title: A Phase 3 Randomized, Open-label Comparative Study of Standard Whole Brain Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Women With Brain Metastases From Breast Cancer

acronym: ENRICH

summary:
RSR13 (efaproxiral) is a radiation sensitizer that has shown positive results in a Phase 3, randomized clinical trial of patients with brain metastases. Of 111 eligible breast cancer patients with brain metastases in that trial, 59 patients who received RSR13 prior to radiation therapy had a median survival time that was twice as long as the 52 patients who did not receive RSR13 prior to radiation therapy.

RSR13 (efaproxiral) is an experimental drug that increases the amount of oxygen released from blood into the tissues. It is well known that certain types of cancer tumors, including those in brain metastases, lack oxygen. Lack of oxygen in a tumor can reduce the effect of radiation therapy (RT). RSR13 may increase the oxygen level in brain tumors so that radiation therapy works better.

This study will enroll up to 360 women with brain metastases from breast cancer, and will evaluate if whole brain radiation therapy given with RSR13 will have a better treatment effect than whole brain radiation therapy alone. RSR13 will be infused intravenously (IV) through a central catheter placed in a central vein. Women randomized (assigned) to receive RSR13, therefore, will need to have a central catheter placed for treatment unless one is already in place.

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
Italy
Austria
United States
Brazil
Chile
Peru
Croatia
France
Greece
Lithuania
Hungary
Argentina
Spain
Canada
United Kingdom

location_facility: Virginia G. Piper Cancer Center, Arizona Oncology Services

location_facility: University of South Florida - H. Lee Moffitt Cancer Center

location_facility: Instituto de Enfermedades Neoplasicas (INEN)

location_facility: Instituto Brasileiro de Controle do Cancer

location_facility: Instituto Privado de Radioterapia y Oncologia

location_facility: Institute of Oncology, Vilnius University

location_facility: Arizona Cancer Center, University of Arizona

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital Edgardo Rebagliati Martins (ESSALUD)

location_facility: Azienda Ospedaliera Maggiore della Carita

location_facility: University of North Carolina Breast Center

location_facility: Fundação Pio XII - Hospital do Câncer de Barretos

location_facility: Hygeia Diagnostic and Therapeutic Center of Athens

location_facility: University of Cincinnati Division of Hematology-Oncology

location_facility: Radiooncologia, Radiation Oncology Center

location_facility: Centre Hospitalier Universitarie de Service de Radio-Oncologie

location_facility: Washington University School of Medicine

location_facility: CHU Zagreb University School of Medicine

location_facility: Hospital Santa Rita da Irmandade da Santa Casa

location_facility: Centro de Terapia Radiante Cumbres (CAICI)

location_facility: Emory University Winship Cancer Institute

location_facility: The University of Arkansas for Medical Sciences


title: A Phase III Randomized Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer.

summary: The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: result

ReferenceCitation: Antoun S, Birdsell L, Sawyer MB, Venner P, Escudier B, Baracos VE. Association of skeletal muscle wasting with treatment with sorafenib in patients with advanced renal cell carcinoma: results from a placebo-controlled study. J Clin Oncol. 2010 Feb 20;28(6):1054-60. doi: 10.1200/JCO.2009.24.9730. Epub 2010 Jan 19.

name: From the Departments of Supportive Care and Medical Oncology, Institut Gustave Roussy, Villejuif, France; and the Department of Oncology, University of Alberta, Edmonton, Canada.

family: Antoun

full_name: Sami Antoun

given: Sami

sequence: first

family: Birdsell

full_name: Laura Birdsell

given: Laura

sequence: additional

family: Sawyer

full_name: Michael B. Sawyer

given: Michael B.

family: Venner

full_name: Peter Venner

given: Peter

family: Escudier

full_name: Bernard Escudier

given: Bernard

family: Baracos

full_name: Vickie E. Baracos

given: Vickie E.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: Journal of Clinical Oncology

publisher: American Society of Clinical Oncology (ASCO)

title: Association of Skeletal Muscle Wasting With Treatment With Sorafenib in Patients With Advanced Renal Cell Carcinoma: Results From a Placebo-Controlled Study

ReferenceCitation: Bellmunt J, Eisen T, Fishman M, Quinn D. Experience with sorafenib and adverse event management. Crit Rev Oncol Hematol. 2011 Apr;78(1):24-32. doi: 10.1016/j.critrevonc.2010.03.006. Epub 2010 Apr 18. Review.

family: Bellmunt

full_name: Joaquim Bellmunt

given: Joaquim

family: Eisen

full_name: Timothy Eisen

given: Timothy

family: Fishman

full_name: Mayer Fishman

given: Mayer

family: Quinn

full_name: David Quinn

given: David

journal_name: Critical Reviews in Oncology/Hematology

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

ReferenceCitation: Massard C, Zonierek J, Gross-Goupil M, Fizazi K, Szczylik C, Escudier B. Incidence of brain metastases in renal cell carcinoma treated with sorafenib. Ann Oncol. 2010 May;21(5):1027-31. doi: 10.1093/annonc/mdp411. Epub 2009 Oct 22.

family: Massard

full_name: C. Massard

given: C.

family: Zonierek

full_name: J. Zonierek

given: J.

family: Gross-Goupil

full_name: M. Gross-Goupil

given: M.

family: Fizazi

full_name: K. Fizazi

given: K.

family: Szczylik

full_name: C. Szczylik

full_name: B. Escudier

given: B.

journal_name: Annals of Oncology

oa_host_type: publisher

evidence: open (via crossref license)

host_type: publisher

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

version: publishedVersion

ReferenceCitation: Negrier S, Jäger E, Porta C, McDermott D, Moore M, Bellmunt J, Anderson S, Cihon F, Lewis J, Escudier B, Bukowski R. Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. Med Oncol. 2010 Sep;27(3):899-906. doi: 10.1007/s12032-009-9303-z. Epub 2009 Sep 12.

