ReferenceCitation: Szarek M, Bhatt DL, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Banks P, Tesfaye E, Ezekowitz JA, Verma S, Pitt B; SOLOIST-WHF committees and investigators. Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial. Ann Intern Med. 2021 Aug;174(8):1065-1072. doi: 10.7326/M21-0651. Epub 2021 Jun 22.

name: CPC Clinical Research and University of Colorado Anschutz Medical Campus, Aurora, Colorado, and State University of New York Downstate School of Public Health, Brooklyn, New York (M.S.)

family: Szarek

full_name: Michael Szarek

given: Michael

name: Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts (D.L.B., C.P.C.)

family: Bhatt

full_name: Deepak L. Bhatt

given: Deepak L.

name: Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique–Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148, Paris, France (P.G.S.)

family: Steg

full_name: Ph. Gabriel Steg

given: Ph. Gabriel

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

name: Li Ka Shing Knowledge Institute, St. Michael's Hospital, and University of Toronto, Toronto, Ontario, Canada (L.A.L., S.V.)

family: Leiter

full_name: Lawrence A. Leiter

given: Lawrence A.

name: University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas, Texas (D.K.M.)

family: McGuire

full_name: Darren K. McGuire

given: Darren K.

name: Vanderbilt University, Nashville, Tennessee (J.B.L.)

family: Lewis

full_name: Julia B. Lewis

given: Julia B.

name: Oregon Health & Science University, Portland, Oregon (M.C.R.)

family: Riddle

full_name: Matthew C. Riddle

given: Matthew C.

name: University of Groningen–University Medical Center Groningen, Groningen, the Netherlands (A.A.V.)

family: Voors

full_name: Adriaan A. Voors

given: Adriaan A.

name: Azienda Socio Sanitaria Territoriale Spedali Civili and University of Brescia, Brescia, Italy (M.M.)

family: Metra

full_name: Marco Metra

given: Marco

name: Karolinska Institutet, Solna, Sweden (L.H.L.)

family: Lund

full_name: Lars H. Lund

given: Lars H.

name: Paris Sorbonne University and Groupe Hospitalier Paris Saint Joseph, Paris, France (M.K.)

family: Komajda

full_name: Michel Komajda

given: Michel

name: Yale University, New Haven, Connecticut (J.M.T.)

family: Testani

full_name: Jeffrey M. Testani

given: Jeffrey M.

name: Georgetown University, Washington, DC (C.S.W.)

family: Wilcox

full_name: Christopher S. Wilcox

given: Christopher S.

name: Wroclaw Medical University, Wroclaw, Poland (P.P.)

family: Ponikowski

full_name: Piotr Ponikowski

given: Piotr

name: Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina (R.D.L.)

family: Lopes

full_name: Renato D. Lopes

given: Renato D.

name: Lexicon Pharmaceuticals, The Woodlands, Texas (P.B., E.T.)

family: Banks

full_name: Phillip Banks

given: Phillip

family: Tesfaye

full_name: Eshetu Tesfaye

given: Eshetu

name: University of Alberta and Mazankowski Alberta Heart Institute, Edmonton, Alberta, Canada (J.A.E.)

family: Ezekowitz

full_name: Justin A. Ezekowitz

given: Justin A.

family: Verma

full_name: Subodh Verma

given: Subodh

name: University of Michigan, Ann Arbor, Michigan (B.P.).

family: Pitt

full_name: Bertram Pitt

given: Bertram

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

ReferenceCitation: Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.

name: From Brigham and Women’s Hospital Heart and Vascular Center and Harvard Medical School, Boston (D.L.B., C.P.C.); Colorado Prevention Center Clinical Research and Department of Medicine, Division of Cardiovascular Medicine, University of Colorado Anschutz Medical Campus, Aurora (M.S.); State University of New York Downstate School of Public Health, Brooklyn (M.S.); Université de Paris, French Alliance for Cardiovascular Trials, Assistance Publique–Hôpitaux de Paris, Hôpital Bichat, INSERM Unité 1148 (P.G...

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

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.

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
France
Poland
Lithuania
Slovakia
Argentina
Canada
Korea, Republic of
Chile
Sweden
Switzerland
Netherlands
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
New Zealand
Spain
Turkey
Latvia

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title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients With Type 2 Diabetes POST Worsening Heart Failure

summary:
Primary Objective:

To compare the effect of sotagliflozin to placebo on the total occurrences of cardiovascular (CV) death, hospitalization for heart failure (HHF), and urgent visit for heart failure (HF) in hemodynamically stable patients after admission for worsening heart failure (WHF)

Secondary Objectives:

To compare the effects of sotagliflozin to placebo on:

The total occurrences of HHF and urgent visit for HF
The occurrence of CV death
The occurrence of all-cause mortality
The total occurrences of CV death, HHF, urgent visit for HF, non-fatal myocardial infarction (MI), and non-fatal stroke
Change in KCCQ-12 score
Change in estimated glomerular filtration rate (eGFR)


design_allocation: Randomized

intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: BeiGene

enrollment_type: Actual

primary_purpose: Treatment

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

location_facility: AO Citta della Salute e della Scienza di Torino - Presidio O

location_facility: Centre Hospitalier Universitaire (CHU) de Liege - Site du Sart Tilman

location_facility: Comprehensive Cancer Center-Gustave Roussy

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Northwestern Medicine Cancer Center Warrenville

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: The First People's Hospital Of Changzhou

location_facility: Fourth Hospital of Hebei Medical University

location_facility: Hamatologisch-Onkologische Praxis Eppendorf (HOPE)

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: Universitat Leipzig, UKL AoR, Universitares Krebszentrum Leipzig (UCCL)

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Universitatsklinikum Koln, Innere Medizin I

location_facility: Sichuan Academy of Medical Sciences& Sichuan Provincial People's Hospital

location_facility: AOU - Seconda Università degli Studi di Napoli

location_facility: Chonnam National University Hwasun Hospital

location_facility: The First Affiliated Hospital of Xinxiang Medical University

location_facility: The Royal Marsden NHS Foundation Trust - Haemato-Oncology

location_facility: The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital)

location_facility: Anhui Medical University - The Second Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Charite - Universitatsmedizin Berlin /Campus Virchow Klinikum (CVK) - Med. Klinik m. S. Hamatologie, Onkologie und Tumorimmunologie (CC14)

location_facility: Universitatsklinikum Carl Gustav Carus Dresden, Medizinische Klinik und Poliklinik

location_facility: The Affiliated Hospital of Xuzhou Medical University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital

location_facility: University of Southern California Norris Comprehensive Cancer Center

location_facility: Kobe City Medical Center General Hospital

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Ospedale Guglielmo da Saliceto, AUSL Piacenza

location_facility: The First Hospital, Sun Yat-sen University

location_facility: St. Marianna University School of Medicine Hospital

location_facility: A.O.U. Pisana, Stabilimento di Santa Chiara

location_facility: Universitaetsmedizin Mannheim, II. Medizinische Klinik

location_facility: Fujian Medical University Union Hospital

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitat Mainz

ipd_sharing: Yes

study_completion_date_type: Anticipated

type: EudraCT Number

type: Registry Identifier

source: euctr

title: A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

summary: The purpose of this study is to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy.

