ReferenceCitation: Vansteenkiste J, Barlesi F, Waller CF, Bennouna J, Gridelli C, Goekkurt E, Verhoeven D, Szczesna A, Feurer M, Milanowski J, Germonpre P, Lena H, Atanackovic D, Krzakowski M, Hicking C, Straub J, Picard M, Schuette W, O'Byrne K. Cilengitide combined with cetuximab and platinum-based chemotherapy as first-line treatment in advanced non-small-cell lung cancer (NSCLC) patients: results of an open-label, randomized, controlled phase II study (CERTO). Ann Oncol. 2015 Aug;26(8):1734-40. doi: 10.1093/annonc/mdv219. Epub 2015 May 4.

family: Vansteenkiste

full_name: J. Vansteenkiste

given: J.

family: Barlesi

full_name: F. Barlesi

given: F.

family: Waller

full_name: C.F. Waller

family: Bennouna

full_name: J. Bennouna

family: Gridelli

full_name: C. Gridelli

given: C.

family: Goekkurt

full_name: E. Goekkurt

given: E.

family: Verhoeven

full_name: D. Verhoeven

given: D.

family: Szczesna

full_name: A. Szczesna

given: A.

family: Feurer

full_name: M. Feurer

given: M.

family: Milanowski

full_name: J. Milanowski

family: Germonpre

full_name: P. Germonpre

given: P.

family: Lena

full_name: H. Lena

given: H.

family: Atanackovic

full_name: D. Atanackovic

family: Krzakowski

full_name: M. Krzakowski

family: Hicking

full_name: C. Hicking

family: Straub

full_name: J. Straub

family: Picard

full_name: M. Picard

family: Schuette

full_name: W. Schuette

given: W.

family: O'Byrne

full_name: K. O'Byrne

given: K.

journal_name: Annals of Oncology

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

repository_institution: Queensland University of Technology - QUT ePrints

location_country:
Italy
France
Poland
Ireland
Belgium
Spain
Germany
Czech Republic

title: Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Cilengitide Regimens in Combination With Cetuximab and Platinum-based Chemotherapy (Cisplatin/Vinorelbine or Cisplatin/Gemcitabine) Compared to Cetuximab and Platinum-based Chemotherapy Alone as First Line Treatment for Subjects With Advanced NSCLC

summary:
Primary objective of the study's Safety run-in:

- To determine the maximum tolerated dose (MTD) of cilengitide in combination with cetuximab, and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).

Primary objective of the study's Randomization Part:

- To assess the efficacy of cilengitide in combination with cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine) compared to cetuximab and platinum-based chemotherapy alone in terms of progression-free survival (PFS) time.

Study design and plan:

This is a multicenter, open-label, randomized, controlled Phase II study with a safety run-in part in subjects with advanced non-small cell lung cancer (NSCLC).

During the safety run-in, the regimen was intensified stepwise by cohort (cilengitide intravenous [i.v.] 1000 milligram [mg] to 2000 mg twice a week) in a classical 3+3 subjects (for each platinum-based chemotherapy regimens separately) approach with predefined dose- and schedule reduction rules.

In the safety run-in 12 subjects were included and evaluated for safety and feasibility of different escalating doses of cilengitide administered twice weekly in combination with cetuximab, cisplatin and vinorelbine or gemcitabine.

After completion of the safety run-in, the randomized part will be started, during which all subjects will receive cetuximab and platinum-based chemotherapy (cisplatin/vinorelbine or cisplatin/gemcitabine).

Subjects will be centrally randomized on a 1:1 basis to either Group A or C; Group B will be closed with implementation of Amendment No. 4 (dated 20 December 2010):

• Group A: Cilengitide 2000 mg once weekly (Days 1, 8, and 15 of every 3-week chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy that will consist of the following:

Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and vinorelbine on Days 1 and 8 of every 3-week chemotherapy cycle, or
Cetuximab once weekly (Days 1, 8, and 15), plus cisplatin on Day 1 and gemcitabine on Days 1 and 8 of every 3-week chemotherapy cycle.

The decision which of the 2 chemotherapy regimens will be applied for a given subject is at the discretion of the treating investigator.

• Group B: Cilengitide 2000 mg twice weekly (Days 1, 4, 8, 11, 15, and 18 of every 3-week chemotherapy cycle) in combination with cetuximab and platinum-based chemotherapy as described for Group A.

Group B will be closed with implementation of Amendment No. 4 (global, dated 20 December 2010). Subjects randomized to Group B before implementation of Amendment No 4 will continue to be treated as planned.

• Group C: Cetuximab and platinum-based chemotherapy as described for Group A

Chemotherapy will be given until radiographically documented progressive disease (PD) or unacceptable toxicity but for no more than 6 cycles.

Cilengitide and cetuximab will be given until radiographically documented PD or unacceptable toxicity.

Randomization will be performed centrally using an interactive voice/web response system (IXRS). A stratified block randomization procedure will be employed using chosen first-line chemotherapy (cisplatin/vinorelbine versus cisplatin/gemcitabine) as stratification criterion.


title: Solifenacin in a Flexible Dose Regimen With Tolterodine as an Active Comparator in a Double-blind, Double-dummy, Randomised Overactive Bladder Symptom Trial

acronym: STAR

summary: Prospective, double-blind, double-dummy, 2-arm, parallel-group, design. Flexible dose regimen for solifenacin succinate, fixed dose treatment regimen for tolterodine. Assessment of OAB symptoms by patient diaries.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, Wright DM, Bolodeoku J; STAR study group. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005 Sep;48(3):464-70.

lead_sponsor: Astellas Pharma Inc

location_country:
Italy
Sweden
United Kingdom
Netherlands
Spain
France
Greece
Slovakia
Norway
Hungary
Belgium
Russian Federation
Belarus
Denmark
Germany
Czech Republic
Ukraine

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: FondaparinUx Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction (UA/NSTEMI) Initially Treated With Subcutaneous Fondaparinux and Referred for Early Coronary Angiography (OASIS 8)

acronym: FUTURA/OASIS 8

summary: The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.

ReferenceCitation: FUTURA/OASIS-8 Trial Group, Steg PG, Jolly SS, Mehta SR, Afzal R, Xavier D, Rupprecht HJ, López-Sendón JL, Budaj A, Diaz R, Avezum A, Widimsky P, Rao SV, Chrolavicius S, Meeks B, Joyner C, Pogue J, Yusuf S. Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux: the FUTURA/OASIS-8 randomized trial. JAMA. 2010 Sep 22;304(12):1339-49. doi: 10.1001/jama.2010.1320. Epub 2010 Aug 31.

ReferenceType: derived

ReferenceCitation: Ducrocq G, Jolly S, Mehta SR, Rao SV, Patel T, Moreno R, Gao P, Steg PG. Activated clotting time and outcomes during percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction: insights from the FUTURA/OASIS-8 Trial. Circ Cardiovasc Interv. 2015 Apr;8(4). pii: e002044. doi: 10.1161/CIRCINTERVENTIONS.114.002044.

name: From the Cardiology Department, APHP, Hôpital Bichat, Paris, France (G.D., P.G.S.); Cardiology Department, INSERM U-698, Paris, France (G.D., P.G.S.); Department of Cardiology, Hamilton Health Sciences, McMaster University, Hamilton, Canada (S.J., S.R.M., P.G.); Department of Cardiology, Duke Clinical Research Institute, Durham, NC (S.V.R.); Department of Cardiology, Apex Heart Institute, Ahmedabad, India (T.P.); Division of Interventional Cardiology, University Hospital La Paz, Madrid, Spain (R.M....

family: Ducrocq

full_name: Gregory Ducrocq

given: Gregory

sequence: first

family: Jolly

full_name: Sanjit Jolly

given: Sanjit

sequence: additional

family: Mehta

full_name: Shamir R. Mehta

given: Shamir R.

family: Rao

full_name: Sunil V. Rao

given: Sunil V.

family: Patel

full_name: Tejas Patel

given: Tejas

family: Moreno

full_name: Raul Moreno

given: Raul

family: Gao

full_name: Peggy Gao

given: Peggy

family: Steg

full_name: Philippe Gabriel Steg

given: Philippe Gabriel

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Activated Clotting Time and Outcomes During Percutaneous Coronary Intervention for Non–ST-Segment–Elevation Myocardial Infarction

ReferenceCitation: Steg PG, Mehta S, Jolly S, Xavier D, Rupprecht HJ, Lopez-Sendon JL, Chrolavicius S, Rao SV, Granger CB, Pogue J, Laing S, Yusuf S. Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux. Am Heart J. 2010 Dec;160(6):1029-34, 1034.e1. doi: 10.1016/j.ahj.2010.07.037.

full_name: Shamir Mehta

given: Shamir

family: Xavier

full_name: Denis Xavier

given: Denis

family: Rupprecht

full_name: Hans-Juergen Rupprecht

given: Hans-Juergen

family: Lopez-Sendon

full_name: Jose Luis Lopez-Sendon

given: Jose Luis

family: Chrolavicius

full_name: Susan Chrolavicius

given: Susan

family: Granger

full_name: Christopher B. Granger

given: Christopher B.

family: Pogue

full_name: Janice Pogue

given: Janice

family: Laing

full_name: Shiona Laing

given: Shiona

family: Yusuf

full_name: Salim Yusuf

title: Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): A randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non–ST-segment elevation acute coronary syndromes initially treated with fondaparinux

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
Brazil
United States
India
United Kingdom
Netherlands
Germany
France
Bulgaria
Greece
Poland
Hungary
Argentina
Russian Federation
Spain
Canada
Czech Republic
Korea, Republic of


title: A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

summary: The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

enrollment_type: Anticipated

lead_sponsor: Merz Pharmaceuticals GmbH

location_country:
South Africa
Netherlands
Poland
France
Belgium
Czech Republic

location_facility: Centre Hospitalier de Bretagne Sud Service

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

location_facility: Teaching University Hospital, ORL klinika

location_facility: Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

location_facility: ORL oddělení, Karlovarská krajská nemocncie a.s.

