title: A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer

acronym: VOLGA

summary: A Global Study to Determine the Efficacy and Safety of Durvalumab in combination with Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer

ipd_sharing: Yes

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

lead_sponsor: AstraZeneca

location_country:
Greece
Russian Federation
Taiwan
Ukraine
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Colombia
Chile
Hong Kong
Netherlands
Vietnam
Portugal
United States
Germany
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Israel
Spain
Turkey

intervention_type: Procedure


title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

acronym: frontMIND

summary: This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: MorphoSys AG

location_country:
Malaysia
Romania
Australia
Russian Federation
Taiwan
Ukraine
France
Poland
Thailand
Slovakia
Argentina
Canada
Korea, Republic of
Colombia
Philippines
Hungary
Ireland
United States
Germany
United Kingdom
Italy
Austria
Serbia
Czechia
Israel
New Zealand
Spain
Turkey

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of SY-1425 Plus Azacitidine Versus Placebo Plus Azacitidine in Newly Diagnosed, RARA-positive Adult Patients With Higher-risk Myelodysplastic Syndrome

summary: This study compares the efficacy of SY-1425 in combination with azacitidine to azacitidine in combination with placebo in participants who are Retinoic Acid Receptor Alpha (RARA) positive, and newly diagnosed with higher-risk myelodysplastic syndrome (MDS), and who have not received treatment for this diagnosis. The primary goal of the study is to compare the complete remission rate between the two treatment arms.

lead_sponsor: Syros Pharmaceuticals

location_country:
Italy
France
Belgium
Spain
United States

location_facility: American Oncology Partners of Maryland, PA

location_facility: Romagnolo Institute to Study Tumors "Dino Amadori "/ Meldona

location_facility: University of Utah Huntsman Cancer Institute

location_facility: Hospital Universitario Central de Asturia

location_facility: Centre Hospitalier de la Côte Basque Hématologie Clinique

location_facility: SCL Health Research Institute, Inc. (St. Vincent Frontier Cancer Center)

location_facility: Fundación Privada Instituto de Investigación Oncológica Vall d'Hebron

location_facility: Hospital Universitario Fundacion Jimenez Diaz


title: Phase III Study of Trastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

summary: The study will evaluate the efficacy and safety of trastuzumab deruxtecan (also known as T-DXd, DS-8201a), either alone or in combination with pertuzumab, in treating patients with Human epidermal growth factor receptor 2 (HER2)-positive breast cancer as a first line of treatment.

location_country:
Peru
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
France
Japan
Argentina
Canada
Korea, Republic of
South Africa
Sweden
Saudi Arabia
Philippines
Hungary
China
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Israel
Spain
Turkey


title: A Phase III Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of PRM-151 in Patients With Idiopathic Pulmonary Fibrosis

acronym: STARSCAPE

summary: This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Peru
Greece
Belgium
Australia
Taiwan
Ukraine
France
Poland
Norway
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Hungary
China
Portugal
United States
Germany
Italy
Czechia
Israel
New Zealand
Spain

location_facility: University of Iowa Hospitals and Clinics; Investigational Drug Services

location_facility: The Catholic University of Korea Yeouido St. Mary's Hospital; Hematology-Oncology

location_facility: Tel Aviv Sourasky Medical Center; Department of Neurology

location_facility: Hospital Ramón y Cajal;Servicio de Neumología

location_facility: Fondazione Policlinico Universitario A Gemelli; Servizio di Farmacia

location_facility: Austin Hospital; Cancer Clinical Trials Centre

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique

location_facility: Az. Osp. Univ. P. Giaccone; UOC di Pneumologia

location_facility: Thomayerova nemocnice; Lekarna - pavilon H

location_facility: National Academy of Medical Science of Ukraine (NAMS); NRCRM

location_facility: Shaare Zedek Medical Center; Nrphrology Dept.

location_facility: Tianjin Medical University General Hospital

location_facility: Hospital Virgen de las Nieves; Servicio de Neumologia

location_facility: Policlinico Riuniti di Foggia - Department of Medical and Surgical Sciences - University of Foggia

location_facility: Praxis für Pneumologie Dr. Silke Mronga & Dr. Lukas Jerrentrup

location_facility: European Hospital Georges Pompidou (HEGP)

location_facility: University Hospital of Ioannina; Pulmonology Department

location_facility: Soon Chun Hyang University Hospital Bucheon

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

location_facility: Buddhist Tzu Chi Dalin General Hospital; Rheumatology

location_facility: Ospedale San Giuseppe; U.O. di Pneumologia

location_facility: Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz

location_facility: Markusovszky Egyetemi Oktatokorhaz ; SZEMESZET

location_facility: Seoul National University Hospital (SNUH) - Medical Oncology Center

location_facility: Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele

location_facility: IFS - Interdisziplinäres Facharztzentrum; Institut für klinische Forschung Pneumologie

location_facility: Fondazione IRCCS Policlinico San Matteo ; Divisione di Ematologia Dipartimento di Onco-Ematologia

location_facility: Jefferson University Physicians (JUP) - Jefferson Pulmonary

location_facility: Haukeland Universitetshospital; Medicine Dept

location_facility: CHU Tours - Hôpital Bretonneau; Pharmacie

location_facility: Bnai Zion Medical Center; Internal Medicine

location_facility: Centre Hospitalier Regional Universitaire de Lille

location_facility: Hospital Senhora da Oliveira - Guimarães, E.P.E

location_facility: Hospital Universitario Puerta de Hierro - Majadahonda

location_facility: University Of Utah Hosp & Clin; Investigational Pharmacy

location_facility: Servie de Pneumologie et centre de Transplantation Pulmonaire

location_facility: Sint Antonius Ziekenhuis, locatie Nieuwegein

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

location_facility: A.O.U. Sassari; Dip. Medicina Clinica e Sperimentale

location_facility: Yanovskyy Inst of Phth. & Pulm; Clinical-functional

location_facility: Borsod-Abauj-Zemplen (BAZ) Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

location_facility: Far Eastern Memorial Hospital; Department of Clinical Pathology

location_facility: A.O.U. S. Luigi Gonzaga; Interstiziopatie Malattie Rare Polmone

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

location_facility: Seoul National University Bundang Hospital

location_facility: University of Florida Health Pulmonology - Jacksonville

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; Dip. Medicina clinica e Scienze Immunologiche

location_facility: Soroka University Medical Center, Psychiatry; Psychiatry

location_facility: Oslo University Hospital HF, Rikshospitalet

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

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

location_facility: The University of Hong Kong; Queen Mary Hospital

location_facility: AORN Ospedali dei Colli Ospedale Monaldi; UOC Pneumologia ad indirizzo Oncologico

location_facility: CHVNG/E_Unidade 1; Servico de Pneumologia

location_facility: Universidad de Navarra - Clinica Universitaria de Navarra (CUN)

location_facility: University of Padova Ca' Foncello Hospital Immunologic & Respiratory Rare Diseases Center

location_facility: Università degli Studi di Napoli Federico II; Dipartimento di Scienze Oftalmologiche

location_facility: Centre Hospitalier Universitaire de Reims; l'Hopital Maison Blanche

location_facility: Policlinico Tor Vergata - U.O.C. Malattie Apparato Respiratorio

location_facility: Fundacion Respirar (Centro Medico Dra. De Salvo)

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: Hospital d Instructions des Armees Percy

