title: TOP: Tysabri® Observational Program

acronym: TOP

summary: The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of natalizumab in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

study_start_date_type: Actual

status: Active, not recruiting

ReferenceCitation: Butzkueven H, Kappos L, Spelman T, Trojano M, Wiendl H, Su R, Liao S, Hyde R, Licata S, Ho PR, Campbell N. No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score-matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP). Ther Adv Neurol Disord. 2021 Sep 27;14:17562864211042458. doi: 10.1177/17562864211042458. eCollection 2021.

name: Department of Neuroscience, Central Clinical School, Monash University, Alfred Centre, Melbourne, VIC 3004, Australia. Department of Neurology, Box Hill Hospital, Monash University, Box Hill, VIC, Australia

family: Butzkueven

full_name: Helmut Butzkueven

given: Helmut

name: Research Center for Clinical Neuroimmunology and Neuroscience Basel, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel, Basel, Switzerland

family: Kappos

full_name: Ludwig Kappos

given: Ludwig

name: Department of Medicine and Melbourne Brain Centre, Royal Melbourne Hospital, The University of Melbourne, Melbourne, VIC, Australia

family: Spelman

full_name: Tim Spelman

given: Tim

name: Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy

family: Trojano

full_name: Maria Trojano

given: Maria

name: Department of Neurology, University of Münster, Münster, Germany

family: Wiendl

full_name: Heinz Wiendl

given: Heinz

name: Biogen, Cambridge, MA, USA, at the time of this analysis

family: Su

full_name: Ray Su

given: Ray

family: Liao

full_name: Shirley Liao

given: Shirley

family: Hyde

full_name: Robert Hyde

given: Robert

family: Licata

full_name: Stephanie Licata

given: Stephanie

family: Ho

full_name: Pei-Ran Ho

given: Pei-Ran

family: Campbell

full_name: Nolan Campbell

given: Nolan

currency_apc_doaj: USD

journal_name: Therapeutic Advances in Neurological Disorders

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

title: No evidence for loss of natalizumab effectiveness with every-6-week dosing: a propensity score–matched comparison with every-4-week dosing in patients enrolled in the Tysabri Observational Program (TOP)

ReferenceCitation: Butzkueven H, Kappos L, Wiendl H, Trojano M, Spelman T, Chang I, Kasliwal R, Jaitly S, Campbell N, Ho PR, Licata S; Tysabri Observational Program (TOP) Investigators. Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). J Neurol Neurosurg Psychiatry. 2020 Jun;91(6):660-668. doi: 10.1136/jnnp-2019-322326. Epub 2020 Mar 31.

family: Chang

full_name: Ih Chang

given: Ih

family: Kasliwal

full_name: Rachna Kasliwal

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

repository_normalized: University of Melbourne - Minerva Access

repositories_institution:
INFN Catania - INFM-OAR
PubMed Central - Europe PMC

ReferenceCitation: Butzkueven H, Kappos L, Pellegrini F, Trojano M, Wiendl H, Patel RN, Zhang A, Hotermans C, Belachew S; TYSABRI Observational Program (TOP) Investigators. Efficacy and safety of natalizumab in multiple sclerosis: interim observational programme results. J Neurol Neurosurg Psychiatry. 2014 Nov;85(11):1190-7. doi: 10.1136/jnnp-2013-306936. Epub 2014 Feb 14.

name: on behalf of the TYSABRI Observational Program (TOP) Investigators

location_country:
Italy
Brazil
Mexico
Netherlands
Germany
Spain
Finland
France
Czechia
Greece
Slovakia
Norway
Belgium
Argentina
Australia
Portugal
Canada
United Kingdom

location_facility: Research site 177, rue de Versailles- Dr Servan

location_facility: Research site ,1 Allée du Château- Dr Wagner


title: An Open-label Extension to Study AVA102670 and AVA102672, to Assess the Long-term Safety and Efficacy of Rosiglitazone (Extended Release Tablets) as Adjunctive Therapy on Cognition in Subjects With Mild to Moderate Alzheimer's Disease.

summary: This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status.

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606.

lead_sponsor: GlaxoSmithKline

location_country:
Finland
Greece
Australia
Belgium
India
France
Poland
Slovakia
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Chile
Sweden
Hong Kong
Netherlands
Philippines
Bulgaria
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Austria
Mexico
Czechia
Spain

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects

acronym: MOTIVATE 2

summary: Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and infected with R5-tropic virus exclusively. This study will involve more than 100 centers in Europe and Australia to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.

status: Completed

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Lewis ME, Simpson P, Mori J, Jubb B, Sullivan J, McFadyen L, van der Ryst E, Craig C, Robertson DL, Westby M. V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1-infected, treatment-experienced persons receiving optimized background regimens. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211030380. doi: 10.1177/20402066211030380.

apc_source: doaj

name: Pfizer Global Research and Development, Sandwich Labs, Sandwich, Kent, UK

name: The Research Network Ltd, Sandwich, Kent, UK

family: Lewis

full_name: ME Lewis

given: ME

sequence: first

family: Simpson

full_name: P Simpson

given: P

sequence: additional

name: hVIVO, Queen Mary BioEnterprise Innovation Centre, London, UK

family: Mori

full_name: J Mori

given: J

family: Jubb

full_name: B Jubb

given: B

family: Sullivan

full_name: J Sullivan

name: Pfizer Inc, Pharmacometrics, Sandwich, UK

family: McFadyen

full_name: L McFadyen

given: L

family: van der Ryst

full_name: E van der Ryst

given: E

family: Craig

full_name: C Craig

given: C

name: MRC-University of Glasgow Centre for Virus Research, Glasgow, UK

family: Robertson

full_name: DL Robertson

given: DL

name: Centauri Therapeutics Limited, Discovery Park, Kent, UK

family: Westby

full_name: M Westby

given: M

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Antiviral Chemistry and Chemotherapy

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

title: V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1–infected, treatment-experienced persons receiving optimized background regimens

ReferenceCitation: Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a.

family: Gulick

full_name: Roy M. Gulick

given: Roy M.

family: Fatkenheuer

full_name: Gerd Fatkenheuer

given: Gerd

family: Burnside

full_name: Robert Burnside

family: Hardy

full_name: W. David Hardy

given: W. David

family: Nelson

full_name: Mark R. Nelson

given: Mark R.

family: Goodrich

full_name: James Goodrich

given: James

family: Mukwaya

full_name: Geoffrey Mukwaya

given: Geoffrey

journal_name: JAIDS Journal of Acquired Immune Deficiency Syndromes

publisher: Ovid Technologies (Wolters Kluwer Health)

title: Five-Year Safety Evaluation of Maraviroc in HIV-1–Infected Treatment-Experienced Patients

ReferenceCitation: Hardy WD, Gulick RM, Mayer H, Fätkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82.

title: Two-Year Safety and Virologic Efficacy of Maraviroc in Treatment-Experienced Patients With CCR5-Tropic HIV-1 Infection: 96-Week Combined Analysis of MOTIVATE 1 and 2

ReferenceCitation: Fätkenheuer G, Nelson M, Lazzarin A, Konourina I, Hoepelman AI, Lampiris H, Hirschel B, Tebas P, Raffi F, Trottier B, Bellos N, Saag M, Cooper DA, Westby M, Tawadrous M, Sullivan JF, Ridgway C, Dunne MW, Felstead S, Mayer H, van der Ryst E; MOTIVATE 1 and MOTIVATE 2 Study Teams. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154.

title: Subgroup Analyses of Maraviroc in Previously Treated R5 HIV-1 Infection

ReferenceCitation: Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.

title: Maraviroc for Previously Treated Patients with R5 HIV-1 Infection

location_country:
Italy
United States
Sweden
Switzerland
Netherlands
Germany
France
Poland
Belgium
Australia
Spain
Canada
United Kingdom


title: A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

summary: The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.

