location_facility: Norrlands University hospital /ID# 250329

location_facility: Dermatology Research Associates /ID# 249829

location_facility: Inselspital, Universitätsspital Bern /ID# 250577

location_facility: Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 249862

location_facility: Taipei Municipal Wan Fang Hospital /ID# 251500

location_facility: D&H National Research Centers /ID# 250734

location_facility: National Taiwan University Hospital - Hsinchu branch /ID# 249265

location_facility: Dermatologische Gemeinschaftspraxis Mahlow /ID# 250306

location_facility: Presidio Ospedaliero San Salvatore /ID# 250127

location_facility: Taipei Veterans General Hosp /ID# 249263

location_facility: Centro de Investigaciones Medicas Tucuman /ID# 250024

location_facility: The second Affiliated hospital of Zhejiang University school of Medicine /ID# 249655

location_facility: Hospital Universitario Austral /ID# 251030

location_facility: Clinical Research Institute SC /ID# 249647


title: BURAN: Effects of Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging Parameters

acronym: BURAN

summary: This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.

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 requests 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.

location_country:
Spain
United Kingdom
Australia
United States
France
Belgium


title: A Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aticaprant 10 mg as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

summary: The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate to severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Brazil
Serbia
United Kingdom
Argentina
Canada
Korea, Republic of
United States
France
South Africa
Mexico
Japan
Bulgaria
Slovakia
Czechia

location_facility: University Clinical Hospital Center Dr Dragisa Misovic- Dedi

location_facility: Univerzitna nemocnica L. Pasteura Kosice

location_facility: Psychiatricka ambulance Saint Anne s.r.o.

location_facility: Psychiatricka ambulance, MUDr. Marta Holanova

location_facility: Nemocnica s poliklinikou Prievidza so sidlom v Bojniciach

location_facility: Diagnostic Consulting Center Mladost - M Varna

location_facility: C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)

location_facility: Instituto de Informacion e Investigacion en Salud Mental A.C.

location_facility: Wexner Medical Center at the Ohio State University

location_facility: Hospital Aranda de la Parra S.A. de C.V.

location_facility: Hospital Das Clinicas Da Universidade Federal De Minas Gerais

location_facility: University of California San Diego Medical Center

location_facility: Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Clinica Privada de Salud Mental Santa Teresa de Ávila

location_facility: University of Ottawa Institute of Mental Health Research

location_facility: Psychiatricka Ambulancia Psycholine S.R.O.

location_facility: True North Clinical Research Halifax - D.B.A Centricity Research Halifax

location_facility: DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD

location_facility: Crisis Resolution and Home Treatment Team

location_facility: CHRU de Tours Clinique Psychiatrique Universitaire

location_facility: Cabinet Medical des Drs Prizac-Desbonnet Scottez

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos

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

location_facility: Centro para el Desarrollo de la Medicina y de Asistencia Médica Especializada S.C. 'SINACOR'


title: Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

summary: This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

lead_sponsor: Celcuity, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Czechia
Poland
Austria
Australia
Argentina
India
Mexico
Singapore
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France

location_facility: Northwest Medical Specialties, PLLC - Tacoma

location_facility: University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics

location_facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: General University Hospital in Prague, Clinic of Oncology

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Salzburg Regional Hospital, Department of Internal Medicine III

location_facility: EUROMEDICA General Clinic of Thessaloniki

location_facility: Rosario's Oncology Institute and Medical Specialities (IOR)

location_facility: Postgraduate Institute of Medical Education and Research (PGIMER)

location_facility: ONCOSITE - Clinical Research Center in Oncology

location_facility: Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)

location_facility: Hollywood Private Hospital, Breast Cancer Research Centre

location_facility: New York Oncology Hematology, P.C. - Albany

location_facility: University Hospital Olomouc, Clinic of Oncology

location_facility: Torrance Memorial Physician Network - Cancer Care

location_facility: Prof. Dr. Ion Chiricuta Institute of Oncology

location_facility: University of Debrecen Clinical Center, Institute of Oncology

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: University Hospital Motol, Clinic of Oncology

