title: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

summary: The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.

status: Enrolling by invitation

location_country:
Greece
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Netherlands
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Czechia
Israel
Spain
Turkey

location_facility: Oaxaca Site Management Organization S.C.

location_facility: University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: St Bartholomew's Hospital - Dept of Haematology

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

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

location_facility: HOPITAL SAINT LOUIS - Hematology / Oncology

location_facility: The First Affliated Hospital of Soochow University

location_facility: University College London Hospitals NHSFT

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Federal Center of Heart, Blood and Endocrinology

location_facility: Karmanos Cancer Institute - Wayne State University

location_facility: University of California San Diego Medical Center

location_facility: Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany

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

location_facility: Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

location_facility: Semmelweis Egyetem, I. Belgyogyaszati Klinika

location_facility: Hospital Clinico Universitario Salamanca

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: The Ohio State University- James Cancer Hospital

location_facility: State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine

location_facility: Khmelnitskiy Regional Hospital, Hematology Department

location_facility: University of Michigan Comprehensive Cancer Center

location_facility: Fundacion Oftalmologica de Santander - FOSCAL

location_facility: Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus

location_facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

location_facility: Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

location_facility: Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika

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

location_facility: Hopital Haut Leveque Service Maladie Du Sang

location_facility: Sahlgrenska University hospital, Hematology Dept

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: University of Pennsylvania Medical Center

location_facility: Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika

location_facility: DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA''

location_facility: Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

location_facility: Universitätsklinikum Heidelberg Med. Klinik IV

location_facility: Louisville Oncology Suburban - Norton Cancer Institute

location_facility: University Hospitals Birmingham NHS Trust,

location_facility: Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

location_facility: 'G. Papanikolaou' Hospital of Thessaloniki

location_facility: Weill Medical College of Cornell University

location_facility: SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine

location_facility: Universitätsklinikum Essen; Klinik f. Hämatologie- Germany

location_facility: Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku

location_facility: Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine

location_facility: Laiko General Hospital - 1st department of Internal Medicine

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany

location_facility: MD Anderson Cancer Center - University of Texas

location_facility: Republican Hospital named by V.A.Baranova

location_facility: Tangdu hospital the Fourth Military Medical

location_facility: Vinnytsya Regional Clinical Hospital named after M.I.Pirogov


type: EudraCT Number

title: BENEFIT 11 a Long-term Follow-up Study of the BENEFIT (Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment, 304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to Further Evaluate the Progress of Patients With First Demyelinating Event Suggestive of Multiple Sclerosis

summary: This study assesses clinical and imaging long-term data, after early or delayed interferon-beta-1b treatment in patients with a first demyelinating event suggestive of multiple sclerosis (MS), 11 years after enrollment in the Betaferon/Betaseron in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study (304747). The main objectives are to describe the disease course, change in disability, cognitive function, resource use and employment status, in relation to Interferon beta-1b in the long term.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Kappos L, Edan G, Freedman MS, Montalbán X, Hartung HP, Hemmer B, Fox EJ, Barkhof F, Schippling S, Schulze A, Pleimes D, Pohl C, Sandbrink R, Suarez G, Wicklein EM; BENEFIT Study Group. The 11-year long-term follow-up study from the randomized BENEFIT CIS trial. Neurology. 2016 Sep 6;87(10):978-87. doi: 10.1212/WNL.0000000000003078. Epub 2016 Aug 10.

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

sequence: first

family: Edan

full_name: Gilles Edan

given: Gilles

sequence: additional

family: Freedman

full_name: Mark S. Freedman

given: Mark S.

family: Montalbán

full_name: Xavier Montalbán

given: Xavier

family: Hartung

full_name: Hans-Peter Hartung

given: Hans-Peter

family: Hemmer

full_name: Bernhard Hemmer

given: Bernhard

family: Fox

full_name: Edward J. Fox

given: Edward J.

family: Barkhof

full_name: Frederik Barkhof

given: Frederik

family: Schippling

full_name: Sven Schippling

given: Sven

family: Schulze

full_name: Andrea Schulze

given: Andrea

family: Pleimes

full_name: Dirk Pleimes

given: Dirk

family: Pohl

full_name: Christoph Pohl

given: Christoph

family: Sandbrink

full_name: Rupert Sandbrink

given: Rupert

family: Suarez

full_name: Gustavo Suarez

given: Gustavo

family: Wicklein

full_name: Eva-Maria Wicklein

given: Eva-Maria

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Neurology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via page says license)

host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery
ganymedesd.lib.unideb.hu

publisher: Ovid Technologies (Wolters Kluwer Health)

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Spain
Germany
United Kingdom
Finland
France
Poland
Israel
Slovenia
Norway
Hungary
Belgium
Portugal
Denmark
Canada
Czech Republic


type: Other Grant/Funding Number

title: An International Randomised Controlled Trial to Compare Targeted Intra-operative Radiotherapy Boost With Conventional External Beam Radiotherapy Boost After Lumpectomy for Breast Cancer in Women With a High Risk of Local Recurrence.

acronym: TARGIT-B

summary:
TARGIT-Boost is an international randomised clinical trial designed to test the hypothesis that the tumour bed boost delivered as a single dose of targeted intraoperative radiotherapy (TARGIT-B) is superior to the conventional course of external beam radiotherapy boost (EBRT-Boost), especially in women with high risk of local recurrence. It is a pragmatic trial in which each participating centre can use the local predefined inclusion/exclusion criteria for entry into the trial. Only centres with access to the Intrabeam® (Carl Zeiss) are eligible to enter patients into the trial.

Eligible patients are those with a higher risk of local recurrence after breast conserving surgery.

After giving consent patients are randomised to either TARGIT Boost or EBRT Boost. All patients will receive whole breast EBRT. They may receive any other adjuvant treatments as deemed necessary. The protocol recommends that patients be followed at six monthly intervals for three years and then annually.

The primary endpoint is ipsilateral breast recurrence rate. Secondary endpoints are relapse-free survival, site of recurrence, overall survival (breast-cancer specific and non-breast cancer deaths) patient satisfaction and quality of life.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Randomized

enrollment_type: Anticipated

lead_sponsor: University College, London

location_country:
Italy
South Africa
Saudi Arabia
Switzerland
Spain
France
Malaysia
Thailand
China
United States
United Kingdom
Korea, Republic of

location_facility: Helen Rey Breast Cancer Research Foundation

location_facility: Centro Di Riferimento Oncologico Di Aviano

location_facility: Hampshire Hospitals NHS Foundation Trust

location_facility: Memorial Health University Medical Center

location_facility: Institut de Cancerologie de l'Ouest site René Gauducheau

location_facility: Institut Universitaire du Cancer de Toulouse - Oncopole

intervention_type: Radiation

lead_sponsor_type: academique

status_simplified: Ongoing


ReferenceCitation: Balasubramanian S, Hodkinson B, Schuster SJ, Fowler NH, Trotman J, Hess G, Cheson BD, Schaffer M, Sun S, Deshpande S, Vermeulen J, Salles G, Gopal AK. Identification of a genetic signature enriching for response to ibrutinib in relapsed/refractory follicular lymphoma in the DAWN phase 2 trial. Cancer Med. 2021 Nov 17. doi: 10.1002/cam4.4422. [Epub ahead of print]

name: Janssen Research & Development Spring House Pennsylvania USA

family: Balasubramanian

full_name: Sriram Balasubramanian

given: Sriram

family: Hodkinson

full_name: Brendan Hodkinson

given: Brendan

name: Lymphoma Program Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania USA

family: Schuster

full_name: Stephen J. Schuster

given: Stephen J.

name: Department of Lymphoma/Myeloma The University of Texas MD Anderson Cancer Center Houston Texas USA

family: Fowler

full_name: Nathan H. Fowler

given: Nathan H.

name: Haematology Department, Concord Hospital University of Sydney Sydney New South Wales Australia

family: Trotman

full_name: Judith Trotman

given: Judith

name: Department of Hematology/Oncology Johannes Gutenberg‐University Mainz Germany

family: Hess

full_name: Georg Hess

given: Georg

name: Lombardi Comprehensive Cancer Center Georgetown University Hospital Washington District of Columbia USA

family: Cheson

full_name: Bruce D. Cheson

given: Bruce D.

