title: An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder

summary:
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.

Key objectives of the study are to:

Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
Determine the blood levels of IM olanzapine depot in patients during long-term treatment

ReferenceCitation: McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study. Int Clin Psychopharmacol. 2014 Nov;29(6):322-31. doi: 10.1097/YIC.0000000000000038.

ReferenceCitation: Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7.

ReferenceCitation: Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130.

ReferenceCitation: McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45.

ReferenceCitation: Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.

lead_sponsor: Eli Lilly and Company

location_country:
Croatia
Spain
Italy
United States
Romania
Belgium
South Africa
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Mexico
Sweden
Slovakia
Brazil
Hungary
Germany
Taiwan
Czech Republic
France
Netherlands

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


type: Registry Identifier

type: Other Identifier

title: A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer

acronym: ExCel

summary:
RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen.

PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.

study_start_date_type: Actual

status: Completed

study_completion_date_type: Actual

study_type: Interventional

primary_purpose: Prevention

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Richardson H, Johnston D, Pater J, Goss P. The National Cancer Institute of Canada Clinical Trials Group MAP.3 trial: an international breast cancer prevention trial. Curr Oncol. 2007 Jun;14(3):89-96.

ReferenceType: result

ReferenceCitation: Goss PE, Richardson H, Chlebowski R, Johnston D, Sarto GE, Maunsell E, Ingle JN, Alés-Martinez JE. National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: evaluation of exemestane to prevent breast cancer in postmenopausal women. Clin Breast Cancer. 2007 Dec;7(11):895-900. doi: 10.3816/CBC.2007.n.057.

ReferenceCitation: Moy B, Richardson H, Johnston D, et al.: NCIC CTG MAP.3: enrollment and study drug adherence of ethnic minority women in a breast cancer prevention trial. [Abstract] Breast Cancer Res Treat 106 (1): A-3048, S141-2, 2007.

ReferenceCitation: Richardson H, Johnston D, Goss PE, et al.: Participant characteristics on an international NCIC CTG breast cancer prevention trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-1531, 2007.

ReferenceCitation: Goss PE, Ingle JN, Alés-Martinez J, Cheung A, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson K, Martin L, Winquist E, Sarto G, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H. Exemestane for primary prevention of breast cancer in postmenopausal women: NCIC CTG MAP.3 - A randomized placebo-controlled clinical trial. J Clin Oncol 29[suppl; abstr LBA504], 2011.

ReferenceCitation: Goss PE, Ingle JN, Alés-Martínez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson KC, Martin LW, Winquist E, Sarto GE, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H; NCIC CTG MAP.3 Study Investigators. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med. 2011 Jun 23;364(25):2381-91. doi: 10.1056/NEJMoa1103507. Epub 2011 Jun 4. Erratum in: N Engl J Med. 2011 Oct 6;365(14):1361.

ReferenceType: derived

ReferenceCitation: Maunsell E, Goss PE, Chlebowski RT, Ingle JN, Alés-Martínez JE, Sarto GE, Fabian CJ, Pujol P, Ruiz A, Cooke AL, Hendrix S, Thayer DW, Rowland KM, Dubé P, Spadafora S, Pruthi S, Lickley L, Ellard SL, Cheung AM, Wactawski-Wende J, Gelmon KA, Johnston D, Hiltz A, Brundage M, Pater JL, Tu D, Richardson H. Quality of life in MAP.3 (Mammary Prevention 3): a randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. J Clin Oncol. 2014 May 10;32(14):1427-36. doi: 10.1200/JCO.2013.51.2483. Epub 2014 Apr 7.

ipd_sharing: No

lead_sponsor: NCIC Clinical Trials Group

location_country:
Puerto Rico
United States
Canada
France

location_facility: University of Medicine and Dentistry of New Jersey

location_facility: Los Angeles Biomedical Research Institute

location_facility: Washington University School of Medicine

location_facility: The University of Chicago Medical Center

location_facility: BCCA - Cancer Centre for the Southern Interior

location_facility: Cancer Centre of Southeastern Ontario at Kingston

location_facility: Univ. Health Network-Princess Margaret Hospital

location_facility: Juravinski Cancer Centre at Hamilton Health Sciences

location_facility: Mid-Illinois Hematology and Oncology Associates, Ltd.

location_facility: Whittingham Cancer Center at Norwalk Hospital

location_facility: John H. Stroger, Jr Hospital of Cook County

location_facility: Maine Center for Cancer Medicine and Blood Disorders

location_facility: Univ. of Wisconsin Center for Women's Health and

location_facility: University of Cincinnati, Barrett Cancer Centre

location_facility: Ottawa Health Research Institute - General Division

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease

summary: This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

design_allocation: Randomized

primary_purpose: Treatment

lead_sponsor: Hoffmann-La Roche

location_country:
Spain
Greece
Italy
Australia
Netherlands
Canada
United Kingdom
Sweden
Puerto Rico
United States
France
Belgium
Germany


title: A Multicenter, Single-Arm, Open-Label Study of the Efficacy and Safety of CC-5013 Monotherapy in Subjects With Myelodysplastic Syndromes

summary: This study is a multi-center, single-arm, open-label study of oral CC-5013 monotherapy administered at a dose of 10 mg daily on Days 1-21 every 28 days (28-day cycles) to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk MDS who do not have a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of first day of study drug treatment. Subjects will receive study drug (CC-5013) in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement (Appendix I) is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.

ReferenceCitation: Raza A, Reeves JA, Feldman EJ, Dewald GW, Bennett JM, Deeg HJ, Dreisbach L, Schiffer CA, Stone RM, Greenberg PL, Curtin PT, Klimek VM, Shammo JM, Thomas D, Knight RD, Schmidt M, Wride K, Zeldis JB, List AF. Phase 2 study of lenalidomide in transfusion-dependent, low-risk, and intermediate-1 risk myelodysplastic syndromes with karyotypes other than deletion 5q. Blood. 2008 Jan 1;111(1):86-93. Epub 2007 Sep 24.

lead_sponsor: Celgene Corporation

location_country:
Denmark
Spain
Greece
Italy
Australia
Netherlands
Russian Federation
Czech Republic
Switzerland
United Kingdom
Sweden
United States
France
Belgium
Germany

location_facility: CHRU de Lille - Service des maladies du sang

location_facility: Universitätsklinikum Ulm - Klinik fur Innere Medizin III

location_facility: St. Luke's Oncology and Hematology Associates

location_facility: Princess Alexandra Hospital - Haematology

location_facility: Fakultní nemocnice Hradec Králové - Hematology

location_facility: University of Athens - Alexandra Hospital; Clinical Therapeutics

location_facility: CHRU - Hôpital du Haut Lévêque - Centre François Magendie

location_facility: Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

location_facility: State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

location_facility: University of Rochester-James P. Wilmot Cancer Center

location_facility: Ospedale San Luigi AO Luigi Gonzaga - Hematology

location_facility: Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

location_facility: Desert Hematology Oncology Medical Group, Inc.