lead_sponsor_type: industriel

status_simplified: Ongoing


ReferenceType: derived

ReferenceCitation: Romero Román A, Campo-Cañaveral de la Cruz JL, Macía I, Escobar Campuzano I, Figueroa Almánzar S, Delgado Roel M, Gálvez Muñoz C, García Fontán EM, Muguruza Trueba I, Romero Vielva L, Cano Garcia JR, Martínez Téllez E, Partida González C, Jiménez López MF, Jiménez Maestre U, Mongil Poce R, Sánchez Lorente D, Álvarez Kindelán A, Provencio Pulla M. Outcomes of surgical resection after neoadjuvant chemoimmunotherapy in locally advanced stage IIIA non-small-cell lung cancer. Eur J Cardiothorac Surg. 2021 Jul 14;60(1):81-88. doi: 10.1093/ejcts/ezab007.

name: Department of Thoracic Surgery, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain

family: Romero Román

full_name: Alejandra Romero Román

given: Alejandra

sequence: first

family: Campo-Cañaveral de la Cruz

full_name: Jose Luis Campo-Cañaveral de la Cruz

given: Jose Luis

sequence: additional

family: Macía

full_name: Iván Macía

given: Iván

name: Department of Thoracic Surgery, Hospital Universitari de Bellvitge, Institut d’Investigació Biomèdica de Bellvitge (IDIBELL) and Unit of Human Anatomy and Embryology, Department of Pathology and Experimental Therapeutics, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona, Barcelona, Spain

name: Department of Thoracic Surgery, Hospital Universitari de Bellvitge;, Institut d’Investigació Biomèdica de Bellvitge (IDIBELL) and Department of Clinical Sciences, Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona, Barcelona, Spain

family: Escobar Campuzano

full_name: Ignacio Escobar Campuzano

given: Ignacio

name: Department of Thoracic Surgery, Hospital Clinic Universitari de València, Valencia, Spain

family: Figueroa Almánzar

full_name: Santiago Figueroa Almánzar

given: Santiago

name: Department of Thoracic Surgery, Complejo Hospitalario Universitario A Coruña, A Coruña, Spain

family: Delgado Roel

full_name: María Delgado Roel

given: María

name: Department of Thoracic Surgery, Hospital General Universitario de Alicante, Alicante, Spain

family: Gálvez Muñoz

full_name: Carlos Gálvez Muñoz

given: Carlos

name: Department of Thoracic Surgery, Complejo Universitario de Vigo, Vigo, Spain

family: García Fontán

full_name: Eva M García Fontán

given: Eva M

name: Department of Thoracic Surgery, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain

family: Muguruza Trueba

full_name: Ignacio Muguruza Trueba

name: Department of Thoracic Surgery, Hospital Vall d'Hebrón, Barcelona, Spain

family: Romero Vielva

full_name: Laura Romero Vielva

given: Laura

name: Department of Thoracic Surgery, Complejo Hospitalario Universitario Insular de Gran Canaria, Las Palmas, Spain

family: Cano Garcia

full_name: José Ramón Cano Garcia

given: José Ramón

name: Department of Thoracic Surgery, Hospital Universitari de la Santa Creu i Sant Pau, Barcelona, Spain

family: Martínez Téllez

full_name: Elisabeth Martínez Téllez

given: Elisabeth

name: Department of Thoracic Surgery, Hospital Universitario La Paz, Madrid, Spain

family: Partida González

full_name: Concepción Partida González

given: Concepción

name: Department of Thoracic Surgery, Hospital Universitario de Salamanca, Salamanca, Spain

family: Jiménez López

full_name: Marcelo Fernando Jiménez López

given: Marcelo Fernando

name: Department of Thoracic Surgery, Hospital Universitario de Cruces, Bizkaia, Spain

family: Jiménez Maestre

full_name: Unai Jiménez Maestre

given: Unai

name: Department of Thoracic Surgery, Hospital Regional Universitario de Málaga, Málaga, Spain

family: Mongil Poce

full_name: Roberto Mongil Poce

given: Roberto

name: Department of Thoracic Surgery, Hospital Clinic i Provincial de Barcelona, Barcelona, Spain

family: Sánchez Lorente

full_name: David Sánchez Lorente

given: David

name: Department of Thoracic Surgery, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain

family: Álvarez Kindelán

full_name: Antonio Álvarez Kindelán

given: Antonio

name: Department of Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain

family: Provencio Pulla

full_name: Mariano Provencio Pulla

given: Mariano

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cardio-Thoracic Surgery

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

lead_sponsor: Merck Sharp & Dohme Corp.

enrollment_type: Anticipated

location_country:
Malaysia
Romania
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Argentina
Canada
Korea, Republic of
South Africa
Ireland
China
Germany
United States
United Kingdom
Italy
Brazil
Spain
Estonia
Latvia

location_facility: OHSU Center for Health & Healing ( Site 1006)

location_facility: Herbert Herman Cancer Center, Sparrow Hospital ( Site 0034)

location_facility: Virginia Cancer Specialists, PC ( Site 0080)

location_facility: LKI Lungenfachklinik Immenhausen ( Site 0268)

location_facility: Azienda Ospedaliera Spedali Civili di Brescia ( Site 0307)

location_facility: S C Oncocenter Oncologie Medicala S R L ( Site 0505)

location_facility: Azienda Ospedaliera San Camillo Forlanini ( Site 0311)

location_facility: Hospital Paulistano - Amil Clinical Research ( Site 0822)

location_facility: St. Peter's Hospital Cancer Care Center ( Site 0039)

location_facility: Miami Cancer Institute-Baptist Hospital ( Site 0068)

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust ( Site 0456)

location_facility: Hospital de Caridade de Ijui ( Site 0153)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 0801)

location_facility: VA Pittsburgh Healthcare System ( Site 0052)

location_facility: Pacific Cancer Medical Center, Inc. ( Site 0004)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0110)

location_facility: Peking Union Medical College Hospital ( Site 0809)

location_facility: Riga East Clinical University Hospital ( Site 0912)

location_facility: Tianjin Medical University General Hospital ( Site 0806)

location_facility: University Malaya Medical Centre ( Site 0781)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0077)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 0804)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0515)

location_facility: China Medical University Hospital ( Site 0724)

location_facility: Stony Brook University Medical Center - Cancer Center ( Site 0019)

location_facility: Azienda Ospedaliera dei Colli V. Monaldi ( Site 0301)

location_facility: Princess Margaret Cancer Centre ( Site 0109)

location_facility: Tri-Service General Hospital ( Site 0726)

location_facility: Hwa Mei Hospital University of Chinese Academy of Sciences ( Site 0802)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0504)

location_facility: HP of the Univ. of Occupational and Environmental Health, Japan ( Site 0770)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0060)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0267)

location_facility: Tokyo Medical University Hospital ( Site 0771)

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0493)

location_facility: City Clinical Hosp.4 of DCC ( Site 0607)

location_facility: SC Radiotherapy Center Cluj SRL ( Site 0509)

location_facility: AOU San Luigi Gonzaga di Orbassano ( Site 0313)

location_facility: Emily Couric Clinical Cancer Center ( Site 0013)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0705)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0104)

location_facility: Hôpital Avicenne - Service d oncologie medicale ( Site 0249)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 0603)

location_facility: Shanghai Pulmonary Hospital-Thoracic Surgery department ( Site 0817)

location_facility: SA Pohja-Eesti Regionaalhaigla ( Site 1100)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0144)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 0388)

