title: FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

acronym: FORWARD I

summary: This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.

ReferenceCitation: Moore KN, Oza AM, Colombo N, Oaknin A, Scambia G, Lorusso D, Konecny GE, Banerjee S, Murphy CG, Tanyi JL, Hirte H, Konner JA, Lim PC, Prasad-Hayes M, Monk BJ, Pautier P, Wang J, Berkenblit A, Vergote I, Birrer MJ. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol. 2021 Jun;32(6):757-765. doi: 10.1016/j.annonc.2021.02.017. Epub 2021 Mar 2.

lead_sponsor: ImmunoGen, Inc.

location_country:
Bosnia and Herzegovina
Serbia
Spain
Ireland
Italy
Russian Federation
United Kingdom
Canada
Switzerland
United States
France
Belgium
Czechia

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Budget-Funded Healthcare Institution of Omsk Oblast "Clinical Oncology Dispensary"

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University

location_facility: Mater Private Hospital and Mater Misericordiae University Hospital

location_facility: Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester)

location_facility: University Clinical Center of Republic of Srpska

location_facility: UCLA Women's Health Clinical Research Unit - OBGYN

location_facility: Froedtert and Medical College of Wisconsin

location_facility: The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center

location_facility: University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)

location_facility: Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center

location_facility: Kantonsspital Winterthur, Medizinische Onkologie

location_facility: Sunnybrook Research Institute - Odette Cancer Centre

location_facility: Institut de Cancerologie de L'Ouest - site Paul Papin

location_facility: The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW

location_facility: Centre hospitalier de l'Université de Montréal

location_facility: University of California San Diego Medical Center

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: Fairview Hospital, Moll Pavilion Cancer Center

location_facility: University of Massachusetts Memorial Medical Center

location_facility: University of Oklahoma Health Sciences Center

location_facility: MD Anderson Cancer Center - Cooper Health

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin

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

location_facility: Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol

location_facility: Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg

location_facility: Institut Català d'Oncologia - Unitad de Investigación Clínica

location_facility: Fondazione IRCCS National Cancer Institute

location_facility: Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

location_facility: Florida State University College of Medicine

location_facility: State Budget-Funded Healthcare Institution of Novosibirsk Oblast "Novosibirsk Oblast Oncology Dispensary"

location_facility: Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga

location_facility: State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary"

location_facility: Levine Cancer Institute - Carolinas Medical Center

location_facility: Servicio de Oncología Médica Hospital Universitario La Paz

location_facility: McGill University Health Centre - Glen Site

location_facility: University of Texas Southwestern Medical Center

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone


status: Active, not recruiting

primary_purpose: Treatment

intervention_type: Drug

title: A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)

study_completion_date_type: Anticipated

lead_sponsor: Bayer

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Matasar MJ, Dreyling M, Leppä S, Santoro A, Pedersen M, Buvaylo V, Fletcher M, Childs BH, Zinzani PL. Feasibility of Combining the Phosphatidylinositol 3-Kinase Inhibitor Copanlisib With Rituximab-Based Immunochemotherapy in Patients With Relapsed Indolent B-cell Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Nov;21(11):e886-e894. doi: 10.1016/j.clml.2021.06.021. Epub 2021 Jul 2.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Russian Federation
Australia
Israel
Turkey
Mexico
Singapore
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Finland
Thailand
Korea, Republic of
France
Chile

location_facility: Tianjin Union Medicine Centre (People's Hospital of Tianjin)

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: The 1st Affiliated Hospital of Zhejiang University

location_facility: Republican Clinical Oncology Dispensary Ufa

location_facility: SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: SCL Health Research at St Joseph's Hospital Denver CO

location_facility: Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr.

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Tianjin Medical University Cancer Institiute & Hospital

location_facility: Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare

location_facility: Hospital Universitario Clinica Puerta de Hierro

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi

location_facility: University Multiprofile Hosp. for Active Treat. Sveti Ivan

location_facility: Centre Hospitalier Universite de Grenoble

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Multiprofile Hospital for Active Treatment Hristo Botev AD

location_facility: Hiroshima Red Cross & Atomic-bomb Survivors Hospital

location_facility: Centro Especializado en Investigación Clínica S.C.

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Hospital Universitario "José Eleuterio González"

location_facility: Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Centro de Atencion e Investigacion Clinica en Oncologia SCP

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva

location_facility: Marmara Uni. Tip Fakultesi Pendik Egitim ve Aras. Hastanesi

location_facility: Recherche soins intensifs, hôpital Maisonneuve-Rosemont

location_facility: Sociedad de Investigaciones Medicas Ltda

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Severance Hospital, Yonsei University Health System

location_facility: S.C. Policlinica de Diagnostic Rapid S.A.

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Saitama Medical University International Medical Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Albert Alberts Stem Cell Transplant Research Centre

location_facility: Multidisciplinary Clinical Hosp. 4 Dnipro

location_facility: Centro de Investigación Clínica Chapultepec S.A. de C.V.

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi"

location_facility: FuJian Medical University Union Hospital

location_facility: Fifth Medical Center, General Hospital of the Chinese People

location_facility: Centro de Investigaciones Clínicas Vina del Mar Ltda.

location_facility: Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg

location_facility: Wojew. Szpital Specjalistyczny im. M. Kopernika

location_facility: Institut Jules Bordet/Jules Bordet Instituut

location_facility: Centre Universitaire de Sante de l'Estrie

location_facility: Spitalul Clinic Municipal Filantropia Craiova

location_facility: Faculdade de Ciencias Medicas-Universidade Estadual Campinas

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Centro Multidisciplinar de Estudos Clínicos EPP - Ltda.

location_facility: Beijing Friendship Hospital, Capital Medical University

location_facility: Institute of Blood Pathology and Transfusion medicine

location_facility: Centre Hospitalier de la Durance - Avignon

location_facility: Centre Hospitalier Intercommunal de la Côte Basque-Bayonne

location_facility: 1st Affiliated hospital of Soochow University

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: University General Hospital of Athens "ATTIKON"

location_facility: Klinikum der Universität München Grosshadern

summary: The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

summary: This is a Phase 3, multicenter, open-label, 3-part rollover study in subjects with CF who are homozygous or heterozygous for the F508del-CFTR mutation and who participated in studies VX13-661-103 (Study 103, NCT02070744), VX14-661-106 (Study 106, NCT02347657), VX14-661-107 (Study 107, NCT02516410), VX14-661-108 (Study 108, NCT02392234), VX14-661-109 (Study 109, NCT02412111), and VX14-661-111 (Study 111, NCT02508207). The study is designed to evaluate the safety and efficacy of long-term treatment of VX-661 in combination with ivacaftor.

design_allocation: Non-Randomized

ReferenceCitation: Flume PA, Biner RF, Downey DG, Brown C, Jain M, Fischer R, De Boeck K, Sawicki GS, Chang P, Paz-Diaz H, Rubin JL, Yang Y, Hu X, Pasta DJ, Millar SJ, Campbell D, Wang X, Ahluwalia N, Owen CA, Wainwright CE; VX14-661-110 study group. Long-term safety and efficacy of tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years or older who are homozygous or heterozygous for Phe508del CFTR (EXTEND): an open-label extension study. Lancet Respir Med. 2021 Jul;9(7):733-746. doi: 10.1016/S2213-2600(20)30510-5. Epub 2021 Feb 10. Erratum in: Lancet Respir Med. 2021 Apr;9(4):e38.