family: Schaffer

full_name: Michael Schaffer

given: Michael

name: Janssen Research & Development Raritan New Jersey USA

family: Sun

full_name: Steven Sun

given: Steven

family: Deshpande

full_name: Sanjay Deshpande

given: Sanjay

name: Janssen Research & Development Leiden The Netherlands

family: Vermeulen

full_name: Jessica Vermeulen

given: Jessica

name: Hospices Civils de Lyon Université de Lyon Pierre‐Bénite Cedex, Lyon France

family: Salles

full_name: Gilles Salles

name: Division of Medical Oncology Department of Medicine The University of Washington Seattle Washington USA

name: Clinical Research Division Fred Hutchinson Cancer Research CenterLymphoma ProgramSeattle Cancer Care Alliance Seattle Washington USA

family: Gopal

full_name: Ajay K. Gopal

given: Ajay K.

journal_name: Cancer Medicine

oa_host_type: publisher

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Gopal AK, Schuster SJ, Fowler NH, Trotman J, Hess G, Hou JZ, Yacoub A, Lill M, Martin P, Vitolo U, Spencer A, Radford J, Jurczak W, Morton J, Caballero D, Deshpande S, Gartenberg GJ, Wang SS, Damle RN, Schaffer M, Balasubramanian S, Vermeulen J, Cheson BD, Salles G. Ibrutinib as Treatment for Patients With Relapsed/Refractory Follicular Lymphoma: Results From the Open-Label, Multicenter, Phase II DAWN Study. J Clin Oncol. 2018 Aug 10;36(23):2405-2412. doi: 10.1200/JCO.2017.76.8853. Epub 2018 May 31.

name: Ajay K. Gopal, The University of Washington; Ajay K. Gopal, Fred Hutchinson Cancer Research Center, Seattle, WA; Stephen J. Schuster, Abramson Cancer Center of the University of Pennsylvania, Philadelphia; Jing-Zhou Hou, University of Pittsburgh Medical Center; Jing-Zhou Hou, University of Pittsburgh Cancer Institute, Pittsburgh; Rajendra N. Damle, Michael Schaffer, and Sriram Balasubramanian, Janssen Research & Development, Spring House, PA; Nathan H. Fowler, The University of Texas MD Anderson Cancer...

family: Hou

full_name: Jing-Zhou Hou

given: Jing-Zhou

family: Yacoub

full_name: Abdulraheem Yacoub

given: Abdulraheem

family: Lill

full_name: Michael Lill

repository_institution: The University of Manchester - Research Explorer

publisher: American Society of Clinical Oncology (ASCO)

location_country:
Germany
France
Poland
Belgium
Australia
Russian Federation
Spain
United States
United Kingdom

title: An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma

summary: The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).


intervention_type: Drug

status: Active, not recruiting

study_start_date_type: Actual

lead_sponsor: Janssen Research & Development, LLC

location_country:
Greece
Belgium
Australia
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Hungary
Ireland
Puerto Rico
China
Germany
United States
United Kingdom
Brazil
Mexico
Czechia
Israel
Spain
Turkey

type: Other Identifier

source: euctr

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

summary: The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

lead_sponsor_type: industriel


title: A Placebo-Controlled, Double-Blind, Parallel-Group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study With an Open-Label Extension Phase to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

summary: This is a multinational, multicenter, double-blind, placebo-controlled, parallel-group study using a Bayesian design with response adaptive randomization across placebo or 5 active arms of lecanemab to determine clinical efficacy and to explore the dose response of lecanemab using a composite clinical score (ADCOMS). BAN2401-G000-201 Core study is an 18-month study in which 3 dose levels (2.5, 5, and 10 mg/kg) are given biweekly (once every 2 weeks) to separate groups of participants and 2 dose levels (5 and 10 mg/kg) are given monthly (once every 4 weeks) to separate groups of participants. Participants will be from 2 clinical subgroups: mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia. Frequent interim analyses will be conducted to continually update randomization allocation on the basis of the primary clinical endpoint. Any participant who completes the study treatment (Visit 42 [Week 79] of the Core study) or discontinues the Core Study will be eligible to participate in the Extension Phase, provided they meet the Extension Phase inclusion and exclusion criteria. Participants will receive 10 mg/kg biweekly for up to 60 months or until the drug is commercially available in the country, where the subject resides, or until the benefit-to-risk ratio from treatment with lecanemab is no longer considered favorable, whichever comes first. The Follow-up Visit in the Extension Phase will take place 3 months after the last dose of study drug.

ReferenceCitation: Swanson CJ, Zhang Y, Dhadda S, Wang J, Kaplow J, Lai RYK, Lannfelt L, Bradley H, Rabe M, Koyama A, Reyderman L, Berry DA, Berry S, Gordon R, Kramer LD, Cummings JL. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Aβ protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. doi: 10.1186/s13195-021-00813-8.

family: Swanson

full_name: Chad J. Swanson

given: Chad J.

family: Zhang

full_name: Yong Zhang

given: Yong

family: Dhadda

full_name: Shobha Dhadda

given: Shobha

family: Wang

full_name: Jinping Wang

given: Jinping

family: Kaplow

full_name: June Kaplow

given: June

family: Lai

full_name: Robert Y. K. Lai

given: Robert Y. K.

family: Lannfelt

full_name: Lars Lannfelt

given: Lars

family: Bradley

full_name: Heather Bradley

given: Heather

family: Rabe

full_name: Martin Rabe

given: Martin

family: Koyama

full_name: Akihiko Koyama

given: Akihiko

family: Reyderman

full_name: Larisa Reyderman

given: Larisa

family: Berry

full_name: Donald A. Berry

given: Donald A.

full_name: Scott Berry

given: Scott

family: Gordon

full_name: Robert Gordon

given: Robert

family: Kramer

full_name: Lynn D. Kramer

given: Lynn D.

family: Cummings

full_name: Jeffrey L. Cummings

given: Jeffrey L.

currency_apc_doaj: GBP

journal_name: Alzheimer's Research & Therapy

oa_colors: green gold

repository_institution: Uppsala University - Uppsala University Publications

evidence: oa repository (via pmcid lookup)

license_normalized: no license

title: A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody

location_country:
Italy
United States
Sweden
Netherlands
France
Japan
Korea, Republic of
Spain
Germany
United Kingdom
Canada

location_facility:
Eisai Trial Site #2
Facility #4
Facility #2
Facility #1
Eisai Trial Site #3
Facility #3
Eisai Trial Site #1


ReferenceCitation: Komrokji R, Garcia-Manero G, Ades L, Prebet T, Steensma DP, Jurcic JG, Sekeres MA, Berdeja J, Savona MR, Beyne-Rauzy O, Stamatoullas A, DeZern AE, Delaunay J, Borthakur G, Rifkin R, Boyd TE, Laadem A, Vo B, Zhang J, Puccio-Pick M, Attie KM, Fenaux P, List AF. Sotatercept with long-term extension for the treatment of anaemia in patients with lower-risk myelodysplastic syndromes: a phase 2, dose-ranging trial. Lancet Haematol. 2018 Feb;5(2):e63-e72. doi: 10.1016/S2352-3026(18)30002-4. Epub 2018 Jan 10.

