title: A Multicenter, Randomized, Open-label, Parallel-group, Phase 3 Trial of Subcutaneous Azacitidine Plus Best Supportive Care Versus Conventional Care Regimens Plus Best Supportive Care for the Treatment of Myelodysplastic Syndromes (MDS)

summary:
The purpose of this study is to determine whether patients with high-risk myelodysplastic syndromes (MDS) treated with azacitidine have improved survival compared to conventional care treatments. The study will also assess the effect of treatments on response, duration of response, and transformation to acute myeloid leukemia (AML). The study will continue for 12 months following last patient enrolled.

See study AZA PH GL 2003 CL 001 E for information about the extension to this study.

primary_purpose: Other

ReferenceCitation: Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Gattermann N, Germing U, Sanz G, List AF, Gore S, Seymour JF, Dombret H, Backstrom J, Zimmerman L, McKenzie D, Beach CL, Silverman LR. Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia. J Clin Oncol. 2010 Feb 1;28(4):562-9. doi: 10.1200/JCO.2009.23.8329. Epub 2009 Dec 21.

ReferenceCitation: Fenaux P, Gattermann N, Seymour JF, Hellstrom-Lindberg E, Mufti GJ, Duehrsen U, Gore SD, Ramos F, Beyne-Rauzy O, List A, McKenzie D, Backstrom J, Beach CL. Prolonged survival with improved tolerability in higher-risk myelodysplastic syndromes: azacitidine compared with low dose ara-C. Br J Haematol. 2010 Apr;149(2):244-9. doi: 10.1111/j.1365-2141.2010.08082.x. Epub 2010 Feb 5. Erratum In: Br J Haematol. 2010 Jun;149(6):919.

ReferenceCitation: Santini V, Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Silverman LR, List A, Gore SD, Seymour JF, Backstrom J, Beach CL. Management and supportive care measures for adverse events in patients with myelodysplastic syndromes treated with azacitidine*. Eur J Haematol. 2010 Aug;85(2):130-8. doi: 10.1111/j.1600-0609.2010.01456.x. Epub 2010 Apr 12.

ReferenceCitation: Seymour JF, Fenaux P, Silverman LR, Mufti GJ, Hellstrom-Lindberg E, Santini V, List AF, Gore SD, Backstrom J, McKenzie D, Beach CL. Effects of azacitidine compared with conventional care regimens in elderly (>/= 75 years) patients with higher-risk myelodysplastic syndromes. Crit Rev Oncol Hematol. 2010 Dec;76(3):218-27. doi: 10.1016/j.critrevonc.2010.04.005. Epub 2010 May 6.

ReferenceCitation: Fenaux P, Mufti GJ, Hellstrom-Lindberg E, Santini V, Finelli C, Giagounidis A, Schoch R, Gattermann N, Sanz G, List A, Gore SD, Seymour JF, Bennett JM, Byrd J, Backstrom J, Zimmerman L, McKenzie D, Beach C, Silverman LR; International Vidaza High-Risk MDS Survival Study Group. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. Lancet Oncol. 2009 Mar;10(3):223-32. doi: 10.1016/S1470-2045(09)70003-8. Epub 2009 Feb 21.

ReferenceCitation: Gore SD, Fenaux P, Santini V, Bennett JM, Silverman LR, Seymour JF, Hellstrom-Lindberg E, Swern AS, Beach CL, List AF. A multivariate analysis of the relationship between response and survival among patients with higher-risk myelodysplastic syndromes treated within azacitidine or conventional care regimens in the randomized AZA-001 trial. Haematologica. 2013 Jul;98(7):1067-72. doi: 10.3324/haematol.2012.074831. Epub 2013 Apr 12.

license: publisher-specific license

license_normalized: publisher-specific

repository_institution: University of Florence - Florence Research

repositories_concat: PubMed Central;flore.unifi.it

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

lead_sponsor: Celgene

location_country:
Germany
Italy
Poland
Hungary
United Kingdom
Australia
Sweden
Netherlands
United States
Spain
Greece
Czechia
Bulgaria
Russian Federation
France

location_facility: University General Hospital of Patra Rio

location_facility: University of Pecs, 1st Dept of Internal Medicine

location_facility: The Newcastle Mater Miseriecordiae Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Institute of Haematology & Blood Transfusion

location_facility: III-rd Internal Department, District Dispensary for Oncology diseases with stationary(DDOncDIU)

location_facility: Ospedale Casa Sollievo Della Sofferenza - Irrc

location_facility: National Centre of Hematology and Transfusiology, Sofia

location_facility: University Multiprofile Hospital for Active Treatment "Sveta Marina"

location_facility: University of Alabama School of Medicine

location_facility: MHAT "St George" Clinic of Hematology, Plovdiv

location_facility: Burdenko Central Military Clinical Hospital

location_facility: Multiprofile Hospital for Active Treatment (MHAT), "St. Marina" Clinic of Hematology

location_facility: University of Szeged, 2nd Department of Internal Medicine

location_facility: University General Hospital of Heraklio Voutes

location_facility: First Clinical Base - Clinic of Hematology, MHAT - Pleven

location_facility: Hospital Universitario Germans Trias I Pujol

location_facility: Instituto Nazionale Tumori "Regina Elena"

location_facility: Samodzelny Publiczny Centralny Szpital Kliniczny


title: A Randomized, Double-blind, Placebo-controlled, Phase III Study of Oxaliplatin/5-fluorouracil/Leucovorin With PTK787/ZK 222584 or Placebo in Patients With Previously Treated Metastatic Adenocarcinoma of the Colon or Rectum

summary: The purpose of this study is to compare treatment with oxaliplatin/5-FU/leucovorin plus vatalanib versus oxaliplatin/5-FU/leucovorin plus placebo in patients with colorectal cancer that has spread to other organs and whose disease has worsened after treatment with irinotecan.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Van Cutsem E, Bajetta E, Valle J, Kohne CH, Hecht JR, Moore M, Germond C, Berg W, Chen BL, Jalava T, Lebwohl D, Meinhardt G, Laurent D, Lin E. Randomized, placebo-controlled, phase III study of oxaliplatin, fluorouracil, and leucovorin with or without PTK787/ZK 222584 in patients with previously treated metastatic colorectal adenocarcinoma. J Clin Oncol. 2011 May 20;29(15):2004-10. doi: 10.1200/JCO.2010.29.5436. Epub 2011 Apr 4.

lead_sponsor: Novartis Pharmaceuticals

sponsor_collaborators:
Novartis Pharmaceuticals
Bayer

location_country:
Germany
Italy
Portugal
New Zealand
Slovakia
United Kingdom
Hong Kong
Australia
Brazil
Sweden
Austria
Belgium
Switzerland
United States
Spain
Taiwan
Canada
France

location_facility: Hematology/Oncology Associates of Central NY

location_facility: Fallon Clinic at Worcester Medical Center

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: Tulane University Health Sciences Center

location_facility: Sansum Santa Barbara Foundation Medical Clinic

location_facility: University of Chicago medical Center, Hematology/Oncology

location_facility: Oncology/Hematology Group of South Florida

location_facility: Consultants in Medical Oncology & Hematology

location_facility: Cancer Treatment Centers of America in Hampton Roads

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Center for Oncology Research & Treatment

location_facility: Oncology Hematology Associates of Central Illinois, PC

location_facility: University of Tennessee Cancer Institute

location_facility: Hematology Oncology Associates of Treasure Coast

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Maine Center for Cancer Medicine & Blood Disorders

location_facility: Vanderbilt University School of Medicine

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Synergy Hematology-Oncology Medical Associates

location_facility: Hematology Oncology Associates of Northern New Jersey

location_facility: Washington University School of Medicine

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Hematology-Oncology Associates of Rockland

location_facility: St. Vincent's Catholic Medical Centers of New York

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: North Central Montana Professional Building

location_facility: California Oncology of the Central Valley

location_facility: West Virginia University Health Sciences Center

location_facility: Hematology & Oncology Associates of NE PA

location_facility: Center for Cancer and Hematologic Disease

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy

summary: The primary purpose of the study is to determine if patients with brain metastases from non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation therapy retain their neurologic function and ability to think for a longer time compared to patients treated with whole brain radiation therapy alone.

ReferenceType: background

ReferenceCitation: Mehta MP, Shapiro WR, Glantz MJ, Patchell RA, Weitzner MA, Meyers CA, Schultz CJ, Roa WH, Leibenhaut M, Ford J, Curran W, Phan S, Smith JA, Miller RA, Renschler MF. Lead-in phase to randomized trial of motexafin gadolinium and whole-brain radiation for patients with brain metastases: centralized assessment of magnetic resonance imaging, neurocognitive, and neurologic end points. J Clin Oncol. 2002 Aug 15;20(16):3445-53. doi: 10.1200/JCO.2002.07.500.

