title: A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer

acronym: FeDeriCa

summary: This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.

ReferenceCitation: Tan AR, Im SA, Mattar A, Colomer R, Stroyakovskii D, Nowecki Z, De Laurentiis M, Pierga JY, Jung KH, Schem C, Hogea A, Badovinac Crnjevic T, Heeson S, Shivhare M, Kirschbrown WP, Restuccia E, Jackisch C; FeDeriCa study group. Fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection plus chemotherapy in HER2-positive early breast cancer (FeDeriCa): a randomised, open-label, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2021 Jan;22(1):85-97. doi: 10.1016/S1470-2045(20)30536-2. Epub 2020 Dec 21. Erratum in: Lancet Oncol. 2021 Feb;22(2):e42.

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Taiwan
Brazil
Spain
Italy
Russian Federation
Mexico
United Kingdom
Argentina
Canada
Thailand
Ukraine
Korea, Republic of
United States
France
Belgium
Japan
Germany
Czechia

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

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

location_facility: Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Omsk Region Clinical Oncology Dispensary; 1St Sergical Department

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre

location_facility: Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie

location_facility: Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

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

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: National Cancer Institute MOH of Ukraine

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Hiroshima City Hiroshima Citizens Hospital

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

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

location_facility: Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: RCI Sumy Regional Clinical Oncological Dispensary

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Saitama Medical University International Medical Center

location_facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont

location_facility: Hospital de Cruces; Servicio de Oncología Médica

location_facility: Seoul National University Bundang Hospital

location_facility: China Medical University Hospital; Surgery

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Chang Gung Medical Foundation - Linkou; Dept of Surgery

location_facility: St Georges University Hospitals NHS Foundation Trust

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

intervention_type: Radiation


status: Active, not recruiting

primary_purpose: Treatment

intervention_type: Biological

title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

study_completion_date_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutiérrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Sweden
Brazil
Canada
Germany
Denmark
Greece
New Zealand
Finland
France
Chile
Colombia

location_facility:
Local Institution - 0068
Local Institution - 0078
Local Institution - 0036
Local Institution - 0127
Local Institution - 0128
Local Institution - 0069
Local Institution - 0029
Local Institution - 0033
Local Institution - 0093
Local Institution - 0003
Local Institution - 0076
Local Institution - 0042
Local Institution - 0038
Local Institution - 0075
Local Institution - 0103
Local Institution - 0026
Local Institution - 0016
Local Institution - 0073
Local Institution - 0108
Local Institution - 0100
Local Institution - 0001
Local Institution - 0052
Local Institution - 0081
Local Institution - 0019
Local Institution - 0013
Local Institution - 0043
Beth Israel Deaconess Medical Center
Local Institution - 0124
Local Institution - 0077
Local Institution - 0117
Local Institution - 0070
Local Institution - 0107
Local Institution - 0022
Local Institution - 0106
Mayo Clinic Rochester
Local Institution - 0119
Local Institution - 0040
Local Institution - 0062
Local Institution - 0010
Local Institution - 0131
Local Institution - 0112
Local Institution - 0122
Local Institution - 0071
Local Institution - 0102
Local Institution - 0034
Local Institution - 0023
Local Institution - 0060
Local Institution - 0109
Local Institution - 0035
Local Institution - 0064
Local Institution - 0039
Local Institution
Local Institution - 0121
Local Institution - 0002
Local Institution - 0045
Local Institution - 0058
Local Institution - 0004
Local Institution - 0089
Local Institution - 0116
UCLA Hematology/Oncology Clinic
Local Institution - 0047
Local Institution - 0094
Local Institution - 0135
Local Institution - 0057
Local Institution - 0061
Local Institution - 0051
Local Institution - 0015
Local Institution - 0110
Local Institution - 0025
Local Institution - 0030
Local Institution - 0082
Local Institution - 0114
Local Institution - 0087
Local Institution - 0085
Local Institution - 0101
Local Institution - 0123
Local Institution - 0028
Local Institution - 0054
Local Institution - 0041
Local Institution - 0065
Local Institution - 0129
Local Institution - 0099
Local Institution - 0133
Local Institution - 0007
Local Institution - 0083
Local Institution - 0063
Local Institution - 0079
Local Institution - 0095
Local Institution - 0072
Local Institution - 0032
Local Institution - 0067
Local Institution - 0049
Local Institution - 0037
Local Institution - 0111
Local Institution - 0056
Local Institution - 0012
Local Institution - 0027
Local Institution - 0096
Coastal Integrative Cancer Care
Local Institution - 0059
Local Institution - 0113
Local Institution - 0090
Local Institution - 0048
Local Institution - 0132
Local Institution - 0125
Local Institution - 0021
Local Institution - 0080
Local Institution - 0088
Local Institution - 0018
Local Institution - 0098
Local Institution - 0024
Local Institution - 0092
Local Institution - 0120
Local Institution - 0031
Local Institution - 0086
Local Institution - 0091
Local Institution - 0118
Local Institution - 0014
Local Institution - 0009
Local Institution - 0044
Local Institution - 0008
Local Institution - 0084

summary: The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.

lead_sponsor_type: industriel

status_simplified: Ongoing


ipd_sharing: Yes

acronym: PROSPER

intervention_type: Drug

title: PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER

lead_sponsor: Pfizer

type: Other Identifier

ReferenceCitation: De Giorgi U, Hussain M, Shore N, Fizazi K, Tombal B, Penson D, Saad F, Efstathiou E, Madziarska K, Steinberg J, Sugg J, Lin X, Shen Q, Sternberg CN. Which traits affect how long patients with advanced prostate cancer live when treated with enzalutamide? Future Oncol. 2022 Oct 13. doi: 10.2217/fon-2022-0661. [Epub ahead of print] Review.

ReferenceCitation: Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.

ReferenceCitation: Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.

ReferenceCitation: De Giorgi U, Hussain M, Shore N, Fizazi K, Tombal B, Penson D, Saad F, Efstathiou E, Madziarska K, Steinberg J, Sugg J, Lin X, Shen Q, Sternberg CN. Consistent survival benefit of enzalutamide plus androgen deprivation therapy in men with nonmetastatic castration-resistant prostate cancer: PROSPER subgroup analysis by age and region. Eur J Cancer. 2021 Dec;159:237-246. doi: 10.1016/j.ejca.2021.10.015. Epub 2021 Nov 14.

ReferenceCitation: Saad F, Sternberg CN, Efstathiou E, Fizazi K, Modelska K, Lin X, Sugg J, Steinberg J, Noerby B, Shore ND, Hussain M. Prostate-specific Antigen Progression in Enzalutamide-treated Men with Nonmetastatic Castration-resistant Prostate Cancer: Any Rise in Prostate-specific Antigen May Require Closer Monitoring. Eur Urol. 2020 Dec;78(6):847-853. doi: 10.1016/j.eururo.2020.08.025. Epub 2020 Oct 1.

ReferenceCitation: Sternberg CN, Fizazi K, Saad F, Shore ND, De Giorgi U, Penson DF, Ferreira U, Efstathiou E, Madziarska K, Kolinsky MP, Cubero DIG, Noerby B, Zohren F, Lin X, Modelska K, Sugg J, Steinberg J, Hussain M; PROSPER Investigators. Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2197-2206. doi: 10.1056/NEJMoa2003892. Epub 2020 May 29.

ReferenceCitation: Tombal B, Saad F, Penson D, Hussain M, Sternberg CN, Morlock R, Ramaswamy K, Ivanescu C, Attard G. Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 Apr;20(4):556-569. doi: 10.1016/S1470-2045(18)30898-2. Epub 2019 Feb 12.

ReferenceCitation: Hussain M, Fizazi K, Saad F, Rathenborg P, Shore N, Ferreira U, Ivashchenko P, Demirhan E, Modelska K, Phung, Krivoshik A, Sternberg CN. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2018 Jun 28;378(26):2465-2474. doi: 10.1056/NEJMoa1800536.

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

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Turkey
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
China
Germany
Denmark
Taiwan
Greece
New Zealand
Finland
Thailand
Korea, Republic of
France
Chile
Netherlands

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

location_facility: Saint-Petersburg State Budgetary Healthcare Institution "Hospital for Veterans of War"

location_facility: The Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: University Health Network- Princess Margaret Cancer Centre

location_facility: The Second Hospital of Tianjin Medical University

location_facility: Clinique Universitaire de Bruxelles Hopital Erasme

location_facility: Chang Gung Medical Fundation,Kaohsiung (Kaohsiung Chang Gung Memorial Hospital)

location_facility: Medicina Nucleare, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Bratislavske radiodiagnosticke centrum, a.s.

