title: A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Two Different Dose Regimens of Orally Administered Dabigatran Etexilate Capsules [150 or 220 mg Once Daily Starting With Half Dose (75 or 110 mg) on the Day of Surgery] Compared to Subcutaneous Enoxaparin 40 mg Once Daily for 28-35 Days, in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip Replacement Surgery. RE-NOVATE (Extended Thromboembolism Prevention After Hip Surgery)

summary: The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Kurth AA. Efficacy of delayed thromboprophylaxis with dabigatran: pooled analysis. Thromb Res. 2012 Dec;130(6):871-6. doi: 10.1016/j.thromres.2012.08.315. Epub 2012 Sep 17.

ReferenceCitation: Rosencher N, Noack H, Feuring M, Clemens A, Friedman RJ, Eriksson BI. Type of anaesthesia and the safety and efficacy of thromboprophylaxis with enoxaparin or dabigatran etexilate in major orthopaedic surgery: pooled analysis of three randomized controlled trials. Thromb J. 2012 Jun 18;10(1):9. doi: 10.1186/1477-9560-10-9.

ReferenceCitation: Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Büller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 Sep 15;370(9591):949-56. Erratum in: Lancet. 2007 Dec 15;370(9604):2004.

location_country:
Denmark
Poland
Spain
Italy
Austria
Australia
Netherlands
Finland
Czech Republic
Sweden
Hungary
France
South Africa
Belgium
Norway
Germany

location_facility: 1160.48.04573 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03605 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04301 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03407 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04570 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35805 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04707 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03902 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35804 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42010 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42005 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03904 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04704 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42006 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42002 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04604 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04703 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03406 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03604 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03101 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03103 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03901 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03405 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04605 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04302 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35802 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03410 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04807 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04608 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04820 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03404 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04808 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03607 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04915 Orthopädische Klinik Lindenlohe

location_facility: 1160.48.03302 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03308 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03602 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02704 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04609 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42001 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04817 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03409 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04810 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03601 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04706 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03903 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03104 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04574 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04606 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04912 Orthopädische Klinik Markgröningen gGmbH

location_facility: 1160.48.42009 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03411 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04701 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04304 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35803 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42008 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02703 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.06111 Haemophillia & Thrombosis Service

location_facility: 1160.48.04802 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03401 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03105 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04803 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03403 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03402 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03202 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02702 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04603 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03603 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04610 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42003 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04907 Johannes Gutenberg-Universität Mainz

location_facility: 1160.48.04571 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04801 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42007 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03107 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04702 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04601 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03304 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04602 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04806 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.02701 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03408 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03606 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04812 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04575 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04303 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03303 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04814 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.35801 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04804 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.04607 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.42004 Boehringer Ingelheim Investigational Site

location_facility: 1160.48.03102 Boehringer Ingelheim Investigational Site


title: A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

summary: The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

status: Completed

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Lebbé C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.

lead_sponsor: Bristol-Myers Squibb

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Russian Federation
Argentina
Canada
Czech Republic
Ukraine
United States
France
Israel
South Africa
Belgium
Norway
Germany

location_facility: Joe Arrington Cancer Research And Treatment Center

location_facility: Washington University School Of Medicine

location_facility: Center For Oncology Research & Treatment, P.A.

location_facility: The Christ Hospital Cancer Center Research

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Completed


title: The Prolongation of the EPAAC™ Trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). A Multi-country, Double Blind, Placebo (PLC) Controlled, Follow-up Trial With 3 Parallel Groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluation of the Long Term Efficacy and Safety of Levocetirizine (LCTZ) (5 mg/ml Oral Drops -0.125 mg/kg b.w. b.i.d.) Administered for an Additional 18 Months Period in Preventing the Onset of Asthma in Children Coming From the EPAAC Trial.

summary:
Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children).

36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.

status: Terminated

design_allocation: Randomized

lead_sponsor: UCB Pharma

location_country:
Poland
Spain
Italy
United Kingdom
Australia
Czech Republic
France
South Africa
Belgium
Germany

intervention_type: Other

status_simplified: Unknown


title: Clinical Protocol For a Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Celecoxib (SC-58635) In The Prevention of Colorectal Sporadic Adenomatous Polyps (PRESAP)

acronym: PRESAP

summary: This study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial to compare the efficacy and safety of celecoxib 400mg QD versus placebo in reducing the occurrence of new colorectal adenomas post-polypectomy at Month 13 (Year 1) and Month 37 (Year 3) of study drug administration.

ReferenceCitation: Arber N, Lieberman D, Wang TC, Zhang R, Sands GH, Bertagnolli MM, Hawk ET, Eagle C, Coindreau J, Zauber A, Lanas A, Levin B. The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. Clin Ther. 2012 Mar;34(3):569-79. doi: 10.1016/j.clinthera.2012.02.001. Epub 2012 Mar 2.

ReferenceCitation: Arber N, Spicak J, Rácz I, Zavoral M, Breazna A, Gerletti P, Lechuga MJ, Collins N, Rosenstein RB, Eagle CJ, Levin B. Five-year analysis of the prevention of colorectal sporadic adenomatous polyps trial. Am J Gastroenterol. 2011 Jun;106(6):1135-46. doi: 10.1038/ajg.2011.116. Epub 2011 Apr 19.

ReferenceCitation: Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31.

ReferenceCitation: Arber N, Eagle CJ, Spicak J, Rácz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B; PreSAP Trial Investigators. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med. 2006 Aug 31;355(9):885-95.

ReferenceCitation: Solomon SD, Pfeffer MA, McMurray JJ, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J; APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006 Sep 5;114(10):1028-35.

lead_sponsor: Pfizer

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
South Africa
Poland
Hong Kong
Portugal
Russian Federation
Australia
Uruguay
Israel
Norway
Singapore
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Ireland
Finland
Czech Republic
France
Chile
Netherlands


title: Double-Blind Parallel-Group Randomized Study Of Efficacy And Safety Of "Continuous Use" Of Celecoxib Vs. The "Usual Use" Of Celecoxib In The Treatment Of Subjects With Chronic Osteoarthritis Of The Hip Or Knee Who Require an Anti-inflammatory Medication for Control Of Their Pain

summary: To determine whether "continuous use" of celecoxib over a 6-month period is more efficacious than "usual or intermittent use" in preventing spontaneous osteoarthritis flares of the knee and hip.

ReferenceCitation: Strand V, Simon LS, Dougados M, Sands GH, Bhadra P, Breazna A, Immitt J. Treatment of osteoarthritis with continuous versus intermittent celecoxib. J Rheumatol. 2011 Dec;38(12):2625-34. doi: 10.3899/jrheum.110636. Epub 2011 Nov 1.

lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

location_country:
Brazil
United Kingdom
Colombia
Canada
United States
Chile
France
Belgium


title: A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

summary:
Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.

lead_sponsor: Cubist Pharmaceuticals LLC

location_country:
Poland
Hong Kong
Portugal
Spain
United Kingdom
Russian Federation
New Zealand
Finland
Canada
United States
France
Peru
Pakistan


title: Open Label, Dose Escalation, Followed by Open Label,Single Arm Clinical Trial of HuMax-CD4 in Patients With Mycosis Fungoides Type CTCL (Stage IB-IVB) or Sezary Syndrome Who Are Refractory or Intolerant to Targretin® (Bexarotene) and One Other Standard Therapy

summary: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.

lead_sponsor: Emergent Product Development Seattle LLC

location_country:
Spain
Italy
United States
France
Germany

location_facility: Consultation Dermatologie Niveau moins 1 Hopital Archet 2

location_facility: Instituto Dermopatico dell'Immacolata IRCCS via Monti di Creta

location_facility: Maternidad Planta Baja, Hospital 12 de Octubre

location_facility: Hopital Saint-Louis Service de Dermatologie

location_facility: University of Wurzburg - Universitatsklinikum Wurzburg dermato-onkologische studien

location_facility: University of Essen - Universitatsklinikum Essen z. Hd. Frau Desire Zieling

location_facility: University of Pennsylvania Health System

location_facility: Centre Hospitalier Lyon Sud Bat. 1F 1er etage service Hematologie

location_facility: Day Hospital Oncologico-Presidio Ospedaliero Firenze Centro Ospedale Santa Maria Nuova Azienda Sanitaria di Firenze, University of Florence

location_facility: University of kiel, Klinik Fur Dermotologie, Christian-Albrechts-Universitat Zu

location_facility: Skin Cancer Center Charite Mitte Dermatologie Fran Ramona Kursawa

location_facility: Instituto di Ematologia e Oncologia Medica "L. & A. Seragnoli"

location_facility: University of Milan-Fondazione IRCCS di Natura Pubblica Ospedale Maggiore Policlinico Mangiagalli e Regina Elena di Milano via Francesco Sforza

location_facility: University of Turin SCDU Dermosifilopatia 2 A.S.O. Molinette S.Giovanni Battista


title: A Phase IIIB Multi-center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

summary: This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

ReferenceCitation: Durez P, Westhovens R, Baeke F, Elbez Y, Robert S, Ahmad HA. Identification of poor prognostic joint locations in an early rheumatoid arthritis cohort at risk of rapidly progressing disease: a post-hoc analysis of the Phase III AGREE study. BMC Rheumatol. 2022 Apr 14;6(1):24. doi: 10.1186/s41927-022-00252-4.