location_facility: Royal Prince Alfred Hospital - Institute of Haematology

location_facility: St Bartholomew's Hospital - Medical Oncology

location_facility: Wake Forest University School of Medicine

location_facility: Northwest Georgia Oncology - Wellstar Cancer Research

location_facility: Hôpitaux Universitaire de Genève - Oncologie

location_facility: Royal Adelaide Hospital - SA Pathology Haematology

location_facility: Peter McCallum Cancer Institute - Directorate of Cancer Medecine

location_facility: Freeman Hospital - Northern Centre for Cancer Care

location_facility: Royal hallamshire Hospital - Haematology

location_facility: Centre Hospitalier Départemental Vendée - Onco-hematologie

location_facility: AO Universitaria San Martino - hematooncology

location_facility: Cliniques Universitaires ULC de Mont-Godinne - Hematology

location_facility: Charles university Hospital - Internal Medicine

location_facility: Centre Hospitalier de la côte basque - Hematologie

location_facility: Karolinska University Hospital Huddinge - Center of hematology

location_facility: Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

location_facility: Wayne State University School of Medicine

location_facility: The Alfred Hospital - malignant haematology & stem cell transplantation

location_facility: Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

location_facility: Royal Bournemouth Hospital - Haematology

location_facility: Rush Presbyterian-St. Luke's Medical Center

location_facility: Ospedale Guglielmo da Saliceto - hematooncology

location_facility: Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

location_facility: University of Miami- Sylvester Comp Cancer Center

location_facility: St. Vincents Comprehensive Cancer Center

location_facility: Hospital Germans Trias i Pujol - Hematology

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

location_facility: St James's University Hospital - Haematology

location_facility: Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

location_facility: Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: Frankston Hospital-peninsula Health - Oncology Day Unit

location_facility: Hôpital Saint Louis - Immuno-hematologie

location_facility: King's College Hospital - Haematology Clinical Trials

location_facility: CHU Angers - Service des maladies du sang

location_facility: Hôpital Bretonneau - Hématologie & Thérapie cellulaire

location_facility: Sahlgrenska Hospital, University of Goteborg - Hematology

location_facility: Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

location_facility: Royal Marsden NHS Foundation Trust - Haematology

location_facility: Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

location_facility: Russian Research Institute of Hematology and Blood Transfusion - Hematology

location_facility: Hospital Universitario Marqués de Valdecilla - Hematology

location_facility: Hospital Clinic i Provincial de Barcelona - Hematology

location_facility: Inselspital, Institut für Medizinische Onkologie

location_facility: Universita degli Studi di Padova - Clinical & Experimental Medicine

location_facility: Centre Hospitalier Lyon sud - Hematologie

location_facility: Universitätsklinikum Essen, Klinik für Hämatologie

location_facility: Karolinska University Hospital Solna- medicine

location_facility: Royal Wolverhampton hospitals trust - Research and development

location_facility: CHU Saint Antoine - Service des maladies du sang

location_facility: Nottingham City Hospital - Centre for Clinical Haematology

location_facility: Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

location_facility: A.O.U. San Giovanni Battista - Hematology


title: The Value of Dexamethasone Versus Prednisolone During Induction and Maintenance Therapy of Prolonged Versus Conventional Duration of L-Asparaginase Therapy During Consolidation and Late Intensification, and of Corticosteroid + VCR Pulses During Maintenance in Acute Lymphoblastic Leukemia and Lymphoblastic Non-Hodgkin Lymphoma of Childhood

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy plus steroid therapy is more effective for acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy plus steroid therapy in treating children who have acute lymphoblastic leukemia or lymphoblastic non-Hodgkin's lymphoma.

status: Unknown status

enrollment_type: Anticipated

ReferenceCitation: Ducassou S, Ferlay C, Bergeron C, Girard S, Laureys G, Pacquement H, Plantaz D, Lutz P, Vannier JP, Uyttebroeck A, Bertrand Y. Clinical presentation, evolution, and prognosis of precursor B-cell lymphoblastic lymphoma in trials LMT96, EORTC 58881, and EORTC 58951. Br J Haematol. 2011 Feb;152(4):441-51. doi: 10.1111/j.1365-2141.2010.08541.x. Epub 2011 Jan 7.

ReferenceCitation: Clappier E, Collette S, Grardel N, Girard S, Suarez L, Brunie G, Kaltenbach S, Yakouben K, Mazingue F, Robert A, Boutard P, Plantaz D, Rohrlich P, van Vlierberghe P, Preudhomme C, Otten J, Speleman F, Dastugue N, Suciu S, Benoit Y, Bertrand Y, Cavé H; EORTC-CLG. NOTCH1 and FBXW7 mutations have a favorable impact on early response to treatment, but not on outcome, in children with T-cell acute lymphoblastic leukemia (T-ALL) treated on EORTC trials 58881 and 58951. Leukemia. 2010 Dec;24(12):2023-31. doi: 10.1038/leu.2010.205. Epub 2010 Sep 23.

ReferenceCitation: Clappier E, Collette S, Grardel N, et al.: Prognostic significance of NOTCH1 and FBXW7 mutations in childhood T-cell acute lymphoblastic leukemia (T-ALL): results from the EORTC Children Leukemia Group. [Abstract] Blood 114 (22): A-909, 2009.

ReferenceCitation: Renneville A, Kaltenbach S, Clappier E, Collette S, Micol JB, Nelken B, Lepelley P, Dastugue N, Benoit Y, Bertrand Y, Preudhomme C, Cave H. Wilms tumor 1 (WT1) gene mutations in pediatric T-cell malignancies. Leukemia. 2010 Feb;24(2):476-80. doi: 10.1038/leu.2009.221. Epub 2009 Oct 22. No abstract available.

ReferenceCitation: Cavé H, Suciu S, Preudhomme C, Poppe B, Robert A, Uyttebroeck A, Malet M, Boutard P, Benoit Y, Mauvieux L, Lutz P, Méchinaud F, Grardel N, Mazingue F, Dupont M, Margueritte G, Pages MP, Bertrand Y, Plouvier E, Brunie G, Bastard C, Plantaz D, Vande Velde I, Hagemeijer A, Speleman F, Lessard M, Otten J, Vilmer E, Dastugue N; EORTC-CLG. Clinical significance of HOX11L2 expression linked to t(5;14)(q35;q32), of HOX11 expression, and of SIL-TAL fusion in childhood T-cell malignancies: results of EORTC studies 58881 and 58951. Blood. 2004 Jan 15;103(2):442-50. Epub 2003 Sep 22.

ReferenceCitation: Mirebeau D, Acquaviva C, Suciu S, Bertin R, Dastugue N, Robert A, Boutard P, Méchinaud F, Plouvier E, Otten J, Vilmer E, Cavé H; EORTC-CLG. The prognostic significance of CDKN2A, CDKN2B and MTAP inactivation in B-lineage acute lymphoblastic leukemia of childhood. Results of the EORTC studies 58881 and 58951. Haematologica. 2006 Jul;91(7):881-5.

ReferenceCitation: Cavé H, Suciu S, Preudhomme C, et al.: HOX11L2 expression linked to t(5;14)(q35;q32) is not associated with poor prognosis in childhood T-ALL treated in EORTC trials 58 881 and 58 951. [Abstract] Blood 100(11 pt 1): A-576, 153a, 2002.

ReferenceCitation: De Moerloose B, Suciu S, Bertrand Y, Mazingue F, Robert A, Uyttebroeck A, Yakouben K, Ferster A, Margueritte G, Lutz P, Munzer M, Sirvent N, Norton L, Boutard P, Plantaz D, Millot F, Philippet P, Baila L, Benoit Y, Otten J; Children's Leukemia Group of the European Organisation for Research and Treatment of Cancer (EORTC). Improved outcome with pulses of vincristine and corticosteroids in continuation therapy of children with average risk acute lymphoblastic leukemia (ALL) and lymphoblastic non-Hodgkin lymphoma (NHL): report of the EORTC randomized phase 3 trial 58951. Blood. 2010 Jul 8;116(1):36-44. doi: 10.1182/blood-2009-10-247965. Epub 2010 Apr 20.

ReferenceCitation: Bertrand Y, Suciu S, Benoit Y, et al.: Dexamethasone(DEX)(6mg/sm/d) and prednisolone(PRED)(60mg/sm/d) in induction therapy of childhood ALL are equally effective: results of the 2nd interim analysis of EORTC trial 58951. [Abstract] Blood 112 (11): A-8, 2008.

ReferenceCitation: Sirvent N, Suciu S, Benoit Y, et al.: Prognostic significance of central nervous system (CNS) status of children with acute lymphoblastic leukemia (ALL) treated without cranial irradiation: results of European Organization for Research and Treatment of Cancer (EORTC) Children Leukemia Group study 58951. [Abstract] Blood 112 (11): A-303, 2008.