ReferenceCitation: Peña C, Lathia C, Shan M, Escudier B, Bukowski RM. Biomarkers predicting outcome in patients with advanced renal cell carcinoma: Results from sorafenib phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. Clin Cancer Res. 2010 Oct 1;16(19):4853-63. doi: 10.1158/1078-0432.CCR-09-3343. Epub 2010 Jul 22.

publisher: American Association for Cancer Research (AACR)

title: Biomarkers Predicting Outcome in Patients with Advanced Renal Cell Carcinoma: Results from Sorafenib Phase III Treatment Approaches in Renal Cancer Global Evaluation Trial

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Staehler M, Negrier S, Chevreau C, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Anderson S, Hofilena G, Shan M, Pena C, Lathia C, Bukowski RM. Sorafenib for treatment of renal cell carcinoma: Final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol. 2009 Jul 10;27(20):3312-8. doi: 10.1200/JCO.2008.19.5511. Epub 2009 May 18.

name: From the From Institut Gustave Roussy, Villejuif; Hôpital Européen Georges Pompidou, Paris; Centre Léon Bérard, Lyon; Institut Claudius Regaud, Toulouse; Centre René Gauducheau, Saint-Herblain, France; Cambridge Research Institute, Cambridge; Royal Marsden Hospital, Surrey, United Kingdom; Military School of Medicine; Centrum Onkologii, Warsaw, Poland; Urologische Klinik und Poliklinik Klinikum der Universität Großhadern Ludwig-Maximilian-Universität, München, Germany; University of Chicago, Chicago, IL;...

title: Sorafenib for Treatment of Renal Cell Carcinoma: Final Efficacy and Safety Results of the Phase III Treatment Approaches in Renal Cancer Global Evaluation Trial

ReferenceCitation: Eisen T, Oudard S, Szczylik C, Gravis G, Heinzer H, Middleton R, Cihon F, Anderson S, Shah S, Bukowski R, Escudier B; TARGET Study Group. Sorafenib for older patients with renal cell carcinoma: subset analysis from a randomized trial. J Natl Cancer Inst. 2008 Oct 15;100(20):1454-63. doi: 10.1093/jnci/djn319. Epub 2008 Oct 7.

journal_name: JNCI Journal of the National Cancer Institute

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

repository_institution: Russian Society of Oncourologists - Oncourology

title: Sorafenib for Older Patients With Renal Cell Carcinoma: Subset Analysis From a Randomized Trial

ReferenceCitation: Bukowski R, Cella D, Gondek K, Escudier B; Sorafenib TARGETs Clinical Trial Group. Effects of sorafenib on symptoms and quality of life: results from a large randomized placebo-controlled study in renal cancer. Am J Clin Oncol. 2007 Jun;30(3):220-7.

ReferenceCitation: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM; TARGET Study Group. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007 Jan 11;356(2):125-34. Erratum in: N Engl J Med. 2007 Jul 12;357(2):203.

ReferenceCitation: Kane RC, Farrell AT, Saber H, Tang S, Williams G, Jee JM, Liang C, Booth B, Chidambaram N, Morse D, Sridhara R, Garvey P, Justice R, Pazdur R. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res. 2006 Dec 15;12(24):7271-8. Review.

ReferenceCitation: Lamuraglia M, Escudier B, Chami L, Schwartz B, Leclère J, Roche A, Lassau N. To predict progression-free survival and overall survival in metastatic renal cancer treated with sorafenib: pilot study using dynamic contrast-enhanced Doppler ultrasound. Eur J Cancer. 2006 Oct;42(15):2472-9. Epub 2006 Sep 11. Erratum in: Eur J Cancer. 2007 May;43(8):1336.

ReferenceCitation: Quintanilha JCF, Racioppi A, Wang J, Etheridge AS, Denning S, Peña CE, Skol AD, Crona DJ, Lin D, Innocenti F. PIK3R5 genetic predictors of hypertension induced by VEGF-pathway inhibitors. Pharmacogenomics J. 2021 Nov 13. doi: 10.1038/s41397-021-00261-5. [Epub ahead of print]

location_country:
Italy
Brazil
Chile
South Africa
Netherlands
Spain
Germany
France
Poland
Israel
Hungary
Belgium
Argentina
Australia
Russian Federation
United States
United Kingdom
Canada
Ukraine


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.

study_start_date_type: Actual

primary_purpose: Other

ReferenceCitation: Fenaux P, Mufti GJ, Hellström-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.

name: From the Avicenne, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris XIII, Bobigny; Hôpital Saint-Louis, AP-HP, Université Paris 7, Paris, France; King's College Hospital, London, United Kingdom; Karolinska University Hospital (Huddinge), Stockholm, Sweden; Azienda Ospedaliera Universitaria Careggi, Florence, Italy; Universitätsklinikum Düsseldorf, Düsseldorf, Germany; Hospital Universitario La Fe, Valencia, Spain; Peter MacCallum Cancer Centre and University of Melbourne, Melbourne,...

family: Fenaux

full_name: Pierre Fenaux

given: Pierre

family: Mufti

full_name: Ghulam J. Mufti

given: Ghulam J.

family: Hellström-Lindberg

full_name: Eva Hellström-Lindberg

given: Eva

family: Santini

full_name: Valeria Santini

given: Valeria

family: Gattermann

full_name: Norbert Gattermann

given: Norbert

family: Germing

full_name: Ulrich Germing

given: Ulrich

family: Sanz

full_name: Guillermo Sanz

given: Guillermo

family: List

full_name: Alan F. List

given: Alan F.

family: Gore

full_name: Steven Gore

given: Steven

family: Seymour

full_name: John F. Seymour

given: John F.

family: Dombret

full_name: Hervé Dombret

given: Hervé

family: Backstrom

full_name: Jay Backstrom

given: Jay

family: Zimmerman

full_name: Linda Zimmerman

given: Linda

family: McKenzie

full_name: David McKenzie

family: Beach

full_name: C.L. Beach

family: Silverman

full_name: Lewis R. Silverman

given: Lewis R.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

title: Azacitidine Prolongs Overall Survival Compared With Conventional Care Regimens in Elderly Patients With Low Bone Marrow Blast Count Acute Myeloid Leukemia

ReferenceCitation: Fenaux P, Gattermann N, Seymour JF, Hellström-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.

family: Duehrsen

full_name: Ulrich Duehrsen

ReferenceCitation: Santini V, Fenaux P, Mufti GJ, Hellström-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, Hellström-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.

title: Effects of azacitidine compared with conventional care regimens in elderly (≥75 years) patients with higher-risk myelodysplastic syndromes

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, Hellström-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.

repository_institution: University of Florence - Florence Research

publisher: Ferrata Storti Foundation (Haematologica)

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

location_facility: Samodzelny Publiczny Centralny Szpital Kliniczny

location_facility: University General Hospital of Heraklio Voutes

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

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

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

location_facility: National Centre of Hematology and Transfusiology, Sofia

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

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: The Newcastle Mater Miseriecordiae Hospital

location_facility: University General Hospital of Patra Rio

location_facility: University of Alabama School of Medicine

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

location_facility: Burdenko Central Military Clinical Hospital

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

location_facility: Institute of Haematology & Blood Transfusion

location_facility: Hospital Universitario Germans Trias I Pujol

location_facility: Instituto Nazionale Tumori "Regina Elena"

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

location_facility: Ospedale Casa Sollievo Della Sofferenza - Irrc


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.