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

location_facility: Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti

location_facility: Tudogyogyintezet Torokbalint; Onkologiai és Jarobeteg Centrum

location_facility: Florida Lung, Asthma and Sleep Specialists (FLASS) - Celebration

location_facility: Ospedale Morgagni Pierantoni; Patologia clinica

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Sarasota Memorial Health Care System; Cancer Research Program

location_facility: Lungenklinik Münnerstadt, Thoraxzentrum Bezirk Unterfranken

location_facility: University General Hospital of Heraklion

location_facility: General Hospital of Thessaloniki G. Papanikolaou

location_facility: CHU de Grenoble - Hôpital André Michallon; Pole Pharmacie

location_facility: Advanced Pulmonary & Sleep Research Institute of Florida

location_facility: CHU Dijon Bourgogne Hôpital François Mitterand

location_facility: Barzilai Medical Center; Neurology Department

location_facility: "Asst Rhodense - Unità operativa di pneumologia Ospedale ""Guido Salvini"" "


ReferenceType: derived

ReferenceCitation: Ross SA, Rafeiro E, Meinicke T, Toorawa R, Weber-Born S, Woerle HJ. Efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, placebo-controlled trial. Curr Med Res Opin. 2012 Sep;28(9):1465-74. Epub 2012 Aug 13.

status: Completed

lead_sponsor: Boehringer Ingelheim

enrollment_type: Actual

location_country:
Italy
India
Netherlands
France
Malaysia
Belgium
Spain
Canada
Korea, Republic of

location_facility: 1218.62.32004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3306A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302G Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304B Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302I Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3308A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304D Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11014 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303C Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39010 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32006 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305B Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39012 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305F Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3303D Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11011 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305H Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31009 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3304A Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3302B Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305I Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11007 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39011 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.34008 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11012 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.60004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.91004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39003 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3305G Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11013 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.32005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39004 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.39002 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11010 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.82001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.31001 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.11005 Boehringer Ingelheim Investigational Site

location_facility: 1218.62.3301A Boehringer Ingelheim Investigational Site

source: euctr

title: 12 Week Randomised Double-blind BI 1356 2.5 mg Bid vs 5 mg qd add-on to Metformin

summary: The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.

status_simplified: Completed


title: An Open-label, Multi-center, Three Arm Randomized Study to Investigate the Safety and Efficacy on Progression-free Survival of RO5072759 + Chlorambucil (GClb) Compared to Rituximab + Chlorambucil (RClb) or Chlorambucil (Clb) Alone in Previously Untreated CLL Patients With Comorbidities.

summary: This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

study_completion_date_type: Actual

ReferenceCitation: Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Döhner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.

family: Sonia Jaramillo

full_name: Sonia Jaramillo

sequence: first

family: Andreas Agathangelidis

full_name: Andreas Agathangelidis

sequence: additional

family: Christof Schneider

full_name: Christof Schneider

family: Jasmin Bahlo

full_name: Jasmin Bahlo

family: Sandra Robrecht

full_name: Sandra Robrecht

family: Eugen Tausch

full_name: Eugen Tausch

family: Johannes Bloehdorn

full_name: Johannes Bloehdorn

family: Manuela Hoechstetter

full_name: Manuela Hoechstetter

family: Kirsten Fischer

full_name: Kirsten Fischer

family: Barbara Eichhorst

full_name: Barbara Eichhorst

family: Valentin Goede

full_name: Valentin Goede

family: Michael Hallek

full_name: Michael Hallek

family: Hartmut Döhner

full_name: Hartmut Döhner

family: Richard Rosenquist

full_name: Richard Rosenquist

family: Paolo Ghia

full_name: Paolo Ghia

family: Kostas Stamatopoulos

full_name: Kostas Stamatopoulos

family: Stephan Stilgenbauer

full_name: Stephan Stilgenbauer

bso_classification: Medical research

currency_apc_doaj: EUR

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: publisher-specific license

license_normalized: publisher-specific

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

license_normalized: no license

repository_normalized: PubMed Central

publisher: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Gibiansky E, Gibiansky L, Buchheit V, Frey N, Brewster M, Fingerle-Rowson G, Jamois C. Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab-refractory follicular lymphoma patients in the GADOLIN phase III study. Br J Clin Pharmacol. 2019 Sep;85(9):1935-1945. doi: 10.1111/bcp.13974. Epub 2019 Jul 12.

family: Gibiansky

full_name: Ekaterina Gibiansky

given: Ekaterina

full_name: Leonid Gibiansky

given: Leonid

name: Pharma Research and Early DevelopmentRoche Innovation Center Basel Basel Switzerland

family: Buchheit

full_name: Vincent Buchheit

given: Vincent

family: Frey

full_name: Nicolas Frey

given: Nicolas

name: Clinical DevelopmentRoche Innovation Center Welwyn Welwyn Garden City UK

family: Brewster

full_name: Michael Brewster

given: Michael

name: Pharma Development Clinical OncologyF. Hoffmann‐La Roche Ltd Basel Switzerland

family: Fingerle‐Rowson

full_name: Günter Fingerle‐Rowson

journal_name: British Journal of Clinical Pharmacology

title: Pharmacokinetics, exposure, efficacy and safety of obinutuzumab in rituximab‐refractory follicular lymphoma patients in the GADOLIN phase III study

ReferenceCitation: Goede V, Fischer K, Busch R, Engelke A, Eichhorst B, Wendtner CM, Chagorova T, de la Serna J, Dilhuydy MS, Illmer T, Opat S, Owen CJ, Samoylova O, Kreuzer KA, Stilgenbauer S, Döhner H, Langerak AW, Ritgen M, Kneba M, Asikanius E, Humphrey K, Wenger M, Hallek M. Obinutuzumab plus chlorambucil in patients with CLL and coexisting conditions. N Engl J Med. 2014 Mar 20;370(12):1101-10. doi: 10.1056/NEJMoa1313984. Epub 2014 Jan 8.

title: Obinutuzumab plus Chlorambucil in Patients with CLL and Coexisting Conditions

location_country:
Romania
Australia
Russian Federation
Denmark
Spain
Croatia
France
Thailand
Slovakia
Argentina
Canada
Hong Kong
Netherlands
Switzerland
Bulgaria
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
Egypt
New Zealand
Estonia


title: A Clinical Outcomes Study of Darapladib Versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE).

acronym: SOLID-TIMI 52

summary: This study will test whether darapladib can safely lower the chances of having a cardiovascular event (such as a heart attack or urgent coronary revascularization (e.g. medical procedures performed to restore the normal blood flow in patients with atherosclerosis)) when treatment is started within 30 days after an acute coronary syndrome (also called ACS).

ReferenceCitation: Correa S, Morrow DA, Braunwald E, Davies RY, Goodrich EL, Murphy SA, Cannon CP, O'Donoghue ML. Cystatin C for Risk Stratification in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2018 Oct 16;7(20):e009077. doi: 10.1161/JAHA.118.009077.

name: TIMI Study Group Division of Cardiovascular Medicine Brigham and Women's Hospital and Harvard Medical School Boston MA

family: Correa

full_name: Simon Correa

given: Simon

family: Morrow

full_name: David A. Morrow

given: David A.

family: Braunwald

full_name: Eugene Braunwald

given: Eugene

name:
GlaxoSmithKline
Collegeville PA

family: Davies

full_name: Richard Y. Davies

given: Richard Y.

family: Goodrich

full_name: Erica L. Goodrich

given: Erica L.

family: Murphy

full_name: Sabina A. Murphy

given: Sabina A.

family: Cannon

full_name: Christopher P. Cannon

given: Christopher P.

family: O'Donoghue

full_name: Michelle L. O'Donoghue

given: Michelle L.

currency_apc_doaj: USD

journal_name: Journal of the American Heart Association

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

version: submittedVersion

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

ReferenceCitation: Barger LK, Rajaratnam SMW, Cannon CP, Lukas MA, Im K, Goodrich EL, Czeisler CA, O'Donoghue ML. Short Sleep Duration, Obstructive Sleep Apnea, Shiftwork, and the Risk of Adverse Cardiovascular Events in Patients After an Acute Coronary Syndrome. J Am Heart Assoc. 2017 Oct 10;6(10). pii: e006959. doi: 10.1161/JAHA.117.006959.

name: Sleep Health Institute and Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA

name: Division of Sleep Medicine, Harvard Medical School, Boston, MA

name: Monash Institute of Cognitive and Clinical Neurosciences and School of Psychological Sciences, Monash University, Clayton, Victoria, Australia

family: Barger

full_name: Laura K. Barger

given: Laura K.

family: Rajaratnam

full_name: Shantha M.W. Rajaratnam

given: Shantha M.W.

name: Thrombolysis in Myocardial Infarction (TIMI) Study Group, Cardiovascular Division, Brigham and Women's Hospital Harvard Medical School, Boston, MA

name: Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, Philadelphia, PA

family: Lukas

full_name: Mary Ann Lukas

given: Mary Ann

family: Im

full_name: KyungAh Im

given: KyungAh

family: Czeisler

full_name: Charles A. Czeisler

given: Charles A.