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0133)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 0491)

location_facility: Spitalul clinic Judetean de urgenta Constanta ( Site 0508)

location_facility: Stanford University, Stanford Cancer Center ( Site 0046)

location_facility: Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 0223)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0158)

location_facility: Ashland-Bellefonte Cancer Center ( Site 0021)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0136)

location_facility: Centro Regional Integrado de Oncologia ( Site 0160)

location_facility: Hospital de la Santa Creu i Sant Pau ( Site 0385)

location_facility: Centrul Medical Medicover Victoria ( Site 0514)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0488)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0524)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 0241)

location_facility: White Plains Hospital Center for Cancer Care ( Site 0007)

location_facility: Zhongshan Hospital of Fudan University ( Site 0808)

location_facility: Instituto do Cancer do Ceara ( Site 0152)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0769)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0101)

location_facility: Azienda Ospedaliera San Gerardo ( Site 0308)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0526)

location_facility: Nacionalinis Vezio Institutas ( Site 0931)

location_facility: University of Arizona Cancer Center - Dignity Health ( Site 0062)

location_facility: McGill University Health Centre ( Site 0111)

location_facility: Euroclinic Hospital Bucharest ( Site 0510)

location_facility: Chang Gung Medical Foundation.Linkou Branch ( Site 0723)

location_facility: Cherkassy Regional Oncological Center ( Site 0613)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0529)

location_facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 0609)

location_facility: Hospital Universitari Vall d Hebron ( Site 0389)

location_facility: UMass Memorial Medical Center ( Site 0030)

location_facility: Providence Regional Cancer Partnership ( Site 0065)

location_facility: ASST Grande Ospedale Metropolitano Niguarda-Oncologia Falck ( Site 0315)

location_facility: University of Nebraska Medical Center ( Site 0047)

location_facility: National Medical Research Radiology Centre ( Site 0535)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0501)

location_facility: Spitalul Judetean de Urgenta .Sf. Ioan cel Nou. ( Site 0503)

location_facility: Hospital Provincial del Centenario ( Site 0131)

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

location_facility: Hospital Privado de Comunidad. ( Site 0130)

location_facility: Pauls Stradins Clinical University Hospital ( Site 0911)

location_facility: MI KhRC Kherson Regional Oncology Dispensary ( Site 0614)

location_facility: S.C.R.T.C.Radiology Therapeutic Center SRL ( Site 0511)

location_facility: National Cancer Center Hospital East ( Site 0761)

location_facility: Harry & Jeanette Weinberg Cancer Institute ( Site 0081)

location_facility: Heartlands Hospital in Birmingham ( Site 0455)

location_facility: National Taiwan University Hospital ( Site 0721)

location_facility: Sirio-Libanes Brasilia - Centro de Oncologia - Asa Sul ( Site 0159)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 0076)

location_facility: Banner MD Anderson Cancer Center ( Site 0028)

location_facility: Evangelische Lungenklinik Berlin ( Site 0274)

location_facility: University of Arizona Cancer Center ( Site 0012)

location_facility: Sun Yat-Sen University Cancer Center ( Site 0816)

location_facility: Juntendo University Hospital ( Site 0768)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0533)

location_facility: SMG-SNU Boramae Medical Center ( Site 0707)

location_facility: UPMC Pinnacle Health System - East Location ( Site 0063)

location_facility: UPMC Hillman Cancer Centers ( Site 0041)

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o. ( Site 0483)

location_facility: Aichi Cancer Center Hospital ( Site 0765)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 0273)

location_facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0053)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0382)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0383)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 0150)

location_facility: Nottingham City Hospital Campus ( Site 0441)

location_facility: Zentralklinik Bad Berka GmbH ( Site 0264)

location_facility: HELIOS Klinikum Emil von Behring ( Site 0280)

location_facility: Plymouth Hospitals NHS Trust ( Site 0443)

location_facility: Zhejiang Cancer Hospital.... ( Site 0814)

location_facility: Hiroshima University Hospital ( Site 0762)

location_facility: Southeastern Regional Medical Center ( Site 0051)

location_facility: Hospital Universitario de Girona Doctor Josep Trueta ( Site 0386)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 0314)

location_facility: Centre Hospitalier Annecy Genevois ( Site 0242)

location_facility: Providence Saint Joseph Medical Center ( Site 0061)

location_facility: Universitaetsklinikum Schleswig Holstein ( Site 0871)

location_facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 0078)

location_facility: IRST-Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori ( Site 0300)

location_facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 0381)

location_facility: St Joseph Heritage Healthcare ( Site 0040)

location_facility: Saint Francis Cancer Center ( Site 0096)

location_facility: Fudan University Shanghai Cancer Center ( Site 0813)

location_facility: Hospital Privado Universitario de Córdoba ( Site 0139)

location_facility: Medical Rehabilitation Center ( Site 0534)

location_facility: Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 0074)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 0145)

location_facility: Peking University Third Hospital ( Site 0812)

location_facility: Helen F. Graham Cancer Center & Research Institute ( Site 0015)

location_facility: Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 0484)

location_facility: Inova Schar Cancer Institute ( Site 0032)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 0605)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0005)

location_facility: Florence Nightingale Krankenhaus ( Site 0874)

location_facility: Universitaetsklinikum Leipzig AOeR ( Site 0277)

location_facility: Municipal Clinical Oncology Center ( Site 0523)

location_facility: University of Iowa Hospital and Clinics ( Site 0010)

location_facility: Katholisches Klinikum Koblenz Haus Marienhof ( Site 0873)

location_facility: IRCCS Ospedale San Raffaele di Milano ( Site 0303)

location_facility: Fukushima Medical University Hospital ( Site 0772)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0146)

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0487)

location_facility: Taipei Veterans General Hospital ( Site 0722)

location_facility: Royal Marsden NHS Foundation Trust ( Site 0458)

location_facility: Kyiv City Clinical Oncological Center ( Site 0601)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0725)

location_facility: Western Regional Medical Center, Inc. ( Site 0050)

location_facility: MI Odessa Regional Oncological Centre ( Site 0608)

location_facility: Hospital Universitario Austral ( Site 0127)

location_facility: Zaporizhzhya Regional Clinical Oncology Center ( Site 0606)

location_facility: John Wayne Cancer Institute ( Site 0049)

location_facility: Centre Hospitalier Metropole Savoie Site de Chambery ( Site 0245)

location_facility: Memorial Sloan Kettering Cancer Center Westchester ( Site 0079)

location_facility: National Cancer Center Hospital ( Site 0767)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0530)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0572)

location_facility: Northwest Oncology and Hematology ( Site 0001)

location_facility: Southwestern Regional Medical Center, Inc. ( Site 0054)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0149)

type: Other Identifier

title: A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)

summary: This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent central review (BICR); and 2) overall survival (OS).


title: 2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

summary: The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Chalasani NP, Porter K, Bhattacharya A, Book AJ, Neis BM, Xiong KM, Ramasubramanian TS, Edwards DK 5th, Chen I, Johnson S, Roberts LR, Kisiel JB, Reddy KR, Singal AG, Olson MC, Bruinsma JJ. Validation of a Novel Multitarget Blood Test Shows High Sensitivity to Detect Early Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2021 Aug 13. pii: S1542-3565(21)00866-1. doi: 10.1016/j.cgh.2021.08.010. [Epub ahead of print]

family: Chalasani

full_name: Naga P. Chalasani

given: Naga P.

