title: A Phase III Randomised, Double-blind Trial to Evaluate Efficacy and Safety of Once Daily Empagliflozin 10 mg Compared to Placebo, in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Ferreira JP, Zannad F, Butler J, Filippatos G, Pocock SJ, Brueckmann M, Steubl D, Schueler E, Anker SD, Packer M. Association of Empagliflozin Treatment With Albuminuria Levels in Patients With Heart Failure: A Secondary Analysis of EMPEROR-Pooled. JAMA Cardiol. 2022 Nov 1;7(11):1148-1159. doi: 10.1001/jamacardio.2022.2924. Erratum in: JAMA Cardiol. 2022 Nov 1;7(11):1177.

ReferenceCitation: Ferreira JP, Zannad F, Butler J, Filipattos G, Ritter I, Schüler E, Kraus BJ, Pocock SJ, Anker SD, Packer M. Empagliflozin and serum potassium in heart failure: an analysis from EMPEROR-Pooled. Eur Heart J. 2022 Aug 14;43(31):2984-2993. doi: 10.1093/eurheartj/ehac306. Erratum in: Eur Heart J. 2022 Jul 22;:.

ReferenceCitation: Ferreira JP, Butler J, Zannad F, Filippatos G, Schueler E, Steubl D, Zeller C, Januzzi JL, Pocock S, Packer M, Anker SD. Mineralocorticoid Receptor Antagonists and Empagliflozin in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Mar 29;79(12):1129-1137. doi: 10.1016/j.jacc.2022.01.029.

ReferenceCitation: Ferreira JP, Anker SD, Butler J, Filippatos G, Iwata T, Salsali A, Zeller C, Pocock SJ, Zannad F, Packer M. Impact of anaemia and the effect of empagliflozin in heart failure with reduced ejection fraction: findings from EMPEROR-Reduced. Eur J Heart Fail. 2022 Apr;24(4):708-715. doi: 10.1002/ejhf.2409. Epub 2022 Jan 9.

ReferenceCitation: Verma S, Dhingra NK, Butler J, Anker SD, Ferreira JP, Filippatos G, Januzzi JL, Lam CSP, Sattar N, Peil B, Nordaby M, Brueckmann M, Pocock SJ, Zannad F, Packer M; EMPEROR-Reduced trial committees and investigators. Empagliflozin in the treatment of heart failure with reduced ejection fraction in addition to background therapies and therapeutic combinations (EMPEROR-Reduced): a post-hoc analysis of a randomised, double-blind trial. Lancet Diabetes Endocrinol. 2022 Jan;10(1):35-45. doi: 10.1016/S2213-8587(21)00292-8. Epub 2021 Nov 30.

ReferenceCitation: Rydén L, Ferrannini G. Is the impact of add on heart failure therapy influenced by background therapy? Lancet Diabetes Endocrinol. 2022 Jan;10(1):3-5. doi: 10.1016/S2213-8587(21)00311-9. Epub 2021 Nov 30.

ReferenceCitation: Böhm M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Mahfoud F, Brueckmann M, Jamal W, Ofstad AP, Schüler E, Ponikowski P, Wanner C, Zannad F, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin Improves Cardiovascular and Renal Outcomes in Heart Failure Irrespective of Systolic Blood Pressure. J Am Coll Cardiol. 2021 Sep 28;78(13):1337-1348. doi: 10.1016/j.jacc.2021.07.049.

ReferenceCitation: Januzzi JL Jr, Zannad F, Anker SD, Butler J, Filippatos G, Pocock SJ, Ferreira JP, Sattar N, Verma S, Vedin O, Schnee J, Iwata T, Cotton D, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Prognostic Importance of NT-proBNP and Effect of Empagliflozin in the EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Sep 28;78(13):1321-1332. doi: 10.1016/j.jacc.2021.07.046.

ReferenceCitation: Packer M, Butler J, Zannad F, Filippatos G, Ferreira JP, Pocock SJ, Carson P, Anand I, Doehner W, Haass M, Komajda M, Miller A, Pehrson S, Teerlink JR, Schnaidt S, Zeller C, Schnee JM, Anker SD. Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction: EMPEROR-Preserved Trial. Circulation. 2021 Oct 19;144(16):1284-1294. doi: 10.1161/CIRCULATIONAHA.121.056824. Epub 2021 Aug 29.

ReferenceCitation: Pocock SJ, Ferreira JP, Gregson J, Anker SD, Butler J, Filippatos G, Gollop ND, Iwata T, Brueckmann M, Januzzi JL, Voors AA, Zannad F, Packer M. Novel biomarker-driven prognostic models to predict morbidity and mortality in chronic heart failure: the EMPEROR-Reduced trial. Eur Heart J. 2021 Nov 14;42(43):4455-4464. doi: 10.1093/eurheartj/ehab579.

ReferenceCitation: Lam CSP, Ferreira JP, Pfarr E, Sim D, Tsutsui H, Anker SD, Butler J, Filippatos G, Pocock SJ, Sattar N, Verma S, Brueckmann M, Schnee J, Cotton D, Zannad F, Packer M. Regional and ethnic influences on the response to empagliflozin in patients with heart failure and a reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021 Nov 14;42(43):4442-4451. doi: 10.1093/eurheartj/ehab360.

ReferenceCitation: Ferreira JP, Zannad F, Pocock SJ, Anker SD, Butler J, Filippatos G, Brueckmann M, Jamal W, Steubl D, Schueler E, Packer M. Interplay of Mineralocorticoid Receptor Antagonists and Empagliflozin in Heart Failure: EMPEROR-Reduced. J Am Coll Cardiol. 2021 Mar 23;77(11):1397-1407. doi: 10.1016/j.jacc.2021.01.044.

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Sattar N, Brueckmann M, Jamal W, Cotton D, Iwata T, Zannad F; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin in Patients With Heart Failure, Reduced Ejection Fraction, and Volume Overload: EMPEROR-Reduced Trial. J Am Coll Cardiol. 2021 Mar 23;77(11):1381-1392. doi: 10.1016/j.jacc.2021.01.033.

ReferenceCitation: Butler J, Anker SD, Filippatos G, Khan MS, Ferreira JP, Pocock SJ, Giannetti N, Januzzi JL, Piña IL, Lam CSP, Ponikowski P, Sattar N, Verma S, Brueckmann M, Jamal W, Vedin O, Peil B, Zeller C, Zannad F, Packer M; EMPEROR-Reduced Trial Committees and Investigators. Empagliflozin and health-related quality of life outcomes in patients with heart failure with reduced ejection fraction: the EMPEROR-Reduced trial. Eur Heart J. 2021 Mar 31;42(13):1203-1212. doi: 10.1093/eurheartj/ehaa1007.

ReferenceCitation: Anker SD, Butler J, Filippatos G, Khan MS, Marx N, Lam CSP, Schnaidt S, Ofstad AP, Brueckmann M, Jamal W, Bocchi EA, Ponikowski P, Perrone SV, Januzzi JL, Verma S, Böhm M, Ferreira JP, Pocock SJ, Zannad F, Packer M. Effect of Empagliflozin on Cardiovascular and Renal Outcomes in Patients With Heart Failure by Baseline Diabetes Status: Results From the EMPEROR-Reduced Trial. Circulation. 2021 Jan 26;143(4):337-349. doi: 10.1161/CIRCULATIONAHA.120.051824. Epub 2020 Nov 11.

ReferenceCitation: Zannad F, Ferreira JP, Pocock SJ, Zeller C, Anker SD, Butler J, Filippatos G, Hauske SJ, Brueckmann M, Pfarr E, Schnee J, Wanner C, Packer M. Cardiac and Kidney Benefits of Empagliflozin in Heart Failure Across the Spectrum of Kidney Function: Insights From EMPEROR-Reduced. Circulation. 2021 Jan 26;143(4):310-321. doi: 10.1161/CIRCULATIONAHA.120.051685. Epub 2020 Oct 23. Erratum in: Circulation. 2021 Jan 26;143(4):e29.

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Ferreira JP, Pocock SJ, Carson P, Anand I, Doehner W, Haass M, Komajda M, Miller A, Pehrson S, Teerlink JR, Brueckmann M, Jamal W, Zeller C, Schnaidt S, Zannad F. Effect of Empagliflozin on the Clinical Stability of Patients With Heart Failure and a Reduced Ejection Fraction: The EMPEROR-Reduced Trial. Circulation. 2021 Jan 26;143(4):326-336. doi: 10.1161/CIRCULATIONAHA.120.051783. Epub 2020 Oct 21. Erratum in: Circulation. 2021 Jan 26;143(4):e30.

ReferenceCitation: Packer M, Anker SD, Butler J, Filippatos G, Pocock SJ, Carson P, Januzzi J, Verma S, Tsutsui H, Brueckmann M, Jamal W, Kimura K, Schnee J, Zeller C, Cotton D, Bocchi E, Böhm M, Choi DJ, Chopra V, Chuquiure E, Giannetti N, Janssens S, Zhang J, Gonzalez Juanatey JR, Kaul S, Brunner-La Rocca HP, Merkely B, Nicholls SJ, Perrone S, Pina I, Ponikowski P, Sattar N, Senni M, Seronde MF, Spinar J, Squire I, Taddei S, Wanner C, Zannad F; EMPEROR-Reduced Trial Investigators. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure. N Engl J Med. 2020 Oct 8;383(15):1413-1424. doi: 10.1056/NEJMoa2022190. Epub 2020 Aug 28.