ReferenceCitation: Van Cutsem E, Bajetta E, Valle J, Köhne 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.

name: From the University Hospital Gasthuisberg, Leuven, Belgium; Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan, Italy; Christie Hospital, Withington, England; Universitätsklinikum Carl Gustav Carus, Dresden; Bayer Schering Pharma AG, Berlin, Germany; David Geffen School of Medicine at UCLA, Santa Monica, CA; Princess Margaret Hospital, Toronto; Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario, Canada; Novartis Pharmaceuticals Corporation...

family: Van Cutsem

full_name: Eric Van Cutsem

given: Eric

family: Bajetta

full_name: Emilio Bajetta

given: Emilio

family: Valle

full_name: Juan Valle

given: Juan

family: Köhne

full_name: Claus-Henning Köhne

given: Claus-Henning

family: Randolph Hecht

full_name: J. Randolph Hecht

given: J.

family: Moore

full_name: Malcolm Moore

given: Malcolm

family: Germond

full_name: Colin Germond

given: Colin

family: Berg

full_name: William Berg

given: William

family: Chen

full_name: Bee-Lian Chen

given: Bee-Lian

family: Jalava

full_name: Tarja Jalava

given: Tarja

family: Lebwohl

full_name: David Lebwohl

given: David

family: Meinhardt

full_name: Gerold Meinhardt

given: Gerold

family: Laurent

full_name: Dirk Laurent

given: Dirk

family: Lin

full_name: Edward Lin

given: Edward

publisher_group: American Society of Clinical Oncology (ASCO)

title: 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

lead_sponsor: Novartis Pharmaceuticals

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

location_facility: Hematology Oncology Associates of Treasure Coast

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

location_facility: Center for Oncology Research & Treatment

location_facility: Sansum Santa Barbara Foundation Medical Clinic

location_facility: Maine Center for Cancer Medicine & Blood Disorders

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: University of Tennessee Cancer Institute

location_facility: Hematology Oncology Associates of Northern New Jersey

location_facility: Compassionate Cancer Care Medical Group, Inc.

location_facility: North Valley Hematology/Oncology Medical Group

location_facility: Consultants in Medical Oncology & Hematology

location_facility: North Central Montana Professional Building

location_facility: Hematology & Oncology Associates of NE PA

location_facility: West Virginia University Health Sciences Center

location_facility: Vanderbilt University School of Medicine

location_facility: Cancer Treatment Centers of America in Hampton Roads

location_facility: Hematology/Oncology Associates of Central NY

location_facility: Oncology Hematology Associates of Central Illinois, PC

location_facility: Washington University School of Medicine

location_facility: University of Chicago medical Center, Hematology/Oncology

location_facility: Hematology-Oncology Associates of Rockland

location_facility: California Oncology of the Central Valley

location_facility: Oncology/Hematology Group of South Florida

location_facility: Fallon Clinic at Worcester Medical Center

location_facility: Synergy Hematology-Oncology Medical Associates

location_facility: Cancer Care Associates Medical Group, Inc.

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Fort Wayne Medical Oncology & Hematology, Inc.

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Center for Cancer and Hematologic Disease

location_facility: Tulane University Health Sciences Center

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.

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.

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.

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.

lead_sponsor: Pharmacyclics LLC.

location_country:
Austria
United States
Netherlands
Germany
France
Australia
Belgium
Canada


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.

family: Dimopoulos

full_name: M. A. Dimopoulos

given: M. A.

family: Orlowski

full_name: R. Z. Orlowski

given: R. Z.

family: Facon

full_name: T. Facon

given: T.

family: Sonneveld

full_name: P. Sonneveld

given: P.

family: Anderson

full_name: K. C. Anderson

given: K. C.

family: Beksac

full_name: M. Beksac

given: M.

family: Benboubker

full_name: L. Benboubker

given: L.

family: Roddie

full_name: H. Roddie

given: H.

family: Potamianou

full_name: A. Potamianou

given: A.

family: Couturier

full_name: C. Couturier

given: C.

family: Feng

full_name: H. Feng

family: Ataman

full_name: O. Ataman

given: O.

family: van de Velde

full_name: H. van de Velde

family: Richardson

full_name: P. G. Richardson

given: P. G.

currency_apc_doaj: EUR

journal_name: Haematologica

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

license: publisher-specific license

license_normalized: publisher-specific

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

evidence: oa repository (via pmcid lookup)

publisher_dissemination: Ferrata Storti Foundation (Haematologica)

publisher_group: Ferrata Storti Foundation (Haematologica)

publisher_normalized: Ferrata Storti Foundation (Haematologica)

ReferenceCitation: Lichter DI, Danaee H, Pickard MD, Tayber O, Sintchak M, Shi H, Richardson PG, Cavenagh J, Bladé J, Façon 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 β-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.

name: Millennium Pharmaceuticals, Cambridge, MA;

family: Lichter

full_name: David I. Lichter

given: David I.

family: Danaee

full_name: Hadi Danaee

given: Hadi

name: Dana-Farber Cancer Institute, Boston, MA;

name: Department of Haematology, St Bartholomew's Hospital, London, United Kingdom;

name: Hematology Department, Hospital Clinic, University of Barcelona, Barcelona, Spain;

name: Center of Excellence for Lymphoma and Myeloma, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, NY;

name: H. Lee Moffitt Cancer Center, Tampa, FL;

name: University Hospital Rotterdam, Rotterdam, The Netherlands;

name: Janssen Research & Development, Beerse, Belgium; and

name: Janssen Research & Development, Raritan, NJ

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.

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

location_facility: Dept. of Clinical Hematology, Academic Medical Center

location_facility: Texas Oncology at Medical City Dallas Hospital

location_facility: Baylor Institute for Immunology Research

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

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

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

location_facility: Dept. Hematology, University Medical Centre

location_facility: Department of Haematology, ICSM, Hammersmith Hospital

location_facility: Medical University Clinic (Oncology/Haematology)

location_facility: Division of Hematology/Stem Cell Transplant

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

location_facility: RAMBAM Medical Center, Department of Hematology and Bone

location_facility: Lombardi Cancer Center, Georgetown University Medical Center

location_facility: Dipartimento di Biotecnologie Cellulari ed Ematologia

location_facility: UZ Gasthuisberg, Department of Hematology

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

location_facility: Hospital Clinico Universitario de Barcelona, Haematology Department

location_facility: Universitatsklinikum Charite, Abt. Fuer Haematologie/Onkologie

location_facility: Azienda Ospedaliera, S. Giovanni Battista

location_facility: Dipartmento Clinico esperimentale Di Oncologia et Ematolgia

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

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

location_facility: Hopital Saint-Louis, Direction Financiere

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

location_facility: Beth Israel Deaconess Medical Center, Kirstein Room 135

location_facility: Karolinska Hospital, Dept. of Hematology

location_facility: Loyola University Medical Center: Cardinal Bernardin Cancer Center

