title: A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

acronym: IMAGINE

summary: This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.

ReferenceCitation: Jordan SC, Ammerman N, Choi J, Huang E, Najjar R, Peng A, Sethi S, Sandhu R, Atienza J, Toyoda M, Ge S, Lim K, Gillespie M, Zhang X, Haas M, Vo A. Evaluation of Clazakizumab (Anti-Interleukin-6) in Patients With Treatment-Resistant Chronic Active Antibody-Mediated Rejection of Kidney Allografts. Kidney Int Rep. 2022 Feb 9;7(4):720-731. doi: 10.1016/j.ekir.2022.01.1074. eCollection 2022 Apr.

lead_sponsor: CSL Behring

location_country:
Spain
Australia
Netherlands
Canada
Sweden
Hungary
United States
France
Germany
Czechia

location_facility: University of Louisville Research Foundation

location_facility: Shared Health Inc. operating as the Health Sciences Centre

location_facility: University Of Colorado Hospital - Anschutz Medical Campus

location_facility: New York Presbyterian Hospital / Weill Cornell Medical Center

location_facility: CHU GRENOBLE ALPES - Consultation Néphrologie Bureau des ARC (Côté Chartreuse, Rez-de-Chaussée Haut)

location_facility: Néphrologie - Pavillon Sainte Venise - CHU de Rouen - Hôpital de Bois Guillaume

location_facility: Uppsala Universitet - Akademiska Sjukhuset

location_facility: Indiana University (IU) Health Physicians - Kidney Diseases Clinic - Medical Diagnostic Center Location

location_facility: Centre Hospitalier Universitaire (CHU) de Bordeaux - Groupe Hospitalier Pellegrin

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: University of Wisconsin School of Medicine and Public Health (UWSMPH)

location_facility: Medical College of WI Froedtert Hospital

location_facility: University of California, San Francisco Medical Center

location_facility: Centre Hospitalier Universitaire de Nice, Hopital Pasteur 2

location_facility: Rush University Medical Center - University Cardiovascular Surgeons

location_facility: Debreceni Egyetem, Klinikai Központ, Auguszta

location_facility: Central Pennsylvania Transplant Foundation

location_facility: Methodist Healthcare System of San Antonio

location_facility: Hospital Universitario 12 de Octubre-Centro de Actividades Ambulatorias

location_facility: Centro Hospital Universitario Dr. Preset

location_facility: The Ohio State University, Comprehensive Transplant Center

location_facility: Hopitaux Universitaire de Strasbourg-Centre de References des Maladies Autoimmunes

location_facility: The University of Queensland - Princess Alexandra Hospital (PAH)

location_facility: Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

location_facility: Centre Hospitalier Regional Universitaire de Tours (CHRU de Tours) - Hopital Bretonneau

location_facility: Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

location_facility: Amsterdam University Medical Center (Amsterdam UMC), Academic Medical Center (AMC)

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: University of Alabama at Birmingham (UAB) - University of Alabama Hospital (UAB Hospital)

location_facility: Tulane University Health Sciences Center

location_facility: Centre Hospitalier Regional Universitaire (CHRU) Montpellier Arnaud de Villeneuve

location_facility: Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor

location_facility: Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics

location_facility: University of California Davis Medical Center

location_facility: Washington University School of Medicine - Infectious Diseases (WU ID) Clinic

location_facility: Vancouver General Hospital - Gordon & Leslie Diamond Centre

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: St. Paul's Hospital, Providence Health Care, Univ. Of British Columbia


type: EudraCT Number

type: Registry Identifier

type: Other Identifier

title: A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects

summary:
This study will compare DS-8201a to physician choice standard treatment.

Participants must have HER2-low breast cancer that has been treated before.

Participants' cancer:

Cannot be removed by an operation
Has spread to other parts of the body

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA; DESTINY-Breast04 Trial Investigators. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. doi: 10.1056/NEJMoa2203690. Epub 2022 Jun 5.

ipd_sharing: Yes

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Taiwan
Portugal
Spain
Greece
Austria
Italy
Russian Federation
Canada
United Kingdom
Switzerland
Sweden
Hungary
Korea, Republic of
United States
France
China
Israel
Belgium
Japan
Germany

location_facility: LKH - Universitätsklinikum der PMU Salzburg

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA

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

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

location_facility: Florida Cancer Specialists (South Region)

location_facility: AKH - Medizinische Universität Wien (4305)

location_facility: Cancer Treatment Centers of America at Western Regional Medical Center

location_facility: University of California at San Francisco (PARENT)

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: SBIH of Yaroslavl Region "Regional Clinical Oncological Hospital"

location_facility: Azienda Ospedaliero Universitaria Mater Domini-Campus Universitario

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

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

location_facility: Ironwood Cancer & Research Centers - Chandler II

location_facility: Klinikum der Universitaet Muenchen - Campus Grosshardern

location_facility: Harbin Medical University Cancer Hospital

location_facility: The Affiliated Drum Tower Hospital of Nanjing University

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Centro Hospitalar Vila Nova de Gaia/Espinho, E.P.E

location_facility: Hospital General Universitario de Valencia

location_facility: Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano)

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: General Oncology Hospital of Kifissia " Agioi Anargyroi"

location_facility: Karolinska universitetssjukhuset - Solna

location_facility: General Hospital of Ningxia Medical University

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE

location_facility: Nottingham University Hospitals City Campus

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Eastern Connecticut Hematology/Oncology Assoc.

location_facility: Kyungpook National University Chilgok Hospital

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

location_facility: University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics

location_facility: Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

location_facility: Sylvester Comprehensive Cancer Center - Deerfield Beach

location_facility: Severance Hospital, Yonsei University Health System

location_facility: SBIH of Moscow City "Moscow City Oncology Hospital №62" of Moscow Healthcare Departement

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

location_facility: Centro Hospitalar de Entre o Douro e Vouga, E.P.E - Hospital de São Sebastião

location_facility: McGill University - Dept. Oncology Clinical Research Program

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Institut Régional du Cancer de Montpellier

