title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer After Failure With Platinum-Containing Chemotherapy

ReferenceType: derived

ReferenceCitation: van der Heijden MS, Loriot Y, Durán I, Ravaud A, Retz M, Vogelzang NJ, Nelson B, Wang J, Shen X, Powles T. Atezolizumab Versus Chemotherapy in Patients with Platinum-treated Locally Advanced or Metastatic Urothelial Carcinoma: A Long-term Overall Survival and Safety Update from the Phase 3 IMvigor211 Clinical Trial. Eur Urol. 2021 Jul;80(1):7-11. doi: 10.1016/j.eururo.2021.03.024. Epub 2021 Apr 23.

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

ReferenceCitation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.

ReferenceCitation: Rassy EE, Bakouny Z, Aoun F, Haddad FG, Sleilaty G, Assi T, Kattan J. A network meta-analysis of the PD(L)-1 inhibitors in the salvage treatment of urothelial bladder cancer. Immunotherapy. 2018 Jun;10(8):657-663. doi: 10.2217/imt-2017-0190. Epub 2018 Mar 22.

ReferenceCitation: Powles T, Durán I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, Oudard S, Retz MM, Castellano D, Bamias A, Fléchon A, Gravis G, Hussain S, Takano T, Leng N, Kadel EE 3rd, Banchereau R, Hegde PS, Mariathasan S, Cui N, Shen X, Derleth CL, Green MC, Ravaud A. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018 Feb 24;391(10122):748-757. doi: 10.1016/S0140-6736(17)33297-X. Epub 2017 Dec 18. Erratum in: Lancet. 2018 Oct 20;392(10156):1402.

ReferenceCitation: Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Durán I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thåström A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8. Erratum in: Lancet. 2017 Aug 26;390(10097):848.

ReferenceCitation: Kim YS, Lee SI, Park SH, Park S, Hwang IG, Lee SC, Sun JM, Lee J, Lim HY. A Phase II Study of Weekly Docetaxel as Second-Line Chemotherapy in Patients With Metastatic Urothelial Carcinoma. Clin Genitourin Cancer. 2016 Feb;14(1):76-81. doi: 10.1016/j.clgc.2015.09.008. Epub 2015 Sep 25.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Turkey
Norway
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France
Netherlands

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: University Hospital Birmingham The Cancer Centre, Queen Elizabeth Hospital

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Urologie

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Istanbul VKV American Hospital; Medical Oncology

location_facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

location_facility: Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg

location_facility: Scunthorpe General Hospital; Dept of Oncology

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie

location_facility: Hospital San Pedro De Alcantara; Servicio de Oncologia

location_facility: The Cancer Institute Hospital, JFCR; Urology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Centrum onkologii Instytutu im. Marii Sklodowskiej-Curie; Klinika Nowotworow Ukladu Moczowego

location_facility: Uniklinik RWTH Aachen; Klinik für Urologie

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Medizinische Fakultät Mannheim, Universitätsklinikum Mannheim, Klinik für Urologie

location_facility: Institute Of Oncology Bucharest; Medical Oncology

location_facility: Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology

location_facility: Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Medical University of Bialystok; Oncology clinic

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: Hiroshima City Hiroshima Citizens Hospital; Urology

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia

location_facility: Clinical Center of Serbia; Clinic of Urology

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Kantonsspital Graubünden;Onkologie und Hämatologie

location_facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

location_facility: Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale

location_facility: Osaka International Cancer Institute; Urology

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

location_facility: Semmelwies University of Medicine; Urology Dept.

location_facility: Karolinska Hospital; Oncology - Radiumhemmet

location_facility: Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust

location_facility: Charité - Universitätsmedizin Berlin; CC 8: Chirurgische Medizin; Klinik für Urologie

location_facility: Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie

location_facility: Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály

location_facility: A.O. Universitaria Policlinico Di Modena; Oncologia

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

location_facility: National Cancer Center Hospital East; Breast and Medical Oncology

location_facility: Northern Centre for Cancer Care; Northern Centre for Cancer Care

location_facility: CHU Henri Mondor; Service d'Oncologie Medicale

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Southampton General Hospital; Medical Oncology

