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.

sponsor_collaborators:
ImmunoGen, Inc.
Gynecologic Oncology Group

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

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

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

location_facility: Florida State University College of Medicine

location_facility: Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol

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

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

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

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

location_facility: University Clinical Center of Republic of Srpska

location_facility: University of Texas Southwestern Medical Center

location_facility: University of California San Diego Medical Center

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

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

location_facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone

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

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Froedtert and Medical College of Wisconsin

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

location_facility: Servicio de Oncología Médica Hospital Universitario La Paz

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

location_facility: Mater Private Hospital and Mater Misericordiae University Hospital

location_facility: University of Oklahoma Health Sciences Center

location_facility: Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg

location_facility: MD Anderson Cancer Center - Cooper Health

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

location_facility: Sunnybrook Research Institute - Odette Cancer Centre

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

location_facility: Fairview Hospital, Moll Pavilion Cancer Center

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

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Texas Oncology - The Woodlands, Gynecologic Oncology

location_facility: Kantonsspital Winterthur, Medizinische Onkologie

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Fondazione IRCCS National Cancer Institute

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

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

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

location_facility: Azienda Unita Sanitaria Locale di Ravenna

location_facility: McGill University Health Centre - Glen Site

location_facility: Centre hospitalier de l'Université de Montréal

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

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

location_facility: Levine Cancer Institute - Carolinas Medical Center


study_start_date_type: Actual

intervention_type: Drug

lead_sponsor: Bayer

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.

ReferenceType: derived

ReferenceCitation: Matasar MJ, Dreyling M, Leppa 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.

oa_colors: green hybrid

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endpoint_id: fhisxppmrqpajgzqkvft

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

host_type: repository

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

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repository_normalized: PubMed Central

version: acceptedVersion

repositories_concat: PubMed Central;cris.unibo.it

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centre Universitaire de Sante de l'Estrie

location_facility: Institut Jules Bordet/Jules Bordet Instituut

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Karadeniz Teknik Universitesi Tip Fakultesi

location_facility: Centre Hospitalier Intercommunal de la Côte Basque-Bayonne

location_facility: Klinikum der Universität München Grosshadern

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office

location_facility: Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department

location_facility: Wojew. Szpital Specjalistyczny im. M. Kopernika

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi

location_facility: Albert Alberts Stem Cell Transplant Research Centre

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

location_facility: Centre Hospitalier Universitaire - Angers

location_facility: Municipal Non-Profit Enterprise "City Clinical Hospital ¿4" of the Dnipro City Council

location_facility: Spitalul Clinic Municipal Filantropia Craiova

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

location_facility: National Hospital Organization Kyushu Cancer Center

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

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

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

location_facility: Centro Multidisciplinar de Estudos Clínicos EPP - Ltda.

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

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

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

location_facility: Republican Clinical Oncology Dispensary Ufa

location_facility: Centro de Investigaciones Clínicas Vina del Mar Ltda.

location_facility: Komarom-Esztergom Varmegyei Szent Borbala Korhaz

location_facility: 1st Affiliated hospital of Soochow University

location_facility: Hospital Universitario "José Eleuterio González"

location_facility: Saitama Medical University International Medical Center

location_facility: Multiprofile Hospital for Active Treatment Hristo Botev AD

location_facility: FuJian Medical University Union Hospital

location_facility: Faculdade de Ciencias Medicas-Universidade Estadual Campinas

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

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: Centro Hospitalar Universitario do Porto

location_facility: State Institution - Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine

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

location_facility: University General Hospital of Athens "ATTIKON"

location_facility: CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council

location_facility: Centro Integrado de Oncologia de Curitiba

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

location_facility: Tianjin Medical University Cancer Institiute & Hospital

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

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

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

location_facility: Centre Hospitalier de la Durance - Avignon

location_facility: CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council"

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva

location_facility: Ankara Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: Beijing Friendship Hospital, Capital Medical University

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

location_facility: Centro de Atencion e Investigacion Clinica en Oncologia SCP

location_facility: Centro Especializado en Investigación Clínica S.C.

