acronym: BERENICE

summary: This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.

ReferenceCitation: Swain SM, Ewer MS, Viale G, Delaloge S, Ferrero JM, Verrill M, Colomer R, Vieira C, Werner TL, Douthwaite H, Bradley D, Waldron-Lynch M, Kiermaier A, Eng-Wong J, Dang C; BERENICE Study Group. Pertuzumab, trastuzumab, and standard anthracycline- and taxane-based chemotherapy for the neoadjuvant treatment of patients with HER2-positive localized breast cancer (BERENICE): a phase II, open-label, multicenter, multinational cardiac safety study. Ann Oncol. 2018 Mar 1;29(3):646-653. doi: 10.1093/annonc/mdx773.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

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

repository_normalized: dnet

repositories:
PubMed Central
air.unimi.it
dnet

repositories_concat: PubMed Central;air.unimi.it;dnet

location_facility: Washington Cancer Institute at MedStar Washington Hospital Center.

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Oslo universitetssykehus HF, Ullevål, Kreftsenteret

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Allina Health, Virginia Piper Cancer Institute

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

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

location_facility: Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Haukeland Universitetssjukehus; Klinisk forskningspost

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

location_facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

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

location_facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: University of South Alabama; Mitchell Cancer Institute

location_facility: Royal Marsden Hospital - Fulham; Oncology Department

location_facility: Asl Le-Ospedale "Vito Fazzi";U.O. Oncologia

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

location_facility: Ospedale Santa Maria Annunziata; Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Centre D'Oncologie de Gentilly; Oncology

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

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

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Hospital Universitario de la Princesa; Servicio de Oncologia

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Guys & St Thomas Hospital; Department of Oncology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centre Oscar Lambret; Cancerologie Gynecologique

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Peterborough City Hospital, Edith Cavell Campus; Oncology Department

location_facility: Royal United Hospital; Oncology Department

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: University of Utah; Huntsman Cancer Hospital

location_facility: Mount Sinai Beth Israel Comprehensive Cancer Center

location_facility: Regional Cancer Care Associates LLC - Morristown

location_facility: MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

location_facility: Centro Clinico Champalimaud; Oncologia Medica

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

location_facility: Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica

location_facility: Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

title: A Multicenter, Multinational, Phase II Study to Evaluate Perjeta in Combination With Herceptin and Standard Neoadjuvant Anthracycline-Based Chemotherapy in Patients With HER2-Positive, Locally Advanced, Inflammatory, or Early-Stage Breast Cancer

design_allocation: Non-Randomized

location_country:
Germany
Italy
Poland
Portugal
Norway
United Kingdom
Denmark
Mexico
United States
Spain
Canada
France


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Hoffmann-La Roche

summary:
This is a randomized, multicenter, open-label, two-arm study in treatment-naive participants with operable, locally advanced, or inflammatory, centrally-assessed HER2-positive early breast cancer (EBC) whose primary tumors were greater than or equal to (>/=) 2 centimeters (cm). The study was designed to evaluate the efficacy and safety of trastuzumab emtansine + pertuzumab (experimental arm; T-DM1 + P) versus chemotherapy, trastuzumab + pertuzumab (control arm; TCH + P). The study comprised a neoadjuvant treatment period, followed by surgery, and an adjuvant treatment period.

Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination.

ReferenceType: derived

ReferenceCitation: Hurvitz SA, Martin M, Jung KH, Huang CS, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Fasching PA, Afenjar K, Spera G, Lopez-Valverde V, Song C, Trask P, Boulet T, Sparano JA, Symmans WF, Thompson AM, Slamon D. Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study. J Clin Oncol. 2019 Sep 1;37(25):2206-2216. doi: 10.1200/JCO.19.00882. Epub 2019 Jun 3.

oa_colors: green hybrid

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license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

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

repository_institution: University of California - eScholarship University of California

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
LIRIAS (KU Leuven)
PubMed Central
escholarship.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;escholarship.org

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Beckmann MW, Afenjar K, Fresco R, Helms HJ, Xu J, Lin YG, Sparano J, Slamon D. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):115-126. doi: 10.1016/S1470-2045(17)30716-7. Epub 2017 Nov 23.

oa_host_type: publisher

evidence: open (via crossref license, author manuscript)

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license_normalized: publisher-specific

version: acceptedVersion

repositories_concat: closed

publisher_dissemination: Elsevier

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr

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

location_facility: CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY

location_facility: Hospital Universitari de Lleida Arnau de Vilanova

location_facility: Comprehensive Cancer Centers of Nevada - Henderson

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: S.I. Russian Oncological Research Center n.a. N.N. Blokhin

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

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

location_facility: Railway Clinical Hospital on Saratov - 2 Station Oao "Rzhd"

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

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Saint-Petersburg City Clinical Oncology Dispensary

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Regional Oncology Hospital Of Kursk; Chemotherapy

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Roper Bon Secours St. Francis Cancer Center

location_facility: Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Hospital Nuestra Señora de Sonsoles; servicio de Oncologia

status: Completed

title: A Randomized, Multicenter, Open-Label, Two-Arm, Phase III Neoadjuvant Study Evaluating Trastuzumab Emtansine Plus Pertuzumab Compared With Chemotherapy Plus Trastuzumab and Pertuzumab for Patients With HER2-Positive Breast Cancer

primary_purpose: Treatment

type: Other Identifier

type: EudraCT Number

source: euctr

enrollment_type: Actual

design_allocation: Randomized

study_completion_date_type: Actual

location_country:
Germany
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Ukraine
Russian Federation
France

study_type: Interventional

lead_sponsor_type: industriel

status_simplified: Completed


lead_sponsor: Pfizer

summary: Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

ReferenceCitation: Brummendorf TH, Cortes JE, Milojkovic D, Gambacorti-Passerini C, Clark RE, le Coutre P, Garcia-Gutierrez V, Chuah C, Kota V, Lipton JH, Rousselot P, Mauro MJ, Hochhaus A, Hurtado Monroy R, Leip E, Purcell S, Yver A, Viqueira A, Deininger MW; BFORE study investigators. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial. Leukemia. 2022 Jul;36(7):1825-1833. doi: 10.1038/s41375-022-01589-y. Epub 2022 May 28.

evidence: open (via crossref license)

license: cc-by

license_normalized: cc-by

repositories_concat: PubMed Central

publisher_dissemination: Springer-Nature

ReferenceCitation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

oa_host_type: closed

ReferenceCitation: Chuah C, Koh LP, Numbenjapon T, Zang DY, Ong KH, Do YR, Ohkura M, Ono C, Viqueira A, Cortes JE, Brummendorf TH. Efficacy and safety of bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia in the Asian subpopulation of the phase 3 BFORE trial. Int J Hematol. 2021 Jul;114(1):65-78. doi: 10.1007/s12185-021-03144-4. Epub 2021 Apr 13.