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

location_facility: Kaiser Permanente Oncology Clinical Trials

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

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

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

location_facility: Royal Marsden Hospital, Leukaemia and Myeloma Units

location_facility: Toronto General Research Institute, Princess Margaret Hospital

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

location_facility: Rochester General Hospital, Lipson Cancer Blood Center

location_facility: Department of Haematology, Queen Elizabeth Hospital

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

location_facility: Institut Gustave-Roussy, Service d'Hematologie

location_facility: VA Medical Center, Sections of Hematology/Oncology

location_facility: Hospital Claude Huriez, Service des Maladies du Sang

location_facility: Hackensack University Medical Center, David Jurist Research Building

location_facility: Hopital de Brabois, Service Hematologie et Medecine Interne

location_facility: Department of Haematology, Huddinge University Hospital M54

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

location_facility: Universitatsklinikum Heidelberg, Abt. Fur Haematologie und Onkologie

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

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

location_facility: Western Pennsylvania Hospital, Dept. of Human Oncology

location_facility: Eberhard-Karls Universitat, Medizinische Klinik

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

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

location_facility: Med Star Institute, Washington Cancer Center

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, Broët 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.

family: Idbaih

full_name: Ahmed Idbaih

given: Ahmed

family: Dalmasso

full_name: Cyril Dalmasso

given: Cyril

family: Kouwenhoven

full_name: Mathilde Kouwenhoven

given: Mathilde

family: Jeuken

full_name: Judith Jeuken

given: Judith

family: Carpentier

full_name: Catherine Carpentier

given: Catherine

family: Gorlia

full_name: Thierry Gorlia

given: Thierry

family: Kros

full_name: Johan M. Kros

given: Johan M.

family: French

full_name: Pim French

given: Pim

family: Teepen

full_name: Johannes Teepen

given: Johannes

family: Broët

full_name: Philippe Broët

given: Philippe

family: Delattre

full_name: Olivier Delattre

given: Olivier

family: Mokhtari

full_name: Karima Mokhtari

given: Karima

family: Sanson

full_name: Marc Sanson

given: Marc

full_name: Jean-Yves Delattre

given: Jean-Yves

family: van den Bent

full_name: Martin van den Bent

given: Martin

family: Hoang-Xuan

full_name: Khê Hoang-Xuan

given: Khê

journal_name: Journal of Neuro-Oncology

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

license: implied-oa

license_normalized: implied-oa

repository_institution: Erasmus University, Rotterdam - RePub

version: submittedVersion

repositories_institution:
Erasmus University, Rotterdam - RePub
PubMed Central - Europe PMC

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.

publisher_dissemination: American Association for Cancer Research

title: A Hypermethylated Phenotype Is a Better Predictor of Survival than MGMT Methylation in Anaplastic Oligodendroglial Brain Tumors: A Report from EORTC Study 26951

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.

title: 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

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.

name: From the Department of Neuro-Oncology and Pathology, Daniel den Hoed Cancer Center and Erasmus University Medical Center, Rotterdam; Department of Pathology, Nijmegen Center for Molecular Life Sciences, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands; Department of Neurology, Groupe Hospitalier Pitié-Salpêtrière, and Université Pierre and Marie Curie, Paris; Department of Neurology, Centre Antoine Lacassagne, Nice, France; Laboratory of Brain Tumor Biology and Genetics, Neurosurgery...

publisher_normalized: American Society of Clinical Oncology (ASCO)

title: 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

ReferenceCitation: Kros JM, Gorlia T, Kouwenhoven MC, Zheng PP, Collins VP, Figarella-Branger D, Giangaspero F, Giannini C, Mokhtari K, Mørk 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.

ReferenceCitation: Mauer ME, Taphoorn MJ, Bottomley A, Coens C, Efficace F, Sanson M, Brandes AA, van der Rijt CC, Bernsen HJ, Frénay 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.

ReferenceCitation: Taphoorn MJ, van den Bent MJ, Mauer ME, Coens C, Delattre JY, Brandes AA, Sillevis Smitt PA, Bernsen HJ, Frénay 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.

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.

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: 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.

name: Lale Erdem-Eraslan, Lonneke A. Gravendeel, Johan de Rooi, Paul H.C. Eilers, Peter A.E. Sillevis Smitt, Johan M. Kros, and Pim J. French, Erasmus MC; Martin J. van den Bent, Erasmus MC–Daniel den Hoed Cancer Center, Rotterdam; Wim G.M. Spliet, University Medical Center Utrecht, Utrecht; Wilfred F.A. den Dunnen, University Medical Center Groningen, Groningen; Johannes L. Teepen, St Elisabeth Hospital, Tilburg; Pieter Wesseling, Radboud University Nijmegen Medical Centre, Nijmegen; Pieter Wesseling, Free...

title: 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

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.

name: Martin J. van den Bent, Johan M. Kros, Mathilde C.M. Kouwenhoven, Roelien H. Enting, Pim J. French, and Winand N.M. Dinjens, Erasmus MC–Daniel den Hoed Cancer Center, Rotterdam; Martin J.B. Taphoorn and Charles J. Vecht, Medical Center Haaglanden, The Hague; Martin J.B. Taphoorn, Vrije Universiteit Medisch Centrum, Amsterdam; Hans J.J.A. Bernsen, Canisius Wilhelmina Ziekenhuis, Nijmegen; Cees C. Tijssen, St Elisabeth Hospital, Tilburg; Roelien H. Enting, University Medical Center Groningen, Groningen,...

title: Adjuvant Procarbazine, Lomustine, and Vincristine Chemotherapy in Newly Diagnosed Anaplastic Oligodendroglioma: Long-Term Follow-Up of EORTC Brain Tumor Group Study 26951

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

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

location_facility: Instituto Portugues de Oncologia de Francisco Gentil

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

location_facility: Klinikum der Friedrich-Schiller Universitaet Jena

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Neurologische Klinik der Henriettenstiftung


type: Other Identifier

type: Registry Identifier

title: The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis

summary:
Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries.

Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance.

Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week.

The study will last for about 5 years. Participants will have up to 21 clinic visits and up to 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day.

Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

status: Recruiting

study_completion_date_type: Anticipated

ipd_sharing: Yes

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Malaysia
Greece
Australia
Belgium
Russian Federation
Denmark
Taiwan
India
Croatia
France
Japan
Poland
Slovakia
Norway
Argentina
Canada
Korea, Republic of
South Africa
Switzerland
Netherlands
Bulgaria
Ireland
Puerto Rico
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Serbia
Mexico
Czechia
Israel
Spain
Turkey

status_simplified: Ongoing


type: EudraCT Number

title: An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)

acronym: PSMAddition

summary: The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study.

