title: A Randomised, Double Blind, Placebo Controlled, Parallel Group Efficacy and Safety Study of Oral Administration of Empagliflozin Twice Daily Versus Once Daily in Two Different Daily Doses Over 16 Weeks as add-on Therapy to a Twice Daily Dosing Regimen of Metformin in Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control

summary: The aim of this study is to investigate the efficacy and safety of two doses (high and low) of empagliflozin as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM) and insufficient glycaemic control. Both doses may be given once daily or split to a twice daily dosage. This results in 4 different dosage regimens of empagliflozin (high dose once daily or split vs. low dose once daily or split). This is done to evaluate whether a twice daily dose regimen of empagliflozin results in a loss of efficacy relative to once daily dosing when given on top of metformin background therapy.

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.

lead_sponsor: Boehringer Ingelheim

location_country:
Poland
Spain
Italy
Georgia
Estonia
Australia
Canada
Latvia
Lithuania
New Zealand
Guatemala
Russian Federation
Ukraine
United States
France
South Africa
Mexico
Germany

location_facility: 1276.10.49007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38005 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50203 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11040 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.11048 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.33006 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50202 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.11001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.38002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39005 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.37003 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.38007 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.50201 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99503 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.70008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34005 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.11002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.99502 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11035 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11034 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.39004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.49004 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20010 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.33003 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.11042 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.11022 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.11051 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.37201 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.48005 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.27002 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.34002 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.38004 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.34006 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.48002 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.50205 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.37204 Boehringer Ingelheim Investigational Site

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location_facility: 1276.10.33008 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.61002 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.39001 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.34003 Boehringer Ingelheim Investigational Site

location_facility: 1276.10.20001 Boehringer Ingelheim Investigational Site


type: EudraCT Number

title: An Open-Label Randomized Phase III Trial of BMS-936558 (Nivolumab) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of the study is to compare the overall survival of BMS-936558 as compared with Docetaxel in subjects with squamous cell non-small cell lung cancer (NSCLC), after failure of prior platinum-based chemotherapy.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Borghaei H, Gettinger S, Vokes EE, Chow LQM, Burgio MA, de Castro Carpeno J, Pluzanski A, Arrieta O, Frontera OA, Chiari R, Butts C, Wójcik-Tomaszewska J, Coudert B, Garassino MC, Ready N, Felip E, García MA, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber DE, Czyzewicz G, Spigel DR, Crino L, Eberhardt WEE, Li A, Marimuthu S, Brahmer J. Five-Year Outcomes From the Randomized, Phase III Trials CheckMate 017 and 057: Nivolumab Versus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Mar 1;39(7):723-733. doi: 10.1200/JCO.20.01605. Epub 2021 Jan 15. Erratum in: J Clin Oncol. 2021 Apr 1;39(10):1190.

ReferenceCitation: Dercle L, Fronheiser M, Lu L, Du S, Hayes W, Leung DK, Roy A, Wilkerson J, Guo P, Fojo AT, Schwartz LH, Zhao B. Identification of Non-Small Cell Lung Cancer Sensitive to Systemic Cancer Therapies Using Radiomics. Clin Cancer Res. 2020 May 1;26(9):2151-2162. doi: 10.1158/1078-0432.CCR-19-2942. Epub 2020 Mar 20.

ReferenceCitation: Long GV, Tykodi SS, Schneider JG, Garbe C, Gravis G, Rashford M, Agrawal S, Grigoryeva E, Bello A, Roy A, Rollin L, Zhao X. Assessment of nivolumab exposure and clinical safety of 480 mg every 4 weeks flat-dosing schedule in patients with cancer. Ann Oncol. 2018 Nov 1;29(11):2208-2213. doi: 10.1093/annonc/mdy408.

ReferenceCitation: Vokes EE, Ready N, Felip E, Horn L, Burgio MA, Antonia SJ, Arén Frontera O, Gettinger S, Holgado E, Spigel D, Waterhouse D, Domine M, Garassino M, Chow LQM, Blumenschein G Jr, Barlesi F, Coudert B, Gainor J, Arrieta O, Brahmer J, Butts C, Steins M, Geese WJ, Li A, Healey D, Crinò L. Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer (CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases. Ann Oncol. 2018 Apr 1;29(4):959-965. doi: 10.1093/annonc/mdy041.

ReferenceCitation: Horn L, Spigel DR, Vokes EE, Holgado E, Ready N, Steins M, Poddubskaya E, Borghaei H, Felip E, Paz-Ares L, Pluzanski A, Reckamp KL, Burgio MA, Kohlhäeufl M, Waterhouse D, Barlesi F, Antonia S, Arrieta O, Fayette J, Crinò L, Rizvi N, Reck M, Hellmann MD, Geese WJ, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Eberhardt WEE. Nivolumab Versus Docetaxel in Previously Treated Patients With Advanced Non-Small-Cell Lung Cancer: Two-Year Outcomes From Two Randomized, Open-Label, Phase III Trials (CheckMate 017 and CheckMate 057). J Clin Oncol. 2017 Dec 10;35(35):3924-3933. doi: 10.1200/JCO.2017.74.3062. Epub 2017 Oct 12.

ReferenceCitation: Brahmer J, Reckamp KL, Baas P, Crinò L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Arén Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.

lead_sponsor: Bristol-Myers Squibb

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Mexico
Norway
Canada
Hungary
Germany
Ireland
France
Chile
Netherlands

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Chattanooga Oncology Hematology Associates

location_facility: CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski

location_facility: University Of Texas Southwestern Medical Center

location_facility: The University Of Texas MD Anderson Cancer Center

intervention_type: Biological

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

summary: This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Japan
South Africa
Hong Kong
Austria
Australia
Russian Federation
Israel
Singapore
Brazil
Canada
Hungary
Germany
Taiwan
Czech Republic
Korea, Republic of
France
Netherlands

location_facility: Rocky Mountain Cancer Centers RMCC Hale Pkwy

location_facility: University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

location_facility: Highlands Oncology Group Dept of Highlands Oncology Grp

location_facility: Arizona Oncology Associates Dept of Oncology

location_facility: H. Lee Moffitt Cancer Center & Research Institute SC

location_facility: Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1

location_facility: Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)

location_facility: New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

location_facility: University of New Mexico Cancer Research Center Dept of Univ New Mexico

location_facility: Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

location_facility: Northwest Cancer Specialists Vancouver Loc

location_facility: University of Kansas Cancer Center Univ Kansas 2

location_facility: University of Texas Southwestern Medical Center Harry Hines

location_facility: Northwest Georgia Oncology Center NW Georgia Onc

location_facility: Washington University School of Medicine Regulatory

location_facility: University of Oklahoma Health Sciences Center OUHSC 2

location_facility: California Cancer Care Marian Speciality

location_facility: Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio

intervention_type: Drug


title: AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

summary: This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.

ReferenceCitation: Stelljes M, Advani AS, DeAngelo DJ, Wang T, Neuhof A, Vandendries E, Kantarjian H, Jabbour E. Time to First Subsequent Salvage Therapy in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin in the Phase III INO-VATE Trial. Clin Lymphoma Myeloma Leuk. 2022 Sep;22(9):e836-e843. doi: 10.1016/j.clml.2022.04.022. Epub 2022 Apr 27.

ReferenceCitation: Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704. Review.

ReferenceCitation: Kantarjian HM, Stock W, Cassaday RD, DeAngelo DJ, Jabbour E, O'Brien SM, Stelljes M, Wang T, Paccagnella ML, Nguyen K, Sleight B, Vandendries E, Neuhof A, Laird AD, Advani AS. Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy, and Safety by Baseline CD22. Clin Cancer Res. 2021 May 15;27(10):2742-2754. doi: 10.1158/1078-0432.CCR-20-2399. Epub 2021 Feb 18.