ReferenceCitation: Nassif ME, Kosiborod M. Effects of sodium glucose cotransporter type 2 inhibitors on heart failure. Diabetes Obes Metab. 2019 Apr;21 Suppl 2:19-23. doi: 10.1111/dom.13678. Review.

location_country:
Poland
Brazil
Spain
Italy
United Kingdom
Australia
Mexico
Argentina
Canada
Netherlands
Hungary
Korea, Republic of
United States
France
China
India
Belgium
Japan
Germany
Czechia

location_facility: Lausmed Kft. Outpatient Unit of Internal Medicine

location_facility: Fejer County Saint George University Teaching Hospital

location_facility: Leszek Bryniarski Specialized Medical Cabinet

location_facility: Centre de sante et de services sociaux de Beauce

location_facility: Novant Health Heart and Vascular Institute

location_facility: National Hospital Organization Kanazawa Medical Center

location_facility: Nanchang University Affiliated 3rd Hospital

location_facility: General Hospital of Shenyang Military Region

location_facility: Instituto Nacional de Cardiologia Ignacio Chavez

location_facility: Consultorios Asociados de Endocrinología e Invest Clínica

location_facility: National Hospital Organization Kobe Medical Center

location_facility: H.C.da Fac. de Medicina de Ribeirao Preto

location_facility: Centro de Investigacion Cardiovascular y Metabolica

location_facility: Centro de Investigaciones Clínicas del Litoral

location_facility: SANTA FAMILIA Centrum Badan, Profilaktyki i Leczenia

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Märkische Gesundheitsholding GmbH & Co. KG, Klinikum Lüdenscheid

location_facility: CAEP - Centro Avançado de Estudos e Pesquisas Ltda.,Campinas

location_facility: University of North Texas Health Science Center

location_facility: St. Antonius ziekenhuis, locatie Nieuwegein

location_facility: ASST Papa Giovanni XXIII - A.O. Papa Giovanni XXIII

location_facility: Seoul National University Bundang Hospital

location_facility: CDEC BRASIL - Centro de Desenvolvimento em Estudos Clínicos Brasil

location_facility: Ziekenhuis Oost-Limburg - Campus Sint-Jan

location_facility: CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc

location_facility: Hospital Interzonal General de Agudos Dr Jose Penna

location_facility: Affiliated Hospital of Jiangsu University

location_facility: Centro Especializado em Cardiol Loema Instituto de Pesq Clin

location_facility: University of Texas Southwestern Medical Center

location_facility: Curnew Medicine Professional Corporation

location_facility: Hyogo Prefectural Amagasaki General Medical Center

location_facility: Instituto de Cardiologia Rio Grande do Sul

location_facility: Gottsegen Gyorgy Hungarian Instit.of Cardiology,Budapest

location_facility: Poradnia Kardiologiczna Jaroslaw Jurowiecki

location_facility: Japan Community Health Care Organization Kyushu Hospital

location_facility: National Hospital Organization Sendai Medical Center

location_facility: CEPIC - Centro Paulista de Investigacao Clinica

location_facility: First Affiliated Hospital of Xi'an JiaoTong University

location_facility: Instituto Cardiovascular de Monclova, S de RL de CV

location_facility: Katholisches Klinikum St. Hildegardiskrankenhaus, Mainz

location_facility: Specialist Hospital J. Dietla NZOZ Specialized Clinic "Gemini"

location_facility: Clinmedica Research Omc sp. z o.o. sp.k., Skierniewice

location_facility: St. Francis Medical Group-Indiana Heart Physicians, Inc

location_facility: Irmandade da Santa Casa de Misericórdia de Curitiba

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Guangzhou First Municipal People's Hospital

location_facility: Centro de Investigacion Medica Alberto Bazzoni S.A. de C.V.

location_facility: Jacksonville Center for Clinical Research

location_facility: Complejo Hospitalario Universitario de Orense

location_facility: Asklepios Klinik Langen-Seligenstadt GmbH

location_facility: Onze Lieve Vrouwe Gasthuis, Locatie West

location_facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

location_facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel

location_facility: Saint Wincenty a Paulo Hosp., Cardiology Dept., Gdynia

location_facility: Centro de Investigaciones Clinicas Instituto del Corazon

location_facility: Ospedale della Val di Chiana Santa Margherita

location_facility: Azienda Ospedaliera Universitaria "Federico II"

location_facility: Mohan Babapulle Medicine Professional Medicine

location_facility: Unidad de Investigacion Clinica Cardiometabolica de Occident

location_facility: Hospital Italiano Regional del Sur, Bahia Blanca

location_facility: William Jennings Bryan Dorn VA Medical Center

location_facility: Cardiac Care and Vascular Medicine, PLLC

location_facility: Hospital Universitario Dr Jose Eleuterio Gonzalez

location_facility: The University of North Carolina at Chapel Hill

location_facility: CEMEDIC - Centro de Especialidades Medicas

location_facility: VA Greater Los Angeles Healthcare System

location_facility: The Provincial Polyclinical Hospital in Torun

location_facility: Internal and Cardiology Practice, MUDr. Karel Kamenik, Brno

location_facility: Nemocnice ve Frydku-Mistku, prispevkova organizace

location_facility: National Hospital Organization Hakodate Hospital

location_facility: Centro de Investigación Clinica Acelerada, S.C.

location_facility: Corporacion Medica de Gral. San Martin S.A.

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Montreal General Hospital - McGill University Health Centre

location_facility: Central Hospital of Medical Academy, Warsaw

location_facility: Instituto de Investigaciones Clinicas de Rosario

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: First Hospital Affiliated with Nanjing Medical University

location_facility: Belgyogyaszati es Kardiologiai Maganrendelo

location_facility: ICDF - Instituto de Cardiologia do Distrito Federal

location_facility: Fundacao Faculdade Regional de Medicina, Sao Jose

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Specialistic Cardiology&Hypertension Out-patient Clin,Kielce

location_facility: North York Diagnostic and Cardiac Centre

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: IPECC - Instituto de Pesquisa Clínica de Campinas

location_facility: Hospital de Messejana Dr. Carlos Alberto Studart Gomes

location_facility: Diseño y Planeación en Investigación Médica SC

location_facility: INCOR e Hospital das Clínicas da Universidade de São Paulo

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Johns Hopkins University Hospital School of Medicine

location_facility: The Second Affiliated Hospital of Lanzhou Medical University

location_facility: Hospital Universitário Pedro Ernesto UERJ

location_facility: Cardiovascular Institute and Fu Wai Hospital

location_facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

location_facility: Santa Casa de Misericórdia de Porto Alegre

location_facility: Cardresearch Cardiologia Assistencial e de Pesquisas Ltda

location_facility: Cardiovascular Research Center of South Florida

location_facility: Batra Hospital and Medical Research Centre

location_facility: Doctor Jivraj Mehta Smarak Health Foundation

location_facility: Azienda Ospedaliera Universitaria Pisana

location_facility: Tianjin Union Medical Center Nankai University Affiliated Hospital

location_facility: Midwest Cardiovascular Research and Education Foundation

location_facility: IPCEM - Instituto de Pesquisa Clínica para Estudos Multicêntricos - Universidade de Caxias do Sul

location_facility: Instituto Medico Fundación Grupo Colaborativo Rosario

location_facility: Umberto I Pol. di Roma-Università di Roma La Sapienza

location_facility: Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza

location_facility: 4. Military Clinical Hospital with Polyclinic SP ZOZ

location_facility: Indywidualna Specjalistyczna Praktyka Lekarska

location_facility: 2nd Xiangya Hospital of Central South University

location_facility: MUDr. Jan Hubac, s.r.o. Kardiologicka ambulance

location_facility: FGM - Clínica Paulista de Doenças Cardiovasculares

location_facility: Shengjing Hospital of China Medical University

location_facility: Dr. Nagy Laszlo Kardiologiai Maganrendeles

location_facility: Captain James A. Lovell Federal Health Care Center

location_facility: National Hospital Organization Tokyo Medical Center

location_facility: The First Afiliated Hospital, Sun Yet-sen University

location_facility: Fukuokaken Saiseikai Futsukaichi Hospital

location_facility: Krakow Specialistic Hospital of John Paul II

location_facility: The First Affiliated Hospital of Lanzhou University

location_facility: Instituto de Investigaciones Clínicas de Quilmes

location_facility: Centre de Dépistage et Recherche Cardiovasculaire Rive-Sud

location_facility: Centro de Investigacion Biomedica y Farmaceutica, S.C.

location_facility: The Affiliated Hospital of Southwest Medical University

summary: The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction.


type: EudraCT Number

title: BYLieve: A Phase II, Multicenter, Open-label, Three-cohort, Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant, Hormone Receptor (HR) Positive, HER2-negative Advanced Breast Cancer (aBC), Who Have Progressed on or After Prior Treatments

acronym: BYLieve

summary: Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole, based on prior endocrine therapy, in patients with PIK3CA mutation with advanced breast cancer who have progressed on or after prior treatments

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Rugo HS, Lerebours F, Ciruelos E, Drullinsky P, Ruiz-Borrego M, Neven P, Park YH, Prat A, Bachelot T, Juric D, Turner N, Sophos N, Zarate JP, Arce C, Shen YM, Turner S, Kanakamedala H, Hsu WC, Chia S. Alpelisib plus fulvestrant in PIK3CA-mutated, hormone receptor-positive advanced breast cancer after a CDK4/6 inhibitor (BYLieve): one cohort of a phase 2, multicentre, open-label, non-comparative study. Lancet Oncol. 2021 Apr;22(4):489-498. doi: 10.1016/S1470-2045(21)00034-6. Erratum In: Lancet Oncol. 2021 May;22(5):e184.

