title: An Open, Prospective, Randomised, Controlled, Multi-Center Study Comparing Fixed Dose vs Concentration Controlled Mycophenolate Mofetil Regimens for de Novo Patients Following Transplantation

summary: Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

ReferenceCitation: van Gelder T, Hilbrands LB, Vanrenterghem Y, Weimar W, de Fijter JW, Squifflet JP, Hené RJ, Verpooten GA, Navarro MT, Hale MD, Nicholls AJ. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999 Jul 27;68(2):261-6.

ReferenceCitation: van Gelder T, Silva HT, de Fijter JW, Budde K, Kuypers D, Tyden G, Lohmus A, Sommerer C, Hartmann A, Le Meur Y, Oellerich M, Holt DW, Tönshoff B, Keown P, Campbell S, Mamelok RD. Comparing mycophenolate mofetil regimens for de novo renal transplant recipients: the fixed-dose concentration-controlled trial. Transplantation. 2008 Oct 27;86(8):1043-51. doi: 10.1097/TP.0b013e318186f98a.

family: van Gelder

full_name: Teun van Gelder

given: Teun

family: Silva

full_name: Helio Tedesco Silva

given: Helio Tedesco

family: de Fijter

full_name: Johan W. de Fijter

given: Johan W.

family: Budde

full_name: Klemens Budde

given: Klemens

family: Kuypers

full_name: Dirk Kuypers

given: Dirk

family: Tyden

full_name: Gunnar Tyden

given: Gunnar

family: Lohmus

full_name: Aleksander Lohmus

given: Aleksander

family: Sommerer

full_name: Claudia Sommerer

given: Claudia

family: Hartmann

full_name: Anders Hartmann

given: Anders

family: Le Meur

full_name: Yann Le Meur

given: Yann

family: Oellerich

full_name: Michael Oellerich

given: Michael

family: Holt

full_name: David W. Holt

given: David W.

family: Tönshoff

full_name: Burkhard Tönshoff

given: Burkhard

family: Keown

full_name: Paul Keown

given: Paul

family: Campbell

full_name: Scott Campbell

given: Scott

family: Mamelok

full_name: Richard D. Mamelok

given: Richard D.

journal_name: Transplantation

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

title: Comparing Mycophenolate Mofetil Regimens for de Novo Renal Transplant Recipients: The Fixed-Dose Concentration-Controlled Trial

ReferenceCitation: Höcker B, van Gelder T, Martin-Govantes J, Machado P, Tedesco H, Rubik J, Dehennault M, Garcia Meseguer C, Tönshoff B; FDCC Study Group. Comparison of MMF efficacy and safety in paediatric vs. adult renal transplantation: subgroup analysis of the randomised, multicentre FDCC trial. Nephrol Dial Transplant. 2011 Mar;26(3):1073-9. doi: 10.1093/ndt/gfq450. Epub 2010 Jul 28.

family: Hocker

full_name: B. Hocker

given: B.

full_name: T. van Gelder

given: T.

family: Martin-Govantes

full_name: J. Martin-Govantes

given: J.

family: Machado

full_name: P. Machado

given: P.

family: Tedesco

full_name: H. Tedesco

given: H.

ReferenceCitation: van Gelder T, Tedesco Silva H, de Fijter JW, Budde K, Kuypers D, Arns W, Soulillou JP, Kanellis J, Zelvys A, Ekberg H, Holzer H, Rostaing L, Mamelok RD. Renal transplant patients at high risk of acute rejection benefit from adequate exposure to mycophenolic acid. Transplantation. 2010 Mar 15;89(5):595-9. doi: 10.1097/TP.0b013e3181ca7d84.

title: Renal Transplant Patients at High Risk of Acute Rejection Benefit From Adequate Exposure to Mycophenolic Acid

ReferenceCitation: van Schaik RH, van Agteren M, de Fijter JW, Hartmann A, Schmidt J, Budde K, Kuypers D, Le Meur Y, van der Werf M, Mamelok R, van Gelder T. UGT1A9 -275T>A/-2152C>T polymorphisms correlate with low MPA exposure and acute rejection in MMF/tacrolimus-treated kidney transplant patients. Clin Pharmacol Ther. 2009 Sep;86(3):319-27. doi: 10.1038/clpt.2009.83. Epub 2009 Jun 3.

title: UGT1A9 -275T>A/-2152C>T Polymorphisms Correlate With Low MPA Exposure and Acute Rejection in MMF/Tacrolimus-Treated Kidney Transplant Patients

location_country:
Austria
Brazil
Sweden
Netherlands
Spain
Germany
France
Poland
Lithuania
Venezuela
Norway
Australia
Belgium
China
Estonia
Denmark
Canada
United Kingdom
Taiwan

location_facility: Karolinska University Hospital, Huddinge

location_facility: Surgical Clinic Of Tartu University Clinics

location_facility: Centre Hospitalier Regional Universitaire

location_facility: West China Hospital of Sichuan University

location_facility: Complejo Hospitalario Univeritario de Santiago

location_facility: Institute of Transplantology, Medical University of Warsaw


intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

lead_sponsor: Lymphoma Study Association

enrollment_type: Actual

primary_purpose: Treatment

location_country: Belgium France

location_facility:
Hôpital Henri Mondor
Hôpital Necker
Hôpital Purpan
CHU de Lens
Hôpital d'Avicenne
CHU Claude Huriez
Centre Hospitalier de Perpigan
CH d'Annecy
CH de Chambery
Centre Leon Berard
Centre Henri Becquerel
Centre Hospitalier d'Avignon
Hôpital Bon Secours
Centre Antoine Lacassagne
Clinique Saint Pierre
Centre Hospitalier Lyon Sud
CHU Clemenceau
CHR de la Citadelle
CHU Le Bocage
Centre Hospitalier de Dunkerque
Hôpital des Chanaux
Centre Francois Baclesse
Polyclinique Bordeaux Nord Aquitaine
Hôpital Bicêtre
Heilig Hart Ziekenhuis
CH de St Germain
UCL - Mont-Godinne
Hôpital Saint Joseph
Hôpital Emile Muller
CH de Meaux
A. Z. Sint-Jan
CH Notre Dame
CH de Brive
Hôpital Andre Mignot
ZNA Stuivenberg
CH de Chartres
CHU Charleroi-Vésale
Hôpital de Bayonne
Hôpital Saint Louis
Hôpital Dupuytren
Hôpital Gilles de Corbeil
Hopital Saint Vincent de Paul
UCL- Saint Luc
Hopital Brabois
AZ VUB

ipd_sharing: No

study_completion_date_type: Actual

source: euctr

title: Prospective Multicentre Phase II Study to Evaluate the Combination of Rituximab and DepoCyte® by Intrathecal Injection in the C5R Chemotherapy Protocol in Patients Between the Ages of 18 and 60 Years With Primary Cerebral Non-Hodgkin Lymphoma and Systemic Diffuse Large B-cell Lymphoma With Neuromeningeal Invasion at Diagnosis

summary:
The purpose of this study is to measure the rate of complete response (CR and UCR) at the end of a course of immuno-chemotherapy:

before cerebral radiotherapy for PCL
after the course of immuno-chemotherapy for aggressive lymphomas with neuromeningeal involvement Toxicity of the protocol Overall survival Survival without relapse Long-term incidence of neurocognitive toxicity

lead_sponsor_type: industriel

status_simplified: Completed


title: A Multi-Center, Double-Blind, Randomized Study Comparing the Efficacy of Combination Therapy of Eprosartan Respectively Ramipril With Low-Dose Hydrochlorothiazide and Moxonidine on Blood Pressure Levels in Patients With Hypertension and Associated Diabetes Mellitus Type 2

summary: This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ.

design_allocation: Randomized

lead_sponsor: Solvay Pharmaceuticals

location_country:
Italy
Sweden
Germany
France
Norway
Spain
Denmark
Canada
United Kingdom

location_facility:
Site 32
Site 2
Site 28
Site 58
Site 55
Site 31
Site 47
Site 57
Site 60
Site 56
Site 11
Site 21
Site 37
Site 35
Site 30
Site 53
Site 15
Site 41
Site 27
Site 50
Site 4
Site 23
Site 10
Site 62
Site 6
Site 8
Site 12
Site 43
Site 48
Site 64
Site 24
Site 46
Site 20
Site 33
Site 14
Site 63
Site 42
Site 7
Site 16
Site 40
Site 38
Site 36
Site 9
Site 19
Site 45
Site 22
Site 44
Site 52
Site 61
Site 29
Site 5
Site 25
Site 3
Site 18
Site 59
Site 17
Site 51
Site 54
Site 34
Site 26
Site 13
Site 49
Site 39


ReferenceType: derived

ReferenceCitation: Bell R, Brown J, Parmar M, Toi M, Suter T, Steger GG, Pivot X, Mackey J, Jackisch C, Dent R, Hall P, Xu N, Morales L, Provencher L, Hegg R, Vanlemmens L, Kirsch A, Schneeweiss A, Masuda N, Overkamp F, Cameron D. Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer. Ann Oncol. 2017 Apr 1;28(4):754-760. doi: 10.1093/annonc/mdw665.

family: Bell

full_name: R. Bell

given: R.

sequence: first

family: Brown

full_name: J. Brown

sequence: additional

family: Parmar

full_name: M. Parmar

given: M.

family: Toi

full_name: M. Toi

family: Suter

full_name: T. Suter

family: Steger

full_name: G.G. Steger

family: Pivot

full_name: X. Pivot

given: X.

family: Mackey

full_name: J. Mackey

family: Jackisch

full_name: C. Jackisch

given: C.

family: Dent

full_name: R. Dent

family: Hall

full_name: P. Hall

family: Xu

full_name: N. Xu

given: N.

family: Morales

full_name: L. Morales

given: L.

family: Provencher

full_name: L. Provencher

family: Hegg

full_name: R. Hegg

family: Vanlemmens

full_name: L. Vanlemmens

family: Kirsch

full_name: A. Kirsch

given: A.

family: Schneeweiss

full_name: A. Schneeweiss

family: Masuda

full_name: N. Masuda

family: Overkamp

full_name: F. Overkamp

given: F.

family: Cameron

full_name: D. Cameron

given: D.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Annals of Oncology

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: University of Edinburgh - Edinburgh Research Explorer

ReferenceCitation: Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. doi: 10.1016/S1470-2045(13)70335-8. Epub 2013 Aug 7.

location_country: Macedonia, The Former Yugoslav Republic of

title: An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.

summary:
The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.