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

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

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: MULTISCAN, s.r.o., Radiologicke centrum Pardubice

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: University Hospital of Patras Medical Oncology

location_facility: Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Royal Brisbane and Women's Hospital; Medical Oncology

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

location_facility: Taichung Veterans General Hospital; Division of Urology

location_facility: Sapporo Medical University Hospital; Urology

location_facility: Azienda Ospedaliero-Universitaria Careggi;S.C. Oncologia Medica 1

location_facility: Spaarne Ziekenhuis; Inwendige Geneeskunde

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Universitätsklinikum Magdeburg A.ö.R., Klinik f. Urologie u. Kinderurologie

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Institute for Oncology and Radiology of Serbia; Medical Oncology

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

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: University Hospital coventry; Oncology Department

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: National Cancer Center Hospital; Urology

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: GBUZ Nizhegorodskay Region: Clinical Diagnostic Center

location_facility: Inselspital Bern; Universitätsklinik für medizinische Onkologie

location_facility: Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Centre Francois Baclesse; Recherche Clinique

location_facility: Uni Hospital of Tromso; Dept. of Oncology

location_facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

location_facility: ASST DI CREMONA; Dip. Medicina - S.C. Oncologia

location_facility: Azienda Ospedaliera A. Cardarelli; Dip. Oncopneumoematologico

location_facility: Turku University Central Hospital; Urology clinic

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: China Medical University Hospital; Urology

location_facility: Royal Devon & Exeter Hospital; Oncology Centre

location_facility: Hopital Hautepierre; Hematologie Oncologie

location_facility: Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia

location_facility: Hopital Cochin; Unite Fonctionnelle D Oncologie

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Hirosaki University School of Medicine & Hospital; Urology

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: National Hospital Organization Shikoku Cancer Center; Urology

location_facility: Hospital de Navarra; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Kantonsspital St. Gallen; Onkologie/Hämatologie

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V

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

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: CHU De Nimes, Hopital Caremeau; Service De Neurologie Du Prof. Pierre Labauge

location_facility: Yokohama City University Hospital; Urology

location_facility: Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

location_facility: Iwate Medical University Hospital; Urology

location_facility: Spitalul Judetean de Urgenta Dr Constantin Opris

location_facility: Emory University; Winship Cancer Institute

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Maastricht University Medical Centre; Medical Oncology

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: TAIPEI VETERANS GENERAL HOSPITAL, Urology

location_facility: Alexandras General Hospital of Athens; Oncology Department

location_facility: Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Austin and Repatriation Medical Centre; Cancer Services

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Georgetown University Medical Center Lombardi Cancer Center

location_facility: The Netherlands Cancer Institute - Antoni Van Leeuwenhoekziekenhuis

summary: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.


type: EudraCT Number

title: A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements FOENIX-CCA3

summary: This is an open-label, multinational, parallel 2-arm, randomized Phase 3 study evaluating the efficacy and safety of futibatinib versus gemcitabine-cisplatin chemotherapy as first-line treatment of patients with advanced, metastatic, or recurrent unresectable iCCA harboring FGFR2 gene rearrangements

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Taiho Oncology, Inc.

location_country:
Poland
Taiwan
Brazil
Hong Kong
Portugal
Italy
Spain
Australia
Mexico
Argentina
Netherlands
Thailand
United Kingdom
Korea, Republic of
United States
France
Peru
Belgium
Japan
Germany

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital de Gastroenterologia Dr. C. Bonorino Udaondo

location_facility: Instituto Nacional de Enfermedades Neoplasicas (INEN)

location_facility: Hospital Universitario Virgen de la Arrixaca HUVA

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Maharaj Nakorn Chiang Mai Hospital, Faculty of Medicine, Chiang Mai University

location_facility: Instituto Nacional de Cancer Jose Alencar Gomes da Silva - INCA

location_facility: Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University

location_facility: Norton Cancer Institute Audubon Hospital Campus Medical Plaza

location_facility: Chi Mei Medical Center CMMC - Yongkang branch

location_facility: Fundacao Antonio Prudente - A.C.Camargo Cancer Center

location_facility: The University of Hong Kong, Queen Mary Hospital

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Szpital Kliniczny Przemienienia Pańskiego UM im. Karola Marcinkowskiego w Poznaniu

location_facility: Institut de Cancerologie Strasbourg Europe ICAENS

location_facility: Ospedale Maggiore della Carita di Novara

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: University College London Hospital NHS Foundation Trust

location_facility: Hospital Universitario Jose Eleuterio Gonzalez

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Servizio Sanitario Regionale Emilia-Romagna - Azienda Ospedaliero-Universitaria di Parma Ospedale Maggiore

location_facility: Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

location_facility: Yonsei University Health System - Severance Hospital

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Technische Universitaet Muenchen - Klinikum rechts der Isar

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: Centro de Estudios y Prevencion del Cancer (CEPREC)

location_facility: Instituto do Cancer do Estado de Sao Paulo

location_facility: Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon

location_facility: Medical Oncology Associates, PS - Summit Cancer Centers

location_facility: University Hospitals Bristol NHS Foundation Trust

location_facility: Fundacion Favaloro para la Docencia e Investigacion Medica

location_facility: The Chinese University of Hong Kong Prince of Wales Hospital

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: Chulabhorn Hospital, HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy

location_facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

location_facility: Medical College of Wisconsin - Froedtert Hospital

location_facility: Khon Kaen University KKU - Faculty of Medicine-Srinagarind Hospital

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]

summary: The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceCitation: Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

ReferenceCitation: Wedzicha JA, Buhl R, Singh D, Vogelmeier CF, de la Hoz A, Xue W, Anzueto A, Calverley PMA. Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO(®)/DYNAGITO(®) Trials. Adv Ther. 2020 Oct;37(10):4266-4279. doi: 10.1007/s12325-020-01438-3. Epub 2020 Aug 10.

ReferenceCitation: Ferguson GT, Buhl R, Bothner U, Hoz A, Voß F, Anzueto A, Calverley PMA. Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials. Respir Med. 2018 Oct;143:67-73. doi: 10.1016/j.rmed.2018.08.012. Epub 2018 Aug 28.

ReferenceCitation: Calverley PMA, Anzueto AR, Carter K, Grönke L, Hallmann C, Jenkins C, Wedzicha J, Rabe KF. Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial. Lancet Respir Med. 2018 May;6(5):337-344. doi: 10.1016/S2213-2600(18)30102-4. Epub 2018 Apr 5.

lead_sponsor: Boehringer Ingelheim

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Japan
Philippines
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
India
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Guatemala
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Latvia
New Zealand
Finland
Thailand
Vietnam
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: 1237.19.91001 Boehringer Ingelheim Investigational Site

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location_facility: 1237.19.10098 Boehringer Ingelheim Investigational Site

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location_facility: 1237.19.81054 Boehringer Ingelheim Investigational Site

location_facility: 1237.19.54019 Boehringer Ingelheim Investigational Site

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location_facility: 1237.19.70046 Boehringer Ingelheim Investigational Site

location_facility: 1237.19.10113 Boehringer Ingelheim Investigational Site

location_facility: 1237.19.38104 Boehringer Ingelheim Investigational Site

location_facility: 1237.19.20003 Boehringer Ingelheim Investigational Site

location_facility: 1237.19.70041 Boehringer Ingelheim Investigational Site

location_facility: 1237.19.81126 Boehringer Ingelheim Investigational Site

status_simplified: Completed


ipd_sharing: Yes

status: Terminated

title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Finding Study To Evaluate The Efficacy and Safety Of CC-90001 In Subjects With Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis

lead_sponsor: Celgene

type: Other Identifier

source: euctr

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

location_country:
Poland
Spain
United Kingdom
Australia
Canada
Korea, Republic of
United States
France
Japan
Germany

location_facility: Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: University of Colorado, School of Medicine - Hepatology Clinic - Anschutz

location_facility: University of Washington Harborview Medical Center

location_facility: Katowice (DRS)Synexus Polska Sp. z o.o. Oddzial w Katowicach

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Cochin

location_facility: Saint Louis University School of Medicine

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Beaujon

location_facility: Samodzielny Publiczny Centralny Szpital Kliniczny Im Prof. Kornela Gibinskiego

