title: A Phase 3, Multicenter, Open-Label 104-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine

lead_sponsor: Allergan

location_country:
Denmark
Poland
Taiwan
Spain
Italy
United Kingdom
Netherlands
Canada
Hungary
Korea, Republic of
United States
France
Germany
Czechia

location_facility: Tri-Service General Hospital /ID# 228998

location_facility: Hospital Universitario Virgen del Rocio /ID# 226333

location_facility: Preferred Primary Care Physicians, Inc. /ID# 226447

location_facility: Zentrum für Neurologie, Neurochirurgie und Psychiatrie /ID# 229991

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 228418

location_facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231571

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 228624

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 228629

location_facility: Hospital Clinico Universitario de Valladolid /ID# 226330

location_facility: Ospedale Ss. Filippo e Nicola /ID# 228627

location_facility: Accel Research Sites - Tampa Clinical Research Unit /ID# 226252

location_facility: Headache Neurology Research Institute /ID# 226234

location_facility: Hospital Universitario Vall d'Hebron /ID# 226338

location_facility: Northwest Clinical Research Center /ID# 226240

location_facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 226335

location_facility: Abington Neurological Associates - Abington /ID# 226449

location_facility: Stetson-University of Cincinnati /ID# 226326

location_facility: Klinische Forschung Hannover-Mitte GmbH /ID# 226305

location_facility: Beth Israel Deaconess Medical Center /ID# 228214

location_facility: Clinical Research Institute, Inc /ID# 226232

location_facility: Alpine Clinical Research Center /ID# 226203

location_facility: Pusan National University Hospital /ID# 231416

location_facility: Barrow Neurological Institute /ID# 228217

location_facility: Albany Medical Center Rheumatology /ID# 228212

location_facility: Ottawa Headache Centre Research Inc /ID# 226451

location_facility: Nowon Eulji Medical Center, Eulji University /ID# 226261

location_facility: J. Lewis Research, Inc. / Foothill Family Clinic /ID# 226248

location_facility: Seoul National University Hospital /ID# 226199

location_facility: Aggarwal and Associates Limited /ID# 226452

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226404

location_facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226456

location_facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226412

location_facility: Albuquerque Clinical Trials, Inc /ID# 226523

location_facility: Canisius-Wilhelmina Ziekenhuis /ID# 226410

location_facility: AP-HP - Hopital Lariboisière /ID# 226220

location_facility: Centrum Leczenia Padaczki i Migreny /ID# 226458

location_facility: Schuster Medical Research Institute /ID# 226246

location_facility: Centrum Medyczne Pratia Gdynia /ID# 226431

location_facility: Allied Physicians - Fort Wayne Neurological Center /ID# 226390

location_facility: FutureSearch Trials of Neurology /ID# 226424

location_facility: Vancouver Island Health Authority /ID# 226255

location_facility: Taipei Veterans General Hospital /ID# 226206

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226433

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228630

location_facility: Dongtan Sacred Heart Hospital /ID# 226264

location_facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 228631

location_facility: California Headache and Balance Center /ID# 226241

location_facility: King's College Hospital NHS Foundation Trust /ID# 226524

location_facility: J. Lewis Research, Inc. Foothill Family Clinic South /ID# 226328

location_facility: AP-HM - Hopital de la Timone /ID# 226407

location_facility: CTI Clinical Research Center /ID# 226278

location_facility: CHU Nice - Hopital de Cimiez /ID# 228419

location_facility: Mount Vernon Clinical Research /ID# 226249

location_facility: Sentara Family Medicine Physicians /ID# 226448

location_facility: Josephson-Wallack-Munshower Neurology - NE /ID# 226295

location_facility: Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 229994

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226409

location_facility: Austin Clinical Trial Partners /ID# 228391

location_facility: Pharmacology Research Institute (PRI) - Newport Beach (Wake) /ID# 226389

location_facility: Diex Recherche Sherbrooke Inc. /ID# 226427

location_facility: Re:Cognition Health - London /ID# 231205

location_facility: Yonsei University Health System Severance Hospital /ID# 226265

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 228625

summary: This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of TL-895 Combined With KRT-232 in Patients With Relapsed/Refractory (R/R) FLT3+ Acute Myeloid Leukemia (AML)

summary: This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia. Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Telios Pharma, Inc.

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

location_facility: University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology

location_facility: Seoul National University Hospital, Department of Hemato-Oncology

location_facility: University Hospital Jena, Clinic of Internal Medicine II, Department of Hematology and Medical Oncology

location_facility: Medical University Vienna, Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology

location_facility: Rush University Medical Center, Division of Hematology Oncology and Cell Therapy

location_facility: Hannover Medical School, Center for Internal Medicine, Clinic of Hematology, Hemostaseology, Oncology and Stem Cell Transplantation

location_facility: Polyclinic S. Orsola-Malpighi, Operative Unit of Hematology

location_facility: University Hospital Germans Trias i Pujol, Department of Clinical Hematology

location_facility: UT Southwestern Medical Center, Harold C. Simmons Cancer Center

location_facility: University Clinical Hospital of Valencia, Department of Hematology and Medical Oncology

location_facility: University Hospital Hamburg-Eppendorf, Department of Internal Medicine II

location_facility: University Duisburg-Essen, University Hospital Essen, Department of Internal Medicine

location_facility: Romagnolo Scientific Institute of Meldola (IRST) S.r.l., Department of Oncology and Clinical and Experimental Haematology

location_facility: University of California, Irvine Medical Center

location_facility: University Hospital - Ospedali Riuniti Umberto I - GM Lancisi - G Salesi of Ancona, Haematology Clinic

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: University of Sunshine Coast-Sippy Downs

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck

summary: The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.

status: Active, not recruiting

design_allocation: Randomized

ipd_sharing: Yes

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).