ReferenceCitation: Jansen DTSL, Emery P, Smolen JS, Westhovens R, Le Bars M, Connolly SE, Ye J, Toes REM, Huizinga TWJ. Conversion to seronegative status after abatacept treatment in patients with early and poor prognostic rheumatoid arthritis is associated with better radiographic outcomes and sustained remission: post hoc analysis of the AGREE study. RMD Open. 2018 Mar 30;4(1):e000564. doi: 10.1136/rmdopen-2017-000564. eCollection 2018.

ReferenceCitation: Smolen JS, Wollenhaupt J, Gomez-Reino JJ, Grassi W, Gaillez C, Poncet C, Le Bars M, Westhovens R. Attainment and characteristics of clinical remission according to the new ACR-EULAR criteria in abatacept-treated patients with early rheumatoid arthritis: new analyses from the Abatacept study to Gauge Remission and joint damage progression in methotrexate (MTX)-naive patients with Early Erosive rheumatoid arthritis (AGREE). Arthritis Res Ther. 2015 Jun 11;17:157. doi: 10.1186/s13075-015-0671-9.

ReferenceCitation: Bathon J, Robles M, Ximenes AC, Nayiager S, Wollenhaupt J, Durez P, Gomez-Reino J, Grassi W, Haraoui B, Shergy W, Park SH, Genant H, Peterfy C, Becker JC, Covucci A, Moniz Reed D, Helfrick R, Westhovens R. Sustained disease remission and inhibition of radiographic progression in methotrexate-naive patients with rheumatoid arthritis and poor prognostic factors treated with abatacept: 2-year outcomes. Ann Rheum Dis. 2011 Nov;70(11):1949-56. doi: 10.1136/ard.2010.145268. Epub 2011 Aug 6.

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
Australia
Mexico
Canada
Czech Republic
Netherlands
United Kingdom
Korea, Republic of
United States
France
Puerto Rico
South Africa
Belgium
Germany

location_facility: Arthritis Clinic Of Northern Virginia, P.C.

location_facility: Arthritis Assoc And Osteo Ctr Of Col Sprgs

location_facility: Rheumatology Associates Of North Alabama


title: A Phase III, 18 Month, Multicenter, Randomized, Double-Blind, Active-Controlled Clinical Trial to Compare Rosiglitazone Versus Glipizide on the Progression of Atherosclerosis in Subjects With Type 2 Diabetes Mellitus and Cardiovascular Disease (APPROACH)

summary: The purpose of this study is to test the safety and effectiveness of rosiglitazone against a sulfonylurea in reducing or slowing the development of atherosclerosis in the blood vessels of the heart.

ReferenceType: background

ReferenceCitation: García-García HM, Garg S, Brugaletta S, Morocutti G, Ratner RE, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Nesto RW, Serruys PW; APPROACH study group. Evaluation of in-stent restenosis in the APPROACH trial (Assessment on the Prevention of Progression by Rosiglitazone On Atherosclerosis in diabetes patients with Cardiovascular History). Int J Cardiovasc Imaging. 2012 Mar;28(3):455-65. doi: 10.1007/s10554-011-9836-z. Epub 2011 Feb 27.

ReferenceCitation: Gerstein HC, Ratner RE, Cannon CP, Serruys PW, García-García HM, van Es GA, Kolatkar NS, Kravitz BG, Miller DM, Huang C, Fitzgerald PJ, Nesto RW; APPROACH Study Group. Effect of rosiglitazone on progression of coronary atherosclerosis in patients with type 2 diabetes mellitus and coronary artery disease: the assessment on the prevention of progression by rosiglitazone on atherosclerosis in diabetes patients with cardiovascular history trial. Circulation. 2010 Mar 16;121(10):1176-87. doi: 10.1161/CIRCULATIONAHA.109.881003. Epub 2010 Mar 1.

ReferenceCitation: Nesto RW. Effect of rosiglitazone versus glipizide on progression of coronary atherosclerosis in patients with type 2 diabetes and coronary artery disease. American Heart Association Scientific Sessions. November 12, 2008, New Orleans, LA. (http://directnews.americanheart.org/extras/pdfs/approach_slides.pdf)

ReferenceCitation: Ratner RE, Cannon CP, Gerstein HC, Nesto RW, Serruys PW, Van Es GA, Kolatkar NS, Kravitz BG, Zalewski A, Fitzgerald PJ; APPROACH Study Group. Assessment on the Prevention of Progression by Rosiglitazone on Atherosclerosis in diabetes patients with Cardiovascular History (APPROACH): study design and baseline characteristics. Am Heart J. 2008 Dec;156(6):1074-9. doi: 10.1016/j.ahj.2008.07.025. Epub 2008 Oct 11.

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:
Poland
Brazil
Hong Kong
Spain
Greece
Italy
Latvia
Netherlands
Argentina
Czech Republic
Canada
Russian Federation
Sweden
Thailand
Korea, Republic of
United States
France
India
Mexico
Germany


type: Other Identifier

title: A Phase IIb Randomized, Partially Blinded, Dose-Finding Trial of TMC278 in Antiretroviral-Naive HIV-1 Infected Subjects

summary: The purpose of this study is to evaluate the dose-response relationship of antiviral activity after 48 weeks treatment with 3 different dose regimens of TMC278.

ReferenceCitation: Pozniak AL, Morales-Ramirez J, Katabira E, Steyn D, Lupo SH, Santoscoy M, Grinsztejn B, Ruxrungtham K, Rimsky LT, Vanveggel S, Boven K; TMC278-C204 Study Group. Efficacy and safety of TMC278 in antiretroviral-naive HIV-1 patients: week 96 results of a phase IIb randomized trial. AIDS. 2010 Jan 2;24(1):55-65. doi: 10.1097/QAD.0b013e32833032ed.

lead_sponsor: Tibotec Pharmaceuticals, Ireland

location_country:
Brazil
United Kingdom
Austria
Russian Federation
Argentina
Thailand
Uganda
Puerto Rico
United States
France
China
South Africa
Mexico
Germany


title: A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

summary: This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

ReferenceCitation: Drobinski PJ, Bay-Jensen AC, Karsdal MA, Sardar S, Siebuhr AS. Connective tissue remodelling is differently modulated by tocilizumab versus methotrexate monotherapy in patients with early rheumatoid arthritis: the AMBITION study. Arthritis Res Ther. 2021 Jan 7;23(1):13. doi: 10.1186/s13075-020-02378-7.

ReferenceCitation: Strand V, Michalska M, Birchwood C, Pei J, Tuckwell K, Finch R, Gabay C, Kavanaugh A, Jones G. Impact of tocilizumab monotherapy on patient-reported outcomes in patients with rheumatoid arthritis from two randomised controlled trials. RMD Open. 2017 Sep 14;3(2):e000496. doi: 10.1136/rmdopen-2017-000496. eCollection 2017.

ReferenceCitation: Jones G, Wallace T, McIntosh MJ, Brockwell L, Gómez-Reino JJ, Sebba A. Five-year Efficacy and Safety of Tocilizumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Methotrexate- and Biologic-naive or Free of Methotrexate for 6 Months: the AMBITION Study. J Rheumatol. 2017 Feb;44(2):142-146. doi: 10.3899/jrheum.160287. Epub 2016 Dec 1.

ReferenceCitation: Wang J, Bansal AT, Martin M, Germer S, Benayed R, Essioux L, Lee JS, Begovich A, Hemmings A, Kenwright A, Taylor KE, Upmanyu R, Cutler P, Harari O, Marchini J, Criswell LA, Platt A. Genome-wide association analysis implicates the involvement of eight loci with response to tocilizumab for the treatment of rheumatoid arthritis. Pharmacogenomics J. 2013 Jun;13(3):235-41. doi: 10.1038/tpj.2012.8. Epub 2012 Apr 10.

ReferenceCitation: Jones G, Sebba A, Gu J, Lowenstein MB, Calvo A, Gomez-Reino JJ, Siri DA, Tomsic M, Alecock E, Woodworth T, Genovese MC. Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan;69(1):88-96. doi: 10.1136/ard.2008.105197.

lead_sponsor: Hoffmann-La Roche

location_country:
Denmark
Portugal
Serbia
Slovenia
Italy
Spain
Australia
Argentina
Canada
Lithuania
United States
France
China
Israel
Mexico
Norway
Peru
South Africa


title: A PhaseIIb, 96 Week, Randomised, Partially Double-blinded, Multicentre, Parallel Group, Repeat Dose Study to Evaluate the Safety, Tolerability, PK and Antiviral Effect of GW873140 in Combination With COMBIVIR (Lamivudine and Zidovudine) Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy Naive Adults

summary: This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.

lead_sponsor: ViiV Healthcare

location_country:
Portugal
Spain
Italy
United Kingdom
Canada
United States
France
Belgium
Germany


title: A Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy

acronym: STRIDE-PD

summary: The CELC200A2401 study has been designed in order to evaluate the hypothesis that administering the combination carbidopa/levodopa/entacapone at the time that levodopa therapy is initiated results in a decrease in the risk of the development of motor complications for patients with Parkinson's disease.

primary_purpose: Prevention

ReferenceCitation: Stocchi F, Rascol O, Kieburtz K, Poewe W, Jankovic J, Tolosa E, Barone P, Lang AE, Olanow CW. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann Neurol. 2010 Jul;68(1):18-27. doi: 10.1002/ana.22060. Erratum in: Ann Neurol. 2010 Sep;68(3):412-3.