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
Denmark
Spain
Ireland
Austria
Australia
Italy
Canada
Netherlands
Switzerland
United Kingdom
Sweden
United States
France
Israel
Belgium
Germany


title: A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer

lead_sponsor: Hoffmann-La Roche

ReferenceCitation: Mohindra NA, Patel JD. Top advances in lung cancer, 2021. Cancer. 2022 Oct 1;128(19):3434-3437. doi: 10.1002/cncr.34406. Epub 2022 Aug 10.

ReferenceCitation: Felip E, Altorki N, Zhou C, Csoszi T, Vynnychenko I, Goloborodko O, Luft A, Akopov A, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Voong D, Wu F, Yi J, Deng Y, McCleland M, Bennett E, Gitlitz B, Wakelee H; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357. doi: 10.1016/S0140-6736(21)02098-5. Epub 2021 Sep 20. Erratum In: Lancet. 2021 Sep 23;:

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
Poland
Hong Kong
Portugal
Russian Federation
Australia
Israel
Canada
Hungary
China
Germany
Taiwan
Korea, Republic of
France
Netherlands

location_facility: Hopital d Instruction des Armees de Sainte Anne

location_facility: First Affiliated Hospital of Soochow University

location_facility: Azienda Ospedaliera Di Rilievo Nazionale E Di Alta Specializzazione Garibaldi

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway

location_facility: Chonnam National University Hwasun Hospital

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: Hematology Oncology Associates of Northern New Jersey

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Hospital de Sao Joao; Servico de Pneumologia

location_facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences

location_facility: Chinese People's Liberation Army (PLA) General Hospital (301 Hospital)

location_facility: Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica

location_facility: Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia

location_facility: Hospital Clinico Universitario de Valencia

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Centre René Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

location_facility: Hematology and Oncology Associates at Bridgepoint

location_facility: Centre Regional de Lutte contre le Cancer Val d Aurelle - Paul Lamarque; Service d oncologie

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

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: University of Miami School of Medicine - Sylvester at Deerfield

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Centre Hospitalier de Saint-Quentin; Pharmacie-URCC

location_facility: Quincy Medical Group; Canc Ctr at Blessing Hosp

location_facility: MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology

location_facility: Praxis fur Hamatologie und internistische Onkologie

location_facility: Hospital of the University of Occupational and Environmental Health,Japan

location_facility: SCRI Florida Cancer Specialists North; Research Office North Region.

location_facility: Prince of Wales Hosp; Dept. Of Clinical Onc

location_facility: Praxair Cancer Center at Danbury Hospital

location_facility: Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: University of Pecs, I st Dept of Internal Medicine

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

location_facility: Municipal Institution Podilskiy Regional Center of Oncology; Department of Chemotherapy

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

location_facility: Florida Cancer Specialists-Broadway, Fort Myers

location_facility: Azienda Sanitaria Ospedaliera s. Croce e Carle; Oncologia Medica

location_facility: SLK Kliniken Heilbronn GmbH, Standort Fachklinik Löwenstein; Onk & Pal

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Scientific Research Institute of Oncology n.a. N.N. Petrov; Department of Oncogynecology

location_facility: Principal Military Clinical Hospital n.a. N.N. Burdenko

location_facility: Southern California Permanente Medical Group Bellflower

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: GBUZ Saint Petersburg Clinical Research Center of Specialized Types of Care (Oncology)

location_facility: Centro Hospitalar de Lisboa Norte E.P.E - Hospital Pulido Valente

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research

location_facility: City Clinical Hospital #1; Dpt of Oncology

location_facility: Southern Illinois University, Simmons Cancer Institute

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: Chang Gung Medical Foundation Linkou Branch

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

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Centre Hospitalier de Mont de Marsan - Hopital Layne

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

location_facility: Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

location_facility: Azienda per l'Assistenza Sanitaria N° 5 - Friuli Occidentale; S.C. Oncologia Pordenone

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Affiliated Hospital of Guangdong Medical University

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Policlinico Universitario Campus Biomedico Di Roma; U.O.Oncologia Medica

location_facility: MI Dnipropetrovsk City Multifield Clinical Hospital 4 of Dnipropetrovsk Regional Council

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

location_facility: Overlook Medical Center; Medical Diagnostic Associates

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Municipal Institution Odesa Regional Oncology Dispensary

location_facility: First Hospital of China Medical University

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

summary: This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.


status: Completed

title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

study_completion_date_type: Actual

ReferenceCitation: Li M, Yang B. Prognostic Value of NUSAP1 and Its Correlation with Immune Infiltrates in Human Breast Cancer. Crit Rev Eukaryot Gene Expr. 2022;32(3):45-60. doi: 10.1615/CritRevEukaryotGeneExpr.2021040248.

ReferenceCitation: Wang H, Ma H, Sove RJ, Emens LA, Popel AS. Quantitative systems pharmacology model predictions for efficacy of atezolizumab and nab-paclitaxel in triple-negative breast cancer. J Immunother Cancer. 2021 Feb;9(2):e002100. doi: 10.1136/jitc-2020-002100. Erratum In: J Immunother Cancer. 2021 Oct;9(10):

ReferenceCitation: Adams S, Diéras V, Barrios CH, Winer EP, Schneeweiss A, Iwata H, Loi S, Patel S, Henschel V, Chui SY, Rugo HS, Emens LA, Schmid P. Patient-reported outcomes from the phase III IMpassion130 trial of atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer. Ann Oncol. 2020 May;31(5):582-589. doi: 10.1016/j.annonc.2020.02.003. Epub 2020 Feb 20.

ReferenceCitation: Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Henschel V, Molinero L, Chui SY, Maiya V, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Investigators. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):44-59. doi: 10.1016/S1470-2045(19)30689-8. Epub 2019 Nov 27.

ReferenceCitation: Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, Diéras V, Hegg R, Im SA, Shaw Wright G, Henschel V, Molinero L, Chui SY, Funke R, Husain A, Winer EP, Loi S, Emens LA; IMpassion130 Trial Investigators. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018 Nov 29;379(22):2108-2121. doi: 10.1056/NEJMoa1809615. Epub 2018 Oct 20.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Costa Rica
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Slovenia
Austria
Australia
Russian Federation
Argentina
Turkey
Panama
Mexico
Norway
Singapore
Sweden
Bosnia and Herzegovina
Brazil
Canada
Switzerland
Guatemala
Hungary
Germany
Taiwan
Greece
Latvia
Estonia
Finland
Thailand
Korea, Republic of
France
Chile
Colombia

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Washington University School of Medicine

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Wellmont Bristol Regional Medical Center

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Kaiser Permanente of Northern California

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre

location_facility: Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters

location_facility: The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.

location_facility: Princess Alexandra Hospital; Division of Cancer Services

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis

location_facility: Treatment and Prevention Institution Volyn Regional Oncology Dispensary

location_facility: Univ of Calif, San Francisco; Breast Cancer Center

location_facility: Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Florida Cancer Specialists - SCRI; Pharmacy

