lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Belgium
Australia
Russian Federation
Taiwan
Ukraine
Costa Rica
France
Japan
Poland
Canada
Korea, Republic of
Colombia
Hungary
Ireland
Puerto Rico
Portugal
China
United States
Germany
United Kingdom
Brazil
Israel
New Zealand
Spain

acronym: Phase III study of pembrolizumab for high-risk early-stage ER+/HER2– breast cancer

location_facility: Zhejiang Provincial People's Hospital ( Site 3225)

location_facility: Fundacion Colombiana de Cancerologia Clinica Vida ( Site 0405)

location_facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0066)

location_facility: Baptist MD Anderson Cancer Center ( Site 0014)

location_facility: Kitasato University Hospital ( Site 2616)

location_facility: CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0101)

location_facility: Virginia Oncology Associates ( Site 8001)

location_facility: Caritas Klinikum Saarbruecken St. Theresia ( Site 1009)

location_facility: MI Odessa Regional Oncological Centre ( Site 2714)

location_facility: Szpitale Pomorskie Sp. z o.o. ( Site 1818)

location_facility: Instituto Nacional de Cancer - INCA HC III ( Site 0200)

location_facility: China Medical University Hospital ( Site 2401)

location_facility: Kumamoto University Hospital ( Site 2602)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1800)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 3220)

location_facility: Hospital Metropolitano - Sede Lindora ( Site 4203)

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 7000)

location_facility: Hospital Clinico Universitario de Valencia ( Site 1355)

location_facility: CEPON - Centro de Pesquisas Oncologicas ( Site 0208)

location_facility: Hospital Clinico San Carlos ( Site 1354)

location_facility: Texas Oncology-Austin Central ( Site 8004)

location_facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 3213)

location_facility: Fudan University Shanghai Cancer Center ( Site 3205)

location_facility: Centro de Investigacion Clinica del Country ( Site 0402)

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer ( Site 0210)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 2907)

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

location_facility: Fujian Medical University Union Hospital-1 Bingfanglou-Oncology ( Site 3207)

location_facility: Complejo Hospitalario de Jaen ( Site 1364)

location_facility: Universitaetsklinikum Carl Gustav Carus ( Site 1008)

location_facility: Goshen Center for Cancer Care ( Site 0021)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 1810)

location_facility: MercyOne Waterloo Cancer Center ( Site 0016)

location_facility: Midwestern Regional Medical Center, Inc. ( Site 0077)

location_facility: Fourth Hospital Of Hebei Medical University ( Site 3216)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0083)

location_facility: Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 0204)

location_facility: Hyogo College of Medicine Hospital ( Site 2600)

location_facility: Peter MacCallum Cancer Centre ( Site 2102)

location_facility: Zhejiang Cancer Hospital.... ( Site 3210)

location_facility: Hospital Universitario 12 de Octubre ( Site 1356)

location_facility: Cancer Treatment Centers of America at Western Regional Medical Center ( Site 0001)

location_facility: Orchard Healthcare Research Inc. ( Site 0020)

location_facility: Harbin Medical University Cancer Hospital ( Site 3200)

location_facility: MI Kryviy Rih Center of Dnipropetrovsk Regional Council ( Site 2700)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi OktatoKorhaz ( Site 2904)

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0039)

location_facility: Bialostockie Centrum Onkologii ( Site 1819)

location_facility: MGH Newton-Wellesley Hospital's Vernon Cancer Center ( Site 0082)

location_facility: Hospital Teresa Herrera - Chuac ( Site 1358)

location_facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1700)

location_facility: Universitaetsklinikum Erlangen ( Site 1001)

location_facility: El Camino Hospital Cancer Center ( Site 0004)

location_facility: CHU UCL Namur Site de Godinne ( Site 0706)

location_facility: The First Hospital of Jilin University ( Site 3201)

location_facility: Cedars Sinai Medical Center Samuel Oschin Comp. Cancer Institute ( Site 0079)

location_facility: Kadlec Clinic Hematology and Oncology ( Site 0070)

location_facility: Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 1363)

location_facility: Gynaekologisch-onkologische Praxis Hannover ( Site 1013)

location_facility: National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 26

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0925)

location_facility: Kyiv City Clinical Oncology Centre ( Site 2716)

location_facility: Fundacion Universitaria Sanitas ( Site 0403)

location_facility: Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1807)

location_facility: Colchester General Hospital ( Site 1508)

location_facility: Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 0207)

location_facility: Associacao Hospitalar Moinhos de Vento ( Site 0201)

location_facility: Medical University of South Carolina ( Site 0053)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 2915)

location_facility: James Graham Brown Cancer Center ( Site 0022)

location_facility: Medical Rehabilitation Center ( Site 1912)

location_facility: National Cancer Center Hospital East ( Site 2613)

location_facility: Saitama Medical University International Medical Center ( Site 2606)

location_facility: Central Clinical Hospital with outpatient Clinic ( Site 1907)

location_facility: Dnipropetrovsk City Multidiscipline Clinical Hosp. 4 of DRC ( Site 2702)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1903)

location_facility: National Cheng Kung University Hospital ( Site 2400)

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8009)

location_facility: Wojewodzkie Centrum Onkologii Copernicus ( Site 1817)

location_facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 2502)

location_facility: Centre Hospitalier Regional de Trois-Rivieres ( Site 0106)

location_facility: Massachusetts General Hospital ( Site 0024)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 1803)

location_facility: Northwest Cancer Specialists, P.C. ( Site 8000)

location_facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1901)

location_facility: National Cancer Institute of the MoH of Ukraine ( Site 2719)

location_facility: Hospital Clinic I Provincial de Barcelona ( Site 1353)

location_facility: Dolnoslaskie Centrum Onkologii. ( Site 1820)

location_facility: University of Colorado Cancer Center ( Site 0008)

location_facility: Hospital Ruber Internacional ( Site 1370)

location_facility: Aichi Cancer Center Hospital ( Site 2601)

location_facility: UC Davis Comprehensive Cancer Center ( Site 0073)

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 1004)

location_facility: The First Affiliated Hospital of Zhejiang University ( Site 3203)

location_facility: Jessa Ziekenhuis Campus Virga Jesse ( Site 0704)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 2707)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 3219)

location_facility: Birmingham & Solihull Heartlands Hospital NHS ( Site 1506)

location_facility: Mayo Clinic and Medical School (Rochester) ( Site 0029)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 1905)

location_facility: Bon Secours St. Francis Medical Center Oncology Research ( Site 0064)

location_facility: Instytut Centrum Zdrowia Matki Polki ( Site 1821)

location_facility: Hospital General Arnau de Vilanova de Valencia ( Site 1369)

location_facility: St. Georges University Hospital NHS Foundation Trust ( Site 1505)

location_facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2603)

location_facility: UPR Comprehensive Cancer Center ( Site 6200)

location_facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1909)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0209)

location_facility: Hospital Universitario Virgen del Rocio ( Site 1360)

location_facility: OHSU Knight Cancer Institute ( Site 0051)

location_facility: Orszagos Onkologiai Intezet ( Site 2908)

location_facility: MI Odesa Regional Clinical Hospital ( Site 2701)

location_facility: Medical center of the Limited Liability Company Yulis ( Site 2720)

location_facility: University Hospitals Bristol NHS Foundation Trust ( Site 1503)

location_facility: Centro Medico Imbanaco de Cali S.A ( Site 0406)

location_facility: Princess Margaret Cancer Centre ( Site 0112)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0114)

location_facility: Sana Klinikum Offenbach GmbH ( Site 1002)

location_facility: Canterbury Regional Cancer & Blood Services ( Site 2303)

location_facility: Linkou Chang Gung Memorial Hospital ( Site 2402)

location_facility: Nottingham University Hospitals NHS Trust ( Site 1504)

location_facility: Maryland Oncology Hematology, P.A. ( Site 8007)

location_facility: Weill Cornell Medical College ( Site 0043)

location_facility: Ryazan Regional Clinical Oncology Dispensary ( Site 1910)

location_facility: Centre Georges Francois Leclerc ( Site 0920)