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: ORL oddělení , Karlovarská krajská nemocnice a. s.

location_facility: Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz

location_facility: University Hospital Leuven, ENT Department

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROMED

location_facility: University Hospital Brussels, ENT department

location_facility: Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej

location_facility: Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi

location_facility: NZOZ Specjalistyczne Centrum Medyczne Nowomed

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi


title: A Randomised, Double-blind, Placebo- and Active Comparator-controlled, Five Parallel Groups Study to Investigate the Efficacy and Safety of BI 44370 TA (50 mg, 200 mg, and 400 mg) Administered Orally Once During an Acute Migraine Attack of Moderate or Severe Intensity

summary: The objective of this trial is to assess the safety, tolerability, and efficacy of three doses of BI 44370 TA in the treatment of patients with an acute migraine attack and headache pain of moderate or severe intensity, compared to placebo and an active comparator.

lead_sponsor: Boehringer Ingelheim

location_country:
Italy
Sweden
Netherlands
France
Belgium
El Salvador
Spain
Germany
United Kingdom

location_facility: 1246.4.49008 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32009 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3307A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3307B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3302B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49010 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3305B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3301B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44013 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3301A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3303A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.46002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49011 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32008 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.31006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3304B Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3304A Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39006 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49007 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49009 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34005 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.39001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.34001 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.44003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.32002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49002 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49003 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.49004 Boehringer Ingelheim Investigational Site

location_facility: 1246.4.3302A Boehringer Ingelheim Investigational Site


title: A Phase II, Randomised, Double-blind, Placebo-controlled and Parallel Group Study to Evaluate the Safety and Efficacy of Four Weeks Treatment of 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) in Patients With COPD Associated With Chronic Bronchitis.

summary: The primary objective of this study is to investigate the effect of 4-week treatment with 7.5 mg b.i.d, 15 mg q.d and 15 mg b.i.d. BIBW 2948 BS and placebo on cough and sputum as determined by the CASA-Q (Cough and Sputum Assessment Questionnaire

status: Withdrawn

location_country:
Germany
United States
France

location_facility: 1219.4.3307B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01001 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01007 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3306A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49002 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3305A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49005 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3306B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49004 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01002 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01004 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01006 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3305B Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3302A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49006 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49003 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01003 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3307A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01008 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3303A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3308A Boehringer Ingelheim Investigational Site

location_facility: 1219.4.01005 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.49001 Boehringer Ingelheim Investigational Site

location_facility: 1219.4.3301A Boehringer Ingelheim Investigational Site

status_simplified: Unknown


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Tolerability of Intravenous Tonapofylline in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency

summary: The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

lead_sponsor: Biogen

location_country:
Italy
Brazil
Sweden
India
Netherlands
Germany
Finland
France
Bulgaria
Poland
Israel
Romania
Argentina
Australia
Russian Federation
United States
Czech Republic
Canada


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Trial of 2 Regimens of Telaprevir (With and Without Delayed Start) Combined With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Subjects With Chronic, Genotype 1, Hepatitis C Infection Who Failed Prior Standard Treatment

summary: The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.

ReferenceCitation: Zeuzem S, DeMasi R, Baldini A, Coate B, Luo D, Mrus J, Witek J. Risk factors predictive of anemia development during telaprevir plus peginterferon/ribavirin therapy in treatment-experienced patients. J Hepatol. 2014 Jun;60(6):1112-7. doi: 10.1016/j.jhep.2014.01.013. Epub 2014 Jan 29.

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: DeMasi

full_name: Ralph DeMasi

given: Ralph

family: Baldini

full_name: Alessandra Baldini

given: Alessandra

family: Coate

full_name: Bruce Coate

given: Bruce

family: Luo

full_name: Donghan Luo

given: Donghan

family: Mrus

full_name: Joseph Mrus

given: Joseph

family: Witek

full_name: James Witek

given: James

journal_name: Journal of Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Younossi Z, Negro F, Serfaty L, Pol S, Diago M, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Focaccia R, Foster GR, Horban A, Lonjon-Domanec I, Coate B, DeMasi R, Picchio G, Witek J. Homeostasis model assessment of insulin resistance does not seem to predict response to telaprevir in chronic hepatitis C in the REALIZE trial. Hepatology. 2013 Dec;58(6):1897-906. doi: 10.1002/hep.26437. Epub 2013 Oct 17.

name: Center for Liver Diseases and Department of Medicine; Inova Fairfax Hospital; Falls Church VA USA

family: Younossi

full_name: Zobair Younossi

given: Zobair

name: Divisions of Clinical Pathology, and of Gastroenterology and Hepatology; University Hospital; Geneva Switzerland

family: Negro

full_name: Francesco Negro

given: Francesco

name: Liver Unit; Hôpital St Antoine; UPMC Paris France

family: Serfaty

full_name: Lawrence Serfaty

given: Lawrence

name: Université Paris Descartes; INSERM Unité 1016, and Assistance Publique-Hôpitaux de Paris, Cochin Hospital; Paris France

family: Pol

full_name: Stanislas Pol

given: Stanislas

name: Hospital General de Valencia; Valencia Spain

family: Diago

full_name: Moises Diago

given: Moises

name: Johann Wolfgang Goethe University Medical Center; Frankfurt am Main Germany

family: Andreone

full_name: Pietro Andreone

given: Pietro

name: Alamo Medical Research; San Antonio TX USA

family: Lawitz

full_name: Eric J. Lawitz

given: Eric J.

name: Department of Gastroenterology; Alfred Hospital; Melbourne VIC Australia

family: Roberts

full_name: Stuart Roberts

given: Stuart

name: Emilio Ribas Infectious Diseases Institute; São Paulo Brazil

family: Focaccia

full_name: Roberto Focaccia

given: Roberto

name: Queen Marys University of London; Institute of Cell and Molecular Science; London UK

family: Foster

full_name: Graham R. Foster

given: Graham R.

name: Warsaw Medical University and Hospital of Infectious Diseases; Warsaw Poland

family: Horban

full_name: Andrzej Horban

given: Andrzej

family: Lonjon-Domanec

full_name: Isabelle Lonjon-Domanec

given: Isabelle

name: Janssen Research & Development; LLC Titusville NJ USA

ReferenceCitation: Pol S, Aerssens J, Zeuzem S, Andreone P, Lawitz EJ, Roberts S, Younossi Z, Foster GR, Focaccia R, Horban A, Pockros PJ, Van Heeswijk RP, De Meyer S, Luo D, Botfield M, Beumont M, Picchio G. Limited impact of IL28B genotype on response rates in telaprevir-treated patients with prior treatment failure. J Hepatol. 2013 May;58(5):883-9. doi: 10.1016/j.jhep.2012.12.023. Epub 2013 Jan 12.

ReferenceCitation: Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Müllhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.

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

repository_institution: Ghent University - Ghent University Academic Bibliography

title: Telaprevir for Retreatment of HCV Infection

location_country:
Austria
Brazil
Sweden
Switzerland
Netherlands
Germany
France
Poland
Israel
Australia
Belgium
Puerto Rico
Spain
United States
United Kingdom
Canada


ReferenceCitation: Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, Dorrepaal C, Martin N. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013 Feb;63(2):296-305. doi: 10.1016/j.eururo.2012.10.048. Epub 2012 Nov 6.

study_start_date_type: Actual

ipd_sharing_description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

location_country:
Finland
Romania
Australia
Belgium
Russian Federation
Denmark
Iceland
Ukraine
Spain
France
Poland
Lithuania
Slovakia
Norway
Canada
South Africa
Sweden
Switzerland
Netherlands
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Czechia
Belarus
Latvia

acronym: TAURUS

ipd_sharing: Yes

type: EudraCT Number

source: euctr

title: A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects With Symptoms of Overactive Bladder

summary: The study is intended to test the safety, tolerability, efficacy of two doses of long term once daily (qd) treatment of Mirabegron in patients with symptoms of overactive bladder and secondly to compare these with active comparator.


title: Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Safety and Efficacy of Eltrombopag to Reduce the Need for Platelet Transfusion in Thrombocytopenic Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures

acronym: ELEVATE

summary: The purpose of this study is to assess the ability of eltrombopag to elevate platelet counts thereby reducing the need for platelet transfusions in chronic liver disease patients with thrombocytopenia undergoing elective invasive procedures. The clinical benefit of eltrombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an invasive procedure. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events and medical resource utilisation will be monitored during this time and for up to 30 days after undergoing an invasive procedure to help further evaluate clinical benefit.

status: Terminated

ReferenceCitation: Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D; ELEVATE Study Group. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia. N Engl J Med. 2012 Aug 23;367(8):716-24. doi: 10.1056/NEJMoa1110709.

family: Afdhal

full_name: Nezam H. Afdhal

given: Nezam H.

family: Giannini

full_name: Edoardo G. Giannini

given: Edoardo G.

family: Tayyab

full_name: Ghias Tayyab

given: Ghias

family: Mohsin

full_name: Aftab Mohsin

given: Aftab

family: Lee

full_name: Jin-Woo Lee

given: Jin-Woo

family: Andriulli

full_name: Angelo Andriulli

given: Angelo

family: Jeffers

full_name: Lennox Jeffers

given: Lennox

family: McHutchison

full_name: John McHutchison

given: John

family: Chen

full_name: Pei-Jer Chen

given: Pei-Jer

family: Han

full_name: Kwang-Hyub Han

given: Kwang-Hyub

family: Campbell

full_name: Fiona Campbell

given: Fiona

family: Hyde

full_name: Denise Hyde

given: Denise

family: Brainsky

full_name: Andres Brainsky

given: Andres

family: Theodore

full_name: Dickens Theodore

given: Dickens

journal_name: New England Journal of Medicine

oa_host_type: repository

host_type: repository

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

repository_institution: 臺灣機構典藏 - NTUR - NTUR

version: submittedVersion

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Eltrombopag before Procedures in Patients with Cirrhosis and Thrombocytopenia

lead_sponsor: GlaxoSmithKline

location_country:
Italy
United States
India
Pakistan
France
Poland
Belgium
Argentina
Russian Federation
Spain
Canada
Korea, Republic of
Taiwan