ReferenceCitation: Carde P, Timmerman R, Mehta MP, Koprowski CD, Ford J, Tishler RB, Miles D, Miller RA, Renschler MF. Multicenter phase Ib/II trial of the radiation enhancer motexafin gadolinium in patients with brain metastases. J Clin Oncol. 2001 Apr 1;19(7):2074-83. doi: 10.1200/JCO.2001.19.7.2074.

ReferenceCitation: Rosenthal DI, Nurenberg P, Becerra CR, Frenkel EP, Carbone DP, Lum BL, Miller R, Engel J, Young S, Miles D, Renschler MF. A phase I single-dose trial of gadolinium texaphyrin (Gd-Tex), a tumor selective radiation sensitizer detectable by magnetic resonance imaging. Clin Cancer Res. 1999 Apr;5(4):739-45.

ReferenceCitation: Magda D, Lepp C, Gerasimchuk N, Lee I, Sessler JL, Lin A, Biaglow JE, Miller RA. Redox cycling by motexafin gadolinium enhances cellular response to ionizing radiation by forming reactive oxygen species. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):1025-36. doi: 10.1016/s0360-3016(01)01810-7.

ReferenceCitation: Miller RA, Woodburn K, Fan Q, Renschler MF, Sessler JL, Koutcher JA. In vivo animal studies with gadolinium (III) texaphyrin as a radiation enhancer. Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):981-9. doi: 10.1016/s0360-3016(99)00274-6.

lead_sponsor: Pharmacyclics LLC.

location_country:
Germany
Australia
Netherlands
Austria
Belgium
United States
Canada
France


title: An International, Multi-Center, Randomized, Open-Label Study of PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

summary: This study will compare the efficacy of PS-341 versus high dose dexamethasone.

ReferenceType: derived

ReferenceCitation: Dimopoulos MA, Orlowski RZ, Facon T, Sonneveld P, Anderson KC, Beksac M, Benboubker L, Roddie H, Potamianou A, Couturier C, Feng H, Ataman O, van de Velde H, Richardson PG. Retrospective matched-pairs analysis of bortezomib plus dexamethasone versus bortezomib monotherapy in relapsed multiple myeloma. Haematologica. 2015 Jan;100(1):100-6. doi: 10.3324/haematol.2014.112037. Epub 2014 Sep 26.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

license_normalized: no license

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

repository_institution: Erasmus University Rotterdam - EUR Research Repository

evidence: oa repository (via pmcid lookup)

repositories_concat: PubMed Central;pure.eur.nl;repub.eur.nl

unpaywall_oa_status: gold

ReferenceCitation: Lichter DI, Danaee H, Pickard MD, Tayber O, Sintchak M, Shi H, Richardson PG, Cavenagh J, Blade J, Facon T, Niesvizky R, Alsina M, Dalton W, Sonneveld P, Lonial S, van de Velde H, Ricci D, Esseltine DL, Trepicchio WL, Mulligan G, Anderson KC. Sequence analysis of beta-subunit genes of the 20S proteasome in patients with relapsed multiple myeloma treated with bortezomib or dexamethasone. Blood. 2012 Nov 29;120(23):4513-6. doi: 10.1182/blood-2012-05-426924. Epub 2012 Sep 27.

ReferenceCitation: van Duin M, Broyl A, de Knegt Y, Goldschmidt H, Richardson PG, Hop WC, van der Holt B, Joseph-Pietras D, Mulligan G, Neuwirth R, Sahota SS, Sonneveld P. Cancer testis antigens in newly diagnosed and relapse multiple myeloma: prognostic markers and potential targets for immunotherapy. Haematologica. 2011 Nov;96(11):1662-9. doi: 10.3324/haematol.2010.037978. Epub 2011 Jul 26.

ReferenceCitation: Vogl DT, Stadtmauer EA, Richardson PG, Sonneveld P, Schuster MW, Irwin D, Facon T, Harousseau JL, Boral A, Neuwirth R, Anderson KC. Impact of prior therapies on the relative efficacy of bortezomib compared with dexamethasone in patients with relapsed/refractory multiple myeloma. Br J Haematol. 2009 Nov;147(4):531-4. doi: 10.1111/j.1365-2141.2009.07875.x. Epub 2009 Sep 1.

lead_sponsor: Millennium Pharmaceuticals, Inc.

location_country:
Germany
Ireland
Italy
Israel
United Kingdom
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
France

location_facility: Department of Internal Medicine, Univ. of Michigan Comp. Cancer Center

location_facility: University of Erlangen-Nurenberg, Division of Hematology/Oncology

location_facility: Loyola University Medical Center: Cardinal Bernardin Cancer Center

location_facility: Hackensack University Medical Center, David Jurist Research Building

location_facility: Department of Haematology, Queen Elizabeth Hospital

location_facility: Kaiser Permanente Oncology Clinical Trials

location_facility: Department of Hematology, Erasmus MC, 1a, Daniel Den Hoed

location_facility: St. Vincent's Comprehensive Cancer Center, Research Department

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia

location_facility: Texas Oncology at Medical City Dallas Hospital

location_facility: Long Island Jewish Medical Center, Division of Hematology/Oncology

location_facility: Baylor Institute for Immunology Research

location_facility: Lombardi Cancer Center, Georgetown University Medical Center

location_facility: St. Marien Hospital, Klinik fur Hamatologie und Onkologie

location_facility: Toronto General Research Institute, Princess Margaret Hospital

location_facility: Western Pennsylvania Hospital, Dept. of Human Oncology

location_facility: Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie

location_facility: Hospital Claude Huriez, Service des Maladies du Sang

location_facility: Instituto di Ematologia e Oncologia Medica, Lorenzo e Ariosto Seragnoli

location_facility: Azienda Ospedaliera, S. Giovanni Battista

location_facility: University of Essen Medical School, Dept. of Internal Medicine

location_facility: Cliniques Universitaires U.C.L de Mont Godinne, Hopital de Jour

location_facility: Dipartmento Clinico esperimentale Di Oncologia et Ematolgia

location_facility: Department of Haematology, Huddinge University Hospital M54

location_facility: Hopital Saint-Louis, Direction Financiere

location_facility: Karolinska Hospital, Dept. of Hematology

location_facility: Medical University Clinic (Oncology/Haematology)

location_facility: UZ Gasthuisberg, Department of Hematology

location_facility: CHU Erasme / ULB University, Hematology 7th Floor

location_facility: Hopital Hotel Dieu, Service d'hematologie et oncologie medicale

location_facility: Institut Gustave-Roussy, Service d'Hematologie

location_facility: Royal Marsden Hospital, Leukaemia and Myeloma Units

location_facility: Hopital de Brabois, Service Hematologie et Medecine Interne

location_facility: Department of Haematology, St. Bartholomew's Hospital

location_facility: Hospital Clinico Universitario de Barcelona, Haematology Department

location_facility: RAMBAM Medical Center, Department of Hematology and Bone

location_facility: Hopital Antoine Beclere, Hopital de Jour de Medecine Interne

location_facility: Rochester General Hospital, Lipson Cancer Blood Center

location_facility: Universitatsklinikum Charite, Abt. Fuer Haematologie/Onkologie

location_facility: Dept. Hematology, University Medical Centre

location_facility: Beth Israel Deaconess Medical Center, Kirstein Room 135

location_facility: Freiburg University Medical Center, Dept. of Hemayology/Oncology

location_facility: Eberhard-Karls Universitat, Medizinische Klinik

location_facility: Division of Hematology/Stem Cell Transplant

location_facility: Dept. of Clinical Hematology, Academic Medical Center

location_facility: University of Rochester Medical Center, James P. Wilmot Cancer Center

location_facility: Universitatsklinikum Heidelberg, Abt. Fur Haematologie und Onkologie

location_facility: Department of Haematology, ICSM, Hammersmith Hospital

location_facility: Med Star Institute, Washington Cancer Center

location_facility: Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique

location_facility: VA Medical Center, Sections of Hematology/Oncology

location_facility: Johannes Gutenberg-Universitat Mainz, III. Med Klinik und Poliknik

location_facility: H. Lee Moffitt Cancer Center, University of S. Florida

location_facility: University of Pennsylvania Cancer Center


title: PHASE III STUDY OF ADJUVANT PROCARBAZINE, CCNU AND VINCRISTINE CHEMOTHERAPY IN PATIENTS WITH HIGHLY ANAPLASTIC OLIGODENDROGLIOMA

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells, and may be an effective treatment for anaplastic oligodendroglioma. Combining combination chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare radiation therapy with and without combination chemotherapy in patients with resected anaplastic oligodendroglioma.

enrollment_type: Anticipated

ReferenceCitation: Idbaih A, Dalmasso C, Kouwenhoven M, Jeuken J, Carpentier C, Gorlia T, Kros JM, French P, Teepen J, Broet P, Delattre O, Mokhtari K, Sanson M, Delattre JY, van den Bent M, Hoang-Xuan K. Genomic aberrations associated with outcome in anaplastic oligodendroglial tumors treated within the EORTC phase III trial 26951. J Neurooncol. 2011 Jun;103(2):221-30. doi: 10.1007/s11060-010-0380-9. Epub 2010 Sep 6.