ipd_sharing: Yes

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:
Denmark
Taiwan
Spain
Italy
United Kingdom
Mexico
Netherlands
Argentina
Canada
Korea, Republic of
United States
Chile
France
India
Belgium
Israel
Germany
Singapore
Japan

location_facility: Texas Oncology Charles A. Sammons Cancer Ctr

location_facility: Kaiser Permanente Medical Group Kaiser Permanente-Moanalua M.C

location_facility: Greater Baltimore Medical Center Cancer Center

location_facility: Massachusetts General Hospital Neuroendocrine Unit

location_facility: University Hospitals of Cleveland Seidman Cancer Center

location_facility: University of Calif Irvine Medical Center

location_facility: University of Louisville Hospital/James Brown Cancer Ctr. SC

location_facility: Cancer Care Centers of South Texas HOAST CCC of So. TX- San Antonio(2)

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia

summary: This study is designed to evaluate the efficacy of acalabrutinib compared with rituximab in combination with idelalisib or bendamustine in previously treated subjects with chronic lymphocytic leukemia (CLL).

design_allocation: Randomized

ReferenceCitation: Eek D, Ivanescu C, Corredoira L, Meyers O, Cella D. Content validity and psychometric evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue scale in patients with chronic lymphocytic leukemia. J Patient Rep Outcomes. 2021 Mar 11;5(1):27. doi: 10.1186/s41687-021-00294-1.

ReferenceCitation: Ghia P, Pluta A, Wach M, Lysak D, Kozak T, Simkovic M, Kaplan P, Kraychok I, Illes A, de la Serna J, Dolan S, Campbell P, Musuraca G, Jacob A, Avery E, Lee JH, Liang W, Patel P, Quah C, Jurczak W. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia. J Clin Oncol. 2020 Sep 1;38(25):2849-2861. doi: 10.1200/JCO.19.03355. Epub 2020 May 27.

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

lead_sponsor: Acerta Pharma BV

location_country:
Croatia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Israel
Singapore
Sweden
Slovakia
Canada
Hungary
Germany
Bulgaria
Taiwan
New Zealand
Korea, Republic of
France


title: A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

summary: The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

status: Recruiting

enrollment_type: Anticipated

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

lead_sponsor: Astellas Pharma Global Development, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Sweden
Slovakia
Canada
Germany
Moldova, Republic of
Denmark
Taiwan
Georgia
New Zealand
Finland
Korea, Republic of
France
Chile

location_facility:
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Site US10034
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Site US10001


title: A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Ramipril on Morbidity and Mortality in High Risk Patients Following an AMI

acronym: PARADISE-MI

summary: The purpose of this study is to evaluate the efficacy and safety of LCZ696 titrated to a target dose of 200 mg twice daily, compared to ramipril titrated to a target dose of 5 mg twice daily, in addition to conventional post-AMI treatment, in reducing the occurrence of composite endpoint of CV death, HF hospitalization and outpatient HF (time-to-first event analysis) in post-AMI patients with evidence of LV systolic dysfunction and/or pulmonary congestion, with no known prior history of chronic HF..

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Mehran R, Steg PG, Pfeffer MA, Jering K, Claggett B, Lewis EF, Granger C, Køber L, Maggioni A, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Ducrocq G, Berwanger O, De Pasquale CG, Landmesser U, Petrie M, Leng DSK, van der Meer P, Lefkowitz M, Zhou Y, Braunwald E. The Effects of Angiotensin Receptor-Neprilysin Inhibition on Major Coronary Events in Patients With Acute Myocardial Infarction: Insights From the PARADISE-MI Trial. Circulation. 2022 Nov 2. doi: 10.1161/CIRCULATIONAHA.122.060841. [Epub ahead of print]

ReferenceCitation: Shah AM, Claggett B, Prasad N, Li G, Volquez M, Jering K, Cikes M, Kovacs A, Mullens W, Nicolau JC, Køber L, van der Meer P, Jhund PS, Ibram G, Lefkowitz M, Zhou Y, Solomon SD, Pfeffer MA. Impact of Sacubitril/Valsartan Compared With Ramipril on Cardiac Structure and Function After Acute Myocardial Infarction: The PARADISE-MI Echocardiographic Substudy. Circulation. 2022 Oct 4;146(14):1067-1081. doi: 10.1161/CIRCULATIONAHA.122.059210. Epub 2022 Sep 9.

ReferenceCitation: Pfeffer MA, Claggett B, Lewis EF, Granger CB, Køber L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, Fernandez A, Filippatos G, Jering K, Landmesser U, Menon V, Merkely B, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Wang Y, Braunwald E. Impact of Sacubitril/Valsartan Versus Ramipril on Total Heart Failure Events in the PARADISE-MI Trial. Circulation. 2022 Jan 4;145(1):87-89. doi: 10.1161/CIRCULATIONAHA.121.057429. Epub 2021 Nov 19.

ReferenceCitation: Pfeffer MA, Claggett B, Lewis EF, Granger CB, Køber L, Maggioni AP, Mann DL, McMurray JJV, Rouleau JL, Solomon SD, Steg PG, Berwanger O, Cikes M, De Pasquale CG, East C, Fernandez A, Jering K, Landmesser U, Mehran R, Merkely B, Vaghaiwalla Mody F, Petrie MC, Petrov I, Schou M, Senni M, Sim D, van der Meer P, Lefkowitz M, Zhou Y, Gong J, Braunwald E; PARADISE-MI Investigators and Committees. Angiotensin Receptor-Neprilysin Inhibition in Acute Myocardial Infarction. N Engl J Med. 2021 Nov 11;385(20):1845-1855. doi: 10.1056/NEJMoa2104508. Erratum in: N Engl J Med. 2021 Dec 30;385(27):2592.

ipd_sharing_description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Croatia
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
Romania
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
Finland
Thailand
Korea, Republic of
France
Colombia
Netherlands

status_simplified: Completed


title: A Phase III, Double-Blinded, Randomized, Placebo-Controlled Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFV600 Mutation-Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

lead_sponsor: Hoffmann-La Roche

source: euctr

ReferenceCitation: Robert C, Lewis KD, Gutzmer R, Stroyakovskiy D, Gogas H, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Caro I, Forbes H, Shah K, Yan Y, Li H, McArthur GA, Ascierto PA. Biomarkers of treatment benefit with atezolizumab plus vemurafenib plus cobimetinib in BRAF(V600) mutation-positive melanoma. Ann Oncol. 2022 May;33(5):544-555. doi: 10.1016/j.annonc.2022.01.076. Epub 2022 Feb 4.

ReferenceCitation: de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAF(V600) wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.

ReferenceCitation: Gutzmer R, Stroyakovskiy D, Gogas H, Robert C, Lewis K, Protsenko S, Pereira RP, Eigentler T, Rutkowski P, Demidov L, Manikhas GM, Yan Y, Huang KC, Uyei A, McNally V, McArthur GA, Ascierto PA. Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAF(V600) mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020 Jun 13;395(10240):1835-1844. doi: 10.1016/S0140-6736(20)30934-X. Erratum in: Lancet. 2020 Aug 15;396(10249):466.

location_country:
Poland
Brazil
Portugal
Spain
Greece
Austria
Australia
Italy
Canada
Netherlands
New Zealand
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
Israel
Belgium
Germany

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Klinikum d.Universität zu Köln Klinik u.Poliklinik f.Dermatologie

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

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

location_facility: Universitatsklinikum Mainz; Klinik und Poliklinik fur Dermatologie

location_facility: Centre Hospitalier Universitaire de Grenoble - Albert Michallon

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Wellington Hospital; Wellington Blood and Cancer Centre

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Medizinische Universität Wien; Univ.Klinik für Dermatologie

location_facility: Narodowy Inst.Onkol.im.Skłodowskiej-Curie Państw.Inst.Badawczy Kraków; Klinika Onkologii Klinicznej

location_facility: Sharett Institute - Hadassah Hebrew University Medical Center

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

location_facility: Metropolitan Hospital; Dept. of Oncology

location_facility: UF Health Cancer Center at Orlando Health

location_facility: Hopital Saint Eloi; CHU de Montpellier; Svc de Dermatologie

location_facility: Hospital General Universitario de Valencia; Servicio de oncologia

location_facility: Juravinski Cancer Clinic; Department of Oncology

location_facility: Istituto Tumori "Giovanni Paolo II", Oncologia

location_facility: IPO de Lisboa; Servico de Oncologia Medica

location_facility: Tauranga Hospital, Clinical Trials Unit; BOP Clinical School

location_facility: Centre Hospitalier Affilie Universitaire de Quebec - Hopital de L'Enfant Jesus

location_facility: Harzklinikum Dorothea Christiane Erxleben GmbH, Standort Quedlinburg; Hautkrebszentrum Harz

location_facility: IRCCS Istituto Nazionale Per La Ricerca Sul Cancro (IST); Oncologia Medica A

location_facility: Elbekliniken Buxtehude; Klinik für Dermatologie

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

location_facility: Medizinische Hochschule Hannover; Klinik für Dermatologie, Allergologie und Venerologie

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

location_facility: Orszagos Onkologiai Intezet; Borgyogyaszati Osztaly

location_facility: FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"

location_facility: Universitätsklinikum Würzburg; Med. Klinik 1, Pneumologie

location_facility: Rabin MC; Davidof Center - Oncology Institute

location_facility: IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica B

location_facility: Severance Hospital, Yonsei University Health System

location_facility: LHSC - Victoria Hospital; London Regional Cancer Program

location_facility: Hospital Universitario Virgen de la Macarena;

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

location_facility: UKSH Universitatsklinikum Schleswig-Holstein; Studienzentrum Dermatologie 10d

location_facility: Centre Eugene Marquis; Service d'oncologie

location_facility: UKSH Kiel; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: University of Szeged Szent-Györgyi Albert Clinical Center; Department of Dermatology and Allergology

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit

location_facility: Fundacion Instituto Valenciano de Oncologia (IVO)

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

location_facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

location_facility: Universitätsklinikum Leipzig; Klinik für Dermatologie, Venerologie und Allergologie

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu.

