acronym: EPCORE DLBCL-1

lead_sponsor: Genmab

summary: The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT

sponsor_collaborators: Genmab AbbVie

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

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

location_facility: The Second Affiliated Hospital Zhejiang University School of Medicine

location_facility: State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr

location_facility: Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094

location_facility: Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU

location_facility: Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116

location_facility: The Second Hospital of Dalian Medical University

location_facility: Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: TriHealth Cancer Institute- Good Samaritan Hospital

location_facility: Josa Andras Teaching Hospital, Hematology Dept

location_facility: Clinical Research Unit, Roskilde Sygehus

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Ordensklinikum Linz Barmherzige Schwestern

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

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

location_facility: Shengjing Hospital of China Medical University

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii

location_facility: Oulu university hospital, Department of hematology

location_facility: AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie

location_facility: State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl

location_facility: Federal State Budgetary Institution of Science

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C

location_facility: Guangxi Medical University Affiliated Tumor Hospital

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: Seoul National University Bundang Hospital

location_facility: Belgyógyászati osztály Markhot Ferenc Kórház

location_facility: SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo

location_facility: Beijing Tongren Hospital, Capital Medical University

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: Haematology - University Hospitals Birmingham NHS Foundation Trust

location_facility: University of Pecs 1st. Internal medicine Clinic Dept. Hematology

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

location_facility: Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43

location_facility: Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra

location_facility: Royal Marsden NHS Foundation Trust (Sutton)

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi

location_facility: Community Health Network Cancer Center North

location_facility: Peninsula Private Hospital Clinical Trials Unit

location_facility: Universitair Ziekenhuis gasthuisberg Leuven

location_facility: Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of

location_facility: Oslo University Hospital location Radium hospital

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

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi)

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

title: A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

location_country:
Finland
Germany
Poland
Australia
Japan
Turkey
Canada
France
Hungary
Denmark
United States
Belgium
China
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Daiichi Sankyo, Inc.

summary: Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence. More effective treatment options are needed for this patient population. This study will examine the efficacy and safety of trastuzumab deruxtecan (T-DXd) compared with trastuzumab emtansine (T-DM1) in high-risk patients with residual invasive breast cancer following neoadjuvant therapy.

sponsor_collaborators: Spanish Breast Cancer Research Group (SOLTI)

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE

location_facility: McGill University Health Centre - Cedars Cancer Centre

location_facility: Policlinico S.Orsola-Malpighi SSD Oncologia Medica Addarii

location_facility: Universitätsklinikum Düsseldorf, Klinik für Frauenheilkunde & Geburtshilfe

location_facility: Mammazentrum HH am Krankenhaus Jerusalem

location_facility: National Hospital Organization - Osaka National Hospital (ONH)

location_facility: Colchester Hospital, East Suffolk & North Essex NHS Foundation Trust

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE

location_facility: Our Lady of the Lake Physician Group-Medical Oncology

location_facility: Jilin University JLU - First Affiliated Hospital

location_facility: SCRI TO Nashville- Southern Hills Tennessee Oncology, PLLC

location_facility: Frankfurt University Department of Gynecology and Obstetrics

location_facility: Union Hospital of Fujian Medical University

location_facility: Medzinische Fakultät Mannheim, Universität Heidelberg

location_facility: Universitätsklinik Freiburg, Klinik für Frauenheilkunde

location_facility: MediOnko-Institut GbR, Praxisklinik Krebsheilkunde

location_facility: Univeristy Hospitals Bristol NHS Foundation Trust

location_facility: Hospital Sirio-Libanes HSL - Centro de Oncologia - Brasilia

location_facility: Nanjing Medical University NMU - Jiangsu Province Hospital

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: Consultorio del Dr. Joaqun Gabriel Reinoso Toledo

location_facility: SCRI FCS North- St. Anthony's/St. Petersburg

location_facility: Harzklinikum Dorothea Christiane Erxleben

location_facility: SCRI FCS North- Gainesville Cancer Center

location_facility: Kanagawa Cancer Center Hospital - Kanagawa Cancer Center (Kanagawa Cancer Centre Research Institute)

location_facility: Elmhurst Memorial Hospital- Nancy W. Knowles Cancer Center

location_facility: Presidio Ospedaliero di Summa - Antonio Perrino

location_facility: Gemeinschaftspraxis Dres. Halder / Bangerter

location_facility: The University of Hong Kong (HKU) - Queen Mary Hospital (QMH)

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: IUC AP-HP. Sorbonne Université, Hôpital Tenon

location_facility: Harbin Medical University Cancer Hospital

location_facility: Institut für Versorgungsforschung in der Onkologie

location_facility: Consorcio Hospitalario Provincial de Castelló

location_facility: SCRI TO Nashville- Gallatin Tennessee Oncology, PLLC

location_facility: Medizinisches Versorgungszentrum für Hämatologie und Onkologie München MVZ GmbH

location_facility: National Taiwan University Hospital NTUH

location_facility: MultiCare Regional Cancer Center - Gig Harbor

location_facility: Tohoku University Hospital (TUH) - Clinical Research, Innovation and Education Center (CRIETO)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Kliniken Essen-Mitte, Klinik für Senologie/ Interdisziplinäres Brustzentrum

location_facility: Krankenhaus St. Elisabeth und St. Barbara Halle/Saale

location_facility: National Hospital Organization (NHO) - Shikoku Cancer Center

location_facility: CIUSSSS de l'Est-de-l'Ile-de-Montréal - Installation Hôpital Maisonneuve-Rosemont

location_facility: MultiCare Institute for Research & Innovation

location_facility: SCRI TO Nashville- Summit Tennessee Oncology, PLLC

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

location_facility: General Hospital of Patras Agios Andreas

location_facility: Showa University Hospital - Breast Center

location_facility: Ochsner Hematology Oncology North Shore - Covington (West Region)

location_facility: St.-Johannes-Hospital Dortmund, Dept. of Obstetrics/Gynecology

location_facility: MedStar Franklin Square Cancer Center at Loch Raven Campus

location_facility: Istanbul Medeniyet University Medical Faculty

location_facility: Johannes Wesling Klinikum Minden, Hämatologie-Onkologie/Brustzentrum

location_facility: Pamela Youde Nethersole Eastern Hospital PYNEH

location_facility: Fundacao Pio XII-Hospital de Cancer de Barretos

location_facility: SCRI TO Nashville- Skyline Tennessee Oncology, PLLC

location_facility: Instituto Nacional de Enfermedades Neoplasicas INEN

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta

location_facility: Osaka International Cancer Institute (OICI)

location_facility: Kliniken der Stadt Köln / Brustzentrum Holweide

location_facility: Department of Gyencology and Obstetrics, Saarland University Hospital

location_facility: Dept. OB/GYN Johanna Etienne Krankenhaus

location_facility: Wellmont Medical Associates Oncology & Hematology

location_facility: CHU de Quebec - Hopital du Saint-Sacrement

location_facility: Soon Chun Hyang Central Medical Center (SCHMC)