The secondary objectives of this trial are to:

compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
evaluate the safety and tolerability of bevacizumab

An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.


title: A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1

summary: The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.

ReferenceCitation: Neumann AU, Pianko S, Zeuzem S, Yoshida EM, Benhamou Y, Mishan M, McHutchison JG, Pulkstenis E, Mani Subramanian G. Positive and negative prediction of sustained virologic response at weeks 2 and 4 of treatment with albinterferon alfa-2b or peginterferon alfa-2a in treatment-naïve patients with genotype 1, chronic hepatitis C. J Hepatol. 2009 Jul;51(1):21-8. doi: 10.1016/j.jhep.2009.01.017. Epub 2009 Mar 11.

family: Neumann

full_name: Avidan U. Neumann

given: Avidan U.

family: Pianko

full_name: Stephen Pianko

given: Stephen

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Yoshida

full_name: Eric M. Yoshida

given: Eric M.

family: Benhamou

full_name: Yves Benhamou

given: Yves

family: Mishan

full_name: Moshe Mishan

given: Moshe

family: McHutchison

full_name: John G. McHutchison

given: John G.

family: Pulkstenis

full_name: Erik Pulkstenis

given: Erik

family: Mani Subramanian

full_name: G. Mani Subramanian

given: G.

journal_name: Journal of Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Zeuzem S, Yoshida EM, Benhamou Y, Pianko S, Bain VG, Shouval D, Flisiak R, Rehak V, Grigorescu M, Kaita K, Cronin PW, Pulkstenis E, Subramanian GM, McHutchison JG. Albinterferon alfa-2b dosed every two or four weeks in interferon-naïve patients with genotype 1 chronic hepatitis C. Hepatology. 2008 Aug;48(2):407-17. doi: 10.1002/hep.22403.

family: Bain

full_name: Vincent G. Bain

given: Vincent G.

family: Shouval

full_name: Daniel Shouval

given: Daniel

family: Flisiak

full_name: Robert Flisiak

given: Robert

family: Rehak

full_name: Vratislav Rehak

given: Vratislav

family: Grigorescu

full_name: Mircea Grigorescu

given: Mircea

family: Kaita

full_name: Kelly Kaita

given: Kelly

family: Cronin

full_name: Patrick W. Cronin

given: Patrick W.

location_country:
France
Poland
Israel
Romania
Australia
Germany
Czech Republic
Canada

location_facility: Katedra i Klinika Chorob Zakaznych i Hepatologii

location_facility: Klinika Hepatologii i Nabytych Niedoborow Immunologicznych

location_facility: University of Marseille, Hopital Saint Joseph

location_facility: Spitalul de Boli Infectioase si Tropicale "Dr. Victor Babes"

location_facility: University of Orleans, Hopital de la Source

location_facility: University of Berlin, Charite Campus Virchow Klinikum

location_facility: University of Toulouse, Clinique Dieulafoy

location_facility: University of Lille, Hopital Claude Huriez

location_facility: Katedra i Oddzial Kliniczny Chorob Zakaznych

location_facility: University of Hamburg, Hospital Hamburg Eppendorf

location_facility: University of Paris, Hopital Pitie-Salpetriere

location_facility: Institutul de Gastroenterologie si Hepatologie

location_facility: University of Bochum, Kliniken Bergmannsheil

location_facility: University of Lyon, Hopital de l'Hotel Dieu

location_facility: University of Creteil, Hopital Henri Mondor

location_facility: University of Paris, Hopital Saint-Antoine

location_facility: McMaster Clinic - Hamilton General Hospital


title: A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)

summary: This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

lead_sponsor: Hoffmann-La Roche

location_country:
Thailand
France
Puerto Rico
United States
Canada


ReferenceCitation: Moreno-Aspitia A, Holmes EM, Jackisch C, de Azambuja E, Boyle F, Hillman DW, Korde L, Fumagalli D, Izquierdo MA, McCullough AE, Wolff AC, Pritchard KI, Untch M, Guillaume S, Ewer MS, Shao Z, Sim SH, Aziz Z, Demetriou G, Mehta AO, Andersson M, Toi M, Lang I, Xu B, Smith IE, Barrios CH, Baselga J, Gelber RD, Piccart-Gebhart M; ALTTO Steering Committee and Investigators. Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D). Eur J Cancer. 2021 May;148:287-296. doi: 10.1016/j.ejca.2021.01.053. Epub 2021 Mar 23.

family: Moreno-Aspitia

full_name: Alvaro Moreno-Aspitia

given: Alvaro

family: Holmes

full_name: Eileen M. Holmes

given: Eileen M.

family: Jackisch

full_name: Christian Jackisch

given: Christian

family: de Azambuja

full_name: Evandro de Azambuja

given: Evandro

family: Boyle

full_name: Frances Boyle

given: Frances

family: Hillman

full_name: David W. Hillman

given: David W.

family: Korde

full_name: Larissa Korde

given: Larissa

family: Fumagalli

full_name: Debora Fumagalli

given: Debora

family: Izquierdo

full_name: Miguel A. Izquierdo

given: Miguel A.

family: McCullough

full_name: Ann E. McCullough

given: Ann E.

family: Wolff

full_name: Antonio C. Wolff

given: Antonio C.

family: Pritchard

full_name: Kathleen I. Pritchard

given: Kathleen I.

family: Untch

full_name: Michael Untch

given: Michael

family: Guillaume

full_name: Sébastien Guillaume

given: Sébastien

family: Ewer

full_name: Michael S. Ewer

given: Michael S.

family: Shao

full_name: Zhimin Shao

given: Zhimin

family: Sim

full_name: Sung Hoon Sim

given: Sung Hoon

family: Aziz

full_name: Zeba Aziz

given: Zeba

family: Demetriou

full_name: Georgia Demetriou

given: Georgia

family: Mehta

full_name: Ajay O. Mehta

given: Ajay O.

family: Andersson

full_name: Michael Andersson

family: Toi

full_name: Masakazu Toi

given: Masakazu

family: Lang

full_name: Istvan Lang

given: Istvan

family: Xu

full_name: Binghe Xu

given: Binghe

family: Smith

full_name: Ian E. Smith

given: Ian E.

ReferenceCitation: Sonnenblick A, Agbor-Tarh D, de Azambuja E, Hultsch S, Izquierdo M, Liu M, Pruneri G, Harbeck N, Piccart M, Moreno-Aspita A, Granit RZ, Rouas G, Fahoum I, Sotiriou C. STAT3 activation in HER2-positive breast cancers: Analysis of data from a large prospective trial. Int J Cancer. 2021 Mar 15;148(6):1529-1535. doi: 10.1002/ijc.33385. Epub 2020 Nov 23.

name: Institute of Oncology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel; Sackler Faculty of Medicine Tel Aviv University  Tel Aviv Israel

name: Frontier Science (Scotland) Ltd  Kingussie UK

name: Institut Jules Bordet Université Libre de Bruxelles (U.L.B)  Brussels Belgium

name: Breast International Group (BIG)‐aisbl  Bruxelles Belgium

name: Oncology Clinical Development Oncology Business Unit, Novartis Pharma AG  Basel Switzerland

name: Department of Pathology, Fondazione IRCCS Istituto Nazionale Tumori Milan and University of Milan, School of Medicine  Milan Italy

name: Brustzentrum der Universität München (LMU)  München Germany

name: Division of Hematology/Oncology, Mayo Clinic  Jacksonville Florida USA

name: Pathology Department Tel Aviv Sourasky Medical Center  Tel Aviv Israel

repository_institution: Université Libre de Bruxelles - Dépôt institutionnel de l'Université libre de Bruxelles

title: STAT3 activation in HER2 ‐positive breast cancers: Analysis of data from a large prospective trial

ReferenceCitation: Eiger D, Pondé NF, Agbor-Tarh D, Moreno-Aspitia A, Piccart M, Hilbers FS, Werner O, Chumsri S, Dueck A, Kroep JR, Gomez H, Láng I, Rodeheffer RJ, Ewer MS, Suter T, de Azambuja E. Long-term cardiac outcomes of patients with HER2-positive breast cancer treated in the adjuvant lapatinib and/or trastuzumab Treatment Optimization Trial. Br J Cancer. 2020 May;122(10):1453-1460. doi: 10.1038/s41416-020-0786-x. Epub 2020 Mar 16.