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Cancer Treatment Centers of America-Georgia

location_facility: Seoul National University Bundang Hospital

location_facility: Cancer Care Associates Medical Group, Inc. TORI

location_facility: Memorial Healthcare System MRH Cancer Center

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Centre Hospitalier Wallonie picarde - Site IMC

location_facility: The Methodist Hospital Research Institute

location_facility: Brig Center for Cancer Care and Survivorship

location_facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE

location_facility: University General Hospital of Heraklion

location_facility: Azienda Ospedaliera Univ. Policlinico Gaspare Rodolico

location_facility: Sun Yat-sen Memorial hospital, Sun Yat-sen University

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

acronym: NATALEE

summary: A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Taiwan
Brazil
Romania
Spain
Ireland
Austria
Australia
Italy
Argentina
Canada
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
China
Belgium
Germany

location_facility: University of Alabama at Birmingham/ Kirklin Clinic

location_facility: Comprehensive Blood and Cancer Center SC-2

location_facility: UCLA Porter Ranch Hematology and Oncology

location_facility: Southern California Oncology Research Alliance SCORA

location_facility: UCLA Pasadena Health Care Hematology Oncology

location_facility: Metro Minnesota CCOP Metro Minneapolis CCOP

location_facility: Cancer Treatment Centers of America Eastern Regional Medical Center

location_facility: UCLA Santa Monica Hematology / Oncology Regulatory-2

location_facility: Orlando Health, Clinical Trials Orlando Health Inc

location_facility: Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01

location_facility: Valley Breast Care and Women s Health Center

location_facility: University of California San Francisco Gynecologic Oncology

location_facility: MD Anderson Cancer Center/University of Texas

location_facility: Central Coast Medical Oncology Corporation Onc Dept

location_facility: Center for Cancer and Blood Disorders Research Department

location_facility: St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr

location_facility: University of Wisconsin / Paul P. Carbone Comp Cancer Center

location_facility: Eastern Connecticut Hematology and Oncology Associates Regulatory

location_facility: Seattle Cancer Care Alliance Medical Oncology

location_facility: Winship Cancer Institute of Emory University

intervention_type: Other


title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

summary: The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Romania
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Singapore
Brazil
Canada
Germany
Denmark
Taiwan
Greece
New Zealand
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility: Cancer Center At Milford Regional Medical Center

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: Columbia University Medical Center (Cumc)

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialists

location_facility: Instituto Medico Especializado Alexander Fleming

intervention_type: Biological


title: A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.

acronym: PICASSO III

summary: This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Ryan CW, Merimsky O, Agulnik M, Blay JY, Schuetze SM, Van Tine BA, Jones RL, Elias AD, Choy E, Alcindor T, Keedy VL, Reed DR, Taub RN, Italiano A, Garcia Del Muro X, Judson IR, Buck JY, Lebel F, Lewis JJ, Maki RG, Schöffski P. PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma. J Clin Oncol. 2016 Nov 10;34(32):3898-3905. doi: 10.1200/JCO.2016.67.6684. Epub 2016 Sep 30.

lead_sponsor: Alaunos Therapeutics

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Poland
Russian Federation
Australia
Argentina
India
Israel
Panama
Singapore
Brazil
Canada
Guatemala
Germany
France
Chile
Colombia

location_facility: Washington University School of Medicine

location_facility: The Royal Marsden NHS Foundation Trust Sarcoma

location_facility: University of Arkansas for Medical Sciences

location_facility: LSU Health Sciences Center, Feist-Weiller Cancer Center

location_facility: University of Washington/Seattle Cancer Care Alliance

location_facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre

location_facility: Institution name: Hospital de Câncer de Barretos - Fundação PIOXII

location_facility: The Ohio State University Medical Center

status_simplified: Completed


title: A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group, Efficacy and Safety Study of BI 10773 (10 mg and 25 mg Administered Once Daily) as Add on to Pre-existing Antidiabetic Therapy Over 52 Weeks in Patients With Type 2 Diabetes Mellitus and Renal Impairment and Insufficient Glycaemic Control

lead_sponsor: Boehringer Ingelheim

source: euctr

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsäßer A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

ReferenceCitation: Cherney D, Lund SS, Perkins BA, Groop PH, Cooper ME, Kaspers S, Pfarr E, Woerle HJ, von Eynatten M. The effect of sodium glucose cotransporter 2 inhibition with empagliflozin on microalbuminuria and macroalbuminuria in patients with type 2 diabetes. Diabetologia. 2016 Sep;59(9):1860-70. doi: 10.1007/s00125-016-4008-2. Epub 2016 Jun 17.

ReferenceCitation: Barnett AH, Mithal A, Manassie J, Jones R, Rattunde H, Woerle HJ, Broedl UC; EMPA-REG RENAL trial investigators. Efficacy and safety of empagliflozin added to existing antidiabetes treatment in patients with type 2 diabetes and chronic kidney disease: a randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2014 May;2(5):369-84. doi: 10.1016/S2213-8587(13)70208-0. Epub 2014 Jan 24.

location_country:
Poland
Hong Kong
Portugal
Spain
United Kingdom
Russian Federation
Netherlands
Canada
India
United States
France
South Africa
Philippines
Malaysia
Slovakia

location_facility: 1245.36.44013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70011 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44024 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33037 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44026 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33038 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44010 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85206 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44016 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91215 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34020 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.35001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20023 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91214 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44023 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60005 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20052 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91216 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44036 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91202 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20054 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20086 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.35004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63005 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34016 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.76020 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91201 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31017 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33044 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91203 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.35003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20048 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91213 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20053 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91210 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33040 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10017 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33042 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34021 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33043 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91204 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.35002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34019 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85204 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10013 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91212 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85201 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.76022 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91209 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44018 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33041 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20051 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60010 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34014 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10011 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74011 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10014 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91211 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10019 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91208 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91207 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10015 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48005 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44007 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31004 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10018 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34015 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.34017 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.91205 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10005 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.76021 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10023 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60006 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.74012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60008 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.33036 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31015 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.31002 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20055 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.63010 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10021 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60001 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.10012 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.20056 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.70009 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.44025 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.48003 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.60011 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85205 Boehringer Ingelheim Investigational Site

location_facility: 1245.36.85202 Boehringer Ingelheim Investigational Site

summary: This study will investigate the efficacy and safety of the BI 10773 in type 2 diabetic patients with renal impairment in order to provide these data for approval for BI 10773 as an antidiabetic agent by regulatory authorities.