ReferenceCitation: Murphy DA, Rini BI, Escudier B, Motzer RJ, Wang P, Li S, Williams JA, Tarazi JC, Martini JF. Angiogenic and immunomodulatory biomarkers in axitinib-treated patients with advanced renal cell carcinoma. Future Oncol. 2020 Jun;16(17):1199-1210. doi: 10.2217/fon-2020-0212. Epub 2020 May 4.

name: Pfizer Oncology, San Diego, CA 92121, USA

family: Murphy

full_name: Danielle A Murphy

given: Danielle A

name: Department of Hematology & Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH 44106, USA

family: Rini

full_name: Brian I Rini

given: Brian I

name: Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France

family: Escudier

full_name: Bernard Escudier

given: Bernard

name: Department of Oncology, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

family: Motzer

full_name: Robert J Motzer

given: Robert J

family: Wang

full_name: Panpan Wang

given: Panpan

family: Li

full_name: Sherry Li

given: Sherry

family: Williams

full_name: J Andrew Williams

given: J Andrew

family: Tarazi

full_name: Jamal C Tarazi

given: Jamal C

family: Martini

full_name: Jean-Francois Martini

given: Jean-Francois

journal_name: Future Oncology

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via page says license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

evidence: oa repository (via pmcid lookup)

repository_normalized: PubMed Central

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Bracarda S, Bamias A, Casper J, Negrier S, Sella A, Staehler M, Tarazi J, Felici A, Rosbrook B, Jardinaud-Lopez M, Escudier B. Is Axitinib Still a Valid Option for mRCC in the Second-Line Setting? Prognostic Factor Analyses From the AXIS Trial. Clin Genitourin Cancer. 2019 Jun;17(3):e689-e703. doi: 10.1016/j.clgc.2019.03.017. Epub 2019 Apr 1.

family: Bracarda

full_name: Sergio Bracarda

given: Sergio

family: Bamias

full_name: Aristotelis Bamias

given: Aristotelis

family: Casper

full_name: Jochen Casper

given: Jochen

family: Negrier

full_name: Sylvie Negrier

given: Sylvie

family: Sella

full_name: Avishay Sella

given: Avishay

family: Staehler

full_name: Michael Staehler

given: Michael

full_name: Jamal Tarazi

given: Jamal

family: Felici

full_name: Alessandra Felici

given: Alessandra

family: Rosbrook

full_name: Brad Rosbrook

given: Brad

family: Jardinaud-Lopez

full_name: Monica Jardinaud-Lopez

given: Monica

ReferenceCitation: de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.

title: Comprehensive Analysis of Survival Outcomes in Non–Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials

ReferenceCitation: Grünwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.

ReferenceCitation: Grünwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.

title: Depth of Remission is a Prognostic Factor for Survival in Patients with Metastatic Renal Cell Carcinoma

ReferenceCitation: Escudier B, Michaelson MD, Motzer RJ, Hutson TE, Clark JI, Lim HY, Porfiri E, Zalewski P, Kannourakis G, Staehler M, Tarazi J, Rosbrook B, Cisar L, Hariharan S, Kim S, Rini BI. Axitinib versus sorafenib in advanced renal cell carcinoma: subanalyses by prior therapy from a randomised phase III trial. Br J Cancer. 2014 Jun 10;110(12):2821-8. doi: 10.1038/bjc.2014.244. Epub 2014 May 13.

ReferenceCitation: Ueda T, Uemura H, Tomita Y, Tsukamoto T, Kanayama H, Shinohara N, Tarazi J, Chen C, Kim S, Ozono S, Naito S, Akaza H. Efficacy and safety of axitinib versus sorafenib in metastatic renal cell carcinoma: subgroup analysis of Japanese patients from the global randomized Phase 3 AXIS trial. Jpn J Clin Oncol. 2013 Jun;43(6):616-28. doi: 10.1093/jjco/hyt054. Epub 2013 Apr 28.

title: Efficacy and Safety of Axitinib Versus Sorafenib in Metastatic Renal Cell Carcinoma: Subgroup Analysis of Japanese Patients from the Global Randomized Phase 3 AXIS Trial

ReferenceCitation: Motzer RJ, Escudier B, Tomczak P, Hutson TE, Michaelson MD, Negrier S, Oudard S, Gore ME, Tarazi J, Hariharan S, Chen C, Rosbrook B, Kim S, Rini BI. Axitinib versus sorafenib as second-line treatment for advanced renal cell carcinoma: overall survival analysis and updated results from a randomised phase 3 trial. Lancet Oncol. 2013 May;14(6):552-62. doi: 10.1016/S1470-2045(13)70093-7. Epub 2013 Apr 16. Erratum in: Lancet Oncol. 2013 Jun;14(7):e254.

ReferenceCitation: Cella D, Escudier B, Rini B, Chen C, Bhattacharyya H, Tarazi J, Rosbrook B, Kim S, Motzer R. Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial. Br J Cancer. 2013 Apr 30;108(8):1571-8. doi: 10.1038/bjc.2013.145. Epub 2013 Apr 11.

ReferenceCitation: Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. doi: 10.1016/S0140-6736(11)61613-9. Epub 2011 Nov 4. Erratum in: Lancet. 2012 Nov 24;380(9856):1818.

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

location_country:
Greece
Australia
Russian Federation
Taiwan
India
France
Japan
Poland
Slovakia
Canada
Korea, Republic of
Sweden
Singapore
Ireland
China
United States
Germany
United Kingdom
Italy
Austria
Brazil
Spain

location_facility: University of Miami Sylvester at Deerfield Beach

location_facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

location_facility: Vanderbilt-Ingram Cancer Center-Cool Springs

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

location_facility: Klinikum Oldenburg gGmbH, Klinik fuer Innere Medizin II Onkologie / Haematologie

location_facility: Moscow Research Institute of Oncology P.A. Herzen

location_facility: Chattanooga Oncology & Hematology Associates

location_facility: Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc

location_facility: Centro di Riferimento Oncologico, Istituto Nazionale Tumori, IRCCS

location_facility: Dipartimento dei laboratori diagnositici e per le terapie cellulari

location_facility: Russian Research Center of Roentgenology and Radiology

location_facility: Georgetown University Hospital, Lombardi Cancer Center

location_facility: Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine

location_facility: Virginia Mason Medical Center, Section of Hematology/Oncology

location_facility: Chattanooga Oncology Hematology Associates P.C.

location_facility: Universitaets-Klinik fuer Innere Medizin I

location_facility: University of Minnesota Medical Center Fairview

location_facility: Cancer Research Center named after N.N.Blokhin, Chemotherapy Department

location_facility: Ludwig-Maximilians-Universitaet Muenchen, Klinikum Grosshadern Urologische Klinik und Poliklinik

location_facility: Brian LeBerthon, MD, A Medical Corporation

location_facility: Institut Catala D'Oncologia L'Hospitalet

location_facility: Chattanooga Oncology and Hematology Associates, PC

location_facility: Sapporo Medical University School of Medicine

location_facility: Klinika Urologii i Onkologii Urologicznej

location_facility: Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: Klinikum Region Hannover Krankenhaus Siloah

location_facility: Taichung Veterans General Hospital, Department of Surgery

location_facility: Department of Medical Oncology, St. Bartholomew's Hospital

location_facility: Azienda Ospedaliera San Camillo Forlanini, Oncologia Medica, Padiglione Flajani, I piano

location_facility: Tokyo Women's Medical University Medical Center East, Department of Urology

location_facility: Raleigh Hematology Oncology Associates, DBA

location_facility: Azienda Ospedaliera Spedali Civili di Brescia, Unita' Operativa Oncologia Medica

location_facility: Peachtree Hematology-Oncology Consultants, P.C.

location_facility: Department of Oncology, National Taiwan University Hospital

location_facility: UO di Oncologia ed Ematologia, Istituto Clinico Humanitas

location_facility: The Main Clinical Hospital of the Ministry of Internal Affairs of Russian Federation

location_facility: University of Birmingham, CRUK Institute for Cancer Studies

location_facility: British Columbia Cancer Agency - Cancer Centre for the Southern Interior

location_facility: The Cancer Center at Hackensack University Medical Center - The Hillcrest Building

location_facility: RSM Durham Regional Cancer Centre Lakeridge Health Oshawa

location_facility: "Theagenio"Cancer Hospital / 3rd. Dept. of Clinical Oncology

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Memorial Sloan Kettering Cancer Center - Sidney Kimmel Center

location_facility: National Cancer Center, Urologic Oncology Clinic, Center for Specific Organs Cancer

location_facility: Divisione di Oncologia, AORN Antonio Cardarelli

location_facility: Klinika Onkologii, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

location_facility: Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Raleigh Hematology Oncology Associates, P.C.

location_facility: Innere Klinik und Poliklinik fuer Tumorforschung, Universitaetsklinikum Essen

location_facility: University Department of Medical Oncology/Oxford Cancer Centre

location_facility: Dept. of Medical Oncology, Tata Memorial Hospital

location_facility: Klinika Onkologii, Wojskowy Instytut Medyczny

location_facility: Lake University - Ireland Cancer Center (LUICC)

location_facility: Klinikum der Johannes-Gutenberg-Universitaet, III. Medizinische Klinik und Poliklinik

location_facility: Unita' Operativa Oncologia Medica 2, Regione del Veneto

location_facility: Department of Medicine MSG @ SUNY HSC @ Syrcacuse, Inc.

location_facility: Hospital Clinico Universitario Virgen de La Victoria

location_facility: Tianjin Oncology Hospital,biology treatment department

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Alexandra University Hospital / Oncology Dept.

location_facility: Fondazione IRCCS, Istituto Nazionale dei Tumori, SC Oncologia Medica 2

location_facility: Loyola University Chicago Cardinal Bernardin Cancer Center

location_facility: Ohio State University Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: University of Tsukuba, Graduate School of Comprehensive Human Sciences, Department of Urology

location_facility: Institut Gustave Roussy / Service d'Immunotherapie

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: US Oncology Research and Clinical Pharmacy

location_facility: Ballarat Oncology & Haematology Services

location_facility: Department of Medicine MSG @ SUNY HSC @ Syracuse, Inc.