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 2905)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0903)

location_facility: Capital & Coast District Health Board - Wellington Hospital ( Site 2301)

location_facility: Khmelnitskiy Regional Onkology Dispensary ( Site 2704)

location_facility: Fukushima Medical University Hospital ( Site 2610)

location_facility: Imelda Ziekenhuis Bonheiden ( Site 0703)

location_facility: The Cancer Institute Hospital of JFCR ( Site 2604)

location_facility: St. Vincent Frontier Cancer Center ( Site 0033)

location_facility: Hospital Geral de Santo Antonio ( Site 2503)

location_facility: MGH - North Shore Cancer Center ( Site 0081)

location_facility: Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 0205)

location_facility: Ruijin Hosp,Shanghai Jiao Tong University School of Medicine ( Site 3215)

location_facility: Kliniken Essen Mitte Gmbh Evang. Huyssens Stiftung ( Site 1006)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0701)

location_facility: Shaare Zedek Medical Center ( Site 1708)

location_facility: Medizinische Management GmbH ( Site 1012)

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

location_facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 1352)

location_facility: Cancer Treatment Centers of America-Eastern Regional Medical Center ( Site 0076)

location_facility: National Hospital Organization Hokkaido Cancer Center ( Site 2607)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 1367)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2403)

location_facility: MI KhRC Kherson Regional Oncology Dispensary ( Site 2713)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3208)

location_facility: Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego ( Site 1814)

location_facility: Arizona Oncology Associates PC- HOPE ( Site 8008)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3209)

location_facility: Institut Curie - Centre Rene Huguenin ( Site 0917)

location_facility: National Taiwan University Hospital ( Site 2404)

location_facility: CHR-METZ-THIONVILLE - Hopital de Mercy ( Site 0919)

location_facility: MVZ Nordhausen gGmbH - Praxis Dr. Grafe ( Site 1005)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0202)

location_facility: Texas Oncology-Dallas Presbyterian Hospital ( Site 8002)

location_facility: Seoul National University Hospital ( Site 2200)

location_facility: Southeastern Regional Medical Center, Inc. ( Site 0075)

location_facility: Communal non profit enterprise Regional Clinical Oncology Center ( Site 2721)

location_facility: CISSS de la Monteregie-Centre ( Site 0108)

location_facility: The University of Chicago Medical Center ( Site 0080)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 2611)

location_facility: Texas Oncology-Memorial City ( Site 8012)

location_facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 1801)

location_facility: Klinikum der Universitaet Muenchen - Grosshadern ( Site 1000)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1900)

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0206)

location_facility: Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0111)

location_facility: UZ Antwerpen - Medical Oncology ( Site 0709)

location_facility: Chaim Sheba Medical Center. ( Site 1707)

title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (KEYNOTE-756)

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.

The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.


title: An Open-label, Single-arm, Multi-centre, Long-term Extension Trial to Evaluate the Safety and Efficacy of Tralokinumab in Subjects With Atopic Dermatitis Who Participated in Previous Tralokinumab Clinical Trials

summary: The purpose of this extension trial is to evaluate the long-term safety of tralokinumab.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ipd_sharing: Yes

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Italy
United States
Germany
France
Czechia
Japan
Poland
Belgium
Spain
Canada
United Kingdom

location_facility:
LEO Pharma Investigational Site
LEO Pharma Investigational Site 1
LEO Pharma Investigational Site 2

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: Observational Study to Assess Frailty of Subjects During ZOSTER-006 and ZOSTER-022 and HZ Efficacy, Immunogenicity and Safety of HZ/su by Frailty Status

summary:
As part of the ZOSTER-006 and ZOSTER-022 pivotal trials of the HZ/su vaccine, all study participants completed quality of life (QoL) questionnaires. The only questionnaires encoded into the data base were those from participants who developed a suspected shingles episode during the study.

The purpose of this study is to allow for the encoding and analysis of questionnaires for all subjects enrolled in ZOSTER-006 and ZOSTER-022. The aim is to assess the baseline frailty of subjects enrolled in these studies and to investigate whether this population is representative of the general population.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Retrospective

ReferenceType: derived

ReferenceCitation: Curran D, Kim JH, Matthews S, Dessart C, Levin MJ, Oostvogels L, Riley ME, Schmader KE, Cunningham AL, McNeil SA, Schuind AE, Andrew MK; Zoster-064 Study Group. Recombinant Zoster Vaccine Is Efficacious and Safe in Frail Individuals. J Am Geriatr Soc. 2021 Mar;69(3):744-752. doi: 10.1111/jgs.16917. Epub 2020 Nov 16.

family: Curran

full_name: Desmond Curran

given: Desmond

sequence: first

family: Kim

full_name: Joon H. Kim

given: Joon H.

sequence: additional

family: Matthews

full_name: Sean Matthews

given: Sean

family: Dessart

full_name: Christophe Dessart

given: Christophe

name: Departments of Pediatrics and Medicine University of Colorado Anschutz Medical Campus  Aurora Colorado USA

family: Levin

full_name: Myron J. Levin

given: Myron J.

family: Oostvogels

full_name: Lidia Oostvogels

given: Lidia

family: Riley

full_name: Megan E. Riley

given: Megan E.

name: Division of Geriatrics, Duke University Medical Center and GRECC Durham Veterans Affairs Medical Center  Durham North Carolina USA

family: Schmader

full_name: Kenneth E. Schmader

given: Kenneth E.

name: The Westmead Institute for Medical Research, Westmead University of Sydney  Sydney Australia

family: Cunningham

full_name: Anthony L. Cunningham

given: Anthony L.

name: Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority Dalhousie University  Halifax Canada

family: McNeil

full_name: Shelly A. McNeil

given: Shelly A.

family: Schuind

full_name: Anne E. Schuind

given: Anne E.

name: Division of Geriatric Medicine, Department of Medicine Dalhousie University  Halifax Canada

family: Andrew

full_name: Melissa K. Andrew

given: Melissa K.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of the American Geriatrics Society

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: GlaxoSmithKline

location_country:
Italy
Brazil
United States
Sweden
Hong Kong
Mexico
Germany
Finland
France
Czechia
Japan
Australia
Spain
Estonia
Canada
United Kingdom
Korea, Republic of
Taiwan

intervention_type: Other

status_simplified: Completed


ReferenceCitation: Luke JJ, Ascierto PA, Carlino MS, Gershenwald JE, Grob JJ, Hauschild A, Kirkwood JM, Long GV, Mohr P, Robert C, Ross M, Scolyer RA, Yoon CH, Poklepovic A, Rutkowski P, Anderson JR, Ahsan S, Ibrahim N, M Eggermont AM. KEYNOTE-716: Phase III study of adjuvant pembrolizumab versus placebo in resected high-risk stage II melanoma. Future Oncol. 2020 Jan;16(3):4429-4438. doi: 10.2217/fon-2019-0666. Epub 2019 Dec 24.

name: Cancer Immunotherapeutics Center, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA 15232, USA

family: Luke

full_name: Jason J Luke

given: Jason J

name: Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale,” Naples, Italy

family: Ascierto

full_name: Paolo A Ascierto

given: Paolo A

name: Department of Medical Oncology, Crown Princess Mary Cancer Centre, Westmead Hospital, Westmead, NSW, Australia

name: Blacktown Cancer and Haematology Centre, Blacktown Hospital, Blacktown, NSW, Australia

name: Melanoma Institute Australia, Sydney, NSW, Australia

name: Sydney Medical School, The University of Sydney, Sydney, NSW, Australia

family: Carlino

full_name: Matteo S Carlino

given: Matteo S

name: Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

family: Gershenwald

full_name: Jeffrey E Gershenwald

given: Jeffrey E

name: Department of Dermatology and Skin Cancers, Hôpital de la Timone, Aix-Marseille Université, Marseille, France

family: Grob

full_name: Jean-Jacques Grob

given: Jean-Jacques

name: Department of Dermatological Oncology, University Hospital Schleswig-Holstein, Kiel, Germany

family: Hauschild

full_name: Axel Hauschild

given: Axel

family: Kirkwood

full_name: John M Kirkwood

given: John M

name: Department of Medical Oncology, Mater Hospital, North Sydney, NSW, Australia

name: Department of Medical Oncology, Royal North Shore Hospital, St Leonards, NSW, Australia

family: Long

full_name: Georgina V Long

given: Georgina V

name: Department of Dermatology, Elbe Kliniken Buxtehude, Buxtehude, Germany

family: Mohr

full_name: Peter Mohr

given: Peter

name: Dermatology Unit, Department of Oncology, Gustave Roussy Cancer Centre, Villejuif, France

name: Department of Medicine, Université Paris-Sud, Orsay, France

family: Robert

full_name: Caroline Robert

given: Caroline

family: Ross

full_name: Merrick Ross

given: Merrick

name: Department of Medicine, Royal Prince Alfred Hospital, Sydney, NSW, Australia

family: Scolyer

full_name: Richard A Scolyer

given: Richard A

name: Department of Surgical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA

family: Yoon

full_name: Charles H Yoon

given: Charles H

name: Department of Internal Medicine, VCU Massey Cancer Center, Richmond, VA 23298, USA

family: Poklepovic

full_name: Andrew Poklepovic

given: Andrew

name: Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute – Oncology Center, Warsaw, Poland

