title: A 24-Week Randomised, Double-Blind, Parallel-Group, Multi-Centre, Active-Controlled (Metformin or Metformin Combined With Fenofibrate) Study to Evaluate the Lipid Metabolic Effects, Safety and Tolerability of Tesaglitazar Therapy in Patients With Type 2 Diabetes and Low HDL-Cholesterol on a Fixed Background Therapy With a Statin

summary: This is a 24-week study to determine the lipid metabolic effects, safety, and tolerability of tesaglitazar compared with metformin and metformin in combination with fenofibrate in patients with type 2 diabetes and low high-density lipoprotein cholesterol (HDL-C). Improvement in dyslipidemia will be evaluated. The study comprises a 2-week enrollment period, 6-week run-in and a 24-week randomized, double blind, parallel group, multi-center, active controlled (metformin with or without fenofibrate) treatment period and a 3-week follow-up. From visit 2 (run-in), all patients will receive a standardized dose of statin (rosuvastatin)

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: AstraZeneca

location_country:
Brazil
South Africa
India
Hong Kong
Switzerland
Philippines
Germany
Finland
France
Malaysia
Norway
Hungary
Russian Federation
Singapore
Portugal
Indonesia
Canada
Taiwan

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Long-Term, Post-Treatment, Safety Follow-Up, Multi-Center Study in Patients With Type 2 Diabetes Mellitus From the GALLANT, GALLEX or ARMOR Studies.

summary: This is a long-term safety follow-up study to assess the post-treatment safety, at 12 and 24 months, in patients with type 2 diabetes after participation in the phaseII/III studies GALLANT, GALLEX and ARMOR. In addition, selected patients, including those with pre-defined laboratory or clinical findings, will have a 12-week post-treatment follow-up visit, including laboratory evaluation and adverse event recording.

study_type: Observational

time_perspective: Prospective

location_country:
Finland
Malaysia
Greece
Belgium
Australia
Russian Federation
Czech Republic
Taiwan
India
France
Poland
Lithuania
Slovakia
Thailand
Norway
Argentina
Indonesia
Canada
Korea, Republic of
South Africa
Sweden
Former Serbia and Montenegro
Hong Kong
Netherlands
Philippines
Switzerland
Vietnam
Singapore
Hungary
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Mexico
Israel
Spain
Estonia
Latvia


title: Supportive Test for Acid-Related Symptoms (STARS I) With Esomeprazole and a Following 7-week, Double-blind, Randomized, Placebo Controlled Treatment Period in Subjects With Upper Gastrointestinal Symptoms and With Normal Findings at Esophagogastroduodenoscopy.

summary: The aim is to evaluate if the resolution of upper abdominal symptoms (pain or burning) during an acid suppressive test trial of esomprazole given daily for 7 days predicts symptoms resolution at the end of a subsequent treatment period of 7 weeks.

status: Completed

ReferenceType: derived

ReferenceCitation: Paggi S, Radaelli F, Amato A, Meucci G, Mandelli G, Imperiali G, Spinzi G, Terreni N, Lenoci N, Terruzzi V. The impact of narrow band imaging in screening colonoscopy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2009 Oct;7(10):1049-54. doi: 10.1016/j.cgh.2009.06.028. Epub 2009 Jul 1.

family: Paggi

full_name: Silvia Paggi

given: Silvia

sequence: first

family: Radaelli

full_name: Franco Radaelli

given: Franco

sequence: additional

family: Amato

full_name: Arnaldo Amato

given: Arnaldo

family: Meucci

full_name: Gianmichele Meucci

given: Gianmichele

family: Mandelli

full_name: Giovanni Mandelli

given: Giovanni

family: Imperiali

full_name: Gianni Imperiali

given: Gianni

family: Spinzi

full_name: Giancarlo Spinzi

given: Giancarlo

family: Terreni

full_name: Natalia Terreni

given: Natalia

family: Lenoci

full_name: Nicoletta Lenoci

given: Nicoletta

family: Terruzzi

full_name: Vittorio Terruzzi

given: Vittorio

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Clinical Gastroenterology and Hepatology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

title: The Impact of Narrow Band Imaging in Screening Colonoscopy: A Randomized Controlled Trial

ReferenceCitation: Talley NJ, Vakil N, Lauritsen K, van Zanten SV, Flook N, Bolling-Sternevald E, Persson T, Björck E, Lind T; STARS I Study Group. Randomized-controlled trial of esomeprazole in functional dyspepsia patients with epigastric pain or burning: does a 1-week trial of acid suppression predict symptom response? Aliment Pharmacol Ther. 2007 Sep 1;26(5):673-82.

location_country:
Italy
Brazil
South Africa
Sweden
Switzerland
Germany
France
Greece
Norway
Romania
Belgium
Argentina
Singapore
Spain
Denmark
Canada
Iceland

status_simplified: Completed


title: Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).

summary: The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.

ReferenceCitation: Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001.

ReferenceCitation: Bousquet J, Boulet LP, Peters MJ, Magnussen H, Quiralte J, Martinez-Aguilar NE, Carlsheimer A. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med. 2007 Dec;101(12):2437-46. Epub 2007 Oct 1. Erratum in: Respir Med. 2008 Jun;102(6):937-8.

location_country:
Brazil
South Africa
India
Mexico
Philippines
Germany
Spain
Vietnam
France
Malaysia
Thailand
Singapore
Argentina
Australia
China
Indonesia
Canada


title: Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo & Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

summary: This study is a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg orally qd vs. placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a period of 4 weeks in treatment of relief of upper GI symptoms.

location_country:
United States
France
Hungary
Belgium
Spain
Germany


title: Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

summary: This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.

ReferenceCitation: Hawkey CJ, Talley NJ, Scheiman JM, Jones RH, Långström G, Naesdal J, Yeomans ND; NASA/SPACE author group. Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: the NASA2 and SPACE2 studies. Arthritis Res Ther. 2007;9(1):R17.


title: A Study to Evaluate the Use of Rosuvastatin in Subjects On Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events (AURORA). A Double Blind, Randomised, Phase 3b, Parallel-group Study to Compare the Effects of Rosuvastatin With Placebo on Assessment of Survival & Cardiovascular Events When Given to Subjects With End-stage Renal Failure on Chronic Haemodialysis Treatment

summary: The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.

primary_purpose: Prevention

enrollment_type: Actual

ReferenceCitation: Fellström BC, Jardine AG, Schmieder RE, Holdaas H, Bannister K, Beutler J, Chae DW, Chevaile A, Cobbe SM, Grönhagen-Riska C, De Lima JJ, Lins R, Mayer G, McMahon AW, Parving HH, Remuzzi G, Samuelsson O, Sonkodi S, Sci D, Süleymanlar G, Tsakiris D, Tesar V, Todorov V, Wiecek A, Wüthrich RP, Gottlow M, Johnsson E, Zannad F; AURORA Study Group. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 Apr 2;360(14):1395-407. doi: 10.1056/NEJMoa0810177. Epub 2009 Mar 30. Erratum in: N Engl J Med. 2010 Apr 15;362(15):1450.

family: Fellström

full_name: Bengt C. Fellström

given: Bengt C.

family: Jardine

full_name: Alan G. Jardine

given: Alan G.

family: Schmieder

full_name: Roland E. Schmieder

given: Roland E.

family: Holdaas

full_name: Hallvard Holdaas

given: Hallvard

family: Bannister

full_name: Kym Bannister

given: Kym

family: Beutler

full_name: Jaap Beutler

given: Jaap

family: Chae

full_name: Dong-Wan Chae

given: Dong-Wan

family: Chevaile

full_name: Alejandro Chevaile

given: Alejandro

family: Cobbe

full_name: Stuart M. Cobbe

given: Stuart M.

family: Grönhagen-Riska

full_name: Carola Grönhagen-Riska

given: Carola

family: De Lima

full_name: José J. De Lima

given: José J.

family: Lins

full_name: Robert Lins

given: Robert

family: Mayer

full_name: Gert Mayer

given: Gert

family: McMahon

full_name: Alan W. McMahon

given: Alan W.