location_facility: Wielkopolskie Centrum Onkologii im.Marii Sklodowskiej-Curie

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Xijing Hospital, The Fourth Military Medical University

location_facility: St. John's Mercy, David C. Pratt Cancer Center

location_facility: Centre Rene Gauducheau - Service Oncologie Medicale

location_facility: Hematology and Oncology Associates of SC, LLC - Eastside Medical Center

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: The Cancer Center at Hackensack University Medical Center

location_facility: UOC Oncologia Medica B, IRCCS AO Universitaria San Martino

location_facility: Heidelberg Repatriation Hospital, Austin Health

location_facility: University of Colorado Denver: Division of Medical Oncology

location_facility: Chang Gung Medical Foundation-Kaohsiung Branch

location_facility: UOC Oncologia Medica, Ospedale San Donato

location_facility: Metropolitan Hematology/Oncology Medical Group

location_facility: The Department of Medical Oncology, PLA Cancer Center, Nanjing Bayi Hospital

location_facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center

location_facility: Cancer Research Center named after N.N. Blokhin, Biotherapy Department

location_facility: East Valley Hematology and Oncology Medical Group

location_facility: Med. Abt. KH Barmherzige Brueder Wien, Krankenhaus der Barmherzigen Brueder Wien

location_facility: Clatterbridge Centre for Oncology NHS Foundation Trust

location_facility: Agajanian Institute of Oncology and Hematology

location_facility: University of Miami Hospital and Clinics

location_facility: Struttura Complessa di Oncologia Medica A

location_facility: Royal Marsden Hospital NHS Foundation Trust

location_facility: Dong-A University Medical Center, Department of Medicine, Division of Hemato-Oncology

location_facility: Tokyo Women's Medical University Hospital

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre (ISCMPA) - Hospital Santa Rita

location_facility: Bhagwan Mahaveer Cancer Hospital and Research Center

location_facility: Medical Radiology Research Center of the Minzdravsotsrazvitiya of Russia

title: AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL

summary: The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen.


title: A Randomized Double-blind Multi-center Parallel Group Three Month Study to Compare the Tolerability and Efficacy of Flexible Dose Vardenafil Versus Placebo in Men With Depression and Erectile Dysfunction.

acronym: DRIVER

summary: The study will last three months. During the first month of treatment the subject will receive either 10 mg vardenafil or placebo. After 1 month of treatment the doctor, can choose to increase the dosage from 10 mg to 20 mg or decrease the dosage to 5 mg. The doctor will again evaluate, after 2 months of treatment if the subject wants to increase the dosage from 10 mg to 20 mg or, if already done, to continue with the dosage of 20 mg or decrease to 10 mg or 5 mg. It will not be possible after this point to increase or decrease the dosage for the rest of the study. The subject will be asked to attend the clinic on four separate occasions over a period of 3 months. Every visit will last about 1 hour. At the first visit the doctor will ask the subject about their medical history, and the subject will be given a medical examination (including your heart rate, blood pressure and weight). The medical examination will also include an ECG. The subject will be asked to provide a blood and urine sample, which will be analysed and screened for drugs of potential abuse (e.g.cocaine, narcotics, sedatives, hypnotics). The subject will then be asked to fill in a questionnaire about their mood and feelings. The subject qualifies, they will have an interview with a trained mental health care provider who will assess their level of depression. At the end of the visit, the doctor will provide the subject with a diary in which they must record details about their attempts at sexual activity during the next 4 weeks. The subject will be asked to make at least 4 attempts at sexual intercourse on 4 separate days and to record the attempts in the diaries. After 4 weeks the subject will return to the clinic. They will be asked to fill in different questionnaires about their sexuality, mood and feelings, general quality of life, self-esteem and sexual activity in the last 4 weeks. Two additional blood and urine samples will be collected. An interview with the trained mental health care provider who will re-assess their level of depression. At this visit all information collected so far will be assessed and the doctor will check to see if the requirements to enter the treatment period are fulfilled. The subject may be excluded from further participation in the study, for example due to results of the blood analysis or if your level of depression did not meet the criteria for the study. If the subject is able to participate to the study they will be given the study drug. At each visit, adverse events will be discussed and whether there is any change in medicine. Vital signs and ECG will be obtained at visit one, two, five and/or Premature Termination. At every visit the subject will receive a diary in which they must record details about their attempts at sexual activity during the period between each visit and the number of tablets taken. Subjects will also be asked to fill in different questionnaires about their sexuality, mood and feelings, self-esteem and sexual activity. Subjects will also be contacted by telephone, at 2, 6 and 10 weeks after starting the study medication, 24 hours after the last dose of study medication. The doctor will give the study drug on 3 occasions. Should the subject or doctor prematurely stop trial participation the subject will be required to return to the clinic for a physical examination, vital signs and have blood samples and ECG obtained. They will also be asked to fill in different questionnaires.

lead_sponsor: Bayer

location_country:
Italy
France
Spain
United States
Canada


ReferenceCitation: Ferrari A, Merks JHM, Chisholm JC, Orbach D, Brennan B, Gallego S, van Noesel MM, McHugh K, van Rijn RR, Gaze MN, Martelli H, Bergeron C, Corradini N, Minard-Colin V, Bisogno G, Geoerger B, Caron HN, De Salvo GL, Casanova M. Outcomes of metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) treated within the BERNIE study: a randomised, phase II study evaluating the addition of bevacizumab to chemotherapy. Eur J Cancer. 2020 May;130:72-80. doi: 10.1016/j.ejca.2020.01.029. Epub 2020 Mar 13.

family: Ferrari

full_name: Andrea Ferrari

given: Andrea

family: Merks

full_name: Johannes H.M. Merks

given: Johannes H.M.

family: Chisholm

full_name: Julia C. Chisholm

given: Julia C.

family: Orbach

full_name: Daniel Orbach

given: Daniel

family: Brennan

full_name: Bernadette Brennan

given: Bernadette

family: Gallego

full_name: Soledad Gallego

given: Soledad

family: van Noesel

full_name: Max M. van Noesel

given: Max M.

family: McHugh

full_name: Kieran McHugh

given: Kieran

family: van Rijn

full_name: Rick R. van Rijn

given: Rick R.

family: Gaze

full_name: Mark N. Gaze

given: Mark N.

family: Martelli

full_name: Helene Martelli

given: Helene

family: Bergeron

full_name: Christophe Bergeron

given: Christophe

family: Corradini

full_name: Nadege Corradini

given: Nadege

family: Minard-Colin

full_name: Veronique Minard-Colin

given: Veronique

family: Bisogno

full_name: Gianni Bisogno

given: Gianni

family: Geoerger

full_name: Birgit Geoerger

given: Birgit

family: Caron

full_name: Hubert N. Caron

given: Hubert N.

family: De Salvo

full_name: Gian Luca De Salvo

given: Gian Luca

family: Casanova

full_name: Michela Casanova

given: Michela

journal_name: European Journal of Cancer

ReferenceCitation: Chisholm JC, Merks JHM, Casanova M, Bisogno G, Orbach D, Gentet JC, Thomassin-Defachelles AS, Chastagner P, Lowis S, Ronghe M, McHugh K, van Rijn RR, Hilton M, Bachir J, Fürst-Recktenwald S, Geoerger B, Oberlin O; European paediatric Soft tissue sarcoma Study Group (EpSSG) and the European Innovative Therapies for Children with Cancer (ITCC) Consortium. Open-label, multicentre, randomised, phase II study of the EpSSG and the ITCC evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients with metastatic soft tissue sarcoma (the BERNIE study). Eur J Cancer. 2017 Sep;83:177-184. doi: 10.1016/j.ejca.2017.06.015. Epub 2017 Aug 23.

location_country:
Italy
Brazil
Chile
Netherlands
Germany
France
Czechia
Poland
Israel
Belgium
Russian Federation
Spain
Canada
United Kingdom

location_facility: Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Nefrologia

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Universitatsklinikum Munster; Padiatrische Hamatologie und Onkologie

location_facility: Hospital Regional Universitario Carlos Haya;Servicio Oncologia Pediatrica

location_facility: CHU Hopital Sud; Service d'Hematologie Pediatrique

location_facility: University Hospital Essen; Department of Pediatric Oncology

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: CHU Bordeaux; Unite Onco-Hematologie Pediatrique

location_facility: U.O.A University Onco-Ematologia Pedicatria; Azienda Ospedaliera A.Meyer

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii

location_facility: St. James's University Hospital; Leeds Regional Paediatric Oncology Unit

location_facility: Center for Children's Hematology, Oncology and Immunology

location_facility: Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita

location_facility: Rambam Health Care Campus; Pediatric Hematology Oncology Department

location_facility: The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit

location_facility: Tel Aviv Sourasky MC, Dana Children's Hospital; Pediatric Hemato-Oncology Clinic

location_facility: Saint-Petersburg SHI City Clinical Hospital #31

location_facility: Hopital Des Enfants; Service d Hemato-Oncologie

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Great Ormond Street Hospital; Dept. Of Pediatric Oncology

location_facility: Chr De Nantes; Service D'oncologie Pediatrique

location_facility: Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology

location_facility: Istituto Gaslini Ospedale Pediatrico; Dipartimento di Oncoematologia pediatrica

location_facility: Birmingham Childrens Hospital; Oncology Dept

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Onco-Hematologia Pediatrica

location_facility: Alder Hey Children s Hospital; Department of Pediatrics

location_facility: Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica

location_facility: Universitaetsklinikum Freiburg - PS; Partnersite - Onkologie

location_facility: University Hospital Queens Medical Centre; Department of Paediatric Oncology

location_facility: Centre Oscar Lambret; Service de Pediatrie

location_facility: Uniwersytet Medyczny W Lublinie; Klinika Hematologii i Onkologii Dzieciecej

location_facility: Emma Kinderziekenhuis; Dept of Pediatric Oncology

location_facility: CHU Hopital d Enfants; Centre hospitalier Universitaire Nancy

location_facility: ITACI - Instituto de Tratamento do Cancer Infantil

title: An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma

summary: This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.