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Fundação Universidade de Caxias do Sul Instituto de Pesquisas em Saúde IPS-UCS

location_facility: Hospital da Senhora da Oliveira, Guimarães EPE

location_facility: SCRI TO Nashville- St. Thomas West Tennessee Oncology, PLLC

location_facility: Klinikverbund Südwest Kliniken Böblingen Frauenklinik Böblingen

location_facility: Complejo Hospitalario Universitario A Coruña (CHUA)

location_facility: Japanese Foundation for Cancer Research (JFCR) - The Cancer Institute Hospital - Breast Oncology Center

location_facility: The 4th Hospital of Heibei Medical University

location_facility: Regional Cancer Center at Indian Path Community Hospital

location_facility: Frederick Health-James M Stockman Cancer Center

location_facility: INCA - Instituto Nacional do Cancer / Hospital do Cancer HCIII

location_facility: St John of God Hospital - Bendat Family Comprehensive Cancer Centre (BFCCC)

location_facility: SCRI TO Nashville- Smyrna Tennessee Oncology, PLLC

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: SCRI TO Nashville- Hendersonville Tennessee Oncology, PLLC

location_facility: Jewish General Hospital Segal Cancer Centre

location_facility: General Hospital of Athens Alexandra Clinic

location_facility: Centre de Cancérologie du Grand Montpellier

location_facility: National Cancer Center (NCC) - Tsukiji Campus - National Cancer Center Hospital (NCCH)

location_facility: Erasmus MC - Daniel den Hoed Oncologisch Centrum

location_facility: Fundación Instituto Valenciano de Oncologia (IVO)

location_facility: SCRI TO Nashville- Lebanon Tennessee Oncology, PLLC

location_facility: Complejo Hospitalario Clínico Universitario de Santiago de Compostela (CHUS)

location_facility: National Cancer Center Hospital East (NCCHE) - Kashiwa Campus

location_facility: Kindai University (Kinki University) - Faculty of Medicine (Kinki University School of Medicine (KUSM)) - Kindai University Hospital (Kinki University Hospital) - Cancer Center

location_facility: Royal United Hospital Bath NHS Trust - Royal United Hospital RUH

location_facility: ALTHAIA, Xarxa Assistencial Universitària de Manresa F.P.

location_facility: Area Vasta Sud Est Sede Operativa Grosseto

location_facility: Clinique Tivoli Ducos - Centre dOncologie et de Radiotherapie a Bordeaux

location_facility: Nanchang University - The First Affiliated Hospital

location_facility: Gemeinschaftspraxis Frauenärzte am Bahnhofsplatz

location_facility: The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)

location_facility: Hospital Clínico Universitario Virgen de la Arrixaca

location_facility: Reading Hospital, McGlinn Cancer Institute

location_facility: Clinica Oncologica, Ospedali Riuniti Umberto 1

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

location_facility: University of Kentucky, Markey Cancer Center, Clinical Research Organization

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Frauenklinik St. Louise - St. Vincenz- Krankenhaus GmbH

location_facility: Hospital Universitario San Pedro de Alcantara

location_facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: Algemeen Ziekenhuis AZ Klina - Borstkliniek

location_facility: National Hospital Organization - Hokkaido Cancer Center

location_facility: Hospital General Universitario Morales Meseguer

location_facility: IOB Institute Of Oncology-Hospital Quironsalud Barcelona

location_facility: SRH Waldklinikum Gera, Brustzentrum Ostthüringen

location_facility: Hospital MD Anderson Cancer Center Madrid

location_facility: Second Affiliated Hospital of Zhejiang University

location_facility: Centro di Riferimento Oncologico di Aviano - SOC Oncologia Medica e Prevenzione Oncologica

location_facility: The Oncology Institute of Hope & Innovation

location_facility: Chi Mei Medical Center CMMC - Yongkang Branch

location_facility: Schwarzwald - Baar Klinikum Frauenklinik

location_facility: National Hospital Organization - National Kyushu Cancer Center

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

location_facility: Unifrauenklinik Köln - Studienzentrum Gynäkologie

location_facility: Chongqing Medical University - The First Affiliated Hospital

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Sichuan University - West China Hospital

location_facility: State Budgetary Healthcare Institution Oncological Dispensary No. 2 of the Ministry of Health of Krasnodar Region

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Hospital General Universitario de Alicante

location_facility: Tennessee Oncology Nashville / Sarah Cannon

location_facility: Hospital Universitario HM Puerta del Sur

location_facility: Seoul National University Bundang Hospital

location_facility: MSCM Cancer Center and Institute of Oncology Department of Breast Cancer and Reconstructive Surgery

location_facility: Tokai University Hospital - Isehara Campus

location_facility: Virginia Commonwealth University Massey Cancer Center

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: University General Hospital of Heraklion

location_facility: LMU Klinikum/ Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

location_facility: SCRI TO Nashville- Franklin Tennessee Oncology, PLLC

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Unidade Local de Saúde de Matosinhos, EPE

location_facility: SBHI Arkhangelsk Region - Arkhangelsk Clinical Oncological Dispensary

location_facility: Hospital Clínico Universitario de Valencia

location_facility: CHA Bundang Medical Center CHA University

location_facility: SCRI TO Nashville- St. Thomas Midtown Tennessee Oncology, PLLC

location_facility: The Sel of Centre dOncologie de Gentilly

location_facility: Centro de Investigación Clinica Trujillo EIRL

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Complejo Asistencial Universitario de León

location_facility: MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute

location_facility: Austin Hospital- Olivia Newto-John Cancer and Wellness Centre

status: Active, not recruiting

title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Participants With High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy (DESTINY-Breast05)

primary_purpose: Treatment

type: EudraCT Number

type: Other Identifier

source: euctr

enrollment_type: Anticipated

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

design_allocation: Randomized

study_completion_date_type: Anticipated

location_country:
Germany
Ireland
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
Czechia
Canada
France
Portugal
Hong Kong
Denmark
United States
Romania
Belgium
China
Peru
Italy
United Kingdom
Singapore
Netherlands
Mexico
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

collaborators: Spanish Breast Cancer Research Group (SOLTI)

lead_sponsor_type: industriel

status_simplified: Ongoing


lead_sponsor: Bayer

summary:
Researchers in this study want to compare how well drug radium-223 dichloride (Xofigo) and new (novel) anti-hormonal (NAH) therapy work in participants with prostate gland cancer which has spread to the bone and progressed on or after one line of NAH therapy. Meanwhile researchers want to compare the safety of radium-223 dichloride and NAH therapy. Radium-223 dichloride is known as a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off a type of radioactivity that travels a very short distance and kills the tumor cells that have spread to the bone without major effects to the healthy cells. It has been approved in many countries for the treatment of patients with prostate cancer which has spread to the bone. The NAH drugs used in this study will be either abiraterone acetate (Zytiga) (plus prednisone/prednisolone) or enzalutamide (Xtandi). Both of them are standard approved medications which are used in the treatment of advanced prostate cancer.

Participants in this study will receive either Radium-223 dichloride or a NAH therapy. Radium-223 dichloride will be given as an infusion into one of the veins on Day 1 of each 4-week cycle for a total of up to 6 cycles. Oral NAH therapy will be given per the standard approved dose once daily until the disease has progressed. Participants will visit the hospital or clinic every 2 weeks for the first 6 cycles, and only on the first day of each cycle from cycle 7 and onwards. Observation for each participant will last for about 2 years in total. Blood and urine samples will be collected from the participants and participants will be asked to complete questionnaires about the well-being and the pain.

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: A.O. Nazionale SS Antonio e Biagio e Cesare Arrigo - Oncologia

location_facility: Gosford Hospital (GH) - Central Coast Cancer Centre

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Szpital Grochowski im. dr.med. Rafala Masztaka

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: The Hospital of Lithuanian University of Health SciencesLUHS

location_facility: Hospital Universitario Virgen de la Victoria | Cardiology Department

location_facility: Samara Regional Clinical Oncology Dispensary

location_facility: Universitätsmedizin Göttingen - Hämatologie und medizin. Onkologie

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi

location_facility: Institut de Cancérologie de Lorraine - Alexis Vautrin

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Hospital de la Santa Creu i Sant Pau | Gynecology Department

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

location_facility: Illawarra Shoalhaven Local Health District

location_facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: IRCCS Centro di Riferimento Oncologico (CRO)

location_facility: Centre Hospitalier Universitaire - Grenoble

location_facility: Izmir Tepecik Egitim ve Arastirma Hastanesi

location_facility: National Medical Research Radiology Center

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Institut Gustave Roussy - Département de Médecine Oncologique

location_facility: Uniwersytecki Szpital Kliniczny UM we Wroclawiu

location_facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

location_facility: Seoul National University Bundang Hospital

location_facility: Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie - Oddzial Dzienny Chemioterapii