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

ReferenceCitation: Eisen A, Cannon CP, Braunwald E, Steen DL, Zhou J, Goodrich EL, Im K, Dalby AJ, Spinar J, Daga S, Lukas MA, O'Donoghue ML. Predictors of Nonuse of a High-Potency Statin After an Acute Coronary Syndrome: Insights From the Stabilization of Plaques Using Darapladib-Thrombolysis in Myocardial Infarction 52 (SOLID-TIMI 52) Trial. J Am Heart Assoc. 2017 Jan 11;6(1). pii: e004332. doi: 10.1161/JAHA.116.004332.

name: Cardiovascular Division, Brigham and Women's Hospital, Boston, MA

name: Milpark Hospital, Johannesburg, South Africa

name: University Hospital Brno, Brno, Czech Republic

title: Predictors of Nonuse of a High‐Potency Statin After an Acute Coronary Syndrome: Insights From the Stabilization of Plaques Using Darapladib‐Thrombolysis in Myocardial Infarction 52 (SOLID‐TIMI 52) Trial

ReferenceCitation: O'Donoghue ML, Braunwald E, White HD, Lukas MA, Tarka E, Steg PG, Hochman JS, Bode C, Maggioni AP, Im K, Shannon JB, Davies RY, Murphy SA, Crugnale SE, Wiviott SD, Bonaca MP, Watson DF, Weaver WD, Serruys PW, Cannon CP; SOLID-TIMI 52 Investigators, Steen DL. Effect of darapladib on major coronary events after an acute coronary syndrome: the SOLID-TIMI 52 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1006-15. doi: 10.1001/jama.2014.11061. Erratum in: JAMA. 2014 Oct 8;312(14):1473. Dylan P. Steen[corrected to Dylan L. Steen].

name: TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts

name: Green Lane Cardiovascular Service, Auckland City Hospital, Auckland University, Auckland, New Zealand

name: Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, Philadelphia, Pennsylvania

name: Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, King of Prussia, Pennsylvania

name: Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, and Université Paris-Diderot, Paris, France6NHLI Imperial College, ICMS Royal Brompton Hospital, United Kingdom

name: Department of Medicine, NYU Langone Medical Center, New York

name: Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg, Germany

name: Metabolic Pathways and Cardiovascular Therapeutic Area, GlaxoSmithKline, Research Triangle Park, North Carolina

name: Henry Ford Heart and Vascular Institute, Detroit, Michigan

name: Erasmus University, Thoraxcentrum, Rotterdam, the Netherlands13International Center for Circulatory Health, Imperial College, London, United Kingdom

repository_institution: Alma Mater Studiorum Università di Bologna - Archivio istituzionale della ricerca - Alma Mater Studiorum Università di Bologna

title: Effect of Darapladib on Major Coronary Events After an Acute Coronary Syndrome

ReferenceCitation: O'Donoghue ML, Braunwald E, White HD, Serruys P, Steg PG, Hochman J, Maggioni AP, Bode C, Weaver D, Johnson JL, Cicconetti G, Lukas MA, Tarka E, Cannon CP. Study design and rationale for the Stabilization of pLaques usIng Darapladib-Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome. Am Heart J. 2011 Oct;162(4):613-619.e1. doi: 10.1016/j.ahj.2011.07.018. Epub 2011 Sep 15.

title: Study design and rationale for the Stabilization of pLaques usIng Darapladib—Thrombolysis in Myocardial Infarction (SOLID-TIMI 52) trial in patients after an acute coronary syndrome

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Peru
Romania
Belgium
Australia
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Japan
Poland
Slovakia
Thailand
Argentina
Canada
Korea, Republic of
Colombia
South Africa
Chile
Sweden
Netherlands
Philippines
Bulgaria
Hungary
China
Germany
United States
United Kingdom
Italy
Brazil
Czechia
Israel
New Zealand
Spain
Turkey


type: Other Identifier

type: Registry Identifier

title: A Phase 3, Randomized, Double-blind Study to Compare the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Lenvatinib (E7080/MK-7902) Versus Pembrolizumab and Placebo as First Line Treatment for Locally Advanced or Metastatic Urothelial Carcinoma in Cisplatin-ineligible Participants Whose Tumors Express PD-L1, and in Participants Ineligible for Any Platinum-containing Chemotherapy Regardless of PD-L1 Expression (LEAP-011)

summary:
The purpose of this study is to evaluate the efficacy and safety of lenvatinib (MK-7902/E7080) in combination with pembrolizumab (MK-3475) in the treatment of cisplatin-ineligible participants with a Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10, or in participants ineligible for any platinum-containing chemotherapy regardless of CPS, with advanced/unresectable or metastatic urothelial carcinoma (UC).

The primary hypotheses for this study are that:

Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR), and
Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Overall Survival (OS).

With Amendment 3 study treatment with lenvatinib and placebo was discontinued and all participants were unblinded and continued treatment with pembrolizumab monotherapy only. The pembrolizumab+lenvatinib and the pembrolizumab+placebo arms are no longer active for this study.

With Amendment 3 the external Data Monitoring Committee was discontinued.

status: Active, not recruiting

ReferenceCitation: Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

name: Earle A Chiles Research Institute, Providence Portland Medical Center, Portland, OR 97213, USA

family: Taylor

full_name: Matthew H Taylor

given: Matthew H

name: Department of Clinical Oncology, Merck & Co. Inc., Kenilworth, NJ 07033, USA

family: Schmidt

full_name: Emmett V Schmidt

given: Emmett V

name: Department of Clinical Research, Eisai Inc., Woodcliff Lake, NJ 07677, USA

family: Dutcus

full_name: Corina Dutcus

given: Corina

family: Pinheiro

full_name: Elaine M Pinheiro

given: Elaine M

name: Biomarker Research Translational Science Department, Eisai Co., Ltd., Tokyo, 112-0002, Japan

family: Funahashi

full_name: Yasuhiro Funahashi

given: Yasuhiro

family: Lubiniecki

full_name: Gregory Lubiniecki

given: Gregory

name: The START Center for Cancer Care, San Antonio, TX 78229, USA

family: Rasco

full_name: Drew Rasco

given: Drew

journal_name: Future Oncology

oa_host_type: publisher

evidence: open (via page says license)

publisher: Future Medicine Ltd

publisher_dissemination: Future Science Ltd

publisher_group: Future Science Ltd

publisher_normalized: Future Science Ltd

lead_sponsor: Merck Sharp & Dohme Corp.

