title: MEA115588 A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Multi-centre Study of the Efficacy and Safety of Mepolizumab Adjunctive Therapy in Subjects With Severe Uncontrolled Refractory Asthma

summary:
This study will evaluate two dose regimens of mepolizumab [75mg intravenous (i.v.) or 100mg subcutaneous (SC) every 4 weeks] compared with placebo over a 32 week treatment period in subjects with severe refractory asthma with elevated blood eosinophils. Efficacy will be measured by a reduction in the frequency of asthma exacerbations. Additional efficacy assessments will include measurements of lung function, symptom scores, and quality of life. Safety will be assessed by clinical laboratory samples, ECGs, immunogenicity and adverse events.

This study is intended to replicate the Phase IIb/III study MEA112997. Subjects in MEA115588, who meet all eligibility criteria at screening visit, will enter the run-in period. Those subjects that are not able/eligible to be randomised at the end of the 6 week run-in period will be deemed run-in failures. Subjects will remain on their current maintenance therapy throughout the run-in, double-blind treatment administration and follow-up periods. Subjects who meet the randomisation eligibility criteria will be randomised in a 1:1:1 ratio to receive one of the following treatments every 4 weeks for a total of 8 doses: Mepolizumab 75 miligram (mg) i.v. and placebo SC, or Mepolizumab 100 mg SC and placebo i.v. or Placebo i.v. and placebo SC.

Subjects that receive all 8 doses of double-blind treatment, and meet the eligibility criteria for the Open-Label Extension (OLE) Study, will be offered the opportunity to participate in the OLE trial.

ReferenceCitation: Lemiere C, Taille C, Lee JK, Smith SG, Mallett S, Albers FC, Bradford ES, Yancey SW, Liu MC. Impact of baseline clinical asthma characteristics on the response to mepolizumab: a post hoc meta-analysis of two Phase III trials. Respir Res. 2021 Jun 22;22(1):184. doi: 10.1186/s12931-021-01767-z.

ReferenceCitation: Gibson PG, Prazma CM, Chupp GL, Bradford ES, Forshag M, Mallett SA, Yancey SW, Smith SG, Bel EH. Mepolizumab improves clinical outcomes in patients with severe asthma and comorbid conditions. Respir Res. 2021 Jun 7;22(1):171. doi: 10.1186/s12931-021-01746-4.

ReferenceCitation: Best N, Price RG, Pouliquen IJ, Keene ON. Assessing efficacy in important subgroups in confirmatory trials: An example using Bayesian dynamic borrowing. Pharm Stat. 2021 May;20(3):551-562. doi: 10.1002/pst.2093. Epub 2021 Jan 21.

ReferenceCitation: Wardlaw A, Howarth PH, Israel E, Taille C, Quirce S, Mallett S, Bates S, Albers FC, Kwon N. Fungal sensitization and its relationship to mepolizumab response in patients with severe eosinophilic asthma. Clin Exp Allergy. 2020 Jul;50(7):869-872. doi: 10.1111/cea.13680. Epub 2020 Jun 25. No abstract available.

repository_institution: University of Illinois at Chicago - INDIGO

repositories_concat: PubMed Central;figshare.com

ReferenceCitation: Kim MK, Park HS, Park CS, Min SJ, Albers FC, Yancey SW, Mayer B, Kwon N. Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies. Korean J Intern Med. 2021 Mar;36(2):362-370. doi: 10.3904/kjim.2019.198. Epub 2020 May 26.

publisher_dissemination: Korean Association of Internal Medicine

ReferenceCitation: Khurana S, Brusselle GG, Bel EH, FitzGerald JM, Masoli M, Korn S, Kato M, Albers FC, Bradford ES, Gilson MJ, Price RG, Humbert M. Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study. Clin Ther. 2019 Oct;41(10):2041-2056.e5. doi: 10.1016/j.clinthera.2019.07.007. Epub 2019 Aug 22.

repository_institution: Ghent University - Ghent University Academic Bibliography

ReferenceCitation: Khurana S, Lyness JM, Mallett S, Nelsen LM, Prazma CM, Albers FC, Forshag M, Llanos JP, Yancey SW, Ortega HG. Association of depressive symptoms with health status and markers of uncontrolled severe asthma. Allergy Asthma Proc. 2019 Jul 1;40(4):230-239. doi: 10.2500/aap.2019.40.4229.

ReferenceCitation: Nelsen LM, Cockle SM, Gunsoy NB, Jones P, Albers FC, Bradford ES, Mullerova H. Impact of exacerbations on St George's Respiratory Questionnaire score in patients with severe asthma: post hoc analyses of two clinical trials and an observational study. J Asthma. 2020 Sep;57(9):1006-1016. doi: 10.1080/02770903.2019.1630640. Epub 2019 Jun 28.

ReferenceCitation: Yancey SW, Bradford ES, Keene ON. Disease burden and efficacy of mepolizumab in patients with severe asthma and blood eosinophil counts of >/=150-300 cells/muL. Respir Med. 2019 May;151:139-141. doi: 10.1016/j.rmed.2019.04.008. Epub 2019 Apr 8.

ReferenceCitation: Ortega HG, Meyer E, Brusselle G, Asano K, Prazma CM, Albers FC, Mallett SA, Yancey SW, Gleich GJ. Update on immunogenicity in severe asthma: Experience with mepolizumab. J Allergy Clin Immunol Pract. 2019 Sep-Oct;7(7):2469-2475.e1. doi: 10.1016/j.jaip.2019.03.042. Epub 2019 Apr 5. No abstract available.

ReferenceCitation: Ortega H, Menzies-Gow A, Llanos JP, Forshag M, Albers F, Gunsoy N, Bradford ES, Yancey SW, Kraft M. Rapid and Consistent Improvements in Morning PEF in Patients with Severe Eosinophilic Asthma Treated with Mepolizumab. Adv Ther. 2018 Jul;35(7):1059-1068. doi: 10.1007/s12325-018-0727-8. Epub 2018 Jun 15.

ReferenceCitation: Ortega H, Yancey SW, Keene ON, Gunsoy NB, Albers FC, Howarth PH. Asthma Exacerbations Associated with Lung Function Decline in Patients with Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):980-986.e1. doi: 10.1016/j.jaip.2017.12.019. Epub 2018 Feb 15.

repository_institution: University of Southampton - ePrints Soton

ReferenceCitation: Gunsoy NB, Cockle SM, Yancey SW, Keene ON, Bradford ES, Albers FC, Pavord ID. Evaluation of Potential Continuation Rules for Mepolizumab Treatment of Severe Eosinophilic Asthma. J Allergy Clin Immunol Pract. 2018 May-Jun;6(3):874-882.e4. doi: 10.1016/j.jaip.2017.11.026. Epub 2017 Dec 16.

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

ReferenceCitation: Albers FC, Price RG, Smith SG, Yancey SW. Mepolizumab efficacy in patients with severe eosinophilic asthma receiving different controller therapies. J Allergy Clin Immunol. 2017 Nov;140(5):1464-1466.e4. doi: 10.1016/j.jaci.2017.06.010. Epub 2017 Jul 4. No abstract available.

ReferenceCitation: Magnan A, Bourdin A, Prazma CM, Albers FC, Price RG, Yancey SW, Ortega H. Treatment response with mepolizumab in severe eosinophilic asthma patients with previous omalizumab treatment. Allergy. 2016 Sep;71(9):1335-44. doi: 10.1111/all.12914. Epub 2016 May 24.

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université d'Artois

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Université Toulouse - Jean Jaurès

ReferenceCitation: Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P; MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1198-207. doi: 10.1056/NEJMoa1403290. Epub 2014 Sep 8. Erratum In: N Engl J Med. 2015 Apr 30;372(18):1777.

repository_institution: University of Liège - ORBi - Open Repository and Bibliography of the University of Liège

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

location_country:
Germany
Italy
United Kingdom
Argentina
Australia
Japan
Mexico
Belgium
United States
Korea, Republic of
Spain
Chile
Canada
Ukraine
Russian Federation
France


type: Other Identifier

title: Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition With Evacetrapib in Patients at a High-Risk for Vascular Outcomes

acronym: ACCELERATE

summary: The purpose of the ACCELERATE study is to evaluate the efficacy and safety of evacetrapib in participants with high-risk vascular disease (HRVD).

