acronym: LUX-Head & Neck 1

summary: This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

ReferenceCitation: Cohen EEW, Licitra LF, Burtness B, Fayette J, Gauler T, Clement PM, Grau JJ, Del Campo JM, Mailliez A, Haddad RI, Vermorken JB, Tahara M, Guigay J, Geoffrois L, Merlano MC, Dupuis N, Kramer N, Cong XJ, Gibson N, Solca F, Ehrnrooth E, Machiels JH. Biomarkers predict enhanced clinical outcomes with afatinib versus methotrexate in patients with second-line recurrent and/or metastatic head and neck cancer. Ann Oncol. 2017 Oct 1;28(10):2526-2532. doi: 10.1093/annonc/mdx344.

repository_institution: KU Leuven - Lirias

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

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repositories_institution: University of California - eScholarship University of California

ReferenceCitation: Clement PM, Gauler T, Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Cohen EE, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Vermorken JB; LUX-H&N 1 investigators. Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial. Ann Oncol. 2016 Aug;27(8):1585-93. doi: 10.1093/annonc/mdw151. Epub 2016 Apr 15.

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

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ReferenceCitation: Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Vermorken JB, Clement PM, Gauler T, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G Jr, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Cohen EE; LUX-H&N 1 investigators. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol. 2015 May;16(5):583-94. doi: 10.1016/S1470-2045(15)70124-5. Epub 2015 Apr 16.

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title: A Randomised, Open-label, Phase III Study to Evaluate the Efficacy and Safety of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy

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Germany
Argentina
Japan
Brazil
Czechia
France
Denmark
Switzerland
United States
Belgium
Italy
Sweden
Austria
Mexico
Spain
Greece
South Africa
Russian Federation
Israel


type: EudraCT Number

title: Open-label, Multi-center, Single Arm Study For The Safety And Efficacy Of Pomalidomide Monotherapy For Subjects With Refractory Or Relapsed And Refractory Multiple Myeloma. A Companion Study For Clinical Trial CC-4047-MM003

summary: The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Moreau P, Weisel KC, Song KW, Gibson CJ, Saunders O, Sternas LA, Hong K, Zaki MH, Dimopoulos MA. Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS). Leuk Lymphoma. 2016 Dec;57(12):2839-2847. doi: 10.1080/10428194.2016.1180685. Epub 2016 May 13.

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ReferenceCitation: Miguel JS, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, Dimopoulos M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1055-1066. doi: 10.1016/S1470-2045(13)70380-2. Epub 2013 Sep 3.

oa_host_type: closed

publisher_dissemination: Elsevier

ReferenceCitation: Morgan G, Palumbo A, Dhanasiri S, Lee D, Weisel K, Facon T, Delforge M, Oriol A, Zaki M, Yu X, Sternas L, Jacques C, Akehurst R, Offner F, Dimopoulos MA. Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone. Br J Haematol. 2015 Mar;168(6):820-3. doi: 10.1111/bjh.13227. Epub 2014 Nov 18.

lead_sponsor: Celgene

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
Spain
Greece
Czechia
Canada
Russian Federation
France

location_facility: Peter McCallum Cancer Institute - Directorate of Cancer Medicine

location_facility: Royal Marsden NHS Foundation Trust - Haematology

location_facility: AO Universitaria San Martino - hematooncology

location_facility: Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

location_facility: Universitätsklinikum Ulm - Klinik fur Innere Medizin III

location_facility: Hospital Clinic i Provincial de Barcelona - Hematology

location_facility: Charles University Hospital - Internal Medicine

location_facility: Centre Hospitalier Départemental Vendée - Onco-hematologie

location_facility: The Alfred Hospital - Malignant Haematology & Stem Cell Transplantation

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie Service des maladies du sang

location_facility: University of Athens - Alexandra Hospital

location_facility: Askepios Klinik Altona-Abteilung Hamatologie und Internistische Onkologie

location_facility: Hospital Germans Trias i Pujol - Hematology

location_facility: Inselspital, Institut für Medizinische Onkologie

location_facility: Royal Prince Alfred Hospital - Institute of Haematology

location_facility: Princess Alexandra Hospital - Haematology

location_facility: Nottingham City Hospital - Centre for Clinical Haematology

location_facility: Karolinska University Hospital Huddinge - Center of hematology

location_facility: Russian Research Institute of Hematology and Blood Transfusion - Hematology

location_facility: Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

location_facility: Universitatsklinikum Carl Gustav Carus-Medizinische Klinik und Poliklinik I

location_facility: Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

location_facility: Royal Bournemouth Hospital - Haematology

location_facility: Royal Wolverhampton Hospitals Trust - Research and Development

location_facility: Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

location_facility: Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

location_facility: Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology

location_facility: A.O.U. San Giovanni Battista - Hematology

location_facility: Ospedale San Luigi AO Luigi Gonzaga - Hematology

location_facility: Centre Hospitalier Lyon sud - Hematologie

location_facility: Hôpital Saint Louis - Immuno-hematologie

location_facility: St James's University Hospital - Haematology

location_facility: CHU Saint Antoine - Service des maladies du sang

location_facility: Karolinska University Hospital Solna- medicine

location_facility: Frankston Hospital-Peninsula Health - Oncology Day Unit

location_facility: Centre Hospitalier de la côte basque - Hematologie

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: British Columbia Cancer Agency, Vancouver Centre

location_facility: Universita degli Studi di Padova - Clinical & Experimental Medicine

location_facility: Freeman Hospital - Northern Centre for Cancer Care

location_facility: Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

location_facility: Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

location_facility: Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

location_facility: Hematological Research Center under the Russian Academy of Medical Sciences - Hematology & BMT

location_facility: Ospedale Guglielmo da Saliceto - hematooncology

location_facility: State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

location_facility: Hôpital Bretonneau - Hématologie & Thérapie cellulaire

location_facility: King's College Hospital - Haematology Clinical Trials

location_facility: CHRU de Lille - Service des maladies du sang

location_facility: Cliniques Universitaires ULC de Mont-Godinne - Hematology

location_facility: St Bartholomew's Hospital - Medical Oncology

location_facility: Hospital Universitario Marqués de Valdecilla - Hematology

location_facility: CHU Angers - Service des maladies du sang

location_facility: Universitätsklinikum Essen, Klinik für Hämatologie Westdeutsches Tumorzentrum

location_facility: Royal Adelaide Hospital - SA Pathology Haematology

location_facility: Royal hallamshire Hospital - Haematology

location_facility: Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

location_facility: Hôpitaux Universitaire de Genève - Oncologie

location_facility: Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

location_facility: Princess Margaret Hospital, University Health Network

location_facility: Sahlgrenska Hospital, University of Goteborg - Hematology

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer

acronym: Prospect

summary: The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.

design_allocation: Randomized

ReferenceType: derived

ReferenceCitation: Gulley JL, Borre M, Vogelzang NJ, Ng S, Agarwal N, Parker CC, Pook DW, Rathenborg P, Flaig TW, Carles J, Saad F, Shore ND, Chen L, Heery CR, Gerritsen WR, Priou F, Langkilde NC, Novikov A, Kantoff PW. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 May 1;37(13):1051-1061. doi: 10.1200/JCO.18.02031. Epub 2019 Feb 28.