family: Komrokji

full_name: Rami Komrokji

given: Rami

family: Garcia-Manero

full_name: Guillermo Garcia-Manero

given: Guillermo

family: Ades

full_name: Lionel Ades

given: Lionel

family: Prebet

full_name: Thomas Prebet

given: Thomas

family: Steensma

full_name: David P Steensma

given: David P

family: Jurcic

full_name: Joseph G Jurcic

given: Joseph G

family: Sekeres

full_name: Mikkael A Sekeres

given: Mikkael A

family: Berdeja

full_name: Jesus Berdeja

given: Jesus

family: Savona

full_name: Michael R Savona

given: Michael R

family: Beyne-Rauzy

full_name: Odile Beyne-Rauzy

given: Odile

family: Stamatoullas

full_name: Aspasia Stamatoullas

given: Aspasia

family: DeZern

full_name: Amy E DeZern

given: Amy E

family: Delaunay

full_name: Jacques Delaunay

given: Jacques

family: Borthakur

full_name: Gautam Borthakur

given: Gautam

family: Rifkin

full_name: Robert Rifkin

family: Boyd

full_name: Thomas E Boyd

given: Thomas E

family: Laadem

full_name: Abderrhamane Laadem

given: Abderrhamane

family: Vo

full_name: Bond Vo

given: Bond

full_name: Jennie Zhang

given: Jennie

family: Puccio-Pick

full_name: Marie Puccio-Pick

given: Marie

family: Attie

full_name: Kenneth M Attie

given: Kenneth M

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

family: List

full_name: Alan F List

given: Alan F

journal_name: The Lancet Haematology

publisher: Elsevier BV

publisher_dissemination: Elsevier

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Yakima Valley Memorial Hospital/ North Star Lodge

location_facility: Monter Cancer Center, North Shore LIJ Health Systems

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Institute Paoli-Calmettes Service Haematology

location_facility: The Cleveland Clinic Foundation Hematology and Medical Oncology Rm 35

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: Columbia University Medical Center/New York-Presbyterian Hospital

location_facility: Texas Oncology Round Rock Cancer Center - Round Rock

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

title: An Open-label, Randomized, Phase 2, Parallel, Dose-Ranging, Multicenter Study of Sotatercept for the Treatment of Patients With Anemia and Low or Intermediate-1 Risk Myelodysplastic Syndromes or Non-proliferative Chronic Myelomonocytic Leukemia (CMML)

summary: The primary objective of this study is to determine a safe, tolerable and effective dose of sotatercept that results in the greatest frequency of improvement of anemia in patients diagnosed with low- or intermediate-1 risk myelodysplastic syndromes (MDS) or non-proliferative chronic myelomonocytic leukemia (CMML).


title: A Phase III, Randomised, Double-blind, Parallel Group, 24 Week Study to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg and 25 mg Compared to Placebo, All Administered as Oral Fixed Dose Combinations With Linagliptin 5 mg, in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control After 16 Weeks Treatment With Linagliptin 5 mg Once Daily on Metformin Background Therapy.

summary: This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM patients on 16 wks linagliptin treatment and metformin background therapy.

ReferenceCitation: Søfteland E, Meier JJ, Vangen B, Toorawa R, Maldonado-Lutomirsky M, Broedl UC. Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial. Diabetes Care. 2017 Feb;40(2):201-209. doi: 10.2337/dc16-1347. Epub 2016 Dec 2.

family: Søfteland

full_name: Eirik Søfteland

given: Eirik

family: Meier

full_name: Juris J. Meier

given: Juris J.

family: Vangen

full_name: Bente Vangen

given: Bente

family: Toorawa

full_name: Robert Toorawa

given: Robert

family: Maldonado-Lutomirsky

full_name: Mario Maldonado-Lutomirsky

given: Mario

family: Broedl

full_name: Uli C. Broedl

given: Uli C.

journal_name: Diabetes Care

evidence: open (via free pdf)

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

lead_sponsor: Boehringer Ingelheim

location_country:
Brazil
United States
Spain
France
Norway
Australia
El Salvador
New Zealand
Canada
Korea, Republic of
Taiwan

location_facility: 1275.9.64002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01106 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33012 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34011 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01032 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34010 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01104 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88604 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01015 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01027 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01010 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01018 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01102 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01016 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01014 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01011 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33008 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01029 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01024 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88606 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88602 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01028 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01022 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01030 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88607 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01101 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01023 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01103 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01031 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01105 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01019 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.34009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.47003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01013 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64005 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82007 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82010 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88605 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.55001 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64003 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.64004 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01021 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.82009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.88603 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.61009 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01017 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.33002 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01006 Boehringer Ingelheim Investigational Site

location_facility: 1275.9.01025 Boehringer Ingelheim Investigational Site

status_simplified: Completed


ReferenceCitation: Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

family: Dercle

full_name: Laurent Dercle

given: Laurent

family: Fronheiser

full_name: Matthew Fronheiser

given: Matthew

family: Lu

full_name: Lin Lu

given: Lin

family: Du

full_name: Shuyan Du

given: Shuyan

family: Hayes

full_name: Wendy Hayes

given: Wendy

family: Leung

full_name: David K. Leung

given: David K.

family: Roy

full_name: Amit Roy

given: Amit

family: Wilkerson

full_name: Julia Wilkerson

given: Julia

family: Guo

full_name: Pingzhen Guo

given: Pingzhen

family: Fojo

full_name: Antonio T. Fojo

given: Antonio T.

family: Schwartz

full_name: Lawrence H. Schwartz

given: Lawrence H.

family: Zhao

full_name: Binsheng Zhao

given: Binsheng

journal_name: Clinical Cancer Research

publisher: American Association for Cancer Research (AACR)

title: Identification of Non–Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics

ReferenceCitation: Rizvi NA, Mazières J, Planchard D, Stinchcombe TE, Dy GK, Antonia SJ, Horn L, Lena H, Minenza E, Mennecier B, Otterson GA, Campos LT, Gandara DR, Levy BP, Nair SG, Zalcman G, Wolf J, Souquet PJ, Baldini E, Cappuzzo F, Chouaid C, Dowlati A, Sanborn R, Lopez-Chavez A, Grohe C, Huber RM, Harbison CT, Baudelet C, Lestini BJ, Ramalingam SS. Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial. Lancet Oncol. 2015 Mar;16(3):257-65. doi: 10.1016/S1470-2045(15)70054-9. Epub 2015 Feb 20.

family: Rizvi

full_name: Naiyer A Rizvi

given: Naiyer A

family: Mazières

full_name: Julien Mazières

given: Julien

family: Planchard

full_name: David Planchard

given: David

family: Stinchcombe

full_name: Thomas E Stinchcombe

family: Dy

full_name: Grace K Dy

given: Grace K

family: Antonia

full_name: Scott J Antonia

given: Scott J

family: Horn

full_name: Leora Horn

given: Leora

family: Lena

full_name: Hervé Lena

given: Hervé

family: Minenza

full_name: Elisa Minenza

given: Elisa

family: Mennecier

full_name: Bertrand Mennecier

given: Bertrand

family: Otterson

full_name: Gregory A Otterson

given: Gregory A

family: Campos

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

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University Hospitals Cleveland Medical Center

location_facility: University Of North Carolina At Chapel Hill

location_facility: Network Office of Research and Innovation

location_facility: University Of California Davis Medical Center

title: A Single-Arm Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer Who Have Received At Least Two Prior Systemic Regimens

summary: The purpose of the study is to assess the objective response rate (change in tumor size from baseline) in patients with advanced or metastatic squamous cell nonsmall-cell lung cancer treated with Nivolumab (BMS-936558) after failure of 2 prior systemic regimens


ReferenceCitation: Azad AA, Armstrong AJ, Alcaraz A, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Rosbrook B, Lee HJ, Haas GP, Stenzl A. Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis. 2021 Aug 21. doi: 10.1038/s41391-021-00436-y. [Epub ahead of print]

family: Azad

full_name: Arun A. Azad

given: Arun A.

family: Armstrong

full_name: Andrew J. Armstrong

given: Andrew J.

family: Alcaraz

full_name: Antonio Alcaraz

given: Antonio

family: Szmulewitz

full_name: Russell Z. Szmulewitz

given: Russell Z.

family: Petrylak

full_name: Daniel P. Petrylak

given: Daniel P.

family: Holzbeierlein

full_name: Jeffrey Holzbeierlein

given: Jeffrey

family: Villers

full_name: Arnauld Villers

given: Arnauld

family: Alekseev

full_name: Boris Alekseev

given: Boris

family: Iguchi

full_name: Taro Iguchi

given: Taro

family: Shore

full_name: Neal D. Shore

given: Neal D.

family: Gomez-Veiga

full_name: Francisco Gomez-Veiga

given: Francisco

family: Rosbrook

full_name: Brad Rosbrook

given: Brad

family: Lee

full_name: Ho-Jin Lee

given: Ho-Jin

family: Haas

full_name: Gabriel P. Haas

given: Gabriel P.

