title: Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

summary: This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.

ReferenceCitation: Saad F, Gillessen S, Heinrich D, Keizman D, O'Sullivan JM, Nilsson S, Miller K, Wirth M, Reeves J, Seger M, Carles J, Heidenreich A. Disease Characteristics and Completion of Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Radium-223 in an International Early Access Program. Clin Genitourin Cancer. 2019 Oct;17(5):348-355.e5. doi: 10.1016/j.clgc.2019.05.012. Epub 2019 May 31.

repository_institution: Queen's University Belfast - Research Portal

ReferenceCitation: Heidenreich A, Gillessen S, Heinrich D, Keizman D, O'Sullivan JM, Carles J, Wirth M, Miller K, Reeves J, Seger M, Nilsson S, Saad F. Radium-223 in asymptomatic patients with castration-resistant prostate cancer and bone metastases treated in an international early access program. BMC Cancer. 2019 Jan 7;19(1):12. doi: 10.1186/s12885-018-5203-y.

repository_institution: Consorci de Serveis Universitaris de Catalunya - RECERCAT

ReferenceCitation: Saad F, Carles J, Gillessen S, Heidenreich A, Heinrich D, Gratt J, Levy J, Miller K, Nilsson S, Petrenciuc O, Tucci M, Wirth M, Federhofer J, O'Sullivan JM; Radium-223 International Early Access Program Investigators. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lancet Oncol. 2016 Sep;17(9):1306-16. doi: 10.1016/S1470-2045(16)30173-5. Epub 2016 Jul 26.

lead_sponsor: Bayer

location_country:
Finland
Germany
Ireland
Poland
Canada
France
Czech Republic
Denmark
Switzerland
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Mexico
Spain
Russian Federation
Israel


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Novartis Pharmaceuticals

summary: This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.

ReferenceType: derived

ReferenceCitation: Campone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Cortes J, De Laurentiis M, Arteaga CL, Jiang Z, Jonat W, Le Mouhaer S, Sankaran B, Bourdeau L, El-Hashimy M, Sellami D, Baselga J. Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2. Eur J Cancer. 2018 Nov;103:147-154. doi: 10.1016/j.ejca.2018.08.002. Epub 2018 Sep 18.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Baselga J, Im SA, Iwata H, Cortes J, De Laurentiis M, Jiang Z, Arteaga CL, Jonat W, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Takahashi M, Vuylsteke P, Hachemi S, Dharan B, Di Tomaso E, Urban P, Massacesi C, Campone M. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):904-916. doi: 10.1016/S1470-2045(17)30376-5. Epub 2017 May 30. Erratum In: Lancet Oncol. 2019 Feb;20(2):e71-e72.

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

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

repository_institution: California Digital Library - eScholarship

version: submittedVersion

repository_institution: Red Federada de Repositorios Institucionales de Publicaciones Científicas - LA Referencia

repository_normalized: dnet

repositories:
PubMed Central
dnet
escholarship.org

repositories_concat: PubMed Central;dnet;escholarship.org

unpaywall_oa_status: green

location_facility: Charleston Hematology Oncology Association PA

location_facility: Cancer Specialists of North Florida SC - F2302

location_facility: Texas Oncology P A TX Onc - Med City Dallas

location_facility: Oncology Hematology Associates of Southeast Virginia Salem VA Branch

location_facility: University of California San Diego - Moores Cancer Center UCSD 3

location_facility: West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology

location_facility: Washington University School of Medicine Regulatory

location_facility: University of Rochester Medical Center Univ Rochester

location_facility: Dean Health System Dean Hematology Oncology

location_facility: West Michigan Cancer Center Dept of Oncology

location_facility: Los Angeles Hematology/Oncology Medical Group LA Cancer Network

location_facility: USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)

location_facility: Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development

location_facility: Central Coast Medical Oncology Corporation

location_facility: Santa Barbara Hematolgy Oncology Medical Group

location_facility: Levine Cancer Institute Levine Cancer Institute

location_facility: Cancer Care Associates Dept.ofCancerCareAssoc.

location_facility: University of California at Los Angeles Dept. of UCLA

location_facility: MD Anderson Cancer Center - Orlando MD Orlando

location_facility: St Joseph Heritage Healthcare Dept. of RRMG (4)

location_facility: Oncology Consultants Oncology Consultants, P.A.

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3

location_facility: Arizona Oncology Associates Dept of Oncology

location_facility: Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc

location_facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center

location_facility: St. Luke's Hospital and Health Network St Luke's (2)

location_facility: Shapiro and Stafford and Yee and Polanski Study Coordinator

location_facility: Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins

location_facility: Vanderbilt University Medical Center Vanderbilt - Thompson Ln

location_facility: Ventura County Hematology and Oncology PMK Medical Group

location_facility: Cancer Care and Hematology Specialists of Chicagoland Niles

location_facility: University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)

location_facility: Frederick Memorial Hospital Fred. Mem. Hosp.

location_facility: Northwest Cancer Specialists Portland Loc

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)

status: Completed

title: A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

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

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

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Czechia
Canada
France
Slovakia
Hungary
Switzerland
United States
Belgium
China
Peru
Italy
United Kingdom
Singapore
Netherlands
Austria
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Israel

study_type: Interventional

ipd_sharing: Yes

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100

summary: This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

version: publishedVersion

repositories_concat: PubMed Central

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Smith M, De Bono J, Sternberg C, Le Moulec S, Oudard S, De Giorgi U, Krainer M, Bergman A, Hoelzer W, De Wit R, Bogemann M, Saad F, Cruciani G, Thiery-Vuillemin A, Feyerabend S, Miller K, Houede N, Hussain S, Lam E, Polikoff J, Stenzl A, Mainwaring P, Ramies D, Hessel C, Weitzman A, Fizazi K. Phase III Study of Cabozantinib in Previously Treated Metastatic Castration-Resistant Prostate Cancer: COMET-1. J Clin Oncol. 2016 Sep 1;34(25):3005-13. doi: 10.1200/JCO.2015.65.5597. Epub 2016 Jul 11.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Paris Descartes

repository_normalized: HAL

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

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - UJM - Université Jean Monnet

repositories_concat: HAL

lead_sponsor: Exelixis

location_country:
Germany
Ireland
Italy
United Kingdom
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
Puerto Rico
France


lead_sponsor: Merck Sharp & Dohme LLC

summary:
The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

ReferenceCitation: Jabbour SK, Cho BC, Bria E, Kato T, Bhosle J, Gainor JF, Reguart N, Wang L, Morgensztern D, Shentu Y, Kim SJ, Souza F, Reck M. Rationale and Design of the Phase III KEYLYNK-012 Study of Pembrolizumab and Concurrent Chemoradiotherapy Followed by Pembrolizumab With or Without Olaparib for Stage III Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Sep;23(6):e342-e346. doi: 10.1016/j.cllc.2022.04.003. Epub 2022 Apr 29.