ipd_sharing: Undecided

title: A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Spain
Italy
United Kingdom
Belgium
Czechia
Poland
Portugal
Slovenia
Argentina
Turkey
Mexico
Norway
Sweden
Slovakia
Kuwait
Brazil
Canada
Hungary
Bulgaria
Denmark
Ireland
Estonia
Finland
France
Netherlands

location_facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia

location_facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia

location_facility: Hospital General de Castellon; Servicio de Neurología

location_facility: VALEOMED Diagnosztikai Központ; VALEOMED Diagnosztikai Központ

location_facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie

location_facility: Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

location_facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

location_facility: Hospital Puerta del Mar; Sevicio de Neurologia

location_facility: Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla

location_facility: Fundacion Rosarina de Neurorehabilitacion

location_facility: HIA de Toulon hôpital militaire; Neurologie

location_facility: The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis

location_facility: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

location_facility: Mustafa Kemal UTF; Department of norology

location_facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

location_facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

location_facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology

location_facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni

location_facility: Hospital Geral de Santo Antonio; Servico de Neurologia

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Rigshospitalet Glostrup; Neurologisk Klinik

location_facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Selcuk University Medical Faculty; Norology department

location_facility: Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico

location_facility: Fondazione Istituto S. Raffaele - Giglio; UO Neurologia

location_facility: Azienda Ospedaliera di Padova; Clinica Neurologica

location_facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia

location_facility: Ospedale Binaghi; Centro Sclerosi Multipla

location_facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA

location_facility: Centro de Especialidades Neurológicas y Rehabilitación - CENyR

location_facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

location_facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

location_facility: Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

location_facility: Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Haukeland universitetssykehus; Nevrologisk avdeling

location_facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

location_facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie

location_facility: Unidad de investigacion en salud (UIS); Neurociencias

location_facility: Centralsjukhuset; Neurologi och rehabiliteringskliniken

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

location_facility: Hopital Central - CHU de Nancy; Service de Neurologie

location_facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Gazi University Medical Faculty; Departmant of Neurology.

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B

location_facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

location_facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Hôpital Guillaume et René Laënnec; Service Neurologie

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

location_facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

location_facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

location_facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

location_facility: Hospital Universitario La Paz; Servicio de Neurologia

location_facility: Hacettepe University Medical Faculty; Neurology

location_facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

location_facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

location_facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia

location_facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika

location_facility: Montreal Neurological Institute and Hospital

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

location_facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

location_facility: Hospital Universitario Central de Asturias; Servicio de Neurología

location_facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

location_facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia

location_facility: VFN Praha Poliklinika Rs Centrum - Budova A

location_facility: AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

location_facility: Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: East Tallinn Central Hospital; Neurology Department

location_facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

location_facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

location_facility: Sykehuset Buskerud HF; Nevrologisk avdeling

location_facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

location_facility: Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken

location_facility: Fakultni nemocnice v Motole; Neurologicka klinika 2. LF UK a FN Motol

location_facility: AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla

location_facility: London Health Sciences Centre Uni Campus

location_facility: Hospital de Braga; Servico de Neurologia

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Hospital Quiron de Madrid; Servicio de Neurologia

location_facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

location_facility: Karolinska Universitetssjukhuset Solna; Neurology

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative

location_facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

location_facility: Cork University Hospital; Clinical Research Facility

location_facility: Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

location_facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

location_facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

summary: This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).


title: Randomized Phase 3 Study Evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patient With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma

summary: This study evaluates the efficacy of Oral azacitidine versus single-agent Investigator's Choice Therapy in patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma.

ipd_sharing: No

lead_sponsor: The Lymphoma Academic Research Organisation

location_country:
Denmark
United Kingdom
Austria
France
Belgium

location_facility: CHU Haut-Lévèque - Centre François Magendie

location_facility: CHU de Clermont-Ferrand - Hôpital Estaing

location_facility: Université Catholique de Louvain Saint-Luc

location_facility: Cliniques Universitaires de Bruxelles - Hôpital Erasme

location_facility: Institut d'Hématologie de Basse Normandie

location_facility: University Hospital for Internal Medicine - University Hospital Graz


title: SELECT - Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity

acronym: SELECT

summary: The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

ReferenceType: result

ReferenceCitation: Ryan DH, Lingvay I, Colhoun HM, Deanfield J, Emerson SS, Kahn SE, Kushner RF, Marso S, Plutzky J, Brown-Frandsen K, Gronning MOL, Hovingh GK, Holst AG, Ravn H, Lincoff AM. Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity (SELECT) rationale and design. Am Heart J. 2020 Nov;229:61-69. doi: 10.1016/j.ahj.2020.07.008. Epub 2020 Jul 17.

ReferenceCitation: Leite AR, Angélico-Gonçalves A, Vasques-Nóvoa F, Borges-Canha M, Leite-Moreira A, Neves JS, Ferreira JP. Effect of glucagon-like peptide-1 receptor agonists on cardiovascular events in overweight or obese adults without diabetes: A meta-analysis of placebo-controlled randomized trials. Diabetes Obes Metab. 2022 Aug;24(8):1676-1680. doi: 10.1111/dom.14707. Epub 2022 May 3.

ReferenceCitation: Mares AC, Chatterjee S, Mukherjee D. Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. Curr Opin Cardiol. 2022 Jul 1;37(4):350-355. doi: 10.1097/HCO.0000000000000955. Epub 2022 Feb 16. Review.

