title: A Two-Cohort, Open-Label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-Based Treatment

summary: This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have received prior anti-HER2 and chemotherapy-based treatment. Participants in Cohort 1 will be drawn from the general participant population; Cohort 2 will include only Asian participants.

design_allocation: Non-Randomized

ReferenceCitation: Wuerstlein R, Ellis P, Montemurro F, Antón Torres A, Delaloge S, Zhang Q, Wang X, Wang S, Shao Z, Li H, Rachman A, Vongsaisuwon M, Liu H, Fear S, Peña-Murillo C, Barrios C. Final results of the global and Asia cohorts of KAMILLA, a phase IIIB safety trial of trastuzumab emtansine in patients with HER2-positive advanced breast cancer. ESMO Open. 2022 Oct;7(5):100561. doi: 10.1016/j.esmoop.2022.100561. Epub 2022 Sep 7.

ReferenceCitation: Engebraaten O, Yau C, Berg K, Borgen E, Garred Ø, Berstad MEB, Fremstedal ASV, DeMichele A, Veer LV', Esserman L, Weyergang A. RAB5A expression is a predictive biomarker for trastuzumab emtansine in breast cancer. Nat Commun. 2021 Nov 5;12(1):6427. doi: 10.1038/s41467-021-26018-z.

ReferenceCitation: Montemurro F, Delaloge S, Barrios CH, Wuerstlein R, Anton A, Brain E, Hatschek T, Kelly CM, Peña-Murillo C, Yilmaz M, Donica M, Ellis P. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial(☆). Ann Oncol. 2020 Oct;31(10):1350-1358. doi: 10.1016/j.annonc.2020.06.020. Epub 2020 Jul 5.

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Luxembourg
Spain
Italy
United Kingdom
Venezuela
Peru
Belgium
Iceland
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Argentina
Indonesia
Turkey
Panama
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Guatemala
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Dominican Republic
Greece
Estonia
Ireland
Ecuador
Finland
Thailand
Korea, Republic of
France
Netherlands
United Arab Emirates

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Istanbul Uni of Medicine Faculty; Oncology Dept

location_facility: Calvary Mater Newcastle; Medical Oncology

location_facility: Hospital Quiron Barcelona; Servicio de Oncologia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Deventer Ziekenhuis; Interne Geneeskunde

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Polyclinique De Courlancy; Centre Radiotherapie Oncologie

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

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

location_facility: Yeovil District Hospital; Macmillan Cancer Unit

location_facility: MHAT Serdika; Department of medical oncology

location_facility: Klinikum Leverkusen; Med. Klinik III / Onkologie

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: Aalborg Universitetshospital, Klinik Kirurgi-Kræft, Onkologisk afd.

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Southlake Regional Health Center; Community Care Clinic / Oncology

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

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

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Dres. Joerg Weniger, Annette Bittrich und Berit Schuetze

location_facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

location_facility: Institut Gustave Roussy; Pathologie Mammaire

location_facility: Ospedale Bellaria; U.O. Oncologia Medica

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica

location_facility: Nordsjællands Hospital, Hillerød, Onkologisk Afdeling

location_facility: Dr. H. Bliss Murphy Cancer Centre; Oncology

location_facility: Castle Hill Hospital; The Queen's Centre for Oncology & Haematology

location_facility: KYS Sadesairaala; Syopatautien poliklinikka

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Unidad de Mastologia y Atencion a la Mujer

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

location_facility: Department of Surgery, King Chulalongkorn Memorial Hospital

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

location_facility: HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie

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

location_facility: Narodny Onkologicky Ustav; Oddelenie klinickej onkologie A

location_facility: Clinique Tivoli; Chimiotherapie Radiotherapie

location_facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker

location_facility: Universitaetsfrauenklinik; Und Poliklinik Am Klinikum

location_facility: Inst. Nacional de Cancerologia; Investigacion Clinica

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

location_facility: Harbin Medical University Cancer Hospital

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: District Oncology Dispensary Wit Stationary

location_facility: Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

location_facility: St Vincent'S Uni Hospital; Medical Oncology

location_facility: Hospital Privado De Comunidad; General Practice

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: University Hospital Birmingham Queen Elizabeth Hospital