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Institut De Cancerologie De L'Ouest; Medical Oncology

location_facility: St John of God Hospital; Bendat Cancer Centre

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: The Mount Siani Comprehensive Cancer Center

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

location_facility: Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica

location_facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

location_facility: Fövárosi Önkormányzat uzsoki utcai Kórház

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Rush University Medical Center - Chicago

location_facility: Barbara Ann Karmanos Cancer Institute; Oncology

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: University Hospital of Patras Medical Oncology

location_facility: Medipol University MF; Oncology Department

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

location_facility: Texas Oncology- El Paso Cancer Treatment Center Gateway

location_facility: Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie

location_facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

location_facility: Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde

location_facility: Saitama Medical University International Medical Center

location_facility: Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department

location_facility: Cukurova Uni Faculty of Medicine; Medical Oncology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Main Military Clinical Hospital named after N.N. Burdenko

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Centro de Cancer Pontificie Universidad Catolica de Chile

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: China Medical University Hospital; Surgery

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

location_facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: St. Johannes Hospital; Abt. für Hämatologie und Onkologie

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

location_facility: Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH

location_facility: National Hospital Organization Osaka National Hospital

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Greenville Health System (GHS) Cancer Institute

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: University of Texas;M.D. Anderson Cancer Center

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Consultorio de Medicina Especializada; Dentro de Condominio San Francisco

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

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Instituto Estatal de Cancerologia Colima

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Western General Hospital; Clinical Oncology

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

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

summary: This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

status_simplified: Completed


type: Registry Identifier

title: An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV

summary: The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.

ReferenceCitation: Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.

ReferenceCitation: Danese S, Sandborn WJ, Colombel JF, Vermeire S, Glover SC, Rimola J, Siegelman J, Jones S, Bornstein JD, Feagan BG. Endoscopic, Radiologic, and Histologic Healing With Vedolizumab in Patients With Active Crohn's Disease. Gastroenterology. 2019 Oct;157(4):1007-1018.e7. doi: 10.1053/j.gastro.2019.06.038. Epub 2019 Jul 4.

lead_sponsor: Takeda

location_country:
Poland
Italy
Canada
Hungary
France
United States
Belgium
Czechia


acronym: DUAL™VII

title: A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus

lead_sponsor: Novo Nordisk A/S

type: Other Identifier

ReferenceType: result

ReferenceCitation: Billings LK, Doshi A, Gouet D, Oviedo A, Rodbard HW, Tentolouris N, Grøn R, Halladin N, Jodar E. Efficacy and Safety of IDegLira Versus Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes Uncontrolled on Metformin and Basal Insulin: The DUAL VII Randomized Clinical Trial. Diabetes Care. 2018 May;41(5):1009-1016. doi: 10.2337/dc17-1114. Epub 2018 Feb 26.

ReferenceCitation: Billings LK, Agner BFR, Altuntas Y, Grøn R, Halladin N, Klonoff DC, Tentolouris N, Jódar E. The Benefit of Insulin Degludec/Liraglutide (IDegLira) Compared With Basal-Bolus Insulin Therapy is Consistent Across Participant Subgroups With Type 2 Diabetes in the DUAL VII Randomized Trial. J Diabetes Sci Technol. 2021 May;15(3):636-645. doi: 10.1177/1932296820906888. Epub 2020 Feb 28.

ReferenceCitation: Meneghini L, Doshi A, Gouet D, Vilsbøll T, Begtrup K, Őrsy P, Ranthe MF, Lingvay I. Insulin degludec/liraglutide (IDegLira) maintains glycaemic control and improves clinical outcomes, regardless of pre-trial insulin dose, in people with type 2 diabetes that is uncontrolled on basal insulin. Diabet Med. 2020 Feb;37(2):267-276. doi: 10.1111/dme.14178. Epub 2019 Nov 28.

location_country:
Spain
Greece
Russian Federation
Argentina
Hungary
United States
France
Israel
Turkey
Mexico
Slovakia
Czechia

summary: This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.


ipd_sharing: Undecided

acronym: OPTIMISE

intervention_type: Biological

title: Long Term Clear Skin Maintenance Treatment Optimization in Patients With Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Multicenter, Open-label With Blinded-assessment, Comparative, 52 Week Study to Evaluate the Efficacy, Safety and Tolerability of Secukinumab 300 mg s.c.

lead_sponsor: Novartis Pharmaceuticals

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

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

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Belgium
Czechia
Poland
Portugal
Austria
Russian Federation
Israel
Sweden
Slovakia
Switzerland
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Finland
France
Netherlands

summary: To demonstrate in the patient pool of PASI 90 responders at Week 24 that secukinumab 300 mg s.c. when administered at a longer dosing interval is non-inferior to secukinumab 300 mg s.c. every 4 weeks treatment with respect to maintaining a PASI 90 response rate at Week 52.


ipd_sharing: Yes

acronym: EAGLE

title: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

lead_sponsor: AstraZeneca

ReferenceCitation: Ferris RL, Haddad R, Even C, Tahara M, Dvorkin M, Ciuleanu TE, Clement PM, Mesia R, Kutukova S, Zholudeva L, Daste A, Caballero-Daroqui J, Keam B, Vynnychenko I, Lafond C, Shetty J, Mann H, Fan J, Wildsmith S, Morsli N, Fayette J, Licitra L. Durvalumab with or without tremelimumab in patients with recurrent or metastatic head and neck squamous cell carcinoma: EAGLE, a randomized, open-label phase III study. Ann Oncol. 2020 Jul;31(7):942-950. doi: 10.1016/j.annonc.2020.04.001. Epub 2020 Apr 12.

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.

location_country:
Croatia
Serbia
Spain
Italy
Ukraine
United States
Romania
Belgium
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Brazil
Hungary
Germany
Bulgaria
Taiwan
Georgia
Korea, Republic of
France
Chile

summary: This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient population.


title: A Phase III Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Nab-Paclitaxel for Chemotherapy-Naive Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

ReferenceCitation: Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.