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Dermatologie

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

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: Medical University of Graz, Department of Dermatology

location_facility: LKH Innsbruck; Universitätsklinik für Dermatologie

location_facility: Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen

location_facility: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

location_facility: Zentrum für Dermatoonkologie, Universitäts-Hautklinik Tübingen

location_facility: Freeman Hospital; Northern Centre For Cancer Care

location_facility: Klinikum der Ludwigs-Maximilians-Universität München; Dermatologie

location_facility: Erasmus Mc - Daniel Den Hoed Kliniek; Interne Oncologie

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: Universitatsklinikum Essen; Klinik für Dermatologie

location_facility: HELIOS Klinikum Erfurt; Klinik für Dermatologie & Allergologie

summary: This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.


intervention_type: Biological

title: A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma

lead_sponsor: Bristol-Myers Squibb

ReferenceCitation: Scherpereel A, Antonia S, Bautista Y, Grossi F, Kowalski D, Zalcman G, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Sun X, Lawrance R, Zhang X, Daumont MJ, Bennett B, McKenna M, Baas P. First-line nivolumab plus ipilimumab versus chemotherapy for the treatment of unresectable malignant pleural mesothelioma: patient-reported outcomes in CheckMate 743. Lung Cancer. 2022 May;167:8-16. doi: 10.1016/j.lungcan.2022.03.012. Epub 2022 Mar 21.

ReferenceCitation: Peters S, Scherpereel A, Cornelissen R, Oulkhouir Y, Greillier L, Kaplan MA, Talbot T, Monnet I, Hiret S, Baas P, Nowak AK, Fujimoto N, Tsao AS, Mansfield AS, Popat S, Zhang X, Hu N, Balli D, Spires T, Zalcman G. First-line nivolumab plus ipilimumab versus chemotherapy in patients with unresectable malignant pleural mesothelioma: 3-year outcomes from CheckMate 743. Ann Oncol. 2022 May;33(5):488-499. doi: 10.1016/j.annonc.2022.01.074. Epub 2022 Feb 3.

ReferenceCitation: Baas P, Scherpereel A, Nowak AK, Fujimoto N, Peters S, Tsao AS, Mansfield AS, Popat S, Jahan T, Antonia S, Oulkhouir Y, Bautista Y, Cornelissen R, Greillier L, Grossi F, Kowalski D, Rodríguez-Cid J, Aanur P, Oukessou A, Baudelet C, Zalcman G. First-line nivolumab plus ipilimumab in unresectable malignant pleural mesothelioma (CheckMate 743): a multicentre, randomised, open-label, phase 3 trial. Lancet. 2021 Jan 30;397(10272):375-386. doi: 10.1016/S0140-6736(20)32714-8. Epub 2021 Jan 21. Erratum in: Lancet. 2021 Feb 20;397(10275):670.

ReferenceCitation: Wright K. FDA Approves Nivolumab Plus Ipilimumab for Previously Untreated Unresectable Malignant Pleural Mesothelioma. Oncology (Williston Park). 2020 Nov 12;34(11):502-503. doi: 10.46883/ONC.2020.3411.0502.

location_country:
United Kingdom
Italy
United States
Romania
Belgium
Japan
South Africa
Poland
Russian Federation
Australia
Turkey
Mexico
Brazil
Switzerland
China
Germany
Greece
France
Chile
Colombia
Netherlands

location_facility: Univ Of Maryland Greenbaum Cancer Center

location_facility: Cancer & Hematology Centers Of Western Michigan

location_facility: H. Lee Moffitt Cancer Center & Research Inst, Inc

summary: The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.


title: A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations - (FIGHT-201)

summary: The purpose of this study is to evaluate the overall response rate (ORR) of pemigatinib as a monotherapy in the treatment of metastatic or surgically unresectable urothelial carcinoma harboring FGF/FGFR alterations.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

lead_sponsor: Incyte Corporation

location_country:
Denmark
Spain
Italy
United Kingdom
Netherlands
United States
France
Israel
Belgium
Japan
Germany

location_facility: University of North Carolina at Chapel Hill

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Texas Oncology - Baylor Charles A. Sammons

location_facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Calaway-Young Cancer Center at Valley View Hospital

location_facility: Fondazione Del Piemonte Per L'Oncologia IRCC Candiolo

location_facility: TRIO - Comprehensive Cancer Centers of Nevada

location_facility: A.O.U. Senese Policlinico Santa Maria alle Scotte

location_facility: Nottingham University Hospitals City Campus

location_facility: ICO Girona - Hospital Universitari de Girona Dr. Josep Trueta

location_facility: University of Maryland, Greenebaum Cancer Center

location_facility: Azienda Ospedaliera Di Rilievo Nazionale A. Cardarellio

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Saitama Medical University International Medical Center

location_facility: Compass Oncology the Northwest Cancer Specialists

location_facility: UCSF Helen Diller Family Comprehensive Care Center

location_facility: Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: University of Wisconsic Hospital and Clinic

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori


acronym: ENTRUST-AF-PCI

title: Evaluation of the Safety and Efficacy of an Edoxaban-based Compared to a Vitamin K Antagonist-based Antithrombotic Regimen in Subjects With Atrial Fibrillation Following Successful Percutaneous Coronary Intervention (PCI) With Stent Placement.

lead_sponsor: Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

ReferenceCitation: Goette A, Eckardt L, Valgimigli M, Lewalter T, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Tijssen JG, Vranckx P. Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis. Clin Res Cardiol. 2021 Jun;110(6):831-840. doi: 10.1007/s00392-020-01760-4. Epub 2020 Oct 24.

ReferenceCitation: Vranckx P, Valgimigli M, Eckardt L, Tijssen J, Lewalter T, Gargiulo G, Batushkin V, Campo G, Lysak Z, Vakaliuk I, Milewski K, Laeis P, Reimitz PE, Smolnik R, Zierhut W, Goette A. Edoxaban-based versus vitamin K antagonist-based antithrombotic regimen after successful coronary stenting in patients with atrial fibrillation (ENTRUST-AF PCI): a randomised, open-label, phase 3b trial. Lancet. 2019 Oct 12;394(10206):1335-1343. doi: 10.1016/S0140-6736(19)31872-0. Epub 2019 Sep 3.

ReferenceCitation: Vranckx P, Lewalter T, Valgimigli M, Tijssen JG, Reimitz PE, Eckardt L, Lanz HJ, Zierhut W, Smolnik R, Goette A. Evaluation of the safety and efficacy of an edoxaban-based antithrombotic regimen in patients with atrial fibrillation following successful percutaneous coronary intervention (PCI) with stent placement: Rationale and design of the ENTRUST-AF PCI trial. Am Heart J. 2018 Feb;196:105-112. doi: 10.1016/j.ahj.2017.10.009. Epub 2017 Oct 23.

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/

location_country:
Poland
Taiwan
Portugal
Romania
Serbia
Italy
Austria
Netherlands
Spain
Lithuania
United Kingdom
Switzerland
Ukraine
Hungary
Korea, Republic of
France
Belgium
Germany

location_facility: Universitäres Herzzentrum Hamburg GmbH (UHZ)

location_facility: Lithuanian University of Health Sciences hospital

location_facility: Communal Institution Rivne Regional Clinical Hospital

location_facility: Nyskie Centrum Sercowo-Naczyniowe, Polsko-Amerykanskie Kliniki Serca

location_facility: Centro Hospitalar de Lisboa Central, EPE - Hospital Santa Marta

location_facility: Communal Institution "Vinnytsia Regional Diagnostic Center of cardiovascular disease"

location_facility: Institutul de Boli Cardiovasculare Timisoara

location_facility: Gottsegen György Országos Kardiológiai Intézet

location_facility: Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin

location_facility: St. Vincenz-Krankenhaus Paderborn - Medizinische Klinik II

location_facility: State Institution 'National Scientific Central Institute of Cardiology named after MD Strazhesko'

location_facility: X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji Polsko-Amerykanskie Kliniki Serca

location_facility: Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie und Pneumologie (Innere Medizin III)

location_facility: Klinikum Coburg Med. Klinik Kardiologie, Angiologie, Pneumologie

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawła II, Oddział Kliniczny Kardiologii Interwencyjnej z Pododdziałem Intenyswengo Nadzoru Kardiologicznego

location_facility: Complejo Asistencial Universitario de León

location_facility: Klinik Dr. Müller GmbH & Co. KG, Peter Osypka Herzzentrum

location_facility: Ospedale Alessandro Manzoni-Azienda Ospedaliera di Lecco

location_facility: China Medical University Hospital (CMUH)

location_facility: Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz

location_facility: III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii Polsko-Amerykanskie Kliniki Serca

location_facility: Kharkiv Railway Clinical Hospital N1 of Brance "Health Center" of the Public joint stock company "Ukrainian Railway"

location_facility: St. Josefs-Hospital - Medizinische Klinik I, Kardiologie

location_facility: Universitätsklinikum Jena Klinik für Innere Medizin I, Kardiologie, Angiologie, Pneumologie, Internistische Intensivmedizin

location_facility: Instytut Kardiologii im. Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego, Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca

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

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

location_facility: CI "Dnipropetrovsk Joint Emergency Hospital"

location_facility: Transcarpathian Regional Clinical Cardiology Clinic

location_facility: Universitätsklinikum Bonn - Medizinische Klinik II - Innere Medizin (Kardiologie, Angiologie und Pneumologie)

location_facility: II Oddział Kardiologiczny, Polsko-Amerykanskie Kliniki Serca

location_facility: Odessa Regional Hospital, Cardiosurgery Center

location_facility: Universitäts-Herzzentrum Freiburg • Bad Krozingen

location_facility: Communal Institution Dnepropetrovsk Regional Diagnostic Center

location_facility: Centro Hospitalar de Lisboa Norte, EPE - Hospital de Santa Maria

location_facility: Universitaetsklinikum Freiburg Klinik für Kardiologie und Angiologie I

location_facility: Vilnius University Hospital "Santariskiu Clinic"

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE - Hospital dos Covões

location_facility: HFR Freiburg - Kantonsspital Kardiologie

location_facility: Lviv Regional State Clinical Treatment and Diagnostic Cardiology Center

location_facility: Ospedale Maggiore C.A. Pizzardi -OR - Laboratorio di Cardiologia Interventistica

location_facility: Ivano-Frankivsk Central City Clinical Hospital

location_facility: S.Camillo Forlanini - Ospedale S.Camillo Reparto di Emodinamica

location_facility: "Prof. C.C. Iliescu" Emergency Institute for Cardiovascular Diseases

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Complejo Hospitalario Universitario de Granada

location_facility: Herzzentrum Leipzig - Universitätsklinik Klinik für Innere Medizin/Kardiologie

location_facility: Chernivtsi Regional Clinical Cardiology Dispensary

location_facility: Oradea Emergency County Clinical Hospital

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Seoul National University Bundang Hospital

location_facility: Emergency Institute of Cardiovascular Diseases and Transplantation

location_facility: Institute of Cardiovascular Diseases of Vojvodina

location_facility: Institute of CV Diseases Clinical Center of Serbia

location_facility: Oleksandrivska Kiyv City Clinical Hospital

location_facility: Universitätsklinik Ulm - Zentrum für Innere Medizin - Klinik für Innere Medizin II

location_facility: Kaohsiung medical University Chung-Ho Memorial Hospital (KMUH)

location_facility: Zaporizhzhia Regional cardiology dispensary

location_facility: "Santa Maria" University Hospital - Azienda Ospedaliera Santa Maria Di Terni

location_facility: Universitätsklinikum Münster - Department für Kardiologie und Angiologie

location_facility: Communal Health Care Institution "Regional Clinical Hospital - Center of Emergency Medical Care and Disaster Medicine"

location_facility: Schwarzwald-Baar Klinikum - Kliniken Villingen-Schwenningen - Innere Medizin III: Kardiologie und Intensivmedizin

location_facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; Klinika Kardiologii i Angiologii Interwencyjnej

location_facility: AOU Materdomini, Magna Graecia University

location_facility: Communal Institution of Kyiv Regional Rada

location_facility: Communal Institution of Sumy Regional Rada

location_facility: Bajcsy-Zsilinszky Kórház és Rendelőintézet

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: L.T. Malaya Therapy National Institute of the National Academy of medical science of Ukraine

location_facility: Vinnytsya Regional Clinical Hospital n.a. Pyrogov

location_facility: Heinrich-Heine-Universität Düsseldorf - Universitätsklinikum Düsseldorf (UKD) Klinik für Kardiologie, Pneumologie und Angiologie

location_facility: Fejér Megyei Szent György Egyetemi Oktató Kórház

location_facility: Charité, Campus Virchow-Klinikum - Medizinische Klinik mit Schwerpunkt Kardiologie

summary: There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting. This study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a vitamin K antagonist (VKA)-based antithrombotic regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.


title: A Phase 2, Double-Blind, Randomized Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 in Combination With Prednisolone Versus Prednisolone Alone in Subjects With Severe Alcoholic Hepatitis (AH)

summary: The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).

lead_sponsor: Gilead Sciences

location_country:
United Kingdom
Austria
Canada
Switzerland
United States
France
Belgium

location_facility: Methodist Healthcare Dallas - The Liver Institute

location_facility: Nottingham University Hospitals NHS Trust

location_facility: University of Arkansas for Medical Sciences

location_facility: Centre Hospitalier Universitaire de Liege

location_facility: Royal Liverpool & Broadgreen University Hospitals NHS Trust

location_facility: Hull and East Yorkshire Hospitals NHS Trust

location_facility: Brighton & Sussex University Hospitals NHS Trust


acronym: Onset® 5

title: Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes

lead_sponsor: Novo Nordisk A/S

type: Other Identifier

ReferenceType: result

ReferenceCitation: Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.

ReferenceCitation: Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.

ReferenceCitation: Gorst-Rasmussen A, Sturis J, Ekelund M. Continuous Glucose Monitoring Sensor Glucose Levels and Insulin Pump Infusion Set Wear-Time During Treatment with Fast-Acting Insulin Aspart: A Post Hoc Analysis of Onset 5. Diabetes Technol Ther. 2022 Jan;24(1):10-17. doi: 10.1089/dia.2021.0199. Epub 2021 Dec 14.

location_country:
Slovenia
United Kingdom
Russian Federation
Netherlands
Canada
United States
France
Belgium
Germany

summary: This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.


title: Phase IIIb Randomized Trial Comparing Irradiation Plus Long Term Adjuvant Androgen Deprivation With GnRH Antagonist Versus GnRH Agonist Plus Flare Protection in Patients With Very High Risk Localized or Locally Advanced Prostate Cancer. A Joint Study of the EORTC ROG and GUCG

acronym: PEGASUS

summary:
The primary objective of the trial is to assess if GnRH antagonists in combination with external beam radiation therapy improve progression free survival (progression that can be biological, clinical, or death) compared to GnRH agonists in combination with external beam radiation therapy.

Secondary objectives include:

documentation of effect of GnRH antagonists on clinically significant cardiovascular events in the subgroup of patients at high risk of such events at baseline;
documentation of side effects and quality of life, I-PSS and urinary tract infections;
assessment of relative treatment effect on secondary efficacy endpoints (clinical progression, time to next line of systemic therapy, time on therapy, overall and cancer specific survival) and on PSA at 6 months after end of RT.

ReferenceCitation: Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blümle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8:CD012548. doi: 10.1002/14651858.CD012548.pub2. Review.

lead_sponsor: European Organisation for Research and Treatment of Cancer - EORTC

location_country:
Denmark
Spain
Italy
United Kingdom
Switzerland
France
Belgium
Germany

location_facility: Otto-Von-Guericke-Universitaet Magdeburg - Universitaetsklinik

location_facility: Hospital General Universitario Santa Lucia

location_facility: Centre D'Onco. & Radioth. De Haute Energie Du Pays Basque

location_facility: Groupe Radiopole Artois - Centre de Radiotherapie Pierre Curie

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopitaux Universitaires Bordet- Institut Jules Bordet

location_facility: Complejo Hospitalario Universitario de Vigo -CHUVI - Hospital Alvaro Cunqueiro

location_facility: Hospital Universitario de Gran Canaria Doctor Negrin

location_facility: Institut de Cancerologie de l'Ouest (ICO) - Centre Rene Gauducheau

location_facility: University Hospitals Copenhagen - Rigshospitalet

location_facility: AUSL Romagna - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

location_facility: Assistance Publique - Hopitaux de Paris - La Pitie Salpetriere

location_facility: CHU de Grenoble - La Tronche - Hôpital A. Michallon

location_facility: Hôpitaux universitaires de Genève - HUG - site de Cluse-Roseraie

location_facility: Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme

location_facility: Oncology Institute of Southern Switzerland (IOSI) - Oncology Institute of Southern Switzerland - Ospedale Regionale Bellinzona e Valli

location_facility: AZ Groeninge Kortrijk - Campus Kennedylaan

location_facility: Gasthuiszusters van Antwerpen - GasthuisZusters Antwerpen - Sint-Augustinus

location_facility: Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

intervention_type: Radiation


status: Terminated

acronym: DAYBREAK-ALZ

title: A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia

lead_sponsor: AstraZeneca

ReferenceCitation: Wessels AM, Tariot PN, Zimmer JA, Selzler KJ, Bragg SM, Andersen SW, Landry J, Krull JH, Downing AM, Willis BA, Shcherbinin S, Mullen J, Barker P, Schumi J, Shering C, Matthews BR, Stern RA, Vellas B, Cohen S, MacSweeney E, Boada M, Sims JR. Efficacy and Safety of Lanabecestat for Treatment of Early and Mild Alzheimer Disease: The AMARANTH and DAYBREAK-ALZ Randomized Clinical Trials. JAMA Neurol. 2020 Feb 1;77(2):199-209. doi: 10.1001/jamaneurol.2019.3988. Erratum in: JAMA Neurol. 2020 Sep 1;77(9):1179.