family: Porter

full_name: Kyle Porter

given: Kyle

family: Bhattacharya

full_name: Abhik Bhattacharya

given: Abhik

family: Book

full_name: Adam J. Book

given: Adam J.

family: Neis

full_name: Brenda M. Neis

given: Brenda M.

family: Xiong

full_name: Kong M. Xiong

given: Kong M.

family: Ramasubramanian

full_name: Tiruvidaimarudur S. Ramasubramanian

given: Tiruvidaimarudur S.

family: Edwards V

full_name: David K. Edwards V

given: David K.

family: Chen

full_name: Irene Chen

given: Irene

family: Johnson

full_name: Scott Johnson

given: Scott

family: Roberts

full_name: Lewis R. Roberts

given: Lewis R.

family: Kisiel

full_name: John B. Kisiel

given: John B.

family: Reddy

full_name: K Rajender Reddy

given: K Rajender

family: Singal

full_name: Amit G. Singal

given: Amit G.

family: Olson

full_name: Marilyn C. Olson

given: Marilyn C.

family: Bruinsma

full_name: Janelle J. Bruinsma

given: Janelle J.

journal_name: Clinical Gastroenterology and Hepatology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Validation of a novel multi-target blood test shows high sensitivity to detect early-stage hepatocellular carcinoma

ReferenceCitation: Chalasani NP, Ramasubramanian TS, Bhattacharya A, Olson MC, Edwards V DK, Roberts LR, Kisiel JB, Reddy KR, Lidgard GP, Johnson SC, Bruinsma JJ. A Novel Blood-Based Panel of Methylated DNA and Protein Markers for Detection of Early-Stage Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2597-2605.e4. doi: 10.1016/j.cgh.2020.08.065. Epub 2020 Sep 2.

ipd_sharing_description: Individual participant data that underlie the results reported in publications of the study will be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be shared.

location_country:
Italy
United States
France
Thailand
Spain
Germany
Taiwan

location_facility: Hospital of the University of Pennsylvania

location_facility: Methodist Healthcare University Hospital

location_facility: Universidad Autonoma de Madrid - Hospital Universitario La Paz

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Centre Hospitalier Universitaire de Grenoble


title: A Phase 1/2, Open-Label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

summary: The trial is an open-label, multi-center safety trial of epcoritamab GEN3013 (DuoBody®-CD3xCD20). The trial consists of two parts: a dose escalation part phase 1, first-in-human (FIH) and an expansion part phase 2a.

status: Recruiting

ReferenceCitation: Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.

family: Hutchings

full_name: Martin Hutchings

given: Martin

family: Mous

full_name: Rogier Mous

given: Rogier

family: Clausen

full_name: Michael Roost Clausen

given: Michael Roost

full_name: Peter Johnson

given: Peter

family: Linton

full_name: Kim M Linton

given: Kim M

family: Chamuleau

full_name: Martine E D Chamuleau

given: Martine E D

family: Lewis

full_name: David John Lewis

given: David John

family: Sureda Balari

full_name: Anna Sureda Balari

given: Anna

family: Cunningham

full_name: David Cunningham

given: David

family: Oliveri

full_name: Roberto S Oliveri

given: Roberto S

family: Elliott

full_name: Brian Elliott

given: Brian

family: DeMarco

full_name: Dena DeMarco

given: Dena

family: Azaryan

full_name: Ada Azaryan

given: Ada

family: Chiu

full_name: Christopher Chiu

given: Christopher

family: Li

full_name: Tommy Li

given: Tommy

full_name: Kuo-mei Chen

given: Kuo-mei

family: Ahmadi

full_name: Tahamtan Ahmadi

given: Tahamtan

family: Lugtenburg

full_name: Pieternella J Lugtenburg

given: Pieternella J

journal_name: The Lancet

ipd_sharing: No

lead_sponsor: Genmab

location_country:
Italy
United States
Sweden
Netherlands
Germany
Finland
France
Poland
Singapore
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of

location_facility: Akademiska sjukhuset Uppsala University Hospital

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

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Hospital Universitario Fundacin Jimnez Daz

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Northside Hospital- The Blood Marrow Transplant Group

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: University of Wisconsin Carbone Cancer Center

location_facility: Seoul National University Bundang Hospital

location_facility: Policlinico S. Orsola-Ematologia LA Seragnoli

location_facility: Klinik fur Innere Medizin Hamatologie and Onkologie

location_facility: Integrated Clinical Oncology Network Pty Ltd (ICON)

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: Keimyung University Dongsan Medical Center

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego

location_facility: Der Universität Munchen Medizinische Klinik III LMU

location_facility: Plymouth University School of Medicine- Derriford Hospital

location_facility: University of California at San Francisco

intervention_type: Biological


title: A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)

summary: The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based chemotherapy.

lead_sponsor: Incyte Corporation

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

location_facility: Centre Hospitalier Universitaire de Besancon

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Hospital General Universitari Vall D Hebron

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

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

location_facility: Texas Oncology-Baylor Charles A. Sammons

location_facility: A.O.U. Policlinico V. Emanuele G. Rodolico

location_facility: University Medical Centre Hamburg-Eppendorf, Centre of Oncology


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies

acronym: AFFINITY

summary:
The primary objective of Part 1 of this study is to evaluate the effects of BIIB033 versus placebo on disability improvement over 72 weeks. The primary objective of Part 2 of this study is to evaluate the long-term safety profile of BIIB033 as an add-on therapy in participants with MS.

The secondary objective of Part 1 is to evaluate the effects of BIIB033 versus placebo on additional measures of disability improvement. The secondary objective of Part 2 is to investigate long-term efficacy (disability improvement) and additional safety measures of BIIB033 as an add-on therapy in participants with MS.

status: Terminated

ReferenceCitation: Hanf KJM, Arndt JW, Liu Y, Gong BJ, Rushe M, Sopko R, Massol R, Smith B, Gao Y, Dalkilic-Liddle I, Lee X, Mojta S, Shao Z, Mi S, Pepinsky RB. Functional activity of anti-LINGO-1 antibody opicinumab requires target engagement at a secondary binding site. MAbs. 2020 Jan-Dec;12(1):1713648. doi: 10.1080/19420862.2020.1713648.

name: Biotherapeutic and Medicinal Sciences, Biogen, Cambridge, MA, USA

family: Hanf

full_name: Karl J. M. Hanf

given: Karl J. M.

family: Arndt

full_name: Joseph W. Arndt

given: Joseph W.