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: St George'S Hospital; Oncology Research Office /Oncology Opd

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Cli De La Porte De Saint Cloud; Hop De Jour De Chimiotherapie

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

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

location_facility: Odense Universitetshospital, Onkologisk Afdeling R

location_facility: Institut Jean Godinot; Oncologie Medicale

location_facility: Bezmialem Vakif Univ Medical; Bezmialem Vakif Univ T

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

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

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: Centre Henri Becquerel; Oncologie Medicale

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Hospital Sirio Libanes; Centro de Oncologia

location_facility: IPO de Lisboa; Servico de Oncologia Medica

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

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: National Cheng Kung Uni Hospital; Surgery

location_facility: Ospedale Maggiore Della Carita; Oncologia Medica

location_facility: Oslo Universitetssykehus HF; Ullevål sykehus

location_facility: Twee Steden Ziekenhuis - Locatie Tilburg; Interne Geneesekunde

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

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

location_facility: Complejo Hospitalario de Pontevedra; Servicio de Oncologia

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Orbis Medisch Centrum; Inwendige Geneeskunde

location_facility: Instituto de Oncologia y Hematologia UCV

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Fakultna nemocnica Trencín; Onkologicke odd.

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: University Hospital of Patras Medical Oncology

location_facility: Cipto Mangunkusumo General Hospital; Hematology & Oncology

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

location_facility: Gaziantep University Medical Faculty, Medical Oncology Department

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

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

location_facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

location_facility: Polyclinique Francheville; Med Chimiotherapie Radiotherapie

location_facility: Hospital General de Elda; Servicio de Oncologia

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Kyungpook National University Medical Center

location_facility: Uni Hospital of Ioannina; Oncology Dept.

location_facility: Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Antoni Van Leeuwenhoek Ziekenhuis; Inwendige Geneeskunde

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: University Hospital coventry; Oncology Department

location_facility: RCCS - Centro di Riferimento; Oncologia Medica B

location_facility: Centre Henry S Kaplan - CHU Bretonneau ; service oncologie

location_facility: Plymouth Oncology Centre; Clinical Trials Unit

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

location_facility: Landspitali University Hospital, Department of Medical Oncology

location_facility: Kartal Dr Lutfi Kirdar Sehir Hastanesi; Medical Oncology Department

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

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Centre Val Aurelle Paul Lamarque; Recherche Clinique

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Szpital Specjalistyczny POO im. ks. B.Markiewicza; Dzienny Oddz Chemioter i Hematologii Onkol

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: Hospital Universitario San Cecilio; Servicio de Oncologia

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

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

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

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

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

location_facility: CENTRO MÉDICO NACIONAL SIGLO XXI; Hospital de Especialidades Oncología

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Hospital Xeral Cíes; Servicio de Oncologia

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

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: Hospital Universitari Sant Joan de Reus; Servicio de Oncologia

location_facility: Kaposi Mor County Hospital; Dept. of Oncology

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Hämatologisch-onkologische Praxis Dr. med. - Heinrich, - Bangerter

location_facility: Hopital Morvan; Oncologie - Radiotherapie

location_facility: Mater Misericordiae Uni Hospital; Oncology

location_facility: Clinique De L Europe; Radiotherapie Chimiotherapie

location_facility: Gachon Medical School Gil Medical Center; Medical Oncology

location_facility: Fondazione Salvatore Maugeri; Divisione Di Oncologia Medica

location_facility: Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

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

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Casa di Cura Multimedica S.p.A.; Dipartimento Oncologico

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Westmead Hospital; Medical Oncology and Pallative Care

location_facility: Mater Hospital; Patricia Ritchie Centre for Cancer Care and Research

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Clinique Armoricaine Radiologie; Hopital de Jour

location_facility: Schwerpunktpraxis Onkologie/Hämatologie Dr. Dirk Pott, Dr. Christian Tirier und Carla Verena u.w.