ReferenceCitation: Mokhtari K, Ducray F, Kros JM, Gorlia T, Idbaih A, Taphoorn M, Wesseling P, Hoang-Xuan K, Van den Bent M, Sanson M. Alpha-internexin expression predicts outcome in anaplastic oligodendroglial tumors and may positively impact the efficacy of chemotherapy: European organization for research and treatment of cancer trial 26951. Cancer. 2011 Jul 1;117(13):3014-26. doi: 10.1002/cncr.25827. Epub 2011 Jan 18.

ReferenceCitation: van den Bent MJ, Gravendeel LA, Gorlia T, Kros JM, Lapre L, Wesseling P, Teepen JL, Idbaih A, Sanson M, Smitt PA, French PJ. A hypermethylated phenotype is a better predictor of survival than MGMT methylation in anaplastic oligodendroglial brain tumors: a report from EORTC study 26951. Clin Cancer Res. 2011 Nov 15;17(22):7148-55. doi: 10.1158/1078-0432.CCR-11-1274. Epub 2011 Sep 13.

ReferenceCitation: Preusser M, Hoeftberger R, Woehrer A, et al.: Prognostic value and analytical performance (reproducibility) of Ki67 index in anaplastic oligodendroglial tumors: A translational study of the EORTC Brain Tumor Group. [Abstract] J Clin Oncol 28 (Suppl 15): A-2029, 2010.

ReferenceCitation: van den Bent MJ, Dubbink HJ, Marie Y, Brandes AA, Taphoorn MJ, Wesseling P, Frenay M, Tijssen CC, Lacombe D, Idbaih A, van Marion R, Kros JM, Dinjens WN, Gorlia T, Sanson M. IDH1 and IDH2 mutations are prognostic but not predictive for outcome in anaplastic oligodendroglial tumors: a report of the European Organization for Research and Treatment of Cancer Brain Tumor Group. Clin Cancer Res. 2010 Mar 1;16(5):1597-604. doi: 10.1158/1078-0432.CCR-09-2902. Epub 2010 Feb 16.

ReferenceCitation: Kouwenhoven MC, Gorlia T, Kros JM, Ibdaih A, Brandes AA, Bromberg JE, Mokhtari K, van Duinen SG, Teepen JL, Wesseling P, Vandenbos F, Grisold W, Sipos L, Mirimanoff R, Vecht CJ, Allgeier A, Lacombe D, van den Bent MJ. Molecular analysis of anaplastic oligodendroglial tumors in a prospective randomized study: A report from EORTC study 26951. Neuro Oncol. 2009 Dec;11(6):737-46. doi: 10.1215/15228517-2009-011.

ReferenceCitation: van den Bent MJ, Dubbink HJ, Sanson M, van der Lee-Haarloo CR, Hegi M, Jeuken JW, Ibdaih A, Brandes AA, Taphoorn MJ, Frenay M, Lacombe D, Gorlia T, Dinjens WN, Kros JM. MGMT promoter methylation is prognostic but not predictive for outcome to adjuvant PCV chemotherapy in anaplastic oligodendroglial tumors: a report from EORTC Brain Tumor Group Study 26951. J Clin Oncol. 2009 Dec 10;27(35):5881-6. doi: 10.1200/JCO.2009.24.1034. Epub 2009 Nov 9.

ReferenceCitation: Kros JM, Gorlia T, Kouwenhoven MC, Zheng PP, Collins VP, Figarella-Branger D, Giangaspero F, Giannini C, Mokhtari K, Mork SJ, Paetau A, Reifenberger G, van den Bent MJ. Panel review of anaplastic oligodendroglioma from European Organization For Research and Treatment of Cancer Trial 26951: assessment of consensus in diagnosis, influence of 1p/19q loss, and correlations with outcome. J Neuropathol Exp Neurol. 2007 Jun;66(6):545-51. doi: 10.1097/01.jnen.0000263869.84188.72.

ReferenceCitation: Mauer ME, Taphoorn MJ, Bottomley A, Coens C, Efficace F, Sanson M, Brandes AA, van der Rijt CC, Bernsen HJ, Frenay M, Tijssen CC, Lacombe D, van den Bent MJ; EORTC Brain Cancer Group. Prognostic value of health-related quality-of-life data in predicting survival in patients with anaplastic oligodendrogliomas, from a phase III EORTC brain cancer group study. J Clin Oncol. 2007 Dec 20;25(36):5731-7. doi: 10.1200/JCO.2007.11.1476.

ReferenceCitation: Taphoorn MJ, van den Bent MJ, Mauer ME, Coens C, Delattre JY, Brandes AA, Sillevis Smitt PA, Bernsen HJ, Frenay M, Tijssen CC, Lacombe D, Allgeier A, Bottomley A; European Organisation for Research and Treatment of Cancer. Health-related quality of life in patients treated for anaplastic oligodendroglioma with adjuvant chemotherapy: results of a European Organisation for Research and Treatment of Cancer randomized clinical trial. J Clin Oncol. 2007 Dec 20;25(36):5723-30. doi: 10.1200/JCO.2007.12.7514.

ReferenceCitation: van den Bent MJ, Carpentier AF, Brandes AA, Sanson M, Taphoorn MJ, Bernsen HJ, Frenay M, Tijssen CC, Grisold W, Sipos L, Haaxma-Reiche H, Kros JM, van Kouwenhoven MC, Vecht CJ, Allgeier A, Lacombe D, Gorlia T. Adjuvant procarbazine, lomustine, and vincristine improves progression-free survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: a randomized European Organisation for Research and Treatment of Cancer phase III trial. J Clin Oncol. 2006 Jun 20;24(18):2715-22. doi: 10.1200/JCO.2005.04.6078.

ReferenceCitation: van den Bent MJ, Delattre JY, Brandes AA, et al.: First analysis of EORTC trial 26951, a randomized phase III study of adjuvant PCV chemotherapy in patients with highly anaplastic oligodendroglioma. [Abstract] J Clin Oncol 23 (Suppl 16): A-1503, 114s, 2005.

ReferenceCitation: Lassman AB, Hoang-Xuan K, Polley MC, Brandes AA, Cairncross JG, Kros JM, Ashby LS, Taphoorn MJB, Souhami L, Dinjens WNM, Laack NN, Kouwenhoven MCM, Fink KL, French PJ, Macdonald DR, Lacombe D, Won M, Gorlia T, Mehta MP, van den Bent MJ. Joint Final Report of EORTC 26951 and RTOG 9402: Phase III Trials With Procarbazine, Lomustine, and Vincristine Chemotherapy for Anaplastic Oligodendroglial Tumors. J Clin Oncol. 2022 Aug 10;40(23):2539-2545. doi: 10.1200/JCO.21.02543. Epub 2022 Jun 22.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by

license_normalized: cc-by

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

repositories_institution: Erasmus University Rotterdam - EUR Research Repository

unpaywall_oa_status: hybrid

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Erdem-Eraslan L, Gravendeel LA, de Rooi J, Eilers PH, Idbaih A, Spliet WG, den Dunnen WF, Teepen JL, Wesseling P, Sillevis Smitt PA, Kros JM, Gorlia T, van den Bent MJ, French PJ. Intrinsic molecular subtypes of glioma are prognostic and predict benefit from adjuvant procarbazine, lomustine, and vincristine chemotherapy in combination with other prognostic factors in anaplastic oligodendroglial brain tumors: a report from EORTC study 26951. J Clin Oncol. 2013 Jan 20;31(3):328-36. doi: 10.1200/JCO.2012.44.1444. Epub 2012 Dec 26.

oa_colors: green other

evidence: open (via free pdf)

repositories_concat: PubMed Central

unpaywall_oa_status: bronze

ReferenceCitation: van den Bent MJ, Brandes AA, Taphoorn MJ, Kros JM, Kouwenhoven MC, Delattre JY, Bernsen HJ, Frenay M, Tijssen CC, Grisold W, Sipos L, Enting RH, French PJ, Dinjens WN, Vecht CJ, Allgeier A, Lacombe D, Gorlia T, Hoang-Xuan K. Adjuvant procarbazine, lomustine, and vincristine chemotherapy in newly diagnosed anaplastic oligodendroglioma: long-term follow-up of EORTC brain tumor group study 26951. J Clin Oncol. 2013 Jan 20;31(3):344-50. doi: 10.1200/JCO.2012.43.2229. Epub 2012 Oct 15.