ReferenceCitation: Cebers G, Alexander RC, Haeberlein SB, Han D, Goldwater R, Ereshefsky L, Olsson T, Ye N, Rosen L, Russell M, Maltby J, Eketjäll S, Kugler AR. AZD3293: Pharmacokinetic and Pharmacodynamic Effects in Healthy Subjects and Patients with Alzheimer's Disease. J Alzheimers Dis. 2017;55(3):1039-1053.

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.

location_country:
Denmark
Poland
Taiwan
Portugal
Spain
Italy
Russian Federation
Netherlands
United Kingdom
Canada
Korea, Republic of
United States
France
China
Mexico
Japan
Germany
Czechia

location_facility: Neurology Specialists of Monmouth County

location_facility: NZOZ Wroclawskie Centrum Alzheimerowskie

location_facility: Mexico Centre for Clinical Research SA de CV

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Chang Gung Memorial Hospital - Kaohsiung

location_facility: RSBIH Smolensk Regional Clinical Hospital

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Instituto de Informacion en Salud Mental (INFOSAM)

location_facility: Taipei Medical University- Shuang Ho Hospital

location_facility: Toronto Sunnybrook Regional Cancer Center

location_facility: Texas Medical Research Associates, L.L.C.

location_facility: Research Center for Clinical Studies, Inc

location_facility: Regional State Institution of Healthcare Tomsk Clinica Psych

location_facility: Specjalistyczny Osrodek Medycyny Wieku Dojrzalego SOMED

location_facility: Fundacion ACE-Institut Catala de Neurociences Aplicades

location_facility: Allied Biomedical Research Institute, Inc.

location_facility: Praxis für Neurologie und Psychiatrie Dr. med. Roth

location_facility: Centro de Estudios Clinicos y Esp Medicas SC

location_facility: Institute for Neurodegenerative Disorders

location_facility: Center for Clinical and Basic Research -CCBR

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: SDN - Istituto di Ricerca Diagnostica e Nucleare

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Nanjing Drum Tower Hosp Affiliated Hosp of Nanjing Univ Med

location_facility: Shanghai Huashan Hospital Affil to Fu Dan University

location_facility: Advanced Memory Research Institute of New Jersey

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: Univ of North Texas Health Science Center

location_facility: LLC City Neurological Centre Sibneuromed

location_facility: The First Affiliated Hospital of Wenzhou Medical College

location_facility: The Research Center of Southern California

location_facility: Jacksonville Center for Clinical Research

location_facility: ISPG - Institut für Studien zur psychischen Gesundheit

location_facility: West China Hospital of Sichuan University

location_facility: IRCCS Azienda Ospedaliera Universitaria San Martino

location_facility: Seoul National University Bundang Hospital

location_facility: CSSS-Institut Universitaire Gériatric de Sherbrooke

location_facility: SAIH Republ. Clinical Hospital of the MoH of Republ. Tatarst

location_facility: Xuanwu Hospital-Capital Medical University

location_facility: The First Affiliated Hospital, Zhejiang University

location_facility: Azienda Ospedaliera - Universitaria Pisana

location_facility: The Catholic University of Korea-Bucheon St. Mary's Hospital

location_facility: True North Clinical Research Halifax, LLC

location_facility: Azienda Ospedaliera Citta della Salute della Scienza Torino

location_facility: Medical Research Health and Education Foundation, Inc

summary: The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.

status_simplified: Unknown


title: Stellarex Vascular E-Registry

acronym: SAVER

summary: Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.

lead_sponsor: Spectranetics Corporation

location_country:
United Kingdom
Italy
Austria
France
Belgium
Germany

location_facility: Krankenhaus der Barmherzigen Schwesterrn Reid

location_facility: Grand Hôpital de l'Est Francilien - Site de Marne la Vallée

location_facility: Âzienda Ospedaliera Per L'emergenza Cannizzaro

location_facility: Krankenhäuser Landkreis Freudenstadt GmbH

location_facility: Ev. Krankenhaus Königin Elisabeth Herzberge

intervention_type: Device


title: A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors

acronym: MEDIOLA

summary: The purpose of this study is to look at the effectiveness, safety, and antitumor activity of study drugs MEDI4736 in combination with olaparib (modules 1, 2, 3, 4, 5 and 7) and MEDI4736 in combination with olaparib and bevacizumab (module 6). It will also examine what happens to the study drugs in the body and investigate how well the combination between MEDI4736, olaparib and bevacizumab is tolerated.

ReferenceCitation: Staniszewska AD, Armenia J, King M, Michaloglou C, Reddy A, Singh M, San Martin M, Prickett L, Wilson Z, Proia T, Russell D, Thomas M, Delpuech O, O'Connor MJ, Leo E, Angell H, Valge-Archer V. PARP inhibition is a modulator of anti-tumor immune response in BRCA-deficient tumors. Oncoimmunology. 2022 Jun 18;11(1):2083755. doi: 10.1080/2162402X.2022.2083755. eCollection 2022.

ReferenceCitation: Domchek SM, Postel-Vinay S, Im SA, Park YH, Delord JP, Italiano A, Alexandre J, You B, Bastian S, Krebs MG, Wang D, Waqar SN, Lanasa M, Rhee J, Gao H, Rocher-Ros V, Jones EV, Gulati S, Coenen-Stass A, Kozarewa I, Lai Z, Angell HK, Opincar L, Herbolsheimer P, Kaufman B. Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study. Lancet Oncol. 2020 Sep;21(9):1155-1164. doi: 10.1016/S1470-2045(20)30324-7. Epub 2020 Aug 6.

location_country:
United Kingdom
Switzerland
Korea, Republic of
United States
Israel
France
Netherlands


title: A Phase 1/2, Open-label, Multi-center Study to Assess the Safety and Tolerability of Durvalumab (Anti-PDL1 Antibody) as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocitic Leukemia

acronym: FUSION NHL 001

summary: This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and rituximab at the RP2D in adults with lymphoma or chronic lymphocytic leukemia (CLL).

lead_sponsor: Celgene

location_country:
United Kingdom
Italy
Netherlands
United States
France
Japan
Germany

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

location_facility: Washington University School of Medicine

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Oxford University Hospitals NHS Trust- Churchill Hospital-Oxford Centre for Respiratory Medicine

location_facility: Centre Hospitalier Universitaire d'Avicennes

location_facility: Medizinische Klinik III Klinikum der UniversitÃ¤t MÃ¼nchen-GroÃŸhadern

location_facility: Centre Hospitalier Universitaire de Nantes

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Southampton University Hospitals NHS Trust

location_facility: Shands Cancer Center University of Florida

location_facility: University of Oklahoma Peggy and Charles Stephenson Cancer Center

location_facility: Northwestern University Feinberg School of Medicine


title: A Phase 1b/2 Open-Label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy

summary:
The purpose of this study are

to determine the recommended combination dose of AG-120 and AG-221 separately when administered with azacitidine and,
to investigate the safety, tolerability, and efficacy of the combinations of AG-120 with azacitidine and AG-221 with azacitidine versus with azacitidine alone in participants with acute myeloid leukemia (AML) with the isocitrate dehydrogenase (IDH) enzyme isoforms 1 or 2 mutations, respectively.

ReferenceCitation: DiNardo CD, Schuh AC, Stein EM, Montesinos P, Wei AH, de Botton S, Zeidan AM, Fathi AT, Kantarjian HM, Bennett JM, Frattini MG, Martin-Regueira P, Lersch F, Gong J, Hasan M, Vyas P, Döhner H. Enasidenib plus azacitidine versus azacitidine alone in patients with newly diagnosed, mutant-IDH2 acute myeloid leukaemia (AG221-AML-005): a single-arm, phase 1b and randomised, phase 2 trial. Lancet Oncol. 2021 Nov;22(11):1597-1608. doi: 10.1016/S1470-2045(21)00494-0. Epub 2021 Oct 18.

ReferenceCitation: DiNardo CD, Stein AS, Stein EM, Fathi AT, Frankfurt O, Schuh AC, Döhner H, Martinelli G, Patel PA, Raffoux E, Tan P, Zeidan AM, de Botton S, Kantarjian HM, Stone RM, Frattini MG, Lersch F, Gong J, Gianolio DA, Zhang V, Franovic A, Fan B, Goldwasser M, Daigle S, Choe S, Wu B, Winkler T, Vyas P. Mutant Isocitrate Dehydrogenase 1 Inhibitor Ivosidenib in Combination With Azacitidine for Newly Diagnosed Acute Myeloid Leukemia. J Clin Oncol. 2021 Jan 1;39(1):57-65. doi: 10.1200/JCO.20.01632. Epub 2020 Oct 29. Erratum in: J Clin Oncol. 2021 Feb 1;39(4):341.

location_country:
Portugal
Spain
Italy
United Kingdom
Australia
Netherlands
Canada
Switzerland
Korea, Republic of
United States
France
Germany

location_facility: Medizinische Klinik III Klinikum der Universität München-Großhadern

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Azienda Ospedaliera Ospedali Riuniti Marche Nord AORMN

location_facility: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square

location_facility: Azienda Ospedaliera S. Andrea - Università La Sapienza

location_facility: Azienda Ospedaliera Universitaria S. Martino di Genova

location_facility: Instituto Portugues de Oncologia do Porto

location_facility: Centro Hospitalar de Lisboa Central - Hospital de Santo António dos Capuchos

location_facility: UT Southwestern Medical Center at Dallas

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Queen Elizabeth Hospital UHB NHS Foundation Trust

location_facility: Centre Hospitalier Universitaire Vaudois CHUV BH-04

location_facility: Institut Universitaire du Cancer Oncopole

location_facility: Princess Margaret Hospital, Medical Oncology

location_facility: The Catholic University of Korea Seoul - Saint Mary's Hospital

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Instituto Portugues de Oncologia de Lisboa

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

location_facility: Zentrum Innere Medizin Klinik fur Hamatologie


title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of RVT-101 in Subjects With Dementia With Lewy Bodies (DLB)

summary: This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

lead_sponsor: Axovant Sciences Ltd.

location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Netherlands


acronym: PRONOUNCE

title: A Multi-Center, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Major Adverse Cardiovascular Events (MACEs) in Patients With Prostate Cancer and Cardiovascular Disease Receiving Degarelix (Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist) or Leuprolide (GnRH Receptor Agonist)

lead_sponsor: Ferring Pharmaceuticals

ReferenceCitation: Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sørensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30. Erratum in: Circulation. 2021 Oct 19;144(16):e273.