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Puri R, Nissen SE, Arsenault BJ, St John J, Riesmeyer JS, Ruotolo G, McErlean E, Menon V, Cho L, Wolski K, Lincoff AM, Nicholls SJ. Effect of C-Reactive Protein on Lipoprotein(a)-Associated Cardiovascular Risk in Optimally Treated Patients With High-Risk Vascular Disease: A Prespecified Secondary Analysis of the ACCELERATE Trial. JAMA Cardiol. 2020 Oct 1;5(10):1136-1143. doi: 10.1001/jamacardio.2020.2413.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

publisher_dissemination: American Medical Association

ReferenceCitation: Menon V, Kumar A, Patel DR, John JS, Wolski KE, McErlean E, Riesmeyer JS, Weerakkody G, Ruotolo G, Cremer PC, Nicholls SJ, Lincoff AM, Nissen SE. Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High-Risk Vascular Disease Treated With Statin Therapy. J Am Heart Assoc. 2020 Jan 7;9(1):e014328. doi: 10.1161/JAHA.119.014328. Epub 2019 Dec 19.

oa_colors: green gold

evidence: oa journal (via doaj)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

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

repository_institution: PubMed Central - Europe PMC

repository_institution: Monash University - Monash University Research Portal

repositories_concat: PubMed Central;monash.edu

unpaywall_oa_status: gold

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Kumar A, Patel DR, Brennan DM, Wolski KE, Lincoff AM, Ruotolo G, McErlean E, Weerakkody G, Riesmeyer JS, Nicholls SJ, Nissen SE, Menon V. Plasma Aldosterone Levels Are Not Associated With Cardiovascular Events Among Patients With High-Risk Vascular Disease: Insights From the ACCELERATE Trial. J Am Heart Assoc. 2019 Dec 3;8(23):e013790. doi: 10.1161/JAHA.119.013790. Epub 2019 Nov 22.

ReferenceCitation: Lincoff AM, Nicholls SJ, Riesmeyer JS, Barter PJ, Brewer HB, Fox KAA, Gibson CM, Granger C, Menon V, Montalescot G, Rader D, Tall AR, McErlean E, Wolski K, Ruotolo G, Vangerow B, Weerakkody G, Goodman SG, Conde D, McGuire DK, Nicolau JC, Leiva-Pons JL, Pesant Y, Li W, Kandath D, Kouz S, Tahirkheli N, Mason D, Nissen SE; ACCELERATE Investigators. Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease. N Engl J Med. 2017 May 18;376(20):1933-1942. doi: 10.1056/NEJMoa1609581.

evidence: open (via free article)

repository_institution: University of Edinburgh - Edinburgh Research Explorer

publisher_dissemination: Massachusetts Medical Society

ipd_sharing: Yes

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
The Cleveland Clinic

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Lithuania
Slovakia
Hungary
Hong Kong
Denmark
Switzerland
United States
Ukraine
Romania
Belgium
China
Estonia
Puerto Rico
Italy
United Kingdom
Sweden
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Russian Federation
Israel

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

intervention_type: Drug

lead_sponsor_type: industriel


type: EudraCT Number

title: 30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis

acronym: EINSTEINJunior

summary: The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.

study_start_date_type: Actual

status: Completed

design_allocation: Non-Randomized

lead_sponsor: Bayer

sponsor_collaborators:
Bayer
Janssen Research & Development, LLC

location_country:
Germany
Italy
Israel
Australia
Netherlands
Austria
Switzerland
United States
Canada
France

status_simplified: Completed


title: A Phase 1/2, Dose-escalation, Open-label, Non-comparative Study of Nivolumab or Nivolumab in Combination With Ipilimumab in Advanced Hepatocellular Carcinoma Subjects With or Without Chronic Viral Hepatitis; and a Randomized, Open-label Study of Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma Subjects Who Are Naive to Systemic Therapy

summary:
The first part of the study is the Dose Escalation Phase designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC) subjects, hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects).

The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses for each of the 3 cohorts. A third cohort has been added in this study to compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. A fourth cohort will generate data on the safety and efficacy of the combination nivolumab plus ipilimumab in the treatment of Advanced HCC. In the fifth cohort, additional clinical data will be generated for Child-Pugh B subjects. A Cabozantinib Combination Cohort has been added to evaluate the safety and tolerability of nivolumab in combination with cabozantinib and nivolumab with ipilimumab in combination with cabozantinib.

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Sove RJ, Verma BK, Wang H, Ho WJ, Yarchoan M, Popel AS. Virtual clinical trials of anti-PD-1 and anti-CTLA-4 immunotherapy in advanced hepatocellular carcinoma using a quantitative systems pharmacology model. J Immunother Cancer. 2022 Nov;10(11):e005414. doi: 10.1136/jitc-2022-005414. Erratum In: J Immunother Cancer. 2023 Jan;11(1):

license: cc-by-nc

license_normalized: cc-by-nc

publisher_dissemination: British Medical Journal

ReferenceCitation: Kudo M, Matilla A, Santoro A, Melero I, Gracian AC, Acosta-Rivera M, Choo SP, El-Khoueiry AB, Kuromatsu R, El-Rayes B, Numata K, Itoh Y, Di Costanzo F, Crysler O, Reig M, Shen Y, Neely J, Tschaika M, Wisniewski T, Sangro B. CheckMate 040 cohort 5: A phase I/II study of nivolumab in patients with advanced hepatocellular carcinoma and Child-Pugh B cirrhosis. J Hepatol. 2021 Sep;75(3):600-609. doi: 10.1016/j.jhep.2021.04.047. Epub 2021 May 26.

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

unpaywall_oa_status: hybrid

publisher_dissemination: Elsevier

ReferenceCitation: Yau T, Kang YK, Kim TY, El-Khoueiry AB, Santoro A, Sangro B, Melero I, Kudo M, Hou MM, Matilla A, Tovoli F, Knox JJ, Ruth He A, El-Rayes BF, Acosta-Rivera M, Lim HY, Neely J, Shen Y, Wisniewski T, Anderson J, Hsu C. Efficacy and Safety of Nivolumab Plus Ipilimumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib: The CheckMate 040 Randomized Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):e204564. doi: 10.1001/jamaoncol.2020.4564. Epub 2020 Nov 12. Erratum In: JAMA Oncol. 2021 Jan 1;7(1):140.

endpoint_id: fhisxppmrqpajgzqkvft

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

version: submittedVersion

repositories_concat: PubMed Central;cris.unibo.it

ReferenceCitation: Sangro B, Melero I, Wadhawan S, Finn RS, Abou-Alfa GK, Cheng AL, Yau T, Furuse J, Park JW, Boyd Z, Tang HT, Shen Y, Tschaika M, Neely J, El-Khoueiry A. Association of inflammatory biomarkers with clinical outcomes in nivolumab-treated patients with advanced hepatocellular carcinoma. J Hepatol. 2020 Dec;73(6):1460-1469. doi: 10.1016/j.jhep.2020.07.026. Epub 2020 Jul 22.

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Navarra - Deposito Adademico Digital Universidad De Navarra

version: acceptedVersion

repositories_concat: PubMed Central;dadun.unav.edu

ReferenceCitation: Yau T, Hsu C, Kim TY, Choo SP, Kang YK, Hou MM, Numata K, Yeo W, Chopra A, Ikeda M, Kuromatsu R, Moriguchi M, Chao Y, Zhao H, Anderson J, Cruz CD, Kudo M. Nivolumab in advanced hepatocellular carcinoma: Sorafenib-experienced Asian cohort analysis. J Hepatol. 2019 Sep;71(3):543-552. doi: 10.1016/j.jhep.2019.05.014. Epub 2019 Jun 7. Erratum In: J Hepatol. 2019 Dec;71(6):1278.

oa_host_type: publisher

repositories_concat: closed

ReferenceCitation: El-Khoueiry AB, Sangro B, Yau T, Crocenzi TS, Kudo M, Hsu C, Kim TY, Choo SP, Trojan J, Welling TH Rd, Meyer T, Kang YK, Yeo W, Chopra A, Anderson J, Dela Cruz C, Lang L, Neely J, Tang H, Dastani HB, Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017 Jun 24;389(10088):2492-2502. doi: 10.1016/S0140-6736(17)31046-2. Epub 2017 Apr 20.

oa_host_type: repository

repository_institution: University College London - UCL Discovery

sponsor_collaborators:
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd

location_country:
Germany
Italy
United Kingdom
Hong Kong
Singapore
Japan
United States
Korea, Republic of
Spain
Taiwan
Canada
Puerto Rico
France

location_facility: The University Of Texas MD Anderson Cancer Center


title: A Randomized, Multicenter, Adaptive Phase II/III Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine (T-DM1) Versus Taxane (Docetaxel Or Paclitaxel) In Patients With Previously Treated Locally Advanced Or Metastatic HER2-Positive Gastric Cancer, Including Adenocarcinoma Of The Gastroesophageal Junction

summary:
This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. At the start of the trial (stage 1), participants will be randomized with a ratio 2:2:1 to one of three treatment arms: Arm A: trastuzumab emtansine 3.6 milligram per kilogram (mg/kg) per intravenous injection (IV) every 3 weeks; Arm B: trastuzumab emtansine 2.4 mg/kg IV every week; Arm C: standard taxane therapy (docetaxel 75 milligram per meter square [mg/m^2] IV every 3 weeks or paclitaxel 80 mg/m^2 kg IV every week per investigator choice). At the end of the first stage of the study, the dose and schedule of trastuzumab emtansine that will be used in the second stage of the study will be selected by an Independent Data Monitoring Committee (IDMC). The regimen selection analysis will be made after approximately 100 participants across all three study arms have been treated for at least 12 weeks.

Once a trastuzumab emtansine regimen has been selected, Stage I participants who were assigned to the treatment arm which was selected for Stage II of the study and participants who were in the standard taxane group will continue to receive their assigned treatment regimen. Stage I participants who were assigned to the regimen that was not selected for further evaluation will continue to receive their assigned regimen and will continue to be followed for efficacy and safety. In Stage II of the study, additional participants will be recruited and randomized with a ratio 2:1 to either the selected regimen of trastuzumab emtansine or to the standard taxane therapy. Participants will receive study treatment until disease progression, unacceptable toxicity, initiation of another cancer therapy or withdrawal.

ReferenceCitation: Shah MA, Kang YK, Thuss-Patience PC, Ohtsu A, Ajani JA, Van Cutsem E, Hoersch S, Harle-Yge ML, de Haas SL. Biomarker analysis of the GATSBY study of trastuzumab emtansine versus a taxane in previously treated HER2-positive advanced gastric/gastroesophageal junction cancer. Gastric Cancer. 2019 Jul;22(4):803-816. doi: 10.1007/s10120-018-00923-7. Epub 2019 Jan 31.

publisher_dissemination: Springer-Nature

ReferenceCitation: Thuss-Patience PC, Shah MA, Ohtsu A, Van Cutsem E, Ajani JA, Castro H, Mansoor W, Chung HC, Bodoky G, Shitara K, Phillips GDL, van der Horst T, Harle-Yge ML, Althaus BL, Kang YK. Trastuzumab emtansine versus taxane use for previously treated HER2-positive locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GATSBY): an international randomised, open-label, adaptive, phase 2/3 study. Lancet Oncol. 2017 May;18(5):640-653. doi: 10.1016/S1470-2045(17)30111-0. Epub 2017 Mar 23.

oa_host_type: closed

lead_sponsor: Hoffmann-La Roche

location_country:
Finland
Germany
Poland
Argentina
Japan
Brazil
Turkey
Czechia
Canada
France
Hungary
United States
Romania
Belgium
China
Malaysia
Peru
Philippines
Italy
Guatemala
United Kingdom
Singapore
Mexico
Korea, Republic of
Spain
Panama
Taiwan
Russian Federation

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: Brampton Memorial Hospital, William Osler Health Center

location_facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

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

location_facility: Toronto East General Hospital; Haematology/Oncology

location_facility: Aichi Cancer Center Hospital; Clinical Oncology

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

location_facility: Hospital Nacional Adolfo Guevara Velasco

location_facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology

location_facility: Third Affiliated Hospital of Third Military Medical University

location_facility: Universitätsklinikum "Carl Gustav Carus"; Med. Klinik & Poliklinik I, Arbeitsgr. intern. Onkologie

location_facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: University Malaya Medical Centre; Clinical Oncology Unit,

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni

location_facility: Zala Megyei Kórház, Külsö Kórház, Pózva; Onkológiai Osztály

location_facility: Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie; Klinika Gastroenterologii Onkologicznej

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Hop Europeen Georges Pompidou; Gastro Enterologie

location_facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

location_facility: Yonsei University Severance Hospital; Medical Oncology

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Hetenyi Geza County Hospital; Onkologiai Kozpont

location_facility: Hopital Robert Debre; Gastro Enterologie

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica

location_facility: National Hospital Organization Shikoku Cancer Center; Gastroenterology

location_facility: Kaohsiung Chang Gung Memorial Hospital; Dept of Hem and Onc

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

location_facility: Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology

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

location_facility: Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología

location_facility: Hopital Saint Antoine; Hepatologie-Gastr-Enterologie

location_facility: Shizuoka General Hospital; Clinical Oncology

location_facility: Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie

location_facility: National Cancer Center Hospital; Gastrointestinal Oncology

location_facility: Spitalul Universitar CF Cluj-Napoca; Sectia Oncologie

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Seoul St.Mary's Hospital; Medical Oncology

location_facility: Shizuoka Cancer Center; Gastroenterology

location_facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center

location_facility: National Cancer Center Hospital East; Gastroenterology

location_facility: General Hospital of Shenyang Military Command of PLA

location_facility: The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)

location_facility: Veterans Memorial Medical Ctr; Cancer Research Centre

location_facility: Istanbul Bilim University School Of Medicine; Department Of Medical Oncology

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Affiliated Hospital of Nantong University

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica

location_facility: Instituto Nacional de Cancer - INCa; Oncologia

location_facility: Tokyo Metropolitan Komagome Hospital; Chemotherapy

location_facility: University of Kansas; Medical Center & Medical pavilion

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital General de México; Unidad de Oncologia

location_facility: Hospital Clinic i Provincial; Servicio de Farmacia

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hyogo College Of Medicine; Upper Gastroenterology

location_facility: Centro Oncológico Sixtino / Centro Oncológico SA

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

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

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

location_facility: Instituto de Oncologia de Sorocaba - CEPOS

location_facility: Omsk Region Clinical Oncology Dispensary; 1St Sergical Department

location_facility: Centre Val Aurelle Paul Lamarque; Medecine A1 A2

location_facility: Hopital Augustin Morvan; Federation De Cancerologie

location_facility: Hospital Nacional Edgardo Rebagliati Martins

location_facility: Ibaraki Prefectural Central Hospital; Gastroenterology

location_facility: The Cancer Institute Hospital, JFCR; Gastroenterology

location_facility: Spitalul Clinic Judetean Mures; Oncologie Medicala

location_facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

location_facility: BRISTOL ONCOLOGY CENTRE; CLINICAL TRIALS UNIT; R & D department

location_facility: Hospital Univ. Central de Asturias; Servicio de Oncologia

location_facility: Korea University Anam Hospital; Oncology Haemotology

location_facility: Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

location_facility: AZ.Osp S. Orsola - Malpighi-Reparto di Oncologia Medica

location_facility: Marmara Uni Faculty of Medicine; Medical Oncology

status_simplified: Unknown


acronym: BLISS-LN

lead_sponsor: Human Genome Sciences Inc., a GSK Company

summary: The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab in adult patients with active lupus nephritis.

ReferenceCitation: Furie R, Rovin BH, Houssiau F, Contreras G, Teng YKO, Curtis P, Green Y, Okily M, Madan A, Roth DA. Safety and Efficacy of Belimumab in Patients with Lupus Nephritis: Open-Label Extension of BLISS-LN Study. Clin J Am Soc Nephrol. 2022 Nov;17(11):1620-1630. doi: 10.2215/CJN.02520322. Epub 2022 Oct 27.

ReferenceCitation: Rovin BH, Furie R, Teng YKO, Contreras G, Malvar A, Yu X, Ji B, Green Y, Gonzalez-Rivera T, Bass D, Gilbride J, Tang CH, Roth DA. A secondary analysis of the Belimumab International Study in Lupus Nephritis trial examined effects of belimumab on kidney outcomes and preservation of kidney function in patients with lupus nephritis. Kidney Int. 2022 Feb;101(2):403-413. doi: 10.1016/j.kint.2021.08.027. Epub 2021 Sep 22.

license: cc-by

license_normalized: cc-by

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

ReferenceCitation: Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, Amoura Z, Yu X, Mok CC, Santiago MB, Saxena A, Green Y, Ji B, Kleoudis C, Burriss SW, Barnett C, Roth DA. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020 Sep 17;383(12):1117-1128. doi: 10.1056/NEJMoa2001180.

title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab Plus Standard of Care Versus Placebo Plus Standard of Care in Adult Subjects With Active Lupus Nephritis

source: euctr

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

location_country:
Germany
Argentina
Brazil
Thailand
Czechia
Canada
France
Colombia
Hungary
Hong Kong
United States
Belgium
China
Philippines
United Kingdom
Netherlands
Mexico
Korea, Republic of
Spain
Taiwan
Russian Federation


title: A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

summary: This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

lead_sponsor: Novo Nordisk A/S

location_country:
Germany
Italy
Poland
Hungary
Argentina
United Kingdom
Brazil
Mexico
Belgium
United States
Spain
Czechia
France


title: A Phase 2, Open-Label Study of Daclatasvir (BMS-790052) and TMC435 in Combination With or Without Ribavirin (RBV) For Treatment-Naive Subjects or Null Responders to Prior Peginterferon Alfa (PegIFN)/RBV Therapy With Genotype 1 Chronic Hepatitis C

summary: The purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis C virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.

ReferenceCitation: Zeuzem S, Hezode C, Bronowicki JP, Loustaud-Ratti V, Gea F, Buti M, Olveira A, Banyai T, Al-Assi MT, Petersen J, Thabut D, Gadano A, Pruitt R, Makara M, Bourliere M, Pol S, Beumont-Mauviel M, Ouwerkerk-Mahadevan S, Picchio G, Bifano M, McPhee F, Boparai N, Cheung K, Hughes EA, Noviello S; LEAGUE-1 Study Team. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection. J Hepatol. 2016 Feb;64(2):292-300. doi: 10.1016/j.jhep.2015.09.024. Epub 2015 Oct 8.

lead_sponsor: Bristol-Myers Squibb

sponsor_collaborators:
Bristol-Myers Squibb
Janssen Research & Development, LLC

location_country:
Germany
Hungary
Argentina
United States
Spain
France

location_facility:
Nashville Medical Research Institute
San Francisco General Hospital
Johns Hopkins University
Texas Clinical Research Institute, Llc
Local Institution
Indiana University
Kaiser Permanente Med Ctr
Metropolitan Research


title: A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)

acronym: TURANDOT

summary: To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.

ReferenceCitation: Zhou H, Xi L, Ziemek D, O'Neil S, Lee J, Stewart Z, Zhan Y, Zhao S, Zhang Y, Page K, Huang A, Maciejewski M, Zhang B, Gorelick KJ, Fitz L, Pradhan V, Cataldi F, Vincent M, Von Schack D, Hung K, Hassan-Zahraee M. Molecular Profiling of Ulcerative Colitis Subjects from the TURANDOT Trial Reveals Novel Pharmacodynamic/Efficacy Biomarkers. J Crohns Colitis. 2019 May 27;13(6):702-713. doi: 10.1093/ecco-jcc/jjy217.

publisher_dissemination: Oxford University Press

ReferenceCitation: Vermeire S, Sandborn WJ, Danese S, Hebuterne X, Salzberg BA, Klopocka M, Tarabar D, Vanasek T, Gregus M, Hellstern PA, Kim JS, Sparrow MP, Gorelick KJ, Hinz M, Ahmad A, Pradhan V, Hassan-Zahraee M, Clare R, Cataldi F, Reinisch W. Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Jul 8;390(10090):135-144. doi: 10.1016/S0140-6736(17)30930-3. Epub 2017 May 17. Erratum In: Lancet. 2019 Dec 22;392(10165):2696.

lead_sponsor: Shire

location_country:
Germany
Poland
New Zealand
Australia
Czechia
Canada
Serbia
France
Slovakia
Hungary
United States
Belgium
Italy
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Israel

location_facility: Hôpital Nord Service de Gastro-entérologie

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III

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

location_facility: The Oregon Clinic, PC - Gastroenterology West

location_facility: Gastroenterology Center of Connecticut, PC

location_facility: Covance Central Laboratory Services, Inc

location_facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center

location_facility: Department of Pharmacy Investigational Drug Services

location_facility: Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa

location_facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem

location_facility: Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department

location_facility: GastroDiagnostics - Community Clinical Trials Drug

location_facility: Steinberg Diagnostic Medical Imaging Centers

location_facility: Vanderbilt University Medical Center: Drug Shipment

location_facility: Vanderbilt University Medical Center: Endoscopy Lab

location_facility: Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,

location_facility: Vanderbilt University Medical Center: IBD Clinic

location_facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre

location_facility: Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.

location_facility: Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva

location_facility: SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "

location_facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

location_facility: Azienda Ospedaliera Universitaria, Policlinico Tor Vergata

location_facility: University of North Carolina at Chapel Hill

location_facility: Gastroenterology Division, Rabin Medical Center, Beilinson Campus

location_facility: Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)

location_facility: IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS

location_facility: Yonsei University College of Medicine, Severance Hospital

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

location_facility: Vanderbilt University Medical Center: Outpatient Radiology

location_facility: Premier Medical Group of the Hudson Valley, PC

location_facility: Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology

location_facility: Ustredna vojenska nemocnice SNP Ruzomberok

location_facility: Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital

location_facility: Barnes-Jewish Hospital Radiology (X-Ray Only)

location_facility: Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont

location_facility: New York Presbyterian Hospital - Weill Cornell Medical College

location_facility: Washington University School of Medicine

location_facility: Houston Hospital for Specialized Surgery

location_facility: Weill Cornell Medical College of Cornell University

location_facility: UNC Hospitals Endoscopy Center At Meadowmont

location_facility: Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"

location_facility: Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.

location_facility: Gastroenterology Associates of Western Michigan

location_facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

location_facility: Azienda Ospedaliera -Università di Padova

location_facility: Academic Medical Center - University of Amsterdam

location_facility: Policlinico Universitario Campus Bio-Medico

location_facility: Clinical and Translational Research Institute

location_facility: Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine

location_facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel

location_facility: University Medical Center Groningen (UMCG)

location_facility: University of Nevada School of Medicine (UNSOM)

location_facility: Wojskowy Szpital Kliniczny z Poliklinika SPOZ

location_facility: Rocky Mountain Gastroenterology Associates

location_facility: London Health Sciences Centre - University Hospital

location_facility: Office of Drs. Ranjit Andrew Singh and Jamie D. Papp

location_facility: Premier Medical Group Research Department - Drug

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: University of Miami Hospital and Clinic - Local Lab

location_facility: Baylor College Of Medicine - Baylor Medical Center

location_facility: Vanderbilt University Medical Center: GI Clinical Research

location_facility: University of Kentucky Chandler Medical Center


title: Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

summary: The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

ReferenceCitation: Fraser GAM, Chanan-Khan A, Demirkan F, Santucci Silva R, Grosicki S, Janssens A, Mayer J, Bartlett NL, Dilhuydy MS, Loscertales J, Avigdor A, Rule S, Samoilova O, Pavlovsky MA, Goy A, Mato A, Hallek M, Salman M, Tamegnon M, Sun S, Connor A, Nottage K, Schuier N, Balasubramanian S, Howes A, Cramer P. Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Leuk Lymphoma. 2020 Dec;61(13):3188-3197. doi: 10.1080/10428194.2020.1795159. Epub 2020 Aug 6.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Plymouth - PEARL

repositories_concat: LIRIAS (KU Leuven);PubMed Central;digitalcommons.wustl.edu;pearl.plymouth.ac.uk

repositories_institution:
KU Leuven - Lirias
University of Plymouth - PEARL

publisher_dissemination: Informa

ReferenceCitation: Lavezzi SM, de Jong J, Neyens M, Cramer P, Demirkan F, Fraser G, Bartlett N, Dilhuydy MS, Loscertales J, Avigdor A, Rule S, Samoilova O, Goy A, Ganguly S, Salman M, Howes A, Mahler M, De Nicolao G, Poggesi I. Systemic Exposure of Rituximab Increased by Ibrutinib: Pharmacokinetic Results and Modeling Based on the HELIOS Trial. Pharm Res. 2019 May 1;36(7):93. doi: 10.1007/s11095-019-2605-8.

