title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prophylaxis of Migraine in Participants With Episodic Migraine Who Have Previously Failed 2 to 4 Classes of Oral Prophylactic Treatments (ELEVATE)

acronym: ELEVATE

summary: This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.

lead_sponsor: Allergan

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Denmark
Australia
Sweden
Netherlands
United States
Spain
Czechia
Canada
Russian Federation
France

location_facility: Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 226361

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 226395

location_facility: Karolinska university hospital, Huddinge /ID# 226215

location_facility: Centrum Leczenia Padaczki i Migreny /ID# 226543

location_facility: Universitaetsklinikum Tuebingen /ID# 226529

location_facility: Hospital Clinico Universitario de Valencia /ID# 226472

location_facility: Re:Cognition Health - London /ID# 226540

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 226239

location_facility: FutureSearch Trials of Neurology /ID# 226423

location_facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 226397

location_facility: King's College Hospital NHS Foundation Trust /ID# 226525

location_facility: Univ. of Bologna-IRCCS-Istituto delle Scienze Neurologiche /ID# 226475

location_facility: The Royal Melbourne Hospital /ID# 226402

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 226538

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226388

location_facility: Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 226235

location_facility: Kazan State Medical University /ID# 226498

location_facility: CHU Clermont Ferand - Hopital Gabriel Montpied /ID# 226438

location_facility: Klinische Forschung Dresden GmbH /ID# 226194

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 226399

location_facility: Velocity Clinical Research - Boise /ID# 226320

location_facility: Aggarwal and Associates Limited /ID# 226321

location_facility: Pharmakologisches Studienzentrum Chemnitz GmbH /ID# 226202

location_facility: Northwest Clinical Research Center /ID# 226228

location_facility: Pharmacology Research Institute (PRI) - Los Alamitos (Wake) /ID# 226405

location_facility: AP-HP - Hopital Lariboisière /ID# 226221

location_facility: Universitaetsmedizin Rostock /ID# 226517

location_facility: University Clinical Hospital of Valladolid /ID# 226528

location_facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 226317

location_facility: Ottawa Headache Centre Research Inc /ID# 226257

location_facility: Allied Physicians - Fort Wayne Neurological Center /ID# 226350

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 226485

location_facility: Alpine Clinical Research Center /ID# 226201

location_facility: AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 226503

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 226502

location_facility: Bashkir State Medical University /ID# 226552

location_facility: Diex Recherche Sherbrooke Inc. /ID# 226375

location_facility: Hospital Universitario Vall d'Hebron /ID# 226230

location_facility: Albuquerque Clinical Trials, Inc /ID# 233445

location_facility: Pharmacology Research Institute (PRI) - Encino (Wake) /ID# 226434

location_facility: Re:Cognition Health - Guildford /ID# 226539

location_facility: Hospital Santa Creu i Sant Pau /ID# 226550

location_facility: Specjalistyczne Gabinety Sp. z o.o. /ID# 226266

location_facility: Hospital Clinico Universitario San Carlos /ID# 226483

location_facility: Universitaetsklinikum Jena Klinik fuer Neurologie /ID# 226439

location_facility: Austin Clinical Trial Partners /ID# 228387

location_facility: Amici Clinical Research - Raritan /ID# 226282

location_facility: FutureSearch Trials of Dallas, LP /ID# 226493

location_facility: St Pancras Clinical Research /ID# 226551

location_facility: Deaconess Clinic - Gateway Health Center /ID# 226481

location_facility: Klinische Forschung Hannover-Mitte GmbH /ID# 226195

location_facility: Department of Neurology, University of Szeged /ID# 226442

location_facility: Ospedale Ss. Filippo e Nicola /ID# 226530

location_facility: Duplicate_RCMed Oddzial Sochaczew /ID# 226369

location_facility: Centrum Medyczne Pratia Gdynia /ID# 226437

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 226441

location_facility: CHU Nice - Hopital de Cimiez /ID# 226401

location_facility: Queen Elizabeth University Hospital /ID# 226492

location_facility: Canisius-Wilhelmina Ziekenhuis /ID# 226488

location_facility: CTI Clinical Trial and Consulting /ID# 226281

location_facility: Vitos Orthopaedische Klinik Kassel gemeinnuetzige GmbH /ID# 231767

location_facility: Gabinet Lekarski Jacek Rozniecki /ID# 226323


type: EudraCT Number

type: Other Identifier

title: A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined With AB154 in Front-Line, PD-L1-High, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This is a phase 3 study to evaluate zimberelimab (AB122) combined with domvanalimab (AB154) compared to pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic NSCLC.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: Yes

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.

For more information, please visit our website.

lead_sponsor: Arcus Biosciences, Inc.

sponsor_collaborators:
Arcus Biosciences, Inc.
Gilead Sciences

location_country:
Slovakia
Hong Kong
Brazil
Mexico
United States
Korea, Republic of
Thailand
Bangladesh
Greece
Malaysia
South Africa
Taiwan
Peru
Turkey
Vietnam
Serbia
Philippines
France

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Health Pharma Professional Research S.A. de C.V.

location_facility: Affinity Health Hope & Healing Cancer Services

location_facility: Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: General Oncology Hospital of Kifissia "Agioi Anargyroi"

location_facility: Port Elizabeth Oncology Centre-Cancercare

location_facility: Associação Mário Pena - Núcleo de Ensino e Pesquisas Mário Penna

location_facility: Centricity Research Columbus Cancer Center

location_facility: Hospital de Câncer de Barretos - Fundação Pio XII

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

location_facility: Cha Bundang Medical Centre Cha University

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

location_facility: Institute for Pulmonary Diseases of Vojvodina

location_facility: Humanity and Health Clinical Trial Centre

location_facility: General Hospital of Patra "Agios Andreas"

location_facility: CEPON - Centro de Pesquisas Oncológicas de Santa Catarina

location_facility: HRH Princess Maha Chakri Sirindhorn Medical Centre

location_facility: Ho Chi Minh City University Medical Centre

location_facility: Oaxaca Site Management Organization S.C.

location_facility: Baskent University Adana Application and Research Center

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: CIONC-Centro Integrado de Oncologia de Curitiba

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Ahsania Mission Cancer and General Hospital

location_facility: Pusan National University Yangsan Hospital

location_facility: Millennium Reasearch & Clinical Development

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"

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

location_facility: Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.

location_facility: Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Center Hospitalier Intercommunal de creteil

location_facility: The Catholic University of Korea St. Vincent Hospital

location_facility: Bangladesh Cancer Society Hospital and Welfare Home

location_facility: Slovak Research Center- team member, Ambulancia klinickej onkologie

location_facility: General Hospital of Athens of Chest Diseases "SOTIRIA"

location_facility: Little Company of Mary Oncology Centre - Mary Potter Cancer Centre

location_facility: Wits Clinical Research CMJAH Clinical Trial Site

location_facility: ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira

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

location_facility: Goztepe Prof. Dr. Suleyman Yalcin City Hospital

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

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Arterial Hypertension

summary:
This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH).