ReferenceType: result

ReferenceCitation: Heier JS, Brown DM, Chong V, Korobelnik JF, Kaiser PK, Nguyen QD, Kirchhof B, Ho A, Ogura Y, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Groetzbach G, Sommerauer B, Sandbrink R, Simader C, Schmidt-Erfurth U; VIEW 1 and VIEW 2 Study Groups. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012 Dec;119(12):2537-48. doi: 10.1016/j.ophtha.2012.09.006. Epub 2012 Oct 17. Erratum in: Ophthalmology. 2013 Jan;120(1):209-10.

family: Heier

full_name: Jeffrey S. Heier

given: Jeffrey S.

family: Brown

full_name: David M. Brown

given: David M.

family: Chong

full_name: Victor Chong

given: Victor

family: Korobelnik

full_name: Jean-Francois Korobelnik

given: Jean-Francois

family: Kaiser

full_name: Peter K. Kaiser

given: Peter K.

family: Nguyen

full_name: Quan Dong Nguyen

given: Quan Dong

family: Kirchhof

full_name: Bernd Kirchhof

given: Bernd

family: Ho

full_name: Allen Ho

given: Allen

family: Ogura

full_name: Yuichiro Ogura

given: Yuichiro

family: Yancopoulos

full_name: George D. Yancopoulos

given: George D.

family: Stahl

full_name: Neil Stahl

given: Neil

family: Vitti

full_name: Robert Vitti

given: Robert

family: Berliner

full_name: Alyson J. Berliner

given: Alyson J.

family: Soo

full_name: Yuhwen Soo

given: Yuhwen

family: Anderesi

full_name: Majid Anderesi

given: Majid

family: Groetzbach

full_name: Georg Groetzbach

given: Georg

family: Sommerauer

full_name: Bernd Sommerauer

family: Sandbrink

full_name: Rupert Sandbrink

given: Rupert

family: Simader

full_name: Christian Simader

given: Christian

family: Schmidt-Erfurth

full_name: Ursula Schmidt-Erfurth

given: Ursula

journal_name: Ophthalmology

title: Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration

ReferenceCitation: Schmidt-Erfurth U, Kaiser PK, Korobelnik JF, Brown DM, Chong V, Nguyen QD, Ho AC, Ogura Y, Simader C, Jaffe GJ, Slakter JS, Yancopoulos GD, Stahl N, Vitti R, Berliner AJ, Soo Y, Anderesi M, Sowade O, Zeitz O, Norenberg C, Sandbrink R, Heier JS. Intravitreal aflibercept injection for neovascular age-related macular degeneration: ninety-six-week results of the VIEW studies. Ophthalmology. 2014 Jan;121(1):193-201. doi: 10.1016/j.ophtha.2013.08.011. Epub 2013 Sep 29.

title: Intravitreal Aflibercept Injection for Neovascular Age-related Macular Degeneration

ReferenceCitation: Moshfeghi DM, Thompson D, Saroj N. Changes in neovascular activity following fixed dosing with an anti-vascular endothelial growth factor agent over 52 weeks in the phase III VIEW 1 and VIEW 2 studies. Br J Ophthalmol. 2020 Sep;104(9):1223-1227. doi: 10.1136/bjophthalmol-2019-315021. Epub 2019 Dec 11.

ReferenceCitation: Yuzawa M, Fujita K, Wittrup-Jensen KU, Norenberg C, Zeitz O, Adachi K, Wang EC, Heier J, Kaiser P, Chong V, Korobelnik JF. Improvement in vision-related function with intravitreal aflibercept: data from phase 3 studies in wet age-related macular degeneration. Ophthalmology. 2015 Mar;122(3):571-8. doi: 10.1016/j.ophtha.2014.09.024. Epub 2014 Nov 6.

title: Improvement in Vision-Related Function with Intravitreal Aflibercept

ReferenceCitation: Ogura Y, Terasaki H, Gomi F, Yuzawa M, Iida T, Honda M, Nishijo K, Sowade O, Komori T, Schmidt-Erfurth U, Simader C, Chong V; VIEW 2 Investigators. Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study. Br J Ophthalmol. 2015 Jan;99(1):92-7. doi: 10.1136/bjophthalmol-2014-305076. Epub 2014 Aug 8.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

location_country:
Australia
Belgium
Czech Republic
India
France
Japan
Poland
Slovakia
Argentina
Korea, Republic of
Colombia
Sweden
Switzerland
Netherlands
Singapore
Hungary
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Latvia

title: A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)

summary: This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America.


title: Randomized Study of LAROTAXEL + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the First Line Treatment of Locally Advanced/Metastatic Urothelial Tract or Bladder Cancer

acronym: CILAB

summary: This is a randomized, open-label, multi-center study comparing the efficacy and safety of XRP9881 plus cisplatin to gemcitabine plus cisplatin in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer. The primary objective is to compare overall survival. Secondary objectives include comparisons of progression free survival, objective response rate, time to definitive deterioration of performance status, duration of response, time to definitive weight loss, and assessments of overall safety, and pharmacokinetics. Patients are treated until disease progression, death, or unacceptable toxicity and are followed-up until death or the end of the study whichever comes first.

lead_sponsor: Sanofi

location_country:
Italy
Brazil
Chile
South Africa
India
Sweden
Mexico
Netherlands
Spain
France
Poland
Israel
Belgium
Argentina
Australia
Russian Federation
Turkey
United States
Canada