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

full_name: Julia A. Beaver

given: Julia A.

family: Amiri-Kordestani

full_name: Laleh Amiri-Kordestani

given: Laleh

family: Bloomquist

full_name: Erik Bloomquist

given: Erik

family: Tang

full_name: Shenghui Tang

given: Shenghui

family: Goldberg

full_name: Kirsten B. Goldberg

given: Kirsten B.

family: Sridhara

full_name: Rajeshwari Sridhara

given: Rajeshwari

family: Ibrahim

full_name: Amna Ibrahim

given: Amna

family: Kim

full_name: Geoffrey Kim

family: Kluetz

full_name: Paul Kluetz

given: Paul

family: McKee

full_name: Amy McKee

given: Amy

family: Pazdur

full_name: Richard Pazdur

given: Richard

journal_name: Journal of Clinical Oncology

oa_host_type: repository

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

repository_institution: PubMed Central - Europe PMC

publisher: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Vahdat LT, Vrdoljak E, Gómez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.

family: Vahdat

full_name: Linda T. Vahdat

given: Linda T.

family: Vrdoljak

full_name: Eduard Vrdoljak

given: Eduard

family: Gómez

full_name: Henry Gómez

given: Henry

family: Li

full_name: Rubi Khaw Li

given: Rubi Khaw

family: Bosserman

full_name: Linda Bosserman

given: Linda

family: Sparano

full_name: Joseph A. Sparano

given: Joseph A.

family: Baselga

full_name: Jose Baselga

given: Jose

ReferenceCitation: Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.

title: Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: A pooled subset analysis of two phase III studies

ReferenceCitation: Roché H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

location_country:
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
Croatia
France
Argentina
Canada
Korea, Republic of
South Africa
Chile
Switzerland
Netherlands
Singapore
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey


title: A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant

summary: The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.

ReferenceType: result

ReferenceCitation: Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roché HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. Epub 2007 Oct 29.

family: Mukhopadhyay

full_name: Pralay Mukhopadhyay

given: Pralay

family: Valero

full_name: Vicente Valero

given: Vicente

journal_name: Journal of Geriatric Oncology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer

family: Jassem

full_name: Jacek Jassem

given: Jacek

family: Fein

full_name: Luis Fein

given: Luis

family: Karwal

full_name: Mark Karwal

given: Mark

family: Campone

full_name: Mario Campone

given: Mario

family: Peck

full_name: Ronald Peck

given: Ronald

family: Poulart

full_name: Valerie Poulart

given: Valerie

full_name: Linda Vahdat

journal_name: The Breast

oa_host_type: publisher

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

family: Roché

full_name: Henri Roché

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - Archive ouverte HAL

repositories_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

title: Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies

location_country:
Peru
Malaysia
Greece
Belgium
Taiwan
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Sweden
Philippines
Hungary
China
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Spain


title: SAINT (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke

summary: This study will determine if NXY-059 will improve recovery from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strengthen and coordination.

ReferenceCitation: Shuaib A, Lees KR, Lyden P, Grotta J, Davalos A, Davis SM, Diener HC, Ashwood T, Wasiewski WW, Emeribe U; SAINT II Trial Investigators. NXY-059 for the treatment of acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):562-71.

lead_sponsor: AstraZeneca

location_country:
Greece
Australia
Belgium
Russian Federation
Czech Republic
Taiwan
France
Poland
Slovakia
Argentina
Canada
Korea, Republic of
South Africa
Chile
Hong Kong
Switzerland
Philippines
Bulgaria
Hungary
China
Portugal
Germany
United States
United Kingdom
Austria
Brazil
Mexico
Israel
New Zealand
Spain

status_simplified: Completed


title: Randomized Phase III Trial Comparing Targretin Capsules/Carboplatin/Paclitaxel Versus Carboplatin/Paclitaxel in Chemotherapy-Naïve Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

lead_sponsor: Eisai Inc.

location_country:
Austria
Germany
France
Spain
United States
Canada

location_facility: Hematology & Oncology Associates of South Texas

location_facility: Charite Universitatsklinikum der Humboldt-Universitat zu Berlin

location_facility: Dept. of Internal Medicine, St. Nikolaus-Stiftshospital Andernach

location_facility: New York Oncology Hematology, P.C., Riverview Cancer Care Medical Associates

location_facility: Yakima Regional Cancer Care Center, Internal Medicine Associates of Yakima, Inc.

location_facility: Montana Cancer & Infectious Disease Specialists

location_facility: Kansas City Oncology and Hematology Group, Kansas City Cancer Centers

location_facility: Louisiana State University Health Sciences Center

location_facility: Pacific Coast Hematology/Oncology Medical Group, Inc.

location_facility: St. Luke's/Mountain State Tumor Institute (MSTI)

location_facility: University of Oklahoma Health Sciences Center

location_facility: Medical Group of North County, Inc., San Diego Cancer Center

location_facility: Southern California Kaiser Permanente Medical Group

location_facility: Centre Regional de Lutte contre le Cancer (CRLC), Val d'Aurelle-Paul Lamarque

location_facility: Service de Pneumology, Hopital Adulte de Brabois

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: Hematology Oncology Centers of the Northern Rockies

location_facility: Krankenhaus GroBhansdorf, Zentrum fur Pneumologie und Thoraxchirurgie

location_facility: Oncology Hematology of Lehigh Valley, PC

location_facility: Hospital de Sagunto Servicio de Oncologia

location_facility: Georgia Oncology Partners Research & Education Foundation

location_facility: Hematology-Oncology Associates of Northern NJ, PA

location_facility: Hospital Clinico Universitario, Servicio Hematologia y Oncologia

location_facility: Hematology Oncology Patient Enterprises, Center for Cancer Care

location_facility: Medical Oncology Associates of Wyoming Valley, PC

location_facility: University of Medicine & Dentistry of NJ, School of Osteopathic Medicine

location_facility: Algoma Regional Cancer Program - Sault Area Hospital

location_facility: South Shore Hematology Oncology Associates, PC

location_facility: Northwest Carolina Oncology and Hematology, P.A.

location_facility: Hospital Universitario La Fe Servicio de Oncologia

location_facility: South Florida Oncology & Hematology Consultants

location_facility: New York Presbyterian Hospital, Weill Medical College of Cornell University

location_facility: Comprehensive Cancer Care Specialists of Boca Raton

location_facility: Eastern Connecticut Hematology & Oncology

location_facility: Centre Hospitalier General de la Region Annecienne

location_facility: Columbus Community Clinical Oncology Program

location_facility: Allgemeines offentliches Krankenhaus der barmherzigen Schwestern vom Heiligen Kreuz Pneumologie

location_facility: New York Oncology Hematology, P.C., Capital District Hematology Oncology Associates

location_facility: Oncology/Hematology Associates of Central Illinois, P.C.