oa_host_type: publisher

repositories_concat: closed

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

location_country:
Finland
Germany
Italy
Portugal
Hungary
United Kingdom
Sweden
Netherlands
Austria
Belgium
Switzerland
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Neurologische Klinik der Henriettenstiftung

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Instituto Portugues de Oncologia de Francisco Gentil


type: Other Identifier

title: A Phase 2, Parallel Group, Randomized, Double- Blind, Placebo-Controlled, 3-Arm, Multicenter Treatment Study to Evaluate the Efficacy and Safety of GSK4527226 [AL101] Intravenous Infusion Compared With Placebo in Patients With Early Alzheimer's Disease

acronym: PROGRESS-AD

summary: The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

lead_sponsor: GlaxoSmithKline

sponsor_collaborators:
GlaxoSmithKline
Alector Inc.

location_country:
Finland
Germany
Italy
Norway
Argentina
United Kingdom
Australia
Sweden
Netherlands
United States
Korea, Republic of
Spain
Turkey
Taiwan
Canada
France

status_simplified: Ongoing


title: A Phase 2a Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AZD4604 Twice Daily for Twelve Weeks in Adult Patients With Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

acronym: AJAX

summary: This is a Phase 2a, multicentre, randomised, placebo-controlled, double-blind, parallel-group study to evaluate the efficacy, safety and PK of AZD4604 administered BID using a dry-powder inhaler at one dose level over a 12-week Treatment period in adult participants with uncontrolled moderate-to-severe asthma.

lead_sponsor: AstraZeneca

location_country:
Germany
United Kingdom
Argentina
Denmark
Brazil
Sweden
United States
Spain
Thailand
Malaysia
Taiwan
Bulgaria
France


title: An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis

summary: The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).

study_start_date_type: Actual

status: Recruiting

lead_sponsor: Eli Lilly and Company

sponsor_collaborators:
Eli Lilly and Company
Rigel Pharmaceuticals

location_country:
Germany
India
United Kingdom
Argentina
Mexico
United States
Czechia
France

location_facility: Institut für Präventive Medizin & Klinische Forschung GbR

location_facility: Grant Medical Foundation - Ruby Hall Clinic

location_facility: Estudios Clínicos Internacionales (ECI) - Querétaro

location_facility: Centro de Atención e Investigación Cardiovascular del Potosí

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Kohler and Milstein Research S.A. de C.V.

location_facility: HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg GmbH

location_facility: Investigacion y Biomedicina de Chihuahua

location_facility: Sushruta Multispeciality Hospital & Research Centre

location_facility: Advanced Clinical Research of Orlando - Ocoee

location_facility: Government Medical College And Hospital - Nagpur

location_facility: Instituto de Alta Complejidad San Isidro

location_facility: Cicmex Centro de Investigación Clínica de México

location_facility: Hopitaux Universitaires Paris Centre-Hopital Cochin

location_facility: Centre Hospitalier Universitaire de Reims - l'Hôpital Maison Blanche

location_facility: Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau

location_facility: All India Institute of Medical Sciences (AIIMS) - Nagpur


title: Official Title: A Phase II Multicenter, Open Label, Non-randomized Study of Neoadjuvant and Adjuvant Treatment With IPH5201 and Durvalumab in Patients With Resectable, Early-stage (II to IIIA) Non-Small Cell Lung Cancer (MATISSE)

summary: The study is intended to assess the safety and efficacy of neoadjuvant combination of IPH5201 and durvalumab in addition to standard chemotherapy and adjuvant combination of IPH5201 and durvalumab in untreated patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer (NSCLC).

lead_sponsor: Innate Pharma

location_country:
Poland
Hungary
United States
Greece
France

location_facility: Eugenia and Janusz Zeyland Wielkopolskie Centre of Pulmonology and Thoracic Surgery

location_facility: Military Institute of Medicine - National Research Institute

location_facility: Rennes University Hospital Center - Hospital Pontchaillou

location_facility: John Paul II Specialist Hospital in Krakow

location_facility: Jasz-Nagykun-Szolnok County Hetenyi Geza Hospital-Clinic, Department of Oncology

location_facility: Mandziuk Slawomir - Specialist Medical Practice

location_facility: St. Anthony's Hospital - BayCare Health System

location_facility: Koranyi National Institute of Pulmonology, 14th Department of Pulmonology

location_facility: Petz Aladar University Teaching Hospital, Department of Pulmonology

location_facility: Specialist Hospital in Prabuty Sp. z o.o. (LLC)

location_facility: Millennium Research & Clinical Development

location_facility: University Teaching Hospital in Bialystok, 2nd Department of Lung Diseases and Tuberculosis

location_facility: Marseille University Hospital Center - North Hospital

location_facility: Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics

location_facility: H. Lee Moffitt Cancer Center & Research Institute


type: EudraCT Number

title: A Randomized, Double-blind, Placebo-controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

acronym: SIRIUS-SLE 2

summary: The trial will evaluate efficacy, safety and tolerability of ianalumab compared to placebo, given as monthly subcutaneous (s.c.) injection on top of standard-of-care (SoC) treatment in participants with active systemic lupus erythematosus (SLE).

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

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Italy
Colombia
Argentina
Romania
Australia
Mexico
United States
Korea, Republic of
Malaysia
Taiwan
France


title: A Double-blind, Randomized, Placebo-controlled Multicenter Study to Investigate Efficacy and Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Induced by Adjuvant Endocrine Therapy, Over 52 Weeks and Optionally for Additional 2 Years in Women With Hormone-receptor Positive Breast Cancer:

summary:
Researchers are looking for a better way to treat women with, or at high risk for developing hormone-receptor positive breast cancer, who have vasomotor symptoms (VMS), a condition of having hot flashes caused by anti-cancer therapy.

VMS, also called hot flashes, are very common medical problems in women with hormone-receptor (HR)-positive breast cancer, who are receiving anti-cancer therapy. HR-positive breast cancer is a type of breast cancer, which has hormone-receptors (proteins) for female sex hormones estrogen and/or progesterone. These hormone-receptors may attach to hormones like estrogen and progesterone and thereby help cancer cells to grow and to spread. Treatments that stop these hormones from attaching to these receptors are currently used to slow or stop the growth of HR-positive breast cancer.

It is already known that women with HR-positive breast cancer benefit from this treatment. However, hot flashes are common medical problems related to this therapy. They negatively affect quality of life of many women and may lead to discontinuation (stopping) of this therapy.

The study treatment, elinzanetant is being developed to treat hot flushes. It works by blocking a substance called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes.

The main purpose of this study is to learn more about how well elinzanetant helps to treat hot flashes caused by anti-cancer therapy in women with or at high risk for developing HR-positive breast cancer compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it.

To answer this, the doctors will ask the participants to record information about their hot flashes before treatment start and at certain time points during the treatment in an electronic diary. The researchers will then assess possible average changes in number and severity of hot flashes after 4 and 12 weeks of treatment.

To see how safe elinzanetant is compared to placebo. The study will collect information about the number of participants who have medical problems after taking treatment.

The study participants will be randomly (by chance) assigned to 2 treatment groups, A and B. The participants from treatment group A will take elinzanetant. The participants from treatment group B will start with placebo and then switch to elinzanetant.

All participants will continue taking the anti-cancer therapy they have been using when entering the study.

Dependent on the treatment group, the participants will either take elinzanetant or placebo as capsules by mouth once a day. After 12 weeks, the participants who have initially received placebo will switch to take elinzanetant for the remaining 40 weeks.

Each participant will be in the study for approximately 62 weeks. The treatment duration in the study will be 52 weeks. There will be up to 12 visits to the study site and 6 phone calls in between. Participants who completed the 52 weeks treatment phase, will be offered to continue treatment for another 2 years. Visit frequency: every 24 weeks until week 152.

During the study, the participants will:

record information about their hot flashes
answer questions about their quality of life and other symptoms.

The doctors and their study team will:

check the participants health and vital signs
take blood and urine samples
examine heart health using electrocardiogram (ECG)
examine pelvic organs like womb or ovaries using a trans vaginal ultrasound scan to see images of these organs
make images of the breast using x-ray (mammogram), a type of radiation that passes through the body to make images of the inside and/or by using ultrasound (if applicable)
check the health of the participant's cervix (neck of the womb) by taking a small sample of cells (smear test) for an analysis called cervical cytology (if applicable)
take an endometrial biopsy, a small piece of tissue from the lining of the womb (called the endometrium) for analysis.
ask the participants questions about what medicines they are taking and if they are having adverse events.