The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12.

The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Germany
Italy
Poland
Colombia
New Zealand
Israel
Argentina
United Kingdom
Australia
Sweden
Mexico
Belgium
United States
Greece
Turkey
Canada
Russian Federation
France

location_facility: Université Libre de Bruxelles - Hôpital Erasme ( Site 0601)

location_facility: UCSF Helen Diller Medical Center at Parnassus Heights ( Site 0063)

location_facility: University of Naples Federico II ( Site 0308)

location_facility: Wolfson Medical Center [Holon, Israel] ( Site 0333)

location_facility: Sahlgrenska Universitetssjukhuset-Cardiology Research Unit ( Site 0452)

location_facility: Almazov National Medical Research Centre of the Ministry of Health ( Site 0402)

location_facility: Sanatorio de la Trinidad Mitre ( Site 0130)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawa II-Oddzial Kliniczny Chorob Serca i Naczyn z Pododd

location_facility: Centro Cardiologico Monzino IRCCS ( Site 0306)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0137)

location_facility: Ospedale San Gerardo - ASST Monza ( Site 0304)

location_facility: Fondazione IRCCS Policlinico San Matteo ( Site 0302)

location_facility: University of California San Diego Health-Pulmonary Critical Care ( Site 0061)

location_facility: Clinical Trials Unit at Eastowne Medical Office Building ( Site 0019)

location_facility: AHEPA University General Hospital of Thessaloniki ( Site 0577)

location_facility: Norton Pulmonary Specialists ( Site 0048)

location_facility: Golden Jubilee National Hospital ( Site 0556)

location_facility: Azienda Ospedaliera Policlinico Umberto I ( Site 0301)

location_facility: Instituto Cardiovascular de Rosario ( Site 0128)

location_facility: University of Miami Hospital-Division of Pulmonary & Critical Care ( Site 0053)

location_facility: Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 0403)

location_facility: Eskisehir Osmangazi Uni. Tip Fakultesi Hastanesi ( Site 0506)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0276)

location_facility: University of Iowa Hospital and Clinics ( Site 0009)

location_facility: Operadora de Hospitales Angeles. S.A. de C.V. -Sucursal Lomas ( Site 0653)

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 0554)

location_facility: West Virginia University-WVU Heart and Vascular Institute ( Site 0051)

location_facility: Specjalistyczny Szpital im. Dr Alfreda Sokolowskiego w Walbrzychu ( Site 0351)

location_facility: University of Colorado - Denver ( Site 0003)

location_facility: University of Nebraska Medical Center ( Site 0041)

location_facility: Georgetown University Hospital ( Site 0025)

location_facility: Centre Hospitalier Universitaire de Rouen ( Site 0253)

location_facility: Istanbul Uni. Kardiyoloji Enstitusu ( Site 0502)

location_facility: University of New Mexico, Health Sciences Center ( Site 0028)

location_facility: Instituto Nacional de Cardiología -Ignacio Chavez ( Site 0651)

location_facility: Royal Brompton and Harefield NHS Trust ( Site 0553)

location_facility: Shaare Zedek Medical Center ( Site 0331)

location_facility: Hospital El Cruce Nestor Carlos Kirchner ( Site 0132)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie ( Site 0352)

location_facility: Dokuz Eylul University Faculty of Medicine ( Site 0505)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0501)

location_facility: Centro Cardiovascular Colombiano Clínica Santa María ( Site 0154)

location_facility: Hospital Universitario Austral ( Site 0138)

location_facility: Statcare Pulmonary Consultants ( Site 0067)

location_facility: Ege Universitesi Hastanesi-Cardilogy Department ( Site 0504)

location_facility: Indiana University Health Methodist Hospital ( Site 0045)

location_facility: Klinikum Würzburg Mitte-Medizinische Klinik - Schwerpunkt Pneumologie & Beatmungsmedizin ( Site 0280

location_facility: The University of Texas Health Science Center at Houston ( Site 0054)

location_facility: The Freeman Hosp.Newcastle upon Tyne Hosp NHS Trust ( Site 0552)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0510)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0258)

location_facility: CHRU Brest - Hopital Cavale Blanche ( Site 0254)

location_facility: University of Kansas Medical Center ( Site 0038)

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi ( Site 0509)

location_facility: Sentara Norfolk General Hospital ( Site 0014)

location_facility: Consultorio 1020 Hospital Angeles Xalapa ( Site 0654)

location_facility: Cardiovascular Institute of North Colorado - Banner Health ( Site 0013)

location_facility: Instituto de Investigaciones Clinicas Quilmes ( Site 0141)

location_facility: Institut Coeur Poumon - CHRU de Lille ( Site 0252)

location_facility: University Health Network - Toronto General Hospital ( Site 0104)

location_facility: Washington University School of Medicine ( Site 0066)

location_facility: Houston Methodist Research Institute ( Site 0036)

location_facility: University of Texas Southwestern Medical Center at Dallas ( Site 0012)

location_facility: Hospital Universitario San Ignacio ( Site 0152)

location_facility: Medizinische Hochschule Hannover ( Site 0284)

location_facility: Fundacion Cardiovascular de Colombia ( Site 0155)

location_facility: Universitaetsklinikum Leipzig ( Site 0285)

location_facility: Akdeniz Uni.Tip Fakultesi Saglik Uygulama ve Arastirma Merkezi ( Site 0508)

location_facility: University of California Davis Health-Internal Medicine: Pulmonary, Critical Care and Sleep Medicine

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 0279)


title: EPIK-O: A Phase III, Multi-center, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

summary: The objective of this study is to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.

status: Active, not recruiting

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Konstantinopoulos PA, Gonzalez-Martin A, Cruz FM, Friedlander M, Glasspool R, Lorusso D, Marth C, Monk BJ, Kim JW, Hinson P, Ajipa O, Pretre V, Han Y, Matulonis UA. EPIK-O/ENGOT-OV61: alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study). Future Oncol. 2022 Oct;18(31):3481-3492. doi: 10.2217/fon-2022-0666. Epub 2022 Sep 6.