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publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: Bavarian Nordic

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Germany
Poland
Israel
United Kingdom
Denmark
Australia
Netherlands
Belgium
United States
Spain
Iceland
Canada
Estonia
Puerto Rico
Russian Federation
France

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries

location_facility: St. Josephs Healthcare Hamilton Research Ethics Board

location_facility: Klinika Urologii i Onkologii Urologicznej, Uniwersytecki Szpital Kliniczny we Wrocławiu

location_facility: National Cancer Institute - Center for Cancer Research

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Centre Alexis Vautrin - Centre Régional de lutte contre le cancer de Lorraine

location_facility: St. Petersburg Medical Academy of Postgraduate Education

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Delaware Valley Urology LLC - Westhampton

location_facility: Urologic Consultants of Southeaster PA LLP

location_facility: University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital

location_facility: Central Texas Veterans Health Care System

location_facility: Presbyterian Hospital Center for Cancer Research

location_facility: Institut Jean Godinot - Centre de lutte contre le cancer

location_facility: Centre Hospitalier Universitaire de Quebec Hotel Dieu

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Orenburg Regional Clinical Oncology Center

location_facility: Klinikum der Johann-Wolfgang-Goethe-Universität Frankfurt am Main

location_facility: Szpital sw Elzbiety - Mokotowskie Centrum Medyczne Sp. z o. o.

location_facility: James H. Quillen Veterans Affairs Medical Center

location_facility: Leeds Teaching Hospitals NHS Trust, St James's University Hospital

location_facility: Hospital Clinico Universitario de Santiago de Compostela

location_facility: Hospital Universitario Fundación Alcorcón

location_facility: James A Haley Veteran Affairs Medical Center

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: Monash Medical Centre - Moorabbin Campus

location_facility: Stavropol Regional Clinical Oncology Dispensary

location_facility: White River Junction Veterans Affairs Medical Center

location_facility: Plymouth Hospitals NHS Trust, Derriford Hospital

location_facility: Klinikum der Friedrich-Schiller-Universität Jena

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Middelheim

location_facility: Urologica Praktyka Lekarska Adam Marcheluk

location_facility: University Hospitals Case Medical Center

location_facility: Miedzyleski Szpital Specjalistyczny w Warszawie

location_facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

location_facility: Moscow Research Oncology Institute n.a. P.A.Gertsen

location_facility: Klinikum der Philipps-Universität Marburg


title: A Phase 3, Muticenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-dose Dexamethasone Versus High-dose Dexamethasone in Subjects With Refractory or Relapsed and Refractory Multiple Myeloma

acronym: NIMBUS

summary: The purpose of this study is to compare efficacy and safety of pomalidomide in combination with low-dose dexamethasone versus high-dose dexamethasone in subjects with refractory or relapsed and refractory multiple myeloma.

ReferenceType: result

ReferenceCitation: Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.

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ReferenceCitation: Weisel KC, Dimopoulos MA, Moreau P, Lacy MQ, Song KW, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Knop S, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel J. Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Haematologica. 2016 Jul;101(7):872-8. doi: 10.3324/haematol.2015.137083. Epub 2016 Apr 14.

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PubMed Central
cris.unibo.it
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ReferenceCitation: Dimopoulos MA, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Spencer A, Knop S, Bahlis NJ, Renner C, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel JF. Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone. Haematologica. 2015 Oct;100(10):1327-33. doi: 10.3324/haematol.2014.117077. Epub 2015 Aug 6.

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ReferenceCitation: San Miguel JF, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Renner C, Bahlis NJ, Yu X, Teasdale T, Sternas L, Jacques C, Zaki MH, Dimopoulos MA. Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma. Haematologica. 2015 Oct;100(10):1334-9. doi: 10.3324/haematol.2015.125864. Epub 2015 Jul 9.

ReferenceCitation: Weisel K, Dimopoulos M, Song KW, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Gibson CJ, Zaki M, Jacques C, San Miguel J. Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. Clin Lymphoma Myeloma Leuk. 2015 Sep;15(9):519-30. doi: 10.1016/j.clml.2015.05.007. Epub 2015 Jun 6.

ReferenceCitation: Song KW, Dimopoulos MA, Weisel KC, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Monzini MS, Zaki M, Jacques C, San Miguel J. Health-related quality of life from the MM-003 trial of pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed and/or refractory multiple myeloma. Haematologica. 2015 Feb;100(2):e63-7. doi: 10.3324/haematol.2014.112557. Epub 2014 Nov 25. No abstract available.

repository_institution: University of Turin - Institutional Research Information System University of Turin

repositories:
PubMed Central
Pure (Denmark)
iris.unito.it

location_country:
Germany
Italy
United Kingdom
Denmark
Australia
Sweden
Netherlands
Switzerland
Belgium
United States
Spain
Greece
Czechia
Canada
Russian Federation
France

location_facility: Azienda Ospedaliera San Giovanni Battista

location_facility: Servizio di Ematologia, A.O. - Arcispedale S.Maria Nuova

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Royal Hallamshire HospitalSheffield Teaching Hospitals NHS Trust

location_facility: St. Petersburg Research Institute of Hematology and Blood Transfusion

location_facility: State Educational Institution, Saint Petersburg State Medical University

location_facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi

location_facility: Royal Victoria Hospital McGill Department of Oncology(RVH)

location_facility: The Royal Wolverhampton Hospital NHS Trust

location_facility: State Institution Hematological Research, Centre of Russian Academy of Medical Science

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: State Institution Moscow Regional Research Clinical Institute

location_facility: Department of Hematology Hematology Centre

location_facility: Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Univerita La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia


title: A Phase III Randomized Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia

acronym: SEAMLESS

summary: This Phase 3 study assesses two drug regimens as the initial treatment of patients who are at least 70 years of age and have newly diagnosed acute myeloid leukemia (AML) for whom the doctor does not recommend the use of standard intensive treatment or the patient has decided not to receive standard intensive treatment after being fully informed about its benefits and risks by his/her doctor. The two drug regimens are sapacitabine administered in alternating cycles with decitabine or decitabine alone. The purpose of the study is to learn which drug regimen is more likely to keep AML in check as long as possible.