ReferenceCitation: Holmes EM, Bradbury I, Williams LS, Korde L, de Azambuja E, Fumagalli D, Moreno-Aspitia A, Baselga J, Piccart-Gebhart M, Dueck AC, Gelber RD; ALTTO Trial Study Team. Are we assuming too much with our statistical assumptions? Lessons learned from the ALTTO trial. Ann Oncol. 2019 Sep 1;30(9):1507-1513. doi: 10.1093/annonc/mdz195.

ReferenceCitation: McCullough AE, Dell'orto P, Reinholz MM, Gelber RD, Dueck AC, Russo L, Jenkins RB, Andrighetto S, Chen B, Jackisch C, Untch M, Perez EA, Piccart-Gebhart MJ, Viale G. Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014 Feb;143(3):485-92. doi: 10.1007/s10549-013-2827-0. Epub 2014 Jan 7.

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

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
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
Pakistan
Croatia
France
Japan
Poland
Slovakia
Norway
Thailand
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Hong Kong
Netherlands
Philippines
Switzerland
Bulgaria
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain
Estonia

title: A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

summary:
This is a randomised, open label multi-centre phase III study comparing the activity of lapatinib alone versus trastuzumab alone versus trastuzumab followed by lapatinib versus lapatinib concomitantly with trastuzumab in the adjuvant treatment of patients with ErbB2 overexpressing and/or amplified breast cancer. Patients will be enrolled according to one of two design schemas, with Design 2 having two chemotherapy options (Design 2 and 2B), and will be randomised to one of four treatment regimens within each design schema.

The primary objective of this study is to compare disease-free survival (DFS) in patients with HER2 overexpressing and/or amplified breast cancer randomised to trastuzumab for one year versus lapatinib for one year versus trastuzumab (12 or 18 weeks, according to assigned design) followed by a six-week treatment-free interval followed by lapatinib (28 or 34 weeks, according to assigned design) versus trastuzumab in combination with lapatinib for one year (52 weeks). Secondary objectives include treatment comparisons with respect to overall survival, time to recurrence, time to distant recurrence, safety and tolerability, incidence of brain metastasis, and analyses conducted separately for cohorts of patients defined by presence or absence of cMyc oncogene amplification, expression level of PTEN and presence or absence of the p95HER2 receptor. On August 18, 2011, the ALTTO Independent Data Monitoring Committee (IDMC) met to review the first planned interim analysis. The IDMC reported that the comparison of lapatinib alone versus trastuzumab alone crossed the futility boundary, indicating that the lapatinib alone arm was unlikely to meet the pre-specified criteria to demonstrate non-inferiority to trastuzumab alone with respect to disease-free survival (DFS). The IDMC also stated that the other three arms (trastuzumab alone, sequential trastuzumab/lapatinib arm and the combination arm) should continue as planned with no changes.


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Comparing the Efficacy of Bevacizumab in Combination With Rituximab and CHOP (R-CHOP + Bevacizumab) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

summary: This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) chemotherapy (R-CHOP) versus rituximab plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles).

status: Terminated

ReferenceCitation: McCord R, Bolen CR, Koeppen H, Kadel EE 3rd, Oestergaard MZ, Nielsen T, Sehn LH, Venstrom JM. PD-L1 and tumor-associated macrophages in de novo DLBCL. Blood Adv. 2019 Feb 26;3(4):531-540. doi: 10.1182/bloodadvances.2018020602.

family: McCord

full_name: Ronald McCord

given: Ronald

family: Bolen

full_name: Christopher R. Bolen

given: Christopher R.

name: Research Pathology, Genentech, South San Francisco, CA;

family: Koeppen

full_name: Hartmut Koeppen

given: Hartmut

family: Kadel

full_name: Edward E. Kadel

given: Edward E.

suffix: III

family: Oestergaard

full_name: Mikkel Z. Oestergaard

given: Mikkel Z.

name: Clinical Development Oncology, Roche, Basel, Switzerland; and

family: Nielsen

full_name: Tina Nielsen

given: Tina

name: Centre for Lymphoid Cancer, British Columbia Cancer Agency, Vancouver, BC, Canada

family: Sehn

full_name: Laurie H. Sehn

given: Laurie H.

family: Venstrom

full_name: Jeffrey M. Venstrom

given: Jeffrey M.

journal_name: Blood Advances

oa_colors: green gold

evidence: open (via free article)

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

publisher: American Society of Hematology

publisher_dissemination: American Society of Hematology

publisher_group: American Society of Hematology

publisher_normalized: American Society of Hematology

title: PD-L1 and tumor-associated macrophages in de novo DLBCL

ReferenceCitation: Seymour JF, Pfreundschuh M, Trnĕný M, Sehn LH, Catalano J, Csinady E, Moore N, Coiffier B; MAIN Study Investigators. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014 Aug;99(8):1343-9. doi: 10.3324/haematol.2013.100818. Epub 2014 Jun 3.

family: Seymour

full_name: J. F. Seymour

given: J. F.

family: Pfreundschuh

full_name: M. Pfreundschuh

given: M.

family: Trneny

full_name: M. Trneny

full_name: L. H. Sehn

given: L. H.

family: Catalano

full_name: J. Catalano

given: J.

family: Csinady

full_name: E. Csinady

given: E.

family: Moore

full_name: N. Moore

given: N.

family: Coiffier

full_name: B. Coiffier

given: B.

name: on behalf of the MAIN Study Investigators

publisher: Ferrata Storti Foundation (Haematologica)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

location_country:
Peru
Malaysia
Greece
Australia
Russian Federation
Taiwan
Ecuador
France
Panama
Lithuania
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Sweden
Hong Kong
Switzerland
Philippines
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
New Zealand
Spain

location_facility: Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia

location_facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

location_facility: HSK Dr.-Horst-Schmidt-Kliniken; Innere Medizin I Kardiologie; Angiologie und Intensivmedizin

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

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

location_facility: Irccs Policlinico San Matteo; Divisione Di Ematologia

location_facility: Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

location_facility: Institut Bergonie; Hematologie Oncologie

location_facility: Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie

location_facility: Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

location_facility: National Institute of Oncology, A Dept of Internal Medicine

location_facility: Fov. Onk. Egyesitett Szent Istvan es Szent Laszlo Korhaz; Dept Of Bone Marrow Transplant

location_facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

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

location_facility: Churchill Hospital; Oxford Cancer and Haematology Centre

location_facility: Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

location_facility: Bradford Royal Infirmary; Haematology Department

location_facility: North Hampshire Hospital; Dept. of Haematology

location_facility: University of Colorado Cancer Center Department of Hematology

location_facility: General Hospital of Chinese PLA; Department of Hematology

location_facility: Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie

location_facility: Westfälische Wilhelms-Universität Münster, Medizinische Klinik und Poliklinik A

location_facility: National Cancer Inst. ; Dept. of Chemotherapy

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

location_facility: Christchurch Hospital; Canterbury Health Laboratories

location_facility: Hospital das Clinicas - UFRGS; Hematologia

location_facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

location_facility: Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

location_facility: Carl-Thiem-Klinik Cottbus; Medizinische Klinik

location_facility: Haematology Research Center; Haematology

location_facility: National Kidney and Transplant Institute; Chemotherapy Unit

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: University of Kansas Medical Center; Department of Hematology

location_facility: Semashko Central Clinical Hospital Moscow; Hematology

location_facility: Birmingham Heartlands Hospital; Department of Haematology

location_facility: Hospital Universitario Dr. Jose E. Gonzalez; Haematology

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

location_facility: Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia

location_facility: Fakultni nemocnice Olomouc; Hemato-onkologicka klinika

location_facility: Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: St.-Marien-Hospital Klinik Knappenstraße; Klinik für Hämatologie und Onkologie

location_facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

location_facility: Zaklad Opieki Zdrowotnej Mswia; Oddzial Chemioterapii

location_facility: Royal Liverpool Uni Hospital; Haematology

location_facility: KRH Klinikum Siloah Medizinische Klinik III

location_facility: Hospital Nacional Guillermo Almenara Irigoyen; Oncology

location_facility: Clinique Claude Bernard; Onco Hematologie

location_facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

location_facility: The Second Affiliated Hospital of Soochow University

location_facility: HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

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

location_facility: Institut J Paolii Calmettes; Onco Hematologie 1

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

location_facility: Skånes University Hospital, Skånes Department of Onclology

location_facility: Princess Alexandra Hospital; Department of Haematology

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

location_facility: Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

location_facility: Helios Klinik Wuppertal; Medizinische Klinik I

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Hospital Duran i Reynals; Servicio de Hematologia

location_facility: Szpital Uniwersytecki W Krakowie; Klinika Hematologii

location_facility: Ch Lyon Sud; Hemato Secteur Jules Courmont

location_facility: Institut Gustave Roussy; Unite D'Hematologie

location_facility: Univ. Cattolica La Sapienza; Cattedra Di Ematologia

location_facility: Uni Medical Center; Division Of Hemotology/Oncology

location_facility: Chuq - Hopital Hotel Dieu de Quebec; Oncology

location_facility: Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

location_facility: Uni of Texas Southwestern Medical Center

location_facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie

location_facility: Eberhard-Karls-Universität Tübingen; Medizinische Klinik I

location_facility: Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia

location_facility: Hospital Carlos Andrade Marin; Servicio de Oncología

location_facility: Cancer Centre of Southeastern Ontario; Kingston General Hospital