location_country:
Italy
United States
Netherlands
Spain
Germany
France
Japan
Poland
Israel
Hungary
Argentina
Australia
Russian Federation
China
Turkey
Denmark
Canada
United Kingdom
Korea, Republic of
Taiwan

location_facility: Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 0509)

location_facility: Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0236)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0216)

location_facility: Kaohsiung Chang Gung Memorial Hospital ( Site 0217)

location_facility: Northwest Georgia Oncology Centers PC ( Site 0707)

location_facility: National Cheng Kung University Hospital ( Site 0215)

location_facility: Centre D Oncologie de Gentilly ( Site 0240)

location_facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0235)

location_facility: Kitasato University Hospital ( Site 0129)

location_facility: Russian Scientific Center of Roentgenoradiology ( Site 0424)

location_facility: Instituto Medico Alexander Fleming ( Site 0578)

location_facility: Chonnam National University Hwasun Hospital ( Site 0194)

location_facility: China Medical University Hospital ( Site 0213)

location_facility: CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507)

location_facility: GBUZ Leningrad Regional Clinical Oncology Dispensary ( Site 0426)

location_facility: Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0271)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0301)

location_facility: Institut de Cancerologie Strasbourg Europe ( Site 0232)

location_facility: Maastricht Universitair Medisch Centrum - MUMC ( Site 0334)

location_facility: Peking University Third Hospital ( Site 0727)

location_facility: Centre Hospitalier de la Cote Basque ( Site 0239)

location_facility: St. Peter's Hospital Cancer Care Center ( Site 0042)

location_facility: Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585)

location_facility: Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0457)

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535)

location_facility: Instituto de Investigaciones Metabolicas ( Site 0589)

location_facility: Hospital General Universitari Vall d Hebron ( Site 0358)

location_facility: Medical Rehabilitation Center ( Site 0411)

location_facility: Centro di Riferimento Oncologico CRO ( Site 0304)

location_facility: Clinical Hospital Saint Luka ( Site 0421)

location_facility: Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0504)

location_facility: Osaka City University Hospital ( Site 0132)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454)

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0774)

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce

location_facility: Zhongshan Hospital Fudan University ( Site 0725)

location_facility: Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284)

location_facility: Kent and Canterbury Hospital ( Site 0390)

location_facility: Fifth Medical Center of CPLA General Hospital ( Site 0732)

location_facility: Taipei Veterans General Hospital ( Site 0212)

location_facility: Xarxa Assistencial Universitaria Manresa ( Site 0354)

location_facility: Ospedale Borgo Roma-Oncologia ( Site 0308)

location_facility: Central Clinical Hospital with Polyclinic ( Site 0415)

location_facility: Hirosaki University Hospital ( Site 0123)

location_facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543)

location_facility: Assaf Harofeh Medical Center ( Site 0556)

location_facility: Universitaetsklinikum Essen ( Site 0274)

location_facility: University College London Hospital NHS Foundation Trust ( Site 0380)

location_facility: Seattle Cancer Care Alliance ( Site 0003)

location_facility: Policlinico S. Orsola - Malpighi (Bologna) ( Site 0302)

location_facility: CHD Vendee-onco-hematologie ( Site 0251)

location_facility: Korea University Anam Hospital ( Site 0197)

location_facility: Hospital Teresa Herrera - Chuac ( Site 0357)

location_facility: Royal Stoke University Hospital Univ. Hosps of North Midlands NHST ( Site 0392)

location_facility: Saitama Medical University International Medical Center ( Site 0125)

location_facility: CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0104)

location_facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0577)

location_facility: Medical Hospital, Tokyo Medical And Dental University ( Site 0130)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 0309)

location_facility: Markusovszky Egyetemi Oktatokorhaz ( Site 0502)

location_facility: University of Tsukuba Hospital ( Site 0126)

location_facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0307)

location_facility: Shaare Zedek Medical Center ( Site 0559)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0541)

location_facility: Taichung Veterans General Hospital ( Site 0214)

location_facility: The First Affiliated Hospital of Xiamen University ( Site 0743)

location_facility: New England Cancer Specialists ( Site 0047)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 0005)

location_facility: Nottingham University Hospital NHS Trust ( Site 0383)

location_facility: University of California Irvine Medical Center ( Site 0078)

location_facility: Thomas Jefferson University Hospital ( Site 0051)

location_facility: Volga District Medical Center Federal Medical and Biological Agency ( Site 0413)

location_facility: Queens Hospital-Purple Zone ( Site 0377)

location_facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 0738)

location_facility: Istituto Tumori Giovanni Paolo II ( Site 0306)

location_facility: Aarhus Universitets hospital ( Site 0683)

location_facility: Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351)

location_facility: Fudan University Shanghai Cancer Center ( Site 0721)

location_facility: Sapporo Medical University Hospital ( Site 0122)

location_facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0282)

location_facility: National Taiwan University Hospital ( Site 0211)

location_facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 0746)

location_facility: Omsk Clinical Oncology Dispensary ( Site 0418)

location_facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 0378)

location_facility: Banner MD Anderson Cancer Center ( Site 0016)

location_facility: Aalborg Universitets Hospital ( Site 0684)

location_facility: Zhejiang Provincial People's Hospital ( Site 0735)

location_facility: Centro Oncológico de Rosario ( Site 0584)

location_facility: Azienda Ospedaliera Santa Maria ( Site 0303)

location_facility: Chungnam National University Hospital ( Site 0195)

location_facility: Hadassah Ein Kerem Medical Center ( Site 0558)

location_facility: Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095)

location_facility: Nanjing Drum Tower Hospital ( Site 0737)

location_facility: Murmansk Regional Oncology Dispensary ( Site 0420)

location_facility: Saint Bartholomew s Hospital - London ( Site 0386)

location_facility: Second Affiliated Hospital, Zhejiang University ( Site 0734)

location_facility: Centro Oncologico de Integracion Regional. COIR ( Site 0576)

location_facility: Tokushima University Hospital ( Site 0134)

location_facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0751)

location_facility: Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0305)

location_facility: National Cancer Center Hospital East ( Site 0128)

location_facility: Universitaetsmedizin Goettingen ( Site 0281)

location_facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0459)

location_facility: Hospital Universitario Gregorio Maranon ( Site 0352)

location_facility: Odense Universitetshospital ( Site 0682)

location_facility: Sun Yat-Sen University Cancer Center ( Site 0752)

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002)

location_facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456)

location_facility: Nagasaki University Hospital ( Site 0136)

location_facility: Seoul National University Hospital ( Site 0191)

location_facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414)

location_facility: Medical University of South Carolina-Hollings Cancer Center ( Site 0029)

location_facility: Harbin Medical University Cancer Hospital ( Site 0750)

location_facility: Sunnybrook Research Institute ( Site 0106)

location_facility: Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277)

location_facility: Peking University First Hospital ( Site 0726)

location_facility: Yamaguchi University Hospital ( Site 0135)

location_facility: Helios Kliniken Schwerin GmbH ( Site 0278)

location_facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 0461)

location_facility: Staedtisches Krankenhaus Kiel GmbH ( Site 0285)

location_facility: Veterans Health Service Medical Center ( Site 0198)

location_facility: Europejskie Centrum Zdrowia Otwock ( Site 0532)

location_facility: Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460)

location_facility: John Wayne Cancer Institute ( Site 0017)

location_facility: Baylor Scott & White Medical Center - Temple ( Site 0706)

location_facility: The First Affiliated Hospital of Guangzhou Medical University ( Site 0749)

location_facility: Orszagos Onkologiai Intezet ( Site 0503)

location_facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0101)

location_facility: Austin Health-Austin Hospital ( Site 0154)

location_facility: Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542)

location_facility: Hospital Universitario HM Sanchinarro ( Site 0356)

location_facility: Nara Medical University Hospital ( Site 0133)

location_facility: Peninsula Health Frankston Hospital ( Site 0153)

location_facility: Centre de Cancerologie du Grand Montpellier ( Site 0249)


intervention_type: Other

ipd_sharing_description: Individual patient level data from this study may be shared with qualified researchers, upon request, following the timelines and process detailed on https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Chile
Mexico
Spain
France
Czechia
Greece
Poland
Romania
Argentina
Russian Federation
Portugal
United States

location_facility: Massachusetts General Hospital Cancer Center Yawkey 7E

location_facility: Radioterapeuticka a onkologicka klinika FNKV

location_facility: Charleston Hematology Oncology Associates, Pa

title: A Phase 3b, Randomized, Double-blind Study of Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy for Patients With Previously Untreated Advanced Renal Cell Carcinoma and Intermediate- or Poor-Risk Factors

summary: The purpose of this study is to test the effectiveness and safety of nivolumab combined with ipilimumab compared to nivolumab monotherapy in participants with previously untreated kidney cancer that has spread.


title: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2)

acronym: LUCENT 2

summary: The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed prior 12-week induction study AMAN (NCT03518086).