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi

location_facility: Koc Universitesi Tip Fakultesi - Radyoloji

location_facility: Consorcio Hospitalario Provincial de Castellón

location_facility: Izmir Ekonomi Universitesi Medikal Point Hastanesi

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Ankara Yildirim Beyazit Universitesi Tip Fakültesi

location_facility: Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

location_facility: Tomsk National Research Medical Center of RAS

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Hospital Universitario Clinica Puerta de Hierro

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Vilnius University Hospital Santaros Klinikos

status: Recruiting

title: A Phase 4, Randomized, Open-label, Multicenter Efficacy and Safety Study of Standard Dose of Radium-223 Dichloride vs. Standard Doses of Novel Anti-hormonal Therapy (NAH) in Patients With Bone Dominant Metastatic Castration Resistant Prostate Cancer (mCRPC) Progressing on/After One Line of NAH

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Finland
Germany
Poland
Australia
Turkey
Czechia
France
Lithuania
Hungary
Hong Kong
Italy
United Kingdom
Singapore
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

ipd_sharing: No


title: Phase III Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-negative Breast Cancer Patients With High Relapse Risk After Standard Neoadjuvant Treatment - SASCIA

acronym: SASCIA

summary:
Phase III, prospective, multi-center, randomized, open label, parallel group, study in patients with HER2-negative breast cancer with residual disease after neoadjuvant chemotherapy with 1:1 allocation to:

Arm A: Sacituzumab govitecan (days 1, 8 q3w for eight cycles);
Arm B: treatment of physician´s choice (TPC, defined as capecitabine or platinum-based chemotherapy for eight cycles or observation.

Treatment in either arm will be given for eight cycles.

In patients with HR-positive breast cancer, endocrine-based therapy, which includes the use of CDK4/6 inhibitors, will be administered according to local guidelines. The start of endocrine therapy will be at the discretion of the investigator; however, it will be encouraged to start after surgery/radiotherapy in patients without additional cytotoxic agents.

Adjuvant pembrolizumab can be given until the completion of radiotherapy before randomization. Within the study the use of pembrolizumab in patients with TNBC who received pembrolizumab as neoadjuvant therapy is allowed as monotherapy in the TPC arm, according to the approval of pembrolizumab in this setting.

ReferenceType: result

ReferenceCitation: Marmé F, Hanusch C, Furlanetto J, et al. Safety interim analysis (SIA) of the phase III postneoadjuvant SASCIA study evaluating sacituzumab govitecan (SG) in patients with primary HER2-negative breast cancer (BC) at high relapse risk after neoadjuvant treatment. ESMO Breast 2022; 58O, proffered paper presentation. https://doi.org/10.1016/j.annonc.2022.03.075

lead_sponsor: German Breast Group

collaborators: Austrian Breast & Colorectal Cancer Study Group

collaborators: Spanish Breast Cancer Research Group (GEICAM)

location_country: Germany Ireland Italy Switzerland Austria Belgium Spain France

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Hospital Universitario Ntra.Sra. de Candelaria

location_facility: Hospital Clínico Universitario Virgen de La Arrixaca

location_facility: MVZ Nordhausen gGmbH im Südharz Krankenhaus

location_facility: Hospital Universitario Virgen de La Macarena

location_facility: Institut de Cancérologie Strasbourg Europe-ICANS

location_facility: Institut régional du Cancer de Montpellier - ICM Val d'Aurelle

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Hôpital Privé Des Côtes d'Armor- Centre CARIO-HPCA

location_facility: Complejo Hospitalario Universitario de Orense-Hospital Santa Maria Nai

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Hospital Universitario Quirónsalud Madrid

location_facility: MUG - Univ.-Klinik f. Frauenheilkunde u. Geburtshilfe Graz

location_facility: Kliniken Essen-Mitte Evang. Huyssens-Stiftung/Knappschaft GmbH

location_facility: Groupe Hospitalier Diaconesses Croix Saint Simon

location_facility: Onkologische Schwerpunktpraxis, Studiengesellschaft Onkologie Bielefeld GbR

location_facility: St. Elisabeth-Krankenhaus, Brustzentrum Köln-Hohenlind

location_facility: Praxisklinik für Hämatologie und Onkologie

location_facility: Complejo Hospitalario Universitario de Santiago (Chus)

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Hochwaldkrankenhaus, Gesundheitszentrum Wetterau gGmbH

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Klinikum Kassel GmbH, Gynäkologische Ambulanz

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: Gemeinschaftspraxis Dr. U. Kronawitter/ Dr. C. Jung

location_facility: Hospital General Universitario de Alicante

location_facility: Sozialstiftung Bamberg, Klinik am Bruderwald

location_facility: Istituti Clinici Scientifici Maugeri SpA-SB

location_facility: Charité Universitätsmedizin Campus Charité Mitte

location_facility: COMPLEJO HOSPITALARIO UNIVERSITARIO A CORUÑA-Hospital Teresa Herrera (CHUAC)

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Institut de cancérologie de l'ouest (Angers)

location_facility: Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus

location_facility: Ico de Badalona (Hospital Universitari Germans Trias I Pujol)

location_facility: Gemeinschaftspraxis Dres. Heinrich / Bangerter

location_facility: SRH Wald-Klinikum Gera gGmbH, Brustzentrum Ostthüringen

location_facility: Centro di Riferimento Oncologico (CRO) - IRCCS

location_facility: MUG - Univ.-Klinik f. Innere Medizin Graz

location_facility: Ospedale Di Trento- Presidio Ospedaliero S.Chiara

location_facility: MUI - Univ. Klinik f. Frauenheilkunde Innsbruck

location_facility: Schwerpunktpraxis der Gynäkologie und Onkologie

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Uniklinikum, Klinik für Geburtshilfe und Gynäkologie


title: A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis

acronym: STARSCAPE

summary: This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

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

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

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Belgium
China
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Israel

location_facility: Tianjin Medical University General Hospital

location_facility: University of Florida Division of Pulmonary, Critical Care, and Sleep Medicine

location_facility: Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup

location_facility: Centro Medico de Enfermedades Respiratorias (CEMER)

location_facility: Hospital Universitario Fundacion Jimenez Diaz.

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

location_facility: Tokyo Medical Ando Dentaluni Hospital Faculty of Medicine; Surgical Oncology

location_facility: Edinburgh Royal Infirmary; Respiratory Department

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: Hospital Ramón y Cajal;Servicio de Neumología

location_facility: University Of Utah Hosp & Clin; Investigational Pharmacy

location_facility: Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken

location_facility: Shaare Zedek Medical Center; Nrphrology Dept.

location_facility: Dokuz Eylul University Faculty of Medicine; Chest Diseases

location_facility: Uludag Universitesi - Saglik Uygulama ve Arastirrma Merkezi

location_facility: University of Iowa Hospitals and Clinics; Investigational Drug Services

location_facility: Universitatsklinikum Gießen und Marburg GmbH

location_facility: IKF Pneumologie Mainz Helix Medical Excellence Center Mainz

location_facility: CMU-Beijing Chao-Yang Hospital-Beijing Institute of Respiratory Medicine

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

location_facility: European Hospital Georges Pompidou (HEGP)

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Advanced Pulmonary & Sleep Research Institute of Florida

location_facility: Fakultni Nemocnice Plzen - Klinika Pneumologie a Ftizeologie

location_facility: Austin Hospital; Cancer Clinical Trials Centre

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

location_facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Municipal Non-Profit Enterprise City Clinical Hospital #16 of Dnipro City Council

location_facility: Fundacion Respirar (Centro Medico Dra. De Salvo)

location_facility: Hospital Universitario Central de Asturias

location_facility: Thoraxklinik-Heidelberg gGmbH; Apotheke der Thoraxklinik

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette

location_facility: Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)

location_facility: Inner Mongolia Autonomous Region People's Hospital

location_facility: Hospital d Instructions des Armees Percy

location_facility: Ben-Gurion University of the Negev - Soroka University Medical Center - Pulmonology Institute

location_facility: Bnai Zion Medical Center; Internal Medicine

location_facility: Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Yanovskyy Inst of Phth. & Pulm; Clinical-functional

location_facility: McGill University, Montreal Chest Institute; Viral and other Infectious

location_facility: University of Louisville Health Sciences Center

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology

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

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: National Hospital Organization Himeji Medical Center

location_facility: 1st Affiliated Hospital of Zhejiang University; Clinical Trial Pharmacy

location_facility: Shengjing Hospital of China Medical University

location_facility: Tangdu Hospital, The Fourth Military Medical University; Neurology Department

location_facility: Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinico Universitario

location_facility: Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie

location_facility: Helse Bergen HF Haukeland universitetssykehus

location_facility: Ismett Istituto Mediterraneo Trapianti E Terapie Alta Specializzazione;Pneumologia

location_facility: Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio

location_facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Cliniques Universitaires Saint-Luc; Pharmacy