location_facility: University General Hospital of Heraklion

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

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

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: Ch Bretagne Sud Site Scorff; Oncologie Medicale

location_facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz

location_facility: Western General Hospital; Clinical Oncology

location_facility: Hospital de Jerez de la Frontera; Servicio de Oncologia

location_facility: Instituto Nacional de Ciencias Médicas Y de La Nutricion Zubirán

location_facility: Centre Rene Huguenin; CONSULT SPECIALISEES

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

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

location_facility: Haematology & Oncology Clinics of Australia Research Centre

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Świętokrzyskie Centrum Onkologii; Dział Chemioterapii


title: European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units

acronym: EUROPAINsurvey

summary:
EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study.

The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries.

The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes.

The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception.

The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lago P, Frigo AC, Baraldi E, Pozzato R, Courtois E, Rambaud J, Anand KJ, Carbajal R. Sedation and analgesia practices at Italian neonatal intensive care units: results from the EUROPAIN study. Ital J Pediatr. 2017 Mar 7;43(1):26. doi: 10.1186/s13052-017-0343-2.

ReferenceCitation: Carbajal R, Eriksson M, Courtois E, Boyle E, Avila-Alvarez A, Andersen RD, Sarafidis K, Polkki T, Matos C, Lago P, Papadouri T, Montalto SA, Ilmoja ML, Simons S, Tameliene R, van Overmeire B, Berger A, Dobrzanska A, Schroth M, Bergqvist L, Lagercrantz H, Anand KJ; EUROPAIN Survey Working Group. Sedation and analgesia practices in neonatal intensive care units (EUROPAIN): results from a prospective cohort study. Lancet Respir Med. 2015 Oct;3(10):796-812. doi: 10.1016/S2213-2600(15)00331-8. Epub 2015 Sep 24. Erratum in: Lancet Respir Med. 2015 Dec;3(12):e44.

lead_sponsor: Hôpital Armand Trousseau

location_country:
Poland
Portugal
Spain
Greece
Austria
Estonia
Italy
Finland
Lithuania
Netherlands
United Kingdom
Sweden
France
Malta
Belgium
Norway
Germany
Cyprus

location_facility: Neonatal Intensiv Care Unit, Arch. Makarios Hospital

location_facility: Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust PICU

location_facility: TIN E Patologia Neonatale Dip. di Salute della donna e del bambino- Università di Padova

location_facility: Department of Anesthesiology and Intensive Care, Tallinn Children's Hospital

location_facility: Great Western Hospitals NHS Foundation Trust

location_facility: Klinik fUr Kinder und Jugendliche Sozialstiftung Bamberg

location_facility: IN Ospedale Macedonio Melloni Milano-AO Fatebenefratellied Oftalmico

location_facility: Jessop Wing, Sheffield Teaching Hospitals NHS Trust

location_facility: University Hospital Of North Staffordshire NHS Trust

location_facility: Northampton General Hospital Neonatal Unit

location_facility: Paediatric Intensive Care Unit, Clinic of Anaesthesiology and Intensive Care, Tartu University Clinics

location_facility: Universitäts-klinik für Kinder- und Jugendheilkunde Innsbruck

location_facility: UO TIN Neonatologia AOU Sant'Orsola Malpighi

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: U.O.Patologia e Terapia Intensiva Neonatale AOUI Borgo Roma

location_facility: Hospital Universitario Principe de Asturias

location_facility: TIN Centro IRCSS Ca Granda-Policlinico Osp.Maggiore Mangiagalli LI

location_facility: Oslo University Hospital - Rikshospitalet

location_facility: Universitäts-klinik für Kinder und Jugendheilkunde Salzburg

location_facility: University Hospital Utrecht - Wilhelmina Children's Hospital

location_facility: Karolinska University Hospital (Stockholm)

location_facility: 1st Dept of Neonatalogy, Aristole University of Thessaloniki

location_facility: Azienda Ospedaliera Universitaria di Sassari

location_facility: Department of obstetric and gynecology, medical University of Warsaw

location_facility: Great Ormond Street Hospital for Sick Children PICU

location_facility: Departement of Neonato- logy Medical University in Wrocław

location_facility: Complexo Hospitalario Universitario de Santiago

location_facility: Terapia Intensiva Neonatale e Pediatrica

location_facility: Southport & Ormskirk & District General Hospital Neonatal Unit