ReferenceCitation: Brown JR, Moslehi J, O'Brien S, Ghia P, Hillmen P, Cymbalista F, Shanafelt TD, Fraser G, Rule S, Kipps TJ, Coutre S, Dilhuydy MS, Cramer P, Tedeschi A, Jaeger U, Dreyling M, Byrd JC, Howes A, Todd M, Vermeulen J, James DF, Clow F, Styles L, Valentino R, Wildgust M, Mahler M, Burger JA. Characterization of atrial fibrillation adverse events reported in ibrutinib randomized controlled registration trials. Haematologica. 2017 Oct;102(10):1796-1805. doi: 10.3324/haematol.2017.171041. Epub 2017 Jul 27.

repository_institution: University of California - eScholarship University of California

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Chanan-Khan A, Cramer P, Demirkan F, Fraser G, Silva RS, Grosicki S, Pristupa A, Janssens A, Mayer J, Bartlett NL, Dilhuydy MS, Pylypenko H, Loscertales J, Avigdor A, Rule S, Villa D, Samoilova O, Panagiotidis P, Goy A, Mato A, Pavlovsky MA, Karlsson C, Mahler M, Salman M, Sun S, Phelps C, Balasubramanian S, Howes A, Hallek M; HELIOS investigators. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study. Lancet Oncol. 2016 Feb;17(2):200-211. doi: 10.1016/S1470-2045(15)00465-9. Epub 2015 Dec 5.

lead_sponsor: Janssen Research & Development, LLC

sponsor_collaborators:
Janssen Research & Development, LLC
Pharmacyclics LLC.

location_country:
Germany
Poland
Argentina
Brazil
Turkey
Czechia
Canada
France
Colombia
Portugal
United States
Ukraine
Belgium
United Kingdom
Sweden
Mexico
Korea, Republic of
Spain
Greece
Russian Federation
Israel


intervention_type: Biological

lead_sponsor: GlaxoSmithKline

summary: The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.

ReferenceCitation: Curran D, Matthews S, Rowley SD, Young JH, Bastidas A, Anagnostopoulos A, Barista I, Chandrasekar PH, Dickinson M, El Idrissi M, Heras I, Milliken ST, Monserrat Coll J, Navarro Matilla MB, Oostvogels L, Piatkowska-Jakubas B, Quiel D, Sabry W, Schwartz S, Selleslag DLD, Sullivan KM, Theunissen K, Yegin ZA, Yeh SP, Zaja F, Szer J; ZOE-HSCT Study group collaborators. Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT). Biol Blood Marrow Transplant. 2019 Dec;25(12):2474-2481. doi: 10.1016/j.bbmt.2019.07.036. Epub 2019 Aug 5.

repository_institution: University of Trieste https://www.units.it/ - ArTS Archivio della ricerca di Trieste

ReferenceCitation: Bastidas A, de la Serna J, El Idrissi M, Oostvogels L, Quittet P, Lopez-Jimenez J, Vural F, Pohlreich D, Zuckerman T, Issa NC, Gaidano G, Lee JJ, Abhyankar S, Solano C, Perez de Oteyza J, Satlin MJ, Schwartz S, Campins M, Rocci A, Vallejo Llamas C, Lee DG, Tan SM, Johnston AM, Grigg A, Boeckh MJ, Campora L, Lopez-Fauqued M, Heineman TC, Stadtmauer EA, Sullivan KM; ZOE-HSCT Study Group Collaborators. Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):123-133. doi: 10.1001/jama.2019.9053. Erratum In: JAMA. 2019 Aug 27;322(8):785.

title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

primary_purpose: Prevention

location_country:
Finland
Germany
Poland
New Zealand
Australia
Japan
Turkey
Czechia
Canada
France
Hong Kong
United States
Romania
Belgium
Malaysia
Estonia
Italy
United Kingdom
Netherlands
Korea, Republic of
Spain
Greece
Panama
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


type: Registry Identifier

title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate Cardiovascular Outcomes of TAK-875, 50 mg in Addition to Standard of Care in Subjects With Type 2 Diabetes and With Cardiovascular Disease or Multiple Risk Factors for Cardiovascular Events

summary: The purpose of this study is to demonstrate no excess risk of cardiovascular (CV) composite events exists following long term treatment with TAK-875 compared with placebo.

ReferenceCitation: Shavadia JS, Sharma A, Gu X, Neaton J, DeLeve L, Holmes D, Home P, Eckel RH, Watkins PB, Granger CB. Determination of fasiglifam-induced liver toxicity: Insights from the data monitoring committee of the fasiglifam clinical trials program. Clin Trials. 2019 Jun;16(3):253-262. doi: 10.1177/1740774519836766. Epub 2019 Mar 18.

publisher_dissemination: SAGE Publications

ReferenceCitation: Menon V, Lincoff AM, Nicholls SJ, Jasper S, Wolski K, McGuire DK, Mehta CR, Rosenstock J, Lopez C, Marcinak J, Cao C, Nissen SE; GRAND 306 Investigators. Fasiglifam-Induced Liver Injury in Patients With Type 2 Diabetes: Results of a Randomized Controlled Cardiovascular Outcomes Safety Trial. Diabetes Care. 2018 Dec;41(12):2603-2609. doi: 10.2337/dc18-0755.

publisher_dissemination: American Diabetes Association

lead_sponsor: Takeda

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Brazil
Thailand
Croatia
Canada
France
Czech Republic
Lithuania
Slovakia
Hungary
Hong Kong
United States
Latvia
Ukraine
Romania
Malaysia
Peru
Estonia
Philippines
Italy
United Kingdom
Mexico
Korea, Republic of
South Africa
Taiwan
Bulgaria
Russian Federation
Israel


summary: This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

ReferenceCitation: Oza AM, Dubois F, Hegg R, Hernandez CA, Finocchiaro G, Ghiringhelli F, Zamagni C, Nick S, Irahara N, Perretti T, Colombo N. A Long-Term Extension Study of Bevacizumab in Patients With Solid Tumors. Oncologist. 2021 Dec;26(12):e2254-e2264. doi: 10.1002/onco.13971. Epub 2021 Oct 4.

location_facility: Addenbrooke'S Hospital; Dept of Neurosurgery

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

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Wits Donald Gordon Clinical Trial Centre; Medical Oncology

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

location_facility: National Cancer Center; Medical Oncology

location_facility: Fundación Rodolfo Padilla Padilla, A.C.; Oncology

location_facility: North Estonia Medical Centre Foundation; Oncology Center

location_facility: Ospedale Nuovo Della Versilia; Divisione Di Oncologia Medica

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Azienda Ospedaliera San Camillo Forlanini; U.O.C. Pneumologia Ad Indirizzo Oncologico 1

location_facility: Altai Region Oncology Dispensory; Oncology

location_facility: Medical Radiological Scientific Center; Department of Radiotherapy of Gynaecological Disease

location_facility: Russian Research Center of Roentgenoradiology; Dept of Chemotherapy

location_facility: Orszagos Onkologiai Intezet; Nogyogyaszati Osztaly

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Centre Georges François Leclerc; Service Pharmacie, Bp 77980

location_facility: Klinikum Joh.Wolfg.Goethe-UNI Senckenbergisches Institut für Neuroonkologie