ReferenceCitation: Bertrand Y, Goutagny MP, Poulat AL, et al.: Asparagine depletion, safety and antibody production after E coli asparaginase treatment in children with newly diagnosed acute lymphoblastic leukaemia treated with EORTC 58951 protocol: a single center report. [Abstract] Blood 110 (11): A-4337, 2007.

ReferenceCitation: Sirvent N, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Paillard C, Costa V, Simon P, Pluchart C, Poirée M, Minckes O, Millot F, Freycon C, Maes P, Hoyoux C, Cavé H, Rohrlich P, Bertrand Y, Benoit Y; Children's Leukemia Group of the European Organisation for Research Treatment of Cancer. CNS-3 status remains an independent adverse prognosis factor in children with acute lymphoblastic leukemia (ALL) treated without cranial irradiation: Results of EORTC Children Leukemia Group study 58951. Arch Pediatr. 2021 Jul;28(5):411-416. doi: 10.1016/j.arcped.2021.04.009. Epub 2021 May 24.

ReferenceCitation: Mondelaers V, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, Yakouben K, Uyttebroeck A, Lutz P, Costa V, Sirvent N, Plouvier E, Munzer M, Poirée M, Minckes O, Millot F, Plantaz D, Maes P, Hoyoux C, Cavé H, Rohrlich P, Bertrand Y, Benoit Y; Children-s Leukemia Group (CLG) of the European Organization for Research and Treatment of Cancer (EORTC). Prolonged versus standard native E. coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma: final results of the EORTC-CLG randomized phase III trial 58951. Haematologica. 2017 Oct;102(10):1727-1738. doi: 10.3324/haematol.2017.165845. Epub 2017 Jul 27.

ReferenceCitation: Ghazavi F, Clappier E, Lammens T, Suciu S, Caye A, Zegrari S, Bakkus M, Grardel N, Benoit Y, Bertrand Y, Minckes O, Costa V, Ferster A, Mazingue F, Plat G, Plouvier E, Poirée M, Uyttebroeck A, van der Werff-Ten Bosch J, Yakouben K, Helsmoortel H, Meul M, Van Roy N, Philippé J, Speleman F, Cavé H, Van Vlierberghe P, De Moerloose B. CD200/BTLA deletions in pediatric precursor B-cell acute lymphoblastic leukemia treated according to the EORTC-CLG 58951 protocol. Haematologica. 2015 Oct;100(10):1311-9. doi: 10.3324/haematol.2015.126953. Epub 2015 Jul 2.

ReferenceCitation: Clappier E, Grardel N, Bakkus M, Rapion J, De Moerloose B, Kastner P, Caye A, Vivent J, Costa V, Ferster A, Lutz P, Mazingue F, Millot F, Plantaz D, Plat G, Plouvier E, Poirée M, Sirvent N, Uyttebroeck A, Yakouben K, Girard S, Dastugue N, Suciu S, Benoit Y, Bertrand Y, Cavé H; European Organisation for Research and Treatment of Cancer, Children's Leukemia Group (EORTC-CLG). IKZF1 deletion is an independent prognostic marker in childhood B-cell precursor acute lymphoblastic leukemia, and distinguishes patients benefiting from pulses during maintenance therapy: results of the EORTC Children's Leukemia Group study 58951. Leukemia. 2015 Nov;29(11):2154-61. doi: 10.1038/leu.2015.134. Epub 2015 Jun 8.

ReferenceCitation: Domenech C, Suciu S, De Moerloose B, Mazingue F, Plat G, Ferster A, Uyttebroeck A, Sirvent N, Lutz P, Yakouben K, Munzer M, Röhrlich P, Plantaz D, Millot F, Philippet P, Dastugue N, Girard S, Cavé H, Benoit Y, Bertrandfor Y; Children's Leukemia Group (CLG) of European Organisation for Research and Treatment of Cancer (EORTC). Dexamethasone (6 mg/m2/day) and prednisolone (60 mg/m2/day) were equally effective as induction therapy for childhood acute lymphoblastic leukemia in the EORTC CLG 58951 randomized trial. Haematologica. 2014 Jul;99(7):1220-7. doi: 10.3324/haematol.2014.103507. Epub 2014 Apr 11.

ReferenceCitation: Dastugue N, Suciu S, Plat G, Speleman F, Cavé H, Girard S, Bakkus M, Pagès MP, Yakouben K, Nelken B, Uyttebroeck A, Gervais C, Lutz P, Teixeira MR, Heimann P, Ferster A, Rohrlich P, Collonge MA, Munzer M, Luquet I, Boutard P, Sirvent N, Karrasch M, Bertrand Y, Benoit Y. Hyperdiploidy with 58-66 chromosomes in childhood B-acute lymphoblastic leukemia is highly curable: 58951 CLG-EORTC results. Blood. 2013 Mar 28;121(13):2415-23. doi: 10.1182/blood-2012-06-437681. Epub 2013 Jan 15.

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

location_country: France Portugal Belgium

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Hopital Universitaire Des Enfants Reine Fabiola

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Instituto Portugues de Oncologia Centro do Porto, SA

intervention_type: Procedure

status_simplified: Unknown


title: An Open Randomised Comparative Multicentre Study of the Efficacy, Safety and Toleration of Voriconazole Versus Amphotericin-B in the Treatment of Acute Invasive Aspergillosis in Immunocompromised Patients

summary:
RATIONALE: Antifungal therapy with voriconazole or amphotericin B may be an effective treatment for aspergillosis. It is not yet known whether voriconazole is more effective than amphotericin B in treating patients with aspergillosis.

PURPOSE: Randomized phase III trial to compare the effectiveness of voriconazole with amphotericin B in treating patients with aspergillosis.

primary_purpose: Supportive Care

location_country:
Luxembourg
Spain
Ireland
Italy
Australia
Netherlands
United Kingdom
Switzerland
Sweden
Hungary
United States
France
Israel
Belgium
Germany

location_facility: Centre Hospitalier Universitaire Henri Mondor

location_facility: Hospital Clinic y Provincial de Barcelona

location_facility: Klinikum Rechts Der Isar/Technische Universitaet Muenchen

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

location_facility: Virchow Klinikum Humboldt Universitaet Berlin

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Birmingham Heartlands and Solihull NHS Trust (Teaching)

location_facility: University and I.R.C.C.S. Policlinico San Matteo

location_facility: National Institute of Haematology and Immunology


type: EudraCT Number

title: A Phase III Double-Blind, Randomised, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Docetaxel Versus Placebo + Docetaxel as Treatment for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)

summary: This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

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: AstraZeneca

location_country:
Poland
Taiwan
Brazil
Spain
Greece
United Kingdom
Australia
Mexico
Canada
Hungary
Korea, Republic of
United States
Chile
China
France
Belgium
India
Netherlands
Japan
Czechia

intervention_type: Other

status_simplified: Ongoing


title: A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination With Chemotherapy With or Without Tislelizumab in Subjects With HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA)

summary:
This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy.

The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

ReferenceCitation: Tabernero J, Shen L, Elimova E, Ku G, Liu T, Shitara K, Lin X, Boyken L, Li H, Grim J, Ajani J. HERIZON-GEA-01: Zanidatamab + chemo ± tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma. Future Oncol. 2022 Sep;18(29):3255-3266. doi: 10.2217/fon-2022-0595. Epub 2022 Aug 24. Review.

lead_sponsor: Zymeworks Inc.