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: U.O. di Radiologia, Ospedale Civile degli Infermi

location_facility: Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica

location_facility: Krankenhaus Barmherzige Schwestern Linz, Abteilung Urologie

location_facility: Farmacia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Kyiv City Clinical Hospital #3, Department of Urology

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven

location_facility: Krankenhaus Barmherzige Schwestern Linz, Abteilung Radiologie

location_facility: Fakultna nemocnica s poliklinikou Zilina, Urologicke oddelenie

location_facility: Instituto Clinico Oncologico del Sur (ICOS)

location_facility: Premier Medical Group of the Hudson Valley

location_facility: Clinical Center Of Serbia, Clinic of Urology

location_facility: Cabrini Hospital- Education and Research Precinct

location_facility: Vanderbilt University Medical Center, Dept. of Urologic Surgery

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Isotopix, Ambulatorium fuer Nuklearmedizin

location_facility: Central City Clinical Hospital, City Oncological Center

location_facility: IRCCS - Istituto Oncologico Veneto (IOV), UOC Oncologia Medica 1

location_facility: State Budgetary Healthcare Institution City Multifield Hospital No.2

location_facility: Farmacia Ospedaliera, AOU San Luigi Gonzaga

location_facility: Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson

location_facility: Fakultna nemocnica s Poliklinikou Skalica a.s

location_facility: NS Health Authority, Queen Elizabeth II Health Sciences Centre

location_facility: Farmacia Studi Clinici e Sperimentali, Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: UVN SNP - FN Ruzomberok, Pracovisko Nuklearnej mediciny CCSR

location_facility: P. Hertsen Moscow Oncology Research Institute - branch of the National Medical Research

location_facility: Institut de Cancerologie de I'Ouest - Rene Gauducheau

location_facility: Medicina Nucleare, Istituto Oncologico Veneto (IOV)

location_facility: Fakultna nemocnica s poliklinikou F.D. Roosevelta

location_facility: Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Urology Reasearch - Victoria Hospital, London Health Sciences Centre(LHSC)

location_facility: Chonnam National University Hwasun Hospital

location_facility: The Male/Female Health and Research Centre

location_facility: Centro de Estudos e Pesquisas em Hematologia e Oncologia (CEPHO)

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza. Korczaka

location_facility: U.O. di Oncologia Medica, Ospedale Santa Chiara

location_facility: SCDU Oncologia Medica II Pad, AOU San Luigi Gonzaga

location_facility: Medicina Nucleare, Azienda Ospedaliero-Universitaria Policlinico di Modena

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

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: MVZ Zentrum fuer Diagnostische Radiologie und Nuklearmedizin Braunschweig GmbH

location_facility: Centre Hospitalier Universitaire de Liege, Site du Sart-Tilman

location_facility: London Regional Cancer Program - Victoria Hospital, London Health Sciences Centre(LHSC)

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: UROEXAM spol. s r.o. urologicka ambulancia

location_facility: Manitoba Prostate Centre CancerCare Manitoba

location_facility: General Hospital of Athens "Alexandra", Therapeutic Clinic

location_facility: GAMMALAB, spol.s.r.o., Oddelenie nuklearnej mediciny

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Servizio Farmacia, Istituto Europeo di Oncologia

location_facility: The First Affiliated Hosptial of Wenzhou Medical University

location_facility: Medizinische Universitaet Wien, Universitaetsklinik fuer Innere Medizin I

location_facility: Dipartimento di Radiologia, Ospedale San Raffaele

location_facility: Reparto Oncologia Medica Urogenitale e Cervico Facciale, Istituto Europeo di Oncologia

location_facility: Universitaetsklinikum Carl Gustav Carus an der TU Dresden

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: SBEI HPE "First Pavlov State Medical University of St. Petersburg" of

location_facility: University of California, Irvine Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Divisione di Radiologia, Istituto Europeo di Oncologia

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Servizio di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona

location_facility: Radiologia I, Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Diagnostiskt centrum for bild- och funktionsmedicin

location_facility: Smilow Cancer Center at Yale New Haven-Hospital

location_facility: Clinique Pasteur- Service Imagerie et Radiologie

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.

location_facility: Universiti Kebangsaan Malaysia Medical Centre

location_facility: SBEI of HPE "Bashkir State Medical University" of MoH of the RF

location_facility: Liga Paranaense de Combate ao cancer / Hospital Erasto Gaertner

location_facility: Qingdao Municipal Hospital (East Hospital)

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Vzw Algemeen Ziekenhuis Maria Middelares

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

location_facility: ALTAHIA. Xarxa Assistencial Universitaria de Manresa

location_facility: Urology Associates / Urologic Medical Research

location_facility: S.C. Diagnostica Radiologica 2, Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Institut de Cancerologie de l'Ouest - Paul Papin

location_facility: Centre Regional de lutte Contre le Cancer Georges Francois Leclerc

location_facility: University General Hospital of Heraklion, Urology Clinic

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: U.O. di Oncologia, Ospedale Civile Umberto I

location_facility: Vychodoslovensky onkologicky ustav, a.s.

location_facility: Helsingin yliopistollinen keskussairaala, Meilahden sairaala

location_facility: Chang Gung Memorial Hospital, Keelung Branch (Keelung Chang Gung Memorial Hospital)

location_facility: S.C. di Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: U.O.S.C. di Oncologia Medica, A.O.R.N. "A. Cardarelli"

location_facility: Chang Gung Medical Fundation, Chiayi Branch(Chiayi Chang Gung Memorial Hospital)

location_facility: Apoteket AB Kliniska Provningar Molnlycke

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: University General Hospital of Larissa, Urology Department

location_facility: Hospital Universitario Pedro Ernesto - UERJ

location_facility: Federal State Budgetary Institution "N.N. Blokhin Russian Cancer Research Center"

location_facility: CI Dnipropetrovsk I.I. Mechnykov RCH, Department of Urology #2

location_facility: Farmacia, Istituto Oncologico Veneto (IOV)

location_facility: King Chulalongkorn Memorial Hospital, Chulalongkorn University

location_facility: General Hospital" Papageorgiou",B' Univ.Urology Clinic

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: University General Hospital of Patras, Oncology Department, Internal Medicine Clinic

location_facility: Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP

location_facility: Vanderbilt University Medical Center, The Urologic Clinic

location_facility: U.O. di Medicina Nucleare e Centro PET, Ospedale San Raffaele

location_facility: UOC Radiodiagnostica Oncologica, Istituto Oncologico Veneto (IOV)

location_facility: U.O. di Oncologia, Ospedale Civile Degli Infermi

location_facility: Hospital Amaral Carvalho - Fundacao Dr. Amaral Carvalho

location_facility: IAMSPE-Inst. de Assist. ao Servidor Publico Estadual

location_facility: SBHI "Saint-Petersburg clinical scientific

location_facility: Laboratorio Medicina Nucleare-Ospedale G.B. Morgagni-Pierantoni

location_facility: Clinical Center "Bezanijska Kosa", Department of Urology

location_facility: Institut nuklearnej a molekularnej mediciny

location_facility: McMaster Institute of Urology @ St. Joseph's Healthcare Hamilton

location_facility: Universitatsmedizin Mannheim, Medizinische Fakultat Mannheim der Universitat Heidelberg

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: Urologic Oncology Department- Institut Bergonie - Centre regional de Lutte contre le Cancer

location_facility: SS Medicina Nucleare, AOU San Luigi Gonzaga

location_facility: GU Research Network/ Wichita Urology Group

location_facility: Farmacia Interna, Azienda Ospedaliero-Universitaria Policlinico di Modena

location_facility: Epic Pharmacy Port Macquarie base hospital

location_facility: Urological Associates of Southern Arizona, PC

location_facility: SCDU Radiodiagnostica, AOU San Luigi Gonzaga

location_facility: RCI Chernivtsi Regional Clinical Hospital

location_facility: Clinical Center "Dr Dragisa Misovic -Dedinje", Clinic of Urology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: GAMMALAB, spol. s.r.o., Oddelenie nuklearnej mediciny

location_facility: Integrated Clinical Oncology Network (ICON)

location_facility: CHI V.I.Shapoval RCC of Urology and Nephrology, Dep. Of Urology#4

location_facility: General Hospital of Athens"Korgialeneio-Benakeio EES".Urology Clinic

location_facility: ICO Girona-Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Urology Associates of San Luis Obispo, a Medical Group, Inc

location_facility: Servizio di Farmacia, Ospedale San Raffaele

location_facility: Izmir Bozyaka Egitim Arastirma Hastanesi

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: U.O. di Radiologia, Ospedale Civile Umberto I

location_facility: CI Zaporizhzhia Regional Clinical Hospital, Dep. Of Urology,

location_facility: Eastern Clinical Research Unit (Eastern Health)

summary: The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.