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

name: Department of Clinical Oncology, Merck & Co., Inc., Kenilworth, NJ 07033, USA

family: Anderson

full_name: James R Anderson

given: James R

family: Ahsan

full_name: Sama Ahsan

given: Sama

family: Ibrahim

full_name: Nageatte Ibrahim

given: Nageatte

name: Department of Medical Oncology, Gustave Roussy Cancer Institute & Université Paris-Saclay, Paris, France

family: M Eggermont

full_name: Alexander M M Eggermont

given: Alexander M

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

design_allocation: Randomized

location_country:
Italy
United States
Brazil
Chile
South Africa
Switzerland
Germany
France
Japan
Poland
Israel
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: IDI - Istituto Dermopatico dell'Immacolata ( Site 0405)

location_facility: Sandton Oncology Medical Group PTY LTD ( Site 0801)

location_facility: Sunnybrook Research Institute ( Site 0060)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0116)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 0812)

location_facility: Hopitaux Universitaires de Geneve HUG ( Site 0556)

location_facility: Universitaetsklinikum Hamburg Eppendorf (UKE) ( Site 0352)

location_facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0359)

location_facility: Hospital de Caridade de Ijui ( Site 0156)

location_facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 0403)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 0004)

location_facility: Dana Farber Cancer Institute ( Site 0124)

location_facility: Instituto Clinico Oncologico del Sur ( Site 0203)

location_facility: Hospital Clinic de Barcelona ( Site 0452)

location_facility: Beth Israel Deaconess Medical Center ( Site 0141)

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0151)

location_facility: CHU de Quebec - Hotel-Dieu de Quebec ( Site 0061)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 0142)

location_facility: IRCCS A.O.U. San Martino - IST ( Site 0404)

location_facility: Oncological Institute of Southern Switzerland ( Site 0557)

location_facility: Moncton Hospital - Horizon Health Network ( Site 0055)

location_facility: Princess Margaret Cancer Centre ( Site 0059)

location_facility: Uniwersyteckie Centrum Kliniczne ( Site 0770)

location_facility: Hopital Ambroise Pare Boulogne ( Site 0316)

location_facility: Shamir Medical Center-Assaf Harofeh ( Site 0657)

location_facility: The Angeles Clinic and Research Institute ( Site 0029)

location_facility: John Wayne Cancer Institute ( Site 0026)

location_facility: Jessa Ziekenhuis Campus Virga Jesse ( Site 0256)

location_facility: Massachusetts General Hospital ( Site 0126)

location_facility: Guy s & St Thomas NHS Foundation Trust ( Site 0601)

location_facility: Instituto Nacional do Cancer II ( Site 0160)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0651)

location_facility: Addenbrooke's Hospital in Cambridge ( Site 0600)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0200)

location_facility: Beskidzkie Centrum Onkologii im. Jana Pawla II ( Site 0754)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0304)

location_facility: Klinik und Poliklinik fuer Dermatologie Venerologie und Allergologie ( Site 0361)

location_facility: SRH Wald-Klinikum Gera GmbH ( Site 0360)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0751)

location_facility: Klinikum der Universitaet in Wuerzburg ( Site 0356)

location_facility: Inova Schar Cancer Institute ( Site 0014)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0408)

location_facility: Charlotte Maxeke Johannesburg Academic Hospital ( Site 0811)

location_facility: Hopital Maisonneuve Rosemont ( Site 0056)

location_facility: The Royal Marsden NHS Foundation Trust. ( Site 0612)

location_facility: Istituto Nazionale Tumori Fondazione Pascale ( Site 0400)

location_facility: University of Arizona Cancer Center ( Site 0121)

location_facility: Seattle Cancer Care Alliance ( Site 0044)

location_facility: Sociedad Medica Aren y Bachero Limitada ( Site 0207)

location_facility: The University of Chicago Medical Center ( Site 0007)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0454)

location_facility: Advocate Medical Group-Park Ridge ( Site 0025)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0047)

location_facility: Universitaetsklinikum in Mannheim ( Site 0351)

location_facility: Hospital General Universitario de Valencia ( Site 0451)

location_facility: Tasman Oncology Research Pty Ltd ( Site 0858)

location_facility: UPMC Hillman Cancer Centers ( Site 0043)

location_facility: Universitaetsspital Zuerich ( Site 0551)

location_facility: Winship Cancer Institute of Emory University ( Site 0046)

location_facility: Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 0155)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 0807)

location_facility: Azienda Ospedaliero Universitaria Senese ( Site 0401)

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 0769)

location_facility: Princess Alexandra Hospital ( Site 0857)

location_facility: Uniwersyteckie Centrum Kliniczne Slaskiego Uniwersytetu Medycznego ( Site 0757)

location_facility: Christie NHS Foundation Trust ( Site 0604)

location_facility: Medizinische Hochschule Hannover ( Site 0358)

location_facility: University of Texas-MD Anderson Cancer Center ( Site 0134)

location_facility: Hospital de Clinicas de Rio Preto ( Site 0162)

location_facility: Chaim Sheba Medical Center. ( Site 0652)

location_facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 0457)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0154)

location_facility: Hospital Universitario Virgen Macarena ( Site 0455)

location_facility: Mayo Clinic [Rochester, MN] ( Site 0016)

location_facility: Melanoma Institute Australia ( Site 0856)

location_facility: Laura and Isaac Perlmutter Cancer Center ( Site 0137)

location_facility: Centro Oncologico Antofagasta ( Site 0206)

location_facility: National Cancer Center Hospital ( Site 0910)

location_facility: Ashford Cancer Centre Research ( Site 0860)

location_facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen ( Site 0357)

location_facility: IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0406)

location_facility: Instytut Pomnik Centrum Zdrowia Dziecka ( Site 0759)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0456)

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0753)

location_facility: Royal Marsden Hospital - Fulham Road London ( Site 0613)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0161)

location_facility: McGill University Health Centre ( Site 0062)

location_facility: Kliniczny Szpital Wojewodzki Nr 1 ( Site 0758)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0201)

location_facility: CHRU Lille - Hopital Claude Huriez ( Site 0301)

location_facility: University of Wisconsin Hospital and Clinics ( Site 0030)

location_facility: Institut Claudius Regaud IUCT Oncopole ( Site 0306)

location_facility: CHU Amiens Picardie Hopital Nord ( Site 0317)

location_facility: Children's Hospital of Pittsburgh UPMC ( Site 0144)

location_facility: Moffitt McKinley Outpatient Center ( Site 0131)

location_facility: Cliniques Universitaires Saint-Luc ( Site 0251)

location_facility: Hospital Sao Vicente de Paulo ( Site 0158)

location_facility: IRCCS Istituto Oncologico Veneto ( Site 0407)

location_facility: West Cancer Center - East Campus ( Site 0022)

location_facility: University of Colorado Cancer Center ( Site 0027)

location_facility: Oregon Health & Science University ( Site 0032)

location_facility: Centre Hospitalier Universitaire Vaudois ( Site 0553)

location_facility: Universitaetsklinikum Tuebingen ( Site 0353)

location_facility: University of Iowa Hospital and Clinics ( Site 0001)

title: Adjuvant Therapy With Pembrolizumab Versus Placebo in Resected High-risk Stage II Melanoma: A Randomized, Double-blind Phase 3 Study (KEYNOTE-716)

summary: This 2-part study will evaluate the safety and efficacy of pembrolizumab (MK-3475) compared to placebo in participants with surgically resected high-risk Stage II melanoma. Participants in Part 1 will receive either pembrolizumab or placebo in a double-blind design for up to 17 cycles (each cycle = 21 days). Participants who receive placebo or who stop treatment after receiving 17 cycles of pembrolizumab in Part 1, do not experience disease recurrence within 6 months of completing pembrolizumab in Part 1, and do not stop treatment with pembrolizumab for disease recurrence or intolerability, may be eligible to receive up to 35 additional cycles of pembrolizumab in Part 2 in an open-label design. The primary hypothesis of this study is that pembrolizumab increases recurrence-free survival (RFS) compared to placebo.


type: EudraCT Number

title: An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

summary:
The purpose of this study was to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

This study compared progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy.