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Academic medical Center Amsterdam - Emma Children's Hospital

location_facility: Centre Hospitalier Régional de la Citadelle

location_facility: Universitäts klinik für Kinder-und Jugenheilkunde Wien

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: 2nd Dept of Neonatalogy, Aristole University of Thessaloniki

location_facility: James Cook University Hospital, Middlesborough

location_facility: Children's Memorial Health Institute Warsaw

location_facility: Department of Paediatric and Adolescent Medicine University Hospital Erlangen

location_facility: U.O. di Neonatologia e PatNeo con T.I. - Istituti Ospitalieri

location_facility: Isala Clinics Zwolle - Amalia Children's Hospital

location_facility: York Teaching Hospital NHS Foundation Trust

location_facility: Department of Neonatology Lithuanian University of Health Sciences,

location_facility: Complexo Hospitalario Universitario de A Coruña

location_facility: TIN/Neonatologia- fondazione MBBM- H San Gerardo

location_facility: "Mitera" General Maternity and Pediatric Clinic

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Central de Asturias

location_facility: UO Neonatologia e TIN Ospedale Santa Chiara

location_facility: Complexo Hospitalario Universitario de Vigo

location_facility: Blackpool Teaching Hospital Foundation Trust

location_facility: Patologia Neonatale Ospedale S.M.Misericordia

location_facility: University Hospital of South Manchester, Wythenshawe

lead_sponsor_type: academique

status_simplified: Completed


type: EudraCT Number

type: Other Identifier

title: COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection

acronym: COMBI-AD

summary: This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus two placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk [Stage IIIa (lymph node metastasis >1 mm), IIIb or IIIc] cutaneous melanoma were screened for eligibility. Subjects were randomized to receive either dabrafenib (150 milligram (mg) twice daily [BID]) and trametinib (2 mg once daily [QD]) combination therapy or two placebos for 12 months.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

ReferenceCitation: Dummer R, Hauschild A, Santinami M, Atkinson V, Mandalà M, Kirkwood JM, Chiarion Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Gasal E, Tan M, Long GV, Schadendorf D. Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma. N Engl J Med. 2020 Sep 17;383(12):1139-1148. doi: 10.1056/NEJMoa2005493. Epub 2020 Sep 2.

ReferenceCitation: Dummer R, Brase JC, Garrett J, Campbell CD, Gasal E, Squires M, Gusenleitner D, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Flaherty K, Larkin J, Robert C, Kefford R, Kirkwood JM, Hauschild A, Schadendorf D, Long GV. Adjuvant dabrafenib plus trametinib versus placebo in patients with resected, BRAF(V600)-mutant, stage III melanoma (COMBI-AD): exploratory biomarker analyses from a randomised, phase 3 trial. Lancet Oncol. 2020 Mar;21(3):358-372. doi: 10.1016/S1470-2045(20)30062-0. Epub 2020 Jan 30.

ReferenceCitation: Schadendorf D, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Lesimple T, Plummer R, Schachter J, Dasgupta K, Manson S, Koruth R, Mookerjee B, Kefford R, Dummer R, Kirkwood JM, Long GV. Patient-reported outcomes in patients with resected, high-risk melanoma with BRAF(V600E) or BRAF(V600K) mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 May;20(5):701-710. doi: 10.1016/S1470-2045(18)30940-9. Epub 2019 Mar 27.

ReferenceCitation: Hauschild A, Dummer R, Schadendorf D, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Haas T, Shilkrut M, Gasal E, Kefford R, Kirkwood JM, Long GV. Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma. J Clin Oncol. 2018 Dec 10;36(35):3441-3449. doi: 10.1200/JCO.18.01219. Epub 2018 Oct 22.