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: CHU Dijon Bourgogne Hôpital François Mitterand

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Hopital Neuchatelois Pourtales (Hopitaux Cadolles Pourtales)

location_facility: Hebei Medical University - The Second Hospital

location_facility: Azienda Ospedale Università Di Padova; Clinica Pneumologica

location_facility: Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche

location_facility: Carmel Medical Center; Obstetrics and Gynecology

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

location_facility: Seoul National University Hospital (SNUH) - Medical Oncology Center

location_facility: Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

location_facility: A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone

location_facility: Inselspital Bern Universitätsklinik für Pneumologie

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: The Third Xiangya Hospital Of Central South University

location_facility: University of Cape Town Lung Institute; Lung Clinical Research

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Oslo University Hospital HF, Rikshospitalet

location_facility: Gaziantep Universitesi - Sahinbey Arastirma ve Uygulama Hastanesi

location_facility: Hospital Virgen de las Nieves; Servicio de Neumologia

location_facility: Xiangya Hospital Central South University

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Southern Medical University Nanfang Hospital

location_facility: Azienda Sanitaria Universitaria Integrata di Trieste

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

location_facility: University Hospitals Cleveland Medical Center

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: China Medical University (CMU) First Affiliated Hospital

location_facility: Ospedale Morgagni Pierantoni; Patologia clinica

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: Henan University of Traditional Chinese Medicine (HUTCM) The First Affiliated Hospital

location_facility: Nippon Medical School Musashi Kosugi Hospital

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Centro Hospitalar Universitario Lisboa Norte - Hospital Pulido Valente

location_facility: Azienda Ospedaliera Universitaria Federico II

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

location_facility: Thomayerova nemocnice; Lekarna - pavilon H

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

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: Universidad de Navarra - Clinica Universitaria de Navarra (CUN)

location_facility: National Hospital Organization Ibarakihigashi National Hospital; Center for Clinical Research

location_facility: Manchester University NHS Foundation Trust - Wythenshawe Hospital

location_facility: Vancouver General Hospital; Gordon and Leslie Diamond Health Care

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)

location_facility: Yedikule Gogus Hastaliklari ve Gogus Cerrahisi EAH;Gogus Hastaliklari

location_facility: Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: University of Texas Southwestern Medical Center; Heart and Lung Clinic

location_facility: The First Affilicated Hospital, Sun Yat-sen University

location_facility: National Academy of Medical Science of Ukraine (NAMS); NRCRM

location_facility: Far Eastern Memorial Hospital; Department of Clinical Pathology

location_facility: Buddhist Tzu Chi Dalin General Hospital; Rheumatology

location_facility: Banner University Medical Center Phoenix; Main Pharmacy

location_facility: Dr. Syed Anees Medicine Profession Corporation

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie

location_facility: Fondazione IRCCS Policlinico San Matteo Divisione di EmatologiaDipartimento di Onco-Ematologia

location_facility: Hospital de Sao Joao; Centro de Investigacao

location_facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

location_facility: Marmara Universitesi Hastanesi Marmara University Hospital

location_facility: Jefferson University Physicians (JUP) - Jefferson Pulmonary

location_facility: Akdeniz University Faculty of Medicine Department of Pulmonology

location_facility: Zentralklinik Bad Berka GmbH; Pneumologie

location_facility: Ospedale San Giuseppe; U.O. di Pneumologia

location_facility: Universitatsklinikum Essen; Innere Klinik

location_facility: Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia

location_facility: University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Instituto de Medicina Respiratoria, IMeR; Clinic/Outpatient Facility

location_facility: University Hospital of Ioannina; Pulmonology Department

location_facility: Cardiopulmonary Research Science and Technology Institute

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Senhora da Oliveira ? Guimarães, E.P.E

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi; Balcali

location_facility: "Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "

location_facility: University of Florida Health Pulmonology - Jacksonville

location_facility: Centre Hospitalier de l'Universite de Montreal - Notre - Dame Hos pital

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: University of Cincinnati Cancer Institute

location_facility: The University of Hong Kong; Queen Mary Hospital

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

location_facility: Sarasota Memorial Health Care System; Cancer Research Program

location_facility: CHU Tours - Hôpital Bretonneau; Pharmacie

location_facility: Unidad Médica para la Salud Integral UMSI

location_facility: Evangelismos Hospital; Department of Critical Care and Pulmonary Services

location_facility: "General hospital of Chest Diseases ""Sotiria"", 7th Pulmonary Clinic "

location_facility: CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung

location_facility: Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche

location_facility: University of Texas Medical Branch; Cardiology Department

location_facility: Seoul National University Bundang Hospital

location_facility: University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

location_facility: Hospital is University General Hospital of Larissa

location_facility: Istanbul Universitesi Onkoloji Enstitüsü Hastanesi

location_facility: Servie de Pneumologie et centre de Transplantation Pulmonaire

location_facility: Barzilai Medical Center; Neurology Department

location_facility: University General Hospital of Heraklion

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Medizinische Hochschule Hannover; Zentrum Innere Medizin - Klinik fur Pneumologie

location_facility: Tel-Aviv Sourasky Medical Center; Department of Pulmonary

location_facility: Peking Union Medical College Hospital; Pharmacy

location_facility: Cairns Base Hospital; Cancer Care Centre

location_facility: Medical University of South Carolina Hospital

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: INER- Instituto Nacional de Enfermedades Respiratorias"Ismae

location_facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum

status_simplified: Completed


title: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer

summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

lead_sponsor: Gilead Sciences

sponsor_collaborators:
Gilead Sciences
Everest Medicines

location_country:
Germany
Ireland
Australia
Turkey
Croatia
Czechia
Canada
France
Portugal
Hong Kong
Switzerland
United States
Belgium
China
Puerto Rico
Italy
United Kingdom
Singapore
Sweden
Austria
Korea, Republic of
Spain
Greece
Taiwan
Bulgaria
Georgia
Israel

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Oklahoma Cancer Specialists and Research Institute (OCSRI)

location_facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E

location_facility: Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi

location_facility: Centrum fur Hamatologie und Onkologie Bethanien

location_facility: Krankenhaus Der Barmherzigen Bruder Wien

location_facility: Thompson Oncology Group - Knoxville Downtown

location_facility: Oxford University Hospitals NHS Foundation Trust

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

location_facility: Istituto Tumori Bari Giovanni Paolo II - IRCCS

location_facility: Chinese People's Liberation Army General Hospital - 301 Hospital

location_facility: Centro Hospitalar de Lisboa Norte - Hospital de Santa Maria

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Hunan Cancer Hospital - Xiangya Hospital - Central South University

location_facility: Universitätsklinik für Innere Medizin Graz

location_facility: The Catholic University of Korea Saint Vincent's Hospital

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Centro Hospitalar de Tras-os-Montes e Alto Douro

location_facility: Istanbul Acibadem University Maslak Hospital

location_facility: Istituto Oncologico Della Svizzera Italiana (IOSI)

location_facility: Union Hospital of Fujian Medical University

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

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Unidade Local de Saúde da Guarda - Hospital Sousa Martins

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Harold C. Simmons Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Institut Régional du Cancer de Montpellier ICM Val d' Aurelle