ReferenceCitation: Kanie T, Mizuno A, Takaoka Y, Suzuki T, Yoneoka D, Nishikawa Y, Tam WWS, Morze J, Rynkiewicz A, Xin Y, Wu O, Providencia R, Kwong JS. Dipeptidyl peptidase-4 inhibitors, glucagon-like peptide 1 receptor agonists and sodium-glucose co-transporter-2 inhibitors for people with cardiovascular disease: a network meta-analysis. Cochrane Database Syst Rev. 2021 Oct 25;10:CD013650. doi: 10.1002/14651858.CD013650.pub2.

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

lead_sponsor: Novo Nordisk A/S

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Norway
Malaysia
Sweden
Brazil
Canada
Hungary
Germany
Bulgaria
Denmark
Taiwan
Greece
Ireland
Latvia
Finland
Thailand
Algeria
France
Colombia
Netherlands


title: Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder: Non-interventional, Multi-national, Prospective Cohort Study to Assess Real-life Effectiveness of Vortioxetine

acronym: RELIEVE

summary:
Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences.

Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice.

The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life.

This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Almeida SS, Christensen MC, Simonsen K, Adair M. Effectiveness of vortioxetine in patients with major depressive disorder and co-morbid generalized anxiety disorder in routine clinical practice: A subgroup analysis of the RELIEVE study. J Psychopharmacol. 2022 Nov 15:2698811221132468. doi: 10.1177/02698811221132468. [Epub ahead of print]

lead_sponsor: H. Lundbeck A/S

location_country:
United States
Italy
Canada
France

location_facility: Policlinico Universitario Di Messina (IT0031)

location_facility: Centre Hospitalier De Martigues (FR0064)

location_facility: International Research Associates LLC (US0060)

location_facility: Quest Therapeutics Of Avon Lake (US0002)

location_facility: St. Joseph's Health Care London - Parkwood Institute (Regional Mental Health Care London and Parkwood Hospital) (CA0004)

location_facility: Northwest Behavioral Research Center (US0007)

location_facility: Chatham-Kent Clinical Trials Research Centre (CA0007)

location_facility: Start Clinic For Mood And Anxiety Disorders (CA0006)

location_facility: Dr Lousqui Charles MD, Office of (FR0033)

location_facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur - Clinique de Psychiatrie et de Psychologie Medicale (FR0041)

location_facility: Millenia Psychiatry and Research, Inc. (US0015)

location_facility: Center For Advanced Improvement (US0011)

location_facility: Dr. Dominique Januel, MD Office of (FR0044)

location_facility: Azienda Ospedaliera San Paolo - Universita Degli Studi Di Milano (IT0014)

location_facility: Rochester Center For Behavioral Medicine (US0059)

location_facility: Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma (IT0032)

location_facility: Dr Philippe Marmor, MD, Office of (FR0035)

location_facility: Università degli Studi di Brescia (IT0029)

location_facility: University Of Kansas Cancer Center (US0078)

location_facility: North County Clinical Research (Nccr) (US0071)

location_facility: St. Charles Psychiatric Associates - Midwest Research Group (US0039)

location_facility: Centre Hospitalier Universitaire de Nimes (FR0018)

location_facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer - Hôpital Sainte Musse (FR0019)

location_facility: Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana (IT0035)

location_facility: Queen's University-Hotel Dieu Hospital (CA0011)

location_facility: Dr. Philippe Remaud MD, Office of (FR0010)

location_facility: Universita Degli Studi Di Catania - Azienda Policlinico (IT0030)

location_facility: Universita Degli Studi Magna Graecia Di Catanzaro (IT0006)

location_facility: Hopital Albert Michallon- CHU Grenoble Alpes (FR0021)

location_facility: Viking Clinical Research Center LLC (US0033)

location_facility: Harmonex Neuroscience Research Inc (US0072)

location_facility: CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)

location_facility: Professional Health Care of Pinellas (US0050)

location_facility: Pneumology Clinic - AO San Gerardo (IT0017)

location_facility: Pharmacology Research Institute (US0045)

location_facility: Southern Illinois Associates LLC (US0079)

location_facility: DSM Giulianova - ospedale di Giulianova (IT0019)

location_facility: Casa di Cura Villa San Benedetto Menni, Suore Ospedaliere (IT0025)

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)

location_facility: Chokka Center For Integrative Health (CA0001)

location_facility: Universita Cattolica del Sacro Cuore (University of Sacred Heart Policlinico A. Gemelli) (IT0018)

location_facility: Dr. Norbert Rigaud Md, Office Of (FR0028)

location_facility: Azienda Toscana nord ovest zona Apuane (IT0039)

location_facility: Dipartimento Salute Mentale ASL Lecce (IT0009)

location_facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)

location_facility: Disturbi Depressivi Ospedale Luigi Sacco Polo Universitario Psichiatria 2 - CTDD (IT0033)


title: COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)

acronym: COMBI-APlus

summary:
This is an open-label Phase IIIb study of dabrafenib in combination with trametinib in the adjuvant treatment of melanoma after complete resection to evaluate the impact on pyrexia related outcomes of an adapted pyrexia AE-management algorithm, as well as safety, efficacy and health-related outcomes.

Approximately 600 subjects will be enrolled to receive dabrafenib (150 mg BID) and trametinib (2 mg once daily) combination therapy for 12 months. At enrollment, subjects will be instructed on the pyrexia management algorithm.

This study consists of two Periods for Enrolled subjects:

Treatment Period - subjects will receive up to 12 months of treatment.
Follow-up Period - subjects will be followed through 24 months from their first dose date for relapse, and through end of study for overall survival. Follow-up will start once treatment is complete or is prematurely discontinued and continue through the end of the study, regardless of disease recurrence.