location_facility: Sanofi-Aventis Investigational Site Number 036003

location_facility: Sanofi-Aventis Investigational Site Number 250004

location_facility: Sanofi-Aventis Investigational Site Number 840039

location_facility: Sanofi-Aventis Investigational Site Number 376001

location_facility: Sanofi-Aventis Investigational Site Number 840021

location_facility: Sanofi-Aventis Investigational Site Number 840005

location_facility: Sanofi-Aventis Investigational Site Number 152001

location_facility: Sanofi-Aventis Investigational Site Number 840033

location_facility: Sanofi-Aventis Investigational Site Number 376007

location_facility: Sanofi-Aventis Investigational Site Number 250009

location_facility: Sanofi-Aventis Investigational Site Number 840020

location_facility: Sanofi-Aventis Investigational Site Number 032002

location_facility: Sanofi-Aventis Investigational Site Number 840012

location_facility: Sanofi-Aventis Investigational Site Number 840025

location_facility: Sanofi-Aventis Investigational Site Number 724001

location_facility: Sanofi-Aventis Investigational Site Number 250003

location_facility: Sanofi-Aventis Investigational Site Number 840010

location_facility: Sanofi-Aventis Investigational Site Number 056006

location_facility: Sanofi-Aventis Investigational Site Number 380008

location_facility: Sanofi-Aventis Investigational Site Number 840060

location_facility: Sanofi-Aventis Investigational Site Number 710008

location_facility: Sanofi-Aventis Investigational Site Number 792002

location_facility: Sanofi-Aventis Investigational Site Number 752001

location_facility: Sanofi-Aventis Investigational Site Number 724009

location_facility: Sanofi-Aventis Investigational Site Number 724008

location_facility: Sanofi-Aventis Investigational Site Number 643005

location_facility: Sanofi-Aventis Investigational Site Number 484005

location_facility: Sanofi-Aventis Investigational Site Number 840019

location_facility: Sanofi-Aventis Investigational Site Number 250011

location_facility: Sanofi-Aventis Investigational Site Number 840049

location_facility: Sanofi-Aventis Investigational Site Number 356001

location_facility: Sanofi-Aventis Investigational Site Number 792001

location_facility: Sanofi-Aventis Investigational Site Number 840041

location_facility: Sanofi-Aventis Investigational Site Number 124001

location_facility: Sanofi-Aventis Investigational Site Number 056003

location_facility: Sanofi-Aventis Investigational Site Number 484004

location_facility: Sanofi-Aventis Investigational Site Number 380002

location_facility: Sanofi-Aventis Investigational Site Number 724006

location_facility: Sanofi-Aventis Investigational Site Number 032001

location_facility: Sanofi-Aventis Investigational Site Number 792003

location_facility: Sanofi-Aventis Investigational Site Number 840001

location_facility: Sanofi-Aventis Investigational Site Number 643011

location_facility: Sanofi-Aventis Investigational Site Number 032003

location_facility: Sanofi-Aventis Investigational Site Number 380004

location_facility: Sanofi-Aventis Investigational Site Number 840056

location_facility: Sanofi-Aventis Investigational Site Number 724010

location_facility: Sanofi-Aventis Investigational Site Number 032005

location_facility: Sanofi-Aventis Investigational Site Number 616002

location_facility: Sanofi-Aventis Investigational Site Number 616004

location_facility: Sanofi-Aventis Investigational Site Number 643003

location_facility: Sanofi-Aventis Investigational Site Number 840032

location_facility: Sanofi-Aventis Investigational Site Number 840008

location_facility: Sanofi-Aventis Investigational Site Number 840015

location_facility: Sanofi-Aventis Investigational Site Number 356007

location_facility: Sanofi-Aventis Investigational Site Number 356005

location_facility: Sanofi-Aventis Investigational Site Number 724004

location_facility: Sanofi-Aventis Investigational Site Number 840026

location_facility: Sanofi-Aventis Investigational Site Number 528007

location_facility: Sanofi-Aventis Investigational Site Number 380003

location_facility: Sanofi-Aventis Investigational Site Number 840018

location_facility: Sanofi-Aventis Investigational Site Number 250006

location_facility: Sanofi-Aventis Investigational Site Number 250008

location_facility: Sanofi-Aventis Investigational Site Number 840017

location_facility: Sanofi-Aventis Investigational Site Number 840057

location_facility: Sanofi-Aventis Investigational Site Number 250007

location_facility: Sanofi-Aventis Investigational Site Number 710009

location_facility: Sanofi-Aventis Investigational Site Number 056005

location_facility: Sanofi-Aventis Investigational Site Number 616001

location_facility: Sanofi-Aventis Investigational Site Number 840036

location_facility: Sanofi-Aventis Investigational Site Number 710005

location_facility: Sanofi-Aventis Investigational Site Number 840050

location_facility: Sanofi-Aventis Investigational Site Number 840068

location_facility: Sanofi-Aventis Investigational Site Number 724002

location_facility: Sanofi-Aventis Investigational Site Number 840065

location_facility: Sanofi-Aventis Investigational Site Number 840038

location_facility: Sanofi-Aventis Investigational Site Number 484007

location_facility: Sanofi-Aventis Investigational Site Number 076005

location_facility: Sanofi-Aventis Investigational Site Number 840044

location_facility: Sanofi-Aventis Investigational Site Number 724003

location_facility: Sanofi-Aventis Investigational Site Number 840047

location_facility: Sanofi-Aventis Investigational Site Number 840011

location_facility: Sanofi-Aventis Investigational Site Number 380006

location_facility: Sanofi-Aventis Investigational Site Number 643008

location_facility: Sanofi-Aventis Investigational Site Number 724012

location_facility: Sanofi-Aventis Investigational Site Number 724011

location_facility: Sanofi-Aventis Investigational Site Number 840024

location_facility: Sanofi-Aventis Investigational Site Number 752002

location_facility: Sanofi-Aventis Investigational Site Number 840048

location_facility: Sanofi-Aventis Investigational Site Number 032004

location_facility: Sanofi-Aventis Investigational Site Number 076003

location_facility: Sanofi-Aventis Investigational Site Number 376002

location_facility: Sanofi-Aventis Investigational Site Number 710007

location_facility: Sanofi-Aventis Investigational Site Number 643007

location_facility: Sanofi-Aventis Investigational Site Number 840006

location_facility: Sanofi-Aventis Investigational Site Number 792004

location_facility: Sanofi-Aventis Investigational Site Number 840030

location_facility: Sanofi-Aventis Investigational Site Number 724013

location_facility: Sanofi-Aventis Investigational Site Number 840003

location_facility: Sanofi-Aventis Investigational Site Number 643010

location_facility: Sanofi-Aventis Investigational Site Number 528004

location_facility: Sanofi-Aventis Investigational Site Number 250012

location_facility: Sanofi-Aventis Investigational Site Number 840045

location_facility: Sanofi-Aventis Investigational Site Number 076002

location_facility: Sanofi-Aventis Investigational Site Number 840016

location_facility: Sanofi-Aventis Investigational Site Number 376004

location_facility: Sanofi-Aventis Investigational Site Number 056002

location_facility: Sanofi-Aventis Investigational Site Number 356002

location_facility: Sanofi-Aventis Investigational Site Number 356004

location_facility: Sanofi-Aventis Investigational Site Number 710006

location_facility: Sanofi-Aventis Investigational Site Number 376005

location_facility: Sanofi-Aventis Investigational Site Number 840013

location_facility: Sanofi-Aventis Investigational Site Number 056001

location_facility: Sanofi-Aventis Investigational Site Number 840064

location_facility: Sanofi-Aventis Investigational Site Number 484003

location_facility: Sanofi-Aventis Investigational Site Number 616005

location_facility: Sanofi-Aventis Investigational Site Number 840046

location_facility: Sanofi-Aventis Investigational Site Number 076006

location_facility: Sanofi-Aventis Investigational Site Number 840035

location_facility: Sanofi-Aventis Investigational Site Number 840007

location_facility: Sanofi-Aventis Investigational Site Number 076004

location_facility: Sanofi-Aventis Investigational Site Number 124007

location_facility: Sanofi-Aventis Investigational Site Number 710003

location_facility: Sanofi-Aventis Investigational Site Number 840061

location_facility: Sanofi-Aventis Investigational Site Number 840062

location_facility: Sanofi-Aventis Investigational Site Number 643002

location_facility: Sanofi-Aventis Investigational Site Number 710001

location_facility: Sanofi-Aventis Investigational Site Number 124003

location_facility: Sanofi-Aventis Investigational Site Number 076001

location_facility: Sanofi-Aventis Investigational Site Number 250001

location_facility: Sanofi-Aventis Investigational Site Number 840052

location_facility: Sanofi-Aventis Investigational Site Number 356003

location_facility: Sanofi-Aventis Investigational Site Number 528002

location_facility: Sanofi-Aventis Investigational Site Number 643006

location_facility: Sanofi-Aventis Investigational Site Number 840009

location_facility: Sanofi-Aventis Investigational Site Number 840029

location_facility: Sanofi-Aventis Investigational Site Number 250005

location_facility: Sanofi-Aventis Investigational Site Number 124006

location_facility: Sanofi-Aventis Investigational Site Number 792006

location_facility: Sanofi-Aventis Investigational Site Number 724007

location_facility: Sanofi-Aventis Investigational Site Number 076007

location_facility: Sanofi-Aventis Investigational Site Number 840031

location_facility: Sanofi-Aventis Investigational Site Number 840004

location_facility: Sanofi-Aventis Investigational Site Number 840002

location_facility: Sanofi-Aventis Investigational Site Number 643001

location_facility: Sanofi-Aventis Investigational Site Number 380001

location_facility: Sanofi-Aventis Investigational Site Number 840054

location_facility: Sanofi-Aventis Investigational Site Number 124002

location_facility: Sanofi-Aventis Investigational Site Number 840058

location_facility: Sanofi-Aventis Investigational Site Number 528001

location_facility: Sanofi-Aventis Investigational Site Number 376003

location_facility: Sanofi-Aventis Investigational Site Number 528003

location_facility: Sanofi-Aventis Investigational Site Number 056004

location_facility: Sanofi-Aventis Investigational Site Number 643004

location_facility: Sanofi-Aventis Investigational Site Number 840034

location_facility: Sanofi-Aventis Investigational Site Number 036004

location_facility: Sanofi-Aventis Investigational Site Number 528006

location_facility: Sanofi-Aventis Investigational Site Number 528005

location_facility: Sanofi-Aventis Investigational Site Number 380005

location_facility: Sanofi-Aventis Investigational Site Number 643009

location_facility: Sanofi-Aventis Investigational Site Number 036002


title: A Phase II, Double-blind, Placebo-controlled, Multi-centre, Randomised Study of AZD0530 in Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy

summary: The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer

ReferenceCitation: Yap TA, Carden CP, Kaye SB. Beyond chemotherapy: targeted therapies in ovarian cancer. Nat Rev Cancer. 2009 Mar;9(3):167-81. doi: 10.1038/nrc2583. Review.

family: Yap

full_name: Timothy A. Yap

given: Timothy A.

family: Carden

full_name: Craig P. Carden

given: Craig P.

family: Kaye

full_name: Stan B. Kaye

given: Stan B.

journal_name: Nature Reviews Cancer

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: AstraZeneca

location_country:
Peru
Netherlands
Spain
France
Bulgaria
Norway
Romania
Russian Federation
Portugal
Denmark
Canada
United Kingdom


title: A PHASE 3 RANDOMIZED, OPEN-LABEL STUDY OF BOSUTINIB VERSUS IMATINIB IN SUBJECTS WITH NEWLY DIAGNOSED CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOGENOUS LEUKEMIA

summary: Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

ReferenceCitation: Gambacorti-Passerini C, Cortes JE, Lipton JH, Dmoszynska A, Wong RS, Rossiev V, Pavlov D, Gogat Marchant K, Duvillié L, Khattry N, Kantarjian HM, Brümmendorf TH. Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia. Am J Hematol. 2014 Oct;89(10):947-53. doi: 10.1002/ajh.23788. Epub 2014 Jul 21.

name: Department of Internal MedicineUniversity of Milano BicoccaMonza Italy

family: Gambacorti‐Passerini

full_name: Carlo Gambacorti‐Passerini

given: Carlo

name: Department of LeukemiaDivision of Cancer MedicineMD Anderson Cancer CenterUniversity of TexasHouston Texas

family: Cortes

full_name: Jorge E. Cortes

given: Jorge E.

name: Department of Hematology/Medical OncologyPrincess Margaret HospitalToronto Ontario Canada

family: Lipton

full_name: Jeff H. Lipton

given: Jeff H.

name: Hematooncology and Bone Marrow Transplantation DepartmentMedical University of LublinLublin Poland

family: Dmoszynska

full_name: Anna Dmoszynska

given: Anna

name: Prince of Wales HospitalThe Chinese University of Hong KongShatin Hong Kong

family: Wong

full_name: Raymond S. Wong

given: Raymond S.

name: Hematology DepartmentSamara Regional Clinical HospitalSamara Russia

family: Rossiev

full_name: Victor Rossiev

given: Victor

name: Oncology Clinical StatisticsPfizer IncNew York New York

family: Pavlov

full_name: Dmitri Pavlov

given: Dmitri

name: Pfizer Global Research and DevelopmentParis France

family: Gogat Marchant

full_name: Karin Gogat Marchant

given: Karin

family: Duvillié

full_name: Ladan Duvillié

given: Ladan

name: Department of Medical OncologyTata Memorial CenterMumbai India

family: Khattry

full_name: Navin Khattry

given: Navin

family: Kantarjian

full_name: Hagop M. Kantarjian

given: Hagop M.

name: Clinic for OncologyHematologyand Stem Cell TransplantationUniversitätsklinikum AachenRWTH Aachen Aachen Germany

name: OncologyHematologyand Stem Cell TransplantationUniversitätsklinikum Hamburg‐EppendorfHamburg Germany

family: Brümmendorf

full_name: Tim H. Brümmendorf

given: Tim H.

journal_name: American Journal of Hematology

oa_colors: green hybrid

evidence: open (via crossref license)

license: cc-by-nc

license_normalized: cc-by-nc

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

repository_institution: PubMed Central - Europe PMC

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10. Retraction in: Drug Metab Pharmacokinet. 2019 Apr;34(2):163.

RetractionSource: Drug Metab Pharmacokinet. 2019 Apr;34(2):163

family: Hsyu

full_name: Poe-Hirr Hsyu

given: Poe-Hirr

family: Mould

full_name: Diane R. Mould

given: Diane R.

family: Abbas

full_name: Richat Abbas

given: Richat

family: Amantea

publisher: Japanese Society for the Study of Xenobiotics

publisher_dissemination: Japanese Society for the Study of Xenobiotics

publisher_group: Japanese Society for the Study of Xenobiotics

publisher_normalized: Japanese Society for the Study of Xenobiotics

title: Population Pharmacokinetic and Pharmacodynamic Analysis of Bosutinib

ReferenceCitation: Trask PC, Cella D, Powell C, Reisman A, Whiteley J, Kelly V. Health-related quality of life in chronic myeloid leukemia. Leuk Res. 2013 Jan;37(1):9-13. doi: 10.1016/j.leukres.2012.09.013. Epub 2012 Oct 29.

ReferenceCitation: Cortes JE, Kim DW, Kantarjian HM, Brümmendorf TH, Dyagil I, Griskevicius L, Malhotra H, Powell C, Gogat K, Countouriotis AM, Gambacorti-Passerini C. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol. 2012 Oct 1;30(28):3486-92. Epub 2012 Sep 4.

ReferenceCitation: O'Hare T, Zabriskie MS, Eiring AM, Deininger MW. Pushing the limits of targeted therapy in chronic myeloid leukaemia. Nat Rev Cancer. 2012 Jul 24;12(8):513-26. doi: 10.1038/nrc3317. Review. Erratum in: Nat Rev Cancer. 2012 Dec;12(12):886.

location_country:
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Lithuania
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Hong Kong
Singapore
Hungary
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain
Turkey
Latvia

location_facility: Advanced Centre for Treatment, Research and Education in Cancer

location_facility: Ankara Universitesi Tip Fakultesi Cebeci Hastanesi

location_facility: Centre d'Investigation Clinique- CIC INSERM802

location_facility: Institut Klinichnoi Radiologii Naukovogo Centru Radiacijnoi Medicini NAMN Ukraini

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: III. Medizinische Klinik, Universitaetsklinikum Mannheim gGmbH

location_facility: Hematology, Oncology & Transfusion Medicine Center

location_facility: Centro De Hematologia E Hemoterapia Da Unicamp

location_facility: Centre Hospitalier de Versailles Hopital Andre Mignot

location_facility: Hospital de Madrid Norte-Sanchinarro Centro Integral Oncologico

location_facility: Ruiging Hospital Affiliated to Shanghai Jiaotong University School of Medicine

location_facility: Department of Radiology, Chris Hani Baragwanath Hospital

location_facility: State Novosibirsk Regional Clinical Hospital

location_facility: Ospedale Ferrarotto - Divisione di Ematologia

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: University Health Network, Princess Margaret Hospital

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: Department of Cardiology, Chris Hani Baragwanath Hospital

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Perm Territory State Budgetary Healthcare Inst

location_facility: Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly

location_facility: Cherkaskiy oblasniy onkologichniy dispanser

location_facility: CIOSAD Centro de Investigaciones Oncologicas

location_facility: Kirov Research Institute of Hematology and Blood Transfusion of

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: St-Petersburg Pavlov's State Medical University

location_facility: Institut Klinichnoi Radiologii DU "Natsionalnyj Naukovyj Centr Radiacijnoi Medicini NAMN Ukraini"

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Indiana Blood and Marrow Transplantation Research

location_facility: Study Supplies: Regional Cancer Care Associates

location_facility: Ultrasaund Educational and Diagnostic Center

location_facility: Sverdlovsk Regional Clinical Hospital #1

location_facility: III. Medizinischen Klinik und Poliklinik des Klinikums Rechts der Isar der TU-MUNCHEN

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: University Hospital Gent - Department of Hematology

location_facility: The Hematology Hospital of Chinese Academy of Medical Science

location_facility: Institut Klinichnoi Radiologii Naukovogo

location_facility: Hospital Universitari Clinic de Barcelona

location_facility: Dipartimento Di Ematologia Ospedale Santo Eugenio

location_facility: 3rd Floor Centre for Clinical Haematology

location_facility: Federal State Budget Institution Hematology Scientific Center of Minzdravsotsrazvitiya of Russia

location_facility: Regional State Budgetary Healthcare Institution "Barnaul City Hospital #8"

location_facility: Clinical Haematology Unit - Department of Medicine

location_facility: Instytut Nevidkladnoi ta Vidnovnoi Hirurgii im. P.K. Husaka NAMN Ukrainy, Viddilennja Hematologii

location_facility: SEAROC Cancer Center, Soni Manipal Hospital

location_facility: Komunalnyj Zaklad "Dnipropetrovska Miska Bagatoprofilna Klinichna Likarnja #4"

location_facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

location_facility: Hamamatsu Medical University Hospital Faculty of Medicine

location_facility: Department of Haematology - Level 3, Bexley Wing

location_facility: Tokyo Metropolitan Cancer & Infectious Disease Centre Komagome Hp

location_facility: Oleksandrovska clinical hospital cardiological rehabilitation department

location_facility: Hospital Clinico Universitario de Valencia (CHUV)

location_facility: Rostov State Medical University of the Minzdravsotsrazvitiya of Russia

location_facility: Samodzielny Publiczny Szpital Kliniczny Im. A. Mieleckiego Slaskiego Uniwersytetu Medycznego

location_facility: Hammersmith Hospital Clinical Trial Units

location_facility: Charite University Medical Center - Campus Virchow Klinikum

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: Tata Memorial Center, Tata Memorial Hospital

location_facility: Niigata University Medical and Dental Hospital

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

location_facility: Stanford Hospital and Clinics Investigational Drug Services

location_facility: Samara Regional Clinical Hospital M.I. Kalinin

location_facility: Instutut Patologii Krovi to Transfuziynoi Medicinu AMN Ukraini

location_facility: Universitaetsklinikum Leipzig Zentrum fur Innere Medizin

location_facility: Johannesburg Hospital, Department of Medical Oncology

location_facility: CHU de Charleroi - Hopital civil Marie Curie

location_facility: Clinical Diagnostic Laboratory of Komunalnyj Zaklad

location_facility: Yaroslavl Region State Budgetary Healthcare Institution Regional Clinical Hospital

location_facility: Division of Hematology, Department of Medicine

location_facility: Japanese Red Cross Nagoya First Hospital

location_facility: Complejo Hospitalario de Toledo- Servicio de Hematologia.

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

location_facility: Indiana Blood and Marrow Transplantation Research Franciscan St. Francis Health Center Inc.


title: A Long-term, Open Label, Noncomparative Study to Evaluate the Safety of 0.1% Tacrolimus (FK506) Ointment for Treatment of Atopic Dermatitis

summary: Patients who have participated in previous studies with Tacrolimus ointment for atopic eczema are entitled to enter this four-year follow study to investigate the safety of treatment with Tacrolimus ointment 0.1%

design_allocation: Non-Randomized

ReferenceCitation: Reitamo S, Rustin M, Harper J, Kalimo K, Rubins A, Cambazard F, Brenninkmeijer EE, Smith C, Berth-Jones J, Ruzicka T, Sharpe G, Taieb A; 0.1% Tacrolimus Ointment Long-term Follow-up Study Group. A 4-year follow-up study of atopic dermatitis therapy with 0.1% tacrolimus ointment in children and adult patients. Br J Dermatol. 2008 Sep;159(4):942-51. doi: 10.1111/j.1365-2133.2008.08747.x. Epub 2008 Jul 15.

location_country:
United Kingdom
Netherlands
Finland
France
Poland
Hungary
Belgium
Ireland
Spain
Denmark
Germany
Latvia


ReferenceCitation: Baselga J, Piccart M, Gelber R, di CosimoS, Viale G, Koehler M, Rojo F. Neo-ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) study [BIG 1-06 /solti/EGF106903]: a phase III translational study for HER2-overexpressing early breast cancer. [Lancet]. 2012;S140-6736(11):

ReferenceCitation: Powles RL, Redmond D, Sotiriou C, Loi S, Fumagalli D, Nuciforo P, Harbeck N, de Azambuja E, Sarp S, Di Cosimo S, Huober J, Baselga J, Piccart-Gebhart M, Elemento O, Pusztai L, Hatzis C. Association of T-Cell Receptor Repertoire Use With Response to Combined Trastuzumab-Lapatinib Treatment of HER2-Positive Breast Cancer: Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):e181564. doi: 10.1001/jamaoncol.2018.1564. Epub 2018 Nov 8.

name: Breast Medical Oncology, Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut

name: Computational Biology and Bioinformatics Program, Yale University, New Haven, Connecticut

family: Powles

full_name: Ryan L. Powles

given: Ryan L.

name: Institute for Computational Biomedicine, Department of Physiology and Biophysics, Weill Cornell Medical College, New York, New York

family: Redmond

full_name: David Redmond

given: David

name: Breast Cancer Translational Research Laboratory, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

family: Sotiriou

full_name: Christos Sotiriou

given: Christos

name: Division of Cancer Medicine and Research, Peter MacCallum Cancer Center, East Melbourne, Victoria, Australia

family: Loi

full_name: Sherene Loi

given: Sherene

family: Fumagalli

full_name: Debora Fumagalli

given: Debora

name: Molecular Oncology Laboratory, Vall d’Hebron Institute of Oncology, Barcelona, Spain

family: Nuciforo

full_name: Paolo Nuciforo

given: Paolo

family: Harbeck

full_name: Nadia Harbeck

given: Nadia

family: de Azambuja

full_name: Evandro de Azambuja

given: Evandro

family: Sarp

full_name: Severine Sarp

given: Severine

name: Department of Oncology, Istituto Nazionale Tumori, Milan, Italy

family: Di Cosimo

full_name: Serena Di Cosimo

given: Serena

name: Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany

family: Huober

full_name: Jens Huober

given: Jens

name: Breast Medical Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York

family: Baselga

full_name: Jose Baselga

given: Jose

family: Piccart-Gebhart

full_name: Martine Piccart-Gebhart

given: Martine

name: Caryl and Israel Englander Institute for Precision Medicine, Weill Cornell Medical College, New York, New York

family: Elemento

full_name: Olivier Elemento

given: Olivier

family: Pusztai

full_name: Lajos Pusztai

given: Lajos

family: Hatzis

full_name: Christos Hatzis

journal_name: JAMA Oncology

version: acceptedVersion

publisher: American Medical Association (AMA)

publisher_dissemination: American Medical Association

publisher_group: American Medical Association

publisher_normalized: American Medical Association

ReferenceCitation: Fumagalli D, Venet D, Ignatiadis M, Azim HA Jr, Maetens M, Rothé F, Salgado R, Bradbury I, Pusztai L, Harbeck N, Gomez H, Chang TW, Coccia-Portugal MA, Di Cosimo S, de Azambuja E, de la Peña L, Nuciforo P, Brase JC, Huober J, Baselga J, Piccart M, Loi S, Sotiriou C. RNA Sequencing to Predict Response to Neoadjuvant Anti-HER2 Therapy: A Secondary Analysis of the NeoALTTO Randomized Clinical Trial. JAMA Oncol. 2017 Feb 1;3(2):227-234. doi: 10.1001/jamaoncol.2016.3824. Erratum in: JAMA Oncol. 2019 Jan 1;5(1):122.

family: Venet

full_name: David Venet

name: Frontier Science Scotland, Kincraig, Inverness-shire, Scotland

name: Breast Medical Oncology Section, Yale Cancer Center, Yale School of Medicine, New Haven, Connecticut

name: Breast Center, Department of Obstetrics and Gynecology, University of Munich, Munich, Germany

name: Department of Medical Oncology, Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru

name: Department of Surgery, National Cheng Kung University Hospital, Tainan, Taiwan

name: Clinical Trial Department, Eastleigh Breast Care Centre, Pretoria, South Africa

name: Breast European Adjuvant Study Team, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

name: SOLTI–Breast Cancer Research Group, Barcelona, Spain

name: Novartis Pharmaceutical, Basel, Switzerland

name: Breast Medicine Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York

name: Department of Medical Oncology, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

ReferenceCitation: Salgado R, Denkert C, Campbell C, Savas P, Nuciforo P, Aura C, de Azambuja E, Eidtmann H, Ellis CE, Baselga J, Piccart-Gebhart MJ, Michiels S, Bradbury I, Sotiriou C, Loi S. Tumor-Infiltrating Lymphocytes and Associations With Pathological Complete Response and Event-Free Survival in HER2-Positive Early-Stage Breast Cancer Treated With Lapatinib and Trastuzumab: A Secondary Analysis of the NeoALTTO Trial. JAMA Oncol. 2015 Jul;1(4):448-54. doi: 10.1001/jamaoncol.2015.0830. Erratum in: JAMA Oncol. 2015 Jul;1(4):544. JAMA Oncol. 2015 Nov;1(8):1172. Nucifero, Paolo [corrected to Nuciforo, Paolo]. JAMA Oncol. 2019 Jan 1;5(1):122.

name: Department of Pathology, Gasthuis Zusters Antwerpen Hospitals, Antwerp, Belgium

name: Institute of Pathology, Charité-Universitätsmedizin, Berlin, Germany

name: German Cancer Consortium, Berlin, Germany

name: Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, United Kingdom

name: Division of Clinical Medicine and Research, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia

name: Val d’Hebron Institute of Oncology, Barcelona, Spain

name: Breast European Adjuvant Study Team, Institut Jules Bordet, Brussels, Belgium

name: Department of Obstetrics and Gynecology, Campus Kiel, University Hospital Kiel, Kiel, Germany

name: GlaxoSmithKline Oncology, Collegeville, Pennsylvania

name: Memorial Sloan-Kettering Cancer Center, New York, New York

name: Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium

name: Centre de Recherche en Epidémiologie et Santé des Populations, INSERM U1018, Service de Biostatistique et d’Epidémiologie, Gustave Roussy, Université Paris-Sud, Villejuif, France

ReferenceCitation: Nuciforo PG, Aura C, Holmes E, Prudkin L, Jimenez J, Martinez P, Ameels H, de la Peña L, Ellis C, Eidtmann H, Piccart-Gebhart MJ, Scaltriti M, Baselga J. Benefit to neoadjuvant anti-human epidermal growth factor receptor 2 (HER2)-targeted therapies in HER2-positive primary breast cancer is independent of phosphatase and tensin homolog deleted from chromosome 10 (PTEN) status. Ann Oncol. 2015 Jul;26(7):1494-500. doi: 10.1093/annonc/mdv175. Epub 2015 Apr 7.

ReferenceCitation: de Azambuja E, Holmes AP, Piccart-Gebhart M, Holmes E, Di Cosimo S, Swaby RF, Untch M, Jackisch C, Lang I, Smith I, Boyle F, Xu B, Barrios CH, Perez EA, Azim HA Jr, Kim SB, Kuemmel S, Huang CS, Vuylsteke P, Hsieh RK, Gorbunova V, Eniu A, Dreosti L, Tavartkiladze N, Gelber RD, Eidtmann H, Baselga J. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): survival outcomes of a randomised, open-label, multicentre, phase 3 trial and their association with pathological complete response. Lancet Oncol. 2014 Sep;15(10):1137-46. doi: 10.1016/S1470-2045(14)70320-1. Epub 2014 Aug 14.

repository_institution: University of Pretoria - UpSpace Institutional Repository

ReferenceCitation: Yarden Y, Pines G. The ERBB network: at last, cancer therapy meets systems biology. Nat Rev Cancer. 2012 Jul 12;12(8):553-63. doi: 10.1038/nrc3309. Review.

ReferenceCitation: Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, Gómez H, Dinh P, Fauria K, Van Dooren V, Aktan G, Goldhirsch A, Chang TW, Horváth Z, Coccia-Portugal M, Domont J, Tseng LM, Kunz G, Sohn JH, Semiglazov V, Lerzo G, Palacova M, Probachai V, Pusztai L, Untch M, Gelber RD, Piccart-Gebhart M; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012 Feb 18;379(9816):633-40. doi: 10.1016/S0140-6736(11)61847-3. Epub 2012 Jan 17. Erratum in: Lancet. 2012 Feb 18;379(9816):616. Dosage error in published abstract; MEDLINE/PubMed abstract corrected.

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

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

location_country:
Peru
Romania
Belgium
Russian Federation
Taiwan
Ukraine
India
Pakistan
France
Lithuania
Norway
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Hungary
Germany
United Kingdom
Italy
Brazil
Czechia
Spain

title: Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study: A Randomised, Multicenter Open-label Phase III Study of Neoadjuvant Lapatinib, Trastuzumab and Their Combination Plus Paclitaxel in Women With HER2/ErbB2 Positive Primary Breast Cancer

summary:
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given as neoadjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer.

Patients will be randomised to receive either: lapatinib 1500 mg daily, trastuzumab 4 mg/kg intravenous (IV) load followed by 2 mg/kg IV weekly, or lapatinib 1000 mg daily with trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for a total of 6 weeks. After this biological window, patients on monotherapy arms will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m^2 for a further 12 weeks, up to definitive surgery. In the combination arm, patients will receive lapatinib 750 mg daily in combination with trastuzumab 2 mg/kg IV plus weekly paclitaxel 80mg/m^2 IV for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with 5-Fluorouracil Epirubicin Cyclophosphamide (FEC) followed by the same targeted therapy as in the biological window of the neoadjuvant setting for a further 34 weeks (in the combination arm, lapatinib dose will be 1000 mg daily in combination with trastuzumab). The planned total duration of the anti-HER2 therapy one year.

Primary objective is to evaluate and compare the rate of pathological complete response (pCR) at the time of surgery in patients with HER2/ErbB2 overexpressing or amplified operable breast cancer randomised to lapatinib followed by lapatinib plus paclitaxel versus trastuzumab followed by trastuzumab plus paclitaxel versus lapatinib in combination with trastuzumab followed by lapatinib, trastuzumab plus paclitaxel.


ReferenceCitation: Raskin JB, Kamm MA, Jamal MM, Márquez J, Melzer E, Schoen RE, Szalóki T, Barrett K, Streck P. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. Gastroenterology. 2014 Oct;147(4):793-802. doi: 10.1053/j.gastro.2014.07.004. Epub 2014 Jul 16.

family: Raskin

full_name: Jeffrey B. Raskin

given: Jeffrey B.

family: Kamm

full_name: Michael A. Kamm

given: Michael A.

family: Jamal

full_name: M. Mazen Jamal

given: M. Mazen

family: Márquez

full_name: Juan Márquez

given: Juan

family: Melzer

full_name: Ehud Melzer

given: Ehud

family: Schoen

full_name: Robert E. Schoen

given: Robert E.

family: Szalóki

full_name: Tibor Szalóki

given: Tibor

family: Barrett

full_name: Karen Barrett

given: Karen

family: Streck

full_name: Paul Streck

given: Paul

journal_name: Gastroenterology

title: Mesalamine Did Not Prevent Recurrent Diverticulitis in Phase 3 Controlled Trials

lead_sponsor: Shire

primary_purpose: Prevention

location_country:
Sweden
India
France
Israel
Argentina
Australia
New Zealand
Spain
United States
United Kingdom
Colombia

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: Lakeshore Hospital & Research Centre Ltd

location_facility: Gastroenterology Associates Clinical Research

location_facility: Florida Medical Clinic/Tampa Clinical Trials

location_facility: Allied Gastrointestinal Associates, P.A.

location_facility: Institute of Postgraduate Medical Education and Research

location_facility: Long Island Clinical Research Associates

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: Cabinet de Gastro-enterologie du Dr Alain Thevenin

location_facility: Long Island Gastrointestinal Research Group

location_facility: Hospital General Universitario de Valencia

location_facility: Gastroenterology Associates of Fairfield County

location_facility: Sree Gokulam Medical College and Research Foundation

location_facility: Aurora Advanced Healthcare, Inc. - Clinical Research Center

title: A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.

summary: The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.


title: A 3 Month, Randomised, Open Label, Parallel Group, Descriptive Study to Explore and Compare Perceptions and Satisfaction for Two Different Delivery Mechanisms for Etanercept (Etanercept Auto-injector and the Etanercept Prefilled Syringe) in Patients With Psoriasis.

summary: Primary objective of this study is to compare patient satisfaction with the prefilled syringe (PFS) and the auto-injector (AI), two different delivery devices for etanercept after 12 weeks of use, using a 10 point scale form totally dissatisfied to totally satisfied.Secondary evaluation focus on the identification of patient and device attributes associated with patient satisfaction.

lead_sponsor: Pfizer

location_country: Italy Sweden Netherlands Finland France Greece Norway Hungary Belgium Spain Denmark Germany

intervention_type: Device