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Southern Adelaide Local Health Network Incorporated

location_facility: Dorset County Hospital NHS Foundation Trust

location_facility: Ordensklinikum Linz GmbH Barmherzige Schwestern

location_facility: Regional University General Hospital of Herakleio, Crete

location_facility: Bagcilar Medipol Mega Universite Hastanesi

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Affiliated Tumor Hospital of Xinjiang Medical University

location_facility: Zhejiang Provincial People's Hospital - Zhaohui

location_facility: Guys and Saint Thomas NHS Foundation Trust, Guy's Hospital

location_facility: Institut Für Versorgungsforschung in Der Onkologie

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Ospedale di Trento - Presidio Ospedaliero Santa Chiara

location_facility: R.S. McLaughlin Durham Regional Cancer Centre

location_facility: Pusan National University Yangsan Hospital

location_facility: Boca Raton Clinical Research Global USA - Plantation

location_facility: Chinese Academy of Medical Sciences Cancer Hospital

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Cancer Hospital of the University of Chinese Academy of Sciences Zhejiang Cancer Hospital

location_facility: Hacettepe Universitesi Tip Fakultesi- Kanser Enstitusu

location_facility: VKV Amerikan Hastanesi Department of Oncology

location_facility: Clinical Hospital Centre "Sestre Milosrdnice"

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

location_facility: Ashford Cancer Centre Research - ICON Cancer Centre Adelaide

location_facility: University of Maryland School of Medicine

location_facility: Theagenio Anticancer Hospital of Thessaloniki

location_facility: Centro Hospitalar de Leiria - Hospital de Santo André

location_facility: Charité Universitätsmedizin Berlin - Campus Benjamin Franklin

location_facility: Specialized Hospital for Active Treatment of Oncological Diseases - Sofia District

location_facility: University Cancer Specialists - Knoxville

location_facility: Universitaetsspital Zurich - Klinik fur Medizinische Onkologie und Hematologie

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: Karolinska Universitetssjukhuset - Solna

location_facility: Interbalkan Medical Center of Thessaloniki

location_facility: Tel Aviv Medical Center (Ichilov Hospital)

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

location_facility: University of Iowa Hospitals and Clinics

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD

location_facility: Centre Hospiltalier Universitaire Brest - Hôpital Morvan

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

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Hospital Universitario Puerta de Hierro de Majadahonda

location_facility: Chang Gung Memorial Hospital - Linkou Branch

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Azienda Ospedaliero Universitaria Pisana


acronym: AMPLITUDE

lead_sponsor: Janssen Research & Development, LLC

summary: The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

location_facility: Institut Regional du Cancer de Montpellier Val d'Aurelle

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

location_facility: Ralph H. Johnson Veterans Affairs Medical Center

location_facility: Fundacao do ABC - Centro Universitario FMABC

location_facility: University College London Hospitals NHSFT

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Jahn Ferenc Del-pesti Korhaz es Rendelointezet

location_facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

location_facility: Communal Institution 'Regional Oncology Dispensary' of Zhytomyr Region Council

location_facility: Marie Curie Research Wing - Mount Vernon Hospital

location_facility: Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

location_facility: Instituto do Cancer Arnaldo Vieira de Carvalho

location_facility: Instituto de Ensino e Pesquisa São Lucas

location_facility: University of Pittsburgh Medical Center (UPMC)

location_facility: Multifunctional clinical medical center 'Medical city'

location_facility: Municipal Institution 'Clinical Oncology Dispensary' Under Dnipropetrovsk Regional Council

location_facility: Institut Kanser Negara - Clinical Research Center

location_facility: T.C. Saglik Bakanlıgi Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi

location_facility: University Health Network (UHN) Princess Margaret Cancer Centre

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: ASL Napoli 2 Nord-SM delle Grazie Hospital

location_facility: Regional Medical Clinical Center for Urology and Nephrology named after V.I. Shapoval

location_facility: Instituto Joinvilense de Hematologia e Oncologia Ltda-Centro de Hematologia e Oncologia

location_facility: Istituto Oncologico Veneto Iov Irccs Padova

location_facility: Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kingston Health Sciences Centre, Kingston General Health Research Institute

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

location_facility: Gomel Regional Clinical Oncology Dispensary

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Centro de Investigación Clínica Gramel S.C.

location_facility: Bobruisk Interregional Oncological Dispensary

location_facility: Municipal Non-profit enterprise 'Bukovinian clinical oncology center'

location_facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: University of California Irvine Medical Center - Chao Family Comprehensive Cancer Center

location_facility: Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital

location_facility: Pyatigorsk Interdistrict Oncology Dispensary

location_facility: Second Affiliated Hospital of Soochow University

location_facility: Shengjing Hospital of China Medical University

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

location_facility: Urological Associates of Southern Arizona, P.C.

location_facility: Przychodnia Lekarska KOMED Roman Karaszewski

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Rabin Medical Center, Beilinson Hospital

location_facility: Specjalistyczna przychodnia lekarska POLIMED

location_facility: The First Affiliated Hospital of NanChang University

location_facility: CIONC - Centro Integrado de Oncologia de Curitiba

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

location_facility: Divisione di Oncologia - Istituto per la ricerca e cura del cancro

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Western Theater General Hospital of the Chinese People's Liberation Army

location_facility: State Institution Institute of Urology NAMS of Ukraine based on Kyiv City Clinical Oncology Center

location_facility: British Columbia Cancer Agency(BCCA)-Sindi Ahluwalia Hawkins Centre for the Southern Interior(CSI)

location_facility: Klinikum rechts der Isar - III. Med. Klinik und Poliklinik

location_facility: McGill University - Jewish General Hospital

location_facility: The Fifth People's Hospital of Shanghai, Fudan University

location_facility: Szpital Uniwersytecki NR 1 IM. Dr. Antoniego Jurasza

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: Communal Institution 'City hospital №7 of Kamianske' of Dnepropetrov'sk Regional Council

location_facility: Ministerio da Saude - Instituto Nacional do Cancer

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: District Oncology Dispensary with In-Patient Stationary - Plovdiv

location_facility: Chelyabinsk Regional Clinical Center Of Oncology And Nuclear Medicine

location_facility: Grand Hopital de Charleroi, site Notre Dame

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: The First Affliated Hospital of Soochow University

location_facility: Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Institut de Cancérologie de l'Ouest (ICO)

location_facility: Istituti Ospitalieri di Cremona, AO di Cremona

location_facility: Sakarya University Training and Research Hospital

location_facility: Huadong Hospital Affiliated to Fudan University

location_facility: The First Affiliated Hospital of Ningbo University

location_facility: Fondazione G. Pascale - Istituto Nazionale Tumori IRCCS

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Bursa Yuksek lhtisas EAH Medikal Onkoloji Klinigi

location_facility: Minsk city Clinical Oncological Dispensary

location_facility: Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

location_facility: Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I

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

location_facility: Southwest Hospital, The Third Military Medical University

location_facility: Städtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

location_facility: Eastern Connecticut Hematology & Oncology Assoc.