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: The University of Glasgow - Enlighten: Publications

version: acceptedVersion

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Finland
Germany
Argentina
Australia
Brazil
Turkey
Czechia
Canada
France
Portugal
Slovakia
Denmark
United States
Belgium
China
Malaysia
Italy
United Kingdom
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation

location_facility: Texas Oncology P A Texas Oncology - South Austin

location_facility: Texas Oncology Charles A. Sammons Cancer Ctr

location_facility: University of Cincinnati Dept of Oncology

location_facility: Massachusetts General Hospital Massachusetts General Hospital


summary: The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

location_facility: The Affiliated Hospital of Xuzhou Medical College ( Site 2818)

location_facility: University Hospital Limerick ( Site 2903)

location_facility: Fondazione IRCCS Policlinico San Matteo ( Site 1407)

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi ( Site 2400)

location_facility: The Second Xiangya Hospital of Central South University ( Site 2820)

location_facility: Sisli Florence Nightingale Hastanesi ( Site 2407)

location_facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0302)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 1600)

location_facility: Sir Charles Gairdner Hospital ( Site 0200)

location_facility: The University of Louisville, James Graham Brown Cancer Center ( Site 2729)

location_facility: The First Hospital of Jilin University-Hematology ( Site 2803)

location_facility: Severance Hospital Yonsei University Health System ( Site 2201)

location_facility: Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 2708)

location_facility: Guangxi Medical University - Liuzhou Renmin Hospital ( Site 2817)

location_facility: Hospital das Clinicas FMUSP-Pesquisa Clínica Hematologia ( Site 0303)

location_facility: Centrul de Diagnostic si Tratament Oncologic Brasov ( Site 1802)

location_facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 2814)

location_facility: Nepean Hospital-Nepean Cancer Care Centre ( Site 0204)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 2710)

location_facility: Huashan Hospital, Fudan University ( Site 2821)

location_facility: The Christie NHS Foundation Trust ( Site 2602)

location_facility: Institute of hematology&blood disease hospital-Hematology ( Site 2800)

location_facility: Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 2601)

location_facility: Fakultni nemocnice Hradec Kralove ( Site 0601)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 2704)

location_facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 1400)

location_facility: Hospital Universitario 12 de Octubre ( Site 2003)

location_facility: IRCCS - Arcispedale Santa Maria Nuova ( Site 1405)

location_facility: Hospital Universitari Vall d'Hebron ( Site 2001)

location_facility: Instit. of Blood Transfusion Medicine of the National Academy ( Site 2506)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 2606)

location_facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 2302)

location_facility: Centre Hospitalier Lyon-Sud ( Site 0804)

location_facility: Fudan University Shanghai Cancer Center ( Site 2801)

location_facility: Hospital Universitario de Salamanca ( Site 2002)

location_facility: The First Affiliated Hospital, Zhejiang University ( Site 2826)

location_facility: Bristol Haematology and Oncology Centre ( Site 2610)

location_facility: Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0110)

location_facility: Universitaetsklinikum Koeln ( Site 0901)

location_facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar ( Site 1202)

location_facility: ASST Spedali Civili di Brescia ( Site 1408)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0311)

location_facility: Szpital Wojewódzki w Opolu-Hematology Department ( Site 1607)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0300)

location_facility: Centre Hospitalier de Versailles ( Site 0809)

location_facility: IRCCS Ospedale San Raffaele ( Site 1402)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site

location_facility: Sarah Cannon Research Institute UK ( Site 2612)

location_facility: Institutul Regional de Oncologie Iasi ( Site 1801)

location_facility: St. Marien-Krankenhaus Siegen ( Site 0914)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 2000)

location_facility: MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( S

location_facility: Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 1206)

location_facility: Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 0810)

location_facility: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0406)

location_facility: Dokuz Eylül Üniversitesi-Hematology ( Site 2402)

location_facility: The First Affiliated Hospital of Nanchang University ( Site 2815)

location_facility: Sun Yat-sen University Cancer Center-Internal Medicine ( Site 2824)

location_facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0103)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0107)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0403)

location_facility: Istituto Tumori Giovanni Paolo II ( Site 1409)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0902)

location_facility: Kyiv City Clinical Hospital 9 ( Site 2502)

location_facility: University of California San Diego Moores Cancer Center ( Site 2717)

location_facility: Hadassah Ein Karem Jerusalem ( Site 1300)

location_facility: 2nd Affiliated Hospital Chongqing Medical Universi-Hematology ( Site 2825)

location_facility: Aalborg Universitetshospital ( Site 0703)

location_facility: Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0600)

location_facility: Henan Cancer Hospital-hematology department ( Site 2802)

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 1201)

location_facility: Colorado Blood Cancer Institute ( Site 2726)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1403)

location_facility: West China Hospital Sichuan University ( Site 2810)

location_facility: Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site

location_facility: Sjaellands Universitetshospital Roskilde ( Site 0701)

location_facility: Orszagos Onkologiai Intezet ( Site 1200)

title: A Phase 2 Study to Evaluate the Efficacy and Safety of MK-1026 in Participants With Hematologic Malignancies

source: euctr

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Turkey
Czechia
Canada
France
Hungary
Denmark
Switzerland
United States
Ukraine
Romania
China
Italy
United Kingdom
Korea, Republic of
Spain
Israel


type: Registry Identifier

title: A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

summary: The purpose of this study is to characterize the safety and tolerability of teclistamab when administered in different combination regimen and to identify the optimal dose(s) of teclistamab combination regimens.

design_allocation: Non-Randomized

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

lead_sponsor: Janssen Research & Development, LLC

location_country:
United Kingdom
Australia
Belgium
United States
France

location_facility: Washington University School of Medicine

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole


summary: This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.

sponsor_collaborators:
Merck Sharp & Dohme LLC
Eisai Inc.

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0010)

location_facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 0405)

location_facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 0800)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1101)

location_facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0300)

location_facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0201)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C

location_facility: Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0304)

location_facility: Vanderbilt University Medical Center ( Site 0008)

location_facility: centre hospitalier lyon sud ( Site 1003)

location_facility: Seattle Cancer Care Alliance ( Site 0014)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1302)

location_facility: Istanbul Universitesi Cerrahpasa ( Site 1104)

location_facility: Centre de Cancérologie du Grand Montpellier ( Site 1005)

location_facility: Princess Margaret Cancer Centre ( Site 1504)

location_facility: Sunnybrook Health Sciences Centre ( Site 1501)

location_facility: CHU de Quebec - Université Laval - Hotel Dieu de Quebec ( Site 1502)

location_facility: SHBI Leningrad Regional Clinical Oncology Dispensary-Clinical Trials Department ( Site 0607)

location_facility: Cambridge University Hospital ( Site 1200)

location_facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0903)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

location_facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 0901)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Oncology Unit ( Site 0902)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 0200)

location_facility: Ankara University Hospital Cebeci ( Site 1105)

location_facility: Ashford Cancer Centre Research ( Site 0404)

location_facility: Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 0900)

location_facility: Ege University Medicine of Faculty ( Site 1102)

location_facility: Georgetown University Medical Center ( Site 0001)

location_facility: Nizhegorodsky Regional Oncology Dispensary, Branch #2-chemotherapy ( Site 0605)

location_facility: Chernihiv Medical Center of Modern Oncology ( Site 0509)

location_facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 1500)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0015)

location_facility: Tallaght University Hospital ( Site 1600)

location_facility: Dnepropetrovsk Regional Clinical Hospital Mechnikov-Department of urology ( Site 0508)

location_facility: Cherkasy Regional Oncology Dispensary ( Site 0504)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0802)

location_facility: Russian Scientific Center of Radiology-Russian Scientific Center of Radiology ( Site 0602)

location_facility: Volga District Medical Center-Urology Department ( Site 0604)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1103)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1007)

location_facility: Fundación Instituto Valenciano de Oncología-Oncologico ( Site 0202)

location_facility: Asan Medical Center-Department of Oncology ( Site 1300)

location_facility: St. Vincent Frontier Cancer Center ( Site 0004)