title: An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities

summary: This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

status: Completed

study_completion_date_type: Actual

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Romania
Czechia
Hong Kong
Austria
Australia
Russian Federation
Argentina
Mexico
Slovakia
Egypt
Brazil
Canada
Switzerland
Germany
Bulgaria
Denmark
Estonia
New Zealand
Thailand
France
Netherlands

status_simplified: Completed


status: Terminated

intervention_type: Other

title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-care Treatment in Adolescent, Adult, and Elderly Non-hospitalized Subjects With Influenza A Infection Who Are at Risk of Developing Complications

lead_sponsor: Janssen Research & Development, LLC

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Malaysia
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Latvia
Estonia
New Zealand
Thailand
Vietnam
Korea, Republic of
France
Chile
Netherlands

location_facility: Gemeinschaftspraxis Dr. Taeschner / Dr. Bonigut

location_facility: Taipei Medical University Shuang-Ho Hospital

location_facility: Hallym University Dongtan Sacred Heart Hospital

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: The First Affiliated Hospital of NanChang University

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

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

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA

location_facility: Universitaetsklinikum Giessen und Marburg GmbH

location_facility: Vilnius University Hospital Santaros Klinikos, Public Institution

location_facility: Department for Heart Failure and Valvular Disease

location_facility: Hospital Interzonal General de Agudos Dr. Jose Penna

location_facility: Centre Hospitalier Intercommunal de Créteil

location_facility: University of Texas Southwestern Medical Center

location_facility: Dr. Anil K Gupta Medicine Professional Corporation

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

location_facility: SMZ Süd - Kaiser Franz Josef Spital Wien

location_facility: Odesa City Municipal Institution Polyclinic #20

location_facility: Suretech Hospital and Research Centre Limited

location_facility: LLC Outpatient department of Private Security Guards and Detectives

location_facility: Hospital Infantil de Mexico Federico Gomez

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Karadeniz Teknik University Medical Faculty

location_facility: HIRG, LLC dba Health Innovation Research Group

location_facility: Carolina Institute for Clinical Research

location_facility: Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy

location_facility: Bamrasnaradura Infectious Disease Institute

location_facility: Paradigm Clinical Research Centers, Inc.

location_facility: Powiatowe Centrum Medyczne w Wołowie Sp. z o.o.

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: University Of Texas Medical Branch At Galveston

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

location_facility: Preferred Primary Care Physicians Research

location_facility: J. Lewis research Inc./ Foothill Family Clinic South

location_facility: J. Lewis research Inc./ Foothill Family Care

location_facility: Azienda Socio Sanitaria Territoriale di Monza Presidio San Gerardo

location_facility: Hospital Nuestra Señora de la Misericordia

location_facility: Johns Hopkins University School of Medicine

location_facility: Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú

location_facility: Hospital Privado Centro Medico de Cordoba

location_facility: Hallym University Kangnam Sacred Heart Hospital

location_facility: Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

location_facility: Siauliai Republican Hospital, Public Institution

location_facility: California Allergy & Asthma Medical Group Inc.

location_facility: Inlita, JSC, Lazdynai KTC clinical trial site

location_facility: San Diego Sports Medicine & Family Health Center

location_facility: Centro de Estudos Clínicos do Interior Paulista - CECIP

location_facility: The Catholic university of Korea, ST Vincent Hospital

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Inese Petrova General Practitioner Practice

location_facility: Detweiler Family Medicine and Associates

location_facility: Institute Of Epidimiology And Microbiology

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Med San Unit OJSC Kharkiv S.OrdzhonikidzeTractor Plant Dept of Ther KMA PGE

location_facility: Rajiv Gandhi Institute of Medical Sciences

location_facility: Hospital Civil de Guadalajara Dr. Juan I. Menchaca

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: J. Lewis Research Inc./Jordan River Family Medicine

location_facility: Irmandade Da Santa Casa de Misericordia de Sao Paulo

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.

location_facility: Nemocnica arm. generala L. Svobodu Svidnik, a.s.,

location_facility: Fuzhou General Hospital of Nanjing Military Command

location_facility: FSBI 'Scientific and Research Institute of Flu' of the MoH of the RF

location_facility: NZOZ Centrum Badań Klinicznych,Piotr Napora,Lekarze Spółka Partnerska

location_facility: Limited Liability company 'MSMC' Euromed

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: SBEI HPE 'Yaroslavl State Medical University' of the MoH of the RF

location_facility: Taipei Medical University-Wan Fang Hospital

summary: The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.

status_simplified: Unknown


title: Pivotal, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Gemcitabine and Nab-paclitaxel for Front-line Treatment of Locally-advanced Pancreatic Adenocarcinoma

summary:
Brief Summary:

The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.

status: Recruiting

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95.

ReferenceCitation: Kirson ED, Dbalý V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. Epub 2007 Jun 5.

ReferenceCitation: Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbalý V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.

ReferenceCitation: Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.

ReferenceCitation: Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.

ReferenceCitation: Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.

ReferenceCitation: Giladi M, Schneiderman RS, Porat Y, Munster M, Itzhaki A, Mordechovich D, Cahal S, Kirson ED, Weinberg U, Palti Y. Mitotic disruption and reduced clonogenicity of pancreatic cancer cells in vitro and in vivo by tumor treating fields. Pancreatology. 2014 Jan-Feb;14(1):54-63. doi: 10.1016/j.pan.2013.11.009. Epub 2013 Dec 4.

ReferenceCitation: Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718. Erratum in: JAMA. 2018 May 1;319(17):1824.

lead_sponsor: NovoCure Ltd.

location_country:
Croatia
Poland
Brazil
Hong Kong
Spain
Italy
Austria
Australia
Mexico
Canada
Switzerland
Hungary
Korea, Republic of
United States
France
China
Israel
Belgium
Germany
Czechia

location_facility: Boca Raton Regional Hospital, Lynn Cancer Institute

location_facility: Oncology and Radiotherapy Clinic, Oncology Center - Institute

location_facility: Hopital haut-Léveque CHU Bordeaux - Service d'Hépato- Gastroentérologie et d'Oncologie digestive

location_facility: HM Hospitales - Centro Integral Oncologico Clara Campal - CIOCC

location_facility: University of Kansas Medical Cancer Center

location_facility: Clinique Sainte Anne - Groupe Hospitalier Saint-Vincent, Strasbourg Oncologie Libérale

location_facility: Texas Oncology - El Paso Cancer Treatment Center Gateway - US Oncology Research

location_facility: Centro de Pesquisa Clínica e Ensino Florianópolis LTDA

location_facility: Jan Mikulicz-Radecki University Teaching Hospital

location_facility: Willamette Valley Cancer Institute and Research Center - US Oncology Research

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: Centro de Investigación Médica Aguascalientes (CIMA),

location_facility: Núcleo de Pesquisa Clínica da Rede São Camilo

location_facility: Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center - US Oncology Research

location_facility: Centre Hospitalier de Bretagne Sud /Site du Scorff

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: Texas Oncology - Tyler - US Oncology Research

location_facility: Centre Hospitalier de I'Universitaire de de Montreal (CHUM)

location_facility: West Virginia University Cancer Institute

location_facility: Sun Yat-sen Memorial Hospital Sun Yat-sen University

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

location_facility: Rambam Health Care Campus, Oncology Institute

location_facility: University of Oklahoma Health Sciences Center

location_facility: University of Maryland Comprehensive Cancer Center

location_facility: Texas Oncology - Bedford - US Oncology Reasearch

location_facility: Centre de Lutte Contre le Cancer (CLCC) - Centre Paul Strauss

location_facility: IRPCc - Instituto Ribeirãopretano de Combate ao Câncer

location_facility: Bonifatius Hospital Hematology and Oncology

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - US Oncology Research

location_facility: Texas Oncology - Baylor - US Oncology Research

location_facility: Centro de Estudios de Alta Especialidad de Sinaloa, ubicado

location_facility: Severance Hospital, Yonsei University Health System

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

location_facility: Hospital Regional Universitario de Málaga

location_facility: Clínica Integral Internacional de Oncología, S de RL de CV

location_facility: Univ. Klinik für Innere Medizin III der PMU

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Centre Hospitalier Universitaire de Sherbrooke CIUSSS de l'Estrie - CHUS

location_facility: Arizona Oncology Associates, PC- HOPE - US Oncology Research

location_facility: Norton Cancer Institute, Norton Healthcare Pavilion

location_facility: Klinikum München Bogenhausen, Klinik für Gastroenterologie und Gastroenterologische Onkologie