An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

About 4 weeks after the participants take their last treatment, the study doctors and their team will check the participants' health.

status: Active, not recruiting

ipd_sharing: No

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

lead_sponsor: Bayer

location_country:
Finland
Germany
Ireland
Italy
Poland
Portugal
Hungary
Israel
Romania
United Kingdom
Austria
Belgium
Spain
Kazakhstan
Canada
France

location_facility: Virgen del Rocio University Hospital - Oncology Department

location_facility: S.C Ovidius Clinical Hospital SRL - Oncology Department

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

location_facility: Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)

location_facility: IRCCS Istituto Europeo di Oncologia s.r.l. (IEO)

location_facility: Kaz. Inst. of oncology and radiology | Dept. of gynecology

location_facility: Centro Hospitalar de Lisboa Ocidental | Clin Res Dept

location_facility: Prywatny Gabinet Lekarski Ginekologia, Poloznictwo i Ultr.

location_facility: Synexus Frankfurt Clinical Research Centre

location_facility: Evangelisches Krankenhaus Bergisch Gladbach

location_facility: Centre de Lutte Contre le Cancer François Baclesse

location_facility: Luz Saude | Hospital Beatriz Angelo - Centro de Investigacao Clinica

location_facility: Health Corporation of Galilee Medical Center

location_facility: Gabinet Ginekologiczny Janusz Tomaszewski

location_facility: Tampereen yliopistollinen sairaala, keskussairaala

location_facility: Hospital Universitario Virgen de las Nieves|Oncologia

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Hospital General Universitario de Valencia

location_facility: Medizinische Univ Graz | Frauenheilkunde & Geburtshilfe

location_facility: AKH Wien | Allg. Gynaekologie & gynaekologische Onkologie

location_facility: Centro Hospitalar Universitario do Porto

location_facility: Ziekenhuis Oost-Limburg - Gynecology Department

location_facility: MedUni Innsbruck | Brust Gesundheit Zentrum

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: CHUC - Hospitais da U. Coimbra - Servico de Ginecologia

location_facility: ICANS - Institut de Cancérologie de Strasbourg Europe

location_facility: Institut du Cancer de Montpellier - Val d'Aurelle

location_facility: Multifield medical center | Chemotherapy department No 1

location_facility: Hospital General Universitario Gregorio Marañón | Oncología

location_facility: Ghent University Hospital | Women's Clinic Department

location_facility: CHULN - H. Sta.Maria (Centro de Investigacao Clinica)

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: S.C. Centrul Medical de Diagn si Tratam Ambulator Neomed SRL

location_facility: Hadassah Hebrew University Hospital Ein Kerem


title: An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)

summary: Patients who completed Study ISEE2008 (GATHER2) and consent to participate will be administered monthly avacincaptad pegol 2 mg.

status: Enrolling by invitation

lead_sponsor: IVERIC bio, Inc.

location_country:
Germany
Italy
Colombia
Hungary
Argentina
Israel
United States
Latvia
Spain
Croatia
Czechia
Canada
France

location_facility: Mid Atlantic Retina - Wills Eye Institute

location_facility: Retina & Vitreous Center of Southern Oregon, PC

location_facility: Jules Stein Eye Institute David Geffen School of Medicine

location_facility: Retina Consultants of Southern California

location_facility: Hospital Clínico Universitario "Lozano Blesa"

location_facility: Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro

location_facility: Instituto Clinico Quirurgico de Oftalmologia

location_facility: Retina Research Institute at New England Retina

location_facility: Clinical Hospital Osiiek, Ophthalmology Clinic

location_facility: Dept. of Ophthalmology Semmelweis University Budapest

location_facility: Retina Vitreous Surgeons of Central New York

location_facility: Jacobs Retina Center at The Shiley Eye Institute USCD

location_facility: Hospital Universitario Puerta de Hierro-Majadahonda

location_facility: P. Stradins Clinical university hospital

location_facility: Centre D'exploration Ophtalmologique De L'odéon

location_facility: Augenklinik der Ludwig-Maximilian Universität München

status_simplified: Unknown


type: Registry Identifier

title: A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

summary: The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd).

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Japan
Brazil
Netherlands
Belgium
United States
China
Korea, Republic of
Spain
Greece
Turkey
Taiwan
Czechia
France

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Centro de Pesquisa e Ensino em Oncologia de Santa Catarina - CEPEN

location_facility: Tokyo Medical and Dental University Hospital

location_facility: A.O. Universitaria Ospedali Riuniti di Ancona

location_facility: The First Affiliated Hospital Zhejiang University College of Medicine

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Sichuan Academy of Medical Science Sichuan Provincial People's Hospital

location_facility: Irmandade Santa Casa de Misericordia de Porto Alegre

location_facility: Universitätsmedizin der Johannes Gutenberg Universität

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: A.O.U. Città della Salute e della Scienza

location_facility: Virginia Commonwealth University - Massey Cancer Center

location_facility: Azienda Ospedaliera Universitaria di Padova

location_facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Hematology Unit

location_facility: First Affiliated Hospital, SooChow University

location_facility: The second Xiangya Hospital of Central South University

location_facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

location_facility: University Hospitals Cleveland Medical Center

location_facility: Fujian Medical University Union Hospital

location_facility: Azienda Ospedaliera Spedali Civili di Brescia

location_facility: Fundacao Antonio Prudente - A.C. Camargo Cancer Center

location_facility: Istanbul University Cerrahpasa Medical Faculty

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Tongji Hospital, Tongji Medical College of HUST

location_facility: Anticancer Hospital of Thessaloniki 'Theageneio'

location_facility: University of Massachusetts Medical School

location_facility: Azienda Ospedaliera Policlinico S. Orsola-Malpighi

location_facility: Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP

location_facility: Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

location_facility: Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach

location_facility: Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

location_facility: Albert Schweitzer ziekenhuis-lokatie Dordwijk

location_facility: University of Arkansas for Medical Sciences

location_facility: Hospitais Integradaos da Gavea S/A - DF Star

location_facility: Santa Casa de Misericordia de Belo Horizonte

location_facility: Istanbul University Istanbul Medical Faculty

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Levine Cancer Institute, Carolinas HealthCare System

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

location_facility: Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza

location_facility: Real e Benemérita Associação Portuguesa de Beneficência

location_facility: Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Washington University School of Medicine

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Institute of Hematology & Blood Disease Hospital Chinese Academy of Medical Science

location_facility: The Ohio State University Wexner Medical Center - James Cancer Hospital

location_facility: 'G. Papanikolaou' Hospital of Thessaloniki

location_facility: On Dokuz Mayıs University Medical Faculty

location_facility: Szpital Kliniczny MSWiA z Warminsko Mazurskim Centrum Onkologii w Olsztynie Oddzial Hematologii

location_facility: University of Mississippi Medical Center

location_facility: Instituto D'Or de Pesquisa e Ensino (IDOR)

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

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

location_facility: Institut Universitaire du cancer de Toulouse-Oncopole

location_facility: IRCCS Ospedale Casa Sollievo della Sofferenza

location_facility: Presidio Ospedaliero Santo Spirito in Sassia


title: A Randomized, Double-blind, Placebo Controlled, 2-arm Multicenter Phase 3 Study to Assess the Efficacy and Safety of Ianalumab in Patients With Active Sjogren's Syndrome (NEPTUNUS-1)

summary: A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Germany
Lithuania
Poland
Guatemala
Portugal
Singapore
Brazil
Austria
Belgium
Mexico
United States
China
Korea, Republic of
Spain
Turkey
Chile
Czechia
France

intervention_type: Other


acronym: LUMA

lead_sponsor: Biogen

summary:
In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study:

Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it.
Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks.
Certain medications for PD will be allowed at enrollment for a subset of participants.
The majority of clinic visits will be every 12 weeks. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD.

To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122.

sponsor_collaborators:
Biogen
Denali Therapeutics Inc.

location_facility: Instytut Zdrowia dr Boczarska-Jedynak sp.z.o.o, Sp.K

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

location_facility: Virginia Commonwealth University Department of Neurology

location_facility: Weill Medical College of Cornell University

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

location_facility: Centre Hospitalier Universitaire de Lyon-Hospices Civils de Lyon-Hopital Pierre Wertheimer

location_facility: Universitaetsklinikum Carl Gustav Carus TU Dresden

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: Xuanwu Hospital Capital Medical University

location_facility: University of California San Francisco (UCSF)

location_facility: Second Affiliated Hospital of Soochow University

location_facility: Institute for Neurodegenerative Disorders (IND)

location_facility: CHU Clermont Ferrand - Hopital Gabriel Montpied

location_facility: The National Hospital for Neurology & Neurosurgery

location_facility: The Methodist Hospital Research Institute

location_facility: CenExel Rocky Mountain Clinical Research

location_facility: IRCCS-Institute of Neurological Sciences of Bologna

title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of BIIB122 in Participants With Parkinson's Disease

source: euctr

ipd_sharing_description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

location_country:
Germany
Italy
Poland
Israel
United Kingdom
Japan
Netherlands
Austria
United States
China
Spain
Canada
France


title: A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Giredestrant in Combination With Phesgo Versus Phesgo After Induction Therapy With Phesgo + Taxane in Patients With Previously Untreated HER2-Positive, Estrogen Receptor-Positive Locally-Advanced or Metastatic Breast Cancer

summary: This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.