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Taiwan
Spain
Greece
Italy
New Zealand
United Kingdom
Thailand
Hungary
Korea, Republic of
United States
France
Czechia

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Washington University School of Medicine

location_facility: Petz Aladar Megyei Oktato Korhaz; Oncoradiologia

location_facility: Attiko Hospital University of Athens; 2Nd Dept. of Propaedeutic Medicine

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H

location_facility: CENTRUM ONKOLOGII ZIEMI LUBELSKIEJ IM. ŚW. JANA Z DUKLI; II Oddział Onkologii Klinicznej

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Moores Cancer Center at UC San Diego Health

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont; Onkoradiologiai Kozpont

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

location_facility: Beskidzkie Centrum Onkologii- Szpital Miejski

location_facility: Hospital Universitari i Politecnic La Fe; Oncologia

location_facility: National Taiwan University Hospital; Oncology

location_facility: Szpital Kliniczny im. H. Swiecickiego w Poznaniu; Oddział Onkologii Klinicznej i Doswiadczalnej

location_facility: Periph. University General Hospital of Heraklion Crete; Oncology Department

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori;S.S. Trattamento MedicoTumori dellaTesta e delCollo

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna


title: A Phase 1b/2, Open-Label, Randomized Platform Study Evaluating The Efficacy and Safety of AB928 Based Treatment Combinations in Patients With Metastatic Colorectal Cancer

summary: This randomized phase 1b/2 open-label study will evaluate the antitumour activity and safety of etrumadenant (AB928) treatment combinations in participants with metastatic colorectal cancer.

enrollment_type: Actual

ipd_sharing_description: Arcus 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.

lead_sponsor: Arcus Biosciences, Inc.

location_country:
Spain
Italy
United Kingdom
Korea, Republic of
United States
France

location_facility: University of Wisconsin School of Medicine

location_facility: Seoul National University Hospital (SNUH)

location_facility: Washington University School of Medicine

location_facility: Groupe Hospitalier Pitie-Salpetriere-Centre De Recherche et de Medecine de l'Obesite

location_facility: IRCCS - Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

location_facility: New York-Presbyterian Hospital-Columbia University Medical Center

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: American Oncology Partners of Maryland,PA

location_facility: Winship Cancer Institute at Emory University

location_facility: NYU Langone Medical Center - NYU Medical Oncology Associates

location_facility: Universita di Siena - Azienda Ospedaliera Universitaria Senese-Policlincio Santa Maria Alle Scotte

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Asan Medical Center, University of Ulsan College of Medicine

location_facility: Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: U.O Farmeaceutica Ospealiera e Politche del Farmaco

location_facility: Seoul National University Bundang Hospital


type: Other Identifier

title: MAGNETISMM-3 AN OPEN-LABEL, MULTICENTER, NON-RANDOMIZED PHASE 2 STUDY OF ELRANATAMAB (PF-06863135) MONOTHERAPY IN PARTICIPANTS WITH MULTIPLE MYELOMA WHO ARE REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY DRUG AND ONE ANTI-CD38 ANTIBODY

summary: The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.

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:
Poland
Spain
United Kingdom
Australia
Canada
United States
France
Belgium
Japan
Germany

location_facility: Uniwersytecki Szpital Kliniczny im.Jana Mikulicza -Radeckiego we Wroclawiu

location_facility: Winship Cancer Institute @ Emory University Hospital Midtown

location_facility: Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care

location_facility: Universitätsklinikum Hamburg - Eppendorf

location_facility: Blood and Marrow Transplant Group of Georgia

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

location_facility: University of Iowa Hospitals and Clinics

location_facility: Norton Cancer Institute, St. Matthews Campus

location_facility: CIUSSS-EMTL, Installation Hopital Maisonneuve-Rosemont

location_facility: Institut Catala d' Oncologia. Hospital Universitari Germans Trias i Pujol

location_facility: Winship Cancer Institute, Emory University

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: UC Irvine Health - Chao Family Comprehensive Cancer Center

location_facility: Loyola University Chicago performing research at Loyola University Medical Center

location_facility: Indiana Blood and Marrow Transplantation-Clinic

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: CHU de Poitiers, Pôle Régional de Cancérologie

location_facility: McGill University Health Centre - Glen Site

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique

location_facility: Indiana Blood and Marrow Transplantation-Administrative Offices

location_facility: Kobe City Medical Center General Hospital


title: A Phase 3, Open-Label, Randomized Study Evaluating Metastatic Castrate Resistant Prostate Cancer Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment (SPLASH)

acronym: SPLASH

summary: The purpose of this study is to evaluate the efficacy and safety of [Lu-177]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).

ReferenceType: background

ReferenceCitation: Baum RP, Kulkarni HR, Schuchardt C, Singh A, Wirtz M, Wiessalla S, Schottelius M, Mueller D, Klette I, Wester HJ. 177Lu-Labeled Prostate-Specific Membrane Antigen Radioligand Therapy of Metastatic Castration-Resistant Prostate Cancer: Safety and Efficacy. J Nucl Med. 2016 Jul;57(7):1006-13. doi: 10.2967/jnumed.115.168443. Epub 2016 Jan 21.

lead_sponsor: POINT Biopharma

location_country:
United Kingdom
Canada
Sweden
United States
France
Netherlands

location_facility: Erasmus University Medical Center Rotterdam

location_facility: Tenon Hospital, Department of Medical Oncology

location_facility: Washington University School of Medicine

location_facility: Radboud University Medical Center (Radboudumc)

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center

location_facility: University of Iowa Hospitals and Clinics

location_facility: Arizona Institute of Urology (AIU) - Tucson

location_facility: Dallas VA Medical Center, Nuclear Medicine Service

location_facility: La Timone Hospital, Nuclear Medicine Department

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Norrlands University Hospital, Department of Radiation Sciences, Oncology

location_facility: Royal Marsden NHS Foundation Trust - Institute of Cancer Research

location_facility: Sunnybrook Research Institute, Odette Cancer Center

location_facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

location_facility: Excel Diagnostics & Nuclear Oncology Center

location_facility: UC Irvine Chao Family Comprehensive Cancer Center

location_facility: University of Kentucky Chandler Medical Center

location_facility: VA Greater Los Angeles Healthcare System

location_facility: University of California Los Angeles, Nuclear Medicine Clinic

location_facility: Montpellier Cancer Institute, Department of Nuclear Medicine

location_facility: London Health Sciences Center - Victoria Hospital

location_facility: Charing Cross Hospital, Department of Medical Oncology

location_facility: New Mexico Oncology Hematology Consultants Ltd., New Mexico Cancer Center

location_facility: Center Jean Perrin, Department of Medical Oncology

location_facility: Chesapeake Urology Associates (CUA) P.A.


title: A Phase 2, Multicenter, Randomized Study of Trastuzumab Deruxtecan in Subjects With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) (DESTINY-LUNG02)

summary: This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one regimen of prior anticancer therapy (second line or later) that must have contained a platinum-based chemotherapy drug.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

lead_sponsor: Daiichi Sankyo, Inc.