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Yonsei University Medical Library - YUHSpace

repositories_institution: Yonsei University Medical Library - YUHSpace

location_facility: Azienda Ospedaliera Umberto I- Torrette ( Site 1009)

location_facility: Seoul National University Bundang Hospital ( Site 2801)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 2001)

location_facility: Clinique de l'Europe-Service de pneumologie ( Site 0816)

location_facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (

location_facility: Peking Union Medical College Hospital ( Site 3201)

location_facility: CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0108)

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0500)

location_facility: McGill University Health Center - Research Institute ( Site 0114)

location_facility: Fakultni nemocnice Kralovske Vinohrady-Radioterapeuticka a onkologicka klinika ( Site 2200)

location_facility: Hospital Universitario La Fe ( Site 1203)

location_facility: Centre Hospitalier Annecy Genevois ( Site 0811)

location_facility: Medical center Medikal Plaza of Ecodnipro LLC ( Site 2107)

location_facility: The Lindner Center for Research and Education at The Christ Hospital ( Site 0060)

location_facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 3213)

location_facility: SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2401)

location_facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2510)

location_facility: Orszagos Koranyi Pulmonologiai Intezet ( Site 2305)

location_facility: Chiang Mai University Maharaj Nakorn Chiang Mai Hospital ( Site 3001)

location_facility: Peking University Shenzhen Hospital ( Site 3216)

location_facility: University of South Alabama, Mitchell Cancer Institute ( Site 0003)

location_facility: H.R.U Málaga - Hospital General ( Site 1206)

location_facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2506)

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum ( Site 0900)

location_facility: Osaka International Cancer Institute ( Site 3106)

location_facility: Universitätsmedizin Göttingen - Georg-August-Universität ( Site 0917)

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0508)

location_facility: Kansai Medical University Hospital ( Site 3103)

location_facility: LungenClinic Grosshansdorf GmbH ( Site 0901)

location_facility: National Hospital Organization Kyushu Cancer Center ( Site 3104)

location_facility: Clinica Adventista Belgrano-Oncology ( Site 4002)

location_facility: Masarykuv onkologicky ustav ( Site 2206)

location_facility: Chungbuk National University Hospital ( Site 2802)

location_facility: Kyiv City Clinical Oncology Center ( Site 2100)

location_facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0095)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1008)

location_facility: Johannes Wesling Klinikum Minden ( Site 0908)

location_facility: Fujian Provincial Cancer Hospital ( Site 3226)

location_facility: St Joseph Heritage Healthcare-Oncology ( Site 0088)

location_facility: Hospital Universitario Quiron Madrid ( Site 1200)

location_facility: SOGrigoriev Inst for Med Radiolgy and Oncology of NAMS of Ukraine-Clinical oncology and hematology (

location_facility: Nizhniy Novgorod Region Oncology Dispensary ( Site 1914)

location_facility: Radiology Therapeutic Center-Oncology ( Site 2502)

location_facility: Second Xiangya Hospital of Central-South University ( Site 3227)

location_facility: Tokyo Metropolitan Komagome Hospital ( Site 3108)

location_facility: Shanghai Pulmonary Hospital ( Site 3203)

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

location_facility: S.C. Radiotherapy Center Cluj S.R.L ( Site 2503)

location_facility: Queen Elizabeth II Health Sciences Centre ( Site 0100)

location_facility: Tianjin Medical University Cancer Institute & Hospital ( Site 3204)

location_facility: Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2000)

location_facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2404)

location_facility: Orlando Health, UF Health Cancer Center Inc ( Site 0092)

location_facility: Vseobecna fakultni nemocnice v Praze ( Site 2208)

location_facility: Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2309)

location_facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1913)

location_facility: Christie NHS Foundation Trust ( Site 1409)

location_facility: Gyeongsang National University Hospital ( Site 2804)

location_facility: Spitalul Clinic Judetean De Urgenta Constanta ( Site 2501)

location_facility: Azienda Ospedaliera Vito Fazzi ( Site 1003)

location_facility: University College Hospital NHS Foundation Trust ( Site 1403)

location_facility: North Estonia Medical Centre Foundation ( Site 1601)

location_facility: Instituto Nacional de Cancerologia ( Site 0502)

location_facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1903)

location_facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1905)

location_facility: Medipol Universite Hastanesi ( Site 2003)

location_facility: Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 4201)

location_facility: Washington University Siteman Cancer Center ( Site 0046)

location_facility: Vestre Viken HF Drammen Sykehus ( Site 1101)

location_facility: Ege University Medical Faculty ( Site 2005)

location_facility: West China Hospital of Sichuan University ( Site 3202)

location_facility: Southampton General Hospital ( Site 1400)

location_facility: Massachusetts General Hospital ( Site 0038)

location_facility: Istituto Clinico Humanitas Research Hospital ( Site 1000)

location_facility: Leeds Teaching Hospitals NHS Trust ( Site 1401)

location_facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

location_facility: Juntendo University Hospital ( Site 3111)

location_facility: Johanna Etienne Hospital-Klinik für Onkologie ( Site 0916)

location_facility: National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 4200)

location_facility: Cancer Hospital Chinese Academy Of Medical Sciences. Shenzhen Center ( Site 3200)

location_facility: Mid Florida Hematology and Oncology Center ( Site 0022)

location_facility: S C Oncocenter Oncologie Clinica S R L-Medical Oncology ( Site 2509)

location_facility: Srinagarind Hospital. Khon Kaen University ( Site 3002)

location_facility: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2302)

location_facility: IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0606)

location_facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1911)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0202)

location_facility: Gral Medical SRL-Medical Oncology ( Site 2511)

location_facility: Hospital Universitario Puerta de Hierro (Majadahonda) ( Site 1202)

location_facility: Instituto Médico Río Cuarto ( Site 4003)

location_facility: UCLA Hematology/Oncology - Santa Monica ( Site 0013)

location_facility: The Catholic University of Korea St. Vincent s Hospital ( Site 2805)

location_facility: Zentralklinik Bad Berka GmbH ( Site 0905)

location_facility: Rutgers Cancer Institute of New Jersey ( Site 0054)

location_facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 2104)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 3219)

location_facility: Medical institute named after Berezin Sergey ( Site 1906)

location_facility: Zhongshan Hospital Fudan University ( Site 3220)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0102)

location_facility: Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0604)

location_facility: Hospital Nacional Cayetano Heredia ( Site 0602)

location_facility: Hospital Clinic de Barcelona ( Site 1204)

location_facility: Katholisches Marienkrankenhaus gGmbH ( Site 0902)

location_facility: St. Joseph Heritage Healthcare Local Lab ( Site 0011)

location_facility: Azienda Ospedaliero Universitaria Careggi ( Site 1001)

location_facility: Xiangya Hospital of Central South University ( Site 3637)

location_facility: Royal Marsden Hospital (Sutton) ( Site 1407)

location_facility: Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0075)

location_facility: Riga East Clinical University Hospital ( Site 1500)

location_facility: Spitalul Universitar de Urgenta Bucuresti ( Site 2508)

location_facility: Hospital Universitario Virgen Macarena ( Site 1205)

location_facility: VA St. Louis Health Care System ( Site 0047)

location_facility: Norton Brownsboro Hospital-Norton Cancer Institute - Brownsboro ( Site 0035)

location_facility: Franciscan Health Lafayette East ( Site 0031)