family: Parving

full_name: Hans-Henrik Parving

given: Hans-Henrik

family: Remuzzi

full_name: Giuseppe Remuzzi

given: Giuseppe

family: Samuelsson

full_name: Ola Samuelsson

given: Ola

family: Sonkodi

full_name: Sandor Sonkodi

given: Sandor

family: Süleymanlar

full_name: Gultekin Süleymanlar

given: Gultekin

family: Tsakiris

full_name: Dimitrios Tsakiris

given: Dimitrios

family: Tesar

full_name: Vladimir Tesar

given: Vladimir

family: Todorov

full_name: Vasil Todorov

given: Vasil

family: Wiecek

full_name: Andrzej Wiecek

given: Andrzej

family: Wüthrich

title: Rosuvastatin and Cardiovascular Events in Patients Undergoing Hemodialysis

location_country:
Finland
Greece
Australia
Belgium
Denmark
Czech Republic
Iceland
France
Poland
Norway
Canada
Korea, Republic of
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Germany
United Kingdom
Italy
Austria
Brazil
Mexico
Turkey


title: A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira

acronym: ReAlise

summary: The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

ReferenceCitation: Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.

family: Burmester

full_name: Gerd R Burmester

given: Gerd R

family: Matucci-Cerinic

full_name: Marco Matucci-Cerinic

given: Marco

family: Mariette

full_name: Xavier Mariette

given: Xavier

family: Navarro-Blasco

full_name: Francisco Navarro-Blasco

given: Francisco

family: Kary

full_name: Sonja Kary

given: Sonja

family: Unnebrink

full_name: Kristina Unnebrink

given: Kristina

family: Kupper

full_name: Hartmut Kupper

given: Hartmut

currency_apc_doaj: GBP

journal_name: Arthritis Research & Therapy

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: University of Florence - Florence Research

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

repository_normalized: HAL

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories:
HAL
PubMed Central
flore.unifi.it

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer

publisher_group: Springer

publisher_normalized: Springer

lead_sponsor: Abbott

location_country:
Italy
Austria
Netherlands
Spain
France
Greece
Australia
Belgium
Portugal
Germany
United Kingdom

location_facility:
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intervention_type: Biological


title: Pompe Disease Registry

summary:
The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes.

The objectives of the Registry are:

To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention.
To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care.
To characterize the Pompe disease population.
To evaluate the long-term effectiveness of alglucosidase alfa.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

time_perspective: Other

enrollment_type: Anticipated

ReferenceType: background

ReferenceCitation: Kishnani PS, Amartino HM, Lindberg C, Miller TM, Wilson A, Keutzer J. Methods of diagnosis of patients with Pompe disease: Data from the Pompe Registry. Mol Genet Metab. 2014 Sep-Oct;113(1-2):84-91. doi: 10.1016/j.ymgme.2014.07.014. Epub 2014 Jul 16.

ReferenceCitation: Kishnani PS, Amartino HM, Lindberg C, Miller TM, Wilson A, Keutzer J; Pompe Registry Boards of Advisors. Timing of diagnosis of patients with Pompe disease: data from the Pompe registry. Am J Med Genet A. 2013 Oct;161A(10):2431-43. doi: 10.1002/ajmg.a.36110. Epub 2013 Aug 30.

ReferenceCitation: Byrne BJ, Kishnani PS, Case LE, Merlini L, Müller-Felber W, Prasad S, van der Ploeg A. Pompe disease: design, methodology, and early findings from the Pompe Registry. Mol Genet Metab. 2011 May;103(1):1-11. doi: 10.1016/j.ymgme.2011.02.004. Epub 2011 Feb 11. Erratum in: Mol Genet Metab. 2011 Nov;104(3):424.

ReferenceCitation: Zhao Y, Wang Z, Lu J, Gu X, Huang Y, Qiu Z, Wei Y, Yan C. Characteristics of Pompe disease in China: a report from the Pompe registry. Orphanet J Rare Dis. 2019 Apr 3;14(1):78. doi: 10.1186/s13023-019-1054-0.

family: Zhao

full_name: Yuying Zhao

given: Yuying

family: Wang

full_name: Zhaoxia Wang

given: Zhaoxia

family: Lu

full_name: Jiahong Lu

given: Jiahong

family: Gu

full_name: Xuefan Gu

given: Xuefan

family: Huang

full_name: Yonglan Huang

given: Yonglan

family: Qiu

full_name: Zhengqing Qiu

given: Zhengqing

family: Wei

full_name: Yanping Wei

given: Yanping

family: Yan

full_name: Chuanzhu Yan

given: Chuanzhu

journal_name: Orphanet Journal of Rare Diseases

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Jordan
Malaysia
Greece
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
India
Pakistan
Croatia
France
Japan
Poland
Kuwait
Slovakia
Thailand
Argentina
Indonesia
Canada
Korea, Republic of
Colombia
Chile
United Arab Emirates
Saudi Arabia
Netherlands
Philippines
Vietnam
Bulgaria
Singapore
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Brazil
Serbia
Lebanon
Czechia
Israel

location_facility:
Investigational Site Number :840053
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Investigational Site Number :124010
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status_simplified: Ongoing


title: Study to Investigate Which Clinical Risk Factors Are Considered by Physicians When Conducting Overall Febrile Neutropenia Risk Assessments for Patients Receiving Chemotherapy With an Intermediate (10% - 20%) Febrile Neutropenia Risk.

summary:
This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy.

Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest.

Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited.

This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.

ReferenceCitation: Freyer G, Kalinka-Warzocha E, Syrigos K, Marinca M, Tonini G, Ng SL, Wong ZW, Salar A, Steger G, Abdelsalam M, DeCosta L, Szabo Z. Attitudes of physicians toward assessing risk and using granulocyte colony-stimulating factor as primary prophylaxis in patients receiving chemotherapy associated with an intermediate risk of febrile neutropenia. Med Oncol. 2015 Oct;32(10):236. doi: 10.1007/s12032-015-0682-z. Epub 2015 Aug 28.

ReferenceCitation: Lyman GH, Dale DC, Legg JC, Abella E, Morrow PK, Whittaker S, Crawford J. Assessing patients' risk of febrile neutropenia: is there a correlation between physician-assessed risk and model-predicted risk? Cancer Med. 2015 Aug;4(8):1153-60. doi: 10.1002/cam4.454. Epub 2015 Mar 23.

name: Hutchinson Institute for Cancer Outcomes Research Fred Hutchinson Cancer Research Center Seattle Washington

family: Lyman

full_name: Gary H. Lyman

given: Gary H.

name: Department of Medicine University of Washington Seattle Washington

family: Dale

full_name: David C. Dale

given: David C.

name: Global Biostatistical Science Amgen Inc. Thousand Oaks California

family: Legg

full_name: Jason C. Legg

given: Jason C.

name: Hematology/Oncology Amgen Inc. Thousand Oaks California

family: Abella

full_name: Esteban Abella

given: Esteban

family: Morrow

full_name: Phuong Khanh Morrow

given: Phuong Khanh

family: Whittaker

full_name: Sadie Whittaker

given: Sadie

name: Department of Medicine Duke University School of Medicine and Duke Cancer Institute Durham North Carolina

family: Crawford

full_name: Jeffrey Crawford

given: Jeffrey

journal_name: Cancer Medicine

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Assessing patients’ risk of febrile neutropenia: is there a correlation between physician‐assessed risk and model‐predicted risk?

lead_sponsor: Amgen

location_country: Italy Austria Germany France Poland Greece Romania Ireland Australia Spain Canada


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas

summary: This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.

ReferenceCitation: Horwitz S, O'Connor OA, Pro B, Illidge T, Fanale M, Advani R, Bartlett NL, Christensen JH, Morschhauser F, Domingo-Domenech E, Rossi G, Kim WS, Feldman T, Lennard A, Belada D, Illés Á, Tobinai K, Tsukasaki K, Yeh SP, Shustov A, Hüttmann A, Savage KJ, Yuen S, Iyer S, Zinzani PL, Hua Z, Little M, Rao S, Woolery J, Manley T, Trümper L; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019 Jan 19;393(10168):229-240. doi: 10.1016/S0140-6736(18)32984-2. Epub 2018 Dec 4. Erratum in: Lancet. 2019 Jan 19;393(10168):228.

