title: A Phase 2 Randomised, Double-blind, Placebo-controlled, Single-dose, Dose-ranging Study of the Efficacy and Safety of MEDI4893, a Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects.

acronym: SAATELLITE

summary: Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients

study_start_date_type: Actual

primary_purpose: Prevention

ReferenceCitation: François B, Jafri HS, Chastre J, Sánchez-García M, Eggimann P, Dequin PF, Huberlant V, Viña Soria L, Boulain T, Bretonnière C, Pugin J, Trenado J, Hernandez Padilla AC, Ali O, Shoemaker K, Ren P, Coenjaerts FE, Ruzin A, Barraud O, Timbermont L, Lammens C, Pierre V, Wu Y, Vignaud J, Colbert S, Bellamy T, Esser MT, Dubovsky F, Bonten MJ, Goossens H, Laterre PF; COMBACTE Consortium and the SAATELLITE Study Group. Efficacy and safety of suvratoxumab for prevention of Staphylococcus aureus ventilator-associated pneumonia (SAATELLITE): a multicentre, randomised, double-blind, placebo-controlled, parallel-group, phase 2 pilot trial. Lancet Infect Dis. 2021 Sep;21(9):1313-1323. doi: 10.1016/S1473-3099(20)30995-6. Epub 2021 Apr 21.

family: François

full_name: Bruno François

given: Bruno

family: Jafri

full_name: Hasan S Jafri

given: Hasan S

family: Chastre

full_name: Jean Chastre

given: Jean

family: Sánchez-García

full_name: Miguel Sánchez-García

given: Miguel

family: Eggimann

full_name: Philippe Eggimann

given: Philippe

family: Dequin

full_name: Pierre-François Dequin

given: Pierre-François

family: Huberlant

full_name: Vincent Huberlant

given: Vincent

family: Viña Soria

full_name: Lucia Viña Soria

given: Lucia

family: Boulain

full_name: Thierry Boulain

given: Thierry

family: Bretonnière

full_name: Cédric Bretonnière

given: Cédric

family: Pugin

full_name: Jérôme Pugin

given: Jérôme

family: Trenado

full_name: Josep Trenado

given: Josep

family: Hernandez Padilla

full_name: Ana Catalina Hernandez Padilla

given: Ana Catalina

family: Ali

full_name: Omar Ali

given: Omar

family: Shoemaker

full_name: Kathryn Shoemaker

given: Kathryn

family: Ren

full_name: Pin Ren

given: Pin

family: Coenjaerts

full_name: Frank E Coenjaerts

given: Frank E

family: Ruzin

full_name: Alexey Ruzin

given: Alexey

family: Barraud

full_name: Olivier Barraud

given: Olivier

family: Timbermont

full_name: Leen Timbermont

given: Leen

family: Lammens

full_name: Christine Lammens

given: Christine

family: Pierre

full_name: Vadryn Pierre

given: Vadryn

family: Wu

full_name: Yuling Wu

given: Yuling

ReferenceCitation: Yu XQ, Robbie GJ, Wu Y, Esser MT, Jensen K, Schwartz HI, Bellamy T, Hernandez-Illas M, Jafri HS. Safety, Tolerability, and Pharmacokinetics of MEDI4893, an Investigational, Extended-Half-Life, Anti-Staphylococcus aureus Alpha-Toxin Human Monoclonal Antibody, in Healthy Adults. Antimicrob Agents Chemother. 2016 Dec 27;61(1). pii: e01020-16. doi: 10.1128/AAC.01020-16. Print 2017 Jan.

name: MedImmune LLC, Gaithersburg, Maryland, USA

name: Miami Research Associates, Miami, Florida, USA

location_country:
United States
Switzerland
Spain
France
Czechia
Greece
Hungary
Belgium
Portugal
Germany


title: A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib (GW572016) in Women With Early-Stage ErbB2 Overexpressing Breast Cancer

summary: This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Goss PE, Smith IE, O'Shaughnessy J, Ejlertsen B, Kaufmann M, Boyle F, Buzdar AU, Fumoleau P, Gradishar W, Martin M, Moy B, Piccart-Gebhart M, Pritchard KI, Lindquist D, Chavarri-Guerra Y, Aktan G, Rappold E, Williams LS, Finkelstein DM; TEACH investigators. Adjuvant lapatinib for women with early-stage HER2-positive breast cancer: a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Jan;14(1):88-96. doi: 10.1016/S1470-2045(12)70508-9. Epub 2012 Dec 10. Erratum in: Lancet Oncol. 2013 Feb;14(2):e47.