ReferenceCitation: Kantarjian HM, Begna KH, Altman JK, Goldberg SL, Sekeres MA, Strickland SA, Arellano ML, Claxton DF, Baer MR, Gautier M, Berman E, Seiter K, Solomon SR, Schiller GJ, Luger SM, Butrym A, Gaidano G, Thomas XG, Montesinos P, Rizzieri DA, Quick DP, Venugopal P, Gaur R, Maness LJ, Kadia TM, Ravandi F, Buyse ME, Chiao JH. Results of a randomized phase 3 study of oral sapacitabine in elderly patients with newly diagnosed acute myeloid leukemia (SEAMLESS). Cancer. 2021 Dec 1;127(23):4421-4431. doi: 10.1002/cncr.33828. Epub 2021 Aug 23.

oa_colors: green other

evidence: open (via free article)

version: acceptedVersion

repository_institution: California Digital Library - eScholarship

version: submittedVersion

repositories_concat: PubMed Central;escholarship.org

unpaywall_oa_status: bronze

publisher_dissemination: Wiley

ipd_sharing: No

lead_sponsor: Cyclacel Pharmaceuticals, Inc.

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Sweden
Switzerland
Austria
Belgium
United States
Spain
France

location_facility: Kings College Hospital and Guys and St Thomas' Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Wroclawiu

location_facility: Cliniques Universitaires UCL de Mont-Godinne

location_facility: Huntsman Cancer Institute at the University of Utah

location_facility: University of Alabama Comprehensive Cancer Center

location_facility: University of Lodz N. Copernicus Memorial Hospital

location_facility: Wojewódzki Szpital Specjalistyczny w Legnicy

location_facility: IHT Instytut Hematologii I Transfuzjologii w Warszawie

location_facility: Shands Cancer Hospital at University of Florida

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: Skåne Universitetssjukhus Univ Hospital Lund

location_facility: John Theurer Cancer Center at the Hackensack University Medical Center

location_facility: Akademickie Centrum Kliniczne Szpital Akademii Medycznej w Gdansku

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Joe Arrington Cancer Research and Treatment Center

location_facility: Ziekenhuis Netwerk Antwerpen Stuivenberg

location_facility: St. Francis Medical Group Oncology and Hematology Specialists

location_facility: Hospital Universitari Germans Trias i Pujol ICO Badalona

location_facility: Abramson Cancer Center of the University of Pennsylvania

location_facility: Westchester Hematology Oncology Group, PC

location_facility: Universita di Bologna Ist Ematologia Oncologia Medica Seragnoli

location_facility: University of Maryland Greenbaum Cancer Center

location_facility: The University of Chicago Medical Center

location_facility: Universitaetsklinikum Charite Berlin, Campus Benjamin Franklin

location_facility: Centre Hospitalier de Saint-Brieuc Yves Ie Foll

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Winship Cancer Institute, Emory University


title: A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an Antidepressants in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

summary: The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

ReferenceCitation: Moller HJ, Demyttenaere K, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Two Phase III randomised double-blind studies of fixed-dose TC-5214 (dexmecamylamine) adjunct to ongoing antidepressant therapy in patients with major depressive disorder and an inadequate response to prior antidepressant therapy. World J Biol Psychiatry. 2015 Oct;16(7):483-501. doi: 10.3109/15622975.2014.989261. Epub 2015 Jan 20.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
Targacept Inc.

location_country:
Germany
Poland
Colombia
Slovakia
Hungary
Argentina
Romania
Brazil
Spain
South Africa
Croatia
Chile
Bulgaria
Ukraine
Serbia
Russian Federation
France


title: Translational Research - Observational Study for Identification of New Possible Prognostic Factors and Future Therapeutic Targets in Children With Acute Lymphoblastic Leukemia (ALL)

summary:
RATIONALE: Collecting and storing samples of tumor tissue, blood, bone marrow, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help the study of cancer in the future. Studying these samples in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is collecting and looking at blood and tissue samples in children with newly diagnosed acute lymphoblastic leukemia.

status: Unknown status

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Other

ReferenceCitation: Matthijssens F, Sharma ND, Nysus M, Nickl CK, Kang H, Perez DR, Lintermans B, Van Loocke W, Roels J, Peirs S, Demoen L, Pieters T, Reunes L, Lammens T, De Moerloose B, Van Nieuwerburgh F, Deforce DL, Cheung LC, Kotecha RS, Risseeuw MD, Van Calenbergh S, Takarada T, Yoneda Y, van Delft FW, Lock RB, Merkley SD, Chigaev A, Sklar LA, Mullighan CG, Loh ML, Winter SS, Hunger SP, Goossens S, Castillo EF, Ornatowski W, Van Vlierberghe P, Matlawska-Wasowska K. RUNX2 regulates leukemic cell metabolism and chemotaxis in high-risk T cell acute lymphoblastic leukemia. J Clin Invest. 2021 Mar 15;131(6):e141566. doi: 10.1172/JCI141566.

evidence: open (via free pdf)

repository_institution: Curtin University - eSpace

repository_institution: Ghent University - Ghent University Academic Bibliography

publisher_dissemination: American Society for Clinical Investigation

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

location_country: Portugal Belgium France

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Hopitaux Universitaires de Strasbourg - Hautepierre

location_facility: Centre Hospitalier Regional De La Citadelle

location_facility: CHU de Toulouse - C.H.U. De Toulouse - Hopital Des Enfants

location_facility: CHRU de Besancon - Hopital Saint-Jacques

location_facility: CHU de Reims - American Memorial Hospital

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Instituto Portugues De Oncologia - Centro Do Porto

intervention_type: Other

status_simplified: Unknown


title: A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)

summary: This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

status: Terminated

time_perspective: Prospective

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Italy
Poland
New Zealand
Slovakia
United Kingdom
Australia
Brazil
Austria
Mexico
United States
Spain
Canada
Puerto Rico
France


lead_sponsor: Shire

summary:
This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation.

Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.