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Malaysia
Romania
Australia
Belgium
Russian Federation
Denmark
Taiwan
Ukraine
India
France
Japan
Lithuania
Poland
Slovakia
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Hungary
Ireland
China
Germany
United States
United Kingdom
Italy
Austria
Serbia
Mexico
Czechia
Israel
Spain
Turkey
Latvia

location_facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine

location_facility: Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -

location_facility: Ishida Clinic of IBD and Gastroenterology

location_facility: The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA

location_facility: UMC Utrecht, Dept. of Internal Medicine, MDL

location_facility: Clinical Trials Center of Medical Institute

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Tokushukai Sapporo Higashi Tokushukai Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2

location_facility: Policlinico Gemelli - Università Cattolica del Sacro Cuore

location_facility: Gastroenterology Research of San Antonio

location_facility: Hamburgisches Forschungsinstitut fuer Chronisch Entzuendliche Darmerkrankungen

location_facility: Pauls Stradins Clinical Univeristy Hospital

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Escorts Heart Institute and Research Centre Ltd

location_facility: KM Management spol. s r.o. Gastroenterologicke a hepatologicke centrum

location_facility: University of North Carolina Center for Inflammatory Bowel Disease

location_facility: Communal City Clinical Hospital of Ambulance

location_facility: Renji Hospital Affliated to Shanghai Jiaotong University

location_facility: Communal Non-Commercial Enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

location_facility: Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica

location_facility: Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2

location_facility: Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus

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

location_facility: Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Hopital de Hautepierre - Service d'Hépatogastroentérolgie

location_facility: Ivano-Frankivsk Regional Clinical Hospital

location_facility: Gastro I s.r.o., Gastroenterologická ambulancia

location_facility: Kunming Medical College Affiliated First Hospital

location_facility: Xiangya Hospital Central South University

location_facility: Shengjing Hospital of China Medical University

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

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Bangalore Medical College and Research Institute

location_facility: Riga Eastern Clinical University Hospital

location_facility: Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia

location_facility: State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan"

location_facility: Care Access Research LLC - Salt Lake City

location_facility: Gen1 Research - Gastroenterology & Nutrition, PC

location_facility: Vilnius University Hospital Santariskiu Clinics

location_facility: Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: Research Associates of South Florida, LLC

location_facility: Centro Para el Desarrollo de la Medicina y de Asistencia Med

location_facility: Multidisciplinary Medical Clinic "Anthurium"

location_facility: The Sixth Affiliated Hospital, Sun Yat-Sen University

location_facility: Karelia Republican Hospital V.A. Baranova

location_facility: Nanjing Medical University - Nanjing Jiangning Hospital

location_facility: Centro de Investigaciones Médicas Tucuman

location_facility: Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo

location_facility: Medical and Sanitary Division of Severstal

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Showa University Northern Yokohama Hospital

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

location_facility: Centro de Investigaciones Metabólicas (CINME)

location_facility: Jiangsu Province Hospital of Chinese Medicine

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM

location_facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne

location_facility: Galilee Medical Center Department of Internal Medicine A

location_facility: The Gordon and Leslie Diamond Health Care Centre

location_facility: Wojewodzki Specjalistyczny Szpital w Olsztynie

location_facility: Apollo Research and Innovations, Apollo Hospitals International Ltd

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

location_facility: Azienda Ospedaliera Universitaria Policlinico de Modena

location_facility: Praxis Balsiger, Seibold & Partner und Crohn-Colitis-Zentrum

location_facility: Centre de santé et de services sociaux Champlain-Charles-Le Moyne

location_facility: Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation

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

location_facility: The First Hospital Affiliated to AMU (Southwest Hospital)

location_facility: The Second Affiliated Hospital of Zhejiang University School of Med

location_facility: No.1 Hospital Affiliated to Xinjiang Medical University

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Yaroslavl Municipal HI Clinical Hospital #8

location_facility: First Affiliated Hosp of College of Med, Zhejiang University

location_facility: Centro de Investigación Clínica Acelerada

location_facility: Centre Hospitalier de Wallonie Picarde - Site Notre Dame

location_facility: Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii

location_facility: Communal Institution "Poltava Reg.Cl.H. n.a.M.V.Sklifosovskogo"

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 4

location_facility: Clinical Applications Laboratories, Inc.

location_facility: Sankikai Yokohama Shin midori General Hospital

location_facility: Tokyo Medical And Dental University Medical Hospital

location_facility: Centrum Zdrowia Matki, Dziecka i Młodzieży (CZMDM) Przychodnie

location_facility: Clinical Center Kragujevac Gastroenterohepatology Clinic

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

location_facility: The Second Affiliated Hospital of Wenzhou Medical College

location_facility: The Second Hospital of Dalian Medical University

location_facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.

location_facility: The University of Hong Kong-Shenzhen Hospital

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas

location_facility: Gastroenterology Associates of Western Michigan, P.L.C.

location_facility: CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro

location_facility: Hospital Privado Centro Medico de Cordoba SA

location_facility: Poona Medical Foundation. Ruby Hall Clinic

location_facility: Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital

location_facility: Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"

location_facility: Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre

location_facility: Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

location_facility: Irkutsk State Medical Academy of Continuing Education

location_facility: Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod

location_facility: The First People's Hospital of Yunnan Province

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika

location_facility: Digestive Health Specialists of the Southeast

location_facility: Hospital Universitario Central de Asturias

location_facility: Gastroenterology Associates of Pensacola, PA

location_facility: LLC Scientific Research Centre EKO-Bezopasnost

location_facility: Kocaeli University Medical Faculty Hospital

location_facility: Azienda Ospedaliero Universitaria San Martino

location_facility: Shinseikai Sai Gastroenterology, proctology

location_facility: Melbourne Gastrointestinal Investigation Unit (MGIU)

location_facility: Toho University School of Medicine, Sakura Hospital

location_facility: NZOZ ALL-MEDICUS, Zaklad Gastroenterologii

location_facility: Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"

location_facility: Nizhegorodskiy Regional Clinical Hospital N.A.Semashko

location_facility: Cotton-O'Neil Clinical Research Center, Digestive Health

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej SONOMED

location_facility: A. Novak Transcarpathian Regional Clinical Hospital

location_facility: M S Ramaiah Medical College and Hospitals

location_facility: Acibadem Universitesi - Acibadem Kozyatagi Hastanesi

location_facility: Endomed, s.r.o.- Gastroenterologicka ambulancia

location_facility: Center Hospital of the National Center for Global Health and Medicine

location_facility: Azienda ospedaliero-universitaria Mater Domini

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia

location_facility: Kitasato University Kitasato Institute Hospital


title: AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

summary: This randomized, open-label, 2-arm study will evaluate the efficacy and safety of Avastin added to chemotherapy versus chemotherapy alone in patients with epithelial ovarian, fallopian tube or primary peritoneal cancer with disease progression within 6 months of platinum therapy. All patients will receive standard chemotherapy with either paclitaxel or topotecan or liposomal doxorubicin. Patients randomized to Arm 2 of the study will receive Avastin (10 mg/kg iv 2-weekly or 15 mg/kg iv 3-weekly) concomitantly. Anticipated time on study treatment is until disease progression. Patients will then receive standard of care, those in Arm 1 (chemotherapy only) may opt to receive Avastin (15 mg/kg iv 3-weekly). Target sample size is 100-500 individuals.