ReferenceType: derived

ReferenceCitation: Boyle FM, Smith IE, O'Shaughnessy J, Ejlertsen B, Buzdar AU, Fumoleau P, Gradishar W, Martin M, Moy B, Piccart-Gebhart M, Pritchard KI, Lindquist D, Amonkar M, Huang Y, Rappold E, Williams LS, Wang-Silvanto J, Kaneko T, Finkelstein DM, Goss PE; TEACH Investigators. Health related quality of life of women in TEACH, a randomised placebo controlled adjuvant trial of lapatinib in early stage Human Epidermal Growth Factor Receptor (HER2) overexpressing breast cancer. Eur J Cancer. 2015 Apr;51(6):685-96. doi: 10.1016/j.ejca.2015.02.005. Epub 2015 Mar 6.

family: Boyle

full_name: Frances M. Boyle

given: Frances M.

sequence: first

family: Smith

full_name: Ian E. Smith

given: Ian E.

sequence: additional

family: O’Shaughnessy

full_name: Joyce O’Shaughnessy

given: Joyce

family: Ejlertsen

full_name: Bent Ejlertsen

given: Bent

family: Buzdar

full_name: Aman U. Buzdar

given: Aman U.

family: Fumoleau

full_name: Pierre Fumoleau

given: Pierre

family: Gradishar

full_name: William Gradishar

given: William

family: Martin

full_name: Miguel Martin

given: Miguel

family: Moy

full_name: Beverly Moy

given: Beverly

family: Piccart-Gebhart

full_name: Martine Piccart-Gebhart

given: Martine

family: Pritchard

full_name: Kathleen I. Pritchard

given: Kathleen I.

family: Lindquist

full_name: Deborah Lindquist

given: Deborah

family: Amonkar

full_name: Mayur Amonkar

given: Mayur

family: Huang

full_name: Yingjie Huang

given: Yingjie

family: Rappold

full_name: Erica Rappold

given: Erica

family: Williams

full_name: Lisa S. Williams

given: Lisa S.

family: Wang-Silvanto

full_name: Jing Wang-Silvanto

given: Jing

family: Kaneko

full_name: Tomomi Kaneko

given: Tomomi

family: Finkelstein

full_name: Dianne M. Finkelstein

given: Dianne M.

family: Goss

full_name: Paul E. Goss

given: Paul E.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: European Journal of Cancer

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Schaid DJ, Spraggs CF, McDonnell SK, Parham LR, Cox CJ, Ejlertsen B, Finkelstein DM, Rappold E, Curran J, Cardon LR, Goss PE. Prospective validation of HLA-DRB1*07:01 allele carriage as a predictive risk factor for lapatinib-induced liver injury. J Clin Oncol. 2014 Aug 1;32(22):2296-303. doi: 10.1200/JCO.2013.52.9867. Epub 2014 Mar 31.

name: Daniel J. Schaid and Shannon K. McDonnell, Mayo Clinic, Rochester, MN; Colin F. Spraggs and Charles J. Cox, GlaxoSmithKline Research and Development, Stevenage, Hertfordshire; Joan Curran, GlaxoSmithKline Research and Development, London, United Kingdom; Laura R. Parham, GlaxoSmithKline Research and Development, Research Triangle Park, NC; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Dianne M. Finkelstein and Paul E. Goss, Massachusetts General Hospital, Boston, MA; and Erica Rappold and Lon R....

family: Schaid

full_name: Daniel J. Schaid

publisher: American Society of Clinical Oncology (ASCO)

title: Prospective Validation of HLA-DRB1*07:01 Allele Carriage As a Predictive Risk Factor for Lapatinib-Induced Liver Injury

location_country:
Peru
Greece
Belgium
Australia
Russian Federation
Denmark
Czech Republic
Ukraine
India
Croatia
France
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Chile
Hong Kong
Philippines
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
New Zealand
Spain
Latvia


type: EudraCT Number

title: A Phase II, Open-Label, Multicenter Trial to Investigate the Clinical Activity and Safety of Avelumab (MSB0010718C) in Subjects With Merkel Cell Carcinoma

summary: This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).

status: Active, not recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

ReferenceType: result

ReferenceCitation: Kaufman HL, Russell J, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Linette GP, Milella M, Brownell I, Lewis KD, Lorch JH, Chin K, Mahnke L, von Heydebreck A, Cuillerot JM, Nghiem P. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016 Oct;17(10):1374-1385. doi: 10.1016/S1470-2045(16)30364-3. Epub 2016 Sep 1.

family: Kaufman

full_name: Howard L Kaufman

given: Howard L

family: Russell

full_name: Jeffery Russell

given: Jeffery

family: Hamid

full_name: Omid Hamid

given: Omid

family: Bhatia

full_name: Shailender Bhatia

given: Shailender

family: Terheyden

full_name: Patrick Terheyden

given: Patrick

family: D'Angelo

full_name: Sandra P D'Angelo

given: Sandra P

family: Shih

full_name: Kent C Shih

given: Kent C

family: Lebbé

full_name: Céleste Lebbé

given: Céleste

family: Linette

full_name: Gerald P Linette

given: Gerald P

family: Milella

full_name: Michele Milella

given: Michele

family: Brownell

full_name: Isaac Brownell

given: Isaac

family: Lewis

full_name: Karl D Lewis

given: Karl D

family: Lorch

full_name: Jochen H Lorch

given: Jochen H

family: Chin

full_name: Kevin Chin

given: Kevin

family: Mahnke

full_name: Lisa Mahnke

given: Lisa

family: von Heydebreck

full_name: Anja von Heydebreck

given: Anja

family: Cuillerot

full_name: Jean-Marie Cuillerot

given: Jean-Marie

family: Nghiem

full_name: Paul Nghiem

given: Paul

journal_name: The Lancet Oncology

oa_host_type: repository

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

ReferenceCitation: Kaufman HL, Russell JS, Hamid O, Bhatia S, Terheyden P, D'Angelo SP, Shih KC, Lebbé C, Milella M, Brownell I, Lewis KD, Lorch JH, von Heydebreck A, Hennessy M, Nghiem P. Updated efficacy of avelumab in patients with previously treated metastatic Merkel cell carcinoma after ≥1 year of follow-up: JAVELIN Merkel 200, a phase 2 clinical trial. J Immunother Cancer. 2018 Jan 19;6(1):7. doi: 10.1186/s40425-017-0310-x.

ReferenceCitation: D'Angelo SP, Russell J, Lebbé C, Chmielowski B, Gambichler T, Grob JJ, Kiecker F, Rabinowits G, Terheyden P, Zwiener I, Bajars M, Hennessy M, Kaufman HL. Efficacy and Safety of First-line Avelumab Treatment in Patients With Stage IV Metastatic Merkel Cell Carcinoma: A Preplanned Interim Analysis of a Clinical Trial. JAMA Oncol. 2018 Sep 1;4(9):e180077. doi: 10.1001/jamaoncol.2018.0077. Epub 2018 Sep 13.

name: Department of Medicine, Weill Cornell Medical College, New York, New York

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

name: H. Lee Moffitt Cancer Center, Tampa, Florida

name: currently affiliated with Immunocore, Ltd, Conshohocken, Pennsylvania

name: Assistance Publique–Hôpitaux de Paris Dermatology and Centre d’Investigation Clinique, University Paris Diderot Institut National de la Santé et de la Recherche Medicale U976, Saint Louis Hospital, Paris, France

name: Department of Medicine, UCLA (University of California, Los Angeles) Medical Center

name: Skin Cancer Center, Department of Dermatology, Ruhr-University Bochum, Bochum, Germany

name: Department of Dermatology, Venerology, and Cutaneous Oncology, Aix-Marseille University, Assistance Publique–Hôpitaux de Marseille, Timone Hospital, Marseille, France

name: Department of Dermatology, Venereology, and Allergology, Charité Universitätsmedizin Berlin, Edmund-Lesser-Haus, Berlin, Germany

name: Dana-Farber Cancer Institute, Boston, Massachusetts

name: Department of Dermatology, Allergology, and Venereology, University of Lübeck, Lübeck, Germany

name: Rutgers Cancer Institute of New Jersey, New Brunswick

name: currently affiliated with Replimune Inc, Woburn, Massachusetts

ReferenceCitation: D'Angelo SP, Lebbé C, Mortier L, Brohl AS, Fazio N, Grob JJ, Prinzi N, Hanna GJ, Hassel JC, Kiecker F, Georges S, Ellers-Lenz B, Shah P, Güzel G, Nghiem P. First-line avelumab in a cohort of 116 patients with metastatic Merkel cell carcinoma (JAVELIN Merkel 200): primary and biomarker analyses of a phase II study. J Immunother Cancer. 2021 Jul;9(7). pii: e002646. doi: 10.1136/jitc-2021-002646.

ReferenceCitation: Kelly K, Manitz J, Patel MR, D'Angelo SP, Apolo AB, Rajan A, Kasturi V, Speit I, Bajars M, Warth J, Gulley JL. Efficacy and immune-related adverse event associations in avelumab-treated patients. J Immunother Cancer. 2020 Nov;8(2). pii: e001427. doi: 10.1136/jitc-2020-001427.

ReferenceCitation: Bharmal M, Nolte S, Lebbé C, Mortier L, Brohl AS, Fazio N, Grob JJ, Pusceddu S, Hanna GJ, Hassel JC, Kiecker F, Ellers-Lenz B, Bajars M, Güzel G, Nghiem P, Hunger M, Schlichting M, Henry-Szatkowski M, D'Angelo SP. Health-related quality of life trajectory of treatment-naive patients with Merkel cell carcinoma receiving avelumab. Future Oncol. 2020 Sep;16(27):2089-2099. doi: 10.2217/fon-2020-0426. Epub 2020 Sep 17.

name: EMD Serono Research & Development Institute, Inc., Rockland, MA 02370, USA; a business of Merck KGaA, Darmstadt, Germany

name: Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin & Berlin Institute of Health, Berlin, Germany

name: Université de Paris, INSERM U976 & Dermatology & CIC, AP-HP, Saint Louis Hospital, Paris, France

name: Department of Dermatology, CARADERM and University of Lille, Inserm U1189, CHU Lille, Lille Cedex, France

name: Moffitt Cancer Center, Tampa, FL 33612, USA

name: Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumours, European Institute of Oncology, IEO, IRCCS, Milan, Italy

name: Aix-Marseille University, AP-HM Hospital, Marseille, France

name: Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

name: Dana-Farber Cancer Institute, Boston, MA 02215, USA

name: Department of Dermatology, Heidelberg University Hospital, Heidelberg, Germany

name: EMD Serono Research & Development Institute, Inc., Billerica, MA 01821, USA; a business of Merck KGaA, Darmstadt, Germany

name: Division of Dermatology, University of Washington Medical Center at South Lake Union, Seattle, WA 98109, USA

name: Department of Medicine, Weill Cornell Medical College & Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA

ReferenceCitation: Lambert J, Marrel A, D'Angelo SP, Burgess MA, Chmielowski B, Fazio N, Gambichler T, Grob JJ, Lebbé C, Robert C, Russell J, Güzel G, Bharmal M. Patient Experiences with Avelumab in Treatment-Naïve Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020 Aug;13(4):457-467. doi: 10.1007/s40271-020-00428-5.

journal_name: The Patient - Patient-Centered Outcomes Research

ReferenceCitation: Bharmal M, Nolte S, Henry-Szatkowski M, Hennessy M, Schlichting M. Update on the psychometric properties and minimal important difference (MID) thresholds of the FACT-M questionnaire for use in treatment-naïve and previously treated patients with metastatic Merkel cell carcinoma. Health Qual Life Outcomes. 2020 May 19;18(1):145. doi: 10.1186/s12955-020-01402-3.

ReferenceCitation: D'Angelo SP, Bhatia S, Brohl AS, Hamid O, Mehnert JM, Terheyden P, Shih KC, Brownell I, Lebbé C, Lewis KD, Linette GP, Milella M, Georges S, Shah P, Ellers-Lenz B, Bajars M, Güzel G, Nghiem PT. Avelumab in patients with previously treated metastatic Merkel cell carcinoma: long-term data and biomarker analyses from the single-arm phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer. 2020 May;8(1). pii: e000674. doi: 10.1136/jitc-2020-000674.

ReferenceCitation: Bullement A, Willis A, Amin A, Schlichting M, Hatswell AJ, Bharmal M. Evaluation of survival extrapolation in immuno-oncology using multiple pre-planned data cuts: learnings to aid in model selection. BMC Med Res Methodol. 2020 May 6;20(1):103. doi: 10.1186/s12874-020-00997-x.

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

repository_institution: University College London - UCL Discovery

repositories:
PubMed Central
UCL Discovery
eprints.whiterose.ac.uk

repositories_institution: University College London - UCL Discovery

ReferenceCitation: Novakovic AM, Wilkins JJ, Dai H, Wade JR, Neuteboom B, Brar S, Bello CL, Girard P, Khandelwal A. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020 Mar;107(3):588-596. doi: 10.1002/cpt.1645. Epub 2019 Nov 18.

name: Merck Institute of Pharmacometrics Merck Serono SA Lausanne Switzerland

title: Changing Body Weight–Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma

ReferenceCitation: Bharmal M, Guillemin I, Marrel A, Arnould B, Lambert J, Hennessy M, Fofana F. How to address the challenges of evaluating treatment benefits-risks in rare diseases? A convergent mixed methods approach applied within a Merkel cell carcinoma phase 2 clinical trial. Orphanet J Rare Dis. 2018 Jun 18;13(1):95. doi: 10.1186/s13023-018-0835-1.

ReferenceCitation: Kaufman HL, Dias Barbosa C, Guillemin I, Lambert J, Mahnke L, Bharmal M. Living with Merkel Cell Carcinoma (MCC): Development of a Conceptual Model of MCC Based on Patient Experiences. Patient. 2018 Aug;11(4):439-449. doi: 10.1007/s40271-018-0301-0.

ReferenceCitation: Bharmal M, Fofana F, Barbosa CD, Williams P, Mahnke L, Marrel A, Schlichting M. Psychometric properties of the FACT-M questionnaire in patients with Merkel cell carcinoma. Health Qual Life Outcomes. 2017 Dec 22;15(1):247. doi: 10.1186/s12955-017-0815-5. Review. Erratum in: Health Qual Life Outcomes. 2019 Mar 27;17(1):52.

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Italy
United States
France
Japan
Australia
Spain
Germany

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Fondazione del Piemonte per l'Oncologia IRCC Candiolo

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Hospital General Universitario de Valencia

location_facility: Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia

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

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Washington University School of Medicine

location_facility: Istituto Nazionale Tumori Fondazione G.Pascale

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: The Angeles Clinic and Research Institute - West LA

location_facility: Universitaetsklinikum Schleswig-Holstein - Klinik fuer Allgemeine Innere Medizin

location_facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck

location_facility: Peggy & Charles Stephenson Oklahoma Cancer Center


title: A Randomized, Double-Blind Study to Compare the Durability of Glucose Lowering and Preservation of Pancreatic Beta-Cell Function of Rosiglitazone Monotherapy Compared to Metformin or Glyburide/Glibenclamide in Patients With Drug-Naive, Recently Diagnosed Type 2 Diabetes Mellitus

summary: The study will compare and evaluate the effects of long-term treatment of monotherapy with rosiglitazone, metformin and glyburide/glibenclamide on the improvement and maintenance of glycemic control in patients with recently diagnosed type 2 diabetes mellitus.

ReferenceCitation: A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care, Vol 25, No. 10, October, 2002.

ReferenceCitation: Viberti G, Lachin J, Holman R, Zinman B, Haffner S, Kravitz B, Heise MA, Jones NP, O'Neill MC, Freed MI, Kahn SE, Herman WH; ADOPT Study Group. A Diabetes Outcome Progression Trial (ADOPT): baseline characteristics of Type 2 diabetic patients in North America and Europe. Diabet Med. 2006 Dec;23(12):1289-94.