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: Oncology Clinic Clinical Hospital of Przemienienia Pańskiego UM in Poznaniu

location_facility: Illinois Cancer Specialist - US Oncology Research

location_facility: Seoul National University Bundang Hospital

location_facility: A.O. SS Antonio e Biagio e Cesare Arrigo

location_facility: Maryland Oncology Hematology, P.A - US Oncology Research

location_facility: Centro Potosino de Investigación Médica SC,

location_facility: Phylasis Clinicas Research S.de R.L. de C.V. (PCR)-Toluca

location_facility: Service d'Oncologie médicale du Pr. Andre, Hôpital Saint-Antoine

location_facility: Sourasky Medical Center, Oncology Department

location_facility: Central Maine Medical Center, Clinical Research Department

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

location_facility: Cancer and Hematology Centers of Western Michigan, PC

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

intervention_type: Device


title: A Phase III, Randomised, Double-Blind, Placebo-Controlled, Multicentre Study Of The Efficacy And Safety Of Atezolizumab Plus Chemotherapy For Patients With Early Relapsing Recurrent (Inoperable Locally Advanced Or Metastatic) Triple-Negative Breast Cancer

location_country:
Serbia
Spain
Italy
United Kingdom
Cuba
Kazakhstan
United States
Peru
South Africa
Montenegro
Poland
Portugal
Russian Federation
Argentina
Turkey
Panama
Mexico
Singapore
Egypt
Bosnia and Herzegovina
Brazil
Hungary
China
Germany
Finland
Algeria
France
Chile
Korea, Republic of
Morocco

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Magee-Woman's Hospital; UPMC Pinnacle Cancer Center

location_facility: Kazakh Scientific Research Institution Of Oncology and Radiology; Chemotherapy department

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

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

location_facility: Centro de Oncologia de Santa Catarina LTDA

location_facility: The First Affiliated Hospital Of Jinzhou Medical University

location_facility: Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare)

location_facility: Helsinki University Central Hospital; Dept of Oncology

location_facility: Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province)

location_facility: Almaty Oncology Center; Chemotherapy department

location_facility: Caritas-Krankenhaus St. Josef; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz;Sugarterapias Klinikai Onkologiai Intez

location_facility: Multidisciplinary medical center; Chemotherapy department

location_facility: Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

location_facility: University Hospital Medical Center Bezanijska kosa

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

location_facility: Harbin Medical University Cancer Hospital

location_facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

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

location_facility: the First Affiliated Hospital of Bengbu Medical College

location_facility: Hacettepe University Medical Faculty; Department of Internal Medicine

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

location_facility: Institut Paoli-Calmettes; Oncologie Medicale 1

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Instituto Nacional de Oncología y Radiología (INOR)

location_facility: Fudan University Shanghai Cancer Center; Medical Oncology

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: James Lind Centro de Investigación Del Cáncer

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

location_facility: Fujian Medical University Union Hospital

location_facility: National Cancer Centre; Medical Oncology

location_facility: The Oncology centre,Durban; Clinical Oncology

location_facility: Medical Oncology Centre of Rosebank; Oncology

location_facility: Clinique specialise Menara; Oncology Medical

location_facility: The First Affiliated Hospital, Chongqing Medical University

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

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

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital

location_facility: Medipol University MF; Oncology Department

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

location_facility: Clinica San Felipe; Centro de Investigacion Unidad de Oncologia Medica

location_facility: Florida Cancer Specialists - Fort Myers (Broadway)

location_facility: University Clinical Center of the Republic of Srpska

location_facility: University of Pretoria Oncology Department; Medical Oncology

location_facility: Oncocentro Serviços Medicos E Hospitalares Ltda

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Clinical Center of Montenegro; Clinic for Oncology and Radiotherapy

location_facility: CHU Constantine; Service d'Oncologie Médicale

location_facility: Centre Hospitalier Universitaire Hassan II

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Private Healthcare Institution Clinical Hospital RZhD Medicine

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Institut National D'oncologie Sidi Med Benabdellah

location_facility: Centre Anti Cancer Beau-fraisier;Service d'oncologie médicale

location_facility: INSTITUT CURIE_SITE PARIS - Service d'Oncologie Médicale.

location_facility: Gemeinschaftspraxis Prof. Dr.med. Christoph Salat und Dr.med. Oliver J. Stötzer

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: Institute of Oncology and Radiology of Serbia

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

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

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

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Centre Hospitalier Universitaire Mohamed VI; Oncologie-Hématologie

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Centre hospitalo-univerisitaire de Rouiba;Service d'oncologie médicale

location_facility: Western General Hospital; Edinburgh Cancer Center

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

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Klinikum Frankfurt Höchst GmbH; Klinik für Gynäkologie und Geburtshilfe

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque

location_facility: Cancer Hospital , Chinese Academy of Medical

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Florida Cancer Specialists & Research Institute

location_facility: Instituto de Investigaciones Metabolicas (Idim)

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Pendik Training and Research Hospital; Medical Oncology

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

location_facility: Azienda Ospedaliero-Universitaria Careggi; SOD Radioterapia

location_facility: Instituto de Pesquisa Grupo NotreDame Intermedica

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: AirForce Specialized Hospital; Clinical Oncology

location_facility: Ankara Oncology Hospital; Medical Oncology Department

location_facility: Świętokrzyskie Centrum Onkologii; Dział Chemioterapii

location_facility: Centre Georges-François Lecler; Ctr de Lutte Contre le Canc

summary: This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Moderate to Severe Atopic Dermatitis

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Katoh N, Takita Y, Isaka Y, Nishikawa A, Torisu-Itakura H, Saeki H. Pooled Safety Analysis of Baricitinib in Adult Participants with Atopic Dermatitis in the Japanese Subpopulation from Six Randomized Clinical Trials. Dermatol Ther (Heidelb). 2022 Oct 18. doi: 10.1007/s13555-022-00828-5. [Epub ahead of print]

ReferenceCitation: Silverberg JI, DeLozier A, Sun L, Thyssen JP, Kim B, Yosipovitch G, Nunes FP, Gugiu PC, Doll HA, Eichenfield LF. Psychometric properties of the itch numeric rating scale, skin pain numeric rating scale, and atopic dermatitis sleep scale in adult patients with moderate-to-severe atopic dermatitis. Health Qual Life Outcomes. 2021 Oct 23;19(1):247. doi: 10.1186/s12955-021-01877-8.

ReferenceCitation: Thyssen JP, Buhl T, Fernández-Peñas P, Kabashima K, Chen S, Lu N, DeLozier AM, Casillas M, Ständer S. Baricitinib Rapidly Improves Skin Pain Resulting in Improved Quality of Life for Patients with Atopic Dermatitis: Analyses from BREEZE-AD1, 2, and 7. Dermatol Ther (Heidelb). 2021 Oct;11(5):1599-1611. doi: 10.1007/s13555-021-00577-x. Epub 2021 Jul 18.

ReferenceCitation: King B, Maari C, Lain E, Silverberg JI, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes FP, Simpson EL. Extended Safety Analysis of Baricitinib 2 mg in Adult Patients with Atopic Dermatitis: An Integrated Analysis from Eight Randomized Clinical Trials. Am J Clin Dermatol. 2021 May;22(3):395-405. doi: 10.1007/s40257-021-00602-x. Epub 2021 Apr 7.

ReferenceCitation: Reich K, DeLozier AM, Nunes FP, Thyssen JP, Eichenfield LF, Wollenberg A, Ross Terres JA, Watts SD, Chen YF, Simpson EL, Silverberg JI. Baricitinib improves symptoms in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: patient-reported outcomes from two randomized monotherapy phase III trials. J Dermatolog Treat. 2022 May;33(3):1521-1530. doi: 10.1080/09546634.2020.1839008. Epub 2020 Nov 22.

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:
Denmark
Taiwan
Italy
Russian Federation
India
France
Mexico
Japan
Germany
Czechia

location_facility: Aarhus Universitehospital Marselisborg Centret

location_facility: SPb SBHI Skin-venerologic dispensary #10

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: Clínica Enfermedades Crónicas y Procedimientos Especiales SC

location_facility: Queen's Square Dermatology and Allergology

location_facility: CRI Centro Regiomontano de Investigacion S.C.