ReferenceCitation: Atkinson V, Robert C, Grob JJ, Gogas H, Dutriaux C, Demidov L, Gupta A, Menzies AM, Ryll B, Miranda F, Banerjee H, Lau M, Del Vecchio M. Improved pyrexia-related outcomes associated with an adapted pyrexia adverse event management algorithm in patients treated with adjuvant dabrafenib plus trametinib: Primary results of COMBI-APlus. Eur J Cancer. 2022 Mar;163:79-87. doi: 10.1016/j.ejca.2021.12.015. Epub 2022 Jan 14.

location_country:
United Kingdom
Italy
Lithuania
Japan
Czechia
Poland
Portugal
Slovenia
Russian Federation
Australia
Argentina
Israel
Turkey
Norway
Sweden
Slovakia
Brazil
Canada
Hungary
Greece
Latvia
Finland
France


title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

ReferenceCitation: Rugo HS, Bianchini G, Cortes J, Henning JW, Untch M. Optimizing treatment management of trastuzumab deruxtecan in clinical practice of breast cancer. ESMO Open. 2022 Aug;7(4):100553. doi: 10.1016/j.esmoop.2022.100553. Epub 2022 Aug 11. Review.

ReferenceCitation: Cortés J, Kim SB, Chung WP, Im SA, Park YH, Hegg R, Kim MH, Tseng LM, Petry V, Chung CF, Iwata H, Hamilton E, Curigliano G, Xu B, Huang CS, Kim JH, Chiu JWY, Pedrini JL, Lee C, Liu Y, Cathcart J, Bako E, Verma S, Hurvitz SA; DESTINY-Breast03 Trial Investigators. Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer. N Engl J Med. 2022 Mar 24;386(12):1143-1154. doi: 10.1056/NEJMoa2115022.

location_country:
Taiwan
Brazil
Hong Kong
Spain
Italy
United Kingdom
Australia
Canada
Korea, Republic of
United States
France
China
Belgium
Japan
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: The University of Texas Health Science Center at Tyler

location_facility: Harbin Medical University Cancer Hospital

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University

location_facility: Nottingham University Hospitals City Campus

location_facility: Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo), U.O Oncologia Medica

location_facility: Complejo Hospitalario Universitario de Santiago

location_facility: Hiroshima City Hiroshima Citizens Hospital

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

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: North Shore Hematology Oncology Associates, PC

location_facility: Sir Run Run Shaw Hospital Xiasha Branch, Zhejiang University, School of Medicine

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Institut de cancérologie de l'ouest, site René Gauducheau

location_facility: Hospital Universitario Clinico San Carlos

location_facility: Houston Methodist Hospital / Houston Methodist Cancer Center

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Klinikum rechts der Isar der TU Muenchen

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

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Peninsula and South Eastern Haematology & Oncology Group

location_facility: ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de Oliveira

location_facility: Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.

location_facility: Koo Foundation, Sun Yat-Sen Cancer Center

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Seoul National University Bundang Hospital

location_facility: Wake Forest University Baptist Medical Center

location_facility: Vanderbilt Breast Center at One Hundred Oaks

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: MultiCare Health System Institute for Research and Innovation

location_facility: Clinique Victor Hugo - Centre Jean Bernard

location_facility: Azienda Ospealiera della Provincia di Lecco

location_facility: Azienda Ospedaliera Ospedali Riuniti Papardo-Piemonte

location_facility: Royal Devon and Exeter Hospital (Wonford)

summary: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.


acronym: LuxLung 5

title: Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator's Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Previous Erlotinib or Gefitinib Treatment (LUX Lung 5)

ReferenceCitation: Schuler M, Yang JC, Park K, Kim JH, Bennouna J, Chen YM, Chouaid C, De Marinis F, Feng JF, Grossi F, Kim DW, Liu X, Lu S, Strausz J, Vinnyk Y, Wiewrodt R, Zhou C, Wang B, Chand VK, Planchard D; LUX-Lung 5 Investigators. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: phase III randomized LUX-Lung 5 trial. Ann Oncol. 2016 Mar;27(3):417-23. doi: 10.1093/annonc/mdv597. Epub 2015 Dec 8.

location_country:
Spain
Italy
United Kingdom
Ukraine
Peru
Belgium
Poland
Austria
Australia
Russian Federation
Argentina
India
Israel
Mexico
Brazil
Hungary
China
Germany
Taiwan
Finland
Korea, Republic of
France
Netherlands

location_facility: Boehringer Ingelheim Investigational Site

summary: The primary objective of this randomized, open-label, active-controlled, multi-center trial is to determine the efficacy of BIBW 2992 given as an add-on to chemotherapy in patients with NSCLC Stage IIIb or IV progressing after BIBW 2992 monotherapy compared to chemotherapy alone in this patient population. Patients on both treatment arms will receive best supportive care in addition to study treatment. Patients enrolled into the trial will be treated and followed until death or lost to follow-up. Additional information on the health-related quality of life (HRQOL) will be collected.


title: A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma

lead_sponsor: Amgen

ReferenceType: background

ReferenceCitation: Dimopoulos M, Wang M, Maisnar V, Minarik J, Bensinger W, Mateos MV, Obreja M, Blaedel J, Moreau P. Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study. J Hematol Oncol. 2018 Apr 4;11(1):49. doi: 10.1186/s13045-018-0583-7.

ReferenceCitation: Avet-Loiseau H, Fonseca R, Siegel D, Dimopoulos MA, Špička I, Masszi T, Hájek R, Rosiñol L, Goranova-Marinova V, Mihaylov G, Maisnar V, Mateos MV, Wang M, Niesvizky R, Oriol A, Jakubowiak A, Minarik J, Palumbo A, Bensinger W, Kukreti V, Ben-Yehuda D, Stewart AK, Obreja M, Moreau P. Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma. Blood. 2016 Sep 1;128(9):1174-80. doi: 10.1182/blood-2016-03-707596. Epub 2016 Jul 20.

ReferenceCitation: Dimopoulos MA, Stewart AK, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Ro S, Aggarwal S, Moreau P, Palumbo A. Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment. Blood Cancer J. 2017 Apr 21;7(4):e554. doi: 10.1038/bcj.2017.31.

ReferenceCitation: Dimopoulos MA, Stewart AK, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Palumbo A, Obreja M, Aggarwal S, Moreau P. Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study. Br J Haematol. 2017 May;177(3):404-413. doi: 10.1111/bjh.14549. Epub 2017 Feb 17.