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

journal_name: Prostate Cancer and Prostatic Diseases

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Feyerabend S, Saad F, Perualila NJ, Van Sanden S, Diels J, Ito T, De Porre P, Fizazi K. Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study. Target Oncol. 2019 Dec;14(6):681-688. doi: 10.1007/s11523-019-00685-x.

family: Feyerabend

full_name: Susan Feyerabend

given: Susan

family: Saad

full_name: Fred Saad

given: Fred

family: Perualila

full_name: Nolen Joy Perualila

given: Nolen Joy

family: Van Sanden

full_name: Suzy Van Sanden

given: Suzy

family: Diels

full_name: Joris Diels

given: Joris

family: Ito

full_name: Tetsuro Ito

given: Tetsuro

family: De Porre

full_name: Peter De Porre

given: Peter

family: Fizazi

ReferenceCitation: Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, Ye D, Feyerabend S, Protheroe A, Sulur G, Luna Y, Li S, Mundle S, Chi KN. Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 May;20(5):686-700. doi: 10.1016/S1470-2045(19)30082-8. Epub 2019 Apr 12.

ReferenceCitation: Li T, Franco-Villalobos C, Proskorovsky I, Sorensen SV, Tran N, Sulur G, Chi KN. Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration-naive prostate cancer: Results from LATITUDE. Cancer. 2019 Feb 15;125(4):626-632. doi: 10.1002/cncr.31847. Epub 2018 Dec 6.

name: Janssen Global Services Raritan New Jersey

name: Janssen Research and Development Los Angeles California

name: BC Cancer–Vancouver Centre, University of British Columbia Vancouver British Columbia Canada

title: Medical resource utilization of abiraterone acetate plus prednisone added to androgen deprivation therapy in metastatic castration‐naive prostate cancer: Results from LATITUDE

ReferenceCitation: Chi KN, Protheroe A, Rodríguez-Antolín A, Facchini G, Suttman H, Matsubara N, Ye Z, Keam B, Damião R, Li T, McQuarrie K, Jia B, De Porre P, Martin J, Todd MB, Fizazi K. Patient-reported outcomes following abiraterone acetate plus prednisone added to androgen deprivation therapy in patients with newly diagnosed metastatic castration-naive prostate cancer (LATITUDE): an international, randomised phase 3 trial. Lancet Oncol. 2018 Feb;19(2):194-206. doi: 10.1016/S1470-2045(17)30911-7. Epub 2018 Jan 8.

ReferenceCitation: Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Özgüroğlu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.

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

repository_institution: Tampere University - Tampere University Institutional Repository

location_country:
Finland
Malaysia
Romania
Belgium
Australia
Russian Federation
Denmark
Ukraine
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United Kingdom
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Turkey

title: A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

summary: The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate and low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).


title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study

acronym: ELEVATE

summary:
This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study.

This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

ReferenceCitation: Viel E, Eerdekens M, Kandaswamy P. Treatment Impact on Patient-Reported Outcomes in Peripheral Neuropathic Pain: Comparing Single Intervention With Topical High-Concentration Capsaicin to Daily Oral Pregabalin. Pain Physician. 2021 Sep;24(6):453-463.

ipd_sharing: Undecided

lead_sponsor: Astellas Pharma Europe Ltd.

location_country:
Armenia
Finland
Greece
Romania
Belgium
Russian Federation
France
Poland
Slovakia
Slovenia
Sweden
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Czechia
Belarus
Spain
Turkey

location_facility: Site 278 Semashko Regional Clinical Hospital

location_facility: Site 323 Ege University Medical Faculty Hospital

location_facility: Site 326 Maramara University, Pendik Training and Research Hospital

location_facility: Site 252 Instituto Portuges de Oncologic

location_facility: Site 271 First Moscow State Medical University named after I.M. Sechenov

location_facility: Site 324 Dokuz Eylul University Medical Faculty Hospital

location_facility: Site 104 Medical Center "Surb Nerses Mets"

location_facility: Site 301 Hospital General Universitario de Alicante

location_facility: Site 321 Hacettepe University Medical Faculty Hospital

location_facility: Site 274 Saint-Petersburg State Medical University

location_facility: Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ

location_facility: Site 103 Scientific research Institute of physiotherapy

location_facility: Site 325 Pamukkale University Medical Faculty Hospital

location_facility: Site 202 Hippokration General Hospital of Athens

location_facility: Site 121 Vitebsk Regional Clinical Hospital # 1


intervention_type: Biological

lead_sponsor: Octapharma

location_country:
Italy
India
United Kingdom
Morocco
Spain
Germany
France
Poland
Georgia
Russian Federation
Belarus
Moldova, Republic of
United States
Slovenia
Canada
Portugal
Ukraine

location_facility: National Children's Specialized Hospital "OHMATDET"

location_facility: Institute of Haematology and Transfusiology

location_facility: Sahyadri Speciality Hospital, Haematology & BMT Unit

location_facility: Unitat d'hemofilia, Hospital Universitari Vall d'Hebron

location_facility: Institut für Experimentelle Hämatologie und Transfusionsmedizin (IHT)

location_facility: Kasturba Medical College, Dr. TMA Pai Hospital

location_facility: Republican Scientific Practical Center for Pediatric Oncology and Hematology

location_facility: Christian Medical College & Hospital, Dept of Haematology

location_facility: Haemophilia Centre, University Clinical Centre

location_facility: Centre de traitement de l'hemophilie, Hôpital Bicêtre

location_facility: Hôtel-Dieu de Nantes, Centre Regional de Traitement de l'hemophilie

location_facility: Universitätsmedizin der Johannes-Gutenberg-Universität Mainz

location_facility: Institute of Blood Pathology and Transfusion Medicine

location_facility: Centro di Referimento per le Malattie Emorragiche e Trombotiche

location_facility: Scientific Research Institute of Mother and Child Health Care

location_facility: Great Ormond Street Hospital for Children

title: Immunogenicity, Efficacy and Safety of Treatment With Human-cl-rhFVIII in Previously Untreated Patients With Severe Hemophilia A

summary: Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.


title: A Phase IIb, Multi-National, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) (BENEFIT-ALS)

summary: The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

lead_sponsor: Cytokinetics

location_country:
United States
Netherlands
France
Ireland
Spain
Germany
United Kingdom
Canada

location_facility: Hôpital Notre Dame (CHUM) Centre Hospitalier de l'Universite de Montreal

location_facility: University of Massachusetts Medical School

location_facility: Hennepin County Medical Center - Berman Center for Research

location_facility: Univ. of Toronto - Sunnybrook Health Sciences Centre

location_facility: Wake Forest University, School of Medicine

location_facility: Barts and the London MND & the Centre Royal London Hospital

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: West Virginia University Department of Neurology

location_facility: Walton Centre for Neurology and Neurosurgery

location_facility: California Pacific Medical Center Forbes Norris MDA/ALS Research Center

location_facility: Ohio State University Department of Neurology

location_facility: Indiana University Department of Neurology

location_facility: University of Iowa Hospitals and Clinics

location_facility: Sheffield Institute for Translational Neuroscience

location_facility: Carolinas Medical Center Department of Neurology

location_facility: Mayo Clinic Florida Department of Neurology

intervention_type: Other


title: A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-3

summary:
The purpose of this study is to assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

A second purpose of this study is to assess the safety and efficacy brodalumab at two different doses compared with ustekinumab in participants with moderate to severe plaque psoriasis.