ReferenceCitation: Stock W, Martinelli G, Stelljes M, DeAngelo DJ, Gökbuget N, Advani AS, O'Brien S, Liedtke M, Merchant AA, Cassaday RD, Wang T, Zhang H, Vandendries E, Jabbour E, Marks DI, Kantarjian HM. Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia. Cancer. 2021 Mar 15;127(6):905-913. doi: 10.1002/cncr.33321. Epub 2020 Nov 24.

ReferenceCitation: DeAngelo DJ, Advani AS, Marks DI, Stelljes M, Liedtke M, Stock W, Gökbuget N, Jabbour E, Merchant A, Wang T, Vandendries E, Neuhof A, Kantarjian H, O'Brien S. Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden. Blood Cancer J. 2020 Aug 7;10(8):81. doi: 10.1038/s41408-020-00345-8.

ReferenceCitation: Jabbour E, Gökbuget N, Advani A, Stelljes M, Stock W, Liedtke M, Martinelli G, O'Brien S, Wang T, Laird AD, Vandendries E, Neuhof A, Nguyen K, Dakappagari N, DeAngelo DJ, Kantarjian H. Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial. Leuk Res. 2020 Jan;88:106283. doi: 10.1016/j.leukres.2019.106283. Epub 2019 Nov 25.

ReferenceCitation: Fujishima N, Uchida T, Onishi Y, Jung CW, Goh YT, Ando K, Wang MC, Ono C, Matsumizu M, Paccagnella ML, Sleight B, Vandendries E, Fujii Y, Hino M. Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. Int J Hematol. 2019 Dec;110(6):709-722. doi: 10.1007/s12185-019-02749-0. Epub 2019 Nov 13.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Stelljes M, Liedtke M, Stock W, Gökbuget N, O'Brien SM, Jabbour E, Wang T, Liang White J, Sleight B, Vandendries E, Advani AS. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019 Jul 15;125(14):2474-2487. doi: 10.1002/cncr.32116. Epub 2019 Mar 28.

ReferenceCitation: Jabbour EJ, DeAngelo DJ, Stelljes M, Stock W, Liedtke M, Gökbuget N, O'Brien S, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS, Kantarjian HM. Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. Cancer. 2018 Apr 15;124(8):1722-1732. doi: 10.1002/cncr.31249. Epub 2018 Jan 30.

ReferenceCitation: Kebriaei P, Cutler C, de Lima M, Giralt S, Lee SJ, Marks D, Merchant A, Stock W, van Besien K, Stelljes M. Management of important adverse events associated with inotuzumab ozogamicin: expert panel review. Bone Marrow Transplant. 2018 Apr;53(4):449-456. doi: 10.1038/s41409-017-0019-y. Epub 2018 Jan 12.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Advani AS, Stelljes M, Kebriaei P, Cassaday RD, Merchant AA, Fujishima N, Uchida T, Calbacho M, Ejduk AA, O'Brien SM, Jabbour EJ, Zhang H, Sleight BJ, Vandendries ER, Marks DI. Hepatic adverse event profile of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukaemia: results from the open-label, randomised, phase 3 INO-VATE study. Lancet Haematol. 2017 Aug;4(8):e387-e398. doi: 10.1016/S2352-3026(17)30103-5. Epub 2017 Jul 4.

ReferenceCitation: Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gökbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12.

ipd_sharing: Yes

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Poland
Taiwan
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
Finland
Sweden
Hungary
Korea, Republic of
United States
France
China
Singapore
Japan
Germany
Czechia

location_facility: The Sidney Kimmel Comprehensive Cancer Center

location_facility: Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet;

location_facility: National University Hospital/National University Cancer Institute Singapore (NCIS)

location_facility: A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto

location_facility: Division of Hematology/Oncology, Stony Brook University Hospital

location_facility: Investigational Drug Services - UC San Diego Moores Cancer Center

location_facility: University of New Mexico Comprehensive Cancer Center

location_facility: Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles

location_facility: Stanford University Hospital and Clinics

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Stony Brook University Medical Center, The Cancer Center

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Chonnam National University, Hwasun Hospital

location_facility: Hospital Clinico Universitario de Valencia

location_facility: University of Colorado Hospital, Cancer Center Infusion Center

location_facility: MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy

location_facility: Northwestern Medicine Developmental Therapeutics Institute

location_facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences,

location_facility: Institut de Cancérologie Lucien Neuwirth

location_facility: C.H.U. de Grenoble, Hopital Albert Michallon

location_facility: U.O. Ematologia, Ospedale S. Maria delle Croci

location_facility: West Virginia University Hospitals Pharmaceutical Services

location_facility: Karmanos Cancer Institute Weisberg Cancer Treatment Center

location_facility: USC/Norris Comprehensive Cancer Center / Investigational Drug Services

location_facility: Eastern Clinical Research Unit, Box Hill Hospital

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: The Hospital of Hyogo College of Medicine

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Azienda Ospedaliera Brotzu CTMO P.O. Businco

location_facility: Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital

location_facility: Universitätsklinikum Köln, Klinik I für Innere Medizin

location_facility: U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna

location_facility: Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

location_facility: UCLA Drug Information/Investigation Drug

location_facility: Yale-New Haven Hospital & Smilow Cancer Center

location_facility: Chang Gung Medical Foundation, Kaohsiung Branch

location_facility: Investigational Drug Service, Emory University Clinic

location_facility: Hospital General Universitario Jose Maria Morales Meseguer

location_facility: Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Winship Cancer Institute, Emory University

location_facility: Interni Hematologicka a Onkologicka Klinika

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Penn State Milton S. Hershey Medical Center,

location_facility: Instytut Hematologii i Transfuzjologii, Klinika Hematologii

location_facility: UNC Hospitals - The University of North Carolina at Chapel Hill

location_facility: CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique

location_facility: Blood and Marrow Transplant Group of Georgia

location_facility: Freidenrich Center for Translational Research (CTRU), Stanford University

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of Chicago Medical Center, Dept. of Pharmacy

location_facility: IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Texas Southwestern Universtiy Hospital - William P Clements Jr.

location_facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika

location_facility: New York Presbyterian Hospital-Weill Cornell Medical College

location_facility: Zentralapotheke des Universitaetsklinikums Muenster

location_facility: Martha Hamilton, Investigational Drug Services, Dept of Pharmacy

location_facility: UT Southwestern University Hospital- Zale Lipshy

location_facility: Hospital de la Santa Creu i Sant Pau(Nuevo Hospital)


type: Other Identifier

title: POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)

acronym: PASCO II

summary: The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

location_country:
Denmark
Croatia
Spain
Greece
Ireland
Italy
United Kingdom
Finland
Sweden
France
Germany
Bulgaria

location_facility: OSPEDALE MAGGIORE DI CHIERI - ASL TO 5 - S.C. Nefrologia e Dialisi

location_facility: ze:ro Dialysezentren und Gemeinschaftspraxis

location_facility: Nephrologische Gemeinschaftspraxis und Dialysezentrum

location_facility: UO Nefrologia, trapianti e dialisi SSN EDIFICIO 30A Azienda Ospedaliera Universitaria Pisa

location_facility: Gemeinschaftspraxis Schuerfeld Moeller Henrich

location_facility: Presidio Ospedaliero S. GIUSEPPE e MELORIO AUSL CE/2 S. - U.O. Nefrologia e Dialisi

location_facility: General Hospital of Komotini Sismanogleio

location_facility: Office of Eleni Stefanopoulou/Private Physician

location_facility: Department of Renal Medicine Medicinerhuset 3 sal Aalborg University Hospital

location_facility: Ospedali Riuniti Anzio-Nettuno, Nefrologia e Dialisi ASL RMH

location_facility: Dipartimento di Nefrologia- Ospedale Mazzoni

location_facility: ASL SA 1 P.O. Umberto I - U.O.C. di NEFROLOGIA E DIALISI

location_facility: CHU Amiens-Picardie Site Sud,, service de Nefrologie

location_facility: A.O. MONALDI- Dept nephrology and Dialysis

location_facility: University General Hospital of Alexandroupoli

location_facility: Ospedale Niguarda Cà Granda - U.O. Nefrologia e Dialisi e Terapia Medica del Trapianto Renale