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

location_facility: Hospital Universitari i PolitÃ¨cnic La Fe

location_facility: Washington University School of Medicine

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Chang Gung Memorial Hospital CGMH - LinKou Branch

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale di Napoli Strutturadi Oncologia

location_facility: Assistance Publique Hopitaux de Marseille AP-HM, Hopital NORD

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: University of Colorado Denver - Anschutz Medical Campus

location_facility: Humanitas Cancer Center Istituto Clinico Humanitas

location_facility: Henry Ford Cancer Institute/Henry Ford Hospital

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Seoul National University Bundang Hospital


title: An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

summary: This study evaluates KRT-232 in Combination With TL-895 for the Treatment of Relapsed or Refractory Myelofibrosis and KRT-232 for the Treatment of JAK Inhibitor Intolerant Myelofibrosis.

lead_sponsor: Kartos Therapeutics, Inc.

location_country:
Poland
Serbia
Spain
Italy
Austria
Hungary
United States
France
Germany
Bulgaria

location_facility: Memorial Sloan Kettering Cancer Center (MSKCC)

location_facility: University Hospital Halle (Saale), Department of Internal Medicine IV - Hematology and Oncology

location_facility: Meduni Wien, Univ. Klinik für Innere Medizin I

location_facility: University Clinical Hospital of Salamanca, Department of Hematology

location_facility: Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine III, Hematology

location_facility: Medical Center of the University of Pecs, 1st Department of Internal Medicine, Division of Hematology

location_facility: University Hospital Marburg, Department of Hematology, Oncology and Immunology

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

location_facility: Hospital Casa Sollievo della Sofferenza, Department of Oncology and Hematology, Division of Hematology

location_facility: University of Alabama at Birmingham School of Medicine, Division of Hematology and Oncology

location_facility: Hospital of Ravenna, Operative Unit of Hematology

location_facility: Hematology Clinic Specialized Hospital for Active Treatment of Hematological Diseases, Sofia

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski, Pleven

location_facility: Frederic Chopin Provincial Teaching Hospital No. 1 in Rzeszow, Department of Hematology

location_facility: CHU de Limoges Service Hématologie Clinique et Thérapie Cellulaire

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Plovdiv

location_facility: Moritz Kaposi General Hospital, Department of Hematology

location_facility: Slupsk Provincial Specialist Hospital n.a. Janusz Korczak, Department of Hematology

location_facility: Jan Biziel University Hospital #2 in Bydgoszcz, Department of Hematology

location_facility: Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Effects of EDP-938 in Hematopoietic Cell Transplant Recipients With Acute Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

acronym: RSVTx

summary: This is a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.

lead_sponsor: Enanta Pharmaceuticals, Inc

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Australia
Argentina
Israel
Turkey
Mexico
Brazil
Canada
China
Germany
Taiwan
Greece
Korea, Republic of
France
Colombia

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

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda ULSS 8 "Berica" - Ospedale San Bortolo

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia - INCIPIT - PIN

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Oddzial w Gliwi


title: A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in Combination With Atezolizumab Plus Pemetrexed and Carboplatin/Cisplatin Versus Pembrolizumab Plus Pemetrexed and Carboplatin/Cisplatin in Patients With Previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer

source: euctr

location_country:
Denmark
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Mexico
New Zealand
Canada
Switzerland
Korea, Republic of
United States
France
China
Turkey
Belgium
Japan
Germany

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Kaiser Permanente - San Jose Medical Center

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Kaiser Permanente - Sacramento; Oncology Pharmacy

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Castle Hill Hospital; The Queen's Centre for Oncology & Haematology

location_facility: CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

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

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Augusta-Kranken-Anstalt gGmbH; Klinik für Hämatologie, Onkologie & Palliativmedizin

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Sault Area Hospital; Algoma District Cancer Program

location_facility: Queen Mary Hospital; Medicine & Respiratory

location_facility: Kaiser Permanente - San Francisco (2238 Geary)

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Fort Wayne Medical Oncology and Hematology, Inc

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Cancer Care Specialists; Division of Clinical Research

location_facility: Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B

location_facility: Hospital Clinic Barcelona; Servicio de oncologia

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Waikato Hospital - Cancer and Blood Research Trials Unit; Regional Cancer Centre

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Victoria Hospital - London Health Sciences Centre

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: St. Bernard's Hospital, Inc. d/b/a St. Bernards Medical Center

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil; Servicio de Oncologia

location_facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

location_facility: Klinikum der Philipps-Universität Marburg

location_facility: Kaiser Permanente - Santa Clara; Oncology Clinical trials

summary:
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).

Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase:

Arm A: Tiragolumab plus atezolizumab plus pemetrexed and carboplatin or cisplatin
Arm B: Placebo plus pembrolizumab plus pemetrexed and carboplatin or cisplatin

Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).


title: A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations

summary: The purpose of this study is to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel, ramucirumab, or atezolizumab in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 genetic aberrations (GA).

ipd_sharing: No

lead_sponsor: Basilea Pharmaceutica

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
United Kingdom
Argentina
Korea, Republic of
United States
Chile
France
Turkey
Belgium
Germany

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

location_facility: Azienda Ospedaliero Universitaria Mater Domini

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Instituto Nacional de Câncer José Alencar Gomes da Silva

location_facility: Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

location_facility: Chonnam National University Hwasun Hospital

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

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

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska sp. komandytowo-akcyjna

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Seoul National University Bundang Hospital

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: SAIH "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of Republic Tatarstan

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

location_facility: Baskent University Adana Application and Research Center

location_facility: Istanbul Medeniyet Uni Goztepe Training&Res Hosp

location_facility: Liga Norte-Rio-Grandense Contra o Câncer

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

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

location_facility: Pavlov First Saint Petersburg State Medical University

location_facility: Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Fundación Favaloro para la Docencia e Investigación Médica


acronym: GLIMMER

intervention_type: Other

title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)

lead_sponsor: Kodiak Sciences Inc

location_country:
Poland
Italy
Hungary
Puerto Rico
United States
France
Israel
Czechia

location_facility: Northern California Retina Vitreous Associates

location_facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Cleveland Clinic Foundation, Cole Eye Institute

location_facility: Retina Consultants of Southern California

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz , Josa Andras Oktatókórház

location_facility: Retina Consultants of Houston - (Woodlands)

location_facility: Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

location_facility: Emanuelli Research & Development Center LLC

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

location_facility: Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

location_facility: Bajcsy-Zsilinszky Korhaz es Rendelointezet

location_facility: Dr Nowosielska Okulistyka i Chirurgia Oka

location_facility: Specjalistyczny Szpital im. Alfreda Sokolowskiego

location_facility: Gabinet Okulistyczny Prof. Edward Wylegala

location_facility: Centre Hospitalier Intercommunal de Créteil

summary: This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME.