ReferenceCitation: Staller K, Hinson J, Kerstens R, Spalding W, Lembo A. Efficacy of Prucalopride for Chronic Idiopathic Constipation: An Analysis of Participants With Moderate to Very Severe Abdominal Bloating. Am J Gastroenterol. 2022 Jan 1;117(1):184-188. doi: 10.14309/ajg.0000000000001521.

repositories_concat: PubMed Central

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Yiannakou Y, Piessevaux H, Bouchoucha M, Schiefke I, Filip R, Gabalec L, Dina I, Stephenson D, Kerstens R, Etherson K, Levine A. A randomized, double-blind, placebo-controlled, phase 3 trial to evaluate the efficacy, safety, and tolerability of prucalopride in men with chronic constipation. Am J Gastroenterol. 2015 May;110(5):741-8. doi: 10.1038/ajg.2015.115. Epub 2015 Apr 14.

oa_host_type: repository

unpaywall_oa_status: green

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska w Dziedzinie Chirurgii Ogólnej i Gastroenterologii

location_facility: Gastroenterologie und Hepatologie am Johannisplatz

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

location_facility: Instytut Medycyny Wsi im. Witolda Chodźki - Zaklad Endoskopowych Badań Kliniczncyh

location_facility: Spitalul Clinic Judetean Cluj,Clinica Medicala I

location_facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"

location_facility: County Durham & Darlington NHS Foundation Trust

location_facility: Przychodnia Polskiej Fundacji Gastroenterologii Filia Nr 1 NZOZ

location_facility: Hopital Archet 2- service gastro-enterologie et hepatologie

location_facility: Service de Gastroenterologie & INSERM CIC-P 803 - CHU de Dijon

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Hôpital Pontchaillou - Service des Maladies de l'Appareil Digestif

location_facility: Hopital Avicenne, Centre d'exploitation fonctionnelle et reducation digestive

location_facility: Krajska Nemocnice T. Bati a.s., Interni oddeleni - klinika IPVZ; Nemocnicni Lekarna

location_facility: CHU - Hopital Nord, service gastro-enterologie et hepatologie

title: A 12-week, Randomised, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Quality of Life, Safety and Tolerability of Prucalopride in Male Subjects With Chronic Constipation

type: Other Identifier

source: euctr

location_country:
Germany
Poland
United Kingdom
Denmark
Romania
Netherlands
Belgium
Czechia
Bulgaria
France


lead_sponsor: Pierre Fabre Medicament

summary: The increasing use of anthracyclines and taxanes in the adjuvant, neoadjuvant and first-line metastatic settings, led to a raise of patients presenting with metastatic breast cancer after treatment with these agents. Options for the treatment of patients who have progressed after an anthracycline and a taxane are limited. The high level of in-vitro synergy of vinflunine combined with 5-fluorouracil (5-FU) together with the good tolerance and the encouraging response rate observed while combining IV vinflunine to oral capecitabine make it a promising combination to investigate further in a phase III trial. This phase III trial will evaluate the effectiveness and the safety profile of such combination for the treatment of patient with advanced breast cancer previously treated with or resistant to anthracycline and taxane resistant.

ReferenceCitation: Martin M, Campone M, Bondarenko I, Sakaeva D, Krishnamurthy S, Roman L, Lebedeva L, Vedovato JC, Aapro M. Randomised phase III trial of vinflunine plus capecitabine versus capecitabine alone in patients with advanced breast cancer previously treated with an anthracycline and resistant to taxane. Ann Oncol. 2018 May 1;29(5):1195-1202. doi: 10.1093/annonc/mdy063.

license: publisher-specific-oa

license_normalized: publisher-specific

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

location_country:
Poland
Argentina
Brazil
Czechia
Serbia
France
Belarus
Hungary
Switzerland
Ukraine
India
Belgium
Estonia
Italy
United Kingdom
Mexico
Spain
South Africa
Taiwan
Bulgaria
Russian Federation


title: A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety And Tolerability Trial Of Bapineuzumab (AAB-001, ELN115727) In Subjects With Alzheimer Disease Who Are Apolipoprotein E e4 Noncarriers And Participated In Study 3133K1-3000

summary: The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years.

ReferenceCitation: Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y.

publisher_dissemination: Springer-Nature

lead_sponsor: Pfizer

location_country:
Finland
Italy
Poland
Portugal
New Zealand
Slovakia
United Kingdom
Australia
Japan
Netherlands
Sweden
Belgium
Switzerland
Spain
South Africa
Chile
France


lead_sponsor: Boehringer Ingelheim

summary: The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2 different doses compared to Metformin or to Sitagliptin given for 78 weeks in different modalities of treatment in patients with type 2 diabetes mellitus.

ReferenceCitation: Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, Broedl UC. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4015-21. doi: 10.2337/dc13-0663. Epub 2013 Nov 1.

publisher_dissemination: American Diabetes Association

location_facility: 1245.24.3302A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.461004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.471005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421107 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3310A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101023 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.391003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701009 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3302B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821009 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701014 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.471003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381010 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3305A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701010 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.370101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.431001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3311B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101016 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101027 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341010 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101015 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3303B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101024 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385106 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3305B Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.431003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.431002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101014 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421108 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491003 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886107 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3303A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3309A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491012 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.471004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3310C Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491010 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.420102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101025 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381009 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701013 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.391005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.886106 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421105 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.391006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.370102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.381008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372104 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.372102 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101028 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401006 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3304A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.385103 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421106 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.101004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.581004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371106 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.461005 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.821001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.461001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.371107 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.3301A Boehringer Ingelheim Investigational Site

location_facility: 1245.24.701012 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361004 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.401007 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.341008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491008 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.421101 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.361002 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.471001 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491011 Boehringer Ingelheim Investigational Site

location_facility: 1245.24.491004 Boehringer Ingelheim Investigational Site

title: A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 10773 as Monotherapy or in Combination With Metformin in Type 2 Diabetic Patients

location_country:
Finland
Germany
Croatia
France
Czech Republic
Lithuania
Slovakia
Hungary
United States
Latvia
Ukraine
Romania
Estonia
Italy
Norway
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Sweden


summary: The main purpose of this research study is to compare the safety, tolerability, and anti tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new preparation of the active drug paclitaxel. It contains the same medication as the prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine will be tested as therapy for people who have not yet had any cancer treatment for the diagnosis of metastatic melanoma.