A third purpose of this study is to assess the safety and efficacy of 4 maintenance regimens of brodalumab.

status: Terminated

ReferenceCitation: Kokolakis G, Vadstrup K, Hansen JB, Carrascosa JM. Increased Skin Clearance and Quality of Life Improvement with Brodalumab Compared with Ustekinumab in Psoriasis Patients with Aggravating Lifestyle Factors. Dermatol Ther (Heidelb). 2021 Oct 2. doi: 10.1007/s13555-021-00618-5. [Epub ahead of print]

family: Kokolakis

full_name: Georgios Kokolakis

given: Georgios

family: Vadstrup

full_name: Kasper Vadstrup

given: Kasper

family: Hansen

full_name: Jes B. Hansen

given: Jes B.

family: Carrascosa

full_name: Jose Manuel Carrascosa

given: Jose Manuel

journal_name: Dermatology and Therapy

license: cc-by-nc

license_normalized: cc-by-nc

ReferenceCitation: Gottlieb A, Lebwohl M, Liu C, Israel RJ, Jacobson A. Malignancy Rates in Brodalumab Clinical Studies for Psoriasis. Am J Clin Dermatol. 2020 Jun;21(3):421-430. doi: 10.1007/s40257-020-00512-4.

family: Gottlieb

full_name: Alice Gottlieb

given: Alice

family: Lebwohl

full_name: Mark Lebwohl

given: Mark

family: Liu

full_name: Clive Liu

given: Clive

family: Israel

full_name: Robert J. Israel

given: Robert J.

family: Jacobson

full_name: Abby Jacobson

given: Abby

journal_name: American Journal of Clinical Dermatology

evidence: open (via crossref license)

ReferenceCitation: McMichael A, Desai SR, Qureshi A, Rastogi S, Alexis AF. Efficacy and Safety of Brodalumab in Patients with Moderate-to-Severe Plaque Psoriasis and Skin of Color: Results from the Pooled AMAGINE-2/-3 Randomized Trials. Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.

family: McMichael

full_name: Amy McMichael

given: Amy

family: Desai

full_name: Seemal R. Desai

given: Seemal R.

family: Qureshi

full_name: Aamir Qureshi

given: Aamir

family: Rastogi

ReferenceCitation: Langley RG, Armstrong AW, Lebwohl MG, Blauvelt A, Hsu S, Tyring S, Rastogi S, Pillai R, Israel R. Efficacy and safety of brodalumab in patients with psoriasis who had inadequate responses to ustekinumab: subgroup analysis of two randomized phase III trials. Br J Dermatol. 2019 Feb;180(2):306-314. doi: 10.1111/bjd.17318. Epub 2018 Dec 27.

name: University of Southern California Los Angeles CA U.S.A

name: Icahn School of Medicine at Mount Sinai New York NY U.S.A

name: Oregon Medical Research Center Portland OR U.S.A

name: Temple University School of Medicine Philadelphia PA U.S.A

name: University of Texas Health Science Center Houston TX U.S.A

name: Ortho Dermatologics Bridgewater NJ U.S.A

name: Dow Pharmaceutical Sciences Petaluma CA U.S.A

name: Valeant Pharmaceuticals North America LLC Bridgewater NJ U.S.A

ReferenceCitation: Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. N Engl J Med. 2015 Oct;373(14):1318-28. doi: 10.1056/NEJMoa1503824.

location_country:
Italy
United States
France
Poland
Greece
Hungary
Belgium
Australia
Russian Federation
Canada
Latvia


design_allocation: Non-Randomized

lead_sponsor: Novartis Pharmaceuticals

location_country:
Italy
Brazil
United States
Sweden
Switzerland
Netherlands
Germany
France
Australia
Russian Federation
Spain
Canada
United Kingdom

location_facility: Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Dept Onc

location_facility: Seattle Cancer Care Alliance Dept Oncology

location_facility: Children's Hospital of Pittsburgh Dept of Oncology

location_facility: Columbia University Medical Center- New York Presbyterian Dept of Oncology

location_facility: University of Texas/MD Anderson Cancer Center SC-3

location_facility: Cincinnati Children's Hospital Medical Center Division of Hema/Onco.

location_facility: Ann & Robert H. Lurie Children Dept of Oncology

title: A Phase II, Multi-center, Open-label, Single-arm Study of the Efficacy and Safety of Oral LDE225 in Patients With Hh-pathway Activated Relapsed Medulloblastoma

summary: This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated, relapsed MB.


title: A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-42756493, a Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, in Subjects With Advanced or Refractory Solid Tumors or Lymphoma

summary: The purpose of this study is to evaluate the safety, pharmacokinetics (study of what the body does to a drug), and pharmacodynamics (study of what a drug does to the body) of JNJ-42756493, a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor, in adult participants with advanced or refractory solid tumors or lymphoma.

ReferenceType: result

ReferenceCitation: Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B, Gazzah A, Zhong B, Platero SJ, Smit JW, Stuyckens K, Chatterjee-Kishore M, Rodon J, Peddareddigari V, Luo FR, Soria JC. Phase I Dose-Escalation Study of JNJ-42756493, an Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors. J Clin Oncol. 2015 Oct 20;33(30):3401-8. doi: 10.1200/JCO.2014.60.7341. Epub 2015 Aug 31.

name: Josep Tabernero, Rodrigo Dienstmann, Barbara Adamo, and Jordi Rodon, Vall d'Hebron University Hospital and Institute of Oncology, Universitat Autònoma de Barcelona, Barcelona; Emiliano Calvo, START Madrid, Centro Integral Oncológico Clara Campal; Victor Moreno, START Madrid, Hospital Fundación Jiménez Díaz, Madrid, Spain; Rastislav Bahleda, Anas Gazzah, and Jean-Charles Soria, Gustave Roussy Cancer Campus and University Paris-Sud, Villejuif; Antoine Italiano, Institut Bergonié, Bordeaux, France; Jeffrey...

family: Tabernero

full_name: Josep Tabernero

given: Josep

family: Bahleda

full_name: Rastislav Bahleda

given: Rastislav

family: Dienstmann

full_name: Rodrigo Dienstmann

given: Rodrigo

family: Infante

full_name: Jeffrey R. Infante

given: Jeffrey R.

family: Mita

full_name: Alain Mita

given: Alain

family: Italiano

full_name: Antoine Italiano

given: Antoine

family: Calvo

full_name: Emiliano Calvo

given: Emiliano

family: Moreno

full_name: Victor Moreno

given: Victor

family: Adamo

full_name: Barbara Adamo

given: Barbara

family: Gazzah

full_name: Anas Gazzah

given: Anas

family: Zhong

full_name: Bob Zhong

given: Bob

family: Platero

full_name: Suso J. Platero

given: Suso J.

family: Smit

full_name: Johan W. Smit

given: Johan W.

family: Stuyckens

full_name: Kim Stuyckens

given: Kim

family: Chatterjee-Kishore

full_name: Moitreyee Chatterjee-Kishore

given: Moitreyee

family: Rodon

full_name: Jordi Rodon

given: Jordi

family: Peddareddigari

full_name: Vijay Peddareddigari

given: Vijay

family: Luo

full_name: Feng R. Luo

given: Feng R.

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Phase I Dose-Escalation Study of JNJ-42756493, an Oral Pan–Fibroblast Growth Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors

ReferenceCitation: Valade E, Dosne AG, Xie H, Kleiman R, Li LY, Perez-Ruixo JJ, Ouellet D. Assessment of the effect of erdafitinib on cardiac safety: analysis of ECGs and exposure-QTc in patients with advanced or refractory solid tumors. Cancer Chemother Pharmacol. 2019 Sep;84(3):621-633. doi: 10.1007/s00280-019-03896-1. Epub 2019 Jul 6.

family: Valade

full_name: Elodie Valade

given: Elodie

family: Dosne

full_name: Anne-Gaëlle Dosne

given: Anne-Gaëlle

title: Assessment of the effect of erdafitinib on cardiac safety: analysis of ECGs and exposure–QTc in patients with advanced or refractory solid tumors

ReferenceCitation: Bahleda R, Italiano A, Hierro C, Mita A, Cervantes A, Chan N, Awad M, Calvo E, Moreno V, Govindan R, Spira A, Gonzalez M, Zhong B, Santiago-Walker A, Poggesi I, Parekh T, Xie H, Infante J, Tabernero J. Multicenter Phase I Study of Erdafitinib (JNJ-42756493), Oral Pan-Fibroblast Growth Factor Receptor Inhibitor, in Patients with Advanced or Refractory Solid Tumors. Clin Cancer Res. 2019 Aug 15;25(16):4888-4897. doi: 10.1158/1078-0432.CCR-18-3334. Epub 2019 May 14.