ReferenceCitation: Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G; ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med. 2006 Dec 7;355(23):2427-43. Epub 2006 Dec 4. Erratum in: N Engl J Med. 2007 Mar 29;356(13):1387-8.

ReferenceCitation: Kahn SE, Zinman B, Haffner SM, O'Neill MC, Kravitz BG, Yu D, Freed MI, Herman WH, Holman RR, Jones NP, Lachin JM, Viberti GC; ADOPT Study Group. Obesity is a major determinant of the association of C-reactive protein levels and the metabolic syndrome in type 2 diabetes. Diabetes. 2006 Aug;55(8):2357-64.

ReferenceCitation: Zinman B, Kahn SE, Haffner SM, O'Neill MC, Heise MA, Freed MI; ADOPT Study Group. Phenotypic characteristics of GAD antibody-positive recently diagnosed patients with type 2 diabetes in North America and Europe. Diabetes. 2004 Dec;53(12):3193-200.

ReferenceCitation: Gnesin F, Thuesen ACB, Kähler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6:CD012906. doi: 10.1002/14651858.CD012906.pub2.

name: Department of Endocrinology, Diabetes and Metabolism; Department 7652, Rigshospitalet; Copenhagen Denmark

family: Gnesin

full_name: Filip Gnesin

given: Filip

name: Steno Diabetes Center Copenhagen; Gentofte Denmark

name: Faculty of Health and Medical Sciences, University of Copenhagen; Novo Nordisk Foundation Center for Basic Metabolic Research; Copenhagen Denmark

family: Thuesen

full_name: Anne Cathrine Baun Thuesen

given: Anne Cathrine Baun

name: Faculty of Health and Medical Sciences; University of Copenhagen; Copenhagen N Denmark

family: Kähler

full_name: Lise Katrine Aronsen Kähler

given: Lise Katrine Aronsen

name: Department of Endocrinology; Hvidovre Hospital, University of Copenhagen; Hvidovre Denmark

family: Madsbad

full_name: Sten Madsbad

given: Sten

name: Cochrane Metabolic and Endocrine Disorders Group; Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf; Düsseldorf Germany

family: Hemmingsen

full_name: Bianca Hemmingsen

given: Bianca

journal_name: Cochrane Database of Systematic Reviews

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

repository_normalized: Pure (Denmark)

version: publishedVersion

repositories:
PubMed Central
Pure (Denmark)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ReferenceCitation: Lachin JM, Viberti G, Zinman B, Haffner SM, Aftring RP, Paul G, Kravitz BG, Herman WH, Holman RR, Kahn SE; ADOPT Study Group. Renal function in type 2 diabetes with rosiglitazone, metformin, and glyburide monotherapy. Clin J Am Soc Nephrol. 2011 May;6(5):1032-40. doi: 10.2215/CJN.09291010. Epub 2011 Mar 31.

family: Lachin

full_name: John M. Lachin

given: John M.

family: Viberti

full_name: Giancarlo Viberti

given: Giancarlo

family: Zinman

full_name: Bernard Zinman

given: Bernard

family: Haffner

full_name: Steven M. Haffner

given: Steven M.

family: Aftring

full_name: R. Paul Aftring

given: R. Paul

family: Paul

full_name: Gitanjali Paul

given: Gitanjali

family: Kravitz

full_name: Barbara G. Kravitz

given: Barbara G.

family: Herman

full_name: William H. Herman

given: William H.

family: Holman

full_name: Rury R. Holman

given: Rury R.

family: Kahn

full_name: Steven E. Kahn

given: Steven E.

journal_name: Clinical Journal of the American Society of Nephrology

title: Renal Function in Type 2 Diabetes with Rosiglitazone, Metformin, and Glyburide Monotherapy

ReferenceCitation: Kahn SE, Haffner SM, Viberti G, Herman WH, Lachin JM, Kravitz BG, Yu D, Paul G, Holman RR, Zinman B; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone decreases C-reactive protein to a greater extent relative to glyburide and metformin over 4 years despite greater weight gain: observations from a Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2010 Jan;33(1):177-83. doi: 10.2337/dc09-1661. Epub 2009 Oct 6.

name: for A Diabetes Outcome Progression Trial (ADOPT) Study Group

title: Rosiglitazone Decreases C-Reactive Protein to a Greater Extent Relative to Glyburide and Metformin Over 4 Years Despite Greater Weight Gain: Observations from A Diabetes Outcome Progression Trial (ADOPT)

ReferenceCitation: Kahn SE, Zinman B, Lachin JM, Haffner SM, Herman WH, Holman RR, Kravitz BG, Yu D, Heise MA, Aftring RP, Viberti G; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2008 May;31(5):845-51. doi: 10.2337/dc07-2270. Epub 2008 Jan 25.

name: for the A Diabetes Outcome Progression Trial (ADOPT) Study Group

title: Rosiglitazone-Associated Fractures in Type 2 Diabetes: An analysis from A Diabetes Outcome Progression Trial (ADOPT)

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

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
Finland
France
Czechia
Norway
Hungary
Belgium
Ireland
Spain
Denmark
Canada
United Kingdom


title: Medtronic CRDM Product Performance Report

acronym: PPR

summary: The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.

status: Recruiting

study_type: Observational

time_perspective: Prospective

enrollment_type: Anticipated

lead_sponsor: Medtronic

location_country:
Malaysia
Greece
Belgium
Denmark
Iceland
France
Japan
Poland
Kuwait
Norway
Canada
Slovenia
Korea, Republic of
Sweden
Saudi Arabia
Switzerland
Netherlands
Hungary
Portugal
China
United States
Germany
United Kingdom
Italy
Serbia
Czechia
Israel
Spain

intervention_type: Device

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment

summary: The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.