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
Peru
Belgium
Romania
South Africa
Czechia
Poland
Hong Kong
Portugal
Australia
Argentina
India
Turkey
Mexico
Malaysia
Singapore
Brazil
Canada
Guatemala
China
Germany
Taiwan
Greece
Georgia
Estonia
Ireland
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: Centro Hospitalar E Universitário de Coimbra EPE

location_facility: Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council - PPDS

location_facility: The First Affiliated Hospital of Bengbu Medical College

location_facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E

location_facility: EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Ruijin hospital Shanghai Jiao Tong University School of Medicine

location_facility: The Second Affiliated Hospital of Anhui Medical University

location_facility: Centre Hospitalier Universitaire Grenoble Alpes - Hopital Albert Michallon

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

location_facility: Tianjin Medical University General Hospital

location_facility: Bioclinic Thessaloniki Oncology Department

location_facility: EDOG Institut de Cancerologie de l'Ouest - PPDS

location_facility: The First Hospital of Lanzhou University

location_facility: Communal Nonprofit Enterprise Kyiv City Clinical Oncological Center

location_facility: Beijing Chao-Yang Hospital, Capital Medical University

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Nanjing Drum Tower Hospital ,The Affiliated Hospital of Nanjing University Medical School

location_facility: Deenanath Mangeshkar Hospital and Research Centre

location_facility: The First Affiliated Hospital of Fujian Medical University

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

location_facility: Centro de Investigaciones Médicas Tucumán

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

location_facility: Instituto de Investigaciones Metabólicas - IDIM

location_facility: Communal Non-profit Enterprise Regional Center of Oncology

location_facility: Universite de Bourgogne - Faculte de Medecine - IN

location_facility: Beijing Luhe Hospital, Capital Medical University

location_facility: Fondazione del Piemonte per l'Oncologia (IRCCS)

location_facility: Instituto Brasileiro de Controle Do Câncer IBCC

location_facility: Gangnam Severance Hospital, Yonsei University Health System

location_facility: Bangkok Metropolitan Administration Medical College and Vajira Hospital

location_facility: First Affiliated Hospital of Xi 'an Jiaotong University

location_facility: Cancer Hospital affiliated to Xinjiang Medical University

location_facility: Hospital Universitario Dr. Jose Eleuterio González

location_facility: Complejo Asistencial Universitario de Salamanca - H. Clinico

location_facility: MNJ Institute of Oncology and Regional Cancer Centre

location_facility: Treatment and Diagnostic Center of LLC Specialized Clinic Prognosis Optima

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Tianjin Medical University Cancer Institute & Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

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

location_facility: Hospital Universitari de Girona Dr Josep Trueta

location_facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Hospital Universitario Vall d'Hebron - PPDS

location_facility: Second Affiliated Hospital of Zhejiang University School of Medicine

location_facility: Regional Cancer Centre Indira Gandhi Institute of Medical Sciences

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: INCA - Instituto Nacional de Câncer José Alencar G

location_facility: Cancer Hospital Chinese Academy of Medical Sciences

location_facility: Centro Medico Integral de Cancerologia CEMIC

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre

location_facility: Interbalkan Medical Center of Thessaloniki Oncology Department

location_facility: Hospital Regional Universitario de Malaga - Hospital General

location_facility: Cryptex Investigación Clínica, S.A. de C.V.

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

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Sociedad de Investigaciones Medicas Limitada

location_facility: Beijing Tiantan Hospital, Capital Medical University

location_facility: Affiliated Hospital of Inner Mongolia Medical University

location_facility: The First People's Hospital of Changzhou

location_facility: The First Hospital of China Medical University

location_facility: The First Affiliated Hospital of Zhengzhou University

location_facility: SI "National Institute of Surgery and Transplantology n.a. O.O. Shalimov " of NAMS of Ukraine

location_facility: Fundación Centro de Medicina Nuclear y Molecular ER

location_facility: Municipal Non-profit Enterprise "Odessa Regional Oncology Dispensary" of Odesa RC

location_facility: The Fourth Hospital of Hebei Medical University

location_facility: Prof Dr I Chiricuta Institute of Oncology - PPDS

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: The Affiliated Hospital of Qingdao University

location_facility: Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital

location_facility: Seoul National University Bundang Hospital

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

location_facility: Fundação Pio XII Hospital de Câncer de Barretos

location_facility: The Sixth Affiliated Hospital of Sun Yat-sen University

location_facility: Azienda ULSS 8 "Berica" - Ospedale San Bortolo

location_facility: Srinagarind Hospital, Khon Kaen University

location_facility: Severance Hospital Yonsei University Health System - PPDS

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: Fudan University Affiliated Zhongshan Hospital

location_facility: CHA Bundang Medical Center, CHA University

location_facility: Affiliated Hospital of Jiangnan University

location_facility: Medical Center of Limited Liability Company "Medical center "VERUM EXPERT"

location_facility: Western General Hospital Edinburgh - PPDS

location_facility: The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council

location_facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

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

location_facility: Centro de Investigacion Clinica de Oaxaca

location_facility: Hospital Universitario Germans Trias i Pujol

intervention_type: Diagnostic Test


title: A Phase 3 Extension Trial of DELTA 1 and DELTA 2 to Evaluate the Long-term Safety of a Twice-daily Treatment With Delgocitinib Cream 20 mg/g as Needed for up to 36 Weeks in Adult Subjects With Chronic Hand Eczema (DELTA 3)

summary:
The purpose of this extension trial is to evaluate the long-term safety of delgocitinib.

Subjects will visit the clinic every 4 week to assess the safety and efficacy of the treatment, until Week 36. A final follow-up phone call is planned on Week 38.

status: Enrolling by invitation

ipd_sharing_description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.

lead_sponsor: LEO Pharma

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
Canada
France
Belgium
Germany

location_facility:
LEO Investigational Site
Leo Investigational Site
LEO Investigational Sites
LEO investigational site
LEO Investigitional Site
LEO Pharma Investigational Site


acronym: Astefania

title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

source: euctr

ReferenceCitation: Hurvitz SA, Bachelot T, Bianchini G, Harbeck N, Loi S, Park YH, Prat A, Gilham L, Boulet T, Gochitashvili N, Monturus E, Lambertini C, Nyawira B, Knott A, Restuccia E, Schmid P. ASTEFANIA: adjuvant ado-trastuzumab emtansine and atezolizumab for high-risk, HER2-positive breast cancer. Future Oncol. 2022 Nov 16. doi: 10.2217/fon-2022-0485. [Epub ahead of print] Review.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Romania
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
India
Turkey
Mexico
Singapore
Kenya
Brazil
Hungary
China
Germany
Bulgaria
Denmark
Taiwan
Greece
New Zealand
Thailand
Korea, Republic of
France

location_facility: Herlev Hospital; Afdeling for Kræftbehandling

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hospital Universitario Clínico San Cecilio; Servicio de oncologia

location_facility: Sahyadri Super Specialty Hospital Hadapsar

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

location_facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

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

location_facility: Manipal Hospital; Department of Oncology

location_facility: St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: LLC Medical and Sanitary Unit "Clinician"

location_facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary

location_facility: Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Taipei Veterans General Hospital; Department of Clinical Trial Pharmacy

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Joe Arrington Cancer Research & Treatment Center

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: ASU FC S. M. DELLA MISERICORDIA; Oncologia

location_facility: Leopoldina Krankenhaus der Stadt Schweinfurt GmbH

location_facility: FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF

location_facility: Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: The First Affilicated Hospital, Sun Yat-sen University

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie

location_facility: Hospital Clínico Universitario de Valencia; Servicio de Oncología

location_facility: Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA

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

location_facility: Centro Hospitalar do Porto - Hospital de Santo António; Oncologia

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Filantropia Clinical Hospital; Medical oncology

location_facility: Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp

location_facility: Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF

location_facility: Harbin Medical University Cancer Hospital

location_facility: Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii

location_facility: Hospital Universitario Virgen Macarena; Servicio de Oncologia

location_facility: Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Kinghorn Cancer Centre; St Vincents Hospital

location_facility: MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy

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

location_facility: SBIH Kaluga Region Clinical Oncology Dispensary

location_facility: Municipal Noncommercial Institution Regional Center of Oncology

location_facility: Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii

location_facility: Metropolitan Hospital; 2Nd Oncology Clinic

location_facility: Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department

location_facility: West China Hospital - Sichuan University

location_facility: Henry Ford Health System; Clinical Trials Office; Clinical Trials Office

location_facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Peter MacCallum Cancer Centre; Medical Oncology

location_facility: Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

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

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

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie

location_facility: University Hospital of Larissa;Department of Medical Oncology

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

location_facility: National Cancer Centre; Medical Oncology

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie

location_facility: Hochtaunus-Kliniken gGmbH; Krankenhaus Bad Homburg; Frauenklinik

location_facility: National Cheng Kung Uni Hospital; Dept of Hematology and Oncology

location_facility: Prof.dr. Alexandru Trestioreanu, The Oncology Institute; Medical oncology I

location_facility: Songklanagarind Hospital; Department of Surgery

location_facility: Crio - Centro Regional Integrado de Oncologia

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

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly

location_facility: Städtische Klinik Lüneburg; Frauenklinik

location_facility: Virginia Oncology Associates - Virginia Beach

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Guangdong Provincial People's Hospital; Breast