ReferenceCitation: Cortes JE, Gambacorti-Passerini C, Deininger MW, Mauro MJ, Chuah C, Kim DW, Dyagil I, Glushko N, Milojkovic D, le Coutre P, Garcia-Gutierrez V, Reilly L, Jeynes-Ellis A, Leip E, Bardy-Bouxin N, Hochhaus A, Brummendorf TH. Bosutinib Versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia: Results From the Randomized BFORE Trial. J Clin Oncol. 2018 Jan 20;36(3):231-237. doi: 10.1200/JCO.2017.74.7162. Epub 2017 Nov 1.

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

repositories:
PubMed Central
dnet
pdfs.semanticscholar.org

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

location_facility: Universitätsklinikum Jena, Klinik für Innere Medizin II

location_facility: Unità di Ricerca Clinica, U.O. Ematologia Adulti

location_facility: Hematology Div. Davidoff Cancer Center, Rabin Medical Center

location_facility: private Practice of Pr Philippe Rousselot

location_facility: Department of Medical Oncology, University of Pretoria and Steve Biko

location_facility: Saint Alphonsus Regional Medical Center, Cancer Care Center

location_facility: Szegedi Tudományegyetem, AOK, Szent-Györgyi Albert Klinikai Központ, II. sz.

location_facility: State Institution "National research center for radiation medicine of NAMS of Ukraine",

location_facility: Catherine Lewis Centre, Hammersmith Hospital

location_facility: Schwerpunktpraxis für Hämatologie und Onkologie

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Hematologii

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

location_facility: SPSK, Klinika Hematoonkologii i Transplantacji Szpiku w Lublinie

location_facility: Cancer & Haematology Centre, Churchill Hospital

location_facility: Regional Clinical Hospital in Ivano-Frankivsk, Hematology Department

location_facility: Samodzielny Publiczny Szpital Kliniczny im. A Mielęckiego, ŚUM w Katowicach

location_facility: Universytet Medyczny im. Piastów Śląskich we Wrocławiu Katedra i

location_facility: Debreceni Egyetem Klinikai Központ, Belgyógyászati Inézet Hematológiai Tanszék

location_facility: USC Ematologia, A. O. Papa Giovanni XXIII

location_facility: MI "Cherkasy Regional Oncological Dispensary " of Cherkasy Regional Council

location_facility: Charité, CVK, Med. Klinik m.S Hämatologie und Onkologie

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: PHARMACY Department Franciscan St. Francis Health ATTN:Jill Leslie, Pharm D

location_facility: Hematology Department, Rambam Medical Centre

location_facility: University of Rochester Investigational Drug Pharmacy

location_facility: A.O.U. Policlinico Università degli Studi di Napoli "Federico II"

location_facility: Hospital (Universitari(o)) Germans Trias i Pujol

location_facility: St George Hospital - Hematology Department

location_facility: transplantation department of hemotology and transplantology division within Clinical Radiology

location_facility: Wojewódzki Szpital Specjalistyczny im M. Kopernika, Klinika Hematologii Uniwersytetu Medycznego

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

location_facility: St. John Hospital&Medical Center-Van Elslander Cancer Center

location_facility: Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum

location_facility: North Mississippi Medical Center Hematology and Oncology Clinic

location_facility: Institut de Cancérologie du Gard - Hématologie Clinique

location_facility: State Institution "Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine"

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi, Géza Kórház-Rendelőintézet

location_facility: St. Joseph Mercy Hospital - Inpatient Pharmacy

location_facility: Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne

location_facility: MUSC University of South Carolina, Investigational Drug Services

location_facility: Department of Haematology at UZ Leuven (7 th Floor)

location_facility: Petz Aladár Megyei OktatóKórház, II. Belgyógyászati Osztály és Haematológiai Részleg

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Mary's Hospital Medical Center

location_facility: Horizon Health Network - The Moncton Hospital

location_facility: Cancer Center of Acadiana at Lafayette General Medical Center

location_facility: Department of Haematology The Royal Hallamshire Hospital

location_facility: Khmelnytskyi Regional Hospital, Hematology Department

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

location_facility: National University Hospital, Main Building

location_facility: IRCCS - AOU San Martino_IST, Ematologia 1

location_facility: Univerzitná Nemocnica Bratislava-Nemocnica sv. Cyrila a Metoda

location_facility: Hospital Angeles del Pedregal (S.A. de C.V.)

location_facility: Haukeland University Hospital Department of Hematology

location_facility: Saint Alphonsus Caldwell Cancer Care Center

location_facility: private Practice of Dr. Viviane Dubruille

location_facility: NYU Winthrop Hospital - Pharmacy Department

location_facility: John H. Stroger, Jr. Hospital of Cook County

location_facility: NYU Winthrop Hospital - Oncology / Hematology department

location_facility: Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele" - P.O. G. Rodolico

location_facility: Pr Mauricette Michallet Centre Hospitalier Lyon Sud

location_facility: HSHS St. Vincent Hospital Regional Cancer Center at HSHS St. Vincent Hospital

location_facility: Universitätsklinikum Freiburg, Klinik für Innere Medizin I

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Division of Hematology, Department of Internal Medicine, Maharaj Nakorn Chiang Mai Hospital

location_facility: SPZOZ ZSM w Chorzowie Oddzial Hematologiczny

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Winship Cancer Institute, Emory University

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Division of Hematology, Department of Medicine, Faculty of Medicine Siriraj Hospital

location_facility: University of Massachusetts Memorial Medical Center, ONC/Research Pharmacy

location_facility: Froedtert Hospital and the Medical College of Wisconsin

title: A MULTICENTER PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN ADULT PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOGENOUS LEUKEMIA

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

location_country:
Finland
Germany
Poland
Australia
Thailand
Czechia
Canada
France
Slovakia
Hungary
Denmark
United States
Ukraine
Belgium
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Israel

ipd_sharing: Yes


title: A Phase IIb Study Evaluating a Long-Acting Intramuscular Regimen of GSK1265744 Plus TMC278 For The Maintenance of Virologic Suppression Following an Induction of Virologic Suppression on an Oral Regimen of GSK1265744 Plus Abacavir/Lamivudine in HIV-1 Infected, Antiretroviral Therapy-Naive Adult Subjects

summary:
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278.

The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA.

The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.

ReferenceType: background

ReferenceCitation: Kerrigan D, Mantsios A, Gorgolas M, Montes ML, Pulido F, Brinson C, deVente J, Richmond GJ, Beckham SW, Hammond P, Margolis D, Murray M. Experiences with long acting injectable ART: A qualitative study among PLHIV participating in a Phase II study of cabotegravir + rilpivirine (LATTE-2) in the United States and Spain. PLoS One. 2018 Jan 5;13(1):e0190487. doi: 10.1371/journal.pone.0190487. eCollection 2018.