ReferenceCitation: Hersh EM, Del Vecchio M, Brown MP, Kefford R, Loquai C, Testori A, Bhatia S, Gutzmer R, Conry R, Haydon A, Robert C, Ernst S, Homsi J, Grob JJ, Kendra K, Agarwala SS, Li M, Clawson A, Brachmann C, Karnoub M, Elias I, Renschler MF, Hauschild A. A randomized, controlled phase III trial of nab-Paclitaxel versus dacarbazine in chemotherapy-naive patients with metastatic melanoma. Ann Oncol. 2015 Nov;26(11):2267-74. doi: 10.1093/annonc/mdv324. Epub 2015 Sep 26.

sponsor_collaborators:
Celgene
University of Arizona

location_facility: IST-Istituto Nazionale per la Ricera sul Cancro

location_facility: San Diego Pacific Oncology and Hematology Associates

location_facility: Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc

location_facility: Sydney West Cancer Trials Centre/Westmead Hospital

location_facility: University of Southern California/Norris Cancer Center

location_facility: Centre Regional Val d' Aurelle Paul Lamarque

location_facility: Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center

location_facility: Univ. of Washington Medical Center/Seattle Cancer Care Alliance

location_facility: Centre Hospitaller Universitaire de Grenoble

location_facility: OH State University Arthur G. James Cancer Hospital

location_facility: Groupe hospitalier Cochin-St. Vincent de Paul

location_facility: University of Miami Hospital and Clincs/SCCC

location_facility: Royal Adelaide Hospital, Department of Medical Oncology

location_facility: University of Arkansa for Medical Sciences

location_facility: McGill University Dept. of Oncology Clinical Research Program

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei T

location_facility: Singleton Hospital, Sothwest Wales Inst.

location_facility: The Ottawa Hospital Regional Cancer Centre

location_facility: Ist. Naz. per lo studio e la cura dei tumori G. Pascale

location_facility: Nottingham University Hospitals NHS Trust

title: An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma

location_country:
Germany
Italy
United Kingdom
Australia
Netherlands
United States
Spain
Canada
France


acronym: BRISK FL

lead_sponsor: Bristol-Myers Squibb

summary: The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

ReferenceCitation: Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27.

repository_institution: University of Cambridge - Apollo

repository_institution: University of Birmingham - University of Birmingham Research Portal

repositories:
PubMed Central
Pure (Denmark)
www.repository.cam.ac.uk

ReferenceCitation: Johnson PJ, Qin S, Park JW, Poon RT, Raoul JL, Philip PA, Hsu CH, Hu TH, Heo J, Xu J, Lu L, Chao Y, Boucher E, Han KH, Paik SW, Robles-Avina J, Kudo M, Yan L, Sobhonslidsuk A, Komov D, Decaens T, Tak WY, Jeng LB, Liu D, Ezzeddine R, Walters I, Cheng AL. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J Clin Oncol. 2013 Oct 1;31(28):3517-24. doi: 10.1200/JCO.2012.48.4410. Epub 2013 Aug 26.

location_facility: Agajanian Institute Of Hematology And Oncology

title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Canada
France
Czech Republic
Hong Kong
United States
India
Belgium
China
Puerto Rico
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden


acronym: ATMOSPHERE

lead_sponsor: Novartis Pharmaceuticals

summary: The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV.

ReferenceCitation: Shen L, Claggett BL, Jhund PS, Abraham WT, Desai AS, Dickstein K, Gong J, Kober LV, Lefkowitz MP, Rouleau JL, Shi VC, Swedberg K, Zile MR, Solomon SD, McMurray JJV. Development and external validation of prognostic models to predict sudden and pump-failure death in patients with HFrEF from PARADIGM-HF and ATMOSPHERE. Clin Res Cardiol. 2021 Aug;110(8):1334-1349. doi: 10.1007/s00392-021-01888-x. Epub 2021 Jun 8.

repository_institution: The University of Glasgow - Enlighten: Publications

repositories_concat: PubMed Central;eprints.gla.ac.uk

ReferenceCitation: Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.

ReferenceCitation: Kristensen SL, Castagno D, Shen L, Jhund PS, Docherty KF, Rorth R, Abraham WT, Desai AS, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators.. Prevalence and incidence of intra-ventricular conduction delays and outcomes in patients with heart failure and reduced ejection fraction: insights from PARADIGM-HF and ATMOSPHERE. Eur J Heart Fail. 2020 Dec;22(12):2370-2379. doi: 10.1002/ejhf.1972. Epub 2020 Sep 14.

repositories_institution: University of Turin - Institutional Research Information System University of Turin

ReferenceCitation: Docherty KF, Shen L, Castagno D, Petrie MC, Abraham WT, Bohm M, Desai AS, Dickstein K, Kober LV, Packer M, Rouleau JL, Solomon SD, Swedberg K, Vazir A, Zile MR, Jhund PS, McMurray JJV. Relationship between heart rate and outcomes in patients in sinus rhythm or atrial fibrillation with heart failure and reduced ejection fraction. Eur J Heart Fail. 2020 Mar;22(3):528-538. doi: 10.1002/ejhf.1682. Epub 2019 Dec 17.

ReferenceCitation: Dewan P, Rorth R, Raparelli V, Campbell RT, Shen L, Jhund PS, Petrie MC, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, O'Meara E, Pfeffer MA, Pitt B, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Sex-Related Differences in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2019 Dec;12(12):e006539. doi: 10.1161/CIRCHEARTFAILURE.119.006539. Epub 2019 Dec 9. Erratum In: Circ Heart Fail. 2020 Jan;13(1):e000036.

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

ReferenceCitation: Shen L, Ramires F, Martinez F, Bodanese LC, Echeverria LE, Gomez EA, Abraham WT, Dickstein K, Kober L, Packer M, Rouleau JL, Solomon SD, Swedberg K, Zile MR, Jhund PS, Gimpelewicz CR, McMurray JJV; PARADIGM-HF and ATMOSPHERE Investigators and Committees. Contemporary Characteristics and Outcomes in Chagasic Heart Failure Compared With Other Nonischemic and Ischemic Cardiomyopathy. Circ Heart Fail. 2017 Nov;10(11):e004361. doi: 10.1161/CIRCHEARTFAILURE.117.004361.

repository_institution: Australian Catholic University - Research Bank

ReferenceCitation: Kristensen SL, Jhund PS, Mogensen UM, Rorth R, Abraham WT, Desai A, Dickstein K, Rouleau JL, Zile MR, Swedberg K, Packer M, Solomon SD, Kober L, McMurray JJV; PARADIGM-HF and ATMOSPHERE Committees and Investigators. Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation. Circ Heart Fail. 2017 Oct;10(10):e004409. doi: 10.1161/CIRCHEARTFAILURE.117.004409.