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

location_facility: P.A. Gertsen Cancer Research Inst. ; Chemotherapy Dept

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

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

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii

location_facility: Ospedale Antonio Perrino; Oncologia Medica

location_facility: Instituto Nacional de Cancerologia; Oncology

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

location_facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

location_facility: Universitetssjukhuset Örebro, Onkologiska kliniken

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

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

location_facility: Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Bashkirian Republican Clinical Oncology Dispensary

location_facility: Ospedale Misericordia E Dolce; Oncologia Medica

title: A Single Arm, Open Label Multicentre Extension Study of Bevacizumab in Patients With Solid Tumours on Study Treatment With Bevacizumab, at the End of A F. Hoffmann-La Roche and/or Genentech Sponsored Study

location_country:
Germany
Brazil
Turkey
Czechia
Canada
France
Slovakia
Hungary
Romania
Estonia
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Sweden


title: A Multicenter, Double-blind, Randomized Withdrawal Extension Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate Long-term Efficacy, Safety, and Tolerability up to 4 Years in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

summary: This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

ipd_sharing: Undecided

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:
Finland
Germany
Poland
Argentina
Australia
Japan
Canada
France
Lithuania
Colombia
Hungary
United States
Latvia
Iceland
Romania
Belgium
Estonia
Italy
Guatemala
United Kingdom
Singapore
Sweden
Korea, Republic of
Spain
Taiwan
Israel


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Chronic Lymphocytic Leukemia

summary: This Phase 3, randomized, double-blind, placebo-controlled study is to evaluate the effect of idelalisib in combination with rituximab on the onset, magnitude, and duration of tumor control in participants previously treated for chronic lymphocytic leukemia (CLL). Eligible patients will be randomized with a 1:1 ratio into 1 of the 2 treatment arms to receive either idelalisib plus rituximab or placebo plus rituximab. Participants who are tolerating primary study therapy but experience definitive CLL progression are eligible to receive active idelalisib therapy in the extension study, GS-US-312-0117.

ReferenceCitation: Barrientos JC, Hillmen P, Salles G, Sharman J, Stilgenbauer S, Gurtovaya O, Xing G, Ruzicka B, Bhargava P, Ghia P, Pagel JM. No increased bleeding events in patients with relapsed chronic lymphocytic leukemia and indolent non-Hodgkin lymphoma treated with idelalisib. Leuk Lymphoma. 2021 Apr;62(4):837-845. doi: 10.1080/10428194.2020.1845339. Epub 2020 Dec 10.

ReferenceCitation: Gordon MJ, Huang J, Chan RJ, Bhargava P, Danilov AV. Medical comorbidities in patients with chronic lymphocytic leukaemia treated with idelalisib: analysis of two large randomised clinical trials. Br J Haematol. 2021 Feb;192(4):720-728. doi: 10.1111/bjh.16879. Epub 2020 Jun 29.

publisher_dissemination: Wiley

ReferenceCitation: Furman RR, Sharman JP, Coutre SE, Cheson BD, Pagel JM, Hillmen P, Barrientos JC, Zelenetz AD, Kipps TJ, Flinn I, Ghia P, Eradat H, Ervin T, Lamanna N, Coiffier B, Pettitt AR, Ma S, Stilgenbauer S, Cramer P, Aiello M, Johnson DM, Miller LL, Li D, Jahn TM, Dansey RD, Hallek M, O'Brien SM. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med. 2014 Mar 13;370(11):997-1007. doi: 10.1056/NEJMoa1315226. Epub 2014 Jan 22.

repository_institution: California Digital Library - eScholarship

repositories_concat: PubMed Central;escholarship.org

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

lead_sponsor: Gilead Sciences

location_country:
Germany
Italy
United Kingdom
United States
France

location_facility: Hämatologische/Onkologische Gemeinschaftspraxis Dr. Peter Schmidt / Dr. Holger Klaproth

location_facility: Winship Cancer Institute at Emory University

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

location_facility: Ventura County Hematology Oncology Specialists

location_facility: Yakima Valley Memorial Hospital / North Star Lodge

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc

location_facility: Ospedale Oncologico Regionale A. Businco

location_facility: Hematology Oncology Associates of Northern New Jersey

location_facility: University of California, San Diego- Moores Cancer Center

location_facility: Collaborative Medical Research Corporation

location_facility: Centre Hospitalier Régional Universitaire de Lille (CHRU)

location_facility: Rocky Mountain Blood and Marrow Transplant Program

location_facility: Georgetown University Medical Center Lombardi Cancer Center


title: A Phase 1/2, Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of Oral Rociletinib in Patients With Previously Treated Mutant EGFR Non-Small Cell Lung Cancer (NSCLC)

summary: Rociletinib is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral rociletinib; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral rociletinib; to assess the safety and efficacy of rociletinib in previously treated NSCLC patients known to have the T790M EGFR mutation.

ReferenceCitation: Krug AK, Enderle D, Karlovich C, Priewasser T, Bentink S, Spiel A, Brinkmann K, Emenegger J, Grimm DG, Castellanos-Rizaldos E, Goldman JW, Sequist LV, Soria JC, Camidge DR, Gadgeel SM, Wakelee HA, Raponi M, Noerholm M, Skog J. Improved EGFR mutation detection using combined exosomal RNA and circulating tumor DNA in NSCLC patient plasma. Ann Oncol. 2018 Mar 1;29(3):700-706. doi: 10.1093/annonc/mdx765.

ReferenceCitation: Sequist LV, Soria JC, Goldman JW, Wakelee HA, Gadgeel SM, Varga A, Papadimitrakopoulou V, Solomon BJ, Oxnard GR, Dziadziuszko R, Aisner DL, Doebele RC, Galasso C, Garon EB, Heist RS, Logan J, Neal JW, Mendenhall MA, Nichols S, Piotrowska Z, Wozniak AJ, Raponi M, Karlovich CA, Jaw-Tsai S, Isaacson J, Despain D, Matheny SL, Rolfe L, Allen AR, Camidge DR. Rociletinib in EGFR-mutated non-small-cell lung cancer. N Engl J Med. 2015 Apr 30;372(18):1700-9. doi: 10.1056/NEJMoa1413654.

lead_sponsor: Clovis Oncology, Inc.

location_country:
United States
Australia
Poland
France

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: University of Pittsburgh Cancer Institute (UPMC), Div. of Medical Oncology

location_facility: Centre Hospitalier Régional Universitaire de Lille

location_facility: University of Chicago Medical Center, The Duchossois Center for Advanced Medicine

location_facility: Providence CancerCenter Oncology and Hematology Care Clinic-Eastside Portland

location_facility: Centre Hospitalier Intercommunal Créteil

location_facility: University of California Davis Medical Center

location_facility: Ohio State University, Comprehensive Cancer Center

location_facility: The Oncology Institute of Hope and Innovations

location_facility: Sylvester Comprehensive Cancer Center/UMHC

location_facility: University of Southern California, Norris Comprehensive Cancer Center

location_facility: East Valley Hematology and Oncology Medical Group, Inc.

location_facility: University of Texas Southwestern Medical Center


title: A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in Which Peginterferon Lambda-1a (BMS-914143) Was Administered for the Treatment of Chronic Hepatitis C

summary: The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with BMS-914143 and achieved sustained virologic response

study_type: Observational

time_perspective: Prospective

location_country:
Finland
Germany
Poland
New Zealand
Argentina
Australia
Canada
France
United States
Romania
Belgium
Puerto Rico
Italy
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece

location_facility: St. Luke'S Episcopal Hospital - Baylor College Of Medicine

location_facility: Toronto Digestive Disease Associates, Inc.

location_facility: University Of Texas Health Science Center At Houston


title: A Randomized, Double-blind, 12-week, Parallel Group, Placebo-controlled Study of Efficacy and Safety of RO4917523 in Patients With Fragile X Syndrome.

summary: This multi-center, randomized, double-blind, placebo-controlled, parallel-group study will investigate the efficacy and safety of RO4917523 in adolescent and adult patients with fragile X syndrome. Patients will be randomized to receive oral doses of 0.5 mg or 1.5 mg of RO4917523, or matching placebo once daily. The anticipated time on study treatment is 12 weeks.