location_facility: Helse Stavanger HF Stavanger Universitetssjukehus ( Site 1103)

location_facility: SNPE National Cancer Institute ( Site 2101)

location_facility: Osaka Medical and Pharmaceutical University Hospital ( Site 3110)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1910)

location_facility: Daping Hospital,Third Military Medical University ( Site 3235)

location_facility: Severance Hospital Yonsei University Health System ( Site 2808)

location_facility: Ankara Bilkent Sehir Hastanesi ( Site 2002)

location_facility: Sverdlovsk Regional Oncology Hospital ( Site 1909)

location_facility: Torrance Memorial Physician Network / Cancer Center ( Site 0093)

location_facility: LLC Ukrainian Center of Tomotherapy ( Site 2105)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 2306)

location_facility: Policlinico Agostino Gemelli ( Site 1002)

location_facility: Akershus Universitetssykehus HF ( Site 1106)

location_facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2400)

location_facility: Fakultni nemocnice v Motole ( Site 2210)

location_facility: The Cancer Institute Hospital of JFCR ( Site 3107)

location_facility: Sanford Cancer Center Oncology Clinic ( Site 0066)

location_facility: Long Beach Memorial Medical Center ( Site 0006)

location_facility: C.H.R.U. de Brest - Hopital Morvan ( Site 0806)

location_facility: Pauls Stradins Clinical University Hospital ( Site 1501)

location_facility: Niigata Cancer Center Hospital ( Site 3109)

location_facility: Krajska nemocnice Liberec, a.s. ( Site 2209)

location_facility: St. Bernards Medical Center ( Site 0089)

location_facility: Fort Wayne Medical Oncology and Hematology ( Site 0094)

location_facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 1004)

location_facility: Institutul Regional de Oncologie Iasi ( Site 2505)

location_facility: Piedmont Hematology-Oncology Associates ( Site 0080)

location_facility: CLIMERS Clinical Medical Research ( Site 0506)

location_facility: Oslo Universitetssykehus HF. Ulleval ( Site 1100)

location_facility: Duke University Medical Center ( Site 0050)

location_facility: The Second Affiliated Hospital of Nanchang University ( Site 3206)

location_facility: Kobe Minimally Invasive Cancer Center ( Site 3100)

location_facility: Keimyung University Dongsan Hospital ( Site 2807)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 2303)

location_facility: The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 3232)

location_facility: Guys and St Thomas NHS Foundation Trust ( Site 1410)

status: Active, not recruiting

title: A Phase 3 Study of Pembrolizumab (MK-3475) in Combination With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib vs Concurrent Chemoradiation Therapy Followed by Durvalumab in Participants With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer (NSCLC)

type: Other Identifier

type: Registry Identifier

enrollment_type: Anticipated

study_completion_date_type: Anticipated

location_country:
Germany
Poland
Argentina
Japan
Thailand
Turkey
Chile
Czechia
Canada
France
Lithuania
Hungary
United States
Latvia
Ukraine
Romania
China
Peru
Estonia
Italy
Norway
United Kingdom
Mexico
Korea, Republic of
Spain
Russian Federation

status_simplified: Ongoing


acronym: ReSPECT

lead_sponsor: Cidara Therapeutics Inc.

summary: The purpose of this pivotal study is to determine if intravenous Rezafungin is efficacious and safe in the prevention of invasive fungal diseases when compared to the standard antimicrobial regimen.

ReferenceCitation: Ham YY, Lewis JS 2nd, Thompson GR 3rd. Rezafungin: a novel antifungal for the treatment of invasive candidiasis. Future Microbiol. 2021 Jan;16(1):27-36. doi: 10.2217/fmb-2020-0217.

publisher_dissemination: Future Science Ltd

location_facility: La Fe University and Polytechnic Hospital

location_facility: Hamilton Health Sciences' Juravinski Hospital

location_facility: Puerta de Hierro Majadahonda University Hospital

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Johannes Gutenberg University Medical Center

location_facility: The University of Oklahoma College of Medicine

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: Grenoble Alpes University Hospital Center

location_facility: University Hospitals Leuven, Campus Gasthuisberg - UZ Leuven

status: Recruiting

title: A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study)

primary_purpose: Prevention

location_country:
Germany
Italy
United Kingdom
Switzerland
Belgium
United States
Spain
Turkey
Canada
France


title: A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

acronym: CAPSTAN CRC

summary:
The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting.

This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.

study_type: Observational

time_perspective: Retrospective

lead_sponsor: Pierre Fabre Medicament

sponsor_collaborators:
Pierre Fabre Medicament
Clinact

location_country:
Germany
Italy
United Kingdom
Austria
Belgium
Spain
France

location_facility: University Hospitals Birmingham NHS Foundation Trust

location_facility: Instituto Nazionale Tumori, IRCCS, Fondazione G. Pascale

location_facility: Barmherzige Brüder Krankenhaus St. Veit/Glan.

location_facility: Clinica Oncologica Ospedali Riuniti di Ancona

location_facility: Harrogate & District NHS Foundation Trust

location_facility: University College London Hospitals NHS Foundation Trust

location_facility: AUSL-IRCCS of Reggio Emilia-Clinical Cancer Center

location_facility: Klinikum Aschaffenburg Medical Klinik IV

location_facility: Hospital General Universitario de Valencia

location_facility: GHPSO (Groupe Hospitalier Sud de l'Oise)

intervention_type: Other


title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis

summary: The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.

ReferenceCitation: Corte TJ, Lancaster L, Swigris JJ, Maher TM, Goldin JG, Palmer SM, Suda T, Ogura T, Minnich A, Zhan X, Tirucherai GS, Elpers B, Xiao H, Watanabe H, Smith RA, Charles ED, Fischer A. Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrotic interstitial lung disease (PF-ILD). BMJ Open Respir Res. 2021 Dec;8(1):e001026. doi: 10.1136/bmjresp-2021-001026.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repositories_concat: PubMed Central;escholarship.org

repositories_institution: California Digital Library - eScholarship

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ReferenceCitation: Cheng PTW, Kaltenbach RF 3rd, Zhang H, Shi J, Tao S, Li J, Kennedy LJ, Walker SJ, Shi Y, Wang Y, Dhanusu S, Reddigunta R, Kumaravel S, Jusuf S, Smith D, Krishnananthan S, Li J, Wang T, Heiry R, Sum CS, Kalinowski SS, Hung CP, Chu CH, Azzara AV, Ziegler M, Burns L, Zinker BA, Boehm S, Taylor J, Sapuppo J, Mosure K, Everlof G, Guarino V, Zhang L, Yang Y, Ruan Q, Xu C, Apedo A, Traeger SC, Cvijic ME, Lentz KA, Tirucherai G, Sivaraman L, Robl J, Ellsworth BA, Rosen G, Gordon DA, Soars MG, Gill M, Murphy BJ. Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA1) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases. J Med Chem. 2021 Nov 11;64(21):15549-15581. doi: 10.1021/acs.jmedchem.1c01256. Epub 2021 Oct 28.

publisher_dissemination: American Chemical Society

lead_sponsor: Bristol-Myers Squibb

location_country:
Germany
Italy
Israel
Argentina
United Kingdom
Australia
Brazil
Japan
Mexico
Belgium
United States
China
Korea, Republic of
Spain
Chile
Taiwan
Canada
France

location_facility: Central Florida Pulmonary Group-Research

location_facility: University of Colorado Anschutz Medical Campus-Department of Medicine


title: A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg

acronym: UNISUS

summary: The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.

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

lead_sponsor: Actelion

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Czechia
Canada
Serbia
France
Belarus
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Ukraine
India
Belgium
China
Malaysia
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

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

location_facility: Rabindranath Tagore International Institute of Cardiac Sciences

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

location_facility: Tianjin Medical University General Hospital

location_facility: Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

location_facility: San Antonio Methodist/TX Transplant Physicians Group

location_facility: SRM Medical College Hospital & Research Centre

location_facility: Secretaria de Estado da Saúde - Instituto Dante Pazzanese de Cardiologia

location_facility: Siyami Ersek Training and Research Hospital

location_facility: The Second Xiangya Hospital of Central South Hospital

location_facility: Fundacao do ABC - Centro Universitario FMABC

location_facility: Universidade Federal De Minas Gerais - Hospital das Clínicas

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 2 PUM

location_facility: Centro Cardiovascular Colombiano Clínica Santa María

location_facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

location_facility: Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: The General Hospital of Northern Theater Command

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: University Of Iowa - Hospitals & Clinics

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

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

location_facility: The Eastern Slovakia Institute of Cardiovascular Diseases

location_facility: Wojewodzki Szpital Specjalist, Osrodek Badawczo-Rozwojowy

location_facility: Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn

location_facility: National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation

location_facility: University Health Network - Toronto General Hospital

location_facility: Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

location_facility: GB Pant Institute of Post Graduate Medical Education & Research

location_facility: SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im. Prof. Leszka Gieca

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

location_facility: Uniao Brasileira de Educaçao e Assistencia-Hospital Sao Lucas da PUCRS

location_facility: Ramathibodi Hospital, Mahidol University

location_facility: Centralny Szpital Kliniczny MSWiA w Warszawie

location_facility: Shengjing Hospital of China Medical University

location_facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

location_facility: Ceti - Centro de Estudos Em Terapias Inovadoras

location_facility: Niigata University Medical & Dental Hospital

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: Samara Regional Clinical Cardiological Dispensary

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Institute for Pulmonary Disease of Vojvodina

location_facility: Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'

location_facility: Volgograd Regional Clinical Cardiology Center

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő

location_facility: Instituto Medico de La Fundacion Estudios Clinicos

location_facility: National University Heart Centre, Singapore

location_facility: Govindaswamy Kuppuswamy Naidu Memorial Hospital

location_facility: Saint Louis University Academic Pavillion

location_facility: The Robert Larner, M.D. College of Medicine at The University of Vermont

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Washington University School of Medicine

location_facility: Jeffrey S. Sager, MD Medical Corporation

location_facility: Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente

location_facility: Scientific and Research Institution of Cardiovascular Diseases Complex Problems

location_facility: Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

location_facility: Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine

location_facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

location_facility: Policlinico Gemelli Universita Cattolica

location_facility: Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: Universidade Federal de Goias - Hospital das Clinicas da UFG

location_facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

location_facility: CNE' City Clinical Hospital #8' of Kharkiv City Council

location_facility: General University Hospital II.department of Internal Medicine-cardiology and angiology

location_facility: Bursa Yuksek Ihtisas Training and Research Hospital

location_facility: Baylor College of Medicine (BCM) - Baylor Heart Clinic

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Ahepa University General Hospital of Thessaloniki

location_facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'

location_facility: Narodny ustav srdcovych a cievnych chorob

location_facility: Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU

location_facility: Centro de Investigacion Clinica Chapultepec

location_facility: State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

location_facility: Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

location_facility: Centro Hospitalar e Universitário de Coimbra - Hospitais da Universidade de Coimbra

location_facility: The Republican Scientific-Practical Center ''Cardiology''

location_facility: Instituto de Medicina Integral Professor Fernando Figueira

location_facility: Lindner Clinical Trial Center/Christ Hospital

location_facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP

location_facility: Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez

location_facility: University Medical Center Ho Chi Minh city

location_facility: State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'

location_facility: MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron

location_facility: Institut Jantung Negara (National Heart Institute)

location_facility: Hopital Bicêtre - Aphp Hôpitaux Universitaires Paris-Sud

location_facility: Ruhr-Universität Bochum / Diabeteszentrum

location_facility: Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

location_facility: Fondazione Toscana Gabriele Monasterio CNR

location_facility: National Cerebral and Cardiovascular Center

location_facility: National Medical Research Center of Cardiology of MoH of Russian Federation

location_facility: Centre Hospitalier Universitaire - de Nice - Hopital Pasteur


title: A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive Phase 3 Study With Open-label Extension to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

acronym: MACiTEPH

summary: The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

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
Argentina
Australia
Japan
Thailand
Turkey
Czechia
Canada
Serbia
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Denmark
United States
Ukraine
Romania
China
Italy
United Kingdom
Singapore
Austria
Mexico
Korea, Republic of
Saudi Arabia
Spain
Taiwan
Bulgaria
Russian Federation
Israel

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

location_facility: Tianjin Medical University General Hospital

location_facility: Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

location_facility: CHU de Grenoble - Hopital Albert Michallon

location_facility: Siyami Ersek Training and Research Hospital

location_facility: University of New Mexico School of Medicine

location_facility: Centro Cardiovascular Colombiano Clínica Santa María

location_facility: Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B

location_facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

location_facility: Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu Sectia cardiologie III

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

location_facility: The First Affiliated Hospital of Chongqing Medical University

location_facility: The General Hospital of Northern Theater Command

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: CHU de Brest - Hôpital de la Cavale Blanche

location_facility: Eskisehir Osmangazi University Medical Faculty Hospital

location_facility: Vilnius University Hospital Santariskiu Klinikos

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

location_facility: National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation

location_facility: University Health Network - Toronto General Hospital

location_facility: CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery'

location_facility: Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

location_facility: Northwestern University Feinberg School of Medicine

location_facility: University of California San Diego Medical Center

location_facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez

location_facility: Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie

location_facility: Europejskie Centrum Zdrowia Otwock Sp. z o.o

location_facility: Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

location_facility: University of Colorado - Anschutz Medical Campus

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

location_facility: National Waiting Times Centre Board Golden Jubilee National Hospital

location_facility: Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály

location_facility: King Faisal Specialist Hospital & Research Center

location_facility: Institute for Pulmonary Disease of Vojvodina

location_facility: CRI Centro Regiomontano de Investigacion SC

location_facility: Volgograd Regional Clinical Cardiology Center

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

location_facility: Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő

location_facility: Wojewódzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego, PZOZ

location_facility: National University Heart Centre, Singapore

location_facility: Medizinische Fakultat Carl Gustav Carus Technische Universitat Dresden

location_facility: The Affiliated Hospital of Medical College Qingdao University

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Istanbul University - Cerrahpasa Cardiology Institution

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

location_facility: Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

location_facility: CHU de Montpellier - Arnaud de Villeneuve

location_facility: Policlinico Gemelli Universita Cattolica

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

location_facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

location_facility: General University Hospital II.department of Internal Medicine-cardiology and angiology

location_facility: University of Florida Health Jacksonville

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: University of Utah Cardiovascular Center

location_facility: Narodny ustav srdcovych a cievnych chorob

location_facility: State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'

location_facility: State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

location_facility: Centro de Investigacion Clinica Chapultepec

location_facility: Toho University Medical Center, Ohashi Hospital

location_facility: Krakowski Szpital Specjalistyczny im Jana Pawla II

location_facility: University Of Calgary - Peter Lougheed Centre


acronym: An Efficacy and Safety Study of Ravulizumab in ALS Patients

lead_sponsor: Alexion Pharmaceuticals, Inc.

summary: The purpose of the study is to assess the efficacy and safety of ravulizumab for the treatment of adult participants with ALS.

