ReferenceCitation: Wu YL, Sequist LV, Tan EH, Geater SL, Orlov S, Zhang L, Lee KH, Tsai CM, Kato T, Barrios CH, Schuler M, Hirsh V, Yamamoto N, O'Byrne K, Boyer M, Mok T, Peil B, Märten A, Chih-Hsin Yang J, Paz-Ares L, Park K. Afatinib as First-line Treatment of Older Patients With EGFR Mutation-Positive Non-Small-Cell Lung Cancer: Subgroup Analyses of the LUX-Lung 3, LUX-Lung 6, and LUX-Lung 7 Trials. Clin Lung Cancer. 2018 Jul;19(4):e465-e479. doi: 10.1016/j.cllc.2018.03.009. Epub 2018 Mar 17.

family: Wu

full_name: Yi-Long Wu

given: Yi-Long

family: Sequist

full_name: Lecia V. Sequist

given: Lecia V.

family: Tan

full_name: Eng-Huat Tan

given: Eng-Huat

family: Geater

full_name: Sarayut L. Geater

given: Sarayut L.

family: Orlov

full_name: Sergey Orlov

given: Sergey

family: Zhang

full_name: Li Zhang

given: Li

family: Lee

full_name: Ki Hyeong Lee

given: Ki Hyeong

family: Tsai

full_name: Chun-Ming Tsai

given: Chun-Ming

family: Kato

full_name: Terufumi Kato

given: Terufumi

family: Barrios

full_name: Carlos H. Barrios

given: Carlos H.

family: Schuler

full_name: Martin Schuler

given: Martin

family: Hirsh

full_name: Vera Hirsh

family: Yamamoto

full_name: Nobuyuki Yamamoto

given: Nobuyuki

family: O’Byrne

full_name: Kenneth O’Byrne

given: Kenneth

family: Boyer

full_name: Michael Boyer

given: Michael

family: Mok

full_name: Tony Mok

given: Tony

family: Peil

full_name: Barbara Peil

given: Barbara

family: Märten

full_name: Angela Märten

given: Angela

family: Chih-Hsin Yang

full_name: James Chih-Hsin Yang

given: James

family: Paz-Ares

full_name: Luis Paz-Ares

given: Luis

family: Park

full_name: Keunchil Park

given: Keunchil

journal_name: Clinical Lung Cancer

repository_institution: Trinity College Dublin - Trinity's Access to Research Output (TARA)

ReferenceCitation: Yang JC, Sequist LV, Zhou C, Schuler M, Geater SL, Mok T, Hu CP, Yamamoto N, Feng J, O'Byrne K, Lu S, Hirsh V, Huang Y, Sebastian M, Okamoto I, Dickgreber N, Shah R, Märten A, Massey D, Wind S, Wu YL. Effect of dose adjustment on the safety and efficacy of afatinib for EGFR mutation-positive lung adenocarcinoma: post hoc analyses of the randomized LUX-Lung 3 and 6 trials. Ann Oncol. 2016 Nov;27(11):2103-2110. Epub 2016 Sep 6.

ReferenceCitation: Schuler M, Wu YL, Hirsh V, O'Byrne K, Yamamoto N, Mok T, Popat S, Sequist LV, Massey D, Zazulina V, Yang JC. First-Line Afatinib versus Chemotherapy in Patients with Non-Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases. J Thorac Oncol. 2016 Mar;11(3):380-90. doi: 10.1016/j.jtho.2015.11.014. Epub 2016 Jan 25.

repository_institution: Queensland University of Technology - QUT ePrints

title: First-Line Afatinib versus Chemotherapy in Patients with Non–Small Cell Lung Cancer and Common Epidermal Growth Factor Receptor Gene Mutations and Brain Metastases

ReferenceCitation: Kato T, Yoshioka H, Okamoto I, Yokoyama A, Hida T, Seto T, Kiura K, Massey D, Seki Y, Yamamoto N. Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activating EGFR mutations: Subgroup analysis of LUX-Lung 3. Cancer Sci. 2015 Sep;106(9):1202-11. doi: 10.1111/cas.12723. Epub 2015 Jul 25.

name: Kanagawa Cardiovascular and Respiratory Center; Yokohama Japan

name: Kurashiki Central Hospital; Kurashiki Japan

name: Kyusyu University Hospital; Fukuoka Japan

name: Niigata Cancer Center Hospital; Niigata Japan

name: Aichi Cancer Center Hospital; Nagoya Japan

name: National Kyushu Cancer Center; Fukuoka Japan

name: Okayama University Hospital; Okayama Japan

name: Nippon Boehringer Ingelheim; Tokyo Japan

name: Wakayama Medical University; Wakayama Japan

title: Afatinib versus cisplatin plus pemetrexed in Japanese patients with advanced non-small cell lung cancer harboring activatingEGFRmutations: Subgroup analysis of LUX-Lung 3

ReferenceCitation: Yang JC, Sequist LV, Geater SL, Tsai CM, Mok TS, Schuler M, Yamamoto N, Yu CJ, Ou SH, Zhou C, Massey D, Zazulina V, Wu YL. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015 Jul;16(7):830-8. doi: 10.1016/S1470-2045(15)00026-1. Epub 2015 Jun 4.

ReferenceCitation: Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.

ReferenceCitation: Yang JC, Hirsh V, Schuler M, Yamamoto N, O'Byrne KJ, Mok TS, Zazulina V, Shahidi M, Lungershausen J, Massey D, Palmer M, Sequist LV. Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3342-50. doi: 10.1200/JCO.2012.46.1764. Epub 2013 Jul 1.

name: James Chih-Hsin Yang, National Taiwan University Hospital, Taipei, Taiwan; Vera Hirsh, McGill University, Montreal, Quebec, Canada; Martin Schuler, West German Cancer Center, University Duisburg-Essen, Essen; Juliane Lungershausen, Boehringer Ingelheim GmbH, Ingelheim, Germany; Nobuyuki Yamamoto, Shizuoka Cancer Center, Shizuoka, Japan; Kenneth J. O'Byrne, St James' Hospital, Dublin, Ireland; Tony S.K. Mok, State Key Laboratory of Southern China, Hong Kong Cancer Institute, The Chinese University of Hong...

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Symptom Control and Quality of Life in LUX-Lung 3: A Phase III Study of Afatinib or Cisplatin/Pemetrexed in Patients With Advanced Lung Adenocarcinoma With EGFR Mutations

ReferenceCitation: Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok T, Geater SL, Orlov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M, Schuler M. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013 Sep 20;31(27):3327-34. doi: 10.1200/JCO.2012.44.2806. Epub 2013 Jul 1.

name: Lecia V. Sequist, Massachusetts General Hospital and Harvard Medical School, Boston, MA; James Chih-Hsin Yang, National Taiwan University Hospital; Chun-Ming Tsai, Taipei Veterans General Hospital, Taipei; Wu-Chou Su, National Cheng Kung University Hospital, Tainan, Taiwan; Nobuyuki Yamamoto, Shizuoka Cancer Center, Shizuoka; Terufumi Kato, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan; Kenneth O'Byrne, St James' Hospital, Dublin, Ireland; Vera Hirsh, McGill University, Montreal, Quebec...

title: Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma With EGFR Mutations

location_country:
Peru
Malaysia
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Thailand
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Philippines
Hungary
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil

location_facility: Instituto de Medicina Nuclear de Bahía Blanca

location_facility: Cross Cancer Institute (University of Alberta)

location_facility: Hospital São Lucas da Pontifícia Universidade Católica

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Hematologiste et oncologue medical CHUM - Hopital Notre-Dame

location_facility: South Texas Institute of Cancer, Northwest Cancer Center

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

location_facility: Clinical Trials and Research Associates Inc

location_facility: Instituto Clínico Oncológico del Sur - ICOS

location_facility: Institute of Biomedical Research and Innovation Hospital

location_facility: Kharkiv Regional Clinical Oncology Center

location_facility: Centro de Pesquisa do Hospital Lifecenter

location_facility: Instituto Nacional de Enfermedades Neoplásicas

location_facility: Centro de Pesquisas Clínicas em Oncología

location_facility: Chonnam National University Hwasun Hospital

location_facility: City Clinical Hospital #4, Dnipropetrovsk State Medical Academy

location_facility: First Pavlov State Medical University Saint Petersburg

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Lviv State Oncological Regional Treatment & Diagnostic CTR

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta"

location_facility: McGill University, Department of Oncology

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: UNIFESP Departamento de Medicina de Pneumologia

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: Seoul National University Bundang Hospital

location_facility: Lehigh Valley Hospital / Lehigh Valley Health Network

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Maidstone Hospital, Kent Oncology Centre

location_facility: Markusovszky County Hospital, Szombathely

location_facility: SMZ Baumgartner Hoehe Otto Wagner Spital

location_facility: Republic Clinical Oncology Dispensary, Dept. Chemotherapy

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: SPb SBIH "City Clinical Oncological Dispensary"

location_facility: FSBSI "N.N Blokhin Medical Research Center of Oncology"

location_facility: Pusat Perubatan University Kebangsaan Malaysia

location_facility: Hospital Dirección de Previsión de Carabineros

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Instituto Oncológico Limitada Viña del Mar

location_facility: Universitätsklinikum Benjamin Franklin, Berlin

location_facility: Innovative Medical Research of South Florida

title: A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation

summary: This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.


title: Action in Diabetes and Vascular Disease Preterax and Diamicron MR Controlled Evaluation Post Trial Observational Study

acronym: ADVANCE-ON

summary: The study is designed to determine the long term, post trial effects of the two interventions studied in ADVANCE (routine blood pressure lowering with perindopril-indapamide as compared with placebo and intensive gliclazide-MR based glucose control as compared to standard guideline based glucose control) in individuals with type 2 diabetes at high risk of cardiovascular events. The long term, post randomization effects of the two study interventions will be investigated separately as they were for the main trial. This study will clarify and quantify the long-term, post trial (often referred to as legacy) effects of these two interventions in a broader population of patients with type 2 diabetes from high and low to middle income countries, and in the setting of comprehensive cardiovascular risk factor treatment. With the ADVANCE trial infrastructure and surveillance system already in place, the implementation of extended follow-up will be feasible. The conclusions of this follow up study will have profound clinical implications for the care of patients with type 2 diabetes around the world.

status: Completed

study_completion_date_type: Actual

study_type: Observational

time_perspective: Prospective

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Patel A; ADVANCE Collaborative Group, MacMahon S, Chalmers J, Neal B, Woodward M, Billot L, Harrap S, Poulter N, Marre M, Cooper M, Glasziou P, Grobbee DE, Hamet P, Heller S, Liu LS, Mancia G, Mogensen CE, Pan CY, Rodgers A, Williams B. Effects of a fixed combination of perindopril and indapamide on macrovascular and microvascular outcomes in patients with type 2 diabetes mellitus (the ADVANCE trial): a randomised controlled trial. Lancet. 2007 Sep 8;370(9590):829-40.

ReferenceCitation: ADVANCE Collaborative Group, Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.

ReferenceType: derived

ReferenceCitation: Oshima M, Jun M, Ohkuma T, Toyama T, Wada T, Cooper ME, Hadjadj S, Hamet P, Harrap S, Mancia G, Marre M, Williams B, Chalmers J, Woodward M, Perkovic V; ADVANCE Collaborative Group. The relationship between eGFR slope and subsequent risk of vascular outcomes and all-cause mortality in type 2 diabetes: the ADVANCE-ON study. Diabetologia. 2019 Nov;62(11):1988-1997. doi: 10.1007/s00125-019-4948-4. Epub 2019 Jul 13.

family: Oshima

full_name: Megumi Oshima

given: Megumi

sequence: first

name: on behalf of the ADVANCE Collaborative Group

family: Jun

full_name: Min Jun

given: Min

sequence: additional

family: Ohkuma

full_name: Toshiaki Ohkuma

given: Toshiaki

family: Toyama

full_name: Tadashi Toyama

given: Tadashi

family: Wada

full_name: Takashi Wada

given: Takashi

family: Cooper

full_name: Mark E. Cooper

given: Mark E.

family: Hadjadj

full_name: Samy Hadjadj

given: Samy

family: Hamet

full_name: Pavel Hamet

given: Pavel

family: Harrap

full_name: Stephen Harrap

given: Stephen

family: Mancia

full_name: Giuseppe Mancia

given: Giuseppe

family: Marre

full_name: Michel Marre

given: Michel

family: Williams

full_name: Bryan Williams

given: Bryan

family: Chalmers

full_name: John Chalmers

given: John

family: Woodward

full_name: Mark Woodward

given: Mark

family: Perkovic

full_name: Vlado Perkovic

given: Vlado

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Diabetologia

oa_colors: green hybrid

oa_host_type: publisher;repository

evidence: open (via crossref license)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

evidence: oa repository (via pmcid lookup)

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University College London - UCL Discovery

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Mohammedi K, Woodward M, Hirakawa Y, Zoungas S, Colagiuri S, Hamet P, Harrap S, Poulter N, Matthews DR, Marre M, Chalmers J; ADVANCE Collaborative Group. Presentations of major peripheral arterial disease and risk of major outcomes in patients with type 2 diabetes: results from the ADVANCE-ON study. Cardiovasc Diabetol. 2016 Sep 2;15(1):129. doi: 10.1186/s12933-016-0446-x.

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

ReferenceCitation: Wong MG, Perkovic V, Chalmers J, Woodward M, Li Q, Cooper ME, Hamet P, Harrap S, Heller S, MacMahon S, Mancia G, Marre M, Matthews D, Neal B, Poulter N, Rodgers A, Williams B, Zoungas S; ADVANCE-ON Collaborative Group. Long-term Benefits of Intensive Glucose Control for Preventing End-Stage Kidney Disease: ADVANCE-ON. Diabetes Care. 2016 May;39(5):694-700. doi: 10.2337/dc15-2322. Epub 2016 Mar 22.

ReferenceCitation: Zoungas S, Chalmers J, Neal B, Billot L, Li Q, Hirakawa Y, Arima H, Monaghan H, Joshi R, Colagiuri S, Cooper ME, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Lisheng L, Mancia G, Marre M, Matthews DR, Mogensen CE, Perkovic V, Poulter N, Rodgers A, Williams B, MacMahon S, Patel A, Woodward M; ADVANCE-ON Collaborative Group. Follow-up of blood-pressure lowering and glucose control in type 2 diabetes. N Engl J Med. 2014 Oct 9;371(15):1392-406. doi: 10.1056/NEJMoa1407963. Epub 2014 Sep 19.

repository_institution: Australian National University - ANU Open Research

repository_institution: Griffith University, Queensland, Australia - Griffith Research Online

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

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

title: Follow-up of Blood-Pressure Lowering and Glucose Control in Type 2 Diabetes

location_country:
Italy
India
United Kingdom
Netherlands
Philippines
Germany
France
Malaysia
Lithuania
Poland
Slovakia
Hungary
Australia
Ireland
New Zealand
China
Estonia
Russian Federation
Canada
Czech Republic

location_facility: LCC 653 - Aff Hospital of Anhui Medical University

location_facility: LCC 420 - Russian Peoples Friendship University

location_facility: LCC 809 - Royal Liverpool University Hospital

location_facility: LCC 622 - The First People's Hospital of Lianyungang City

location_facility: LCC 606 - Shandong Academy of Medical Sciences,

location_facility: LCC 642 - The Institute of Aged Gerontology of Inner Mongolia

location_facility: LCC 610 - Second Affiliated Hospital of Dalian Medical University

location_facility: LCC 633 - Cardiovascular Institute & Fu Wai Hospital

location_facility: LCC 613 - Cardiovascular Institute of Shanxi Province

location_facility: LCC 654 - The 3rd Aff Hospital of Jiangxi Medical University

location_facility: LCC 741 - Madras Diabetic Research Foundation

location_facility: LCC 816 - Peninsula Medical School Headquarters

location_facility: LCC 641 - The 2nd Aff Hospital of Harbin Medical University

location_facility: LCC 626 - First Hospital of Peking University

location_facility: LCC 638 - Shanghai 6th People's Hospital

location_facility: LCC 658 - The 1st Aff Hospital of Guiyang Medical College

location_facility: LCC 618 - Hebei Academy of Medical Sciences

location_facility: LCC 632 - Dept Endocrinology Beijing 306 Hospital

location_facility: LCC 616 - Center Hospital of Zhumadian City

location_facility: LCC 627 - Peking Union Medical College Hospital

location_facility: LCC 426 - NZOZ Specjalistyczna Poradnia Endokrynologii

location_facility: LCC 646 - The 2nd Aff Hospital of Hebei Medical University

location_facility: LCC 424 - Research Institute of Cardiology

location_facility: LCC 902 - University of Malaya Medical Centre

location_facility: LCC 660 - Shandong Academy of Medical Sciences

location_facility: LCC 643 - 2nd Aff Hospital of Baotou Medical College

location_facility: LCC 614 -The First Affiliated Hospital of Henan Medical University

location_facility: LCC 635 -Aff Ruijin Hospital of Shanghai Second Medical University

location_facility: LCC 620 - Municipal Hospital of Chengdou

location_facility: LCC 330 - Klinikyum der Universitat Munchen

location_facility: LCC 466 - Centre de recherche d'endocrinologie

location_facility: LCC 467 - Queen Elizabeth II Health Science Centre

location_facility: LCC 109 - Rural Clinical Trials Research Unit

location_facility: LCC 273 - Institute Psychophysiology and Rehabilitation

location_facility: LCC 607 - People's Hospital of Binzhou City

location_facility: LCC 639 - Metabolic Disease Hospital of Tianjin Medical University

location_facility: LCC 336 - Heart Center Foundation-DRC Ltd

location_facility: LCC 651 - Jiangsu Institute of Geriatrics,

location_facility: LCC 647 - First Hospital of Yang Quan City

location_facility: LCC 630 - Beijing Hypertension League Institute

location_facility: LCC 636 - Chang Zheng Hospital of Shanghai

location_facility: LCC 460 - Centre Hospitalier de L'universitaire de Sherbrooke

location_facility: LCC 453 - Centre hospitalier de l'Universite de Montreal

location_facility: LCC 376 - CH Avignon - Hôpital Henri Duffaut

location_facility: LCC 637 - Chinese Air Force General Hospital

location_facility: LCC 354 - Stichting Huisartsen Laboratorium

location_facility: LCC 356 - Huisartsenpraktijk Tollenslaan

location_facility: LCC 661 - Institute of Gerontology of Benxi City

location_facility: LCC 624 - The First Affiliated Hospital of Fujian Medical University

location_facility: Universiti Kebangsaan Malaysia & Universiti Teknologi MARA

location_facility: LCC 315 - Hôpital Jean Bernard la Miletrie

location_facility: LCC 655 - The 1st Aff Hospital of Jiangxi Medical College

location_facility: LCC 619 - The First Hospital of Ning Bo City Municipal

location_facility: LCC 644 - Baotou Iron & Steel Corporation's Hospital,

location_facility: LCC 452 - Centre de recherche clinique de Laval

location_facility: LCC 421 - St Petersburg State Medical University

location_facility: LCC 394 - II Oddzial Chorob Wewnetrznvch

location_facility: LCC 468 - Calgary Metabolic Education and Research Centre


ReferenceCitation: Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

family: Camidge

full_name: D. Ross Camidge

given: D. Ross

family: Kim

full_name: Elizabeth E. Kim

given: Elizabeth E.

family: Usari

full_name: Tiziana Usari

given: Tiziana

family: Polli

full_name: Anna Polli

given: Anna

family: Lewis

full_name: Iona Lewis

given: Iona

family: Wilner

full_name: Keith D. Wilner

given: Keith D.

journal_name: Journal of Thoracic Oncology

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Wilner KD, Usari T, Polli A, Kim EE. Comparison of cardiovascular effects of crizotinib and chemotherapy in ALK-positive advanced non-small-cell lung cancer. Future Oncol. 2019 Apr;15(10):1097-1103. doi: 10.2217/fon-2018-0869. Epub 2019 Jan 17.

name: Pfizer Oncology, La Jolla, CA 92121, USA

full_name: Keith D Wilner

given: Keith D

full_name: Elizabeth E Kim

given: Elizabeth E

journal_name: Future Oncology

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

ReferenceCitation: Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

family: Yoneda

full_name: Ken Y. Yoneda

given: Ken Y.

family: Scranton

full_name: Judith R. Scranton

given: Judith R.

family: Cadogan

full_name: Michael A. Cadogan

given: Michael A.

family: Tassell

full_name: Vanessa Tassell

given: Vanessa

family: Nadanaciva

full_name: Sashi Nadanaciva

given: Sashi

family: Stollenwerk

full_name: Nicholas S. Stollenwerk

given: Nicholas S.

title: Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non–Small Cell Lung Cancer: Independent Review of Four PROFILE Trials

ReferenceCitation: Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30. Review.

title: Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non–Small-Cell Lung Cancer: Analysis and Literature Review

ReferenceCitation: Costa DB, Shaw AT, Ou SH, Solomon BJ, Riely GJ, Ahn MJ, Zhou C, Shreeve SM, Selaru P, Polli A, Schnell P, Wilner KD, Wiltshire R, Camidge DR, Crinò L. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol. 2015 Jun 10;33(17):1881-8. doi: 10.1200/JCO.2014.59.0539. Epub 2015 Jan 26.

name: Daniel B. Costa, Beth Israel Deaconess Medical Center, Harvard Medical School; Alice T. Shaw, Massachusetts General Hospital, Harvard Medical School, Boston, MA; Sai-Hong I. Ou, Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Irvine; S. Martin Shreeve, Paulina Selaru, and Keith D. Wilner, Pfizer Oncology, La Jolla, CA; Benjamin J. Solomon, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia; Gregory J. Riely, Memorial Sloan-Kettering Cancer Center;...

publisher: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non–Small-Cell Lung Cancer and Brain Metastases

ReferenceCitation: Lin YT, Wang YF, Yang JC, Yu CJ, Wu SG, Shih JY, Yang PC. Development of renal cysts after crizotinib treatment in advanced ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2014 Nov;9(11):1720-5. doi: 10.1097/JTO.0000000000000326.

title: Development of Renal Cysts after Crizotinib Treatment in Advanced ALK-Positive Non–Small-Cell Lung Cancer

ReferenceCitation: Shaw AT, Kim DW, Nakagawa K, Seto T, Crinó L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD, Jänne PA. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013 Jun 20;368(25):2385-94. doi: 10.1056/NEJMoa1214886. Epub 2013 Jun 1. Erratum in: N Engl J Med. 2015 Oct 15;373(16):1582.

repository_institution: The University of Manchester - Research Explorer

repositories_institution: The University of Manchester - Research Explorer

title: Crizotinib versus Chemotherapy in AdvancedALK-Positive Lung Cancer

ReferenceCitation: Tamiya A, Okamoto I, Miyazaki M, Shimizu S, Kitaichi M, Nakagawa K. Severe acute interstitial lung disease after crizotinib therapy in a patient with EML4-ALK-positive non-small-cell lung cancer. J Clin Oncol. 2013 Jan 1;31(1):e15-7. doi: 10.1200/JCO.2012.43.3730. Epub 2012 Nov 19.

name: Kinki-Chuo Chest Medical Center, Osaka, Japan

title: Severe Acute Interstitial Lung Disease After Crizotinib Therapy in a Patient With EML4-ALK–Positive Non–Small-Cell Lung Cancer

location_country:
Greece
Australia
Russian Federation
Taiwan
France
Japan
Poland
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Bulgaria
Hungary
Ireland
China
United States
Germany
United Kingdom
Italy
Brazil
Spain

location_facility: Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital

location_facility: Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion

location_facility: Alberta Health Services, Holy Cross Site

location_facility: Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute

location_facility: A.O. di Rilievo Nazionale e di Alta Specialita - S. G. Moscati

location_facility: Drug Shipping for Yale; C/O Thomas Ferencz, RPh, BCOP

location_facility: Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany

location_facility: Centralna Izba Przyjec Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: MBAL Voennomeditsinska Academia, MMA HAT Sofia

location_facility: Shanghai Chest Hospital/Department of Pulmonary Medicine

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine

location_facility: Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren

location_facility: University General Hospital of Heraklion/ Department of Clinical Oncology

location_facility: National Taiwan University Hospital, Department of Internal Medicine

location_facility: Orszagos Koranyi TBC és Pulmonologiai Intezet, VI. Bronchologia

location_facility: UMBAL "Tsaritsa Yoanna - ISUL", Klinika po onkoterapiya

location_facility: University of Pittsburgh Medical Center-Shadyside

location_facility: Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy

location_facility: Georgia Cancer Specialists-Administrative Annex

location_facility: Lawrence and Idell Weisberg Cancer Treatment Center

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung

location_facility: Ingalls Memorial Hospital (Drug Shipment Only)

location_facility: Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil)

location_facility: Taipei Veterans General Hospital, Chest Department

location_facility: Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology

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

location_facility: Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya

location_facility: Institut Catala Doncologia - Hospital Duran I Reynals

location_facility: Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani

location_facility: Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Unviersity of Colorado Hospital, Anschutz Cancer Pavilion

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly

location_facility: The Ohio State University James Cancer Hospital and Solove Research Institute

location_facility: Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie

location_facility: Cancer Center of South Florida Foundation, Inc.

location_facility: Centre Rene Gauducheau / Service d'Oncologie Medicale

location_facility: Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion

location_facility: University of California, Irvine-Medical Center

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi

location_facility: Tuen Mun Hospital, Department of Clinical Oncology

location_facility: H Lee Moffitt Cancer Center & Research Institute

location_facility: Hospital Universitario Central de Asturias

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion

location_facility: MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: University of California Davis Medical Center

location_facility: Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative

location_facility: State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: Washington University, School of Medicine

location_facility: Investigational Drug Service, Pharmacy Department, UNC Hospitals

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Tudogyogyaszati Klinika

location_facility: Zhongshan Hospital Fudan University / Respiratory Department

location_facility: Fundacao Pio XII Hospital de Cancer de Barretos

location_facility: Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine

location_facility: Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: National Cancer Center, Center for Lung Cancer

location_facility: Karolinska Universitetssjukhuset, Onkologiska kliniken

location_facility: Shanghai Pulmonary Hospital/Dept. of Oncology

location_facility: Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk

location_facility: Christie Hospital NHS Trust, Department of Medical Oncology

location_facility: UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP)

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: Pracownia Tomografii Komputerowej "ALL MEDI" Sp. z o.o.

location_facility: Santa Monica-UCLA Medical Center and Orthopaedic Hospital

location_facility: Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette

location_facility: Pest Megyei Tudogyogyintezet, III. Osztaly

location_facility: Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: State Medical Institution "Oncology Center #2" of Healthcare Department of Krasnodar Region

location_facility: Indiana University Melvin and Bren Simon Cancer Center

location_facility: University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute

location_facility: SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav

location_facility: Instituto do Câncer de São Paulo "Octavio Frias de Oliveira" - ICESP

location_facility: Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

location_facility: NSLIJ Health System/Monter Cancer Center

location_facility: Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians

location_facility: Ship Drug to: Investigational Drug Services

location_facility: Hospital General Universitari Vall D´Hebron

location_facility: HSK Dr.- Horst-Schmidt-Kliniken, Innere Medizin III Haematologie, Onkologie, Palliativmedizin

location_facility: Southampton University Hospitals NHS Trust

title: Phase 3, Randomized, Open-label Study Of The Efficacy And Safety Of Pf-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

summary: This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small cell lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


title: Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC

ReferenceCitation: Blackhall F, Ross Camidge D, Shaw AT, Soria JC, Solomon BJ, Mok T, Hirsh V, Jänne PA, Shi Y, Yang PC, Pas T, Hida T, Carpeño JC, Lanzalone S, Polli A, Iyer S, Reisman A, Wilner KD, Kim DW. Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK-positive non-small-cell lung cancer. ESMO Open. 2017 Aug 17;2(3):e000219. doi: 10.1136/esmoopen-2017-000219. eCollection 2017.

family: Blackhall

full_name: Fiona Blackhall

given: Fiona

family: Ross Camidge

given: D.

family: Shaw

full_name: Alice T. Shaw

given: Alice T.

family: Soria

full_name: Jean-Charles Soria

given: Jean-Charles

family: Solomon

full_name: Benjamin J. Solomon

given: Benjamin J.

family: Mok

full_name: Tony Mok

given: Tony

family: Hirsh

full_name: Vera Hirsh

given: Vera

family: Jänne

full_name: Pasi A. Jänne

given: Pasi A.

family: Shi

full_name: Yuankai Shi

given: Yuankai

family: Yang

full_name: Pan-Chyr Yang

given: Pan-Chyr

family: De Pas

full_name: Tommaso De Pas

given: Tommaso

family: Hida

full_name: Toyoaki Hida

given: Toyoaki

family: De Carpeño

full_name: Javier Castro De Carpeño

given: Javier Castro

family: Lanzalone

full_name: Silvana Lanzalone

given: Silvana

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

repository_institution: Seoul National University - Seoul National University Open Repository

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

ReferenceCitation: Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186. Review.

location_facility: Drug Shipping Address: Ronald Reagen University of California-Los Angeles

location_facility: Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital

location_facility: Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion

location_facility: Alberta Health Services, Holy Cross Site

location_facility: Sarah Cannon Research Institute (Pharmacy)

location_facility: Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute

location_facility: Ship drug to: Investigational Drug Services

location_facility: Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany

location_facility: University of Arkansas for Medical Sciences

location_facility: Medical University of South Carolina - Hollings Cancer Center

location_facility: MBAL Voennomeditsinska Academia, MMA HAT Sofia

location_facility: Samsung Medical Center, Sungkyunkwan Univ School of Medicine

location_facility: University of Hawaii - Cancer Research Center of Hawaii

location_facility: The Ohio State University Investigational Drug Services

location_facility: Shanghai Chest Hospital/Department of Pulmonary Medicine

location_facility: University General Hospital of Heraklion/ Department of Clinical Oncology

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: National Taiwan University Hospital, Department of Internal Medicine

location_facility: UNC Hospitals, The University of North Carolina at Chapel Hill

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Veszprem Megyei Onkormanyzat Tudogyogyintezete

location_facility: General Hospital of Chest Diseases of Athens "Sotiria"

location_facility: Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung

location_facility: Lisa Nakatsu, RPh (Drug Shipment Address)

location_facility: Indiana University Hospital Clarian Health

location_facility: Ingalls Memorial Hospital (Drug Shipment Only)

location_facility: Smilow Cancer Center at Yale New Haven, Oncology Pharmacy

location_facility: University of California, Irvine-Pharmacy

location_facility: Taipei Veterans General Hospital, Chest Department

location_facility: Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology

location_facility: National Kyushu Cancer Center/Department of Thoracic Oncology

location_facility: Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya

location_facility: Memorial Sloan - Kettering Cancer Center

location_facility: Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: DRUG SHIPMENT: University of Colorado Cancer Center

location_facility: Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie

location_facility: The Ohio State University James Cancer Hospital and Solove Research Institute

location_facility: Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly

location_facility: Cancer Center of South Florida Foundation, Inc.

location_facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department

location_facility: Centre Rene Gauducheau / Service d'Oncologie Medicale

location_facility: Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika

location_facility: University of California, Irvine-Medical Center

location_facility: Irmandade da Santa Casa de Misericordia de Porto Alegre

location_facility: MDOZS "Dr. Marko Markov", Otdelenie po onkoterapiya i paliativni grizhi

location_facility: Tuen Mun Hospital, Department of Clinical Oncology

location_facility: Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory

location_facility: APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques

location_facility: H Lee Moffitt Cancer Center & Research Institute

location_facility: Hospital Universitario Central de Asturias

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

location_facility: Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie, Zaklad Medycyny Nuklearnej

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia

location_facility: UT Southwestern University Hospital - William P. Clements, Jr

location_facility: Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM)

location_facility: University of California Davis Medical Center

location_facility: Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative

location_facility: State Institution "National Cancer Research Center named after N.N. Blokhin' RAMS"

location_facility: Hospital Universitari Germans Trias I Pujol

location_facility: National Institutes of Health National Cancer Institute

location_facility: Georgia Cancer Specialists - Administrative Annex

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location_facility: Sarah Cannon Research Institute (Administration)

location_facility: Washington University School of Medicine

location_facility: UT Southwestern Medical Center - Simmons Cancer Center Pharmacy

location_facility: RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa

location_facility: Beth Isreal Deaconess Medical Center, Pharmacy FD B18

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: University of Texas Southwestern University Hospital - Zale Lipshy

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location_facility: National Cancer Center, Center for Lung Cancer

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Dartmouth Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

location_facility: Karolinska Universitetssjukhuset, Onkologiska kliniken

location_facility: Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk

location_facility: Christie Hospital NHS Trust, Department of Medical Oncology

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette

location_facility: Pest Megyei Tudogyogyintezet, III. Osztaly

location_facility: MCG Health System Pharmacy (Drug Shipment Only)

location_facility: SUNY Upstate Medical University, Regional Oncology Center

location_facility: Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera

location_facility: Karmanos Cancer lnstitute at Farmington Hllls

location_facility: Institut Catala D'Oncologia - Hospital Duran I Reynals

title: Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

summary: This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.


ReferenceCitation: Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

name: All authors: Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

family: Wedam

full_name: Suparna B. Wedam

given: Suparna B.

family: Beaver

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family: Amiri-Kordestani

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family: Bloomquist

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family: Tang

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family: Goldberg

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family: Sridhara

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family: Kim

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family: Pazdur

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journal_name: Journal of Clinical Oncology

oa_host_type: repository

license_normalized: no license

ReferenceCitation: Chandarlapaty S, Chen D, He W, Sung P, Samoila A, You D, Bhatt T, Patel P, Voi M, Gnant M, Hortobagyi G, Baselga J, Moynahan ME. Prevalence of ESR1 Mutations in Cell-Free DNA and Outcomes in Metastatic Breast Cancer: A Secondary Analysis of the BOLERO-2 Clinical Trial. JAMA Oncol. 2016 Oct 1;2(10):1310-1315. doi: 10.1001/jamaoncol.2016.1279. Erratum in: JAMA Oncol. 2019 Jan 1;5(1):122.

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

family: Chandarlapaty

full_name: Sarat Chandarlapaty

given: Sarat

name: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

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given: David

family: He

full_name: Wei He

given: Wei

family: Sung

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family: Samoila

full_name: Aliaksandra Samoila

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family: You

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given: Daoqi

family: Bhatt

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family: Patel

full_name: Parul Patel

given: Parul

family: Voi

name: Department of Surgery and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria

ReferenceCitation: Hortobagyi GN, Chen D, Piccart M, Rugo HS, Burris HA 3rd, Pritchard KI, Campone M, Noguchi S, Perez AT, Deleu I, Shtivelband M, Masuda N, Dakhil S, Anderson I, Robinson DM, He W, Garg A, McDonald ER 3rd, Bitter H, Huang A, Taran T, Bachelot T, Lebrun F, Lebwohl D, Baselga J. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From BOLERO-2. J Clin Oncol. 2016 Feb 10;34(5):419-26. doi: 10.1200/JCO.2014.60.1971. Epub 2015 Oct 26. Erratum in: J Clin Oncol. 2019 Feb 1;37(4):354. J Clin Oncol. 2019 Feb 1;37(4):355.

name: Gabriel N. Hortobagyi, University of Texas MD Anderson Cancer Center, Houston, TX; David Chen, Tetiana Taran, and David Lebwohl, Novartis Pharmaceuticals, East Hanover, NJ; Martine Piccart and Fabienne Lebrun, Université Libre de Bruxelles, Brussels; Ines Deleu, Oncology Centre, AZ Nikolaas, Sint-Nikolaas, Belgium; Hope S. Rugo, University of California, San Francisco; Ian Anderson, Redwood Regional Oncology Center, Santa Rosa, CA; Howard A. Burris, Sarah Cannon Research Institute, Nashville, TN;...

title: Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: Results From BOLERO-2

ReferenceCitation: Piccart M, Hortobagyi GN, Campone M, Pritchard KI, Lebrun F, Ito Y, Noguchi S, Perez A, Rugo HS, Deleu I, Burris HA 3rd, Provencher L, Neven P, Gnant M, Shtivelband M, Wu C, Fan J, Feng W, Taran T, Baselga J. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†. Ann Oncol. 2014 Dec;25(12):2357-2362. doi: 10.1093/annonc/mdu456. Epub 2014 Sep 17.

ReferenceCitation: Rugo HS, Pritchard KI, Gnant M, Noguchi S, Piccart M, Hortobagyi G, Baselga J, Perez A, Geberth M, Csoszi T, Chouinard E, Srimuninnimit V, Puttawibul P, Eakle J, Feng W, Bauly H, El-Hashimy M, Taran T, Burris HA 3rd. Incidence and time course of everolimus-related adverse events in postmenopausal women with hormone receptor-positive advanced breast cancer: insights from BOLERO-2. Ann Oncol. 2014 Apr;25(4):808-815. doi: 10.1093/annonc/mdu009. Epub 2014 Mar 10.

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

repositories: California Digital Library - eScholarship

ReferenceCitation: Yardley DA, Noguchi S, Pritchard KI, Burris HA 3rd, Baselga J, Gnant M, Hortobagyi GN, Campone M, Pistilli B, Piccart M, Melichar B, Petrakova K, Arena FP, Erdkamp F, Harb WA, Feng W, Cahana A, Taran T, Lebwohl D, Rugo HS. Everolimus plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. Adv Ther. 2013 Oct;30(10):870-84. doi: 10.1007/s12325-013-0060-1. Epub 2013 Oct 25. Erratum in: Adv Ther. 2014 Sep;31(9):1008-9.

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

title: Everolimus Plus Exemestane in Postmenopausal Patients with HR+ Breast Cancer: BOLERO-2 Final Progression-Free Survival Analysis

ReferenceCitation: Campone M, Beck JT, Gnant M, Neven P, Pritchard KI, Bachelot T, Provencher L, Rugo HS, Piccart M, Hortobagyi GN, Nunzi M, Heng DY, Baselga J, Komorowski A, Noguchi S, Horiguchi J, Bennett L, Ziemiecki R, Zhang J, Cahana A, Taran T, Sahmoud T, Burris HA 3rd. Health-related quality of life and disease symptoms in postmenopausal women with HR(+), HER2(-) advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy. Curr Med Res Opin. 2013 Nov;29(11):1463-73. doi: 10.1185/03007995.2013.836078. Epub 2013 Sep 4.

title: Health-related quality of life and disease symptoms in postmenopausal women with HR+, HER2−advanced breast cancer treated with everolimus plus exemestane versus exemestane monotherapy

ReferenceCitation: Noguchi S, Masuda N, Iwata H, Mukai H, Horiguchi J, Puttawibul P, Srimuninnimit V, Tokuda Y, Kuroi K, Iwase H, Inaji H, Ohsumi S, Noh WC, Nakayama T, Ohno S, Rai Y, Park BW, Panneerselvam A, El-Hashimy M, Taran T, Sahmoud T, Ito Y. Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2. Breast Cancer. 2014 Nov;21(6):703-14. doi: 10.1007/s12282-013-0444-8. Epub 2013 Feb 13.

repository_institution: Yonsei University Medical Library - YUHSpace

repositories_institution: Yonsei University Medical Library - YUHSpace

ReferenceCitation: Baselga J, Campone M, Piccart M, Burris HA 3rd, Rugo HS, Sahmoud T, Noguchi S, Gnant M, Pritchard KI, Lebrun F, Beck JT, Ito Y, Yardley D, Deleu I, Perez A, Bachelot T, Vittori L, Xu Z, Mukhopadhyay P, Lebwohl D, Hortobagyi GN. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9. doi: 10.1056/NEJMoa1109653. Epub 2011 Dec 7.

title: Everolimus in Postmenopausal Hormone-Receptor–Positive Advanced Breast Cancer

location_country:
Australia
Belgium
Czech Republic
France
Japan
Poland
Thailand
Norway
Canada
Korea, Republic of
Turkey
Sweden
Hong Kong
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Egypt
Spain
New Zealand

location_facility: Cancer Center of Kansas Dept.ofCancerCtr.ofKansas

location_facility: University of Louisville / James Graham Brown Cancer Center SC

location_facility: The Center for Cancer and Blood Disorders Dept. of The Ctr for C & BD(2)

location_facility: Clinical Research Alliance Dept.ofArenaOncologyAssoc(2)

location_facility: Rush University Medical Center Study Coordinator

location_facility: Penn State University / Milton S. Hershey Medical Center Division of Oncology (2)

location_facility: MD Anderson Cancer Center - Orlando Dept.ofMDACC-Orlando(2)

location_facility: St. Louis Cancer & Breast Institute Dept.ofSt.LouisCancer&Breast

location_facility: Southeast Nebraska Oncology Cancer Center

location_facility: University of Wisconsin Hospital & Clinics UW ComprehensiveCancerCtr(2)

location_facility: Crescent City Research Consortium, LLC Dept of Hem&Onc Specialist - 2

location_facility: Medical University of South Carolina -Hollings Cancer Center Dept. MUSC/HollingsCancerCtr

location_facility: Anne Arundel Health System Research Institute Wayson Pavilion

location_facility: Weill Cornell Medical College Weill Cornell Med. Ctr.

location_facility: Weinberg Cancer Institute at Franklin Square Hospital

location_facility: Trinitas Comprehensive Cancer Center Dept. of Trinitas

location_facility: Frederick Memorial Hospital Dept. of FMH-IRB

location_facility: Regional Cancer Care Associates Dept. of the CCHD

location_facility: Memorial Hospital Memorial Cancer Institute

location_facility: Medical Oncology & Hematology Associates of Northern VA Med. Onc&Hem Assoc. of No.VA

location_facility: University of California San Francisco UCSF Medical Center

location_facility: Comprehensive Cancer Center - Boca Raton Deerfield Beach

location_facility: Hematology Oncology Association of Rockland

location_facility: St Joseph Heritage Healthcare Dept. of RRMG (4)

location_facility: Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C

location_facility: Cancer Care Associates Dept.ofCancerCareAssoc. (2)

location_facility: Maryland Hematology/Oncology Associates, P.A.

location_facility: University of Texas Southwestern Medical Center SimmonsComprehensiveCancerCtr.

location_facility: Fairview Southdale Medical Oncology Clinic

location_facility: The Angeles Clinic and Research Institute

location_facility: Comprehensive Blood and Cancer Center Dept. of CBCC (3)

location_facility: Beth Israel Medical Center Dept.ofBeth Israel Med. Ctr(2)

location_facility: Sarah Cannon Research Institute Dept.ofSarahCannonCancerCtr(5)

location_facility: Hematology Oncology Clinic Hematology Oncology Clinic (2)

location_facility: Oncology Specialists, SC Dept.of Oncology Specialists

location_facility: Highlands Oncology Group DeptofHighlandsOncologyGrp(2)

location_facility: University of New Mexico Cancer Research Center Dept of UNM Cancer & Research

location_facility: Cancer Centers of Southwest Oklahoma Cancer Research Dept.of Southwest Oklahoma

location_facility: Florida Medical Clinic PA Dept.ofFloridaMedicalClinic

location_facility: University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(2)

location_facility: Florida Cancer Specialists DeptofFloridaCancerSpecialists

location_facility: University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(2)

location_facility: Sharp Memorial Hospital SharpClinicalOncologyResearch

location_facility: Grass Valley Hematology Oncology Medical Group Dept. of Grass Valley Hem/Onc

location_facility: USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3

location_facility: Mercy Medical Center Medical Oncology & Hematology

location_facility: Utah Cancer Specialists Dept.of Utah Cancer Spec. (2)

location_facility: Premiere Oncology/Pinnacle Oncology Hematology Dept.ofPremiereOncologyAZ

title: A Randomized Double-Blind, Placebo-Controlled Study of Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole

summary: There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.


design_allocation: Non-Randomized

intervention_type: Drug

status: Terminated

study_type: Interventional

lead_sponsor: Merz Pharmaceuticals GmbH

primary_purpose: Treatment

location_country:
Austria
Brazil
South Africa
United Kingdom
Mexico
Netherlands
Germany
Spain
France
Poland
Belgium
Portugal
United States
Czech Republic

acronym: OLLTT

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku

location_facility: ORL oddělení, Všeobecná Fakultní Nemocnice v Praze

location_facility: Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag

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

location_facility: Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS

location_facility: UC Davis Health System Department of Otolaryngology

location_facility: Erie County Medical Center, Department of Rehabilitation Medicine

location_facility: Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)

location_facility: University Hospital Leuven, ENT Department

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

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

location_facility: Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery

location_facility: Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje

location_facility: Instituto Biomédico de Investigación A.C.

location_facility: Clin Pharm International GmbH, Zentrum Wien

location_facility: Centre Hospitalier de Bretagne Sud Service ORL-B9

location_facility: Clínica Universitaria de Navarra, Dept. ORL

location_facility: Teaching University Hospital, ORL klinika

location_facility: Monterrey International Research Center (MIRC)

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu

location_facility: Unidad Médica de Especialidades del Noroeste (UMEN)

location_facility: Montefiore Medical Center Attn: Anxiety and Depression Center

location_facility: NZOZ Specjalistyczne Centrum Medyczne Nowomed

location_facility: Hospital Universitario Príncipe de Asturias

location_facility: Hospital Clínico Barcelona, Dept. Of ORL

location_facility: The university Hospitals of Leicester, Leicester Royal Infirmary

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

location_facility: Fundación Hospital de Alcorcón, Otorhinolaryngology

location_facility: Hospital General de Chihuahua. "Dr. Salvador Anchondo"

location_facility: Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia

location_facility: University of Kansas Department of Otolaryngology Head & Neck Surgery

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

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

location_facility: Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología

location_facility: Wojewodzki Szpital Specjalistyczny w Olsztynie

location_facility: Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej PROMED

location_facility: Hospital Universitario de Salamanca- Hospital Virgen de la Vega

location_facility: Hospital Puerta del Hierro, Madrid- Servicio de ORL

type: EudraCT Number

source: euctr

title: An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus

summary: The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency

acronym: EFFICACY-HF

summary: This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.

design_allocation: Randomized

lead_sponsor: Vifor Pharma

location_country: Netherlands France Israel Denmark Germany


lead_sponsor: Boehringer Ingelheim

location_country:
Germany
United States
United Kingdom
France

location_facility: 1100.1526.4915 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4403 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4912 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4911 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3312A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3302A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1014 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3306A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4908 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3310A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3311A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3308A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1011 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1004 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1001 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1007 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4910 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4405 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4904 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3301A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4914 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1012 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1013 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4901 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3304A Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4902 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4909 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1006 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4907 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4903 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1002 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4402 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4913 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1005 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4905 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4906 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.1003 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.4404 Boehringer Ingelheim Investigational Site

location_facility: 1100.1526.3307A Boehringer Ingelheim Investigational Site

title: An Open Label, Phase IIIb, Randomised Parallel Group Study to Assess the Efficacy and Safety of Switching HIV-1 Infected Patients Successfully Treated With a Nevirapine IR Based Regiment to Nevirapine XR 400 mg QD or Remaining on Nevirapine IR 200 mg BID Based Program

summary: The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.

status_simplified: Completed


title: A Randomised Double Blind Placebo-controlled, Long-term Phase III Study to Assess the Efficacy and Safety of Oralgen Grass Pollen in Patients With Grass Pollen Related Allergic Rhinoconjunctivitis

summary: This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

status: Unknown status

study_completion_date_type: Anticipated

lead_sponsor: Artu Biologicals

location_country:
Netherlands
Poland
France
Belgium
Germany
United Kingdom

location_facility: SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 3

location_facility: Royal National Throat, Nose & Ear Hospital

location_facility: Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach

location_facility: Rijnland Ziekenhuis, Location Alphen - Poli KNO

location_facility: Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust

location_facility: SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1

location_facility: QMC Notthingham, Nottingham University Hospitals NHS Trust

location_facility: Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny

location_facility: SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela

intervention_type: Other


ReferenceCitation: Blay JY, Shen L, Kang YK, Rutkowski P, Qin S, Nosov D, Wan D, Trent J, Srimuninnimit V, Pápai Z, Le Cesne A, Novick S, Taningco L, Mo S, Green S, Reichardt P, Demetri GD. Nilotinib versus imatinib as first-line therapy for patients with unresectable or metastatic gastrointestinal stromal tumours (ENESTg1): a randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):550-60. doi: 10.1016/S1470-2045(15)70105-1. Epub 2015 Apr 14.

family: Blay

full_name: Jean-Yves Blay

given: Jean-Yves

family: Shen

full_name: Lin Shen

given: Lin

family: Kang

full_name: Yoon-Koo Kang

given: Yoon-Koo

family: Rutkowski

full_name: Piotr Rutkowski

given: Piotr

family: Qin

full_name: Shukui Qin

given: Shukui

family: Nosov

full_name: Dmitry Nosov

given: Dmitry

family: Wan

full_name: Desen Wan

given: Desen

family: Trent

full_name: Jonathan Trent

given: Jonathan

family: Srimuninnimit

full_name: Vichien Srimuninnimit

given: Vichien

family: Pápai

full_name: Zsuzsanna Pápai

given: Zsuzsanna

family: Le Cesne

full_name: Axel Le Cesne

given: Axel

family: Novick

full_name: Steven Novick

given: Steven

family: Taningco

full_name: Lilia Taningco

given: Lilia

family: Mo

full_name: Shuyuan Mo

given: Shuyuan

family: Green

full_name: Steven Green

family: Reichardt

full_name: Peter Reichardt

given: Peter

family: Demetri

full_name: George D Demetri

given: George D

journal_name: The Lancet Oncology

version: acceptedVersion

lead_sponsor: Novartis Pharmaceuticals

location_country:
Romania
Russian Federation
Denmark
Czech Republic
Taiwan
France
Japan
Poland
Slovakia
Thailand
Norway
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Sweden
Hong Kong
Netherlands
Bulgaria
Singapore
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Venezuela
Israel
Egypt
Spain
Turkey

location_facility: University of California at Los Angeles GI Oncology Program

location_facility: Stanford University Medical Center Stanford Cancer Center

location_facility: City of Hope National Medical Center Regulatory Document

location_facility: Vanderbilt Univeristy Ingram Cancer Ctr.

location_facility: University of Michigan Comprehensive Cancer Center DeptofMichiganCancerCenter(6)

location_facility: University of Texas/MD Anderson Cancer Center Dept. of MD Anderson (13)

location_facility: Kootenai Medical Center Dept.ofKootenai Med.Ctr.

location_facility: Tyler Cancer Center Dept.ofTylerCancerCtr. (2)

location_facility: University of California San Diego - Moores Cancer Center Dept of Moores Cancer Ctr (2)

location_facility: University of Colorado Dept. of Univ. of Colorado

location_facility: New York Oncology Hematology, P.C. NYOH@AlbanyMedicalCenter(2)

location_facility: University of Utah / Huntsman Cancer Institute Dept.ofHuntsmanCancerInst.(3)

location_facility: Washington Hospital Center Wash Hospital

location_facility: New York Oncology Hematology, P.C. NYOH Amsterdam

location_facility: University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3)

location_facility: City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(4)

location_facility: Northern Arizona Hematology/Oncology Associates, P.C. Dept. of No. AZ Hem-Onc

location_facility: Dana Farber Cancer Institute Centerfor Sarcoma&BoneOncology

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio(2)

location_facility: Rocky Mountain Cancer Centers Dept. of Rocky Mountain Cancer

location_facility: Ocala Oncology Center Dept. of Ocala Oncology Center

location_facility: Northwestern University Clinical Research Office (2)

location_facility: Mayo Clinic - Rochester Division of Hematology

location_facility: University of Pennsylvania Medical Center CAMN107G2301

location_facility: Birmingham Hematology and Oncology Associates

title: A Randomized, Open Label, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Nilotinib Versus Imatinib in Adult Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST)

summary: This study will evaluate efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST).


location_country:
Austria
United States
Switzerland
Netherlands
Spain
Germany
United Kingdom
France
Romania
Argentina
Australia
Portugal
Canada
Czech Republic
Korea, Republic of

location_facility: 1220.5.4903 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8207 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3308A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4909 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6102 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1006 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4904 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3301A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4906 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4303 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4905 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6110 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4103 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4202 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4912 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3101 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4101 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4106 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6108 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3404 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8205 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5403 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4915 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8211 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3305A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0005 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8208 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4914 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3302A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8203 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4302 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4102 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6104 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3303A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3501 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3504 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3406 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8201 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3102 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0009 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8210 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4408 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4902 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3309A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4917 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6103 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4104 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6109 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3304A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6107 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1007 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6105 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3503 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0006 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5402 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4301 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0008 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3502 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0007 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4203 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0003 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4908 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5405 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4910 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4410 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3307A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3306A Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4907 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.0010 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1002 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4409 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.5401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3506 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8206 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4001 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4401 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8209 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.3507 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.1004 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8202 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.8204 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.4913 Boehringer Ingelheim Investigational Site

location_facility: 1220.5.6101 Boehringer Ingelheim Investigational Site

title: Antiviral Effect, Safety and Pharmacokinetics of BI 201335 NA in Hepatitis C Virus Genotype 1 Infected Treatment-naïve and Treatment-experienced Patients for 24 Weeks as Combination Therapy With Pegylated Interferon-alpha 2a and Ribavirin (Double-blinded, Randomised, Placebo-controlled, Phase II)

summary: The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.


type: Other Identifier

title: A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy

summary: A medical research study in adult patients who have moderate to severe Crohn's disease designed to determine whether or not treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not and to determine if the treatment will reduce the symptoms of Crohn's disease.

ReferenceCitation: Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum in: Drug Saf. 2019 Apr 22;:.

family: Ghosh

full_name: Subrata Ghosh

given: Subrata

family: Gensler

full_name: Lianne S. Gensler

given: Lianne S.

family: Yang

full_name: Zijiang Yang

given: Zijiang

family: Gasink

full_name: Chris Gasink

given: Chris

family: Chakravarty

full_name: Soumya D. Chakravarty

given: Soumya D.

family: Farahi

full_name: Kamyar Farahi

given: Kamyar

family: Ramachandran

full_name: Paraneedharan Ramachandran

given: Paraneedharan

family: Ott

full_name: Elyssa Ott

given: Elyssa

family: Strober

full_name: Bruce E. Strober

given: Bruce E.

journal_name: Drug Safety

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

repository_institution: University of Birmingham - University of Birmingham Research Portal

repository_normalized: Pure (Denmark)

repository_institution: California Digital Library - eScholarship

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

ReferenceCitation: Di Narzo AF, Telesco SE, Brodmerkel C, Argmann C, Peters LA, Li K, Kidd B, Dudley J, Cho J, Schadt EE, Kasarskis A, Dobrin R, Hao K. High-Throughput Characterization of Blood Serum Proteomics of IBD Patients with Respect to Aging and Genetic Factors. PLoS Genet. 2017 Jan 27;13(1):e1006565. doi: 10.1371/journal.pgen.1006565. eCollection 2017 Jan.

family: Di Narzo

full_name: Antonio F. Di Narzo

given: Antonio F.

family: Telesco

full_name: Shannon E. Telesco

given: Shannon E.

family: Brodmerkel

full_name: Carrie Brodmerkel

given: Carrie

ReferenceCitation: Sandborn WJ, Gasink C, Gao LL, Blank MA, Johanns J, Guzzo C, Sands BE, Hanauer SB, Targan S, Rutgeerts P, Ghosh S, de Villiers WJ, Panaccione R, Greenberg G, Schreiber S, Lichtiger S, Feagan BG; CERTIFI Study Group. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med. 2012 Oct 18;367(16):1519-28. doi: 10.1056/NEJMoa1203572.

title: Ustekinumab Induction and Maintenance Therapy in Refractory Crohn's Disease

location_country:
Austria
United States
Netherlands
Germany
France
Israel
Australia
Belgium
New Zealand
Spain
Canada
United Kingdom


title: ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF)

acronym: ARTEMIS-IPF

summary: The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

ReferenceType: result

ReferenceCitation: Raghu G, Behr J, Brown KK, Egan JJ, Kawut SM, Flaherty KR, Martinez FJ, Nathan SD, Wells AU, Collard HR, Costabel U, Richeldi L, de Andrade J, Khalil N, Morrison LD, Lederer DJ, Shao L, Li X, Pedersen PS, Montgomery AB, Chien JW, O'Riordan TG; ARTEMIS-IPF Investigators*. Treatment of idiopathic pulmonary fibrosis with ambrisentan: a parallel, randomized trial. Ann Intern Med. 2013 May 7;158(9):641-9. doi: 10.7326/0003-4819-158-9-201305070-00003. Erratum in: Ann Intern Med. 2014 May 6;160(9):658.

family: Raghu

full_name: Ganesh Raghu

given: Ganesh

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

title: Treatment of Idiopathic Pulmonary Fibrosis With Ambrisentan

ReferenceCitation: Raghu G, Lynch D, Godwin JD, Webb R, Colby TV, Leslie KO, Behr J, Brown KK, Egan JJ, Flaherty KR, Martinez FJ, Wells AU, Shao L, Zhou H, Pedersen PS, Sood R, Montgomery AB, O'Riordan TG. Diagnosis of idiopathic pulmonary fibrosis with high-resolution CT in patients with little or no radiological evidence of honeycombing: secondary analysis of a randomised, controlled trial. Lancet Respir Med. 2014 Apr;2(4):277-84. doi: 10.1016/S2213-2600(14)70011-6. Epub 2014 Feb 18.

family: Lynch

full_name: David Lynch

given: David

family: Godwin

full_name: J David Godwin

given: J David

family: Webb

full_name: Richard Webb

given: Richard

family: Colby

full_name: Thomas V Colby

given: Thomas V

family: Leslie

full_name: Kevin O Leslie

given: Kevin O

family: Behr

full_name: Juergen Behr

given: Juergen

family: Brown

full_name: Kevin K Brown

given: Kevin K

family: Egan

full_name: James J Egan

given: James J

family: Flaherty

full_name: Kevin R Flaherty

given: Kevin R

family: Martinez

full_name: Fernando J Martinez

given: Fernando J

family: Wells

full_name: Athol U Wells

given: Athol U

family: Shao

full_name: Lixin Shao

given: Lixin

family: Zhou

full_name: Huafeng Zhou

given: Huafeng

family: Pedersen

full_name: Patricia S Pedersen

given: Patricia S

family: Sood

full_name: Rohit Sood

given: Rohit

family: Montgomery

full_name: A Bruce Montgomery

given: A Bruce

family: O'Riordan

full_name: Thomas G O'Riordan

given: Thomas G

journal_name: The Lancet Respiratory Medicine

ReferenceCitation: Chien JW, Richards TJ, Gibson KF, Zhang Y, Lindell KO, Shao L, Lyman SK, Adamkewicz JI, Smith V, Kaminski N, O'Riordan T. Serum lysyl oxidase-like 2 levels and idiopathic pulmonary fibrosis disease progression. Eur Respir J. 2014 May;43(5):1430-8. doi: 10.1183/09031936.00141013. Epub 2013 Oct 31.

location_country:
Peru
Australia
Belgium
Czech Republic
France
Poland
Argentina
Canada
Colombia
Chile
Switzerland
Netherlands
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain

location_facility: Pulmonary And Critical Care Services, P.C.

location_facility: University of Pennsylvania Health Systems

location_facility: University of Miami Miller School of Medicine

location_facility: National Jewish Medical And Research Center

location_facility: University of Alabama at Birmingham Hospital

location_facility: Complejo Asistencial Universitario de León

location_facility: David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)


ReferenceCitation: Goy A, Sinha R, Williams ME, Kalayoglu Besisik S, Drach J, Ramchandren R, Zhang L, Cicero S, Fu T, Witzig TE. Single-agent lenalidomide in patients with mantle-cell lymphoma who relapsed or progressed after or were refractory to bortezomib: phase II MCL-001 (EMERGE) study. J Clin Oncol. 2013 Oct 10;31(29):3688-95. doi: 10.1200/JCO.2013.49.2835. Epub 2013 Sep 3.

ReferenceCitation: Goy A, Kalayoglu Besisik S, Drach J, Ramchandren R, Robertson MJ, Avivi I, Rowe JM, Herbrecht R, Van Hoof A, Zhang L, Cicero S, Fu T, Witzig T. Longer-term follow-up and outcome by tumour cell proliferation rate (Ki-67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL-001(EMERGE) pivotal trial. Br J Haematol. 2015 Aug;170(4):496-503. doi: 10.1111/bjh.13456. Epub 2015 Apr 28.

name: John Theurer Cancer Center at HUMC Hackensack NJ USA

family: Goy

full_name: Andre Goy

given: Andre

name: Istanbul University Faculty of Medicine Istanbul Turkey

family: Kalayoglu Besisik

full_name: Sevgi Kalayoglu Besisik

given: Sevgi

name: Medical University of Vienna Vienna Austria

family: Drach

full_name: Johannes Drach

given: Johannes

family: Ramchandren

full_name: Radhakrishnan Ramchandren

given: Radhakrishnan

name: Indiana University Medical Center Indianapolis IN USA

family: Robertson

full_name: Michael J. Robertson

given: Michael J.

family: Avivi

full_name: Irit Avivi

given: Irit

name: Shaare Zedek Medical Centre Jerusalem Israel

family: Rowe

full_name: Jacob M. Rowe

given: Jacob M.

name: Hôpital de Hautepierre Strasbourg France

family: Herbrecht

full_name: Raoul Herbrecht

given: Raoul

family: Van Hoof

full_name: Achiel Van Hoof

given: Achiel

family: Zhang

full_name: Lei Zhang

given: Lei

family: Cicero

full_name: Sherri Cicero

given: Sherri

family: Fu

full_name: Tommy Fu

given: Tommy

family: Witzig

full_name: Thomas Witzig

given: Thomas

journal_name: British Journal of Haematology

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: PubMed Central - Europe PMC

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Longer‐term follow‐up and outcome by tumour cell proliferation rate (Ki‐67) in patients with relapsed/refractory mantle cell lymphoma treated with lenalidomide on MCL‐001(EMERGE) pivotal trial

ReferenceCitation: Witzig TE, Luigi Zinzani P, Habermann TM, Tuscano JM, Drach J, Ramchandren R, Kalayoglu Besisik S, Takeshita K, Casadebaig Bravo ML, Zhang L, Fu T, Goy A. Long-term analysis of phase II studies of single-agent lenalidomide in relapsed/refractory mantle cell lymphoma. Am J Hematol. 2017 Oct;92(10):E575-E583. doi: 10.1002/ajh.24854. Epub 2017 Aug 28.

full_name: Thomas E. Witzig

given: Thomas E.

name: Institute of Hematology Seràgnoli, University of Bologna; Bologna Italy

family: Luigi Zinzani

full_name: Pier Luigi Zinzani

given: Pier

family: Habermann

full_name: Thomas M. Habermann

given: Thomas M.

name: UC Davis Cancer Center; Sacramento California

family: Tuscano

full_name: Joseph M. Tuscano

given: Joseph M.

name: Karmanos Cancer Institute; Detroit Michigan

name: Istanbul University Faculty of Medicine; Istanbul Turkey

name: John Theurer Cancer Center at HUMC; Hackensack New Jersey

ReferenceCitation: San-Miguel JF, Richardson PG, Günther A, Sezer O, Siegel D, Bladé J, LeBlanc R, Sutherland H, Sopala M, Mishra KK, Mu S, Bourquelot PM, Victoria Mateos M, Anderson KC. Phase Ib study of panobinostat and bortezomib in relapsed or relapsed and refractory multiple myeloma. J Clin Oncol. 2013 Oct 10;31(29):3696-703. doi: 10.1200/JCO.2012.46.7068. Epub 2013 Sep 9.

name: Jesús F. San-Miguel and María Victoria Mateos, Servicio e Hematologia, Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca, Institut de Bilogia Molecular de Barcelona (Universidad de Salamanca–Spanish National Research Council), Salamanca; Joan Bladé, Hospital Clinic de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain; Paul G. Richardson and Kenneth C. Anderson, Dana-Farber Cancer Institute, Boston, MA; David Siegel, Hackensack...

title: Phase Ib Study of Panobinostat and Bortezomib in Relapsed or Relapsed and Refractory Multiple Myeloma

location_country:
Italy
Austria
Germany
France
Israel
Singapore
Hungary
Belgium
Puerto Rico
Spain
Turkey
United States
United Kingdom
Colombia

location_facility: Universita Federico II di Napoli Nuovo Policlinico

location_facility: University of Rochester Cancer Center, James P. Wilmot Cancer Center

location_facility: University of Virginia Cancer Center Clinical Trials Office

location_facility: MD Anderson Cancer Center, Orlando Regional Healthcare

location_facility: Universitair Ziekenhuis Leuven, Campus Gasthuisberg

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Petz Aladar Megyei Oktato Korhaz,II. Belgyogyaszat

location_facility: Boca Raton Community Hospital, Inc., Research Dept.

location_facility: Duran i Reynals Institut Catala d'Oncologia

location_facility: Centro De Cancer, Hospital Espanol Auxilio De Puerto Rico

location_facility: Winship Cancer Institute of Emory University

location_facility: University of Debrecen, DEOEC, Institute of Internal Medicine

location_facility: University of Massachusetts Medical Center

location_facility: Loyola University Medical Center - Smith

location_facility: University of Tennessee Cancer Institute

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Alvin and Lois Lapidus Cancer Institute Sinai Hospital of Baltimore

location_facility: Washington University Siteman Cancer Center

title: A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib

summary: To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.