publisher_dissemination: American Association for Cancer Research


ReferenceCitation: Royce M, Bachelot T, Villanueva C, Özgüroglu M, Azevedo SJ, Cruz FM, Debled M, Hegg R, Toyama T, Falkson C, Jeong J, Srimuninnimit V, Gradishar WJ, Arce C, Ridolfi A, Lin C, Cardoso F. Everolimus Plus Endocrine Therapy for Postmenopausal Women With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: A Clinical Trial. JAMA Oncol. 2018 Jul 1;4(7):977-984. doi: 10.1001/jamaoncol.2018.0060.

name: University of New Mexico Comprehensive Cancer Center, Albuquerque

family: Royce

full_name: Melanie Royce

given: Melanie

name: Breast Cancer Unit and the Clinical Trial Unit, Centre Léon Bérard, Lyon, France

family: Bachelot

full_name: Thomas Bachelot

given: Thomas

name: Service d'Oncologie Médicale, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France

family: Villanueva

full_name: Cristian Villanueva

given: Cristian

name: Department of Oncology, Cerrahpaşa School of Medicine, Istanbul University, Istanbul, Turkey

family: Özgüroglu

full_name: Mustafa Özgüroglu

given: Mustafa

name: Oncology Service, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil

family: Azevedo

full_name: Sergio J. Azevedo

given: Sergio J.

name: Instituto Brasileiro de Controle do Câncer, São Paulo, Brazil

family: Cruz

full_name: Felipe Melo Cruz

given: Felipe Melo

name: Département d'Oncologie Médicale, Institut Bergonié, Bordeaux, France

family: Debled

full_name: Marc Debled

given: Marc

name: Centro de Referência da Saúde da Mulher, Hospital Pérola Byington/Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil

family: Hegg

full_name: Roberto Hegg

given: Roberto

name: Department of Breast Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan

family: Toyama

full_name: Tatsuya Toyama

given: Tatsuya

name: University of Alabama Comprehensive Cancer Center, Birmingham

family: Falkson

full_name: Carla Falkson

given: Carla

name: Department of Surgery, Breast Cancer Center, Yonsei University Health System, Seoul, Republic of Korea

family: Jeong

full_name: Joon Jeong

given: Joon

name: Department of Internal Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand

family: Srimuninnimit

full_name: Vichien Srimuninnimit

given: Vichien

name: Division of Hematology/Oncology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois

family: Gradishar

full_name: William J. Gradishar

given: William J.

name: Novartis Oncology, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

family: Arce

full_name: Christina Arce

given: Christina

name: Global Medical Affairs Biostatistics, Novartis Pharma S.A.S., Rueil-Malmaison, France

family: Ridolfi

full_name: Antonia Ridolfi

given: Antonia

family: Lin

full_name: Chinjune Lin

given: Chinjune

name: Breast Unit, Champalimaud Clinical Centre, Champalimaud Foundation, Lisbon, Portugal

family: Cardoso

full_name: Fatima Cardoso

given: Fatima

bso_classification: Biology (fond.)

journal_name: JAMA Oncology

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

title: Everolimus Plus Endocrine Therapy for Postmenopausal Women With Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer

location_country:
Brazil
Netherlands
Spain
France
Japan
Thailand
Hungary
Argentina
Portugal
Turkey
United States
United Kingdom
Korea, Republic of

location_facility: Saint Barnabas Medical Center CancerCenter of Saint Barnabas

location_facility: St. Francis Health Comprehensive Cancer Center

location_facility: Breastlink Medical Group Dept. of BreastlinkResearchGrp

location_facility: University of Alabama Comprehensive Cancer Center SC-2

location_facility: Oncology Specialists, SC Advocate Medical Group-Niles

location_facility: Columbia University Medical Center- New York Presbyterian Columbia

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

title: An Open-label, Phase II, Single-arm Study of Everolimus in Combination With Letrozole in the Treatment of Postmenopausal Women With Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer

summary: The purpose of this study is to find out if combining everolimus with letrozole is safe and has beneficial effects in postmenopausal women who have estrogen positive HER2 negative locally advanced or metastatic breast cancer. Additionally, this study aims to find out if everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole. This study will also aim to find out if a mouth rinse can help reduce the severity of oral stomatitis, a common side effect of everolimus. This part of the study will be conducted only in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially available.


title: MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

summary:
This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events.

This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC.

Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.

ReferenceCitation: Lemiere C, Taillé C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z.

family: Lemiere

full_name: Catherine Lemiere

given: Catherine

family: Taillé

full_name: Camille Taillé

given: Camille

family: Lee

full_name: Jason Kihyuk Lee

given: Jason Kihyuk

family: Smith

full_name: Steven G. Smith

given: Steven G.

family: Mallett

full_name: Stephen Mallett

given: Stephen

family: Albers

full_name: Frank C. Albers

given: Frank C.

family: Bradford

full_name: Eric S. Bradford

given: Eric S.

family: Yancey

full_name: Steven W. Yancey

given: Steven W.

family: Liu

full_name: Mark C. Liu

given: Mark C.

journal_name: Respiratory Research

oa_host_type: repository

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

family: Gibson

full_name: Peter G. Gibson

given: Peter G.

family: Prazma

full_name: Charlene M. Prazma

given: Charlene M.

family: Chupp

full_name: Geoffrey L. Chupp

given: Geoffrey L.

family: Forshag

full_name: Mark Forshag

given: Mark

full_name: Stephen A. Mallett

given: Stephen A.

full_name: Steve W. Yancey

given: Steve W.

family: Bel

full_name: Elisabeth H. Bel

given: Elisabeth H.

ReferenceCitation: Best N, Price RG, Pouliquen IJ, Keene ON. Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing. Pharm Stat. 2021 May;20(3):551-562. doi: 10.1002/pst.2093. Epub 2021 Jan 21.

name: Department of Biostatistics GlaxoSmithKline Research and Development  Brentford UK

name: Department of Clinical Pharmacology Modelling & Simulation GlaxoSmithKline Research and Development  Stevenage Herts UK

ReferenceCitation: Wardlaw A, Howarth PH, Israel E, Taillé C, Quirce S, Mallett S, Bates S, Albers FC, Kwon N. Fungal sensitization and its relationship to mepolizumab response in patients with severe eosinophilic asthma. Clin Exp Allergy. 2020 Jul;50(7):869-872. doi: 10.1111/cea.13680. Epub 2020 Jun 25.

name: Institute for Lung Health University of Leicester Leicester UK

name: Global Medical Franchise GSK House Brentford UK

name: Clinical and Experimental Sciences Faculty of Medicine University of Southampton and NIHR Respiratory Biomedical Research Unit Southampton General Hospital Southampton UK

name: Respiratory Medical Franchise GSK Brentford UK

name: Harvard Medical School and Brigham and Women's Hospital Boston MA USA

name: AP‐HP, Hôpital Bichat, Service de Pneumologie et Centre de Référence des Maladies Pulmonaires Rares, Dépt Hospitalo‐Universitaire FIRE Université Paris Diderot, INSERM UMR Paris France

name: Department of Allergy Hospital La Paz Institute for Health Research (IdiPAZ), and CIBER of Respiratory Diseases (CIBERES) Madrid Spain

name: Respiratory Discovery Medicine GSK Stevenage UK

name: Respiratory Medical Franchise GSK Research Triangle Park NC USA

ReferenceCitation: Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Khurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, Forshag M, Llanos JP, Yancey SW, Ortega HG. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):230-239. doi: 10.2500/aap.2019.40.4229.

name: From the Department of Medicine, Pulmonary Diseases and Critical Care, University of Rochester Medical Center, Rochester, New York

name: Department of Psychiatry and Neurology, University of Rochester Medical Center, Rochester, New York

name: Clinical Statistics, GlaxoSmithKline (GSK), Stockley Park, Middlesex, United Kingdom

name: Value Evidence and Outcomes, GSK, Collegeville, Pennsylvania

name: Respiratory Franchise, GSK, Research Triangle Park, North Carolina

name: Respiratory United States Medical Affairs, GSK, Research Triangle Park, North Carolina

name: Respiratory Therapeutic Area, GSK, Research Triangle Park, North Carolina

ReferenceCitation: Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

name: Patient Centered Outcomes, Value Evidence and Outcomes, GSK, Collegeville, PA, USA;

name: Value Evidence and Outcomes, GSK House, Brentford, UK;

name: Clinical Statistics, GSK, Stockley Park, UK;

name: Respiratory Medical, GSK House, Brentford, UK;

name: Respiratory Medical Franchise, GSK SK, Research Triangle Park, NC, USA;

name: Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA;

name: Real World Evidence and Epidemiology, GSK, Stockley Park, Uxbridge, UK

title: Impact of exacerbations on St George’s Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150-300 cells/μL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

title: Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of ≥150–300 cells/μL

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep - Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5.

journal_name: The Journal of Allergy and Clinical Immunology: In Practice

ReferenceCitation: Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.

