ReferenceCitation: Gelmon K, Walshe JM, Mahtani R, Joy AA, Karuturi M, Neven P, Lu DR, Kim S, Schnell P, Bananis E, Schwartzberg L. Efficacy and safety of palbociclib in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2. Breast. 2021 Oct;59:321-326. doi: 10.1016/j.breast.2021.07.017. Epub 2021 Jul 28.

family: Gelmon

full_name: Karen Gelmon

given: Karen

family: Walshe

full_name: Janice M. Walshe

given: Janice M.

family: Mahtani

full_name: Reshma Mahtani

given: Reshma

family: Joy

full_name: Anil A. Joy

given: Anil A.

family: Karuturi

full_name: Meghan Karuturi

given: Meghan

family: Neven

full_name: Patrick Neven

given: Patrick

family: Lu

full_name: Dongrui Ray Lu

given: Dongrui Ray

family: Kim

full_name: Sindy Kim

given: Sindy

family: Schnell

full_name: Patrick Schnell

family: Bananis

full_name: Eustratios Bananis

given: Eustratios

family: Schwartzberg

full_name: Lee Schwartzberg

given: Lee

journal_name: The Breast

title: Efficacy and safety of palbociclib in patients with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2

ReferenceCitation: Iwata H, Umeyama Y, Liu Y, Zhang Z, Schnell P, Mori Y, Fletcher O, Marshall JC, Johnson JG, Wood LS, Toi M, Finn RS, Turner NC, Bartlett CH, Cristofanilli M. Evaluation of the Association of Polymorphisms With Palbociclib-Induced Neutropenia: Pharmacogenetic Analysis of PALOMA-2/-3. Oncologist. 2021 Jul;26(7):e1143-e1155. doi: 10.1002/onco.13811. Epub 2021 Jun 7.

name: Aichi Cancer Center Hospital  Nagoya Japan

family: Iwata

full_name: Hiroji Iwata

given: Hiroji

family: Umeyama

full_name: Yoshiko Umeyama

given: Yoshiko

family: Liu

full_name: Yuan Liu

given: Yuan

family: Zhang

full_name: Zhe Zhang

given: Zhe

family: Mori

full_name: Yuko Mori

given: Yuko

name: Breast Cancer Now Toby Robins Research Centre, The Institute for Cancer Research  London United Kingdom

family: Fletcher

full_name: Olivia Fletcher

given: Olivia

family: Marshall

full_name: Jean‐Claude Marshall

given: Jean‐Claude

family: Johnson

name: Kyoto University Graduate School of Medicine  Kyoto Japan

name: David Geffen School of Medicine, University of California Los Angeles  Santa Monica California USA

name: Royal Marsden Hospital  London United Kingdom

name: Pfizer Inc  Collegeville Pennsylvania USA

name: Northwestern University Feinberg School of Medicine  Chicago Illinois USA

title: Evaluation of the Association of Polymorphisms With Palbociclib‐Induced Neutropenia: Pharmacogenetic Analysis of PALOMA ‐2/‐3

ReferenceCitation: Finn RS, Rugo HS, Gelmon KA, Cristofanilli M, Colleoni M, Loi S, Schnell P, Lu DR, Theall KP, Mori A, Gauthier E, Bananis E, Turner NC, Diéras V. Long-Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow-Up. Oncologist. 2021 May;26(5):e749-e755. doi: 10.1002/onco.13684. Epub 2021 Mar 10.

name: David Geffen School of Medicine at the University of California Los Angeles  Santa Monica California USA

name: University of California San Francisco Comprehensive Cancer Center  San Francisco California USA

name: British Columbia Cancer Agency  Vancouver British Columbia Canada

name: Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine  Chicago Illinois USA

name: IEO European Institute of Oncology, IRCCS  Milan Italy

name: Peter MacCallum Cancer Centre, University of Melbourne  Melbourne Victoria Australia

name: Pfizer Oncology  Cambridge Massachusetts USA

name: Pfizer Inc.  San Francisco California USA

name: Royal Marsden Hospital and Institute of Cancer Research  London United Kingdom

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repositories: University of Melbourne - Minerva Access

repositories_institution: University of Melbourne - Minerva Access

title: Long‐Term Pooled Safety Analysis of Palbociclib in Combination with Endocrine Therapy for Hormone Receptor‐Positive/Human Epidermal Growth Factor Receptor 2‐Negative Advanced Breast Cancer: Updated Analysis with up to 5 Years of Follow‐Up

ReferenceCitation: Zheng J, Yu Y, Durairaj C, Diéras V, Finn RS, Wang DD. Impact of Dose Reduction on Efficacy: Implications of Exposure-Response Analysis of Palbociclib. Target Oncol. 2021 Jan;16(1):69-76. doi: 10.1007/s11523-020-00771-5.

ReferenceCitation: Finn RS, Cristofanilli M, Ettl J, Gelmon KA, Colleoni M, Giorgetti C, Gauthier E, Liu Y, Lu DR, Zhang Z, Bartlett CH, Slamon DJ, Turner NC, Rugo HS. Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials. Breast Cancer Res Treat. 2020 Nov;184(1):23-35. doi: 10.1007/s10549-020-05782-4. Epub 2020 Aug 11.

ReferenceCitation: Huang Bartlett C, Mardekian J, Cotter MJ, Huang X, Zhang Z, Parrinello CM, Bourla AB. Concordance of real-world versus conventional progression-free survival from a phase 3 trial of endocrine therapy as first-line treatment for metastatic breast cancer. PLoS One. 2020 Apr 21;15(4):e0227256. doi: 10.1371/journal.pone.0227256. eCollection 2020.

ReferenceCitation: Ettl J, Im SA, Ro J, Masuda N, Colleoni M, Schnell P, Bananis E, Lu DR, Cristofanilli M, Rugo HS, Finn RS. Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies. Breast Cancer Res. 2020 Mar 12;22(1):27. doi: 10.1186/s13058-020-01263-0.

title: Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies

ReferenceCitation: Rugo HS, Finn RS, Gelmon K, Joy AA, Harbeck N, Castrellon A, Mukai H, Walshe JM, Mori A, Gauthier E, Lu DR, Bananis E, Martin M, Diéras V. Progression-free Survival Outcome Is Independent of Objective Response in Patients With Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor 2-negative Advanced Breast Cancer Treated With Palbociclib Plus Letrozole Compared With Letrozole: Analysis From PALOMA-2. Clin Breast Cancer. 2020 Apr;20(2):e173-e180. doi: 10.1016/j.clbc.2019.08.009. Epub 2019 Sep 5.

ReferenceCitation: Diéras V, Harbeck N, Joy AA, Gelmon K, Ettl J, Verma S, Lu DR, Gauthier E, Schnell P, Mori A, Rugo HS, Finn RS. Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2- Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA-2 Trial. Oncologist. 2019 Dec;24(12):1514-1525. doi: 10.1634/theoncologist.2019-0019. Epub 2019 Jun 19.

name: Department of Medical Oncology, Centre Eugène Marquis Rennes France

name: Brustzentrum der Universität München Munich Germany

name: Cross Cancer Institute, University of Alberta Edmonton Alberta Canada

name: British Columbia Cancer Agency Vancouver British Columbia Canada

name: Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universität München, Munich Germany

name: University of Calgary Calgary Alberta Canada

name: Pfizer Inc. San Francisco California USA

name: University of California San Francisco Helen Diller Family Comprehensive Cancer Center San Francisco California USA

name: David Geffen School of Medicine at UCLA Santa Monica California USA

repositories: California Digital Library - eScholarship

repositories_institution: University of California - eScholarship University of California

title: Palbociclib with Letrozole in Postmenopausal Women with ER+/HER2− Advanced Breast Cancer: Hematologic Safety Analysis of the Randomized PALOMA‐2 Trial

ReferenceCitation: Masuda N, Mukai H, Inoue K, Rai Y, Ohno S, Mori Y, Hashigaki S, Muramatsu Y, Umeyama Y, Iwata H, Toi M. Neutropenia management with palbociclib in Japanese patients with advanced breast cancer. Breast Cancer. 2019 Sep;26(5):637-650. doi: 10.1007/s12282-019-00970-7. Epub 2019 May 24. Erratum in: Breast Cancer. 2019 Jun 5;:.