title: Randomized, Open Label, Multicenter, Phase III Study of Entrectinib Versus Crizotinib in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring ROS1 Gene Rearrangements With and Without Central Nervous System Metastases

summary: The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.

location_country:
Croatia
Brazil
Jordan
Romania
Greece
Italy
Russian Federation
Spain
Sweden
France
India
China
Turkey
Mexico
Netherlands
Slovakia

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology

location_facility: Affiliated Hospital of Jining Medical University

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: Taihe Hospital of Hubei University of Medicine

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; SSD Oncologia Polomonare (II PAD. IV PIANO)

location_facility: Tata Medical Center; Department of Medical Oncology

location_facility: Univerzitna nemocnica Bratislava; Oddelenie Klinickej Onkologie, Klinika Pneumologie A Ftizeologie

location_facility: Karolinska Universitetssjukhuset, Solna; Kliniska prövningsenheten Z:4:01

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Hospital Universitario; Dr. Jose E. Gonzalez

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: Mumbai Oncocare Center; Medical Oncology

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Harbin Medical University Cancer Hospital


title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of AL002 in Participants With Early Alzheimer's Disease

summary: A phase 2 randomized, double blind, placebo controlled study evaluating the efficacy and safety of AL002 in participants with Early Alzheimer's Disease.

lead_sponsor: Alector Inc.

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
New Zealand
United States
France
Germany

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Ospedale S Giovanni Calibita Fatebenefratelli

location_facility: Synexus Clinical Research US, Inc - The Villages

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Columbia University College of Physicians and Surgeons

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Alzheimers Research and Treatment Center

location_facility: True North Clinical Research - New Minas

location_facility: Greater Manchester Mental Health NHS Foundation Trust

location_facility: Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

location_facility: Charité - Universitätsmedizin Berlin (CBF)

location_facility: Fundacion ACE Instituto Catalan de Neurociencias

location_facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

location_facility: AMITA Health Clinical Research Institute

location_facility: IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: Centro de Psiquiatría Biológica Instituto Senecta

location_facility: Conquest Clinical Research (Winter Park)


title: Tumor-Agnostic Precision Immunooncology and Somatic Targeting Rational for You (TAPISTRY) Phase II Platform Trial

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Swaziland
Poland
Hong Kong
Portugal
Australia
Puerto Rico
Israel
Singapore
Brazil
Canada
Switzerland
China
Germany
Denmark
Taiwan
New Zealand
Korea, Republic of
France
Netherlands

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: University of California at San Francisco

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

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

location_facility: Praxis für Hämatologie, Onkologie und Palliativmedizin

location_facility: Montefiore Einstein Center for Cancer Care

location_facility: Institut de Cancerologie Gustave-Roussy (IGR)

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Miami Cancer Institute of Baptist Health, Inc.

location_facility: Centre Oscar Lambret; Service de Pediatrie

location_facility: Medizinische Hochschule Zentrum Innere Medizin Abt.Gastroenterologie, Endokrinologie und Hepatologie

location_facility: Consultants in Medical Oncology and Hematology

location_facility: Ospedale Regionale di Bellinzona Medizin Onkologie

location_facility: New York Cancer and Blood Specialists - Setauket Medical Oncology

location_facility: Northwest Medical Specialties, PLLC; Research Department

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

location_facility: Ospedale Pediatrico Bambino Gesù - IRCCS; Dipartimento di Onco-Ematologia Pediatrica

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: Uniklinikum, Comprehensive Cancer Center Mainfranken; Interdisziplinäres Studienzentrum mit ECTU

location_facility: Inselspital, Klinik und Poliklinik für Medizinische Onkologie

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: West China Hospital - Sichuan University

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: National Cancer Centre; Medical Oncology

location_facility: Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1

location_facility: London Health Sciences Centre · Victoria Hospital; Department of Medicine

location_facility: CENTRE LEON BERARD; Département d'Hématologie et d'Oncologie

location_facility: Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: National Taiwan University Hospital; Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: START Madrid-FJD, Hospital Fundacion Jimenez Diaz

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Universitätsklinikum Freiburg Medizinische Klinik Innere Medizin I

location_facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Western Regional Medical Center at Cancer Treatment Centers of America

location_facility: SLK-Kliniken Heilbronn GmbH; Klinik für Innere Medizin III; Schwerpunkt Häma./Onko./Palliativm.

location_facility: Taipei Veterans General Hospital; Department of Oncology

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Azienda Ospedaliera Meyer; Centro di Eccellenza di Oncologia ed Ematologia Pediatrica

location_facility: Cancer Treatment Centers of America; Eastern Regional Medical Center

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Froedtert and The Medical College of Wisconsin

location_facility: Beijing Children's Hospital, Capital Medical University; Oncological Surgery Department

location_facility: Azienda Ospedaliera Universitaria Senese, U.O.C. Immunoterapia Oncologica

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Seoul National University Bundang Hospital

location_facility: Seoul National University Hospital- Pediatric Site

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

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

location_facility: Kaiser Permanente Los Angeles; Clinic/Infusion -LA

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole

location_facility: Seoul National University Hospital- Adult Site

location_facility: PanOncology Trials; Hospital Oncológico, Puerto Rico Medical Center

location_facility: University of New Mexico; Comprehensive Cancer Center

location_facility: Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

location_facility: Sourasky / Ichilov Hospital; Dept. of Oncology

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Christiana Care Health Srvcs; Helen F Graham Can Center

location_facility: Chang Gung Memorial Hospital-Linkou; Dept of Oncology

location_facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Metro-Minnesota Community Oncology Research Consortium

summary: TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.


title: A Randomized, Phase 2, Double-blind Study to Evaluate the Efficacy of Dostarlimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Metastatic Non-Squamous Non-Small Cell Lung Cancer

summary: NSCLC comprises of approximately 84 percent (%) of all lung cancers and is often diagnosed at advanced stage due to poor prognosis. Dostarlimab is an immunoglobulin G (IgG)4 kappa humanized monoclonal antibody (mAb) that binds with high affinity to programmed cell death protein 1 (PD 1), resulting in inhibition of binding to programmed death ligand 1 (PD L1) and programmed death ligand 2 (PD L2). This study aims to compare the efficacy and safety PD-1 inhibitors dostarlimab and pembrolizumab, when administered in combination with chemotherapy (pemetrexed, cisplatin and carboplatin), in participants with non-squamous NSCLC without a known sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase-1 (ROS-1) mutation, BRAF V600E mutation, or other genomic aberration for which an approved targeted therapy is available. A total of approximately 240 participants will be enrolled in the study for a period of 5 years.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Argentina
Korea, Republic of
United States
Chile
France
Romania
Germany