ReferenceCitation: Kristensen SL, Mogensen UM, Tarnesby G, Gimpelewicz CR, Ali MA, Shao Q, Chiang Y, Jhund PS, Abraham WT, Dickstein K, McMurray JJV, Kober L. Aliskiren alone or in combination with enalapril vs. enalapril among patients with chronic heart failure with and without diabetes: a subgroup analysis from the ATMOSPHERE trial. Eur J Heart Fail. 2018 Jan;20(1):136-147. doi: 10.1002/ejhf.896. Epub 2017 Sep 25.

ReferenceCitation: McMurray JJ, Krum H, Abraham WT, Dickstein K, Kober LV, Desai AS, Solomon SD, Greenlaw N, Ali MA, Chiang Y, Shao Q, Tarnesby G, Massie BM; ATMOSPHERE Committees Investigators. Aliskiren, Enalapril, or Aliskiren and Enalapril in Heart Failure. N Engl J Med. 2016 Apr 21;374(16):1521-32. doi: 10.1056/NEJMoa1514859. Epub 2016 Apr 4.

repository_institution: University of Zurich - Zurich Open Repository and Archive

title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of Both Aliskiren Monotherapy and Aliskiren/Enalapril Combination Therapy Compared to Enalapril Monotherapy, on Morbidity and Mortality in Patients With Chronic Heart Failure (NYHA Class II - IV). The Study is Also Known as Aliskiren Trial of Minimizing OutcomeS in Patients With HEart Failure (ATMOSPHERE).

location_country:
Finland
Germany
Ireland
Poland
Argentina
Australia
Brazil
Costa Rica
Japan
Thailand
Turkey
Canada
France
Czech Republic
Lithuania
Colombia
Portugal
Slovakia
Denmark
Switzerland
United States
Latvia
Dominican Republic
India
Romania
Belgium
China
Peru
Estonia
Puerto Rico
Italy
Norway
United Kingdom
Venezuela
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
South Africa
Taiwan
Russian Federation
Sweden


acronym: ENDORSE

lead_sponsor: Biogen

summary: The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.

ReferenceCitation: Gold R, Arnold DL, Bar-Or A, Fox RJ, Kappos L, Chen C, Parks B, Miller C. Safety and efficacy of delayed-release dimethyl fumarate in patients with relapsing-remitting multiple sclerosis: 9 years' follow-up of DEFINE, CONFIRM, and ENDORSE. Ther Adv Neurol Disord. 2020 May 12;13:1756286420915005. doi: 10.1177/1756286420915005. eCollection 2020. Erratum In: Ther Adv Neurol Disord. 2020 Oct 21;13:1756286420968357.

repository_institution: PubMed Central - Europe PMC

publisher_dissemination: SAGE Publications

ReferenceCitation: Mehta D, Miller C, Arnold DL, Bame E, Bar-Or A, Gold R, Hanna J, Kappos L, Liu S, Matta A, Phillips JT, Robertson D, von Hehn CA, Campbell J, Spach K, Yang L, Fox RJ. Effect of dimethyl fumarate on lymphocytes in RRMS: Implications for clinical practice. Neurology. 2019 Apr 9;92(15):e1724-e1738. doi: 10.1212/WNL.0000000000007262. Epub 2019 Mar 27.

ReferenceCitation: Gold R, Giovannoni G, Phillips JT, Fox RJ, Zhang A, Marantz JL. Sustained Effect of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis: 6-Year Interim Results From an Extension of the DEFINE and CONFIRM Studies. Neurol Ther. 2016 Jun;5(1):45-57. doi: 10.1007/s40120-016-0042-8. Epub 2016 Mar 1.

location_facility:
research Site
Research Site

title: A Dose-Blind, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of Two Doses of BG00012 Monotherapy in Subjects With Relapsing-Remitting Multiple Sclerosis

location_country:
Germany
Ireland
Poland
New Zealand
Australia
Bosnia and Herzegovina
Croatia
Czechia
Canada
Serbia
France
Belarus
Slovakia
Switzerland
United States
Latvia
Ukraine
North Macedonia
India
Romania
Belgium
Moldova, Republic of
Estonia
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Greece
South Africa
Bulgaria
Israel


title: A Randomized, Double-blind Study of the Effect of Avastin Plus Cisplatin and Gemcitabine or Placebo Plus Cisplatin and Gemcitabine on Progression-free Survival in Treatment-naïve Patients With Advanced or Recurrent Non-squamous NSCLC

summary: This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

ReferenceCitation: Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.

ReferenceCitation: Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.

ReferenceCitation: Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.

location_country:
Germany
Poland
Argentina
Australia
Brazil
Thailand
Canada
France
Czech Republic
Hungary
Hong Kong
Belgium
Italy
United Kingdom
Spain
Greece
Taiwan
Bulgaria
Russian Federation
Israel


lead_sponsor: Bayer

summary: The aim of the present study is to investigate whether women taking a new combined oral contraceptive pill (SH T00658ID, estradiol valerate/dienogest) experience fewer hormone withdrawal-associated symptoms such as pelvic pain or headache during their monthly cycle compared to a commonly used contraceptive pill (Microgynon).

ReferenceCitation: Macias G, Merki-Feld GS, Parke S, Mellinger U, Serrani M. Effects of a combined oral contraceptive containing oestradiol valerate/dienogest on hormone withdrawal-associated symptoms: results from the multicentre, randomised, double-blind, active-controlled HARMONY II study. J Obstet Gynaecol. 2013 Aug;33(6):591-6. doi: 10.3109/01443615.2013.800851.

title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Microgynon on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment

primary_purpose: Prevention

location_country:
Finland
Germany
United Kingdom
Australia
Switzerland
Mexico
Spain
Thailand
France


acronym: REALISTIC

lead_sponsor: UCB Pharma

summary: This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.

ReferenceCitation: Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME. Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity. Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.

ReferenceCitation: Weinblatt ME, Fleischmann R, van Vollenhoven RF, Emery P, Huizinga TW, Cutolo M, van der Heijde D, Duncan B, Davies O, Luijtens K, Dougados M. Twenty-eight-week results from the REALISTIC phase IIIb randomized trial: efficacy, safety and predictability of response to certolizumab pegol in a diverse rheumatoid arthritis population. Arthritis Res Ther. 2015 Nov 15;17:325. doi: 10.1186/s13075-015-0841-9.