ReferenceCitation: West H, McCleod M, Hussein M, Morabito A, Rittmeyer A, Conter HJ, Kopp HG, Daniel D, McCune S, Mekhail T, Zer A, Reinmuth N, Sadiq A, Sandler A, Lin W, Ochi Lohmann T, Archer V, Wang L, Kowanetz M, Cappuzzo F. Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer (IMpower130): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jul;20(7):924-937. doi: 10.1016/S1470-2045(19)30167-6. Epub 2019 May 20.

location_country:
Spain
Italy
Canada
United States
France
Israel
Belgium
Germany

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: Fort Wayne Med Oncology & Hematology Inc

location_facility: Duke University Medical Center; Department of Medicine

location_facility: Universitatsklinikum Schleswig-Holstein; Klinik fuer Innere Medizin I

location_facility: Kaiser Permanente - San Jose Medical Center

location_facility: Hopital American de Paris (American Hospital of Paris)

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: SRH Wald-Klinikum Gera; Klinik für Hautkrankheiten und Allergologie

location_facility: Walter Reed National Military Medical Center

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Hematology and Oncology Associates at Bridgepoint

location_facility: Schwarzwald-Baar Klinikum/VS GmbH; Onkologie/Hämatologie/Infektologie

location_facility: Centre D'oncologie de Gentilly; Service Oncologie Medicale

location_facility: University of Miami School of Medicine - Sylvester at Deerfield

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Hospital General Universitario de Valencia

location_facility: Rambam Health Corporation; Oncology Institute

location_facility: SCRI The Center For Cancer and Blood Disorders

location_facility: Fondation Hopital Saint Joseph;Cardiologie Clinique

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Praxis fur Haematologie und Internistische Onkologie

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Kaiser Permanente Medical Center - Roseville

location_facility: Hospital General Universitario de Guadalajara

location_facility: Kaiser Permanente - San Francisco Medical Center

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Kaiser Permanente - San Leandro Medical Center

location_facility: Southern Illinois University, Simmons Cancer Institute

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

location_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Laura and ISAAC Perlmutter Cancer Center at NYU Langone.

location_facility: Charite - Universitätsmedizin Berlin; Klinik fur Infektiologie und Pneumologie

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: University of Iowa Hospitals and Clinics

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune

location_facility: Cancer Care Network of South Texas - SAT & BC

location_facility: Ospedale Santa Maria Della; Misericordia Di Perugia; Farmacia Ospedaliera

location_facility: Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

location_facility: University of Texas M.D. Anderson Cancer Center

location_facility: Malteser Krankenhaus St. Franziskus-Hospital

location_facility: Suburban Hematology / Oncology Associates

location_facility: Kaiser Permanente - Sacramento Medical Center and Medical Offices

summary: This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).


title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer

ReferenceCitation: Nogami N, Barlesi F, Socinski MA, Reck M, Thomas CA, Cappuzzo F, Mok TSK, Finley G, Aerts JG, Orlandi F, Moro-Sibilot D, Jotte RM, Stroyakovskiy D, Villaruz LC, Rodríguez-Abreu D, Wan-Teck Lim D, Merritt D, Coleman S, Lee A, Shankar G, Yu W, Bara I, Nishio M. IMpower150 Final Exploratory Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in Key NSCLC Patient Subgroups With EGFR Mutations or Metastases in the Liver or Brain. J Thorac Oncol. 2022 Feb;17(2):309-323. doi: 10.1016/j.jtho.2021.09.014. Epub 2021 Oct 7.

ReferenceCitation: Socinski MA, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodríguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kong S, Lee A, Coleman S, Zou W, McCleland M, Shankar G, Reck M. IMpower150 Final Overall Survival Analyses for Atezolizumab Plus Bevacizumab and Chemotherapy in First-Line Metastatic Nonsquamous NSCLC. J Thorac Oncol. 2021 Nov;16(11):1909-1924. doi: 10.1016/j.jtho.2021.07.009. Epub 2021 Jul 24.

ReferenceCitation: Reck M, Wehler T, Orlandi F, Nogami N, Barone C, Moro-Sibilot D, Shtivelband M, González Larriba JL, Rothenstein J, Früh M, Yu W, Deng Y, Coleman S, Shankar G, Patel H, Kelsch C, Lee A, Piault E, Socinski MA. Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Aug 1;38(22):2530-2542. doi: 10.1200/JCO.19.03158. Epub 2020 May 27.

ReferenceCitation: Reck M, Mok TSK, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodríguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Lee A, Coleman S, Deng Y, Kowanetz M, Shankar G, Lin W, Socinski MA; IMpower150 Study Group. Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir Med. 2019 May;7(5):387-401. doi: 10.1016/S2213-2600(19)30084-0. Epub 2019 Mar 25.

ReferenceCitation: Socinski MA, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodríguez-Abreu D, Moro-Sibilot D, Thomas CA, Barlesi F, Finley G, Kelsch C, Lee A, Coleman S, Deng Y, Shen Y, Kowanetz M, Lopez-Chavez A, Sandler A, Reck M; IMpower150 Study Group. Atezolizumab for First-Line Treatment of Metastatic Nonsquamous NSCLC. N Engl J Med. 2018 Jun 14;378(24):2288-2301. doi: 10.1056/NEJMoa1716948. Epub 2018 Jun 4.

location_country:
Spain
Italy
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Portugal
Austria
Australia
Russian Federation
Argentina
Mexico
Singapore
Slovakia
Brazil
Canada
Switzerland
Germany
Bulgaria
Taiwan
Latvia
France
Chile
Netherlands

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Hospital Universitario Fundación Jimenez Díaz

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs

location_facility: MNPE Transcarpathian Antitumor Center of the Transcarpathian Regional Council; Chemotherapy Dept

location_facility: Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Hospital de Sao Joao; Servico de Pneumologia

location_facility: Hematology-Oncology; Associates of the Quad Cities

location_facility: West Virginia University; Mary Babb Randolph Can Ctr

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Hospital Pulido Valente; Servico de Pneumologia

location_facility: Russian Oncology Research Center n.a. N.N. Blokhin

location_facility: Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: MNPE Zaporizhzhia Regional Antitumor Center ZRC

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy

location_facility: Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

location_facility: National Cancer Centre; Medical Oncology

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Centro Especializado de Enfermedades Neoplásicas

location_facility: Park Nicolett - Frauenshuh Cancer Center

location_facility: St. Charles Medical Center Bend; Cancer Care Of The Cascades

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Hospital Universitario Insular de Gran Canaria

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

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: University of Texas Health Science Center at San Antonio

location_facility: SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine

location_facility: Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie

location_facility: Prince Charles Hospital; Department of Medical Oncology

location_facility: Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia

location_facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

location_facility: Willamette Valley Cancer Insitute and Research Center

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

location_facility: Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department

location_facility: Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon

location_facility: Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Chao Family Comprehensive Cancer Center UCI

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: Universität Des Saarlandes; Klinik für Innere Medizin V

location_facility: Cancer Specialists of North Florida - Baptist South

location_facility: Centro de Investigacion; Clinica - Clinica Viedma S.A.

location_facility: Centro Hemato Oncologico Privado; Oncologia

summary: This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).


title: A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

summary: The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.

ReferenceCitation: Siefker-Radtke AO, Necchi A, Park SH, García-Donas J, Huddart RA, Burgess EF, Fleming MT, Rezazadeh Kalebasty A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Akapame S, Santiago-Walker AE, Monga M, O'Hagan A, Loriot Y; BLC2001 Study Group. Efficacy and safety of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma: long-term follow-up of a phase 2 study. Lancet Oncol. 2022 Feb;23(2):248-258. doi: 10.1016/S1470-2045(21)00660-4. Epub 2022 Jan 11.

ReferenceCitation: Dosne AG, Valade E, Goeyvaerts N, De Porre P, Avadhani A, O'Hagan A, Li LY, Ouellet D, Perez Ruixo JJ. Exposure-response analyses of erdafitinib in patients with locally advanced or metastatic urothelial carcinoma. Cancer Chemother Pharmacol. 2022 Feb;89(2):151-164. doi: 10.1007/s00280-021-04381-4. Epub 2022 Jan 3.