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Perron Institute for Neurological and Translational Science

location_facility: Johns Hopkins University School Of Medicine

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: Neuromuscular Research Center and Clinic

location_facility: Klinikum rechts der Isar der TU Muenchen

location_facility: University of California San Diego Medical Center

location_facility: Aarhus University Hospital Department of Neurology

location_facility: Houston Methodist Neurological Institute-Movement Disorders Clinic

location_facility: Montreal Neurological Institute and Hospital

location_facility: Niigata University Medical & Dental Hospital

location_facility: University of California San Francisco Medical Center

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: University of Colorado Anschutz Medical Campus School of Medicine

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Azienda Ospedaliero-Universitaria di Modena - Ospedale Civile di Baggiovara

location_facility: University Hospital of Quebec-Universite Laval

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: Shiga University of Medical Science Hospital

location_facility: Virginia Commonwealth University, Neurology Clinical and Translational Research Office

location_facility: University of Florida at Shands Jacksonville

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Medical Hospital, Tokyo Medical and Dental University

status: Terminated

title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Ravulizumab in Patients With Amyotrophic Lateral Sclerosis (ALS)

location_country:
Germany
Ireland
Italy
Poland
Israel
United Kingdom
Denmark
Australia
Japan
Netherlands
Sweden
Belgium
Switzerland
United States
Spain
Canada
France

status_simplified: Unknown


acronym: SafeHER

lead_sponsor: Hoffmann-La Roche

summary: This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer following tumor excision. Participants will receive Herceptin 600 milligrams (mg) SC every 3 weeks for 18 cycles, either by an assisted administration using a conventional syringe and needle/vial formulation (Cohort A) or with assisted and self-administration using a single-use injection device (SID) in selected participants (Cohort B).

ReferenceCitation: Jung KH, Ataseven B, Verrill M, Pivot X, De Laurentiis M, Al-Sakaff N, Lauer S, Shing M, Gligorov J, Azim HA. Adjuvant Subcutaneous Trastuzumab for HER2-Positive Early Breast Cancer: Subgroup Analyses of Safety and Active Medical Conditions by Body Weight in the SafeHer Phase III Study. Oncologist. 2018 Oct;23(10):1137-1143. doi: 10.1634/theoncologist.2018-0065. Epub 2018 Jul 17.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

publisher_dissemination: Oxford University Press

ReferenceCitation: Gligorov J, Ataseven B, Verrill M, De Laurentiis M, Jung KH, Azim HA, Al-Sakaff N, Lauer S, Shing M, Pivot X; SafeHer Study Group. Safety and tolerability of subcutaneous trastuzumab for the adjuvant treatment of human epidermal growth factor receptor 2-positive early breast cancer: SafeHer phase III study's primary analysis of 2573 patients. Eur J Cancer. 2017 Sep;82:237-246. doi: 10.1016/j.ejca.2017.05.010. Epub 2017 Jun 16.

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Universitätsklinikum Hamburg-Eppendorf; Zentrum für operative Medizin Klinik für Gynäkologie

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Ospedale Oncologico A.Businco; Div. Oncologia Medica II

location_facility: Klinikum Meiningen Klinik f.Gynäkologie und Geburtshilfe

location_facility: Kantonsspital Frauenfeld, Frauenklinik Thurgau

location_facility: Hasan Sadikin Hospital; Internal Medicine

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Gesellschaft für Medizinische Studien Würselen

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Hopitaux Du Leman Site Thonon; Maternite Gynecologie

location_facility: Poradnia Onkologiczna oraz Oddzial Kliniczny Onkologii SPZOZ Szpital Uniwersytecki

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

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

location_facility: MHAT Serdika; Department of medical oncology

location_facility: The Clatterbridge Cancer Ctr For Oncolgy

location_facility: Maasstad ziekenhuis; Afdeling oncologie hematologie

location_facility: Heartlands Hospital; Department Of Medicine

location_facility: Chp Saint Gregoire; Cancerologie Radiotherapie

location_facility: NZOZ Onko-Dent SP. P. G. L. Slomian, Poradnia Onkologiczna

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: University Hospital of Larissa; Oncology

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: University Medical Centre Maribor; Depart. of Gynecology & Breast Oncology

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Glan Clwyd Distr Gen Hospital;Nth Wales Cancer Treatment Ctr

location_facility: CMCO De La Cote D Opale; Auberge De Jour

location_facility: Policlinica Sfanta Maria - Oncology; Medical Oncology

location_facility: CiptoMangunkusumo Hospital; Internal Medicine

location_facility: Rijnstate Ziekenhuis; Inwendige Geneeskunde

location_facility: University Clinical Center of the Republic of Srpska

location_facility: Clinique Sainte Marguerite; Oncologie Medicale

location_facility: Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe

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

location_facility: Atrium Medisch Centrum Parkstad, Heerlen

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

location_facility: Sardjito Hospital; Instalasi Kanker Tulip

location_facility: Ch Francois Mitterrand; Medecine Oncologie

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii

location_facility: Azienda usl 5 Di Pisa-Ospedale Di Pontedera;U.O. Oncologia

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Cluj Clinical County Hospital; Oncology Dept

location_facility: Tri-Service General Hospital, Division of General Surgery

location_facility: Hospital General Univ. de Alicante; Servicio de Oncologia

location_facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel

location_facility: Solca Guayaquil- Sociedad de Lucha Contra El Cáncer; Oncology

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

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

location_facility: National Cancer Centre; Medical Oncology

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: Maxima Medisch Centrum; Inwendige Geneeskunde

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Kantonsspital Winterthur; Medizinische Onkologie

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie

location_facility: Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Ausl Frosinone - Ospedale Umberto I; Divisione Di Oncologia

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori; S. C. Oncologia Medica 2

location_facility: medius KLINIK OSTFILDERN-RUIT; Brustzentrum

location_facility: Fakultna nemocnica s poliklinikou J.A. Reimana Presov

location_facility: Royal Perth Hospital; Department of Medical Oncology

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

location_facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Caritas Klinik St. Theresia -Frauenklinik Brustzentrum