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Subjects With Amyotrophic Lateral Sclerosis (ALS)

summary: This is a 24-month, Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (ALS)

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Poland
Spain
Ireland
Italy
Australia
Netherlands
United Kingdom
Ukraine
United States
France
Belgium
Japan
Germany
Czechia

location_facility: National Hospital Organization Okinawa National Hospital

location_facility: National Hospital Organization Iou National Hospital

location_facility: Azienda Ospedaliera Universitaria di Torino - Città della Salute e della Scienza di Torino

location_facility: Ospedale Niguarda - Nemo Clinical Center - Fondazione Serena Onlus

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Centre of Reconstructive and Restorative Medicine (University Clinic) Odessa National Medical University

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: National Hospital Organization Hyogo-Chuo National Hospital

location_facility: Universitätsmedizin Rostock, Klinik und Poliklinik für Neurologie

location_facility: Medizinische Hochschule Hannover Klinik für Neurologie

location_facility: Nueor-Immunology Clinical Researh Education and Support Service (N-CRESS), Austin Health

location_facility: Shizuoka Institute of Epilepsy and Neurological Disorders

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: National Hospital Organization Higashinagoya National Hospital

location_facility: National Hospital Organization Higashisaitama National Hospital

location_facility: National Hospital Organization Omuta National Hospital

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU

location_facility: Universitaire Ziekenhuizen Leuven (UZ Leuven)

location_facility: University Hospitals Sussex NHS Foundation Trust

location_facility: Ospedale Civile S. Agostino Estense di Modena, Azienda Ospedaliero Universitaria di Modena

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Uniwersytecki Szpital Kliniczny w Olsztynie Klinika Neurologii

location_facility: Maurice Wohl Clinical Neuroscience Institute, King's College London

location_facility: Niigata National Hospital National Hospital Organization


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function

acronym: ALIGN

summary: The ALIGN Study is a phase 3, double-blind, placebo-controlled study to compare the efficacy and safety of atrasentan to placebo in patients with IgA nephropathy (IgAN) at risk of progressive loss of renal function.

lead_sponsor: Chinook Therapeutics U.S., Inc.

location_country:
Poland
Taiwan
Brazil
Hong Kong
Spain
Italy
United Kingdom
Australia
New Zealand
Argentina
Canada
Korea, Republic of
United States
France
China
Japan
Germany

location_facility: Nephrology Associates Of Northern Virginia

location_facility: Hospital das Clinicas da Faculdade de Medicina da USP

location_facility: Istituto di Ricerche Farmacologiche Mario Negri

location_facility: National Taiwan University Hospital Hsin-Chu Branch

location_facility: Kyung Hee University Hospital at Gangdong

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Clinica de Nefrologia Urologia y Enf. Cardiovasculares

location_facility: Samodzielny Publiczny ZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Dokkyo Medical University - Saitama Medical Center

location_facility: The Second Hospital of Anhui Medical University

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Brookview Hills Research Associates, LLC

location_facility: San Antonio Kidney Disease Center Physicians Group, P.L.L.C

location_facility: Pelican Point Dialysis - DaVita Clinical Research

location_facility: The Third Xiangya Hospital of Central South University

location_facility: Nanfang Hospital of Southern Medical University

location_facility: Kokura Memorial Hospital (Kokura Kinen Hospital)

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: St. Marianna University (SMU) School of Medicine

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital das Clínicas Universidade Federal de Minas Gerais - UFMG

location_facility: Mountain Kidney and Hypertension Associates

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: CHA Bundang Medical Center, CHA University


type: Registry Identifier

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS)

acronym: phaethuSA

summary:
Primary Objective:

To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with primary Sjögren's syndrome (pSjS), assessed by the change of the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI)

Secondary Objectives:

To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
To evaluate the therapeutic efficacy on fatigue of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 12 weeks in adult patients with pSjS
To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo in adult patients with pSjS as determined by adverse events (AEs)
To evaluate the local tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS
To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS determined by electrocardiogram, vital signs, and laboratory evaluations
To measure the immunogenicity of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS

This is a multicenter, randomized, double blind, placebo controlled, parallel group proof of concept Phase 2 study to evaluate the therapeutic efficacy of SAR441344 in adult patients with primary Sjögren's syndrome (pSjS), as well as safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).

Study visit frequency: every 2 weeks in the treatment period and every 4 weeks in the follow-up period.
The total duration of the study will be 24 weeks (28 weeks including maximum screening duration) for each participant, including a 12-week treatment period and a 12-week follow-up period.

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Taiwan
Spain
Mexico
Argentina
Canada
Hungary
Korea, Republic of
United States
Chile
France
Belgium
Germany

location_facility: Prolato Clinical Research Center-Site Number:8400009

location_facility: Altoona Center For Clinical Research-Site Number:8400001

location_facility: Tekton Research, Inc.-Site Number:8400002

location_facility: Omega Research Consultants Debary-Site Number:8400005

location_facility: Ramesh C. Gupta, M.D.-Site Number:8400007


title: A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression

summary: This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

lead_sponsor: Seagen Inc.

location_country:
Spain
Italy
United Kingdom
United States
France
Czechia

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Stanford Cancer Center / Blood and Marrow Transplant Program

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Virginia Commonwealth University Medical Center

location_facility: Azienda Ospedaliero-Universitaria di Bologna - IRCCS

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Virginia Oncology Associates - Virginia Beach

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Illinois Cancer Specialists / Advocate Lutheran General Hospital

location_facility: CHD Vendee, Site de La Roche-sur-Yon, Les Oudairies

location_facility: University College London Hospitals NHS Foundation Trust


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

acronym: LUNA 3

summary:
This is a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients will receive rilzabrutinib or placebo 400mg twice daily.

For each patient, the study will last up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This includes Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up.