location_facility: Kath.Krankenhaus Hagen gem.GmbH St.-Marien-Hospital

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

location_facility: Research Inst. of Hematology & Blood Transfusion ; Hematology

location_facility: Hopital De La Miletrie; Hematologie Et Oncologie Medicale

location_facility: Hospital de Sao Joao; Servico de Hematologia Clinica

location_facility: Hospital de Basurto; Servicio de Hematologia

location_facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: Col Instituto Tecnologico Y Estudios Superiores de Monterrey

location_facility: Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie

location_facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

location_facility: Hopital Bretonneau; Hematologie Therapie Cellulaire

location_facility: St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

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

location_facility: Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

location_facility: Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

location_facility: Cebu Cancer Institute; Perpetual Succour Hospital

location_facility: Klinikum der Universitaet Muenchen; Campus Großhadern; Medizinische Klinik III und Poliklinik

location_facility: DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Fakultní Nemocnice Královské Vinohrady; Hematologická Klinika

location_facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie

location_facility: VshEOBECNÁ FAKULTNÍ NEMOCNICE; I. INTERNI KLINIKA

location_facility: Hopital de L'Archet; Hematologie Clinique

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología

location_facility: Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

location_facility: Veterans General Hospital; Division of Oncology

location_facility: Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates

location_facility: Instituto Biomedico De Investigacion A.C.

location_facility: The Royal Wolverhampton Hospitals NHS Trust; Department of Haematology

location_facility: Teodoro Maldonado Carbo Hospital; Oncology Service

location_facility: Evang.Krankenhaus Abt. Hämatologie und Onkologie

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: Border Medical Oncology; Murray Valley Private Hospital

location_facility: Kliniken St. Antonius; Zentrum Für Innere Medizin, Haematologie/Onkologie

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

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

location_facility: Hopital Pitie Salpetriere; Hematologie Clinique

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

location_facility: Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science

location_facility: Hospital Universitario la Fe; Servicio de Medicina Intena

location_facility: Hospital das Clinicas - FMUSP; Hematologia

location_facility: Severance Hospital - Yonsei University; Medicine Dept.

location_facility: Royal Hallamshire Hospital; Haematology Dept

location_facility: Krankenhaus Nordwest Medizinische Klinik

location_facility: Saskatoon Cancer Centre; Uni of Saskatoon Campus

location_facility: Klinikzentrum Mitte; Medizinische Klinik Gastroenterologie Haematologie / Onkologie

location_facility: First Affiliated Hospital of Soochow University

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.

location_facility: Fakultni nemocnice Brno; Interni hematoonkologicka klinika

location_facility: Università Cattolica Del Sacro Cuore S.S. Giovanni Paolo Ii; Uoc Di Onco-Ematologia

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

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

location_facility: Chu Estaing; Cons Hemato Medecine Interne

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Hematologia

location_facility: Asklepios Klinik St. Georg; Allgemeine Innere Medizin

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

location_facility: Städtisches Klinikum Karlsruhe gGmbH, II. Medizinische Klinik

location_facility: Uni Hospital Santariskiu Clinic; Haematology

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Centralny Szpital Kliniczny Mswia; Klinika onkologii, hematologii i chorob wewnetrznych

location_facility: Instituto Cancerologia Medellin; Clinica Las Americas

location_facility: Polyclinique Kenval ; Radiotherapie Oncologie

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

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

location_facility: Hospital Mutua de Terrassa; Servicio de Hematologia

location_facility: Universitätsspital Zürich; Klinik für Onkologie

location_facility: Fakultni Nemocnice Plzen, Hematologicko-Onkologicke Oddeleni

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Uni of California - San Diego; Cancer Center & Dept of Medicine

location_facility: Tianjin Institute of Hematology & Blood Diseases Hospital

location_facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

location_facility: Ospedale Gen.Le Prov.Le 'C.G.Mazzoni'; Ematologia

location_facility: St Marien Krankenhaus; Medizinische Klinik Iii

location_facility: Greenslopes Private Hospital; Gallipoli Research Centre

location_facility: St. Johannes Hospital; Abt. Innere Medizin

location_facility: Klinikum Oldenburg gGmbH; Klinik für Onkologie und Hämatologie

location_facility: Ospedale Ferrarotto; Divisione Di Ematologia

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Hematología

location_facility: Hospital Universitario la Paz; Servicio de Hematologia

location_facility: Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Uni of Auckland; Dept of Molecular Medicine & Haematology

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.

location_facility: Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

location_facility: St Antonius Hospital; Haematologie/Onkologie

location_facility: CH Dptal Les Oudairies; Hematologie Oncologie

location_facility: Centre Hospitalier Uni Ire; Service de Medecine D

location_facility: Fn Hr. Kralove; IV. Interni Hematologicka Klinika

location_facility: King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

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

location_facility: Clinique Pont de Chaume; Oncologie Et Radiotherapie

location_facility: Hopital Saint Eloi; Hematologie Oncologie Medicale

location_facility: Klinikum Mannheim III. Medizinische Klinik

location_facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

location_facility: Alfred Hospital; Bone Marrow Transplant Unit

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Toronto Sunnybrook Regional Cancer Centre

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

location_facility: Medical University School; Dept. of Haematology

location_facility: Peter Maccallum Cancer Institute; Medical Oncology

location_facility: St. Joseph Mercy Hospital; Department of Oncology

location_facility: Georgios Papanikolaou Hospital; Hematology Department

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


type: Registry Identifier

title: ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving carboplatin and paclitaxel together with bevacizumab is more effective than carboplatin and paclitaxel alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase III trial is studying carboplatin, paclitaxel, and bevacizumab to see how well they work compared with carboplatin and paclitaxel alone in treating patients with newly diagnosed ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Dhillon S. Bevacizumab combination therapy: for the first-line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Drugs. 2012 May 7;72(7):917-30. doi: 10.2165/11208940-000000000-00000. Review.

ReferenceType: result

ReferenceCitation: Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, Carey MS, Beale P, Cervantes A, Kurzeder C, du Bois A, Sehouli J, Kimmig R, Stähle A, Collinson F, Essapen S, Gourley C, Lortholary A, Selle F, Mirza MR, Leminen A, Plante M, Stark D, Qian W, Parmar MK, Oza AM; ICON7 Investigators. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med. 2011 Dec 29;365(26):2484-96. doi: 10.1056/NEJMoa1103799. Erratum in: N Engl J Med. 2012 Jan 19;366(3):284.

family: Perren

full_name: Timothy J. Perren

given: Timothy J.

family: Swart

full_name: Ann Marie Swart

given: Ann Marie

family: Pfisterer

full_name: Jacobus Pfisterer

given: Jacobus

family: Ledermann

full_name: Jonathan A. Ledermann

given: Jonathan A.

family: Pujade-Lauraine

full_name: Eric Pujade-Lauraine

given: Eric

family: Kristensen

full_name: Gunnar Kristensen

given: Gunnar

family: Carey

full_name: Mark S. Carey

given: Mark S.

family: Beale

full_name: Philip Beale

given: Philip

family: Cervantes

full_name: Andrés Cervantes

given: Andrés

family: Kurzeder

full_name: Christian Kurzeder

given: Christian

family: Bois

full_name: Andreas du Bois

given: Andreas du

family: Sehouli

full_name: Jalid Sehouli

given: Jalid

family: Kimmig

full_name: Rainer Kimmig

given: Rainer

family: Stähle

full_name: Anne Stähle

given: Anne

family: Collinson

full_name: Fiona Collinson

given: Fiona

family: Essapen

full_name: Sharadah Essapen

given: Sharadah

family: Gourley

full_name: Charlie Gourley

given: Charlie

family: Lortholary

full_name: Alain Lortholary

given: Alain

family: Selle

full_name: Frédéric Selle

given: Frédéric

family: Mirza

full_name: Mansoor R. Mirza

given: Mansoor R.

family: Leminen

full_name: Arto Leminen

given: Arto

family: Plante

full_name: Marie Plante

given: Marie

family: Stark

full_name: Dan Stark

given: Dan

repository_institution: The University of Manchester - Research Explorer

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

title: A Phase 3 Trial of Bevacizumab in Ovarian Cancer

ReferenceCitation: Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.

location_country:
France
Norway
Australia
Germany
United Kingdom

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: Portsmouth Oncology Centre at Saint Mary's Hospital

location_facility: Klinikum Dorothea Christiane Erxleben - Quedlingburg

location_facility: Praxis Fuer Haemotologie Und Internistischer Onkologie

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: University Hospital Schleswig-Holstein - Kiel Campus

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Mid Kent Oncology Centre at Maidstone Hospital

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

location_facility: Leeds Cancer Centre at St. James's University Hospital

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Universitaetsklinikum Giessen und Marburg GmbH - Marburg

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Gloucestershire Oncology Centre at Cheltenham General Hospital

location_facility: Centre for Cancer Research and Cell Biology at Queen's University Belfast

location_facility: Princess Royal Hospital at Hull and East Yorkshire NHS Trust

location_facility: I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

location_facility: Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Klinikum Rechts Der Isar - Technische Universitaet Muenchen

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Cancer Therapy Centre at Liverpool Hospital

location_facility: St. Luke's Cancer Centre at Royal Surrey County Hospital

location_facility: Charite University Hospital - Campus Virchow Klinikum

location_facility: Klinikum der Universitaet Muenchen - Grosshadern Campus

location_facility: Murray Valley Private Hospital and Cancer Treatment Centre

location_facility: Kreiskrankenhaus Leonberg - Frauenklinik

location_facility: Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet


ReferenceCitation: Vansteenkiste JF, Cho BC, Vanakesa T, De Pas T, Zielinski M, Kim MS, Jassem J, Yoshimura M, Dahabreh J, Nakayama H, Havel L, Kondo H, Mitsudomi T, Zarogoulidis K, Gladkov OA, Udud K, Tada H, Hoffman H, Bugge A, Taylor P, Gonzalez EE, Liao ML, He J, Pujol JL, Louahed J, Debois M, Brichard V, Debruyne C, Therasse P, Altorki N. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):822-835. doi: 10.1016/S1470-2045(16)00099-1. Epub 2016 Apr 27.