family: Horwitz

full_name: Steven Horwitz

given: Steven

family: O'Connor

full_name: Owen A O'Connor

given: Owen A

family: Pro

full_name: Barbara Pro

given: Barbara

family: Illidge

full_name: Tim Illidge

given: Tim

family: Fanale

full_name: Michelle Fanale

given: Michelle

family: Advani

full_name: Ranjana Advani

given: Ranjana

family: Bartlett

full_name: Nancy L Bartlett

given: Nancy L

family: Christensen

full_name: Jacob Haaber Christensen

given: Jacob Haaber

family: Morschhauser

full_name: Franck Morschhauser

given: Franck

family: Domingo-Domenech

full_name: Eva Domingo-Domenech

given: Eva

family: Rossi

full_name: Giuseppe Rossi

given: Giuseppe

family: Kim

full_name: Won Seog Kim

given: Won Seog

family: Feldman

full_name: Tatyana Feldman

given: Tatyana

family: Lennard

full_name: Anne Lennard

given: Anne

family: Belada

full_name: David Belada

given: David

family: Illés

full_name: Árpád Illés

given: Árpád

family: Tobinai

full_name: Kensei Tobinai

given: Kensei

family: Tsukasaki

full_name: Kunihiro Tsukasaki

given: Kunihiro

family: Yeh

full_name: Su-Peng Yeh

given: Su-Peng

family: Shustov

full_name: Andrei Shustov

given: Andrei

family: Hüttmann

full_name: Andreas Hüttmann

given: Andreas

family: Savage

full_name: Kerry J Savage

given: Kerry J

family: Yuen

full_name: Sam Yuen

given: Sam

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

repository_institution: The University of Manchester - Research Explorer

ReferenceCitation: Fanale MA, Horwitz SM, Forero-Torres A, Bartlett NL, Advani RH, Pro B, Chen RW, Davies A, Illidge T, Huebner D, Kennedy DA, Shustov AR. Brentuximab vedotin in the front-line treatment of patients with CD30+ peripheral T-cell lymphomas: results of a phase I study. J Clin Oncol. 2014 Oct 1;32(28):3137-43. doi: 10.1200/JCO.2013.54.2456. Epub 2014 Aug 18.

name: Michelle A. Fanale, The University of Texas MD Anderson Cancer Center, Houston, TX; Steven M. Horwitz, Memorial Sloan-Kettering Cancer Center, New York, NY; Andres Forero-Torres, University of Alabama at Birmingham, Birmingham, AL; Nancy L. Bartlett, Washington University School of Medicine, St Louis, MO; Ranjana H. Advani, Stanford University Medical Center, Palo Alto; Robert W. Chen, City of Hope National Medical Center, Duarte, CA; Barbara Pro, Fox Chase Cancer Center, Philadelphia, PA; Dirk Huebner,...

publisher: American Society of Clinical Oncology (ASCO)

title: Brentuximab Vedotin in the Front-Line Treatment of Patients With CD30+ Peripheral T-Cell Lymphomas: Results of a Phase I Study

location_country:
Italy
United States
Germany
France
Czechia
Poland
Israel
Romania
Hungary
Australia
Spain
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Shands Cancer Center / University of Florida

location_facility: Istituto Clinico Humanitas-Humanitas Cancer Center

location_facility: Soroka Medical Center, Dept. of Oncology

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Memorial Sloan Kettering Cancer Center - Basking Ridge

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Virginia Commonwealth University Medical Center

location_facility: University Hospitals of Leicester NHS Trust

location_facility: James P. Wilmot Cancer Center / University of Rochester Medical Center

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Seattle Cancer Care Alliance / University of Washington

location_facility: Instituto di Ematologia ed Oncologia Medica

location_facility: St Vincent's Public Hospital Sydney - Fitzroy

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou

location_facility: MD Anderson Cancer Center / University of Texas

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center

location_facility: Benaroya Research Institute/Virginia Mason Medical Center

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular

location_facility: Centrum Onkologii Institut im. Marii Sklodowskiej-Curie

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord

location_facility: Chonnam National University Hwasun Hospital

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren

location_facility: Università degli Studi di Roma "La Sapienza, Policlinico Umberto I

location_facility: Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria

location_facility: McGill University Department of Oncology / McGill University Health Centre

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Memorial Sloan Kettering Cancer Center - Commack

location_facility: Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino

location_facility: Washington University School of Medicine

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Seoul National University Bundang Hospital

location_facility: Holden Comprehensive Cancer Center / University of Iowa

location_facility: Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu

location_facility: Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer

location_facility: Hopital Saint-Louis / Service d'Hematologie

location_facility: Centre Hospitalier Universitaire Nantes-Hotel Dieu

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich

location_facility: Charles A. Sammons Cancer Center / Baylor University Medical Center

location_facility: Keimyung University Dongsan Medical Center

location_facility: Klinik für Innere Medizin II, Friedrich-Schiller-Universität

location_facility: Klinikum der Ludwig-Maximilians-Universität München

location_facility: CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies

location_facility: Nottingham University Hospitals NHS Trust

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie


status: Unknown status

lead_sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group

location_country: Belgium France

acronym: SUNLAND

location_facility:
UZ Leuven
Hôpital Edouard Herriot
Hôpital Saint André
Hôpital Henri Mondor
CHU Cochin
CHU Robert Debré
CHRU Trousseau
CHU Pontchaillou
ULB Erasme
CHU La Timone
Hôpital Pitié Salpêtrière
Institut Jules Bordet
UZ Gent
Hopital Saint Vincent de Paul
Hôpital St Antoine
CHU Rouen
Cliniques Universitaires Saint Luc
UZ Antwerpen
Institut Mutualiste Montsouris
Hôpital Beaujon

source: euctr

title: A RANDOMIZED PHASE II DOUBLE-BLIND TRIAL OF SUNITINIB VERSUS PLACEBO IN COMBINATION WITH LANREOTIDE IN PATIENTS WITH PROGRESSIVE ADVANCED/METASTATIC MIDGUT CARCINOID TUMORS

summary: Sunitinib may provide an opportunity for a novel therapeutic strategy for the treatment of subjects with neuroendocrine tumors.


title: A Phase 3 Randomized,Open-Label Study of Ponatinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

summary: The purpose of this study is to compare the efficacy of ponatinib and imatinib in patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase.

ReferenceCitation: Hanley MJ, Diderichsen PM, Narasimhan N, Srivastava S, Gupta N, Venkatakrishnan K. Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model-Informed Dose Selection for Pediatric Development. J Clin Pharmacol. 2021 Oct 26. doi: 10.1002/jcph.1990. [Epub ahead of print]

name: Millennium Pharmaceuticals Inc. Cambridge MA USA a wholly owned subsidiary of Takeda Pharmaceutical Company Limited

family: Hanley

full_name: Michael J. Hanley

given: Michael J.

family: Diderichsen

full_name: Paul M. Diderichsen

given: Paul M.

family: Narasimhan

full_name: Narayana Narasimhan

given: Narayana

family: Srivastava

full_name: Shouryadeep Srivastava

given: Shouryadeep

family: Gupta

full_name: Neeraj Gupta

given: Neeraj

family: Venkatakrishnan

full_name: Karthik Venkatakrishnan

given: Karthik

journal_name: The Journal of Clinical Pharmacology

oa_host_type: publisher

evidence: open (via page says Open Access)

license: implied-oa

license_normalized: implied-oa

title: Population Pharmacokinetics of Ponatinib in Healthy Adult Volunteers and Patients With Hematologic Malignancies and Model‐Informed Dose Selection for Pediatric Development

ReferenceCitation: Lipton JH, Chuah C, Guerci-Bresler A, Rosti G, Simpson D, Assouline S, Etienne G, Nicolini FE, le Coutre P, Clark RE, Stenke L, Andorsky D, Oehler V, Lustgarten S, Rivera VM, Clackson T, Haluska FG, Baccarani M, Cortes JE, Guilhot F, Hochhaus A, Hughes T, Kantarjian HM, Shah NP, Talpaz M, Deininger MW; EPIC investigators. Ponatinib versus imatinib for newly diagnosed chronic myeloid leukaemia: an international, randomised, open-label, phase 3 trial. Lancet Oncol. 2016 May;17(5):612-21. doi: 10.1016/S1470-2045(16)00080-2. Epub 2016 Apr 12.