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

location_facility: Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin

location_facility: IRRCCS San Matteo; Dip Oncoematologico ; Divisione Oncologia

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

location_facility: Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde

location_facility: S.C. Life Search S.R.L; Medical Oncology Clinic

location_facility: Catharina Ziekenhuis; Dept of Internal Medicin

location_facility: DONAU ISAR Klinikum Deggendorf; Frauenklinik

location_facility: Josa Andras Korhaz; Dept of Oncoradiology

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia

location_facility: King Faisal Specialist Hospital & Research Centre

location_facility: Laiko General Hospital; 1St Pathological Clinic

location_facility: Philippine General Hospital; Section Of Medical Oncology

location_facility: Ospedale Oncologico Regionale; U.O. Oncologia Medica Ed Ematologia

location_facility: Hopital Clinique Claude Bernard; Oncologie Medicale

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Princess Alexandra Hospital; Oncology Department

location_facility: Hameed Latif Hospital; Department of Oncology

location_facility: Krankenhaus St. Elisabeth und St. Barbara, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

location_facility: University Hospital Birmingham Queen Elizabeth Hospital

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche

location_facility: Martini Ziekenhuis; Dept of Internal Medicine

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: University "Mother Theresa" Hospital Center; Oncology Department

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

location_facility: Hospital of Lithuanian University of Health. Sciences Kaunas Clinics

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

location_facility: Centro Médico Docente La Trinidad; Unidad de Protocolos Clínicos

location_facility: Aga Khan University; Department of Oncology

location_facility: Department of Surgery, King Chulalongkorn Memorial Hospital

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: Centro Clinico Champalimaud; Oncologia Medica

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Universitätsklinikum Essen; Zentrum Für Frauenheilkunde

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: Hospital Do Meixoeiro; Servicio de Oncologia

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: ASKLEPIOS KREISKRANKENHÄUSER WEIßENFELS-HOHENMÖLSEN GMBH

location_facility: Kyiv City Clinical Oncological Center; Chemotherapy Department

location_facility: Ospedale Civile SS Annunziata; oncologia medica

location_facility: Clinical Centre Nis, Clinic for Oncology

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Ch Du Mans; Medecine Hematologie Oncologie

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Shaukat Khanum Memorial Cancer Hospital; Department of Oncology

location_facility: Clinical Hospital Osijek; Dept For Oncology & Radiotherapy

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

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

location_facility: University Malaya Medical Centre; Clinical Oncology Unit,

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Royal Shrewsbury Hospital; Pharmacy Department

location_facility: GRN-Klinik Weinheim; Abt.Gynäkologie und Geburtshilfe

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

location_facility: State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: National Cancer Institute - Comenius University; Dept. Clinical Oncology

location_facility: Hospital General de Elda; Servicio de Oncologia

location_facility: Oncology Unit, Faculty of Medicine, Vajira Hospital; Department of Medicine

location_facility: Gelre Ziekenhuis Apeldoorn, Lokatie Lukas; Afdeling Interne Geneeskunde

location_facility: Hospital Carlos Van Buren, Servicio de Oncologia

location_facility: Institut of Oncology Al. Trestioreanu Bucharest; Oncology Department

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Szent Margit Hospital; Dept. of Oncology

location_facility: Internist; Praxis Für Haemotologie & Onkologie

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Klinikum St. Georg GmbH; Franziskus-Hospital Harderberg; Klinik für Gynaekologie und Geburtshilfe

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Katholische Hospitalvereinigung Ostwestfalen gGmbH

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Shifa International Hospital; Department of Oncology

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

location_facility: Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen

location_facility: Ospedale Garibaldi Nesima; Biomedicina Clinica e Molecolare

location_facility: Hospital Lluis Alcanys; Servicio de Oncologia

location_facility: Centre Azureen De Cancerologie; Cons externes

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

location_facility: Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

location_facility: Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Institut de Cancerologie de La Loire; Pneumologie

location_facility: State Inst. Of Healthcare Orenburg Regional Clinical Oncology Dis

location_facility: Clinical Hospital 1 Craiova; Medical Oncology

location_facility: Lahn-Dill Kliniken GmbH Klinikum Wetzlar Gynäkologie/Geburtshilfe

location_facility: Institut National D'oncologie Sidi Med Benabdellah

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Centro Estatal de Cancerologia de Nayarit

location_facility: CH Bretagne Sud Site Bodelio; Oncologie Radiotherapie

location_facility: Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia

location_facility: St. Elisabeth Krankenhaus Köln GmbH; Gynäkologie und Geburtshilfe

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Instituto de Cáncer SOLCA Cuenca; Oncología

location_facility: Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

location_facility: Centre Antoine Lacassagne; B3 Medecine Conventionnelle

location_facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Periph. University General Hospital of Heraklion Crete; Oncology Department

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

location_facility: 19 Mayis University Medical Faculty; Medical Oncology Department

location_facility: Ankara Uni School of Medicine; Medical Oncology

location_facility: Emergency University Bucharest Hospital; Oncology Department

location_facility: Hospital Pulau Pinang; Jabatan Radioterapi & Onkologi

location_facility: ASST DI CREMONA; Unità di Patologia Mammaria Senologia e Breast Unit

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

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

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: Instituto De Investigaciones Clinicas Zarate

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Waterford Regional Hospital; Department Of Medical Oncology

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

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

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Princess Alexandra Hospital; Division of Cancer Services

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hospital de Cabueñes; Servicio de Oncologia

location_facility: Great Western Hospital, Swindon Cancer Research Unit; Osprey Unit Level 3

location_facility: IRCCS Istituto Clinico Humanitas; Oncologia

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

location_facility: Vlietland Ziekenhuis, Locatie Schiedam; Interne Geneeskunde

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Hospital Pereira Rossell; Oncology Department

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Ch Lyon Sud; Onco Secteur Jules Courmont

location_facility: China Medical University Hospital; Surgery

location_facility: Beaumont Hospital; Cancer Clinical Trials Unit

location_facility: Az. Osp. Ospedale Civile; U.O. Di Oncologia Medica Ed Ematologia

location_facility: Klinikum Leverkusen; Med. Klinik III / Onkologie

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

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

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

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

location_facility: Complejo Hospitalario Universitario de Albacete; Servicio de Oncologia

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

location_facility: Praxis Dr. Prechtl & Dr. Kowolik; Frauenklinik

location_facility: Kreiskrankenhaus Torgau; Abt.Gynäkologie und Geburtshilfe

location_facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde

location_facility: Skaraborgs sjukhus Skoevde, Dept of surgery

location_facility: Klinikum Ludwigsburg; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: King Abdul Aziz Medical City, King Fahd National Guard; Oncology

location_facility: Uni Hospital of Alexandroupoli; Dept. of Oncology - Duth

location_facility: Forth Valley Royal Hospital ; Oncology Department

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Fakultna nemocnica Trencín; Onkologicke odd.

location_facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

location_facility: Royal Hampshire County Hospital; Winchester & Andover Breast Unit