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

location_facility: National Hospital Organization Kumamoto Medical Center

location_facility: Centre Hospitalier Universite de Grenoble

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

location_facility: Sociedad de Investigaciones Medicas Ltda

location_facility: Clinical Oncological Dispensary of Omsk Region

location_facility: The 1st Affiliated Hospital of Zhejiang University

location_facility: Hospital Universitario Clinica Puerta de Hierro

location_facility: Governmental Noncommercial Institution "National Cancer Institute

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Hiroshima Red Cross & Atomic-bomb Survivors Hospital

status: Terminated

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)

primary_purpose: Treatment

type: EudraCT Number

source: euctr

enrollment_type: Actual

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

design_allocation: Randomized

study_completion_date_type: Actual

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

study_type: Interventional

ipd_sharing: No

lead_sponsor_type: industriel

status_simplified: Unknown


lead_sponsor: Vertex Pharmaceuticals Incorporated

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), VX14-661-111 (Study 111, NCT02508207), VX15-661-112 (NCT02730208), and VX16-661-114 (NCT03150719). The study is designed to evaluate the safety and efficacy of long-term treatment of VX-661 in combination with ivacaftor.

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.

oa_host_type: repository

repository_institution: Queen's University Belfast - Research Portal

unpaywall_oa_status: green

status: Completed

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

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

status_simplified: Completed


lead_sponsor: Hoffmann-La Roche

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.

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.

repositories_concat: PubMed Central

publisher_dissemination: Wiley

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;:

oa_host_type: closed

repositories_concat: closed

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

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

location_facility: Southern California Permanente Medical Group Bellflower

location_facility: Municipal Institution SubCarpathian ClinicalOncological Centre; Chemotherapy department

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

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

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Compassionate Cancer Care Medical Group, Inc

location_facility: Hematology and Oncology Associates at Bridgepoint

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

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Consorcio Hospitalario Provincial de Castellon

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

location_facility: Quincy Medical Group; Canc Ctr at Blessing Hosp

location_facility: First Hospital of China Medical University

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

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

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

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

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: Hopital d Instruction des Armees de Sainte Anne

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

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

location_facility: University Cancer & Blood Center, LLC; Research

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

location_facility: City Clinical Hospital #1; Dpt of Oncology

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

location_facility: Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz

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

location_facility: Affiliated Hospital of Guangdong Medical University

location_facility: Hôpital Saint Joseph; Oncologie Medicale

location_facility: Praxair Cancer Center at Danbury Hospital

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

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

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Cancer and Hematology Centers of Western Michigan

location_facility: Hospital de Sao Joao; Servico de Pneumologia

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

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Volgograd Regional Clinical Oncology Dispensary

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

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

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

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

location_facility: Chang Gung Medical Foundation Linkou Branch

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

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

location_facility: Praxis fur Hamatologie und internistische Onkologie

location_facility: Cancer Institute and Hospital Chinese Academy of Medical Sciences

location_facility: Florida Cancer Specialists-Broadway, Fort Myers

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

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

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

location_facility: First Affiliated Hospital of Soochow University

location_facility: Hematology Oncology Associates of Northern New Jersey

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

location_facility: MultiCare Regional Cancer Center - Auburn

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

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

location_facility: Chonnam National University Hwasun Hospital

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

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

location_facility: Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica

location_facility: Overlook Medical Center; Medical Diagnostic Associates

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Southern Illinois University, Simmons Cancer Institute

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

location_facility: Centre Hospitalier de Mont de Marsan - Hopital Layne

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

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

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

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

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

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

location_facility: Municipal Institution Odesa Regional Oncology Dispensary

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

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

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

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

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

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

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

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie

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

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: Private Enterprise Private Manufacturing Company Acinus

status: Active, not recruiting

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

study_completion_date_type: Anticipated

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

status_simplified: Ongoing


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.