ipd_sharing_description:
For eligible studies, qualified researchers may request access to individual patient level data through the 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 Sharing of Clinical Study 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).

lead_sponsor: Hoffmann-La Roche

location_country:
Germany
Poland
Argentina
Brazil
Thailand
Turkey
France
Colombia
Portugal
Hungary
United States
Kenya
Uganda
India
Belgium
China
Italy
Jordan
United Kingdom
Mexico
Korea, Republic of
Spain
Taiwan

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Budapesti Szent Margit Korhaz; Onkologia Osztaly

location_facility: Adana Baskent University Hospital; Medical Oncology

location_facility: Hospital Universitario de Canarias;servicio de Oncologia

location_facility: Prof. Dr. Cemil Tascioglu City Hospital; Med Onc

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: The First Affiliated Hospital of China Medical University

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

location_facility: Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe

location_facility: Przychodnia Lekarska KOMED, Roman Karaszewski

location_facility: Nottingham University Hospitals NHS Trust - City Hospital

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: the First Affiliated Hospital of Bengbu Medical College

location_facility: ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

location_facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

location_facility: Affiliated Hospital of Hebei University; Department of medical oncology

location_facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept

location_facility: Changhua Christian Hospital; Dept of Surgery

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

location_facility: Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii

location_facility: No. 900 Hospital (Fuzhou General Hospital)

location_facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

location_facility: Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial

location_facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia

location_facility: Institut Sainte Catherine;Recherche Clinique

location_facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz; Onkologiai Osztaly

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

location_facility: Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology

location_facility: Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100

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

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

location_facility: Taipei Veterans General Hospital Office of General Surgery

location_facility: Hospital Clínic i Provincial; Servicio de Oncología

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

location_facility: Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie

location_facility: Maryland Oncology Hematology - Annapolis

location_facility: China Medical University Hospital; Surgery

location_facility: Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

location_facility: Guangxi Cancer Hospital of Guangxi Medical University

location_facility: Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

location_facility: Manipal Hospital; Department of Oncology

location_facility: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department

location_facility: Hospital Araujo Jorge; Departamento de Ginecologia E Mama

location_facility: Pronutrir - suporte nutricional e quimioterapia ltda.

location_facility: Swedish Cancer Institute - Edmonds Campus

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Songklanagarind Hospital; Department of Oncology

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

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

location_facility: Fundação Pio XII Hospital de Câncer de Barretos

location_facility: Centro Estatal de Cancerologia de Chihuahua; ONCOLOGY

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont

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

location_facility: Komarom-Eszergom Varmegyei Szent Borbala Korhaz; Onkologiai Osztaly

location_facility: Fundación CENIT para la Investigación en Neurociencias

location_facility: Karadeniz Tecnical University Medical Faculty; Oncology Department

location_facility: Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu

location_facility: Centro Oncologico Riojano Integral (CORI)

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Eszak-Pesti Centrumkorhaz - Honvedkorhaz; Podmaniczky utcai telephely

location_facility: MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

location_facility: Mersin City Education and Research Hospital

location_facility: Ospedale Infermi AUSL della Romagna; U.O Operativa di Oncologia

location_facility: West China Hospital - Sichuan University

location_facility: The Tumor Hospital of Xinjiang Medical University

location_facility: Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Medical Park Seyhan Hospital; Oncology Department

location_facility: Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz; Onkologiai Központ

location_facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

location_facility: Azienda ULSS 8 Berica; Oncologia Medica - Ospedlae di Vicenza

location_facility: Szpital Morski im.PCK; Oddzial Onkologii Klinicznej, Oddzial Dzienny

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

location_facility: National Cheng Kung University Hospital; Oncology

location_facility: Royal Cornwall Hospital; Dept of Clinical Oncology

location_facility: Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim; Gynäkologie/ onkolog. Tagesklinik

location_facility: CH de la Côte Basque - Hôpital de Bayonne

location_facility: Royal United Hospital; Oncology Department

location_facility: Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica

location_facility: Hospital Beatriz Angelo; Departamento de Oncologia

location_facility: Uganda Cancer Institute; Fred Hutchinson Cancer Research Center

location_facility: Florida Cancer Specialists - EAST - SCRI - PPDS

location_facility: The First Affiliated Hospital Of Jinzhou Medical University

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: The First Affiliated Hospital of Xian Jiao Tong University

location_facility: Humanitas Centro Catanese Di Oncologia; Oncologia Medica

location_facility: Hospital de S. Francisco Xavier; Unidade de Oncologia Medica

location_facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg

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

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Hospital Universitario; Dr. Jose E. Gonzalez

location_facility: Gazi Uni Medical Faculty Hospital; Oncology Dept

location_facility: Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard

location_facility: Studienzentrum Onkologie Ravensburg GbR; Onkologie Ravensburg

location_facility: Medipol University Medical Faculty; Oncology Department

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Maidstone Hospital; Kent Oncology Centre


title: A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

acronym: SEQUOIA-HCM

summary: The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

lead_sponsor: Cytokinetics

collaborators: Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.

location_country:
Germany
Italy
Poland
Portugal
Hungary
Israel
Denmark
United Kingdom
Netherlands
United States
China
Spain
Czechia
France

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

location_facility: University of Virginia Health System University Hospital

location_facility: Universitaetsklinikum Jena Klinik fuer Innere Medizin 1

location_facility: The Ohio State University Wexner Medical Center

location_facility: UOC Cardiologica Azienda Ospedaliera Spedali Civili di Brescia

location_facility: The Olga & Lev Leviev Heart Center The Chaim Sheba Medical Center

location_facility: Narodowy Instytut Kardiologii Stefana Kardynała Wyszynskiego- Panstwowy Instytut Badawczy

location_facility: Kerckhoff-Klinik GmbH Abteilung Administration Forschung und Lehre

location_facility: Xiangya Hospital of the Central South University

location_facility: Semmelweis Egyetem Varosmajori Sziv es Ergyogyasazati Klinika

location_facility: Liverpool Heart and Chest Hospital - Liverpool Heart and Chest Hospital NHS Foundation Trust- HWS Greater Glasgow and Clyde

location_facility: Cedars-Sinai Medical Center - Smidt Heart Institute Clinic

location_facility: CHU Pitie-Salpetriere, Centre de reference maladies cardiaques hereditaires ou rares

location_facility: Columbia University Medical Center/NY Presbyterian Hospital

location_facility: Hospital Universitario Son Llatzer Secretaria de Cardiologia

location_facility: The University of Texas Southwestern Medical Center

location_facility: Hopital Universitaire de Rangueil (CHU de Toulouse) Service de Cardiologie

location_facility: The First Affiliated Hospital of Zhengzhou University

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

location_facility: CHU de Bordeaux Hopital Cardiologique Haut-Leveque

location_facility: MedStar Medical Group Cardiology at Union Memorial

location_facility: Ascension St. John Clinical Research Institute

location_facility: Centro Hospitalar Do Baixo Vouga, EPE AV ARTUR RAVARA

location_facility: Charite-Universitaetsmedizin Berlin Campus Virchow-Klinikum (CVK) Medizinische Klinik mit Schwerpunkt Kardiologie

location_facility: Nanfang Hospital Southern Medical University

location_facility: Oxford Centre for Clinical Magnetic Resonance Research

location_facility: Fondazione toscana Gabriele Monesterio per la ricarca medica Dipartimento Cardiotoracico UOC Cardiologia e Medicina Cardiovasculare Ospedale San Cataldo

location_facility: UC San Diego Health - Sulpizio Cardiovascular Center

location_facility: CHU de Marseille - Hopital de la Timone Service de cardiologie

location_facility: Holy Cross Hospital / Cardiology Associates

location_facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

location_facility: Hospital Universitario Virgen Macarena-merge

location_facility: Interni klinika kardiologie a angiologie

location_facility: Washington University School of Medicine

location_facility: M Health Fairview University of Minnesota Medical Center - East Bank

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Universitaetsklinikum Essen Westdeutsches Herz-Gefaesszentrum

location_facility: Sanger Heart and Vascular Institute - HCM Clinic

location_facility: Queen Elizabeth University Hospital - HWS Greater Glasgow and Clyde

location_facility: Dipartimento di Medicina Clinica e Molecolare Universita Sapienza di Roma Unita di Terapia Intensiva Cardiologica Azienda Ospedaliero Universitaria Sant'Andrea

location_facility: Beijing Chao-Yang Hospital, Capital Medical University

location_facility: Department of Cardiology Aarhus University Hospital

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Azienda Ospedaliero Universitaria Careggi Dipartimento Cardiotoracovascolare - Cardiomiopatie Unit

location_facility: Queen Elizabeth Hospital Birmingham University Hospitals Birmingham NHS Foundation Trust

location_facility: Spectrum Health Medical Group Cardiovascular Medicine

location_facility: Hopital Lariboisiere, Service de Cardiologie

location_facility: Unniversitaetsklinikum Magdeburg Klinik fur Kardiologie und Anglologie

location_facility: Aalborg University Hospital, Department of Cardiology


intervention_type: Biological

lead_sponsor: ModernaTX, Inc.

summary: The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants.