ReferenceCitation: Melloni C, Slovin SF, Blemings A, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Zubovskiy K, Olesen TK, Dugi K, Clarke NW, Higano CS, Roe MT; PRONOUNCE Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. JACC CardioOncol. 2020 Mar 17;2(1):70-81. doi: 10.1016/j.jaccao.2020.01.004. eCollection 2020 Mar.

location_country:
Poland
United Kingdom
Greece
Russian Federation
Finland
Canada
United States
France
South Africa
Germany
Slovakia
Czechia

location_facility: University of Arizona College of Medicine

location_facility: Staedtisches Klinikum Braunschweig GmbH - Standort Salzdahlumer

location_facility: Urological Associates of Southern Arizona

location_facility: SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov"

location_facility: Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt

location_facility: Jewish General Hospital / McGill University

location_facility: FSBI "Moscow scientific research oncology institute"

location_facility: Urology Associates Urologic Medical Research

location_facility: FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine"

location_facility: Medical University of South Carolina (MUSC)

location_facility: FBHI Privolzhskiy District Medical Centre FMBA of Russia

location_facility: Urologic Consultants of Southeaster PA LLP

location_facility: VA Greater Los Angeles Healthcare System

location_facility: Vychodoslovensky onkologicky ustav, a.s.

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

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

location_facility: BHI of Omsk region "Clinical Oncology Dispensary

location_facility: Veterans Affairs Medical Center-Salisbury, NC

location_facility: University of Washington School of Medicine

location_facility: G. Kenneth Jansz Medicine Professional Corporation

location_facility: University of California, Irvine Medical Center

location_facility: Advanced Urology Centers of New York Elmont Division

location_facility: Centre Hospitalier Régional Universitaire de Tours

location_facility: Groote Schuur Hospital Department of Urology

location_facility: Fakultna nemocnica s poliklinikou Zilina

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: University General Hospital of Heraklion

location_facility: J. Giddens Medicine Professional Corporation

location_facility: Royal Devon and Exeter Hospital (Wonford)

location_facility: University of Kansas Medical Center Research Institute, Inc.

location_facility: SBHI of Sverdiovsk Region "Sverdiovsk Regional Clinical Hospital #1

summary: The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.


title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-Pd-L1 Antibody) in Combination With Carboplatin or Cisplatin + Pemetrexed Compared With Carboplatin or Cisplatin + Pemetrexed in Patients Who Are Chemotherapy-Naive and Have Stage IV Non-Squamous Non-Small Cell Lung Cancer

ReferenceCitation: Lu S, Fang J, Wang Z, Fan Y, Liu Y, He J, Zhou J, Hu J, Xia J, Liu W, Shi J, Yi J, Cao L. Results from the IMpower132 China cohort: Atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer. Cancer Med. 2022 Sep 2. doi: 10.1002/cam4.5144. [Epub ahead of print]

ReferenceCitation: Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.

location_country:
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Peru
Belgium
Japan
Romania
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Malaysia
Hungary
China
Bulgaria
Taiwan
Ireland
Latvia
Korea, Republic of
France
Chile
Netherlands

location_facility: Sociedad de Investigaciones Medicas Ltda (SIM)

location_facility: Hopital d Instruction des Armees de Sainte Anne

location_facility: Fort Wayne Med Oncology & Hematology Inc

location_facility: Chelyabinsk Regional Clinical Oncology Dispensary

location_facility: Ospedale Casa Sollievo Della Sofferenza IRCCS

location_facility: Anhui Provincial Hospital; Respiratory Department

location_facility: Tianjin Medical University General Hospital

location_facility: ICO L'Hospitalet; Servicio de oncologia medica

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

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

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: Centre Hospitalier de Mulhouse - Hopital Emile Muller

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

location_facility: Centro Oncologico de Galicia COG; Medical Oncology

location_facility: Anhui Provincial Hospital; 2F,Tumor chemotherapy Department

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

location_facility: Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Private Enterprise Private Manufacturing Company Acinus

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

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

location_facility: Complejo Hospitalario de Navarra; Servicio de Oncologia

location_facility: Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica

location_facility: Kyiv Railway Clinical Hospital #3 of Branch Health Center of PJSC Ukrainian Railway; Surgery Dept

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

location_facility: Advanced Medical and Dental Institute; Kompleks Klinikal

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: Niigata University Medical & Dental Hospital

location_facility: Hopital d'Instruction des Armees de Begin

location_facility: Ospedale San Vincenzo Taormina :Divisione di Oncologia Medica

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: Beijing Friendship Hospital Affiliated of Capital University of Medical Science

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Hospital Lucus Augusti; Servicio de Oncologia

location_facility: Hospital Universitari de Girona Dr Josep Trueta; Departamento de Oncologia Medica

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Riga East Clinical University Hospital Latvian Oncology Centre

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

location_facility: University of Kentucky; Markey Cancer Center

location_facility: Polyclinique de Limoges - Site Chenieux; Oncologie Medicale

location_facility: Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia

location_facility: Hospital CUF Porto; Servico de Imunoalergologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Multiprofile Hospital for Active Treatment Serdika EOOD

location_facility: Centre Hospitalier Intercommunal; Service de Pneumologie

location_facility: Presidio Ospedaliero Vito Fazzi; Unita Operativa Di Oncologia Medica

location_facility: Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary; Oncothoracic department

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica

location_facility: National Hospital Organization Nagoya Medical Center

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Complejo Hospitalario Nuestra Senora de Valme

location_facility: C.A.U de Burgos- Hospital Universitario de Burgos; Servicio de Oncologia

location_facility: Gartnavel General Hospital; Beatson West of Scotland Cancer Centre

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

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

location_facility: HealthCare Research Network II, LLC - PPDS

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: MICR Oncology Dispensary of Cherkasy Regional Council; Regional Center of Clinical Oncology

location_facility: Peninsula and South Eastern Haematology and Oncology Group

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Virginia Cancer Specialists (Fairfax) - USOR

location_facility: National Hospital Organization Yamaguchi - Ube Medical Center

location_facility: Sydney Adventist Hospital; Clinical Trial Unit

location_facility: The First Affiliated Hospital of Medical School of Zhejiang University

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

location_facility: Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

location_facility: First Hospital of China Medical University

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

location_facility: Hospital Universitario Germans Trias i Pujol

summary: This is a randomized, Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab in combination with cisplatin or carboplatin + pemetrexed compared with treatment with cisplatin or carboplatin + pemetrexed in participants who are chemotherapy-naive and have Stage IV non-squamous NSCLC. Eligible participants will be randomized by a 1:1 ratio into 2 groups: Arm A (Atezolizumab + Carboplatin or Cisplatin + Pemetrexed) and Arm B (Carboplatin or Cisplatin + Pemetrexed). The study will be conducted in two phases: Induction Phase and Maintenance Phase.


title: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

summary: This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

ReferenceCitation: Sullivan WG, Hatswell AJ. Letter re: 'Intrapatient comparisons of efficacy in a single-arm trial of entrectinib in tumour-agnostic indications'. ESMO Open. 2021 Dec;6(6):100282. doi: 10.1016/j.esmoop.2021.100282. Epub 2021 Oct 28.

ReferenceCitation: Doebele RC, Perez L, Trinh H, Martinec M, Martina R, Riehl T, Krebs MG, Meropol NJ, Wong WB, Crane G. Comparative effectiveness analysis between entrectinib clinical trial and crizotinib real-world data in ROS1+ NSCLC. J Comp Eff Res. 2021 Dec;10(17):1271-1282. doi: 10.2217/cer-2021-0131. Epub 2021 Aug 24. Erratum in: J Comp Eff Res. 2022 May;11(7):545-548.

ReferenceCitation: Dziadziuszko R, Krebs MG, De Braud F, Siena S, Drilon A, Doebele RC, Patel MR, Cho BC, Liu SV, Ahn MJ, Chiu CH, Farago AF, Lin CC, Karapetis CS, Li YC, Day BM, Chen D, Wilson TR, Barlesi F. Updated Integrated Analysis of the Efficacy and Safety of Entrectinib in Locally Advanced or Metastatic ROS1 Fusion-Positive Non-Small-Cell Lung Cancer. J Clin Oncol. 2021 Apr 10;39(11):1253-1263. doi: 10.1200/JCO.20.03025. Epub 2021 Mar 1.