ReferenceCitation: Dizier B et al. (2019) A T-helper 1/interferon-ϒ gene signature is prognostic in the adjuvant setting of resectable high-risk melanoma but not in non-small cell lung cancer. Clin Cancer Res. pii: clincanres.3717.2018. doi: 10.1158/1078-0432.CCR-18-3717. [Epub ahead of print].

intervention_type: Biological

ipd_sharing_description: IPD for this study is available via the Clinical Study Data Request site.

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Thailand
Norway
Argentina
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain
Estonia

ipd_sharing: Yes

type: EudraCT Number

title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer

summary: The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

status_simplified: Unknown


title: Review of Safety and Efficacy With Adalimumab in Patients With Active Ankylosing Spondylitis - An Open-Label Study to Evaluate the Response to Adalimumab in Patients Who Have Failed Standard Therapy or TNF-Alpha Inhibitors (RHAPSODY)

acronym: RHAPSODY

summary:
Due to the rigor of the clinical development program of adalimumab for the indication of AS, the population of subjects with active AS that could enroll in previous phase 3 studies was limited. Therefore, it is necessary to further evaluate the use of adalimumab in a setting that mimics day-to-day clinical practice to obtain further safety and efficacy data by allowing subjects meeting the characteristics noted below to enter this study:

Subjects who failed another TNF inhibitor (etanercept, infliximab)
Subjects with advanced spinal ankylosis
Subjects with AS associated disorders (i.e., uveitis, IBD, and psoriasis)

ReferenceCitation: Rudwaleit M, Van den Bosch F, Kron M, Kary S, Kupper H. Effectiveness and safety of adalimumab in patients with ankylosing spondylitis or psoriatic arthritis and history of anti-tumor necrosis factor therapy. Arthritis Res Ther. 2010;12(3):R117. doi: 10.1186/ar3054. Epub 2010 Jun 16.

family: Rudwaleit

full_name: Martin Rudwaleit

given: Martin

family: Van den Bosch

full_name: Filip Van den Bosch

given: Filip

family: Kron

full_name: Martina Kron

given: Martina

family: Kary

full_name: Sonja Kary

given: Sonja

family: Kupper

full_name: Hartmut Kupper

given: Hartmut

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

evidence: oa journal (via doaj)

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

ReferenceCitation: Rudwaleit M, Claudepierre P, Kron M, Kary S, Wong R, Kupper H. Effectiveness of adalimumab in treating patients with ankylosing spondylitis associated with enthesitis and peripheral arthritis. Arthritis Res Ther. 2010;12(2):R43. doi: 10.1186/ar2953. Epub 2010 Mar 15.

family: Claudepierre

full_name: Pascal Claudepierre

given: Pascal

family: Wong

full_name: Robert Wong

given: Robert

ReferenceCitation: Rudwaleit M, Claudepierre P, Wordsworth P, Cortina EL, Sieper J, Kron M, Carcereri-De-Prati R, Kupper H, Kary S. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol. 2009 Apr;36(4):801-8. doi: 10.3899/jrheum.081048. Epub 2009 Feb 27.

title: Effectiveness, Safety, and Predictors of Good Clinical Response in 1250 Patients Treated with Adalimumab for Active Ankylosing Spondylitis

ReferenceCitation: Rudwaleit M, Rødevand E, Holck P, Vanhoof J, Kron M, Kary S, Kupper H. Adalimumab effectively reduces the rate of anterior uveitis flares in patients with active ankylosing spondylitis: results of a prospective open-label study. Ann Rheum Dis. 2009 May;68(5):696-701. doi: 10.1136/ard.2008.092585. Epub 2008 Jul 28.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Finland
France
Greece
Norway
Ireland
Belgium
Spain
Denmark
Germany
United Kingdom


type: Other Identifier

title: APPLES: A Prospective Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Tacrolimus Ointment for the Treatment of Atopic Dermatitis

acronym: APPLES

summary: This is an observational study to assess the long-term safety of Protopic® Ointment for the treatment of atopic dermatitis. Patients whose ages are/were < 16 years at the time of first tacrolimus ointment exposure are eligible to participate. No drug is distributed during this observational trial.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: D3T01.1J No increased risk of cancer in children using topical tacrolimus for atopic dermatitis: A 10-year prospective cohort study Prof. Dr. Regina Fölster-Holst - Germany 12 October 2019 11:00 - 11:15 EADV 2019

lead_sponsor: LEO Pharma

location_country:
Austria
Netherlands
Germany
France
Poland
Ireland
United States
United Kingdom
Canada

location_facility: Carolina Dermatology & Skin Cancer Surgery

location_facility: SPZOZ Szpital Specjalistyczny im. S. Zeromskiego

location_facility: Helendale Dermatology & Medical Spa, LLC

location_facility: NZOZ Przychodnia Dermatologiczna DERMED s.c

location_facility: University of Arkansas for Medical Sciences

location_facility: Centre Hospitalier Service de Dermatologie

location_facility: Universitaetsklinikum Klinische Forschung, Zentrum d. Dermatologie u. Venerologie

location_facility: Midwest Center for Dermatology and Cosmetic Surgery

location_facility: Haber Dermatology and Cosmetic Surgery, Inc

location_facility: Szpital Dzieciecy Specjalistyczny Z.O.Z. nad Matka i Dzieckiem

location_facility: National Allergy and Asthma Research, LLC

location_facility: Fort Lauderdale Dermatology & Cosmetic Skin Center

location_facility: Wojewodzki Szpital Dzieciecy im. J. Brudzinskiego w Bydgoszczy, Wojewodzka Przychodnia Specjalistyczna Dla Dzieci Poradnia ermatologiczna, Budynek "A"

location_facility: HOPITAL CHARLES NICOLLE Service de Dermatologie

location_facility: Universitair Medisch Centrum St. Radboud

location_facility: Dermatology Center for Children and Young Adults

location_facility: Georgia Pollens Clinical Research Centers, Inc

location_facility: Charite - Universitaetsmedizin Berlin Klinik fuer Dermatologie, Venerologie u. Allergologie

location_facility: Leeds General Infirmary, Dept of Dermatology

location_facility: Dermatology Treatment and Research Center, PA

location_facility: Columbia University Medical Center., Dept. of Medicine

location_facility: Total Skin and Beauty Dermatology Center

location_facility: Allergy Associates of the Palm Beaches, PA

location_facility: Children's Hospital of the Kings Daughters

location_facility: University of Manchester, Dermatology-Pharmacology Unit Hope Hospital

location_facility: Lubbock Dermatology and Skin Cancer Center

location_facility: Universitaet Bonn Klinik und Poliklinik fuer Dermatologie

location_facility: Dawes Fretzin Clinical Research Group, LLC

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: Connecticut Children's Medical Center Dept of Dermatology

location_facility: AeroAllergy Research Labs of Savannah, Inc.

location_facility: Cabinet de Dermatologie - Boulogne-Sur-Mer

location_facility: Asthma & Allergy Center of North Jackson

location_facility: Dermatology and Laser Center of Charleston

location_facility: Dermatology Research Associates of Tyler

location_facility: North Texas Institute for Clinical Trials

location_facility: Hautklinik des Universitaetsklinikums Erlangen

location_facility: Universitaetsklinikum Giessen+ Marburg Dermatolgie und Allergologie

location_facility: Klinik fuer Kinder u. Jugendmedizin der Ruhr Universitaet Bochum im St.-Josef-Hospital

location_facility: University Dermatology Consultants, Inc.

location_facility: Allergy Associates, PA dba East Tennessee Center for Clinical Research

location_facility: Amersham Hospital, Department of Dermatology

location_facility: Ludwig - Maximilians Universitaet, Klinik u. Poliklinik fuer Dermatologie u. Allergologie

location_facility: Licca Fachklinik f. aesthetisch- operative Dermatologie und Chirurgie

location_facility: Pediatric & Adult Asthma and Allergy, P.C.

location_facility: Eastern Canada Cutaneous Research Association

location_facility: Capital Allergy & Respiratory Disease Center

location_facility: Department of Pediatric Allergy and Immunology

location_facility: Harrogate & District Foundation NHS Trust Hospital

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Wake Forest University School of Medicine

location_facility: Universitaetsklinikum Muenster, Klinik & Poliklinik Fuer Hautkrankheiten

location_facility: Oklahoma University Health Sciences Center

location_facility: University of N. Texas Health Science Center

location_facility: Klinik und Poliklinik f. Dermatologie Universitaetsklinikum Dresden

location_facility: University of Miami Miller School of Medicine

location_facility: North Florida Dermatology Associates, P.A.

location_facility: Richter - Fachaerztin fuer Kinder- und Jugendmedizin

location_facility: Wales College of Medicine, Cardiff University, Heath Park

location_facility: Johns Hopkins University, Division of Pediatric Dermatolgy


ReferenceCitation: Schreiner A, Lahaye M, Peuskens J, Naber D, Dilbaz N, Millet B, Franco MA, Rancans E, Turczynski J, Smeraldi E, Lara E, Neznanov NG. Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics. Expert Opin Pharmacother. 2014 Apr;15(5):593-603. doi: 10.1517/14656566.2014.884071. Epub 2014 Feb 3.

family: Schreiner

full_name: Andreas Schreiner

given: Andreas

family: Lahaye

full_name: Marjolein Lahaye

given: Marjolein

family: Peuskens

full_name: Joseph Peuskens

given: Joseph

family: Naber

full_name: Dieter Naber

given: Dieter

family: Dilbaz

full_name: Nesrin Dilbaz

given: Nesrin

family: Millet

full_name: Bruno Millet

given: Bruno

family: Franco

full_name: Manuel A Franco

given: Manuel A

family: Rancans

full_name: Elmars Rancans

given: Elmars

family: Turczynski

full_name: Jacek Turczynski

given: Jacek

family: Smeraldi

full_name: Enrico Smeraldi

given: Enrico

family: Lara

full_name: Elsa Lara

given: Elsa

family: Neznanov

full_name: Nikolaj G Neznanov

given: Nikolaj G

journal_name: Expert Opinion on Pharmacotherapy

publisher: Informa Healthcare

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

lead_sponsor: Janssen-Cilag International NV

location_country:
Finland
Greece
Belgium
Russian Federation
Denmark
Croatia
France
Lithuania
Poland
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Portugal
Germany
United Kingdom
Serbia
Israel
Spain
Turkey
Latvia

acronym: PERFlexS

title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia

summary: The purpose of this study is to explore tolerability, safety and effectiveness of flexibly dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with an oral antipsychotic medication.


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 Autoinjector And The Etanercept Prefilled Syringe) In Patients With Rheumatoid Arthritis

summary: The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Autoinjector and the Etanercept Prefilled Syringe) in patients with rheumatoid arthritis (RA).

lead_sponsor: Pfizer

location_country:
Italy
Sweden
Netherlands
Finland
France
Norway
Denmark
Germany
United Kingdom

intervention_type: Device


title: Open-label Study of Bevacizumab (AVASTIN®) in Combination With Platinum-containing Chemotherapy as First-line Treatment of Patients With Advanced or Recurrent Non-squamous Non-small Cell Lung Cancer

summary: This single arm study will assess the safety and efficacy of Avastin combined with platinum-containing chemotherapy regimens in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC). Avastin will be given as first-line treatment in combination with platinum-based chemotherapy or in combination with any standard of care NSCLC first-line chemotherapy used in line with the licensed national prescribing information. Eligible patients will receive Avastin (15mg/kg iv on day 1 of each 3 week cycle) concomitantly with chemotherapy. Avastin treatment will continue after completion of chemotherapy cycles until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Bearz A, Passalacqua R, Alabiso O, Cinieri S, Gridelli C, Cravesana C, Crinò L. First-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer : analysis of the Italian patients enrolled in the SAiL study. Clin Drug Investig. 2012 Nov;32(11):755-60. doi: 10.1007/s40261-012-0001-9.

family: Bearz

full_name: Alessandra Bearz

given: Alessandra

family: Passalacqua

full_name: Rodolfo Passalacqua

given: Rodolfo

family: Alabiso

full_name: Oscar Alabiso

given: Oscar

family: Cinieri

full_name: Saverio Cinieri

given: Saverio

family: Gridelli

full_name: Cesare Gridelli

given: Cesare

family: Cravesana

full_name: Claudia Cravesana

given: Claudia

family: Crinò

full_name: Lucio Crinò

given: Lucio

journal_name: Clinical Drug Investigation

title: First-Line Bevacizumab-Based Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer

ReferenceCitation: Crinò L, Dansin E, Garrido P, Griesinger F, Laskin J, Pavlakis N, Stroiakovski D, Thatcher N, Tsai CM, Wu YL, Zhou C. Safety and efficacy of first-line bevacizumab-based therapy in advanced non-squamous non-small-cell lung cancer (SAiL, MO19390): a phase 4 study. Lancet Oncol. 2010 Aug;11(8):733-40. doi: 10.1016/S1470-2045(10)70151-0. Epub 2010 Jul 23.

family: Dansin

full_name: Eric Dansin

given: Eric

family: Garrido

full_name: Pilar Garrido

given: Pilar

family: Griesinger

full_name: Frank Griesinger

given: Frank

family: Laskin

full_name: Janessa Laskin

given: Janessa

family: Pavlakis

full_name: Nick Pavlakis

given: Nick

family: Stroiakovski

full_name: Daniel Stroiakovski

given: Daniel

family: Thatcher

full_name: Nick Thatcher

family: Tsai

full_name: Chun-Ming Tsai

given: Chun-Ming

family: Wu

full_name: Yi-long Wu

given: Yi-long

family: Zhou

full_name: Caicun Zhou

given: Caicun

journal_name: The Lancet Oncology

location_country:
Finland
Romania
Australia
Russian Federation
Denmark
Czech Republic
Taiwan
Iceland
Ecuador
France
Poland
Lithuania
Slovakia
Argentina
Canada
Slovenia
Turkey
Colombia
Sweden
Hong Kong
Netherlands
Switzerland
Hungary
China
Portugal
Germany
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Brazil
Serbia
Lebanon
Mexico
Venezuela
Israel
Egypt
Spain
Estonia
Latvia


title: An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

summary: This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Llombart-Cussac A, Pivot X, Biganzoli L, Cortes-Funes H, Pritchard KI, Pierga JY, Smith I, Thomssen C, Srock S, Sampayo M, Cortes J. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast. 2014 Oct;23(5):656-62. doi: 10.1016/j.breast.2014.06.017. Epub 2014 Jul 19.

family: Llombart-Cussac

full_name: Antonio Llombart-Cussac

given: Antonio

family: Pivot

full_name: Xavier Pivot

given: Xavier

family: Biganzoli

full_name: Laura Biganzoli

given: Laura

family: Cortes-Funes

full_name: Hernan Cortes-Funes

given: Hernan

family: Pritchard

full_name: Kathleen I. Pritchard

given: Kathleen I.

family: Pierga

full_name: Jean-Yves Pierga

given: Jean-Yves

family: Smith

full_name: Ian Smith

given: Ian

family: Thomssen

full_name: Christoph Thomssen

given: Christoph

family: Srock

full_name: Stefanie Srock

given: Stefanie

family: Sampayo

full_name: Miguel Sampayo

given: Miguel

family: Cortes

full_name: Javier Cortes

given: Javier

journal_name: The Breast

oa_host_type: publisher

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

title: A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: An analysis of the ATHENA trial

ReferenceCitation: Xu BH, Jiang ZF, Shen ZZ, Guan ZZ, Chen ZD, Cheng Y, Zheng H, Jiang J, Wang XJ, Tong ZS, Qin SK, Luo Y, Yao M, Wang LW, He J. Safety and efficacy of first-line bevacizumab combined with taxane therapy in Chinese patients with HER2-negative locally recurrent or metastatic breast cancer: findings from the ATHENA study. Chin Med J (Engl). 2012 Mar;125(5):764-9.

location_country:
Finland
Australia
Russian Federation
Czech Republic
Ecuador
Morocco
France
Poland
Lithuania
Slovakia
Argentina
Canada
Slovenia
Turkey
Colombia
Sweden
Saudi Arabia
Hong Kong
Netherlands
Switzerland
Bulgaria
Hungary
China
Portugal
Germany
United Kingdom
Italy
Austria
Brazil
Lebanon
Mexico
Israel
Egypt
Spain
Estonia
Latvia


title: An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications

summary: To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

ReferenceCitation: Leizorovicz A, Becker F, Buchmüller A, Quéré I, Prandoni P, Decousus H; CALISTO Study Group. Clinical relevance of symptomatic superficial-vein thrombosis extension: lessons from the CALISTO study. Blood. 2013 Sep 5;122(10):1724-9. doi: 10.1182/blood-2013-04-498014. Epub 2013 Jul 2.