ReferenceCitation: Briggs AH, Glick HA, Lozano-Ortega G, Spencer M, Calverley PM, Jones PW, Vestbo J; TOwards a Revolution in COPD Health (TORCH) investigators. Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study. Eur Respir J. 2010 Mar;35(3):532-9. doi: 10.1183/09031936.00153108. Epub 2009 Aug 28.

ReferenceCitation: Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89.

ReferenceCitation: Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, Vestbo J, Knobil K, Yates JC, Calverley PM. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med. 2008 Aug 15;178(4):332-8. doi: 10.1164/rccm.200712-1869OC. Epub 2008 May 29.

ReferenceCitation: Jenkins CR, Jones PW, Calverley PM, Celli B, Anderson JA, Ferguson GT, Yates JC, Willits LR, Vestbo J. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. Respir Res. 2009 Jun 30;10:59. doi: 10.1186/1465-9921-10-59.

ReferenceCitation: Crim C, Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Willits LR, Yates JC, Vestbo J. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J. 2009 Sep;34(3):641-7. doi: 10.1183/09031936.00193908. Epub 2009 May 14.

ReferenceCitation: Ernst P, Suissa S. Pneumonia in elderly patients with chronic obstructive pulmonary disease. Curr Infect Dis Rep. 2008 May;10(3):223-8.

ReferenceCitation: Ferguson GT, Calverley PMA, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B. Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. Chest. 2009 Dec;136(6):1456-1465. doi: 10.1378/chest.08-3016. Epub 2009 Jul 6.

ReferenceCitation: Hanania NA. The impact of inhaled corticosteroid and long-acting beta-agonist combination therapy on outcomes in COPD. Pulm Pharmacol Ther. 2008;21(3):540-50. doi: 10.1016/j.pupt.2007.12.004. Epub 2008 Jan 6. Review.

ReferenceCitation: Houghton CM, Lawson N, Borrill ZL, Wixon CL, Yoxall S, Langley SJ, Woodcock A, Singh D. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respir Res. 2007 Jul 14;8:52.

ReferenceCitation: Johnson M, Agusti AG, Barnes NC. Reflections on TORCH: potential mechanisms for the survival benefit of salmeterol/fluticasone propionate in COPD patients. COPD. 2008 Dec;5(6):369-75. doi: 10.1080/15412550802522924.

ReferenceCitation: Keene ON, Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Jones PW. Methods for therapeutic trials in COPD: lessons from the TORCH trial. Eur Respir J. 2009 Nov;34(5):1018-23. doi: 10.1183/09031936.00122608.

ReferenceCitation: Drummond MB, Wise RA, John M, Zvarich MT, McGarvey LP. Accuracy of death certificates in COPD: analysis from the TORCH trial. COPD. 2010 Jun;7(3):179-85. doi: 10.3109/15412555.2010.481695.

ReferenceCitation: Marchand E. Effect of pharmacotherapy on rate of decline of FEV(1) in the TORCH study. Am J Respir Crit Care Med. 2009 Mar 1;179(5):426; author reply 426-7.

ReferenceCitation: McGarvey LP, John M, Anderson JA, Zvarich M, Wise RA; TORCH Clinical Endpoint Committee. Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee. Thorax. 2007 May;62(5):411-5. Epub 2007 Feb 20.

ReferenceCitation: Middleton PG. Management of patients with COPD: a comparison of the INSPIRE and TORCH studies. Am J Respir Crit Care Med. 2008 Jul 1;178(1):106; author reply 106-7.

ReferenceCitation: Miravitlles M, Anzueto A. Insights into interventions in managing COPD patients: lessons from the TORCH and UPLIFT studies. Int J Chron Obstruct Pulmon Dis. 2009;4:185-201. Epub 2009 May 7. Review.

ReferenceCitation: Niewoehner DE. TORCH and UPLIFT: what has been learned from the COPD "mega-trials"? COPD. 2009 Feb;6(1):1-3. doi: 10.1080/15412550902723984.

ReferenceCitation: Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Crim C, Willits LR, Yates JC, Vestbo J; TORCH Investigators. Cardiovascular events in patients with COPD: TORCH study results. Thorax. 2010 Aug;65(8):719-25. doi: 10.1136/thx.2010.136077.

ReferenceCitation: Salmeterol plus fluticasone fails to reduce mortality in patients with COPD. Formulary 2007;42:245-6.

ReferenceCitation: Stockley RA. Progression of chronic obstructive pulmonary disease: impact of inflammation, comorbidities and therapeutic intervention. Curr Med Res Opin. 2009 May;25(5):1235-45. doi: 10.1185/03007990902868971 . Review.

ReferenceCitation: Suissa S, Ernst P, Vandemheen KL, Aaron SD. Methodological issues in therapeutic trials of COPD. Eur Respir J. 2008 May;31(5):927-33. doi: 10.1183/09031936.00098307. Epub 2008 Jan 23. Review.