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Dr. D. Y. Patil Medical College & Hospital

location_facility: Kyoto Prefectural University of Medicine

location_facility: Praxis für Ganzheitliche Dermatologie im Ärztehaus

location_facility: Universität Leipzig - Universitätsklinikum

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

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Hospital Univ. Dr. Jose Eleuterio Gonzalez

location_facility: Byramjee Jeejeebhoy Medical College & Civil Hospital

location_facility: Rosenpark Research Geschäftsbereich der Rosenparkklinik GmbH

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

location_facility: Chennai Meenakshi Multispeciality Hospital

location_facility: Russian state medical-stomatological university n.a. Evdokimov

location_facility: GBUZ Clinical dermatology and venereological dispensary

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: State scientific centre for dermatovenerology and cosmetolog

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: All India Institue of Medical Sciences (AIIMS)

summary: The purpose of this study is to evaluate the efficacy and safety of baricitinib as monotherapy in participants with moderate to severe atopic dermatitis.


title: A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b

summary: First-in-human, Phase 1b/2 safety study of the antibody-drug conjugate (ADC) XMT-1536 (upifitamab rilsodotin) administered as an intravenous infusion once every four weeks. Patients with tumor types likely to express NaPi2b were enrolled in dose escalation. Patients with platinum-resistant ovarian cancer and non-small cell lung cancer (adenocarcinoma subtype) were enrolled in the expansion segment of this study. Patients with platinum-resistant, high-grade serous ovarian cancer are being enrolled in the UPLIFT segment of this study. In addition to safety assessments, the pharmacokinetics of the drug will be assessed along with ADC activity. A QTc sub-study has been added for the UPLIFT cohort for a sub-set of sites.

design_allocation: Non-Randomized

ipd_sharing: No

lead_sponsor: Mersana Therapeutics

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
New Zealand
Canada
Finland
Lithuania
United Kingdom
Hungary
United States
France
Belgium
Norway
Sweden
Bulgaria
Czechia

location_facility: McGill University Health Centre - The Montreal General Hospital

location_facility: Institute of Transnational Oncology-Greenville Hospital System University Medical Center

location_facility: Kaiser Permanente Medical Center - South San Francisco

location_facility: University Teaching Hospital in Bialystok

location_facility: University of Miami - Miller School of Medicine

location_facility: Strasbourg Europe Institut of Cancerology

location_facility: Kaiser Permanente Medical Center - Oakland

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

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc. - Salem

location_facility: Kaiser Permanente Medical Center - San Jose

location_facility: MD Anderson Cancer Center at Cooper - Camden

location_facility: Kaiser Permanente Medical Center - San Francisco

location_facility: Oslo University Hospital, Rikshospitalet (The National Hospital)

location_facility: Rigshospitalet - University Hospital Copenhagen

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

location_facility: Provincial Hospitals in Gdynia Sp. z o.o. (LLC)

location_facility: Kaiser Permanente Medical Center - Santa Clara

location_facility: South Texas Accelerated Research Therapeutics (START)

location_facility: Stephenson Cancer Centre-University of Oklahoma

location_facility: South Lyon Hospital Center, Department of Clinical Hematology

location_facility: University Hospital Foundation Jimenez Diaz

location_facility: Auckland District Health Board, Auckland City Hospital

location_facility: Georgia Cancer Center at Augusta University

location_facility: Multiprofile Hospital for Active Treatment" Park Hospital EOOD

location_facility: University Hospital Virgen del Rocio (HUVR)

location_facility: National Cancer Institute Regina Elena, IRCCS

location_facility: Kaiser Permanente Medical Center - Vallejo

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: Oklahoma Cancer Specialists and Research Institute

location_facility: Women & Infants Hospital of Rhode Island

location_facility: Heliodor Swiecicki Clinical Hospital at the Karol Marcinkowski Medical University in Poznan

location_facility: Kaiser Permanente Medical Center - Roseville

location_facility: National Cancer Institute - IRCCS "Fondazione G. Pascale"

location_facility: University Clinical Center, Clinic of Gynecology

location_facility: The Ohio State University Wexner Medical Center

location_facility: University of Virginia- Emily Couric Clinical Cancer Center

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

location_facility: Royal Marsden Hospital - London, Gynae Trials Unit

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

location_facility: University Clinical Hospital of Valencia

location_facility: University Polyclinic Foundation "Agostino Gemelli" - IRCCS

location_facility: Petz Aladar University Teaching Hospital

location_facility: Texas Oncology Baylor Charles A. Sammons Cancer Center

location_facility: Clara Campal Comprehensive Cancer Center

location_facility: University Hospital Germans Trias i Pujol

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Campus Kennedylaan, President Kennedylaan 4

location_facility: Institute of Cancer Research and Treatment of Candiolo

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Austin Health - Olivia Newton John Cancer Center

location_facility: Kaiser Permanente Medical Center - Sacramento

location_facility: Kaiser Permanente Medical Center - Walnut Creek

location_facility: US Oncology Research/Investigational Product Center

location_facility: University Hospital Innsbruck - Tyrolean Hospital

location_facility: Southwest Women's Oncology- Optimum Clinical Research Group

location_facility: Vilnius University Hospital Santaros Klinikos

location_facility: University Clinical Hospital Virgen de la Arrixaca

location_facility: Maria Sklodowska-Curie Bialystok Oncology Center

location_facility: Kaiser Permanente Medical Center - San Leandro


title: A Phase IIIb, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Long-acting Cabotegravir Plus Long-acting Rilpivirine Administered Every 8 Weeks or Every 4 Weeks in HIV-1-infected Adults Who Are Virologically Suppressed

summary: This Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.

ReferenceCitation: Overton E, Richmond G, Rizzardini G, et al.Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study.Lancet.2020; DOI: https://doi.org/10.1016/S0140-6736(20)32666-0 PMID: 33308425

doi: overton

ReferenceCitation: Chounta V, Snedecor SJ, Wu S, Van de Velde N. Indirect comparison of 48-week efficacy and safety of long-acting cabotegravir and rilpivirine maintenance every 8 weeks with daily oral standard of care antiretroviral therapy in participants with virologically suppressed HIV-1-infection. BMC Infect Dis. 2022 May 4;22(1):428. doi: 10.1186/s12879-022-07243-3.

ReferenceCitation: Jaeger H, Overton ET, Richmond G, Rizzardini G, Andrade-Villanueva JF, Mngqibisa R, Hermida AO, Thalme A, Belonosova E, Ajana F, Benn PD, Wang Y, Hudson KJ, Español CM, Ford SL, Crauwels H, Margolis DA, Talarico CL, Smith KY, van Eygen V, Van Solingen-Ristea R, Vanveggel S, Spreen WR. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021 Nov;8(11):e679-e689. doi: 10.1016/S2352-3018(21)00185-5. Epub 2021 Oct 11.

ReferenceCitation: Swindells S, Lutz T, Van Zyl L, Porteiro N, Stoll M, Mitha E, Shon A, Benn P, Huang JO, Harrington CM, Hove K, Ford SL, Talarico CL, Chounta V, Crauwels H, Van Solingen-Ristea R, Vanveggel S, Margolis DA, Smith KY, Vandermeulen K, Spreen WR. Week 96 extension results of a Phase 3 study evaluating long-acting cabotegravir with rilpivirine for HIV-1 treatment. AIDS. 2022 Feb 1;36(2):185-194. doi: 10.1097/QAD.0000000000003025.

ReferenceCitation: Chounta V, Overton ET, Mills A, Swindells S, Benn PD, Vanveggel S, van Solingen-Ristea R, Wang Y, Hudson KJ, Shaefer MS, Margolis DA, Smith KY, Spreen WR. Patient-Reported Outcomes Through 1 Year of an HIV-1 Clinical Trial Evaluating Long-Acting Cabotegravir and Rilpivirine Administered Every 4 or 8 Weeks (ATLAS-2M). Patient. 2021 Nov;14(6):849-862. doi: 10.1007/s40271-021-00524-0. Epub 2021 May 31.