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Greece
Austria
Italy
United Kingdom
Finland
Canada
Switzerland
Sweden
United States
France
Turkey
Belgium
Germany

location_facility: Parkinson's Disease and Movement Disorders Center of Long Island

location_facility: Keck School of Medicine, Division of Movement Disorders

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Baylor College of Medicine, Parkinson's Disease Center

location_facility: Parkinson's Disease and Movement Disorder Center of Albany Medical

location_facility: Wisconsin Institute for Neurologic and Sleep Disorders

location_facility: Duke University Medical Center Movement Disorders Center

location_facility: Columbia University, Neurological Institute


title: The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients With Moderate Hypertension

summary: The purpose of this clinical research is to learn if moderate hypertension can be better controlled by initially treating with a combination of drugs (Irbesartan/HCTZ), in patients who are unlikely to achieve blood pressure (B/P) control with only one drug. In addition, the study will also evaluate the safety and tolerability of the drugs.

enrollment_type: Anticipated

location_country:
Russian Federation
Canada
United States
France
Germany


title: A Multicenter Study to Evaluate the Effect of Rituximab (IDEC-102) on Primary Humoral Response, Recall Response, and Maintenance of Acquired Immunity to Specific Antigens

summary: The purpose of this study is to provide treatment for patients who have relapsed Non-Hodgkin's lymphoma (NHL) or refractory NHL, and to test the immunity of study subjects after receiving four treatments with rituximab.

lead_sponsor: Biogen

location_country:
United Kingdom
Austria
Russian Federation
Lithuania
Czech Republic
Sweden
United States
France
Turkey
Romania
Germany

location_facility: University of Texas Health Science Center at San Antonio


title: A Phase 3 Multicenter, Open Label, Randomized Study of XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors Not Amenable to Conventional Surgery

summary: The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.

lead_sponsor: Helsinn Healthcare SA

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
Canada
Hungary
United States
France
Belgium
Germany

location_facility: University of Alabama at Birmingham Comprehensive Cancer Center

location_facility: Centre Hospitalier Universite de Montreal

location_facility: Josephine Ford Cancer Center at Henry Ford Health System

location_facility: Medical Consultants, PC c/o Ball Cancer Center

location_facility: Winship Cancer Institute, Emory University Hospital

location_facility: Klinikum Grosshadern der Ludwig Maximilians Universitaet

location_facility: British Columbia Cancer Agency - Vancouver Centre

location_facility: University of Wisconsin Comprehensive Cancer Center

location_facility: Hospital Regional Universitario Carlos Haya

location_facility: Cancer Research Center named after N.N. Blokhin, RAMS

location_facility: University of California, Irvine Medical Center

location_facility: Centro di Riferimento Oncologico di Aviano

location_facility: Hospital Clinic i Provincial (Oncology Department)


title: A Multicenter, Randomized, Double-Blind, Parallel-group, Placebo-Controlled Study of Pexelizumab in Patients Undergoing Coronary Artery Bypass Grafting With Cardiopulmonary Bypass (PRIMO-CABG II)

summary: During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.

study_start_date_type: Actual

ReferenceCitation: Smith PK, Shernan SK, Chen JC, Carrier M, Verrier ED, Adams PX, Todaro TG, Muhlbaier LH, Levy JH; PRIMO-CABG II Investigators. Effects of C5 complement inhibitor pexelizumab on outcome in high-risk coronary artery bypass grafting: combined results from the PRIMO-CABG I and II trials. J Thorac Cardiovasc Surg. 2011 Jul;142(1):89-98. doi: 10.1016/j.jtcvs.2010.08.035. Epub 2010 Sep 28.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Germany
United States
Netherlands
France

location_facility: Kaiser Permanente Moanalua Medical Center

location_facility: Clarian Health Partners, Inc. Methodist Hospital

location_facility: University of California Irvine Medical Center

location_facility: Southern Arizona Veterans Affairs Health Care System

location_facility: Veterans Administration Greater Los Angeles Healthcare Sysytem

location_facility: Atlanta Veteran's Administration (VA) Medical Center

location_facility: Health First Holmes Regional Medical Center

location_facility: Zentrum fuer Herzchirurgie der Frederick-Alexander-Universitaet

location_facility: Veterans Administration Palo Alto Healthcare System

location_facility: Cooper Health System/University Medical Center

location_facility: University of Colorado Health Sciences Center

location_facility: University of Southern California University Hospital

location_facility: Shands Hospital at the University of Florida

location_facility: University of North Carolina at Chapel Hill Hospitals

location_facility: Los Angeles County-University of Southern California Medical Center

location_facility: Michael E. DeBakey Veterans Affairs Medical Center

location_facility: Veterans Administration (VA) Boston Healthcare System

location_facility: St. Luke's Episcopal Hospital - Texas Heart

location_facility: University of Alabama at Birmingham Hospital

location_facility: West Shore Cardiology Research Department

location_facility: Cooper Hospital University Medical Center


title: Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus

acronym: ZEPHYR

summary: To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.

ReferenceCitation: Equils O, da Costa C, Wible M, Lipsky BA. The effect of diabetes mellitus on outcomes of patients with nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: data from a prospective double-blind clinical trial comparing treatment with linezolid versus vancomycin. BMC Infect Dis. 2016 Sep 6;16:476. doi: 10.1186/s12879-016-1779-5.

ReferenceCitation: Shorr AF, Puzniak LA, Biswas P, Niederman MS. Predictors of Clinical Success in the Treatment of Patients with Methicillin-Resistant Staphylococcus aureus (MRSA) Nosocomial Pneumonia (NP). PLoS One. 2015 Jul 21;10(7):e0131932. doi: 10.1371/journal.pone.0131932. eCollection 2015.

ReferenceCitation: Quartin AA, Scerpella EG, Puttagunta S, Kett DH. A comparison of microbiology and demographics among patients with healthcare-associated, hospital-acquired, and ventilator-associated pneumonia: a retrospective analysis of 1184 patients from a large, international study. BMC Infect Dis. 2013 Nov 27;13:561. doi: 10.1186/1471-2334-13-561.

ReferenceCitation: Puzniak LA, Morrow LE, Huang DB, Barreto JN. Impact of weight on treatment efficacy and safety in complicated skin and skin structure infections and nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Ther. 2013 Oct;35(10):1557-70. doi: 10.1016/j.clinthera.2013.08.001. Epub 2013 Sep 3.

location_country:
Spain
United Kingdom
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Russian Federation
Argentina
Puerto Rico
Turkey
Mexico
Malaysia
Brazil
Germany
Taiwan
Greece
Korea, Republic of
France
Chile
Colombia


type: EudraCT Number

title: A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome

summary: The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

ReferenceCitation: Dudrick SJ, Latifi R, Fosnocht DE. Management of the short-bowel syndrome. Surg Clin North Am. 1991 Jun;71(3):625-43. Review.

ReferenceCitation: Rombeau JL, Rolandelli RH. Enteral and parenteral nutrition in patients with enteric fistulas and short bowel syndrome. Surg Clin North Am. 1987 Jun;67(3):551-71.

ReferenceCitation: Shanbhogue LK, Molenaar JC. Short bowel syndrome: metabolic and surgical management. Br J Surg. 1994 Apr;81(4):486-99. Review.

ReferenceCitation: Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. Review.

ReferenceType: result

ReferenceCitation: Jeppesen PB, Gilroy R, Pertkiewicz M, Allard JP, Messing B, O'Keefe SJ. Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome. Gut. 2011 Jul;60(7):902-14. doi: 10.1136/gut.2010.218271. Epub 2011 Feb 11.

ReferenceCitation: Fujioka K, Jeejeebhoy K, Pape UF, Li B, Youssef NN, Schneider SM. Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide. JPEN J Parenter Enteral Nutr. 2017 Nov;41(8):1419-1422. doi: 10.1177/0148607116663481. Epub 2016 Aug 9.

lead_sponsor: Shire

location_country:
Denmark
Poland
United Kingdom
Netherlands
Canada
United States
France
Belgium
Germany

location_facility: Northwestern Center for Clinical Research

location_facility: University of Pennsylvania - Penn Nursing

location_facility: Rigshospitalet, University of Copenhagen

location_facility: Samodzielny Publiczny Szpital Kliniczny-Im.prof W.Orłowskiego CMKP


title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis

summary: Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO Class III and IV, to a new category of patients suffering from ILD associated with SSc.

ReferenceCitation: Liu C, Chen J, Gao Y, Deng B, Liu K. Endothelin receptor antagonists for pulmonary arterial hypertension. Cochrane Database Syst Rev. 2021 Mar 26;3:CD004434. doi: 10.1002/14651858.CD004434.pub6.