ReferenceCitation: Kadambari S, Evans C, Lyall H. Congenital Infections: Priorities and Possibilities for Resource-limited Settings. Pediatr Infect Dis J. 2023 Feb 1;42(2):e45-e47. doi: 10.1097/INF.0000000000003710. Epub 2022 Sep 12. No abstract available.

evidence: open (via free article)

publisher_dissemination: Wolters Kluwer Health

location_facility: University of Colorado Anschutz Medical Campus

location_facility: Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

location_facility: Health Research of Hampton Roads Inc. - ClinEdge

location_facility: Carolina Institute for Clinical Research - M3 WR - ERN - PPDS

location_facility: Dr. Anil K. Gupta Medicine Professional Corporation

location_facility: Womens Healthcare Research Corporation ERN PPDS

location_facility: Carbon Health- NoHo West Urgent Care and Primary Care

location_facility: Applied Research Center of Arkansas - Clinedge - PPDS

location_facility: Meridian Clinical Research-(Omaha Nebraska)

location_facility: Premier Family Physicians - Austin - Hunt

location_facility: Medislim GmbH - Zentrum fuer Ambulante Klinische Forschung

location_facility: Tucson Neuroscience Research - M3 WR - ERN - PPDS

location_facility: Centricity Research - Montreal - HyperCore - PPDS

location_facility: David Ramstad Associates Research - IACT - HyperCore - PPDS

location_facility: Emerson Clinical Research Institute LLC - Kennedy St

location_facility: University of Minnesota Clinical Research Unit

location_facility: Clinical Trials Management Services, LLC

location_facility: Centricity Research - Quebec - HyperCore - PPDS

location_facility: Precision Clinical Research - Plantation

location_facility: Bernhard Nocht Centre for Clinical Trials (BNCCT)am Bernhard-Nocht-Institut für Tropenmedizin

location_facility: MediSync Clinical Research Hattiesburg Clinic

location_facility: Diex Recherche - Joilette - HyperCore - PPDS

location_facility: Velocity Clinical Research - Hamburg - PPDS

location_facility: McGill University Health Centre-Vaccine Study Centre

location_facility: SEC Clinical Research LLC - Dothan - ClinEdge - PPDS

location_facility: Meridian Clinical Research (Norfolk-Nebraska)

location_facility: Groupe Hospitalier Cochin Saint Vincent de Paul

location_facility: Centre Hospitalier Universitaire de Saint Etienne

location_facility: Paradigm Clinical Research Institute Inc - ClinEdge

location_facility: Meridian Clinical Research (Grand Island, Nebraska)

location_facility: Del Sol Research Management - ClinEdge - PPDS

location_facility: Centricity Research - Mirabel - HyperCore - PPDS

location_facility: Velocity Clinical Research, New Smyrna Beach

location_facility: Accel Research Site - Achieve - Birmingham - ERN - PPDS

location_facility: Velocity Clinical Research - Spokane - PPDS

location_facility: University of Texas Medical Branch - Bay Colony, SIVS Clinical Trials Program

location_facility: Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS

location_facility: University of Cincinnati Medical Center-Goodman St

location_facility: Velocity Clinical Research - Chula Vista

location_facility: Village Health Partners Frisco Medical Village

location_facility: Diex Recherche - Victoriaville - HyperCore

location_facility: LMC Manna Research - Burlington - HyperCore - PPDS

location_facility: Boeson Research KAL - Kalispell - ERN - PPDS

location_facility: Ideal Clinical Research, Inc. - ClinEdge - PPDS

location_facility: Fondazione IRCCS San Gerardo dei Tintori - MBBM - c/o Centro Maria Letizia Verga

location_facility: Floridian Clinical Research - ClinEdge - PPDS

location_facility: New England Research Associates LLC - ERN - PPDS

location_facility: Alliance for Multispecialty Research, LLC

location_facility: Baptist Health Center for Clinical Research

location_facility: CTI Clinical Research Center - ClinEdge - PPDS

location_facility: Berliner Centrum für Reise- und Tropenmedizin BCRT GmbH

location_facility: ACRC Trials - Independence Parkway - Plano - Hunt - PPDS

location_facility: Austin Regional Clinic ARC Clinical Research at Kelly Lane

location_facility: Mount Vernon Clinical Research, LLC - M3 WR - ERN - PPDS

location_facility: Tampereen Yliopisto Seinajoen Rokotusklinikka

location_facility: WellNow Urgent Care & Research - Huber Heights

location_facility: Long Beach Clinical Trials Services Inc.

location_facility: Cedar Health Research - Fort Worth - PPDS

location_facility: NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust

location_facility: Meridian Clinical Research-(Rockville Maryland)

location_facility: Centre Hospitalier Departemental de Vendee

location_facility: Centre Hospitalier et Universitaire de Limoges

location_facility: University of the Sunshine Coast, Health Hub Morayfield

location_facility: Clinical Trials of Texas, Inc. - HyperCor

location_facility: Paratus Clinical Research - Western Sydney

location_facility: Clinical Research Institute, Inc - CRN - PPDS

location_facility: Centennial Medical Group - Elkridge - Rx Trials

location_facility: Meridian Clinical Research (Hastings, Nebraska)

location_facility: M3 Wake Research, Inc - M3 WR - ERN - PPDS

location_facility: NIHR Patient Recruitment Centre: Newcastle

location_facility: Paradigm Clinical Research Institute, Inc. - ClinEdge

title: A Phase 3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

primary_purpose: Prevention

location_country:
Finland
Germany
Italy
Israel
United Kingdom
Australia
Japan
Belgium
United States
Spain
Canada
Estonia
France


title: A Randomised, Open-Label, Phase 2 Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Unresectable or Advanced Melanoma and Primary or Secondary Resistance to PD-(L)1 Inhibition

acronym: MONETTE

summary: Main study: This is an open-label, phase 2 study that aims to evaluate the efficacy and safety/tolerability of ceralasertib, when administered as monotherapy and in combination with durvalumab in participants with unresectable or advanced melanoma and primary or secondary resistance to PD-(L)1 inhibition.

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:
Germany
Italy
Poland
United Kingdom
Australia
Belgium
United States
Korea, Republic of
Spain
Canada
France


title: An Open-label, Randomized, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)

summary: DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

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.

sponsor_collaborators:
AstraZeneca
Daiichi Sankyo, Inc.

location_country:
Germany
Poland
Japan
Brazil
Turkey
Canada
France
Hong Kong
Denmark
United States
India
Belgium
China
Italy
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Taiwan


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of AMX0035 Versus Placebo for 48-week Treatment of Adult Patients With Amyotrophic Lateral Sclerosis (ALS)

acronym: Phoenix

summary: The Phoenix Trial is a randomized double blind placebo controlled Phase III trial to evaluate the safety and efficacy of AMX0035 for treatment of ALS

lead_sponsor: Amylyx Pharmaceuticals Inc.

location_country:
Ireland
Germany
Italy
Poland
Portugal
United Kingdom
Sweden
Netherlands
Belgium
United States
Spain
France

location_facility: Hôpitaux Universitaires de Marseille Timone

location_facility: Sheffield Institute for Translational Neuroscience (SITraN)

location_facility: Università degli Studi della Campania Luigi Vanvitelli

location_facility: Biodonostia Health Research Institute; Hospital Universitario Donostia

location_facility: Johns Hopkins University School of Medicine Outpatient Center

location_facility: Healey & AMG Center for ALS Research at Massachusetts General Hospital

location_facility: Hopital Gabriel Montpied Service de Neurologie

location_facility: Lewis Katz School of Medicine at Temple University

location_facility: Centro Hospitalar Universitário Lisboa-Norte

location_facility: Medizinische Fakultät Mannheim der Universität Heidelberg

location_facility: Washington University School of Medicine

location_facility: Hospital Universitari de Bellvitge-IDIBELL

location_facility: University of North Carolina at Chapel Hill

location_facility: Università degli Studi di Bari Aldo Moro

location_facility: Hospital Universitario y Politécnico La Fe

location_facility: California Pacific Medical Center Research Institute

location_facility: Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer Cellule Mutualisée de Recherche Clinique (CMRC)

location_facility: Le Centre Hospitalier Régional Universitaire de Tours

location_facility: Azienda Ospedaliero Universitaria Di Modena

location_facility: Trinity College Dublin/Beaumont Hospital


title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults With Newly Diagnosed Nucleophosmin 1-mutated Acute Myeloid Leukemia

summary: The primary objective of this study is to evaluate the efficacy of entospletinib (ENTO) compared to placebo when added to chemotherapy in previously untreated nucleophosmin-1 mutated (NPM1-m) acute myeloid leukemia (AML), as defined by the rate of molecularly defined measurable residual disease (MRD).