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:
Austria
Sweden
Netherlands
France
Poland
Belgium
Spain
United States

location_facility:
Urology Cancer Center PC
Tulane Cancer Center
Cancer Specialists of North Florida
Nebraska Cancer Specialists
Novartis Investigative Site


ipd_sharing_description: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

lead_sponsor: Bayer

location_country:
Italy
United States
France
Japan
Israel
Spain
Germany
Korea, Republic of

location_facility: Kyoto Prefectural University of Medicine

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: University of Miami Miller School of Medicine

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Seoul National University Bundang Hospital

location_facility: Ciutat Sanitària i Universitaria de la Vall d'Hebron

location_facility: Centre Hospitalier Universitaire de Nancy

location_facility: Hospital General Universitario Gregorio Marañón

location_facility: Universitätsmedizin der Johannes Gutenberg Universität Mainz

location_facility: University of California Irvine Medical Center

location_facility: Klinikum der Universität München Grosshadern

location_facility: Medizinische Fakultät der Otto-von-Guericke Universität

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Universitätsklinikum Hamburg Eppendorf (UKE)

location_facility: Japanese Red Cross Society Musashino Red Cross Hospital

location_facility: Hospital Clínic i Provincial de Barcelona

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: Hadassah Hebrew University Hospital Ein Kerem

location_facility: Medical Oncology Hematology Consultants, PA

ipd_sharing: No

source: euctr

title: An Open-Label Study of Regorafenib in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC) After PD1/PD-L1 Immune Checkpoint Inhibitors

summary:
Researchers are looking for a better way to treat people suffering from liver cancer which may have spread to nearby tissue and is unlikely to be cured or controlled with treatment (advanced metastatic hepatocellular carcinoma, HCC). Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers will learn more about the trial treatment, regorafenib, in a small number of participants. They will study the results when the trial treatment is taken with another cancer treatment called pembrolizumab.

There will be 2 parts to this trial. The part 1 (pilot phase) will include about 52 men and women. The part 2 (expansion phase) will include about 67 men and women. All of the participants will have HCC and will be aged 18 years or older. All of the participants will have tried other treatments that did not help their HCC. These other treatments (PD-1/PD-L1 Immune Checkpoint Inhibitors) are designed to work by stopping the activity of certain proteins in the immune system thought to play a role in HCC.

During both parts of the trial, the participants will take regorafenib and receive pembrolizumab. In the pilot phase, there will be 2 groups of participants. The group that each participant joins will be based on the treatment they already received for their HCC. The researchers will review the results in each group to learn if regorafenib and pembrolizumab are helping one group of participants more than others. Outcome of this review will determine the population to be treated in the expansion phase.


title: A Phase 2 Randomized Double-blind Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

summary: The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves progression free survival (PFS) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

lead_sponsor: Bristol-Myers Squibb

location_country:
Romania
Australia
Belgium
Russian Federation
France
Poland
Argentina
Chile
Switzerland
Netherlands
Ireland
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
New Zealand
Spain
Turkey

location_facility: FSBI &quot,Research Institute of Influenza named after A.A. Smorodintsev &quot,of the MoH of the Rus

location_facility: University of Cincinnati Cancer Institute

location_facility: Hematology Oncology Assoc of the Treasure Coast

location_facility: Bradford Hill Centro de Investigacion Clinica

location_facility: Vivantes Klinikum Neukoelln Klinik feur Haematologie, Onkologie Und Palliativmedizin

location_facility: Medical Oncology Associates, PS (dba Summit Cancer Centers)

location_facility: Oncology Hematology West P.C. dba Nebraska Cancer Specialist

location_facility: AZ Maria Middelares - Campus Maria Middelares

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Oddzial Onkologii I Radioterapii Szpital Morski ImPck

location_facility: Fundacion CORI para la Investigacion y Prevencion del Cancer

location_facility: Philipps-Universitaet Marburg Comprehensive Cancer Center

location_facility: The University of Texas Health Science Center at Tyler DBA UT Health East Texas Hope Cancer Center

location_facility: Phylasis Clinicas Research S. de R.L. de C.V.

location_facility: Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria

location_facility: IRCCS - Istituto Europeo di Oncologia IEO


title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Assess the Efficacy and Safety of JNJ-63733657, an Anti-tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease

acronym: Autonomy

summary: The primary purpose of this study is to evaluate the effect of JNJ-63733657 versus placebo on clinical decline as measured by the Integrated Alzheimer's Disease Rating Scale (iADRS), a composite of cognition and function.

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:
United States
Sweden
Netherlands
France
Japan
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: GIGA Centre de Recherches du Cyclotron, Université de Liège

location_facility: Alzheimers Research and Treatment Center

location_facility: The National Hospital for Neurology and Neurosurgery Centre

location_facility: Toronto Memory Program (Neurology Research Inc.)

location_facility: Cleveland Clinic Lou Revo Center for Brain Health

location_facility: Australian Alzheimer's Research Foundation Incorporated

location_facility: Wexner Medical Center at the Ohio State University

location_facility: National Hospital Organization Hizen Psychiatric Center

location_facility: National Center For Geriatrics And Gerontology

location_facility: University of California San Diego Medical Center

location_facility: Alexian Brothers Medical Center - Neuroscience Research Institute

location_facility: HammondCare Neurodegenerative Clinical Trials - VIC

location_facility: The University of Texas Health Science Center at Houston

location_facility: Anil Nair dba Alzheimer's Disease Center

location_facility: Neuropsychiatric Research Center of SWFL

location_facility: Washington University School of Medicine

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Advanced Memory Research Institute of NJ

location_facility: University of Arizona - Behavioral Neuroscience and Alzheimer's Clinic

location_facility: Rijikai Medical Corporation Katayama Medical Clinic

location_facility: University of Miami Miller School of Medicine

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Kobe City Medical Center General Hospital

location_facility: University of South Florida - Health Byrd Alzheimer Institute

location_facility: Palm Beach Neurology and Premier Research Institute


title: Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs

acronym: CHANCE

summary: Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solís-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepción M, Córdoba J, McCormick A, Stauber R, Vogel W, de Gottardi A, Welzel TM, Domenicali M, Risso A, Wendon J, Deulofeu C, Angeli P, Durand F, Pavesi M, Gerbes A, Jalan R, Moreau R, Ginés P, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Clinical Course of acute-on-chronic liver failure syndrome and effects on prognosis. Hepatology. 2015 Jul;62(1):243-52. doi: 10.1002/hep.27849. Epub 2015 May 29.