ReferenceCitation: Seibold JR, Denton CP, Furst DE, Guillevin L, Rubin LJ, Wells A, Matucci Cerinic M, Riemekasten G, Emery P, Chadha-Boreham H, Charef P, Roux S, Black CM. Randomized, prospective, placebo-controlled trial of bosentan in interstitial lung disease secondary to systemic sclerosis. Arthritis Rheum. 2010 Jul;62(7):2101-8. doi: 10.1002/art.27466. Erratum in: Arthritis Rheum. 2010 Oct;62(10):3005.

lead_sponsor: Actelion

location_country:
United Kingdom
Italy
Netherlands
Switzerland
Sweden
United States
Israel
France
Germany

location_facility: University of Texas Houston Medical School

location_facility: University of Illinois College of Medicine


title: An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)

summary: This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

ReferenceCitation: Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2022 Oct 28:JCO2102726. doi: 10.1200/JCO.21.02726. Online ahead of print.

ReferenceCitation: Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
Poland
Hong Kong
Portugal
Russian Federation
Australia
Israel
Panama
Mexico
Singapore
Brazil
Canada
Switzerland
Hungary
China
Germany
Taiwan
Greece
Ireland
New Zealand
Finland
Thailand
Korea, Republic of
France

location_facility: Tampere University Hospital; Dept of Oncology

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Hematology-Oncology Centers of the Northern Rockies

location_facility: Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

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

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

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

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: New Mexico Oncology Hematology Consultants

location_facility: Turku Uni Central Hospital; Oncology Clinics

location_facility: Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech

location_facility: Petrov Research Inst. of Oncology; Dept of Bio-Therapy & Transplantation of Bone Marrow

location_facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

location_facility: Az. Osp. Uni Ria San Martino; Cliniche Uni Rie Convenzionate U.O. Oncologia Medical

location_facility: Innovative clinical research institute/American institute of research

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

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

location_facility: The Royal Sussex County Hospital; the Sussex Cancer Centre

location_facility: Hopital Claude Huriez; Medecine Interne Oncologie

location_facility: A.O.U. Ospedali Riuniti Umberto I-G.M.Lancisi-G.Salesi Ancona;S.O.D. MED.Interna-Clinica Oncologica

location_facility: St. Petersburg City Clinical Oncological Dispensary; Colorectal (Department 4)

location_facility: Chaim Sheba Medical Center; Oncology Dept

location_facility: Sourasky / Ichilov Hospital; Oncology Department

location_facility: Asst Papa Giovanni XXIII; Oncologia Medica

location_facility: Dunedin Hospital; Oncology - Haematology Clinical Practice Group

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Oncology-Hematology of Lehigh Valley, Pc

location_facility: Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

location_facility: Dr. H. Bliss Murphy Cancer Centre; Oncology

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

location_facility: The Ottawa Hospital Cancer Centre; Oncology

location_facility: Institut Paoli Calmettes; Oncologie Medicale

location_facility: Per. Gen. Hospital Ippokrateion; Oncology Dept.

location_facility: Hospital Jose Joaquim Fernandes; Unidade de Oncologia Medica

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: St. Vincent'S Hospital; Comprehensive Care Center

location_facility: St John of God Hospital; Medical Oncology

location_facility: Ospedale Cervesi di Cattolica; ONCOLOGIA

location_facility: Little Company of Mary Hospital; Mary Potter Oncology Centre

location_facility: Ospedale Civile; Unita Operativa Di Oncologia Medica

location_facility: Central Hematology Oncology Medical Group Inc.

location_facility: Pramongkutklao Hospital; Medicine - Medical Oncology Unit

location_facility: University Health Network; Princess Margaret Hospital; Medical Oncology Dept

location_facility: Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

location_facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

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

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Hamilton Health Sciences - Juravinski Cancer Centre

location_facility: Santa Barbara Hematology Oncology Medical Group, Inc.

location_facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

location_facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia

location_facility: Cruk Clinical Trials Unit; Level 0 Beatson West Of Scotland Cancer Ctr

location_facility: National Cancer Centre; Medical Oncology

location_facility: Derriford Hospital; Plymouth Oncology Centre

location_facility: University of Colorado Health Science Center; Biomedical Research Bldg. Room 511

location_facility: Universitaetsklinikum Halle; Klinik u.Poliklinik fuer Innere Medizin IV

location_facility: Isthmian Medical Research Center, S.A.; Oncology

location_facility: Wojewodzki Szpital Specjalistyczny Im. M. Kopernika; Oddzial Chorob Rozrostowych

location_facility: Addenbrooke'S Hospital; Univ.Dept.& Mrc Unit of Clin.Oncology & Radiotherapeutics

location_facility: Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology

location_facility: Mackay Memorial Hospital; Department of Surgery, Division of Colon and Rectal Surgery

location_facility: Orszagos Onkologial Intezet; Onkologiai Osztaly X

location_facility: Lubuski Osrodek Onkologii, Szpital Wojewodzki; Oddzial Onkologii

location_facility: Mount Vernon Hospital; Centre For Cancer Treatment

location_facility: Nanfang Hospital, Southern Medical University

location_facility: Hospital Universitario la Fe; Servicio de Oncologia

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: Queen Elizabeth II Health Sciences Centre; Oncology

location_facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology

location_facility: Northern Centre for Cancer Care;Oncology

location_facility: Georgetown Uni Medical Center; Lombardi Cancer Center

location_facility: University Hospital of Patras Medical Oncology

location_facility: Hopital Du Sacre Coeur de Montreal; Pneumologie

location_facility: Hanyang Uni Hospital; Dept. of Internal Medicine , Section of Hemato-Oncology

location_facility: Wellington Hospital; Regional Oncology Unit

location_facility: Aberdeen Royal Infirmary; Medical Oncology Dept

location_facility: Hospital Universitario de la Princesa; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Ospedale Degli Infermi; Divisione Di Oncologia

location_facility: The 1st Affiliated Hospital of Nanchang Unversity

location_facility: Uni of Pittsburgh Cancer Inst. ; Oncology

location_facility: Bumrungrad Hospital Foundation; Horizon Centre

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Mercy Uni Hospital; Deparment of Medical Oncology

location_facility: Hospital das Clinicas - FMUSP; Gastroenterologia

location_facility: Hammersmith Hospital; Mrc Clinical Science Centre

location_facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika

location_facility: Univ General Hosp Heraklion; Medical Oncology

location_facility: Bcca - Vancouver Island Cancer Centre; Oncology

location_facility: Royal Prince Alfred Hospital; Medical Oncology

location_facility: Hopelands Cancer Centre ST. ANNES HOSPITAL; DEPT. OF ONCOLOGY

location_facility: Fovarosi Szent Laszlo Korhaz-Rendelointezet; Onkologiai Osztaly X

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

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Derbyshire Royal Infirmary; Dept of Oncology

location_facility: Christie Hospital; Breast Cancer Research Office

location_facility: Internal Medicine Associates of Yakima Inc.

location_facility: Kaiser Permanente San Diego; Hepatology Research

location_facility: Hospital General Universitario de Elche; Servicio de Oncologia

location_facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)

location_facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia

location_facility: Cross Cancer Institute ; Dept of Medical Oncology

location_facility: Chuq - Hopital Hotel Dieu de Quebec; Oncology

location_facility: Instituto Valenciano Oncologia; Oncologia Medica

location_facility: Srinagarind Hospital; Medical Oncology Unit

location_facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

location_facility: Overlook Oncology Center; Summit Medical Group

location_facility: National University Hospital; National University Cancer Institute, Singapore (NCIS)

location_facility: Hadassah Ein Karem Hospital; Oncology Dept

location_facility: Royal Surrey County Hospital; St. Lukes Cancer Centre

location_facility: Instituto Nacional De Ciencias Medicas Y Nutricion; Nefrology

location_facility: West Suffolk Hospital Nhs Trust; Gi Corridor

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

location_facility: Royal Marsden Nhs Trust; Consultant Cancer Physician

location_facility: Chang Gung Medical Foundation - Linkou; Colo-rectal Surgery

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

location_facility: Hospital of the Uni of Pennsylvania; Section of Hematology/Oncology

location_facility: Clinica de Especialidades # 30 Dr. Humberto Torres Sangines; Oncology

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Southampton General Hospital; Somers Cancer Research Building

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Oncologia

location_facility: N.N.Burdenko Main Military Clinical Hospital; Chemotherapy

location_facility: Blokhin Cancer Research Center; Combined Treatment

location_facility: Shaare Zedek Medical Center; Oncology Dept

location_facility: Salisbury District General Hospital; Medical Oncology Dept

location_facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

location_facility: Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

location_facility: Hospital de Baleia; Serviço de Oncologia Clínica

location_facility: Cancer Hospital Chinese Academy of Medical Sciences.

location_facility: Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

location_facility: Leicester Royal Infirmary; Dept. of Medical Oncology

location_facility: Palmerston North Hospital; Regional Cancer Treatment Service

location_facility: Hospital Severo Ochoa; Servicio de Oncologia

location_facility: West Valley Hematology Oncology The Thomas and Dorothy Leavey Cancer Center

location_facility: Hospital Christus Muguerza Del Parque; Centro de Rehabilitacion

location_facility: Morristown Medical Center;Hematology-Oncology Assoc

location_facility: Presbyterian Healthcare; Cancer Research Dept

location_facility: Theageneio Anticancer Hospital; Gastroenterology

location_facility: UNI OF WISCONSIN SCHOOL OF MEDICINE; GI Oncology Research Group, Paul P Carbone Cancer Center

location_facility: Southern Medical Day Care; Clinical Trials Unit

location_facility: The Second Affiliated Hospital of Zhejiang University College

location_facility: Theagenio Anticancer Hospital; 3Rd Oncology Clinic

location_facility: Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Klinika Nowotworow Jelita Grubego

location_facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

location_facility: Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: North Wales Cancer Treatment Centre, Glan Clwyd Hospital

location_facility: Queen Elizabeth Hospital; Medical Oncology


title: A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy

acronym: EFECT

summary: The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

lead_sponsor: AstraZeneca

location_country:
Denmark
Brazil
Spain
United Kingdom
Russian Federation
Argentina
Canada
Sweden
Hungary
United States
France
Israel
South Africa
Belgium
Germany


title: Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma

summary: The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

lead_sponsor: Eli Lilly and Company

location_country:
Hong Kong
Portugal
United Kingdom
Italy
Austria
Australia
Netherlands
Finland
Czech Republic
Switzerland
Sweden
United States
France
Belgium
Norway
Germany
Slovakia


title: The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism

summary:
Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.