ReferenceCitation: Vestbo J; TORCH Study Group. The TORCH (towards a revolution in COPD health) survival study protocol. Eur Respir J. 2004 Aug;24(2):206-10.

ReferenceCitation: Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Knobil K, Willits LR, Yates JC, Jones PW. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax. 2009 Nov;64(11):939-43. doi: 10.1136/thx.2009.113662. Epub 2009 Aug 23.

ReferenceCitation: Paly VF, Naya I, Gunsoy NB, Driessen MT, Risebrough N, Briggs A, Ismaila AS. Long-term cost and utility consequences of short-term clinically important deterioration in patients with chronic obstructive pulmonary disease: results from the TORCH study. Int J Chron Obstruct Pulmon Dis. 2019 May 3;14:939-951. doi: 10.2147/COPD.S188898. eCollection 2019.

family: Paly

full_name: Victoria Federico Paly

given: Victoria Federico

family: Naya

full_name: Ian Naya

given: Ian

family: Gunsoy

full_name: Necdet B Gunsoy

given: Necdet B

family: Driessen

full_name: Maurice T Driessen

given: Maurice T

family: Risebrough

full_name: Nancy Risebrough

given: Nancy

family: Briggs

full_name: Andrew Briggs

given: Andrew

family: Ismaila

full_name: Afisi S Ismaila

given: Afisi S

currency_apc_doaj: USD

journal_name: International Journal of Chronic Obstructive Pulmonary Disease

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: London School of Hygiene and Tropical Medicine - LSHTM Research Online

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Informa UK Limited

publisher_dissemination: Informa

publisher_group: Informa

publisher_normalized: Informa

ReferenceCitation: Naya IP, Tombs L, Muellerova H, Compton C, Jones PW. Long-term outcomes following first short-term clinically important deterioration in COPD. Respir Res. 2018 Nov 20;19(1):222. doi: 10.1186/s12931-018-0928-3.

full_name: Ian P. Naya

given: Ian P.

ReferenceCitation: Jenkins CR, Celli B, Anderson JA, Ferguson GT, Jones PW, Vestbo J, Yates JC, Calverley PM. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J. 2012 Jan;39(1):38-45. doi: 10.1183/09031936.00194610. Epub 2011 Jul 7.

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Jones PW, Anderson JA, Calverley PM, Celli BR, Ferguson GT, Jenkins C, Yates JC, Vestbo J, Spencer MD; TORCH investigators. Health status in the TORCH study of COPD: treatment efficacy and other determinants of change. Respir Res. 2011 May 31;12:71. doi: 10.1186/1465-9921-12-71.

repository_institution: Harvard University - Digital Access to Scholarship at Harvard (DASH)

repository_institution: St George's University of London - St George's Online Research Archive

ReferenceCitation: Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM, Yates JC, Anderson JA, Willits LR, Wise RA; Investigators of the TORCH Study. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease. The TORCH experience. Am J Respir Crit Care Med. 2011 Feb 1;183(3):317-22. doi: 10.1164/rccm.201004-0665OC. Epub 2010 Sep 2.

journal_name: American Journal of Respiratory and Critical Care Medicine

title: Sex Differences in Mortality and Clinical Expressions of Patients with Chronic Obstructive Pulmonary Disease

location_country:
Finland
Malaysia
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
Taiwan
Iceland
Ukraine
Pakistan
Croatia
France
Lithuania
Poland
Slovakia
Norway
Thailand
Argentina
Canada
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Singapore
Hungary
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
New Zealand
Spain
Estonia
Latvia


title: Phase III Study of an Optimized Chemotherapy Followed by Maintenance With Bevacizumab Strategy With or Without Erlotinib in Unresectable Metastatic Colorectal Cancer. DREAM OPTIMOX 3. C04-2

acronym: DREAM

summary: PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer that cannot be removed by surgery.

ReferenceCitation: Tournigand C, Chibaudel B, Samson B, Scheithauer W, Vernerey D, Mésange P, Lledo G, Viret F, Ramée JF, Tubiana-Mathieu N, Dauba J, Dupuis O, Rinaldi Y, Mabro M, Aucoin N, Latreille J, Bonnetain F, Louvet C, Larsen AK, André T, de Gramont A. Bevacizumab with or without erlotinib as maintenance therapy in patients with metastatic colorectal cancer (GERCOR DREAM; OPTIMOX3): a randomised, open-label, phase 3 trial. Lancet Oncol. 2015 Nov;16(15):1493-1505. doi: 10.1016/S1470-2045(15)00216-8. Epub 2015 Oct 22. Erratum in: Lancet Oncol. 2015 Dec;16(16):e589.