ReferenceCitation: Artru F, Louvet A, Ruiz I, Levesque E, Labreuche J, Ursic-Bedoya J, Lassailly G, Dharancy S, Boleslawski E, Lebuffe G, Kipnis E, Ichai P, Coilly A, De Martin E, Antonini TM, Vibert E, Jaber S, Herrerro A, Samuel D, Duhamel A, Pageaux GP, Mathurin P, Saliba F. Liver transplantation in the most severely ill cirrhotic patients: A multicenter study in acute-on-chronic liver failure grade 3. J Hepatol. 2017 Oct;67(4):708-715. doi: 10.1016/j.jhep.2017.06.009. Epub 2017 Jun 21.

ReferenceCitation: Sundaram V, Jalan R, Wu T, Volk ML, Asrani SK, Klein AS, Wong RJ. Factors Associated with Survival of Patients With Severe Acute-On-Chronic Liver Failure Before and After Liver Transplantation. Gastroenterology. 2019 Apr;156(5):1381-1391.e3. doi: 10.1053/j.gastro.2018.12.007. Epub 2018 Dec 18.

lead_sponsor: European Foundation for Study of Chronic Liver Failure

location_country:
Peru
Australia
Belgium
Taiwan
India
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Colombia
Hong Kong
Netherlands
Switzerland
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Mexico
Czechia
New Zealand
Spain
Turkey

location_facility: University Medical Center, Hamburg Eppendorf

location_facility: Scottish Liver Transplant Unit, Royal Infirmary

location_facility: Baylor College of Medicine (Scott & White)

location_facility: Global Hospital. Super speciality & transplant centre

location_facility: Medical University of Vienna, Department of Transplant Surgery

location_facility: APHP Hôpitaux Universitaires Pitié Salpêtrière

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University of Maryland School of Medicine

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: Hepato-Biliary-Pancreatic and Transplantation Centre

location_facility: Cedars-Sinai Comprehensive Transplant Center

location_facility: Medical University of Warsaw, Dept. of General, Transplant & Liver Surgery

location_facility: Queen Mary Hospital, The University of Hong Kong

location_facility: University Medical Center Groningen (UMCG)

location_facility: Auckland City Hospital- New Zealand Liver Transplant Unit

location_facility: S.Orsola Hospital - Alma Mater Studiorum University of Bologna

location_facility: Hospital Universitari i Politècnic La Fe

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Irmandade Santa Casa de Misericórdia de Porto Alegre

location_facility: University of Toronto, Multiorgan Transplant Program

location_facility: Hautepièrre Hospital, Service de Réanimation Médicale

location_facility: Hospital das Clínicas da Universidade de São Paulo

intervention_type: Other


title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kδ Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

summary: The purpose of the study is to compare the efficacy of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.

ipd_sharing_description:
Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

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

lead_sponsor: Incyte Corporation

location_country:
Italy
Austria
Spain
Germany
Finland
France
Japan
Poland
Israel
Norway
Belgium
China
Turkey
Denmark
United States
United Kingdom
Korea, Republic of

location_facility: New Jersey Hematology Oncology Associates Llc

location_facility: Hospital General Universitario Vall D Hebron

location_facility: Barts Health NHS Trust - St. Bartholomews Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Im. Andrzeja Mielckiego

location_facility: A.O. Universitaria Ospedale Di Circolo E Fondazione Macchi

location_facility: Aormn Hospital Hematology and Bmt Center

location_facility: Tianjin Medical University General Hospital

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori

location_facility: Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

location_facility: Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center

location_facility: Japanese Red Cross Nagoya Daini Hospital

location_facility: Centre Hospitalier de Versailles - Hopital Andre Mignot

location_facility: Japanese Red Cross Society Himeji Hospital

location_facility: Universita Degli Studi Di Genova - Facolta Di Medicina E Chirurgia

location_facility: Samson Assuta Ashdod University Hospital

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

location_facility: Hospital Clinico Universitario de Salamanca

location_facility: Fondazione Irccs Ca Granda Ospedale Maggiore

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1

location_facility: Hospices Civils de Lyon Centre Hospitalier Lyon Sud

location_facility: Azienda Sanitaria Universitaria Friuli Centrale (Asu Fc) - Presidio Ospedaliero Universitario Santa

location_facility: The First Affiliated Hospital of Zhejiang University

location_facility: Institute of Hematology and Transfusion Medicine

location_facility: Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia

location_facility: Hospital General Universitario Morales Meseguer

location_facility: Westchester Medical Center Advanced Oncology and Infusion Center

location_facility: Azienda Ospedaliera San Giuseppe Moscati

location_facility: Sheffield Teaching Hospitals Nhs Foundation Trust - Weston Park Hospital

location_facility: The Affiliated Hospital of Inner Mongolia Medical University

location_facility: University College London Hospitals Nhs Foundation Trust

location_facility: Davidoff Cancer Center Rabin Medical Center

location_facility: Harbin Institute of Hematology and Oncology

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

location_facility: Stamford Hospital - Medical Oncology Hematology

location_facility: Istanbul Medipol Universitesi Ibagcilar Medipol Mega Universitesi Hastanesi

location_facility: Ap-Hp Groupe Hospitalier Saint-Louis Lariboisiere Fernand-Widal Site Saint Louis (Paris)

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

location_facility: Hospital Universitari I Politecnic La Fe

location_facility: Hospital Universitario Insular de Gran Canaria

location_facility: The First Affiliated Hospital of Anhui Medical University

location_facility: Texas Oncology - Baylor Sammons Cancer Center

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital General Unviersitario de Alicante

location_facility: The First Affiliated Hospital of Nanchang University

location_facility: University of Kentucky - Markey Cancer Center

location_facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli

location_facility: The First Hospital of Lanzhou University

location_facility: Fujian Medical University Union Hospital

location_facility: Morristown Medical Center - Atlantic Health System

location_facility: Dokkyo Medical University Saitama Medical Center

location_facility: Xiangya Hospital Central South University

location_facility: Hadassah Hebrew University Medical Center Ein Karem Hadassah

location_facility: Centre Hospitalier Universitaire Grenoble Alpes (Chu Grenoble Alpes) - Hopital Albert Michallon

location_facility: University Hospital of North Midlands Nhs Trust

location_facility: Providence Regional Medical Center Everett


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

location_country:
Malaysia
Belgium
Australia
Russian Federation
Taiwan
Ukraine
India
France
Japan
Poland
Thailand
Canada
Korea, Republic of
Hungary
Puerto Rico
China
Portugal
United States
Germany
United Kingdom
Italy
Brazil
Mexico
Israel
Spain
Turkey