ReferenceCitation: Smith GHR, Henry WK, Podzamczer D, Masia MDM, Bettacchi CJ, Arasteh K, Jaeger H, Khuong-Josses MA, Montes-Ramirez ML, Stellbrink HJ, Yazdanpanah Y, Richmond GJ, Sutton KC, Zhang F, McCoig CC, St Clair MH, Vandermeulen K, Van Solingen-Ristea R, Smith KY, Margolis DA, Spreen WR. Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study. Open Forum Infect Dis. 2021 Aug 25;8(9):ofab439. doi: 10.1093/ofid/ofab439. eCollection 2021 Sep.

oa_colors: green gold

evidence: oa journal (via doaj)

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repositories_concat: PubMed Central;diposit.ub.edu

unpaywall_oa_status: gold

publisher_dissemination: Oxford University Press

ReferenceCitation: Letendre SL, Mills A, Hagins D, Swindells S, Felizarta F, Devente J, Bettacchi C, Lou Y, Ford S, Sutton K, Shaik JS, Crauwels H, D'Amico R, Patel P. Pharmacokinetics and antiviral activity of cabotegravir and rilpivirine in cerebrospinal fluid following long-acting injectable administration in HIV-infected adults. J Antimicrob Chemother. 2020 Mar 1;75(3):648-655. doi: 10.1093/jac/dkz504.

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ReferenceCitation: Murray M, Pulido F, Mills A, Ramgopal M, LeBlanc R, Jaeger H, Canon V, Dorey D, Griffith S, Mrus J, Spreen W, Margolis D. Patient-reported tolerability and acceptability of cabotegravir + rilpivirine long-acting injections for the treatment of HIV-1 infection: 96-week results from the randomized LATTE-2 study. HIV Res Clin Pract. 2019 Aug-Oct;20(4-5):111-122. doi: 10.1080/25787489.2019.1661696. Epub 2019 Sep 18.

publisher_dissemination: Informa

ReferenceCitation: Margolis DA, Gonzalez-Garcia J, Stellbrink HJ, Eron JJ, Yazdanpanah Y, Podzamczer D, Lutz T, Angel JB, Richmond GJ, Clotet B, Gutierrez F, Sloan L, Clair MS, Murray M, Ford SL, Mrus J, Patel P, Crauwels H, Griffith SK, Sutton KC, Dorey D, Smith KY, Williams PE, Spreen WR. Long-acting intramuscular cabotegravir and rilpivirine in adults with HIV-1 infection (LATTE-2): 96-week results of a randomised, open-label, phase 2b, non-inferiority trial. Lancet. 2017 Sep 23;390(10101):1499-1510. doi: 10.1016/S0140-6736(17)31917-7. Epub 2017 Jul 24.

oa_host_type: repository

repository_institution: University of North Carolina at Chapel Hill - Carolina Digital Repository

unpaywall_oa_status: green

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

lead_sponsor: ViiV Healthcare

collaborators:
Janssen Pharmaceuticals
GlaxoSmithKline

sponsor_collaborators:
ViiV Healthcare
Janssen Pharmaceuticals
GlaxoSmithKline

location_country:
Germany
United States
Spain
Canada
France


title: Stryker Neurovascular Trevo® Retriever Registry

summary: The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Nogueira RG, Haussen DC, Liebeskind D, Jovin TG, Gupta R, Jadhav A, Budzik RF, Baxter B, Krajina A, Bonafe A, Malek A, Narata AP, Shields R, Zhang Y, Morgan P, Bartolini B, English J, Frankel MR, Veznedaroglu E; Trevo Registry and DAWN Trial Investigators. Stroke Imaging Selection Modality and Endovascular Therapy Outcomes in the Early and Extended Time Windows. Stroke. 2021 Jan;52(2):491-497. doi: 10.1161/STROKEAHA.120.031685. Epub 2021 Jan 12.

evidence: open (via free pdf)

unpaywall_oa_status: bronze

publisher_dissemination: Wolters Kluwer Health

lead_sponsor: Stryker Neurovascular

location_country:
Germany
Italy
Hungary
Singapore
Switzerland
United States
Korea, Republic of
Spain
Thailand
Czechia
Canada
France

location_facility: National Institute of Clinical Neurosciences

location_facility: Good Samaritan Hospital Regional Medical Center

location_facility: La Fondation Ophtalmologique Adolphe de Rothschild

location_facility: Emory University at Grady Memorial Hospital

location_facility: Center for Advanced Research Excellence (St. Mary's Medical Center)

location_facility: Oregon Stroke Center, Oregon Health & Science University (OHSU)

location_facility: Hospital Universitario Central De Asturias

location_facility: Seoul National University Bundang Hospital

location_facility: Riverside Methodist Hospital/ Ohio Health Research Institute

location_facility: Methodist Healthcare - Memphis Hospitals

location_facility: Peoria Radiology Research & Education Foundation

location_facility: Yale University / Yale-New Haven Hospital

location_facility: University of Tennessee Medical Center Knoxville

location_facility: St. Joseph's Hospital and Medical Center - Dignity Health (BNI Phoenix)

location_facility: California Pacific Medical Center (CPMC)


title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil

acronym: STARBEAM

summary: To establish efficacy of Idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

ReferenceCitation: Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019.

publisher_dissemination: Wiley

ReferenceCitation: Cummings JL, Atri A, Ballard C, Boneva N, Frolich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2.

repository_institution: Heidelberg University - heiDOK - The Heidelberg Document Repository

ReferenceCitation: Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.

oa_colors: green other

publisher_dissemination: American Medical Association

lead_sponsor: H. Lundbeck A/S

sponsor_collaborators:
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.

location_country:
Finland
Ireland
Poland
Argentina
Brazil
Croatia
Czechia
Canada
France
Lithuania
Portugal
Hungary
United States
Estonia
Italy
United Kingdom
Korea, Republic of
Taiwan
Israel


acronym: FIDELIO-DKD

lead_sponsor: Bayer

summary: The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

ReferenceCitation: Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Nowack C, Kolkhof P, Ferreira AC, Schloemer P, Filippatos G; on behalf of the FIDELIO-DKD study investigators; FIDELIO-DKD study investigators. Design and Baseline Characteristics of the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease Trial. Am J Nephrol. 2019;50(5):333-344. doi: 10.1159/000503713. Epub 2019 Oct 25.

ReferenceType: result

ReferenceCitation: Bakris GL, Agarwal R, Anker SD, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Nowack C, Schloemer P, Joseph A, Filippatos G; FIDELIO-DKD Investigators. Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes. N Engl J Med. 2020 Dec 3;383(23):2219-2229. doi: 10.1056/NEJMoa2025845. Epub 2020 Oct 23.

evidence: open (via free article)

license: public-domain

license_normalized: public-domain

repositories_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

publisher_dissemination: Massachusetts Medical Society

ReferenceCitation: Filippatos G, Anker SD, Agarwal R, Pitt B, Ruilope LM, Rossing P, Kolkhof P, Schloemer P, Tornus I, Joseph A, Bakris GL; FIDELIO-DKD Investigators. Finerenone and Cardiovascular Outcomes in Patients With Chronic Kidney Disease and Type 2 Diabetes. Circulation. 2021 Feb 9;143(6):540-552. doi: 10.1161/CIRCULATIONAHA.120.051898. Epub 2020 Nov 16.