ReferenceCitation: Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.

ReferenceCitation: van Gogh Investigators, Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104.

lead_sponsor: Sanofi

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Australia
Netherlands
Argentina
Canada
Czech Republic
Finland
Sweden
Switzerland
United States
France
United Kingdom
Belgium
Norway
Germany

location_facility: Pulmonary Associates of Fredericksburg, Inc.

location_facility: The University of Texas Health Center at Tyler

location_facility: University of California, San Diego Medical Center

location_facility: Scott & White Memorial Hospital & Clinic

location_facility: Lovelace Health Systems, Clinical Thrombosis Center

location_facility: Hamilton Health Sciences - General Hospital

location_facility: University Health Network, Toronto General Hospital

location_facility: Loyola University Medical Center and Outpatient Clinic


title: A Double Blind- Randomized, Placebo-controlled Study of Two Doses of Capravirine (AG1549) in Combination With Viracept and Two Nucleoside Reverse Transcriptase Inhibitors in HIV Infected Patients Who Failed an Initial Nonnucleoside Reverse Transcriptase Inhibitor Containing Regimen

summary: This is a 48 week study that is intended for HIV Infected persons whose first treatment regimen was with a nonnucleoside reverse transcriptase inhibitor (NNRTI) and who are now failing that regimen. They must be currently on their failing regimen to be eligible.

lead_sponsor: Pfizer

location_country:
Spain
Italy
United States
France
South Africa
Germany


title: Randomized Phase III Trial Comparing Targretin Capsules/Cisplatin/Vinorelbine Versus Cisplatin/Vinorelbine in Chemotherapy-Naive Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

summary: This study evaluates the use of Targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic Non-Small Cell Lung Cancer (NSCLC) in patients who have not yet received chemotherapy for their lung cancer.

lead_sponsor: Eisai Inc.

location_country:
Poland
United Kingdom
Greece
Russian Federation
Australia
Canada
Czech Republic
Hungary
United States
France
Israel

location_facility: Desert Hematology-Oncology Medical Group, Inc.

location_facility: Koranyi National Institute for Pulmonology

location_facility: Louisiana State University Health Science Center

location_facility: Capitol Comprehensive Cancer Care Clinic

location_facility: Research Institute of Oncology n.a. Hertzen

location_facility: Centre Hospitalier Intercommunal de la Haute-Saone

location_facility: 7th Pneumonology Clinic, Sotiria Hospital for Diseases of the Chest

location_facility: St. Petersburg Pavlov State Medical University

location_facility: Klinika pneumologie a hrudni chirurgie 3.LF

location_facility: Wielkopolskie Centrum Chorob Pluc I Gruzlicy

location_facility: 2nd Pulmonary Clinic of G. Papanikolaou Hospital

location_facility: Fovarosi Onkormanyzat Uzsoki utcai, Korhaza

location_facility: University General Hospital of Heraklion

location_facility: Research Institute of Oncology n.a. Petrov

location_facility: Semmelweis University Department of Pulmonology

location_facility: University Oncology & Hematology Associates

location_facility: 1st Pulmonary Clinic of G. Papanikolaou Hospital

location_facility: 6th Pneumonology Department, Sotiria Hospital for Diseases of the Chest

location_facility: Russian Oncology Research Center n.a. Blokhin

location_facility: Centrum Onkologii Instytut im. M. Sklodowskiej-Curie


summary: The purpose of this study is to determine if patients who take YM598 in addition to mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated with prostate cancer metastases in the bone.

lead_sponsor: Astellas Pharma Inc

location_country:
Poland
Spain
Ireland
United Kingdom
Australia
Netherlands
United States
France
Belgium
Germany

location_facility: Hospital Universitario de Getafe, Servicio de Urologia, Crta

location_facility: Washington University School of Medicine

location_facility: University of Chicago, Section of Hematology/Oncology

location_facility: Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie

location_facility: Hospital Universitario Príncipe de Asturias, Servicio de Urología

location_facility: Department of Urological Research, Derriford Hospital

location_facility: Division of Oncology Ward, Royal Brisbane Hospital

location_facility: Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot

location_facility: Department of Urology, St Bartholomew's Hospital

location_facility: Imperial College School of Medicine, Dept Cancer Medicine

location_facility: Krankenhause am Urban, Urologie Dieffenfachstr

location_facility: Department of Medical Oncology, The Canberra Hospital

location_facility: Instituto Valenciano de Oncologia, Servicio de Oncologia

location_facility: University of Illinois, Department of Urology

location_facility: Clinical Research Centre, St George's Hospital, Urology Division

location_facility: Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow

location_facility: Queen Elizabeth Hospital, Clinical Hematology & Oncology

location_facility: Hospital Clinic i Provincial, Servicio de Oncologia

location_facility: Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie

location_facility: Department of Medical Oncology, Concord Hospital Medical Centre

location_facility: Service d'Urologie, Hôpital Henri Mondor

location_facility: Department of Medical Oncology, Newcastle Mater Hospital

location_facility: Hospital General Vall d'Hebron, Servicio de Oncología

location_facility: Department of Urology, East Surrey Hospital

location_facility: Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie

location_facility: Cliniques Universitaires St-Luc, Service d'Urologie

location_facility: Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii

location_facility: Department of Clinical Oncology, Royal North Shore Hospital


title: A Phase II, Randomized, Partially-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of 12 Weeks of Treatment with Clevudine (10 mg, 30 mg or 50 mg QD) in Patients Infected with Hepatitis B Virus.

summary: The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.

status: Unknown status

lead_sponsor: Triangle Pharmaceuticals

location_country:
Canada
United States
France
China
Singapore

location_facility: University of British Columbia, Downtown Infectious Disease Clinic

location_facility: Prince of Wales Hospital, Department of Medicine and Therapeutics

location_facility: Hospital St Louis, Service de Medecine Interne

location_facility: National University Hospital, Division of Gastroenterology, Department of Medicine

location_facility: Hospital Dieu, Service Hepatogastroenterologie-endoscopie

location_facility: Thomas Jefferson University Hospital, Jefferson Medical College

location_facility: The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital

location_facility: Hospital Beaujon, Service Hepatologie Centre Pierre Abrami

location_facility: Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie


title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.

summary: This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.

lead_sponsor: GlaxoSmithKline

location_country:
Spain
Italy
United Kingdom
Honduras
Lithuania
United States
Costa Rica
Belgium
South Africa
Poland
Austria
Russian Federation
Puerto Rico
Panama
Mexico
Norway
Singapore
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Estonia
New Zealand
Finland
Czech Republic
Korea, Republic of
France
Chile
Netherlands
Jamaica


title: CLOCC Trial (Chemotherapy + Local Ablation Versus Chemotherapy) Randomized Phase II Study Of Local Treatment Of Liver Metastases By Radiofrequency Combined With Chemotherapy Versus Chemotherapy Alone In Patients With Unresectable Colorectal Liver Metastases

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread by blocking blood flow. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiofrequency ablation uses high-frequency electric current to kill tumor cells. It is not yet known if chemotherapy is more effective with or without radiofrequency ablation in treating liver metastases.

PURPOSE: This randomized phase II trial is studying combination chemotherapy, bevacizumab, and radiofrequency ablation to see how well they work compared to combination chemotherapy and bevacizumab alone in treating unresectable liver metastases in patients with colorectal cancer.

ReferenceCitation: Ruers T, van Coevorden F, Pierie J, et al.: Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): interim results of a randomised phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC). [Abstract] J Clin Oncol 26 (Suppl 15): A-9535, 2008.

ReferenceCitation: Ruers T, Punt C, Van Coevorden F, Pierie JPEN, Borel-Rinkes I, Ledermann JA, Poston G, Bechstein W, Lentz MA, Mauer M, Van Cutsem E, Lutz MP, Nordlinger B; EORTC Gastro-Intestinal Tract Cancer Group; Arbeitsgruppe Lebermetastasen und-tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie (ALM-CAO) and the National Cancer Research Institute Colorectal Clinical Study Group (NCRI CCSG). Radiofrequency ablation combined with systemic treatment versus systemic treatment alone in patients with non-resectable colorectal liver metastases: a randomized EORTC Intergroup phase II study (EORTC 40004). Ann Oncol. 2012 Oct;23(10):2619-2626. doi: 10.1093/annonc/mds053. Epub 2012 Mar 19.

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

location_country:
United Kingdom
Italy
Austria
Netherlands
Sweden
Hungary
France
Belgium
Germany
Egypt

location_facility: Centre Hospitalier Regional et Universitaire d'Angers

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Centre Hospitalier Universitaire Ambroise Pare - Boulogne

location_facility: Azienda Ospedaliera S. Camillo-Forlanini

location_facility: Staedtische Kliniken Frankfurt am Main - Hoechst

location_facility: Sahlgrenska University Hospital at Gothenburg University

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Cancer Research UK and University College London Cancer Trials Centre

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

location_facility: Karolinska University Hospital - Huddinge

location_facility: Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

location_facility: Velindre Cancer Center at Velindre Hospital

location_facility: Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

intervention_type: Biological


title: A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis

summary: A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.

lead_sponsor: Boehringer Ingelheim

location_country:
Taiwan
Brazil
Italy
Russian Federation
Australia
Argentina
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Belgium
Germany

location_facility: National Institute for Rheumatology and Physiotherapy

location_facility: Boehringer Ingelheim Investigational Site

location_facility: Clínica de Doenças Parasitárias e Infecciosas-Hospital Dia

location_facility: Università degli Studi di Napoli "Federico II"

location_facility: Rheumatologie und Physikalische Therapie

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital


title: A Multi-Center, Randomized Phase III Study of Adjuvant Oncophage® Versus Observation in Subjects With High Risk of Recurrence After Surgical Treatment for Renal Cell Carcinoma

summary: Determine whether patients receiving adjuvant HSPPC-96 treatment after surgically resected, locally advanced renal cell carcinoma have improved recurrence-free survival as compared to subjects with no adjuvant treatment.

ReferenceCitation: Wood C, Srivastava P, Bukowski R, Lacombe L, Gorelov AI, Gorelov S, Mulders P, Zielinski H, Hoos A, Teofilovici F, Isakov L, Flanigan R, Figlin R, Gupta R, Escudier B; C-100-12 RCC Study Group. An adjuvant autologous therapeutic vaccine (HSPPC-96; vitespen) versus observation alone for patients at high risk of recurrence after nephrectomy for renal cell carcinoma: a multicentre, open-label, randomised phase III trial. Lancet. 2008 Jul 12;372(9633):145-154. doi: 10.1016/S0140-6736(08)60697-2. Epub 2008 Jul 3.

lead_sponsor: Agenus Inc.

location_country:
Poland
Spain
United Kingdom
Austria
Canada
United States
France
Israel
Belgium
Norway
Sweden


title: A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases

summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.

ReferenceCitation: Suh JH, Stea B, Nabid A, Kresl JJ, Fortin A, Mercier JP, Senzer N, Chang EL, Boyd AP, Cagnoni PJ, Shaw E. Phase III study of efaproxiral as an adjunct to whole-brain radiation therapy for brain metastases. J Clin Oncol. 2006 Jan 1;24(1):106-14. Epub 2005 Nov 28.

ReferenceCitation: Nabid A, Kresl J, Stea B, et al.: Standard whole brain radiation (WBRT) with supplemental oxygen (O2) with or without RSR13 (efaproxiral) in patients with brain metastases originating from NSCLC: results of a subgroup analysis. [Abstract] J Clin Oncol 22 (Suppl 14): A-7115, 645s, 2004.

ReferenceCitation: Shaw E, Stea B, Pinter T, et al.: Pharmacokinetics (PK) of RSR13 (efaproxiral) predict survival in patients with brain metastases randomized to receive whole brain radiation therapy (WBRT) with or without RSR13 (REACH RT-009). [Abstract] J Clin Oncol 22 (Suppl 14): A-1561, 122s, 2004.

ReferenceCitation: Stea B, Suh J, Shaw E, et al.: Efaproxiral (EFAPROXYN) as an adjunct to whole brain radiation therapy for the treatment of brain metastases originating from breast cancer: updated survival results of the randomized REACH (RT-009) study. [Abstract] Breast Cancer Res Treat 88 (1): A-4064, 2004.

ReferenceCitation: Suh J, Stea BD, Nabid A, et al.: Prognostic factors for survival in patients with brain metastases enrolled on a worldwide phase 3 randomized trial of 538 patients (study RSR13 RT-009). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-60, S165, 2004.

ReferenceCitation: Suh J, Stea B, Nabid A, et al.: Standard whole brain radiation therapy (WBRT) with supplemental oxygen (O2), with or without RSR13 (efaproxiral) in patients with brain metastases: results of the randomized REACH (RT-009) study. [Abstract] J Clin Oncol 22 (Suppl 14): A-1534, 115s, 2004.

lead_sponsor: Spectrum Pharmaceuticals, Inc

location_country:
United Kingdom
Italy
Australia
Canada
Hungary
United States
France
Belgium
Germany

location_facility: Comprehensive Cancer Center at Wake Forest University

location_facility: Newfoundland Cancer Treatment and Research Foundation

location_facility: State University of New York - Upstate Medical University

location_facility: University of Texas - MD Anderson Cancer Center

location_facility: Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Cooper Hospital/University Medical Center

location_facility: Centre de Lutte Contre le Cancer, Georges-Francois Leclerc

location_facility: Centre Hospitalier Universitaire de Quebec

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

location_facility: Royal Prince Alfred Hospital Medical Center

location_facility: Comprehensive Cancer Care Specialists of Boca Raton

location_facility: Decatur Memorial Hospital Cancer Care Institute

location_facility: Veterans Affairs Medical Center - Milwaukee (Zablocki)

location_facility: Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of Massachusetts Memorial Medical Center

location_facility: Centre Hospitalier de l'Universite de Montreal

location_facility: Centro di Riferimento Oncologico - Aviano

location_facility: British Columbia Cancer Agency - Fraser Valley Cancer Centre

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

intervention_type: Radiation


title: A Randomized, Double-Blind, Phase III Study of ABT-378/Ritonavir Plus Stavudine and Lamivudine vs Nelfinavir Plus Stavudine and Lamivudine in Antiretroviral Naive HIV-Infected Subjects

summary:
The purpose of this study is to see how safe a new protease inhibitor (PI) is and how well it fights HIV infection. A PI is a drug that stops HIV from using healthy cells to make more virus. This study will compare the new PI combination of ABT-378 plus ritonavir (RTV) with another PI, nelfinavir (NFV).

Earlier studies suggest ABT-378/RTV will be just as good as and perhaps better than NFV at fighting HIV infection.

ReferenceCitation: Murphy RL, Brun S, Hicks C, Eron JJ, Gulick R, King M, White AC Jr, Benson C, Thompson M, Kessler HA, Hammer S, Bertz R, Hsu A, Japour A, Sun E. ABT-378/ritonavir plus stavudine and lamivudine for the treatment of antiretroviral-naive adults with HIV-1 infection: 48-week results. AIDS. 2001 Jan 5;15(1):F1-9.

lead_sponsor: Abbott

location_country:
Denmark
Poland
Brazil
Spain
United Kingdom
Austria
Australia
Canada
Switzerland
Puerto Rico
United States
France
South Africa
Germany

location_facility: Community Research Initiative of New England

location_facility: Univ of Michigan Hospitals and Health Ctrs

location_facility: Cornell Clinical Trials Unit - Chelsea Clinic

location_facility: Division of Inf Diseases/ Indiana Univ Hosp

location_facility: Orange County Ctr for Special Immunology

location_facility: San Francisco Veterans Administration Med Ctr

location_facility: Duke Univ Med Ctr / Infectious Disease Clinic

location_facility: SUNY at Stony Brook / Div of Infectious Disease

location_facility: Hosp Do Servidor Publico Estadual De Sao Paulo

location_facility: East Orange Veterans Administration Med Ctr

location_facility: Groupe Hospitalier Bichat-Claude Bernard

location_facility: Klinikum Der Johann Wolfgang Goethe Universitat

location_facility: Holmes Hosp / Univ of Cincinnati Med Ctr


title: A Randomized, Open-Label, Phase III Study of ABT-378/Ritonavir in Combination With Nevirapine and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) vs. Investigator Selected Protease Inhibitor(s) in Combination With Nevirapine and Two NRTIs in Antiretroviral-Experienced HIV-Infected Subjects

summary: The purpose of this study is to compare the safety and effectiveness of 2 anti-HIV drug combinations in HIV-infected patients. Both combinations will include nevirapine (NVP), 2 nucleoside reverse transcriptase inhibitors (NRTIs), and at least 1 protease inhibitor (PI). One combination will include a new protease inhibitor, ABT-378, combined in a capsule with ritonavir (RTV).

location_facility: Univ of Utah Med School / Clinical Trials Ctr

location_facility: Saint Michael's Med Ctr / Dept of Infectious Diseases

location_facility: SUNY / Health Sciences Ctr at Stony Brook


title: A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer.

ReferenceCitation: Chi DS, Musa F, Dao F, Zivanovic O, Sonoda Y, Leitao MM, Levine DA, Gardner GJ, Abu-Rustum NR, Barakat RR. An analysis of patients with bulky advanced stage ovarian, tubal, and peritoneal carcinoma treated with primary debulking surgery (PDS) during an identical time period as the randomized EORTC-NCIC trial of PDS vs neoadjuvant chemotherapy (NACT). Gynecol Oncol. 2012 Jan;124(1):10-4. doi: 10.1016/j.ygyno.2011.08.014. Epub 2011 Sep 13.

ReferenceCitation: Verleye L, Ottevanger PB, Kristensen GB, Ehlen T, Johnson N, van der Burg ME, Reed NS, Verheijen RH, Gaarenstroom KN, Mosgaard B, Seoane JM, van der Velden J, Lotocki R, van der Graaf W, Penninckx B, Coens C, Stuart G, Vergote I. Quality of pathology reports for advanced ovarian cancer: are we missing essential information? An audit of 479 pathology reports from the EORTC-GCG 55971/NCIC-CTG OV13 neoadjuvant trial. Eur J Cancer. 2011 Jan;47(1):57-64. doi: 10.1016/j.ejca.2010.08.008. Epub 2010 Sep 16.

ReferenceCitation: Vergote I, Tropé CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

ReferenceCitation: Fruehauf JP, Yu I, Parker R: In vitro drug response and biomarker profiles for ovarian cancer specimens obtained at initial debulking or after neoadjuvant chemotherapy (EORTC 55971). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2177, 2002.

ReferenceCitation: Tajik P, van de Vrie R, Zafarmand MH, Coens C, Buist MR, Vergote I, Bossuyt PMM, Kenter GG. The FIGO Stage IVA Versus IVB of Ovarian Cancer: Prognostic Value and Predictive Value for Neoadjuvant Chemotherapy. Int J Gynecol Cancer. 2018 Mar;28(3):453-458. doi: 10.1097/IGC.0000000000001186.

ReferenceCitation: Vizzielli G, Fanfani F, Chiantera V, Tortorella L, Lucidi A, Petrillo M, Costantini B, Scambia G, Fagotti A. Does the diagnosis center influence the prognosis of ovarian cancer patients submitted to neoadjuvant chemotherapy? Anticancer Res. 2015 May;35(5):3027-32.

ReferenceCitation: van Meurs HS, Tajik P, Hof MH, Vergote I, Kenter GG, Mol BW, Buist MR, Bossuyt PM. Which patients benefit most from primary surgery or neoadjuvant chemotherapy in stage IIIC or IV ovarian cancer? An exploratory analysis of the European Organisation for Research and Treatment of Cancer 55971 randomised trial. Eur J Cancer. 2013 Oct;49(15):3191-201. doi: 10.1016/j.ejca.2013.06.013. Epub 2013 Jul 11.

location_country:
Denmark
Portugal
Spain
Ireland
Austria
Italy
Netherlands
Argentina
Canada
United Kingdom
Sweden
France
Belgium
Norway
Germany

location_facility: Herlev Hospital - University Hospital of Copenhagen

location_facility: Queen Elizabeth The Queen Mother Hospital

location_facility: Hospital de Clinicas "Jose De San Martin"

location_facility: Cancer Centre of Southeastern Ontario at Kingston General Hospital

location_facility: Allgemeines Krankenhaus - Universitatskliniken

location_facility: Academisch Medisch Centrum at University of Amsterdam

location_facility: Hospitais da Universidade de Coimbra (HUC)

location_facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center

location_facility: Centre Hospitalier Regional et Universitaire de Lille

location_facility: McGill Cancer Centre at McGill University

location_facility: Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A.

location_facility: Azienda Sanitaria Ospedaliera Ordine Mauriziano

location_facility: Universitair Medisch Centrum St. Radboud - Nijmegen

location_facility: Clatterbridge Centre for Oncology NHS Trust

location_facility: Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital

location_facility: Hospital Universitario Central de Asturias

location_facility: Haukeland Hospital - University of Bergen

location_facility: Karolinska University Hospital - Huddinge

location_facility: British Columbia Cancer Agency - Vancouver Cancer Centre

location_facility: Cazk Groeninghe - Campus Maria's Voorzienigheid

location_facility: Akademisch Ziekenhuis Vrije Universiteit - Medisch Centrum

location_facility: Mount Vernon Cancer Centre at Mount Vernon Hospital

location_facility: Libero Istituto Universitario Campus Bio-Medico

location_facility: Academisch Ziekenhuis der Vrije Universiteit Brussel

intervention_type: Procedure


title: Autologous Peripheral Blood Stem Cell Transplantation (PSCT) Versus a Second Intensive Consolidation Course After a Common Induction and Consolidation Course in Patients With Bad Prognosis Myelodysplastic Syndromes (MDS) and Acute Myelogenous Leukemia Secondary (SAML) to MDS of More Acute Than 6 Months Duration

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer 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: Randomized phase III trial to compare the effectiveness of peripheral stem cell transplantation with high-dose cytarabine in treating patients with myelodysplastic syndrome or acute myelogenous leukemia.

ReferenceCitation: de Witte T, Hagemeijer A, Suciu S, Belhabri A, Delforge M, Kobbe G, Selleslag D, Schouten HC, Ferrant A, Biersack H, Amadori S, Muus P, Jansen JH, Hellström-Lindberg E, Kovacsovics T, Wijermans P, Ossenkoppele G, Gratwohl A, Marie JP, Willemze R. Value of allogeneic versus autologous stem cell transplantation and chemotherapy in patients with myelodysplastic syndromes and secondary acute myeloid leukemia. Final results of a prospective randomized European Intergroup Trial. Haematologica. 2010 Oct;95(10):1754-61. doi: 10.3324/haematol.2009.019182. Epub 2010 May 21.

location_country:
Croatia
Italy
Netherlands
Czech Republic
Switzerland
Sweden
France
Belgium
Germany

location_facility: Institute of Hematology and Blood Transfusion

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: University Hospital - Rotterdam Dijkzigt

location_facility: Hopital Cantonal Universitaire de Geneva

location_facility: Universitaetsklinik und Strahlenklinik - Essen


title: A RANDOMIZED PHASE III TRIAL COMPARING DEXAMETHASONE WITH PREDNISONE IN INDUCTION TREATMENT AND BONE MARROW TRANSPLANTATION WITH INTENSIVE MAINTENANCE TREATMENT IN ADOLESCENT AND ADULT ACUTE LYMPHOBLASTIC LEUKEMIA (ALL-4)

summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells. Bone marrow transplantation can replace immune cells that were destroyed by chemotherapy.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy compared with or without bone marrow transplantation in treating patients with acute lymphoblastic leukemia.

ReferenceCitation: Reman O, Pigneux A, Huguet F, Vey N, Delannoy A, Fegueux N, de Botton S, Stamatoullas A, Tournilhac O, Buzyn A, Charrin C, Boucheix C, Gabert J, Lhéritier V, Vernant JP, Fière D, Dombret H, Thomas X; GET-LALA group. Central nervous system involvement in adult acute lymphoblastic leukemia at diagnosis and/or at first relapse: results from the GET-LALA group. Leuk Res. 2008 Nov;32(11):1741-50. doi: 10.1016/j.leukres.2008.04.011. Epub 2008 May 27.

ReferenceCitation: Tavernier E, Le QH, de Botton S, Dhédin N, Bulabois CE, Reman O, Vey N, Lhéritier V, Dombret H, Thomas X. Secondary or concomitant neoplasms among adults diagnosed with acute lymphoblastic leukemia and treated according to the LALA-87 and LALA-94 trials. Cancer. 2007 Dec 15;110(12):2747-55.

ReferenceCitation: Dhédin N, Dombret H, Thomas X, Lhéritier V, Boiron JM, Rigal-Huguet F, Vey N, Kuentz M, Reman O, Witz F, Delannoy A, Kovacsovics T, Bradstock K, Charrin C, Boucheix C, Gabert J, Blaise D, Fière D, Vernant JP. Autologous stem cell transplantation in adults with acute lymphoblastic leukemia in first complete remission: analysis of the LALA-85, -87 and -94 trials. Leukemia. 2006 Feb;20(2):336-44.

ReferenceCitation: Picard C, Hayette S, Bilhou-Nabera C, Cayuela JM, Delabesse E, Frenoy N, Preudhomme C, Dupont M, Bastard C, Bories D, Vaerman JL, Davi F, Dastugue N, Raynaud S, Lafage M, Deschaseaux F, Fest T, Gaub MP, Lhéritier V, Thomas X, Charrin C, Boucheix C, Dombret H, Macintyre E, Fière D, Gabert J. Prospective multicentric molecular study for poor prognosis fusion transcripts at diagnosis in adult B-lineage ALL patients: the LALA 94 experience. Leukemia. 2006 Dec;20(12):2178-81. Epub 2006 Oct 12.

ReferenceCitation: Charrin C, Thomas X, Ffrench M, Le QH, Andrieux J, Mozziconacci MJ, Laï JL, Bilhou-Nabera C, Michaux L, Bernheim A, Bastard C, Mossafa H, Perot C, Maarek O, Boucheix C, Lheritier V, Delannoy A, Fière D, Dastugue N. A report from the LALA-94 and LALA-SA groups on hypodiploidy with 30 to 39 chromosomes and near-triploidy: 2 possible expressions of a sole entity conferring poor prognosis in adult acute lymphoblastic leukemia (ALL). Blood. 2004 Oct 15;104(8):2444-51. Epub 2004 Mar 23.

ReferenceCitation: Boissel N, Auclerc MF, Lhéritier V, Perel Y, Thomas X, Leblanc T, Rousselot P, Cayuela JM, Gabert J, Fegueux N, Piguet C, Huguet-Rigal F, Berthou C, Boiron JM, Pautas C, Michel G, Fière D, Leverger G, Dombret H, Baruchel A. Should adolescents with acute lymphoblastic leukemia be treated as old children or young adults? Comparison of the French FRALLE-93 and LALA-94 trials. J Clin Oncol. 2003 Mar 1;21(5):774-80. Epub 2003 Mar 1.

ReferenceCitation: Labar B, Suciu S, Willemze R, Muus P, Marie JP, Fillet G, Berneman Z, Jaksic B, Feremans W, Bron D, Sinnige H, Mistrik M, Vreugdenhil G, De Bock R, Nemet D, Gilotay C, Amadori S, de Witte T; EORTC Leukemia Group. Dexamethasone compared to prednisolone for adults with acute lymphoblastic leukemia or lymphoblastic lymphoma: final results of the ALL-4 randomized, phase III trial of the EORTC Leukemia Group. Haematologica. 2010 Sep;95(9):1489-95. doi: 10.3324/haematol.2009.018580. Epub 2010 Apr 7.

ReferenceCitation: Le QH, Thomas X, Ecochard R, Iwaz J, Lhéritier V, Michallet M, Fiere D. Proportion of long-term event-free survivors and lifetime of adult patients not cured after a standard acute lymphoblastic leukemia therapeutic program: adult acute lymphoblastic leukemia-94 trial. Cancer. 2007 May 15;109(10):2058-67.

ReferenceCitation: Tavernier E, Boiron JM, Huguet F, Bradstock K, Vey N, Kovacsovics T, Delannoy A, Fegueux N, Fenaux P, Stamatoullas A, Tournilhac O, Buzyn A, Reman O, Charrin C, Boucheix C, Gabert J, Lhéritier V, Vernant JP, Dombret H, Thomas X; GET-LALA Group; Swiss Group for Clinical Cancer Research SAKK; Australasian Leukaemia and Lymphoma Group. Outcome of treatment after first relapse in adults with acute lymphoblastic leukemia initially treated by the LALA-94 trial. Leukemia. 2007 Sep;21(9):1907-14. Epub 2007 Jul 5.

ReferenceCitation: Vey N, Thomas X, Picard C, Kovascovicz T, Charin C, Cayuela JM, Dombret H, Dastugue N, Huguet F, Bastard C, Stamatoulas A, Giollant M, Tournilhac O, Macintyre E, Buzyn A, Bories D, Kuentz M, Dreyfus F, Delannoy A, Raynaud S, Gratecos N, Bordessoule D, de Botton S, Preudhomme C, Reman O, Troussard X, Pigneux A, Bilhou C, Vernant JP, Boucheix C, Gabert J; GET-LALA Group the Swiss Group for Clinical Cancer Research (SAKK). Allogeneic stem cell transplantation improves the outcome of adults with t(1;19)/E2A-PBX1 and t(4;11)/MLL-AF4 positive B-cell acute lymphoblastic leukemia: results of the prospective multicenter LALA-94 study. Leukemia. 2006 Dec;20(12):2155-61. Epub 2006 Oct 12.

ReferenceCitation: Asnafi V, Buzyn A, Thomas X, Huguet F, Vey N, Boiron JM, Reman O, Cayuela JM, Lheritier V, Vernant JP, Fiere D, Macintyre E, Dombret H. Impact of TCR status and genotype on outcome in adult T-cell acute lymphoblastic leukemia: a LALA-94 study. Blood. 2005 Apr 15;105(8):3072-8. Epub 2005 Jan 6.

ReferenceCitation: Thomas X, Boiron JM, Huguet F, Dombret H, Bradstock K, Vey N, Kovacsovics T, Delannoy A, Fegueux N, Fenaux P, Stamatoullas A, Vernant JP, Tournilhac O, Buzyn A, Reman O, Charrin C, Boucheix C, Gabert J, Lhéritier V, Fiere D. Outcome of treatment in adults with acute lymphoblastic leukemia: analysis of the LALA-94 trial. J Clin Oncol. 2004 Oct 15;22(20):4075-86. Epub 2004 Sep 7.

ReferenceCitation: Asnafi V, Buzyn A, Thomas X, et al.: Impact of immunophenotype and genotype on outcome in LALA94 T-ALLs: toward risk adapted stratification of adult T-ALL. [Abstract] Blood 102 (11): A-67, 2003.

ReferenceCitation: Dombret H, Gabert J, Boiron JM, Rigal-Huguet F, Blaise D, Thomas X, Delannoy A, Buzyn A, Bilhou-Nabera C, Cayuela JM, Fenaux P, Bourhis JH, Fegueux N, Charrin C, Boucheix C, Lhéritier V, Espérou H, MacIntyre E, Vernant JP, Fière D; Groupe d'Etude et de Traitement de la Leucémie Aiguë Lymphoblastique de l'Adulte (GET-LALA Group). Outcome of treatment in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia--results of the prospective multicenter LALA-94 trial. Blood. 2002 Oct 1;100(7):2357-66.

location_country:
Croatia
Portugal
Italy
Netherlands
Czech Republic
France
Turkey
Belgium
Germany
Slovakia

location_facility: Universita Degli Studi di Bari Policlinico

location_facility: Istituto di Ematologia Universita - University di Sassari

location_facility: Maxima Medisch Centrum - locatie Eindhoven

location_facility: Ospedale Gen. Provinciale Santa Maria Goretti

location_facility: Institute of Hematology & Transfusiology, University Hospital


title: A Retrospective, Multicenter, European Study to Characterize the Natural History of Danon Disease

summary:
This is a multicenter, international, non-interventional, natural history study designed to collect longitudinal retrospective clinical information on patients with Danon disease (DD). This study is composed of 2 parts:

Feasibility study: to identify participating sites, assess site and team capabilities, confirm the site and investigator qualification for taking part in the study,
Retrospective chart review: Data will be collected retrospectively by means of a chart review of living and/or deceased DD patients with a confirmed lysosome associated membrane protein-2 gene (LAMP2) mutation, and,
For living patients (who have not undergone heart transplantation or placement of a cardiac assist device), availability of at least 6-month cardiology follow-up data,
For living patients who underwent heart transplantation or placement of a cardiac assist device, and for deceased patients, at least 1 MRI or echo assessment prior to heart transplantation/cardiac assist device placement or death.

study_start_date_type: Anticipated

status: Not yet recruiting

study_completion_date_type: Anticipated

study_type: Observational

time_perspective: Retrospective

ipd_sharing: No

lead_sponsor: Rocket Pharmaceuticals Inc.

location_country: Spain Ireland Italy France Czechia

location_facility: IRCCS Burlo Garogolo- Hospital Burlo Garofolo

location_facility: Hospital Clínic de Barcelona - Barnaclínic+

location_facility: Hospital Universitario La Paz - La Paz University Hospital

location_facility: APHP, Hôpital de la Pitié Salppêtrière - Charles Foix

location_facility: Institut klinické a experimentální medicíny (IKEM)- Institute for Clinical and Experimental Medicine

location_facility: Hospital Universitario Virgen de la Victoria- Virgen de la Victoria University Hosptial

location_facility: Ospedale Papa Giovanni XXIII di Bergamo ASST Pap Giovanni XXIII Hospital

location_facility: Hospital Universitario y Politécnico La Fe, Instituto De Investigación Sanitaria La Fe, La Fe University and Polytechnic Hospital

location_facility: University of Florence Dept. of Experimental and Clinical Medicine

location_facility: Hospital Universitario Puerta de Hierro Majadahonda Puerta de Hierro Majadahonda - University Hospital

location_facility: Hospital Universitario de Bellvitge- Bellvitge University Hospital

status_simplified: Ongoing


title: A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.

summary: The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).

status: Recruiting

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

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

lead_sponsor: Novartis Pharmaceuticals

location_country: Hungary Germany France Czechia


title: Outcomes in Patients With Relapse/Refractory Diffuse Large B-Cell Lymphoma Treated With Systemic Therapy From Real-World Experience (ORCHID)

acronym: ORCHID

summary:
Primary Objective:

To evaluate objective response rate (ORR) in adult patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL) who receive systemic treatment after at least 2 prior systemic therapies in the real-world setting according to Lugano classification of malignant lymphoma (Cheson, 2014) and as assessed by independent central review

Secondary Objectives:

To evaluate the following outcomes in adult patients with r/r DLBCL who are treated with currently available therapies in the real-world setting:

ORR according to Lugano classification and as assessed by treating physician evaluation

Complete Response (CR) rate according to Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation

Progression Free Survival (PFS) according to Lugano classification and as assessed by:

Independent central review, and
Treating physician evaluation
Overall Survival (OS)

Duration of response (DOR) according to Lugano classification and as assessed by

Independent central review and
Treating physician evaluation

Disease control rate (DCR) according to Lugano classification and as assessed by:

Independent central reviewed
Treating physician evaluation
Time to next treatment (TTNT)

lead_sponsor: Regeneron Pharmaceuticals

location_country:
Austria
Germany
France
United Kingdom