ReferenceCitation: Roncolato FT, Gibbs E, Lee CK, Asher R, Davies LC, Gebski VJ, Friedlander M, Hilpert F, Wenzel L, Stockler MR, King M, Pujade-Lauraine E. Quality of life predicts overall survival in women with platinum-resistant ovarian cancer: an AURELIA substudy. Ann Oncol. 2017 Aug 1;28(8):1849-1855. doi: 10.1093/annonc/mdx229.

family: Roncolato

full_name: F.T. Roncolato

family: Gibbs

full_name: E. Gibbs

given: E.

family: Lee

full_name: C.K. Lee

family: Asher

full_name: R. Asher

given: R.

family: Davies

full_name: L.C. Davies

family: Gebski

full_name: V.J. Gebski

family: Friedlander

full_name: M. Friedlander

given: M.

family: Hilpert

full_name: F. Hilpert

given: F.

family: Wenzel

full_name: L. Wenzel

given: L.

family: Stockler

full_name: M.R. Stockler

family: King

full_name: M. King

family: Pujade-Lauraine

full_name: E. Pujade-Lauraine

journal_name: Annals of Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Bamias A, Gibbs E, Khoon Lee C, Davies L, Dimopoulos M, Zagouri F, Veillard AS, Kosse J, Santaballa A, Mirza MR, Tabaro G, Vergote I, Bloemendal H, Lykka M, Floquet A, Gebski V, Pujade-Lauraine E. Bevacizumab with or after chemotherapy for platinum-resistant recurrent ovarian cancer: exploratory analyses of the AURELIA trial. Ann Oncol. 2017 Aug 1;28(8):1842-1848. doi: 10.1093/annonc/mdx228.

family: Bamias

full_name: A. Bamias

given: A.

family: Khoon Lee

full_name: C. Khoon Lee

given: C.

full_name: L. Davies

family: Dimopoulos

full_name: M. Dimopoulos

family: Zagouri

full_name: F. Zagouri

ReferenceCitation: Sorio R, Roemer-Becuwe C, Hilpert F, Gibbs E, García Y, Kaern J, Huizing M, Witteveen P, Zagouri F, Coeffic D, Lück HJ, González-Martín A, Kristensen G, Levaché CB, Lee CK, Gebski V, Pujade-Lauraine E; AURELIA Investigators. Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial. Gynecol Oncol. 2017 Jan;144(1):65-71. doi: 10.1016/j.ygyno.2016.11.006. Epub 2016 Nov 18.

ReferenceCitation: Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E. Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer. J Clin Oncol. 2014 May 1;32(13):1309-16. doi: 10.1200/JCO.2013.51.4240. Epub 2014 Mar 31.

name: Martin R. Stockler, Madeleine T. King, Chee Khoon Lee, The University of Sydney; Michael Friedlander, Prince of Wales Clinical School, University of New South Wales, Sydney, Australia; Felix Hilpert, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Klinik für Gynäkologie und Geburtshilfe, Kiel; Nikolaus de Gregorio, AGO and University of Ulm Medical Center, Ulm, Germany; Lari Wenzel, University of California Irvine, Irvine, CA; Florence Joly, Group d'Investigateurs Nationaux pour l'Etude des...

publisher: American Society of Clinical Oncology (ASCO)

title: Patient-Reported Outcome Results From the Open-Label Phase III AURELIA Trial Evaluating Bevacizumab-Containing Therapy for Platinum-Resistant Ovarian Cancer

ReferenceCitation: Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17. Erratum in: J Clin Oncol. 2014 Dec 10;32(35):4025.

name: Eric Pujade-Lauraine, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Université Paris Descartes, Assistance Publique–Hôpitaux de Paris, Paris; Béatrice Weber, GINECO and Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Philippe Follana, GINECO and Centre Antoine-Lacassagne, Nice; Isabelle Ray-Coquard, GINECO and Centre Léon Bérard, Lyon, France; Felix Hilpert, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Klinik für Gynäkologie und Geburtshilfe, Kiel; Alexander Reuss...

title: Bevacizumab Combined With Chemotherapy for Platinum-Resistant Recurrent Ovarian Cancer: The AURELIA Open-Label Randomized Phase III Trial

location_country:
Italy
Bosnia and Herzegovina
Sweden
Netherlands
Spain
Finland
France
Greece
Norway
Belgium
Portugal
Turkey
Denmark
Germany


ReferenceCitation: Modi S. Trastuzumab deruxtecan in previously treated HER2-positive metastatic breast cancer: Plain language summary of the DESTINY-Breast01 study. Future Oncol. 2021 Sep 1;17(26):3415-3423. doi: 10.2217/fon-2021-0427. Epub 2021 Jul 15.

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

family: Modi

full_name: Shanu Modi

given: Shanu

license: cc-by-nd

license_normalized: cc-by-nd

ReferenceCitation: Yin O, Iwata H, Lin CC, Tamura K, Watanabe J, Wada R, Kastrissios H, AbuTarif M, Garimella T, Lee C, Zhang L, Shahidi J, LaCreta F. Exposure-Response Relationships in Patients With HER2-Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan. Clin Pharmacol Ther. 2021 Oct;110(4):986-996. doi: 10.1002/cpt.2291. Epub 2021 Jun 10.

name: Daiichi Sankyo, Inc. Basking Ridge New Jersey USA

family: Yin

full_name: Ophelia Yin

given: Ophelia

family: Iwata

full_name: Hiroji Iwata

given: Hiroji

name: National Taiwan University Hospital Taipei Taiwan

family: Lin

full_name: Chia‐Chi Lin

given: Chia‐Chi

name: National Cancer Center Japan Tokyo Japan

family: Tamura

full_name: Kenji Tamura

given: Kenji

family: Watanabe

full_name: Junichiro Watanabe

given: Junichiro

name: Certara USA, Inc. Princeton New Jersey USA

family: Wada

full_name: Russ Wada

given: Russ

family: Kastrissios

full_name: Helen Kastrissios

given: Helen

family: AbuTarif

full_name: Malaz AbuTarif

given: Malaz

family: Garimella

full_name: Tushar Garimella

given: Tushar

full_name: Caleb Lee

given: Caleb

family: Zhang

full_name: Lin Zhang

given: Lin

family: Shahidi

full_name: Javad Shahidi

given: Javad

family: LaCreta

full_name: Frank LaCreta

given: Frank

journal_name: Clinical Pharmacology & Therapeutics

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

title: Exposure‐Response Relationships in Patients With HER2‐Positive Metastatic Breast Cancer and Other Solid Tumors Treated With Trastuzumab Deruxtecan

ReferenceCitation: Modi S, Saura C, Yamashita T, Park YH, Kim SB, Tamura K, Andre F, Iwata H, Ito Y, Tsurutani J, Sohn J, Denduluri N, Perrin C, Aogi K, Tokunaga E, Im SA, Lee KS, Hurvitz SA, Cortes J, Lee C, Chen S, Zhang L, Shahidi J, Yver A, Krop I; DESTINY-Breast01 Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):610-621. doi: 10.1056/NEJMoa1914510. Epub 2019 Dec 11.

name: From Memorial Sloan Kettering Cancer Center, New York (S.M.); Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona (C.S., J.C.), and IOB Institute of Oncology, Quiron Group, Barcelona and Madrid (J.C.); Kanagawa Cancer Center, Yokohama (T.Y.), National Cancer Center Hospital (K.T.), the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (Y.I.), and the Advanced Cancer Translational Research Institute, Showa University (J.T.), Tokyo, Aichi Cancer Center...

family: Saura

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Italy
United States
France
Japan
Belgium
Spain
Canada
United Kingdom
Korea, Republic of

location_facility: North Shore Hematology Oncology Associates PC DBA NY Cancer and Blood Specialists

location_facility: University of Louisville Research Foundation

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Washington University School of Medicine

location_facility: Seoul National University Bundang Hospital

location_facility: The Methodist Hospital Research Institute

location_facility: Providence Regional Medical Center - Everett

location_facility: ICO l´Hospitalet - Hospital Duran i Reynals

location_facility: Institut Régional du Cancer de Montpellier

location_facility: Miami Cancer Institute at Baptist Health, Inc.

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Innovative Clinical Research Institute, LLC

location_facility: Sylvester Comprehensive Cancer Center - Deerfield Beach

location_facility: The Regents of the University of California

location_facility: Nottingham University Hospitals City Campus

title: A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)

summary: Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.


ReferenceType: result

ReferenceCitation: Capehorn MS, Catarig AM, Furberg JK, Janez A, Price HC, Tadayon S, Vergès B, Marre M. Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10). Diabetes Metab. 2020 Apr;46(2):100-109. doi: 10.1016/j.diabet.2019.101117. Epub 2019 Sep 17.

family: Capehorn

full_name: M.S. Capehorn

family: Catarig

full_name: A.-M. Catarig

family: Furberg

full_name: J.K. Furberg

family: Janez

full_name: A. Janez

family: Price

full_name: H.C. Price

family: Tadayon

full_name: S. Tadayon

given: S.

family: Vergès

full_name: B. Vergès

given: B.

family: Marre

full_name: M. Marre

given: M.

journal_name: Diabetes & Metabolism

title: Efficacy and safety of once-weekly semaglutide 1.0 mg vs once-daily liraglutide 1.2 mg as add-on to 1–3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10)

ReferenceCitation: Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jódar E. Once-Weekly Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.

full_name: Matthew Capehorn

given: Matthew

family: Ghani

full_name: Yasmin Ghani

given: Yasmin

family: Hindsberger

full_name: Charlotte Hindsberger

given: Charlotte

family: Johansen

full_name: Pierre Johansen

given: Pierre

family: Jódar

full_name: Esteban Jódar

given: Esteban

journal_name: Diabetes Therapy

license: cc-by-nc

license_normalized: cc-by-nc

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

title: Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2–4 and 10

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

lead_sponsor: Novo Nordisk A/S

location_country:
Italy
Sweden
United Kingdom
Finland
France
Czechia
Bulgaria
Poland
Hungary
Spain
Germany
Slovenia

acronym: SUSTAIN 10

title: Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes

summary: This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.


title: A Randomized Controlled, Open Label, Adaptive Phase-3 Trial to Evaluate Safety and Efficacy of EndoTAG-1 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas Failed on FOLFIRINOX Treatment

summary: The aim of this adaptive Phase 3 trial is to show a statistically significant superiority of EndoTAG-1 in combination with gemcitabine compared to gemcitabine monotherapy in patients with locally advanced/metastatic pancreatic cancer after FOLFIRINOX failure.

lead_sponsor: SynCore Biotechnology Co., Ltd.

location_country:
France
Israel
Hungary
Russian Federation
United States
Korea, Republic of
Taiwan

location_facility: Chang Gung Medical Foundation - Kaohsiung Branch

location_facility: Budget Institution of Healthcare of Omsk Region "Clinical Oncology Dispensary"

location_facility: Dél-pesti Centrumkórház - Országos Hematológia és Infektológia Intézet

location_facility: The Center for Cancer and Blood Disorders

location_facility: Kursk State Clinical Oncology Dispensary

location_facility: Chang Gung Medical Foundation - Linkou Branch

location_facility: Pécsi Tudomány Egyetem Onkoterápiás Intézet

location_facility: Cotton O'Neil Cancer Center (Stormont-Vail Cancer Center)

location_facility: Clinique Sainte Anne/Strasbourg Oncologie Leberale

location_facility: State Budget Healthcare Institution "Orenburg Region Clinical Oncological Dispensary"

location_facility: Investigator Clinical Research Centers of Indiana

location_facility: Scott & White Vasicek Cancer Treatment Center

location_facility: Federal State Budgetary Scientific Institution "Russian Oncological Scientific Center named after N.N.Blokhin"

location_facility: John B. Amos Cancer Center / IACT Health

location_facility: Southeast Nebraska Cancer Center (SNCC) - Central Clinic - Main Clinic

location_facility: State Budgetary Healthcare Institution Leningrad Regional Oncology Center

location_facility: North Mississippi Hematology & Oncology Associates, Ltd.

location_facility: Guthrie - Corning Hospital - Guthrie Cancer Center

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Chonnam National University Hwasun Hospital

location_facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház

location_facility: Bács-Kiskun Megyei Kórház Onkoradiológiai Központ

location_facility: Compassionate Cancer Care Medical Group, Inc


title: An Observational Study of Blinatumomab Safety and Effectiveness, Utilization, and Treatment Practices

summary: An observational study of blinatumomab safety and effectiveness, utilisation, and treatment practices.

study_type: Observational

time_perspective: Prospective

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

lead_sponsor: Amgen

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
Finland
France
Czechia
Greece
Poland
Portugal
Germany
United Kingdom

location_facility: Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

location_facility: Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo

location_facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im K Marcinkowskiego w Poznaniu

location_facility: Centro Hospitalar Universitario de Coimbra

location_facility: Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

location_facility: Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito

location_facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez

location_facility: Szpital Specjalistyczny imienia Ludwika Rydygiera w Krakowie Sp zoo

location_facility: Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universität Frankfurt am Main

location_facility: Azienda Ospedaliero Universitaria Careggi

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Azienda Ospedaliera Ordine Mauriziano - Presidio Umberto I

location_facility: Azienda Unita Sanitaria Locale Istituto di Ricovero di Reggio Emilia Arcispedale Santa Maria Nuova

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Centre Hospitalier Universitaire de Clermont Ferrand - Hopital Estaing

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: Centre Hospitalier Universitaire Dieu Angers

location_facility: Instituto Oncologico Della Svizzera Italiana

location_facility: Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele Presidio Ospedaliero G Rodolico

location_facility: St James University Hospital, St James Institute of Oncology

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Azienda Ospedaliero Universitaria di Modena

location_facility: Uniwersytecki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Centre Hospitalier Universitaire de Nice

location_facility: Centre Hospitalier Universitaire de Poitiers - Hopital la Miletrie

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint Eloi

location_facility: Centre Hospitalier Regional Universitaire de Besancon, Hopital Jean Minjoz


ReferenceCitation: Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2021 Sep 13. doi: 10.1038/s41391-021-00447-9. [Epub ahead of print]

family: Tombal

full_name: Bertrand F. Tombal

given: Bertrand F.

family: Freedland

full_name: Stephen J. Freedland

given: Stephen J.

family: Armstrong

full_name: Andrew J. Armstrong

given: Andrew J.

family: Beer

full_name: Tomasz M. Beer

given: Tomasz M.

family: Stenzl

full_name: Arnulf Stenzl

given: Arnulf

family: Sternberg

full_name: Cora N. Sternberg

given: Cora N.

family: Hussain

full_name: Maha Hussain

given: Maha

family: Ganguli

full_name: Arijit Ganguli

given: Arijit

family: Ramaswamy

full_name: Krishnan Ramaswamy

given: Krishnan

family: Bhadauria

full_name: Hemant Bhadauria

given: Hemant

family: Ivanescu

full_name: Cristina Ivanescu

given: Cristina

family: Turnbull

full_name: James Turnbull

given: James

family: Holmstrom

full_name: Stefan Holmstrom

given: Stefan

family: Saad

full_name: Fred Saad

given: Fred

journal_name: Prostate Cancer and Prostatic Diseases

license: cc-by

license_normalized: cc-by

ReferenceCitation: Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.