ReferenceCitation: Pitt B, Agarwal R, Anker SD, Ruilope LM, Rossing P, Ahlers C, Brinker M, Joseph A, Lambelet M, Lawatscheck R, Filippatos GS; FIDELIO-DKD and FIGARO-DKD Investigators. Association of Finerenone Use With Reduction in Treatment-Emergent Pneumonia and COVID-19 Adverse Events Among Patients With Type 2 Diabetes and Chronic Kidney Disease: A FIDELITY Pooled Secondary Analysis. JAMA Netw Open. 2022 Oct 3;5(10):e2236123. doi: 10.1001/jamanetworkopen.2022.36123.

ReferenceCitation: Ruilope LM, Agarwal R, Anker SD, Filippatos G, Pitt B, Rossing P, Sarafidis P, Schmieder RE, Joseph A, Rethemeier N, Nowack C, Bakris GL; FIDELIO-DKD Investigators. Blood Pressure and Cardiorenal Outcomes With Finerenone in Chronic Kidney Disease in Type 2 Diabetes. Hypertension. 2022 Dec;79(12):2685-2695. doi: 10.1161/HYPERTENSIONAHA.122.19744. Epub 2022 Oct 12.

ReferenceCitation: Rossing P, Burgess E, Agarwal R, Anker SD, Filippatos G, Pitt B, Ruilope LM, Gillard P, MacIsaac RJ, Wainstein J, Joseph A, Brinker M, Roessig L, Scott C, Bakris GL; FIDELIO-DKD Investigators. Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study. Diabetes Care. 2022 Apr 1;45(4):888-897. doi: 10.2337/dc21-1944. Erratum In: Diabetes Care. 2023 Sep 1;46(9):1721.

evidence: oa repository (via page says license)

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

publisher_dissemination: American Diabetes Association

ReferenceCitation: Rossing P, Filippatos G, Agarwal R, Anker SD, Pitt B, Ruilope LM, Chan JCN, Kooy A, McCafferty K, Schernthaner G, Wanner C, Joseph A, Scheerer MF, Scott C, Bakris GL; FIDELIO-DKD Investigators. Finerenone in Predominantly Advanced CKD and Type 2 Diabetes With or Without Sodium-Glucose Cotransporter-2 Inhibitor Therapy. Kidney Int Rep. 2021 Oct 14;7(1):36-45. doi: 10.1016/j.ekir.2021.10.008. eCollection 2022 Jan.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

ReferenceCitation: Agarwal R, Anker SD, Filippatos G, Pitt B, Rossing P, Ruilope LM, Boletis J, Toto R, Umpierrez GE, Wanner C, Wada T, Scott C, Joseph A, Ogbaa I, Roberts L, Scheerer MF, Bakris GL. Effects of canagliflozin versus finerenone on cardiorenal outcomes: exploratory post hoc analyses from FIDELIO-DKD compared to reported CREDENCE results. Nephrol Dial Transplant. 2022 Jun 23;37(7):1261-1269. doi: 10.1093/ndt/gfab336.

ReferenceCitation: Filippatos G, Bakris GL, Pitt B, Agarwal R, Rossing P, Ruilope LM, Butler J, Lam CSP, Kolkhof P, Roberts L, Tasto C, Joseph A, Anker SD; FIDELIO-DKD Investigators. Finerenone Reduces New-Onset Atrial Fibrillation in Patients With Chronic Kidney Disease and Type 2 Diabetes. J Am Coll Cardiol. 2021 Jul 13;78(2):142-152. doi: 10.1016/j.jacc.2021.04.079. Epub 2021 May 17.

ReferenceCitation: Erraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish.

ReferenceCitation: Agarwal R, Anker SD, Bakris G, Filippatos G, Pitt B, Rossing P, Ruilope L, Gebel M, Kolkhof P, Nowack C, Joseph A; FIDELIO-DKD and FIGARO-DKD Investigators. Investigating new treatment opportunities for patients with chronic kidney disease in type 2 diabetes: the role of finerenone. Nephrol Dial Transplant. 2022 May 25;37(6):1014-1023. doi: 10.1093/ndt/gfaa294.

repository_institution: Universidad Europea - ABACUS. Repositorio de Producción Científica

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

location_country:
Finland
Germany
Ireland
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Thailand
Vietnam
Turkey
Chile
Czechia
Canada
France
Lithuania
Colombia
Portugal
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
China
Malaysia
Puerto Rico
Philippines
Italy
Norway
Singapore
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


title: POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)

acronym: CONNECT-IBD

summary:
This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:

To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade
To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade
To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade

ipd_sharing: No

collaborators: Hospira, now a wholly owned subsidiary of Pfizer

location_country:
Germany
Finland
Italy
Portugal
Slovakia
Hungary
United Kingdom
Netherlands
Belgium
Spain
Greece
Czechia
France

location_facility: V. interna klinika LFUK a UNB, Ambulancia pre nespecificke zapalove ochorenia

location_facility: Internistische Gemeinschaftspraxis fuer Verdauungs- und Stoffwechselerkrankungen

location_facility: Azienda Ospedaliera Universitaria di PISA

location_facility: Gemeinschaftspraxis Dr. R Denger und Dr. T. Pfitzner

location_facility: A.O.U. "S. Maria della Misericordia di Udine"

location_facility: Azienda Ospedaliera - Universitaria di Modena Policlinico

location_facility: Centrum péce o zažívací trakt, Vítkovická nemocnice

location_facility: Centro Hospitalar Lisboa Norte, E.P.E.- Hospital Santa Maria

location_facility: Università degli Studi "G. d'Annunzio" Chieti - Pescara

location_facility: Magen-Darm Praxis Prof. Dr. Krammer & Kollegen

location_facility: Ospedale Generale Provinciale di Macerata

location_facility: Az.Osp. Ospedali Riuniti 'Villa Sofia-Cervello

location_facility: Internisten am Markt Dres. Schwerdtfeger & Lehmann

location_facility: IKEM (Institut Klinické a Experimentální Medicíny)

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Gastroenterologische Gemeinschaftspraxis am Germania-Campus

location_facility: ASUR Area Vasta n. 4 - Ospedale A. Murri

location_facility: Hospital Universitari de Girona Dr. Josep Trueta

location_facility: Hamburgisches Forschungsinstitut fur chronisch entzuendliche

location_facility: Azienda Ospedaliera per l'Emergenza Cannizzaro

location_facility: Hospital Universitario de Gran Canaria DR NEGRIN

location_facility: General Hospital of Thessaloniki Ippokrateio

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Medizinisches Versorgungszentrum Portal 10