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.

publisher_dissemination: Begell House

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):

oa_colors: green gold

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license_normalized: cc-by-nc

unpaywall_oa_status: gold

publisher_dissemination: British Medical Journal

ReferenceCitation: Adams S, Dieras 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.

oa_host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

unpaywall_oa_status: bronze

ReferenceCitation: Schmid P, Rugo HS, Adams S, Schneeweiss A, Barrios CH, Iwata H, Dieras 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, Dieras 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.

evidence: open (via free article)

publisher_dissemination: Massachusetts Medical Society

location_facility: Tampere University Hospital; Dept of Oncology

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

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

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

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

location_facility: Cukurova Uni Faculty of Medicine; Medical Oncology

location_facility: National Hospital Organization Osaka National Hospital

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

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

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

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

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

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Universitätsklinikum Schleswig-Holstein; Campus Lübeck

location_facility: Wellmont Bristol Regional Medical Center

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

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

location_facility: Medipol University MF; Oncology Department

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

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

location_facility: Centro de Cancer Pontificie Universidad Catolica de Chile

location_facility: Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Clinic of Oncology, University Clinical Center Sarajevo

location_facility: Western General Hospital; Clinical Oncology

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

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

location_facility: Princess Alexandra Hospital; Division of Cancer Services

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Crio - Centro Regional Integrado de Oncologia

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

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

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

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

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

location_facility: China Medical University Hospital; Surgery

location_facility: Rush University Medical Center - Chicago

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

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

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

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

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk

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

location_facility: Songklanagarind Hospital; Department of Oncology

location_facility: University Hospital of Patras Medical Oncology

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

location_facility: Instituto Estatal de Cancerologia Colima

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

location_facility: Saitama Medical University International Medical Center

location_facility: Lviv State Oncology Regional Treatment and Diagnostic Centre

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

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

location_facility: Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Kaiser Permanente of Northern California

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

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

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: St John of God Hospital; Bendat Cancer Centre

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

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

location_facility: Tartu Uni Hospital; Hematology - Oncology Clinic

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Universitätsklinik Tübingen; Frauenklinik & Poliklinik

location_facility: Washington University School of Medicine

location_facility: National Taiwan Uni Hospital; General Surgery

location_facility: Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

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

location_facility: Florida Cancer Specialists - SCRI; Pharmacy

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

location_facility: The Mount Siani Comprehensive Cancer Center

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

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

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

location_facility: VETERANS GENERAL HOSPITAL; Department of General Surgery

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

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

location_facility: North Estonia Medical Centre Foundation; Oncology Centre

location_facility: Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie

location_facility: Treatment and Prevention Institution Volyn Regional Oncology Dispensary

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

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

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: Greenville Health System (GHS) Cancer Institute

location_facility: Univ General Hosp Heraklion; Medical Oncology

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

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

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

location_facility: Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum

location_facility: Fövárosi Önkormányzat uzsoki utcai Kórház

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

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

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

location_facility: Barbara Ann Karmanos Cancer Institute; Oncology

location_facility: Texas Oncology- El Paso Cancer Treatment Center Gateway

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

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


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.

publisher_dissemination: Wolters Kluwer Health

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.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
LIRIAS (KU Leuven)
Zenodo

repositories_concat: LIRIAS (KU Leuven);Zenodo

repositories_institution:
INFN Catania - INFM-OAR
KU Leuven - Lirias

lead_sponsor: Takeda

location_country:
Italy
Poland
Hungary
Belgium
United States
Czechia
Canada
France


acronym: DUAL™VII

lead_sponsor: Novo Nordisk A/S

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.

ReferenceType: result

ReferenceCitation: Billings LK, Doshi A, Gouet D, Oviedo A, Rodbard HW, Tentolouris N, Gron 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.

evidence: open (via free pdf)

publisher_dissemination: American Diabetes Association

ReferenceCitation: Billings LK, Agner BFR, Altuntas Y, Gron R, Halladin N, Klonoff DC, Tentolouris N, Jodar 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.

oa_colors: green other

publisher_dissemination: SAGE Publications

ReferenceCitation: Meneghini L, Doshi A, Gouet D, Vilsboll T, Begtrup K, Orsy 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.

licence_repositories: cc-by-nc cc-by-nd

repository_institution: PubMed Central - Europe PMC

license: cc-by-nd

license_normalized: cc-by-nd

repository_institution: University of Copenhagen - Research at the University of Copenhagen

repository_normalized: Pure (Denmark)

repositories:
PubMed Central
Pure (Denmark)

repositories_concat: PubMed Central;Pure (Denmark)

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

type: Other Identifier

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


acronym: OPTIMISE

intervention_type: Biological

lead_sponsor: Novartis Pharmaceuticals

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.

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.

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

ipd_sharing: Undecided


acronym: EAGLE

lead_sponsor: AstraZeneca

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.

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.

repository_institution: Universitat de Barcelona - Dipòsit Digital de la Universitat de Barcelona

repository_institution: Sumy State University - Electronic Sumy State University Institutional Repository

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)

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

ipd_sharing: Yes


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).

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.

evidence: oa repository (via page says license)

license: cc-by

license_normalized: cc-by

version: submittedVersion

publisher_dissemination: American Association for Cancer Research

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_facility: Institut Hospitalier Franco-Britannique; Cancerologie

location_facility: Kaiser Permanente; Oncology Clinical Trials

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Kaiser Permanente Oakland Medical Center

location_facility: Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie

location_facility: Hematology and Oncology Associates at Bridgepoint

location_facility: Consorcio Hospitalario Provincial de Castellon

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

location_facility: Duke University Medical Center; Department of Medicine

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

location_facility: Hospital General Universitario de Guadalajara

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

location_facility: Complejo Hospitalario Universitario A Coruña

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

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Joliet Oncology-Hematology; Associates, Ltd.

location_facility: Centre Hospitalier Regional Sud Reunion; Service de Pneumologie

location_facility: Walter Reed National Military Medical Center

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

location_facility: Fondation Hopital Saint Joseph;Cardiologie Clinique

location_facility: Hopital d'Instruction des Armees de Begin

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

location_facility: Praxis fur Haematologie und Internistische Onkologie

location_facility: Hospital General Universitario de Valencia

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: SCRI The Center For Cancer and Blood Disorders

location_facility: Kaiser Permanente - Sacramento Medical Center and Medical Offices

location_facility: Kaiser Permanente - San Leandro Medical Center

location_facility: Malteser Krankenhaus St. Franziskus-Hospital

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

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

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

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

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

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

location_facility: Kaiser Permanente Medical Center - Roseville

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

location_facility: Kaiser Permanente - San Francisco Medical Center

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

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Southern Illinois University, Simmons Cancer Institute

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

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

location_facility: Suburban Hematology / Oncology Associates

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

location_facility: Hospital Universitario Virgen de Las Nieves

location_facility: Kaiser Permanente - San Jose Medical Center

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

location_facility: Fort Wayne Med Oncology & Hematology Inc

location_facility: University of Iowa Hospitals and Clinics

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

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

location_facility: Rambam Health Corporation; Oncology Institute

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

location_country:
Germany
Italy
Israel
Belgium
United States
Spain
Canada
France


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).

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, Rodriguez-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.

license: publisher-specific-oa

license_normalized: publisher-specific

ReferenceCitation: Socinski MA, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-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, Gonzalez Larriba JL, Rothenstein J, Fruh 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.

evidence: open (via page says license)

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Reck M, Mok TSK, Nishio M, Jotte RM, Cappuzzo F, Orlandi F, Stroyakovskiy D, Nogami N, Rodriguez-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, Rodriguez-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.

repository_institution: Universidad de Las Palmas de Gran Canaria - Acceda

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

location_facility: IPCEM; Instituto de Pesquisa de Estudos Multicêntricos

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

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

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

location_facility: Hematology Oncology Associates of the Treasure Coast

location_facility: Willamette Valley Cancer Insitute and Research Center

location_facility: Hospital Universitario Marques de Valdecilla

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

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary

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

location_facility: Prince Charles Hospital; Department of Medical Oncology

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Hospital Universitario Fundación Jimenez Díaz

location_facility: Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

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

location_facility: Hospital Pulido Valente; Servico de Pneumologia

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

location_facility: Azienda Ospedaliera San Camillo Forlanini

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

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Kaohsiung Medical University Hospital; Department of Urology

location_facility: Centro Hemato Oncologico Privado; Oncologia

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

location_facility: National Hospital Organization Osaka Toneyama Medical Center

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Park Nicolett - Frauenshuh Cancer Center

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Universitario HM Sanchinarro-CIOCC

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Hospital de Sao Joao; Servico de Pneumologia

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Chang Gung Medical Foundation Linkou Branch

location_facility: National Hospital Organization Shikoku Cancer Center

location_facility: Changhua Christian Hospital; Hematology-Oncology

location_facility: Multiprofile Hospital for Active Treatment Central Onco Hospital OOD

location_facility: Chao Family Comprehensive Cancer Center UCI

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

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

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: MultiCare Regional Cancer Center - Auburn

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

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

location_facility: Centro Oncologico Riojano Integral (CORI)

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

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: West Virginia University; Mary Babb Randolph Can Ctr

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Pauls Stradins Clinical University Hospital

location_facility: Hospital de Base de Sao Jose do Rio Preto

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

location_facility: Centre Jean Bernard Clinique Victor Hugo

location_facility: National Cancer Centre; Medical Oncology

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

location_facility: MNPE Zaporizhzhia Regional Antitumor Center ZRC

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE

location_facility: Krankenhaus Martha-Maria; Halle-Dolau gGmbH

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

location_facility: Universität Des Saarlandes; Klinik für Innere Medizin V

location_facility: Hematology-Oncology; Associates of the Quad Cities

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

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Centro Especializado de Enfermedades Neoplásicas

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

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Krankenhaus Barmherzige Bruder Regensburg

location_facility: Cancer Specialists of North Florida - Baptist South

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

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


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, Garcia-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.

publisher_dissemination: Springer-Nature

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


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, Ryden 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.

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

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


title: A Phase 2b Open-label Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

summary: A multicenter, open-label Phase 2b study of selinexor (KPT-330) in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have no therapeutic options of demonstrated clinical benefit.

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Schuster M, Zijlstra J, Casasnovas RO, Vermaat JSP, Kalakonda N, Goy A, Choquet S, Neste EVD, Hill B, Thieblemont C, Cavallo F, De la Cruz F, Kuruvilla J, Hamad N, Jaeger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Follows G, Egyed M, Offner F, Vassilakopoulos T, Samal P, Ku M, Ma X, Corona K, Chamoun K, Shah J, Shacham S, Kauffman MG, Canales M, Maerevoet M. Effect of Prior Therapy and Disease Refractoriness on the Efficacy and Safety of Oral Selinexor in Patients with Diffuse Large B-cell Lymphoma (DLBCL): A Post-hoc Analysis of the SADAL Study. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):483-494. doi: 10.1016/j.clml.2021.12.016. Epub 2021 Dec 25.

repository_institution: Leiden University - Leiden Repository

ReferenceCitation: Maerevoet M, Zijlstra JM, Follows G, Casasnovas RO, Vermaat JSP, Kalakonda N, Goy A, Choquet S, Van Den Neste E, Hill B, Thieblemont C, Cavallo F, De la Cruz F, Kuruvilla J, Hamad N, Jaeger U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Schuster M, Egyed M, Offner F, Vassilakopoulos TP, Samal P, Ku M, Ma X, Corona K, Chamoun K, Shah J, Shacham S, Kauffman MG, Canales M. Survival among patients with relapsed/refractory diffuse large B cell lymphoma treated with single-agent selinexor in the SADAL study. J Hematol Oncol. 2021 Jul 16;14(1):111. doi: 10.1186/s13045-021-01122-1.

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

repository_institution: University of Melbourne - Minerva Access

repository_normalized: University of Melbourne - Minerva Access

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories: University of Melbourne - Minerva Access

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;archive.ugent.be;scholarlypublications.universiteitleiden.nl;www.repositoriosalud.es

repositories_institution: University of Melbourne - Minerva Access

ReferenceCitation: Shah J, Shacham S, Kauffman M, Daniele P, Tomaras D, Tremblay G, Casasnovas RO, Maerevoet M, Zijlstra J, Follows G, P Vermaat JS, Kalakonda N, Goy AH, Choquet S, Den Neste EV, Hill BT, Thieblemont C, Cavallo F, la Cruz F, Kuruvilla J, Hamad N, Bouabdallah R, Jager U, Caimi P, Gurion R, Warzocha K, Bakhshi S, Sancho JM, Schuster M, Egyed M, Offner F, Vasilakopoulos TP, Samal P, Nagy A, Ku M, Canales Albendea MA. Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma. Future Oncol. 2021 Apr;17(11):1295-1310. doi: 10.2217/fon-2020-0946. Epub 2021 Feb 2.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université de Nantes