name: Unité Mixte de Recherche/Centre National de la Recherche Scientifique 5558, Faculté de Médecine René Thomas Hyacinthe Laennec, University of Lyon, Lyon, France;

family: Leizorovicz

full_name: Alain Leizorovicz

given: Alain

name: Division of Angiology and Hemostasis, University Hospital, Geneva, Switzerland;

family: Becker

full_name: François Becker

given: François

name: Institut National de la Santé et de la Recherche Médicale, Centre d'Investigation Clinique/Epidémiologie Clinique-3, EA3065, and Department of Medicine and Therapeutics, North Hospital, Saint Etienne University Hospital, Saint Etienne, France;

family: Buchmüller

full_name: Andrea Buchmüller

given: Andrea

name: Institut National de la Santé et de la Recherche Médicale, Centre d'Investigation Clinique 1001, EA2992, and Vascular Medicine Department, Saint Eloi Hospital, Montpellier University Hospital, Montpellier, France; and

family: Quéré

full_name: Isabelle Quéré

given: Isabelle

name: Thromboembolism Unit, University of Padua, Padua, Italy

family: Prandoni

full_name: Paolo Prandoni

given: Paolo

family: Decousus

full_name: Hervé Decousus

given: Hervé

journal_name: Blood

ReferenceCitation: Decousus H, Prandoni P, Mismetti P, Bauersachs RM, Boda Z, Brenner B, Laporte S, Matyas L, Middeldorp S, Sokurenko G, Leizorovicz A; CALISTO Study Group. Fondaparinux for the treatment of superficial-vein thrombosis in the legs. N Engl J Med. 2010 Sep 23;363(13):1222-32. doi: 10.1056/NEJMoa0912072.

family: Mismetti

full_name: Patrick Mismetti

given: Patrick

family: Bauersachs

full_name: Rupert M. Bauersachs

given: Rupert M.

family: Boda

full_name: Zoltán Boda

given: Zoltán

family: Brenner

full_name: Benjamin Brenner

given: Benjamin

family: Laporte

full_name: Silvy Laporte

given: Silvy

family: Matyas

full_name: Lajos Matyas

given: Lajos

family: Middeldorp

full_name: Saskia Middeldorp

given: Saskia

family: Sokurenko

full_name: German Sokurenko

given: German

journal_name: New England Journal of Medicine

oa_host_type: repository

repository_institution: University of Debrecen - University of Debrecen Electronic Archive

repository_institution: University of Valladolid - University of Valladolid Documentary Repository

publisher: Massachusetts Medical Society

title: Fondaparinux for the Treatment of Superficial-Vein Thrombosis in the Legs

location_country:
Italy
Switzerland
Netherlands
France
Bulgaria
Greece
Israel
Poland
Slovakia
Hungary
Latvia
Russian Federation
Spain
Estonia
Germany
Czech Republic
Ukraine


type: Other Grant/Funding Number

title: A Randomized Phase 3 Multicenter Open-label Study to Compare the Efficacy of TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy in Patients With Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations

summary: The purpose of this study is to compare the efficacy of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
France
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
China
Portugal
United States
Germany
United Kingdom
Italy
Austria
Israel
Spain
Turkey

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

location_facility: University of Maryland Greenebaum Cancer Center

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: The Christie NHS Foundation Trust - PPDS

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Municipal Non-profit Enterprise SubCarpathian Clinical Oncological Centre of Ivano-Frankivsk RC

location_facility: The Second Affiliated Hospital of Nanchang University

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Baskent University Medical Faculty Adana Practice and Research Center

location_facility: Centro Hospitalar do Porto Hospital de Santo Antonio

location_facility: ICO lHospitalet Hospital Duran i Reynals

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Chonnam National University Hwasun Hospital

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Centro Hospitalar de Lisboa Norte E.P.E Hospital Pulido Valente

location_facility: Istanbul University Cerrahpasa Medical Faculty Hospital

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Private Enterprise Private Manufacturing Company Acinus

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

location_facility: National Taiwan University Hospital - YunLin Branch

location_facility: Harbin Medical University Tumor Hospital

location_facility: Hospital General Universitario de Alicante

location_facility: Eastern CT Hematology and Oncology Associates

location_facility: Saguk Bankanligi Istanbul Medeniyet Universitesi Goztepe Egitim ve Arastirma Hastanesi

location_facility: Scientific Research Institute of Oncology n.a. N.N. Petrov

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Hospital Regional Universitario de Malaga Hospital General

location_facility: Kaohsiung Medical University - Chung-Ho Memorial Hospital

location_facility: University College London Hospitals (UCLH)

location_facility: Malteser Krankenhaus St. Franziskus-Hospital

status_simplified: Ongoing


ReferenceCitation: EINSTEIN Investigators, Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Oral Rivaroxaban for Symptomatic Venous Thromboembolism

ReferenceCitation: Cohen AT, Dobromirski M. The use of rivaroxaban for short- and long-term treatment of venous thromboembolism. Thromb Haemost. 2012 Jun;107(6):1035-43. doi: 10.1160/TH11-12-0859. Epub 2012 Feb 28. Review.

family: Cohen

full_name: Alexander Cohen

given: Alexander

family: Dobromirski

full_name: Mark Dobromirski

given: Mark

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

ReferenceCitation: Prins MH, Lensing AW. Derivation of the non-inferiority margin for the evaluation of direct oral anticoagulants in the treatment of venous thromboembolism. Thromb J. 2013 Jul 6;11(1):13. doi: 10.1186/1477-9560-11-13.

family: Prins

full_name: Martin H Prins

given: Martin H

family: Lensing

full_name: Anthonie WA Lensing

given: Anthonie WA

journal_name: Thrombosis Journal

ReferenceCitation: Prins MH, Lensing AW, Bauersachs R, van Bellen B, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Decousus H, Raskob GE, Berkowitz SD, Wells PS; EINSTEIN Investigators. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013 Sep 20;11(1):21. doi: 10.1186/1477-9560-11-21.

full_name: Rupert Bauersachs

given: Rupert

family: van Bellen

full_name: Bonno van Bellen

given: Bonno

family: Bounameaux

full_name: Henri Bounameaux

given: Henri

family: Brighton

full_name: Timothy A Brighton

given: Timothy A

full_name: Alexander T Cohen

given: Alexander T

family: Davidson

full_name: Bruce L Davidson

given: Bruce L

repository_institution: University of Geneva - Archive ouverte UNIGE

ReferenceCitation: Wang Y, Wang C, Chen Z, Zhang J, Liu Z, Jin B, Ying K, Liu C, Shao Y, Jing Z, Meng IL, Prins MH, Pap AF, Müller K, Lensing AW; Chinese EINSTEIN Investigators. Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies. Thromb J. 2013 Dec 16;11(1):25. doi: 10.1186/1477-9560-11-25.

ReferenceCitation: Bamber L, Wang MY, Prins MH, Ciniglio C, Bauersachs R, Lensing AW, Cano SJ. Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of acute symptomatic deep-vein thrombosis. Thromb Haemost. 2013 Oct;110(4):732-41. doi: 10.1160/TH13-03-0243. Epub 2013 Jul 11.

ReferenceCitation: van Bellen B, Bamber L, Correa de Carvalho F, Prins M, Wang M, Lensing AW. Reduction in the length of stay with rivaroxaban as a single-drug regimen for the treatment of deep vein thrombosis and pulmonary embolism. Curr Med Res Opin. 2014 May;30(5):829-37. doi: 10.1185/03007995.2013.879439. Epub 2014 Jan 22.

name:
Hospital Beneficência Portuguesa
São PauloBrazil

name:
University of Maastricht
MaastrichtThe Netherlands

ReferenceCitation: Cano SJ, Lamping DL, Bamber L, Smith S. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes. 2012 Sep 26;10:120. doi: 10.1186/1477-7525-10-120.

ReferenceCitation: Yang L, Wu J. Cost-effectiveness of rivaroxaban compared with enoxaparin plus warfarin for the treatment of hospitalised acute deep vein thrombosis in China. BMJ Open. 2020 Jul 30;10(7):e038433. doi: 10.1136/bmjopen-2020-038433.

ReferenceCitation: Ten Cate H, Lensing AWA, Weitz JI, Middeldorp S, Beyer-Westendorf J, Kubitza D, Brighton T, Raskob GE, Mismetti P, Prandoni P, Gebel M, Prins MH. The prothrombin time does not predict the risk of recurrent venous thromboembolism or major bleeding in rivaroxaban-treated patients. Thromb Res. 2018 Oct;170:75-83. doi: 10.1016/j.thromres.2018.08.008. Epub 2018 Aug 15.

ReferenceCitation: Di Nisio M, Vedovati MC, Riera-Mestre A, Prins MH, Mueller K, Cohen AT, Wells PS, Beyer-Westendorf J, Prandoni P, Bounameaux H, Kubitza D, Schneider J, Pisters R, Fedacko J, Fontes-Carvalho R, Lensing AW. Treatment of venous thromboembolism with rivaroxaban in relation to body weight. A sub-analysis of the EINSTEIN DVT/PE studies. Thromb Haemost. 2016 Sep 27;116(4):739-46. doi: 10.1160/TH16-02-0087. Epub 2016 Aug 18.