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Virginia Oncology Associates - New Port News

location_facility: Velindre Cancer Centre; Clinical Trials Unit

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde

location_facility: Republican Clinical Oncological Dispensary of the Ministry of Healthcare; Chemotherapy department

location_facility: Oncology Dispensary#1; Out-Patient Oncology Dept

location_facility: Tianjin Medical University Cancer Institute & Hospital

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

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

location_facility: Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe

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

location_facility: SBI of Healthcare Leningrad Regional Oncology Dispensary

location_facility: Katip Celebi University Ataturk Training and Research Hospital; Oncology

location_facility: Srinagarind Hospital; Department of Surgery

location_facility: University Cancer & Blood Center, LLC; Research

location_facility: Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen

location_facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Tata Memorial Hospital; Dept of Medical Oncology

location_facility: University of Eastern Piedmont - Maggiore della Carità University Hospital

location_facility: Mackay Memorial Hospital; Dept of Surgery

location_facility: Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Kyungpook National University Medical Center

location_facility: Hemato Oncology Clinic Ahmedabad Pvt Ltd

location_facility: Hospital Alvaro Cunqueiro; Servicio de Oncologia

location_facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

location_facility: Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie

location_facility: National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center

location_facility: Antalya Training and Research Hospital ; Oncology Department

location_facility: Municipal Institution Kirovograd Regional Oncology Dispensary

location_facility: HOPITAL RENE HUGUENIN, Institut Curie; Service d'Oncologie Médicale.

location_facility: Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie

location_facility: Hospital Universitario Dr. Peset; Servicio de Oncologia

location_facility: California Cancer Associate for Research & Excellence

location_facility: Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN

location_facility: COC Plovdiv; First Medical Oncology Department

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie

location_facility: Medical Center "Nadezhda Clinical" EOOD; Medical Oncology Department

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Gynonco Düsseldorf, MVZ Medical Center GmbH

location_facility: AKH - Medizinische Universität Wien; Department of Oncology

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk

location_facility: Bradford Royal Infirmary; Oncology Department

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Barts & London School of Med; Medical Oncology

location_facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology

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

location_facility: Seoul National University Bundang Hospital

location_facility: China Medical University Hospital; Surgery

location_facility: Hospital Clinic Barcelona; Servicio de oncologia

location_facility: Klinikum Ernst von Bergmann; Frauenklinik

location_facility: Royal North Shore Hospital; Department of Medical Oncology

location_facility: Städtisches Klinikum Karlsruhe gGmbH; Frauenklinik

location_facility: Hospital Quiron de Madrid; Servicio de Oncologia

location_facility: UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Hospital CUF Tejo; Oncologia Médica e Hematologia

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

location_facility: Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe

location_facility: Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy

location_facility: MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department

location_facility: Euromedical General Clinic of Thessaloniki; Oncology Department

location_facility: Max Super Speciality Hospital; Medical Oncology

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

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Mays Cancer Center at UT Health San Antonio MD Anderson Cancer

location_facility: Auckland City Hospital, Cancer and Blood Research

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

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

location_facility: Hospital de Basurto; Servicio de Oncologia

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Princess Alexandra Hospital; Cancer Trials Unit

location_facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD

location_facility: Narodowy Instytut Onkologii Odział w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi

location_facility: University General Hospital of Heraklion

location_facility: Inonu University Medical Faculty of Medicine; Medical Oncology Department

location_facility: Nizhny Novgorod Regional Clinical Oncology Center

location_facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly

location_facility: Hematology Oncology Associates of Fredericksburg, Inc.

location_facility: Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit

location_facility: Masarykův onkologický ústav; Klinika komplexní onkologické péče

location_facility: Rajiv Gandhi Cancer Institute & Research Center

location_facility: Adana Baskent University Hospital; Medical Oncology

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

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

location_facility: Sf. Nectarie Oncology Center; Medical oncology

location_facility: Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center

location_facility: SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM"

summary: This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.


title: A Pivotal Phase II Randomised, Multi-centre, Open-label Study to Evaluate the Efficacy and Safety of MB-CART2019.1 Compared to SoC Therapy in Participants With r/r DLBCL, Who Are Not Eligible for HDC and ASCT

acronym: DALY 2-EU

summary: This is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.

lead_sponsor: Miltenyi Biomedicine GmbH

location_country: Poland Spain Italy Austria Netherlands Lithuania Sweden Hungary France Belgium Germany Czechia

location_facility: University Medical Center Hamburg-Eppendorf

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu. Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku

location_facility: Amsterdam Universitaire Medische Centra (UMC) - locatie Amsterdam Medisch Centrum (AMC)

location_facility: Klinikum der Universitat München, Studienzentrale fur Hematologie der Medizinischen Klinik II

location_facility: Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin

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

location_facility: Centre Hospitalier Universitaire de Montpellier - Hopital Saint-Eloi

location_facility: Universitaetsklinikum Knappschaftskrankenhaus Bochum der Ruhr-Universitat Bochum

location_facility: IRCCS - AOU di Bologna - Sant¿Orsola Malpighi

location_facility: Catalan Institute of Oncology (ICO) Hospitalet

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Universite Catholique de Louvain Namur, Centre Hospitalier Universitaire Dinant Godinne Site Godinne

location_facility: Azienda Ospedaliera San Giovanni Battista Di Torino

location_facility: Institut Universitaire du Cancer Service d´hématologie

location_facility: Universitatsklinikum Innsbruck Universitatsklinik fur Innere Medizin V

location_facility: Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH)

location_facility: Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Groupement Hospitalier Sud

location_facility: Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu

location_facility: Centre Hospitalier Universitaire de Poitiers

location_facility: Klinikum Erlangen der Friedrich-Alexander-Universitaet Erlangen-Nuernberg

location_facility: Hospital Clinic de Barcelona - Institut Clinic de Malalties Hematologiques i Oncologiques (ICMHO)

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

location_facility: Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque


title: A Phase III, Open-Label, Randomized Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

summary: This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here ( https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

location_country:
Croatia
Spain
Italy
United Kingdom
Costa Rica
Belgium
Philippines
Japan
Slovenia
Austria
Russian Federation
Israel
Turkey
Malaysia
Brazil
Canada
Switzerland
China
Germany
Taiwan
Greece
Finland
Thailand
Korea, Republic of
France
Chile

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

location_facility: Pontificia Universidad Catolica de Chile; Clinica San Carlos de Apoquindo

location_facility: I.M.Sechenov First Moscow State Medical University (1st MSMU)

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Clinica Universitaria de Navarra; Servicio de Hepatologia

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: A.O. S. Orsola Malpighi; Ambulatorio Epatocarcinoma (Bolondi)

location_facility: Hammersmith Hospital; Clinical trials unit

location_facility: CHU Grenoble Sud; Service hépato-gastroentérologie

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Moscow City Oncology Hospital #62; Outpatient Care Center