ReferenceCitation: Im SA, Mukai H, Park IH, Masuda N, Shimizu C, Kim SB, Im YH, Ohtani S, Huang Bartlett C, Lu DR, Iyer S, Mori Y, Mori A, Gauthier E, Finn RS, Toi M. Palbociclib Plus Letrozole as First-Line Therapy in Postmenopausal Asian Women With Metastatic Breast Cancer: Results From the Phase III, Randomized PALOMA-2 Study. J Glob Oncol. 2019 May;5:1-19. doi: 10.1200/JGO.18.00173.

name: Seoul National Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea

name: National Cancer Center Hospital East, Chiba, Japan

name: National Cancer Center, Gyeonggi-do, South Korea

name: National Hospital Organization Osaka National Hospital, Osaka, Japan

name: National Center for Global Health and Medicine, Tokyo, Japan

name: University of Ulsan College of Medicine, Seoul, South Korea

name: Sungkyunkwan University School of Medicine, Seoul, South Korea

name: Hiroshima City Hospital, Hiroshima, Japan

name: David Geffen School of Medicine, Los Angeles, CA

ReferenceCitation: Mukai H, Shimizu C, Masuda N, Ohtani S, Ohno S, Takahashi M, Yamamoto Y, Nishimura R, Sato N, Ohsumi S, Iwata H, Mori Y, Hashigaki S, Muramatsu Y, Nagasawa T, Umeyama Y, Lu DR, Toi M. Palbociclib in combination with letrozole in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients. Int J Clin Oncol. 2019 Mar;24(3):274-287. doi: 10.1007/s10147-018-1353-9. Epub 2018 Dec 4.

journal_name: International Journal of Clinical Oncology

title: Palbociclib in combination with letrozole in patients with estrogen receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients

ReferenceCitation: Rugo HS, Turner NC, Finn RS, Joy AA, Verma S, Harbeck N, Masuda N, Im SA, Huang X, Kim S, Sun W, Iyer S, Schnell P, Bartlett CH, Johnston S. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies. Eur J Cancer. 2018 Sep;101:123-133. doi: 10.1016/j.ejca.2018.05.017. Epub 2018 Jul 25.

title: Palbociclib plus endocrine therapy in older women with HR+/HER2– advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies

ReferenceCitation: Diéras V, Rugo HS, Schnell P, Gelmon K, Cristofanilli M, Loi S, Colleoni M, Lu DR, Mori A, Gauthier E, Huang Bartlett C, Slamon DJ, Turner NC, Finn RS. Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer. J Natl Cancer Inst. 2019 Apr 1;111(4):419-430. doi: 10.1093/jnci/djy109.

name: University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA (HSR)

name: British Columbia Cancer Agency, Vancouver, BC, Canada (KG)

name: Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Chicago, IL (MC)

name: Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia (SL)

name: Istituto Europeo di Oncologia, Milan, Italy (MC)

name: David Geffen School of Medicine, Los Angeles, CA (DJS, RSF)

name: Institute of Cancer Research and Royal Marsden Hospital, London, UK (NCT)

journal_name: JNCI: Journal of the National Cancer Institute

repository_institution: California Digital Library - eScholarship

repositories_institution: California Digital Library - eScholarship

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.

ReferenceCitation: Rugo HS, Diéras V, Gelmon KA, Finn RS, Slamon DJ, Martin M, Neven P, Shparyk Y, Mori A, Lu DR, Bhattacharyya H, Bartlett CHUANG, Iyer S, Johnston S, Ettl J, Harbeck N. Impact of palbociclib plus letrozole on patient-reported health-related quality of life: results from the PALOMA-2 trial. Ann Oncol. 2018 Apr 1;29(4):888-894. doi: 10.1093/annonc/mdy012.

repository_institution: Technical University Munich - mediaTUM – the media and publications repository of the Technical University Munich

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

ReferenceCitation: Turner NC, Finn RS, Martin M, Im SA, DeMichele A, Ettl J, Diéras V, Moulder S, Lipatov O, Colleoni M, Cristofanilli M, Lu DR, Mori A, Giorgetti C, Iyer S, Bartlett CH, Gelmon KA. Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Ann Oncol. 2018 Mar 1;29(3):669-680. doi: 10.1093/annonc/mdx797.

ReferenceCitation: Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Diéras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936.

location_country:
Italy
United States
Spain
Germany
France
Czechia
Japan
Poland
Hungary
Belgium
Australia
Ireland
Russian Federation
Canada
United Kingdom
Korea, Republic of
Taiwan
Ukraine

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: US Oncology Investigational Products Center

location_facility: UCLA Santa Monica Medical Center and Orthopaedic Hospital

location_facility: Texas Oncology-El Paso Cancer Treatment Center Joe Battle

location_facility: UCLA West Medical Pharmacy: Drug Management Only

location_facility: Sylvester Comprehensive Cancer Center Plantation

location_facility: Petz Aladar Megyei Oktato Korhaz, Onkoradiologiai Osztaly

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center.

location_facility: Lviv State Oncologic Regional Treatment and Diagnostic Center, Chemotherapy Department

location_facility: Texas Oncology-El Paso Cancer Treatment Center Grandview

location_facility: Szegedi Tudomanyegyetem Altalanos Orvosi Kar, Patologia Intezet

location_facility: Saint Francis Medical Center, Saint Francis Cancer Treatment Center

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong

location_facility: SBHI of Republic of Bashkortostan Emergency Hospital

location_facility: Institute of Postgraduate education and preuniversity preparing of Uzhgorod National Univ.

location_facility: Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.

location_facility: Memorial Cancer Institute at Memorial Regional Hospital

location_facility: Cancer Specialist of North Florida, Pharmacy

location_facility: Cancer Specialists of North Florida - St. Augustine

location_facility: Whittingham Cancer Center @ Norwalk Hospital

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Onko-Dent" SP.P. G.L. Słomian

location_facility: Regional Municipal Establishment "Sumy Regional Clinical Oncology Dispensary", Thoracic Department

location_facility: James Graham Brown Cancer Center and University Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Samsung Medical Center, Division of Hematology-Oncology, Department of Medicine

location_facility: Regional Budgetary Healthcare Institution Kursk Regional Clinical

location_facility: The West Clinic, PC dba West Cancer Centre

location_facility: Országos Onkológiai Intézet, Radiologiai Diagnosztikai Osztily

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Walter Reed National Military Medical Center

location_facility: Grand Hopital de Charleroi / Service d'Hematologie et Oncologie

location_facility: Universitaetsklinikum Magdeburg AOR Universitaetsfrauenklinik

location_facility: Center Hospitalier Affilie Universitaire de Quebec, Universite Laval, Hopital du Saint Sacrement

location_facility: Administrative Address: UCLA Hematology/Oncology

location_facility: Memorial Cancer Institute at Memorial Hospital West

location_facility: QEII Health Sciences Centre, Victoria General Site

location_facility: Centro Oncologico MD Anderson Internacional España

location_facility: Memorial Breast Cancer Center at Memorial Hospital West

location_facility: City Oncology Centre of Central Municipal Clinical Hospital

location_facility: Gasthuis Zusters Antwerpen - Campus Sint- Augustinus

location_facility: TRIO-US Central Administration: Regulatory Management Only

location_facility: Oncology & Hematology Associates of Southwest Virginia, INC., D.B.A. Blue Rigde Cancer Care

location_facility: Bendigo Health Care Group, The Bendigo Hospital Campus

location_facility: Ryazan Regional Clinical Oncology Dispensary

location_facility: Smilow Cancer Hospital at Yale New Haven

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Institut Curie, Departement d'Oncologie Medicale

location_facility: Torrance Health Association, DBa Torrance Memorial Physician Network

location_facility: Hospital Universitario Arnau De Vilanova de Lleida

location_facility: Asan Medical Center, Division of Oncology, Department of Internal Medicine

location_facility: National Cancer Center, Center for Breast Cancer

location_facility: Klinikverbund Sudwest - Kliniken Sidelfingen-Boblingen

location_facility: Fakultni nemocnice Hradec Kralove, Klinika onkologie a radiologie

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Carle Foundation Hospital DBA Carle Cancer Center

location_facility: Országos Onkológiai Intézet, Nuklearis Medicina Osztaly

location_facility: Los Angeles Hematology/Oncology Medical Group

location_facility: Hospital Madrid Universitario Sanchinarro

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Mercy Hospital St. Louis - David C. Pratt Cancer Center

location_facility: UCLA West Medical Pharmacy; Drug Management Only

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Drug Management Only: TRIO-US Pharmacy UCLA Medical Plaza, Attn: Steven L Wong, Pharm.D.