ReferenceCitation: Wells PS, Gebel M, Prins MH, Davidson BL, Lensing AW. Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy. Thromb J. 2014 Nov 26;12:26. doi: 10.1186/1477-9560-12-26. eCollection 2014.

repositories_institution:
PubMed Central - Europe PMC
University of Ottawa - uO Research

ReferenceCitation: Prins MH, Lensing AW, Brighton TA, Lyons RM, Rehm J, Trajanovic M, Davidson BL, Beyer-Westendorf J, Pap ÁF, Berkowitz SD, Cohen AT, Kovacs MJ, Wells PS, Prandoni P. Oral rivaroxaban versus enoxaparin with vitamin K antagonist for the treatment of symptomatic venous thromboembolism in patients with cancer (EINSTEIN-DVT and EINSTEIN-PE): a pooled subgroup analysis of two randomised controlled trials. Lancet Haematol. 2014 Oct;1(1):e37-46. doi: 10.1016/S2352-3026(14)70018-3. Epub 2014 Sep 28.

ReferenceCitation: Bauersachs RM, Lensing AW, Prins MH, Kubitza D, Pap ÁF, Decousus H, Beyer-Westendorf J, Prandoni P. Rivaroxaban versus enoxaparin/vitamin K antagonist therapy in patients with venous thromboembolism and renal impairment. Thromb J. 2014 Nov 24;12:25. doi: 10.1186/1477-9560-12-25. eCollection 2014.

location_country:
Finland
Malaysia
Australia
Belgium
Denmark
Czech Republic
Taiwan
India
France
Poland
Thailand
Norway
Indonesia
Canada
Korea, Republic of
South Africa
Sweden
Hong Kong
Netherlands
Philippines
Switzerland
Singapore
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Israel
New Zealand
Spain

title: Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

summary: This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).


title: A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk

summary: This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.

status: Active, not recruiting

ReferenceCitation: Hofmann F, Hwang EC, Lam TB, Bex A, Yuan Y, Marconi LS, Ljungberg B. Targeted therapy for metastatic renal cell carcinoma. Cochrane Database Syst Rev. 2020 Oct 14;10:CD012796. doi: 10.1002/14651858.CD012796.pub2.

name: Department of Urology; Sunderby Sjukhus, Umeå University; Luleå Sweden

family: Hofmann

full_name: Fabian Hofmann

given: Fabian

name: Department of Urology; Chonnam National University Medical School, Chonnam National University Hwasun Hospital; Hwasun Korea, South

family: Hwang

full_name: Eu Chang Hwang

given: Eu Chang

name: Academic Urology Unit; University of Aberdeen; Aberdeen UK

family: Lam

full_name: Thomas BL Lam

given: Thomas BL

name: Department of Urology and UCL Division of Surgery and Interventional Science; Royal Free London NHS Foundation Trust; London UK

family: Bex

full_name: Axel Bex

given: Axel

name: Department of Medicine, Division of Gastroenterology; McMaster University; Hamilton Canada

family: Yuan

full_name: Yuhong Yuan

given: Yuhong

name: Department of Urology and Renal Transplantation; Centro Hospitalar e Universitario de Coimbra; Coimbra Portugal

family: Marconi

full_name: Lorenzo SO Marconi

given: Lorenzo SO

name: Department of Surgical and Perioperative Sciences; Umeå University; Umeå Sweden

family: Ljungberg

full_name: Börje Ljungberg

given: Börje

journal_name: Cochrane Database of Systematic Reviews

repository_institution: Aberdeen University - Aberdeen University Research Archive

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

lead_sponsor: Exelixis

location_country:
Finland
Australia
Belgium
Taiwan
France
Poland
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Netherlands
Singapore
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

location_facility:
Exelixis Clinical Site #44
Exelixis Clinical Site #125
Exelixis Clinical Site #106
Exelixis Clinical Site #161
Exelixis Clinical Site #147
Exelixis Clinical Site #4
Exelixis Clinical Site #45
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ipd_sharing_description:
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Italy
Brazil
United States
Netherlands
Germany
France
Poland
Greece
Belgium
Russian Federation
Spain
Denmark
Canada

location_facility: Universidade Estadual de Campinas (UNICAMP) - Centro De Hematologia e Hemoterapia

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: University of Athens - Evaggelismos Hospital (Evangelismos Hospital)

location_facility: Istituto di Ematologia Seràgnoli azienda ospedaliera univeristaria Policlinico S.Orsola-Malpighi

location_facility: Klinikum der Eberhard-Karls-Universität/Abt. für innere Med. II/Hämatologie/Onkologie-Germany

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: Fort Wayne Medical Oncology and Hematology, Inc.

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Nizhniy Novgorod Region Clinical Hospital

location_facility: Hospital Das Clinicas Da Universidade Federal De Goias

location_facility: Clinical Research Institute of Hematology and Transfusiology

location_facility: Karmanos Cancer Institute - Wayne State University

location_facility: Asst Ovest Milanese - Ospedale Di Legnano

location_facility: IBCC Instituto Brasileiro de Controle do Cancer

location_facility: Instituto de Ensino E Pesquisa Sao Lucas

location_facility: Centre Hospitalier Lyon-Sud Service d'hematologie

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hopitaux Universitaires Est Parisien Hopital Saint Antoine

location_facility: Oncology Institute of Hope and Innovation

location_facility: S.P. Botkin Moscow City Clinical Hospital

location_facility: Universitätsklinik Carl Gustav Carus, Med. Klinik u. Poliklinik I

location_facility: Universitätsmedizin der Johannes gutenberg-Universität; III. Med. Klinik - Germany

location_facility: Universitätsklinikum Würzburg Med. Klinik U. Poliklinik Ii

location_facility: Universita Degli Studi di Roma 'Tor Vergata'

location_facility: Hospital Erasto Gaertner- Liga Paranaense de Combate ao Câncer

location_facility: Washington University School of Medicine

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Albert Schweitzer ziekenhuis-lokatie Dordwijk

location_facility: Fentre F Magendie, Hôpital Haut Leveque, CHU Bordeaux

location_facility: Weill Medical College of Cornell University

location_facility: Szpital Uniwersytecki nr 2 im. Jana Biziela w Bydgoszczy

location_facility: Fondazione Policlinico Universitario A. Gemelli IRCCS

location_facility: IRCCS Azienda Ospedaliera San Martino - IST

location_facility: Praxisklinik für Haematologie und Onkologie Koblenz

title: A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab to Evaluate Daratumumab Retreatment

summary: The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.


title: A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)

acronym: COAST

summary: The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.

ipd_sharing_description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

lead_sponsor: MedImmune LLC

location_country:
Italy
Hong Kong
Spain
France
Poland
Portugal
United States
Canada
Taiwan


title: Relevance of Maintenance Therapy Using Lenalidomide (Revimid®) After Autologous Stem Cell Transplantation Patients Under the Age Of 65. (Open, Randomised, Multi-centric Trial Versus Placebo).

summary: Maintenance treatment of myeloma.

ReferenceCitation: Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Myeloma Trialists' Collaborative Group. J Clin Oncol. 1998 Dec;16(12):3832-42.

ReferenceCitation: Attal M, Lauwers-Cances V, Marit G, Caillot D, Moreau P, Facon T, Stoppa AM, Hulin C, Benboubker L, Garderet L, Decaux O, Leyvraz S, Vekemans MC, Voillat L, Michallet M, Pegourie B, Dumontet C, Roussel M, Leleu X, Mathiot C, Payen C, Avet-Loiseau H, Harousseau JL; IFM Investigators. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012 May 10;366(19):1782-91. doi: 10.1056/NEJMoa1114138.

family: Attal

full_name: Michel Attal

given: Michel

family: Lauwers-Cances

full_name: Valerie Lauwers-Cances

given: Valerie

family: Marit

full_name: Gerald Marit

given: Gerald

family: Caillot

full_name: Denis Caillot

given: Denis

family: Moreau

full_name: Philippe Moreau

given: Philippe

family: Facon

full_name: Thierry Facon

given: Thierry

family: Stoppa

full_name: Anne Marie Stoppa

given: Anne Marie

family: Hulin

full_name: Cyrille Hulin

given: Cyrille

family: Benboubker

full_name: Lofti Benboubker

given: Lofti

family: Garderet

full_name: Laurent Garderet

given: Laurent

family: Decaux

full_name: Olivier Decaux

given: Olivier

family: Leyvraz

full_name: Serge Leyvraz

given: Serge

family: Vekemans

full_name: Marie-Christiane Vekemans

given: Marie-Christiane

family: Voillat

full_name: Laurent Voillat

family: Michallet

full_name: Mauricette Michallet

given: Mauricette

family: Pegourie

full_name: Brigitte Pegourie

given: Brigitte

family: Dumontet

full_name: Charles Dumontet

given: Charles

family: Roussel

full_name: Murielle Roussel

given: Murielle

family: Leleu

full_name: Xavier Leleu

given: Xavier

family: Mathiot

full_name: Claire Mathiot

given: Claire

family: Payen

full_name: Catherine Payen

given: Catherine

family: Avet-Loiseau

full_name: Hervé Avet-Loiseau

given: Hervé

family: Harousseau

full_name: Jean-Luc Harousseau

title: Lenalidomide Maintenance after Stem-Cell Transplantation for Multiple Myeloma

location_facility: Istituto Oncologico Sviss. Italiana IOSI Ospedale Regionale Bellinzona e Valli

location_facility: Institute of Oncology and Hematology Stadtspital Triemli

location_facility: Center of Oncology/Hematology and transfusion Medicine, Kantonsspital

location_facility: Onkologie/Hämatologie Kantonsspital st Gallen

location_facility: Centre hospitalier Argenteuil Victor Dupouy

location_facility: Centre hospitalier de la région d'Annecy