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0303)

location_facility: CNPE "Regional Center of Oncology"-oncourology department ( Site 0502)

location_facility: MEDICAL COLLEGE OF WISCONSIN ( Site 0006)

title: A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants With First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)

location_country:
Ireland
Italy
Poland
Hungary
United Kingdom
Australia
United States
Korea, Republic of
Spain
Turkey
Canada
Ukraine
Russian Federation
France


title: A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 (HER2) Overexpression (OE) (DESTINY-Lung03)

summary: DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

location_country:
Italy
Poland
Israel
Singapore
Australia
Netherlands
Belgium
United States
Korea, Republic of
Spain
Thailand
Malaysia
Turkey
Taiwan
Canada
Philippines
France


lead_sponsor: Bioverativ, a Sanofi company

summary:
Primary Objectives:

Part A: Efficacy of SAR445088 across three subpopulations of CIDP patients: standard of care (SOC)-Treated, SOC-Refractory and SOC-Naive
Part B:Long-term safety and tolerability of SAR445088 in CIDP

Secondary Objectives:

Part A:

Safety and tolerability of SAR445088 in CIDP
Immunogenicity of SAR445088
Efficacy of SAR445088 with overlapping SOC (SOC-Treated group)

Part B:

Durability of efficacy during long-term treatment with SAR445088 in CIDP
Long-term immunogenicity of SAR445088 in CIDP

location_facility: University of Kansas Medical Center-Site Number:8400003

location_facility: University of Minnesota-Site Number:8400006

location_facility: University of Southern California-Site Number:8400004

location_facility: University of California Irvine-Site Number:8400002

title: A Phase 2, Multicenter, Open-label, Non-randomized, Proof-of-concept Study Evaluating the Efficacy, Safety, and Tolerability of SAR445088 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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

location_country:
Germany
Italy
Poland
Netherlands
United States
China
Spain
Canada
Serbia
France


title: A Phase 2, Open-label, Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis and Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis

summary: This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment.

lead_sponsor: Telios Pharma, Inc.

location_country:
Germany
Italy
Poland
Hungary
Australia
Brazil
Belgium
United States
Korea, Republic of
Spain
Taiwan
Bulgaria
France

location_facility: National Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi

location_facility: Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete

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

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden

location_facility: Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero Universitaria Policlinico Umberto I

location_facility: University of Cincinnati (UC) Physicians Company, LLC

location_facility: Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall

location_facility: Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

location_facility: University of Texas, MD Anderson Cancer Center

location_facility: Institut Catala d'Oncologia - L'Hospitalet

location_facility: Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku

location_facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli

location_facility: University of Colorado - Aurora Cancer Center

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Praxisklinik fur Hamatologie und Onkologie

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

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii

location_facility: Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas

location_facility: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

location_facility: Hematologista e Pesquisadora Clínica Hospital A Beneficência Portugues

location_facility: AUSL della Romagna-Ospedale S.Maria delle Croci

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita'

location_facility: Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia


lead_sponsor: UCB Biopharma SRL

summary: The purpose of this study is to assess the safety, tolerability and efficacy of additional 6-week treatment cycles with rozanolixizumab in study participants with generalized myasthenia gravis (gMG).

title: An Open-Label Extension Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Germany
Italy
Poland
Denmark
Japan
United States
Spain
Taiwan
Czechia
Canada
Georgia
Serbia
Russian Federation
France


acronym: XTEND-ed

summary:
Primary Objective:

- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A

Secondary Objectives:

To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes.
To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes.
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes.
To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes.
To evaluate the safety and tolerability of BIVV001 treatment.
To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B).
To evaluate the efficacy of BIVV001 for perioperative management

location_facility: University of California San Diego Site Number : 8400007

location_facility: University of Florida Health Site Number : 8400008

location_facility: Children's Hospital of Wisconsin Site Number : 8400014

location_facility: Orthopaedic Institute for Children Site Number : 8400003

location_facility: Bloodworks Northwest Site Number : 8400005

location_facility: Hemocentro Campinas - UNICAMP Site Number : 0760001

location_facility: Hemostasis and Thrombosis Center of Nevada Site Number : 8400001

location_facility: Children's Hospital Of Iowa Site Number : 8400011

location_facility: Children's Healthcare of Atlanta Site Number : 8400016

location_facility: Michigan State University School Of Med Site Number : 8400002

location_facility: New York Presbyterian Hospital/Weill Cornell Medical Center Site Number : 8400017

location_facility: Cincinnati Children's Hospital Medical Center Site Number : 8400012

location_facility: Children's Research Institute Site Number : 8400013

location_facility: Rush University Medical Center Site Number : 8400010

location_facility: East Carolina University -2390 Hemby Ln Site Number : 8400015

location_facility: University of Michigan Medical Center Site Number : 8400006

location_facility: Children's Hospital Los Angeles Site Number : 8400009

title: A Phase 3 Open-label, Multicenter Study of the Long-term Safety and Efficacy of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients With Severe Hemophilia A

location_country:
Germany
Ireland
Argentina
Australia
Brazil
Japan
Turkey
Canada
France
Hungary
Switzerland
United States
Belgium
China
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Sweden


title: A Three-period Multicenter Study, With a Randomized-withdrawal, Double-blind, Placebo-controlled Design to Evaluate the Clinical Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations

summary: This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.

location_country:
Italy
Japan
United States
Spain
Turkey
Czechia
Canada
France

location_facility:
Novartis Investigative Site
Seattle Children´s Hospital

intervention_type: Biological


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.

status: Terminated

study_completion_date_type: Actual

lead_sponsor: Enanta Pharmaceuticals, Inc

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

location_facility: Hospital Universitario Virgen de La Arrixaca

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

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Fondazione Policlinico Universitario A Gemelli

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

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

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

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

location_facility: Hospital Regional Universitario de Malaga - Hospital General

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

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

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Hospital General Universitario Morales Meseguer

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

location_facility: Changhua Christian Medical Foundation Changhua Christian Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Albert Alberts Stem Cell Transplant Centre

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

status_simplified: Unknown


title: A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy

acronym: MAJESTY

summary: This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

ReferenceCitation: Dossier C, Hogan J. Response to Majeranowski. Pediatr Nephrol. 2021 Jun;36(6):1653. doi: 10.1007/s00467-021-04982-4. Epub 2021 Mar 10. No abstract available.