ReferenceCitation: Loriot Y, Necchi A, Park SH, Garcia-Donas J, Huddart R, Burgess E, Fleming M, Rezazadeh A, Mellado B, Varlamov S, Joshi M, Duran I, Tagawa ST, Zakharia Y, Zhong B, Stuyckens K, Santiago-Walker A, De Porre P, O'Hagan A, Avadhani A, Siefker-Radtke AO; BLC2001 Study Group. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2019 Jul 25;381(4):338-348. doi: 10.1056/NEJMoa1817323.

lead_sponsor: Janssen Research & Development, LLC

location_country:
Taiwan
Romania
Spain
United Kingdom
Austria
Russian Federation
Korea, Republic of
United States
France
India
Israel
Belgium
Turkey
Germany
Moldova, Republic of


title: A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).

acronym: ARCTIC

summary: This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib [TARCEVA®]), gemcitabine or vinorelbine (NAVELBINE®)

ReferenceCitation: Martin ML, Correll J, Walding A, Rydén A. How patients being treated for non-small cell lung cancer value treatment benefit despite side effects. Qual Life Res. 2022 Jan;31(1):135-146. doi: 10.1007/s11136-021-02882-6. Epub 2021 May 31.

ReferenceCitation: Planchard D, Reinmuth N, Orlov S, Fischer JR, Sugawara S, Mandziuk S, Marquez-Medina D, Novello S, Takeda Y, Soo R, Park K, McCleod M, Geater SL, Powell M, May R, Scheuring U, Stockman P, Kowalski D. ARCTIC: durvalumab with or without tremelimumab as third-line or later treatment of metastatic non-small-cell lung cancer. Ann Oncol. 2020 May;31(5):609-618. doi: 10.1016/j.annonc.2020.02.006. Epub 2020 Feb 20.

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

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Israel
Singapore
Canada
Hungary
Germany
Bulgaria
Taiwan
Greece
Thailand
Korea, Republic of
France
Chile
Netherlands


title: An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)

acronym: TOPAZ-I

summary: The purpose of this study is to evaluate Long-term outcomes following treatment with ABT-450/r/ABT-267 and ABT-333 with or without RBV in adults with genotype 1 Chronic Hepatitis C Virus (HCV) infection.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Saudi Arabia
Italy
Spain
United Kingdom
Romania
Belgium
Poland
Portugal
Austria
Australia
Russian Federation
Israel
Turkey
Mexico
Norway
Sweden
Canada
Switzerland
Germany
Bulgaria
Denmark
Greece
Ireland
Finland
Algeria
France
Netherlands

location_facility: AOU Citta della Salute Scienza /ID# 131100

location_facility: Hospital Universitario Germans Trias i Pujol /ID# 132293

location_facility: Medizinisches Versorgungszentrum Düsseldorf /ID# 131052

location_facility: Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270

location_facility: Odense Universitets Hospital /ID# 131029

location_facility: Hospital Universitario Virgen de la Victoria /ID# 131136

location_facility: Vancouver Infectious Diseases Centre /ID# 134369

location_facility: Hospital Universitario de la Princesa /ID# 131131

location_facility: Istanbul University Istanbul Medical Faculty /ID# 131153

location_facility: Ege University Medical Faculty /ID# 132298

location_facility: Ministry Nat Guard Hosp Health /ID# 145126

location_facility: Hospital Universitario Reina Sofia /ID# 131135

location_facility: King's College Hospital NHS Foundation Trust /ID# 131157

location_facility: Azienda Ospedaliero Uni Parma /ID# 132183

location_facility: Policlinico Univ Tor Vergata /ID# 132185

location_facility: Hacettepe University Faculty of Medicine /ID# 131150

location_facility: Izmir Tepecik Egitim ve Arastirma Hastanesi /ID# 134968

location_facility: General University Hospital of Alexandroupolis /ID# 131056

location_facility: Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107

location_facility: Universita di Napoli Federico II /ID# 132191

location_facility: Royal Brisbane and Women's Hospital /ID# 131004

location_facility: Moscow Clinical Scientific Center /ID# 132266

location_facility: Greenslopes Private Hospital /ID# 131003

location_facility: I. M. Sechenov First Moscow State Medical University /ID# 132275

location_facility: Universitaetsklinikum Freiburg /ID# 131044

location_facility: Universita di Napoli Federico II /ID# 131096

location_facility: Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 131041

location_facility: Uludag University Medical Faculty /ID# 132297

location_facility: King Khalid University Hospita /ID# 132291

location_facility: Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288

location_facility: Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278

location_facility: Hospital Universitario Central de Asturias /ID# 131138

location_facility: Universitaetsklinik Heidelberg /ID# 134371

location_facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051

location_facility: Medizinische Universität Graz /ID# 131018

location_facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095

location_facility: Azienda Ospedaliera - Polo Uni /ID# 132198

location_facility: Stavropol State Medical Univ /ID# 132279

location_facility: GIRI Gastrointestinal Research Institute /ID# 132171

location_facility: Medizinische Hochschule Hannover /ID# 131054

location_facility: The Royal Bournemouth Hospital /ID# 132306

location_facility: Central Cliniсal Hospital of teh Russian Academy of Sciences /ID# 132289

location_facility: St. Vincent's Hospital, Darlinghurst /ID# 131001

location_facility: Multidisciplinary Consultative and Diagnostic Center /ID# 131130

location_facility: St. James University Hospital /ID# 132305

location_facility: Samara State Medical University /ID# 136913

location_facility: Centro Hospitalar do Porto EPE /ID# 131117

location_facility: Hospital Universitari Son Espases /ID# 131140

location_facility: Clinical Infectious Diseases Hospital #1 /ID# 132272

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 131053

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115

location_facility: Hospital Universitario La Paz /ID# 131132

location_facility: Institutul Nat. de Boli Infectioase /ID# 131124

location_facility: A.O.U. Policlinico G. Martino /ID# 132193

location_facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120

location_facility: Stavanger University Hospital /ID# 132211

location_facility: University of Calgary - Cumming School of Medicine - Adult Cystic Fibrosis Clini /ID# 134370

location_facility: St Vincent's Hospital Melbourne /ID# 131000

location_facility: Helsinki Univ Central Hospital /ID# 131034

location_facility: Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269

location_facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 131104

location_facility: Diagnostic Consultative Center /ID# 131027

location_facility: Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie "Dr. Victor Babes" /Id# 131126

location_facility: Inselspital, Universitaetsklinik /ID# 132294

location_facility: St Vincent's University Hosp /ID# 132181

location_facility: Akershus Universitetssykehus_MAIN /ID# 132212

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097

location_facility: Toronto Digestive Disease Asso /ID# 130968

location_facility: University Hospital Southampton NHS Foundation Trust /ID# 131161