ReferenceCitation: Jakubowiak AJ, Campioni M, Benedict Á, Houisse I, Tichy E, Giannopoulou A, Aggarwal SK, Barber BL, Panjabi S. Cost-effectiveness of adding carfilzomib to lenalidomide and dexamethasone in relapsed multiple myeloma from a US perspective. J Med Econ. 2016 Nov;19(11):1061-1074. Epub 2016 Jun 16.

ReferenceCitation: Stewart AK, Dimopoulos MA, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel DS, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Buchanan J, Cocks K, Yang X, Xing B, Zojwalla N, Tonda M, Moreau P, Palumbo A. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma. J Clin Oncol. 2016 Nov 10;34(32):3921-3930. doi: 10.1200/JCO.2016.66.9648.

ReferenceCitation: Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545. Review.

ReferenceCitation: Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.

ReferenceCitation: Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.

ReferenceCitation: Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5. Review.

ReferenceCitation: Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.

ReferenceCitation: Siegel DS, Dimopoulos MA, Ludwig H, Facon T, Goldschmidt H, Jakubowiak A, San-Miguel J, Obreja M, Blaedel J, Stewart AK. Improvement in Overall Survival With Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 10;36(8):728-734. doi: 10.1200/JCO.2017.76.5032. Epub 2018 Jan 17.

ReferenceCitation: Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.

ReferenceCitation: Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Špička I, Oriol A, Hájek R, Rosiñol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6.

location_country:
Poland
Romania
Serbia
Spain
Greece
Austria
Italy
Netherlands
Canada
Russian Federation
United Kingdom
Sweden
Hungary
United States
France
Israel
Belgium
Germany
Bulgaria
Czechia

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

location_facility: Hospital Universitario y Politeecnico La Fe

location_facility: Nicolaus Copernicus Municipal Specialist Hospital

location_facility: Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.

location_facility: McGill University Health Center, Royal Victoria Hospital

location_facility: University of Szeged, Albert Szent-Gyorgi Clinical Center

location_facility: UT Southwestern Medical Center at Dallas

location_facility: SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant

location_facility: University of Alberta, Cross Cancer Institute

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

location_facility: St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare

location_facility: Azienda Ospedllero Maggiore della Carita

location_facility: Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum

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

location_facility: Clinical Center of Vojvodina, Clinic of Hematology

location_facility: State Medical Institution Komi Republican Oncological Center

location_facility: Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main

location_facility: University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"

location_facility: The University of Michigan - Comprehensive Cancer Center

location_facility: Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)

location_facility: FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B

location_facility: Clinical Center of Serbia, Clinic of Hematology

location_facility: Independent Public Teaching Hospital of Medical University of Silesia in Katowice

location_facility: Military Medical Academy, Clinic of Hematology

location_facility: University Clinical Centre, Department of Hematologii Transplantologii

location_facility: Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center

location_facility: First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation

location_facility: Froedtert & Medical College of Wisconsin

location_facility: Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie

location_facility: Indiana University Health Melvin and Bren Simon Cancer Center

location_facility: Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg

location_facility: General Hospital, Health Sciences Centre

location_facility: Federal State Budget Institution: Hematology Research Center under MoH

location_facility: Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: University of Debrecen, Medical and Health Science Center

location_facility: Sir Mortimer B. Davis - Jewish General Hospital

location_facility: Specialized Hospital for Active Treatment of Hematological Diseases

location_facility: The Royal Wolverhampton Hospital NHS Trust

location_facility: Maria Sklodowska-Curie Institute of Oncology

location_facility: University Multiprofile Hospital for Active Treatment "Sveti Georgi"

location_facility: Nottingham University Hospitals (City Campus)

location_facility: Clinical Hospital Center Bezanijska Kosa

location_facility: Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach

location_facility: Clinical Center Nis, Clinic of Hematology

location_facility: The Don & Sybil Harrington Cancer Center

location_facility: University Hospital Kralovske Vinohrady - Prague

location_facility: Groupe Hospitalier Necker - Enfants Malades

location_facility: University Hospital Brno, Department of Internal Medicine - Hematooncology

location_facility: Military Medical Academy Multiprofile Hospital for Active Treatment

location_facility: Karolinska Universitetsjukhuset i Huddinge

location_facility: Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: St. Istvan and St. Laszlo Hospital of Budapest

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare

summary: The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.


title: Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes and Inadequate Glycemic Control Treated With Lifestyle Modification and Oral Antidiabetic Medications

summary: No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.

ReferenceCitation: Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660.

ReferenceCitation: Buse JB, Nauck M, Forst T, Sheu WH, Shenouda SK, Heilmann CR, Hoogwerf BJ, Gao A, Boardman MK, Fineman M, Porter L, Schernthaner G. Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (DURATION-6): a randomised, open-label study. Lancet. 2013 Jan 12;381(9861):117-24. doi: 10.1016/S0140-6736(12)61267-7. Epub 2012 Nov 7.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
Romania
South Africa
Belgium
Poland
Austria
Australia
Argentina
India
Israel
Mexico
Slovakia
Canada
Hungary
Germany
Taiwan
Greece
Czech Republic
Korea, Republic of
France

location_facility:
Research site
Research Site


title: A Multicenter, Randomized, Double Blind, Placebo Controlled Phase III Study of Panobinostat in Combination With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma

ReferenceCitation: San-Miguel JF, Einsele H, Moreau P. The Role of Panobinostat Plus Bortezomib and Dexamethasone in Treating Relapsed or Relapsed and Refractory Multiple Myeloma: A European Perspective. Adv Ther. 2016 Nov;33(11):1896-1920. Epub 2016 Sep 27. Review.

ReferenceCitation: San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Günther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Binlich F, Richardson PG. Overall survival of patients with relapsed multiple myeloma treated with panobinostat or placebo plus bortezomib and dexamethasone (the PANORAMA 1 trial): a randomised, placebo-controlled, phase 3 trial. Lancet Haematol. 2016 Nov;3(11):e506-e515. doi: 10.1016/S2352-3026(16)30147-8. Epub 2016 Oct 14.