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi

location_facility: West China Hospital of Sichuan University

location_facility: Universidade do Estado do Rio de Janeiro - UERJ

location_facility: Greater Los Angeles VA Healthcare System

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Beijing Friendship Hospital Capital Medical University

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Multifunctional Hospital for Active Treatment for Women Health Nadezhda

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: Consultorio de Especialidad en Urologia Privado

location_facility: Renji Hospital Affiliated to Medical College of Shanghai Jiaotong University

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Irmandade Santa Casa de Misericordia de Sao Paulo

location_facility: Municipal non-profit enterprise 'Regional Center of Oncology'

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Instituto Português de Oncologia Francisco Gentil - Centro Regional de Oncologia de Coimbra, S.A.

location_facility: Seoul National University Bundang Hospital

location_facility: Private Medical Institution Euromedservice

location_facility: British Columbia Cancer Agency (BCCA) - Vancouver Centre

location_facility: PERSONAL - Oncologia de Precisão e Personalizada

location_facility: Specialized Hospital for Active Treatment in Oncology

location_facility: University of Florida Health Jacksonville

location_facility: Associacao de Combate ao Cancer em Goias - Hospital de Cancer Araujo Jorge

location_facility: Cemaic - Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

location_facility: Centre Hopitalier Inter-Communal De Cornouaille

location_facility: Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council'

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

location_facility: Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital

location_facility: State Institution National Cancer Institute

title: A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

type: Registry Identifier

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

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Turkey
Czechia
Canada
France
Belarus
Portugal
Hungary
Denmark
United States
Ukraine
Belgium
China
Malaysia
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


lead_sponsor: AstraZeneca

summary: This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

sponsor_collaborators: Daiichi Sankyo Company, Limited 3-5-1 Nihonbashihoncho, Chuo-ku, Tokyo

title: A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Canada
France
Portugal
Hungary
Denmark
United States
India
Belgium
China
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Russian Federation
Israel


acronym: Darolutamide roll-over study

summary: The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

location_facility: N.N. Alexandrov National Cancer Centre of Belarus

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Medizinische Fakultät der Otto-von-Guericke Universität

location_facility: Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.

location_facility: National hospital Organization Mito Medical Center

location_facility: P. Stradins Clinical University Hospital

location_facility: Instituto Peruano de Oncología & Radioterapia- Oncologia SAC

location_facility: TC Saglik Bakanligi Goztepe ProfDr Suleyman Yalcin Sehir Has

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Republican Clinical Oncology Dispensary Kazan

location_facility: Universitätsklinikum der Johann Wolfgang Goethe Universität

location_facility: National Hospital Organization Shinshu Ueda Medical Center

location_facility: Fundacion Jimenez Diaz (Clinica de la Concepcion)

location_facility: Transkarpathian Regional Oncology Center

location_facility: Spitalul Clinic Judetean de Urgenta Oradea

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Hospital Garcia de Orta | Research Department

location_facility: Centre d'Oncologie et de Radiologie du Parc

location_facility: G. Kenneth Jansz Medicine Professional Corporation

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: H Virgen del Rocio |Cardiology|AF|Stroke prevention

location_facility: Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina

location_facility: Associação Hospitalar Beneficente São Vicente de Paulo

location_facility: Liga Norte Riograndense Contra o Cancer | Centro de Pesquisa Clínica

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

location_facility: Multi-Field Clinical Medical Center "Medical City"

location_facility: Clinical Hospital Center Bezanijska kosa

location_facility: Minsk City Clinical Oncological Dispensary

location_facility: Instituto do Câncer do Estado de São Paulo

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

location_facility: Chelyabinsk Regional Oncology Dispensary

location_facility: Keimyung University Dongsan Medical Center

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Fundación Oftalmológica de Santander Carlos Ardila Lule

location_facility: Urologische Gemeinschaftspraxis Dr. Simone Maier

location_facility: IBCC - Instituto Brasileiro de Controle do Cancer

location_facility: Kharkiv regional Clinical Centre of urology and nephrology

location_facility: Riga East Clinical University Hospital "Gailezers"

location_facility: Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopi

location_facility: Hospital Clinico Universitario San Carlos | Oncologia

location_facility: Princess Margaret Hospital-University Health Network

location_facility: Ciutat Sanitaria i Universitaria de la Vall d'Hebron

location_facility: New Mexico Oncology Hematology Consultants, Ltd.

location_facility: Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

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

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: IRCCS Fondazione del Piemonte per l'Oncologia

location_facility: Hospital General Universitario Gregorio Marañón | Oncología

location_facility: União Bras. de Edu. e Assist. Hospital São Lucas da PUCRS

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: ETZ TweeSteden Ziekenhuis (vh Maria Ziekenhuis)

location_facility: Hospital Evangélico de Cachoeiro de Itapemirim

location_facility: Inst. de Assistência Médica ao Sérvidor Público Estadual

location_facility: Hospital Universitario Virgen de la Victoria | Oncology

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: City Dnipropetrovsk Multi- field Clinical Hosp. 4 DSMA

location_facility: Hospital of LT University of Health Sciences Kaunas Clinics

location_facility: Krasnoyarsk Regional Clinical Oncology Dispensary

location_facility: Uro-Gyn-Zentrum Wall Hr. Dr. Jochen Gleißner

location_facility: Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.

location_facility: Institut Gustave Roussy - Département de Médecine Oncologique

location_facility: Tianjin Medical University Cancer Institiute & Hospital

location_facility: Fundação Pio XII - Hospital de Câncer de Barretos

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention

location_facility: Litavniece Dzintra practice in urology and oncological chem.

location_facility: Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

location_facility: St. Petersburg Medical University n.a. I.P. Pavlov

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Kyungpook National University Chilgok Hospital

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Moscow Scient. Res. Institute of Oncology n.a P.A. Hertzen

location_facility: Huadong Hospital, Affiliated to Fudan University

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Szpital Grochowski im. dr.med. Rafala Masztaka

location_facility: Liga Paranaense de Combate ao Cancer-Hosp Erasto Gaertner

location_facility: Istituto Nazionale Tumori IRCCS Fondazione G.Pascale

location_facility: Hosp. Araujo Jorge da Associação de Combate ao Câncer

location_facility: CIUSSS de l'Estrie- Centre Haute-Yamaska

location_facility: National Medical Research Radiology Center

location_facility: AS "Association of Health Centers" polyclinic "Elite"

location_facility: Pinderfields Hospital The Mid Yorkshire Hospitals NHS Trust

location_facility: Hospital de la Santa Creu i de Sant Pau | Oncología

location_facility: Zuyderland Medisch Centrum Sittard-Geleen

location_facility: Hospital Universitario "José Eleuterio González"

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Androgeos - private center of urology and andrology

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: Health Corporation of the Ziv Medical Center (R.A.)

location_facility: Associated Medical Professionals of NY, PLLC

location_facility: Dept Radiation and Oncology Tygerberg Academic Hospital

location_facility: Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

location_facility: Hospital Central de la Fuerza Aerea del Perú

location_facility: City Outpatient Clinic #1 of Privolzhsky Regional Med. Cent.

location_facility: Tokyo Metropolitan Institute for Geriatrics and Gerontology

location_facility: Vilnius University Hospital Santaros Klinikos

title: An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

primary_purpose: Other

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
Serbia
France
Belarus
Lithuania
Colombia
Portugal
Slovakia
Hungary
United States
Latvia
Ukraine
Romania
Belgium
China
Peru
Estonia
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


acronym: TrilynX

lead_sponsor: EMD Serono Research & Development Institute, Inc.

summary: The primary objective of the study is to demonstrate superior efficacy of Xevinapant (Debio 1143) vs placebo when added to chemoradiotherapy (CRT) in locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN).