location_facility: LMU Klinikum Campus Grosshadern /ID# 131049

location_facility: Azienda Ospedaliera Luigi Sacc /ID# 134372

location_facility: South-Ural State Med. Academy /ID# 132274

location_facility: Hospital Universitario A Coruña - CHUAC /ID# 131137

location_facility: CHU de Nantes, Hotel Dieu -HME /ID# 132179

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108

location_facility: Centro Hosp de Lisboa Central /ID# 131116

location_facility: Saint John Regional Hospital /ID# 131210

location_facility: Hospital General Universitario Santa Lucia /ID# 131139

location_facility: Centrum für interdisziplinaere Medizin /ID# 131046

location_facility: Hospital Universitario Virgen del Rocio /ID# 131134

location_facility: Universitaetsklinikum Tuebingen /ID# 131045

location_facility: Montreal General Hospital - McGill University Health Center /ID# 132166

location_facility: Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190

location_facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031

location_facility: AOU San Giovanni di Dio e Ruggi d'Aragona /ID# 132192

location_facility: Hospital Universitario 12 de Octubre /ID# 131133

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106

location_facility: KH der Elisabethinen Linz GmbH /ID# 131017

location_facility: Sverdlovsk Regional Clinical Hospital #1 /ID# 132267

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 131141

location_facility: Group Practice Gastroenterolog /ID# 131050

location_facility: Tel Aviv Sourasky Medical Center /ID# 132182

location_facility: Instituto Metropolitano de Inv /ID# 132201

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 132292

location_facility: Medizinische Universitat Wien /ID# 131015

location_facility: Univ Hospitals Birmingham NHS Foundation trust /ID# 131154

location_facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118

location_facility: Universitair Ziekenhuis Leuven /ID# 131021

location_facility: General Hospital of Athens Laiko /ID# 131088

location_facility: Hippokration General Hospital /ID# 131057

location_facility: ITESM campus Ciudad de Mexico /ID# 132383

location_facility: Leids Universitair Medisch Centrum /ID# 132204

location_facility: Universitatsklinikum Frankfurt /ID# 131055

location_facility: OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143

location_facility: Azienda Sanitaria Universitaria Friuli Centrale /ID# 132196

location_facility: Aarhus Univ Hospital, Skejby /ID# 131030

location_facility: Policlinico Agostino Gemelli /ID# 131098

location_facility: Tolyatti City Clinical Hospital #1 /ID# 132273


acronym: RE-DUAL PCI

title: A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Nicolau JC, Bhatt DL, Hohnloser SH, Kimura T, Lip GYH, Miede C, Nordaby M, Oldgren J, Steg PG, Ten Berg JM, Godoy LC, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial. Drugs. 2020 Jul;80(10):995-1005. doi: 10.1007/s40265-020-01323-x.

ReferenceCitation: De Caterina R, Procopio A, Lopez Sendon JL, Raev D, Mehta SR, Opolski G, Oldgren J, Steg PG, Hohnloser SH, Lip GYH, Kimura T, Kleine E, Ten Berg JM, Bhatt DL, Miede C, Nordaby M, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Comparison of Dabigatran Plus a P2Y(12) Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI. Am J Med. 2020 Nov;133(11):1302-1312. doi: 10.1016/j.amjmed.2020.03.045. Epub 2020 May 7.

ReferenceCitation: Berry NC, Mauri L, Steg PG, Bhatt DL, Hohnloser SH, Nordaby M, Miede C, Kimura T, Lip GYH, Oldgren J, Ten Berg JM, Cannon CP. Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial. Circ Cardiovasc Interv. 2020 Apr;13(4):e008349. doi: 10.1161/CIRCINTERVENTIONS.119.008349. Epub 2020 Apr 7.

ReferenceCitation: Hohnloser SH, Steg PG, Oldgren J, Nickenig G, Kiss RG, Ongen Z, Navarro Estrada JL, Oude Ophuis T, Lip GYH, Nordaby M, Kleine E, Ten Berg JM, Bhatt DL, Cannon CP; RE-DUAL PCI Steering Committee and Investigators. Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI. JACC Cardiovasc Interv. 2019 Aug 26;12(16):1553-1561. doi: 10.1016/j.jcin.2019.05.050.

ReferenceCitation: Chi G, Kerneis M, Kalayci A, Liu Y, Mehran R, Bode C, Halperin JL, Verheugt FWA, Wildgoose P, van Eickels M, Lip GYH, Cohen M, Peterson ED, Fox KAA, Gibson CM. Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial. Am Heart J. 2018 Sep;203:17-24. doi: 10.1016/j.ahj.2018.06.003. Epub 2018 Jun 13.

ReferenceCitation: Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, Nordaby M, Kleine E, Harper R, Manassie J, Januzzi JL, Ten Berg JM, Steg PG, Hohnloser SH; RE-DUAL PCI Steering Committee and Investigators. Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation. N Engl J Med. 2017 Oct 19;377(16):1513-1524. doi: 10.1056/NEJMoa1708454. Epub 2017 Aug 27.

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
New Zealand
Finland
Thailand
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Novant Health Heart and Vascular Institute

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Herz- und Gefäßzentrum (HGZ-Göttingen) am Krankenhaus Neu Bethlehem

location_facility: Cukurova Universitesi Tip Fakultesi Kardiyoloji AnabilimDali

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Siyami Ersek Gogus Kalp ve Damar Cerrahisi Hastanesi

location_facility: Prince of Wales Hosp, Dept of Med & Therapeutics

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: State Autonomous Healthc Insti City Clin Hosp#7,Cardio,Kazan

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: Independent Public Clin.Hosp.#4, Cardiology Clinic,Lubilin

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Oslo Universitetssykehus HF, Ullevål sykehus

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

location_facility: HYKS, Kardiologian klinikka, Sydän- ja keuhkokeskus

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

location_facility: Hippokration Hospital, Univ Clinic of Cardiology

location_facility: State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr

location_facility: Instituto de Cardiologia Rio Grande do Sul

location_facility: Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

location_facility: Ospedale Molinette, AO Città della Salute e della

location_facility: North-Western Fed.Med.Resear.Centr na V.I.Almazov,Cardio.dep

location_facility: Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi

location_facility: General Hospital of Chios, Department of Cardiology

location_facility: National Hospital Organization Saitama National Hospital

location_facility: MHAT "Deva Maria", Dept. of Cardiology, Burgas

location_facility: Karlovarska Reg.Hosp, Cardiology Dept, Karlovy Vary

location_facility: Independent Public Healthcare, Dept. of Cardiology, Pulawy

location_facility: Instituto Dante Pazzanese de Cardiologia

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Kansas City Veterans Administration Medical Center

location_facility: Saint Mary's Medical Center dba Essentia Health Saint Mary's Medical Center

location_facility: MHAT "Sv. Vrach" EOOD, Cardiology Dept., Sandanski

location_facility: Shri Krishna Hrudayalaya and Critical Care

location_facility: Irmandade da Santa Casa de Misericordia de Curitiba

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi

location_facility: Asklepios Klinik Langen-Seligenstadt GmbH

location_facility: Clinical Hospital Sstre Milosrdnice, Cardiology Dept, Zagreb

location_facility: Türkiye Yüksek Ihtisas Egitim ve Arastirma Hastanesi

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: State Budg.Healthc.Instit.Samara Reg.Clin.Cardiology Dispens

location_facility: Thunder Bay Regional Health Science Centre

location_facility: Lower Silesian Spec.Hosp.T.Marciniaka,Cardiology Dep,Wroclaw

location_facility: General Hospital of Athens Konstantopoulio-Agia Olga

location_facility: Erciyes Universitesi Tip Fakultesi Kardiyoloji Anabilim Dali

location_facility: Royal Bournemouth and Christchurch Hospital

location_facility: National Hospital Organization Takasaki General Medical Center

location_facility: St. Josef- und St. Elisabeth-Hospital gGmbH

location_facility: Cntr of CV Surgery na Bakulev,Surg.Treatm of Inter.Path.dept

location_facility: Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol

location_facility: Tokyo Women's Medical University Hospital

location_facility: Kardiocentrum Nitra,Internal Medicine Dept, Nitra

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: Swissmed Vascular Sp. Z.o.o Hosp., Cardiology Dept., Gdansk