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Centro Hospitalar Barreiro Montijo, E.P.E

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Hôpital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie

location_facility: Szte szent-gyorgyi albert klinikai kozpont

location_facility: Azienda Ospedaliero Universitaria - Policlinico "Vittorio Emanuele"

location_facility: Groupe hospitalier mutualiste les portes du Sud

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Interdisciplinaeres Crohn-Colitis Centrum Rhein-Main

location_facility: Onco Studies an der Onkologie Dreiländereck

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Hradecká Poliklinika III, HEPATO-GASTROENTEROLOGIE HK, s.r.o

location_facility: Gloucestershire Hospitals - NHS Foundation Trust

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Hospital Prof. Doutor Fernando Fonseca E.P.E

location_facility: Zentrum für Gastroenterologie Saarbrücken MVZ GmbH

location_facility: Fondazione Poliambulanza - Istituto Ospedaliero

location_facility: Centro Hospitalar entre Douro e Vouga E.P.E.

location_facility: Consorci Hospital General Universitari de Valencia

location_facility: Gastroenterologische Praxis Dr. med. B. Adami


summary:
Medtronic is sponsoring the Micra Registry to further confirm safety and effectiveness of the Micra Transcatheter Pacing System (Micra system) when used as intended, in "real-world" clinical practice, following commercial release.

The Micra Registry is conducted within Medtronic's Product Surveillance Registry.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Piccini JP, Cunnane R, Steffel J, El-Chami MF, Reynolds D, Roberts PR, Soejima K, Steinwender C, Garweg C, Chinitz L, Ellis CR, Stromberg K, Fagan DH, Mont L. Development and validation of a risk score for predicting pericardial effusion in patients undergoing leadless pacemaker implantation: experience with the Micra transcatheter pacemaker. Europace. 2022 Jul 21;24(7):1119-1126. doi: 10.1093/europace/euab315.

repositories:
LIRIAS (KU Leuven)
PubMed Central

repositories_concat: LIRIAS (KU Leuven);PubMed Central

ReferenceCitation: El-Chami MF, Garweg C, Iacopino S, Al-Samadi F, Martinez-Sande JL, Tondo C, Johansen JB, Prat XV, Piccini JP, Cha YM, Grubman E, Bordachar P, Roberts PR, Soejima K, Stromberg K, Fagan DH, Clementy N. Leadless pacemaker implant, anticoagulation status, and outcomes: Results from the Micra Transcatheter Pacing System Post-Approval Registry. Heart Rhythm. 2022 Feb;19(2):228-234. doi: 10.1016/j.hrthm.2021.10.023. Epub 2021 Oct 29.

ReferenceCitation: El-Chami MF, Shinn T, Bansal S, Martinez-Sande JL, Clementy N, Augostini R, Ravindran B, Sagi V, Ramanna H, Garweg C, Roberts PR, Soejima K, Stromberg K, Fagan DH, Zuniga N, Piccini JP. Leadless pacemaker implant with concomitant atrioventricular node ablation: Experience with the Micra transcatheter pacemaker. J Cardiovasc Electrophysiol. 2021 Mar;32(3):832-841. doi: 10.1111/jce.14881. Epub 2021 Jan 23.

ReferenceCitation: Garg A, Koneru JN, Fagan DH, Stromberg K, Padala SK, El-Chami MF, Roberts PR, Piccini JP, Cheng A, Ellenbogen KA. Morbidity and mortality in patients precluded for transvenous pacemaker implantation: Experience with a leadless pacemaker. Heart Rhythm. 2020 Dec;17(12):2056-2063. doi: 10.1016/j.hrthm.2020.07.035. Epub 2020 Aug 4.

ReferenceCitation: El-Chami MF, Al-Samadi F, Clementy N, Garweg C, Martinez-Sande JL, Piccini JP, Iacopino S, Lloyd M, Vinolas Prat X, Jacobsen MD, Ritter P, Johansen JB, Tondo C, Liu F, Fagan DH, Eakley AK, Roberts PR. Updated performance of the Micra transcatheter pacemaker in the real-world setting: A comparison to the investigational study and a transvenous historical control. Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repositories_concat: LIRIAS (KU Leuven);Pure (Denmark);air.unimi.it;sdu.dk

repositories_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

lead_sponsor: Medtronic

location_country:
Germany
Poland
New Zealand
Japan
Kuwait
Czechia
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Iceland
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Saudi Arabia
Spain
Greece
Israel

intervention_type: Device

status_simplified: Ongoing


lead_sponsor: Aragon Pharmaceuticals, Inc.

summary: The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.

ReferenceCitation: Poterala JE, Wisinski KB. Abbreviated endocrine therapy duration for low estrogen receptor-positive breast cancer: The counter to extended endocrine therapy. Cancer. 2022 May 1;128(9):1724-1726. doi: 10.1002/cncr.34158. Epub 2022 Feb 25. No abstract available.

title: ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Czechia
Canada
France
United States
Ukraine
Romania
Belgium
China
Malaysia
United Kingdom
Sweden
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel


title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, PK, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications

summary: The main purpose of this Phase I study is to test MSB0011359C (M7824) at different dose levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means the study drug has not previously been given to humans or has only been given to a limited number of people, although it has been extensively studied in animals. Based on this information, it is hoped to find out which dose could be best for the treatment of patients. There are two parts of this research study: a dose-escalation part and an expansion part. Dose escalation means that the first people taking part in the study will receive low doses of the study drug, and as more people take part, the additional participants will receive a higher dose. This is done to find the safest dose for the study drug. Expansion means that after the dose-escalation part of the study has looked at the safety and effectiveness of different doses, many more people will be invited to take part in the study and will receive the study drug at the safest dose. Additional purposes of the study are to find out whether the study drug has anti-cancer effects and how the study drug is processed by the body.

ReferenceCitation: Strauss J, Gatti-Mays ME, Cho BC, Hill A, Salas S, McClay E, Redman JM, Sater HA, Donahue RN, Jochems C, Lamping E, Burmeister A, Marte JL, Cordes LM, Bilusic M, Karzai F, Ojalvo LS, Jehl G, Rolfe PA, Hinrichs CS, Madan RA, Schlom J, Gulley JL. Bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with human papillomavirus-associated malignancies. J Immunother Cancer. 2020 Dec;8(2):e001395. doi: 10.1136/jitc-2020-001395.

repository_institution: Yonsei University Medical Library - YUHSpace

repositories_concat: PubMed Central;ir.ymlib.yonsei.ac.kr

publisher_dissemination: British Medical Journal

ReferenceCitation: Cho BC, Daste A, Ravaud A, Salas S, Isambert N, McClay E, Awada A, Borel C, Ojalvo LS, Helwig C, Rolfe PA, Gulley JL, Penel N. Bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in advanced squamous cell carcinoma of the head and neck: results from a phase I cohort. J Immunother Cancer. 2020 Jul;8(2):e000664. doi: 10.1136/jitc-2020-000664. Erratum In: J Immunother Cancer. 2020 Oct;8(2):

ReferenceCitation: Wilkins JJ, Vugmeyster Y, Dussault I, Girard P, Khandelwal A. Population Pharmacokinetic Analysis of Bintrafusp Alfa in Different Cancer Types. Adv Ther. 2019 Sep;36(9):2414-2433. doi: 10.1007/s12325-019-01018-0. Epub 2019 Jul 5.