In addition, this study evaluated the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assessed the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

ReferenceCitation: Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Durán I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Wu C, Campbell M, Matsangou M, Petrylak DP. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021 Mar 25;384(12):1125-1135. doi: 10.1056/NEJMoa2035807. Epub 2021 Feb 12.

name: From Barts Cancer Centre, Queen Mary University of London, London (T.P.); Memorial Sloan Kettering Cancer Center, New York (J.E.R.); Dana–Farber Cancer Institute, Harvard Medical School, Boston (G.P.S.); Gustave Roussy, Université Paris-Saclay, Villejuif, France (Y.L.); Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Cantabria (I.D.), and Hospital Universitario 12 de Octubre, Madrid (D.C.) — both in Spain; Asan Medical Center and University of Ulsan College...

family: Powles

full_name: Thomas Powles

given: Thomas

family: Rosenberg

full_name: Jonathan E. Rosenberg

given: Jonathan E.

family: Sonpavde

full_name: Guru P. Sonpavde

given: Guru P.

family: Loriot

full_name: Yohann Loriot

given: Yohann

family: Durán

full_name: Ignacio Durán

given: Ignacio

family: Lee

full_name: Jae-Lyun Lee

given: Jae-Lyun

family: Matsubara

full_name: Nobuaki Matsubara

given: Nobuaki

family: Vulsteke

full_name: Christof Vulsteke

given: Christof

family: Castellano

full_name: Daniel Castellano

given: Daniel

family: Wu

full_name: Chunzhang Wu

given: Chunzhang

family: Campbell

full_name: Mary Campbell

given: Mary

family: Matsangou

full_name: Maria Matsangou

given: Maria

family: Petrylak

full_name: Daniel P. Petrylak

given: Daniel P.

journal_name: New England Journal of Medicine

oa_colors: green other

evidence: open (via free article)

version: acceptedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Italy
Austria
Switzerland
Netherlands
Spain
Germany
France
Japan
Korea, Republic of
Argentina
Australia
Belgium
Portugal
Russian Federation
Denmark
United States
United Kingdom
Canada
Taiwan

location_facility: Sidney Kimmel Center for Prostate and Urologic Cancers

location_facility: White Plains Hospital Center for Cancer Care - Oncology Site

location_facility: Smilow Cancer Hospital at Yale-New Haven

location_facility: Benaroya Research Institute at Virginia Mason

location_facility: UCI Chao Family Comprehensive Cancer Center


type: Other Identifier

title: A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

summary: The purpose of this study is to: (a) characterize the safety and tolerability of and to identify the recommended Phase 2 dose (RP2D) and schedule for erdafitinib in combination with cetrelimab, and for erdafitinib in combination with cetrelimab and platinum (cisplatin and carboplatin) chemotherapy and; (b) to evaluate the safety and clinical activity of erdafitinib alone and in combination with cetrelimab in cisplatin-ineligible participants with metastatic or locally advanced urothelial cancer (UC) with select fibroblast growth factor receptor (FGFR) gene alterations and no prior systemic therapy for metastatic disease.

status: Recruiting

enrollment_type: Anticipated

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
Brazil
Spain
France
Poland
Georgia
Belgium
Russian Federation
Belarus
Turkey
United States
United Kingdom
Korea, Republic of
Taiwan

location_facility: Azienda Socio Sanitaria Territoriale (ASST) della Valtellin

location_facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia

location_facility: Clinical Diagnostic Centre of Nizhny Novgorod Region

location_facility: Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

location_facility: White Plains Hospital Center for Cancer Care

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: Istanbul University Cerrahpasa Medical Faculty

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

location_facility: Pusan National University Yangsan Hospital

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: University of Oklahoma Health Sciences Center

location_facility: Istanbul Medeniyet University Goztepe Training and Research Hospital

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: University College London Hospitals Nhs Foundation Trust / Division Of Gi Services

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Clinical Hospital #122 n.a. after L.G. Sokolov

location_facility: Private Medical Institution Euromedservice

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Ospedale S. Maria Della Misericordia Centro Operativo Studi Clinici SC Oncologia Medica

location_facility: PO A.Manzoni di Lecco, ASST Lecco - Oncologia Medica - Lecco

location_facility: Minsk city Clinical Oncological Dispensary

location_facility: AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: State Institution N.N. Alexandrov Republican Scientific and

location_facility: Chonnam National University Hwasun Hospital

location_facility: CHA Bundang Medical Center, CHA University

location_facility: LTD Mammological Center Named after K Madichi

location_facility: Instituto do Cancer do Estado de Sao Paulo ICESP

location_facility: Necmettin Erbakan University Meram Medical Faculty

location_facility: GBUZ 'Regional clinical oncologic dispensary of Volgograd'

location_facility: Russian Scientific Center of Radiology and Surgical Technologies

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: AZ Nikolaas - Campus Sint-Niklaas Moerland

location_facility: Centro de Pesquisa Urologica e Oncologia de Campinas

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Adnan Menderes University Training and Research Hospital

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

location_facility: CHU de Liège - Domaine Universitaire du Sart Tilman

location_facility: Fundacao Pio Xii - Hospital De Cancer De Barretos

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Instituto de Oncologia de Sorocaba/Onco Clinicas Especializadas

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Weill Cornell Medical College - NY Presbyterian Hospital

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: H. Clinico Universitario de Santiago de Compostela

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Clinical and research Oncological Center

location_facility: Institut de Cancerologie de Ouest (ICO) Site Paul Papin

location_facility: Tambov Regional Oncology Clinical Dispansary


ReferenceCitation: Menzies-Gow A, Corren J, Bourdin A, Chupp G, Israel E, Wechsler ME, Brightling CE, Griffiths JM, Hellqvist Å, Bowen K, Kaur P, Almqvist G, Ponnarambil S, Colice G. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021 May 13;384(19):1800-1809. doi: 10.1056/NEJMoa2034975.

name: From Royal Brompton Hospital, London (A.M.-G.), Leicester National Institute for Health Research Biomedical Research Centre, University of Leicester, Leicester (C.E.B.), and Late-stage Development, Respiratory and Immunology, BioPharmaceuticals R&D, AstraZeneca, Cambridge (S.P.) — all in the United Kingdom; the David Geffen School of Medicine, University of California, Los Angeles, Los Angeles (J.C.), and Global Development, Amgen, Thousand Oaks (P.K.) — both in California; Physiologie et Médecine...

family: Menzies-Gow

full_name: Andrew Menzies-Gow

given: Andrew

family: Corren

full_name: Jonathan Corren

given: Jonathan

family: Bourdin

full_name: Arnaud Bourdin

given: Arnaud

family: Chupp

full_name: Geoffrey Chupp

given: Geoffrey

family: Israel

full_name: Elliot Israel

given: Elliot

family: Wechsler

full_name: Michael E. Wechsler

given: Michael E.

family: Brightling

full_name: Christopher E. Brightling

given: Christopher E.