family: Liu

full_name: YuTing Liu

given: YuTing

family: Gong

full_name: Bang Jian Gong

given: Bang Jian

family: Rushe

full_name: Mia Rushe

given: Mia

family: Sopko

full_name: Richelle Sopko

given: Richelle

name: Research and Early Development, Biogen, Cambridge, MA, USA

family: Massol

full_name: Ramiro Massol

given: Ramiro

family: Smith

full_name: Benjamin Smith

given: Benjamin

family: Gao

full_name: Yan Gao

given: Yan

family: Dalkilic-Liddle

full_name: Isin Dalkilic-Liddle

given: Isin

family: Lee

full_name: Xinhua Lee

given: Xinhua

family: Mojta

full_name: Shanell Mojta

given: Shanell

family: Shao

full_name: Zhaohui Shao

given: Zhaohui

family: Mi

full_name: Sha Mi

given: Sha

family: Pepinsky

full_name: R. Blake Pepinsky

given: R. Blake

currency_apc_doaj: GBP

journal_name: mAbs

oa_colors: green gold

oa_host_type: publisher;repository

evidence: open (via free pdf)

license_normalized: no license

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

host_type: repository

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Biogen

location_country:
Italy
United States
Switzerland
Netherlands
Germany
France
Czechia
Poland
Israel
Hungary
Belgium
Australia
Spain
Canada
United Kingdom


design_allocation: Non-Randomized

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

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

lead_sponsor: Eli Lilly and Company

location_country:
Italy
United States
Mexico
Spain
Germany
France
Czechia
Japan
Israel
Poland
Hungary
Argentina
Australia
Puerto Rico
Russian Federation
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: National Taiwan University Hospital Hsin-Chu

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: The South Bend Clinic Center for Research

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: California Dermatology & Clinical Research Institute

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Presidio Ospedaliero Firenze Centro Piero Palagi

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Shiga University of Medical Science Hosptial

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

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

location_facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii

location_facility: DermoDent Centrum Medyczne Aldona Czajkowska Rafał Czajkowski s.c.

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Instituto de Neumonología y Dermatología

location_facility: Keck School of Medicine University of Southern California

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

location_facility: University of North Carolina Dermatology and Skin Cancer Cen

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Seoul National University Bundang Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: NZOZ Specjalistyczna Przychodnia Dermatologiczna Specderm

location_facility: Toho University School of Medicine, Sakura Hospital

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Kyoto Furitsu Medical University Hospital

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Florida Academic Centers Research and Education, LLC

location_facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

location_facility: Clinica De Enfermedades Cronicas y Procedimientos Especiales

location_facility: Eastern Canada Cutaneous Research Assoicates Ltd

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: The Pennsylvania Centre for Dermatology, LLC

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: University Hospitals Cleveland Medical Center

location_facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C

location_facility: Tokyo Medical University Ibaraki Medical Center

location_facility: GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'

title: A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3

summary: The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.


ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Italy
United States
Germany
France
Czechia
Japan
Israel
Poland
Hungary
Argentina
Australia
Puerto Rico
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: The Guenther Dermatology Research Centre

location_facility: LASER CLINIC Specjalistyczne Gabinety Lekarskie

location_facility: Austin Institute for Clinical Research, Inc.

location_facility: Bakersfield Dermatology and Skin Cancer Medical Group

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem, o.z.

location_facility: Presidio Ospedaliero Firenze Centro Piero Palagi

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

location_facility: Psoriasis Treatment Center of Central New Jersey

location_facility: Shiga University of Medical Science Hosptial

location_facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology

location_facility: Centralny Szpital Kliniczny MSW Klinika Dermatologii

location_facility: CEDIC-Centro de Investigaciones Clinicas

location_facility: California Dermatology and Clinical Research Institute

location_facility: Instituto de Neumonología y Dermatología

location_facility: Keck School of Medicine University of Southern California

location_facility: Kyoto Prefectural University of Medicine

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

location_facility: University of North Carolina Dermatology and Skin Cancer Cen

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Elbe Kliniken Stade Buxtehude GmbH Klinikum Buxtehude

location_facility: Seoul National University Bundang Hospital

location_facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

location_facility: San Luis Dermatology & Laser Clinic, Inc

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-2

summary: The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

status_simplified: Completed


title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients

acronym: POTOMAC

summary: This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer.

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.

lead_sponsor: AstraZeneca

location_country:
Austria
Netherlands
Germany
France
Japan
Poland
Slovakia
Australia
Belgium
Russian Federation
Spain
Canada
United Kingdom


title: A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

summary: This is a 30-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.

lead_sponsor: Apellis Pharmaceuticals, Inc.

location_country:
Italy
Brazil
United States
Netherlands
Germany
France
Czechia
Poland
Israel
Australia
New Zealand
Spain
Canada
United Kingdom

location_facility: Northwestern Feinberg School of Medicine

location_facility: New York Eye and Ear Infirmary of Mount Sinai

location_facility: Radboud University Medical Center Oogheelkunde

location_facility: Centre Ophtalmologique d'Imagerie et Laser

location_facility: Byers Eye Institute at Stanford, Stanford School of Medicine

location_facility: University of California, San Diego, Jacobs Retina

location_facility: Vision Research Center Eye Associates of NM

location_facility: Liverpool University Hospitals NHS Foundation Trust

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: Retina Vitreous Associates Medical Group

location_facility: National Ophthalmic Research Institute (Retina Consultants of Southwest Florida)

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Vitreous Retina Macula Consultants of NY

location_facility: Blue Ocean Clinical Research / The Macula Center

location_facility: University of Utah - John A. Moran Center

location_facility: Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky

intervention_type: Other


ReferenceCitation: Choueiri TK, Tomczak P, Park SH, Venugopal B, Ferguson T, Chang YH, Hajek J, Symeonides SN, Lee JL, Sarwar N, Thiery-Vuillemin A, Gross-Goupil M, Mahave M, Haas NB, Sawrycki P, Gurney H, Chevreau C, Melichar B, Kopyltsov E, Alva A, Burke JM, Doshi G, Topart D, Oudard S, Hammers H, Kitamura H, Bedke J, Perini RF, Zhang P, Imai K, Willemann-Rogerio J, Quinn DI, Powles T; KEYNOTE-564 Investigators. Adjuvant Pembrolizumab after Nephrectomy in Renal-Cell Carcinoma. N Engl J Med. 2021 Aug 19;385(8):683-694. doi: 10.1056/NEJMoa2106391.

name: From Dana–Farber Cancer Institute, Boston (T.K.C.); Poznan University of Medical Sciences, Poznan (P.T.), and Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu, Torun (P.S.) — both in Poland; Sungkyunkwan University, Samsung Medical Center (S.H.P.), and Asan Medical Center, University of Ulsan College of Medicine (J.L.L.) — both in Seoul, South Korea; Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow (B.V.), Edinburgh Cancer Centre and University of Edinburgh, Edinburgh (S.N...

family: Choueiri

full_name: Toni K. Choueiri

given: Toni K.

family: Tomczak

full_name: Piotr Tomczak

given: Piotr

family: Park

full_name: Se Hoon Park

given: Se Hoon

family: Venugopal

full_name: Balaji Venugopal

given: Balaji

family: Ferguson

full_name: Thomas Ferguson

given: Thomas

family: Chang

full_name: Yen-Hwa Chang

given: Yen-Hwa

family: Hajek

full_name: Jaroslav Hajek

given: Jaroslav

family: Symeonides

full_name: Stefan N. Symeonides

given: Stefan N.

full_name: Jae Lyun Lee

given: Jae Lyun

family: Sarwar

full_name: Naveed Sarwar

given: Naveed

family: Thiery-Vuillemin

full_name: Antoine Thiery-Vuillemin

given: Antoine

family: Gross-Goupil

full_name: Marine Gross-Goupil

given: Marine

family: Mahave

full_name: Mauricio Mahave

given: Mauricio

family: Haas

full_name: Naomi B. Haas

given: Naomi B.