location_facility: American Oncology Partners of Maryland, PA

location_facility: Center for Medical Education and Clinical Research (CEMIC)

location_facility: Cancer Specialists of North Florida - Jacksonville

location_facility: Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

location_facility: Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I

location_facility: Maria Sklodowska-Curie - National Research Institute of Oncology

location_facility: Polish Mother's Memorial Hospital-Research Institute

location_facility: CHU La Timone - La Timone Children's Hospital

location_facility: Cone Health Cancer Center at Alamance Regional, Hematology/Oncology

location_facility: Administrative Society of Health Services, SC

location_facility: Hematology/Oncology Associates of Central New York

location_facility: University Clinical Hospital Virgen de la Arrixaca, Department of Oncology

location_facility: Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.

location_facility: University Hospital Johannes Gutenberg - University of Mainz

location_facility: University Hospital Foundation Jimenez Diaz

location_facility: University Hospitals Leuven, Campus Gasthuisberg

location_facility: National Institute of Oncology, Department of Oncology, Internal Medicine "B" and Clinical Pharmacology

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke

location_facility: Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)

location_facility: Clinical Research Center Chapultepec Mexico City

location_facility: Virginia Oncology Associates - Newport News

location_facility: Maryland Oncology Hematology, P.A. - Rockville

location_facility: Kaiser Permanente Medical Center - Vallejo

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Thomayer University Hospital, Clinic of Oncology

location_facility: St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre

location_facility: South Broward Hospital District d/b/a Memorial Healthcare System

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University Hospital Complex of Santiago (CHUS), Department of Oncology

location_facility: University Hospitals Cleveland Medical Center

location_facility: Local Healthcare Company of Monza (ASST Monza)

location_facility: University Polyclinic Hospital of Modena

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Caceres Hospital Complex - San Pedro de Alcantara General Hospital

location_facility: Illinois Cancer Specialists - Arlington Heights

location_facility: Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow

location_facility: Northwest Cancer Specialists, PC - Tigard

location_facility: Multiprofile Hospital for Active Treatment "Serdika", Sofia

location_facility: Weill Cornell Medicine/New York-Presbyterian Hospital

location_facility: University of California, Irvine Medical Center

location_facility: Royal Marsden Hospital - London, Department of Medical Oncology

location_facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS

location_facility: Theageneio Anticancer Hospital of Thessaloniki

location_facility: Santa Maria della Misericordia University Hospital of Udine

location_facility: Royal United Hospital, Department of Oncology/Hematology

location_facility: Catalan Institute of Oncology, Hospital Duran i Reynals

location_facility: Kaiser Permanente South Bay Medical Center

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy)

location_facility: Oncology Hematology West PC dba Nebraska Cancer Specialists

location_facility: Medical University Vienna, Department of Gynecology and Obstetrics

location_facility: Arizona Oncology (US Oncology/McKesson) - Goodyear

location_facility: Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Hospital Hietzing, Department of Gynecology

location_facility: University Hospital St. Poelten, Department of Internal Medicine I

location_facility: Mater Hospital Brisbane, Mater Cancer Care Centre

location_facility: Christian Medical College, Department of Medical Oncology

location_facility: Prof. Dr. Alexandru Trestioreanu Institute of Oncology

location_facility: Bacs-Kiskun County Hospital, Center for Oncoradiology

location_facility: European Institute of Oncology (IEO), IRCCS


title: A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours (TROPION-PanTumor03)

summary: TROPION-PanTumor03 will investigate the safety, tolerability, and anti-tumour activity of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination with Anticancer Agents in Patients with Advanced/Metastatic Solid Tumours.

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:
Poland
Taiwan
Spain
Italy
United Kingdom
Canada
Switzerland
Korea, Republic of
United States
France
China
Turkey
Japan
Germany