Patients who respond per specified criteria at the end of the Open-Label Period will be able to enter the Long-Term Extension (LTE) where they will continue to receive treatment until the last patient who enters the LTE has completed 12 months.

lead_sponsor: Principia Biopharma, a Sanofi Company

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Singapore
Brazil
Canada
Hungary
China
Germany
Thailand
Korea, Republic of
France
Chile

location_facility: The Oncology Institute of Hope and Innovation_Investigational Site Number 84031

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital - Investigational Site Number: 39203

location_facility: University of Utah-Huntsman Cancer Institute_Investigational Site Number 84035

location_facility: Second Affiliated Hospital of Kunming Medical University - Investigational Site Number: 15604

location_facility: Shengjing Hospital of China Medical University - Investigational Site Number: 15603

location_facility: Qilu Hospital of Shandong University - Investigational Site Number: 15605

location_facility: Children's Hospital Colorado_Investigational Site Number 84025

location_facility: Local Incorporated Administrative Institution Saitama prefectural hospital organization Saitama prefectural Children's Medical Center - Investigational Site Number: 39206

location_facility: Wuhan Union Hospital of Tongji Medical College of HUST - Investigational Site Number: 15601

location_facility: Ishikawa Prefectural Central Hospital - Investigational Site Number: 39205

location_facility: University of Southern California_Investigational Site Number 84024

location_facility: Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037

location_facility: ASCLEPES Research Centers_Investigational Site Number 84023

location_facility: IMMUNOe International Research Centers_Investigational Site Number 84028

location_facility: Kitasato University Hospital - Investigational Site Number: 39207

location_facility: National Hospital Organization Tokyo Medical Center - Investigational Site Number: 39210

location_facility: Cleveland Clinic_Investigational Site Number 84026

location_facility: Tokyo Metropolitan Bokutoh Hospital - Investigational Site Number: 39209

location_facility: Montefiore Medical Center_Investigational Site Number 84032

location_facility: Rush University Medical Center_Investigational Site Number 84029

location_facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences - Investigational Site Number: 15602

location_facility: UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020

location_facility: Saitama Medical University Hospital - Investigational Site Number: 39201

location_facility: National Center for Child Health and Development - Investigational Site Number: 39204

location_facility: The University of Tokyo Hospital - Investigational Site Number: 39208

location_facility: The Children's Hospital of Philadelphia (CHOP)_Investigational Site Number 84027

location_facility: Shaanxi Provincial People's Hospital - Investigational Site Number: 15607

location_facility: University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033

location_facility: CHU Sainte-Justine_Investigational site number 12405

location_facility: Children's Healthcare of Atlanta_Investigational Site Number 84034

location_facility: Osaka University Hospital - Investigational Site Number: 39202


title: A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.

acronym: FENtrepid

summary: A study to evaluate the efficacy and safety of fenebrutinib on disability progression in adult participants with Primary Progressive Multiple Sclerosis (PPMS). All eligible participants will be randomized 1:1 to either daily oral fenebrutinib (or placebo) or intravenous (IV) ocrelizumab (or placebo) in a blinded fashion through an interactive voice or web-based response system (IxRS). Approximately 946 participants will be enrolled and will be recruited globally. Participants who discontinue study medication early or discontinue from the study will not be replaced. The Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Brazil
Canada
Switzerland
Hungary
North Macedonia
Germany
Bulgaria
Denmark
Greece
France
Chile
Colombia

location_facility: Box Hill Hospital; Department of Neurology

location_facility: Studienzentrum für Neurologie und Psychiatrie

location_facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

location_facility: Austin Hospital; Department of Neurology

location_facility: Hospital de Santa Maria; Servico de Neurologia

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

location_facility: Fraser Health Authority - Fraser Health Multiple Sclerosis

location_facility: Johns Hopkins University School Of Medicine; Outpatient Center

location_facility: Josephson Wallack Munshower Neurology PC

location_facility: Palo Alto Medical Foundation Research Center

location_facility: UniversitätsSpital Zürich; Klinik für Neurologie

location_facility: Regional Clinical Hospital; Neurology Department

location_facility: Hospital Alvaro Cunqueiro; Servicio de Neurologia

location_facility: Hospital Eginition; First Department of Neurology

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia

location_facility: Holy Name Hospital; Institute For Clinical Research

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Hospital Ramon y Cajal; Servicio de Neurologia

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

location_facility: FSBIH Siberian Regional Medical Centre of FMBA of Russia

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas

location_facility: UMHAT Dr. Georgi Stranski; 2nd Neurology Clinic, Occupational Diseases

location_facility: Texas Institute for Neurological Disorders

location_facility: Atrium Health Neurosciences Institute - Charlotte

location_facility: Odesa Regional Clinical Hospital; Neurosurgery Department

location_facility: Hospital de Sao Joao; Servico de Neurologia

location_facility: Mersin University Medical Faculty; Neurology

location_facility: Uni of Texas Health Science Center At Houston

location_facility: 401 Military Hospital of Athens; Neurology Department

location_facility: AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit

location_facility: A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)

location_facility: FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

location_facility: Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru

location_facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

location_facility: Universitaetsklinikum Tuebingen; Abteilung Neurologie

location_facility: Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

location_facility: Vero Beach Neurology and Research Institute

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: Regional health authority A vitalite health network

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Medical Clinical Research Center of Medical Center LLC Health Clinic

location_facility: Hopital Civil de Strasbourg; Service de Neurologie

location_facility: University of Maryland Medical Center; Department of Neurology

location_facility: University Clinic of Neurology; Movement Disorders

location_facility: CNPE City Clinical Hospital #3 of Chernivtsi City Council

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Hospital Santo Antonio dos Capuchos; Servico de Neurologia

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Federal center of brain research and neurotechnologies

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie

location_facility: Montreal Neurological Institute and Hospital

location_facility: Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie

location_facility: Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: City Hospital #40 of Resort Administrative District

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: OhioHealth Riverside Methodist Hospital; Pharmacy Services

location_facility: Medical Centre of PE First Private Clinic

location_facility: City Clinical Hospital #24; Multipal Sclerosis department

location_facility: AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.

location_facility: Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

location_facility: Royal Melbourne Hospital; Department of Neurology

location_facility: Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie

location_facility: Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD

location_facility: Instituto De Neurología Cognitiva - INECO

location_facility: The Chaim Sheba Medical Center; Multiple Sclerosis Center

location_facility: Rigshospitalet; Neurologisk Klinik Glostrup

location_facility: Ondokuz Mayis Univ. Med. Fac.; Neurology

location_facility: Clinica Internacional; Unidad De Investigacion

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Ams of Ukraine; Inst. of Neurology, Psychiatry & Narcology

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Van Yuzuncu Yil University Hospital; Neurology

location_facility: Municipal Institution Dnipropetrovsk Regional Clinical Hospital n a I I Mechnykov; Neurology dept #1

location_facility: Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

location_facility: London Health Sciences Centre Uni Campus

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: National Center of Social Significant Disease

location_facility: Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology

location_facility: Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

location_facility: Miami Valley Hospital South; Dayton Physician's Office

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla


title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)

summary: The purpose of this study is to assess the effect of tavapadon on the change from baseline in total daily hours of "on" time without troublesome dyskinesia in L-Dopa-treated participants with Parkinson's Disease (PD) who are experiencing motor fluctuations.