ReferenceType: derived

ReferenceCitation: Bourhis J, Burtness B, Licitra LF, Nutting C, Schoenfeld JD, Omar M, Bouisset F, Nauwelaerts H, Urfer Y, Zanna C, Cohen EE. Xevinapant or placebo plus chemoradiotherapy in locally advanced squamous cell carcinoma of the head and neck: TrilynX phase III study design. Future Oncol. 2022 May;18(14):1669-1678. doi: 10.2217/fon-2021-1634. Epub 2022 Feb 17.

oa_host_type: publisher

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: hybrid

publisher_dissemination: Future Science Ltd

sponsor_collaborators: EMD Serono Research & Development Institute, Inc.

sponsor_collaborators: GORTEC (Head and Neck Oncology and Radiotherapy Group)

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Lombardi Comprehensive Cancer Center, Georgetown University Medical Center

location_facility: Comprehensive Cancer Center of Nevada (Southern Hills) (USA)

location_facility: Service d'Oncologie Médicale, CHU Timone

location_facility: Princess Alexandra Hospital, Cancer Trials Unit

location_facility: Institut Català d'Oncologia, Hospital Duran

location_facility: University of Missouri - Ellis Fischel Cancer Center

location_facility: Academician Fridon Todua Medical Center-Ltd Research Institute of Clinical Medicine

location_facility: Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intazet

location_facility: Medical center of Yuriy Spizhenko, Soborna Vulytsia

location_facility: Xiangya Hospital Central South University

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

location_facility: University Hospital Kyoto Prefectural University of Medicine

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho

location_facility: Centro Hospitalar Universitario São João

location_facility: Universitätsklinik für Innere Medizin III der PMU

location_facility: Institut Regional du Cancer de Montpellier

location_facility: Pusan National University Yangsan Hospital, Oncol & Hematology

location_facility: Charité - Universitätsmedizin Berlin Campus Virchow

location_facility: Centre Hospitalier Universitaire Vaudois Lausanne

location_facility: Saint- Petersburg Clinical Research Center of Specialized Types of Medical Care (Oncology)

location_facility: Research Fund of the Hadassah Medical Organization

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: University of Colorado at Denver and Health Sciences Center

location_facility: London Regional Cancer Program, London Health Sciences Centre

location_facility: The Oncology Institute of Hope & Innovation

location_facility: Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia

location_facility: Centre hospitalier Universitaire de Bordeaux

location_facility: University Hospital Cleveland Medical Center

location_facility: Szegedi Tudományegyetem ÁOK Onkoterápiás Klinika

location_facility: Hospital de Caridade de Ijui, Avenida David Jose Martins

location_facility: Taipei Veterans General Hospital (VGHTP)

location_facility: Tongji Hospital/Tongji Medical College, Huazhong University of Science

location_facility: Hospital de Base de Sao Jose do Rio Preto, Av. Brigadeiro Faria Lima

location_facility: Norton Cancer Institute, Louisville, Kentucky, Brownsboro Hospital Campus

location_facility: FGBU N.N.Blokhin Russian Cancer Research Center

location_facility: University Medical Center Schleswig-Holstein, Campus Kiel

location_facility: Centro Hospitalar Universitário Lisboa Norte

location_facility: Fondazione Policlinico Universitario Agostino Gemelli

location_facility: Universitaetsmedizin Mannheim UMM, Klinik fuer Hals-Nasen-Ohrenheilkunde Kopf- und Halschirurgie

location_facility: Univesitätsklinikum Essen (AöR) Klinikum und Poliklinik für Strahlentherapie

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: The Royal Marsden NHS Foundation Trust - Sutton

location_facility: Centrum Onkologii- Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: The Public Hospital L'Institut de Cancerologie de Lorraine

location_facility: Hospital Civil (Hospital Regional Universitario)

location_facility: Institut Gustave Roussy - Service de radiotherapie

location_facility: Agioi Anargiroi General Oncology Hospital of Kifissia

location_facility: Saitama Medical University International Medical Center

location_facility: Centro Hospitalar Universitário do Algarve - Hospital de Faro (PRT)

location_facility: Fundacion Investigacion Hospital General Universitario de Valencia FiHgU (ESP)

location_facility: Petz Aladár Megyei Kórház Onkoradiológiai Osztály

location_facility: FSBI National Med Research Cancer Center N.N. Petrov

location_facility: Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - FMABC - Faculdade de Medicina do ABC

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Kaohsiung Medical University Memorial Hospital

location_facility: Beth Israel Deaconess (BI Lahey)/Harvard Cancer Center

location_facility: State Autonomous Healthcare Institution "Republican Clinical Oncological Dispensary of the Ministry of Healthcare of the Republic of Tatarstan"

location_facility: Ashford Cancer Centre Research, Tennyson Centre

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Istituto Nazionale Tumori (INT) IRCCS Fondazione "G. Pascale"

location_facility: Instituto Português de Oncologia de Coimbra Francisco Gentil, EPE

location_facility: The 5th Affiliated Hospital of Sun yet-sen university

location_facility: IRCCS - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: Universitatsklinikum Leipzig AoR, Klinik für Strahlentherapie

location_facility: Washington University School of Medicine

location_facility: Az. USL 6 Ospedali Riuniti-Ospedale di Livorno

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

location_facility: Azienda Sanitaria Ospedaliera Santa Croce e Carle - Oncologia Medica -Ospedale Carle

location_facility: State Budgetary Healthcare Institution Republican Clinical Oncology Dispensary (RUS)

location_facility: Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I.Kryzhanovsky

location_facility: Institut de Cancérologie de l Ouest (ICO)

location_facility: Fundacin Oncolgico de Galicia Jos Antonio Quiroga y Pieyro

location_facility: National Cancer Center Hematologic Oncology

location_facility: The University of Alabama at Birmingham - Hazelrig-Salter Radiation Oncology Center (HSROC)

location_facility: LEPL First University Clinic of Tbilisi State Medical University

location_facility: Medical University of Vienna, Department of Medicine I, Division of Oncology

location_facility: Republican Clinical Oncological Dispensary of Bashkortostan

location_facility: Harbin Medical University Cancer Hospital

location_facility: Instituto Portugues de Oncologia Porto Francisco Gentil, E.P.E

location_facility: IRCCS-Istituto Europeodi Oncologia The European Institute of Oncology IEO

location_facility: NYU Langone Hospital-Long Island Oncology

location_facility: Fundacion Centro Oncologico de Galicia (COG) "Jose Antonio Quiroga y Pineyro"

location_facility: Inselspital, Bern University Hospital, Universitätsklinik für Radio-Onkologie

location_facility: Chang Gung Medical Foundatoin Linkou Chang Gung Memorial Hospital

location_facility: The 2nd Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Hospital Santa Rita, Centro de Pesquisa Clínica Novos Tratamentos Em Câncer

location_facility: CAMPUS CHARITÉ MITTE, Klinik f.Strahlentherapie

location_facility: Orszagos Onkologiai Intezet Sugarterapias Osztaly

location_facility: State Budgetary Institution of Healthcare of Yaroslavl region Clinical oncology hospital

location_facility: University of Oklahoma Health Sciences Center- Stephenson Cancer Center

location_facility: Liga Norte Riograndense Contra o Câncer, Avenida Miguel Castro

location_facility: Hospital Universitario Marqués de Valdecilla. Santander

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Klinische Abteilung fur Allgemeine HNO Universitatsklinik fur Hals-, Nasen- und Ohrenheilkunde

location_facility: Fundação Pio XII- Hospital de Cancer de Barretos, Rua Antenor Duarte Vilela

location_facility: CIUSSS de l'Est de l'Ile de Montreal - Hopital Maisonneuve-Rosemont

location_facility: West China Hospital of Sichuan University

location_facility: Seoul National University Boramae Medical Center

location_facility: Institut Universitari Dexeus-Quiron (ESP)

location_facility: Hospital Santa Rita Centro de Pesquisa Clínica Novos Tratamentos Em Câncer

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

location_facility: Affiliated Tumor Hospital of Guangxi Medical University

location_facility: Department of radiation oncology, University Hospital Essen

location_facility: Aberdeen Royal infirmary, Dept. of Oncology

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Uniwersyteckie Centrum Kliniczne - Klinika Onkologii i Radioterapii

location_facility: Wake Forest University School of Medicine

location_facility: Medical University of South Carolina- Hollings Cancer Center

location_facility: Institut de Cancérologie de l'Ouest - Site Saint Herblain

title: A Randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

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

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Czechia
Canada
France
Portugal
Hungary
Switzerland
United States
Ukraine
Belgium
China
Italy
United Kingdom
Austria
Korea, Republic of
Spain
Greece
Taiwan
Georgia
Russian Federation
Israel

collaborators: GORTEC (Head and Neck Oncology and Radiotherapy Group)


lead_sponsor: Assistance Publique - Hôpitaux de Paris

summary: In this study, we will assess the efficacy and safety of a reduced dose of thrombolytic therapy given in addition to low-molecular-weight heparin in patients with intermediate-high-risk acute pulmonary embolism. Half of participants will receive thrombolytic treatment, while the other half will receive a placebo.