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Centro Especializado en Terapia Endovascular (CETEN)

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Richmond Cardiology Associates Research, LLC

location_facility: Hospitals of Pardubice Region, Internal Department, Svitavy

location_facility: Central Hospital of Medical Academy, Warsaw

location_facility: Istanbul Universitesi Kardiyoloji Enstitusu

location_facility: National Hospital Organization Hokkaido Medical Center

location_facility: Carl-von-Basedow Klinikum Saalekreis gGmgH

location_facility: Bayview Physicians Services PC dba Cardiovascular Associates

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

location_facility: University Hospital of Thessaloniki AHEPA

location_facility: University General Hospital of Heraklion

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH

location_facility: Keski-Pohjanmaan keskussairaala, Kardiologian pkl, Kokkola

location_facility: Mission Cardiovascular Research Institute

location_facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto

location_facility: Westküstenkliniken Brunsbüttel und Heide gGmbH

location_facility: Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb

location_facility: Herz- und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen

location_facility: Ziekenhuis Netwerk Antwerpen (ZNA) - Campus Middelheim

location_facility: General Hospital Izola, Cardiology Department

location_facility: Regional Clinical Hospital No.3, Cardiology Dept,Chelyabinsk

location_facility: INCOR e Hospital das Clínicas da Universidade de São Paulo

location_facility: City Clin.Hosp.#15 n.a.O.M.Filatov,Cardiology Dept.#2,Moscow

location_facility: B and M Patel Cardiac Centre, Shree Krishna Hospital,

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: Istanbul Mehmet Akif Ersoy Egitim ve Arastirma Hastanesi

location_facility: Hosp.of Pardubice Reg,Orlickoustecka,Internal Dept, Ustinad

location_facility: City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia

location_facility: CHUC - Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: University of Florida College of Medicine

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: University of Utah Health Sciences Center

location_facility: Reg.Hosp Kielce,Swietokrzyskie,1.Clinic of Cardiology,Kielce

location_facility: Bacs-Kiskun Megyei Onkormanyzat Hospital

location_facility: Altaiskyi Reg.Cardiologic Dispensary,Cardiology Dept,Barnaul

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

location_facility: City Clin.Hosp#51,Moscow Healthcare Dep.X-ray surgery method

location_facility: Shaare Zedek Medical Center, Jerusalem 91031

location_facility: Sint-Niklaas - HOSP AZ Nikolaas (Campus St-Niklaas)

location_facility: City Pokrovskiy Hospital, Cardiology Dept., Saint Petersburg

location_facility: General Hospital of Attica "Sismanoglio - Amalia Fleming"

summary:
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.


title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

acronym: ALLAY-LID-I

summary: This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

status: Terminated

lead_sponsor: Adamas Pharmaceuticals, Inc.

location_country:
Spain
Canada
United States
France
Germany

status_simplified: Unknown


title: A Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced Dyskinesias

acronym: ALLAY-LID-II

summary: The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.

location_facility:
Hospital de la Santa Creu i Sant Pau
Hospital General de Cataluna


acronym: PERLES

title: PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

lead_sponsor: Pierre Fabre Medicament

location_country:
Spain
Italy
Czech Republic
France
Germany

summary: The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.


title: Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed or Refractory Multiple Myeloma

summary: The purpose of this study is to compare the effectiveness of daratumumab when combined with lenalidomide and dexamethasone (DRd) to that of lenalidomide and dexamethasone (Rd), in terms of progression-free survival in participants with relapsed or refractory multiple myeloma.

ReferenceCitation: Cavo M, San-Miguel J, Usmani SZ, Weisel K, Dimopoulos MA, Avet-Loiseau H, Paiva B, Bahlis NJ, Plesner T, Hungria V, Moreau P, Mateos MV, Perrot A, Iida S, Facon T, Kumar S, van de Donk NWCJ, Sonneveld P, Spencer A, Krevvata M, Heuck C, Wang J, Ukropec J, Kobos R, Sun S, Qi M, Munshi N. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA. Blood. 2022 Feb 10;139(6):835-844. doi: 10.1182/blood.2021011101.

ReferenceCitation: Plesner T, Dimopoulos MA, Oriol A, San-Miguel J, Bahlis NJ, Rabin N, Suzuki K, Yoon SS, Ben-Yehuda D, Cook G, Goldschmidt H, Grosicki S, Qin X, Fastenau J, Garvin W, Carson R, Renaud T, Gries KS. Health-related quality of life in patients with relapsed or refractory multiple myeloma: treatment with daratumumab, lenalidomide, and dexamethasone in the phase 3 POLLUX trial. Br J Haematol. 2021 Jul;194(1):132-139. doi: 10.1111/bjh.17435. Epub 2021 Apr 6.

ReferenceCitation: Avet-Loiseau H, San-Miguel J, Casneuf T, Iida S, Lonial S, Usmani SZ, Spencer A, Moreau P, Plesner T, Weisel K, Ukropec J, Chiu C, Trivedi S, Amin H, Krevvata M, Ramaswami P, Qin X, Qi M, Sun S, Qi M, Kobos R, Bahlis NJ. Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR. J Clin Oncol. 2021 Apr 1;39(10):1139-1149. doi: 10.1200/JCO.20.01814. Epub 2021 Jan 29.

ReferenceCitation: Mateos MV, Spencer A, Nooka AK, Pour L, Weisel K, Cavo M, Laubach JP, Cook G, Iida S, Benboubker L, Usmani SZ, Yoon SS, Bahlis NJ, Chiu C, Ukropec J, Schecter JM, Qin X, O'Rourke L, Dimopoulos MA. Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies. Haematologica. 2020 Jan 31;105(2):468-477. doi: 10.3324/haematol.2019.217448. Print 2020.