oa_host_type: publisher

evidence: open (via free pdf)

license_normalized: no license

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Springer-Nature

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:
Italy
Poland
Israel
Argentina
Brazil
United States
China
Spain
Turkey
Peru
Ukraine
Russian Federation
France

location_facility: Accel Research Sites; Mid-Florida Kidney and Hypertension Care

location_facility: ASST Monza - Ospedale San Gerardo; Clinica Nefrologica

location_facility: Uniwersytecki Szpital Kliniczny im WAM CSW; Klinika Nefrologii i Transplantologii Nerek

location_facility: Hospital General Universitaro Gregorio Marañon ;Servicio de Nefrologia

location_facility: Istanbul Florence Nightingale Hospital; Nephrology

location_facility: Hospital Universitario Dr. Peset; Servicio de Nefrologia

location_facility: Szpital Uniwersytecki im.dr.A.Jurasza w Bydgoszczy; Klinika Nefrologii, Nadcisnienia Tetniczego

location_facility: Policlinico di Bari; Divisione di Nefrologia, Dialisi e Trapianto

location_facility: Hacettepe Uni School of Medicine; Nephrology

location_facility: SPSK Slaskiego UM w Katowicach; Katedra i Klinika Nefrologii, Endokryn.I Chorob Przemiany Materii

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: Hadassah Medical Orgainastion; Nephrology

location_facility: Penn State Univ. Milton S. Hershey Medical Center

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

location_facility: Keck School of Medicine - University of Southern California

location_facility: Henry Ford Hospital; Div of Nephrology & Hypertension

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

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie; ODDZIA? NEFROLOGICZNY

location_facility: Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego; Oddzial Nefrologii

location_facility: Hospital Clinic i Provincial; Servicio de Nefrologia

location_facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine

location_facility: University of Colorado in Denver-Anschutz Medical Campus

location_facility: Hospital Italiano de Buenos Aires; Rheumatology department

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: Hopital Bichat Claude Bernard; Nephrologie

location_facility: Autonomous non-commercial organization "Medical Research Center of Drug Therapy "Yuninova"

location_facility: Hospital Universitari de Bellvitge; Servicio de Nefrologia

location_facility: Institute of Nephrology NAMS of Ukraine; Department of Nephrology, Dialysis and IT Support

location_facility: Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos

location_facility: Regional Clinical Hospital n.a I.I. Mechnicov

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: West China Hospital - Sichuan University

location_facility: Nanfang Hospital, Southern Medical University

location_facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili; Nefrologia

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Chinese People's Liberation Army Eastern Theater General Hospital

location_facility: Rambam Medical Center; Department of Nephrology and Hypertension

location_facility: Ospedale San Giovanni Bosco; Unita Operativa Nefrologia Dialisi

location_facility: Hospital Universitario 12 de Octubre; Servicio de Nefrologia

location_facility: A.O. U. Federico II; U.O. di Nefrologia - Dipartimento di Sanità Pubblica

location_facility: Istanbul University Istanbul Medical Faculty; Department of Internal Medicine

location_facility: First Moscow State Medical University n.a. I.M. Sechenov

location_facility: Hopital Tenon; Service de Nephrologie et Dialyses

location_facility: Mayo Clinic; Nephrology and Hypertension

location_facility: Hospital Britanico Buenos Aires; Rheumatology Service

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku; II Klinika Nefrologii

location_facility: Hospital das Clinicas - FMUSP; Nefrologia

location_facility: Akdeniz University Medical Faculty; Internal Medicine, Nephrology

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: General Hospital of Ningxia Medical University

location_facility: University of Utah Health Science center; Department of Pediatrics for the University of Utah

location_facility: The 1st Affiliated hospital of Fujian Medical University

location_facility: HOPITAL HENRI MONDOR; SERVICE DE Nephrologie

location_facility: Hopital Rangueil; Service de Nephrologie & D'Immunologie Clinique


title: An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients With Sickle Cell Disease (HIBISCUS)

summary: This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).

ReferenceCitation: Forsyth S, Schroeder P, Geib J, Vrishabhendra L, Konstantinidis DG, LaSalvia K, Ribadeneira MD, Wu E, Kelly P, Kalfa TA. Safety, Pharmacokinetics, and Pharmacodynamics of Etavopivat (FT-4202), an Allosteric Activator of Pyruvate Kinase-R, in Healthy Adults: A Randomized, Placebo-Controlled, Double-Blind, First-in-Human Phase 1 Trial. Clin Pharmacol Drug Dev. 2022 May;11(5):654-665. doi: 10.1002/cpdd.1058. Epub 2022 Jan 12.

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

repositories_concat: PubMed Central

publisher_dissemination: Wiley

lead_sponsor: Forma Therapeutics, Inc.

sponsor_collaborators:
Forma Therapeutics, Inc.
Novo Nordisk A/S

location_country:
Germany
Italy
United Kingdom
Lebanon
United States
Spain
Greece
Oman
Canada
France

location_facility: UCSF Benioff Children's Hospital Oakland

location_facility: Arnold Palmer Hospital for Children - Haley Center for Children's Cancer and Blood Disorders

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital - Cancer and Haematology Centre

location_facility: Collaborative Neuroscience Research, LLC.

location_facility: Imperial College Healthcare NHS Trust - St Mary's Hospital

location_facility: Cincinnati Childrens Hospital Medical Center

location_facility: General Hospital of Thessaloniki "Hippokration"

location_facility: Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

location_facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

location_facility: Medical University of South Carolina (MUSC)

location_facility: University of Connecticut (UCONN) Health

location_facility: East Carolina University (ECU) Physicians

location_facility: Children's Healthcare of Atlanta - Pediatric Research Center

location_facility: University of Illinois at Chicago Sickle Cell Center

location_facility: University of Miami - Miller School of Medicine

location_facility: The University of Texas Health Science Center at Houston

location_facility: American University of Beirut Medical Center

location_facility: UC Davis Medical Center - UC Davis Comprehensive Cancer Center - Hemotology/Oncology Clinic

location_facility: Hospital Universitari Vall d'Hebron de Barcelona

location_facility: Hammersmith Hospital - Imperial College Healthcare NHS Trust

location_facility: University of Maryland School of Medicine

location_facility: Guy's and St Thomas' NHS Foundation Trust

location_facility: St. Jude Children's Research Hospital (SJCRH)

location_facility: Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine

location_facility: The Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust

location_facility: Washington University School of Medicine Barnes - Jewish Hospital

location_facility: Augusta University Center for Blood Disorders.