location_facility: Metropolitan Hematology/Oncology Medical Group

location_facility: Oncology/Hematology, Kaiser Permanente Northwest

location_facility: UCSF/Mount Zion Comprehensive Cancer Center

location_facility: Coast Hematology and Oncology Associates

location_facility: University of Cincinnati, Barrett Cancer Center

location_facility: Hospital Arnau de Villanova, Servicio de Oncologia

location_facility: Tulane University Health Sciences Center

location_facility: University of Texas, MD Anderson Cancer Center


title: Randomized Study of Rituximab (Mabthera) in Patients With Relapsed Follicular Lymphoma Prior to High-Dose Therapy as In Vivo Purging and to Maintain Remission Following High-Dose Therapy

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. It is not yet known if combination chemotherapy plus peripheral stem cell transplantation is more effective with or without rituximab for non-Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy and peripheral stem cell transplantation together with rituximab to see how well it works compared to combination chemotherapy and peripheral stem cell transplantation alone in treating patients with relapsed non-Hodgkin's lymphoma.

enrollment_type: Anticipated

ReferenceCitation: Pettengell R, Schmitz N, Gisselbrecht C, Smith G, Patton WN, Metzner B, Caballero D, Tilly H, Walewski JA, Bence-Bruckler I, To B, Geisler CH, Schots R, Kimby E, Taverna CJ, Kozák T, Dreger P, Uddin R, Ruiz de Elvira C, Goldstone AH. Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the lymphoma working party of the European group for blood and marrow transplantation. J Clin Oncol. 2013 May 1;31(13):1624-30. doi: 10.1200/JCO.2012.47.1862. Epub 2013 Apr 1.

name: Ruth Pettengell, St George's University of London; Ruzena Uddin and Carmen Ruiz de Elvira, European Group for Blood and Marrow Transplantation; Anthony H. Goldstone, University College London Hospital, London; Graeme Smith, Leeds General Infirmary, Leeds, United Kingdom; Norbert Schmitz, Asklepios Hospital St Georg, Hamburg; Bernd Metzner, Klinikum Oldenburg, Oldenburg; Peter Dreger, University of Heidelberg, Heidelberg, Germany; Christian Gisselbrecht, Hospital Saint Louis, Paris; Herve Tilly, Centre...

family: Pettengell

full_name: Ruth Pettengell

given: Ruth

family: Schmitz

full_name: Norbert Schmitz

given: Norbert

family: Gisselbrecht

full_name: Christian Gisselbrecht

given: Christian

family: Smith

full_name: Graeme Smith

given: Graeme

family: Patton

full_name: William N. Patton

given: William N.

family: Metzner

full_name: Bernd Metzner

given: Bernd

family: Caballero

full_name: Dolores Caballero

given: Dolores

family: Tilly

full_name: Herve Tilly

given: Herve

family: Walewski

full_name: Jan A. Walewski

given: Jan A.

family: Bence-Bruckler

full_name: Isabelle Bence-Bruckler

given: Isabelle

family: To

full_name: Bik To

given: Bik

family: Geisler

full_name: Christian H. Geisler

given: Christian H.

family: Schots

full_name: Rik Schots

given: Rik

family: Kimby

full_name: Eva Kimby

given: Eva

family: Taverna

full_name: Christian J. Taverna

given: Christian J.

family: Kozák

full_name: Tomáš Kozák

given: Tomáš

family: Dreger

full_name: Peter Dreger

given: Peter

family: Uddin

full_name: Ruzena Uddin

given: Ruzena

family: Ruiz de Elvira

full_name: Carmen Ruiz de Elvira

given: Carmen

family: Goldstone

full_name: Anthony H. Goldstone

given: Anthony H.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Rituximab Purging and/or Maintenance in Patients Undergoing Autologous Transplantation for Relapsed Follicular Lymphoma: A Prospective Randomized Trial From the Lymphoma Working Party of the European Group for Blood and Marrow Transplantation

lead_sponsor: EBMT Solid Tumors Working Party

location_country:
Austria
Sweden
Switzerland
Spain
United Kingdom
Germany
France
Poland
Israel
Australia
Belgium
New Zealand
Portugal
Turkey
Denmark
Canada
Czech Republic

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Karolinska University Hospital - Huddinge

location_facility: Centre Hospitalier Universitaire de Rennes

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Centre Hospitalier Universitaire Bretonneau de Tours

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

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

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Hospital Universitario Central de Asturias

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Singleton Hospital of the Swansea NHS Trust

location_facility: Clinical Trials and Research Unit of the University of Leeds

location_facility: Southampton University Hospital NHS Trust

location_facility: Rotherham District General Hospital - NHS Trust

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

location_facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Southwest German Cancer Center at Eberhard-Karls-University

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Hospital Clinico Universitario Lozano Blesa

location_facility: Royal Liverpool and Broadgreen Hospitals NHS Trust

intervention_type: Procedure


title: Phase II Study of Fludarabine + Idarubicin + Aracytine in Refractory or Relapsed ALL in Children

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have relapsed or refractory acute lymphocytic leukemia.

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

location_country: Belgium France Portugal

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Centre Hospitalier Regional de la Citadelle


title: IDA VS MTZ IN INDUCTION AND INTENSIFICATION TREATMENT OF AML OR MDS IN CHILDREN, A PHASE III RANDOMIZED STUDY

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which regimen of combination chemotherapy is more effective for acute myeloid leukemia or myelodysplastic syndrome.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating children who have newly diagnosed acute myeloid leukemia or myelodysplastic syndrome.

ReferenceCitation: Brunet AS, Ploton C, Galambrun C, Pondarré C, Pages MP, Bleyzac N, Freydière AM, Barbé G, Bertrand Y. Low incidence of sepsis due to viridans streptococci in a ten-year retrospective study of pediatric acute myeloid leukemia. Pediatr Blood Cancer. 2006 Nov;47(6):765-72.

ReferenceCitation: Entz-Werle N, Suciu S, van der Werff ten Bosch J, Vilmer E, Bertrand Y, Benoit Y, Margueritte G, Plouvier E, Boutard P, Vandecruys E, Ferster A, Lutz P, Uyttebroeck A, Hoyoux C, Thyss A, Rialland X, Norton L, Pages MP, Philippe N, Otten J, Behar C; EORTC Children Leukemia Group. Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogeneic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group report. Leukemia. 2005 Dec;19(12):2072-81.

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

intervention_type: Radiation


type: Other Identifier

type: Registry Identifier

title: A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)

summary:
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.

Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.

The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.

Participants must have a study partner, who is willing to take part in the study.

Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.

A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Finland
Greece
Australia
Belgium
Russian Federation
Denmark
Ukraine
France
Japan
Poland
Slovakia
Norway
Argentina
Canada
Slovenia
Korea, Republic of
South Africa
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey

status_simplified: Ongoing


title: A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of the study is to compare progression-free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab in combination with placebo) as assessed by investigators according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) and to compare overall survival (OS) between Arm A and Arm B.

lead_sponsor: BeiGene

location_country:
Netherlands
Spain
Germany
France
Georgia
Australia
Russian Federation
China
Turkey
United States
Korea, Republic of
Taiwan
Ukraine

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: Public Non-profit Institution "Kyiv City Clinical Oncology Center"

location_facility: Communal Non-profit Institution of Kharkiv Regional Council "Regional Clinical Specialized Health Di

location_facility: The Second Hospital of Anhui Medical University

location_facility: Stichting Het Nederlands Kanker Instituut - Antoni Van Leeuwenhoek Ziekenhuis

location_facility: National Taiwan University Hospital Yunlin Branch

location_facility: The First Affiliated Hospital of Zhengfzhou University

location_facility: Cancer Hospital of Guangxi Zhuang Autonomous Region

location_facility: Hospital Regional Universitario de Malaga

location_facility: Klinikum Der Universitat muenchen - Campus Innenstadt

location_facility: The Smorodintsev Research Institute of Influenze

location_facility: Regional Budgetary Healthcare Institution "G.E. Ostroverkhov Kursk Oncology Scientific and Clinical"