family: Lipton

full_name: Jeffrey H Lipton

given: Jeffrey H

family: Chuah

full_name: Charles Chuah

given: Charles

family: Guerci-Bresler

full_name: Agnès Guerci-Bresler

given: Agnès

family: Rosti

full_name: Gianantonio Rosti

given: Gianantonio

family: Simpson

full_name: David Simpson

family: Assouline

full_name: Sarit Assouline

given: Sarit

family: Etienne

full_name: Gabriel Etienne

given: Gabriel

family: Nicolini

full_name: Franck E Nicolini

given: Franck E

family: le Coutre

full_name: Philipp le Coutre

given: Philipp

family: Clark

full_name: Richard E Clark

given: Richard E

family: Stenke

full_name: Leif Stenke

given: Leif

family: Andorsky

full_name: David Andorsky

family: Oehler

full_name: Vivian Oehler

given: Vivian

family: Lustgarten

location_country:
Finland
Australia
Belgium
Czech Republic
Taiwan
France
Poland
Slovakia
Canada
Korea, Republic of
Sweden
Hong Kong
Netherlands
Switzerland
Singapore
Puerto Rico
Portugal
United States
Germany
United Kingdom
Italy
Austria
New Zealand
Spain

location_facility: Ustav hematologie a krevni transfuse, Site #516

location_facility: Willis-Knighton Cancer Center, Site #196

location_facility: Mount Sinai School of Medicine, Site #189

location_facility: Bay Area Cancer Research Group, Site #157

location_facility: Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika, Site #514

location_facility: US Oncology - Providence Health System, Site #167

location_facility: Siouxland Hematology-Oncology Associates, Site #198

location_facility: Bay Area Cancer Research Group, Site #156

location_facility: Hospital Clinico Universitario de Valencia, Site #964

location_facility: Massachusetts General Hospital, Site #047

location_facility: Centre Hospitalier de Versailles, Site #958

location_facility: University Health Network, Princess Margaret Hospital, Site #083

location_facility: Charite - Universitatsmedizin Berlin, Site #701

location_facility: University of Massachusetts Worcester, Site #152

location_facility: Universitatsklinikum Carl Gustav Carus an der TU Dresden, Site #526

location_facility: Universitatsklinikum Koln-AOR, Site #525

location_facility: Hospital Universitario La Princesa, Site #555

location_facility: Cancer Center of Central Connecticut, Site #147

location_facility: Christiana Care Health Services, Site #155

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia Universita La Sapienza - Policlinico Umberto I, Site #511

location_facility: University of Iowa Hospitals and Clinics, Site #050

location_facility: Karolinska University Hospital Huddinge, Site #534

location_facility: Medical University of South Carolina, Site #148

location_facility: University of Michigan Medical Center, Site #011

location_facility: Istituto di Ematologia "L. & A. Seragnoli", Site #959

location_facility: Oregon Health & Science University, Site #048

location_facility: Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Medyczne, Site #548

location_facility: CHRU de Brest, Hopital Morvan, Site #523

location_facility: China Medical University Hospital, Site #978

location_facility: The Catholic University of Korea, Site #938

location_facility: US Oncology - Cancer Center of Kansas, Site #168

location_facility: University of Maryland, Greenebaum Cancer Center, Site #040

location_facility: Medizinische Universitat Wien / AKH, Universitatsklinik fur Inniere Medizin I, Site #561

location_facility: Southeastern Medical Oncology Center, Site #188

location_facility: Fundacion de Investigacion de Diego, Site #199

location_facility: University of New Mexico Cancer Center, Site #166

location_facility: Hospital Universitari Germans Trias i Pujol, Site #512

location_facility: US Oncology - Texas Oncology Midland, Site #173

location_facility: Providence Cancer Center Oncology and Hematology Care Eastside, Site #194

location_facility: Associates in Oncology & Hematology, Site #186

location_facility: Klinika Hematologii Wojewodzkiego Szpitala Specjalistycznego, Site #550

location_facility: US Oncology - Northwest Cancer Specialists, Site #174

location_facility: Weill Cornell Medical College, Site #006

location_facility: Clinique Universitaire de Saint-Luc, Department of Haematology, Site #508

location_facility: Hospital Universitario Central de Asturias, Site #535

location_facility: Hospital Universitario de Salamanca, Site #965

location_facility: Hospital Universitario 12 de Octubre, Site #537

location_facility: Kaohsiung Chang Gung Memorial Hospital, Site #980

location_facility: Ospedale Niguarda Ca' Granda di Milano, Site #531

location_facility: Universitatsklinikum Freiburg, Site #527

location_facility: Institut Catala d' Oncologia de Girona, S. de Hematologia Clinica, Site #734

location_facility: Helsinki University Central Hospital, Site #542

location_facility: Kent and Medway Cancer Research Network, Site #558

location_facility: A.O. Universitaria Policlinico Vittorio Emanuele di Catania, Site #530

location_facility: Memorial Sloan-Kettering Cancer Center, Site #078

location_facility: Nottingham University Hospitals NHS Trust, Site #968

location_facility: Complejo Hospitalario Universitario A Coruna, Hospital "Teresa Herrera," Site #554

location_facility: Western Pennsylvania Hospital, Site #159

location_facility: Oxford University Hospitals NHS Trust, Site #543

location_facility: Hospital Universitari Son Espases, Site #553

location_facility: UZ Gent - Department Hematology, Site #756

location_facility: U.O. di Ematologia - Ospedale S. Eugenio, Site #962

location_facility: Instituto Portugues de Oncologia, Site #545

location_facility: Sarah Cannon Research Institute, Site #076

location_facility: Green Bay Oncology, Ltd. / St. Mary's Hospital Medical Center, Site #193

location_facility: US Oncology - Texas Oncology Austin, Site #172

location_facility: VU Medical Centre - Department Haematology, Site #948

location_facility: US Oncology - Texas Oncology Dallas, Site #171

location_facility: The Peter MacCallum Cancer Center, Site #950

location_facility: Katedra i Klinika Hematologii, Site #547

location_facility: Norfolk & Norwich University Hospital Foundation Trust, Site #557

location_facility: Oncology Research Park Nicollet Institute, Site #195

location_facility: Nebraska Hematology-Oncology, P.C., Site # 133

location_facility: U.O.C Ematologia con trapianto di midollo osseo, Site #560

location_facility: Royal Liverpool University Hospital, Site #969

location_facility: Fakultni nemocnice Olomouc, Hematoonkologicka klinika, Site #515

location_facility: Unita Operativa di Ematologia con Trapianto, Site #529

location_facility: National Taiwan University Hospital, Site #979

location_facility: US Oncology - Comprehensive Cancer Center of Nevada, Site #169

location_facility: Service Hematologie - Hospital Archet I, Site #509

location_facility: Greater Baltimore Medical Center, Site #140

location_facility: Karolinska University Hospital Solna, Site #763

location_facility: St. James University Hospital, Site #540

location_facility: SCDU Medicina Interna II - Indirizzo Ematologico, Site #785

location_facility: UZ Brussel - Department Hematology, Site #544

location_facility: University of Texas Southwestern Medical Center, Site #178

location_facility: Signal Point Clinical Research Center, Site #139

location_facility: VCU Massey Cancer Center, Dalton Oncology Clinic, Site #069

location_facility: Mercy Clinic - Cancer & Hematology, Site #151

location_facility: Franciscan St. Francis Health, Site #138

location_facility: Universitat Heidelberg, CML - Studienzentrale III. Medizinische Klinik, Site #947

location_facility: Rocky Mountain Cancer Centers, Site #191

location_facility: Universitatsklinikum Hamburg-Eppendorf, Site #524

location_facility: UZ Gasthuisberg - Department of Hematology, Site #700

location_facility: John H. Stroger, Jr. Hospital of Cook County, Site #192

location_facility: US Oncology - Cancer Care Center of South Texas, Site #170

location_facility: Universitätsklinikum Aachen, AÖR, Site #513


title: A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.

summary: Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.

ReferenceCitation: Pohlmann-Eden B, Marson AG, Noack-Rink M, Ramirez F, Tofighy A, Werhahn KJ, Wild I, Trinka E. Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study. BMC Neurol. 2016 Aug 23;16(1):149. doi: 10.1186/s12883-016-0663-7.

family: Pohlmann-Eden

full_name: Bernd Pohlmann-Eden

given: Bernd

family: Marson

full_name: Anthony G. Marson

given: Anthony G.

family: Noack-Rink

full_name: Matthias Noack-Rink

given: Matthias

family: Ramirez

full_name: Francisco Ramirez

given: Francisco

family: Tofighy

full_name: Azita Tofighy

given: Azita

family: Werhahn

full_name: Konrad J. Werhahn

given: Konrad J.

family: Wild

full_name: Imane Wild

given: Imane

family: Trinka

full_name: Eugen Trinka

given: Eugen

journal_name: BMC Neurology

ReferenceCitation: Trinka E, Marson AG, Van Paesschen W, Kälviäinen R, Marovac J, Duncan B, Buyle S, Hallström Y, Hon P, Muscas GC, Newton M, Meencke HJ, Smith PE, Pohlmann-Eden B; KOMET Study Group. KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy. J Neurol Neurosurg Psychiatry. 2013 Oct;84(10):1138-47. doi: 10.1136/jnnp-2011-300376. Epub 2012 Aug 29.

full_name: Anthony G Marson

given: Anthony G

family: Van Paesschen

full_name: Wim Van Paesschen

given: Wim

family: Kälviäinen

full_name: Reetta Kälviäinen

given: Reetta

family: Marovac

full_name: Jacqueline Marovac

given: Jacqueline

family: Duncan

full_name: Benjamin Duncan

given: Benjamin

family: Buyle

full_name: Sonja Buyle

given: Sonja

family: Hallström

full_name: Yngve Hallström

journal_name: Journal of Neurology, Neurosurgery & Psychiatry

location_country:
Finland
Greece
Romania
Australia
Belgium
Russian Federation
Denmark
Czech Republic
France
Poland
Slovakia
Norway
Sweden
Switzerland
Netherlands
Bulgaria
Hungary
Ireland
Germany
United Kingdom
Italy
Austria
Spain
Turkey


title: A Phase IIIb - IV, Randomised, Open Label Trial Evaluating the Efficacy and Safety of Tenecteplase Together With Unfractionated Heparin Prior to Early PCI as Compared to Standard Primary PCI in Patients With Acute Myocardial Infarction. ASSENT 4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy for Acute Myocardial Infarction.)

summary: To show whether addition of thrombolytic treatment by a single bolus injection of tenecteplase prior to early standard PCI (percutaneous coronary intervention) will improve the clinical outcome in patients with large acute myocardial infarcts as compared to primary PCI alone.