ReferenceType: background

ReferenceCitation: Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

license_normalized: no license

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

host_type: repository

repository_institution: University of Bern - Bern Open Repository and Information System

unpaywall_oa_status: bronze

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Barco S, Vicaut E, Klok FA, Lankeit M, Meyer G, Konstantinides SV; PEITHO Investigators. Improved identification of thrombolysis candidates amongst intermediate-risk pulmonary embolism patients: implications for future trials. Eur Respir J. 2018 Jan 18;51(1):1701775. doi: 10.1183/13993003.01775-2017. Print 2018 Jan. No abstract available.

ReferenceCitation: Konstantinides SV, Vicaut E, Danays T, Becattini C, Bertoletti L, Beyer-Westendorf J, Bouvaist H, Couturaud F, Dellas C, Duerschmied D, Empen K, Ferrari E, Galie N, Jimenez D, Kostrubiec M, Kozak M, Kupatt C, Lang IM, Lankeit M, Meneveau N, Palazzini M, Pruszczyk P, Rugolotto M, Salvi A, Sanchez O, Schellong S, Sobkowicz B, Meyer G. Impact of Thrombolytic Therapy on the Long-Term Outcome of Intermediate-Risk Pulmonary Embolism. J Am Coll Cardiol. 2017 Mar 28;69(12):1536-1544. doi: 10.1016/j.jacc.2016.12.039.

evidence: open (via crossref license)

license: publisher-specific-oa

license_normalized: publisher-specific

publisher_dissemination: Elsevier

ReferenceCitation: Marti C, John G, Konstantinides S, Combescure C, Sanchez O, Lankeit M, Meyer G, Perrier A. Systemic thrombolytic therapy for acute pulmonary embolism: a systematic review and meta-analysis. Eur Heart J. 2015 Mar 7;36(10):605-14. doi: 10.1093/eurheartj/ehu218. Epub 2014 Jun 10.

ReferenceCitation: Sanchez O, Charles-Nelson A, Ageno W, Barco S, Binder H, Chatellier G, Duerschmied D, Empen K, Ferreira M, Girard P, Huisman MV, Jimenez D, Katsahian S, Kozak M, Lankeit M, Meneveau N, Pruszczyk P, Petris A, Righini M, Rosenkranz S, Schellong S, Stefanovic B, Verhamme P, de Wit K, Vicaut E, Zirlik A, Konstantinides SV, Meyer G; PEITHO-3 Investigators. Reduced-Dose Intravenous Thrombolysis for Acute Intermediate-High-risk Pulmonary Embolism: Rationale and Design of the Pulmonary Embolism International THrOmbolysis (PEITHO)-3 trial. Thromb Haemost. 2022 May;122(5):857-866. doi: 10.1055/a-1653-4699. Epub 2021 Oct 31.

sponsor_collaborators: Life Sciences Research Partners (D Collen Research Foundation)

sponsor_collaborators: Canadian Institutes of Health Research (CIHR)

sponsor_collaborators: International Network of VENous Thromboembolism Clinical Research Networks

location_facility: The Ottawa Hopsital, General and Civic campuses

location_facility: Bucuresti - Spitalul Clinic de Urgenta Sf. Pantelimon

location_facility: AP-HP - hôpital européen Georges-Pompidou

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Cardiology Clinic, Clinical Center of Niš

location_facility: Juravinski Hospital - Hamilton Health Sciences Corporation

location_facility: Institute for Lung Diseases of Vojvodina, Sremska Kamenica

location_facility: Department of Cardiac and Vascular Diseases

location_facility: University of Warmia Mazury in Olsztyn - School of Medicine

location_facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen

location_facility: Hamilton General Hospital - Hamilton Health Sciences Corporation

location_facility: Centro Hospitalar de Lisboa Norte/ Hospitalde Santa Maria

location_facility: Iasi - St Spiridon Emergency Conty Hospital

location_facility: University Hospital Ancona / Ospedali Riunit

location_facility: Institutul de Boli Cardio-Vasculare Timisoara

location_facility: CHU de Clermont-Ferrand - Hôpital Gabriel Montpied

location_facility: Cardiology Clinic, Emergency Center, Clinical Center of Serbia

location_facility: Hannover, Medizinische Hochschule Hannover

title: A Reduced Dose of Thrombolytic Treatment for Patients With Intermediate High-risk Acute Pulmonary Embolism: a Randomized Controled Trial

type: Other Grant/Funding Number

ipd_sharing_description: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.

location_country: Germany Italy Poland Slovenia Portugal Romania Netherlands Austria Belgium Switzerland Spain Canada Serbia France

lead_sponsor_type: academique

appel_a_projets: PHRCN

region: Île-de-France

nom_etablissement: ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS

type_etablissement: CHUR

acronyme: PEITHO 3

titre: Demi dose de thrombolytique chez les patients avec une embolie pulmonaire à risque intermédiaire élevé.

discipline_principale: cardiologie

nom_porteur: MEYER

prenom_porteur: Guy


title: A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI

summary:
Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients admitted to the ICU with acute kidney injury that is caused by sepsis.

The study has three distinct SA-AKI trial populations:

The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.
A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and <45 mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.
A Corona Virus Disease 2019 (COVID-19) population: Patients with proven or suspected SARS-CoV-2 at time of randomization with or without 'moderate' CKD. For patients in this population, COVID-19 should be the main cause of SA-AKI.

In the main study population approximately 1400 patients will be enrolled and in the two cohorts with moderate CKD and COVID-19 each up to 100 patients.

There are two arms in the study, one with active treatment and one with an inactive compound (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180 days for mortality and other outcomes e.g. long-term kidney function and quality of life.

status: Terminated

lead_sponsor: AM-Pharma

location_country:
Finland
Germany
Ireland
New Zealand
United Kingdom
Denmark
Australia
Japan
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: Alberta Health Services - South Health Campus Hospital

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: University of New Mexico School of Medicine

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: Sunshine Hospital ICU - Western Hospital

location_facility: Centre Hospitalier Départemental de Vendée - Les Oudairies

location_facility: Plymouth Hospitals NHS Trust - Derriford Hospital

location_facility: CHU de Nimes - Hopital Universitaire Caremeau

location_facility: Hospital Universitari de Bellvitge (IDIBELL)

location_facility: Sjaellands Universitetshospital, Koge - Kardiologisk Afdeling

location_facility: UPMC CancerCenter at Magee - Womens Hospital

location_facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin I

location_facility: University Hospital Jena - Klinik fur Neurologie

location_facility: University of Cincinnati Cancer Institute

location_facility: The George Washington University Medical Faculty Associates - Anesthesiology

location_facility: Hospital Universitari Germans Trias i Pujol

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

location_facility: Helsinki University Central Hospital (HUCH)

location_facility: Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Gastroenterologie und Rheumatologie

location_facility: National Hospital Organization - Yokohama Medical Center

location_facility: University of Kentucky College of Medicine (UKCM)

location_facility: Hôpitaux Universitaires de Strasbourg - Hôpital Civil

location_facility: Medizinische Universitaet Graz - Klinik fuer Innere Medizin

location_facility: Hospital Universitari de Girona Doctor Josep Trueta

location_facility: Universitat de Barcelona - Hospital Universitari Mutua Terrassa (HUMT)

location_facility: The Ohio State University - Dorothy M. Davis Heart and Lung Research Institute

location_facility: University College London Hospitals NHS Foundation Trust - University College Hospital

location_facility: Centre Hospitalier Universitaire Brugmann

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Centre Hospitalier de Bethune Germon et Gauthier

location_facility: Centre Hospitalier Universitaire (CHU) de Charleroi - Hopital Civil Marie Curie

location_facility: Emory Clinical Cardiovascular Research Institute

location_facility: Froedtert & the Medical College of Wisconsin Froedtert Hospital

location_facility: Centre Hospitalier Universitaire d'Angers

location_facility: Lakes District Health Board - Rotorua Hospital

intervention_type: Other

status_simplified: Unknown