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Complexo Hospitalario Universitario de Ourense

location_facility: The First Affiliated Hospital of Zhengzhou University

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

location_facility: Tianjin Medical University General Hospital

location_facility: State Budgetary Healthcare Institution - Nizhny Novgorod Regional Clinical Oncology Dispensary

location_facility: Calvary Mater Newcastle, Medical Oncology Trial Unit, Edith Street

location_facility: Acad. Fridon Todua medical Center LTD - Research Institute of Clinical Medicine LTD

location_facility: Affiliated Zhongshan Hospital of Fudan University

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: HealthPartners Institute - MMCORC (Metro Minnesota Community Oncology Research Consortium)

location_facility: Timi - Tbilisi Institute of Medicine LTD

location_facility: West Penn Hospital (Allegheny Health Network)

location_facility: The People's Hospital of Guangxi Zhuang Autonomous Region

location_facility: Federal State Budgetary Educational Institution of Higher Education "National Research Ogarev Morodov"

location_facility: Chu Tours - Hopital Bretonneau - Service Pneumologie 2

location_facility: State Budgetary Healthcare Institution-Chelyabinsk Regional Clinical Center of Oncology and Nuclear

location_facility: State Budgetary Healthcare Institution-Regional Oncology Dispensary Number 2

location_facility: The Second Affiliated Hospital of Soochow University

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

location_facility: Private Medical Institution "Evromedservis"

location_facility: UAB O'Neal Comprehensive Cancer Center at University of Alabama at Birmingham

location_facility: State Budgetary Healthcare Institution "City Clinical Hospital #1"

location_facility: Hospices Civils de Lyon-Hôpital de la Croix Rousse

location_facility: The Affiliated Hospital of Qingdao University

location_facility: FSBI "National Medical Research Center for Oncology N.A.N.N. Petrov" of the MOH of the RF

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: BIH of OMSK Region "Clinical Oncology Dispensary"

location_facility: Necmettin Erbakan University Selcuklu Faculty of Medicine

location_facility: Hospices Civils de Lyon- Centre Hospitalier Lyon Sud

location_facility: Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

location_facility: Universitaetsklinikum Ulm, Innere Medizin III

location_facility: The First Affiliated Hospital of Soochow University

location_facility: The Fourth Affiliated Hospital Zhejinaang University School of Medicine

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: West Jefferson Medical Center Cancer Center (University Medical Center New Orleans)

location_facility: Israel-Georgian Medical Research Clinic Helsicore LTD

location_facility: Affiliated Hospital of North Sichuan Medical College

location_facility: Beijing Chest Hospital, Capital Medical University

location_facility: State Autonomous Healthcare Institution - Republican Clinical Oncological Dispensary of the Republic

location_facility: Agaplesion Diakonieklinikum Rotenburg Gemeinnutzige GMBH

location_facility: Klinikum Ludwigshafen, Medizinische Klinik A

location_facility: Komunalne Nekomertsiine Pidryiemstvo Oblasnyi Tsentr Onkolohii

location_facility: Onkologische Scwerpunktpraxis Leer - Emden

location_facility: Daping Hospital, Third Military Medical University

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: Arkhangelsk Regional Clinical Oncological Dispensary

location_facility: Istanbul Medeniyet Uni Goztepe Training & Res Hosp

location_facility: Lviv State Regional Oncology Treatment and Diagnostic Center

location_facility: FSBI "Clinical Research and Practical Center for Specialized Medical Care (Oncology)"

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: State Budgetary Healthcare Institution - Samara Regional Clinical Oncology Dispensary

location_facility: Medical Center "Verum" Limited Liability Company

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Private Healthcare Institution - Clinical Hospital Russian Railways - Medicine of the City of St. Petersburg

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Hospital Universitario Insularde Gran Canaria

location_facility: Multiprofile Clinic Consilium Medula LTD

location_facility: Volyn Regional Medical Center of Oncology

location_facility: Communal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical Oncological Dispensar

location_facility: Xiangya Hospital of Central South University

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Baskent University Practice and Research Hospital Adana - Medical Oncology Department

location_facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: Affiliated Cancer Hospital of Xinjiang Medical University

location_facility: Hospital Universitario Nuestra Señora de Valme

location_facility: Fujian Medical University Union Hospital

location_facility: Hospices Civils de Lyon- Hopital Louis Pradel

location_facility: Komunalne Nekomertsiine Pidryiemstvo - Miska Klinichna Likarnia #4

location_facility: Zakarpatska Regional Clinical Oncological Center

location_facility: Centre Hospitalier de la Cote Basque - Saint Léon - Service de Pneumologie


title: Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects ≤70 Years With Previously Untreated Non-GCB DLBCL

acronym: ESCALADE

summary: Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP in subjects ≤70 years of age with previously untreated non-germinal center diffuse large B-cell lymphoma.

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

lead_sponsor: Acerta Pharma BV

location_country:
Australia
Belgium
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Canada
Korea, Republic of
China
Portugal
Germany
United States
Italy
Austria
Brazil
Mexico
Czechia
Israel
Spain
Turkey


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

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Peru
Malaysia
Romania
Australia
Russian Federation
Taiwan
India
Croatia
France
Poland
Slovakia
Norway
Argentina
Slovenia
Korea, Republic of
Colombia
South Africa
Switzerland
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey

location_facility: Fort Wayne Medical Oncology/Hematology, Inc. Jefferson Blvd

location_facility: Florida Cancer Specialists Dept of Oncology (2)

location_facility: University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2

location_facility: Northwest Medical Specialties Northwest Medical - Puyallup

location_facility: Tennessee Oncology Tennessee Oncology (3)

location_facility: Comprehensive Blood and Cancer Center Dept. of CBCC (2)

location_facility: University of Pittsburgh Cancer Institute Cancer Pavilion, 5th floor

location_facility: University of Texas MD Anderson Cancer Center

location_facility: University of Illinois Cancer Center at Chicago

location_facility: Comprehensive Cancer Centers of Nevada CCC of Nevada (1)

location_facility: Cleveland Clinic Foundation Taussig Cancer Center

location_facility: Chattanooga Oncology and Hematology Assoicates, PC Tennessee Oncology Chattanooga

location_facility: Texas Oncology PA Dallas Presbyterian Hospital SC

location_facility: Research Medical Center HCA Midwest Division

location_facility: University of California at Los Angeles Santa Monica Location

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

location_facility: Sinai Hospital of Baltimore Dept of Sinai Hospital - 2

location_facility: Florida Cancer Specialists FL Cancer Specialists

location_facility: Cancer Care Associates Medical Group Center

type: EudraCT Number

source: euctr

title: A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

summary: The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)


ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

lead_sponsor: Sanofi

location_country:
Greece
Romania
Belgium
Australia
Russian Federation
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Chile
Netherlands
Bulgaria
Hungary
China
Portugal
Germany
United States
Italy
Brazil
Mexico
Israel
Spain
Turkey

location_facility:
Investigational Site Number :0760016
Investigational Site Number :6420004
Investigational Site Number :1560006
Investigational Site Number :0320005
Investigational Site Number :3800003
Investigational Site Number :0320002
Investigational Site Number :7240001
Investigational Site Number :2500012
Investigational Site Number :0320001
Investigational Site Number :6420009
Investigational Site Number :3920008
Investigational Site Number :0320003
Investigational Site Number :8400029
Investigational Site Number :1560050
Investigational Site Number :3000004
Investigational Site Number :7240009
Investigational Site Number :1560038
Investigational Site Number :3480003
Investigational Site Number :8400019
Investigational Site Number :0320014
Investigational Site Number :1560017
Investigational Site Number :2500011
Investigational Site Number :0360002
Investigational Site Number :3920011
Investigational Site Number :7240005
Investigational Site Number :7920009
Investigational Site Number :3920007
Investigational Site Number :6160004
Investigational Site Number :0320008
Investigational Site Number :1000008
Investigational Site Number :1560040
Investigational Site Number :7920005
Investigational Site Number :4840004
Investigational Site Number :8400004
Investigational Site Number :3920005
Investigational Site Number :3480008
Investigational Site Number :6420005
Investigational Site Number :3000001
Investigational Site Number :3920014
Investigational Site Number :6430001
Investigational Site Number :0760018
Investigational Site Number :3920012
Investigational Site Number :5280005
Investigational Site Number :1560016
Investigational Site Number :0360003
Investigational Site Number :3920013
Investigational Site Number :4100003
Investigational Site Number :8400027
Investigational Site Number :8400031
Investigational Site Number :2500007
Investigational Site Number :3480006
Investigational Site Number :3480004
Investigational Site Number :1560024
Investigational Site Number :1560041
Investigational Site Number :3480001
Investigational Site Number :1560032
Investigational Site Number :1000004
Investigational Site Number :1000010
Investigational Site Number :1520006
Investigational Site Number :6200005
Investigational Site Number :1520009
Investigational Site Number :1520005
Investigational Site Number :6420002
Investigational Site Number :2500004
Investigational Site Number :7240002
Investigational Site Number :1560009
Investigational Site Number :1560035
Investigational Site Number :1560043
Investigational Site Number :7240006
Investigational Site Number :1560001
Investigational Site Number :6200001
Investigational Site Number :7240010
Investigational Site Number :3480005
Investigational Site Number :5280004
Investigational Site Number :0320009
Investigational Site Number :2760001
Investigational Site Number :3480002
Investigational Site Number :2760002
Investigational Site Number :3920016
Investigational Site Number :7240008
Investigational Site Number :6420011
Investigational Site Number :0760002
Investigational Site Number :2500014
Investigational Site Number :1560036
Investigational Site Number :7920004
Investigational Site Number :3760001
Investigational Site Number :1000002
Investigational Site Number :6420010
Investigational Site Number :8400026
Investigational Site Number :4100006
Investigational Site Number :0760012
Investigational Site Number :5280003
Investigational Site Number :8400020
Investigational Site Number :0760023
Investigational Site Number :3920003
Investigational Site Number :4100001
Investigational Site Number :3800002
Investigational Site Number :3000003
Investigational Site Number :3920010
Investigational Site Number :8400007
Investigational Site Number :0560001
Investigational Site Number :2500005
Investigational Site Number :7920008
Investigational Site Number :2500013
Investigational Site Number :1560023
Investigational Site Number :0760020
Investigational Site Number :1560044
Investigational Site Number :2500001
Investigational Site Number :3800005
Investigational Site Number :8400003
Investigational Site Number :7240004
Investigational Site Number :4100005
Investigational Site Number :7920001
Investigational Site Number :2500009
Investigational Site Number :8400024
Investigational Site Number :0560003
Investigational Site Number :7920006
Investigational Site Number :0560005
Investigational Site Number :1560010
Investigational Site Number :1560033
Investigational Site Number :1560015
Investigational Site Number :3760002
Investigational Site Number :8400030
Investigational Site Number :1560039
Investigational Site Number :1520004
Investigational Site Number :2500010
Investigational Site Number :1560025
Investigational Site Number :1000003
Investigational Site Number :1560018
Investigational Site Number :3000005
Investigational Site Number :3920017
Investigational Site Number :6430003
Investigational Site Number :6200002
Investigational Site Number :3920015
Investigational Site Number :1560029
Investigational Site Number :6160001
Investigational Site Number :1560014
Investigational Site Number :7920003
Investigational Site Number :8400028
Investigational Site Number :4840002
Investigational Site Number :0560004
Investigational Site Number :1560030
Investigational Site Number :1520002
Investigational Site Number :0760001
Investigational Site Number :3000002
Investigational Site Number :1520001
Investigational Site Number :1000005
Investigational Site Number :3920006
Investigational Site Number :0760010
Investigational Site Number :4100007
Investigational Site Number :2500006
Investigational Site Number :6200004
Investigational Site Number :7920007
Investigational Site Number :1520007
Investigational Site Number :1240003
Investigational Site Number :3800001
Investigational Site Number :1560042
Investigational Site Number :1560028
Investigational Site Number :1000007
Investigational Site Number :0320012
Investigational Site Number :1560045
Investigational Site Number :8400025
Investigational Site Number :3920002
Investigational Site Number :8400016
Investigational Site Number :4100004
Investigational Site Number :6420003
Investigational Site Number :0760005
Investigational Site Number :1560037
Investigational Site Number :3480007
Investigational Site Number :3920018
Investigational Site Number :4100008
Investigational Site Number :0760007
Investigational Site Number :0760022
Investigational Site Number :1000001
Investigational Site Number :1560005
Investigational Site Number :3920009
Investigational Site Number :6200006
Investigational Site Number :6420008
Investigational Site Number :6430004
Investigational Site Number :8400014
Investigational Site Number :1560047
Investigational Site Number :1560034
Investigational Site Number :7240106
Investigational Site Number :1560026
Investigational Site Number :4840003
Investigational Site Number :3920004
Investigational Site Number :7920002
Investigational Site Number :1560004
Investigational Site Number :1560012
Investigational Site Number :3920001
Investigational Site Number :7240011
Investigational Site Number :0360001
Investigational Site Number :0320004
Investigational Site Number :2500003
Investigational Site Number :3760003
Investigational Site Number :3800004
Investigational Site Number :8400017
Investigational Site Number :2500008
Investigational Site Number :7240007
Investigational Site Number :2760003
Investigational Site Number :8400013
Investigational Site Number :2500002
Investigational Site Number :1560048
Investigational Site Number :8400015
Investigational Site Number :1560019
Investigational Site Number :8400006
Investigational Site Number :3800006
Investigational Site Number :1560027
Investigational Site Number :1560021
Investigational Site Number :0560002
Investigational Site Number :1560011
Investigational Site Number :0760008

title: Randomized, Open Label Phase 3 Study of SAR408701 Versus Docetaxel in Previously Treated Metastatic Non- Squamous Non-Small Cell Lung Cancer Patients With CEACAM5 Positive Tumors

summary:
Primary Objectives:

Study is designed with two primary endpoints that will be analyzed on randomized participants at the time of the cutoff date for each given analysis (progression free survival [PFS] and overall survival [OS]).

Study success is defined either on PFS or OS

The primary objective is to determine whether tusamitamab ravtansine improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 ≥2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI).
The primary objective is to determine whether tusamitamab ravtansine improves the overall survival (OS) when compared with docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 ≥2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor.