location_facility: GUZ Republic Clinical Oncology Dispensary of Ministry of Health of Republic of Tatarstan

location_facility: Seoul National University Hospital / Department of Internal Medicine

location_facility: MI "Zaporizhzhia Regional Clinical Oncology Dispensary" Zaporizhzhia Regional Assembly,

location_facility: State institution "Zaporizhzhia Medical Academy of Postgraduate Education MOH Ukraine",

location_facility: Saint-Petersburg State Budget Healthcare Institution (SBHCI)

location_facility: National Hospital Organization Osaka National Hospital

location_facility: State Budget Healthcare Institution Moscow City Oncology Hospital

location_facility: Southlake Regional Health Centre- Stronach Regional Cancer Centre

location_facility: Institut de Cancérologie de l'Ouest-Rene Gauducheau

location_facility: Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola-Malpighi

location_facility: University Hospital Carl Gustav Carus - Department for Obstetrics and Gynecology.

location_facility: Seoul National University Bundang Hospital

location_facility: Texas Oncology- El Paso Cancer Treatment Center Gateway

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Non-State Health Care agency "Road Clinical Hospital of PLC" Russian Railways

location_facility: Breast Cancer, University of Munich, Grosshadern Hospital

location_facility: Instituto Catalan de Oncologia L'Hospitalet

location_facility: Municipal Non-profit Enterprise "Regional Centre of Oncology"

location_facility: Southern California Permanente Medical Group

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Altalanos Orvostudomanyi Kar

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Institut de Cancerologie de l'Ouest- Paul Papin

location_facility: San Luis Obispo Oncology and Hematology Health Center/ Pacific Central Coast Health Centers

location_facility: Regulatory Office: Comprehensive Cancer Centers of Nevada Research Department

location_facility: Memorial Breast Cancer Center at Memorial Regional Hospital

location_facility: The Mark M. Connolly Center for Cancer and Specialty Care

location_facility: The Research And Development Office, The Christie NHS Foundation Trust

location_facility: Petz Aladar Megyei Oktato Korhaz Izotopdiagnosztikai es Terapias Szakambulancia

location_facility: Hospital Universitario Fundacion de Alcorcon

location_facility: State Institution Dnipropetrovsk Medical Academy at the Ministry of Health of Ukraine

location_facility: Frauenklinik und Poliklinik Klinikum rechts der Isar, Technische Universitaet Muenchen

location_facility: MI "Dnipropetrovsk City Multidisciplinary Clinical Hospital No.4" of the Dnipropetrovsk City Council

location_facility: North Coast Cancer Institute/Port Macquarie Base Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Municipal Medical Institution "Makiivka City Hospital No.2 of Donetsk Region"

location_facility: Cancer Specialists of North Florida-Southpoint

location_facility: State Budget Medical Institution Republican Clinical Oncology

location_facility: Mercy Clinic St. Louis Cancer and Breast Institute

location_facility: Institut Claudius Regaud- Cancer Comprehensive Center- IUCT-O-Medical Oncology Department

location_facility: Országos Onkológiai Intézet "B" Belgyogyaszati osztaly

location_facility: McGill University Health Centre (MUHC), Glen Site, Cedars Cancer Centre

location_facility: St. Mary's Hospital Regional Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center, Department of Breast Medical Oncology

location_facility: Central Coast Medical Oncology Corporation

location_facility: Regulatory Management Only: TRIO-US Central Administration

location_facility: Republican Clinical Hospital n.a. G.G. Kuvatov

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

location_facility: Freidenrich Center for Translational Research

location_facility: State Budget Healthcate Institution "Leningrad Region Oncology Dispensary"

location_facility: Edinburgh Cancer Centre, Western General Hospital

title: A RANDOMIZED, MULTICENTER, DOUBLE-BLIND PHASE 3 STUDY OF PD-0332991 (ORAL CDK 4/6 INHIBITOR) PLUS LETROZOLE VERSUS PLACEBO PLUS LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN WITH ER (+), HER2 (-) BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI CANCER TREATMENT FOR ADVANCED DISEASE

summary: The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.


type: EudraCT Number

title: A Prospective, Randomized, Open-label, Parallel-group, Active-controlled, Multicenter Study Exploring the Efficacy and Safety of Once-daily Oral Rivaroxaban (BAY59-7939) Compared With That of Dose-adjusted Oral Vitamin K Antagonists (VKA) for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion

acronym: X-VERT

summary: A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm). The study will compare patients assigned randomly (like flipping a coin) to either Rivaroxaban or vitamin K antagonist (VKA). The study will measure common medical outcomes for this type of patient such as bleeding and stroke.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Cappato R, Ezekowitz MD, Klein AL, Camm AJ, Ma CS, Le Heuzey JY, Talajic M, Scanavacca M, Vardas PE, Kirchhof P, Hemmrich M, Lanius V, Meng IL, Wildgoose P, van Eickels M, Hohnloser SH; X-VeRT Investigators. Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation. Eur Heart J. 2014 Dec 14;35(47):3346-55. doi: 10.1093/eurheartj/ehu367. Epub 2014 Sep 2.

ReferenceCitation: Hai Z, Guangrui S. Cardiac paraganglioma. Eur Heart J. 2018 Jun 14;39(23):2219. doi: 10.1093/eurheartj/ehu241.

lead_sponsor: Bayer

location_country:
Italy
Brazil
United States
South Africa
Netherlands
Spain
Germany
Finland
France
Greece
Singapore
Belgium
China
Denmark
Canada
United Kingdom
Portugal

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

acronym: OPTIMISMM

summary: The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

primary_purpose: Treatment

ReferenceType: derived

ReferenceCitation: Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.

family: Richardson

full_name: Paul G Richardson

given: Paul G

sequence: first

family: Oriol

full_name: Albert Oriol

given: Albert

sequence: additional

family: Beksac

full_name: Meral Beksac

given: Meral

family: Liberati

full_name: Anna Marina Liberati

given: Anna Marina

family: Galli

full_name: Monica Galli

given: Monica

family: Schjesvold

full_name: Fredrik Schjesvold

given: Fredrik

family: Lindsay

full_name: Jindriska Lindsay

given: Jindriska

family: Weisel

full_name: Katja Weisel

given: Katja

family: White

full_name: Darrell White

given: Darrell

family: Facon

full_name: Thierry Facon

given: Thierry

family: San Miguel

full_name: Jesus San Miguel

given: Jesus

family: Sunami

full_name: Kazutaka Sunami

given: Kazutaka

family: O'Gorman

full_name: Peter O'Gorman

given: Peter

family: Sonneveld

full_name: Pieter Sonneveld

given: Pieter

family: Robak

full_name: Pawel Robak

given: Pawel

family: Semochkin

full_name: Sergey Semochkin

given: Sergey

family: Schey

full_name: Steve Schey

given: Steve

family: Yu

full_name: Xin Yu

given: Xin

family: Doerr

full_name: Thomas Doerr

given: Thomas

family: Bensmaine

full_name: Amine Bensmaine

given: Amine

family: Biyukov

full_name: Tsvetan Biyukov

given: Tsvetan

family: Peluso

full_name: Teresa Peluso

given: Teresa

family: Zaki

full_name: Mohamed Zaki

given: Mohamed

ReferenceCitation: Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2. Erratum in: Leukemia. 2018 Oct;32(10):2305.