ReferenceCitation: Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, van Vollenhoven RF, Wollenhaupt J, Bingham CO 3rd, Duncan B, Goel N, Davies OR, Dougados M. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec;51(12):2204-14. doi: 10.1093/rheumatology/kes150. Epub 2012 Aug 25.

title: A Phase IIIb Multicenter Study With a 12-week Double-blind, Placebo-controlled, Randomized Period Followed by an Open-label, Extension Phase Evaluating Safety/Efficacy of Certolizumab Pegol Given to Patients With Active Rheumatoid Arthritis.

location_country:
Germany
Italy
Netherlands
United States
Spain
Canada
France


title: A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma

summary: The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.

ReferenceCitation: Abuhelwa AY, Badaoui S, Yuen HY, McKinnon RA, Ruanglertboon W, Shankaran K, Tuteja A, Sorich MJ, Hopkins AM. A clinical scoring tool validated with machine learning for predicting severe hand-foot syndrome from sorafenib in hepatocellular carcinoma. Cancer Chemother Pharmacol. 2022 Apr;89(4):479-485. doi: 10.1007/s00280-022-04411-9. Epub 2022 Feb 28.

ReferenceCitation: Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.

ReferenceCitation: Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovacs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.

location_country:
Germany
Poland
Australia
Japan
Thailand
Turkey
Canada
France
Hong Kong
United States
Belgium
China
Malaysia
Philippines
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Sweden


title: A Multi-center, Randomized, Vehicle-Controlled Study to Assess the Efficacy and Safety of Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment (BELIEVE)

acronym: BELIEVE

summary: The objective of this study is to assess the efficacy and safety of adalimumab in combination with topical psoriasis treatment, calcipotriol/betamethasone, vs. adalimumab in combination with matching vehicle in subjects with moderate to severe chronic plaque psoriasis.

ReferenceCitation: Paul C, van de Kerkhof P, Puig L, Unnebrink K, Goldblum O, Thaci D. Influence of psoriatic arthritis on the efficacy of adalimumab and on the treatment response of other markers of psoriasis burden: subanalysis of the BELIEVE study. Eur J Dermatol. 2012 Nov-Dec;22(6):762-9. doi: 10.1684/ejd.2012.1863.

lead_sponsor: Abbott

location_country:
Finland
France
Germany
Italy
United Kingdom
Denmark
Sweden
Netherlands
Austria
Belgium
Switzerland
Spain
Greece
Turkey
Czech Republic


title: A Randomized, Multicenter, Phase III Study Comparing the Combination of Pazopanib and Lapatinib Versus Lapatinib Monotherapy in Patients With ErbB2 Over-expressing Inflammatory Breast Cancer

summary: The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Australia
Thailand
Turkey
Pakistan
Chile
Canada
France
Czech Republic
Hong Kong
United States
Morocco
Romania
Tunisia
Belgium
China
Peru
Philippines
Egypt
Italy
United Kingdom
Singapore
Korea, Republic of
Spain
Greece
Taiwan
Russian Federation
Israel


summary: The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.

ReferenceCitation: Chan DL, Yao JC, Carnaghi C, Buzzoni R, Herbst F, Ridolfi A, Strosberg J, Kulke MH, Pavel M, Singh S. Markers of Systemic Inflammation in Neuroendocrine Tumors: A Pooled Analysis of the RADIANT-3 and RADIANT-4 Studies. Pancreas. 2021 Feb 1;50(2):130-137. doi: 10.1097/MPA.0000000000001745.

ReferenceCitation: Yao JC, Voi M, Lincy J, Pavel M. Reply to V. Amoroso et al. J Clin Oncol. 2017 May 1;35(13):1488-1489. doi: 10.1200/JCO.2017.71.3875. Epub 2017 Jan 23. No abstract available.

ReferenceCitation: Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Oberg K. Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. doi: 10.1200/JCO.2016.68.0702. Epub 2016 Sep 30.

ReferenceCitation: Lombard-Bohas C, Yao JC, Hobday T, Van Cutsem E, Wolin EM, Panneerselvam A, Stergiopoulos S, Shah MH, Capdevila J, Pommier R. Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors: a subgroup analysis of the phase III RADIANT-3 trial. Pancreas. 2015 Mar;44(2):181-9. doi: 10.1097/MPA.0000000000000262.

license: unspecified-oa

license_normalized: unspecified-oa

ReferenceCitation: Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Oberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. doi: 10.1056/NEJMoa1009290.

location_facility: Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (4)

location_facility: Indiana University Health Goshen Center for Cancer Dept. of Indiana Univ. Cancer

location_facility: LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Dept. of Neuroendocrine Clinic

location_facility: Oregon Health & Science University Dept. of OHSU (3)

location_facility: University of California San Francisco Dept. of UCSF Comp. Cancer

location_facility: Kaiser Permanente Northwest Franklin Medical Offices

location_facility: Columbia University Medical Center- New York Presbyterian Dept. of Columbia Med. Center

location_facility: St. Luke's Hospital and Health Network St. Luke's Cancer Network

location_facility: Littleton Regional Hospital Dept. of Hematology/Oncology

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept. of OHSU Medical Center

location_facility: University of Pittsburgh Medical Center Hillman Cancer Center

location_facility: University of California at Los Angeles UCLA (3)

location_facility: University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)

location_facility: The Center for Cancer and Blood Disorders

location_facility: University of Texas/MD Anderson Cancer Center Dept of MD Anderson CancerCent

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

location_facility: University of Iowa Medical Center Dept. of Iowa Medical Center

location_facility: H. Lee Moffitt Cancer Center & Research Institute Malignant Hematology Clinic

title: A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)

location_country:
Germany
Italy
Slovakia
United Kingdom
Japan
Brazil
Netherlands
Sweden
Belgium
Switzerland
United States
Korea, Republic of
Spain
Thailand
Greece
Taiwan
Canada
France


title: A Twenty-Four Week, Randomized, Double-Blind, Placebo Controlled, Safety and Efficacy Trial of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in Premenopausal European Women With Hypoactive Sexual Desire Disorder

summary:
To establish efficacy of Flibanserin 50 Milligrams Daily and 100 Milligrams Daily in 6-month treatment, vs placebo for Hypoactive Sexual Desire Disorder in premenopausal European women.