Secondary Objectives:

To compare the objective response rate (ORR) of tusamitamab ravtansine with docetaxel
To compare the health related quality of life (HRQOL) of tusamitamab ravtansine with docetaxel
To evaluate the safety of tusamitamab ravtansine compared to docetaxel
To assess the duration of response (DOR) of tusamitamab ravtansine with docetaxel


title: A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

acronym: CheckMate 9DW

summary: The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

lead_sponsor: Bristol-Myers Squibb

location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Chile
Hong Kong
Switzerland
Singapore
Puerto Rico
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
New Zealand
Spain

location_facility: Hospital Clinico de la Universidad De Chile

location_facility: N.N. Blokhin National Medical Research Center of Oncology

location_facility: S.C. Oncocenter Oncologie Clinica S.R.L.

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: The Liver Institute at Methodist Dallas Medical Center

location_facility: Fundacion Favaloro Para La Docencia E Investigacion

location_facility: Hospital Clinic I Provincialde Barcelona

location_facility: Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon

location_facility: Policlinico Universitario A. Gemelli IRCCS

location_facility: Real E Benemerita Associacao Portuguesa de Beneficencia

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: AULSS 8 Berica Ospedale san Bortolo UOC Oncologia

location_facility: Universtitaetsklinikum Essen Medizinisches Zentrum I

location_facility: Centro De Pesquisa Clinica do Hospital Escola

location_facility: Centro Para La Atencion Integral Del Paciente Oncologico

location_facility: Institut Catala dOncologia ICO - Hospital Duran i Reynals Location

location_facility: Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico

location_facility: The University of Arizona Cancer Center - North

location_facility: University Hospital Kyoto Prefectural University Of Medicine

location_facility: Instituto do Cancer do Estado de Sao Paulo ICESP

location_facility: SBHI of Stavropol Region Pyatigorsk Oncology Dispensary

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

location_facility: Allegheny General Hospital AGH - Allegheny Cancer Center

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS

location_facility: Instituto De Assistencia Medica Ao Servidor Publico Estadual

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carita

location_facility: Bradford Hill Centro de Investigacion Clinica

location_facility: Pan American Center for Oncology Trials, LLC

location_facility: Centro de Investigaciones Clinicas Vina del Mar

location_facility: Sociedad de Investigaciones Medicas - SIM

location_facility: Ensino e Terapia de Inovacao -Clinica AMO

location_facility: Centre Hospitalier Universitaire Caen Normandie

location_facility: A.O.U.Senese - Policl.S.Maria alle Scotte

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: Medizinische Universitat Wien AKH - Allgemeines Krankenhaus Wien

location_facility: M Sklodowska Curie Memorial Cancer Center

location_facility: Universite Libre de Bruxelles (ULB) - Hopital Erasme

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Fondazione del Piemonte per lOncologia (IRCCS)

location_facility: Instituto Medico Especialazado Alexander Fleming

location_facility: Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud

location_facility: KEM - Evang. Kliniken Essen-Mitte/Huyssens-Stift gGmbH

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: State Budget Healthcare Institution of Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary

location_facility: Centro de Pesquisa Fundacao Dr. Amaral Carvalho

location_facility: Imperial College Hospital - Hammersmith Hospital

location_facility: Prof Dr I Chiricuta Institute of Oncology


ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Jordan
Malaysia
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Sweden
Netherlands
Bulgaria
Hungary
Ireland
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Czechia
Israel
New Zealand
Spain
Turkey
Latvia

acronym: QUASAR

location_facility: Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways

location_facility: University Clinical Hospital Center Dr Dragisa Misovic- Dedi

location_facility: The Second Affiliated Hospital of Zhejiang University

location_facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center

location_facility: Mersin University Medical Faculty Hospital

location_facility: Northshore Gastroenterology Research, LLC

location_facility: MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

location_facility: GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

location_facility: Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.

location_facility: Gastroenterology Associates of Tidewater

location_facility: Dışkapı Yıldırım Beyazıd Training and Research Hospital

location_facility: Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine

location_facility: Hospital General de Agudos José Maria Ramos Mejía

location_facility: Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont

location_facility: Gastroenterologist Lafayette - Jacque F. Noel III MD

location_facility: Sai Clinic, Gastrointestinal and Protology Divisions

location_facility: Istituto Clinico Humanitas Rozzano, IRCCS

location_facility: Semmelweis Egyetem, Ii. Belgyogyaszati Klinika

location_facility: El Paso Integrated Physicians Group, P.A.

location_facility: GUZ of Moscow City Clinical Hospital #24

location_facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital

location_facility: NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: The Second Hospital Affiliated To Suzhou University

location_facility: Hadassah Hebrew University Medical Center

location_facility: Pusat Perubatan Universiti Kebangsaan Malaysia

location_facility: The First Affiliated Hospital of NanChang University

location_facility: First Affiliated Hospital of Gannan Medical University

location_facility: Shengjing Hospital of China Medical University

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvostudomanyi Kar, Belgyogyaszati Klinika

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E

location_facility: Södra Älvsborgs Sjukhus, Kirurgkliniken, Borås

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: UF Health Jacksonville Gastroenterology- Emerson

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Budgetary Healthcare Intitution of Omsk Region

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

location_facility: Illinois Gastroenterology Institute, S.C.

location_facility: Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

location_facility: Gastromed Kralisz Romatowski Stachurska Sp. j.

location_facility: United Health Services Hospitals Office of Clinical Trials

location_facility: Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Capital Medical University, Beijing Friendship Hospital

location_facility: Chang-Gung Memorial Hospital, LinKou Branch

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh'

location_facility: Japan Community Health Care Organization Saitama Medical Center

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

location_facility: Zentrum für Gastroenterologie Saar MVZ GmbH

location_facility: Tongji Hospital, Tongji Medical College of HUST

location_facility: Gastroenterology Department GASTROMART s.r.o.

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

location_facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne

location_facility: All-Russian Center of Emergency and Radiation Medicine MCRS

location_facility: Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS

location_facility: Ankara Gulhane Training and Research Hospital

location_facility: Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

location_facility: University Hospital in Bratislava, St. Cyril and Method Hospital

location_facility: The Second Hospital To Dalian Medical University

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

location_facility: West China Hospital of Sichuan University

location_facility: Gastroenterology Associates of Orangeburg, SC

location_facility: UFRJ-Hospital Universitário Clementino Fraga Filho

location_facility: CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao

location_facility: CINME - Centro de Investigaciones Metabolicas

location_facility: Gastroenterologie, s.r.o., Hradec Kralove

location_facility: The first affiliated hospital of suzhou University

location_facility: The second Xiangya Hospital of Central South University

location_facility: CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

location_facility: Universidade Federal Do Piaui - Campos Universitario

location_facility: Centro de Investigaciones Medicas Mar Del Plata

location_facility: Medical Center Ltd 'Health Clinic', Department Of General Therapy

location_facility: Hospital de Alta Complejidad en Red 'El Cruce'

location_facility: GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii

location_facility: The Hospital of Hyogo College of Medicine

location_facility: University of North Carolina at Chapel Hill

location_facility: Seoul National University Bundang Hospital

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Irkutsk State Medical Academy of Postgraduate Education

location_facility: Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway

location_facility: GIRI Gastrointestinal Research Institute

location_facility: Frankston Gastrointestinal and Liver Specialists

location_facility: Sumy State University, Sumy Regional Clinical Hospital

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: University Hospital Kyoto Perfectural University of Medicine

location_facility: Gastroenterolgy Associates of Central GA

location_facility: Fondazione Policlinico Gemelli Università Cattolica

location_facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

location_facility: SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine'

location_facility: The Third Xiangya Hospital of Central Sourth University

location_facility: The 1st affiliated hospital of Anhui Medical University

location_facility: Tianjin Medical University General Hospital

location_facility: St.Marianna University School of Medicine

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: China-Japan Union Hospital of Jilin University

location_facility: Universitaetsklinikum Charite, Campus Virchow Klinikum

location_facility: Severance Hospital, Yonsei University Health System

location_facility: First Affiliated Hospital of Kunming Medical Unversity

location_facility: Azienda Ospedaliera G.Salvini Ospedale di Rho

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Accout Center, s.r.o., Gastroenterologická ambulancia

location_facility: Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov'

location_facility: Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov

location_facility: Medical corporation Kokikai Tsujinaka Hospital Kashiwanoha

location_facility: National Hospital Organization Kochi National Hospital

location_facility: University Hospital in Bratislava, Ruzinov Hospital

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Universitätsklinikum Salzburg - Landeskrankenhaus

location_facility: NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways'

location_facility: Harmony Medical Research Institute, Inc.

location_facility: Asclepiades - interna a gastroenterologie s.r.o

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Toronto Immune & Digestive Health Institute Inc.