family: Griffiths

full_name: Janet M. Griffiths

given: Janet M.

family: Hellqvist

full_name: Åsa Hellqvist

given: Åsa

family: Bowen

full_name: Karin Bowen

given: Karin

family: Kaur

full_name: Primal Kaur

given: Primal

family: Almqvist

full_name: Gun Almqvist

given: Gun

family: Ponnarambil

full_name: Sandhia Ponnarambil

given: Sandhia

family: Colice

full_name: Gene Colice

given: Gene

ReferenceCitation: Menzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, Ruberto G, Bowen K, Hellqvist Å, Mo M, Garcia Gil E. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respir Res. 2020 Oct 13;21(1):266. doi: 10.1186/s12931-020-01526-6.

family: Ruberto

full_name: Gennaro Ruberto

given: Gennaro

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:
Austria
Brazil
South Africa
Saudi Arabia
Vietnam
Germany
France
Japan
Korea, Republic of
Israel
Argentina
Australia
Russian Federation
United States
United Kingdom
Canada
Taiwan
Ukraine

title: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)

summary: A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma


title: A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (Including BRCA1/2) (VIOLETTE).

summary: This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib [AZD6738]) and olaparib monotherapy versus olaparib in combination with an inhibitor of WEE1 (adavosertib [AZD1775]) in second or third line setting in patients with Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment arms are olaparib monotherapy, olaparib+ Ceralasertib and olaparib+adavosertib. The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different schedules of administration of each of the treatment options as well as their different toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the option of consenting to the main part of the study within the 28-day screening period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the total number of patients randomised will be lower (approximately 350 patients). Approximately 300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being discontinued.

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:
Italy
United States
Netherlands
Spain
Germany
France
Czechia
Poland
Ireland
Belgium
Portugal
Canada
United Kingdom
Korea, Republic of
Taiwan


title: A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.

summary: The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.

ReferenceType: result

ReferenceCitation: Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther. 2004 May;26(5):724-36.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Sweden
Netherlands
Finland
France
Norway
Ireland
Belgium
Australia
Denmark
United Kingdom


lead_sponsor: Hoffmann-La Roche

location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Thailand
Argentina
Canada
Slovenia
Korea, Republic of
Chile
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
New Zealand
Spain
Turkey

location_facility: Royal Free Hospital; Oncology & Haematology

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology

location_facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia

location_facility: Northwest Cancer Specialists - Portland (N Broadway)

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Changhua Christian Hospital; Internal Medicine

location_facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: Centre Medico-Chirurgical Foch; Service de Pneumologie

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Princess AleXandra Hospital; Department of Medical Oncology

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Lakeridge Health Corporation-Oshawa; Oncology clinic

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

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

location_facility: Semmelweis Egyetem X; Pulmonologiai Klinika

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: HonorHealth Research Institute - Bisgrove

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: Centre René Gauducheau - cancer Nantes - Atlantique; Service Oncologie Médicale

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

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

location_facility: Texas Oncology-Baylor Sammons Cancer Center

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Oddział Onkologii Klinicznej i Chemioterapii Szpitala ELBLĄSKA

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

location_facility: Chonnam National University Hwasun Hospital

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD; Medical Oncology Department

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy

location_facility: Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico

location_facility: Northwestern University; Robert H. Lurie Comp Can Ctr

location_facility: Beth Israel Medical Center; Division of Digestive Diseases

location_facility: Virginia Oncology Associates - Lake Wright Cancer Center

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: US oncology research at Minnesota Oncology

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Washington University School of Medicine

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

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

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Okayama University Hospital; Respiratory and Allergy Medicine

location_facility: Dana Farber Cancer Inst. ; Dept. of Medical Oncology

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: University Hospital Medical Center Bezanijska kosa

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Iwate Medical University Hospital; Urology

location_facility: Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

location_facility: Centre Antoine Lacassagne, Centre de Lutte Contre le Cancer (CLCC) de Nice

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

location_facility: Klinikum d.Universität München Campus Großhadern

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: China Medical University Hospital; Urology

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

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

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

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Sunnybrook Odette Cancer Centre; Clinical Trials

location_facility: University Of Chicago Medical Center; Section Of Hematology/Oncology

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

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

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Rocky Mountain Cancer Ctr - Denver (Williams)

location_facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas

location_facility: Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica

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

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Hospital Clinic de Barcelona. Unidad de Nuevas Terapias;Oncology Department

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Kaiser Permanente - San Diego (Zion Ave)

location_facility: Clinic for Pulmonology, Clinical Center of Serbia

location_facility: University of Washington Seattle Cancer Care Alliance

source: euctr

title: An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

summary: This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure and do not have access to the study treatment locally are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.


ReferenceCitation: Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, Lesiak A, Kircik L, Cho SH, Herranz P, Cork MJ, Peris K, Steffensen LA, Bang B, Kuznetsova A, Jensen TN, Østerdal ML, Simpson EL; ECZTRA 1 and ECZTRA 2 study investigators. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2021 Mar;184(3):437-449. doi: 10.1111/bjd.19574. Epub 2020 Dec 30.

name: Department of Dermatology and Allergy Ludwig Maximilian University of Munich Munich Germany

family: Wollenberg

full_name: A. Wollenberg

given: A.

name: Oregon Medical Research Center Portland OR USA

family: Blauvelt

full_name: A. Blauvelt

name: Department of Dermatology and the Immunology InstituteIcahn School of Medicine at Mount Sinai New York NY USA

family: Guttman‐Yassky

full_name: E. Guttman‐Yassky

given: E.

name: Division of Allergy and Immunology Department of Dermatology, Venereology and Allergy Charité – Universitätsmedizin Berlin Berlin Germany

family: Worm

full_name: M. Worm

given: M.

name: Lynde DermatologyProbity Medical Research Markham ON Canada

name: Department of Medicine University of Toronto Toronto ON Canada

family: Lynde

full_name: C. Lynde

given: C.

name: Department of Dermatology University Hospital of Nice Nice France

family: Lacour

full_name: J.‐P. Lacour

name: Veracity Clinical Research Brisbane QLD Australia

name: Probity Medical Research Woolloongabba QLD Australia

family: Spelman

full_name: L. Spelman

given: L.

name: Department of Dermatology Graduate School of Medical Science Kyoto Prefectural University of Medicine Kyoto Japan

family: Katoh

full_name: N. Katoh

given: N.

name: Department of DermatologyNippon Medical School Tokyo Japan

family: Saeki

full_name: H. Saeki

given: H.

name: Laval University and Centre Dermatologique du Québec Métropolitain and Centre de Recherche Dermatologique du Québec Métropolitain Québec QC Canada

family: Poulin

full_name: Y. Poulin

given: Y.

name: Department of Dermatology and Pediatric and Oncologic Dermatology Medical University of Łódź Łódź Poland

family: Lesiak

full_name: A. Lesiak

name: Indiana University Medical Center Indianapolis IN USA

family: Kircik

full_name: L. Kircik

name: Department of Dermatology The Catholic University of Korea Seoul South Korea

family: Cho

full_name: S.H. Cho

name: Department of Dermatology Hospital Universitario La Paz Madrid Spain

family: Herranz

full_name: P. Herranz

given: P.

name: Sheffield Dermatology Research Department of Infection, Immunity, and Cardiovascular Disease The University of Sheffield and Sheffield Teaching Hospitals NIHR Clinical Research Facility Sheffield UK

family: Cork

full_name: M.J. Cork

name: Dermatology Catholic University and Fondazione Policlinico Universitario A. GemelliIRCCS Rome Italy

family: Peris

full_name: K. Peris

given: K.

family: Steffensen

full_name: L.A. Steffensen

family: Bang

full_name: B. Bang

given: B.

family: Kuznetsova

full_name: A. Kuznetsova

family: Jensen

full_name: T.N. Jensen

family: Østerdal

full_name: M.L. Østerdal

name: Department of Dermatology Oregon Health & Science University Portland OR USA

family: Simpson

full_name: E.L. Simpson

name: the ECZTRA 1 and ECZTRA 2 study investigators

journal_name: British Journal of Dermatology

oa_host_type: repository

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

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

title: Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2)*

location_country:
United States
France
Japan
Spain
Germany

location_facility: Hôpital Saint vincent de paul, Clinique de Dermatologie

location_facility: Hospital de Fuenlabrada, Servicio Dermatología

location_facility: Georgia Pollens Clinical Research Centers, Inc.