ReferenceCitation: Richardson PG, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Guenther A, Nakorn TN, Siritanaratkul N, Schlossman RL, Hou J, Moreau P, Lonial S, Lee JH, Einsele H, Sopala M, Bengoudifa BR, Corrado C, Binlich F, San-Miguel JF. Panobinostat plus bortezomib and dexamethasone in previously treated multiple myeloma: outcomes by prior treatment. Blood. 2016 Feb 11;127(6):713-21. doi: 10.1182/blood-2015-09-665018. Epub 2015 Dec 2. Erratum in: Blood. 2016 Jun 30;127(26):3460.

ReferenceCitation: San-Miguel JF, Hungria VT, Yoon SS, Beksac M, Dimopoulos MA, Elghandour A, Jedrzejczak WW, Günther A, Nakorn TN, Siritanaratkul N, Corradini P, Chuncharunee S, Lee JJ, Schlossman RL, Shelekhova T, Yong K, Tan D, Numbenjapon T, Cavenagh JD, Hou J, LeBlanc R, Nahi H, Qiu L, Salwender H, Pulini S, Moreau P, Warzocha K, White D, Bladé J, Chen W, de la Rubia J, Gimsing P, Lonial S, Kaufman JL, Ocio EM, Veskovski L, Sohn SK, Wang MC, Lee JH, Einsele H, Sopala M, Corrado C, Bengoudifa BR, Binlich F, Richardson PG. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial. Lancet Oncol. 2014 Oct;15(11):1195-206. doi: 10.1016/S1470-2045(14)70440-1. Epub 2014 Sep 18. Erratum in: Lancet Oncol. 2015 Jan;16(1):e6.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Egypt
Brazil
Lebanon
Canada
China
Germany
Denmark
Taiwan
Greece
Finland
Thailand
Korea, Republic of
France
Netherlands

summary:
Panobinostat (LBH589) is a highly potent pan-deacetylase inhibitor (pan-DACi), inclusive of HDAC6, which disrupts aggresome function, promotes accumulation of cytotoxic misfolded protein aggregates and triggers myeloma cell death. Combination of pan-DAC and protease inhibition by co-treatment with panobinostat (PAN) and bortezomib (BTZ) has demonstrated synergistic cytotoxicity in vitro and in vivo in pre-clinical experiments. Furthermore, clinical experience in advanced multiple myeloma (MM) patients treated by oral panobinostat and i.v bortezomib ± dexamethasone showed very encouraging results for efficacy and manageable toxicity profile.

Given the medical need for improved treatment strategies for patients with previously treated and relapsed MM, the purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies, panobinostat with bortezomib and dexamethasone or placebo with bortezomib and dexamethasone, in patients with previously treated MM whose disease has recurred or progressed.


title: A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group, Safety and Efficacy Study of BI 10773 (10 mg and 25 mg) Administered Orally, Once Daily Over 78 Weeks in Type 2 Diabetic Patients Receiving Treatment With Basal Insulin (Glargine, Detemir, or NPH Insulin Only) With or Without Concomitant Metformin and/or Sulfonylurea Therapy and Insufficient Glycemic Control

ReferenceCitation: Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsäßer A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.

location_country:
Denmark
Portugal
United Kingdom
Ireland
Korea, Republic of
United States
France

location_facility: 1245.33.44003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44010 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45013 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01032 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01046 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01049 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01042 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01025 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01009 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3310A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01017 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01030 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35104 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01031 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01037 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01054 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01041 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35303 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01023 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44009 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01020 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45011 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01040 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01062 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01047 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3301A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35304 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01045 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01048 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01005 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3306A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01038 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01019 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01002 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35302 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35106 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3304A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01018 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35101 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01055 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01058 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01061 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01013 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01056 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01029 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01059 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01024 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82008 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01033 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01026 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01035 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01010 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3308A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82003 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01012 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01011 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01050 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3309A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01036 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35102 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01027 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01015 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3302A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.82001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01014 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01043 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01051 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01022 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3303A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01007 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01016 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44001 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01044 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.35107 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01028 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.3305A Boehringer Ingelheim Investigational Site

location_facility: 1245.33.44006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.45006 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01004 Boehringer Ingelheim Investigational Site

location_facility: 1245.33.01060 Boehringer Ingelheim Investigational Site

summary: The objective of the current study is to investigate the efficacy, safety and tolerability of BI 10773 at two different doses compared to placebo during long term treatment (78 weeks) in combination with basal insulin in patients with type 2 diabetes mellitus with insufficient glycaemic control.


status: Terminated

title: An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

lead_sponsor: Abbott

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

ReferenceCitation: Cainap C, Qin S, Huang WT, Chung IJ, Pan H, Cheng Y, Kudo M, Kang YK, Chen PJ, Toh HC, Gorbunova V, Eskens FA, Qian J, McKee MD, Ricker JL, Carlson DM, El-Nowiem S. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol. 2015 Jan 10;33(2):172-9. doi: 10.1200/JCO.2013.54.3298. Epub 2014 Dec 8. Erratum in: J Clin Oncol. 2017 Aug 1;35(22):2590.

location_country:
Spain
Italy
United States
Belgium
Japan
Romania
Hong Kong
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Mexico
Norway
Malaysia
Singapore
Egypt
Canada
China
Germany
Denmark
Taiwan
Greece
New Zealand
Czech Republic
Korea, Republic of
France
Chile
Netherlands