name: Division of Medical Oncology and Urology, Duke Cancer Institute Center for Prostate and Urologic Cancers, Duke University, Durham, North Carolina

name: Biostatistics, Pfizer Inc, Cambridge, Massachusetts

family: Al-Adhami

full_name: Mohammed Al-Adhami

given: Mohammed

name: Biostatistics, Pfizer Inc, San Francisco, California

family: Lin

full_name: Ping Lin

given: Ping

name: Clinical Development, Pfizer Inc, San Francisco, California

family: Parli

full_name: Teresa Parli

given: Teresa

name: Biostatistics, Astellas Pharma Inc, Northbrook, Illinois

family: Sugg

full_name: Jennifer Sugg

given: Jennifer

name: Clinical Development, Astellas Pharma Inc, Northbrook, Illinois

family: Steinberg

full_name: Joyce Steinberg

given: Joyce

name: Division of Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium

full_name: Bertrand Tombal

given: Bertrand

name: Medical Oncology, Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, New York

name: Division of Clinical Studies, The Institute of Cancer Research, The Royal Marsden National Health Service Foundation Trust, London, United Kingdom

name: Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, New York

name: Division of Hematology/Medical Oncology, OHSU Knight Cancer Institute, Oregon Health & Science University, Portland

ReferenceCitation: Poon DMC, Wong KCW, Chan TW, Law K, Chan K, Lee EKC, Lee C, Chan M; Hong Kong Society of Uro-Oncology (HKSUO). Survival Outcomes, Prostate-specific Antigen Response, and Tolerance in First and Later Lines of Enzalutamide Treatment for Metastatic Castration-resistant Prostate Cancer: A Real-World Experience in Hong Kong. Clin Genitourin Cancer. 2018 Oct;16(5):402-412.e1. doi: 10.1016/j.clgc.2018.07.008. Epub 2018 Jul 21. Erratum in: Clin Genitourin Cancer. 2019 Jun;17(3):240.

ReferenceCitation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

name: Glenn Heller, Martin Fleisher, and Howard I. Scher, Memorial Sloan Kettering Cancer Center; Howard I. Scher, Weill Cornell Medical College, New York, NY; Robert McCormack, Janssen Research & Development, Raritan, NJ; Thian Kheoh and Arturo Molina, Janssen Research & Development, Los Angeles; Dana T. Aftab, Exelixis, South San Francisco; Mohammad Hirmand, Medivation, San Francisco, CA; Matthew R. Smith, Massachusetts General Hospital, Boston; Ana Limon, Takeda Oncology, Cambridge, MA; Robert Dreicer,...

publisher_dissemination: American Society of Clinical Oncology (ASCO)

publisher_group: American Society of Clinical Oncology (ASCO)

publisher_normalized: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.

ReferenceCitation: Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.

title: Clinical Pharmacokinetic Studies of Enzalutamide

ReferenceCitation: Cella D, Ivanescu C, Holmstrom S, Bui CN, Spalding J, Fizazi K. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol. 2015 Jan;26(1):179-185. doi: 10.1093/annonc/mdu510. Epub 2014 Oct 30.

ReferenceCitation: Saad F, de Bono J, Shore N, Fizazi K, Loriot Y, Hirmand M, Franks B, Haas GP, Scher HI. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol. 2015 Feb;67(2):223-30. doi: 10.1016/j.eururo.2014.08.025. Epub 2014 Aug 27.

title: Efficacy Outcomes by Baseline Prostate-specific Antigen Quartile in the AFFIRM Trial

ReferenceCitation: Merseburger AS, Scher HI, Bellmunt J, Miller K, Mulders PF, Stenzl A, Sternberg CN, Fizazi K, Hirmand M, Franks B, Haas GP, de Bono J, de Wit R. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int. 2015 Jan;115(1):41-9. doi: 10.1111/bju.12898. Epub 2014 Oct 23.

name: Medizinische Hochschule Hannover; Hannover Germany

name: Memorial Sloan-Kettering Cancer Center; New York NY USA

name: Dana-Farber Cancer Institute; Harvard Medical School; Boston MA USA

name: Charité - Universitätsmedizin Berlin; Berlin Germany

name: Radboud University Nijmegen Medical Centre; Nijmegen The Netherlands

name: Universitätsklinikum Tübingen; Tübingen Germany

name: San Camillo - Forlanini Hospitals; Rome Italy

name: Institut Gustave Roussy; University of Paris Sud; Villejuif France

name: Astellas Scientific and Medical Affairs, Inc.; Northbrook IL USA

name: Institute of Cancer Research and Royal Marsden NHS Foundation Trust; Sutton UK

name: Erasmus University Medical Center; Rotterdam The Netherlands

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

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

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

ReferenceCitation: Fizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4. Erratum in: Lancet Oncol. 2014 Oct;15(11):e475.

ReferenceCitation: Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Fléchon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. Epub 2012 Aug 15.

location_country:
Italy
Austria
Chile
South Africa
Netherlands
Germany
France
Poland
Argentina
Australia
Belgium
Spain
United States
United Kingdom
Canada

location_facility: Cambridge University Hospitals NHS Foundation Trust

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Tom Baker Cancer Centre - Holy Cross Site

location_facility: Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie

location_facility: UCSF Helen Diller Family Comprehensive Cancer Center

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga

location_facility: Centre Regional Francois Baclesse de lutte contre le cancer

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Stanford Hospital and Clinics Research Pharmacy

location_facility: Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin

location_facility: Staedtisches Klinikum Braunschweig gGmbH

location_facility: Sydney West Cancer Trials Centre, Department of Medical Oncology

location_facility: Hospital of the University of Pennsylvania

location_facility: George Washington University-Medical Faculty Associates

location_facility: Peachtree Hematology-Oncology Consultants, P.C.

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)

location_facility: Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin

location_facility: University of Pittsburgh Cancer Institute

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika

location_facility: Abt.f.Diagnostische u. Interventionelle Radiologie

location_facility: Sir Charles Gairdner Hospital, Department of Medical Oncology

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Krankenhaus der Barmherzigen Schwestern Linz

location_facility: Wojewodzki szpital specjalistyczny im. Janusza Korczaka

location_facility: British Columbia Cancer Agency, Centre for the Southern Interior

location_facility: New Mexico Oncology Hematology Consultants, Ltd.

location_facility: Weill Cornell Medical College-New York Presbyterian Hospital

location_facility: Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie

location_facility: Clinica Universitaria Privada Reina Fabiola

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

location_facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny

location_facility: Centre de rechereche clinique et evaluative en oncologie

location_facility: Nevada Cancer Institute, an affiliate of the UC San Diego Health System

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: The Beatson West of Scotland Cancer Centre

location_facility: Centre Hospitalier Intercommunal Frejus-Saint Raphael

location_facility: Medical University of South Carolina (MUSC)

location_facility: Sharp Memorial Hospital Investigational Pharmacy

location_facility: Instituto de Investigaciones Clinicas Cipolletti

location_facility: Instituto de Oncologia y Especialidades Medicas

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: North County Oncology Medical Clinic, Inc,

location_facility: Groupement Hospitalier Edouard Herriot - Pavillon V

location_facility: Azienda Ospedaliero-Universitaria di Modena Policlinico

location_facility: University of Colorado Denver, Anschutz Cancer Pavilion

location_facility: Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie

location_facility: Prince of Wales Hospital, Department of Medical Oncology

location_facility: Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group

location_facility: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego

title: Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

summary: This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.