location_facility: Dutchmed Dialysis Clinic (in the building of 5 DCC)

location_facility: U.O.C. Nefrologia, Dialisi e Trapianto - Azienda Ospedaliera Universitaria Senese

location_facility: Medizinisches Versorgungszentrum MVZ Diaverum Kleve GmbH

location_facility: "Presidio Ospedaliero" di Soverato - Servizio Dialisi

location_facility: Presidio ospesdaliero G.CRISCUOLI - UO DIALISI

location_facility: Nephrologisches- und Dialysezentrum Niebüll

location_facility: Njurmedicinska kliniken, Danderyds sjukhus

location_facility: Städtisches Klinikum Solingen Abt. Nephrologie - Innere Medizin

location_facility: Fondazione S. Maugeri - IRCCS Clinica del Lavoro e della Riabilitazione,

location_facility: Acibadem City Clinic Tokuda Hospital EAD MHAT "Tokuda Hospital Sofia"

location_facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli" - U.O. S. C. Nefrologia ed Emodialisi

location_facility: 35 Nephrologie Centre Medico Chirurgical de l'Europe

location_facility: Azienda Ospedaliera Universitaria della Università degli Studi della Campania "Luigi Vanvitelli"

location_facility: Universita degli Studi di Napoli Federico II - Dipartimento di Patologia Sistematica

location_facility: U.O.C. Nefrologia e Dialisi Ospedale degli Infermi-S.Miniato-USL 11 Empoli

location_facility: Centro Dialisi Nefrologia - Ospedale S. Donato Arezzo

location_facility: Div. of Nephrology, Helsinki University HospitalHUS Kirurginen sairaala

location_facility: Hopital de Rangueil, service de nephrologie

location_facility: Dipartimento di Medicina -DIMED- Policlinico Padova

location_facility: Gemeinschaftspraxis Dr. Gööck & Dr. Anger

location_facility: Ospedale SANTA MARIA DELLA PIETA - U.O.C. di NEFROLOGIA E DIALISI

location_facility: U.O.C. Nefrologia e Dialisi - Ospedale "Del Ceppo"

location_facility: A.O.U. San Giovanni Battista di Torino - S.C. di Nefrologia, Dialisi e Trapianto

location_facility: Deutsche Klinik fuer Diagnostik Department of Nephrology

location_facility: Polyclinique de la Louvière, Service Hemodialyse Nephrologie CHSA Maubeuge

location_facility: Hospital Gabriel Montpied, Centre de Dialyse

location_facility: U.O. Nefrologia e Dialisi, Azienda Ospedaliero-Universitaria Ospedali Riuniti

location_facility: Ospedale Martini - S.C. Nefrologia E Dialisi

location_facility: Hospital Universitario Central de Asturias

location_facility: Dipartimento di Nefrologia Ospedale Versilia-Viareggio (Lucca)

location_facility: Ospedale San Giovanni Bosco - Struttura Complessa Nefrologia e Dialisi

location_facility: Märkische Kliniken GmbH Klinikum Lüdenscheid

location_facility: Praxisklinik-Dialysezentrum Herne DOKUSAN Gesellschaft für medizinische Studien mbH & Co. KG

location_facility: U.O.C. Nefrologia e Dialisi Azienda Ospedaliera

location_facility: Policlinico S. Marco di Istituti Ospedalieri Bergamaschi, U.O. Nefrologia e Dialisi


acronym: PERTAIN

title: A Randomized, Two-Arm, Open-Label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab Plus an Aromatase Inhibitor in First Line Patients With HER2-Positive and Hormone Receptor-Positive Advanced (Metastatic or Locally Advanced) Breast Cancer

lead_sponsor: Hoffmann-La Roche

source: euctr

ReferenceCitation: Rimawi M, Ferrero JM, de la Haba-Rodriguez J, Poole C, De Placido S, Osborne CK, Hegg R, Easton V, Wohlfarth C, Arpino G; PERTAIN Study Group. First-Line Trastuzumab Plus an Aromatase Inhibitor, With or Without Pertuzumab, in Human Epidermal Growth Factor Receptor 2-Positive and Hormone Receptor-Positive Metastatic or Locally Advanced Breast Cancer (PERTAIN): A Randomized, Open-Label Phase II Trial. J Clin Oncol. 2018 Oct 1;36(28):2826-2835. doi: 10.1200/JCO.2017.76.7863. Epub 2018 Aug 14.

location_country:
Brazil
Spain
Italy
United Kingdom
India
United States
France
Turkey

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Weston Park Hospital; Cancer Clinical Trials Centre

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: A.O. Santa Maria Degli Angeli; U.O Di Oncologia Medica

location_facility: Centre Catherine de Sienne; Chimiotherapie

location_facility: Hopital Morvan; Oncologie - Radiotherapie

location_facility: Baylor College of Medicine; Lester & Sue Smith Breast Ctr

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

location_facility: Ospedale Antonio Perrino; Oncologia Medica

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

location_facility: Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Ege Uni Medical Faculty Hospital; Oncology Dept

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

location_facility: University Hospital coventry; Oncology Department

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

location_facility: Clinique De La Sauvegarde; Chimiotherapie

location_facility: IRCCS Fondazione Maugeri; Oncologia Medica I

location_facility: Centre Antoine Lacassagne; Hopital De Jour A2

location_facility: Washington University School of Medicine; Internal Medicine - Renal

location_facility: Hematology Oncology Associates; Carol G. Simon Ctr

location_facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

location_facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología

location_facility: Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia

location_facility: Università degli Studi Federico II; Clinica di Oncologia Medica

location_facility: Ospedale S.S. Trinità Nuovo; Divisione Oncologia

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Centre Alexis Vautrin; Oncologie Medicale

location_facility: Ospedale Vito Fazzi; Div. Oncoematologia

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

location_facility: Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia

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

location_facility: Jaslok Hospital & Research Centre; Medical Oncology

location_facility: Casa di Cura MultiMedica Ospedale di Castellanza; UO Senologia Medica

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Instituto do Cancer do Estado de Sao Paulo - ICESP

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

summary: This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in first-line participants with HER2-positive and hormone receptor-positive advanced breast cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. The anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.


title: A Phase 3b Randomized, Open-Label Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI + RTV) Plus Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (EVG/COBI/FTC/TDF) in Virologically-Suppressed, HIV-1 Infected Patients

summary: This study will evaluate the non-inferiority of Stribild® (elvitegravir/cobicistat/ emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) single-tablet regimen (STR) relative to regimens consisting of a protease inhibitor (PI) boosted with ritonavir (RTV) plus Truvada® (FTC/TDF) fixed-dose combination in maintaining HIV-1 RNA < 50 copies/mL at Week 48 in virologically suppressed, HIV-1 infected adults. This study will also evaluate the safety, tolerability, and efficacy of the two regimens through 96 weeks of treatment.

ReferenceType: result

ReferenceCitation: Arribas JR, Pialoux G, Gathe J, Di Perri G, Reynes J, Tebas P, Nguyen T, Ebrahimi R, White K, Piontkowsky D. Simplification to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of ritonavir-boosted protease inhibitor with emtricitabine and tenofovir in adults with virologically suppressed HIV (STRATEGY-PI): 48 week results of a randomised, open-label, phase 3b, non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):581-9. doi: 10.1016/S1473-3099(14)70782-0. Epub 2014 Jun 5.

ReferenceCitation: Pozniak A, Markowitz M, Mills A, Stellbrink HJ, Antela A, Domingo P, Girard PM, Henry K, Nguyen T, Piontkowsky D, Garner W, White K, Guyer B. Switching to coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus continuation of non-nucleoside reverse transcriptase inhibitor with emtricitabine and tenofovir in virologically suppressed adults with HIV (STRATEGY-NNRTI): 48 week results of a randomised, open-label, phase 3b non-inferiority trial. Lancet Infect Dis. 2014 Jul;14(7):590-9. doi: 10.1016/S1473-3099(14)70796-0. Epub 2014 Jun 5.

ReferenceCitation: Arribas JR, DeJesus E, van Lunzen J, Zurawski C, Doroana M, Towner W, Lazzarin A, Nelson M, McColl D, Andreatta K, Swamy R, Szwarcberg J, Nguyen T. Simplification to single-tablet regimen of elvitegravir, cobicistat, emtricitabine, tenofovir DF from multi-tablet ritonavir-boosted protease inhibitor plus coformulated emtricitabine and tenofovir DF regimens: week 96 results of STRATEGY-PI. HIV Clin Trials. 2017 May;18(3):118-125. doi: 10.1080/15284336.2017.1330440. Epub 2017 May 30. Erratum in: HIV Clin Trials. 2018 Aug;19(4):163.

ReferenceCitation: Gathe J, Arribas JR, Van Lunzen J, Garner W, Speck RM, Bender R, Shreay S, Nguyen T. Patient-Reported Symptoms over 48 Weeks in a Randomized, Open-Label, Phase 3b Non-inferiority Trial of Adults with HIV Switching to Coformulated Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir DF Versus Continuation of Ritonavir-Boosted Protease Inhibitor with Emtricitabine and Tenofovir DF. Patient. 2015 Oct;8(5):445-54. doi: 10.1007/s40271-015-0137-9.

lead_sponsor: Gilead Sciences

location_country:
Portugal
Spain
Italy
Austria
United Kingdom
Canada
Switzerland
Puerto Rico
United States
France
Belgium
Germany

location_facility: University Hospital of Zurich; Division of Infectious Diseases and Hospital Epidemiology

location_facility: National Institute for Infectious Diseases "L. Spallanzani"

location_facility: Johann Wolfgang Goethe-University Hospital / Infectious Diseases Hs 68

location_facility: Archet 1 Chu Nice Department of Infectology

location_facility: Midway Immunology & Research Center, LLC

location_facility: Hospital Universitari Bellvitge HIV Unit. Infectious Disease Service.

location_facility: Hospital Santo Antonio Dos Capuchos, Centro Hospitalar de Lisboa

location_facility: La Playa Medical Group and Clinical Research

location_facility: Northwestern University Division of Infectious Diseases

location_facility: Tarrant County Infectious Disease Associates

location_facility: Universitätsklinikum Hamburg-Eppendorf, Ambulanzzentrum des UKE GmbH, Bereich Infektiologie

location_facility: Infectious Diseases Department, Hospital Carlos III

location_facility: University of Torino, Dept of Infectious Disease

location_facility: Universitätsklinikum Essen, Dermatologie, HIV Ambulanz

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: Southwest Infectious Disease Clinical Research, Inc

location_facility: John H. Stroger, Jr. Hospital of Cook County/Ruth M. Rothstein CORE Center

location_facility: Infektionsambulanz, Med Poliklink, Klinikum der Universitat Munchnen

location_facility: Infectious Diseases Associates of NW FL, P.A.

location_facility: Clinic of Infectious Diseases, University of Milan-San Paolo Hospital

location_facility: Brighton and Sussex University Hospitals NHS Trust

location_facility: University of Puerto Rico School of Medicine


title: A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

acronym: OCTAVE

summary: This study is an open label, long-term extension study for subjects with moderate to severe ulcerative colitis designed to evaluate long term therapy of CP-690,550.

design_allocation: Non-Randomized

ReferenceCitation: Lichtenstein GR, Bressler B, Francisconi C, Vermeire S, Lawendy N, Salese L, Sawyerr G, Shi H, Su C, Judd DT, Jones T, Loftus EV. Assessment of Safety and Efficacy of Tofacitinib, Stratified by Age, in Patients from the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2022 Nov 7. pii: izac084. doi: 10.1093/ibd/izac084. [Epub ahead of print]

ReferenceCitation: Hudesman DP, Torres J, Salese L, Woolcott JC, Mundayat R, Su C, Mosli MH, Allegretti JR. Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program. Patient. 2022 Nov 7. doi: 10.1007/s40271-022-00603-w. [Epub ahead of print]

ReferenceCitation: Biedermann L, Dubinsky MC, Vermeire S, Fellmann M, Gardiner S, Hur P, Mundayat R, Panés J, Rubin DT. Health-Related Quality of Life Outcomes With Tofacitinib Treatment in Patients With Ulcerative Colitis in the Open-Label Extension Study, OCTAVE Open. Inflamm Bowel Dis. 2022 Oct 15. pii: izac222. doi: 10.1093/ibd/izac222. [Epub ahead of print]

ReferenceCitation: Winthrop KL, Vermeire S, Long MD, Panés J, Ng SC, Kulisek N, Mundayat R, Lawendy N, Vranic I, Modesto I, Su C, Melmed GY. Long-term Risk of Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2022 Jun 1. pii: izac063. doi: 10.1093/ibd/izac063. [Epub ahead of print]

ReferenceCitation: Dubinsky MC, Magro F, Steinwurz F, Hudesman DP, Kinnucan JA, Ungaro RC, Neurath MF, Kulisek N, Paulissen J, Su C, Ponce de Leon D, Regueiro M. Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2022 Apr 5. pii: izac061. doi: 10.1093/ibd/izac061. [Epub ahead of print]

ReferenceCitation: Feagan BG, Khanna R, Sandborn WJ, Vermeire S, Reinisch W, Su C, Salese L, Fan H, Paulissen J, Woodworth DA, Niezychowski W, Sands BE. Agreement between local and central reading of endoscopic disease activity in ulcerative colitis: results from the tofacitinib OCTAVE trials. Aliment Pharmacol Ther. 2021 Dec;54(11-12):1442-1453. doi: 10.1111/apt.16626. Epub 2021 Oct 6.

ReferenceCitation: Panés J, Vermeire S, Dubinsky MC, Loftus EV, Lawendy N, Wang W, Salese L, Su C, Modesto I, Guo X, Colombel JF. Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials. J Crohns Colitis. 2021 Nov 8;15(11):1852-1863. doi: 10.1093/ecco-jcc/jjab065.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Sharara AI, Su C, Modesto I, Mundayat R, Gunay LM, Salese L, Sands BE. Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol. 2022 Mar;20(3):591-601.e8. doi: 10.1016/j.cgh.2021.02.043. Epub 2021 Mar 6.

ReferenceCitation: Curtis JR, Regueiro M, Yun H, Su C, DiBonaventura M, Lawendy N, Nduaka CI, Koram N, Cappelleri JC, Chan G, Modesto I, Lichtenstein GR. Tofacitinib Treatment Safety in Moderate to Severe Ulcerative Colitis: Comparison of Observational Population Cohort Data From the IBM MarketScan® Administrative Claims Database With Tofacitinib Trial Data. Inflamm Bowel Dis. 2021 Aug 19;27(9):1394-1408. doi: 10.1093/ibd/izaa289.

ReferenceCitation: Sandborn WJ, Peyrin-Biroulet L, Quirk D, Wang W, Nduaka CI, Mukherjee A, Su C, Sands BE. Efficacy and Safety of Extended Induction With Tofacitinib for the Treatment of Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1821-1830.e3. doi: 10.1016/j.cgh.2020.10.038. Epub 2020 Oct 27.

ReferenceCitation: Colombel JF, Osterman MT, Thorpe AJ, Salese L, Nduaka CI, Zhang H, Lawendy N, Friedman GS, Quirk D, Su C, Reinisch W. Maintenance of Remission With Tofacitinib Therapy in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):116-125.e5. doi: 10.1016/j.cgh.2020.10.004. Epub 2020 Oct 9.

ReferenceCitation: Sands BE, Colombel JF, Ha C, Farnier M, Armuzzi A, Quirk D, Friedman GS, Kwok K, Salese L, Su C, Taub PR. Lipid Profiles in Patients With Ulcerative Colitis Receiving Tofacitinib-Implications for Cardiovascular Risk and Patient Management. Inflamm Bowel Dis. 2021 May 17;27(6):797-808. doi: 10.1093/ibd/izaa227.