ReferenceCitation: Drilon A, Siena S, Dziadziuszko R, Barlesi F, Krebs MG, Shaw AT, de Braud F, Rolfo C, Ahn MJ, Wolf J, Seto T, Cho BC, Patel MR, Chiu CH, John T, Goto K, Karapetis CS, Arkenau HT, Kim SW, Ohe Y, Li YC, Chae YK, Chung CH, Otterson GA, Murakami H, Lin CC, Tan DSW, Prenen H, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Doebele RC; trial investigators. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):261-270. doi: 10.1016/S1470-2045(19)30690-4. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341.

ReferenceCitation: Doebele RC, Drilon A, Paz-Ares L, Siena S, Shaw AT, Farago AF, Blakely CM, Seto T, Cho BC, Tosi D, Besse B, Chawla SP, Bazhenova L, Krauss JC, Chae YK, Barve M, Garrido-Laguna I, Liu SV, Conkling P, John T, Fakih M, Sigal D, Loong HH, Buchschacher GL Jr, Garrido P, Nieva J, Steuer C, Overbeck TR, Bowles DW, Fox E, Riehl T, Chow-Maneval E, Simmons B, Cui N, Johnson A, Eng S, Wilson TR, Demetri GD; trial investigators. Entrectinib in patients with advanced or metastatic NTRK fusion-positive solid tumours: integrated analysis of three phase 1-2 trials. Lancet Oncol. 2020 Feb;21(2):271-282. doi: 10.1016/S1470-2045(19)30691-6. Epub 2019 Dec 11. Erratum in: Lancet Oncol. 2020 Feb;21(2):e70. Lancet Oncol. 2020 Jul;21(7):e341. Lancet Oncol. 2020 Aug;21(8):e372. Lancet Oncol. 2021 Oct;22(10):e428.

ReferenceCitation: Sigal D, Tartar M, Xavier M, Bao F, Foley P, Luo D, Christiansen J, Hornby Z, Maneval EC, Multani P. Activity of Entrectinib in a Patient With the First Reported NTRK Fusion in Neuroendocrine Cancer. J Natl Compr Canc Netw. 2017 Nov;15(11):1317-1322. doi: 10.6004/jnccn.2017.7029.

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Aichi Cancer Center Hospital; Respiratory Medicine

location_facility: Institut de Recherche en Cancérologie de Montpellier

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Dignity Health St Joseph's Hospital and Medical Center

location_facility: Centrum Onkologii-Instytut im.M.Sklodowskiej Curie; Dept of Nuclear Med. and Endocrine Oncology

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Cancer Treatment Centers of America; Tulsa

location_facility: Hôpital de la Timone; Oncologie Médicale Hématologie & Soins Palliatifs

location_facility: University of Washington Seattle Cancer Care Alliance

location_facility: University of Michigan Comprehensive Cancer Center; Clinical Trials Office

location_facility: Harbin Medical University Cancer Hospital

location_facility: Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy

location_facility: Cancer Center of Guangzhou Medical University

location_facility: Niigata Cancer Center Hospital; Internal Medicine

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

location_facility: Centro Nacional de Investigaciones Oncológicas(CNIO); Gastrointestinal Cancer Clinical Research Unit

location_facility: Seconda Università degli Studi di Napoli; Servizio Epato-Gastroenterologia

location_facility: Evang. Lungenklinik Berlin Klinik für Pneumologie

location_facility: IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II

location_facility: National University Hospital; Haematology/Oncology

location_facility: NCT Uniklinikum Heidelberg; Medizinische Onkologie

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

location_facility: Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie

location_facility: National Cancer Center Hospital; Dept of Respiratory Medicine

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Universitaetsklinikum Koeln; Innere Medizin I, Haematologie

location_facility: Shizuoka Cancer Center; Respiratory Internal Medicine

location_facility: Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley

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

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut De Cancerologie De L'ouest - Rene Gauducheau - Biology

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Weinberg Cancer Institution at Franklin Square

location_facility: Southeastern Regional Medical Center, Inc.

location_facility: Advocate Medical Group - Park Ridge, Luther Lane - Oncology

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda); Oncologico -Onc.Falck

location_facility: Miyagi Cancer Center; Respiratory Medicine

location_facility: Hôpital Nord - AP-HM Marseille#; Service d'Oncologie Multidisciplinaire

location_facility: NHO Shikoku Cancer Center; Dept of Respiratory Medicine

location_facility: Univ Of California Irvine College Of Medicine; 300194620

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: OSAKA CITY GENERAL HOSPITAL;Medical Oncology

location_facility: Hospital Universitario Ramon y Cajal; Servicio de Farmacia

location_facility: Università Campus Bio-Medico di Roma; Oncologia Medica

location_facility: Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica

location_facility: University of California San Diego Moores Cancer Center; Dept of Lung Cancer

location_facility: Hyogo Cancer Center, Dept of Respiratory Medicine

location_facility: Vall d´Hebron Institute of Oncology (VHIO), Barcelona

location_facility: University of Southern California Medical Center

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego

location_facility: H. Lee Moffitt Cancer Center and Research Inst.

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia ; S.C. Oncologia Medica

location_facility: Institut Gustave Roussy; Pathologie Thoracique

location_facility: Kindai University Hospital; Medical Oncology

location_facility: Georgetown University Medical Center Lombardi Cancer Center


acronym: KESTREL

title: A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination With Tremelimumab Versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients

ReferenceCitation: Hwang M, Seiwert TY. Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era. Lancet Oncol. 2021 Apr;22(4):413-415. doi: 10.1016/S1470-2045(21)00121-2. Epub 2021 Mar 5. Erratum in: Lancet Oncol. 2021 Apr;22(4):e134.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Philippines
Belgium
Japan
Poland
Austria
Russian Federation
India
Slovakia
Brazil
Canada
Germany
Taiwan
Greece
Thailand
Vietnam
Korea, Republic of
France

summary: This is a randomized, open-label, multi-center, 3-arm, global Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination or MEDI4736 monotherapy versus SoC (EXTREME regimen) in the treatment of patients with SCCHN who have not received prior systemic chemotherapy for recurrent or metastatic disease.


acronym: MIRROS

intervention_type: Other

title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

ReferenceCitation: Montesinos P, Beckermann BM, Catalani O, Esteve J, Gamel K, Konopleva MY, Martinelli G, Monnet A, Papayannidis C, Park A, Récher C, Rodríguez-Veiga R, Röllig C, Vey N, Wei AH, Yoon SS, Fenaux P. MIRROS: a randomized, placebo-controlled, Phase III trial of cytarabine ± idasanutlin in relapsed or refractory acute myeloid leukemia. Future Oncol. 2020 May;16(13):807-815. doi: 10.2217/fon-2020-0044. Epub 2020 Mar 13.

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
Finland
New Zealand
Russian Federation
Switzerland
Korea, Republic of
United States
France
Israel
Panama
Belgium
Norway
Germany
United Kingdom

location_facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

location_facility: Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli

location_facility: Centre Hospitalier Uni Ire; Service Des Maladies Du Sang

location_facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia

location_facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

location_facility: Hadassah Ein Karem Hospital; Haematology

location_facility: Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia

location_facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); Onco-Ematologia

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

location_facility: Complejo Hospitalario Arnulfo Arias Madrid; Servicio de Hematología

location_facility: Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III

location_facility: Royal Adelaide Hospital; Haematology Clinical Trials

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: M.D. Anderson Cancer Center; Department of Hematology

location_facility: Institut J Paoli I Calmettes; Onco Hematologie 2

location_facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

location_facility: Oslo Universitetssykehus HF, Rikshospitalet

location_facility: FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health

location_facility: Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie

location_facility: Medizinische Hochschule Hannover; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

location_facility: IRCCS AOU S.Martino; Clinica Ematologica

location_facility: Ospedale Cardarelli; Divisione Di Ematologia

location_facility: Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I

location_facility: Juravinski Cancer Clinic; Clinical Trials Department

location_facility: Shaare Zedek Medical Center; Hematology Dept.

location_facility: Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stamm.

location_facility: Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

location_facility: Hopital De Haut Leveque; Hematologie Clinique

location_facility: Universitätsspital Zürich Medizin Hämatologie; Klinik für Hämatologie

location_facility: Hopitaux De Brabois; Hematologie Medecine Interne

location_facility: Hopital Hotel Dieu Et Hme;Hopital De Jour

location_facility: Ichilov Sourasky Medical Center; Heamatology

location_facility: Az. Osp. Di Careggi; Divisione Di Ematologia

location_facility: Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie

location_facility: Concord Repatriation General Hospital; Haematology

location_facility: HOPITAL SAINT ANTOINE;Hematologie Clinique

location_facility: Helsinki University Central Hospital; Hematology

location_facility: Haukeland Universitetssjukehus; Klinisk forskningspost

location_facility: Canberra Hospital; Haematology Department

location_facility: Hospital Universitario la Fe; Servicio de Hematologia

location_facility: Abramson Cancer Center; Univ of Pennsylvania

location_facility: Universitätsklinikum Bonn; Med. Klinik und Poliklinik III; Hämatologie, Onkologie und Rheumatologie

location_facility: Geelong Hospital; Andrew Love Cancer Centre

location_facility: St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

location_facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia

location_facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik

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

location_facility: Rabin Medical Center-Beilinson Campus;Hematology-Oncology

location_facility: Universitätsklinikum Marburg Zentrum f. Innere Medizin

location_facility: Alfred Hospital; Clinical Haematology and Bone Marrow Transplantation

summary: This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.