ReferenceCitation: Overton ET, Richmond G, Rizzardini G, Jaeger H, Orrell C, Nagimova F, Bredeek F, García Deltoro M, Swindells S, Andrade-Villanueva JF, Wong A, Khuong-Josses MA, Van Solingen-Ristea R, van Eygen V, Crauwels H, Ford S, Talarico C, Benn P, Wang Y, Hudson KJ, Chounta V, Cutrell A, Patel P, Shaefer M, Margolis DA, Smith KY, Vanveggel S, Spreen W. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994-2005. doi: 10.1016/S0140-6736(20)32666-0. Epub 2020 Dec 9.

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

lead_sponsor: ViiV Healthcare

location_country:
Spain
Italy
Russian Federation
Australia
Argentina
Canada
Sweden
Korea, Republic of
United States
France
South Africa
Mexico
Germany


title: A Phase 2 Open-Label Study to Determine the Effect of Blinatumomab on Minimal Residual Disease in Subjects With High-risk Diffuse Large B-cell Lymphoma Post-autologous Hematopoietic Stem-cell Transplantation.

summary: The study will estimate the MRD-negative response rate after treatment with blinatumomab in subjects with high-risk DLBCL who are MRD-positive following aHSCT. The clinical hypothesis is that the MRD-negative response rate will be greater than 10%. Achieving an MRD-negative response rate of 30% would be of scientific and clinical interest.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Greece
Italy
Australia
Switzerland
United States
France
Belgium


title: A Study of Enfortumab Vedotin (ASG-22CE) as Monotherapy or in Combination With Other Anticancer Therapies for the Treatment of Urothelial Cancer

summary: This study will test an experimental drug (enfortumab vedotin) alone and with different combinations of anticancer therapies. Pembrolizumab is an immune checkpoint inhibitor (CPI) that is used to treat patients with cancer of the urinary system (urothelial cancer). This type of cancer includes cancer of the bladder, renal pelvis, ureter or urethra. Some parts of the study will look at locally advanced or metastatic urothelial cancer (la/mUC), which means the cancer has spread to nearby tissues or to other areas of the body. Other parts of the study will look at muscle-invasive bladder cancer (MIBC), which is cancer at an earlier stage that has spread into the muscle wall of the bladder. This study will look at the side effects of enfortumab vedotin alone and with other anticancer therapies. A side effect is a response to a drug that is not part of the treatment effect. This study will also test if the cancer shrinks with the different treatment combinations.

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Spain
Italy
Canada
Puerto Rico
United States
France

location_facility: Stanford Cancer Center / Blood & Marrow Transplant Program

location_facility: University of California at San Francisco

location_facility: University of California Irvine - Newport

location_facility: Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center

location_facility: Boca Raton Regional Hospital / Lynn Cancer Institute

location_facility: Northwell Cancer Center / Monter Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center - Basking Ridge

location_facility: University of Colorado Hospital / University of Colorado

location_facility: Memorial Sloan Kettering Cancer Center - Nassau

location_facility: Southcoast Centers for Cancer Care - Fairhaven Site

location_facility: Memorial Sloan Kettering Cancer Center - Monmouth

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Northwestern Medicine Cancer Center - Kishwaukee / Kishwaukee Cancer Center

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Winship Cancer Institute / Emory University School of Medicine

location_facility: Memorial Sloan Kettering Cancer Center - Bergen

location_facility: Texas Oncology - Fort Worth Cancer Center

location_facility: UNC Lineberger Comprehensive Cancer Center / University of North Carolina

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Northwestern Medicine Cancer Center Delnor

location_facility: Medical University of South Carolina/Hollings Cancer Center

location_facility: University of Mississippi Medical Center

location_facility: Medical College of Wisconsin (Milwaukee)

location_facility: Northwestern Medicine Cancer Center - Warrenville / Central DuPage Hospital - Cancer Care

location_facility: Case Western Reserve University / University Hospitals Case Medical Center

location_facility: New York University (NYU) Cancer Institute

location_facility: Memorial Sloan Kettering Cancer Center - Westchester

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Washington University School of Medicine - Siteman Cancer Center

location_facility: University of California, Davis Comprehensive Cancer Center

location_facility: Tennessee Oncology / Sarah Cannon Research Institute

location_facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center


acronym: Dose Ranging Trial of MK-8591 Given in Combination with Doravirine (DOR) and Lamivudine (3TC)

title: A Phase 2B, Randomized, Double-Blind, Active-Comparator-Controlled, Dose-Ranging Clinical Trial to Evaluate the Safety, Tolerability, Antiretroviral Activity, and Pharmacokinetics of MK-8591 Given in Combination With Doravirine (DOR) and Lamivudine (3TC) in HIV-1-Infected Treatment-Naïve Adults

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceCitation: Molina JM, Yazdanpanah Y, Afani Saud A, Bettacchi C, Chahin Anania C, Klopfer SO, Grandhi A, Eves K, Hepler D, Robertson MN, Hwang C, Hanna GJ, Correll T. Brief Report: Efficacy and Safety of Oral Islatravir Once Daily in Combination With Doravirine Through 96 Weeks for Treatment-Naive Adults With HIV-1 Infection Receiving Initial Treatment With Islatravir, Doravirine, and Lamivudine. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):68-72. doi: 10.1097/QAI.0000000000002879. Epub 2021 Dec 8.

ReferenceCitation: Molina JM, Yazdanpanah Y, Afani Saud A, Bettacchi C, Chahin Anania C, DeJesus E, Olsen Klopfer S, Grandhi A, Eves K, Robertson MN, Correll T, Hwang C, Hanna GJ, Sklar P. Islatravir in combination with doravirine for treatment-naive adults with HIV-1 infection receiving initial treatment with islatravir, doravirine, and lamivudine: a phase 2b, randomised, double-blind, dose-ranging trial. Lancet HIV. 2021 Jun;8(6):e324-e333. doi: 10.1016/S2352-3018(21)00021-7. Epub 2021 May 14.

location_country:
United States
Chile
United Kingdom
France

location_facility: North Texas Infectious Diseases Consultants, PA ( Site 0103)

location_facility: Centre Hospitalier de Tourcoing ( Site 2301)

location_facility: Orlando Immunology Center (OIC) ( Site 0105)

location_facility: The Crofoot Research Center, Inc. ( Site 0118)

location_facility: Hospital Dr. Hernan Henriquez Aravena ( Site 0203)

location_facility: North Manchester General Hospital ( Site 2104)

location_facility: Hopital Bichat - Claude Bernard ( Site 2309)

location_facility: CHU de Nice Hopital Archet 1 ( Site 2303)

location_facility: Brighton and Sussex University Hospitals NHS Trust ( Site 2105)

location_facility: University California / Davis ( Site 0101)

location_facility: Chelsea and Westminster Hospital ( Site 2101)

location_facility: The Royal Free London NHS Foundation Trust ( Site 2102)

location_facility: Saint Hope Foundation, Inc. ( Site 0116)

location_facility: Tarrant County Infectious Disease Associates ( Site 0112)

summary: This study will evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of 3 doses of islatravir (MK-8591) in combination with doravirine (DOR) and lamivudine (3TC) administered to antiretroviral treatment-naïve adult participants with human immunodeficiency virus type 1 (HIV-1) infection.


acronym: CheckMate 9LA

title: A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

ReferenceCitation: Paz-Ares L, Ciuleanu TE, Cobo M, Schenker M, Zurawski B, Menezes J, Richardet E, Bennouna J, Felip E, Juan-Vidal O, Alexandru A, Sakai H, Lingua A, Salman P, Souquet PJ, De Marchi P, Martin C, Pérol M, Scherpereel A, Lu S, John T, Carbone DP, Meadows-Shropshire S, Agrawal S, Oukessou A, Yan J, Reck M. First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 Feb;22(2):198-211. doi: 10.1016/S1470-2045(20)30641-0. Epub 2021 Jan 18. Erratum in: Lancet Oncol. 2021 Mar;22(3):e92.

location_country:
Poland
Brazil
Romania
Spain
Ireland
Italy
Australia
Mexico
Argentina
Canada
Russian Federation
United Kingdom
United States
Chile
China
France
Belgium
Japan
Germany

location_facility: University of Wisconsin Carbone Cancer Center

summary: The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease


acronym: First-line Esophageal Carcinoma Study with Chemo vs. Chemo + Pembrolizumab

title: A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)

type: Registry Identifier

ReferenceCitation: Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Sakata T, Yatsuzuka N, Doi T, Kato K. First-line pembrolizumab + chemotherapy in Japanese patients with advanced/metastatic esophageal cancer from KEYNOTE-590. Esophagus. 2022 Oct;19(4):683-692. doi: 10.1007/s10388-022-00920-x. Epub 2022 Jun 7.

ReferenceCitation: Zhu Y, Liu K, Ding D, Zhou Y, Peng L. Pembrolizumab Plus Chemotherapy as First-Line Treatment for Advanced Esophageal Cancer: A Cost-Effectiveness Analysis. Adv Ther. 2022 Jun;39(6):2614-2629. doi: 10.1007/s12325-022-02101-9. Epub 2022 Apr 8.

ReferenceCitation: Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Mansoor W, Li SH, Sunpaweravong P, Maqueda MA, Goekkurt E, Hara H, Antunes L, Fountzilas C, Tsuji A, Oliden VC, Liu Q, Shah S, Bhagia P, Kato K; KEYNOTE-590 Investigators. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4. Erratum in: Lancet. 2021 Nov 20;398(10314):1874.

ReferenceCitation: Kato K, Shah MA, Enzinger P, Bennouna J, Shen L, Adenis A, Sun JM, Cho BC, Özgüroğlu M, Kojima T, Kostorov V, Hierro C, Zhu Y, McLean LA, Shah S, Doi T. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609. Epub 2019 Feb 8.

location_country:
Spain
United Kingdom
United States
Costa Rica
Peru
Romania
South Africa
Japan
Hong Kong
Russian Federation
Australia
Argentina
Turkey
Malaysia
Brazil
Canada
Guatemala
China
Germany
Denmark
Taiwan
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto. ( Site 0203)

location_facility: The Affiliated Tumour Hospital of Harbin Medical University ( Site 0102)

location_facility: WITS Clinical Research CMJAH Clinical Trial Site ( Site 2500)

location_facility: Hokkaido University Hospital ( Site 0916)

location_facility: Hospital Universitari Vall d Hebron ( Site 0702)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0801)

location_facility: National Cheng Kung University Hospital ( Site 1905)

location_facility: Universitatsklinikum Mannheim GmbH ( Site 1504)

location_facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0602)

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0209)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0804)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 0406)

location_facility: Istanbul Medeniyet Universitesi Goztepe EAH ( Site 0807)

location_facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0201)

location_facility: Institut du Cancer de Montpellier ( Site 0306)

location_facility: Fujian Provincial Cancer Hospital ( Site 0104)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0904)

location_facility: Princess Margaret Cancer Centre ( Site 0505)

location_facility: University Hospitals Cleveland Medical Center ( Site 0002)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0914)

location_facility: Klinik fuer Haematologie. Onkologie und Gastroenterologie ( Site 1508)

location_facility: Hospital Universitario Reina Sofia ( Site 0706)

location_facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 0803)

location_facility: Roswell Park Cancer Institute ( Site 0004)

location_facility: Bumrungrad International Hospital ( Site 2203)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 0119)

location_facility: Hospital Clinico Universidad de Chile ( Site 1002)

location_facility: Osaka Medical College Hospital ( Site 0925)

location_facility: Hospital Universitario Central de Asturias ( Site 0708)

location_facility: Centro Regional de Sub Especialidades Medicas SA ( Site 1403)

location_facility: Staedtisches Klinikum Dresden ( Site 1507)

location_facility: Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1502)

location_facility: Chonnam National University Hwasun Hospital ( Site 1305)

location_facility: Kuang Tien General Hospital ( Site 1909)

location_facility: PLA Cancer Centre of Nanjing Bayi Hospital ( Site 0110)

location_facility: Osaka International Cancer Institute ( Site 0923)

location_facility: Fudan University Shanghai Cancer Center ( Site 0108)

location_facility: Hosp. Gral. Universitari Germans Trias i Pujol ( Site 0701)

location_facility: ICIMED - Instituto de Investigacion en Ciencias Medicas ( Site 2601)

location_facility: University of Tennessee Medical Center Knoxville ( Site 0017)

location_facility: CISSS de la Monteregie-Centre ( Site 0504)

location_facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 1705)

location_facility: CHU Brest - Institut de Cancerologie et d Hematologie ( Site 0305)

location_facility: National Medical and Surgical Center n.a. N.I.Pirogov ( Site 0402)

location_facility: National Cancer Center Hospital East ( Site 0908)

location_facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2404)

location_facility: Niigata Cancer Center Hospital ( Site 0924)

location_facility: S C Oncocenter Oncologie Medicala S R L ( Site 2405)

location_facility: Humanity Health Research Centre ( Site 1603)

location_facility: Centro de Investigacion Oncologica ( Site 1402)

location_facility: Chi Mei Medical Center Liuying ( Site 1907)

location_facility: Sanatorio Allende - Cordoba ( Site 0604)

location_facility: Tongji Medical College Huazhong University of Science and Technology ( Site 0109)

location_facility: University Malaya Medical Centre ( Site 1802)

location_facility: Clinica de Hematologia e Oncologia Viver Ltda ( Site 0211)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0120)

location_facility: Peking Union Medical College Hospital ( Site 0123)

location_facility: National Taiwan University Hospital ( Site 1900)

location_facility: Chang Gung Medical Foundation. Linkou ( Site 1903)

location_facility: Instituto Regional de Enfermedades Neoplasicas del Sur IRENSUR ( Site 1702)

location_facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 1902)

location_facility: Pamela Youde Nethersole Eastern Hospital ( Site 1601)

location_facility: National Cancer Center Hospital ( Site 0907)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0603)

location_facility: Odense Universitetshospital ( Site 2300)

location_facility: Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0114)

location_facility: Lothian University Hospitals NHS Trust ( Site 1101)

location_facility: Princess Alexandra Hospital ( Site 2005)

location_facility: Zhongda Hospital Southeast University ( Site 0125)

location_facility: Hospital Alemao Oswaldo Cruz ( Site 0207)

location_facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0206)

location_facility: Peter MacCallum Cancer Centre ( Site 2003)

location_facility: Medical Park Izmir Hastanesi ( Site 0800)

location_facility: Princess Margaret Hospital. ( Site 1602)

location_facility: Seoul National University Cancer Hospital ( Site 1301)

location_facility: St Petersburg City Clinical Oncology Dispensary ( Site 0409)

location_facility: China Medical University Hospital ( Site 1904)

location_facility: Ibaraki Prefectural Central Hospital ( Site 0918)

location_facility: The First Affiliated Hospital of Anhui Medical University ( Site 0112)

location_facility: The Medical Oncology Centre of Rosebank ( Site 2506)

location_facility: University of Maryland Medical Center ( Site 0013)

location_facility: Institut Mutualiste Montsouris ( Site 0300)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2402)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0901)

location_facility: Hospital Privado Centro Medico Cordoba ( Site 0601)

location_facility: Kansai Medical University Hospital ( Site 0931)

location_facility: Taipei Medical University Shuang Ho Hospital ( Site 1908)

location_facility: Universitaetsklinikum Leipzig ( Site 1501)

location_facility: Beacon International Specialist Centre ( Site 1803)

location_facility: Inst de Medicina Integral Professor Fernando Figueira- IMIP ( Site 0210)

location_facility: Complejo Hospitalario Virgen De La Victoria ( Site 0705)

location_facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 1701)

location_facility: III. Medizinische Klinik Klinikum rechts der Isar ( Site 1506)

location_facility: Kobe City Medical Center General Hospital ( Site 0929)

location_facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 2501)

location_facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 1906)

location_facility: Hospital Regional de Concepcion Dr. Guillermo Grant Benavente ( Site 1003)

location_facility: Kumamoto University Hospital ( Site 0919)

location_facility: Outeniqua Cancercare Oncology Unit ( Site 2504)

location_facility: Washington University School of Medicine ( Site 0031)

location_facility: The Ottawa Hospital - Cancer Care ( Site 0501)

location_facility: Pontificia Universidad Catolica de Chile ( Site 1001)

location_facility: The Christie NHS Foundation Trust ( Site 1100)

location_facility: The University of Chicago Medical Center ( Site 0001)

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2407)

location_facility: Hospital Universitario La Paz ( Site 0700)

location_facility: Severance Hospital Yonsei University Health System ( Site 1302)

location_facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 2600)

location_facility: Weill Cornell Medical College ( Site 0024)

location_facility: Hospital Sao Vicente de Paulo ( Site 0204)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 0906)

location_facility: CETUS Hospital Dia Oncologia ( Site 0208)

location_facility: CHU de Saint Etienne Hopital Nord ( Site 0309)

location_facility: University of Tsukuba Hospital ( Site 0910)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 0200)

location_facility: Leningrad Regional Oncology Center ( Site 0405)

location_facility: Tomsk Scientific Research Institute of Oncology ( Site 0403)

location_facility: Aichi Cancer Center Hospital ( Site 0902)

location_facility: St. Marianna University School of Medicine Hospital ( Site 0903)

location_facility: Osaka General Medical Center ( Site 0912)

location_facility: Cape Town Oncology Trials Pty Ltd ( Site 2508)

location_facility: UPMC Cancer Center/Hillman Cancer Center ( Site 0015)

location_facility: Kaiser Permanente Southern California ( Site 0003)

summary:
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma.