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

location_country:
Finland
Greece
Russian Federation
Denmark
France
Japan
Poland
Norway
Canada
Sweden
Netherlands
Ireland
Puerto Rico
Portugal
Germany
United States
United Kingdom
Italy
Austria
Israel
Spain
Turkey

location_facility: National Hospital Organization Disaster Medical Center

location_facility: State Budgetary Healthcare Institution of Nizhniy Novgorod Region

location_facility: University of Tennessee Medical Center - Cancer Institute

location_facility: University of California San Francisco Fresno Campus

location_facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin

location_facility: Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine

location_facility: Worcestershire Acute Hospitals NHS Trust

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency

location_facility: Hematology-Oncology Associates of NNJ, P

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: Investigative Clinical Research of Indiana, LLC

location_facility: Alves Domenech Oncology and Hematology Clinic

location_facility: Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara

location_facility: Centre De Sante Et De Services Sociaux De Rimouski-Neigette

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi

location_facility: Klinika Hematoonkologii i Transplantacji Szpiku

location_facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego

location_facility: Tel Aviv Sourasky Medical Center Department of Hematology

location_facility: Universitaetsklinikum EssenInnere Klinik und Poliklinik

location_facility: USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII

location_facility: Wilhelminenspital-Center for Hematology and Oncology

location_facility: Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute

location_facility: St. John's Clinic Cancerand Hematology - Springfield

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: University of Athens Medical school - Regional General Hospital

location_facility: Western Kentucky Hematology and Oncology Group, PSC

location_facility: George Papanikolaou General Hospital of Thessaloniki

location_facility: Hospital Universitari Germans Trias i Pujol Can Ruti

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: Henry Ford Medical Center - New Center One

location_facility: Kansas City VA Medical Center University of Kansas Medical Center

location_facility: Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Azienda Ospedaliera San Giovanni Battista

location_facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie

location_facility: University Hospital of North Staffordshire Nhs Trust - City General Hospital

location_facility: Copenhagen University Hospital Rigshosptalet

location_facility: Klinika Hematologii Akademii Medycznej w Gdansku

location_facility: Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit

location_facility: Complejo Hospitalario Nuestra Senora de Valme

location_facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela

location_facility: A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC

location_facility: Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole

location_facility: RSM Durham Regional Cancer Center - Lakeridge Health Oshawa

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital


lead_sponsor: Pierre Fabre Medicament

location_country:
Italy
Sweden
Switzerland
Spain
France
Hungary
Belgium
Russian Federation
Portugal
Germany
Czech Republic

acronym: LIFE

location_facility: Scientific Research Neurology Institute of Russian Academy of Medical Services

location_facility: Smolensk State Medical Academy of RosZdrav

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Municipal Healthcare Institution "Municipal Clinical Hospital # 3"

location_facility: Non-state Healthcare Institution "N.A. Semashko Central Clinical Hospital #2 of JSC "Russian Railway

location_facility: Municipal Medical Institute "N.I.Pirogov City Clinical hospital #1"

location_facility: Azienda Sanitaria Ospedaliera "San Giovanni Battista"

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

location_facility: Hopital Jean Minjoz Centre Hospitalier Universitaire Besancon

location_facility: State Budget Healthcare Institution "City clinical hospital #20"

location_facility: Centre Hospitalier Universitaire de Poitiers Hôpital de la Milétrie

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire de Saint Etienne, Hôpital Nord

location_facility: Universitätsklinik Charité, Campus Mitte

location_facility: Professor S.V. Ochapovsky Territorial Clinical Hospital #1

location_facility: State Healthcare Institution "Samara M.I.Kalinin Regional Clinical Hospital"

location_facility: Centro Hospitalar do Porto / Hospital Geral de Santo António

location_facility: State Institution of Healthcare of Moscow City "City Clinical Hospital #61"

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Hospital Universitario de Girona Doctor Josep Trueta

location_facility: State Institution "Saint Petersburg I.I. Dzhanelidze Research Institute of Emergency"

location_facility: Hospital Clinico Universitario de Valladolid

source: euctr

title: Effect of 3-month Treatment With F2695 (75mg OD) on Improving Functional Recovery of Patients With Ischemic Stroke. A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-Controlled Study

summary: The purpose of the study is to assess the efficacy of a new serotonin-norepinephrine reuptake inhibitor (SNRI) nin functional recovery after ischemic stroke.


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study Evaluating the Efficacy and Safety of Onartuzumab in Combination With Bevacizumab or Onartuzumab Monotherapy in Patients With Recurrent Glioblastoma

summary: This randomized, double-blind, placebo-controlled, multicenter phase II study will evaluate the safety and efficacy of onartuzumab in combination with bevacizumab as compared to bevacizumab alone in participants with recurrent glioblastoma. Participants will be randomized 1:1 to receive either placebo plus bevacizumab every 3 weeks, or onartuzumab plus bevacizumab. Study treatment will continue until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
United States
Switzerland
France
Spain
Germany
United Kingdom
Canada

location_facility: University of Alabama At Birmingham; Neuro-Oncology

location_facility: Princess Margaret Hospital; Pencer Brain Tumour Centre, 18-727

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: A.O. Universitaria Di Parma; Oncologia Medica

location_facility: Uni Klinikum München - Großhardern; Med. Klinik U. Poliklinik III - Abt. Onkologie u. Hämatologie

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Presidio Ospedaliero Marconi Bufalini; U.O. di Oncologia

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Cedars Sinai Medical Center; Neurosurgery

location_facility: Ospedale Bellaria; U.O. Oncologia Medica

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Az. Osp. Pisana Ospedale S. Chiara; U.O. Di Reumatologia

location_facility: Nottingham City Hospital; David Evans Centre

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Klinikum der Johannes Gutenberg Uni Mainz; Studienz. Neurologie, Klinik und Poliklinik Neurologie

location_facility: Seattle Cancer Care Alliance; Investigational Drug Service

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Northshore University Health System; Cardiology

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)

location_facility: Hôpital Central; Departement de Neuro-Oncologie

location_facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

location_facility: Centre Val Aurelle Paul Lamarque; Medecine B3

location_facility: Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

location_facility: Universitatsklinikum Hamburg-Eppendorf; Klinik und Poliklinik fur Neurochirurgie

location_facility: Universitätsspital Zürich; Klinik für Neurologie


ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

lead_sponsor: Boehringer Ingelheim

location_country:
Finland
Greece
Belgium
Russian Federation
Taiwan
India
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
South Africa
Netherlands
Hungary
Portugal
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
Spain

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: University Hospital Plzen, Plzen-Lochotin

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Med. Klinik m.S. Hämatologie und Onkologie

location_facility: Centro Hospitalar Universitário São João,EPE

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Univ. of Szeged, 2nd Dept. of Internal Med., Haematology

location_facility: General Hospital of Athens "G. Gennimatas"

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: General Hospital of Thessaloniki "G. Papanikolaou"

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: Chonnam National University Hwasun Hospital

location_facility: University of Alberta Hospital (University of Alberta)

location_facility: FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

location_facility: Reg. Specialist Hospital of M. Kopernik, Dept. Haematology

location_facility: Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: ASST Grande Ospedale Metropolitano Niguarda

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

location_facility: St. Luke's Hospital Association of Duluth, Inc.

location_facility: Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: City Hospital Torun, Department of Hematology

location_facility: Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology

location_facility: Regional Clinical Hospital 'The Badge of Honor Order'

location_facility: Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology

location_facility: Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2

location_facility: Hospital Central de Salud Zenón Santillan

ipd_sharing: Yes

title: A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy

summary: To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients >= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy


title: A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of RO4602522 Added to Background Alzheimer's Disease Therapy in Patients With Moderate Severity Alzheimer's Disease

acronym: MAyflOwer RoAD

summary: This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in participants with moderate severity Alzheimer's disease. Participants who are taking background therapy of acetylcholinesterase inhibitors (AChEI) alone or in combination with memantine for at least 4 months before screening will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.

ReferenceCitation: Nave S, Doody RS, Boada M, Grimmer T, Savola JM, Delmar P, Pauly-Evers M, Nikolcheva T, Czech C, Borroni E, Ricci B, Dukart J, Mannino M, Carey T, Moran E, Gilaberte I, Muelhardt NM, Gerlach I, Santarelli L, Ostrowitzki S, Fontoura P. Sembragiline in Moderate Alzheimer's Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD). J Alzheimers Dis. 2017;58(4):1217-1228. doi: 10.3233/JAD-161309.

name: Roche Pharma Research & Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Switzerland

family: Nave

full_name: Stephane Nave

given: Stephane

name: Department of Neurology, Alzheimer’s Disease and Memory Disorders Center, Baylor College of Medicine, Houston, TX, USA

family: Doody

full_name: Rachelle S. Doody

given: Rachelle S.