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

location_facility: Hippokratio Hospital; 4Th Internal Medicine Dpt

location_facility: Sourasky Medical Center; Oncology Department

location_facility: START Madrid. Centro Integral Oncologico Clara Campal; CIOCC

location_facility: Harbin Medical University Cancer Hospital

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: Medizinische Universität Innsbruck; Universitätsklinik für Innere Medizin I

location_facility: Chi-Mei Medical Centre; Hematology & Oncology

location_facility: Hospital Universitario Reina Sofia; Servicio de Hepatologia

location_facility: Laiko General Hospital Athen; Uni Clinic of Gastrenterology

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

location_facility: West China Hospital - Sichuan University

location_facility: King College Hospital NHS Foundation Trust

location_facility: Centre Eugene Marquis; Service d'oncologie; Direction de la Recherche Clinique

location_facility: Clinica Universidad de Navarra Madrid; Servicio de Oncología

location_facility: Sociedade beneficente de senhoras Hospital Sirio Libanes

location_facility: Azienda Osp Uni Seconda Università Degli Studi Di Napoli; Unità Operativa Oncologia Medica

location_facility: University Medical Center Ljubljana; Clinical Dept. of Gastroenterology

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: A.O.U. Policlinico Paolo Giaccone; Gastroenterologia ed Epatologia

location_facility: The Clatterbridge Cancer Centre NHS Foundation Trust

location_facility: National Taiwan University Hospital; Oncology

location_facility: CHU Nice - Hôpital de l'Archet 2; service Hepato gastro enterologie

location_facility: Universitätsklinikum Ulm; Zentrum für Innere Medizin Klinik für Innere Medizin I

location_facility: Klinikum Esslingen; Allg. Innere Med., Onkologie, Hämatologie, Gastroenterologie und Infektiologie

location_facility: Anticancer Hospital of Thessaloniki " Theagenio"

location_facility: Hospital Son Llatzer; Servicio de Oncologia

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

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Azienda Ospedaliera Ordine Mauriziano di Torino

location_facility: Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia

location_facility: Med. Hochschule Hannover; Gastroenterologie

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Shengjing Hospital of China Medical University

location_facility: The First Affiliated Hospital, Sun Yat-sen University

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Hepatologia

location_facility: Universitätsspital Zürich Medizin Gastroenterologie; Klinik für Gastroenterologie und Hepatologie

location_facility: Hopitaux de Brabois - Gastro-Entereologie

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

location_facility: Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2

location_facility: Adana Acıbadem Hospital Oncology Department

location_facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Cebu Doctors' University Hospital; Research Office

location_facility: TAYS Radius rakennus; onkologinen lääketutkimusyksikkö

location_facility: Inselspital Bern Medizin Gastroenterologie

location_facility: Uni Malaya Medical Center; Clinical Oncology Unit, Menara Timur

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: FSBI "National Medical Research Center of Oncology N.N. Blokhin"

location_facility: Universitätsklinikum St. Pölten; Innere Medizin 2

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Universität Tübingen; Med. Klinik; Innere Medizin I

location_facility: Agioi Anargiroi Hospital of Kifissia; University Internal Medicine Clinic

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Beacon International Specialist Centre; Clinical Research Department, Level 2

location_facility: Hospital Clinico de La Universidad de Chile J.J.A.; Oncologia

location_facility: Medipol Mega Üniversite Hastanesi Göztepe

location_facility: Fondazione Pascale; U.O. Sperimentazioni Cliniche

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

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

location_facility: Churchill Hospital; Department of Oncology

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Hopital Paul Brousse; Centre Hepatologie Biliaire


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma

acronym: InMIND

summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.

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:
Spain
Italy
United Kingdom
United States
Belgium
Japan
Czechia
Poland
Austria
Australia
Israel
Turkey
Norway
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Ireland
Finland
Korea, Republic of
France
Netherlands

location_facility: Uo Ematologia Univ - Aoup Santa Chiara Pisa

location_facility: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego

location_facility: Taipei Veterans General Hospital Institutional Review Board

location_facility: The Royal Marsden Nhs Foundation Trust - Sutton

location_facility: Queen Elizabeth Ii Health Sciences Centre

location_facility: Goetalandsregionen - Uddevalla Sjukhus Us

location_facility: Hospital Universitario Quironsalud Madrid

location_facility: John Muir Health Clinical Research Center

location_facility: Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori

location_facility: Complejo Hospitalario Universitario A Coruna

location_facility: University of Maryland - Greenebaum Cancer Center

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Consorci Hospitalari Parc Tauli de Sabadell

location_facility: Institut Catala Doncologia Ico - Hospital Duran I Reynals Location

location_facility: Fundacion Jimenez Diaz University Hospital

location_facility: Chu Ucl Namur University Hospital Mont-Godinne

location_facility: Pusan National University Yangsan Hospital

location_facility: Texas Oncology-Baylor Charles A. Sammons

location_facility: Rabin Medical Center - Beilinson Hospital

location_facility: Medizinische Universitat Wien Allgemeines Krankenhaus Der Stadt Wien

location_facility: Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara

location_facility: National Cheng Kung University (Ncku) Hospital

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Uppsala Universitet - Akademiska Sjukhuset

location_facility: Kobe City Medical Center General Hospital

location_facility: Istituto Nazionale Tumori Irccs Fondazione Pascale

location_facility: University Hospitals Birmingham Nhs Foundation Trust

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: University Hospital of West Attica - Attikon

location_facility: Oncological Institute of Southern Switzerland

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Hospital of the University of Occupation and Environmental Health

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Irccs Azienda Ospedaliera Universitaria San Martino

location_facility: University Clinic Giessen Und Marburg Ukgm

location_facility: Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Pratia Onkologia Katowice,Ul. Kosciuszki 92

location_facility: Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand

location_facility: Uniwersytet Medyczny W Lodzi - Klinika Hematologii

location_facility: Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

location_facility: Universitair Ziekenhuis Antwerpen, Dienst Hematologie

location_facility: Hospital Universitario Virgen de La Arrixaca

location_facility: Wollongong Hospital - Illawarra Regional Hospital

location_facility: The Royal Marsden Nhs Foundation Trust - Chelsea

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: The Catholic University of Korea Yeoido St.Mary'S Hospital

location_facility: Chru Hopitaux de Tours Hospital Bretonneau

location_facility: Fondazione Del Piemonte Per L Oncologia Ircc Candiolo

location_facility: Daegu Catholic University Medical Center

location_facility: Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Des Moines Oncology Research Association

location_facility: Hospital Universitario Virgen de La Victoria

location_facility: Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna

location_facility: McGill University Jewish General Hospital

location_facility: Keimyung University Dongsan Medical Center

location_facility: Ausl Di Placenza Ospedale Guglielmo Da Saliceto

location_facility: Charleston Hematology Oncology Associates

location_facility: The Center For Cancer and Blood Disorders

location_facility: University of Washington - Seattle Cancer Care Alliance

location_facility: Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika

location_facility: Universitetssykehuset I Trondheim - St. Olavs Hospital

location_facility: Hospital General Unviersitario de Alicante

location_facility: Severance Hospital Yonsei University Health System

location_facility: Hospital Universitario Virgen del Rocio Sevilla

location_facility: Klinik Fur Innere Medizin Hamatologie and Onkologie

location_facility: Hospital Saint-Louis Service Oncologie Medicale

location_facility: Medizinische Fakultaet Mannheim Der Universitaet Heidelberg

location_facility: Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc)

location_facility: University Hospital of Basel Department of Oncology

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: "Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic

location_facility: Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center


title: A Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy

summary: This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Czechia
Poland
Russian Federation
Argentina
Israel
Turkey
Brazil
Canada
China
Germany
Greece
Ireland
Korea, Republic of
France
Colombia

location_facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Huashan Hospital Affiliated to Fudan University

location_facility: Centro Oncologico MD Anderson Internacional; Servicio de Oncologia

location_facility: *X*Fundação Pio XII Hospital de Câncer de Barretos

location_facility: Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes

location_facility: Hospital Universitari Vall d'Hebron; Oncology

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Russian Scientific Center of Roentgenoradiology

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4

location_facility: Azienda Ospedaliera Santa Maria di Terni

location_facility: Institut Mutualiste Montsouris; Oncologie

location_facility: A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica

location_facility: The First Affiliated Hospital of Guangzhou Medical University

location_facility: Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o.