ReferenceCitation: Long GV, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma. N Engl J Med. 2017 Nov 9;377(19):1813-1823. doi: 10.1056/NEJMoa1708539. Epub 2017 Sep 10.

ipd_sharing: Yes

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Norway
Sweden
Brazil
Canada
Switzerland
Germany
Denmark
Taiwan
Greece
New Zealand
France
Netherlands

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)

summary: In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.

ReferenceCitation: Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25.

ReferenceCitation: Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol. 2022 Sep;111(9):1057-1068. doi: 10.1007/s00392-022-02022-1. Epub 2022 Apr 29.

ReferenceCitation: Lip GYH, Kotalczyk A, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Marler S, Gurusamy VK, Huisman MV; GLORIA-AF Investigators. Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry. Clin Res Cardiol. 2022 May;111(5):560-573. doi: 10.1007/s00392-022-01996-2. Epub 2022 Mar 16. Erratum In: Clin Res Cardiol. 2022 Apr 6;:

ReferenceCitation: Huisman MV, Teutsch C, Lu S, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Lohmann R, Gurusamy VK, Bartels DB, Lip GYH; GLORIA-AF Investigators. Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry. Clin Res Cardiol. 2022 May;111(5):548-559. doi: 10.1007/s00392-021-01957-1. Epub 2022 Mar 16.

ReferenceCitation: Bayer V, Kotalczyk A, Kea B, Teutsch C, Larsen P, Button D, Huisman MV, Lip GYH, Olshansky B. Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry. J Am Heart Assoc. 2022 Mar 15;11(6):e023907. doi: 10.1161/JAHA.121.023907. Epub 2022 Mar 4.

ReferenceCitation: Ntaios G, Huisman MV, Diener HC, Halperin JL, Teutsch C, Marler S, Gurusamy VK, Thompson M, Lip GYH, Olshansky B; GLORIA-AF Investigators. Anticoagulant selection in relation to the SAMe-TT(2)R(2) score in patients with atrial fibrillation: The GLORIA-AF registry. Hellenic J Cardiol. 2021 Mar-Apr;62(2):152-157. doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15.

ReferenceCitation: Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Lu S, Bartels DB, Lip GYH; GLORIA-AF Investigators. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018 Apr;198:55-63. doi: 10.1016/j.ahj.2017.08.018. Epub 2017 Aug 31.

ReferenceCitation: Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.

lead_sponsor: Boehringer Ingelheim

location_country:
Croatia
Spain
Italy
United Kingdom
Romania
Belgium
Czechia
Poland
Portugal
Slovenia
Austria
Norway
Sweden
Germany
Bulgaria
Denmark
Greece
Ireland
Estonia
Latvia
France
Netherlands

location_facility: Liepaja Regional Hospital, Therapy Department

location_facility: KH d. Barmherzigen Brüder Wien, Neurologie

location_facility: CAB Phan Cao Phai, Cardio, Levallois Perret

location_facility: Praxis Dr.med. Jens Taggeselle, Markkleeberg

location_facility: HOP d'Aix en Provence, cardio, Aix-en-Provence

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Cardiology Out-patient Clinic "Cardio-Plus", Radlin

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: MHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, Sofia

location_facility: General Hospital of Edessa, Cardiology Clinic

location_facility: MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak

location_facility: Hospital Regional Universitario de Málaga

location_facility: A.O. Univ. Vittorio Ferrarotto S. Bambino

location_facility: Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb

location_facility: Gemeinschaftspraxis Dr. med. J. Sek, Chemnitz

location_facility: Osp. Guglielmo da Saliceto AUSL di Piacenza

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: MHAT "National Cardiology Hosp." Cardiology Dept., Sofia