repository_normalized: HAL

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

ReferenceCitation: Kalakonda N, Maerevoet M, Cavallo F, Follows G, Goy A, Vermaat JSP, Casasnovas O, Hamad N, Zijlstra JM, Bakhshi S, Bouabdallah R, Choquet S, Gurion R, Hill B, Jaeger U, Sancho JM, Schuster M, Thieblemont C, De la Cruz F, Egyed M, Mishra S, Offner F, Vassilakopoulos TP, Warzocha K, McCarthy D, Ma X, Corona K, Saint-Martin JR, Chang H, Landesman Y, Joshi A, Wang H, Shah J, Shacham S, Kauffman M, Van Den Neste E, Canales MA. Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial. Lancet Haematol. 2020 Jul;7(7):e511-e522. doi: 10.1016/S2352-3026(20)30120-4.

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

location_country:
Germany
Poland
New Zealand
Australia
Canada
Serbia
France
Hungary
United States
India
Belgium
Italy
United Kingdom
Netherlands
Austria
Spain
Greece
Bulgaria
Israel

location_facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

location_facility: Liverpool Hospital, Ingham Institute of Medical Research

location_facility: Semmelweis University Department of Medicine and Oncology

location_facility: Szpitale Wojewódzkie w Gdyni, Gdyńskie Centrum onkologii

location_facility: Memorial Provincial Specialist Hospital in Lodz

location_facility: Klinicko Bolnick Centar Zemun Odeljenje hematologije

location_facility: Pécsi Tudományegyetem, ÁOK, I. számú Belgyógyászati Klinika

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Meenakshi Mission Hospital & Research Centre

location_facility: Hostpial Saint Louis - CIRCO (Centre d'Investigations et de Recherche Clinique en Oncologie)

location_facility: Princess Royal University Hospital (PRUH)

location_facility: Hematology Department St John's Cancer Centre

location_facility: Unite Hemopathies Lymphoides Chu Henri Mondor

location_facility: Fondazione Policlinico Universitario A. Gemelli

location_facility: University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski EAD

location_facility: Medical University of Vienna (MUW) Department of Medicine I

location_facility: Krankenhaus Barmherzigen Schwestern Linz

location_facility: Uniklinik Aachen Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Uni. Klinik für Innere Medizin III Universitätsklinikum der PMU LKH Salzburg

location_facility: Hematology-Oncology & Stem Cell Transplantation Unit, National Cancer Institute, Fondazione 'G. Pascale', IRCCS

location_facility: Martin-Luther-University Halle-Wittenberg Department of Oncology

location_facility: Hematology Clinic,General Hospital of Athens,G. Gennimatos

location_facility: Hôpital Necker Service d'Hématologie Adult

location_facility: Gemeinschaftspraxis Haematologie and Onkologie-Dresden

location_facility: Instituto di Ematologia Seragnoli Pad 8 Universita di Bologna

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza

location_facility: Sir Mortimer B Davis Jewish General Hospital/McGill University

location_facility: University of Massachusetts Medical School

location_facility: Charite Universitatsmedizin Berlin (Virchow Campus)

location_facility: Boca Raton Cancer Research Medical Center

location_facility: Centrum Onkologii- Insytut Im. Marii Skłodowskiej-Curie Klinika Nowotworow Ukladu Chlonnego

location_facility: Robert H. Lurie Comprehensive Cancer Center/Northwestern University

location_facility: Akh Linz Innere Med III - Zentrum für Hämatologie und med. Onkologie

location_facility: Samodzielny Publiczny Zakład Opieki Zdrowotnej Ministerstwa

location_facility: AOU Maggiore della Carità SCDU Ematologia

location_facility: Città della Salute e della Scienza di Torino

location_facility: Institute of Medical Sciences & SUM Hospital

location_facility: Nil Ratan Sircar Medical College and Hospital

location_facility: Oxford University Hospitals NHS Trust Oxford Cancer and Haematology Centre, Churchill Hospital

location_facility: Dr. B.R.A. Institute Rotary Cancer Hospital All India Institute of Medical Sciences

location_facility: Netaji Subhas Chandra Bose Cancer Research Institute

location_facility: Maria Sklodowska Curie National Research Institute

location_facility: National & Kapodistrian University of Athens, Laiko General Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: IRCH, All India Institute of Medical Sciences

location_facility: National & Kapodistrian University of Athens, Attiko University Hospital

location_facility: Wojewodzki Szpital Specjalistyczny w Legnicy

location_facility: LUMC (leidse universitair medisch centrum)

location_facility: Országos Onkológiai Intézet "A" Belgyógyászati Onkológiai Osztály

location_facility: Netaji Subhas Chandra Bose Cancer Research Hospital

location_facility: Klinički centar Srbije Klinika za hematologiju

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: SCDU Ematologia, Division of Hematology, Dept. of Translational Medicine, Universita del Piemonte Orientale

location_facility: Institut za onkologiju i radiologiju Srbije

location_facility: LKH Leoben Department for Haemato-Oncology

location_facility: Universität Heidelberg Medizinische Klinik V Hämatologie, Onkologie und Rheumatologie

location_facility: Charite Universitatsmedizin Berlin (Benjamin Franklin Campus)

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

location_facility: Haematology Department and HCT Unit G.Papanicolaou Hospital

location_facility: Klinikum Kempten Klinik für Innere Medizin III - Hämatologie, Onkologie und Palliativmedizin

location_facility: Virginia Mason Hospital & Medical Center

location_facility: Hospitla Universitari Germans Trias i Pujol - ICO

location_facility: Specialized Hospital for Active Treatment of Haematological Diseases EAD

location_facility: New York Presbyterian Hospital/ Cornell Medical College

location_facility: Department of clinical hematology ,university hospital Ioannina

location_facility: University of California Los Angeles (UCLA)

location_facility: Medizinische Universität Innsbruck für Innere Medizin

location_facility: Second Depth of Internal Medicine, Attiko University Hospital

location_facility: Hematology Department Laiko General Hospital

location_facility: Klinički centar Niš Klinika za hematologiju

location_facility: University Hospital for Active Treatment Dr. Georgi Stranski

location_facility: University Hospitals Seidman Cancer Center

location_facility: Chu Dijon-Bourgogne - Hematologie Clinique


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 was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) 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:
Finland
Germany
Ireland
Poland
Algeria
Australia
Turkey
Canada
France
Portugal
Denmark
Switzerland
Romania
Belgium
Italy
Norway
United Kingdom
Sweden
Netherlands
Austria
Mexico
Saudi Arabia
Spain
Greece
Bulgaria
Russian Federation
Israel

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

location_facility: Medizinische Universitaet Graz /ID# 131018

location_facility: Fondazione PTV Policlinico Tor Vergata /ID# 132185

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

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

location_facility: St Vincent's Hospital Sydney /ID# 131001

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

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

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

location_facility: Izmir Tepecik Training and Research Hospital /ID# 134968

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

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196

location_facility: LMU Klinikum der Universitat Muchen /ID# 131049

location_facility: Toronto Digestive Disease Asso /ID# 130968

location_facility: Vancouver Infectious Diseases Centre /ID# 134369

location_facility: Azienda Ospedaliero-Universitaria di Parma /ID# 132183

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188

location_facility: Samara State Medical University /ID# 136913

location_facility: University Hospitals Birmingham NHS Foundation Trust /ID# 131154

location_facility: University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969

location_facility: The Lady Davis Carmel Medical Center /ID# 131091

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

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

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

location_facility: Moscow Clinical Scientific Center n.a. Loginov /ID# 132266

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100

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

location_facility: Ottawa Hospital Research Institute /ID# 132170

location_facility: Central Clinical Hospital of Russian Academy of Science /ID# 132289