location_facility: Hospital Virgen de la Macarena, Servicio Dermatología

location_facility: CHRU de Brest - Hôpital Morvan, Service de Dermatologie

location_facility: Klinikum Augsburg, Klinik für Dermatologie und Allergologie

location_facility: Hospital de Cruces, Servicio Dermatología

location_facility: SRH Wald-Klinikum Gera, Klinik für klinische Studien

location_facility: Hôpital Charles Nicolle, Clinique Dermatologique

location_facility: Hospital Reina Sofía, Servicio Dermatología

location_facility: Hospital Universitario y Politécnico La Fe, Servicio Dermatología

location_facility: Hospital Infanta Leonor, Servicio Dermatología

location_facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

location_facility: Hôpital de l'Archet II, Service de Dermatologie- Vénérologie

location_facility: Hospital Clinic de Barcelona, Dermatology Department

location_facility: Cabinet Médical, Le Bateau Blanc-Immeuble A

location_facility: Centre Hospitalier Universitaire, Clinique dermatologique 7 eme nord

location_facility: Hospital de Basurto, Servicio Dermatología

location_facility: Universitätsklinikum Bonn, Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: Hospital de la Santa Creu i Sant Pau, Servicio Dermatología

location_facility: Hôpital Claude Huriez-CHRU, Service de dermatologie

location_facility: Universitätsklinikum Essen (AöR), Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Dermtology Treatment and Research Center

location_facility: Research Institute of the Southeast, LLC

location_facility: Clínica Universitaria de Navarra, Servicio Dermatología

location_facility: Klinikum Bielefeld Rosenhöhe, Hautklinik

location_facility: Charité - Universitätsmedizin Berlin, Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Facharztpraxis für Dermatologie, Allergologie, Venerologie und Umweltmedizin

location_facility: Hôpital Robert Debré, Service de Dermatologie

location_facility: LMU München, Klinik und Poliklinik für Dermatologie und Allergologie

location_facility: CHU de Toulouse Hôpital Larrey, Service de Dermatologie

location_facility: Medizinische Hochschule Hannover, Klinik für Dermatologie, Allergologie und Venerologie

location_facility: Hospital Universitario de la Princesa, Servicio Dermatología

location_facility: University at Buffalo Department of Dermatology

location_facility: Hospital Germans Trias i Pujol, Servicio Dermatología

location_facility: C.H.U. de Saint-Etienne - Hôpital Nord, Service de dermatologie

location_facility: Center for Dermatology and Laser Surgery

location_facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Dermatologie und Venerologie

location_facility: University Hospitals Cleveland Medical Center

location_facility: Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Dermatologie

location_facility: Niesmann, Hautzentrum im Jahrhunderthaus

location_facility: Universitätsklinikum Münster Klinik und Poliklinik für Hautkrankheiten Münster, Zentrale Studienkoordination für innovative Dermatologie

location_facility: Hôpital St ANDRE, CHU de BORDEAUX, Service de Dermatologie

location_facility: Hospital Universitario La Paz, Servicio Dermatología

title: A Randomised, Double-blind, Placebo-controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Tralokinumab Monotherapy in Subjects With Moderate to Severe Atopic Dermatitis Who Are Candidates for Systemic Therapy

summary:
Primary objective:

To evaluate the efficacy of tralokinumab compared with placebo in treating moderate to severe atopic dermatitis (AD).

Secondary objectives:

To evaluate the efficacy of tralokinumab on severity and extent of AD, itch, and health related quality of life compared with placebo.

Maintenance objective:

To evaluate maintenance of effect with continued tralokinumab dosing up to 52 weeks compared to placebo for subjects achieving clinical response at Week 16.


title: A Prospective Non-interventional Post-authorization Safety Study (PASS) of Lenalidomide in Previously Untreated Adult Multiple Myeloma Patients Who Are Not Eligible for Transplant ("Transplant Noneligible" [TNE])

summary: This post authorization safety study is designed as prospective non interventional study for patients with newly diagnosed multiple myeloma who are not eligible for transplant. The objective is to compare the incidence of cardiovascular events between patients treated with a first-line lenalidomide containing regimen and those treated with a first-line non-lenalidomide containing regimen. Treatment in both cohorts will be done according to standard care. The study will gather risk factor information at baseline and throughout follow-up. Any cardiovascular event occurring will be assessed by an independent committee. Other safety endpoints will be collected through standard procedures. Observation period will be 3 years on treatment, with an additional evaluation of cardiovascular events 6 months' post treatment and a follow up period until 5 years after inclusion. During follow up the incidence of second primary malignancies (SPM) and overall survival will be assessed.

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: Celgene

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

location_facility: London North West University Healthcare NHS Trust -Northwick Park Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Piazza Ospedale Maggiore, 3 -

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Medizinisches Zentrum für Hämatologie und Onkologie München MVZ GmbH

location_facility: "S.C. di Ematologia e Centro Trapianti di Cellule Staminali Emopoietiche

location_facility: Royal Hallamshire Hospital - Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust - The Royal Liverpool Hospital

location_facility: Klinikum Nord, Klinik für Innere Medizin 5

location_facility: Queen Alexandra Hospital - Portsmouth Hospitals NHS Trust

location_facility: Servizio immunoematologia e medicina trasfusionale-ASP

location_facility: A.O Bianchi Melacrino Morelli - Presidio Riuniti

location_facility: Istituto di Ematologia ed Ocnologia Medica "Seràgnoli" AUO Sant'Orsola - Bologna

location_facility: Dr. med. Christoph Losem Praxis für Onkologie und Hämatologie

location_facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Dipartimento di Oncologia Medica e Chirurgica AORN S. Anna e S. Sebastiano

location_facility: Southmead Hospital -North Bristol NHS Trust

location_facility: Midlands Regional Hospital , Hematology/Oncology

location_facility: MVZ Mitte - Onkologische Schwerpunktpraxis

location_facility: Worcestershire Acute Hospitals NHS Trust - Worcestershire Royal Hospital

location_facility: Internistische Facharztzentrum mit Dialyse

location_facility: UO di Ematologia Osp. S. Carlo - Potenza

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: UOSD Ematologia Complesso Opsedaliero-Ospedale S. Spirito e Nuovo Regina Margherita

location_facility: Northern Health and Social Care Trust -Antrim Area Hospital

location_facility: Hôpital privé d'Antony - Ramsay Générale de Santé

location_facility: Charité - Universitätsmedizin Berlin - Campus Charité Mitte

location_facility: Medizinische Klinik II, DONAUISAR Klinikum Deggendorf, Akademisches Lehrkrankenhaus der Medizinischen Hochschule Hannover

location_facility: S.C. Ematologia, Dip.to Oncologico e Tecnologie Avanzate

location_facility: Dres. Neise & Lollert, Praxis für Hämatologie & Onkologie

location_facility: überörtl. Gem. Praxis, Dr. med. Markus Klein und Olav Heringer

location_facility: Betsi Cadwaladr University Health Board - Glan Clwyd Hospital

location_facility: Ospedale Alessandria, Via Venezia, 16, 15121 Alessandria AL

location_facility: UO Ematologia e Centro Trapianti di Midollo Osseo dell'Ospedale San Francesco di Nuoro

location_facility: Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

location_facility: South Eastern Health and Social Care Trust - The Ulster Hospital


lead_sponsor: United Therapeutics

location_country:
Malaysia
Romania
Australia
Russian Federation
Taiwan
Ukraine
India
Thailand
France
Lithuania
Poland
Slovakia
Canada
Korea, Republic of
Hong Kong
Philippines
Bulgaria
Hungary
United States
United Kingdom
Italy
Georgia
Spain

location_facility: Radiation Oncology, Campus Bio-Medico University

location_facility: Municipal Nonprofit Institution "Odessa Regional Oncology Dispensary" of Odessa Regional Council, Municipal Institution Odesa Regional Oncology Dispensary, Hospital of Day Stay (Unit of Dispensary-Polyclinic Department)