family: Tournigand

full_name: Christophe Tournigand

given: Christophe

family: Chibaudel

full_name: Benoist Chibaudel

given: Benoist

family: Samson

full_name: Benoit Samson

given: Benoit

family: Scheithauer

full_name: Werner Scheithauer

given: Werner

family: Vernerey

full_name: Dewi Vernerey

given: Dewi

family: Mésange

full_name: Paul Mésange

given: Paul

family: Lledo

full_name: Gérard Lledo

given: Gérard

family: Viret

full_name: Frédéric Viret

given: Frédéric

family: Ramée

full_name: Jean-François Ramée

given: Jean-François

family: Tubiana-Mathieu

full_name: Nicole Tubiana-Mathieu

given: Nicole

family: Dauba

full_name: Jérôme Dauba

given: Jérôme

family: Dupuis

full_name: Olivier Dupuis

given: Olivier

family: Rinaldi

full_name: Yves Rinaldi

given: Yves

family: Mabro

full_name: May Mabro

given: May

family: Aucoin

full_name: Nathalie Aucoin

given: Nathalie

family: Latreille

full_name: Jean Latreille

given: Jean

family: Bonnetain

full_name: Franck Bonnetain

given: Franck

family: Louvet

full_name: Christophe Louvet

family: Larsen

full_name: Annette K Larsen

given: Annette K

family: André

full_name: Thierry André

given: Thierry

family: de Gramont

full_name: Aimery de Gramont

given: Aimery

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_facility: Centre Hospitalier Saint Joseph Saint Luc

location_facility: Centre Hospitalier Intercommunal Le Raincy - Montfermeil

location_facility: AKH Universitätsklinik für Innere Medizin I


title: A Randomized, Multicenter, Phase III Study of Erlotinib Versus Observation in Patients With no Evidence of Disease Progression After First Line, Platinum-Based Chemotherapy For High-Risk Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sometimes after treatment, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether erlotinib is more effective than observation after first-line chemotherapy in treating patients with ovarian cancer, peritoneal cancer, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to observation in treating patients who have undergone first-line chemotherapy for ovarian cancer, peritoneal cancer, or fallopian tube cancer.

ReferenceCitation: Vergote IB, Jimeno A, Joly F, Katsaros D, Coens C, Despierre E, Marth C, Hall M, Steer CB, Colombo N, Lesoin A, Casado A, Reinthaller A, Green J, Buck M, Ray-Coquard I, Ferrero A, Favier L, Reed NS, Curé H, Pujade-Lauraine E. Randomized phase III study of erlotinib versus observation in patients with no evidence of disease progression after first-line platin-based chemotherapy for ovarian carcinoma: a European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup study. J Clin Oncol. 2014 Feb 1;32(4):320-6. doi: 10.1200/JCO.2013.50.5669. Epub 2013 Dec 23.

name: Ignace B. Vergote and Evelyn Despierre, University Hospitals Leuven and Katholieke Universiteit Leuven, Leuven; Corneel Coens, European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium; Antonio Jimeno, University of Colorado School of Medicine, Aurora, CO; Florence Joly, Centre François Baclesse Caen, Caen; Anne Lesoin, Centre Oscar Lambret, Lille; Isabelle Ray-Coquard, Centre Léon Bérard, Lyon; Laure Favier, Centre Georges François Leclerc, Dijon; Hervé Curé, Unicancer...

family: Vergote

full_name: Ignace B. Vergote

given: Ignace B.

family: Jimeno

full_name: Antonio Jimeno

given: Antonio

family: Joly

full_name: Florence Joly

given: Florence

family: Katsaros

full_name: Dionyssios Katsaros

given: Dionyssios

family: Coens

full_name: Corneel Coens

given: Corneel

family: Despierre

full_name: Evelyn Despierre

given: Evelyn

family: Marth

full_name: Christian Marth

given: Christian

family: Hall

full_name: Marcia Hall

given: Marcia

family: Steer

full_name: Christopher B. Steer

given: Christopher B.

family: Colombo

full_name: Nicoletta Colombo

given: Nicoletta

family: Lesoin

full_name: Anne Lesoin

given: Anne

family: Casado

full_name: Antonio Casado

family: Reinthaller

full_name: Alexander Reinthaller

given: Alexander

family: Green

full_name: John Green

given: John

family: Buck

full_name: Martin Buck

given: Martin

family: Ray-Coquard

full_name: Isabelle Ray-Coquard

given: Isabelle

family: Ferrero

full_name: Annamaria Ferrero

given: Annamaria

family: Favier

full_name: Laure Favier

given: Laure

family: Reed

full_name: Nick Simon Reed

given: Nick Simon

family: Curé

full_name: Hervé Curé

given: Hervé

family: Pujade-Lauraine

full_name: Eric Pujade-Lauraine

given: Eric

journal_name: Journal of Clinical Oncology

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Randomized Phase III Study of Erlotinib Versus Observation in Patients With No Evidence of Disease Progression After First-Line Platin-Based Chemotherapy for Ovarian Carcinoma: A European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup Study

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Italy
Austria
Netherlands
Spain
France
Australia
Portugal
United Kingdom

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Centre Hospital General Robert Ballanger

location_facility: Sir Charles Gairdner Hospital - Nedlands

location_facility: Centre Hospitalier de L' Agglomeration Montargoise

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: Mid Kent Oncology Centre at Maidstone Hospital

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

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

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Velindre Cancer Center at Velindre Hospital

location_facility: Centre Hospitalier General de Mont de Marsan

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Centre Hospitalier General Andre Boulloche

location_facility: Murray Valley Private Hospital and Cancer Treatment Centre

location_facility: Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

intervention_type: Drug

status_simplified: Completed