acronym: PAPILLON

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

location_facility: UPCO Unidade de Pesquisa Clinica em Oncologia

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

location_facility: Beijing Chest hospital, Capital medical university

location_facility: Azienda Ospedaliero Univ. Policlinico Gaspare Rodolico

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

location_facility: Nizhny Novgorod Regional Oncological Dispensary

location_facility: University of Mississippi Medical Center

location_facility: Başkent University Medical Faculty Adana Application and Research Center

location_facility: Peking University International Hospital

location_facility: Tianjin Medical University General Hospital

location_facility: Centro Hospitalar Universitario do Porto, EPE

location_facility: Fundação Antônio Prudente - A.C. Camargo Cancer Center

location_facility: The First People's Hospital Of Changzhou

location_facility: Cancer hospital Chinese Academy of Medical Sciences, Shenzhen Center

location_facility: Municipal Institution 'Odesa Clinical Oncology Dispensary'

location_facility: Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

location_facility: Yaroslavl Regional Clinical Oncology Hospital

location_facility: N.N. Petrov Research Institute Of Oncology

location_facility: Moscow Oncology Research Center n.a. Blokhin

location_facility: Taipei Medical University Shuang Ho Hospital

location_facility: Santa Casa de Misericordia de Porto Alegre

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori

location_facility: Langone Health at NYC University, NYU School of Medicine

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Private Specialist Hospitals - MedPolonia

location_facility: Harbin medical university cancer hospital

location_facility: Oncology Medical Clinics AV Medical group

location_facility: Songklanagarind Hospital, Prince of Songkla University

location_facility: H. Lee Moffitt Cancer & Research Institute

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd

location_facility: The Second Affiliated Hospital of Zhejiang University College of Medicine

location_facility: Saitama Medical University International Medical Center

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

location_facility: Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

location_facility: Chonnam National University Hwasun Hospital

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

location_facility: Mexico Centre for Clinical Research, S.A. de C.V.

location_facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc w Olsztynie

location_facility: Municipal Oncology Centre of Uzhgorod Central Municipal Clinical Hospitlal

location_facility: Instituto do Cancer do Estado de Sao Paulo ICESP

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz

location_facility: Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4

location_facility: State Medical Institution 'Republican Clinical Oncological Centre' at Republic of Tatarstan

location_facility: National Hospital Organization Nagoya Medical Center

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

location_facility: Seoul National University Bundang Hospital

location_facility: Pan American Center for Oncology Trials LLC

location_facility: Hospital Evangélico de Cachoeiro de Itapemirim

location_facility: Fort Wayne Medical Oncology and Hematology

location_facility: Fundacao Pio Xii - Hospital De Cancer De Barretos

location_facility: National Hospital Organization Himeji Medical Center

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

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

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

location_facility: TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

location_facility: Ibcc - Instituto Brasileiro de Controle Do Cancer

location_facility: Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting

location_facility: Pacific Shores Medical Group in Long Beach

location_facility: IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado

location_facility: Thoraxklinik am Universitätsklinikum Heidelberg

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Centrum Onkologii im. Prof. F. Lukaszczyka

location_facility: Rajiv Gandhi Cancer Institute & Research Centre

location_facility: National Hospital Organization Yamaguchi Ube Medical Center

location_facility: Orszagos Koranyi Tbc es Pulmonologiai Intezet

location_facility: Centro Hospitalar e Universitário de Coimbra, EPE

location_facility: Krasnoyarsk Regional Oncology Dispensary

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Phramongkutklao Hospital and Medical College

location_facility: Shengjing Hospital of China Medical University

title: A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

summary: The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.


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

lead_sponsor: LEO Pharma

location_country:
Italy
Austria
Sweden
Switzerland
Netherlands
France
Czechia
Greece
Australia
Belgium
Spain
Denmark
Germany
United Kingdom

acronym: COBRA

location_facility:
LEO Pharma Investigational Site
LEO Pharma Investigational Site 1
Pharma Investigational Site
LEO Pharma Investigational Site 2
LEO Pharma investigational site

title: Efficacy and Safety Comparison of Brodalumab Versus Guselkumab in Adult Subjects With Moderate-to-severe Plaque Psoriasis and Inadequate Response to Ustekinumab

summary: The trial investigates the efficacy and safety of brodalumab against guselkumab in treatment for patients with moderate-to-severe plaque psoriasis who still have some remaining symptoms after ustekinumab treatment.


title: A Randomized Open-Label Phase III Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Subjects With Metastatic or Locally Advanced Unresectable Urothelial Cancer (TROPiCS-04)

summary: The primary objective of this study is to assess overall survival (OS) with sacituzumab govitecan-hziy in comparison with treatment of physician's choice (TPC) in participants with metastatic or locally advanced unresectable urothelial cancer (UC).

lead_sponsor: Gilead Sciences

location_country:
United States
Spain
Germany
France
Belgium
Australia
Puerto Rico
China
Canada
United Kingdom

location_facility: Sarah Cannon Research Institute LondonSarah Cannon Research Institute London

location_facility: Ashford Cancer Centre Research - ICON Cancer Centre Adelaide

location_facility: Centre Hospitalier Universitaire de Nimes

location_facility: University of Iowa Hospitals and Clinics

location_facility: Les Hôpitaux Universitaires de Strasbourg

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Zhejiang Provincial People's Hospital - Zhaohui

location_facility: The First Affiliated Hospital of Wenzhou Medical University

location_facility: Institut Für Versorgungsforschung in Der Onkologie

location_facility: Centre Hospiltalier Universitaire Brest - Hôpital Morvan

location_facility: University Cancer Specialists - Knoxville

location_facility: British Columbia Cancer Agency-Vancouver Centre

location_facility: University of Maryland School of Medicine

location_facility: Boca Raton Clinical Research Global USA - Plantation

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

location_facility: Thompson Oncology Group - Knoxville Downtown

location_facility: Oklahoma Cancer Specialists and Research Institute (OCSRI)


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

lead_sponsor: Hoffmann-La Roche

location_country:
Greece
Australia
Belgium
Taiwan
France
Japan
Poland
Thailand
Argentina
Canada
Korea, Republic of
Hong Kong
Netherlands
Hungary
China
Portugal
Germany
United States
United Kingdom
Italy
Austria
Brazil
Czechia
Israel
Spain
Turkey

location_facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

location_facility: IRCCS Istituto Regina Elena (IFO); Oncologia Medica B

location_facility: Texas Oncology-El Paso Cancer Treatment Center Grandview

location_facility: Klinikum Bogenhausen; Klinik für Pneumologie und Pneumologische Onkologie

location_facility: Hospital Universitari Vall d'Hebron; Oncology

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

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: China Medical University Hospital; Pulmonary and Critical Care Medicine

location_facility: SMZ - Baumgartner Hohe, Otto-Wagner-Spital; 2.Interne Lungenabteilung