ReferenceCitation: Strauss J, Heery CR, Schlom J, Madan RA, Cao L, Kang Z, Lamping E, Marte JL, Donahue RN, Grenga I, Cordes L, Christensen O, Mahnke L, Helwig C, Gulley JL. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFbeta, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295. doi: 10.1158/1078-0432.CCR-17-2653. Epub 2018 Jan 3.

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Tan B, Khattak A, Felip E, Kelly K, Rich P, Wang D, Helwig C, Dussault I, Ojalvo LS, Isambert N. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-beta and PD-L1, in Patients with Esophageal Adenocarcinoma: Results from a Phase 1 Cohort. Target Oncol. 2021 Jul;16(4):435-446. doi: 10.1007/s11523-021-00809-2. Epub 2021 May 19.

ReferenceCitation: Vugmeyster Y, Grisic AM, Wilkins JJ, Loos AH, Hallwachs R, Osada M, Venkatakrishnan K, Khandelwal A. Model-informed approach for risk management of bleeding toxicities for bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1. Cancer Chemother Pharmacol. 2022 Oct;90(4):369-379. doi: 10.1007/s00280-022-04468-6. Epub 2022 Sep 6.

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Germany
Italy
United Kingdom
Australia
Japan
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris

location_facility: Greenville Hospital System University Medical Center (ITOR)

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Gallipoli Medical Research Foundation Ltd

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

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

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: GZA Ziekenhuizen - Campus Sint-Augustinus

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Institut Régional du Cancer de Montpellier

location_facility: University of North Carolina at Chapel Hill

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Penn State University Milton S. Hershey Medical Center

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Seoul National University Bundang Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: Peter MacCallum Cancer Centre-East Melbourne

location_facility: University of California Davis Health System

location_facility: Hematology - Oncology Associates of Treasure Coast

location_facility: South Texas Accelerated Research Therapeutics, LLC

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo


acronym: VOYAGER PAD

summary: The purpose of study was to test whether rivaroxaban added to standard of care treatment, when compared to placebo, had the potential to reduce the incidence of the clinical events related to the clots and complications of the heart and brain (CV death, MI, or stroke) or the legs (acute limb ischemia or major amputation) in patients who had undergone recent procedure(s) to improve the blood flow of their legs.

ReferenceCitation: Hess CN, Baumgartner I, Anand SS, Nehler MR, Patel MR, Debus ES, Szarek M, Capell W, Muehlhofer E, Berkowitz SD, Haskell LP, Bauersachs RM, Bonaca MP, Hsia J. Sex-Based Differences in Outcomes Following Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Heart Assoc. 2022 Jun 21;11(12):e024655. doi: 10.1161/JAHA.121.024655. Epub 2022 Jun 14.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repositories_concat: PubMed Central;boris.unibe.ch

ReferenceCitation: Hogan SE, Nehler MR, Anand S, Patel MR, Debus S, Jackson MT, Buchanan C, King RW, Hess C, Muehlhofer E, Haskell LP, Bauersachs RM, Berkowitz SD, Hsia J, Bonaca MP. Improvement in walking impairment following surgical and endovascular revascularization: Insights from VOYAGER PAD. Vasc Med. 2022 Aug;27(4):343-349. doi: 10.1177/1358863X221085606. Epub 2022 Apr 25.

publisher_dissemination: SAGE Publications

ReferenceCitation: Hess CN, Patel MR, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Fanelli F, Yeh RW, Secemsky EA, Beckman JA, Mauri L, Govsyeyev N, Capell WH, Brackin T, Berkowitz SD, Muehlhofer E, Haskell LP, Hiatt WR, Bonaca MP. Safety and Effectiveness of Paclitaxel Drug-Coated Devices in Peripheral Artery Revascularization: Insights From VOYAGER PAD. J Am Coll Cardiol. 2021 Nov 2;78(18):1768-1778. doi: 10.1016/j.jacc.2021.08.052.

ReferenceCitation: Debus ES, Nehler MR, Govsyeyev N, Bauersachs RM, Anand SS, Patel MR, Fanelli F, Capell WH, Brackin T, Hinterreiter F, Krievins D, Nault P, Piffaretti G, Svetlikov A, Jaeger N, Hess CN, Sillesen HH, Conte M, Mills J, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP. Effect of Rivaroxaban and Aspirin in Patients With Peripheral Artery Disease Undergoing Surgical Revascularization: Insights From the VOYAGER PAD Trial. Circulation. 2021 Oct 5;144(14):1104-1116. doi: 10.1161/CIRCULATIONAHA.121.054835. Epub 2021 Aug 12.

ReferenceCitation: Bauersachs RM, Szarek M, Brodmann M, Gudz I, Debus ES, Nehler MR, Anand SS, Patel MR, Hess CN, Capell WH, Rogers K, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR, Bonaca MP; VOYAGER PAD Committees and Investigators. Total Ischemic Event Reduction With Rivaroxaban After Peripheral Arterial Revascularization in the VOYAGER PAD Trial. J Am Coll Cardiol. 2021 Jul 27;78(4):317-326. doi: 10.1016/j.jacc.2021.05.003. Epub 2021 May 16.

ReferenceCitation: Hiatt WR, Bonaca MP, Patel MR, Nehler MR, Debus ES, Anand SS, Capell WH, Brackin T, Jaeger N, Hess CN, Pap AF, Berkowitz SD, Muehlhofer E, Haskell L, Brasil D, Madaric J, Sillesen H, Szalay D, Bauersachs R. Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety. Circulation. 2020 Dec 8;142(23):2219-2230. doi: 10.1161/CIRCULATIONAHA.120.050465. Epub 2020 Nov 3.

ReferenceCitation: Bonaca MP, Bauersachs RM, Anand SS, Debus ES, Nehler MR, Patel MR, Fanelli F, Capell WH, Diao L, Jaeger N, Hess CN, Pap AF, Kittelson JM, Gudz I, Matyas L, Krievins DK, Diaz R, Brodmann M, Muehlhofer E, Haskell LP, Berkowitz SD, Hiatt WR. Rivaroxaban in Peripheral Artery Disease after Revascularization. N Engl J Med. 2020 May 21;382(21):1994-2004. doi: 10.1056/NEJMoa2000052. Epub 2020 Mar 28.