The overall primary efficacy hypotheses are as follows:

In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score [CPS] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.
In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.


title: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)(PACIFICA)

acronym: PACIFICA

summary:
This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count <50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients)

Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis

Intervention/treatment: Drug-Pacritinib

ReferenceCitation: Gerds AT, Savona MR, Scott BL, Talpaz M, Egyed M, Harrison CN, Yacoub A, Vannucchi A, Mead AJ, Kiladjian JJ, O'Sullivan J, García-Gutiérrez V, Bose P, Rampal RK, Miller CB, Palmer J, Oh ST, Buckley SA, Mould DR, Ito K, Tyavanagimatt S, Smith JA, Roman-Torres K, Devineni S, Craig AR, Mascarenhas JO. Determining the recommended dose of pacritinib: results from the PAC203 dose-finding trial in advanced myelofibrosis. Blood Adv. 2020 Nov 24;4(22):5825-5835. doi: 10.1182/bloodadvances.2020003314.

lead_sponsor: CTI BioPharma

location_country:
Poland
Belarus
Serbia
Italy
Georgia
Australia
Russian Federation
Canada
Spain
United Kingdom
Ukraine
Hungary
Korea, Republic of
United States
France
Israel
Germany
Bulgaria
Czechia

location_facility: Royal Hallamshire Hospital, Department of Hematology

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

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

location_facility: University Hospital Ulm, Center for Internal Medicine,

location_facility: University Clinical Hospital of Salamanca, Department of Hematology

location_facility: Dana Farber Cancer Institute, Massachusetts General Hospital

location_facility: Centre Hospitalier de Toulouse- Hôpital Purpan

location_facility: The University of Chicago Medical Center

location_facility: Rabin Medical Center, Clinic for Myeloproliferative Disorders

location_facility: University Polyclinic Foundation "Agostino Gemelli"

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

location_facility: Bashkiria State Medical University, Department of Internal Medicine

location_facility: Cherkasy Regional Oncology Dispensary of Cherkasy Oblast Council, Regional Treatment and Diagnostic Hematology Center, Department of Hematology

location_facility: Kyiv City Clinical Hospital #9, Hematology Department #1

location_facility: Oxford University Hospitals NHS Trust - Churchill Hospital

location_facility: The Tel Aviv Sourasky Medical Center, Department of Internal Medicine

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Memorial Sloan-Kettering Cancer Center- Commack

location_facility: Institute of Blood Pathology and Transfusion Medicine, Department of Hematology

location_facility: Communal Non-profit enterprise "Regional Center of Oncology", Department of Hematology

location_facility: American Oncology Partners of Maryland, PA

location_facility: Research Institute of Hematology and Transfusiology

location_facility: Nicolaus Copernicus Provincial Multispecialty Oncology and Traumatology Center in Lodz

location_facility: Meir Medical Center, Hematology Institute and Blood Bank

location_facility: LTD S.Khechinashvili University Hospital

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: Poltava M.V. Sklifosovskyi Regional Clinical Hospital under Poltava Regional Council, Department of Hematology

location_facility: Nova Scotia Health Authority, Centre for Clinical Research

location_facility: Morales Meseguer University General Hospital, Department of Hematology and Hemotherapy

location_facility: Jan Mikulicz Radecki University Hospital in Wroclaw, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation

location_facility: Clinical Center of Vojvodina, Clinic of Hematology

location_facility: Republican Research Center for Radiation Medicine and Human Ecology

location_facility: Tom Baker Cancer Center, Internal Medicine/Hematology

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: S.M. Kirov Military Medical Academy, Department and Clinic for Intermediate-Level Training in Internal Medicine, Hematology Division

location_facility: V.D. Seredavin Samara Regional Clinical Hospital, Department of Hematology

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv

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

location_facility: Multiprofile Hospital for Active Treatment - Sofia, part of Military Medical Academy

location_facility: Jewish General Hospital; Clinical Research Unit

location_facility: Comprehensive Cancer Centers of Nevada- Twain Office

location_facility: V.A. Almazov North-West Federal Medical Research Center, Institute of Oncology and Hematology, Scientific Department of Clinical Oncology

location_facility: Lady Davis Carmel Medical Center, Department of Hematology,

location_facility: University Hospital Kralovske Vinohrady, Clinic of Internal Hematology

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

location_facility: CHU Hopitaux de Bordeaux - Hôpital Haut-Lévêque

location_facility: Maryland Oncology Hematology, PA- Columbia

location_facility: LTD M.Zodelava's Hematology Center, Department of Hematology

location_facility: Hadassah Medical Center, Department of Hematology,

location_facility: George Washington University-Medical Faculty Associates

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

location_facility: Ohio State University Comprehensive Cancer Center

location_facility: Cancer Institute "Giovanni Paolo II", IRCCS

location_facility: Regional Clinical Hospital, Department of Hematology,

location_facility: Alfred Hospital, Malignant Hematology and Stem Cell Transplantation Service

location_facility: University of Utah - Huntsman Cancer Institute

location_facility: City Clinical Hospital #4" under Dnipro City Council

location_facility: Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: Semmelweis University SE ÁOK I. sz. Belgyógyászati Klinika

location_facility: Volgograd Regional Clinical Oncology Center

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Washington University School of Medicine-Siteman Cancer Center

location_facility: Hospital rechts der Isar, Department of Internal Medicine III, Hematology and Oncology

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: JSC K. Eristavi National Center For Experimental and Clinical Surgery

location_facility: The Sarah Cannon Research Institute-Tennessee Oncology

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

location_facility: Scientific Institute of Romagna for the Study and Treatment of Cancer (IRST), IRCCS

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

location_facility: Institute of Hematology and Transfusion Medicine, Teaching Department of Hematology

location_facility: University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center

location_facility: Regional Cancer Care Associates LLC - CCBD Division

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: University Hospital Cologne, Department of Internal Medicine I,

location_facility: Rocky Mountain Cancer Centers (US Oncology/McKesson)

location_facility: University of Debrecen Clinical Center (Debreceni Egyetem Klinikai Központ)

location_facility: Michigan Medicine Hematology Clinic-Rogel Cancer Center

location_facility: Johannes Wesling Hospital Minden, Department of Oncology and Hematology

location_facility: City Clinical Hospital n.a. V.V. Veresaev of the Moscow City Health

location_facility: Kyiv Regional Oncology Center, Department of Hematology,

location_facility: Barts Health NHS Trust - The Royal London Hospital

location_facility: Bacs-Kiskun County Hospital, 2nd Department of Internal Medicine

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

location_facility: Nasz Lekarz Medical Outpatient Clinics Slawomir Jeka


acronym: AERISTO

title: A Randomised, Double-Blind, Double-Dummy, Multicentre, Parallel Group Study to Assess the Efficacy and Safety of Glycopyrronium/Formoterol Fumarate Fixed-dose Combination Relative to Umeclidinium/Vilanterol Fixed-dose Combination Over 24 Weeks in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (AERISTO)

lead_sponsor: AstraZeneca

ReferenceCitation: Maltais F, Ferguson GT, Feldman GJ, Deslee G, Bourdin A, Fjällbrant H, Siwek-Posłuszna A, Jenkins MA, Martin UJ. A Randomized, Double-Blind, Double-Dummy Study of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Relative to Umeclidinium/Vilanterol Dry Powder Inhaler in COPD. Adv Ther. 2019 Sep;36(9):2434-2449. doi: 10.1007/s12325-019-01015-3. Epub 2019 Jul 2.

location_country:
Russian Federation
Canada
Ukraine
Hungary
United States
France
Bulgaria

summary: This is a phase IIIb randomised, double-blind, double-dummy, multicentre, parallel group, 24 week study to assess the efficacy and safety of Glycopyrronium/Formoterol Fumarate (GFF) fixed-dose combination 7.2/4.8 μg 2 inhalations twice daily compared to Umeclidinium/Vilanterol (UV) 62.5/25 μg fixed-dose combination 1 inhalation once daily in Patients with moderate to very severe COPD.