status: Terminated

lead_sponsor: Kronos Bio

location_country:
Germany
Italy
Poland
Hungary
Israel
Brazil
United States
Korea, Republic of
Spain
Czechia
Canada
France

location_facility: Instituto Brasileiro de Controle do Câncer - São Camilo Oncologia - Unidade Mooca

location_facility: Irmandade da Santa Casa de Misericórdia Hospital - Porto Alegre

location_facility: Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

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

location_facility: Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari

location_facility: Institut D'Investigacions Biomédiques August Pi I Sunyer

location_facility: Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

location_facility: Centre Hosptitalier Universitaire d'Angers

location_facility: Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)

location_facility: UCLA - Jonsson Comprehensive Cancer Center

location_facility: Hospital de Base - São José do Rio Preto

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr im. Prof. Tadeusza Sokołowskiego

location_facility: Samson Assuta Ashdod University Hospital

location_facility: A Beneficência Portuguesa de São Paulo - Unidade Mirante

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Daegu Catholic University Medical Center

location_facility: Hospital Universitario Central de Asturias

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

location_facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

location_facility: Uniwersyteckie Centrum Kliniczne w Gdańsku

location_facility: Uniwersyteckie Centrum Kliniczne WUM - Centralny Szpital Kliniczny

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Centre de Lutte Contre le Cancer - Centre Henri-Becquerel

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Ospedale Santa Maria delle Croci di Ravenna


title: A Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients

acronym: EVEREST

summary:
Primary Objective

-To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell

Secondary Objectives

To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab
To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab
To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab
To evaluate the safety of dupilumab and omalizumab

ReferenceCitation: De Prado Gomez PharmD MSc L, Khan Mbbs Mph AH, Peters Md AT, Bachert Md PhD C, Wagenmann Md M, Heffler Md PhD E, Hopkins BMBCh C, Hellings Md PhD PW, Zhang PhD M, Xing PhD J, Rowe Md P, Jacob-Nara Md Mph DHSc JA. Efficacy and Safety of Dupilumab Versus Omalizumab in Chronic Rhinosinusitis With Nasal Polyps and Asthma: EVEREST Trial Design. Am J Rhinol Allergy. 2022 Nov;36(6):788-795. doi: 10.1177/19458924221112211. Epub 2022 Jul 15.

oa_host_type: closed

publisher_dissemination: SAGE Publications

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

sponsor_collaborators:
Sanofi
Regeneron Pharmaceuticals

location_country:
Finland
Germany
Italy
Poland
Portugal
Hungary
United Kingdom
Denmark
Romania
Sweden
Belgium
United States
Spain
Czechia
Canada
France

location_facility: Modena Allergy + Asthma Site Number : 8400033

location_facility: Cedars Sinai Medical Center Site Number : 8400026

location_facility: Oregon Health & Science University Site Number : 8400031

location_facility: University of Missouri Health Care - University Hospital Site Number : 8400016

location_facility: The University Of Texas Health Science Center At Houston Site Number : 8400019

location_facility: Asthma Allergy & Immunology Clinical Research Unit Site Number : 8400027

location_facility: Allergy, Asthma and Clinical Research Center Site Number : 8400037

location_facility: Essential Medical Research, LLC Site Number : 8400024

location_facility: Optimed Research, LTD Site Number : 8400014

location_facility: Chryaslis Clinical Research Site Number : 8400017

location_facility: Cleveland Clinic Foundation Site Number : 8400029

location_facility: Eastern Virginia Medical School Site Number : 8400010

location_facility: Advanced ENT and Allergy Site Number : 8400013

location_facility: Dept of Otolaryngology, Head and Neck Surgery Site Number : 8400028

location_facility: University of Rochester Site Number : 8400015

location_facility: Northwestern University Site Number : 8400001


title: Deep Learning-Enabled Exploration of Predictive Signatures in a Multicenter Retrospective and Prospective Observational Study Allowing the Analysis of the Aggregation of Multimodal Clinical, Biological, Genomic and Radiomics Data Associated With the Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer

acronym: DEEP-Lung-IV

summary: Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.

study_type: Observational

time_perspective: Other

lead_sponsor: Sophia Genetics SAS

location_country:
Germany
Italy
Israel
Brazil
United States
Spain
Canada
France

location_facility: Sunnybrook Health Sciences Centre Toronto

location_facility: Roswell Park Comprehensive Cancer Center

location_facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)

location_facility: Carbone Comprehensive Cancer Center at University of Wisconsin

location_facility: Holden Comprehensive Cancer Center at University of Iowa Health Care


title: Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

summary: The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

lead_sponsor: Amgen

location_country:
Finland
Germany
Australia
Japan
Turkey
Canada
France
Portugal
Hungary
Denmark
Switzerland
United States
Romania
Belgium
Italy
Netherlands
Austria
Mexico
Spain
Greece
Taiwan
Bulgaria
Sweden

location_facility: Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

location_facility: Centro Hospitalar Universitario de Lisboa Central, EPE - Hospital de Santo Antonio dos Capuchos

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

location_facility: Hospital Universitario Marques de Valdecilla

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

location_facility: Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo

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

location_facility: Kobe City Medical Center General Hospital

location_facility: University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

location_facility: Azienda Ospedaliera Policlinico Umberto I

location_facility: Centre Hospitalier Universitaire de Liege - Sart Tilman

location_facility: Institutul Oncologic Prof Dr Ion Chiricuta

location_facility: Specialized Hospital for Active Treatment of Hematology Diseases EAD

location_facility: University of California San Francisco Medical Center

location_facility: Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi

location_facility: Bagcilar Medipol Mega Universite Hastanesi

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

location_facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

location_facility: Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

location_facility: National Hospital Organization Okayama Medical Center

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

location_facility: Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito

location_facility: Institut Universitaire du Cancer Toulouse Oncopole

location_facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc

location_facility: General Hospital of Thessaloniki Georgios Papanikolaou

location_facility: COI Centro Oncológico Internacional S.A.P.I. de C.V.

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi

location_facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

location_facility: Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet

location_facility: Centre Hospitalier Universitaire Archet 2


title: A Randomized Multicenter Phase 3 Study of Milademetan Versus Trabectedin in Patients With Dedifferentiated Liposarcoma

acronym: MANTRA

summary: Randomized, multicenter, open-label, Phase 3 registration study designed to evaluate the safety and efficacy of milademetan compared to trabectedin in patients with unresectable (i.e., where resection is deemed to cause unacceptable morbidity or mortality) or metastatic DD liposarcoma that progressed on 1 or more prior systemic therapies, including at least 1 anthracycline-based therapy.

lead_sponsor: Rain Oncology Inc

location_country:
Germany
Ireland
Italy
Poland
United Kingdom
Hong Kong
Austria
Belgium
United States
Korea, Republic of
Spain
Taiwan
Canada
Georgia
France

location_facility: University Polyclinic Hospital "Paolo Giaccone" Palermo

location_facility: Severance Hospital, Yonsei University Health System Seoul

location_facility: Santo Stefano Hospital of Prato - USL Company Toscana Center

location_facility: UCLA Department of Medicine - Hematology/ Oncology

location_facility: Abramson Cancer Center at Pennsylvania Hospital

location_facility: University Hospital Mannheim, Mannheim Cancer Center

location_facility: Asan Medical Center, Department of Oncology

location_facility: University Hospitals Leuven Campus Gasthuisberg

location_facility: National Cancer Institute-IRCCS "Fondazione G. Pascale"

location_facility: Duke University School of Medicine, Duke Cancer Institute

location_facility: Georges-Francois Leclerc Cancer Research Center

location_facility: Helios Hospital Bad Saarow, Clinic for Hematology, Oncology and Palliative Medicine

location_facility: University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center

location_facility: CU Anschutz Medical Campus, Anschutz Cancer Pavilion

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

location_facility: M. Curie National Research Institute of Oncology, Department of Soft Tissue/Bone Sarcoma and Melanoma

location_facility: Washington University School of Medicine

location_facility: Institute of Cancer Research and Treatment of Candiolo - IRCCS

location_facility: Medical University Vienna, Department of Internal Medicine I

location_facility: University Hospital Foundation Jimenez Diaz

location_facility: Department of Clinical Oncology, Prince of Wales Hospital

location_facility: The Royal Marsden Hospital NHS Foundation Trust

location_facility: The Christie NHS Foundation Trust, Department of Medical Oncology

location_facility: Malkhaz Katsiashvili Multiprofile Emergency Medicin Center LLC

location_facility: University General Hospital Gregorio Marañon

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: The James Cancer Hospital and Solove Research Institute