ReferenceCitation: Dimopoulos MA, Oriol A, Nahi H, San-Miguel J, Bahlis NJ, Usmani SZ, Rabin N, Orlowski RZ, Komarnicki M, Suzuki K, Plesner T, Yoon SS, Ben Yehuda D, Richardson PG, Goldschmidt H, Reece D, Lisby S, Khokhar NZ, O'Rourke L, Chiu C, Qin X, Guckert M, Ahmadi T, Moreau P; POLLUX Investigators. Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med. 2016 Oct 6;375(14):1319-1331.

location_country:
Denmark
Poland
Taiwan
Spain
Greece
Russian Federation
Australia
Netherlands
Canada
United Kingdom
Sweden
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany


title: A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

lead_sponsor: CTI BioPharma

ReferenceType: background

ReferenceCitation: Mascarenhas J, Hoffman R, Talpaz M, Gerds AT, Stein B, Gupta V, Szoke A, Drummond M, Pristupa A, Granston T, Daly R, Al-Fayoumi S, Callahan JA, Singer JW, Gotlib J, Jamieson C, Harrison C, Mesa R, Verstovsek S. Pacritinib vs Best Available Therapy, Including Ruxolitinib, in Patients With Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):652-659. doi: 10.1001/jamaoncol.2017.5818.

ReferenceCitation: Verstovsek S, Mesa R, Talpaz M, Kiladjian JJ, Harrison CN, Oh ST, Vannucchi AM, Rampal R, Scott BL, Buckley SA, Craig AR, Roman-Torres K, Mascarenhas JO. Retrospective analysis of pacritinib in patients with myelofibrosis and severe thrombocytopenia. Haematologica. 2022 Jul 1;107(7):1599-1607. doi: 10.3324/haematol.2021.279415.

ReferenceCitation: Tremblay D, Mesa R, Scott B, Buckley S, Roman-Torres K, Verstovsek S, Mascarenhas J. Pacritinib demonstrates spleen volume reduction in patients with myelofibrosis independent of JAK2V617F allele burden. Blood Adv. 2020 Dec 8;4(23):5929-5935. doi: 10.1182/bloodadvances.2020002970.

location_country:
United Kingdom
Russian Federation
Australia
Netherlands
Canada
New Zealand
Hungary
United States
France
Belgium
Germany
Czechia

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Siouxland Hematology-Oncology Associates, L.L.P (SHOA)

location_facility: SCRI- Florida Cancer Specialists South Region

location_facility: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőint

location_facility: SCRI - Florida Cancer Specialists North Region

location_facility: Hematology-Oncology Associates of Northern Jersey

location_facility: Auckland District Health Board, Auckland City Hospital

location_facility: Texas Onocolgy-Baylor Sammons Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: George Washington University- Medical Faculty Associates

location_facility: Investigative Clinical Research of Indiana

location_facility: Russian Research Institute of Hematology and Transfusiology

location_facility: Froedtert Hospital and the Medical College of Wisconsin

location_facility: Washington University School of Medicine Division of Oncology

location_facility: University of Iowa Hospitals and Clinics

location_facility: Klinik I fur Innere Medizin, Universitat Koln

location_facility: University of Debrecen, Belgyogyaszati Intezet

location_facility: Haematology and Oncology Clinics of Australia

location_facility: Military Medical Academy n.a. S.M. Kirov

location_facility: SZTE II. sz Belgyogyoszati Klinika es Kardiologiai Kozpont

summary: Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.


title: A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

summary: This is a multi-center, randomized, double-blinded, placebo controlled trial.

ReferenceCitation: Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, Conte P, Cameron DA, André F, Arteaga CL, Zarate JP, Chakravartty A, Taran T, Le Gac F, Serra P, O'Shaughnessy J. Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med. 2022 Mar 10;386(10):942-950. doi: 10.1056/NEJMoa2114663.

ReferenceCitation: Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

ReferenceCitation: Prat A, Chaudhury A, Solovieff N, Paré L, Martinez D, Chic N, Martínez-Sáez O, Brasó-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26. Erratum in: J Clin Oncol. 2021 Nov 1;39(31):3525.

ReferenceCitation: Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

ReferenceCitation: Hortobagyi GN. Ribociclib for the first-line treatment of advanced hormone receptor-positive breast cancer: a review of subgroup analyses from the MONALEESA-2 trial. Breast Cancer Res. 2018 Oct 19;20(1):123. doi: 10.1186/s13058-018-1050-7.

ReferenceCitation: Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155. Erratum in: Ann Oncol. 2019 Nov 1;30(11):1842.

ReferenceCitation: Janni W, Alba E, Bachelot T, Diab S, Gil-Gil M, Beck TJ, Ryvo L, Lopez R, Tsai M, Esteva FJ, Auñón PZ, Kral Z, Ward P, Richards P, Pluard TJ, Sutradhar S, Miller M, Campone M. First-line ribociclib plus letrozole in postmenopausal women with HR+ , HER2- advanced breast cancer: Tumor response and pain reduction in the phase 3 MONALEESA-2 trial. Breast Cancer Res Treat. 2018 Jun;169(3):469-479. doi: 10.1007/s10549-017-4658-x. Epub 2018 Feb 5.

ReferenceCitation: Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, André F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. Epub 2016 Oct 7. Erratum in: N Engl J Med. 2018 Dec 27;379(26):2582.

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

This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Czechia
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Norway
Singapore
Sweden
Brazil
Lebanon
Canada
Hungary
Germany
Denmark
Taiwan
Ireland
Finland
Thailand
Korea, Republic of
France
Netherlands

location_facility: The Ohio State University Comprehensive Cancer Center Ohio State-2

location_facility: Florida Cancer Specialists FL Cancer Specialists

location_facility: Ingalls Memorial Hospital Ingalls Mem Hosp

location_facility: University of Texas MD Anderson Cancer Center UT MDAnderson

location_facility: Chattanooga Oncology and Hematology Associates PC Chattanooga Oncology

location_facility: The Angeles Clinic and Research Institute SC-3

location_facility: City of Hope National Medical Center SC-5

location_facility: Lewis Hall Singletary Onc Ctr at John D. Archbold Mem Hosp. Onc Dept

location_facility: Oncology Hematology Care Inc Oncology Hematology Care (3)

location_facility: Mercy Clinic Oklahoma Communities Mercy Oncology

location_facility: Dana Farber Cancer Institute Dana Farber-9

location_facility: NYU Langone Medical Center CV Research center SC-2

location_facility: Penn State University Milton S Hershey Medical Center SC-3

location_facility: Virginia Piper Cancer Institute, Allina Health

location_facility: Utah Cancer Specialists Utah Cancer Specialists (11)

location_facility: Northwest Medical Specialties Dept of Onc

location_facility: Rocky Mountain Cancer Centers RMCC - Aurora

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: University of Illinois Cancer Center at Chicago

location_facility: Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med SC-3

location_facility: Center for Cancer and Blood Disorders SC

location_facility: University of Texas Southwestern Medical Center

location_facility: UC Davis Comprehensive Cancer Center SC-2

location_facility: Richardson Hematology Oncology Associates

location_facility: University of Colorado School of Medicine Onc Dept.

location_facility: Moanalua Medical Center. Attn: Oncology Dept

location_facility: Cooper Cancer Center Cooper Cancer Center

location_facility: Vanderbilt University Medical Center SC-4

location_facility: Florida Cancer Research Institute Dept of Oncology

location_facility: Virginia Cancer Specialists Fairfax Northern Virginia

location_facility: Saint Luke's Hospital/Marion Bloch Neuroscience Institute Oncology Dept

location_facility: Georgia Cancer Specialists Georgia Cancer Spec

location_facility: Glendale-Adventist Medical Center Dept of Oncology