lead_sponsor: Cerevel Therapeutics, LLC

location_country:
Poland
Serbia
Spain
Italy
Australia
Canada
Ukraine
Hungary
United States
France
Israel
Germany
Bulgaria
Czechia

location_facility:
Kraków
Muenchen
Kragujevac
Tampa, Florida
Spokane, Washington
Muenster
Houston, Texas
Creteil,
Bochum
Sevilla
San Sebastián
West Bloomfield, Michigan
Nantes CEDEX 1
Lodz
Asheville, North Carolina
Haifa
Shoham
Barcelona
Toronto, Ontario
Columbus, Ohio
Jerusalem
Vinnitsa
Rozzano Milano
Strasbourg
Torino
Boca Raton, Florida
Pasadena, California
Pecs
Adventura, Florida
Sofia
Padova
Woolloongabba, Queensland
Terrassa
Elk Grove Village, Illinois
Georgetown, Texas
Petah Tiqva
Little Rock, Arkansas
Stadtroda
Pheonix, Arizona
Coral Springs, Florida
Long beach, California
Atlantis, Florida
Lublin
Lviv
Maitland, Florida
Zaporozhya
Los Angeles, California
Belgrade, Serbia
Chocen
Las Vegas
Saint Louis, Missouri
Kirkland, Washington
Chicago, Illinois
Boulevard Pinel, Bron
Budapest
Reseda, California
Kogarah, New South Wales
Hallandale Beach, Florida
Duesseldorf,
Pamplona
Memphis, Tennessee
Szeged
Gera
Dayton, Ohio
Augusta, Georgia
Ancona
Belgrade
Syracuse, New York
Prague
Fountain Valley, California
Haag in Oberbayern
Gyor,
Ottawa, Ontario
Round Rock, Texas
Milano
Frenso, California
Winter Park, Florida
Kiev
Prague 5, Czech Republic
Virginia Beach, Virginia
Nîmes cedex
Zaporizhzhya
Rychnov nad Kněžnou
Port Charlotte, Florida
Erina, New South Wales
Clayton VIC
Warsaw
Pisa
Toledo, Ohio
Cassino
Lubbock, Texas
Belgrade,
Katowice
Elche
Siemianowice Slaskie
Ashkelon
Zaporiizhzhya
Kharkiv
Scarborough, Maine
Rome
Valencia
Madrid
Cincinnati, Ohio
Englewood, Colorado
Parkville, Victoria
Farmington Hills, Michigan
Berlin
Cleveland, Ohio
Pleven
Ocala, Florida
Krakow
Boston, Massachusettes
Tel Aviv
Burlington, Vermont
Houston,Texas
Las Vegas, Nevada
Richmond, Virginia
Kansas
Lexington, Kentucky
Toulouse Cedex


acronym: REEF-D

title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled Study With Deferred Active Treatment to Investigate the Efficacy, Safety, and Pharmacokinetics of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus

lead_sponsor: Janssen Research & Development, LLC

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

location_country:
Taiwan
Brazil
Spain
Italy
Russian Federation
Australia
New Zealand
United Kingdom
Sweden
United States
France
China
Turkey
Japan
Germany

location_facility: Johns Hopkins University School of Medicine

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Guangzhou Eighth People's Hospital, Guangzhou Medical University

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

location_facility: Fundação De Medicina Tropical Doutor Heitor Vieira Dourado

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: The First Bethune Hospital of Jilin University

location_facility: Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis

location_facility: North East Federal University n.a. M.K.Amosov

location_facility: The First Affiliated Hospital, Zhejiang University College of Medicine

location_facility: Beijing Ditan Hospital Capical Medical University

location_facility: Cepem - Centro de Pesquisa Em Medicina Tropical

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Ospedale Molinette, AO Città della Salute e della Scienza di

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Republic Clinical Infectious Hospital n.a. AF Agafonov

location_facility: The Second Affiliated Hospital of Chongqing Medical University

location_facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital

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

location_facility: Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1

location_facility: Harvard Medical School - Massachusetts General Hospital

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: St George's, University of London and St George's University Hospitals NHS Foundation Trust

summary: The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.


acronym: KALAHARI

title: A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

lead_sponsor: Oxurion

location_country:
Spain
Italy
United Kingdom
United States
France
Germany
Slovakia
Czechia

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Retina-Vitreous Surgeons of Central New York, PC

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: University Hospitals Cleveland Medical Center

location_facility: Mid and South Essex NHS Foundation Trust

location_facility: South Tyneside and Sunderland NHS Foundation Trust

location_facility: Univerzitná nemocnica Bratislava, Nemocnica Ružinov

location_facility: Azienda Sanitaria Universitaria Friuli Centrale

location_facility: Retina-Vitreous Associates Medical Group

location_facility: King's College Hospital NHS Foundation Trust

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: University Retina and Macula Associates, PC

location_facility: Northern California Retina Vitreous Associates Medical Group, Inc.

location_facility: Fakultná nemocnica s poliklinikou Žilina

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: London North West University Healthcare NHS Trust

location_facility: Instituto Clínico Quirúrgico de Oftalmología

summary:
Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.


title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

acronym: CAHtalyst

summary: This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult subjects with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6 month randomized, double blind, placebo-controlled period, followed by 1 year of treatment with crinecerfont. Duration of participation is approximately 20 months.