family: Sawrycki

full_name: Piotr Sawrycki

family: Gurney

full_name: Howard Gurney

given: Howard

family: Chevreau

full_name: Christine Chevreau

given: Christine

family: Melichar

full_name: Bohuslav Melichar

given: Bohuslav

family: Kopyltsov

full_name: Evgeniy Kopyltsov

given: Evgeniy

family: Alva

full_name: Ajjai Alva

given: Ajjai

family: Burke

full_name: John M. Burke

given: John M.

family: Doshi

full_name: Gurjyot Doshi

given: Gurjyot

family: Topart

full_name: Delphine Topart

given: Delphine

family: Oudard

full_name: Stephane Oudard

given: Stephane

family: Hammers

full_name: Hans Hammers

given: Hans

ReferenceCitation: Marconi L, Sun M, Beisland C, Klatte T, Ljungberg B, Stewart GD, Dabestani S, Choueiri TK, Bex A. Prevalence, Disease-free, and Overall Survival of Contemporary Patients With Renal Cell Carcinoma Eligible for Adjuvant Checkpoint Inhibitor Trials. Clin Genitourin Cancer. 2021 Apr;19(2):e92-e99. doi: 10.1016/j.clgc.2020.12.005. Epub 2021 Jan 7.

location_country:
Finland
Australia
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Chile
Netherlands
Ireland
United States
Germany
United Kingdom
Italy
Brazil
Czechia
Spain

acronym: Ph 3 Placebo-Controlled Trial of Adjuvant MK-3475 in RCC Post Nephrectomy

location_facility: Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)

location_facility: Hospital Universitario Infanta Cristina ( Site 1805)

location_facility: Kumamoto University Hospital ( Site 0434)

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 2201)

location_facility: St. Vincent Healthcare Frontier Cancer Center ( Site 0008)

location_facility: University of Iowa Hospital and Clinics ( Site 0031)

location_facility: Oncologos del Occidente S.A. ( Site 0800)

location_facility: Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)

location_facility: Hospital Clinico Universidad de Chile ( Site 0905)

location_facility: Centrum Medyczne Onkologii I Hipertermii ( Site 1321)

location_facility: Beth Israel Deaconess Medical Ctr. ( Site 0044)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)

location_facility: Dana-Farber Cancer Institute (Boston) ( Site 0007)

location_facility: Oulun yliopistollinen sairaala - OYS ( Site 2304)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)

location_facility: Universitaetsklinikum Tuebingen ( Site 2100)

location_facility: Osaka International Cancer Institute ( Site 0401)

location_facility: Taipei Veterans General Hospital ( Site 0201)

location_facility: Bayandin Murmansk Regional Clinical Hospital ( Site 1214)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0904)

location_facility: Niagara Health System - St. Catharines ( Site 0120)

location_facility: Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)

location_facility: Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1316)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1209)

location_facility: Universidade de Caxias do Sul ( Site 1004)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)

location_facility: Nara Medical University Hospital ( Site 0416)

location_facility: Hospital Universitario Gregorio Maranon ( Site 1801)

location_facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)

location_facility: Providence Regional Cancer Partnership ( Site 0016)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 2200)

location_facility: Clinica Universitaria de Navarra ( Site 1803)

location_facility: Hospital de Girona Dr. Josep Trueta ( Site 1806)

location_facility: Hospital Regional de La Serena ( Site 0907)

location_facility: USC Norris Comprehensive Cancer Center ( Site 0038)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)

location_facility: St Vincents University Hospital ( Site 1610)

location_facility: Universitaetsklinikum Freiburg ( Site 2119)

location_facility: Northwest Medical Specialties, PLLC ( Site 0034)

location_facility: Istituto Europeo di Oncologia ( Site 2000)

location_facility: Urology Associates [Nashville, TN] ( Site 0063)

location_facility: Instituto Nacional de Cancerologia E.S.E ( Site 0807)

location_facility: Yamaguchi University Hospital ( Site 0406)

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)

location_facility: Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)

location_facility: Fairview Southdale Medical Oncology Clinic ( Site 0041)

location_facility: Park Nicollet Frauenshuh Cancer Center ( Site 0020)

location_facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)

location_facility: Hospital Militar de Santiago ( Site 0911)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 1013)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)

location_facility: Illinois Cancer Specialists ( Site 8001)

location_facility: Nippon Medical School Hospital ( Site 0400)

location_facility: CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)

location_facility: Centro Oncologico Antofagasta ( Site 0914)

location_facility: Hospital de la Santa Creu i Sant Pau ( Site 1807)

location_facility: Saint George Hospital [Kogarah, Australia] ( Site 0707)

location_facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)

location_facility: Oncology Hematology Care, Inc. ( Site 8008)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)

location_facility: Osaka City University Hospital ( Site 0428)

location_facility: Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)

location_facility: Georgetown University Medical Center ( Site 0002)

location_facility: Hospital Nossa Senhora da Conceicao ( Site 1000)

location_facility: Severance Hospital Yonsei University Health System ( Site 0303)

location_facility: Macquarie University Hospital ( Site 0700)

location_facility: St-Jerome Medical Research Inc ( Site 0103)

location_facility: Medical University of South Carolina ( Site 0033)

location_facility: Universitaetsklinikum Frankfurt ( Site 2121)

location_facility: Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)

location_facility: Minnesota Oncology Specialist, PA ( Site 8002)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 1208)

location_facility: Casa de Saude Santa Marcelina ( Site 1006)

location_facility: University of Wisconsin Carbone Cancer Center ( Site 0019)

location_facility: Universitaetsklinikum Schleswig Holstein ( Site 2109)

location_facility: Clinical Hospital Bashkirsky Medical State University ( Site 1202)

location_facility: The James Cook University Hospital ( Site 1606)

location_facility: Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)

location_facility: China Medical University Hospital ( Site 0200)

location_facility: Medical Oncology Ospedale San Donato ( Site 2004)

location_facility: Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)

location_facility: Rocky Mountain Cancer Center ( Site 8010)

location_facility: Manatee Medical Research Institute ( Site 0039)

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)

location_facility: Seoul National University Hospital ( Site 0302)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0902)

location_facility: University of New Mexico Cancer Center ( Site 0043)

location_facility: Virginia Oncology Associates ( Site 8011)