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

location_facility: Medizinische Hochschule Hannover /ID# 131054

location_facility: Hospital Universitario Virgen del Rocio /ID# 131134

location_facility: Leeds Teaching Hospitals NHS Trust /ID# 132305

location_facility: Universitaetsklinikum Freiburg /ID# 131044

location_facility: Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155

location_facility: The Royal Melbourne Hospital /ID# 130998

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

location_facility: Sahlgrenska University Hospital /ID# 131147

location_facility: Portsmouth Hospitals University NHS Trust /ID# 131158

location_facility: Universitair Ziekenhuis Leuven /ID# 131021

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

location_facility: Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045

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

location_facility: General University Hospital of Alexandroupolis /ID# 131056

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

location_facility: Tel Aviv Sourasky Medical Center /ID# 132182

location_facility: University Hospital Plymouth NHS Trust /ID# 131160

location_facility: Aarhus Univ Hospital, Skejby /ID# 131030

location_facility: Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195

location_facility: Universitaetsklinikum Frankfurt /ID# 131055

location_facility: Leids Universitair Medisch Centrum /ID# 132204

location_facility: Northern Care Alliance NHS Group /ID# 131156

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

location_facility: Hacettepe University Faculty of Medicine /ID# 131150

location_facility: Hospital Universitario 12 de Octubre /ID# 131133

location_facility: Hospital Universitari Son Espases /ID# 131140

location_facility: HCL - Hopital de la Croix-Rousse /ID# 131042

location_facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 131017

location_facility: Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117

location_facility: ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372

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

location_facility: General Hospital of Athens Laiko /ID# 131088

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

location_facility: Medizinische Universitaet Wien /ID# 131015

location_facility: Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116

location_facility: Stavropol State Medical University /ID# 132279

location_facility: Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108

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

location_facility: Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104

location_facility: St George's University Hospitals NHS Foundation Trust /ID# 132301

location_facility: Centrum für interdisziplinaere Medizin /ID# 131046

location_facility: Inselspital, Universitätsspital Bern /ID# 132294

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 131141

location_facility: ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198

location_facility: Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050

location_facility: Uludag University Medical Faculty /ID# 132297

location_facility: Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119

location_facility: Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102

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

location_facility: Hospital Universitario Reina Sofia /ID# 131135

location_facility: CHU de Quebec-Université Laval hôpital CHUL /ID# 132132

location_facility: Instituto Metropolitano de Inv /ID# 132201

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

location_facility: Stavanger University Hospital /ID# 132211

location_facility: Diagnostic Consultative Center /ID# 131027

location_facility: Saint John Regional Hospital /ID# 131210

location_facility: Universitaetsklinik Heidelberg /ID# 134371

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 131096

location_facility: Helsinki University Hospital /ID# 131034

location_facility: The Chaim Sheba Medical Center /ID# 131092

location_facility: Multidisciplinary Consultative and Diagnostic Center /ID# 131130

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

location_facility: Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975

location_facility: Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184

location_facility: Akershus Universitetssykehus_MAIN /ID# 132212

location_facility: Greenslopes Private Hospital /ID# 131003

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

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

location_facility: King Khalid University Hospita /ID# 132291

location_facility: Hospital Universitario La Paz /ID# 131132

location_facility: Hospital General Universitario Santa Lucia /ID# 131139

location_facility: Istanbul University Istanbul Medical Faculty /ID# 131153

location_facility: CHU Strasbourg - Hopital Civil /ID# 132174

location_facility: General Hospital of Athens Ippokratio /ID# 131057

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

location_facility: Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306

location_facility: Karolinska University Hospital Solna /ID# 131145

location_facility: CHU Grenoble - Hopital Michallon /ID# 131041

location_facility: The Royal Free London NHS Foundation Trust /ID# 131159

location_facility: Policlinico Agostino Gemelli /ID# 131098

location_facility: Ege University Medical Faculty /ID# 132298

location_facility: ITESM campus Ciudad de Mexico /ID# 132383

location_facility: Hospital Clinico Universitario Lozano Blesa /ID# 132292

location_facility: Ministry Nat Guard Hosp Health /ID# 145126

location_facility: Hopital Universitaire Purpan Hopital Rangueil /ID# 131035

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

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

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

location_facility: Zentru fur HIV und Heaptogastroenterologie /ID# 131052

location_facility: Azienda Ospedaliera Universitaria Federico II /ID# 132191

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

location_facility: Royal Victoria Hospital / McGill University Health Centre /ID# 132166

location_facility: GIRI Gastrointestinal Research Institute /ID# 132171

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

location_facility: Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053

location_facility: Azienda Ospedaliero Universitaria Careggi /ID# 132197

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

location_facility: Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020

location_facility: Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 132192

location_facility: Hospital Universitario Central de Asturias /ID# 131138

location_facility: NHS Greater Glasgow and Clyde /ID# 131162

location_facility: Hospital Universitario de la Princesa /ID# 131131