ReferenceType: result

ReferenceCitation: Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention (ASSENT-4 PCI) investigators. Primary versus tenecteplase-facilitated percutaneous coronary intervention in patients with ST-segment elevation acute myocardial infarction (ASSENT-4 PCI): randomised trial. Lancet. 2006 Feb 18;367(9510):569-78.

ReferenceCitation: Zalewski J, Bogaerts K, Desmet W, Sinnaeve P, Berger P, Grines C, Danays T, Armstrong P, Van de Werf F. Intraluminal thrombus in facilitated versus primary percutaneous coronary intervention: an angiographic substudy of the ASSENT-4 PCI (Assessment of the Safety and Efficacy of a New Treatment Strategy with Percutaneous Coronary Intervention) trial. J Am Coll Cardiol. 2011 May 10;57(19):1867-73. doi: 10.1016/j.jacc.2010.10.061.

family: Zalewski

full_name: Jaroslaw Zalewski

given: Jaroslaw

family: Bogaerts

full_name: Kris Bogaerts

given: Kris

family: Desmet

full_name: Walter Desmet

given: Walter

family: Sinnaeve

full_name: Peter Sinnaeve

given: Peter

family: Berger

full_name: Peter Berger

family: Grines

full_name: Cindy Grines

given: Cindy

family: Danays

full_name: Thierry Danays

given: Thierry

family: Armstrong

full_name: Paul Armstrong

given: Paul

family: Van de Werf

full_name: Frans Van de Werf

given: Frans

journal_name: Journal of the American College of Cardiology

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

title: Intraluminal Thrombus in Facilitated Versus Primary Percutaneous Coronary Intervention

ReferenceCitation: Jarai R, Huber K, Bogaerts K, Sinnaeve PR, Ezekowitz J, Ross AM, Zeymer U, Armstrong PW, Van de Werf FJ; ASSENT-4 PCI investigators. Prediction of cardiogenic shock using plasma B-type natriuretic peptide and the N-terminal fragment of its pro-hormone [corrected] concentrations in ST elevation myocardial infarction: an analysis from the ASSENT-4 Percutaneous Coronary Intervention Trial. Crit Care Med. 2010 Sep;38(9):1793-801. doi: 10.1097/CCM.0b013e3181eaaf2a. Erratum in: Crit Care Med. 2010 Dec;38(12):2430.

family: Jarai

full_name: Rudolf Jarai

given: Rudolf

family: Huber

full_name: Kurt Huber

given: Kurt

full_name: Peter R. Sinnaeve

given: Peter R.

family: Ezekowitz

full_name: Justin Ezekowitz

given: Justin

family: Ross

full_name: Allan M. Ross

given: Allan M.

family: Zeymer

full_name: Uwe Zeymer

given: Uwe

full_name: Paul W. Armstrong

given: Paul W.

full_name: Frans J. Van de Werf

given: Frans J.

journal_name: Critical Care Medicine

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

title: Prediction of cardiogenic shock using plasma B-type natriuretic peptide and the N-terminal fragment of its pro-hormone concentrations in ST elevation myocardial infarction: An analysis from the ASSENT-4 Percutaneous Coronary Intervention Trial

location_country:
Italy
Austria
United States
Brazil
Mexico
Germany
France
Poland
Greece
Thailand
Norway
Hungary
Belgium
Ireland
Portugal
Turkey
Canada
Czech Republic

location_facility: Boehringer Ingelheim Investigational Site


title: A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer

acronym: VELVET

summary: This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.

design_allocation: Non-Randomized

ReferenceCitation: Perez EA, López-Vega JM, Petit T, Zamagni C, Easton V, Kamber J, Restuccia E, Andersson M. Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results. Breast Cancer Res. 2016 Dec 13;18(1):126.

lead_sponsor: Hoffmann-La Roche

location_country:
Italy
Brazil
Germany
France
Spain
Denmark
United States


title: A Phase III Clinical Trial Evaluating TheraSphere® in Patients With Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

acronym: EPOCH

summary: The effectiveness and safety of TheraSphere will be evaluated in patients with colorectal cancer with metastases in the liver, who are scheduled to receive second line chemotherapy. All patients receive the standard of care chemotherapy with or without the addition of TheraSphere.

ReferenceCitation: Chauhan N, Mulcahy MF, Salem R, Benson Iii AB, Boucher E, Bukovcan J, Cosgrove D, Laframboise C, Lewandowski RJ, Master F, El-Rayes B, Strosberg JR, Sze DY, Sharma RA. TheraSphere Yttrium-90 Glass Microspheres Combined With Chemotherapy Versus Chemotherapy Alone in Second-Line Treatment of Patients With Metastatic Colorectal Carcinoma of the Liver: Protocol for the EPOCH Phase 3 Randomized Clinical Trial. JMIR Res Protoc. 2019 Jan 17;8(1):e11545. doi: 10.2196/11545.

family: Chauhan

full_name: Nikhil Chauhan

given: Nikhil

family: Mulcahy

full_name: Mary F Mulcahy

given: Mary F

family: Salem

full_name: Riad Salem

given: Riad

family: Benson III

full_name: Al B Benson III

given: Al B

family: Boucher

full_name: Eveline Boucher

given: Eveline

family: Bukovcan

full_name: Janet Bukovcan

given: Janet

family: Cosgrove

full_name: David Cosgrove

given: David

family: Laframboise

full_name: Chantal Laframboise

given: Chantal

family: Lewandowski

full_name: Robert J Lewandowski

given: Robert J

family: Master

full_name: Fayaz Master

given: Fayaz

family: El-Rayes

full_name: Bassel El-Rayes

given: Bassel

family: Strosberg

full_name: Jonathan R Strosberg

given: Jonathan R

family: Sze

full_name: Daniel Y Sze

given: Daniel Y

family: Sharma

full_name: Ricky A Sharma

given: Ricky A

currency_apc_doaj: USD

journal_name: JMIR Research Protocols

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

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

repository_institution: University College London - UCL Discovery

repository_normalized: UCL Discovery

repositories:
PubMed Central
UCL Discovery
pdfs.semanticscholar.org

location_country:
Italy
Austria
United States
Spain
Germany
France
Poland
Singapore
Belgium
China
Canada
United Kingdom
Korea, Republic of

location_facility: Allina Health, Virginia Piper Cancer Institute

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: CHU de Nice,, Hopital Archet 2 - Service d'Imagerie Médicale niveau -2

location_facility: Nottingham University Hospital NHS Trust

location_facility: Walsall Healthcare NHS Trust - Manor Hospital

location_facility: Onze-Lieve-Vrouwziekenuis VZW Campus Aalst

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Wayne State Harper Hospita Karmanos Cancer Institute

location_facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital

location_facility: Beatson Cancer Centre and University of Glasgow

location_facility: Hôpital La Milétrie, CHU Poitiers, hépato gastroenterologie

location_facility: Szpital Kliniczny im. Heliodora Święcickiego

location_facility: Regionalny Szpital Specjalistyczny im. Dr Władysława Biegańskiego

location_facility: The Royal Wolverhampton NHS Trust - New Cross Hospital

location_facility: Avenida de Roma, s/n, Hospital Universitario Central de Asturias