name: Memory Clinic ofFundació ACE, Institut Catalá de Neurociències Aplicades, Barcelona, Spain

family: Boada

full_name: Mercè Boada

given: Mercè

name: Department of Psychiatry and Psychotherapy, Klinikum rechts der Isar, Technische Universitaet Muenchen, Munich, Germany

family: Grimmer

full_name: Timo Grimmer

given: Timo

family: Savola

full_name: Juha-Matti Savola

given: Juha-Matti

family: Delmar

full_name: Paul Delmar

given: Paul

family: Pauly-Evers

full_name: Meike Pauly-Evers

given: Meike

family: Nikolcheva

full_name: Tania Nikolcheva

given: Tania

family: Czech

full_name: Christian Czech

given: Christian

family: Borroni

full_name: Edilio Borroni

given: Edilio

family: Ricci

full_name: Benedicte Ricci

given: Benedicte

family: Dukart

full_name: Juergen Dukart

given: Juergen

name: RocheSafety Risk Management, Licensing & Early Development, RocheInnovation Center, NY, USA

family: Mannino

full_name: Marie Mannino

given: Marie

name: Roche Product Development, Roche Innovation Center, NY, USA

family: Carey

full_name: Tracie Carey

given: Tracie

name: Roche Products Limited, Roche Innovation Center Welwyn, Welwyn Garden City, UK

family: Moran

full_name: Emma Moran

given: Emma

family: Gilaberte

full_name: Inma Gilaberte

given: Inma

name: Roche Product Development Neuroscience, Roche Innovation Center Basel, F.Hoffmann-La Roche Ltd, Switzerland

family: Muelhardt

full_name: Nicoletta Milani Muelhardt

given: Nicoletta Milani

family: Gerlach

full_name: Irene Gerlach

given: Irene

family: Santarelli

full_name: Luca Santarelli

given: Luca

name: Genentech Inc., Product Development Neuroscience, South San Francisco, CA, USA

family: Ostrowitzki

full_name: Susanne Ostrowitzki

given: Susanne

family: Fontoura

full_name: Paulo Fontoura

given: Paulo

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Alzheimer's Disease

oa_colors: green hybrid

title: Sembragiline in Moderate Alzheimer’s Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD)

location_country:
Italy
United States
Sweden
Germany
France
Czechia
Poland
Australia
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: Klinikum rechts der Isar der Technischen Universität München

location_facility: Inha University Hospital; Pulmonary Medicine

location_facility: McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

location_facility: Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo

location_facility: West London Cognitive Disorders Treatment and Research Unit; Lakeside Metal Health Unit

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Institut Universitaire de gériatrie de Sherbrooke; Service de gériatrie/pavillon Argyll

location_facility: New York University Medical Center;Child Study Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog

location_facility: Hospital Universitario Clínico San Carlos

location_facility: Umberto I Policlinico di Roma-Università di Roma La Sapienza

location_facility: Groupe Hospitalier Sud - Hôpital Xavier Arnozan

location_facility: Medical Research Group of Central Florida

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Artemis Institute for Clinical Research, LLC

location_facility: Memory Enhancement Center of America, Inc.

location_facility: Seoul National University Bundang Hospital

location_facility: Comprehensive Clinical Development, Inc.- St. Petersburg, FL

location_facility: Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Advanced Research Center, Inc.;In-Patient Unit

location_facility: Hospital Perpetuo Socorro, Servicio de Geriatria

location_facility: University of North Texas Health Science Center

location_facility: Policlinico Universitario Agostino Gemelli; Farmacia

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

location_facility: Alzheimer's Research & Clinical Programs

location_facility: Parkinson's Disease and Movement Disorders Center of Boca Raton

location_facility: ISPG - Institut fuer Studien zur Psychischen Gesundheit

location_facility: Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

location_facility: Hospital General Universitario de Elche; Servicio de Farmacia

location_facility: Nuovo Ospedale Civile S.Agostino - Estense


title: cAlprotectin and hsCRP as Markers of a New Diagnostic-therapeutic strAtegy That Assesses muCosal Activity to individuaLize Treatment and Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants

acronym: ADACAL

summary: This study will test that individualized treatment in patients with Crohn's Disease in remission or mild clinical activity under immunosuppressants may improve prognosis, rather than just treating flares.

status: Terminated

ipd_sharing: No

lead_sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

location_country: Belgium France Spain

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Complejo Hospitalario Santiago de Compostela

status_simplified: Unknown


title: More Options Available With a Quadripolar Left Ventricular (LV) Lead pRovidE In-clinic Solutions to Cardiac Resynchronization Therapy (CRT) Challenges

acronym: MORE-CRT

summary: This investigation is designed with the hypothesis that using a quadripolar left ventricular lead results in less interventions when dealing with high pacing thresholds and Phrenic Nerve Stimulation (PNS), both at implant and during follow-up, compared to standard bipolar left ventricular leads.

ReferenceCitation: Boriani G, Connors S, Kalarus Z, Lemke B, Mullens W, Osca Asensi J, Raatikainen P, Gazzola C, Farazi TG, Leclercq C. Cardiac Resynchronization Therapy With a Quadripolar Electrode Lead Decreases Complications at 6 Months: Results of the MORE-CRT Randomized Trial. JACC Clin Electrophysiol. 2016 Apr;2(2):212-220. doi: 10.1016/j.jacep.2015.10.004. Epub 2015 Nov 11.

family: Boriani

full_name: Giuseppe Boriani

given: Giuseppe

family: Connors

full_name: Sean Connors

given: Sean

family: Kalarus

full_name: Zbigniew Kalarus

given: Zbigniew

family: Lemke

full_name: Bernd Lemke

given: Bernd

family: Mullens

full_name: Wilfried Mullens

given: Wilfried

family: Osca Asensi

full_name: Joaquin Osca Asensi

given: Joaquin

family: Raatikainen

full_name: Pekka Raatikainen

given: Pekka

family: Gazzola

full_name: Carlo Gazzola

given: Carlo

family: Farazi

full_name: Taraneh G. Farazi

given: Taraneh G.

family: Leclercq

full_name: Christophe Leclercq

given: Christophe

journal_name: JACC: Clinical Electrophysiology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

lead_sponsor: Abbott Medical Devices

location_country:
Italy
India
Switzerland
Netherlands
Finland
France
Poland
Israel
Belgium
Spain
Germany
United Kingdom
Canada

location_facility: Escorts Heart Institute and Research Center

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Azienda Ospedaliera S.Anna e S.Sebastiano

location_facility: Ospedale Civile Maggiore Verona Borgo Trento

location_facility: Institut de Cardiologie du Quebec - Hopital Laval

location_facility: Azienda Sanitaria Ospedaliera Molinette S. Giovanni Battista

location_facility: Hopital du Nord - CH Bourrely St. Antoine

intervention_type: Device


title: A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

acronym: RESONATE™

summary: The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

ReferenceCitation: Munir T, Brown JR, O'Brien S, Barrientos JC, Barr PM, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Kipps TJ, Moreno C, Montillo M, Burger JA, Byrd JC, Hillmen P, Dai S, Szoke A, Dean JP, Woyach JA. Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Am J Hematol. 2019 Dec;94(12):1353-1363. doi: 10.1002/ajh.25638. Epub 2019 Oct 13.

name: Department of Haematology St. James's University Hospital  Leeds UK

family: Munir

full_name: Talha Munir

given: Talha

name: CLL Center, Dana‐Farber Cancer Institute  Boston Massachusetts

family: Brown

full_name: Jennifer R. Brown

given: Jennifer R.

name: UC Irvine, Chao Family Comprehensive Cancer Center  Irvine California

family: O'Brien

full_name: Susan O'Brien

given: Susan

name: Division of Medical Oncology and Hematology Northwell Health Cancer Institute  Lake Success New York

family: Barrientos

full_name: Jacqueline C. Barrientos

given: Jacqueline C.

name: Wilmot Cancer Institute University of Rochester Medical Center  Rochester New York

family: Barr

full_name: Paul M. Barr

given: Paul M.

name: Vanderbilt‐Ingram Cancer Center  Nashville Tennessee

family: Reddy

full_name: Nishitha M. Reddy

given: Nishitha M.

name: Stanford Cancer Center Stanford University School of Medicine  Stanford California

family: Coutre

full_name: Steven Coutre

given: Steven

name: Peter MacCallum Cancer Centre St. Vincent's Hospital and University of Melbourne  Melbourne Australia

family: Tam

full_name: Constantine S. Tam

given: Constantine S.

name: Royal North Shore Hospital  Sydney Australia

family: Mulligan

full_name: Stephen P. Mulligan

given: Stephen P.

name: Division of Hematology and Hemostaseology Medical University of Vienna  Wien Austria

family: Jaeger

full_name: Ulrich Jaeger

given: Ulrich

name: UCSD Moores Cancer Center  San Diego California

family: Kipps

full_name: Thomas J. Kipps

given: Thomas J.