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: University of Alabama at Birmingham (UAB)


type: Other Grant/Funding Number

type: U.S. NIH Grant/Contract

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

acronym: DIAN-TU

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

This is an analysis study for an MPRP: DIAN-TU-001 Master NCT01760005

status: Completed

ReferenceType: background

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

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

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

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

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

ReferenceCitation: Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001. No abstract available.

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

ReferenceCitation: McDade E, Bateman RJ. Stop Alzheimer's before it starts. Nature. 2017 Jul 12;547(7662):153-155. doi: 10.1038/547153a. No abstract available.

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

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

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

ReferenceCitation: Atkins KJ, Evered L, Scott DA, Fowler C, Masters CL, Silbert B. Cerebrospinal fluid sampling for research of Alzheimer's disease and other neurodegenerative diseases when lumbar punctures are performed by anaesthetists. BMJ Neurol Open. 2022 Sep 5;4(2):e000335. doi: 10.1136/bmjno-2022-000335. eCollection 2022.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc

license_normalized: cc-by-nc

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

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

lead_sponsor: Washington University School of Medicine

collaborators: Accelerating Medicines Partnership (AMP)

location_country:
Ireland
United Kingdom
Australia
United States
Spain
Canada
Puerto Rico
France

location_facility: University of California San Diego Medical Center

location_facility: The McCuster Foundation of Alzheimer's Disease Research

location_facility: University of Puerto Rico, School of Medicine

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Hospital Clínic I Provincial de Barcelona

lead_sponsor_type: academique

status_simplified: Completed


title: A Phase 2 Study of Avutometinib (VS-6766) (Dual RAF/MEK Inhibitor) as a Single Agent and In Combination With Defactinib (FAK Inhibitor) in Recurrent KRAS-Mutant (KRAS-MT) and BRAF-Mutant (BRAF-MT) Non-Small Cell Lung Cancer (NSCLC) (RAMP 202)

summary: This study will assess the safety and efficacy of avutometinib (VS-6766) monotherapy or VS-6766 in combination with defactinib in subjects with recurrent Non-small cell lung cancer.

ReferenceCitation: Capelletto E, Bironzo P, Denis L, Koustenis A, Bungaro M, Novello S. Single agent VS-6766 or VS-6766 plus defactinib in KRAS-mutant non-small-cell lung cancer: the RAMP-202 phase II trial. Future Oncol. 2022 May;18(16):1907-1915. doi: 10.2217/fon-2021-1582. Epub 2022 Mar 14.

oa_host_type: closed

lead_sponsor: Verastem, Inc.

location_country:
Germany
Italy
United States
Spain
France

location_facility: Henry Ford Cancer Institute/Henry Ford Health System

location_facility: Cancerologie Gustave Roussy - Cancer Medicine

location_facility: Institute De Cancerologie De L'Ouest Site Paul Papin Oncologie Medicale

location_facility: Complejo Hospitalario Universiario a Coruna Teresa

location_facility: Washington University School of Medicine

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: University of Chicago Medical Center-Duchossois Center for Advanced Medicine


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).

location_facility: Cancer Care Specialists; Division of Clinical Research

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Prince of Wales Hospital; Department of Clinical Onocology

location_facility: Barts & London School of Med; Medical Oncology

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

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Sault Area Hospital; Algoma District Cancer Program

location_facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

location_facility: Xiangya Hospital Central South University

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

location_facility: Affiliated Hospital of Chengde Medical University

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: University Hospital Kyoto Prefectural University of Medicine

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

location_facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Universite de Montreal - Hopital Maisonneuve-Rosemont

location_facility: Northwest Georgia Oncology Centers PC - Marietta

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

location_facility: Fort Wayne Medical Oncology and Hematology, Inc

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

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: Crio - Centro Regional Integrado de Oncologia

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

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Adana Baskent University Medical Faculty; Oncology

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

location_facility: Queen Mary Hospital; Dept. of Clinical Oncology

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

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

location_facility: Sjællands Universitetshospital, Roskilde; Klinisk Onkologisk Afdeling og Palliativ Enhed

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

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

location_facility: Qingdao Central Hospital; Department of Respiratory and Critical Care Medicine

location_facility: Victoria Hospital - London Health Sciences Centre

location_facility: Kaiser Permanente - Sacramento; Oncology Pharmacy

location_facility: Hospital Clinic Barcelona; Servicio de oncologia

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

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Christie Hospital Nhs Trust; Medical Oncology

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

location_facility: Changzhou First People's Hospital; Oncology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Medicine

location_facility: West China Hospital - Sichuan University

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: Kaiser Permanente - Santa Clara; Oncology Clinical trials

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Torrance Memorial Physician Network/Cancer Care

location_facility: Kaiser Permanente - San Jose Medical Center

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

location_facility: Kaiser Permanente - San Francisco (2238 Geary)

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

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: Anhui Provincial Hospital; Respiratory Department

location_facility: Inova Schar Cancer Institute; Inova Schar Cancer Institute Infusion Pharmacy

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

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

location_facility: Queen Mary Hospital; Medicine & Respiratory

location_facility: Kyungpook National University Chilgok Hospital

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

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

location_facility: Klinikum der Philipps-Universität Marburg

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

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


acronym: GRACE

lead_sponsor: GlaxoSmithKline

summary:
The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant.

Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants will continue to be monitored as part of the study.

ReferenceCitation: Ginsburg AS, Srikantiah P. Respiratory syncytial virus: promising progress against a leading cause of pneumonia. Lancet Glob Health. 2021 Dec;9(12):e1644-e1645. doi: 10.1016/S2214-109X(21)00455-1. Epub 2021 Nov 11. No abstract available.

publisher_dissemination: Elsevier

title: A Phase III, Randomized, Double-blind, Placebo-controlled Multi-country Study to Demonstrate Efficacy of a Single Dose of Unadjuvanted RSV Maternal Vaccine, Administered IM to Pregnant Women 18 to 49 Years of Age, for Prevention of RSV Associated LRTIs in Their Infants up to 6 Months of Age

primary_purpose: Prevention

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

location_country:
Finland
New Zealand
Argentina
Australia
Brazil
Thailand
Canada
France
Colombia
United States
Honduras
Dominican Republic
India
Belgium
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
Bangladesh
Panama
South Africa
Taiwan


title: A Phase 1 Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations

summary: This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard therapy

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Loxo Oncology, Inc.

location_country:
Finland
Germany
Israel
Singapore
Australia
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: University of California, Davis - Health Systems

location_facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital Universitario Fundación Jiménez Díaz


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.

sponsor_collaborators:
Alector Inc.
AbbVie

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

location_facility: True North Clinical Research - New Minas

location_facility: Centro de Psiquiatría Biológica Instituto Senecta

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

location_facility: IRCCS - Centro S. Giovanni di Dio Fatebenefratelli

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

location_facility: Ospedale S Giovanni Calibita Fatebenefratelli

location_facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Greater Manchester Mental Health NHS Foundation Trust

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Fundacion ACE Instituto Catalan de Neurociencias

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

location_facility: AMITA Health Clinical Research Institute

location_facility: Alzheimers Research and Treatment Center

location_facility: Conquest Clinical Research (Winter Park)

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Charité - Universitätsmedizin Berlin (CBF)

location_facility: Columbia University College of Physicians and Surgeons

location_facility: Azienda Ospedaliero Universitaria Pisana


acronym: ADAGIO

summary: This Phase 2b study aims to evaluate the efficacy and safety of adavosertib, an inhibitor of the tyrosine kinase WEE1, in subjects with recurrent or persistent uterine serous carcinoma (USC) who have previously received at least 1 prior platinum-based chemotherapy regimen for the management of USC.