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)

location_facility: Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)

location_facility: IHO Corporation- Utah Cancer Specialists ( Site 0055)

location_facility: UT Southwestern Medical Center ( Site 0003)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)

location_facility: Fundacao Dr Amaral Carvalho ( Site 1005)

location_facility: Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)

location_facility: Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)

location_facility: Nebraska Cancer Specialists ( Site 0012)

location_facility: Hospital Pablo Tobon Uribe. ( Site 0805)

location_facility: Texas Oncology-Memorial City ( Site 8015)

location_facility: St George s Healthcare Trust ( Site 1608)

location_facility: Niigata University Medical & Dental Hospital ( Site 0421)

location_facility: Universitaetsklinikum Jena. ( Site 2104)

location_facility: UTHealth/Memorial Hermann Cancer Center ( Site 0001)

location_facility: North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)

location_facility: Arizona Oncology Associates, PC- HAL ( Site 8018)

location_facility: St. Luke's University Health Network ( Site 0042)

location_facility: Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8013)

location_facility: Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)

location_facility: National Medical Research Radiology Centre ( Site 1200)

location_facility: Istituto Nazionale Tumori Regina Elena ( Site 2009)

location_facility: National Taiwan University Hospital ( Site 0202)

location_facility: Charleston Hematology Oncology Associates PA ( Site 8000)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 0203)

location_facility: Saitama Medical University International Medical Center ( Site 0404)

location_facility: CISSS-CA Hotel Dieu de Levis ( Site 0111)

location_facility: University Medical Center New Orleans ( Site 0053)

location_facility: Centro Oncologico de Integracion Regional. COIR ( Site 1109)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)

location_facility: Keski-Suomen keskussairaala ( Site 2303)

location_facility: Instituto Medico Alexander Fleming ( Site 1105)

location_facility: Helios Klinikum Berlin Buch ( Site 2125)

location_facility: Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)

location_facility: Hopital Europeen Georges Pompidou ( Site 2206)

location_facility: Sociedad de Investigaciones Medicas Limitadas ( Site 0913)

location_facility: Universitatsklinikum Dusseldorf ( Site 2108)

location_facility: Hospital Universitario Ramon y Cajal ( Site 1800)

location_facility: Japan Community Health care Organization Sendai Hospital ( Site 0430)

location_facility: Instituto de Oncologia de Rosario ( Site 1100)

location_facility: Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)

location_facility: Texas Oncology-Austin Central ( Site 8003)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0014)

location_facility: COT Centro Oncologico do Triangulo Ltda ( Site 1014)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)

location_facility: Woodlands Medical Specialists, PA ( Site 8021)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)

location_facility: London Regional Cancer Program - London HSC ( Site 0107)

location_facility: Universitaetsklinikum Essen ( Site 2116)

location_facility: Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)

location_facility: Dr. Leon Richard Oncology Centre ( Site 0106)

location_facility: Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8006)

location_facility: Hospital Universitario Virgen de la Victoria ( Site 1808)

location_facility: Ivanovo Regional Oncology Dispensary ( Site 1204)

location_facility: The Christie NHS Foundation Trust ( Site 1602)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)

location_facility: Centro Oncologico Riojano Integral ( Site 1101)

location_facility: University Hospital Waterford ( Site 1614)

location_facility: Instituto Nacional del Cancer ( Site 0912)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 0046)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1201)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0059)

location_facility: Taichung Veterans General Hospital ( Site 0204)

location_facility: Maryland Oncology Hematology, P.A. ( Site 8020)

location_facility: Sapporo Medical University Hospital ( Site 0424)

location_facility: Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)

location_facility: Texas Oncology-Denton South ( Site 8016)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1605)

location_facility: William Osler Health System ( Site 0115)

location_facility: Fakultni nemocnice v Motole ( Site 1504)

location_facility: Instituto Valenciano de Oncologia ( Site 1804)

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)

location_facility: Administradora Country SA - Clinica del Country ( Site 0808)

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

summary:
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component.

The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.


title: An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)

summary: This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.

ReferenceCitation: Kang YK, George S, Jones RL, Rutkowski P, Shen L, Mir O, Patel S, Zhou Y, von Mehren M, Hohenberger P, Villalobos V, Brahmi M, Tap WD, Trent J, Pantaleo MA, Schöffski P, He K, Hew P, Newberry K, Roche M, Heinrich MC, Bauer S. Avapritinib Versus Regorafenib in Locally Advanced Unresectable or Metastatic GI Stromal Tumor: A Randomized, Open-Label Phase III Study. J Clin Oncol. 2021 Oct 1;39(28):3128-3139. doi: 10.1200/JCO.21.00217. Epub 2021 Aug 3.

name: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

name: Department of Medical Oncology, Sarcoma Center, Dana Farber Cancer Institute, Boston, MA

family: George

full_name: Suzanne George

given: Suzanne

name: Royal Marsden Hospital and Institute of Cancer Research, London, UK

family: Jones

full_name: Robin L. Jones

given: Robin L.

name: Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

name: Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing, China

family: Shen

full_name: Lin Shen

given: Lin

name: Institut Gustave Roussy, Villejuif, France

family: Mir

full_name: Olivier Mir

given: Olivier

name: Department of Sarcoma Medical Oncology, MD Anderson Cancer Center, Houston, TX

family: Patel

full_name: Shreyaskumar Patel

given: Shreyaskumar

name: Fujian Medical University, Fujian, China

family: Zhou

full_name: Yongjian Zhou

given: Yongjian

name: Department of Hematology Oncology, Fox Chase Cancer Center, Philadelphia, PA

family: von Mehren

full_name: Margaret von Mehren

given: Margaret

name: Division of Surgical Oncology and Thoracic Surgery, University of Heidelberg (UMM), Mannheim, Germany

family: Hohenberger

full_name: Peter Hohenberger

given: Peter

name: Division of Medical Oncology, University of Colorado School of Medicine, Aurora, CO

name: Currently at Janssen Oncology, Aurora, CO

family: Villalobos

full_name: Victor Villalobos

given: Victor

family: Brahmi

full_name: Mehdi Brahmi

given: Mehdi

name: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY

family: Tap

full_name: William D. Tap

given: William D.

name: Department of Medicine, University of Miami-Sylvester Comprehensive Cancer Center, Miami, FL

family: Trent

full_name: Jonathan Trent

given: Jonathan

name: IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

family: Pantaleo

full_name: Maria A. Pantaleo

given: Maria A.

name: Department of General Medicine Oncology, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium

family: Schöffski

full_name: Patrick Schöffski

given: Patrick

name: Blueprint Medicines Corporation, Cambridge, MA

family: He

full_name: Kevin He

given: Kevin

family: Hew

full_name: Paggy Hew

given: Paggy

family: Newberry

full_name: Kate Newberry

given: Kate

family: Roche

full_name: Maria Roche

given: Maria

name: Portland VA Health Care System and OHSU Knight Cancer Institute, Portland, OR

family: Heinrich

full_name: Michael C. Heinrich

given: Michael C.

name: Department of Medical Oncology, Sarcoma Center, West German Cancer Center, DKTK-Partner-Site, University of Duisburg-Essen, Essen, Germany

family: Bauer

full_name: Sebastian Bauer

given: Sebastian

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Gebreyohannes YK, Wozniak A, Zhai ME, Wellens J, Cornillie J, Vanleeuw U, Evans E, Gardino AK, Lengauer C, Debiec-Rychter M, Sciot R, Schöffski P. Robust Activity of Avapritinib, Potent and Highly Selective Inhibitor of Mutated KIT, in Patient-derived Xenograft Models of Gastrointestinal Stromal Tumors. Clin Cancer Res. 2019 Jan 15;25(2):609-618. doi: 10.1158/1078-0432.CCR-18-1858. Epub 2018 Oct 1.

publisher: American Association for Cancer Research (AACR)

location_country:
Italy
Austria
United States
Sweden
Netherlands
Spain
Germany
France
Czechia
Poland
Singapore
Hungary
Australia
Belgium
China
Canada
United Kingdom
Korea, Republic of

location_facility: The University of Chicago Medical Center

location_facility: Universita degli Studi di Palermo - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

location_facility: Studienzentrale GbR Lübecker Onkologische Schwerpunktpraxis Dres. med. Uthgenannt

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Magyar Honvédség Egészségügyi Központ Onkológiai Osztály

location_facility: Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Onkologická klinika Fakultní nemocnice Olomouc

location_facility: Washington Hospital Center - Oncology and Hematology

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z W-MCO

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

location_facility: Fundacion Instituto Valenciano de Oncologia, Servicio de Oncologia

location_facility: Dolnoslaskie Centrum Onkologii we Wrocawiu

location_facility: Shanghai Jiaotong University School of Medicine, Renji Hospital

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Maria Skodowska Curie Memorial Cancer Centre and Institute of Oncology

location_facility: Azienda Ospedaliero Universitaria Sant'Orsola Malpighi

location_facility: Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: AOUC Azienda Ospedaliero - Universitaria Careggi

location_facility: The Sixth Affiliated Hospital of Sun Yat-Sen University

location_facility: Harbin Medical University Cancer Hospital

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Sanodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwesytecki w Krakowie, Oddzial Kliniczny Onkologii

location_facility: Fovarosi Onkormanyzat Szent Laszlo Korhaz

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals

location_facility: The First Affiliated Hospital of Nanchang Medical University

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori Milano

location_facility: Affiliated Cancer Hospital of Xinjiang Medical University

location_facility: The First Affiliated Hospital of Sun Yat-sen University

location_facility: Fujian Medical University Union Hospital


ReferenceCitation: Pagano G, Boess FG, Taylor KI, Ricci B, Mollenhauer B, Poewe W, Boulay A, Anzures-Cabrera J, Vogt A, Marchesi M, Post A, Nikolcheva T, Kinney GG, Zago WM, Ness DK, Svoboda H, Britschgi M, Ostrowitzki S, Simuni T, Marek K, Koller M, Sevigny J, Doody R, Fontoura P, Umbricht D, Bonni A; PASADENA Investigators; Prasinezumab Study Group. A Phase II Study to Evaluate the Safety and Efficacy of Prasinezumab in Early Parkinson's Disease (PASADENA): Rationale, Design, and Baseline Data. Front Neurol. 2021 Oct 1;12:705407. doi: 10.3389/fneur.2021.705407. eCollection 2021.

family: Pagano

full_name: Gennaro Pagano

given: Gennaro

family: Boess

full_name: Frank G. Boess

given: Frank G.

family: Taylor

full_name: Kirsten I. Taylor

given: Kirsten I.

family: Ricci

full_name: Benedicte Ricci

given: Benedicte

family: Mollenhauer

full_name: Brit Mollenhauer

given: Brit

family: Poewe

full_name: Werner Poewe

given: Werner

family: Boulay

full_name: Anne Boulay

given: Anne

family: Anzures-Cabrera

full_name: Judith Anzures-Cabrera

given: Judith

family: Vogt

full_name: Annamarie Vogt

given: Annamarie

family: Marchesi

full_name: Maddalena Marchesi

given: Maddalena

family: Post

full_name: Anke Post

given: Anke

family: Nikolcheva

full_name: Tania Nikolcheva

given: Tania

family: Kinney

full_name: Gene G. Kinney

given: Gene G.

family: Zago

full_name: Wagner M. Zago

given: Wagner M.

family: Ness

full_name: Daniel K. Ness

given: Daniel K.

family: Svoboda

full_name: Hanno Svoboda

given: Hanno

family: Britschgi

full_name: Markus Britschgi

given: Markus

family: Ostrowitzki

full_name: Susanne Ostrowitzki

given: Susanne

family: Simuni

full_name: Tanya Simuni

given: Tanya

family: Marek

full_name: Kenneth Marek

given: Kenneth

family: Koller

full_name: Martin Koller

given: Martin

family: Sevigny

full_name: Jeff Sevigny

given: Jeff

family: Doody

full_name: Rachelle Doody

given: Rachelle

family: Fontoura

full_name: Paulo Fontoura

given: Paulo

family: Umbricht

full_name: Daniel Umbricht

given: Daniel

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

ReferenceCitation: Jankovic J, Goodman I, Safirstein B, Marmon TK, Schenk DB, Koller M, Zago W, Ness DK, Griffith SG, Grundman M, Soto J, Ostrowitzki S, Boess FG, Martin-Facklam M, Quinn JF, Isaacson SH, Omidvar O, Ellenbogen A, Kinney GG. Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti-α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease: A Randomized Clinical Trial. JAMA Neurol. 2018 Oct 1;75(10):1206-1214. doi: 10.1001/jamaneurol.2018.1487.

name: Parkinson’s Disease Center and Movement Disorders Clinic, Department of Neurology, Baylor College of Medicine, Houston, Texas

name: Prothena Biosciences Inc, South San Francisco, California

name: ClinPharma Resources, San Diego, California

name: Global R&D Partners, LLC, San Diego, California

name: Genentech Inc, Product Development, Neuroscience, South San Francisco, California

name: F. Hoffmann-La Roche Ltd, Basel, Switzerland

name: Oregon Health & Science University, Portland

name: Portland Veterans Affairs Medical Center, Portland, Oregon

name: Parkinson’s Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida

name: Collaborative Neuroscience Network LLC, Long Beach, California

name: QUEST Research Institute, Farmington Hills, Michigan

title: Safety and Tolerability of Multiple Ascending Doses of PRX002/RG7935, an Anti–α-Synuclein Monoclonal Antibody, in Patients With Parkinson Disease

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

location_country:
Austria
Germany
France
Spain
United States

location_facility: Philipps Universität Marburg; Klinik für Neurologie

location_facility: Hopital Henri Mondor; Service de Neurologie

location_facility: Medizinische Universität Innsbruck; Universitätsklinik für Neuroradiologie

location_facility: Cleveland Clinic Lou Ruvo; Center for Brain Research

location_facility: CHU Rouen Charles Nicolle; Centre Expert Parkinson Hôpitaux de Rouen

location_facility: Parkinson's Institute and Clinical Center

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Fundacion Jimenez Diaz; Servicio de Neurología

location_facility: Policlínica Guipuzcoa; Servicio de Neurología

location_facility: Sentara Medical Group Sentara Neurology Specialists

location_facility: Hospital Clinic de Barcelona; Neurologia

location_facility: Klinik und Poliklinik für Neurologie Universitätsklinikum

location_facility: Associated Neurologists of Southern CT PC

location_facility: Rocky Mountain Movement Disorders Center

location_facility: The Movement Disorder Clinic of Oklahoma

location_facility: Hospital Vithas Santa Catalina Las Palmas

location_facility: Barrow Neurology Clinics; Movement Disorders Program

location_facility: Hôpital Michallon - Centre d'Investigation Clinique; Unité de Pharmacologie Clinique - Inserm

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: Aventura Neurologic Associates; Department of Research

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia

location_facility: University of California at San Francisco

location_facility: Altman Clinical Translational Research Institute

location_facility: Hospital Universitario de la Princesa; Servicio de Neurologia

location_facility: University of Vermont Medical Center; Investigational Drug Service, Pharmacy Department/Baird 1

location_facility: USF Parkinsons Disease and Movement Disorders Center

title: A Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment Extension

summary: This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous prasinezumab (RO7046015/PRX002) versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of three parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2). Participants who complete Part 2 (including the 12-week treatment-free follow up visit assessing long term safety and efficacy of RO7046015) will be offered participation in Part 3 open-label extension (all-participants-on-RO7046015-treatment) for an additional 260 weeks.