name: Hospital de la Santa Creu i Sant Pau Autonomous University of Barcelona  Barcelona Spain

family: Moreno

full_name: Carol Moreno

given: Carol

name: Niguarda Ca' Granda Hospital  Milan Italy

family: Montillo

full_name: Marco Montillo

given: Marco

name: Department of Leukemia University of Texas MD Anderson Cancer Center  Houston Texas

family: Burger

full_name: Jan A. Burger

given: Jan A.

name: The Ohio State University Comprehensive Cancer Center  Columbus Ohio

family: Byrd

full_name: John C. Byrd

given: John C.

name: The Leeds Teaching Hospitals St. James Institute of Oncology  Leeds UK

family: Hillmen

full_name: Peter Hillmen

given: Peter

name: Pharmacyclics LLC, an AbbVie Company  Sunnyvale California

family: Dai

full_name: Sandra Dai

given: Sandra

family: Szoke

full_name: Anita Szoke

given: Anita

family: Dean

full_name: James P. Dean

given: James P.

family: Woyach

full_name: Jennifer A. Woyach

given: Jennifer A.

journal_name: American Journal of Hematology

oa_host_type: publisher;repository

license: cc-by-nc-nd

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

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: University of California - eScholarship University of California

repository_normalized: California Digital Library - eScholarship

title: Final analysis from RESONATE: Up to six years of follow‐up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma

ReferenceCitation: Coutre SE, Byrd JC, Hillmen P, Barrientos JC, Barr PM, Devereux S, Robak T, Kipps TJ, Schuh A, Moreno C, Furman RR, Burger JA, O'Dwyer M, Ghia P, Valentino R, Chang S, Dean JP, James DF, O'Brien SM. Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. Blood Adv. 2019 Jun 25;3(12):1799-1807. doi: 10.1182/bloodadvances.2018028761.

name: Stanford University School of Medicine, Stanford, CA;

name: The Ohio State University Comprehensive Cancer Center, Columbus, OH;

name: Leeds Cancer Centre, St. James’s Institute of Oncology, Leeds, United Kingdom;

name: Hofstra Northwell School of Medicine, Hempstead, NY;

name: Wilmot Cancer Institute, University of Rochester Cancer Center, Rochester, NY;

name: King’s College Hospital, National Health Service Foundation Trust, London, United Kingdom;

name: Medical University of Lodz, Lodz, Poland;

name: Moores Cancer Center, University of California San Diego, La Jolla, CA;

name: Oxford National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom;

name: Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain;

name: Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY;

name: The University of Texas MD Anderson Cancer Center, Houston, TX;

name: University College Hospital Galway, Galway, Ireland;

name: Università Vita-Salute San Raffaele and Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy;

name: Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and

name: Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA

ReferenceCitation: Byrd JC, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Barr PM, Furman RR, Kipps TJ, Thornton P, Moreno C, Montillo M, Pagel JM, Burger JA, Woyach JA, Dai S, Vezan R, James DF, Brown JR. Long-term follow-up of the RESONATE phase 3 trial of ibrutinib vs ofatumumab. Blood. 2019 May 9;133(19):2031-2042. doi: 10.1182/blood-2018-08-870238. Epub 2019 Mar 6.

name: The Leeds Teaching Hospitals, St. James Institute of Oncology, Leeds, United Kingdom;

name: UC Irvine, Chao Family Comprehensive Cancer Center, Irvine, CA;

name: Zucker School of Medicine at Hofstra/Northwell, Lake Success, NY;

name: Vanderbilt-Ingram Cancer Center, Nashville, TN;

name: Department of Haematology, Peter MacCallum Cancer Centre and St. Vincent’s Hospital, Melbourne, VIC, Australia;

name: Royal North Shore Hospital, Sydney, NSW, Australia;

name: Division of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria;

name: University of Rochester Medical Center, Rochester, NY;

name: Weill Cornell Medical College/New York Presbyterian Hospital, New York, NY;

name: UCSD Moores Cancer Center, San Diego, CA;

name: Hospital de la Santa Creu Sant Pau, Barcelona, Spain;

name: Niguarda Ca’ Granda Hospital, Milan, Italy;

name: Swedish Cancer Institute Hematologic Malignancies Program, Seattle, WA;

name: University of Texas MD Anderson Cancer Center, Houston, TX;

name: CLL Center, Dana-Farber Cancer Institute, Boston, MA

ReferenceCitation: O'Brien SM, Jaglowski S, Byrd JC, Bannerji R, Blum KA, Fox CP, Furman RR, Hillmen P, Kipps TJ, Montillo M, Sharman J, Suzuki S, James DF, Chu AD, Coutre SE. Prognostic Factors for Complete Response to Ibrutinib in Patients With Chronic Lymphocytic Leukemia: A Pooled Analysis of 2 Clinical Trials. JAMA Oncol. 2018 May 1;4(5):712-716. doi: 10.1001/jamaoncol.2017.5604.

name: Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange

name: Division of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus

name: Division of Hematology Oncology, Rutgers Cancer Institute of New Jersey, New Brunswick

name: Department of Clinical Haematology, Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom

name: Division of Hematology and Medical Oncology, Weill Cornell Medical College, New York, New York

name: Department of Haematology, The Leeds Teaching Hospitals, St James Institute of Oncology, Leeds, United Kingdom

name: Department of Medicine, University of California San Diego Moores Cancer Center, La Jolla

name: Department of Haematology and Oncology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy

name: Willamette Valley Cancer Institute and Research Center, Springfield, Oregon

name: Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California

name: Division of Hematology, Stanford Cancer Center, Stanford University School of Medicine, Stanford, California

ReferenceCitation: Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

publisher: Ferrata Storti Foundation (Haematologica)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Barr PM, Brown JR, Hillmen P, O'Brien S, Barrientos JC, Reddy NM, Coutre S, Mulligan SP, Jaeger U, Furman RR, Cymbalista F, Montillo M, Dearden C, Robak T, Moreno C, Pagel JM, Burger JA, Suzuki S, Sukbuntherng J, Cole G, James DF, Byrd JC. Impact of ibrutinib dose adherence on therapeutic efficacy in patients with previously treated CLL/SLL. Blood. 2017 May 11;129(19):2612-2615. doi: 10.1182/blood-2016-12-737346. Epub 2017 Apr 3.

name: Wilmot Cancer Institute, University of Rochester, Rochester, NY;

name: Dana-Farber Cancer Institute, Boston, MA;

name: Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX;

name: Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA;

name: Division of Hematology, Department of Medicine I, Medical University of Vienna, Vienna, Austria;

name: Royal Marsden Hospital, London, United Kingdom;

name: Department of Hematology, Medical University of Lodz, Lodz, Poland;

name: Pharmacyclics LLC, AbbVie, Sunnyvale, CA;

name: The Ohio State University Medical Center, The Ohio State University, Columbus, OH

ReferenceCitation: Maddocks KJ, Ruppert AS, Lozanski G, Heerema NA, Zhao W, Abruzzo L, Lozanski A, Davis M, Gordon A, Smith LL, Mantel R, Jones JA, Flynn JM, Jaglowski SM, Andritsos LA, Awan F, Blum KA, Grever MR, Johnson AJ, Byrd JC, Woyach JA. Etiology of Ibrutinib Therapy Discontinuation and Outcomes in Patients With Chronic Lymphocytic Leukemia. JAMA Oncol. 2015 Apr;1(1):80-7. doi: 10.1001/jamaoncol.2014.218.

name: Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus

name: Department of Pathology, The Ohio State University, Columbus

ReferenceCitation: Byrd JC, Brown JR, O'Brien S, Barrientos JC, Kay NE, Reddy NM, Coutre S, Tam CS, Mulligan SP, Jaeger U, Devereux S, Barr PM, Furman RR, Kipps TJ, Cymbalista F, Pocock C, Thornton P, Caligaris-Cappio F, Robak T, Delgado J, Schuster SJ, Montillo M, Schuh A, de Vos S, Gill D, Bloor A, Dearden C, Moreno C, Jones JJ, Chu AD, Fardis M, McGreivy J, Clow F, James DF, Hillmen P; RESONATE Investigators. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014 Jul 17;371(3):213-23. doi: 10.1056/NEJMoa1400376. Epub 2014 May 31.