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

location_facility: Ch De Brive La Gaillarde; Radiotherapie Oncologie

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

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Complejo Asistencial Universitario de Leon; Servicio de Oncologia

location_facility: City Clinical Oncology Dispensary, SPb SBIH CCOD

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Azienda USL di Ravenna; Unità Operativa di Oncologia Medica

location_facility: Kliniken der Stadt Köln gGmbH Krankenhaus Holweide; Brustzentrum

location_facility: Albert Schweitzer Ziekenhuis - loc Dordrecht

location_facility: Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem

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

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

location_facility: Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: Queen Elizabeth Hospital; Medical Oncology

title: A Phase III Prospective, Two-Cohort Non-Randomized, Multi-Centre, Multinational, Open-Label Study to Assess the Safety of Assisted- and Self-Administered Subcutaneous Trastuzumab as Therapy in Patients With Operable HER2-Positive Early Breast Cancer

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study 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).

design_allocation: Non-Randomized

location_country:
Germany
Ireland
Poland
New Zealand
Argentina
Algeria
Australia
Brazil
Bosnia and Herzegovina
Thailand
Vietnam
Turkey
Croatia
Chile
Pakistan
Czechia
Canada
Serbia
France
Slovenia
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Switzerland
Morocco
Dominican Republic
Ukraine
Indonesia
Romania
El Salvador
Malaysia
Peru
Egypt
Philippines
Italy
Guatemala
Albania
Ecuador
Norway
Singapore
United Kingdom
Venezuela
Netherlands
Mexico
United Arab Emirates
Korea, Republic of
Saudi Arabia
Spain
Uruguay
Greece
Panama
South Africa
Taiwan
Bulgaria
Russian Federation
Sweden


title: Adjuvant Systemic Treatment for Oestrogen-receptor (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) Multicentre Phase III Trial

acronym: ASTER 70s

summary: The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.

lead_sponsor: UNICANCER

location_country: Belgium France

location_facility: Centre d'oncologie et de radiothérapie du Parc

location_facility: Cliniques universitaires Saint-Luc - UCL

location_facility: Groupement Hospitalier Public du Sud de l'Oise - site de Creil

location_facility: Groupe Hospitalier des Diaconesses - Croix Saint Simon

location_facility: Centre Hospitalier Intercommunal de Meulan - Les Mureaux

location_facility: Institut Curie - Hôpital Claudius Regaud

location_facility: Centre Hôspitalier de Wallonie Picarde (CHWAPI)

location_facility: RISSA Sarcelles (GCS Recherche & Innovation Santé Sarcelles)


title: A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.

summary: This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

time_perspective: Prospective

location_country:
Germany
Italy
Colombia
Portugal
Norway
United Kingdom
Mexico
Spain
Greece
Monaco
Canada
France


acronym: LIBERTY-PN PRIME2

lead_sponsor: Sanofi

summary:
Primary Objective:

To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable.

Secondary Objectives:

To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable.

To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number :1240006
Investigational Site Number :1520001
Investigational Site Number :4100001
Investigational Site Number :8400002
Investigational Site Number :6200002
Investigational Site Number :7240009
Investigational Site Number :1520003
Investigational Site Number :1580002
Investigational Site Number :8400054
Investigational Site Number :2500005
Investigational Site Number :1240002
Investigational Site Number :8400008
Investigational Site Number :8260001
Investigational Site Number :8400006
Investigational Site Number :7240001
Investigational Site Number :4100003
Investigational Site Number :3480002
Investigational Site Number :4100005
Investigational Site Number :3480004
Investigational Site Number :4100002
Investigational Site Number :8400003
Investigational Site Number :1240001
Investigational Site Number :8400001
Investigational Site Number :1520004
Investigational Site Number :3800003
Investigational Site Number :4100007
Investigational Site Number :1240008
Investigational Site Number :1240007
Investigational Site Number :2500002
Investigational Site Number :8400005
Investigational Site Number :1580001
Investigational Site Number :1240009
Investigational Site Number :2500001
Investigational Site Number :1520006
Investigational Site Number :1520002
Investigational Site Number :2500008
Investigational Site Number :2500004
Investigational Site Number :3480005
Investigational Site Number :3800002
Investigational Site Number :3480003
Investigational Site Number :2500006
Investigational Site Number :2500007
Investigational Site Number :7240002
Investigational Site Number :1580005
Investigational Site Number :3800001
Investigational Site Number :6200001
Investigational Site Number :6200003
Investigational Site Number :7240003
Investigational Site Number :1520005
Investigational Site Number :4100006
Investigational Site Number :7240008
Investigational Site Number :1580006
Investigational Site Number :2500003
Investigational Site Number :1580008
Investigational Site Number :7240007
Investigational Site Number :3800004
Investigational Site Number :7240004

title: A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

location_country:
Italy
Portugal
Hungary
United Kingdom
United States
Korea, Republic of
Spain
Chile
Taiwan
Canada
France


summary: The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

location_facility: City clinical oncological dispensary ( Site 1154)

location_facility: Okayama University Hospital ( Site 1020)

location_facility: Sapporo Medical University Hospital ( Site 1008)

location_facility: Oncologos del Occidente S.A. ( Site 1708)

location_facility: Tampereen yliopistollinen sairaala ( Site 0300)

location_facility: The Cancer Institute Hospital of JFCR ( Site 1000)

location_facility: Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 0603)

location_facility: Nara Medical University Hospital ( Site 1009)

location_facility: Institut de Cancerologie du Gard - CHU Caremeau ( Site 0352)

location_facility: Fakultni Thomayerova nemocnice ( Site 0107)

location_facility: Azienda Ospedaliera Santa Maria ( Site 0602)

location_facility: Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 1306)

location_facility: Debreceni Egyetem Klinikai Kozpont ( Site 0504)

location_facility: SBIH City clinical hospital named after D.D. Pletniov ( Site 1160)

location_facility: Chang Gung Medical Foundation - Kaohsiung ( Site 1104)

location_facility: National Cancer Center Hospital ( Site 1003)

location_facility: Policlinico S. Orsola-Malpighi ( Site 0606)

location_facility: The University of Chicago Medical Center ( Site 1539)

location_facility: Yamaguchi University Hospital ( Site 1018)

location_facility: Masarykuv onkologicky ustav ( Site 0105)

location_facility: Texas Oncology-Austin Central ( Site 1533)

location_facility: University of North Carolina at Chapel Hill ( Site 1537)

location_facility: Royal Marsden NHS Foundation Trust ( Site 1403)

location_facility: Kyiv City Clinical Oncology Center ( Site 1450)

location_facility: Beth Israel Deaconess Medical Center ( Site 1501)

location_facility: Kuopion Yliopistollinen Sairaala ( Site 0304)

location_facility: Texas Oncology, P.A.-Dallas ( Site 1534)

location_facility: Universitaetsklinik fuer Urologie ( Site 0405)

location_facility: Central Clinical Hospital with Polyclinic ( Site 1157)

location_facility: University of California San Diego Moores Cancer Center ( Site 1546)

location_facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1106)

location_facility: Azienda Ospedaliera Policlinico di Bari ( Site 0610)

location_facility: Centre Alexis Vautrin Institut de Cancerologie de Lorraine ( Site 0356)

location_facility: Centre Hospitalier Lyon Sud ( Site 0354)

location_facility: Universitaetsmedizin Berlin ( Site 0400)

location_facility: Medical University of South Carolina ( Site 1518)

location_facility: Kindai University Hospital- Osakasayama Campus-Urology ( Site 1011)