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: HOP de Courbevoie, Spécialités Med, Neuilly sur Seine

location_facility: HOP Sud Francilien, Cardio, Corbeil-Essonnes

location_facility: Multiprofile Hospital for Active Treatment, Sliven

location_facility: Slaskie Center Heart Disease SUM,Cardiol.&Electr.Clin.Zabrze

location_facility: Individual Specialistic Private Practice,Dr.A.Tomasik,Zabrze

location_facility: MHAT, Fourth Dept. of Internal Medicine, Rousse

location_facility: Univ. Hosp. Sisters of Mercy, Cardiology Dept., Zagreb

location_facility: Evangelisches Elisabeth-Krankenhaus, Berlin Mitte

location_facility: General Hosp. Zadar, Clinic of Internal Med, Cardiology Dept

location_facility: Praxis für Herz-Kreislauf-Erkrankungen Zeulenroda-Greiz

location_facility: Thalassoterapia,Rehab.of heart&lung,Cardiology Clin, Opatija

location_facility: HOP Privé de la Loire, Cardio, Saint Etienne

location_facility: Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã

location_facility: HOP de la région d'Annecy, Cardio, Metz-Tessy

location_facility: MHAT "Deva Maria", Dept. of Cardiology, Burgas

location_facility: Ordination Dr. Martin Koschutnik, Oberwart

location_facility: Hospital General Universitario de Alicante

location_facility: Emergency University Hospital, Bucharest

location_facility: General Panarkadiko Hospital of Tripolis, Cardiology Clinic

location_facility: Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH

location_facility: Polyclinic St. Luke, Cardiology Dept., Zagreb

location_facility: Diagnostic & Consultancy Center "Ascendent", Sofia

location_facility: Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Cardiology Private Practice, Roznov pod Radhostem

location_facility: Gesundheit Nord gGmbH | Klinikverbund Bremen

location_facility: Sotiria Hosp.,Hypertension Unit,3rd Clinic of Internal Med.

location_facility: Az.Osp. Universitaria "Ospedali Riuniti"

location_facility: HOP Raincy Montfermeil, Cardio, Montfermeil

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: Gen. Hosp. of Thessaloniki "Hippokation", Cardiology Clinic

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: UMHAT, Clinic of Cardiology, Stara Zagora

location_facility: "Papageorgiou" General Hospital of Thessaloniki, B' Cardiolo

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol

location_facility: Klinik Pirawarth, Therapie und Rehabilitation, Bad Pirawarth

location_facility: Research Unit, Liverpool Heart and Chest Hospital

location_facility: Nuovo Ospedale Civile S. Agostino-Estense

location_facility: Specialist Out-patient Clinics 'Na Gornej',Cieszyn

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: North Estonia Med.Centre,Internal Med.Clin/Cardiology,Tallin

location_facility: CHLO, EPE - Hospital S. Francisco Xavier

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Sydvestjysk Sygehus Esbjerg, Hjertemedicinsk afd.

location_facility: University General Hospital of Heraklion

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: CAB Houppe Nousse MP, Cardio, Thionville

location_facility: HOP Louis Pasteur, Cardio, Bagnols sur Ceze

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Specialistic Cardiology&Hypertension Out-patient Clin,Kielce

location_facility: Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb

location_facility: METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

location_facility: "Korgialeneio-Benakeio" Hellenic Red Cross Hospital

location_facility: Univ. Medical Centre Ljubljana, Dept. of Vascular Diseases

location_facility: Private Practice of Heart Diseases Malgorzata Lelonek,Lodz

location_facility: Hospital General Universitario de Valencia

location_facility: CAB Dascotte O, Cardio, St André lez Lille

location_facility: Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Azienda Complessa Ospedaliera Ospedale San Fiippo Neri