location_facility: Baylor College of Medicine - Baylor Heart Clinic

location_facility: Carolinas HealthCare System Digestive Health

location_facility: Brooke Army Medical Center Francis Street Medical Center

location_facility: New York Presbyterian Hospital - Weill-Cornell

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: Centre Hospitalier Universitaire de Rennes - Hopital de Pontchaillou

location_facility: North Tees (DRS) Synexus North Teesside Clinical Research Centre

location_facility: University of Pittsburgh Medical Center - Center for Liver Diseases

location_facility: Toronto Center for Liver Disease - Francis Family Liver Clinic

location_facility: Chelsea and Westminster Hospital NHS Foundation Trust - Chelsea and Westminster Hospital (CWH)

location_facility: WestGlen Gastrointestinal Consultants, P.A.

location_facility: University of Miami Schiff Center for Liver Diseases

location_facility: University of Birmingham Institute of Biomedical Research

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Soon Chun Hyang University Hospital Bucheon

location_facility: University of Vermont Medical Center Gastro

location_facility: Digestive Health Associates of Texas (DHAT)

location_facility: University of Mississippi Medical Center

location_facility: Virginia Commonwealth University School of Medicine

location_facility: Yonsei University Wonju Severance Christian Hospital

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: Tulane University Health Sciences Center

location_facility: Synexus Hexham Clinical Research Centre, Hexham (DRS)

location_facility: University of Calgary, Cumming School of Medicine

location_facility: Johann Wolfgang Goethe University Hospital

location_facility: Assistance Publique - Hopitaux de Paris - Hopital Universitaire Pitie Salpetriere

location_facility: University of Sydney - Royal Prince Alfred Hospital

location_facility: University of California Davis Medical Center

location_facility: Bon Secours Liver Institute of Hampton Roads

location_facility: Wojewodzki Specjalistyczny Szpital im. dr Wladyslawa Bieganskiego

location_facility: Gastrointestinal Specialists of Georgia, PC

location_facility: Lodz (DRS)Synexus Polska Sp. Z o.o. Oddzial w Lodzi

location_facility: The Institute for Digestive Health & Liver Disease at Mercy Medical Center

location_facility: University Hospital of Girona Dr. Josep Trueta

location_facility: Ohio State University Wexner Medical Center

summary:
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver fibrosis.

This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters. It will also assess dose response and overall safety.

status_simplified: Unknown


title: Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma

acronym: ROBUST

summary: To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.

ReferenceType: background

ReferenceCitation: Nowakowski GS, Chiappella A, Witzig TE, Spina M, Gascoyne RD, Zhang L, Flament J, Repici J, Vitolo U. ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma. Future Oncol. 2016 Jul;12(13):1553-63. doi: 10.2217/fon-2016-0130. Epub 2016 Apr 18.

ReferenceCitation: Nowakowski GS, Chiappella A, Gascoyne RD, Scott DW, Zhang Q, Jurczak W, Özcan M, Hong X, Zhu J, Jin J, Belada D, Bergua JM, Piazza F, Mócikova H, Molinari AL, Yoon DH, Cavallo F, Tani M, Yamamoto K, Izutsu K, Kato K, Czuczman M, Hersey S, Kilcoyne A, Russo J, Hudak K, Zhang J, Wade S, Witzig TE, Vitolo U. ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2021 Apr 20;39(12):1317-1328. doi: 10.1200/JCO.20.01366. Epub 2021 Feb 23.