ReferenceCitation: Liu J, Oza AM, Colombo N, Oaknin A. ADAGIO: a phase IIb international study of the Wee1 inhibitor adavosertib in women with recurrent or persistent uterine serous carcinoma. Int J Gynecol Cancer. 2022 Jan;32(1):89-92. doi: 10.1136/ijgc-2021-003144. Epub 2021 Oct 29.

sponsor_collaborators: AstraZeneca Parexel

title: A Phase 2b, Open-label, Single-arm, Multi-centre Study Assessing the Efficacy and Safety of Adavosertib as Treatment for Recurrent or Persistent Uterine Serous Carcinoma

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

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Italy
United States
Spain
Canada
France


title: A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

acronym: FENhance 2

summary: A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

location_country:
Italy
Poland
Guatemala
India
United Kingdom
Denmark
Brazil
Austria
Mexico
United States
Korea, Republic of
Greece
Turkey
Bulgaria
Canada
Russian Federation
France

location_facility: Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

location_facility: State Novosibirsk Regional Clinical Hospital

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

location_facility: Wayne State University; Department of Neurology

location_facility: Clinica Neurologica; Neurocirurgica de Joinville

location_facility: Regional Clinical Hospital N.A. Semashko; Neurology

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

location_facility: Federal center of brain research and neurotechnologies

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: Regional clinical hospital named after prof. S.V. Ochapovsky

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

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

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Deenanath Mangeshkar Hospital & Research Centre

location_facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

location_facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie

location_facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie

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

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Unidad de Investigación en Salud; Psiquiatria

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Mersin University Medical Faculty; Neurology

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

location_facility: Keimyung University Dongsan Medical Center

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych

location_facility: National Center of Social Significant Disease

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Neurology

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Stanford University Medical Center; Stanford Neuroscience Health Center

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

location_facility: IBISMED Wielospecjalistyczne Centrum Medyczne

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

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie

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

location_facility: University General Hospital of Larisa; Neurology Clinic

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Van Yuzuncu Yil University Hospital; Neurology

location_facility: Sydvestjysk Sygehus Esbjerg; Neurologisk Afd., Skleroseklinikken

location_facility: Postgraduate Institute of Medical Education and Research

location_facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

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

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche

location_facility: Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso

location_facility: University General Hospital of Ioannina; Neurology Clinic

location_facility: Baskent Universitesi Ankara Hastanesi; Noroloji Bolumu

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: Hôpital Charles Nicolle; Service de Neurologie

location_facility: CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: Hospital Santa Marcelina; AME - Ambulatório de Especialidades Médicas

location_facility: Neuro Institute of New England P.C.; Research

location_facility: Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k.

location_facility: L2 Ip Instituto de Pesquisas Clinicas Ltda ME; Centro Medico Hospitalar

location_facility: Kocaeli University Hospital; Department of Neurology

location_facility: Sancaktepe Training and Research Hospital; Neurology

location_facility: Los Angeles Biomedical Research Institute at Harbor-UCLA

location_facility: MUCH - Montreal Neurological Institute & Hospital

location_facility: Zydus Hospital; Department of Neuro Sciences

location_facility: Gazi University Medical Faculty; Departmant of Norology

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

location_facility: University of Cincinnati; Department of Neurology

location_facility: Hospital Eginition; First Department of Neurology

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: KI Health Partners, LLC; New England Institute for Clinical Research


lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.

location_facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia

location_facility: Unidade de Pesquisa Clínica do Hospital da Clínicas de Ribeirão Preto-Clinical Oncology

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica

title: A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)

location_country:
Poland
New Zealand
Argentina
Hong Kong
Japan
Brazil
Romania
Mexico
Singapore
Korea, Republic of
China
Spain
Turkey
Chile
Taiwan
Czechia
France


title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies

summary: This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency. The primary endpoints are Dose limiting toxicities (Parts A-1 and A-2), Overall response rate per RECIST v1.1 (Part B) and Safety and tolerability (Part C).

lead_sponsor: BicycleTx Limited

location_country:
Italy
United Kingdom
United States
Spain
Canada
France

location_facility: University Hospitals Cleveland Medical Center

location_facility: Thomas Jefferson University, Sidney Kimmel Cancer Center

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Sarah Cannon Research Institute at HealthONE

location_facility: Next Oncology - Hospital Quironsalud Madrid

location_facility: University Health Network, Princess Margaret Cancer Centre

location_facility: The University of Texas MD Anderson Cancer Center


acronym: Ravulizumab in Pediatric Participants with TMA after HSCT

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab administered by intravenous infusion to pediatric participants, from 1 month to < 18 years of age, with HSCT-TMA. The treatment period is 26 weeks, followed by a 26-week off-treatment follow-up period.

location_facility:
Clinical Trial Site
Clinical Study Site

title: A Phase 3, Open-label, Single Arm, Multicenter Study of Ravulizumab in Addition to Best Supportive Care in Pediatric Participants With Thrombotic Microangiopathy (TMA) After Hematopoietic Stem Cell Transplantation (HSCT)

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

ipd_sharing: No


lead_sponsor: Vertex Pharmaceuticals Incorporated

summary: This study will evaluate the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in subjects with CF who are 6 years of age and older with F/MF genotypes.