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

location_facility: Lynn Clinical Research Center, Boca Raton Regional Hospital

location_facility: QEII Health Services Center, Halifax Infirmary Site

location_facility: Hospital Regional Universitario de Málaga - Hospital General

location_facility: HCU Lozano Blesa, Planta 11-Oncología-Secretaría

location_facility: Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital

location_facility: University of Colorado Denver Anschutz Medical Campus

location_facility: Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital

location_facility: University of Miami Miller School of Medicine, Florida

location_facility: Azienda Ospedaliera-Universitaria, Policlinico Sant'Orsola Malpighi

location_facility: UCLH, University College London Hospitals

location_facility: Great Western Hospitals NHS Foundation Trust - The Great Western Hospital

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

location_facility: Parc Taulí Sabadell Hospital Universitari

location_facility: The Clatterbrdige Cancer Centre NHSF Trust

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: McGill University Health Center - Glen Site

location_facility: The Ohio State University, Wexner Medical Center

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Oddział Onkologii Klinicznej; Centrum Onkologii Ziemi Lubelskiej im. Św.Jana z Dukli.

location_facility: Centrum Onkologii - Instytut, im. Marii Skłodowskiej-Curie

location_facility: Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital

location_facility: University Health Network , Mount Sinai Hospital

location_facility: Oxford University Hospitals NHS Foundation Trust Churchill Hospital

location_facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Universitaetsklinikum Marburg Klinik für Dermatologie und Allergologie

location_facility: Calderdale and Huddersfield NHS Foundation Trust - Huddersfield Royal Infirmary

location_facility: University of California San Fransico, Moffitt Hospital

location_facility: University Hospitals Bristol NHS Foundation Trust - Bristol Haematology and Oncology Centre

location_facility: Hospital Universitario Fundación Alcorcón


ReferenceCitation: Varlet P, Le Teuff G, Le Deley MC, Giangaspero F, Haberler C, Jacques TS, Figarella-Branger D, Pietsch T, Andreiuolo F, Deroulers C, Jaspan T, Jones C, Grill J. WHO grade has no prognostic value in the pediatric high-grade glioma included in the HERBY trial. Neuro Oncol. 2020 Jan 11;22(1):116-127. doi: 10.1093/neuonc/noz142.

name: Department of Neuropathology, Sainte-Anne Hospital, University Hospital Group (GHU), Paris, France

family: Varlet

full_name: Pascale Varlet

given: Pascale

name: Gustave Roussy Institute, Villejuif, France

name: University of Paris Saclay, University Paris-Sud, Villejuif, France

family: Le Teuff

full_name: Gwénaël Le Teuff

given: Gwénaël

family: Le Deley

full_name: Marie-Cécile Le Deley

given: Marie-Cécile

name: Department of Radiological, Oncological, and Anatomo-Pathological Sciences, Sapienza University of Rome, Rome, Italy

name: Institute of Hospitalization and Scientific Care (IRCCS) Neuromed, Pozzilli, Italy

family: Giangaspero

full_name: Felice Giangaspero

given: Felice

name: Institute of Neurology, Medical University of Vienna, Vienna, Austria

family: Haberler

full_name: Christine Haberler

given: Christine

name: University College London (UCL) Great Ormond Street Institute of Child Health and Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK

family: Jacques

full_name: Thomas S Jacques

given: Thomas S

family: Figarella-Branger

full_name: Dominique Figarella-Branger

given: Dominique

name: Department of Neuropathology, University of Bonn, Bonn, Germany

family: Pietsch

full_name: Torsten Pietsch

given: Torsten

family: Andreiuolo

full_name: Felipe Andreiuolo

given: Felipe

name: Imaging and Modeling in Neurobiology and Oncology (IMNC) Laboratory, Paris Diderot University, Paris, France

family: Deroulers

full_name: Christophe Deroulers

given: Christophe

name: Department of Radiology, Nottingham University Hospitals NHS Trust, Nottingham, UK

family: Jaspan

full_name: Tim Jaspan

given: Tim

name: Institute of Cancer Research, London, UK

family: Jones

full_name: Chris Jones

given: Chris

name: Joint Research Unit 8203, Gustave Roussy Institute and University of Paris Saclay, Villejuif, France

family: Grill

full_name: Jacques Grill

given: Jacques

journal_name: Neuro-Oncology

oa_colors: green hybrid

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Oxford University Press (OUP)

publisher_dissemination: Oxford University Press

publisher_group: Oxford University Press

publisher_normalized: Oxford University Press

ReferenceCitation: Rodriguez D, Chambers T, Warmuth-Metz M, Aliaga ES, Warren D, Calmon R, Hargrave D, Garcia J, Vassal G, Grill J, Zahlmann G, Morgan PS, Jaspan T. Evaluation of the Implementation of the Response Assessment in Neuro-Oncology Criteria in the HERBY Trial of Pediatric Patients with Newly Diagnosed High-Grade Gliomas. AJNR Am J Neuroradiol. 2019 Mar;40(3):568-575. doi: 10.3174/ajnr.A5982. Epub 2019 Feb 28.

family: Rodriguez

full_name: D. Rodriguez

given: D.

family: Chambers

full_name: T. Chambers

given: T.

family: Warmuth-Metz

full_name: M. Warmuth-Metz

given: M.

family: Aliaga

repositories_institution: University College London - UCL Discovery

publisher: American Society of Neuroradiology (ASNR)

ReferenceCitation: Mackay A, Burford A, Molinari V, Jones DTW, Izquierdo E, Brouwer-Visser J, Giangaspero F, Haberler C, Pietsch T, Jacques TS, Figarella-Branger D, Rodriguez D, Morgan PS, Raman P, Waanders AJ, Resnick AC, Massimino M, Garrè ML, Smith H, Capper D, Pfister SM, Würdinger T, Tam R, Garcia J, Thakur MD, Vassal G, Grill J, Jaspan T, Varlet P, Jones C. Molecular, Pathological, Radiological, and Immune Profiling of Non-brainstem Pediatric High-Grade Glioma from the HERBY Phase II Randomized Trial. Cancer Cell. 2018 May 14;33(5):829-842.e5. doi: 10.1016/j.ccell.2018.04.004.

repository_institution: University of Nottingham - Repository@Nottingham

ReferenceCitation: Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Cañete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, Open-Label, Randomized, Multicenter Trial (HERBY) of Bevacizumab in Pediatric Patients With Newly Diagnosed High-Grade Glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. doi: 10.1200/JCO.2017.76.0611. Epub 2018 Feb 7.

name: Jacques Grill, Marie-Cécile Le Deley, and Gilles Vassal, Institut Gustave-Roussy, Villejuif; Marie-Cécile Le Deley, Paris-Saclay and Paris-Sud Universities, CESP, Institut National de la Santé et de la Recherche Médicale, Orsay; Pascale Varlet, Sainte-Anne Hospital, Paris, France; Maura Massimino, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan; Felice Giangaspero, Sapienza University, Rome; Felice Giangaspero, IRCCS Neuromed, Pozzilli, Italy;...

publisher_dissemination: American Society of Clinical Oncology (ASCO)

location_country:
Italy
Austria
Sweden
Netherlands
France
Czechia
Poland
Hungary
Australia
Belgium
Spain
Denmark
Canada
United Kingdom

location_facility: Lady Cilento Children's Hospital; Oncology Services Group, Level 12b

location_facility: Skejby Sygehus - Aarhus University Hospital; CF Center, Børneafdeling A

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Addenbrookes Hospital; Paediatric Oncology Ward C2

location_facility: Bristol Royal Hospital for Children; Paediatric Haematology, Oncology, BMT

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

location_facility: Fakultni nemocnice Brno; 2. detska klinika, pracoviste Detska nemocnice

location_facility: Alder Hey Children's NHS Foundation Trust

location_facility: Semmelweis University, 2nd Dept of Pediatrics Neurooncology Unit

location_facility: Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii

location_facility: Centre Hospitalier d'Angers; Service de cancérologie pédiatrique

location_facility: Karolinska Universitetssjukhuset, Solna; Astrid Lindgrens Barnsjukhus, Barcanceravdelningen

location_facility: CHRU de Tours - Centre de Pédiatrie Clocheville; Service d'Oncopédiatrie

location_facility: Hopital Des Enfants; Service d Hemato-Oncologie

location_facility: Institut Gustave Roussy; Service Pediatrique

location_facility: Sahlgrenska Universitetssjukhuset, Östra Sjukhus; Drottning Silvias Barnsjukhus

location_facility: Kepler Universitätskliniken GmbH - Med Campus IV.

location_facility: Great Ormond Street Hospital; Dept. Of Pediatric Oncology

location_facility: Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

location_facility: Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique

location_facility: Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology

location_facility: Birmingham Childrens Hospital; Oncology Dept

location_facility: Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS; U.O.S. Neuroncologia

location_facility: University College London NHS Foundation Trust

location_facility: Universitetssjukhuset Linköping; Barn och Ungdomskliniken

location_facility: Hopital Lenval; Service Hématologie Infantile

location_facility: CHU ESTAING; Centre Regional de Cancérologie et Thérapie Cellulaire Pédiatrique (CRCTCP)

location_facility: Centre Oscar Lambret; Service de Pediatrie

location_facility: CHRU de Rennes - Hôpital Sud- Service d'Hématologie Pédiatrique

title: A Phase II Open-Label, Randomized, Multi-Centre Comparative Study Of Bevacizumab-Based Therapy In Paediatric Patients With Newly Diagnosed Supratentorial, Infratentorial Cerebellar, or Peduncular High-Grade Glioma

summary:
This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms.

Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children >/= 6 months and < 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.


title: A Multicenter, Randomized, Double-Blind, Comparative Trial Of Maraviroc + Darunavir/Ritonavir Versus Emtricitabine/Tenofovir + Darunavir/Ritonavir For The Treatment Of Antiretroviral-Naive Hiv-Infected Patients With Ccr5-Tropic Hiv-1

acronym: MODERN

summary: The purpose of this study is to assess whether maraviroc administered once daily is non-inferior to emtricitabine/tenofovir also administered once daily each in combination with darunavir/ritonavir in the treatment of antiretroviral-naive patients as evaluated at Week 48 of treatment.

lead_sponsor: ViiV Healthcare

location_country:
Italy
Austria
United States
Sweden
Switzerland
Netherlands
Spain
Germany
Finland
France
Poland
Hungary
Australia
Belgium
Puerto Rico
Portugal
Denmark
Canada
United Kingdom

location_facility: Klinikum der J.W. Goethe-Universitaet, Medizinische Klinik II

location_facility: Inselspital Universitaetsklinik fuer Infektiologie

location_facility: Community AIDS Resource Inc dba Care Resource

location_facility: Hvidovre Hospital, Infektionsmedicinsk afd.

location_facility: Yale - New Haven Hospital Nathan Smith Clinic

location_facility: Broward Health - Comprehensive Care Center

location_facility: University of Colorado Denver - University of Colorado Hospital

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Centre for Sexual Health & HIV Research, University College London

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: North Texas Infectious Diseases Consultants, PA

location_facility: East Carolina University Division of Infectious Diseases

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Michigan State University College of Osteopathic Medicine - Department of Internal Medicine

location_facility: University Health Network / Toronto General Hospital

location_facility: The Office of Dr. Gordon E. Crofoot, M.D., PA

location_facility: Hopital Tenon, Service des Maladies Infectieuses

location_facility: Ludwig-Maximilians-Universitaet, Medizinische Poliklinik - Klinikum Innenstadt

location_facility: Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet

location_facility: Infectious Disease Research Institute, Inc.

location_facility: Biomedical and Health Institutional Review Board

location_facility: George Washington University Medical Faculty Associates

location_facility: Infektiosairauksien poliklinikka,HUS Auroran sairaala, rakennus 5, 1. krs

location_facility: Wojewodzki Szpital Obserwacyjno - Zakazny im. Tadeusza Browicza

location_facility: University of Iowa, University of Hospitals and Clinics - Division of Infectious Disease

location_facility: AKH Wien Universitaetsklinik fuer Dermatologie

location_facility: UMHC/Sylvester Comprehensive Cancer Center

location_facility: Universitaetsklinikum Bonn, Immunologische Ambulanz HIV

location_facility: University of Alabama at Birmingham - 1917 Research Clinic

location_facility: AIDS Community Research Initiative of America (ACRIA)

location_facility: Vancouver ID Research and Care Centre Society

location_facility: Department of Infectious Diseases & Tropical Medicine, Pennine Acute Trust Hospitals

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: (DEXA Scan Facility) East Carolina University Brody Outpatient Center

location_facility: Hospital Clinic I Provincial de Barcelona

location_facility: HIV Research Department, Elton John Centre

location_facility: Infectious Diseases Associates of Northwest Florida, PA

location_facility: St Stephen's Centre, Chelsea and Westminster Hospital NHS Foundation Trust

location_facility: EMC Instytut Medyczny S.A. Przychodnia przy ul. Lowieckiej

location_facility: Hospital General Universitario de Alicante

location_facility: Centro Hospitalar de Lisboa - Zona Central - Hospital Santo António Capuchos

location_facility: Universitaetsspital Basel Infektiologie und Spitalhygiene

location_facility: University of South Florida Health-HIV Clinical Research Unit

location_facility: Maple Leaf Research / Maple Leaf Medical Clinic

location_facility: University of Puerto Rico Medical Sciences Campus

location_facility: SU Ostra sjukhuset, Infektionsmottagningen

location_facility: Hospital Universitario Reina Sofia - Hospital Provincial

location_facility: University of Miami AIDS Clinical Research Unit

location_facility: Beth Israel Medical Center - AIDS Clinical Trials Unit

location_facility: Clinical Research Unit, Infectious Diseases

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

location_facility: Kaiser Permanente - Clinical Trials Unit

location_facility: University of Cincinnati - Department of Internal Medicine

location_facility: Ian Charleson Day Centre, Royal Free Hospital

location_facility: Hospital Universitario Virgen de la Macarena

location_facility: EPIMED - Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Hospital Prof. Doutor Fernando Fonseca E.P.E.

location_facility: Grahame Hayton Unit, Ambrose King Centre, Royal London Hospital,

location_facility: TICON I Research Clinic (DEXA Scan only)


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer

acronym: SELECT

summary: This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period).

ReferenceCitation: Taylor MH, Takahashi S, Capdevila J, Tahara M, Leboulleux S, Kiyota N, Dutcus CE, Xie R, Robinson B, Sherman S, Habra MA, Elisei R, Wirth LJ. Correlation of Performance Status and Neutrophil-Lymphocyte Ratio with Efficacy in Radioiodine-Refractory Differentiated Thyroid Cancer Treated with Lenvatinib. Thyroid. 2021 Aug;31(8):1226-1234. doi: 10.1089/thy.2020.0779. Epub 2021 Apr 29.

name: Earle A. Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA.

family: Taylor

full_name: Matthew H. Taylor

given: Matthew H.

name: Department of Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.

family: Takahashi

full_name: Shunji Takahashi

given: Shunji

name: Medical Oncology Department, University Hospital Vall d'Hebron, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.

family: Capdevila

full_name: Jaume Capdevila

given: Jaume

name: Division of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.

family: Tahara

full_name: Makoto Tahara

given: Makoto

name: Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Villejuif, France.

family: Leboulleux

full_name: Sophie Leboulleux

given: Sophie

name: Department of Medical Oncology and Hematology and Cancer Center, Kobe University Hospital, Kusunoki Cho, Chuo-ku, Japan.

family: Kiyota

full_name: Naomi Kiyota

given: Naomi

family: Dutcus

full_name: Corina E. Dutcus

given: Corina E.

name: Department of Biostatistics, Eisai Inc., Woodcliff Lake, New Jersey, USA.

family: Xie

full_name: Ran Xie

given: Ran

name: Royal North Shore Hospital, University of Sydney, Australia.

family: Robinson

full_name: Bruce Robinson

given: Bruce

name: Department of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.

family: Sherman

full_name: Steven Sherman

given: Steven

family: Habra

full_name: Mouhammed Amir Habra

given: Mouhammed Amir

name: Endocrine Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

family: Elisei

full_name: Rossella Elisei

given: Rossella

name: Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.

family: Wirth

full_name: Lori J. Wirth

given: Lori J.

journal_name: Thyroid

evidence: open (via page says license)

publisher: Mary Ann Liebert Inc

publisher_dissemination: Mary Ann Liebert Inc

publisher_group: Mary Ann Liebert Inc

publisher_normalized: Mary Ann Liebert Inc

ReferenceCitation: Tahara M, Kiyota N, Hoff AO, Badiu C, Owonikoko TK, Dutcus CE, Suzuki T, Ren M, Wirth LJ. Impact of lung metastases on overall survival in the phase 3 SELECT study of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer. Eur J Cancer. 2021 Apr;147:51-57. doi: 10.1016/j.ejca.2020.12.032. Epub 2021 Feb 19.

family: Hoff

full_name: Ana O. Hoff

given: Ana O.

family: Badiu

full_name: Corin Badiu

given: Corin

ReferenceCitation: Tahara M, Brose MS, Wirth LJ, Suzuki T, Miyagishi H, Fujino K, Dutcus CE, Gianoukakis A. Impact of dose interruption on the efficacy of lenvatinib in a phase 3 study in patients with radioiodine-refractory differentiated thyroid cancer. Eur J Cancer. 2019 Jan;106:61-68. doi: 10.1016/j.ejca.2018.10.002. Epub 2018 Nov 22.