ReferenceCitation: Capell WH, Bonaca MP, Nehler MR, Chen E, Kittelson JM, Anand SS, Berkowitz SD, Debus ES, Fanelli F, Haskell L, Patel MR, Bauersachs R, Hiatt WR. Rationale and design for the Vascular Outcomes study of ASA along with rivaroxaban in endovascular or surgical limb revascularization for peripheral artery disease (VOYAGER PAD). Am Heart J. 2018 May;199:83-91. doi: 10.1016/j.ahj.2018.01.011. Epub 2018 Feb 3.

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC
Colorado Prevention Center

title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Undergoing Lower Extremity Revascularization Procedures

primary_purpose: Prevention

location_country:
Finland
Germany
Poland
Argentina
Japan
Brazil
Thailand
Czechia
Canada
Serbia
France
Lithuania
Portugal
Slovakia
Hungary
Denmark
Switzerland
United States
Latvia
Ukraine
Romania
Belgium
China
Estonia
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Bulgaria
Russian Federation
Sweden


acronym: APPRISE

lead_sponsor: Sanofi

summary:
Primary Objective:

To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population.

Secondary Objectives:

To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment.

To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).

ReferenceCitation: Cefalu AB, Garbelotto R, Mombelli G, Pirro M, Rubba P, Arca M, Borghi C, Bonomo K, Gonnelli S, Massaroni K, Tirone G, Averna M; ODYSSEY APPRISE Study Italian Investigators. A subgroup analysis of the ODYSSEY APPRISE study: Safety and efficacy of alirocumab in the Italian cohort. Nutr Metab Cardiovasc Dis. 2022 Nov;32(11):2638-2646. doi: 10.1016/j.numecd.2022.07.020. Epub 2022 Aug 9.

repository_institution: Nova Science Publishers, Inc. - Nova Science Publishers

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_facility:
Investigational Site Number 250038
Investigational Site Number 250037
Investigational Site Number 724017
Investigational Site Number 250046
Investigational Site Number 250008
Investigational Site Number 276003
Investigational Site Number 756002
Investigational Site Number 056007
Investigational Site Number 703002
Investigational Site Number 724004
Investigational Site Number 642-002
Investigational Site Number 250036
Investigational Site Number 724008
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Investigational Site Number 124017
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Investigational Site Number 724001
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Investigational Site Number 250051
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Investigational Site Number 056013
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Investigational Site Number 056006
Investigational Site Number 348003
Investigational Site Number 756003
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Investigational Site Number 208002
Investigational Site Number 056004
Investigational Site Number 124024
Investigational Site Number 250049
Investigational Site Number 250013
Investigational Site Number 203005
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Investigational Site Number 250033
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Investigational Site Number 040003
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Investigational Site Number 250012
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Investigational Site Number 250050
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Investigational Site Number 056019
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Investigational Site Number 300001
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Investigational Site Number 246001
Investigational Site Number 250044
Investigational Site Number 056018
Investigational Site Number 724011
Investigational Site Number 724009
Investigational Site Number 705001
Investigational Site Number 040004
Investigational Site Number 724015
Investigational Site Number 250017
Investigational Site Number 124020
Investigational Site Number 724016
Investigational Site Number 056001

title: A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies

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: Finland Germany Poland Slovenia Slovakia Hungary Denmark Romania Switzerland Austria Belgium Spain Greece Czechia Canada France


title: A Randomized, Open-label, Active-controlled, 3-arm Parallel-group, 26-week Study Comparing the Efficacy and Safety of Lixisenatide to That of Insulin Glulisine Once Daily and Insulin Glulisine Three Times Daily in Patients With Type 2 Diabetes Insufficiently Controlled With Insulin Glargine With or Without Metformin

summary:
Primary Objective:

- To compare lixisenatide versus insulin glulisine in terms of glycosylated hemoglobin (HbA1c) reduction and body weight change at Week 26 in type 2 diabetic participants not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

- To compare the treatments/regimens on:

The percentage of participants reaching the target of HbA1c <7% or ≤6.5%,
Body weight,
Self-Monitored Glucose profiles,
Fasting Plasma Glucose (FPG),
Post-prandial plasma glucose (PPG) /glucose excursions during a standardized meal test (subset of participants),
Daily doses of insulins,
Safety and tolerability.

ReferenceCitation: Rosenstock J, Guerci B, Hanefeld M, Gentile S, Aronson R, Tinahones FJ, Roy-Duval C, Souhami E, Wardecki M, Ye J, Perfetti R, Heller S; GetGoal Duo-2 Trial Investigators. Prandial Options to Advance Basal Insulin Glargine Therapy: Testing Lixisenatide Plus Basal Insulin Versus Insulin Glulisine Either as Basal-Plus or Basal-Bolus in Type 2 Diabetes: The GetGoal Duo-2 Trial. Diabetes Care. 2016 Aug;39(8):1318-28. doi: 10.2337/dc16-0014. Epub 2016 May 23.

ReferenceCitation: Tabak AG, Anderson J, Aschner P, Liu M, Saremi A, Stella P, Tinahones FJ, Wysham C, Meier JJ. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther. 2020 Jan;11(1):305-318. doi: 10.1007/s13300-019-00735-7. Epub 2019 Dec 17.

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery
www.repositoriosalud.es

ReferenceCitation: Rosenstock J, Handelsman Y, Vidal J, Ampudia Blasco FJ, Giorgino F, Liu M, Perfetti R, Meier JJ. Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes. Diabetes Obes Metab. 2018 Dec;20(12):2821-2829. doi: 10.1111/dom.13462. Epub 2018 Aug 13.

repositories_concat: PubMed Central;ricerca.uniba.it

location_country:
France
Germany
Italy
Lithuania
Poland
Hungary
United Kingdom
Romania
Mexico
United States
Latvia
Spain
Chile
Ukraine
Canada
Estonia
Russian Federation
Czech Republic

location_facility:
Investigational Site Number 124016
Investigational Site Number 484109
Investigational Site Number 840028
Investigational Site Number 276109
Investigational Site Number 804105
Investigational Site Number 840012
Investigational Site Number 124021
Investigational Site Number 643106
Investigational Site Number 428105
Investigational Site Number 642114
Investigational Site Number 428104
Investigational Site Number 484105
Investigational Site Number 348108
Investigational Site Number 840029
Investigational Site Number 484103
Investigational Site Number 724105
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title: A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection

summary: The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

ReferenceCitation: Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.

repository_institution: PubMed Central - Europe PMC

repository_institution: Goethe University Frankfurt - Publication Server of Goethe University Frankfurt am Main