ReferenceCitation: Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.

repository_institution: University of Southampton - ePrints Soton

repositories_institution: University of Southampton - ePrints Soton

ReferenceCitation: Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May - Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Albers FC, Price RG, Smith SG, Yancey SW. Mepolizumab efficacy in patients with severe eosinophilic asthma receiving different controller therapies. J Allergy Clin Immunol. 2017 Nov;140(5):1464-1466.e4. doi: 10.1016/j.jaci.2017.06.010. Epub 2017 Jul 4.

journal_name: Journal of Allergy and Clinical Immunology

ReferenceCitation: Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.

name: INSERM UMR 1087 CNRS UMR 6291 L'Institut du Thorax CHU de Nantes Université de Nantes Nantes France

name: Département de Pneumologie et Addictologie INSERM U1046 CNRS UMR 9214 Hôpital Arnaud de Villeneuve CHU Montpellier, and PhyMedExp, University of Montpellier Montpellier France

name: Respiratory Therapeutic Area GSK Research Triangle ParkNCUSA

name: Clinical Statistics GSK Uxbridge Middlesex UK

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

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

ReferenceCitation: Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8. Erratum in: N Engl J Med. 2015 Apr 30;372(18):1777.

repository_institution: University of Liège - Open Repository and Bibliography

repositories_institution: University of Liège - Open Repository and Bibliography

title: Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Italy
United States
Chile
Mexico
Spain
Germany
France
Japan
Belgium
Argentina
Australia
Russian Federation
Canada
United Kingdom
Korea, Republic of
Ukraine


title: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

acronym: ACCELERATE

summary: The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

ReferenceCitation: Puri R, Nissen SE, Arsenault BJ, St John J, Riesmeyer JS, Ruotolo G, McErlean E, Menon V, Cho L, Wolski K, Lincoff AM, Nicholls SJ. Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial. JAMA Cardiol. 2020 Oct 1;5(10):1136-1143. doi: 10.1001/jamacardio.2020.2413.

name: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio

name: Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, Ohio

family: Puri

full_name: Rishi Puri

given: Rishi

family: Nissen

full_name: Steven E. Nissen

given: Steven E.

name: Québec Heart & Lung Institute, Université de Laval, Québec, Québec, Canada

family: Arsenault

full_name: Benoit J. Arsenault

given: Benoit J.

family: St John

full_name: Julie St John

given: Julie

family: Riesmeyer

full_name: Jeffrey S. Riesmeyer

given: Jeffrey S.

family: Ruotolo

full_name: Giacomo Ruotolo

given: Giacomo

family: McErlean

full_name: Ellen McErlean

given: Ellen

family: Menon

full_name: Venu Menon

given: Venu

family: Cho

full_name: Leslie Cho

given: Leslie

family: Wolski

full_name: Kathy Wolski

given: Kathy

family: Lincoff

full_name: A. Michael Lincoff

given: A. Michael

name: MonashHeart, Department of Cardiology, Monash University, Clayton, Victoria, Australia

family: Nicholls

full_name: Stephen J. Nicholls

given: Stephen J.

journal_name: JAMA Cardiology

oa_colors: green other

ReferenceCitation: Menon V, Kumar A, Patel DR, John JS, Wolski KE, McErlean E, Riesmeyer JS, Weerakkody G, Ruotolo G, Cremer PC, Nicholls SJ, Lincoff AM, Nissen SE. Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High-Risk Vascular Disease Treated With Statin Therapy. J Am Heart Assoc. 2020 Jan 7;9(1):e014328. doi: 10.1161/JAHA.119.014328. Epub 2019 Dec 19.

name: Heart and Vascular Institute Cleveland Clinic Foundation Cleveland OH

family: Kumar

full_name: Anirudh Kumar

given: Anirudh

family: Patel

full_name: Divyang R. Patel

given: Divyang R.

family: St. John

full_name: Julie St. John

full_name: Kathy E. Wolski

given: Kathy E.

name: Monash Cardiovascular Research Centre Monash University Melbourne Australia

journal_name: Journal of the American Heart Association

title: Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High‐Risk Vascular Disease Treated With Statin Therapy

ReferenceCitation: Kumar A, Patel DR, Brennan DM, Wolski KE, Lincoff AM, Ruotolo G, McErlean E, Weerakkody G, Riesmeyer JS, Nicholls SJ, Nissen SE, Menon V. Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High-Risk Vascular Disease: Insights From the ACCELERATE Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e013790. doi: 10.1161/JAHA.119.013790. Epub 2019 Nov 22.

title: Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High‐Risk Vascular Disease: Insights From the ACCELERATE Trial

ReferenceCitation: Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, Nissen SE; ACCELERATE Investigators. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933-1942. doi: 10.1056/NEJMoa1609581.

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

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Turkey
South Africa
Sweden
Hong Kong
Netherlands
Switzerland
Bulgaria
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Estonia

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: 30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

acronym: EINSTEINJunior

summary: The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.

lead_sponsor: Bayer

location_country:
Italy
Austria
United States
Switzerland
Netherlands
Germany
France
Israel
Australia
Canada


title: A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Advanced Hepatocellular Carcinoma Subjects With or Without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects Who Are Naive to Systemic Therapy

summary:
The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects).

The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.

ReferenceCitation: Kudo M, Matilla A, Santoro A, Melero I, Gracián AC, Acosta-Rivera M, Choo SP, El-Khoueiry AB, Kuromatsu R, El-Rayes B, Numata K, Itoh Y, Di Costanzo F, Crysler O, Reig M, Shen Y, Neely J, Tschaika M, Wisniewski T, Sangro B. CheckMate 040 cohort 5: A phase I/II study of nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh B cirrhosis. J Hepatol. 2021 Sep;75(3):600-609. doi: 10.1016/j.jhep.2021.04.047. Epub 2021 May 26.

family: Kudo

full_name: Masatoshi Kudo

given: Masatoshi

family: Matilla

full_name: Ana Matilla

given: Ana

family: Santoro

full_name: Armando Santoro

given: Armando

family: Melero

full_name: Ignacio Melero

given: Ignacio

family: Gracián

full_name: Antonio Cubillo Gracián

given: Antonio Cubillo

family: Acosta-Rivera

full_name: Mirelis Acosta-Rivera

given: Mirelis

family: Choo

full_name: Su-Pin Choo

given: Su-Pin

family: El-Khoueiry

full_name: Anthony B. El-Khoueiry

given: Anthony B.

family: Kuromatsu

full_name: Ryoko Kuromatsu

given: Ryoko

family: El-Rayes

full_name: Bassel El-Rayes

given: Bassel

family: Numata

full_name: Kazushi Numata

given: Kazushi

family: Itoh

full_name: Yoshito Itoh

given: Yoshito

family: Di Costanzo

full_name: Francesco Di Costanzo

given: Francesco

family: Crysler

full_name: Oxana Crysler

given: Oxana

family: Reig

full_name: Maria Reig

given: Maria

family: Shen

full_name: Yun Shen

given: Yun

family: Neely

full_name: Jaclyn Neely

given: Jaclyn

family: Tschaika

full_name: Marina Tschaika

given: Marina

family: Wisniewski

full_name: Tami Wisniewski

given: Tami

family: Sangro

full_name: Bruno Sangro

given: Bruno

journal_name: Journal of Hepatology

ReferenceCitation: Yau T, Kang YK, Kim TY, El-Khoueiry AB, Santoro A, Sangro B, Melero I, Kudo M, Hou MM, Matilla A, Tovoli F, Knox JJ, Ruth He A, El-Rayes BF, Acosta-Rivera M, Lim HY, Neely J, Shen Y, Wisniewski T, Anderson J, Hsu C. Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):e204564. doi: 10.1001/jamaoncol.2020.4564. Epub 2020 Nov 12. Erratum in: JAMA Oncol. 2021 Jan 1;7(1):140.