location_facility: Universitätsklinikum Tübingen; Klinik für Urologie

location_facility: ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico

location_facility: Instituto Cancerologia Medellin; Clinica Las Americas

location_facility: The First Affiliated Hospital of Fujian Medical University

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

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

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

location_facility: Medeniyet University Goztepe Training and Research Hospital.

location_facility: Harbin Medical University Cancer Hospital

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Szpital Uniwersytecki Nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy; Klinika Urologii i Onkologicznej

location_facility: Universitätsklinikum Ulm; Klinik für Urologie

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

location_facility: Universitätsklinikum der Ruhr-Universität Bochum, Marien-Hospital Herne, Urologische Klinik

location_facility: Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit

location_facility: Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

location_facility: Fujian Medical University Union Hospital

location_facility: Hiroshima City Hiroshima Citizens Hospital

location_facility: University Hospital of Larissa;Department of Medical Oncology

location_facility: Universitätsklinikum Würzburg; Klinik und Poliklinik für Urologie und Kinderurologie

location_facility: Ankara University Faculty of Medicine Cebeci Hospital

location_facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

location_facility: Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

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

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: Hospital Alemao Oswaldo Cruz; Pesquisa Clinica

location_facility: Corporacio Sanitaria Parc Tauli; Servicio de Oncologia

location_facility: Murmansk Regional Clinical Hospital named after P.A. Bayandin

location_facility: Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli", Day Hospital Oncologico

location_facility: Southampton University Hospitals NHS Trust

location_facility: University Hospital of Patras Medical Oncology

location_facility: Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: University College London NHS Foundation Trust

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Oncocentro Serviços Medicos E Hospitalares Ltda

location_facility: CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER

location_facility: Saitama Medical University International Medical Center

location_facility: Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

location_facility: Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Krankenhaus Martha-Maria Halle-Dölau, Klinik für Urologie

location_facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Chemioterapii

location_facility: Universitätsklinikum Jena, Urologische Klinik und Poliklinik

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Hospital de Donostia; Servicio de Oncologia Medica

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

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: St-Petersburg Regional Oncology Dispensary; Oncology

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

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica

location_facility: ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council

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

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Xinjiang Medical University Cancer Hospital

location_facility: Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

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

location_facility: Friendship Hospital, Capital Medical University

location_facility: Alexandras General Hospital of Athens; Oncology Department

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

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Universitätsklinikum Düsseldorf; Urologische Klinik

location_facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

location_facility: FSI Russian Centre of Radiology and Surgical Technologies


title: Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)

summary: This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

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

lead_sponsor: Daiichi Sankyo, Inc.

location_country:
Spain
Italy
United Kingdom
United States
Romania
Belgium
Japan
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
Puerto Rico
Mexico
Singapore
Brazil
Canada
Switzerland
Hungary
China
Germany
Taiwan
Korea, Republic of
France
Netherlands

location_facility: The Center for Cancer and Blood Disorders

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

location_facility: CHU de Poitier Pole regional de Cancerologie

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: The Catholic University of Korea, Seoul St. Marys Hospital

location_facility: Szpital Specjalistyczny w Prabutach Sp. z o.o.

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Oddział Onkologii Wojewódzki Szpital Specjalistyczny Słupsk

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Hospital General Universitario de Valencia

location_facility: Instituicao de Fisioterapeutas Ocupacionais

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: University Health Network - Princess Margaret Hospital

location_facility: Seoul National University Boramae Medical Center

location_facility: ASL 3 Genovese Oncologia Medica Villa Scassi

location_facility: FN Olomouc â€" Klinika plicnich nemoci a onkologie

location_facility: Azienda Ospedaliera Universitaria Policlinico G Rodolico San Marco

location_facility: Hospital Puerte de Hierro de Majadahonda

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

location_facility: MUHC-Glen Site and MUHC Research Institute

location_facility: Tianjin Medical University Cancer Institute and Hospital

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

location_facility: Hospital Universitario Jose Eleuterio Gonzalez

location_facility: Stadtspital Waid ; Triemli, Site Triemli - clinic for Medical oncology & hematology

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Chi Mei Medical Center CMMC - Liouying Branch

location_facility: Crown Princess Mary Cancer Centre Westmead Hospital

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Fondazione IRCCS Istituto Nazionale Tumori

location_facility: Institutul Oncologic Profesor Doctor Alexandru Trestioreanu

location_facility: N.N. Petrov Research Institute of Oncology

location_facility: OncoCare Cancer Centre - Gleneagles Medical Centre Location

location_facility: University Hospitals Cleveland Medical Center

location_facility: Saitama Medical University International Medical Center

location_facility: Maria Sklodowska-Curie National Research Institute of Oncology

location_facility: Ft. Wayne Medical Oncology and Hematology

location_facility: Portsmouth Hospitals University NHS Trust

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

location_facility: Yonsei University Health System - Severance Hospital

location_facility: The Oncology Institute of Hope and Innovation

location_facility: Chang Gung Memorial Hospital CGMH - Kaohsiung Branch

location_facility: Memorial Healthcare System- Memorial Cancer Institute

location_facility: Seoul National University Bundang Hospital

location_facility: National Taiwan University Hospital NTUH

location_facility: Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS

location_facility: Federal State Budgetary Institution - N.N. Blokhin National Medical Research Center of Oncology

location_facility: Hospital Clinico Universitario Lozano Bleza

location_facility: National Cheng Kung University Hospital NCKUH

location_facility: St. Vincents Hospital The Catholic University of Korea

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Hospital Universitario Fundacion Jimenez Diaz

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: University Hospital of Nantes - Thoracic Oncology

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet

location_facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC)

summary: This is a Global Study of Neoadjuvant-Adjuvant Durvalumab or Placebo and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN).

status: Active, not recruiting

ReferenceCitation: Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304. Review.

ReferenceCitation: Janjigian YY, Van Cutsem E, Muro K, Wainberg Z, Al-Batran SE, Hyung WJ, Molena D, Marcovitz M, Ruscica D, Robbins SH, Negro A, Tabernero J. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. Future Oncol. 2022 Jun;18(20):2465-2473. doi: 10.2217/fon-2022-0093. Epub 2022 May 10. Review.

ReferenceCitation: Cowzer D, Janjigian YY. Top advances in esophageal/gastroesophageal junction cancers in 2021. Cancer. 2022 May 15;128(10):1894-1899. doi: 10.1002/cncr.34140. Epub 2022 Feb 18.

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.

location_country:
Denmark
Poland
Taiwan
Brazil
Spain
United Kingdom
Russian Federation
Netherlands
Argentina
Canada
Hungary
Korea, Republic of
United States
Chile
France
Peru
Belgium
Japan
Germany
Turkey


title: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Spain
Italy
United States
Japan
Hong Kong
Russian Federation
Australia
Argentina
Puerto Rico
Israel
Turkey
Mexico
Malaysia
Sweden
Canada
China
Germany
Taiwan
Greece
New Zealand
Korea, Republic of
France
Chile
Colombia

location_facility: The Liver Institute at Methodist Dallas Medical Center ( Site 2638)

location_facility: Universitaetsklinikum Leipzig ( Site 0447)

location_facility: South Texas Research Institute ( Site 9012)

location_facility: hopital haut leveque chu de bordeaux-Service d'Hépato-gastroentérologie ( Site 0805)

location_facility: UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si

location_facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 1405)

location_facility: Regional Gastroenterology Associates of Lancaster, LTD ( Site 9020)

location_facility: Texas Clinical Research Institute ( Site 2619)

location_facility: The First People's Hospital of Foshan-Infection Department ( Site 0612)

location_facility: NYU Langone Health, New York ( Site 2627)

location_facility: Hospital Universitario Austral ( Site 0003)

location_facility: Maccabi Health Services - Ramat Hasharon ( Site 1206)

location_facility: Medical Care and Research S.A. de C.V. ( Site 1506)

location_facility: Azienda Ospedaliera Policlinico Umberto I ( Site 1300)

location_facility: Kagoshima University Hospital ( Site 1418)