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Asclepion Voulas Hospital, Cardiological Clinic

location_facility: University Multiprofile Hospital 'Alexandrovska', Sofia

location_facility: HOP William Morey, Cardio, Chalon-Sur-Saône

location_facility: Individual Specialist.Private Practice Dr.W.Krysiak,Szczecin

location_facility: Sykehuset Innlandet HF, Avd. Lillehammer

location_facility: CAB Brunehaut M, Cardio, Clermont Ferrand

location_facility: Ospedale S.Maria della Misericordia, AO di Perugia

location_facility: Med.Centre Diagnosis,Treatm&Prev Med.Cardiol.Dept, Bucharest

location_facility: CLI les Cedres, Cardio, Brive La Gaillarde

location_facility: Azienda Sanitaria Ospedale S. Luigi Gonzaga

location_facility: Policlinico Universitario Mater Domini, Universita di Catanzaro

location_facility: Reg.Hosp, Intern.Med.Ward w/ Intensive Cardiol.Care, Opoczno


title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

summary: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy

ReferenceCitation: Klijn SL, Fenwick E, Kroep S, Johannesen K, Malcolm B, Kurt M, Kiff C, Borrill J. What Did Time Tell Us? A Comparison and Retrospective Validation of Different Survival Extrapolation Methods for Immuno-Oncologic Therapy in Advanced or Metastatic Renal Cell Carcinoma. Pharmacoeconomics. 2021 Mar;39(3):345-356. doi: 10.1007/s40273-020-00989-1. Epub 2021 Jan 11.

ReferenceCitation: Ambavane A, Yang S, Atkins MB, Rao S, Shah A, Regan MM, McDermott DF, Michaelson MD. Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 Jan;12(1):37-51. doi: 10.2217/imt-2019-0199. Epub 2020 Jan 29.

ReferenceCitation: Shah R, Botteman M, Solem CT, Luo L, Doan J, Cella D, Motzer RJ. A Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) Analysis of Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma (aRCC). Clin Genitourin Cancer. 2019 Oct;17(5):356-365.e1. doi: 10.1016/j.clgc.2019.05.010. Epub 2019 May 31.

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

ReferenceCitation: Escudier B, Motzer RJ, Sharma P, Wagstaff J, Plimack ER, Hammers HJ, Donskov F, Gurney H, Sosman JA, Zalewski PG, Harmenberg U, McDermott DF, Choueiri TK, Richardet M, Tomita Y, Ravaud A, Doan J, Zhao H, Hardy H, George S. Treatment Beyond Progression in Patients with Advanced Renal Cell Carcinoma Treated with Nivolumab in CheckMate 025. Eur Urol. 2017 Sep;72(3):368-376. doi: 10.1016/j.eururo.2017.03.037. Epub 2017 Apr 12.

ReferenceCitation: Escudier B, Sharma P, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Gurney H, Donskov F, Peltola K, Wagstaff J, Gauler TC, Ueda T, Zhao H, Waxman IM, Motzer RJ; CheckMate 025 investigators. CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma. Eur Urol. 2017 Dec;72(6):962-971. doi: 10.1016/j.eururo.2017.02.010. Epub 2017 Mar 3. Erratum in: Eur Urol. 2018 Jan 3;:.

ReferenceCitation: Cella D, Grünwald V, Nathan P, Doan J, Dastani H, Taylor F, Bennett B, DeRosa M, Berry S, Broglio K, Berghorn E, Motzer RJ. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):994-1003. doi: 10.1016/S1470-2045(16)30125-5. Epub 2016 Jun 6. Erratum in: Lancet Oncol. 2016 Jul;17 (7):e270.

ReferenceCitation: Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, Tykodi SS, Sosman JA, Procopio G, Plimack ER, Castellano D, Choueiri TK, Gurney H, Donskov F, Bono P, Wagstaff J, Gauler TC, Ueda T, Tomita Y, Schutz FA, Kollmannsberger C, Larkin J, Ravaud A, Simon JS, Xu LA, Waxman IM, Sharma P; CheckMate 025 Investigators. Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1803-13. doi: 10.1056/NEJMoa1510665. Epub 2015 Sep 25.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Norway
Sweden
Brazil
Canada
Germany
Denmark
Greece
Ireland
Finland
France

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Ucsf Helen Diller Family Comprehensive Cancer Center

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: University Of Iowa Hospitals And Clinics

location_facility: University Of Michigan Comprehensive Cancer Center

location_facility: Euromedica General Clinic of Thessaloniki

intervention_type: Biological