name: Department of Medicine, University of Hong Kong, Hong Kong, China

name: Asan Medical Center, Department of Oncology, University of Ulsan, Seoul, South Korea

name: Department of Internal Medicine, Seoul National University, Seoul, South Korea

name: Norris Comprehensive Cancer Center, Division of Medical Oncology/Hematology, University of Southern California, Los Angeles, California

name: Humanitas Clinical and Research Center – IRCCS, Humanitas Cancer Center, Rozzano, Milan, Italy

name: Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

name: Department of Internal Medicine, Clinica Universidad de Navarra, Instituto de Investigación Sanitaria de Navarra, and Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas, Pamplona, Spain

name: Department of Immunology and Immunotherapy, Clinica Universidad de Navarra and Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain

name: Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan

name: Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan

name: Department of Medicine, Servicio de Digestivo, Hospital General Universitario Gregorio Marañón, Centro de Investigacion Biomedica en Red de Enfermedades Hepaticas y Digestivas, Madrid, Spain

name: Department of Medical & Surgical Sciences, University of Bologna, Bologna, Italy

name: Cancer Clinical Research Unit, Princess Margaret Cancer Centre, Toronto, Ontario, Canada

name: Division of Hematology/Oncology, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC

name: Department of Hematology, Emory University Winship Cancer Institute, Atlanta, Georgia

name: Department of Hematology and Oncology, Fundacion de Investigacion, San Juan, Puerto Rico

name: Samsung Medical Center, Department of Hematology and Oncology, Sungkyunkwan University School of Medicine, Seoul, South Korea

name: Department of Immuno-Oncology, Biomarkers, and Translational Medicine, Bristol Myers Squibb, Princeton, New Jersey

name: Department of Immuno-Oncology, Oncology, and Immunology, Bristol Myers Squibb, Princeton, New Jersey

name: Department of Clinical Research, Bristol Myers Squibb, Princeton, New Jersey

name: Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan

ReferenceCitation: Sangro B, Melero I, Wadhawan S, Finn RS, Abou-Alfa GK, Cheng AL, Yau T, Furuse J, Park JW, Boyd Z, Tang HT, Shen Y, Tschaika M, Neely J, El-Khoueiry A. Association of inflammatory biomarkers with clinical outcomes in nivolumab-treated patients with advanced hepatocellular carcinoma. J Hepatol. 2020 Dec;73(6):1460-1469. doi: 10.1016/j.jhep.2020.07.026. Epub 2020 Jul 22.

repository_institution: Universidad De Navarra - Deposito Academico Digital Universidad De Navarra

ReferenceCitation: Yau T, Hsu C, Kim TY, Choo SP, Kang YK, Hou MM, Numata K, Yeo W, Chopra A, Ikeda M, Kuromatsu R, Moriguchi M, Chao Y, Zhao H, Anderson J, Cruz CD, Kudo M. Nivolumab in advanced hepatocellular carcinoma: Sorafenib-experienced Asian cohort analysis. J Hepatol. 2019 Sep;71(3):543-552. doi: 10.1016/j.jhep.2019.05.014. Epub 2019 Jun 7. Erratum in: J Hepatol. 2019 Dec;71(6):1278.

ReferenceCitation: El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

repositories_institution: University College London - UCL Discovery

location_country:
Italy
United States
Hong Kong
France
Japan
Korea, Republic of
Singapore
Puerto Rico
Spain
Germany
United Kingdom
Canada
Taiwan

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Azienda Ospedaliera Di Bologna S. Orsola-Malpighi

location_facility: University Health Network - Princess Margaret Cancer Centre


title: A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

summary:
This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks.

Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.

ReferenceCitation: Shah MA, Kang YK, Thuss-Patience PC, Ohtsu A, Ajani JA, Van Cutsem E, Hoersch S, Harle-Yge ML, de Haas SL. Biomarker analysis of the GATSBY study of trastuzumab emtansine versus a taxane in previously treated HER2-positive advanced gastric/gastroesophageal junction cancer. Gastric Cancer. 2019 Jul;22(4):803-816. doi: 10.1007/s10120-018-00923-7. Epub 2019 Jan 31.

family: Shah

full_name: Manish A. Shah

given: Manish A.

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Thuss-Patience

full_name: Peter C. Thuss-Patience

given: Peter C.

family: Ohtsu

full_name: Atsushi Ohtsu

given: Atsushi

family: Ajani

full_name: Jaffer A. Ajani

given: Jaffer A.

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Hoersch

full_name: Silke Hoersch

given: Silke

family: Harle-Yge

full_name: Marie-Laurence Harle-Yge

given: Marie-Laurence

family: de Haas

full_name: Sanne Lysbet de Haas

given: Sanne Lysbet

journal_name: Gastric Cancer

ReferenceCitation: Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.

full_name: Peter C Thuss-Patience

given: Peter C

full_name: Manish A Shah

given: Manish A

full_name: Jaffer A Ajani

given: Jaffer A

family: Castro

full_name: Hugo Castro

given: Hugo

family: Mansoor

full_name: Wasat Mansoor

given: Wasat

family: Chung

full_name: Hyun Cheol Chung

given: Hyun Cheol

family: Bodoky

full_name: Gyorgy Bodoky

given: Gyorgy

family: Shitara

full_name: Kohei Shitara

given: Kohei

location_country:
Peru
Guatemala
Finland
Malaysia
Romania
Belgium
Russian Federation
Taiwan
France
Japan
Panama
Poland
Argentina
Canada
Korea, Republic of
Philippines
Singapore
Hungary
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Czechia
Spain
Turkey

location_facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

location_facility: Instituto Nacional de Enfermedades Neoplasicas

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

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

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

location_facility: National Cancer Center Hospital East; Gastroenterology

location_facility: Affiliated Hospital of Nantong University

location_facility: Yonsei University Severance Hospital; Medical Oncology

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

location_facility: University of Kansas; Medical Center & Medical pavilion

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica

location_facility: Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Shizuoka General Hospital; Clinical Oncology

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Toronto East General Hospital; Haematology/Oncology

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

location_facility: Ibaraki Prefectural Central Hospital; Gastroenterology

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: The Cancer Institute Hospital, JFCR; Gastroenterology

location_facility: National Cancer Center Hospital; Gastrointestinal Oncology

location_facility: Spitalul Clinic Judetean Mures; Oncologie Medicala

location_facility: Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie

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

location_facility: Tokyo Metropolitan Komagome Hospital; Chemotherapy

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

location_facility: National Hospital Organization Shikoku Cancer Center; Gastroenterology

location_facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

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

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: General Hospital of Shenyang Military Command of PLA

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

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie

location_facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

location_facility: Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Veterans Memorial Medical Ctr; Cancer Research Centre

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Centre Val Aurelle Paul Lamarque; Medecine A1 A2

location_facility: Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hyogo College Of Medicine; Upper Gastroenterology

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: Istanbul Bilim University School Of Medicine; Department Of Medical Oncology

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hospital General de México; Unidad de Oncologia

location_facility: BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

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

location_facility: Seoul St.Mary's Hospital; Medical Oncology

location_facility: Third Affiliated Hospital of Third Military Medical University

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

location_facility: Aichi Cancer Center Hospital; Clinical Oncology

location_facility: Brampton Memorial Hospital, William Osler Health Center

location_facility: Hop Europeen Georges Pompidou; Gastro Enterologie

location_facility: University Malaya Medical Centre; Clinical Oncology Unit,

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

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

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

location_facility: Shizuoka Cancer Center; Gastroenterology