ReferenceCitation: Tahara M, Schlumberger M, Elisei R, Habra MA, Kiyota N, Paschke R, Dutcus CE, Hihara T, McGrath S, Matijevic M, Kadowaki T, Funahashi Y, Sherman SI. Exploratory analysis of biomarkers associated with clinical outcomes from the study of lenvatinib in differentiated cancer of the thyroid. Eur J Cancer. 2017 Apr;75:213-221. doi: 10.1016/j.ejca.2017.01.013. Epub 2017 Feb 24.

repository_institution: Kobe University - Kobe University Repository Kernel

ReferenceCitation: Robinson B, Schlumberger M, Wirth LJ, Dutcus CE, Song J, Taylor MH, Kim SB, Krzyzanowska MK, Capdevila J, Sherman SI, Tahara M. Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer. J Clin Endocrinol Metab. 2016 Nov;101(11):4103-4109. Epub 2016 Aug 22.

ReferenceCitation: Kiyota N, Schlumberger M, Muro K, Ando Y, Takahashi S, Kawai Y, Wirth L, Robinson B, Sherman S, Suzuki T, Fujino K, Gupta A, Hayato S, Tahara M. Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer. Cancer Sci. 2015 Dec;106(12):1714-21. doi: 10.1111/cas.12826. Epub 2015 Nov 2.

name: Department of Medical Oncology and Hematology Kobe University Hospital Kobe Japan

name: Department of Nuclear Medicine and Endocrine Oncology Gustave Roussy and University Paris‐Sud Villejuif France

name: Department of Clinical Oncology Aichi Cancer Center Hospital Nagoya Japan

name: Department of Clinical Oncology and Chemotherapy Nagoya University Hospital Nagoya Japan

name: Department of Medical Oncology Cancer Institute Hospital of JFCR Tokyo Japan

name: Department of Hematology and Oncology Fukui Prefectural Hospital Fukui Japan

name: Department of Medicine Massachusetts General Hospital Boston Massachusetts USA

name: Kolling Institute of Medical Research University of Sydney Sydney New South Wales Australia

name: Department of Endocrine Neoplasia and Hormonal Disorders Division of Internal Medicine The University of Texas M.D. Anderson Cancer Center Houston Texas USA

name: Oncology Clinical Development Eisai Co., Ltd Tokyo Japan

name: Japan Biostatistics Eisai Co., Ltd Tokyo Japan

name: Clinical Pharmacology Eisai Ltd. Hatfield UK

name: Clinical Pharmacology Eisai Co., Ltd Tokyo Japan

name: Department of Head and Neck Medical Oncology National Cancer Center Hospital East Kashiwa Japan

title: Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine‐refractory differentiated thyroid cancer

ReferenceCitation: Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30. doi: 10.1056/NEJMoa1406470.

title: Lenvatinib versus Placebo in Radioiodine-Refractory Thyroid Cancer

location_country:
Romania
Australia
Belgium
Russian Federation
Denmark
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Chile
Sweden
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Spain

location_facility:
Facility 1
Facility 3
Eisai Trial Site 1
Facility 4
Facility 2
Facility 5
Eisai Trial Site 2


title: A Postmarket Registry of the BioMatrix™ and BioMatrix Flex™ Drug Eluting Stents.

acronym: eBMX-PMR

summary: The purpose of this registry is to capture clinical data of the BioMatrix™ and BioMatrix Flex™ (Biolimus A9™-Eluting) stent systems in relation to safety and effectiveness.

lead_sponsor: Biosensors Europe SA

location_country:
Austria
Jordan
Switzerland
Morocco
Spain
United Kingdom
France
Czechia
Lithuania
Poland
Ireland
Russian Federation
Portugal
Denmark
Germany
Latvia

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: Hôpital Cardiovasculaire et Pneumologique Louis Pradel

location_facility: Brighton and Sussex University Hospitals

location_facility: Sheffield Teaching Hospitals NHS Foundation Trust

location_facility: Hôpital Militaire d'instruction Mohamed-V


type: Other Identifier

title: Phase 2 Study of LY2157299 in Patients With Hepatocellular Carcinoma

summary: The purpose of this study is to estimate the median time to progression in participants with hepatocellular carcinoma (HCC) when treated with LY2157299 as monotherapy and in combination with sorafenib or ramucirumab.

ReferenceCitation: Giannelli G, Santoro A, Kelley RK, Gane E, Paradis V, Cleverly A, Smith C, Estrem ST, Man M, Wang S, Lahn MM, Raymond E, Benhadji KA, Faivre S. Biomarkers and overall survival in patients with advanced hepatocellular carcinoma treated with TGF-βRI inhibitor galunisertib. PLoS One. 2020 Mar 25;15(3):e0222259. doi: 10.1371/journal.pone.0222259. eCollection 2020. Erratum in: PLoS One. 2020 Jun 25;15(6):e0235580. PLoS One. 2021 Jun 17;16(6):e0253671.

family: Giannelli

full_name: Gianluigi Giannelli

given: Gianluigi

family: Santoro

full_name: Armando Santoro

given: Armando

family: Kelley

full_name: Robin K. Kelley

given: Robin K.

family: Gane

full_name: Ed Gane

given: Ed

family: Paradis

full_name: Valerie Paradis

given: Valerie

family: Cleverly

full_name: Ann Cleverly

given: Ann

family: Smith

full_name: Claire Smith

given: Claire

family: Estrem

full_name: Shawn T. Estrem

given: Shawn T.

family: Man

full_name: Michael Man

given: Michael

family: Wang

full_name: Shuaicheng Wang

given: Shuaicheng

family: Lahn

full_name: Michael M. Lahn

given: Michael M.

family: Raymond

full_name: Eric Raymond

given: Eric

family: Benhadji

full_name: Karim A. Benhadji

given: Karim A.

family: Faivre

full_name: Sandrine Faivre

given: Sandrine

journal_name: PLOS ONE

repository_institution: California Digital Library - eScholarship

publisher: Public Library of Science (PLoS)

publisher_dissemination: Public Library of Science

publisher_group: Public Library of Science

publisher_normalized: Public Library of Science

ReferenceCitation: Addepalli A, Kalyani S, Singh M, Bandyopadhyay D, Mohan KN. CalPen (Calculator of Penetrance), a web-based tool to estimate penetrance in complex genetic disorders. PLoS One. 2020 Jan 29;15(1):e0228156. doi: 10.1371/journal.pone.0228156. eCollection 2020. Erratum in: PLoS One. 2020 Jun 25;15(6):e0235547.

repository_institution: RePEc: Research Papers in Economics - RePEc

ReferenceCitation: Faivre S, Santoro A, Kelley RK, Gane E, Costentin CE, Gueorguieva I, Smith C, Cleverly A, Lahn MM, Raymond E, Benhadji KA, Giannelli G. Novel transforming growth factor beta receptor I kinase inhibitor galunisertib (LY2157299) in advanced hepatocellular carcinoma. Liver Int. 2019 Aug;39(8):1468-1477. doi: 10.1111/liv.14113. Epub 2019 Jun 3.

name: Oncologie Médicale Hopital Beaujon Clichy France

name: Istituto Clinico Humanitas Humanitas University Rozzano Italy

name: University of California San Francisco CA

name: Auckland City Hospital Auckland New Zealand

name: Lilly Research Centre Erl Wood Manor Windlesham UK

name: Centre Hospitalier Paris Saint‐Joseph Paris France

name: National Institute of Gastroenterology Research Instituts “S. De Bellis” Research Hospital, Castellana Grotte Bari Italy

ReferenceCitation: Li S, Yang F, Ren X. Immunotherapy for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):363-71. doi: 10.5582/ddt.2015.01054. Review.

name: National Clinical Research Center for Cancer; Key Laboratory of Cancer Immunology and Biotherapy; Key Laboratory of Cancer Prevention and Therapy

name: Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital

publisher: International Research and Cooperation Association for Bio & Socio-Sciences Advancement (IRCA-BSSA)

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

location_country:
Italy
United States
France
Australia
New Zealand
Spain
Germany

location_facility: Indiana Univ Melvin & Bren Simon Cancer Center

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.