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.

oa_host_type: repository

unpaywall_oa_status: green

location_facility: Justus-Liebig-Universität Gießen Zentrum fur Kinderheilkunde und Jugendmedizin

location_facility: Groupe Hospitaler Pellegrin, CHU De Bordeaux

location_facility: Universitatsklinikum Essen (AoR), Kinderklinik III, Abt. fur Pneumologie

location_facility: Great Ormond Street Hospital for Sick Children

location_facility: Universitaetsklinikum Heidelberg, Zenter fuer Kinder-und Jugendmedizin

location_facility: Schneider Children's Medical Center of Israel

location_facility: Erasmus Medical Center / Sophia Children's Hospital

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Charite Paediatric Pulmonology Department

location_facility: Hadassah University Hospital Mount Scopus

location_facility: Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital

location_facility: University Hospitals Bristol and Weston NHS Foundation Trust, Bristol Royal Hospital

location_facility: McGill University Health Centre, Glen Site, Montreal Children's Hospital

title: A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

ipd_sharing_description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

location_country:
Germany
Israel
United Kingdom
Denmark
Australia
Netherlands
Switzerland
Spain
Canada
France


acronym: MITIGATE

lead_sponsor: Viela Bio (acquired by Horizon Therapeutics)

summary: This study aims to evaluate the efficacy and safety of inebilizumab for the prevention of flare of Immunoglobulin G4-related disease (IgG4-RD).

location_facility:
Viela Bio Investigative Siite
Viela Bio Investigative Site 2
Viela Bio Investigative Site 1
Viela Bio Investigative Site 4
Viela Bio Investigative Site
Viela Bio Investigative Site 5
Viela Bio Investigative Site 3

title: A Phase 3, Randomized, Double-blind, Multicenter, Placebo Controlled Study of Inebilizumab Efficacy and Safety in IgG4-Related Disease

location_country:
Germany
Ireland
Poland
Argentina
Australia
Japan
Turkey
Canada
France
Hungary
Hong Kong
United States
India
China
Italy
United Kingdom
Sweden
Netherlands
Mexico
Spain
Israel


acronym: REEF-D

lead_sponsor: Janssen Research & Development, LLC

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.

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

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

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Karadeniz Teknik University Medical Faculty

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

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: The First Affiliated Hospital Zhejiang University College of Medicine

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: National Hospital Organization Nagasaki Medical Center

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

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

location_facility: The Second Affiliated Hospital of Chongqing Medical University

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

location_facility: The First Bethune Hospital of Jilin University

location_facility: Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Ege University Medical of Faculty, Department of Gastroenterology

location_facility: Harvard Medical School - Massachusetts General Hospital

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

location_facility: Cepem - Centro de Pesquisa Em Medicina Tropical

location_facility: Beijing Ditan Hospital Capical Medical University

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

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


title: A Double-Blind, Vehicle-Controlled, Randomized Withdrawal and Treatment Extension Study to Assess the Long-Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo

summary: The purpose of this study is to evaluate the duration of response following withdrawal of ruxolitinib cream (Cohort A vehicle group), safety and maintenance of response with continued use of ruxolitinib cream in participants who have completed either Study NCT04052425 or NCT04057573 (parent studies) in which the participants will have been using ruxolitinib cream BID for the previous 28 to 52 weeks depending on their initial randomization in the parent study.

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

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

lead_sponsor: Incyte Corporation

location_country:
Germany
Poland
Netherlands
United States
Spain
Bulgaria
Canada
France

location_facility: Vitiligo & Pigmentation Institute of Southern California

location_facility: Synexus Polska Sp Z Oo Oddzial W Czestochowie

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

location_facility: The Dermatology and Laser Center of San Antonio

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hospital Haut-Leveque

location_facility: Diagnostic Consultative Center Xxviii - Sofia - Eood

location_facility: Synexus Affiliate - Krakowskie Centrum Medyczne

location_facility: International Clinical Research Tennessee Llc

location_facility: Synexus - Polska Sp Z Oo Oddzial W Gdansk

location_facility: Simcoderm Medical and Surgical Dermatology Center

location_facility: Diagnostic Consultative Center Ii Sofia Eood

location_facility: Synexus Polska Sp. Z O.O. Oddzial We Wroclawiu

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

location_facility: Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol

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

location_facility: Poradnia Dermatologiczno-Wenerologiczna Mediderm S.C. Nzoz

location_facility: Forcare Clinical Research Fcr Forward Clinical Trials, Inc

location_facility: Delricht Clinical Research - Clinedge - Ppds Baton Rouge

location_facility: Center For Dermatology Cosmetic and Laser Surgery

location_facility: Dermatology Associates of Plymouth Meeting

location_facility: Hopital Charles Nicolle Chu Rouen Hospital de Bois-Guillaume

location_facility: Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii

location_facility: University Multiprofile Hospital For Active Treatment Aleksandrovska


title: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors

summary: This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in patients with unresectable or metastatic cholangiocarcinoma (CCA) and other solid tumors. The study consists of 3 parts: a dose escalation (Part 1), a dose expansion (Part 2), and an extension (Part 3).

lead_sponsor: Relay Therapeutics, Inc.

location_country:
Germany
Italy
United Kingdom
Hong Kong
Singapore
Australia
Sweden
Netherlands
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: Hospital Universitario Fundación Jiménez Díaz- START MADRID

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: The University of Texas M.D. Anderson Cancer Center

location_facility: Hospital Universitario HM Sanchinarro-START MADRID-CIOCC

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Winship Cancer Institute, Emory University

location_facility: Huntsman Cancer Institute, University of Utah

location_facility: Taussig Cancer Institute Cleveland Clinic


lead_sponsor: Concert Pharmaceuticals

summary: This study evaluates the safety and effectiveness of an investigational study drug (called CTP-543) in adults (18 years and older) who have 50% or greater scalp hair loss.

location_facility: Skin Laser and Surgery Specialists of NJ

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Dr Wei Jing Loo Medicine Professional Corporation

location_facility: UC Irvine Dermatology Clinical Research Center

location_facility: Dr. S. K. Siddha Medicine Professional Corporation

location_facility: Clinical Investigation Specialists, Inc.

location_facility: Wake Forest University Health Sciences, Department of Dermatology

location_facility: Yale University, Church Street Research Unit

location_facility: Clinical Research Center of the Carolinas

location_facility: Dermatology Treatment and Research Center

location_facility: Dermatology Associates Of Plymouth Meeting

location_facility: Vital Prospects Clinical Research Institute, P.C.

location_facility: University of Minnesota Department of Dermatology

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: Northwestern Memorial Hospital, Department of Dermatology

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: California Dermatology & Clinical Research Institute

location_facility: Hospital Clínico Y Provincial de Barcelona

location_facility: Colorado Center for Dermatology and Skin Surgery

location_facility: SimcoDerm Medical and Surgical Dermatology Center

location_facility: Hôpital Saint Louis, Centre de Santé Sabouraud

location_facility: Clinical Research Trials of Florida, Inc.

location_facility: Dermatology Clinical Research Center of San Antonio

title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata (THRIVE-AA1)

location_country:
Poland
United States
Spain
Canada
France


acronym: DREAMM 8

summary: This study will evaluate the efficacy and safety of belantamab mafodotin in combination with pomalidomide and dexamethasone (Arm A) compared with that of combination of pomalidomide, bortezomib and dexamethasone (Arm B) in participants with relapsed/refractory multiple myeloma (RRMM).

title: A Phase III, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma (DREAMM 8)

location_country:
Germany
Poland
New Zealand
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
United States
China
Italy
United Kingdom
Korea, Republic of
Spain
Greece
Russian Federation
Israel