location_facility: Ankara University Cebeci Research and Application Hospital ( Site 2406)

location_facility: GIRI GI Research Institute - Vancouver ( Site 0404)

location_facility: Velocity Clinical Research, Panorama City-National Research Institute ( Site 9001)

location_facility: Shinyurigaoka General Hospital ( Site 1420)

location_facility: SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910)

location_facility: Pusan National University Hospital-Internal Medicine ( Site 2010)

location_facility: Velocity Clinical Research, Santa Ana ( Site 9002)

location_facility: Kansas City Research Institute ( Site 9018)

location_facility: Fukui-ken Saiseikai Hospital ( Site 1410)

location_facility: Hope Clinical Research, Inc. ( Site 2601)

location_facility: Universitätsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445)

location_facility: Osaka Metropolitan University Hospital ( Site 1415)

location_facility: Beijing YouAn Hospital, Capital Medical University ( Site 0605)

location_facility: Velocity Clinical Research, Huntington Park ( Site 9022)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0501)

location_facility: Chung Shan Medical University Hospital ( Site 2307)

location_facility: Gazi University Medical Faculty ( Site 2405)

location_facility: Hospital Británico de Buenos Aires ( Site 0002)

location_facility: Centro de Investigaciones Clinicas Vina del Mar ( Site 0502)

location_facility: Hiroshima University Hospital ( Site 1413)

location_facility: The Crofoot Research Center, Inc. ( Site 2611)

location_facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)

location_facility: Centro de Investigacion Medico Biologica y Terapia Avanzada SC ( Site 1511)

location_facility: University Health Network - Toronto General Hospital ( Site 0401)

location_facility: Hospital Universitario Virgen del Rocio ( Site 2105)

location_facility: Centre Hospitalier et Universitaire Dupuytren ( Site 0810)

location_facility: Centro de Investigacion y Gastroenterologia SC ( Site 1503)

location_facility: IRCCS Istituto Clinico Humanitas di Rozzano ( Site 1303)

location_facility: Sweet Hope Research Specialty Inc ( Site 2660)

location_facility: Baylor College of Medicine - Advanced Liver Therapies ( Site 2670)

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)

location_facility: Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401)

location_facility: Seoul National University Bundang Hospital-Internal Medicine ( Site 2005)

location_facility: The National Diabetes & Obesity Research Institute ( Site 9017)

location_facility: California Liver Research Institute ( Site 9025)

location_facility: Southeast Clinical Research Center ( Site 9003)

location_facility: The Affiliated Hospital of Hangzhou Normal University ( Site 0600)

location_facility: Hospital Italiano de Buenos Aires-Hepatology ( Site 0014)

location_facility: Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2402)

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 2100)

location_facility: Center targetnoy therapy-Gastroenterology ( Site 1918)

location_facility: American Research Corporation at Texas Liver Institute ( Site 2634)

location_facility: Ege University Medical Faculty ( Site 2404)

location_facility: Korea University Guro Hospital ( Site 2004)

location_facility: Hospital Kuala Lumpur-Gastroenterology Department ( Site 2701)

location_facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)

location_facility: Del Sol Research Management ( Site 2674)

location_facility: Adobe Clinical Research, LLC ( Site 2644)

location_facility: Hospital Regional de Concepcion ( Site 0505)

location_facility: Ruane Clinical Research Group, Inc ( Site 9014)

location_facility: Catalina Research Institute, LLC ( Site 2643)

location_facility: Indago Research and Health Center Inc ( Site 2610)

location_facility: Taichung Veterans General Hospital ( Site 2306)

location_facility: A O U Policlinico di Modena ( Site 1307)

location_facility: Hospital Clinic de Barcelona ( Site 2102)

location_facility: Regional Gastroenterology Associates of Lancaster, LTD ( Site 9004)

location_facility: Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602)

location_facility: Excel Clinical Research, LLC ( Site 2603)

location_facility: Hospital Provincial del Centenario ( Site 0007)

location_facility: National Taiwan University Hospital ( Site 2301)

location_facility: Universitaetsklinikum Freiburg ( Site 0446)

location_facility: Hanyang University Seoul Hospital ( Site 2002)

location_facility: Azienda Ospedaliera Universitaria Integrata Verona ( Site 1301)

location_facility: C.H.U. Nancy Hopital de Brabois ( Site 0803)

location_facility: Covenant Metabolic Specialists, LLC ( Site 9027)

location_facility: McGill University Health Centre ( Site 0400)

location_facility: Legacy Clinical Solutions: Tandem Clinical Research, LLC ( Site 2650)

location_facility: Charite Universitaetsmedizin Berlin ( Site 0443)

location_facility: Kawasaki Medical School General Medical Center ( Site 1412)

location_facility: A.P.H. Paris, Hopital Saint Antoine ( Site 0807)

location_facility: Hippokration University Hopsital-4th Department of Internal Medicine ( Site 3300)

location_facility: Ocean Blue Medical Research Center Inc ( Site 2667)

location_facility: CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0816)

location_facility: Aichi Medical University Hospital ( Site 1402)

location_facility: Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2008)

location_facility: Velocity Clinical Research, Westlake ( Site 9013)

location_facility: Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906)

location_facility: Yokohama City University Hospital ( Site 1411)

location_facility: Nara Medical University Hospital ( Site 1407)

location_facility: Floridian Clinical Research, LLC ( Site 2656)

location_facility: Velocity Clinical Research, Syracuse ( Site 9016)

location_facility: Pan American Center for Oncology Trials ( Site 3102)

location_facility: Clinical Trials of Texas, LLC ( Site 2614)

location_facility: DHR Health Institute for Research and Development ( Site 9006)

location_facility: Clinical Research Chile SpA ( Site 0506)

location_facility: Hospital Clinico Universitario de Santiago ( Site 2104)

location_facility: Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416)

location_facility: Hospital Universitari Vall d Hebron ( Site 2101)

location_facility: Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006)

location_facility: Hospital San Juan de Dios de La Serena ( Site 0500)

location_facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404)

location_facility: Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1515)

location_facility: General Hospital of Ningxia Medical University ( Site 0607)

location_facility: Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403)

location_facility: Arkansas Gastroenterology - North Little Rock ( Site 9015)

location_facility: North Florida South Georgia Veterans Health System ( Site 2613)

location_facility: Shaare Zedek Medical Center ( Site 1205)

location_facility: Centro de Investigacion Medica de Occidente S.C. ( Site 1514)

location_facility: Genoma Research Group, Inc. ( Site 2669)

location_facility: Russian University of People Friendship ( Site 1907)

location_facility: Peak Gastroenterology Associates ( Site 2645)

location_facility: Klinical Investigations Group ( Site 3100)

location_facility: City Clinical Hospital named V.M.Buyanova ( Site 1922)

location_facility: Royal Prince Alfred Hospital ( Site 0102)

location_facility: Kanazawa University Hospital ( Site 1419)

location_facility: Auckland Clinical Studies Limited ( Site 1600)

location_facility: Scientific research center ECO-security ( Site 1920)

location_facility: Seoul National University Hospital ( Site 2003)

location_facility: CHU de Nice Hopital de l Archet II ( Site 0800)

location_facility: Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2106)

location_facility: Medical Rehabilitation Center ( Site 1904)

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302)

location_facility: National Cheng Kung University Hospital ( Site 2304)

location_facility: Glenny Corp. S.A.-CLINICAL RESEARCH ( Site 0013)

location_facility: Chungang University Hospital ( Site 2007)

location_facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 2305)

location_facility: Chongqing Three Gorges Central Hospital ( Site 0618)

location_facility: Fundacion Santa Fe de Bogota ( Site 0705)

location_facility: Virginia Commonwealth University Health System ( Site 2657)

location_facility: Karolinska Universitetssjukhuset Huddinge ( Site 2900)

location_facility: Johannes Gutenberg Universitat Mainz ( Site 0442)

location_facility: Hopital de la Pitie Salpetriere ( Site 0813)

summary: This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.