title: Ibrutinib versus Ofatumumab in Previously Treated Chronic Lymphoid Leukemia

location_country:
Italy
Austria
France
Poland
Ireland
Australia
Belgium
Spain
United States
United Kingdom

location_facility:
Site # 516
Site # 501
Site # 200
Site # 552
Site # 127
Site # 529
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title: A Phase III, Randomised, Double-blind and Placebo-controlled Study of Once Daily BI 201335 120 mg for 12 or 24 Weeks or BI 201335 240 mg for 12 Weeks in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Patients With Genotype 1 Chronic Hepatitis C Infection

summary: The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

ReferenceCitation: Jensen DM, Asselah T, Dieterich D, Foster GR, Sulkowski MS, Zeuzem S, Mantry P, Yoshida EM, Moreno C, Ouzan D, Wright M, Morano LE, Buynak R, Bourlière M, Hassanein T, Nishiguchi S, Kao JH, Omata M, Paik SW, Wong DK, Tam E, Kaita K, Feinman SV, Stern JO, Scherer J, Quinson AM, Voss F, Gallivan JP, Böcher WO, Ferenci P. Faldaprevir, pegylated interferon, and ribavirin for treatment-naïve HCV genotype-1: pooled analysis of two phase 3 trials. Ann Hepatol. 2016 May-Jun;15(3):333-49. doi: 10.5604/16652681.1198803.

family: Jensen

full_name: Donald M. Jensen

given: Donald M.

family: Asselah

full_name: Tarik Asselah

given: Tarik

family: Dieterich

full_name: Douglas Dieterich

given: Douglas

family: Foster

full_name: Graham R. Foster

given: Graham R.

family: Sulkowski

full_name: Mark S. Sulkowski

given: Mark S.

family: Zeuzem

full_name: Stefan Zeuzem

given: Stefan

family: Mantry

full_name: Parvez Mantry

given: Parvez

family: Yoshida

full_name: Eric M. Yoshida

given: Eric M.

full_name: Christophe Moreno

given: Christophe

family: Ouzan

full_name: Denis Ouzan

given: Denis

family: Wright

full_name: Mark Wright

given: Mark

family: Morano

full_name: Luis E. Morano

given: Luis E.

family: Buynak

full_name: Robert Buynak

given: Robert

family: Bourlière

full_name: Marc Bourlière

given: Marc

family: Hassanein

full_name: Tarek Hassanein

given: Tarek

family: Nishiguchi

full_name: Shuhei Nishiguchi

given: Shuhei

family: Kao

full_name: Jia-Horng Kao

given: Jia-Horng

family: Omata

full_name: Masao Omata

given: Masao

family: Paik

full_name: Seung W. Paik

given: Seung W.

family: Wong

full_name: David K. Wong

given: David K.

full_name: Edward Tam

given: Edward

family: Kaita

full_name: Kelly Kaita

given: Kelly

family: Feinman

full_name: S. Victor Feinman

given: S. Victor

ReferenceCitation: Dieterich D, Nelson M, Soriano V, Arastéh K, Guardiola JM, Rockstroh JK, Bhagani S, Laguno M, Tural C, Ingiliz P, Jain MK, Stern JO, Manero M, Vinisko R, Kort J; STARTVerso4 study group. Faldaprevir and pegylated interferon α-2a/ribavirin in individuals co-infected with hepatitis C virus genotype-1 and HIV. AIDS. 2015 Mar 13;29(5):571-81. doi: 10.1097/QAD.0000000000000579.

publisher: Ovid Technologies (Wolters Kluwer Health)

ReferenceCitation: Ferenci P, Asselah T, Foster GR, Zeuzem S, Sarrazin C, Moreno C, Ouzan D, Maevskaya M, Calinas F, Morano LE, Crespo J, Dufour JF, Bourlière M, Agarwal K, Forton D, Schuchmann M, Zehnter E, Nishiguchi S, Omata M, Kukolj G, Datsenko Y, Garcia M, Scherer J, Quinson AM, Stern JO; STARTVerso1 Study Group. STARTVerso1: A randomized trial of faldaprevir plus pegylated interferon/ribavirin for chronic HCV genotype-1 infection. J Hepatol. 2015 Jun;62(6):1246-55. doi: 10.1016/j.jhep.2014.12.024. Epub 2015 Jan 2.

repository_institution: RCAAP Project by FCT - Portuguese National Funding Agency for Science, Research and Technology - RCAAP Search Portal

location_country:
Austria
Switzerland
Spain
France
Japan
Romania
Belgium
Russian Federation
Portugal
Germany
United Kingdom

location_facility: 1220.30.4001 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.3202 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.4410 Boehringer Ingelheim Investigational Site

location_facility: 1220.30.8115 Boehringer Ingelheim Investigational Site

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location_facility: 1220.30.4004 Boehringer Ingelheim Investigational Site

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location_facility: 1220.30.4101 Boehringer Ingelheim Investigational Site


title: A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In Outpatients With Major Depressive Disorder.

summary: The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).

design_allocation: Non-Randomized

ReferenceCitation: Tourian KA, Pitrosky B, Padmanabhan SK, Rosas GR. A 10-month, open-label evaluation of desvenlafaxine in outpatients with major depressive disorder. Prim Care Companion CNS Disord. 2011;13(2). pii: PCC.10m00977. doi: 10.4088/PCC.10m00977blu.

lead_sponsor: Pfizer

location_country:
South Africa
Former Serbia and Montenegro
Germany
Finland
France
Poland
Lithuania
Slovakia
Estonia
United States
Latvia

location_facility: The George Washington University Medical Center

location_facility: Psychoneurological hospital of Jelgava, Dept No12

location_facility: SP ZOZ Swietokrzyskie Centrum Psychiatrii w Morawicy

location_facility: Praxis für Psychiatrie, Dr. Alexander Schulze

location_facility: Wojewodzki Osrodek Lecznictwa Psychiatrycznego w Toruniu

location_facility: UCSD Department of Psychiatry Psychopharmacology Research

location_facility: Wojewodzki Szpital dla Nerwowo i Psychicznie Chorych

location_facility: California Clinical Trials Medical Group, Inc.

location_facility: Psychiatrische Praxis Dr. Hans-Peter Wunderlich

location_facility: Viljandi Hospital Foundation Psychiatric Clinic

location_facility: Nemocnica s poliklinikou Liptovsky Mikulas

location_facility: Poradnia Zdrowia Psychicznego w Chelmnie

location_facility: Inventiva Biomedical and Sport Research Sp. z o.o.

location_facility: Southeastern Pennsylvania Medical Institute

location_facility: Specjalistyczny Psychiatryczny ZOZ w Lodzi

location_facility: Praxis f. Neurologie u. Psychiatrie Dr. Lutz D. Lohse

location_facility: Riga Mental Health Care Center, Dept of Psychiatry

location_facility: Turku Psychiatric Services Aurakatu 14 B 3 Krs

location_facility: Capital Clinical Research Associates, LLP

location_facility: Atlanta Institute of Medicine & Research

location_facility: Klinicko-bolnicki centar Dr Dragisa Misovic - Dedinje

location_facility: Pivotal Research Centers 13128 North 94th Drive, Suite 200

location_facility: Kolin Research Group 1065 West Morse Blvd. Suite 202


ReferenceType: result

ReferenceCitation: Weller M, Butowski N, Tran DD, Recht LD, Lim M, Hirte H, Ashby L, Mechtler L, Goldlust SA, Iwamoto F, Drappatz J, O'Rourke DM, Wong M, Hamilton MG, Finocchiaro G, Perry J, Wick W, Green J, He Y, Turner CD, Yellin MJ, Keler T, Davis TA, Stupp R, Sampson JH; ACT IV trial investigators. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. Lancet Oncol. 2017 Oct;18(10):1373-1385. doi: 10.1016/S1470-2045(17)30517-X. Epub 2017 Aug 23.