location_country:
United Kingdom
Argentina
Sweden
Mexico
United States
Spain
Chile
Peru
Canada
France


title: A Randomised, Placebo-controlled, Double-blind, Multicenter Phase II Trial of Intravenous GC33 at 1600 mg Q2W in Previously Treated Patients With Unresectable Advanced or Metastatic Hepatocellular Carcinoma (HCC)

summary: This randomized, placebo-controlled, multicenter study will evaluate the efficacy and safety of GC33 (RO5137382) in previously treated patients with unresectable advanced or metastatic hepatocellular carcinoma. Participants will be stratified according to the level of GPC-3 expression in tumors and randomized to receive either GC33 (1600 mg intravenously) or placebo on Days 1 and 8 of Cycle 1 and every 2 weeks thereafter. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Pradier MF, Reis B, Jukofsky L, Milletti F, Ohtomo T, Perez-Cruz F, Puig O. Case-control Indian buffet process identifies biomarkers of response to Codrituzumab. BMC Cancer. 2019 Mar 28;19(1):278. doi: 10.1186/s12885-019-5472-0.

repository_institution: ETH Zurich - Repository for Publications and Research Data

ReferenceCitation: Abou-Alfa GK, Puig O, Daniele B, Kudo M, Merle P, Park JW, Ross P, Peron JM, Ebert O, Chan S, Poon TP, Colombo M, Okusaka T, Ryoo BY, Minguez B, Tanaka T, Ohtomo T, Ukrainskyj S, Boisserie F, Rutman O, Chen YC, Xu C, Shochat E, Jukofsky L, Reis B, Chen G, Di Laurenzio L, Lee R, Yen CJ. Randomized phase II placebo controlled study of codrituzumab in previously treated patients with advanced hepatocellular carcinoma. J Hepatol. 2016 Aug;65(2):289-95. doi: 10.1016/j.jhep.2016.04.004. Epub 2016 Apr 13.

location_country:
Germany
Italy
New Zealand
United Kingdom
Hong Kong
Singapore
Japan
Belgium
United States
Korea, Republic of
Spain
Taiwan
France

location_facility: Auckland Hospital; New Zealand Liver Transplant Unit

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I

location_facility: National Cancer Institute; Ctr for Cancer Research

location_facility: Azienda Ospedaliera G. Rummo; Unità Operativa di Oncologia Medica 1

location_facility: Klinikum rechts der Isar der TU München; Klinikapotheke

location_facility: National Cancer Centre; Medical Oncology

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: Hôpital Saint Antoine; Service Hépathologie

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Hospital Clínic i Provincial; Servicio de Hematología y Oncología

location_facility: Uni Heidelberg Med. Klinik; Innere Medizin IV

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Charité Uni.-medizin Berlin, Campus Virchow-Klinikum; Med. Klinik m.S. Hepatologie Gastroenterologie

location_facility: Hôpital d'Adultes; Service hépato-gastro-entérologie

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Washington Univ School of Med; Barnes-Jewish Hospital; Siteman Cancer Center

location_facility: Hopital de L'Archet; Pole de Reference Hepatite C

location_facility: Hopital Purpan;Gastro Enterologie Hepatologie

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital Universitari Vall d'Hebron; Servicio de Hepatologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: National Taiwan Uni Hospital; Dept of Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Hematologia

location_facility: The Clatterbridge Cancer Ctr NHS Foundation Trust

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

location_facility: Chang Gung Memorial Foundation - Kaohsiung


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury

summary: The purpose of this research study is to gather scientific information about the effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive substance) in participants with acute spinal cord injury.

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:
Poland
United Kingdom
United States
Spain
Czechia
Canada
France


lead_sponsor: Genentech, Inc.

summary: This multicenter, international, Phase Ib/II trial consists of three stages: a Phase Ib, open-label stage in which the recommended Phase II dose was determined for ipataseritib administrated in combination with abiraterone and of apitolisib administrated in combination with abiraterone (this phase is no longer active), a Phase II, 3-arm, double-blind, randomized comparison of ipatasertib with abiraterone and prednisone/prednisolone versus placebo with abiraterone and prednisone/prednisolone and a safety single-arm, open-label cohort of ipatasertib 400 mg daily alone or in combination with prednisone/prednisolone or prednisone/prednisolone plus abiraterone.

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Ospedale S. Donato; Divisione Di Reumatologia

location_facility: Sarah Cannon Cancer Center - Tennessee Oncology, Pllc

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

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: GH Paris Saint Joseph; Hopital De Jour Oncologie

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Johns Hopkins Univ; Bunting Blaustein Cancer Center

location_facility: Fakultni nemocnice Hradec Kralove; I. interni klinika,Oddeleni invazivni kardiologie

location_facility: Queen Elizabeth Hospital; Centre for Clinical Haematology

location_facility: Hospital Clinico Universitario Virgen de la Victoria

location_facility: Prof. Dr. Th. Burghele Clin Urology Hosp

location_facility: Vu Medisch Centrum; Afdeling Longziekten

location_facility: HonorHealth Research Institute ? Bisgrove

location_facility: Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: New York Cancer and Blood Specialists - Setauket Medical Oncology

location_facility: Metropolitan Hospital; 2Nd Oncology Clinic

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: University Hospital of Larissa; Oncology

location_facility: Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Azienda Ospedaliera Istituti Ospitalieri

location_facility: Prof. Dr. I. Chiricuta Institute of Oncology

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

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: St. James University Hospital; Pharmacy Department

location_facility: Urology Cancer Center & GU Research Network

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

location_facility: Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

location_facility: University Hospital of Patras Medical Oncology

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

location_facility: Fakultni Thomayerova Nemocnice; Revmatologicke Oddeleni

location_facility: Sint Franciscus Gasthuis; Inwendige Geneeskunde

title: A Phase Ib/II Study of Ipatasertib (GDC-0068) or Apitolisib (GDC-0980) With Abiraterone Acetate Versus Abiraterone Acetate in Patients With Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

location_country:
Italy
United Kingdom
Romania
Netherlands
United States
Spain
Greece
Czechia
France


title: A Phase IIa, Randomised, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of Tralokinumab (CAT-354), a Recombinant Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), as add-on Therapy, on Clinical Response in Patients With Active, Moderate-to-severe, Ulcerative Colitis

summary: The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection. All patients will continue background therapy for ulcerative colitis as per local standards of care in addition to investigational product.

ReferenceType: result

ReferenceCitation: Danese S, Rudzinski J, Brandt W, Dupas JL, Peyrin-Biroulet L, Bouhnik Y, Kleczkowski D, Uebel P, Lukas M, Knutsson M, Erlandsson F, Hansen MB, Keshav S. Tralokinumab for moderate-to-severe UC: a randomised, double-blind, placebo-controlled, phase IIa study. Gut. 2015 Feb;64(2):243-9. doi: 10.1136/gutjnl-2014-308004. Epub 2014 Oct 10.

lead_sponsor: AstraZeneca

sponsor_collaborators:
AstraZeneca
MedImmune Ltd

location_country:
Germany
Italy
Poland
United Kingdom
Czech Republic
France


title: A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma

summary: The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)].

ReferenceCitation: Jakubowiak A, Offidani M, Pegourie B, De La Rubia J, Garderet L, Laribi K, Bosi A, Marasca R, Laubach J, Mohrbacher A, Carella AM, Singhal AK, Tsao LC, Lynch M, Bleickardt E, Jou YM, Robbins M, Palumbo A. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016 Jun 9;127(23):2833-40. doi: 10.1182/blood-2016-01-694604. Epub 2016 Apr 18.

repositories_concat: PubMed Central;iris.unimore.it

publisher_dissemination: American Society of Hematology

sponsor_collaborators:
Bristol-Myers Squibb
AbbVie

location_country:
Italy
United States
Spain
Canada
France

location_facility: University Of Kentucky Markey Cancer Center

location_facility: Kaiser Permanente-Moanalua Medical Center

location_facility: Pikeville Medical Center Leonard Lawson Cancer Center

location_facility: Investigative Clinical Research Of Indiana, Llc

location_facility: Southern Nevada Cancer Research Foundation

location_facility: Washington University School Of Medicine


title: A Phase 2 Open-label Study of MEDI-551 and Bendamustine vs Rituximab and Bendamustine in Adults With Relapsed or Refractory CLL

summary: The overall purpose of the study was to determine if MEDI-551, when used in combination with salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to rituximab in the same population.

lead_sponsor: MedImmune LLC

location_country:
Germany
Italy
Poland
Israel
Belgium
United States
Canada
France


title: Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-dose Combinations Compared With Individual Components and Placebo When Administered to Patients With Stable Chronic Obstructive Pulmonary Disease.

summary: The objective is to provide data supporting the use of LAS40464 as an efficacious and safe maintenance bronchodilator treatment of patients with Chronic Obstructive Pulmonary Disease (COPD).

ReferenceCitation: Singh D, D'Urzo AD, Donohue JF, Kerwin EM, Molins E, Chuecos F, Ribera A, Jarreta D. An Evaluation Of Single And Dual Long-Acting Bronchodilator Therapy As Effective Interventions In Maintenance Therapy-Naive Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2019 Dec 6;14:2835-2848. doi: 10.2147/COPD.S217710. eCollection 2019.

ReferenceCitation: Singh D, D'Urzo AD, Chuecos F, Munoz A, Garcia Gil E. Reduction in clinically important deterioration in chronic obstructive pulmonary disease with aclidinium/formoterol. Respir Res. 2017 May 30;18(1):106. doi: 10.1186/s12931-017-0583-0.

repository_institution: University of Toronto - TSpace

repository_normalized: localhost

repositories:
PubMed Central
localhost

repositories_concat: PubMed Central;localhost

repositories_institution:
PubMed Central - Europe PMC
University of Toronto - TSpace

ReferenceCitation: Bateman ED, Chapman KR, Singh D, D'Urzo AD, Molins E, Leselbaum A, Gil EG. Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT). Respir Res. 2015 Aug 2;16(1):92. doi: 10.1186/s12931-015-0250-2.

repository_institution: University of Cape Town - Open University of Cape Town

ReferenceCitation: Singh D, Jones PW, Bateman ED, Korn S, Serra C, Molins E, Caracta C, Gil EG, Leselbaum A. Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm Med. 2014 Nov 18;14:178. doi: 10.1186/1471-2466-14-178.

location_country:
Finland
Germany
Poland
Croatia
France
Czech Republic
Slovakia
Hungary
Denmark
Ukraine
Romania
Belgium
Italy
United Kingdom
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Bulgaria
Russian Federation
Sweden

location_facility:
Almirall Investigational Site #32
Almirall Investigational Site #2
Almirall Investigational Site #7
Almirall Investigational Site #36
Almirall Investigational Site #12
Almirall Investigational Site #9
Almirall Investigational Site #25
Almirall Investigational Site #27
Almirall Investigational Site #16
Almirall Investigational Site #21
Almirall Investigational Site #6
Almirall Investigational Site #20
Almirall Investigational Site #1
Almirall Investigational Site #23
Almirall Investigational Site #33
Almirall Investigational Site #35
Almirall Investigational Site #8
Almirall Investigational Site #10
Almirall Investigational Site #3
Almirall Investigational Site #28
Almirall Investigational Site #24
Almirall Investigational Site #22
Almirall Investigational Site #19
Almirall Investigational Site #15
Almirall Investigational Site #13
Almirall Investigational Site #5
Almirall Investigational Site #4
Almirall Investigational Site #11
Almirall Investigational Site #14
Almirall Investigational Site #18
Almirall Investigational Site #17
Almirall Investigational Site #34
Almirall Investigational Site #26


title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study of SAR302503 in Patients With Intermediate-2 or High-Risk Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Splenomegaly

acronym: JAKARTA

summary:
Primary Objective:

To evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 (Investigational Medicinal Product, IMP) compared to placebo in the reduction of spleen volume as determined by magnetic resonance imaging (MRI) (or computed tomography scan in patients with contraindications for MRI).

Secondary Objectives:

To evaluate the effect on Myelofibrosis (MF)-associated symptoms (key MF symptoms) as measured by the modified Myelofibrosis Symptom Assessment Form (MFSAF) diary.
To evaluate the Overall Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
To evaluate the Progression Free Survival of patients treated with either 400 mg/day or 500 mg/day of IMP as compared to placebo.
To evaluate the durability of splenic response.
To evaluate the safety of IMP.

ReferenceCitation: Pardanani A, Harrison C, Cortes JE, Cervantes F, Mesa RA, Milligan D, Masszi T, Mishchenko E, Jourdan E, Vannucchi AM, Drummond MW, Jurgutis M, Kuliczkowski K, Gheorghita E, Passamonti F, Neumann F, Patki A, Gao G, Tefferi A. Safety and Efficacy of Fedratinib in Patients With Primary or Secondary Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2015 Aug;1(5):643-51. doi: 10.1001/jamaoncol.2015.1590.

lead_sponsor: Sanofi

location_country:
Germany
Ireland
Poland
Australia
Brazil
Canada
France
Lithuania
Portugal
Hungary
United States
Romania
Belgium
Italy
United Kingdom
Singapore
Sweden
Austria
Mexico
Korea, Republic of
Spain
South Africa
Taiwan
Russian Federation
Israel

location_facility:
Investigational Site Number 410004
Investigational Site Number 840012
Investigational Site Number 410006
Investigational Site Number 643007
Investigational Site Number 036005
Investigational Site Number 036002
Investigational Site Number 276006
Investigational Site Number 380003
Investigational Site Number 158002
Investigational Site Number 642003
Investigational Site Number 724001
Investigational Site Number 642006
Investigational Site Number 440001
Investigational Site Number 158001
Investigational Site Number 702002
Investigational Site Number 056003
Investigational Site Number 616003
Investigational Site Number 380007
Investigational Site Number 348001
Investigational Site Number 840013
Investigational Site Number 250007
Investigational Site Number 250002
Investigational Site Number 348003
Investigational Site Number 643010
Investigational Site Number 840002
Investigational Site Number 840001
Investigational Site Number 840014
Investigational Site Number 710002
Investigational Site Number 826004
Investigational Site Number 484001
Investigational Site Number 040001
Investigational Site Number 036003
Investigational Site Number 124002
Investigational Site Number 410002
Investigational Site Number 616006
Investigational Site Number 276008
Investigational Site Number 410003
Investigational Site Number 410005
Investigational Site Number 124003
Investigational Site Number 348007
Investigational Site Number 826007
Investigational Site Number 616002
Investigational Site Number 380006
Investigational Site Number 642002
Investigational Site Number 620003
Investigational Site Number 642001
Investigational Site Number 620001
Investigational Site Number 250004
Investigational Site Number 840009
Investigational Site Number 616010
Investigational Site Number 643008
Investigational Site Number 348006
Investigational Site Number 076004
Investigational Site Number 620004
Investigational Site Number 710003
Investigational Site Number 620005
Investigational Site Number 250005
Investigational Site Number 036004
Investigational Site Number 826009
Investigational Site Number 642004
Investigational Site Number 376002
Investigational Site Number 840006
Investigational Site Number 276007
Investigational Site Number 376003
Investigational Site Number 616005
Investigational Site Number 276001
Investigational Site Number 752002
Investigational Site Number 036001
Investigational Site Number 840008
Investigational Site Number 250003
Investigational Site Number 840004
Investigational Site Number 826005
Investigational Site Number 826001
Investigational Site Number 826008
Investigational Site Number 643005
Investigational Site Number 372002
Investigational Site Number 724002
Investigational Site Number 250006
Investigational Site Number 702001
Investigational Site Number 643009
Investigational Site Number 250001
Investigational Site Number 124001
Investigational Site Number 348002
Investigational Site Number 380001
Investigational Site Number 410007
Investigational Site Number 372001
Investigational Site Number 380004
Investigational Site Number 826006
Investigational Site Number 076002
Investigational Site Number 440002
Investigational Site Number 826003
Investigational Site Number 826002
Investigational Site Number 643001
Investigational Site Number 643004
Investigational Site Number 826010
Investigational Site Number 380002
Investigational Site Number 158003
Investigational Site Number 076001
Investigational Site Number 752001
Investigational Site Number 056001
Investigational Site Number 410001