location_facility: Department of Medical Oncology, Complex Oncology Center - Burgas EOOD, Burgas

location_facility: State Budgetary Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary

location_facility: State Budgetary Healthcare Institution of Yaroslavl Region, Regional Oncology Hospital

location_facility: Windsor Regional Hospital Cancer Program

location_facility: First Department of Medical Oncology, Gastroenterology and Pulmology, Complex Oncology Center - Plovdiv EOOD

location_facility: Samodzielny Specjalistyczny ZespółZakładów Opieki Zdrowotnej im. dr. Teodora Dunina

location_facility: Hospital Universitario Madrid Norte Sanchinarro

location_facility: St. Jacob´s Hospital Bardejov - Department of Clinical Oncology

location_facility: Complexo Hospitalario Universitario de Ourense (CHUO)

location_facility: Institut Regional du Cancer de Montpellier

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

location_facility: Pusan National University Yangsan Hospital

location_facility: Region Budgetary Healthcare Institution, Kursk Regional Clinical Oncology Dispensary of Healthcare Committee of Kursk Region

location_facility: High Technology Medical Center, University Clinic

location_facility: Medical Oncology Department, Specialized Hospital for Active Treatment of Oncology Sveti Mina EOOD - Blagoevgrad

location_facility: The University of New Mexico Comprehensive Cancer Center

location_facility: Emergency County Hospital Satu-Mare, Medical Oncology Clinic

location_facility: Seoul National University Boramae Medical Center

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: University of Wisoncsin - Carbone Cancer Ctr

location_facility: Spartanburg Medical Center/Gibbs Cancer Center and Research Institute

location_facility: Saint-Petersburg State Budgetary Healthcare Institution, City Clinical Oncology Dispensary

location_facility: Hospital Regional de Málaga (H. Carlos Haya)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház, Semmelweis Tagkórház, Tüdőgyógyászati Osztály

location_facility: Centrum Onkologii-Instytut im. Sklodowskiej-Curie

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dobrich AD, Dobrich

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region, Novosibirsk Regional Oncology Dispensary

location_facility: Institut de Cancérologie de l'Ouest - Centre René Gauducheau

location_facility: Horizon Health Network - The Moncton Hosoital

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o

location_facility: Federal State Budgetary Institution, Natiоnal Medical Research Center of Oncology n.a. N.N. Blokhin of Ministry of Healthcare of the Russian Federation

location_facility: Budgetary Healthcare Institution of Omsk Region, Clinical Oncology Dispensary

location_facility: Koranyi National Institute of Pulmonology - Horváth

location_facility: Mid North Coast Cancer Institute Coff Habour Health Campus

location_facility: Medical Oncology Clinic, Multiprofile Hospital for Active Treatment (MHAT) for Female's Health - Nadezhda OOD, Sofia

location_facility: Instituto Catalán de Oncología (ICO) - Josep Trueta

location_facility: Kaiser Permanente Northwest Center for Health Research CRSS

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Northwest Georgia Oncology Centers, P.C.

location_facility: A.O.U. San Luigi Gonzaga, Orbassano (Torino)

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Division of Medical Oncology and Immunotherapy, Department of Oncology, University Hospital of Siena

location_facility: Kyungpook National University Medical Center

location_facility: Istituto Europeo di Oncologia (IEO), Milano

location_facility: State Budgetary Healthcare Institution, Leningrad Regional Clinical Hospital

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

location_facility: Hospital Universitario y Politécnico de La Fe

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Dr. Tota Venkova AD, Gabrovo

location_facility: L'Institut Universitaire de Cardiologie et de pneumologie de Quebec

location_facility: Federal State Budgetary Institution, Scientific Research Institute of Oncology n.a. Petrov

location_facility: LTD ''Accad. F. Todua Medical Center-Research Institute of Clinical Medicine''

location_facility: First Department for Medical Oncology, Multiprofile Hospital for Active Treatement Serdika EOOD, Sofia

location_facility: Winship Cancer Institute, Emory University

location_facility: Szpital Chorób Płuc im Św. Józefa w Pilchowicach

location_facility: Medical Oncology Department, University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Sofia

location_facility: Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

location_facility: Cross Cancer Institute - Clinical Trials Unit

location_facility: Institut de Cancérologie de l'Ouest - Centre Paul Papin

location_facility: Ospedale Santa Maria della Misericordia, Perugia

location_facility: Hospital General Universitário Gregorio Marañón

location_facility: Keimyung University Dongsan Medical Centre

location_facility: Seoul National University Bundang Hospital

location_facility: Institute of Oncology Prof. Dr. I.Chiricuta Cluj-Napoca

location_facility: Hospital of Lithuanian University of Health Sciences (LSMU) Kauno Klinikos

location_facility: State Budgetary Healthcare Institution, Samara Regional Clinical Oncology Dispensary

location_facility: Grant Medical Foundation Ruby Hall Clinic

location_facility: Camden Clark Medical Center / Regional Cancer Center

location_facility: State Budgetary Healthcare Institution, Orenburg Regional Clinical Oncology Dispensary

location_facility: Clinic of Oncology, UMHAT Dr. Georgi Stranski - Pleven

location_facility: Institut Paoli-Calmettes, Service Dòncologie Médicale

location_facility: Eastern Connecticut Hematology and Oncology Assoc

location_facility: URCOT : Unité de Recherche Commune en Oncologie Thoracique Service de pneumologie de l'hôpital de la Croix-Rousse

location_facility: Department of Medicine, Faculty of Medicine

location_facility: Communal Non-profit Enterprise "Kyiv City Clinical Oncology Center" of Executive body of Kyiv City Council, Kyiv City Clinical Oncology Center by Main Department of Health Protection Kyiv, Hospital of Day Stay for Oncology Patients

location_facility: Mater Misericordiae Limited and Mater Medical Research Institute Limited

location_facility: Fox Chase Cancer Center Office of Clinical Research

location_facility: Clinic for Chemotherapy, Specialized Hospital for Active Treatment in Oncology EAD, Sofia

location_facility: State Budgetary Healthcare Institution of Moscow, Moscow City Oncology Hospital #62 of Moscow Healthcare Department

location_facility: Semmelweis Egyetem AOK Pulmonologiai Klinika

location_facility: Samodzielny Publiczny Zespół Gruźlicy i Chorób Płuc w Olsztynie

location_facility: Municipal Nonprofit Institution "Podilsky Regional Oncology Center" of Vinnytsa City Council, Podilsky Regional Oncology Сenter, Department of Chemotherapy

location_facility: Cancer Treatment Centers of America at Southwestern RMC

location_facility: Municipal Nonprofit Institution "Cental Municipal Clinical Hospital" of Uzhgorod City Council, Municipal Oncology Centre

location_facility: State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk Clinical Oncology Dispensary"

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandów

location_facility: Physicians' Clinic of Iowa Hematology and Oncology

location_facility: State Budgetary Healthcare Institution of Novosibirsk Region, Сity Clinical Hospital #1

location_facility: The University of Texas Health Science Center at Tyler, Office of Clinical Studies

location_facility: Koranyi National Institute of TBC and Pulmonology

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

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council," Municipal Institution "Multifield Dnipropetrovsk City Hospital #4" of Dnipropetrovsk Regional Council, Department of Chemotherapy

location_facility: State Budgetary Healthcare Institution, Saint-Petersburg Clinical Scientific Practical Center of Specialized Kinds of Medical Care (Oncological)

location_facility: Regional Communal Nonprofit Enterprise, Municipal Institution Chernivtsi Regional Clinical Oncology Dispensary, Surgery Department, State Higher Educational Establishment of Ukraine, Bukovinian State Medical University, Department of Onc and Radiology

location_facility: State Budgetary Healthcare Institution of Sverdlovsk Region, Sverdlovsk Regional Oncology Dispensary

location_facility: Medical Oncology Department, Multiprofile Hospital for Active Treatment - Uni Hospital OOD, Panagiurishte

location_facility: Dipartimento di Oncologia, ARNAS Garibaldi

location_facility: Service de Pneumologie aiguë et Cancérologie Thoracique Centre hospitalier Lyon-Sud

title: A Two-part, Open-label, Randomized, Phase 2/3 Study of Dinutuximab and Irinotecan Versus Irinotecan for Second Line Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer

summary: This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months).