family: Weller

full_name: Michael Weller

given: Michael

family: Butowski

full_name: Nicholas Butowski

given: Nicholas

family: Tran

full_name: David D Tran

given: David D

family: Recht

full_name: Lawrence D Recht

given: Lawrence D

family: Lim

full_name: Michael Lim

family: Hirte

full_name: Hal Hirte

given: Hal

family: Ashby

full_name: Lynn Ashby

given: Lynn

family: Mechtler

full_name: Laszlo Mechtler

given: Laszlo

family: Goldlust

full_name: Samuel A Goldlust

given: Samuel A

family: Iwamoto

full_name: Fabio Iwamoto

given: Fabio

family: Drappatz

full_name: Jan Drappatz

given: Jan

family: O'Rourke

full_name: Donald M O'Rourke

given: Donald M

full_name: Mark Wong

family: Hamilton

full_name: Mark G Hamilton

given: Mark G

family: Finocchiaro

full_name: Gaetano Finocchiaro

given: Gaetano

family: Perry

full_name: James Perry

given: James

family: Wick

full_name: Wolfgang Wick

given: Wolfgang

family: Green

full_name: Jennifer Green

given: Jennifer

family: He

full_name: Yi He

given: Yi

family: Turner

full_name: Christopher D Turner

given: Christopher D

family: Yellin

full_name: Michael J Yellin

given: Michael J

family: Keler

full_name: Tibor Keler

given: Tibor

family: Davis

full_name: Thomas A Davis

given: Thomas A

family: Stupp

full_name: Roger Stupp

given: Roger

family: Sampson

full_name: John H Sampson

given: John H

repository_institution: University of Szeged - SZTE Publicatio Repozitórium - SZTE - Repository of Publications

repository_institution: University of Zurich - Zurich Open Repository and Archive

location_country:
Peru
Greece
Australia
Belgium
Taiwan
India
France
Thailand
Canada
Colombia
Switzerland
Netherlands
Hungary
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
New Zealand
Spain

location_facility: Waikato Hospital, Regional Cancer Center

location_facility: Servicios Medicos de Investigacion Clinica Sc

location_facility: Real e Benemerita Associação Portuguesa de Beneficiência/ Hospital São José

location_facility: Inselspital, Universitatsspital Bern, Universitatsklinik fur Medizinische Onkologie, Freiburgstrasse

location_facility: Institut de Cancerologie de l'ouest-Center Rene Gauducheau

location_facility: Guy's and St Thomas' NHS, Westminister Bridge Road

location_facility: University of Arkansas for Medical Sciences

location_facility: Mount Sinai Medical Center, Comprehensive Cancer Center

location_facility: Institut de Cancerologie de L'Quest-Center Rane Gauducheau

location_facility: Klinik und Poliklinik fur Neurologie der Universitat Regensburg

location_facility: Brain Tumor Center, University Hospital Zurich

location_facility: Hospital Civil de Guadalajara "Fray Antonio Alcalde"

location_facility: Hospital Mae de Deus-Centro de Pesquisa em Oncologia Clinica

location_facility: The Crown Princess Mary Cancer Centre, Westmead Hospital

location_facility: Dra. Sonia Del Barco Berron, ICO Girona Avda,

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Johns Hopkins University School of Medicine

location_facility: University of Tennessee Medical Center - Knoxville

location_facility: University of Massachusetts Memorial Medical Center

location_facility: BC Cancer Agency - Vancouver Island Centre

location_facility: Sree Chitra Tirunal Institute for Medical Sciences & Technology, Thiruvananthapuram

location_facility: Lehigh Valley Physician Group-Hematology-Oncology Associates

location_facility: Szegedi Tudományegyetem Onkoterápiás Klinika

location_facility: HCG Shanti Mukand Hospital - Curie Cancer Centre, Delhi

location_facility: Columbia University Medical Center - The Neurologic Institute of New York

location_facility: Kaiser Permanente, Redwood City Medical Center

location_facility: Radboud University Nijmegen Medical Center

location_facility: Kaiser Permanente Hawaii Moanalua Medical Center

location_facility: Ensayos Clínicos y Medicina de Alta Especialidad, S.C.

location_facility: Waikato Hospital, Regional Cancer Centre

location_facility: Fondazione IRCCS Instituto Neurologico Carlo Besta

location_facility: New Jersey Neuroscience Institute, JFK Medical Center

location_facility: University of Pittsburgh Cancer Institute

location_facility: Universita e AO Citta delia Scienza, Universita Di Torino

location_facility: The Bristol Haematology and Oncology Centre

location_facility: Providence Portland Medical Center, Oncology & Hematology Care

location_facility: Medical University Innsbruck, Dept of Neurology, Anichstrabe 35

location_facility: Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute

location_facility: Winship Cancer Institute, Emory University School of Medicine

location_facility: Universitaetsklinikum Heidelberg, Neurologische Klinik, IM Neuenheimer Feld 672

location_facility: UO Oncologie Medica Dipartimento Oncologico

location_facility: Center for Cancer and Blood Disorders, PC

location_facility: Edinburgh Cancer Centre Western General Hospital

location_facility: Marathwada Regional Cancer Centre and Research Institute - Government

location_facility: University of Virginia Healthcare System

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum Onkológiai Intézet

location_facility: Stanford Cancer Institute, Stanford University

location_facility: Hopitaux Universitaires de Geneve-HUG-Centre d'Oncologie

location_facility: London Regional Cancer Program, London Health Sciences Centre

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

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: University of Manitoba-Cancer Care Manitoba

location_facility: University Hospital Hamburg Kopf und Neurozentrum

location_facility: Allina Health, Abbott Northwestern Hospital, John Nasseff Neuroscience Institute

location_facility: The Preston Robert Tisch Brain Tumor Center at Duke University Medical Center

location_facility: Institut de Cancerologie de I'Quest-Paul Papin

location_facility: Pécsi Tudományegyetem Általános Orvostudományi Kar

location_facility: CHUV, Centre Hospitalier Universitaire Vaudois

location_facility: Medical University of South Carolina - Department of Neuroscience

location_facility: Vas Megyei Markusovszky Lajos Általános Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktatókórház Nonprofit Zrt

location_facility: Instituto do Câncer do Estado de São Paulo - ICESP

location_facility: Hospital Central "Ignacio Morones Prieto"

location_facility: Országos Onkológiai Intézet Sugárterápiás Osztály

location_facility: Fundação Faculdade Regional de Medicina de de São José do Rio Preto - Hospital de Base

location_facility: Montreal Neurological Institute and Hospital

location_facility: Umiversity Hospital (Fakultni Nemocnice)

location_facility: British Columbia Cancer Agency, Vancouver Clinic

location_facility: HCG - Bangalore Institute of Oncology, Bangalore

location_facility: Dana-Farber Cancer Institute and Mass General Hospital

location_facility: Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

location_facility: University of Wisconsin Paul P Carbone Comprehensive Cancer Center

location_facility: Edward W. Sparrow Hospital Association - Sparrow Regional Cancer Center

location_facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház, Sugárterápiás Osztály

location_facility: Mater Adult Hospital, Mater Misericordiae Health Services Brisbane Limited

location_facility: University Hospitals, Case Medical Center (Cleveland)

location_facility: University of Cincinnati Cancer Institute

location_facility: ICO Badalona-Hospital Germans Trias i Pujol

location_facility: Covenant Clinic / Iowa Spine and Brain Institute

location_facility: St. Mary's of Michigan Medical Center/Field Neurosciences Institute

location_facility: The Long Island Brain Tumor Center at Neurology Surgery, P.C.

location_facility: Northwestern University Robert H. Lurie Comprehensive Cancer Center

location_facility: Centro de Pesquisas Clinicas da Fundação Dr Amaral Carvalho

location_facility: University of Utah Department of Neurosurgery

location_facility: Dr. Rai Memorial Medical Centre, Chennai

location_facility: Medizinische Universität Wien, Innere Medizin I, Onkologie

location_facility: Oncology Institute of Southern Switzerland (IOSI)

location_facility: Amrita Institute of Medical Sciences and Research Centre, Kochi

location_facility: Dr. Senchkenbergisches Institut fur Neuroonkologie

location_facility: Kantonsspital Aarau Medizinische Onkologie Tellstrasse

location_facility: University of South Alabama Mitchell Cancer Institute

title: An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF With Adjuvant Temozolomide in Patients With Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma

summary:
This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.


lead_sponsor: GlaxoSmithKline

location_country:
Belgium
Australia
Russian Federation
Denmark
Czech Republic
Taiwan
France
Japan
Poland
Norway
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Bulgaria
Hungary
Germany
United Kingdom
Italy
Brazil
Israel
Spain
Turkey

title: An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of GSK2402968 in Subjects With Duchenne Muscular Dystrophy

summary: The purpose of this study is to explore long-term safety, tolerability and efficacy of GSK2402968 in DMD subjects who previously participated in either DMD114117 or DMD114044.