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: National Hospital Organization Higashi Ohmi General Medical Center

title: A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

summary: The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).


ReferenceCitation: EINSTEIN-PE Investigators, Büller HR, Prins MH, Lensin AW, Decousus H, Jacobson BF, Minar E, Chlumsky J, Verhamme P, Wells P, Agnelli G, Cohen A, Berkowitz SD, Bounameaux H, Davidson BL, Misselwitz F, Gallus AS, Raskob GE, Schellong S, Segers A. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012 Apr 5;366(14):1287-97. doi: 10.1056/NEJMoa1113572. Epub 2012 Mar 26.

journal_name: New England Journal of Medicine

repository_institution: University of Geneva - Archive ouverte UNIGE

publisher: Massachusetts Medical Society

publisher_dissemination: Massachusetts Medical Society

publisher_group: Massachusetts Medical Society

publisher_normalized: Massachusetts Medical Society

title: Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism

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

family: Prins

full_name: Martin H Prins

given: Martin H

family: Lensing

full_name: Anthonie WA Lensing

given: Anthonie WA

currency_apc_doaj: GBP

journal_name: Thrombosis Journal

license: cc-by

license_normalized: cc-by

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

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

family: Bauersachs

full_name: Rupert Bauersachs

given: Rupert

family: van Bellen

full_name: Bonno van Bellen

given: Bonno

family: Bounameaux

full_name: Henri Bounameaux

given: Henri

family: Brighton

full_name: Timothy A Brighton

given: Timothy A

family: Cohen

full_name: Alexander T Cohen

given: Alexander T

family: Davidson

full_name: Bruce L Davidson

given: Bruce L

family: Decousus

full_name: Hervé Decousus

given: Hervé

family: Raskob

full_name: Gary E Raskob

given: Gary E

family: Berkowitz

full_name: Scott D Berkowitz

given: Scott D

family: Wells

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

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

name:
Hospital Beneficência Portuguesa
São PauloBrazil

name:
University of Maastricht
MaastrichtThe Netherlands

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

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

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

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

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

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

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

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

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

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


full_name: Alexander Cohen

given: Alexander

family: Dobromirski

full_name: Mark Dobromirski

given: Mark

journal_name: Thrombosis and Haemostasis

publisher: Georg Thieme Verlag KG

publisher_dissemination: Georg Thieme

publisher_group: Georg Thieme

publisher_normalized: Georg Thieme

title: The use of rivaroxaban for short- and long-term treatment of venous thromboembolism

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

title: Oral Rivaroxaban for Symptomatic Venous Thromboembolism

ReferenceCitation: Wells PS, Prins MH, Levitan B, Beyer-Westendorf J, Brighton TA, Bounameaux H, Cohen AT, Davidson BL, Prandoni P, Raskob GE, Yuan Z, Katz EG, Gebel M, Lensing AWA. Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension. Chest. 2016 Nov;150(5):1059-1068. doi: 10.1016/j.chest.2016.05.023. Epub 2016 Jun 1.

full_name: Philip S. Wells

given: Philip S.

full_name: Martin H. Prins

given: Martin H.

family: Levitan

full_name: Bennett Levitan

given: Bennett

family: Beyer-Westendorf

full_name: Jan Beyer-Westendorf

given: Jan

full_name: Timothy A. Brighton

given: Timothy A.

full_name: Alexander T. Cohen

given: Alexander T.

full_name: Bruce L. Davidson

given: Bruce L.

family: Prandoni

full_name: Paolo Prandoni

given: Paolo

full_name: Gary E. Raskob

given: Gary E.

family: Yuan

full_name: Zhong Yuan

given: Zhong

family: Katz

full_name: Eva G. Katz

given: Eva G.

family: Gebel

full_name: Martin Gebel

given: Martin

full_name: Anthonie W.A. Lensing

given: Anthonie W.A.

journal_name: Chest

full_name: Philip S Wells

given: Philip S

title: Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy

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

title: Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study

summary: This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).


title: A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

summary: This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

ReferenceCitation: Kelley RK, W Oliver J, Hazra S, Benzaghou F, Yau T, Cheng AL, Rimassa L. Cabozantinib in combination with atezolizumab versus sorafenib in treatment-naive advanced hepatocellular carcinoma: COSMIC-312 Phase III study design. Future Oncol. 2020 Jul;16(21):1525-1536. doi: 10.2217/fon-2020-0283. Epub 2020 Jun 3.

name: UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA 94143, USA

family: Kelley

full_name: Robin Kate Kelley

given: Robin Kate

family: W Oliver

full_name: Jennifer W Oliver

given: Jennifer

family: Hazra

full_name: Saswati Hazra

given: Saswati

name: Ipsen Bioscience, Inc., Cambridge, MA, USA

family: Benzaghou

full_name: Fawzi Benzaghou

given: Fawzi

name: University of Hong Kong, Hong Kong, China

family: Yau

full_name: Thomas Yau

given: Thomas

name: National Taiwan University College of Medicine, Taipei, Taiwan

family: Cheng

full_name: Ann-Lii Cheng

given: Ann-Lii

name: Medical Oncology & Hematology Unit, Humanitas Cancer Center, Humanitas Clinical & Research Center, IRCCS, Rozzano, Milan, Italy

name: Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy

family: Rimassa

full_name: Lorenza Rimassa

given: Lorenza

journal_name: Future Oncology

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Exelixis

location_country:
Romania
Australia
Belgium
Russian Federation
Taiwan
Ukraine
France
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Hong Kong
Netherlands
Philippines
Switzerland
Singapore
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Israel
Georgia
New Zealand
Spain
Turkey