To evaluate safety and tolerability of flibanserin in such patients.

lead_sponsor: Sprout Pharmaceuticals, Inc

location_country:
Finland
Germany
Italy
Hungary
Norway
United Kingdom
Sweden
Netherlands
Austria
Belgium
Spain
Czech Republic
France

location_facility: 511.77.46009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44011 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.39001 IRCCS S. Fondazione Maugeri

location_facility: 511.77.32004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31009 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3305A Boehringer Ingelheim Investigational Site

location_facility: 511.77.3314A Boehringer Ingelheim Investigational Site

location_facility: 511.77.46007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3306A Boehringer Ingelheim Investigational Site

location_facility: 511.77.3302A Boehringer Ingelheim Investigational Site

location_facility: 511.77.44007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3308A Boehringer Ingelheim Investigational Site

location_facility: 511.77.35801 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3312A Boehringer Ingelheim Investigational Site

location_facility: 511.77.49001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35804 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31007 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.43002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3301A Boehringer Ingelheim Investigational Site

location_facility: 511.77.3303A Boehringer Ingelheim Investigational Site

location_facility: 511.77.46002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.42001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49008 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44002 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3311A Boehringer Ingelheim Investigational Site

location_facility: 511.77.35803 Boehringer Ingelheim Investigational Site

location_facility: 511.77.35802 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.32005 Boehringer Ingelheim Investigational Site

location_facility: 511.77.46003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.31001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44010 Boehringer Ingelheim Investigational Site

location_facility: 511.77.3310A Boehringer Ingelheim Investigational Site

location_facility: 511.77.35805 Boehringer Ingelheim Investigational Site

location_facility: 511.77.47004 Boehringer Ingelheim Investigational Site

location_facility: 511.77.34003 Boehringer Ingelheim Investigational Site

location_facility: 511.77.49006 Boehringer Ingelheim Investigational Site

location_facility: 511.77.36001 Boehringer Ingelheim Investigational Site

location_facility: 511.77.44009 Boehringer Ingelheim Investigational Site


acronym: DASISION

summary: The purpose of this clinical research study is to compare the confirmed complete cytogenetic response of dasatinib with that of imatinib within 12 months after randomization in patients with newly diagnosed chronic-phase Philadelphia positive chronic myeloid leukemia. The safety of this treatment will also be studied.

ReferenceCitation: Glauche I, Kuhn M, Baldow C, Schulze P, Rothe T, Liebscher H, Roy A, Wang X, Roeder I. Quantitative prediction of long-term molecular response in TKI-treated CML - Lessons from an imatinib versus dasatinib comparison. Sci Rep. 2018 Aug 17;8(1):12330. doi: 10.1038/s41598-018-29923-4.

repository_normalized: qucosa

repositories:
PubMed Central
qucosa

repositories_concat: PubMed Central;qucosa

ReferenceCitation: Hughes TP, Saglio G, Quintas-Cardama A, Mauro MJ, Kim DW, Lipton JH, Bradley-Garelik MB, Ukropec J, Hochhaus A. BCR-ABL1 mutation development during first-line treatment with dasatinib or imatinib for chronic myeloid leukemia in chronic phase. Leukemia. 2015 Sep;29(9):1832-8. doi: 10.1038/leu.2015.168. Epub 2015 Jun 29.

repository_institution: University of Adelaide - Adelaide Research & Scholarship (AR&S)

ReferenceCitation: Fujisawa S, Nakamae H, Ogura M, Ishizawa K, Taniwaki M, Utsunomiya A, Matsue K, Takamatsu Y, Usuki K, Tanimoto M, Ishida Y, Akiyama H, Onishi S. Efficacy and safety of dasatinib versus imatinib in Japanese patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP): Subset analysis of the DASISION trial with 2-year follow-up. Int J Hematol. 2014 Feb;99(2):141-53. doi: 10.1007/s12185-013-1470-1. Epub 2013 Dec 20.

publisher_dissemination: Springer

ReferenceCitation: Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boque C, Chuah C, Pavlovsky C, Mayer J, Cortes J, Baccarani M, Kim DW, Bradley-Garelik MB, Mohamed H, Wildgust M, Hochhaus A. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2014 Jan 23;123(4):494-500. doi: 10.1182/blood-2013-06-511592. Epub 2013 Dec 5.

publisher_dissemination: American Society of Hematology

ReferenceCitation: Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS, Wang J, Ipina JJ, Kim DW, Ogura M, Pavlovsky C, Junghanss C, Milone JH, Nicolini FE, Robak T, Van Droogenbroeck J, Vellenga E, Bradley-Garelik MB, Zhu C, Hochhaus A. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood. 2012 Feb 2;119(5):1123-9. doi: 10.1182/blood-2011-08-376087. Epub 2011 Dec 9.

ReferenceCitation: Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M, Moiraghi B, Shen Z, Mayer J, Pasquini R, Nakamae H, Huguet F, Boque C, Chuah C, Bleickardt E, Bradley-Garelik MB, Zhu C, Szatrowski T, Shapiro D, Baccarani M. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2260-70. doi: 10.1056/NEJMoa1002315. Epub 2010 Jun 5.

location_facility:
Molecular Md
Local Institution

title: An Open-Label, Randomized, Multicenter Phase III Trial of Dasatinib (SPRYCEL®) vs. Standard Dose Imatinib (400 mg) in the Treatment of Subjects With Newly Diagnosed Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia

location_country:
Germany
Poland
Argentina
Australia
Brazil
Japan
Turkey
Chile
France
Czech Republic
Colombia
Hungary
Denmark
United States
India
Belgium
China
Peru
Italy
Singapore
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Russian Federation


acronym: NEXUS

summary: Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

ReferenceCitation: Paz-Ares LG, Biesma B, Heigener D, von Pawel J, Eisen T, Bennouna J, Zhang L, Liao M, Sun Y, Gans S, Syrigos K, Le Marie E, Gottfried M, Vansteenkiste J, Alberola V, Strauss UP, Montegriffo E, Ong TJ, Santoro A; NSCLC [non-small-cell lung cancer] Research Experience Utilizing Sorafenib (NExUS) Investigators Study Group. Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous non-small-cell lung cancer. J Clin Oncol. 2012 Sep 1;30(25):3084-92. doi: 10.1200/JCO.2011.39.7646. Epub 2012 Jul 30.

title: A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

location_country:
Finland
Germany
Cyprus
Italy
Hungary
Israel
United Kingdom
Brazil
Netherlands
Austria
Belgium
Mexico
Switzerland
China
Spain
Greece
Canada
France