lead_sponsor: Neurocrine Biosciences

location_country:
Poland
Portugal
Spain
Greece
Austria
Italy
Netherlands
Canada
United Kingdom
Sweden
United States
France
Israel
Belgium
Germany
Bulgaria
Czechia


status: Completed

title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer

study_completion_date_type: Actual

lead_sponsor: EMD Serono Research & Development Institute, Inc.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

location_country:
Spain
Italy
Russian Federation
United States
France
Belgium

location_facility: Institut Curie - Centre René Huguenin - Service d'Oncologie Médicale

location_facility: Universitair Ziekenhuis Brussel - Geriatrie

location_facility: Hospital Universitario Reina Sofia - Dept of Oncology

location_facility: TheOhio State University, Stefanie Spielman Comprehensive Breast Center

location_facility: Texas Oncology, P.A. - Medical City Dallas - Pediatric Hematology/Oncology

location_facility: Centre François Baclesse - Pathologies Gynecologiques

location_facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia

location_facility: IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

location_facility: SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" - Chemotherapy

location_facility: BHI of Omsk region "Clinical Oncology Dispensary"

location_facility: Tomsk Research Instutite of Oncology - Chemotherapy

location_facility: Hospital Universitario Ramon y Cajal - Servicio de Oncologia

location_facility: FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"

location_facility: Texas Oncology, P.A. - Austin - Austin Central Cancer Center

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

location_facility: Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center, Suite 3400

location_facility: Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

location_facility: SBIH " Clinical Oncological Dispensary 1" - Location

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

location_facility: Charleston Hematology Oncology Associates, PA

location_facility: Hospital Ruber Internacional - Servicio de Oncologia

location_facility: SBIH " Clinical Oncological Dispensary # 1" - Location

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento di Senologia

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" - Moscow Cancer Research Centre

location_facility: Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale

location_facility: UPMC Hillman Cancer Center - Hillman Cancer Center

location_facility: Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

summary: The main purpose of this study is to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.

status_simplified: Completed


title: Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients

acronym: COVA

summary: The COVA clinical study is a global multicentric, double-blind, placebo-controlled, group sequential and adaptive 2 parts phase 2-3 study targeting in patients with SARS-CoV-2 pneumonia. Part 1 is a Phase 2 exploratory Proof of Concept (PoC) study to provide preliminary data on the activity, safety and tolerability of BIO101 in the target population. Part 2 is a phase 3 pivotal randomized study to provide further evidence of safety and efficacy of BIO101 after 28 days of double-blind dosing. BIO101 is the investigational new drug that activates the Mas receptor (MasR) through the protective arm of the Renin Angiotensin System (RAS).

ReferenceType: derived

ReferenceCitation: Dioh W, Chabane M, Tourette C, Azbekyan A, Morelot-Panzini C, Hajjar LA, Lins M, Nair GB, Whitehouse T, Mariani J, Latil M, Camelo S, Lafont R, Dilda PJ, Veillet S, Agus S. Testing the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia (COVA study): a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 11;22(1):42. doi: 10.1186/s13063-020-04998-5.

lead_sponsor: Biophytis

location_country:
Brazil
Puerto Rico
France
United States
Belgium

location_facility: CHU CLU Namur (Saint-Elisabeth) Place Louise Godin

location_facility: Unité ambulatoire Service de Pneumologie, Médecine Intensive et Réanimation (SPMIR) 47-83 Boulevard de l'Hôpital

location_facility: Hospital Municipal de Barueri Dr. Francisco Moran

location_facility: Hospital e Maternidade Celso Pierro - PUCCAMP

location_facility: Avenida Dr. Enéas de Carvalho Aguiar, 44 - Centro de Pesquisa Clínica Prof. Dr. Fúlvio Pileggi - Bloco 1 - 1º Andar

location_facility: Centre Hospitalier Départemental de Vendée

location_facility: FDI Clinical Research - San Juan City Hospital

location_facility: Centre Hospitalier Universitaire Bordeaux

location_facility: Barnum Medical Research, Inc. 1029 Keyser Ave Suite H

location_facility: Hôpital Pitié-Salpêtrière, 47 bd de l'Hôpital, 75013 Paris

location_facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto


title: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

summary: This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

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

lead_sponsor: Incyte Corporation

location_country:
Greece
Georgia
Italy
United States
France
Belgium
Germany

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: Mount Sinai Medical Center Comprehensive Cancer Center

location_facility: University Hospital of West Attica - Attikon

location_facility: H. Lee Moffitt Cancer Center and Research Institute Hospital

location_facility: Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

location_facility: Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau

location_facility: Cario - Centre Armoricain de Radiotherapie Imagerie Medicale Et Oncologie

location_facility: Presidio Ospedaliero Di Summa Antonio Perrino

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Universitaire Ziekenhuis Leuven - Gasthuisberg

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: University Clinic Carl Gustav Carus Technical University Dresden

location_facility: Advent Health Medical Group-Orlando 2501

location_facility: University of North Carolina At Chapel Hill

location_facility: L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola ? Malpighi

location_facility: Multiprofile Clinic Consilium Medulla Llc

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

location_facility: The Ohio State University Wexner Medical Center Division of Gynecologic Oncology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli Irccs

location_facility: Euromedica General Clinic of Thessaloniki


title: Phase IIb Multi-Center, Randomised, Partial-Blind Parallel Cohort Study to Assess the Efficacy and Safety of Treatment With GSK3228836 in Participants With Chronic Hepatitis B Virus (B-Clear)

acronym: B-Clear

summary: Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide therapy. This study is intended to evaluate if treatment with GSK3228836 can achieve sustained virologic response (SVR), that is hepatitis B virus surface antigen (HBsAg) less than (<) lower limit of quantitation (LLOQ) and HBV deoxyribonucleic acid (DNA) <LLOQ sustained for 24 weeks post-GSK3228836 treatment end. In addition, the study will also evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GSK3228836 in the 4 dosing regimens. This study will assess the efficacy and safety of treatment with GSK3228836 in two populations of participants with CHB; participants on stable nucleos(t)ide treatment (Cohort 1) and participants who are not currently on nucleos(t)ide therapy (Cohort 2). For each population, participants will be randomized into one of the 4 different parallel arms to receive treatment. The study will consist of a screening, treatment, and post-treatment follow-up phase. Approximately, 440 participants will be enrolled in the study.

ReferenceCitation: Yuen MF, Lim SG, Plesniak R, Tsuji K, Janssen HLA, Pojoga C, Gadano A, Popescu CP, Stepanova T, Asselah T, Diaconescu G, Yim HJ, Heo J, Janczewska E, Wong A, Idriz N, Imamura M, Rizzardini G, Takaguchi K, Andreone P, Arbune M, Hou J, Park SJ, Vata A, Cremer J, Elston R, Lukić T, Quinn G, Maynard L, Kendrick S, Plein H, Campbell F, Paff M, Theodore D; B-Clear Study Group. Efficacy and Safety of Bepirovirsen in Chronic Hepatitis B Infection. N Engl J Med. 2022 Nov 8. doi: 10.1056/NEJMoa2210027. [Epub ahead of print]

location_country:
Spain
Italy
United Kingdom
United States
Romania
Philippines
Japan
South Africa
Poland
Hong Kong
Russian Federation
Argentina
Malaysia
Singapore
Canada
China
Germany
Bulgaria
Taiwan
Thailand
Korea, Republic of
France