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514)

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

location_facility: Chungnam National University Hospital ( Site 1205)

location_facility: Nippon Medical School Hospital ( Site 1010)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 1155)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0152)

location_facility: Fakultni nemocnice Hradec Kralove ( Site 0106)

location_facility: Taipei Veterans General Hospital ( Site 1101)

location_facility: Hamamatsu University Hospital ( Site 1005)

location_facility: Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)

location_facility: TYKS T-sairaala Syopatautien pkl ( Site 0301)

location_facility: Administradora Country SA - Clinica del Country ( Site 1701)

location_facility: Orszagos Onkologiai Intezet ( Site 0503)

location_facility: Hospital General Universitario 12 de Octubre ( Site 1252)

location_facility: Dana Farber Cancer Institute ( Site 1505)

location_facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)

location_facility: Gazi Universitesi Tip Fakultesi ( Site 1308)

location_facility: Karolinska Universitetssjukhuset Solna ( Site 1850)

location_facility: Korea University Anam Hospital ( Site 1203)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1303)

location_facility: Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)

location_facility: Princess Margaret Hospital. ( Site 1053)

location_facility: National Taiwan University Hospital ( Site 1100)

location_facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1709)

location_facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1163)

location_facility: Omsk Clinical Oncology Dispensary ( Site 1150)

location_facility: Massachusetts General Hospital ( Site 1558)

location_facility: Royal Marsden Hospital Sutton-Surrey ( Site 1411)

location_facility: Fundacion Centro de Investigacion Clinica CIC ( Site 1703)

location_facility: CHU de Bordeaux Hop St ANDRE ( Site 0359)

location_facility: Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1650)

location_facility: CHU Besancon - Hopital Jean Minjoz ( Site 0351)

location_facility: Niigata University Medical & Dental Hospital ( Site 1022)

location_facility: Hospital de Clinicas de Porto Alegre ( Site 1655)

location_facility: Medical Oncology Ospedale San Donato ( Site 0609)

location_facility: St Joseph Heritage Healthcare ( Site 1531)

location_facility: Saitama Medical University International Medical Center ( Site 1012)

location_facility: Centro Avancado de Tratamento Oncologico ( Site 1657)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 0509)

location_facility: MI Precarpathian Clinical Oncology Center ( Site 1452)

location_facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)

location_facility: Northwest Georgia Oncology Centers PC ( Site 1520)

location_facility: Istituto Nazionale dei Tumori ( Site 0601)

location_facility: Oncology Hematology Care, Inc. ( Site 1524)

location_facility: Centro Investigación del Cáncer James Lind ( Site 0004)

location_facility: Liga Norte Riograndense Contra o Cancer ( Site 1651)

location_facility: Hadassah Medical-Oncology department ( Site 1164)

location_facility: Fakultni nemocnice Kralovske Vinohrady ( Site 0102)

location_facility: Instituto Catalan de Oncologia - ICO ( Site 1251)

location_facility: SBHI SPb Clinical Research Centre of specialized types of medical care ( Site 1159)

location_facility: Oregon Health & Science University ( Site 1553)

location_facility: University of Alabama - Birmingham ( Site 1538)

location_facility: Nova Scotia Health Authority QEII-HSC ( Site 0150)

location_facility: MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 1453)

location_facility: Hacettepe Universitesi Tip Fakultesi ( Site 1300)

location_facility: Ankara Universitesi Tip Fakultesi ( Site 1311)

location_facility: UCHealth Highlands Ranch Hospital ( Site 1560)

location_facility: Cambridge University Hospitals NHSFT ( Site 1405)

location_facility: Yokohama City University Hospital ( Site 1015)

location_facility: Universitaetsklinikum Magdeburg A.o.R. ( Site 0404)

location_facility: Fondazione Policlinico Universitario A. Gemelli ( Site 0607)

location_facility: Sunnybrook Research Institute ( Site 0153)

location_facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0151)

location_facility: Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)

location_facility: Taichung Veterans General Hospital ( Site 1105)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)

location_facility: Akershus universitetssykehus ( Site 0851)

location_facility: Instituto Valenciano de Oncologia - IVO ( Site 1254)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523)

location_facility: Tokushima University Hospital-Department of Urology ( Site 1017)

location_facility: Universitaetsklinikum Essen ( Site 0401)

location_facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0350)

location_facility: Severance Hospital Yonsei University Health System ( Site 1202)

location_facility: Universitatsklinikum Hamburg-Eppendorf ( Site 0408)

location_facility: Aarhus University Hospital Skejby ( Site 0250)

location_facility: National Cancer Center Hospital East ( Site 1001)

location_facility: Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)

location_facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)

location_facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1702)

location_facility: Russian Scientific Center of Radiology and Surgical Technologies ( Site 1153)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)

location_facility: St. Vincent Frontier Cancer Center ( Site 1549)

location_facility: The Christie NHS Foundation Trust ( Site 1401)

location_facility: Hospital Universitari Vall d Hebron ( Site 1250)

location_facility: BC Cancer - Vancouver Center ( Site 0155)

location_facility: Universitaetsklinikum Duesseldorf ( Site 0410)

location_facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513)

location_facility: University of Rochester Medical Center ( Site 1543)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 0605

location_facility: National Cheng Kung University Hospital ( Site 1103)

location_facility: The Beatson West of Scotland Cancer Centre ( Site 1402)

location_facility: Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0505)

location_facility: Norrlands Universitetssjukhus ( Site 1856)

title: An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies

location_country:
Finland
Germany
Japan
Brazil
Turkey
Chile
Czechia
Canada
France
Colombia
Hungary
Hong Kong
Denmark
United States
Ukraine
Italy
Norway
United Kingdom
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden


lead_sponsor: Taiho Oncology, Inc.

summary: The purpose of this study is to evaluate the efficacy and safety of futibatinib in patients with FGFR aberrations in 3 distinct cohorts. Patients will be enrolled into one of 3 cohorts: patients with advanced, metastatic or locally-advanced solid tumors harboring FGFR1-4 rearrangements (excluding primary brain tumors and intrahepatic cholangiocarcinoma [iCCA]); patients with gastric or gastro-esophageal junction (GEJ) cancer harboring FGFR2 amplification; and patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos

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

location_facility: Karolinska universitetssjukhuset - Solna

location_facility: Hospital Universitario HM Madrid Sanchinarro

location_facility: Mercy Clinic Oncology and Hematology - Coletta

location_facility: Seoul National University Bundang Hospital

location_facility: Georgetown University - Lombardi Comprehensive Cancer Center

location_facility: University of Chicago Comprehensive Cancer Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Trento)

location_facility: Hospital Clinico Universitario de Valencia

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

location_facility: Centro Hospitalar do Porto, E.P.E - Hospital de Santo Antonio

title: A Phase 2 Study of Futibatinib in Patients With Specific FGFR Aberrations

location_country:
Germany
Italy
Portugal
United Kingdom
Hong Kong
Singapore
Japan
Sweden
Netherlands
Belgium
United States
Korea, Republic of
Spain
Turkey
France

ipd_sharing: No