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Policlinico Universitario Campus Biomedico; U.O.C. di Radioterapia Oncologica

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

location_facility: ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii;Wojska Polskiego 37

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Inonu University Faculty of Medicine Turgut Ozal Medical Center; Onkoloji, Elazig Yolu,

location_facility: Pusan National University Yangsan Hospital

location_facility: Changzhou Tumor Hospital, Changzhou Fourth People's Hospital

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Hospital Univ. Nuestra Señora de Valme; Servicio de Oncologia

location_facility: Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

location_facility: Fakultni nemocnice Olomouc; Onkologicka klinika

location_facility: Medisch Centrum Haaglanden, locatie Antoniushove

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Zhongda Hospital Affiliated to Southeast University

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: The Affiliated Hospital of Xuzhou Medical College

location_facility: Ramathibodi Hospital; Medicine/Oncology; Clinical Research Center

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Zuyderland Medisch Centrum - Sittard Geleen

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

location_facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

location_facility: Centro Integrado de Oncologia de Curitiba

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Universitaetsmedizin Goettingen; Abteilung Haematologie und Onkologie

location_facility: New York Oncology Hematology,P.C.-Albany

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Medipol University MF; Oncology Department

location_facility: Institut Gustave Roussy; Pathologie Thoracique

location_facility: National Taiwan Uni Hospital; Internal Medicine

location_facility: Cancer Hospital of Shantou University Medical College

location_facility: Queen Elizabeth Hospital; Clinical Oncology

location_facility: Crio - Centro Regional Integrado de Oncologia

location_facility: CENTRE FRANCOIS BACLESSE; Oncologie- Pneumologie

location_facility: Beijing Chest Hospital; Oncology Department

location_facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers

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

location_facility: Princess Margaret Hospital, Oncology; Department of Oncology

location_facility: Hospital Provincial de Castellon; Servicio de Oncologia

location_facility: Chonnam National University Hwasun Hospital

location_facility: Hospital Clinico San Carlos; Servicio de Oncologia

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

location_facility: Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

location_facility: Florida Cancer Specialists; Department of Oncology

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Dolnośląskie Centrum Onkologii; Oddział Onkologii Klinicznej i Chemioterapii

location_facility: Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials

location_facility: Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.

location_facility: Ankara University Medical Faculty; Medikal Onkoloji

location_facility: Beijing Cancer Center; Renal Cancer And Melanoma Department.

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi; Ic Hastaliklari Anabiim Dali

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

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

location_facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory

location_facility: William Osler Health System Brampton Civic Hospital

location_facility: Monash Health Translational Precinct; Clinical Trials Centre, Level 3

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Seoul National University Bundang Hospital

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)

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

location_facility: Hospital da Luz; Departamento de Oncologia Medica

location_facility: Calderdale & Huddersfield Nhs Trust; Oncology

location_facility: Gazi University Medical Faculty, Oncology Hospital

location_facility: Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit

location_facility: Willamette Valley Cancer Institute and Research Center

location_facility: National Hospital Organization Himeji Medical Center

location_facility: Adana Baskent University Medical Faculty; Oncology

location_facility: Istanbul University Cerrahpasa Faculty of Medicine

location_facility: Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

location_facility: Titan Health Partners LLC, d/b/a Astera Cancer Care

location_facility: Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii

location_facility: Ege University Medical Faculty; Medical Oncology Department

location_facility: The First Affiliated Hospital to Henan University of Science and Technology

location_facility: Kyungpook National University Chilgok Hospital

location_facility: Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology

location_facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Oncologia

location_facility: Hospital Son Llatzer; Servicio de Oncologia

location_facility: Pamela Youde Nethersole Eastern Hospital; Clinical Oncology

location_facility: The First Affiliated Hospital of Xiamen University

location_facility: Cliniche Gavazzeni SpA Humanitas Gavazzeni

location_facility: Northwest Georgia Oncology Centers PC - Marietta

location_facility: Tennessee Oncology; Sarah Cannon Research Institute

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Fakultni nemocnice Olomouc; Pneumologicka klinika

location_facility: Leicester Royal Infirmary; Oncology Department

location_facility: Hospital de Base de Sao Jose do Rio Preto

location_facility: Sir Run Run Shaw Hospital Zhejiang University

location_facility: Fujian Medical University Union Hospital

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

location_facility: General Hospital "G.Papanikolaou"; Pulmonogy Clinic

title: A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation

summary: The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis

summary:
AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract.

The primary purpose of this study is to determine if CAEL-101 improves the overall survival in Patients with cardiac AL Amyloidosis.

ipd_sharing_description: Each patient will be assigned a unique identifier after signing the Informed Consent Form (ICF). Patient numbers will not be reassigned. Any patient records or datasets transferred to the Sponsor must contain only the unique identifier and must not include patient names or any information which would make the patient identifiable. Patients will be informed that their personal study-related data will be used by the Sponsor in accordance with local data protection laws and that their medical records may be examined by representatives of the Sponsor, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) members and by inspectors from regulatory authorities. Study monitors will inspect all documents and records that are required to be maintained by the Investigator for this study.

lead_sponsor: Caelum Biosciences, Inc.

location_country:
Italy
United States
Germany
France
Japan
Greece
Israel
Poland
Belgium
Australia
Russian Federation
Spain
Canada
United Kingdom


title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis


title: Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study

summary: Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.

lead_sponsor: Medtronic

location_country:
Italy
Spain
France
Greece
Portugal
United States
United Kingdom

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: NewYork-Presbyterian/Columbia University Irving Medical Center

location_facility: North Memorial Heart and Vascular Institute

location_facility: Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists

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

location_facility: Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital

location_facility: Imperial College Healthcare NHS Trust - Hammersmith Hospital

location_facility: Azienda Sanitaria Provinciale di Cosenza "Ospedale di Castrovillari"

location_facility: Texas Cardiac Arrhythmia Research Foundation

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

location_facility: Azienda ospedaleria Santa Maria della Misericordia di Udine

location_facility: Centro Hospitalar Universitário de São João

location_facility: Hospital Clínico Universitario de Valladolid

location_facility: Hospital Universitario Nuestra Señora de Candelaria

location_facility: Presidio Ospedaliero Centrale - SS. Annunziata

location_facility: Cardiology Associates of Northeast Arkansas

location_facility: Cardiovascular Consultants Medical Group

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: Hospital da Senhora da Oliveira - Guimarães

location_facility: Azienda Ospedaliera Ospedale Niguarda Ca Granda

location_facility: Washington University School of Medicine

location_facility: Azienda Ospedaliera - Universitaria Consorziale Policlinico di Bari

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust