title: A Randomized Trial of Switching Antiviral Therapy From Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults With Chronic Hepatitis B

summary: This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

lead_sponsor: Novartis

location_country:
Taiwan
United Kingdom
Australia
New Zealand
Canada
Thailand
United States
France
China
Israel
Singapore


title: A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan

summary: The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

lead_sponsor: Abbott

location_country:
United Kingdom
Canada
United States
France
Netherlands

location_facility: Beth Isreal Medical Center, Phillips Ambulatory Care Ceneter

location_facility: ViaHealth Rochester General Hospital Center for Urology

location_facility: Leighton Hospital Urology Research Dept., Michael Heal Outpatients Dept.

location_facility: Oregon Urology Specialist, Division of Clinical Research

location_facility: University Hospital Rotterdam, Department of Urology

location_facility: CroMedia Prime/Prime Trials Vancouver Hospital

location_facility: McGill University Health Center Royal VIctoria Hosptial

location_facility: University of Pittsburgh Department of Urology

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH

summary: The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

study_start_date_type: Actual

ReferenceType: derived

ReferenceCitation: Hillmen P, Muus P, Dührsen U, Risitano AM, Schubert J, Luzzatto L, Schrezenmeier H, Szer J, Brodsky RA, Hill A, Socié G, Bessler M, Rollins SA, Bell L, Rother RP, Young NS. Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria. Blood. 2007 Dec 1;110(12):4123-8. Epub 2007 Aug 16.

ipd_sharing: No

lead_sponsor: Alexion Pharmaceuticals

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

location_facility: Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin

location_facility: Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica

location_facility: London Regional Cancer Centre, Clinical Research Unit Room C3080

location_facility: Hospital De La Paz, Servicio de Hematologia

location_facility: Stockholm South Hospital, Division of Hematology

location_facility: Leeds General Infirmary, D Floor Brotherton Wing

location_facility: Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico

location_facility: Stanford University Medical Center, Division of Hematology

location_facility: Princess Alexandra Hospital, Oncology Haematology Radiation Department

location_facility: Washington University, Department of Internal Medicine/Division of Hematology

location_facility: Universitatsklinikum Essen, Zentrum fur Innere Medizin

location_facility: St. James's Hospital, Cancer Clinical Trial Office

location_facility: Hospital Clinic i Provincial, Servicio de Hematologia

location_facility: Universitatskliniken des Saarlandes, Innere Medizin 1

location_facility: UMC St. Radboud, Department of Hematology

location_facility: Ospedale San Bortolo, Divisione di Ematologia

location_facility: Institut fur Klinische Transfusionmedizin und Immunogenetik, Abtlg. Transfusionmedizin des Univ. Ulm

location_facility: Royal North Shore Hospital, Haematology Department

location_facility: The Royal Perth Hospital, Department of Haematology/Level 2

location_facility: National Heart, Lung, and Blood Institute, National Institutes of Health

location_facility: University of Alberta, Cross Cancer Institute

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thombosis Program

location_facility: Ospedale Maggiore di Milano, Divisione di Ematologia

location_facility: Cleveland Clinic Florida, Department of Clinical Research

location_facility: Hartford Hospital, Cancer Clinical Research Office

location_facility: The Queen Elizabeth Hospital, Haematology/Oncology Department

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

location_facility: Hopital Saint Louis, Centre d'investigation Clinique

location_facility: Hospital Universitario Germans Trias I Pujol, Servicio de Hematologia

location_facility: Royal Melbourne Hospital, Department of Clinical Haematology & Medical Oncology

location_facility: Duke University Medical Center, Division Cell Therapy, Heme Malignancies Program

location_facility: Ospedale San Martino, Department of Hematology


title: Safety in Hemolytic PNH Patients Treated With Eculizumab: a Multi-Center Open-Label Research Design Study

summary: The primary objective is to evaluate the safety of eculizumab in patients with transfusion-dependent hemolytic PNH

location_country:
Spain
Ireland
Italy
Australia
Netherlands
Canada
United Kingdom
Switzerland
Sweden
United States
France
Belgium
Germany

location_facility: Medizinische Hochschule Hannover, Abt. Hamatologie/Onkologie, Zentrum fur Innere Medizin

location_facility: Azienda Ospedaliera Universitaria Careggi, Dipartimento di area critica medico-chirurgica

location_facility: Washington University Medical Center, Department of Internal Medicine/Division of Hematology

location_facility: Cooper University Hospital, Cooper Cancer Institute

location_facility: London Regional Cancer Centre, Clinical Research Unit Room C3080

location_facility: Hopital Saint-Louis, Centre d'investigation Clinique

location_facility: Hospital De La Paz, Servicio de Hematologia

location_facility: Stockholm South Hospital, Division of Hematology

location_facility: St. Georges Hospital, Department of Haematology

location_facility: Leeds General Infirmary, D Floor Brotherton Wing

location_facility: Universita degli Studi di Napoli, Divisione di Ematologia, Azienda Universitar Policlinico

location_facility: Cleveland Clinic Florida, Dept. of Clinical Research

location_facility: Stanford University Medical Center, Division of Hematology

location_facility: Princess Alexandra Hospital, Oncology Haematology Radiation Department

location_facility: Institut fur Klinische Transfusionmedizin und Immungenetik, Abtlg. Transfusionmedizin des Univer. Ulm

location_facility: Royal Melbourne Hospital, Dept. of Clinical Haematology & Medical Oncology

location_facility: Universitatsklinikum Essen, Zentrum fur Innere Medizin

location_facility: The Royal Perth Hospital, Dept. of Haematology/Level 2

location_facility: Hospital Clinic i Provincial, Servicio de Hematologia

location_facility: Presbyterian Medical Center, PENN Comprehensive Hemophilia & Thrombosis Program

location_facility: Universitatskliniken des Saarlandes, Innere Medizin 1

location_facility: Ospedale San Bortolo, Divisione di Ematologia

location_facility: UMC St. Radboud, Department of Hematology

location_facility: St. James Hospital, Haematology Dept., Cancer Clinical Trial Office

location_facility: Kantonsspital Basel, Abteilung fuer Haematologie

location_facility: OHSU Center for Hematologic Malignancies

location_facility: University Hospital, Dept. of Haematology

location_facility: Ospedale San Martino, Dept. of Hematology

location_facility: University of Utah, Hematology-BMT Department


title: A Phase III Randomized Trial of Docetaxel Based Induction Chemotherapy in Patients With N2/N3 Locally Advanced Head and Neck Cancer

acronym: DeCIDE

summary: The combined use of chemotherapeutic drugs with radiation has proven to be effective in improving overall survival and local control among patients with locally advanced head and neck cancer. Induction chemotherapy given before receiving local treatment has been shown to reduce the rate of distant failure. Many drugs have been found to prevent tumor cells from growing or dividing, although it has yet to be determined which agent, or specific combination of agents, is most effective in treating head and neck cancer. Docetaxel is a drug which has been reported to show promising activity in Phase II head and neck cancer studies. Therefore, the purpose of this trial is to compare the effectiveness of induction chemotherapy followed by chemoradiotherapy versus the same chemoradiotherapy alone in patients with locally advanced head and neck cancer.

design_allocation: Randomized

lead_sponsor: University of Chicago

location_country:
Croatia
Spain
Russian Federation
United States
France

location_facility: NN Blokhin Russian Cancer Research Centre RAMS

location_facility: University of Tennessee Cancer Institute

location_facility: USC University of Southern California Keck School of Medicine

location_facility: UM Sylvester Comprehensive Cancer Center

location_facility: Clinic of Oncology, University Hospital Center Zagreb

location_facility: Fort Wayne Medical Oncology/Hematology Inc.

intervention_type: Procedure

lead_sponsor_type: academique


title: A Randomized, Open-Label Trial of Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis B

summary: This research study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (telbivudine) versus adefovir dipivoxil, a drug approved by the Food and Drug Administration (FDA) for the treatment of hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking adefovir dipivoxil.

ReferenceCitation: Chan HL, Heathcote EJ, Marcellin P, Lai CL, Cho M, Moon YM, Chao YC, Myers RP, Minuk GY, Jeffers L, Sievert W, Bzowej N, Harb G, Kaiser R, Qiao XJ, Brown NA; 018 Study Group. Treatment of hepatitis B e antigen positive chronic hepatitis with telbivudine or adefovir: a randomized trial. Ann Intern Med. 2007 Dec 4;147(11):745-54. Epub 2007 Oct 1.

location_country:
Taiwan
Australia
Canada
Thailand
Korea, Republic of
United States
France
China
Singapore


title: A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin Alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis

summary: Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events.

primary_purpose: Prevention

ReferenceCitation: DeJongh J, Frieling J, Lowry S, Drenth HJ. Pharmacokinetics of recombinant human antithrombin in delivery and surgery patients with hereditary antithrombin deficiency. Clin Appl Thromb Hemost. 2014 May;20(4):355-64. doi: 10.1177/1076029613516188. Epub 2013 Dec 11.

lead_sponsor: rEVO Biologics

location_country:
United Kingdom
Italy
Austria
Australia
Canada
United States
France
Germany

intervention_type: Biological


title: A Single Agent Phase II Study of Depsipeptide (FK228) in the Treatment of Cutaneous T-cell Lymphoma

summary: GPI-04-0001 was a Phase II, non-randomized, open label, single arm study that was conducted at approximately 30 sites, primarily in the United States, Europe and Russia. It assessed the efficacy, safety, and tolerability of romidepsin as a treatment for cutaneous T-cell lymphoma (CTCL). Study patients (pts) received romidepsin in a dose of 14 mg/m^2 intravenously over 4 hours on Days 1, 8 and 15 of each 28-day cycle. The duration of study treatment was 6 cycles although pts who showed an objective response or stable disease could continue to receive therapy, at the discretion of the investigator, until disease progression or another withdrawal criterion was met.

ReferenceType: background

ReferenceCitation: Duvic M, Bates SE, Piekarz R, Eisch R, Kim YH, Lerner A, Robak T, Samtsov A, Becker JC, McCulloch W, Waksman J, Whittaker S. Responses to romidepsin in patients with cutaneous T-cell lymphoma and prior treatment with systemic chemotherapy. Leuk Lymphoma. 2018 Apr;59(4):880-887. doi: 10.1080/10428194.2017.1361022. Epub 2017 Aug 30.

ReferenceCitation: Foss F, Duvic M, Lerner A, Waksman J, Whittaker S. Clinical Efficacy of Romidepsin in Tumor Stage and Folliculotropic Mycosis Fungoides. Clin Lymphoma Myeloma Leuk. 2016 Nov;16(11):637-643. doi: 10.1016/j.clml.2016.08.009. Epub 2016 Aug 10.

ReferenceCitation: Foss F, Coiffier B, Horwitz S, Pro B, Prince HM, Sokol L, Greenwood M, Lerner A, Caballero D, Baran E, Kim E, Nichols J, Balser B, Wolfson J, Whittaker S. Tolerability to romidepsin in patients with relapsed/refractory T-cell lymphoma. Biomark Res. 2014 Sep 8;2:16. doi: 10.1186/2050-7771-2-16. eCollection 2014.

ReferenceCitation: Demierre M, et al. Pooled analyses of two international, multicenter clinical studies of romidepsin in 167 patients with cutaneous T-cell lymphoma (CTCL). Presented at 2009 ASCO Annual Meeting, May 29-June 2, 2009, Orlando, FL. Abstract No: 8546. J Clin Oncol 27:15s, 2009 (suppl)

ReferenceCitation: Cabell C, et al. Systematic Assessment of Potential Cardiac Effects of the Novel Histone Deacetylase (HDAC) Inhibitor Romidepsin. Presented at 2009 ASCO Annual Meeting, May 29-June 2, 2009, Orlando, FL. Abstract No: e19533. C J Clin Oncol 2009;27(suppl)

ReferenceCitation: Kim YH, et al. Clinically Significant Responses Achieved with Romidepsin in 37 Patient with Cutaneous T-Cell Lymphoma (CTCL) with Blood Involvement. Presented at American Society of Hematology 2009, New Orleans, LA. Abstract No. 2683.

ReferenceType: result

ReferenceCitation: Whittaker SJ, Demierre MF, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T, Becker JC, Samtsov A, McCulloch W, Kim YH. Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. J Clin Oncol. 2010 Oct 10;28(29):4485-91. doi: 10.1200/JCO.2010.28.9066. Epub 2010 Aug 9.

lead_sponsor: Celgene

location_country:
Poland
United Kingdom
Russian Federation
United States
France
Germany

location_facility: University of Pennsylvania Abrahamson Cancer Center


title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab

summary: The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

ReferenceCitation: Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D'Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38. Epub 2007 Apr 30.

location_country:
United States
France
Canada
Belgium

location_facility: Long Island Clinical Research Assoc. LLP

location_facility: Outpatient Clinical Research Facility University of Indianapolis

location_facility: Queen Elizabeth II Health Sciences Centre

location_facility: Gastroenterology Center of the Mid South

location_facility: Gastroenterology Associates of Cleveland

location_facility: The Oregon Clinic, PC Gastroenterology Division

location_facility: Atlantic Gastroenterology Associates, LLC

location_facility: University of Kentucky Medical Center Division of Digestive Diseases

location_facility: Gastrointestinal and Liver Disease Consultants

location_facility: Regional Gastroenterologist Associates of Lancaster

location_facility: Capitol Gastroenterology Consultants Medical Group, Inc.

location_facility: Mount Sinai School of Medicine IBD Research Center

location_facility: Heritage Medical Research Clinic Health Sciences Centre University of Calgary

location_facility: Liver and Intestinal Disease Research Center


title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

summary: The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).

lead_sponsor: Sanofi

location_country:
Taiwan
Hong Kong
Spain
Italy
Australia
United States
France
Singapore
South Africa
Netherlands

location_facility: Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"

location_facility: Neurological Physicians of Arizona, Inc.

location_facility: Alzheimer's Research & Clinical Programs

location_facility: sanofi-aventis Australia & New Zealand administrative office

location_facility: University Medical Center, Dept. of Psychiatry Clinical Trials


title: A Phase III Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had =>2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months

acronym: ASSERT

summary: The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.

status: Terminated

ReferenceCitation: Stocker JW, De Franceschi L, McNaughton-Smith GA, Corrocher R, Beuzard Y, Brugnara C. ICA-17043, a novel Gardos channel blocker, prevents sickled red blood cell dehydration in vitro and in vivo in SAD mice. Blood. 2003 Mar 15;101(6):2412-8. Epub 2002 Nov 14.

lead_sponsor: Icagen

location_country:
Brazil
United Kingdom
Trinidad and Tobago
United States
France
Jamaica

status_simplified: Unknown


title: A Multinational, Randomized, Double-blind, Placebo-controlled, Forced-titration, 2 x 2 Factorial Design Study of the Efficacy and Safety of Long-term Administration of Nateglinide and Valsartan in the Prevention of Diabetes and Cardiovascular Outcomes in Subjects With Impaired Glucose Tolerance (IGT)

acronym: Navigator

summary: This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.

ReferenceCitation: Harumi Higuchi Dos Santos M, Sharma A, Sun JL, Pieper K, McMurray JJ, Holman RR, Lopes RD. International Variation in Outcomes Among People with Cardiovascular Disease or Cardiovascular Risk Factors and Impaired Glucose Tolerance: Insights from the NAVIGATOR Trial. J Am Heart Assoc. 2017 Jan 13;6(1). pii: e003892. doi: 10.1161/JAHA.116.003892.

ReferenceCitation: Preiss D, Thomas LE, Wojdyla DM, Haffner SM, Gill JM, Yates T, Davies MJ, Holman RR, McMurray JJ, Califf RM, Kraus WE; NAVIGATOR Investigators. Prospective relationships between body weight and physical activity: an observational analysis from the NAVIGATOR study. BMJ Open. 2015 Aug 14;5(8):e007901. doi: 10.1136/bmjopen-2015-007901.

ReferenceCitation: Katz M, Califf RM, Sun JL, McMurray JJ, Thomas L, Lopes RD. Venous thromboembolism and cardiovascular risk: results from the NAVIGATOR trial. Am J Med. 2015 Mar;128(3):297-302. doi: 10.1016/j.amjmed.2014.08.022. Epub 2014 Nov 20.

ReferenceCitation: Preiss D, Haffner SM, Thomas LE, Sun JL, Sattar N, Yates T, J Davies M, McMurray JJ, Holman RR, Califf RM, Kraus WE. Change in levels of physical activity after diagnosis of type 2 diabetes: an observational analysis from the NAVIGATOR study. Diabetes Obes Metab. 2014 Dec;16(12):1265-8. doi: 10.1111/dom.12320. Epub 2014 Jun 19.

ReferenceCitation: Huffman KM, Sun JL, Thomas L, Bales CW, Califf RM, Yates T, Davies MJ, Holman RR, McMurray JJ, Bethel MA, Tuomilehto J, Haffner SM, Kraus WE. Impact of baseline physical activity and diet behavior on metabolic syndrome in a pharmaceutical trial: results from NAVIGATOR. Metabolism. 2014 Apr;63(4):554-61. doi: 10.1016/j.metabol.2014.01.002. Epub 2014 Jan 15.

ReferenceCitation: Yates T, Haffner SM, Schulte PJ, Thomas L, Huffman KM, Bales CW, Califf RM, Holman RR, McMurray JJ, Bethel MA, Tuomilehto J, Davies MJ, Kraus WE. Association between change in daily ambulatory activity and cardiovascular events in people with impaired glucose tolerance (NAVIGATOR trial): a cohort analysis. Lancet. 2014 Mar 22;383(9922):1059-66. doi: 10.1016/S0140-6736(13)62061-9. Epub 2013 Dec 20.

ReferenceCitation: Shen L, Shah BR, Reyes EM, Thomas L, Wojdyla D, Diem P, Leiter LA, Charbonnel B, Mareev V, Horton ES, Haffner SM, Soska V, Holman R, Bethel MA, Schaper F, Sun JL, McMurray JJ, Califf RM, Krum H. Role of diuretics, β blockers, and statins in increasing the risk of diabetes in patients with impaired glucose tolerance: reanalysis of data from the NAVIGATOR study. BMJ. 2013 Dec 9;347:f6745. doi: 10.1136/bmj.f6745. Erratum in: BMJ. 2014;348:f1339.

ReferenceCitation: NAVIGATOR Study Group, McMurray JJ, Holman RR, Haffner SM, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM, Chacra AR, Chiang FT, Charbonnel B, Chow CC, Davies MJ, Deedwania P, Diem P, Einhorn D, Fonseca V, Fulcher GR, Gaciong Z, Gaztambide S, Giles T, Horton E, Ilkova H, Jenssen T, Kahn SE, Krum H, Laakso M, Leiter LA, Levitt NS, Mareev V, Martinez F, Masson C, Mazzone T, Meaney E, Nesto R, Pan C, Prager R, Raptis SA, Rutten GE, Sandstroem H, Schaper F, Scheen A, Schmitz O, Sinay I, Soska V, Stender S, Tamás G, Tognoni G, Tuomilehto J, Villamil AS, Vozár J, Califf RM. Effect of valsartan on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010 Apr 22;362(16):1477-90. doi: 10.1056/NEJMoa1001121. Epub 2010 Mar 14. Erratum in: N Engl J Med. 2010 May 6;362(18):1748.

ReferenceCitation: NAVIGATOR Study Group, Holman RR, Haffner SM, McMurray JJ, Bethel MA, Holzhauer B, Hua TA, Belenkov Y, Boolell M, Buse JB, Buckley BM, Chacra AR, Chiang FT, Charbonnel B, Chow CC, Davies MJ, Deedwania P, Diem P, Einhorn D, Fonseca V, Fulcher GR, Gaciong Z, Gaztambide S, Giles T, Horton E, Ilkova H, Jenssen T, Kahn SE, Krum H, Laakso M, Leiter LA, Levitt NS, Mareev V, Martinez F, Masson C, Mazzone T, Meaney E, Nesto R, Pan C, Prager R, Raptis SA, Rutten GE, Sandstroem H, Schaper F, Scheen A, Schmitz O, Sinay I, Soska V, Stender S, Tamás G, Tognoni G, Tuomilehto J, Villamil AS, Vozár J, Califf RM. Effect of nateglinide on the incidence of diabetes and cardiovascular events. N Engl J Med. 2010 Apr 22;362(16):1463-76. doi: 10.1056/NEJMoa1001122. Epub 2010 Mar 14. Erratum in: N Engl J Med. 2010 May 6;362(18):1748.

ReferenceCitation: Krum H, McMurray JJ, Horton E, Gerlock T, Holzhauer B, Zuurman L, Haffner SM, Bethel MA, Holman RR, Califf RM. Baseline characteristics of the Nateglinide and Valsartan Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial population: comparison with other diabetes prevention trials. Cardiovasc Ther. 2010 Apr;28(2):124-32. doi: 10.1111/j.1755-5922.2010.00146.x. Epub 2010 Feb 23.

ReferenceCitation: Bethel MA, Deedwania P, Levitt NS, Schmitz O, Huntsman-Labed A, Califf RM, Haffner SM, Diem P; NAVIGATOR Study Group. Metabolic syndrome and alanine aminotransferase: a global perspective from the NAVIGATOR screening population. Diabet Med. 2009 Dec;26(12):1204-11. doi: 10.1111/j.1464-5491.2009.02864.x.

ReferenceCitation: Bethel MA, Holman R, Haffner SM, Califf RM, Huntsman-Labed A, Hua TA, McMurray J. Determining the most appropriate components for a composite clinical trial outcome. Am Heart J. 2008 Oct;156(4):633-40. doi: 10.1016/j.ahj.2008.05.018. Epub 2008 Jul 31.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
South Africa
Poland
Hong Kong
Austria
Australia
Russian Federation
Argentina
Uruguay
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Guatemala
Hungary
China
Germany
Denmark
Taiwan
Greece
Ecuador
Czech Republic
Finland
France
Chile
Colombia
Netherlands


title: A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period

summary:
Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.

Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.

lead_sponsor: Eisai Inc.

location_country:
United Kingdom
Ireland
Australia
Canada
United States
France


title: An Open-label, Non-comparative, Multi-centre Study to Assess the Efficacy and Safety of Bicalutamide When Used in Combination With Anastrozole for the Treatment of Gonadotropin-independent Precocious Puberty in Boys With Testotoxicosis

acronym: BATT

summary: The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .

lead_sponsor: AstraZeneca

location_country:
United Kingdom
Russian Federation
Canada
India
United States
France


title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)

summary: The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.

ReferenceCitation: Galiè N, Rubin Lj, Hoeper M, Jansa P, Al-Hiti H, Meyer G, Chiossi E, Kusic-Pajic A, Simonneau G. Treatment of patients with mildly symptomatic pulmonary arterial hypertension with bosentan (EARLY study): a double-blind, randomised controlled trial. Lancet. 2008 Jun 21;371(9630):2093-100. doi: 10.1016/S0140-6736(08)60919-8.

lead_sponsor: Actelion

location_country:
Spain
Italy
Austria
Australia
Netherlands
Canada
Czech Republic
Switzerland
United Kingdom
United States
France
China
Belgium
Germany

location_facility: Centre de Pneumologie de L'Hospital Laval


title: Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine

summary: The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.

location_country:
Denmark
Belgium
Spain
Italy
Netherlands
Argentina
Canada
Switzerland
Korea, Republic of
United States
France
South Africa
Turkey
Colombia
Germany


type: EudraCT Number

title: A Phase III Randomized Trial to Evaluate the Efficacy and Safety of Second-Line Therapy With Fludarabine Plus Alemtuzumab vs. Fludarabine Alone in Patients With B-Cell Chronic Lymphocytic Leukemia

summary: This is a Phase 3, prospective, multicenter, open-label, randomized, controlled study to evaluate and compare the efficacy and safety of fludarabine plus alemtuzumab versus fludarabine alone as second-line therapy for patients with relapsed or refractory B-cell chronic lymphocytic leukemia (B-CLL). Patients who meet all eligibility criteria and sign the informed consent document may be entered on the study.

ReferenceCitation: Engert A, et al. Overall Survival Advantage and Acceptable Safety Profile with Fludarabine in Combination with Alemtuzumab (FluCam) in Previously Treated Patients with Advanced Stage Chronic Lymphocytic Leukemia. Poster Presentation at American Society of Hematology 10 December 2010; Blood (ASH Annual Meeting Abstracts), Nov 2010;116:919. http://ash.confex.com/ash/2010/webprogram/Paper31687.html

ReferenceCitation: Engert A, et al. Improved Progression-free Survival (PFS) of Alemtuzumab (Campath®, MabCampath®) plus Fludarabine (Fludara®) versus Fludarabine Alone as Second-line Treatment of Patients with B-Cell Chronic Lymphocytic Leukemia: Preliminary Results from a Phase III Randomized Trial. 51st ASH Annual Meeting. Blood 2009;114. Abstract 537. http://ash.confex.com/ash/2009/webprogram/Paper21929.html

ReferenceCitation: Engert A, et al. Fludarabine (FLU) plus Alemtuzumab (FluCAM) Improves Progression Free Survival versus Fludarabine in Previously Treated Chronic Lymphocytic Leukemia and Demonstrates Activity in High Risk Patients. Poster Presentation at European Hematology Association 12 June 2010. Abstract 0768. http://www.eventure-online.com/eventure/publicAbstractView.do?id=136964&congressId=3446

ReferenceCitation: Elter T, Gercheva-Kyuchukova L, Pylylpenko H, Robak T, Jaksic B, Rekhtman G, Kyrcz-Krzemień S, Vatutin M, Wu J, Sirard C, Hallek M, Engert A. Fludarabine plus alemtuzumab versus fludarabine alone in patients with previously treated chronic lymphocytic leukaemia: a randomised phase 3 trial. Lancet Oncol. 2011 Dec;12(13):1204-13. doi: 10.1016/S1470-2045(11)70242-X. Epub 2011 Oct 10.

lead_sponsor: Genzyme, a Sanofi Company

location_country:
Croatia
Poland
Portugal
Greece
Austria
Italy
Russian Federation
Canada
Ukraine
Sweden
United States
France
Romania
Germany
Bulgaria

location_facility: State Healthcare Department "Sverdlovsk Regional Clinical Hospital #1",

location_facility: Khmelnitskiy Regional Hospital, Hematology Department

location_facility: National Center for Heamtology and Transfusiology

location_facility: Orebro University Hospital, Dep. of Medicine

location_facility: Charite-Universitatsmedizin Berlin Campus Benjamin-Franklin

location_facility: University Multiprofile Hospital for Active Treatment Dr. Georgi Stranski

location_facility: Lviv National Medical University named Danilo Galytcky

location_facility: Multiprofile Hospital for Active Treatment, St. Marina

location_facility: Hospital de Sao Teotonio, Servico de Hematologia/Hosptial de Dia Oncologico

location_facility: Klinika Hematologii, Nowotworow Krwii 1 Transplantacji Szpiku

location_facility: Scientific Centre for Radiation Medicine AMS of Ukraine, Dept of Hematology and Transplantology

location_facility: Institute of Hematology and Transfusiology AMS of Ukraine, City Clinical Hospital #9

location_facility: Multiprofile Hospital for Active Treatment "Alexandrovska"

location_facility: Institutol Clinic Fundeni, Clinica Heamtologie

location_facility: "Laikon" General Hospital, University of Athens

location_facility: Hospital de Santa Maria Servico de Hematologia Clinica/Hospital de dia de Hematologia

location_facility: Klinika Hematologii Pomorskiej Akademii Medycznej w Szczecinie

location_facility: GU "Main Military Clinical Hospital named after acad. N.N.Burdenko of MO of Russia", Haematology Centre 3

location_facility: Charite Universitatsklinikum der Humboldt-Universitat zu Berlin

location_facility: City Clinical Hospital #4, Regional Hematology Center

location_facility: Klinikum der Universitat zu Koln, Klinik 1 fur Innere Medizin

location_facility: GOUVPO "Saint-Petersburg State Medical University named after acad I.P.Pavlov of Roszdrav", Bone Marrow Transplantology Clinic

location_facility: Saint-Petersburg GUZ "City Hospital #31" 3, Dynamo Prospect

location_facility: Clinical Hospital Center Rijeka, Department of Haematology

location_facility: Klinika Hematologii i Transplantacji Szpiku

location_facility: University Hospital, Dept. of Hematology

location_facility: Kharkov Regional Clinical Oncology Center, Department of Hematology

location_facility: U.O. Oncologia Medica Azienda Ospedaliera "Pugliese-Ciaccio"

location_facility: Istituto di Ematologia Dipartmento di Biotechnologie Celluari ed Ematologia, Universita di Roma "La Sapienza"

location_facility: Katedra i Klinika Hamatologii, Onkologii I Chorob Wewnetrznych AM

location_facility: Unita Operativa di Medicina Generale Reumatologia e Oncoematologia


title: Randomized Phase II Trial of Docetaxel (Taxotere) and Oblimersen (Antisense Oligonucleotide Directed to BCL-2) Versus Taxotere Alone in Patients With Hormone-Refractory Prostate Cancer

summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making tumor cells more sensitive to the drug.

PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with oblimersen works compared to docetaxel alone in treating patients with hormone-refractory adenocarcinoma (cancer) of the prostate.

ReferenceCitation: Sternberg CN, Dumez H, Van Poppel H, Skoneczna I, Sella A, Daugaard G, Gil T, Graham J, Carpentier P, Calabro F, Collette L, Lacombe D; EORTC Genitourinary Tract Cancer Group. Docetaxel plus oblimersen sodium (Bcl-2 antisense oligonucleotide): an EORTC multicenter, randomized phase II study in patients with castration-resistant prostate cancer. Ann Oncol. 2009 Jul;20(7):1264-9. doi: 10.1093/annonc/mdn784. Epub 2009 Mar 17.

ReferenceCitation: Sternberg CN, Dumez H, Van Poppel H, et al.: Multicenter randomized EORTC trial 30021 of docetaxel + oblimersen and docetaxel in patients (pts) with hormone refractory prostate cancer (HRPC). [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-144, 2007.

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

location_country:
Denmark
Poland
Portugal
Spain
Italy
Austria
United Kingdom
France
Israel
Belgium
Netherlands

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Rigshospitalet - Copenhagen University Hospital

location_facility: Hospital General Universitari Vall d'Hebron

location_facility: Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology


title: Double-blind, Partially Randomized, Parallel Group, Multicenter Study to Assess the Efficacy and Safety of 100 mg and 150 mg Monthly Oral Ibandronate in Women With Postmenopausal Osteoporosis Having Completed the Phase III Oral Ibandronate Trial BM16549

summary: This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

lead_sponsor: Hoffmann-La Roche

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


title: Phase II Study of Campath-1H in Lymphoplasmacytic Lymphoma (Waldenstrom's Macroglobulinemia)

summary:
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying how well alemtuzumab works in treating patients with Waldenstrom's macroglobulinemia.

status: Withdrawn

lead_sponsor: Jonsson Comprehensive Cancer Center

location_country:
United Kingdom
Australia
Canada
United States
France

location_facility: Rocky Mountain Cancer Centers - Denver Midtown

location_facility: Herbert Irving Comprehensive Cancer Center at Columbia University

location_facility: McMaster Children's Hospital at Hamilton Health Sciences

location_facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University

location_facility: Greenebaum Cancer Center at University of Maryland Medical Center

location_facility: Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

location_facility: Jonsson Comprehensive Cancer Center at UCLA

location_facility: Massachusetts General Hospital Cancer Center


title: A Randomized, Double-Blind, Double-Dummy , Parallel Group, Multinational, Clinical Study to Evaluate the Efficacy and Safety of Enoxaparin Versus Unfractionated Heparin in Patients With Acute ST-Segment Elevation Myocardial Infarction Receiving Fibrinolytic Therapy

summary: The primary objective of the study is to determine whether enoxaparin compared to unfractionated heparin will reduce the composite endpoint of all-cause mortality and non-fatal myocardial re-infarction within 30 days after randomization in patients with acute ST-segment elevation myocardial infarction who are eligible to receive fibrinolytic therapy

ReferenceCitation: Antman EM, Morrow DA, McCabe CH, Murphy SA, Ruda M, Sadowski Z, Budaj A, López-Sendón JL, Guneri S, Jiang F, White HD, Fox KA, Braunwald E; ExTRACT-TIMI 25 Investigators. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006 Apr 6;354(14):1477-88. Epub 2006 Mar 14.

ReferenceCitation: Morrow DA, Antman EM, Fox KA, White HD, Giugliano R, Murphy SA, McCabe CH, Braunwald E; ExTRACT-TIMI 25 Investigators. One-year outcomes after a strategy using enoxaparin vs. unfractionated heparin in patients undergoing fibrinolysis for ST-segment elevation myocardial infarction: 1-year results of the ExTRACT-TIMI 25 trial. Eur Heart J. 2010 Sep;31(17):2097-102. doi: 10.1093/eurheartj/ehq098. Epub 2010 Apr 17.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Belgium
Romania
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Uruguay
India
Israel
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Slovakia
Brazil
Lebanon
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Denmark
Belarus
Jordan
Greece
Ireland
Estonia
Latvia
Finland
Thailand
Korea, Republic of
France
Chile
Netherlands

location_facility: sanofi-aventis Australia & New Zealand administrative office


title: A Double-Blind, Placebo-Controlled, Parallel, Multicenter Study on Extended VTE Prophylaxis in Acutely Ill Medical Patients With Prolonged Immobilization

summary:
Primary objective:

To demonstrate the superiority of extended VTE prophylaxis with enoxaparin 40mg sc qd for 28 ± 4 days, compared to placebo, both following 10 ± 4 days of initial treatment with enoxaparin 40mg sc qd

Secondary objectives:

To assess the reduction in mortality rate at the end of the double-blind treatment period, at 3 (90 ± 10 days) and at 6 (180 ± 10 days) months from the time of entry to the study, in patients on extended prophylaxis
To assess the incidence of VTE at 3 months (90 ± 10 days) from the time of randomization to the study

To evaluate the safety of extended enoxaparin VTE prophylaxis in acutely ill medical patients with prolonged immobilization. Safety evaluation includes:

Major and minor hemorrhage
Heparin induced thrombocytopenia
Serious adverse events
To assess differences in levels of health-care utilization and cost between patients receiving extended VTE prophylaxis versus those receiving placebo.

ReferenceCitation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.

ReferenceCitation: Turpie AG, Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Chen M, Yusen RD; EXCLAIM Investigators. Venous thromboembolism risk in ischemic stroke patients receiving extended-duration enoxaparin prophylaxis: results from the EXCLAIM study. Stroke. 2013 Jan;44(1):249-51. doi: 10.1161/STROKEAHA.112.659797. Epub 2012 Nov 1.

ReferenceCitation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x. Review.

ReferenceCitation: Hull RD, Schellong SM, Tapson VF, Monreal M, Samama MM, Nicol P, Vicaut E, Turpie AG, Yusen RD; EXCLAIM (Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization) study. Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. Ann Intern Med. 2010 Jul 6;153(1):8-18. doi: 10.7326/0003-4819-153-1-201007060-00004.

location_country:
Poland
Brazil
Spain
Colombia
Austria
Australia
Italy
Argentina
Canada
Mexico
Russian Federation
Tunisia
United States
France
India
Israel
Belgium
South Africa
Germany
United Kingdom


title: Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis

summary: This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.

ReferenceCitation: E.J. Gane, H.L. Chan, G. Choudhuri, D.J. Suh4, A. Chutaputti, R. Safadi, T. Tanwandee, S. Thongsawat, N. Assy, S.K. Sarin, W. Bao, A. Trylesinski, C. Avila. TREATMENT OF DECOMPENSATED HBV-CIRRHOSIS: RESULTS FROM 2-YEARS RANDOMIZED TRIAL WITH TELBIVUDINE OR LAMIVUDINE. Journal of Hepatology 52, Supplement 1, Page S4. April 2010

location_country:
Spain
United Kingdom
United States
Poland
Russian Federation
Australia
India
Israel
Turkey
Malaysia
Singapore
Canada
China
Germany
Taiwan
Latvia
New Zealand
Thailand
Vietnam
Korea, Republic of
France


title: Phase 2 Study of AG 013736 as Second-Line Treatment in Patients With Metastatic Renal Cell Cancer

summary: The primary purpose of this protocol is to determine the activity of AG 013736 in patients with metastatic renal cell cancer who have received 1 prior cytokine-based therapy.

ReferenceCitation: Rixe O, Bukowski RM, Michaelson MD, Wilding G, Hudes GR, Bolte O, Motzer RJ, Bycott P, Liau KF, Freddo J, Trask PC, Kim S, Rini BI. Axitinib treatment in patients with cytokine-refractory metastatic renal-cell cancer: a phase II study. Lancet Oncol. 2007 Nov;8(11):975-84. Epub 2007 Oct 23.

lead_sponsor: Pfizer

location_country:
Germany
United States
France


type: Other Identifier

title: A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

summary:
RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection.

PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

ReferenceCitation: Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5.

ReferenceCitation: Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11. Erratum in: Lancet Oncol. 2013 Jun;14(7):e254.

lead_sponsor: ETOP IBCSG Partners Foundation

location_country:
Denmark
Brazil
Slovenia
Italy
Australia
New Zealand
Switzerland
France
Peru
Belgium

location_facility: CHU Liege - Domaine Universitaire du Sart Tilman

location_facility: Oncology Institute of Southern Switzerland

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Westmead Institute for Cancer Research at Westmead Hospital

location_facility: Instituto Nacional de Enfermedades Neoplasicas

location_facility: Sydney Cancer Centre at Royal Prince Alfred Hospital

location_facility: Centro di Riferimento Oncologico - Aviano


title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)

acronym: ORIGIN

summary:
The primary objectives of the ORIGIN study were:

To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

total mortality (all causes);
the risk of diabetic microvascular outcomes;
the rate of progression of IGT or IFG to type 2 diabetes.

ReferenceCitation: Origin Trial Investigators, Gerstein H, Yusuf S, Riddle MC, Ryden L, Bosch J. Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia: the ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention). Am Heart J. 2008 Jan;155(1):26-32, 32.e1-6. Epub 2007 Nov 26.

ReferenceCitation: Hanefeld M, Koehler C, Hoffmann C, Wilhelm K, Kamke W, Gerstein H. Effect of targeting normal fasting glucose levels with basal insulin glargine on glycaemic variability and risk of hypoglycaemia: a randomized, controlled study in patients with early Type 2 diabetes. Diabet Med. 2010 Feb;27(2):175-80. doi: 10.1111/j.1464-5491.2009.02915.x.

ReferenceCitation: Badings EA, Dyal L, Schoterman L, Lok DJ, Stoel I, Gerding MN, Gerstein HC, Tijssen JG. Strategies to detect abnormal glucose metabolism in people at high risk of cardiovascular disease from the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial population. J Diabetes. 2011 Sep;3(3):232-7. doi: 10.1111/j.1753-0407.2011.00124.x.

ReferenceCitation: Ramachandran A, Riddle MC, Kabali C, Gerstein HC; ORIGIN Investigators. Relationship between A1C and fasting plasma glucose in dysglycemia or type 2 diabetes: an analysis of baseline data from the ORIGIN trial. Diabetes Care. 2012 Apr;35(4):749-53. doi: 10.2337/dc11-1918. Epub 2012 Feb 8.

ReferenceCitation: ORIGIN Trial Investigators, Gerstein HC, Bosch J, Dagenais GR, Díaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Rydén LE, Yusuf S. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012 Jul 26;367(4):319-28. doi: 10.1056/NEJMoa1203858. Epub 2012 Jun 11.

ReferenceCitation: ORIGIN Trial Investigators, Bosch J, Gerstein HC, Dagenais GR, Díaz R, Dyal L, Jung H, Maggiono AP, Probstfield J, Ramachandran A, Riddle MC, Rydén LE, Yusuf S. n-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. N Engl J Med. 2012 Jul 26;367(4):309-18. doi: 10.1056/NEJMoa1203859. Epub 2012 Jun 11.

ReferenceCitation: Cukierman-Yaffe T, Lee SF, Pare G, McQueen M, Hess S, Gerstein HC. Biomarkers of Prevalent and Incident Cognitive Dysfunction in People with Dysglycemia: Data from the ORIGIN Trial. J Alzheimers Dis. 2022;87(3):1143-1150. doi: 10.3233/JAD-215195.

ReferenceCitation: Shao H, Kianmehr H, Guo J, Li P, Fonseca V, Shi L. Efficacy of iGlarLixi on 5-year risk of diabetes-related complications: A simulation study. J Diabetes Complications. 2022 Mar;36(3):108132. doi: 10.1016/j.jdiacomp.2022.108132. Epub 2022 Jan 25.

ReferenceCitation: Pigeyre M, Hess S, Gomez MF, Asplund O, Groop L, Paré G, Gerstein H. Validation of the classification for type 2 diabetes into five subgroups: a report from the ORIGIN trial. Diabetologia. 2022 Jan;65(1):206-215. doi: 10.1007/s00125-021-05567-4. Epub 2021 Oct 21.

ReferenceCitation: Wang A, Gerstein HC, Lee SF, Hess S, Paré G, Rydén L, Mellbin LG. Testosterone and sex hormone-binding globulin in dysglycemic women at high cardiovascular risk: A report from the Outcome Reduction with an Initial Glargine Intervention trial. Diab Vasc Dis Res. 2021 Mar-Apr;18(2):14791641211002475. doi: 10.1177/14791641211002475.

ReferenceCitation: Pigeyre M, Sjaarda J, Chong M, Hess S, Bosch J, Yusuf S, Gerstein H, Paré G. ACE and Type 2 Diabetes Risk: A Mendelian Randomization Study. Diabetes Care. 2020 Apr;43(4):835-842. doi: 10.2337/dc19-1973. Epub 2020 Feb 4.

ReferenceCitation: Thériault S, Sjaarda J, Chong M, Hess S, Gerstein H, Paré G. Identification of Circulating Proteins Associated With Blood Pressure Using Mendelian Randomization. Circ Genom Precis Med. 2020 Feb;13(1):e002605. doi: 10.1161/CIRCGEN.119.002605. Epub 2020 Jan 12.

ReferenceCitation: Gerstein HC, Paré G, McQueen MJ, Lee SF, Bangdiwala SI, Kannt A, Hess S; ORIGIN Trial Investigators. Novel Biomarkers for Change in Renal Function in People With Dysglycemia. Diabetes Care. 2020 Feb;43(2):433-439. doi: 10.2337/dc19-1604. Epub 2019 Nov 14.

ReferenceCitation: Pigeyre M, Sjaarda J, Mao S, Chong M, Hess S, Yusuf S, Gerstein H, Paré G. Identification of Novel Causal Blood Biomarkers Linking Metabolically Favorable Adiposity With Type 2 Diabetes Risk. Diabetes Care. 2019 Sep;42(9):1800-1808. doi: 10.2337/dc18-2444. Epub 2019 Jun 24.

ReferenceCitation: Cukierman-Yaffe T, Bosch J, Jung H, Punthakee Z, Gerstein HC. Hypoglycemia and Incident Cognitive Dysfunction: A Post Hoc Analysis From the ORIGIN Trial. Diabetes Care. 2019 Jan;42(1):142-147. doi: 10.2337/dc18-0690. Epub 2018 Nov 13.

ReferenceCitation: Mohammadi-Shemirani P, Sjaarda J, Gerstein HC, Treleaven DJ, Walsh M, Mann JF, McQueen MJ, Hess S, Paré G. A Mendelian Randomization-Based Approach to Identify Early and Sensitive Diagnostic Biomarkers of Disease. Clin Chem. 2019 Mar;65(3):427-436. doi: 10.1373/clinchem.2018.291104. Epub 2018 Oct 18.

ReferenceCitation: Morieri ML, Gao H, Pigeyre M, Shah HS, Sjaarda J, Mendonca C, Hastings T, Buranasupkajorn P, Motsinger-Reif AA, Rotroff DM, Sigal RJ, Marcovina SM, Kraft P, Buse JB, Wagner MJ, Gerstein HC, Mychaleckyj JC, Parè G, Doria A. Genetic Tools for Coronary Risk Assessment in Type 2 Diabetes: A Cohort Study From the ACCORD Clinical Trial. Diabetes Care. 2018 Nov;41(11):2404-2413. doi: 10.2337/dc18-0709. Epub 2018 Sep 27.

ReferenceCitation: Birkeland KI, Grill V, Wium C, McQueen MJ, Lopez-Jaramillo P, Lee SF, Gerstein HC. The association of basal insulin treatment versus standard care with outcomes in anti-GAD positive and negative subjects: A post-hoc analysis of the ORIGIN trial. Diabetes Obes Metab. 2019 Feb;21(2):429-433. doi: 10.1111/dom.13528. Epub 2018 Oct 3.

ReferenceCitation: Sjaarda J, Gerstein H, Chong M, Yusuf S, Meyre D, Anand SS, Hess S, Paré G. Blood CSF1 and CXCL12 as Causal Mediators of Coronary Artery Disease. J Am Coll Cardiol. 2018 Jul 17;72(3):300-310. doi: 10.1016/j.jacc.2018.04.067. Epub 2018 Jul 9.

ReferenceCitation: Gerstein HC, Ferrannini E, Riddle MC, Yusuf S; ORIGIN Trial Investigators. Insulin resistance and cardiovascular outcomes in the ORIGIN trial. Diabetes Obes Metab. 2018 Mar;20(3):564-570. doi: 10.1111/dom.13112. Epub 2017 Oct 8.

ReferenceCitation: Papademetriou V, Nylen ES, Doumas M, Probstfield J, Mann JFE, Gilbert RE, Gerstein HC. Chronic Kidney Disease, Basal Insulin Glargine, and Health Outcomes in People with Dysglycemia: The ORIGIN Study. Am J Med. 2017 Dec;130(12):1465.e27-1465.e39. doi: 10.1016/j.amjmed.2017.05.047. Epub 2017 Aug 31.

ReferenceCitation: Yates T, Davies MJ, Jung H, Bosch J, Spinas GA, Sreenan S, Commerford P, Gerstein HC; ORGIN investigators. Effect of insulin glargine on recreational physical activity and TV viewing: Analysis of the randomised ORIGIN trial. Diabetes Res Clin Pract. 2017 Oct;132:137-143. doi: 10.1016/j.diabres.2017.07.035. Epub 2017 Jul 31.

ReferenceCitation: Rautio A, Boman K, Gerstein HC, Hernestål-Boman J, Lee SF, Olofsson M, Mellbin LG. The effect of basal insulin glargine on the fibrinolytic system and von Willebrand factor in people with dysglycaemia and high risk for cardiovascular events: Swedish substudy of the Outcome Reduction with an Initial Glargine Intervention trial. Diab Vasc Dis Res. 2017 Jul;14(4):345-352. doi: 10.1177/1479164117703034. Epub 2017 Apr 12.

ReferenceCitation: Gerstein HC, Paré G, McQueen MJ, Lee SF, Hess S; ORIGIN Trial Investigators. Validation of the ORIGIN Cardiovascular Biomarker Panel and the Value of Adding Troponin I in Dysglycemic People. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2251-2257. doi: 10.1210/jc.2017-00273.

ReferenceCitation: Gerstein HC, Pare G, Hess S, Ford RJ, Sjaarda J, Raman K, McQueen M, Lee S, Haenel H, Steinberg GR; ORIGIN Investigators. Growth Differentiation Factor 15 as a Novel Biomarker for Metformin. Diabetes Care. 2017 Feb;40(2):280-283. doi: 10.2337/dc16-1682. Epub 2016 Dec 14.

ReferenceCitation: ORIGIN Trial Investigators. Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE). Diabetes Care. 2016 May;39(5):709-16. doi: 10.2337/dc15-1676. Epub 2015 Dec 17.

ReferenceCitation: Gerstein HC, Paré G, McQueen MJ, Haenel H, Lee SF, Pogue J, Maggioni AP, Yusuf S, Hess S; Outcome Reduction With Initial Glargine Intervention Trial Investigators. Identifying Novel Biomarkers for Cardiovascular Events or Death in People With Dysglycemia. Circulation. 2015 Dec 15;132(24):2297-304. doi: 10.1161/CIRCULATIONAHA.115.015744. Epub 2015 Oct 30.

ReferenceCitation: Cukierman-Yaffe T, Bosch J, Diaz R, Dyal L, Hancu N, Hildebrandt P, Lanas F, Lewis BS, Marre M, Yale JF, Yusuf S, Gerstein HC; ORIGIN Investigators. Effects of basal insulin glargine and omega-3 fatty acid on cognitive decline and probable cognitive impairment in people with dysglycaemia: a substudy of the ORIGIN trial. Lancet Diabetes Endocrinol. 2014 Jul;2(7):562-72. doi: 10.1016/S2213-8587(14)70062-2. Epub 2014 Jun 2.

ReferenceCitation: ORIGIN trial investigators, Gilbert RE, Mann JF, Hanefeld M, Spinas G, Bosch J, Yusuf S, Gerstein HC. Basal insulin glargine and microvascular outcomes in dysglycaemic individuals: results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial. Diabetologia. 2014 Jul;57(7):1325-31. doi: 10.1007/s00125-014-3238-4. Epub 2014 Apr 26.

ReferenceCitation: Lopez-Jaramillo P, Cohen DD, Gómez-Arbeláez D, Bosch J, Dyal L, Yusuf S, Gerstein HC; ORIGIN Trial Investigators. Association of handgrip strength to cardiovascular mortality in pre-diabetic and diabetic patients: a subanalysis of the ORIGIN trial. Int J Cardiol. 2014 Jun 15;174(2):458-61. doi: 10.1016/j.ijcard.2014.04.013. Epub 2014 Apr 13.

ReferenceCitation: Lamy A, Tong W, Jung H, Gafni A, Singh K, Tyrwhitt J, Yusuf S, Gerstein HC; ORIGIN Investigators. Cost implications of the use of basal insulin glargine in people with early dysglycemia: the ORIGIN trial. J Diabetes Complications. 2014 Jul-Aug;28(4):553-8. doi: 10.1016/j.jdiacomp.2014.02.012. Epub 2014 Mar 2.

ReferenceCitation: Bordeleau L, Yakubovich N, Dagenais GR, Rosenstock J, Probstfield J, Chang Yu P, Ryden LE, Pirags V, Spinas GA, Birkeland KI, Ratner RE, Marin-Neto JA, Keltai M, Riddle MC, Bosch J, Yusuf S, Gerstein HC; ORIGIN Trial Investigators. The association of basal insulin glargine and/or n-3 fatty acids with incident cancers in patients with dysglycemia. Diabetes Care. 2014;37(5):1360-6. doi: 10.2337/dc13-1468. Epub 2014 Feb 26.

ReferenceCitation: ORIGIN Trial Investigators, Mellbin LG, Rydén L, Riddle MC, Probstfield J, Rosenstock J, Díaz R, Yusuf S, Gerstein HC. Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial. Eur Heart J. 2013 Oct;34(40):3137-44. doi: 10.1093/eurheartj/eht332. Epub 2013 Sep 2.

ReferenceCitation: ORIGIN Trial Investigators. Characteristics associated with maintenance of mean A1C<6.5% in people with dysglycemia in the ORIGIN trial. Diabetes Care. 2013 Oct;36(10):2915-22. doi: 10.2337/dc12-2238. Epub 2013 May 8.

ReferenceCitation: Lonn EM, Bosch J, Diaz R, Lopez-Jaramillo P, Ramachandran A, Hâncu N, Hanefeld M, Krum H, Ryden L, Smith S, McQueen MJ, Dyal L, Yusuf S, Gerstein HC; GRACE and ORIGIN Investigators. Effect of insulin glargine and n-3FA on carotid intima-media thickness in people with dysglycemia at high risk for cardiovascular events: the glucose reduction and atherosclerosis continuing evaluation study (ORIGIN-GRACE). Diabetes Care. 2013 Sep;36(9):2466-74. doi: 10.2337/dc12-2129. Epub 2013 Apr 5.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Venezuela
United States
Romania
Philippines
South Africa
Poland
Austria
Australia
Russian Federation
Argentina
Bermuda
India
Israel
Turkey
Mexico
Norway
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Belarus
Ireland
Latvia
Estonia
Finland
Korea, Republic of
France
Chile
Colombia
Netherlands

location_facility:
Sanofi-Aventis Administrative Office
Makati City
Sanofi-Aventis Aministrative Office

intervention_type: Device


title: Phase I/II Randomized, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Bay 50-4798 Administration in Patients With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to Patients on HAART Alone.

summary: The purpose of this study is to evaluate the safety of the experimental drug Bay 50-4798 in HIV positive patients receiving HAART and to test the drug's effect on the CD4+ T-cell count.

lead_sponsor: Bayer

location_country:
United States
United Kingdom
France


title: European Study Group For Pancreatic Cancer - Trial 3

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery.

PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.

enrollment_type: Anticipated

ReferenceCitation: Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Oláh A, Rawcliffe CL, Verbeke CS, Campbell F, Büchler MW; European Study Group for Pancreatic Cancer. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA. 2012 Jul 11;308(2):147-56. doi: 10.1001/jama.2012.7352. Erratum in: JAMA. 2012 Nov 14;308(18):1861.

ReferenceCitation: Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Oláh A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. doi: 10.1001/jama.2010.1275.

ReferenceCitation: Jones RP, Psarelli EE, Jackson R, Ghaneh P, Halloran CM, Palmer DH, Campbell F, Valle JW, Faluyi O, O'Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ting Y, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Lerch MM, Mayerle J, Tjaden C, Strobel O, Hackert T, Büchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial. JAMA Surg. 2019 Nov 1;154(11):1038-1048. doi: 10.1001/jamasurg.2019.3337.

ReferenceCitation: Ghaneh P, Kleeff J, Halloran CM, Raraty M, Jackson R, Melling J, Jones O, Palmer DH, Cox TF, Smith CJ, O'Reilly DA, Izbicki JR, Scarfe AG, Valle JW, McDonald AC, Carter R, Tebbutt NC, Goldstein D, Padbury R, Shannon J, Dervenis C, Glimelius B, Deakin M, Anthoney A, Lerch MM, Mayerle J, Oláh A, Rawcliffe CL, Campbell F, Strobel O, Büchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. The Impact of Positive Resection Margins on Survival and Recurrence Following Resection and Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma. Ann Surg. 2019 Mar;269(3):520-529. doi: 10.1097/SLA.0000000000002557.

lead_sponsor: Royal Liverpool University Hospital

location_country:
United Kingdom
Greece
Italy
Australia
Finland
Canada
Czech Republic
Switzerland
Sweden
Hungary
France
Japan
Germany

location_facility: Edmond Odette Cancer Centre at Sunnybrook

location_facility: British Columbia Cancer Agency - Centre for the Southern Interior

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Cancer Research Institute at Queen's University

location_facility: Ottawa Hospital Regional Cancer Centre - General Campus

location_facility: McGill Cancer Centre at McGill University

location_facility: Institute for Clinical and Experimental Medicine

location_facility: Cross Cancer Institute at University of Alberta

location_facility: British Columbia Cancer Agency - Vancouver Island Centre

location_facility: London Regional Cancer Program at London Health Sciences Centre

location_facility: Institute of Oncology at Prince of Wales Hospital

intervention_type: Other


title: A Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Plus BCG Versus Placebo Plus BCG as a Post-Surgical Treatment for Stage IV Melanoma

summary: This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

status: Unknown status

ReferenceCitation: Faries MB, Mozzillo N, Kashani-Sabet M, Thompson JF, Kelley MC, DeConti RC, Lee JE, Huth JF, Wagner J, Dalgleish A, Pertschuk D, Nardo C, Stern S, Elashoff R, Gammon G, Morton DL; MMAIT-IV Clinical Trial Group. Long-Term Survival after Complete Surgical Resection and Adjuvant Immunotherapy for Distant Melanoma Metastases. Ann Surg Oncol. 2017 Dec;24(13):3991-4000. doi: 10.1245/s10434-017-6072-3. Epub 2017 Oct 10.

ReferenceCitation: Hoshimoto S, Faries MB, Morton DL, Shingai T, Kuo C, Wang HJ, Elashoff R, Mozzillo N, Kelley MC, Thompson JF, Lee JE, Hoon DS. Assessment of prognostic circulating tumor cells in a phase III trial of adjuvant immunotherapy after complete resection of stage IV melanoma. Ann Surg. 2012 Feb;255(2):357-62. doi: 10.1097/SLA.0b013e3182380f56.

lead_sponsor: CancerVax Corporation

location_country:
Brazil
United Kingdom
Ireland
Italy
Australia
Netherlands
Canada
New Zealand
Switzerland
United States
France
Israel
Germany

location_facility: Lineberger Comprehensive Cancer Center, UNC

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: University of Pennsylvania Cancer Center

location_facility: St. Louis University Health Sciences Center

location_facility: Central Arkansas Veterans Healthcare System

location_facility: Arthur G. James Cancer Hospital - Ohio State University

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: UCSF Cancer Center and Cancer Research Institute

location_facility: University of Arkansas for Medical Sciences

location_facility: Intermountain Health Care- Mckay-Dee Hospital

location_facility: Cedars Sinai Comprehensive Cancer Center

location_facility: Sidney Kimmel Comprehensive Cancer Center

location_facility: The Cancer Cener at Hackensack University Medical Center

location_facility: The Cancer Institute at Good Samaritan Medical Center


title: Phase III Randomized Double-Blind Pivotal Trial of Immunotherapy With BCG Plus a Polyvalent Melanoma Vaccine, CancerVax™ Vaccine Versus BCG Plus a Placebo as a Post-Surgical Treatment for Stage III Melanoma

summary: This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

location_facility: Winship Cancer Institute at Emory University


title: A Phase III, Multicenter, Multinational, Randomized, Parallel Group, Double-blind Trial of Clopidogrel Versus Placebo in High-risk Patients Aged 45 Years and Older, at Risk of Atherothrombotic Events, and Who Are Receiving Background Therapy Including Low-dose ASA.

summary:
RATIONALE:

Atherothrombosis is a progressive and generalized vascular disease resulting in events leading to myocardial infarction (heart attack), stroke, and vascular death.
In patients at risk for this disease, it is characterized by an unpredictable, sudden disruption of atherosclerotic plaques, which may lead to total occlusion of artery due to formation of a clot. The use of aspirin (blood thinner agent) for reducing those major ischemic events is either indicated, or recommended by international guidelines. However, aspirin fails to prevent a high percentage of such life-threatening events. Therefore, more effective blood thinning therapy may provide additional clinical benefit to such patients.
The results of the CURE trial in patients with unstable angina demonstrate the additional benefit of long-term treatment (up to one year) with clopidogrel, (a blood thinner agent), when administered in combination with standard therapy including aspirin. The purpose of CHARISMA is to investigate whether a similar clinical benefit of clopidogrel may apply to a broad population of high-risk patients receiving low-dose aspirin therapy. Such population includes patients with previous cardiovascular, neurovascular or peripheral arterial manifestations of atherothrombosis and patients with combinations of recognized risk factors for atherosclerosis.

OBJECTIVES:

To assess the efficacy of clopidogrel 75 mg once-daily by comparison with a placebo, in preventing cardiovascular morbidity/mortality. The study will compare the efficacy of the two regimens in preventing the occurrence of major cardiovascular complications (stroke, heart attack, cardiovascular death) in high-risk patients who are otherwise receiving low-dose aspirin therapy (75-162 mg daily).
To evaluate the safety of clopidogrel in this population, and more specifically the incidence of fatal or severe bleeding (as per GUSTO definition), in order to estimate the global benefit of clopidogrel in this patient population.

ReferenceCitation: Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. Epub 2006 Mar 12.

ReferenceCitation: Bhatt DL, Paré G, Eikelboom JW, Simonsen KL, Emison ES, Fox KA, Steg PG, Montalescot G, Bhakta N, Hacke W, Flather MD, Mak KH, Cacoub P, Creager MA, Berger PB, Steinhubl SR, Murugesan G, Mehta SR, Kottke-Marchant K, Lincoff AM, Topol EJ; CHARISMA Investigators. The relationship between CYP2C19 polymorphisms and ischaemic and bleeding outcomes in stable outpatients: the CHARISMA genetics study. Eur Heart J. 2012 Sep;33(17):2143-50. Epub 2012 Mar 26.

ReferenceCitation: Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2:CD008834. doi: 10.1002/14651858.CD008834.pub4. Review.

ReferenceCitation: Bangalore S, Bhatt DL, Steg PG, Weber MA, Boden WE, Hamm CW, Montalescot G, Hsu A, Fox KA, Lincoff AM. β-blockers and cardiovascular events in patients with and without myocardial infarction: post hoc analysis from the CHARISMA trial. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):872-81. doi: 10.1161/CIRCOUTCOMES.114.001073. Epub 2014 Sep 30.

ReferenceCitation: Berger PB, Bhatt DL, Fuster V, Steg PG, Fox KA, Shao M, Brennan DM, Hacke W, Montalescot G, Steinhubl SR, Topol EJ; CHARISMA Investigators. Bleeding complications with dual antiplatelet therapy among patients with stable vascular disease or risk factors for vascular disease: results from the Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) trial. Circulation. 2010 Jun 15;121(23):2575-83. doi: 10.1161/CIRCULATIONAHA.109.895342. Epub 2010 Jun 1.

ReferenceCitation: Steinhubl SR, Bhatt DL, Brennan DM, Montalescot G, Hankey GJ, Eikelboom JW, Berger PB, Topol EJ; CHARISMA Investigators. Aspirin to prevent cardiovascular disease: the association of aspirin dose and clopidogrel with thrombosis and bleeding. Ann Intern Med. 2009 Mar 17;150(6):379-86.

ReferenceCitation: Mak KH, Bhatt DL, Shao M, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Montalescot G, Steg PG, Steinhubl SR, Fox KA, Topol EJ. The influence of body mass index on mortality and bleeding among patients with or at high-risk of atherothrombotic disease. Eur Heart J. 2009 Apr;30(7):857-65. doi: 10.1093/eurheartj/ehp037. Epub 2009 Feb 20.

ReferenceCitation: Eikelboom JW, Hankey GJ, Thom J, Bhatt DL, Steg PG, Montalescot G, Johnston SC, Steinhubl SR, Mak KH, Easton JD, Hamm C, Hu T, Fox KA, Topol EJ; Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA) Investigators. Incomplete inhibition of thromboxane biosynthesis by acetylsalicylic acid: determinants and effect on cardiovascular risk. Circulation. 2008 Oct 21;118(17):1705-12. doi: 10.1161/CIRCULATIONAHA.108.768283. Epub 2008 Oct 6.

ReferenceCitation: Bhatt DL, Flather MD, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Fabry-Ribaudo L, Hu T, Topol EJ, Fox KA; CHARISMA Investigators. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol. 2007 May 15;49(19):1982-8. Epub 2007 Apr 11.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Norway
Malaysia
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Greece
Finland
Czech Republic
France
Chile
Netherlands

location_facility:
Sanofi-aventis Administrative Office
The Cleveland Clinic Foundation


summary: The purpose of this study is to determine the optimal dosage of YM598 for slowing down disease progression in patients with rising PSA after initial therapy for localized prostate cancer.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Spain
United Kingdom
Czech Republic
France
Belgium
Germany

location_facility: Klinik und Poliklinik für Urologie, Universitätsklinikum Carl-Gustav-Carus

location_facility: Department of Urology, Gartnavel Hospital

location_facility: Department of Urology, Taunton & Somerset Hospital

location_facility: Complejo Hospitaliaro Juan Canalejo, Servicio de Urología

location_facility: Klinik u. Poliklinik für Urologie, Philipps Universität, Baldingerstraße

location_facility: Hospital Universitario Principe de Asturias, Servicio de Urología, Ctra.

location_facility: Bielanski Hospital, Department of Urology

location_facility: Fundacion Hospital Alcorcón, Servicio Urología

location_facility: Oncology Center, Department of Urinary Tract Cancer

location_facility: Department of Urology, Norfolk & Norwich Hospital

location_facility: Department of Urology, Bristol Royal Infirmary

location_facility: Regional Hospital, Department of Urology


title: A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab

summary: This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

location_country:
Poland
Spain
United Kingdom
Australia
Mexico
Canada
Sweden
United States
France
Belgium
Norway
Germany


title: A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Patients With Moderate to Severe Pulmonary Arterial Hypertension

summary: The purpose of this study is to determine if treating patients suffering from moderate to severe pulmonary arterial hypertension with BSF 208075 will improve the patients' ability to exercise.

lead_sponsor: Gilead Sciences

location_country:
Italy
Australia
United States
France
Belgium
Germany

location_facility: University of Bologna - Institute of Cardiology

location_facility: Los Angeles County Harbor-UCLA Medical Center

location_facility: University of California San Diego Medical Center

location_facility: University of Colorado Health Sciences Center

location_facility: University of California - San Francisco


title: An Open-Label, Uncontrolled, Long-Term Study to Assess the Safety of LAMICTAL in Pediatric Subjects Previously Enrolled in Protocol LAM20006 and In LAMICTAL-naive Subjects (1-24 Months of Age)

summary: This study will evaluate the long-term safety of LAMICTAL(lamotrigine)in subjects with partial seizures previously enrolled in protocol LAM20006 and in subjects 1-24 months of age who have never received LAMICTAL(LAMICTAL-naive). For LAMICTAL-naive subjects, LAMICTAL will be added to the subject's current epilepsy medications.

ipd_sharing: Yes

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

lead_sponsor: GlaxoSmithKline

location_country:
Portugal
Italy
Latvia
Estonia
Australia
Argentina
Lebanon
Lithuania
Hungary
Puerto Rico
United States
France
Turkey
Netherlands
Slovakia


title: A Double-Blind, Placebo-Controlled, Add-On Clinical Trial of the Safety, Pharmacokinetics and Efficacy of Lamictal in Pediatric Age Subjects (1-24 Months)

summary: This study is being conducted to evaluate the effectiveness and safety of LAMICTAL added to the current therapy of pediatric patients age 1-24 months old with partial seizures. The medication used in this study has been approved by FDA for the adjunctive treatment of partial seizures in patients 2 years and older.

location_country:
Portugal
Spain
Italy
Latvia
Estonia
Australia
Lebanon
Lithuania
Hungary
United States
France
Turkey
Netherlands
Slovakia


title: An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (QLQ-PR25) For Assessing Quality Of Life Of Patients With Prostate Cancer

summary:
RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients.

PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.

study_type: Observational

time_perspective: Prospective

ReferenceCitation: Arraras JI, Villafranca E, Arias de la Vega F, Romero P, Rico M, Vila M, Asín G, Chicata V, Domínguez MA, Lainez N, Manterola A, Martínez E, Martínez M. The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients. Clin Transl Oncol. 2009 Mar;11(3):160-4.

ReferenceCitation: Arraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Domínguez Domínguez MA, Lainez Milagro N, Manterola Burgaleta A, Martínez Lopez E, Romero Rojano P, Martínez Aguillo M. The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol. 2008 Oct;61(8):949-54.

location_country:
Denmark
Romania
United Kingdom
Italy
Australia
Netherlands
France
Turkey
Belgium
Norway
Germany

location_facility: Velindre Cancer Center at Velinde Hospital

location_facility: Azienda Ospedaliera Maggiore Della Carita

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Dokuz Eylul University School of Medicine

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel


title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Safety and Efficacy Trial of LJP 394 in Systemic Lupus Erythematosus (SLE) Patients With a History of Renal Disease

summary: The purpose of this study is to determine whether LJP 394 (abetimus sodium) is safe and effective in delaying and reducing renal flares in patients with lupus nephritis.

ReferenceCitation: Cardiel MH, Tumlin JA, Furie RA, Wallace DJ, Joh T, Linnik MD; LJP 394-90-09 Investigator Consortium. Abetimus sodium for renal flare in systemic lupus erythematosus: results of a randomized, controlled phase III trial. Arthritis Rheum. 2008 Aug;58(8):2470-80. doi: 10.1002/art.23673.

lead_sponsor: La Jolla Pharmaceutical Company

location_country:
Spain
Italy
Austria
United Kingdom
Canada
Sweden
United States
France
Mexico
Germany

location_facility: University of Michigan Health System, Internal Medicine-Rheumatology

location_facility: San Antonio Kidney Disease Center, Research Center

location_facility: Hospital for Joint Diseases, Department of Rheumatology

location_facility: Wake Forest University School of Medicine

location_facility: Presbyterian Hospital of Dallas, Arthritis Consultation Center

location_facility: Service De Rhumatologie Hopital de Hautepierre

location_facility: Emory University School of Medicine, Renal Division

location_facility: Universitatklinikum Charite, Medizinische Universitatsklinik

location_facility: Ambulatory Clinical Research Center, Hospital for Joint Diseases Orthopaedic Institute, NYU

location_facility: Rheumatology Associates of North Alabama

location_facility: U.O di Reumatologia, Dipartimento di Medicina Interna, Universita di Pisa

location_facility: University of Louisville, Dept of Medicine/Division of Rheumatology

location_facility: Texas Tech University Health Sciences Center, Department of Internal Medicine

location_facility: Hospital Clinic y Provinical de Barcelona, Unitat de Malalties Autoimmunes

location_facility: Hospital Universitario La Paz Servico de Medicina

location_facility: Insituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran, Depto. de Immunology y Rheumatology

location_facility: Metrohealth Medical Center, Division of Rheumatology

location_facility: Hospital General Valle de Hebron Servicio Medicina Interna. Edificio

location_facility: Thomas Jefferson University, Division of Rheumatology

location_facility: Department of Rheumatology, University Hospital of Lund

location_facility: Arthritis Center of Excellence, Toronto Western Hospital, University Health Network

location_facility: Lupus Research Unit St. Thomas Hospital, The Rayne Institute

location_facility: Hospital for Joint Diseases, NYU Medical Center

location_facility: University of Connecticut Health Center, Division of Rheumatology

location_facility: Division of Rheumatology, Department of Internal Medicine

location_facility: Wayne State University, Rheumatology Division

location_facility: Department of Rheumatology, Karolinska Hospital

location_facility: Harbor-UCLA Research & Education Institute, Medicine/Rheumatology Division

location_facility: Saint Louis University Health Sciences Center

location_facility: University of Pittsburgh, Div. of Rheumatology and Clinical Immun.

location_facility: Department for Internal Medicine and Institute of Immunology and Rheumatology

location_facility: LSU Health Sciences Center, Department of Rheumatology


title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of Weight-Reducing Effect and Safety in Obese Patients With Type 2 Diabetes

acronym: RIO-Diabetes

summary: To assess the effect on weight loss and weight maintenance over a period of one year when prescribed with a hypocaloric diet in obese patients with Type 2 Diabetes

ReferenceCitation: Scheen AJ, Finer N, Hollander P, Jensen MD, Van Gaal LF; RIO-Diabetes Study Group. Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study. Lancet. 2006 Nov 11;368(9548):1660-72. Erratum in: Lancet. 2006 Nov 11;368(9548):1650.

lead_sponsor: Sanofi

location_country:
Poland
United Kingdom
Netherlands
Argentina
Czech Republic
Canada
Finland
United States
France
Belgium
Germany

location_facility: Medical University of South Carolina, Division of Clinical Pharmacology

location_facility: Endocrinology and Diabetes Consultants, PC

location_facility: Center for Nutrition and Preventive Medicine

location_facility: Jacksonville Center for Clinical Research

location_facility: Salem Veterans Affairs Medical Center (151)

location_facility: University of Oklahoma Health Sciences Center

location_facility: Southern California Prevention and Research Center Inc. (SPARC)


title: Multicenter Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab (Herceptin)(AC-TH) and With Docetaxel, Carboplatin and Trastuzumab (TCH) In The Adjuvant Treatment Of Node Positive and High Risk Node Negative Patients With Operable Breast Cancer Containing The HER2 Alteration

summary:
Primary objective:

Compare disease-free survival in women with human epidermal growth factor receptor 2 (HER2)-neu-expressing node-positive or high-risk node-negative operable breast cancer treated with adjuvant doxorubicin, cyclophosphamide, and docetaxel with or without trastuzumab (Herceptin) vs trastuzumab, docetaxel, and carboplatin.

Secondary objective:

Compare overall survival of participants treated with these regimens.
Compare the toxic effects (including cardiac) of these regimens in these participants.
Compare quality of life of participants treated with these regimens.
Compare pathologic and molecular markers for predicting efficacy of these regimens in these participants.
For substudy: Compare peripheral levels of shed HER2-neu extracellular domain with fluorescence in situ hybridization in predicting outcome in participants treated with these regimens.

ReferenceCitation: Slamon D, Eiermann W, Robert N, Pienkowski T, Martin M, Press M, Mackey J, Glaspy J, Chan A, Pawlicki M, Pinter T, Valero V, Liu MC, Sauter G, von Minckwitz G, Visco F, Bee V, Buyse M, Bendahmane B, Tabah-Fisch I, Lindsay MA, Riva A, Crown J; Breast Cancer International Research Group. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011 Oct 6;365(14):1273-83. doi: 10.1056/NEJMoa0910383.

ReferenceCitation: Au HJ, Eiermann W, Robert NJ, Pienkowski T, Crown J, Martin M, Pawlicki M, Chan A, Mackey J, Glaspy J, Pintér T, Liu MC, Fornander T, Sehdev S, Ferrero JM, Bée V, Santana MJ, Miller DP, Lalla D, Slamon DJ; Translational Research in Oncology BCIRG 006 Trial Investigators. Health-related quality of life with adjuvant docetaxel- and trastuzumab-based regimens in patients with node-positive and high-risk node-negative, HER2-positive early breast cancer: results from the BCIRG 006 Study. Oncologist. 2013;18(7):812-8. doi: 10.1634/theoncologist.2013-0091. Epub 2013 Jun 28.

ReferenceCitation: Perez EA, Press MF, Dueck AC, Jenkins RB, Kim C, Chen B, Villalobos I, Paik S, Buyse M, Wiktor AE, Meyer R, Finnigan M, Zujewski J, Shing M, Stern HM, Lingle WL, Reinholz MM, Slamon DJ. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat. 2013 Feb;138(1):99-108. doi: 10.1007/s10549-013-2444-y. Epub 2013 Feb 19.

ReferenceCitation: Press MF, Sauter G, Buyse M, Bernstein L, Guzman R, Santiago A, Villalobos IE, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Bee V, Taupin H, Flom KJ, Tabah-Fisch I, Pauletti G, Lindsay MA, Riva A, Slamon DJ. Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy. J Clin Oncol. 2011 Mar 1;29(7):859-67. doi: 10.1200/JCO.2009.27.5644. Epub 2010 Dec 28.

ReferenceCitation: Stern HM, Gardner H, Burzykowski T, Elatre W, O'Brien C, Lackner MR, Pestano GA, Santiago A, Villalobos I, Eiermann W, Pienkowski T, Martin M, Robert N, Crown J, Nuciforo P, Bee V, Mackey J, Slamon DJ, Press MF. PTEN Loss Is Associated with Worse Outcome in HER2-Amplified Breast Cancer Patients but Is Not Associated with Trastuzumab Resistance. Clin Cancer Res. 2015 May 1;21(9):2065-74. doi: 10.1158/1078-0432.CCR-14-2993. Epub 2015 Feb 3.

ReferenceCitation: Press MF, Sauter G, Buyse M, Fourmanoir H, Quinaux E, Tsao-Wei DD, Eiermann W, Robert N, Pienkowski T, Crown J, Martin M, Valero V, Mackey JR, Bee V, Ma Y, Villalobos I, Campeau A, Mirlacher M, Lindsay MA, Slamon DJ. HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): Comparison of the ASCO-College of American Pathologists Guidelines With FISH Scores Used for Enrollment in Breast Cancer International Research Group Clinical Trials. J Clin Oncol. 2016 Oct 10;34(29):3518-3528. doi: 10.1200/JCO.2016.66.6693.

location_country:
Croatia
Spain
Italy
United Kingdom
Venezuela
United States
Belgium
Romania
South Africa
Poland
Hong Kong
Slovenia
Austria
Australia
Russian Federation
Argentina
Tunisia
Uruguay
India
Israel
Turkey
Mexico
Sweden
Slovakia
Egypt
Bosnia and Herzegovina
Brazil
Lebanon
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Greece
Ireland
Estonia
New Zealand
Czech Republic
Korea, Republic of
France
Colombia


title: A Phase III Double-Blind, Randomized, Placebo-Controlled Study of Erythropoietin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Epoetin alfa may help prevent or treat cancer-related anemia. It is not yet known whether radiation therapy is more effective with or without epoetin alfa in treating head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without epoetin alfa in treating patients who have head and neck cancer.

ReferenceCitation: Bourhis J, Lapeyre M, Tortochaux J, Rives M, Aghili M, Bourdin S, Lesaunier F, Benassi T, Lemanski C, Geoffrois L, Lusinchi A, Verrelle P, Bardet E, Julieron M, Wibault P, Luboinski M, Benhamou E. Phase III randomized trial of very accelerated radiation therapy compared with conventional radiation therapy in squamous cell head and neck cancer: a GORTEC trial. J Clin Oncol. 2006 Jun 20;24(18):2873-8.

location_country:
Spain
United Kingdom
Australia
Netherlands
Switzerland
Hungary
France
Israel
Belgium
Germany

location_facility:
Hopital de Jolimont
Newcastle Mater Misericordiae Hospital
U.Z. Gasthuisberg
Hospital de la Santa Cruz I Sant Pau
Ospedale San Giovanni
Radius Hungaricus Oncology Group
Beatson Oncology Centre
Radiotherapeutisch Instituut Limburg
Clinique Sainte Elisabeth
Universitaetsklinikum Charite
Rambam Medical Center
Institut Jules Bordet
Institut Gustave Roussy
Cliniques Universitaires Saint-Luc
Algemeen Ziekenhuis Middelheim


title: Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation therapy to the brain may be effective in preventing brain metastases. It is not yet known if radiation therapy is effective following chemotherapy in preventing brain metastases.

PURPOSE: Randomized phase III trial to determine the effectiveness of radiation therapy in preventing brain metastases in patients who have received chemotherapy for extensive-stage small cell lung cancer.

ReferenceCitation: Slotman BJ, Mauer ME, Bottomley A, Faivre-Finn C, Kramer GW, Rankin EM, Snee M, Hatton M, Postmus PE, Collette L, Senan S. Prophylactic cranial irradiation in extensive disease small-cell lung cancer: short-term health-related quality of life and patient reported symptoms: results of an international Phase III randomized controlled trial by the EORTC Radiation Oncology and Lung Cancer Groups. J Clin Oncol. 2009 Jan 1;27(1):78-84. doi: 10.1200/JCO.2008.17.0746. Epub 2008 Dec 1. Erratum in: J Clin Oncol. 2009 Feb 20;27(6):1002.

ReferenceCitation: Slotman B, Faivre-Finn C, Kramer G, et al.: A randomized trial of prophylactic cranial irradiation (PCI) versus no PCI in extensive disease small cell lung cancer after a response to chemotherapy (EORTC 08993-22993). [Abstract] J Clin Oncol 25 (Suppl 18): A-4, 2s, 2007.

ReferenceCitation: Slotman B, Faivre-Finn C, Kramer G, Rankin E, Snee M, Hatton M, Postmus P, Collette L, Musat E, Senan S; EORTC Radiation Oncology Group and Lung Cancer Group. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med. 2007 Aug 16;357(7):664-72.

ReferenceCitation: Slotman BJ, Faivre-Finn C, Kramer GWPM, et al.: Prophylactic cranial irradiation (PCI) in extensive stage small cell lung cancer (ES-SCLC) (EORTC 22993-08993). [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-7, S4, 2007.

ReferenceCitation: Bernhardt D, Adeberg S, Bozorgmehr F, Opfermann N, Hoerner-Rieber J, Repka MC, Kappes J, Thomas M, Bischoff H, Herth F, Heußel CP, Debus J, Steins M, Rieken S. Nine-year Experience: Prophylactic Cranial Irradiation in Extensive Disease Small-cell Lung Cancer. Clin Lung Cancer. 2017 Jul;18(4):e267-e271. doi: 10.1016/j.cllc.2016.11.012. Epub 2016 Dec 2.

ReferenceCitation: Slotman BJ, Faivre-Finn C, Kramer GW, Rankin E, Snee M, Hatton M, Postmus PE, Collette L, Musat E, Senan S. [Prophylactic cranial irradiation in patients with extensive disease caused by small-cell lung cancer responsive to chemotherapy: fewer symptomatic brain metastases and improved survival]. Ned Tijdschr Geneeskd. 2008 Apr 26;152(17):1000-4. Dutch.

location_country:
Poland
United Kingdom
Italy
Netherlands
Hungary
France
Israel
Turkey
Belgium
Germany
Cyprus
Egypt

location_facility: Cancer Research Centre at Weston Park Hospital

location_facility: University Medical Center Rotterdam at Erasmus Medical Center

location_facility: Northern Centre for Cancer Treatment at Newcastle General Hospital

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Istituto Nazionale per la Ricerca sul Cancro

location_facility: Royal Marsden NHS Foundation Trust - Surrey

location_facility: Edinburgh Cancer Centre at Western General Hospital

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Cookridge Hospital at Leeds Teaching Hospital NHS Trust

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Centre Hospitalier Regional de la Citadelle

location_facility: Nijmegen Cancer Center at Radboud University Medical Center

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Velindre Cancer Center at Velindre Hospital

intervention_type: Radiation


type: Registry Identifier

title: Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelofibrosis.

ReferenceCitation: Anderson JE, Tefferi A, Craig F, Holmberg L, Chauncey T, Appelbaum FR, Guardiola P, Callander N, Freytes C, Gazitt Y, Razvillas B, Deeg HJ. Myeloablation and autologous peripheral blood stem cell rescue results in hematologic and clinical responses in patients with myeloid metaplasia with myelofibrosis. Blood. 2001 Aug 1;98(3):586-93.

lead_sponsor: Fred Hutchinson Cancer Center

location_facility: University of Illinois College of Medicine

location_facility: Washington University Siteman Cancer Center

location_facility: H. Lee Moffitt Cancer Center and Research Institute

location_facility: New York Presbyterian Hospital - Cornell Campus


title: Vancomycin Versus Placebo in Persistently Febrile Granulocytopenic Patients Given Piperacillin/Tazobactam

summary:
RATIONALE: Antibiotic therapy may prevent the development of infection in patients with hematologic cancer and the persistent fever caused by a low white blood cell count. It is not yet known which regimen of antibiotics is most effective in preventing infection in these patients.

PURPOSE: Randomized phase III trial to study the effectiveness of piperacillin-tazobactam with or without vancomycin in reducing fever in patients who have leukemia, lymphoma, or Hodgkin's disease.

primary_purpose: Supportive Care

location_country:
United Kingdom
Greece
Finland
Czech Republic
Canada
Switzerland
United States
France
Israel
Turkey
Belgium
Germany
Slovakia

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hellenic Institute for Cancer-Saint Savas Hospital

location_facility: Athens University-Laikon General Hospital

location_facility: Ottawa Regional Cancer Center - General Division

location_facility: Marlene & Stewart Greenebaum Cancer Center, University of Maryland