ReferenceCitation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum in: Dig Dis Sci. 2020 Oct 10;:.

ReferenceCitation: Lichtenstein GR, Rogler G, Ciorba MA, Su C, Chan G, Pedersen RD, Lawendy N, Quirk D, Nduaka CI, Thorpe AJ, Panés J. Tofacitinib, an Oral Janus Kinase Inhibitor: Analysis of Malignancy (Excluding Nonmelanoma Skin Cancer) Events Across the Ulcerative Colitis Clinical Program. Inflamm Bowel Dis. 2021 May 17;27(6):816-825. doi: 10.1093/ibd/izaa199.

ReferenceCitation: Sands BE, Armuzzi A, Marshall JK, Lindsay JO, Sandborn WJ, Danese S, Panés J, Bressler B, Colombel JF, Lawendy N, Maller E, Zhang H, Chan G, Salese L, Tsilkos K, Marren A, Su C. Efficacy and safety of tofacitinib dose de-escalation and dose escalation for patients with ulcerative colitis: results from OCTAVE Open. Aliment Pharmacol Ther. 2020 Jan;51(2):271-280. doi: 10.1111/apt.15555. Epub 2019 Oct 29.

ReferenceCitation: Sandborn WJ, Panés J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.

ReferenceCitation: Sands BE, Taub PR, Armuzzi A, Friedman GS, Moscariello M, Lawendy N, Pedersen RD, Chan G, Nduaka CI, Quirk D, Salese L, Su C, Feagan BG. Tofacitinib Treatment Is Associated With Modest and Reversible Increases in Serum Lipids in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Jan;18(1):123-132.e3. doi: 10.1016/j.cgh.2019.04.059. Epub 2019 May 8.

ReferenceCitation: Sandborn WJ, Panés J, D'Haens GR, Sands BE, Su C, Moscariello M, Jones T, Pedersen R, Friedman GS, Lawendy N, Chan G. Safety of Tofacitinib for Treatment of Ulcerative Colitis, Based on 4.4 Years of Data From Global Clinical Trials. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1541-1550. doi: 10.1016/j.cgh.2018.11.035. Epub 2018 Nov 23.

ReferenceCitation: Winthrop KL, Melmed GY, Vermeire S, Long MD, Chan G, Pedersen RD, Lawendy N, Thorpe AJ, Nduaka CI, Su C. Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib. Inflamm Bowel Dis. 2018 Sep 15;24(10):2258-2265. doi: 10.1093/ibd/izy131.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Israel
Slovakia
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Latvia
Estonia
New Zealand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Limited Liability Company Medical Company "Hepatolog"

location_facility: Krankenhaus Barmherzige Brueder St. Veit/Glan

location_facility: Baylor College of Medicine- Baylor Medical Center

location_facility: North Florida Gastroenterology Research, LLC

location_facility: MGG Group Co., Inc., Chevy Chase Clinical Research

location_facility: Samara Diagnostic center, X-ray Department

location_facility: Hopital Saint Antoine - Service de Gastroenterologie

location_facility: Regional Municipal Institution 'Chernivtsi Regional Clinical Hospital'

location_facility: Carolina Research, Carolina Digestive Diseases

location_facility: Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza; III. Belgyogyaszat - Gasztroenterologia'.

location_facility: Nemocnice Strakonice, a.s., Interni oddeleni

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

location_facility: McGovern Medical School -The University of Texas Health Science Center at Houston

location_facility: Spitalul Universitar de Urgenta Bucharest, Medicina Interna II Gastroenterologie

location_facility: CI of Uzhgorod Regional Rada Uzhgorod Central Regional Hospital". Therapy Department. SHEI Uzhgorod

location_facility: Cabinet Particular Policlinic Algomed SRL

location_facility: National Hospital Organization Sendai Medical Center

location_facility: Clinical Trials Unit- Tauranga Hospital-Bay of Plenty (BOP) Clinical School

location_facility: National Hospital Organization Mito Medical Center

location_facility: Clinical Centre of Kragujevac Clinic for Gastroenterology and Hepatology

location_facility: State budget Healthcare Institution Moscow regional scientific research clinical institute

location_facility: North Shore Hospital (Waitemata District Health Board)

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

location_facility: UZ Leuven (University Hospital Leuven), Campus Gasthuisberg

location_facility: Municipal Budget Institution of Healthcare of Novosibirsk

location_facility: Hôpital Saint Louis - Service d'hepato-gastroenterologie

location_facility: Istituto Clinico Humanitas IRCCS-IBD Center

location_facility: Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

location_facility: Wisconsin Center for Advanced Research - a division of GI Associates, LLC

location_facility: Municipal Institution "Odesa Regional Clinical Hospital", polyclinic department

location_facility: Tokyo Medical And Dental University Hospital, Faculty of Medicine

location_facility: VCU Health System Digestive Health Center

location_facility: Huron Gastroenterology Associates - Center for Digestive Care

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust

location_facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital"

location_facility: Altman Clinical and Translational Research Institute

location_facility: Hospital de Clinicas de Porto Alegre - HCPA

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Manninger Jeno Orszagos Traumatologiai Intezet

location_facility: Federal State Budgetary Institution "State Scientific Centre of Coloproctology n.a. A.N. Ryzhikh"

location_facility: State budget institution of healthcare of Yaroslavl region Regional clinical hospital

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Clinical Centre of Vojvodina Emergency Internal Medicine Division

location_facility: Hopital Haut-Leveque-CMC Magellan- Unite de Recherche Clinique

location_facility: University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre

location_facility: University of Alberta - Zeidler Ledcor Centre

location_facility: Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej, Uniwersytecki Szpital Kliniczny nr

location_facility: Clinical Centre of Serbia Clinic for Gastroenterology and Hepatology

location_facility: Universitaetsmedizin Berlin, Charite Campus Virchow-Klinikum, Medizinische Klinik mit

location_facility: UCSF Center for Colitis and Crohn's Disease

location_facility: The Hospital of Hyogo College of Medicine

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Poliklinika Libris, Synergy group, a.s.,

location_facility: National Hospital Organization Hirosaki National Hospital

location_facility: Minicipal Institution City Hospital #7, Therapeutic Department,

location_facility: FSBI "Scientific Research Institute of Physiology and Fundamental Medicine"

location_facility: Clinical Centre of Vojvodina, Clinic for Gastroenterology and Hepatology

location_facility: Perlman Medical Offices - UC San Diego Health System

location_facility: Atlanta Gastroenterology Specialists, PC

location_facility: Great Lakes Gastroenterology Research, LLC

location_facility: Non-State Healthcare Institution "Road Clinical Hospital at the station Samara"

location_facility: Klinicke Centrum ISCARE I.V.F., Gastroenterologie

location_facility: State Institution "L.T. Malaya Therapy Institute of NAMS of Ukraine"

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

location_facility: "Odesa Clinical Hospital for Railway ""Branch of ""Healthcare center of Private JSC ""Ukrainian

location_facility: The Gastroenterology Group of South Jersey

location_facility: Federal State Budgetary Institution Scientific Research Institute of Physiology and Fundamental

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Gastroenterology Associates of Central Georgia, LLC

location_facility: East Ann Arbor Health and Geriatrics Center -UMHS

location_facility: AOU Mater Domini - U.O. Fisiopatologia Digestiva

location_facility: Hopital Beaujon, Gastroenterologie, MICI et Assistance Nutritive

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

location_facility: Atlanta Center for Gastroenterology, P.C.

location_facility: Municipal Healthcare Institution Kharkiv City Clinical Hospital #2

location_facility: Kyiv Municipal Clinical Hospital #18, Proctology Department

location_facility: Shiga University of Medical Science Hospital

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

location_facility: NYU Langone Long Island Clinical Research Associates

location_facility: Montreal General Hospital - McGill University Health Care Centre

location_facility: Columbia University Irving Medical Center

location_facility: University Medical Center Groningen (UMCG)

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

location_facility: Clinical Hospital Center Zvezdara - Clinic for Gastroenterology and Hepatology

location_facility: Clinical Research Institute of Michigan, LLC

location_facility: Universitatsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Centrum Medyczne Szpital Sw. Rodziny Sp. z o. o.

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

location_facility: The Edith Wolfson Medical Center/Gastroenterology Department

location_facility: Chris Hani Baragwanath Academic Hospital

location_facility: University of Calgary, Heritage Medical Research Clinic, TRW Building

location_facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1-st Therapy Department of hospital,

location_facility: The North West London Hospitals NHS Trust

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem Leczenia Nieswoistych Chorob

location_facility: Medical Science Research Building 1 - UMHS

location_facility: Oddzial Chorob Wewnetrznych i Gastroenterologii, SP ZOZ Wojewodzki Szpital

location_facility: Vinnytsia Regional Clinical Hospital for War Veterans, Therapeutics Dept. No. 2

location_facility: Szent Margit Kórház, III. Belgyógyászati-Gasztroenterológiai Osztály

location_facility: Universitaesklinikum Halle, Klinik und Poliklinik fuer Innere Medizin I

location_facility: Center for Endoscopy- Covenant Surgical Partners

location_facility: SI 'Institute of Gastroenterology of the NAMS of Ukraine', Dep.-nt of Stomach and Duodenum diseases

location_facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak I Belgyogyaszati-Gasztroenterologiai Osztaly

location_facility: London Health Sciences Centre - University Hospital

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: CHU de Nantes - Hotel Dieu-Service d'Hepato-Gastroenterologie

location_facility: Medical Research Center of Connecticut, LLC

location_facility: State budget Institution of Healthcare Nizhniy Novgorod Regional Clinical Hospital named after N. A.

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza III.sz. Belgyoyaszat Gasztroenterologia


title: Lux-Breast 3; Randomised Phase II Study of Afatinib Alone or in Combination With Vinorelbine Versus Investigator's Choice of Treatment in Patients With HER2 Positive Breast Cancer With Progressive Brain Metastases After Trastuzumab and/or Lapatinib Based Therapy

summary: The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

ReferenceCitation: Cortés J, Dieras V, Ro J, Barriere J, Bachelot T, Hurvitz S, Le Rhun E, Espié M, Kim SB, Schneeweiss A, Sohn JH, Nabholtz JM, Kellokumpu-Lehtinen PL, Taguchi J, Piacentini F, Ciruelos E, Bono P, Ould-Kaci M, Roux F, Joensuu H. Afatinib alone or afatinib plus vinorelbine versus investigator's choice of treatment for HER2-positive breast cancer with progressive brain metastases after trastuzumab, lapatinib, or both (LUX-Breast 3): a randomised, open-label, multicentre, phase 2 trial. Lancet Oncol. 2015 Dec;16(16):1700-10. doi: 10.1016/S1470-2045(15)00373-3. Epub 2015 Nov 17.

location_country:
Spain
Italy
Finland
Canada
Korea, Republic of
United States
France
Germany

location_facility: 1200.67.33012 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.39002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33010 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34006 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35802 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33011 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10105 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.82003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49005 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33002 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35801 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.35803 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10106 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49008 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10108 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.10004 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49006 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.49007 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.34003 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.39001 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33009 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.33008 Boehringer Ingelheim Investigational Site

location_facility: 1200.67.11002 Boehringer Ingelheim Investigational Site


title: A Multicenter, Two Arm, Randomized, Open Label Clinical Study Investigating Renal Function in an Advagraf® Based Immunosuppressive Regimen With or Without Sirolimus in Kidney Transplant Patients

acronym: ADHERE

summary: The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.

primary_purpose: Prevention

ipd_sharing_description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Taiwan
Hong Kong
Belarus
Spain
Italy
Austria
Australia
Netherlands
Russian Federation
Hungary
Korea, Republic of
France
Turkey
Belgium
Germany
Czechia


title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

summary: This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

ReferenceCitation: Celli B, Crater G, Kilbride S, Mehta R, Tabberer M, Kalberg CJ, Church A. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014 May;145(5):981-991. doi: 10.1378/chest.13-1579. Erratum in: Chest. 2022 Jul;162(1):269.

lead_sponsor: GlaxoSmithKline

location_country:
Denmark
Estonia
Netherlands
Ukraine
Sweden
Hungary
Philippines
United States
France
Norway
Belgium
Japan
Germany
Slovakia


title: A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

summary:
The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications.

Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.

location_country:
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
Puerto Rico
United States
France
Belgium
Germany

location_facility: Hopital Tenon Service des Maladies infectieuses et tropicales

location_facility: Hospital Universitario de Elche, Unidad de Enfermedades Infecciosas

location_facility: IRCCS Ospedale San Raffaele Centro San Luigi, Unità Operativa di Malattie Infettive

location_facility: Department of Dermatology, Allergy, and Infectious Disease University Vienna Medical School

location_facility: Living Hope Education and Research Consultants

location_facility: Clinical and Translational Research Center - UNC Hospitals

location_facility: Division of Infectious Disease, Department of Medicine, University Hospital Freiburg

location_facility: Hopital Saint Antoine- Service Maladies infectieuses

location_facility: University Health Network/Toronto General Hospital

location_facility: Community Research Initiative of New England

location_facility: Private Practice Gute & Locher & Lutz, Infektiologikum

location_facility: North Shore University Hospital--Division of Infectious Diseases

location_facility: HOSPITAL SAINT LOUIS - Services des Maladies Infectieuses

location_facility: Hospital of the University of Pennsylvania

location_facility: The Brody School of Medicine at East Carolina University

location_facility: Department of Dermatology University Hospital Essen

location_facility: San Gerardo Hospital - Uo Malattie Infettive

location_facility: La Playa Medical Group and Clinical Research

location_facility: National Institute for Infectious Diseases "L. Spallanzani" IRCCS

location_facility: Tarrant County Infectious Disease Associates

location_facility: Claudia T Martorell, MD., LLC dba The Research Institute

location_facility: Medizinische Universitätsklinik I der Friedrich-Wilhelms Universität Bonn

location_facility: Hôpital Pitié Salpêtrière - Service des Maladies Infectieuses

location_facility: Serviço de Doenças Infecciosas, Hospital S. Joao

location_facility: Southwest Infectious Disease Associates, Inc.

location_facility: Clinical Research - Infectious Diseases Unit Alfred Hospital

location_facility: Foundation "IRCCS Policlinico San Matteo Hospital"

location_facility: St. Joseph's Hospital d/b/a Comprehensive Research Institute

location_facility: Vancouver ID Research and Care Centre Society

location_facility: McGill University Health Center, Montreal Chest Institute

location_facility: LKH Medical University Graz West, Department of Internal Medicine

location_facility: Maple Leaf Research Maple Leaf Medical Clinic

location_facility: Clinical Research, Grahame Hayton Unit Ambrose King Centre, The Royal London Hospital

location_facility: Universitätsklinikum Eppendorf Ambulanzzentrum des UKE GmbH, Infekiologie

location_facility: Wohlfeiler, Piperato and Associates, LLC

location_facility: Universitätsklinikum Innsbruck Universitätsklinik für Dermatologie und Venerologie

location_facility: Infectious Disease Specialists of America

location_facility: Johns Hopkins Rockland Physicians Practice and Research Group at Greenspring Station

location_facility: Division of HIV/AIDS, St. Paul's Hospital

location_facility: I Div Infectious Diseases, Luigi Sacco Hospital

location_facility: Jeffrey Goodman Special Care Clinic/Los Angeles Gay and Lesbian Center

location_facility: Kaiser Permanente Medical Center, San Francisco

location_facility: Cliniques Universitaires Saint-Luc - UCL


title: Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

acronym: FIRSTANA

summary:
Primary Objective:

To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m^2 (Arm A) or 20 mg/m^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

To evaluate safety in the 3 treatment arms.

To compare efficacy of cabazitaxel at 20 mg/m^2 and 25 mg/m^2 to docetaxel for:

Progression Free Survival (PFS) (RECIST 1.1)
Tumor progression free survival (RECIST 1.1)
Tumor response in participants with measurable disease (RECIST 1.1),
PSA response
PSA-Progression free survival (PSA-PFS).
Pain response in participants with stable pain at baseline
Pain progression free survival
Time to occurrence of any skeletal related events (SRE)
To compare Health-Related Quality of Life (HRQL).
To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

ReferenceCitation: Thiery-Vuillemin A, Fizazi K, Sartor O, Oudard S, Bury D, Thangavelu K, Ozatilgan A, Poole EM, Eisenberger M, de Bono J. An analysis of health-related quality of life in the phase III PROSELICA and FIRSTANA studies assessing cabazitaxel in patients with metastatic castration-resistant prostate cancer. ESMO Open. 2021 Apr;6(2):100089. doi: 10.1016/j.esmoop.2021.100089. Epub 2021 Mar 16.

ReferenceCitation: Mehra N, Dolling D, Sumanasuriya S, Christova R, Pope L, Carreira S, Seed G, Yuan W, Goodall J, Hall E, Flohr P, Boysen G, Bianchini D, Sartor O, Eisenberger MA, Fizazi K, Oudard S, Chadjaa M, Macé S, de Bono JS. Plasma Cell-free DNA Concentration and Outcomes from Taxane Therapy in Metastatic Castration-resistant Prostate Cancer from Two Phase III Trials (FIRSTANA and PROSELICA). Eur Urol. 2018 Sep;74(3):283-291. doi: 10.1016/j.eururo.2018.02.013. Epub 2018 Feb 28.

ReferenceCitation: Oudard S, Fizazi K, Sengeløv L, Daugaard G, Saad F, Hansen S, Hjälm-Eriksson M, Jassem J, Thiery-Vuillemin A, Caffo O, Castellano D, Mainwaring PN, Bernard J, Shen L, Chadjaa M, Sartor O. Cabazitaxel Versus Docetaxel As First-Line Therapy for Patients With Metastatic Castration-Resistant Prostate Cancer: A Randomized Phase III Trial-FIRSTANA. J Clin Oncol. 2017 Oct 1;35(28):3189-3197. doi: 10.1200/JCO.2016.72.1068. Epub 2017 Jul 28.

ReferenceCitation: de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

ReferenceCitation: Winquist E, Rodrigues G. Open clinical uro-oncology trials in Canada. Can J Urol. 2012 Dec;19(6):6587-91.

lead_sponsor: Sanofi

location_country:
Spain
Italy
Ukraine
United States
Peru
Romania
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Israel
Turkey
Mexico
Sweden
Brazil
Canada
China
Germany
Denmark
Taiwan
Belarus
Finland
France

location_facility:
Investigational Site Number 392006
Investigational Site Number 840006
Investigational Site Number 643006
Investigational Site Number 158004
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Investigational Site Number 392003
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Investigational Site Number 376002
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Investigational Site Number 124005
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Investigational Site Number 376004
Investigational Site Number 604006
Investigational Site Number 156005
Investigational Site Number 840001
Investigational Site Number 203002
Investigational Site Number 208002
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Investigational Site Number 643003
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Investigational Site Number 246002
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Investigational Site Number 804002
Investigational Site Number 392001
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Investigational Site Number 076006
Investigational Site Number 616004
Investigational Site Number 642005
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Investigational Site Number 840007
Investigational Site Number 616003
Investigational Site Number 642002
Investigational Site Number 840011
Investigational Site Number 076005
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Investigational Site Number 724006
Investigational Site Number 380004
Investigational Site Number 036003
Investigational Site Number 124003
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Investigational Site Number 484002
Investigational Site Number 276002
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Investigational Site Number 804004
Investigational Site Number 158003
Investigational Site Number 112002
Investigational Site Number 250009
Investigational Site Number 840017
Investigational Site Number 724007
Investigational Site Number 643008
Investigational Site Number 620001
Investigational Site Number 250010
Investigational Site Number 840016
Investigational Site Number 380002
Investigational Site Number 620002
Investigational Site Number 752001
Investigational Site Number 840036
Investigational Site Number 076003
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Investigational Site Number 208004
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Investigational Site Number 840008
Investigational Site Number 804008
Investigational Site Number 380001
Investigational Site Number 642008
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Investigational Site Number 124004
Investigational Site Number 250002
Investigational Site Number 840021
Investigational Site Number 604005
Investigational Site Number 804001
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Investigational Site Number 392002
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 036001
Investigational Site Number 643005
Investigational Site Number 840009
Investigational Site Number 840023
Investigational Site Number 804003
Investigational Site Number 724001
Investigational Site Number 840010
Investigational Site Number 124007
Investigational Site Number 203001
Investigational Site Number 643001
Investigational Site Number 643004
Investigational Site Number 804010
Investigational Site Number 156003
Investigational Site Number 840005
Investigational Site Number 203003
Investigational Site Number 076001
Investigational Site Number 380005
Investigational Site Number 036002


type: Registry Identifier

title: A Phase II, Single-arm Study of Orally Administered BEZ235 as Second-line Therapy in Patients With Advanced or Metastatic Endometrial Carcinoma

summary: This is an open label and single arm study to investigate the safety and efficacy of BEZ235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.

status: Withdrawn

study_completion_date_type: Anticipated

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Canada
United States
France
Singapore
Turkey
Japan
Germany

location_facility: University of Texas Southwestern Medical Center

location_facility: University of Oklahoma Health Sciences Center

status_simplified: Unknown


title: A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor

summary: This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.

status: Terminated

location_country:
Denmark
Spain
Greece
Italy
Netherlands
Russian Federation
Finland
Sweden
Puerto Rico
United States
France
Germany


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS US 196 0140

summary: This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

location_country:
Poland
United Kingdom
Austria
Netherlands
United States
France
Belgium
Germany

location_facility: Infectious Disease Specialists of Atlanta

location_facility: Radaboud University Nijmegen Medical Centre (UMC St Radboud)

location_facility: Centre Hospitalier Régional d'Orléans, Hôpital de la Source

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Digestive Health Specialists of the Southeast

location_facility: Hôpital de I´Archet 2, Service Hépatologie

location_facility: Klinikum der Johann Wolfgang Goethe-Universität

location_facility: University Hospitals Case Medical Center

location_facility: South Florida Center of Gastroenterology, LLC

location_facility: Virginia Mason Medical Center, Digestive Disease Institute

location_facility: Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Erasmus University Medical Center Rotterdam

location_facility: Emory University, Infectious Disease Clinic

location_facility: Liver Institute of Virginia, Bon Secours

location_facility: Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego

location_facility: Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny

location_facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie

location_facility: Henry Ford Health System-Columbus center

location_facility: San Francisco Veterans Affairs Medical Center

location_facility: Niepubliczny Zakład Opieki Zdrowotnej "Pol-SaNa-Med" Sp. z o.o.

location_facility: Asheville Gastroenterology Associates, P.A.

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

location_facility: Centre Hospitalier Universitaire Sart Tilman Liège

location_facility: Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby

location_facility: Columbia Medical Group, The Frist Clinic

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Wisconsin Hospital & Clinics

location_facility: Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil

location_facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny

location_facility: Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research

location_facility: Cornell University Gastroenterology & Hepatology

location_facility: Academisch Medisch Centrum Universiteit Van Amsterdam


title: A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury

summary: The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.

ReferenceCitation: Esquenazi A, Brashear A, Deltombe T, Rudzinska-Bar M, Krawczyk M, Skoromets A, O'Dell MW, Grandoulier AS, Vilain C, Picaut P, Gracies JM. The Effect of Repeated abobotulinumtoxinA (Dysport®) Injections on Walking Velocity in Persons with Spastic Hemiparesis Caused by Stroke or Traumatic Brain Injury. PM R. 2021 May;13(5):488-495. doi: 10.1002/pmrj.12459. Epub 2020 Sep 11.

ReferenceCitation: Esquenazi A, Stoquart G, Hedera P, Jacinto LJ, Dimanico U, Constant-Boyer F, Brashear A, Grandoulier AS, Vilain C, Picaut P, Gracies JM. Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Hemiparesis in Adults with Lower Limb Spasticity Previously Treated With Other Botulinum Toxins: A Secondary Analysis of a Randomized Controlled Trial. PM R. 2020 Sep;12(9):853-860. doi: 10.1002/pmrj.12348. Epub 2020 Mar 27.

ReferenceCitation: Gracies JM, Esquenazi A, Brashear A, Banach M, Kocer S, Jech R, Khatkova S, Benetin J, Vecchio M, McAllister P, Ilkowski J, Ochudlo S, Catus F, Grandoulier AS, Vilain C, Picaut P; International AbobotulinumtoxinA Adult Lower Limb Spasticity Study Group. Efficacy and safety of abobotulinumtoxinA in spastic lower limb: Randomized trial and extension. Neurology. 2017 Nov 28;89(22):2245-2253. doi: 10.1212/WNL.0000000000004687. Epub 2017 Nov 1.

ipd_sharing_description:
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of study participants.

Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.

lead_sponsor: Ipsen

location_country:
Poland
Portugal
Italy
Russian Federation
Australia
Hungary
United States
France
Belgium
Slovakia
Czechia

location_facility: Wake Forest University Baptist Medical Center

location_facility: Service de Réeducation Fonctionnelle, CHU de Brest, Hôpital Morvan

location_facility: Associated Neurologists of Southern CT, PC

location_facility: Polo IRCCS Eugenio Medea La Nostra Famiglia

location_facility: Hôpital Sébastopol, Médecine Physique et Réadaptation, CHU Reims

location_facility: University of North Texas HSC at Ben Hogan Center

location_facility: National Institute for Medical Rehabilitation

location_facility: The University of Texas Southwestern Medical Center at Dallas

location_facility: Université catholique de Louvain av Hippocrate 10

location_facility: Neurologicka klinika, Univerzitna nemocnica Bratislava

location_facility: University of North Carolina - Chapel Hill

location_facility: Servizio di Neurofisiologia Clinica-Ospedale San Raffaele

location_facility: State Institution "Scientific Centre of Neurology of Russian Academy of Medical Sciences"

location_facility: Parkinson's Disease & Movement Disorders Center of Boca Raton


title: Efficacy and Safety of HIV Vaccine 732462 in ART-naïve HIV-1 Infected Persons

summary: This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

location_country:
Germany
United States
Spain
France


acronym: BLAST

title: A Confirmatory Multicenter, Single-arm Study to Assess the Efficacy, Safety, and Tolerability of the BiTE® Antibody Blinatumomab in Adult Patients With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (BLAST)

lead_sponsor: Amgen Research (Munich) GmbH

ReferenceCitation: Gökbuget N, Zugmaier G, Dombret H, Stein A, Bonifacio M, Graux C, Faul C, Brüggemann M, Taylor K, Mergen N, Reichle A, Horst HA, Havelange V, Topp MS, Bargou RC. Curative outcomes following blinatumomab in adults with minimal residual disease B-cell precursor acute lymphoblastic leukemia. Leuk Lymphoma. 2020 Nov;61(11):2665-2673. doi: 10.1080/10428194.2020.1780583. Epub 2020 Jul 3.

ReferenceCitation: Jen EY, Xu Q, Schetter A, Przepiorka D, Shen YL, Roscoe D, Sridhara R, Deisseroth A, Philip R, Farrell AT, Pazdur R. FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease. Clin Cancer Res. 2019 Jan 15;25(2):473-477. doi: 10.1158/1078-0432.CCR-18-2337. Epub 2018 Sep 25.

ReferenceCitation: Gökbuget N, Dombret H, Bonifacio M, Reichle A, Graux C, Faul C, Diedrich H, Topp MS, Brüggemann M, Horst HA, Havelange V, Stieglmaier J, Wessels H, Haddad V, Benjamin JE, Zugmaier G, Nagorsen D, Bargou RC. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018 Apr 5;131(14):1522-1531. doi: 10.1182/blood-2017-08-798322. Epub 2018 Jan 22. Erratum in: Blood. 2019 Jun 13;133(24):2625.

ReferenceCitation: Zhu M, Wu B, Brandl C, Johnson J, Wolf A, Chow A, Doshi S. Blinatumomab, a Bispecific T-cell Engager (BiTE(®)) for CD-19 Targeted Cancer Immunotherapy: Clinical Pharmacology and Its Implications. Clin Pharmacokinet. 2016 Oct;55(10):1271-1288. doi: 10.1007/s40262-016-0405-4.

location_country:
Poland
Romania
Spain
Italy
Austria
Netherlands
Russian Federation
United Kingdom
France
Belgium
Germany

location_facility: 1309 - Azienda Ospedaliera Antonio Cardarelli

location_facility: 1001 - Julius-Maximilians-Universität Würzburg

location_facility: 1308 - Ospedali Riuniti "Villa Sofia-Cervello"

location_facility: 1312 - Azienda Ospedaliera Universitaria San Martino

location_facility: 1213 - Centre Hospitalier Universitaire de Nice

location_facility: 1905 - Uniwersytecki Szpital Kliniczny w Białymstoku

location_facility: 1404 - Hospital Clínic Servei d´Hematologia

location_facility: 1607 - Nottingham City Hospital NHS Trust

location_facility: 1502 - Cliniques Universitaires de Saint-Luc

location_facility: 1315 - Azienda Ospedaliero-Universitaria S. Giovanni Battista (Le Molinette)

location_facility: 1010 - Klinikum der Universität München - Großhadern

location_facility: 1202 - CHU de Bordeaux - Hôpital Haut Lévêque

location_facility: 1003 - Universitätsklinikum Schleswig-Holstein

location_facility: 1310 - Fondazione Policlinico Tor Vergata

location_facility: 1406 - Hospital Universitari i Politècnic La Fe de Valencia

location_facility: 1405 - Hospital Universitari Son Espases

location_facility: 1501 - Cliniques Universitaires UCL de Mont Godinne

location_facility: 1022 - Universitätsklinkum Carl Gustav Carus Dresden

location_facility: 2101 - Institutul Clinic Fundeni, Hematologie II

location_facility: 1303 - Istituto di Ematologia "L.& A.Seràgnoli" Azienda

location_facility: 1901 - Klinika Hematologii - Instytut Hematologii i Transfuzjologii

location_facility: 1402 - Complexo Hospitalario Universitario A Coruña

location_facility: 2106 - Institutul Oncologic "Prof. Dr. I. Chiricuta"

location_facility: 1401 - ICO Hospital Germans Trias I Pujol

location_facility: 2001 - Russian Hematology Research Center

location_facility: 1407 - Unidad de Citogenética Oncológica

location_facility: 1314 - Azienda Ospedaliera Spedali Civili Brescia

location_facility: 2102 - Spitalul Clinic Coltea, Hematologie

summary: The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.


title: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Phase III Efficacy and Safety Study of TC-5214 (S-mecamylamine) in Flexible Doses as an Adjunct to an Antidepressant in Patients With Major Depressive Disorder Who Exhibit an Inadequate Response to Antidepressant Therapy

summary: The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

ReferenceCitation: Vieta E, Thase ME, Naber D, D'Souza B, Rancans E, Lepola U, Olausson B, Szamosi J, Wilson E, Hosford D, Dunbar G, Tummala R, Eriksson H. Efficacy and tolerability of flexibly-dosed adjunct TC-5214 (dexmecamylamine) in patients with major depressive disorder and inadequate response to prior antidepressant. Eur Neuropsychopharmacol. 2014 Apr;24(4):564-74. doi: 10.1016/j.euroneuro.2013.12.008. Epub 2013 Dec 21.

lead_sponsor: AstraZeneca

location_country:
Poland
Latvia
Estonia
Finland
Czech Republic
Lithuania
Sweden
Hungary
France
Germany