location_country:
Spain
Italy
United States
Belgium
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Puerto Rico
Israel
Turkey
Canada
Switzerland
China
Taiwan
Ireland
New Zealand
Korea, Republic of
France
Netherlands

location_facility: Chang Gung Medical Foundation-Linkou Branch

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest

location_facility: Centre Hospitalier Universitaire de Sherbrooke CHUS

location_facility: Harbin Medical University Tumor Hospital

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Japan Mutual Aid Association of Public School Teachers Chugoku Central Hospital

location_facility: Samodz.Pub.Zaklad Opieki Zdrow-ej Min-wa Spraw Wewnetrznych w Poznaniu im Prof.Ludwika Bierkowskiego

location_facility: Russian Cancer Research Center n.a. Blokhin, Chemotherapy Department

location_facility: Policlinico Universitario Campus Biomedico Di Roma

location_facility: H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Presidio Ospedaliero Di Treviso Ca' Foncello

location_facility: Trakya Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Universitaria Senese

location_facility: University of Texas Southwestern Medical Center

location_facility: Azienda Ospedaliero Universitaria Di Modena Policlinico

location_facility: University Hospital, Kyoto Prefectural University of Medicine

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Ankara University Medical Faculty Cebeci Hospital

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Fakultni nemocnice Kralovske Vinohrady, Interni hematologicka klinika

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Regional Cancer Care Associates - Somerset Division

location_facility: Azienda Ospedaliero Universitaria Ospedali

location_facility: Azienda Ospedaliera Universitaria Integrata di Verona

location_facility: Complejo Hospitalario Nuestra Senora de Valme

location_facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil

location_facility: Cliniques Universitaires UCL de Mont-Godine

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

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

location_facility: Cukurova Universitesi Tip Fakultesi Balcali Hastanesi

location_facility: Regional Cancer Care Associates/Cherry Hill Division, LLC.

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

location_facility: Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

location_facility: Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale

location_facility: Fujian Medical University Union Hospital

location_facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

location_facility: Nanfang Hospital of Southern medicine university in Guangzhou

location_facility: Zaklad Opieki Zdrowotnej MSW z Warminsko-Mazurskim Centrum Onkologii

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Azienda Ospedaliero Universitaria Di Bologna Policlinico Sorsola Malpighi

location_facility: Koc Universitesi Tip Fakultesi Amerikan Hastanesi

location_facility: Siouxland Hematology-Oncology Associates, LLP

location_facility: Xinqiao Hospital, Third Military Medical University

location_facility: The Cancer Institute Hospital of Japanese Foundation For Cancer Research

location_facility: Centre Hospitalier Universitaire de Toulouse

location_facility: Hospital Universitario Central de Asturias

location_facility: Research Oncology Institute of Rosmed Technologies n.a. prof. N.N. Petrov

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: First Affiliated Hospital of Soochow University

location_facility: VU University Medical Center VU Medisch Centrum

location_facility: West China Medical School West China Hospital Sichuan University

location_facility: Azienda Ospedaliera Santi Antonio Biagio E Cesare Arrigo

location_facility: Centro Hospitalar E Universitario de Coimbra EPE

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Tianjin Medical University Cancer Institute and Hospital

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Cancer Treatment Centers of America - Southeastern Regional Medical Center

location_facility: Seoul St Marys Hospital College of Medicine The Catholic University of Korea

location_facility: Centre Hospitalier de Saint Brieuc Hopital Yves le Foll

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Azienda Ospedaliera Universitaria San Martino

location_facility: Azienda Sanitaria Ospedaliera S. Croce e Carle

location_facility: California Cancer Associates for Research and Excellence cCARE

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi


title: A Phase 1/2 Multicenter, Open-label, Study to Determine the Recommended Dose and Regimen, and Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

summary: The purpose of this study is to evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments.

design_allocation: Non-Randomized

location_country:
Denmark
Spain
Greece
Italy
Canada
United States
France
Germany
Czechia

location_facility: Wake Forest University Baptist Medical Center

location_facility: Hospital Universitario y Politecnico La Fe

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Hopital Maisonneuve Rosemont dba CIUSSS de lEst de lIle de Montreal

location_facility: Charite - Universitaetsmedizin Berlin Charité - Campus Benjamin Franklin

location_facility: The Ohio State University Comprehensive Cancer Center

location_facility: Hospital Universtario Marques de Valdecilla

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova

location_facility: University of Alberta - Faculty of Medicine and Dentistry

location_facility: Universitatsklinikum Freiburg Medizinische Klinik und Poliklinik

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

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

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen

location_facility: Northwestern University Feinberg School of Medicine

location_facility: Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole

location_facility: Winship Cancer Institute of Emory University