location_facility:
Site Reference ID/Investigator# 33979
Site Reference ID/Investigator# 23183
Site Reference ID/Investigator# 35705
Site Reference ID/Investigator# 44063
Site Reference ID/Investigator# 23461
Site Reference ID/Investigator# 26508
Site Reference ID/Investigator# 23462
Site Reference ID/Investigator# 23842
Site Reference ID/Investigator# 23846
Site Reference ID/Investigator# 23199
Site Reference ID/Investigator# 23849
Site Reference ID/Investigator# 23166
Site Reference ID/Investigator# 23186
Site Reference ID/Investigator# 23476
Site Reference ID/Investigator# 24103
Site Reference ID/Investigator# 23843
Site Reference ID/Investigator# 23471
Site Reference ID/Investigator# 23467
Site Reference ID/Investigator# 41488
Site Reference ID/Investigator# 26509
Site Reference ID/Investigator# 42817
Site Reference ID/Investigator# 26503
Site Reference ID/Investigator# 23469
Site Reference ID/Investigator# 23252
Site Reference ID/Investigator# 28189
Site Reference ID/Investigator# 44444
Site Reference ID/Investigator# 27967
Site Reference ID/Investigator# 23450
Site Reference ID/Investigator# 23470
Site Reference ID/Investigator# 38902
Site Reference ID/Investigator# 35702
Site Reference ID/Investigator# 23449
Site Reference ID/Investigator# 23845
Site Reference ID/Investigator# 29757
Site Reference ID/Investigator# 29758
Site Reference ID/Investigator# 23447
Site Reference ID/Investigator# 37602
Site Reference ID/Investigator# 23460
Site Reference ID/Investigator# 23158
Site Reference ID/Investigator# 23159
Site Reference ID/Investigator# 23603
Site Reference ID/Investigator# 26505
Site Reference ID/Investigator# 23168
Site Reference ID/Investigator# 23445
Site Reference ID/Investigator# 24523
Site Reference ID/Investigator# 23268
Site Reference ID/Investigator# 23190
Site Reference ID/Investigator# 27970
Site Reference ID/Investigator# 43203
Site Reference ID/Investigator# 27122
Site Reference ID/Investigator# 24042
Site Reference ID/Investigator# 23456
Site Reference ID/Investigator# 23472
Site Reference ID/Investigator# 23257
Site Reference ID/Investigator# 39614
Site Reference ID/Investigator# 24522
Site Reference ID/Investigator# 26507
Site Reference ID/Investigator# 23150
Site Reference ID/Investigator# 23184
Site Reference ID/Investigator# 25562
Site Reference ID/Investigator# 33343
Site Reference ID/Investigator# 39002
Site Reference ID/Investigator# 36782
Site Reference ID/Investigator# 24525
Site Reference ID/Investigator# 43442
Site Reference ID/Investigator# 27968
Site Reference ID/Investigator# 23852
Site Reference ID/Investigator# 44062
Site Reference ID/Investigator# 27343
Site Reference ID/Investigator# 29759
Site Reference ID/Investigator# 23459
Site Reference ID/Investigator# 23457
Site Reference ID/Investigator# 23244
Site Reference ID/Investigator# 23155
Site Reference ID/Investigator# 26506
Site Reference ID/Investigator# 23269
Site Reference ID/Investigator# 23424
Site Reference ID/Investigator# 33345
Site Reference ID/Investigator# 23253
Site Reference ID/Investigator# 23425
Site Reference ID/Investigator# 23201
Site Reference ID/Investigator# 40448
Site Reference ID/Investigator# 33346
Site Reference ID/Investigator# 28345
Site Reference ID/Investigator# 23250
Site Reference ID/Investigator# 23160
Site Reference ID/Investigator# 23167
Site Reference ID/Investigator# 43237
Site Reference ID/Investigator# 23267
Site Reference ID/Investigator# 33977
Site Reference ID/Investigator# 23454
Site Reference ID/Investigator# 42706
Site Reference ID/Investigator# 43202
Site Reference ID/Investigator# 27969
Site Reference ID/Investigator# 40624
Site Reference ID/Investigator# 40930
Site Reference ID/Investigator# 37603
Site Reference ID/Investigator# 23270
Site Reference ID/Investigator# 23442
Site Reference ID/Investigator# 36967
Site Reference ID/Investigator# 23162
Site Reference ID/Investigator# 23254
Site Reference ID/Investigator# 27242
Site Reference ID/Investigator# 23463
Site Reference ID/Investigator# 23198
Site Reference ID/Investigator# 43102
Site Reference ID/Investigator# 42563
Site Reference ID/Investigator# 36964
Site Reference ID/Investigator# 42705
Site Reference ID/Investigator# 23247
Site Reference ID/Investigator# 26543
Site Reference ID/Investigator# 40623
Site Reference ID/Investigator# 23844
Site Reference ID/Investigator# 23444
Site Reference ID/Investigator# 41542
Site Reference ID/Investigator# 39003
Site Reference ID/Investigator# 43145
Site Reference ID/Investigator# 23465
Site Reference ID/Investigator# 44443
Site Reference ID/Investigator# 33344
Site Reference ID/Investigator# 23272
Site Reference ID/Investigator# 24782
Site Reference ID/Investigator# 23473
Site Reference ID/Investigator# 23466
Site Reference ID/Investigator# 28347
Site Reference ID/Investigator# 23428
Site Reference ID/Investigator# 28187
Site Reference ID/Investigator# 23163
Site Reference ID/Investigator# 36308
Site Reference ID/Investigator# 23194
Site Reference ID/Investigator# 26063
Site Reference ID/Investigator# 23197
Site Reference ID/Investigator# 43444
Site Reference ID/Investigator# 23152
Site Reference ID/Investigator# 25262
Site Reference ID/Investigator# 23477
Site Reference ID/Investigator# 40162
Site Reference ID/Investigator# 23200
Site Reference ID/Investigator# 23266
Site Reference ID/Investigator# 23161
Site Reference ID/Investigator# 43482
Site Reference ID/Investigator# 24848
Site Reference ID/Investigator# 23609
Site Reference ID/Investigator# 23153
Site Reference ID/Investigator# 43443
Site Reference ID/Investigator# 23165
Site Reference ID/Investigator# 26504
Site Reference ID/Investigator# 23475
Site Reference ID/Investigator# 23189
Site Reference ID/Investigator# 27998
Site Reference ID/Investigator# 26702
Site Reference ID/Investigator# 23191
Site Reference ID/Investigator# 23478
Site Reference ID/Investigator# 23608
Site Reference ID/Investigator# 27959
Site Reference ID/Investigator# 40931
Site Reference ID/Investigator# 43144
Site Reference ID/Investigator# 25482
Site Reference ID/Investigator# 23474
Site Reference ID/Investigator# 23468
Site Reference ID/Investigator# 29756
Site Reference ID/Investigator# 43302
Site Reference ID/Investigator# 24980

summary: The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.

status_simplified: Unknown