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

endpoint_id: fhisxppmrqpajgzqkvft

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

repository_institution: Università degli Studi di Brescia - Institutional Research Information System

lead_sponsor: Boehringer Ingelheim

location_country:
Germany
Ireland
Italy
Portugal
Hungary
United Kingdom
Romania
Netherlands
Austria
United States
Spain
Canada
Russian Federation
France

location_facility: 1241.20.49002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.40002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00033 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49014 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00024 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00032 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.40003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.43003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35302 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35104 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00017 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33009 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35101 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35103 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35105 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.36001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00018 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00014 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35303 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.40001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00012 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00019 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35102 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00022 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00020 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49011 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49012 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49009 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.36002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00013 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00026 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49013 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39003 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01010 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00015 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.70001 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00031 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.35301 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33002 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.34008 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.44004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.33005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.31006 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00016 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.01007 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.39005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00009 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00004 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.49005 Boehringer Ingelheim Investigational Site

location_facility: 1241.20.00008 Boehringer Ingelheim Investigational Site


title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects With Moderate to Severe Crohn's Disease

summary: The primary objective of this study is to evaluate the efficacy of abrilumab as measured by the proportion of participants achieving Crohn's Disease Activity Index (CDAI) remission (CDAI < 150) after treatment for 8 weeks.

ReferenceCitation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.

lead_sponsor: Amgen

location_country:
Germany
Hungary
United Kingdom
Denmark
Netherlands
Austria
Belgium
Switzerland
United States
Czechia
Canada
France

location_facility:
Research Site
Hospital


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Bevacizumab or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma

summary: This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Participants will be randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

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

location_facility: Ospedale Bellaria; U.O. Oncologia Medica

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie

location_facility: Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: University of Alabama At Birmingham; Neuro-Oncology

location_facility: Northshore University Health System; Cardiology

location_facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Cedars Sinai Medical Center; Neurosurgery

location_facility: Presidio Ospedaliero Marconi Bufalini; U.O. di Oncologia

location_facility: Centre Val Aurelle Paul Lamarque; Medecine B3

location_facility: Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727

location_facility: Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

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

location_facility: Universitätsspital Zürich; Klinik für Neurologie

location_facility: Seattle Cancer Care Alliance; Investigational Drug Service

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Nottingham City Hospital; David Evans Centre

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

location_facility: Hôpital Central; Departement de Neuro-Oncologie

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

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


title: A Phase III, Randomized, Double-blinded Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to Dabrafenib and Placebo as First-line Therapy in Subjects With Unresectable (Stage IIIC) or Metastatic (Stage IV) BRAF V600E/K Mutation-positive Cutaneous Melanoma

summary: This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

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.

repository_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Syeda MM, Wiggins JM, Corless BC, Long GV, Flaherty KT, Schadendorf D, Nathan PD, Robert C, Ribas A, Davies MA, Grob JJ, Gasal E, Squires M, Marker M, Garrett J, Brase JC, Polsky D. Circulating tumour DNA in patients with advanced melanoma treated with dabrafenib or dabrafenib plus trametinib: a clinical validation study. Lancet Oncol. 2021 Mar;22(3):370-380. doi: 10.1016/S1470-2045(20)30726-9. Epub 2021 Feb 12.

repository_institution: California Digital Library - eScholarship

ReferenceCitation: Robert C, Grob JJ, Stroyakovskiy D, Karaszewska B, Hauschild A, Levchenko E, Chiarion Sileni V, Schachter J, Garbe C, Bondarenko I, Gogas H, Mandala M, Haanen JBAG, Lebbe C, Mackiewicz A, Rutkowski P, Nathan PD, Ribas A, Davies MA, Flaherty KT, Burgess P, Tan M, Gasal E, Voi M, Schadendorf D, Long GV. Five-Year Outcomes with Dabrafenib plus Trametinib in Metastatic Melanoma. N Engl J Med. 2019 Aug 15;381(7):626-636. doi: 10.1056/NEJMoa1904059. Epub 2019 Jun 4.

ReferenceCitation: Long GV, Grob JJ, Nathan P, Ribas A, Robert C, Schadendorf D, Lane SR, Mak C, Legenne P, Flaherty KT, Davies MA. Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials. Lancet Oncol. 2016 Dec;17(12):1743-1754. doi: 10.1016/S1470-2045(16)30578-2. Epub 2016 Nov 16.

ReferenceCitation: Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, Garbe C, Jouary T, Hauschild A, Grob JJ, Chiarion-Sileni V, Lebbe C, Mandala M, Millward M, Arance A, Bondarenko I, Haanen JB, Hansson J, Utikal J, Ferraresi V, Kovalenko N, Mohr P, Probachai V, Schadendorf D, Nathan P, Robert C, Ribas A, DeMarini DJ, Irani JG, Swann S, Legos JJ, Jin F, Mookerjee B, Flaherty K. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015 Aug 1;386(9992):444-51. doi: 10.1016/S0140-6736(15)60898-4. Epub 2015 May 31.

ReferenceCitation: Schadendorf D, Amonkar MM, Stroyakovskiy D, Levchenko E, Gogas H, de Braud F, Grob JJ, Bondarenko I, Garbe C, Lebbe C, Larkin J, Chiarion-Sileni V, Millward M, Arance A, Mandala M, Flaherty KT, Nathan P, Ribas A, Robert C, Casey M, DeMarini DJ, Irani JG, Aktan G, Long GV. Health-related quality of life impact in a randomised phase III study of the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600 metastatic melanoma. Eur J Cancer. 2015 May;51(7):833-40. doi: 10.1016/j.ejca.2015.03.004. Epub 2015 Mar 17.

ReferenceCitation: Menzies AM, Ashworth MT, Swann S, Kefford RF, Flaherty K, Weber J, Infante JR, Kim KB, Gonzalez R, Hamid O, Schuchter L, Cebon J, Sosman JA, Little S, Sun P, Aktan G, Ouellet D, Jin F, Long GV, Daud A. Characteristics of pyrexia in BRAFV600E/K metastatic melanoma patients treated with combined dabrafenib and trametinib in a phase I/II clinical trial. Ann Oncol. 2015 Feb;26(2):415-21. doi: 10.1093/annonc/mdu529. Epub 2014 Nov 18.

ReferenceCitation: Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, Garbe C, Jouary T, Hauschild A, Grob JJ, Chiarion Sileni V, Lebbe C, Mandala M, Millward M, Arance A, Bondarenko I, Haanen JB, Hansson J, Utikal J, Ferraresi V, Kovalenko N, Mohr P, Probachai V, Schadendorf D, Nathan P, Robert C, Ribas A, DeMarini DJ, Irani JG, Casey M, Ouellet D, Martin AM, Le N, Patel K, Flaherty K. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med. 2014 Nov 13;371(20):1877-88. doi: 10.1056/NEJMoa1406037. Epub 2014 Sep 29.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
Sweden
Netherlands
United States
Spain
Greece
Canada
Ukraine
Russian Federation
France