location_facility:
Exelixis Clinical Site #44
Exelixis Clinical Site #125
Exelixis Clinical Site #106
Exelixis Clinical Site #161
Exelixis Clinical Site #147
Exelixis Clinical Site #4
Exelixis Clinical Site #45
Exelixis Clinical Site #173
Exelixis Clinical Site #86
Exelixis Clinical Site #230
Exelixis Clinical Site #19
Exelixis Clinical Site #156
Exelixis Clinical Site #3
Exelixis Clinical Site #177
Exelixis Clinical Site #146
Exelixis Clinical Site #58
Exelixis Clinical Site #123
Exelixis Clinical Site #178
Exelixis Clinical Site #205
Exelixis Clinical Site #164
Exelixis Clinical Site #75
Exelixis Clinical Site #13
Exelixis Clinical Site #219
Exelixis Clinical Site #169
Exelixis Clinical Site #7
Exelixis Clinical Site #48
Exelixis Clinical Site #77
Exelixis Clinical Site #136
Exelixis Clinical Site #159
Exelixis Clinical Site #81
Exelixis Clinical Site #112
Exelixis Clinical Site #162
Exelixis Clinical Site #122
Exelixis Clinical Site #8
Exelixis Clinical Site #214
Exelixis Clinical Site #170
Exelixis Clinical Site #206
Exelixis Clinical Site #90
Exelixis Clinical Site #181
Exelixis Clinical Site #134
Exelixis Clinical Site #143
Exelixis Clinical Site #196
Exelixis Clinical Site #172
Exelixis Clinical Site #211
Exelixis Clinical Site #203
Exelixis Clinical Site #119
Exelixis Clinical Site #145
Exelixis Clinical Site #39
Exelixis Clinical Site #98
Exelixis Clinical Site #175
Exelixis Clinical Site #130
Exelixis Clinical Site #213
Exelixis Clinical Site #14
Exelixis Clinical Site #60
Exelixis Clinical Site #9
Exelixis Clinical Site #30
Exelixis Clinical Site #165
Exelixis Clinical Site #101
Exelixis Clinical Site #216
Exelixis Clinical Site #5
Exelixis Clinical Site #237
Exelixis Clinical Site #65
Exelixis Clinical Site #34
Exelixis Clinical Site #22
Exelixis Clinical Site #94
Exelixis Clinical Site #87
Exelixis Clinical Site #111
Exelixis Clinical Site #28
Exelixis Clinical Site #105
Exelixis Clinical Site #6
Exelixis Clinical Site #83
Exelixis Clinical Site #236
Exelixis Clinical Site #50
Exelixis Clinical Site #103
Exelixis Clinical Site #107
Exelixis Clinical Site #191
Exelixis Clinical Site #96
Exelixis Clinical Site #174
Exelixis Clinical Site #208
Exelixis Clinical Site #198
Exelixis Clinical Site #200
Exelixis Clinical Site #31
Exelixis Clinical Site #185
Exelixis Clinical Site #118
Exelixis Clinical Site #66
Exelixis Clinical Site #197
Exelixis Clinical Site #204
Exelixis Clinical Site #110
Exelixis Clinical Site #176
Exelixis Clinical Site #2
Exelixis Clinical Site #56
Exelixis Clinical Site #79
Exelixis Clinical Site #142
Exelixis Clinical Site #166
Exelixis Clinical Site #167
Exelixis Clinical Site #168
Exelixis Clinical Site #189
Exelixis Clinical Site #193
Exelixis Clinical Site #171
Exelixis Clinical Site #215
Exelixis Clinical Site #132
Exelixis Clinical Site #25
Exelixis Clinical Site #97
Exelixis Clinical Site #157
Exelixis Clinical Site #68
Exelixis Clinical Site #33
Exelixis Clinical Site #234
Exelixis Clinical Site #63
Exelixis Clinical Site #150
Exelixis Clinical Site #231
Exelixis Clinical Site #26
Exelixis Clinical Site #16
Exelixis Clinical Site #140
Exelixis Clinical Site #93
Exelixis Clinical Site #201
Exelixis Clinical Site #158
Exelixis Clinical Site #41
Exelixis Clinical Site #187
Exelixis Clinical Site #202
Exelixis Clinical Site #20
Exelixis Clinical Site #92
Exelixis Clinical Site #80
Exelixis Clinical Site #76
Exelixis Clinical Site #24
Exelixis Clinical Site #139
Exelixis Clinical Site #179
Exelixis Clinical Site #227
Exelixis Clinical Site #71
Exelixis Clinical Site #116
Exelixis Clinical Site #151
Exelixis Clinical Site #89
Exelixis Clinical Site #190
Exelixis Clinical Site #235
Exelixis Clinical Site #217
Exelixis Clinical Site #69
Exelixis Clinical Site #74
Exelixis Clinical Site #40
Exelixis Clinical Site #104
Exelixis Clinical Site #43
Exelixis Clinical Site #220
Exelixis Clinical Site #114
Exelixis Clinical Site #126
Exelixis Clinical Site #18
Exelixis Clinical Site #102
Exelixis Clinical Site #29
Exelixis Clinical Site #23
Exelixis Clinical Site #188
Exelixis Clinical Site #212
Exelixis Clinical Site #148
Exelixis Clinical Site #54
Exelixis Clinical Site #144
Exelixis Clinical Site #84
Exelixis Clinical Site #12
Exelixis Clinical Site #163
Exelixis Clinical Site #47
Exelixis Clinical Site #11
Exelixis Clinical Site #46
Exelixis Clinical Site #55
Exelixis Clinical Site #229
Exelixis Clinical Site #52
Exelixis Clinical Site #207
Exelixis Clinical Site #15
Exelixis Clinical Site #78
Exelixis Clinical Site #85
Exelixis Clinical Site #192
Exelixis Clinical Site #124
Exelixis Clinical Site #82
Exelixis Clinical Site #182
Exelixis Clinical Site #194
Exelixis Clinical Site #88
Exelixis Clinical Site #233
Exelixis Clinical Site #72
Exelixis Clinical Site #210
Exelixis Clinical Site #32
Exelixis Clinical Site #99
Exelixis Clinical Site #228
Exelixis Clinical Site #120
Exelixis Clinical Site #51
Exelixis Clinical Site #49
Exelixis Clinical Site #131
Exelixis Clinical Site #36
Exelixis Clinical Site #180
Exelixis Clinical Site #10
Exelixis Clinical Site #155
Exelixis Clinical Site #225
Exelixis Clinical Site #117
Exelixis Clinical Site #232
Exelixis Clinical Site #115
Exelixis Clinical Site #59
Exelixis Clinical Site #128
Exelixis Clinical Site #121
Exelixis Clinical Site #67
Exelixis Clinical Site #53
Exelixis Clinical Site #42
Exelixis Clinical Site #138
Exelixis Clinical Site #38
Exelixis Clinical Site #218
Exelixis Clinical Site #199
Exelixis Clinical Site #223
Exelixis Clinical Site #108
Exelixis Clinical Site #195
Exelixis Clinical Site #224
Exelixis Clinical Site #129
Exelixis Clinical Site #209
Exelixis Clinical Site #184
Exelixis Clinical Site #17
Exelixis Clinical Site #221
Exelixis Clinical Site #186
Exelixis Clinical Site #1
Exelixis Clinical Site #141
Exelixis Clinical Site #21
Exelixis Clinical Site #222
Exelixis Clinical Site #226
Exelixis Clinical Site #95
Exelixis Clinical Site #61
Exelixisi Clinical Site #100
Exelixis Clinical Site #137
Exelixis Clinical Site #70
Exelixis Clinical Site #183
Exelixis Clinical Site #73
Exelixis Clinical Site #127
Exelixis Clinical Site #133
Exelixis Clinical Site #149
Exelixis Clinical Site #35
Exelixis Clinical Site #152
Exelixis Clinical Site #91
Exelixis Clinical Site #135
Exelixis Clinical Site #153
Exelixis Clinical Site #109
Exelixis Clinical Site #154
Exelixis Clinical Site #113
Exelixis Clinical Site #160
Exelixis Clinical Site #27
Exelixis Clinical Site #37
Exelixis Clinical Site #64
Exelixis Clinical Site #57
Exelixis Clinical Site #62