ReferenceCitation: Francque SM, Bedossa P, Ratziu V, Anstee QM, Bugianesi E, Sanyal AJ, Loomba R, Harrison SA, Balabanska R, Mateva L, Lanthier N, Alkhouri N, Moreno C, Schattenberg JM, Stefanova-Petrova D, Vonghia L, Rouzier R, Guillaume M, Hodge A, Romero-Gómez M, Huot-Marchand P, Baudin M, Richard MP, Abitbol JL, Broqua P, Junien JL, Abdelmalek MF; NATIVE Study Group. A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH. N Engl J Med. 2021 Oct 21;385(17):1547-1558. doi: 10.1056/NEJMoa2036205.

name: From Antwerp University Hospital and the Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp (S.M.F., L.V.), and Service d’Hépato-Gastroentérologie, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain (N.L.) and Cliniques Universitaires de Bruxelles–Hôpital Erasme, Université Libre de Bruxelles (C.M.), Brussels — all in Belgium; the Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom (P....

family: Francque

full_name: Sven M. Francque

given: Sven M.

family: Bedossa

full_name: Pierre Bedossa

given: Pierre

family: Ratziu

full_name: Vlad Ratziu

given: Vlad

family: Anstee

full_name: Quentin M. Anstee

given: Quentin M.

family: Bugianesi

full_name: Elisabetta Bugianesi

given: Elisabetta

family: Sanyal

full_name: Arun J. Sanyal

given: Arun J.

family: Loomba

full_name: Rohit Loomba

given: Rohit

family: Harrison

full_name: Stephen A. Harrison

given: Stephen A.

family: Balabanska

full_name: Rozalina Balabanska

given: Rozalina

family: Mateva

full_name: Lyudmila Mateva

given: Lyudmila

family: Lanthier

full_name: Nicolas Lanthier

given: Nicolas

family: Alkhouri

full_name: Naim Alkhouri

given: Naim

family: Moreno

full_name: Christophe Moreno

given: Christophe

family: Schattenberg

full_name: Jörn M. Schattenberg

given: Jörn M.

family: Stefanova-Petrova

full_name: Diana Stefanova-Petrova

given: Diana

family: Vonghia

full_name: Luisa Vonghia

given: Luisa

family: Rouzier

full_name: Régine Rouzier

given: Régine

family: Guillaume

full_name: Maeva Guillaume

given: Maeva

family: Hodge

full_name: Alexander Hodge

given: Alexander

family: Romero-Gómez

full_name: Manuel Romero-Gómez

given: Manuel

family: Huot-Marchand

full_name: Philippe Huot-Marchand

given: Philippe

family: Baudin

full_name: Martine Baudin

given: Martine

family: Richard

full_name: Marie-Paule Richard

given: Marie-Paule

family: Abitbol

full_name: Jean-Louis Abitbol

given: Jean-Louis

family: Broqua

full_name: Pierre Broqua

ReferenceCitation: Sven M F, Pierre B, Manal F A, Quentin M A, Elisabetta B, Vlad R, Philippe HM, Bruno S, Jean-Louis J, Pierre B, Jean-Louis A. A randomised, double-blind, placebo-controlled, multi-centre, dose-range, proof-of-concept, 24-week treatment study of lanifibranor in adult subjects with non-alcoholic steatohepatitis: Design of the NATIVE study. Contemp Clin Trials. 2020 Nov;98:106170. doi: 10.1016/j.cct.2020.106170. Epub 2020 Oct 8.

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

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

location_country:
Italy
Austria
Switzerland
United Kingdom
Germany
France
Bulgaria
Czechia
Poland
Australia
Belgium
Spain
United States
Slovenia
Canada
Mauritius

location_facility: Flinders Medical Centre Department of Hepatology

location_facility: Institut klinické a experimentální medicíny, IKEM

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Hôpital Purpan - Centre Hospitalier Universitaire (CHU) de Toulouse

location_facility: A.O. Città della Salute e della Scienza di Torino

location_facility: Granda Ospedale Maggiore Policlinico - Università di Milano

location_facility: Innere Medizin II - Universitätsklinik Freiburg

location_facility: Katedra i Klinika Chorób Zakaźnych i Hepatologii Uniwersytetu Medycznego w Łodzi

location_facility: Centre Hospitalier Régional Universitaire de Montpellier

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Florida Digestive Health Specialists, LLP

location_facility: Acibadem City Clinic University Hospital EOOD

location_facility: Universitätsklinik für Viszerale Chirurgie und Medizin

location_facility: Universitätsmedizin Mainz, I. Med. Klinik

location_facility: University of Western Ontario, London Health Sciences Centre

location_facility: Lyell McEwin Hospital & The University of Adelaide

location_facility: Ospedali Riuniti di Ancona-Università Politecnica delle Marche

location_facility: Oddzial Gastroenterologii Hepatologii UCK

location_facility: Virgen de la Victoria University Hospital

title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)

summary:
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need.

IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic.

The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.


title: A Phase 2, Multicenter, International, Open-Label, Safety and Efficacy Study of INCB050465 in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (CITADEL-202)

summary: The purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large B-cell lymphoma.

design_allocation: Non-Randomized

ReferenceCitation: Coleman M, Belada D, Casasnovas RO, Gressin R, Lee HP, Mehta A, Munoz J, Verhoef G, Corrado C, DeMarini DJ, Zhao W, Li J, Fay K. Phase 2 study of parsaclisib (INCB050465), a highly selective, next-generation PI3Kδ inhibitor, in relapsed or refractory diffuse large B-cell lymphoma (CITADEL-202). Leuk Lymphoma. 2021 Feb;62(2):368-376. doi: 10.1080/10428194.2020.1832660. Epub 2020 Nov 3.

name: Clinical Research Alliance/Weill Cornell Medicine, New York, NY, USA

family: Coleman

full_name: Morton Coleman

given: Morton

name: 4th Department of Internal Medicine – Haematology, Charles University, Hospital and Faculty of Medicine, Hradec Králové, Czech Republic

family: Belada

full_name: David Belada

given: David

name: University Hospital F. Mitterrand and Inserm UMR 1231, Dijon, France

family: Casasnovas

full_name: René-Olivier Casasnovas

given: René-Olivier

name: Department of Oncohaematology, University Hospital Grenoble-Alpes, Grenoble, France

name: Institute for Advanced Biosciences, Inserm U 823, Grenoble, France

family: Gressin

full_name: Rémy Gressin

given: Rémy

name: Flinders Medical Centre, Bedford Park, SA, Australia

family: Lee

full_name: Hui-Peng Lee

given: Hui-Peng

name: UAB School of Medicine, Birmingham, AL, USA

family: Mehta

full_name: Amitkumar Mehta

given: Amitkumar

name: Banner MD Anderson Cancer Center, Gilbert, AZ, USA

family: Munoz

full_name: Javier Munoz

given: Javier

name: Department of Hematology, University Hospitals Leuven, Leuven, Belgium

family: Verhoef

full_name: Gregor Verhoef

given: Gregor

family: Corrado

full_name: Claudia Corrado

given: Claudia

family: DeMarini

full_name: Douglas J. DeMarini

given: Douglas J.

family: Zhao

full_name: Wanying Zhao

given: Wanying

family: Li

full_name: Jia Li

given: Jia

name: Department of Haematology, St Vincent’s Hospital, Darlinghurst, NSW, Australia

family: Fay

full_name: Keith Fay

given: Keith

journal_name: Leukemia & Lymphoma

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Incyte Corporation

location_country:
Italy
United States
France
Czechia
Poland
Belgium
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

location_facility: Chu Vandoeuvre-Les-Nancy Hopital Brabois

location_facility: Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza

location_facility: Chu de Grenoble - Hopital Albert Michallon

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

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Advocate Medical Group Niles Milwaukee Ave